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RF_DIS_17_SUDHA
17th September, 1998
Ref: CHC: 4.5/98
Dr. D.V. Saldhana,
Chairman,
National Blood Transfusion Council,
Ministry of Health,
Nirman Bhavan,
New Delhi.
Dear Dr. Saldhana,
Sub: Blood Bank - draft rules (15th December 1997)
We are happy that the Rules for Blood Banking are being reconsid
ered. We have the following suggestions:
1. Unbanked Directed Bleed. Transfusion
There is great need for blood as a life-saving measure in
villages where there may not be recognized blood banks.
The
only way to save lives (e.g., in rupture of tuboid pregnancy)
is to give blood made available by relatives and volunteers.
Valuable time will be lost, leading to irreversible shock if
the relatives/friends have to go to recognized blood banks in
the cities/towns, collect blood after the necessary tests and
transfer the blood. It is therefore suggested taht we recog
nize the life-saving role of Unbanked Directed Blood Transfu
sion to be carried out by a registered medical practitioner in
emergencies and in situations where delay can threaten life.
2.
Space for Blood Bank
We must have enough space for the proper functioning of
banks but it need not be lavish.
blood
In India, many of the "blood banks" are mainly blood collec
tion and storage banks, without component separation/preparation, except possibly separation of plasma and cells.
The
requirements for such banks will be less than those where
components are separated/prepared.
In the ordinary blood banks, there is no need for:
i. separate rooms for group serology and infectious diseases
serology; one room would suffice;
ii. airconditioning being made mandatory; it may be prefered;
8
2
iii. insisting on 150 sq.m, space. About half that space is
ample to carry out all the articles of our blood bank
(without separation/preparation of components). Insisting
on too much space increases the capital expenditure and
expenses on upkeep.
It must be insisted that the place
(including floor, walls, furniture, etc.) must be kept
scrupulously clean.
3.
Blood. component production centroa
The requirements for the
centres will be larger.
component
separation/production
The supervisory person should be a graduate in Medicine with
further
training
in
Blood
Banking
and
components
separation/production of at least one year in a recognized
institution, with all the necessary facilities.
4. Deferment of. blood donation in case of. haemorrhage. or illness.
It is a sensible idea to defer blood donation in cases of
blood loss. Where there is blood loss of moderate severity,
at least 120 days (4 months) must intervene. This will ensure
safety to the donor. Similar consideration should apply in
cases of illness also.
5.
Voluntary Blood Donation
We must take all steps to root out commercialization of
transfusion.
Buying (professional donors) and selling
(commercial blood banks) should be stopped.
6.
blood
blood
Blood. Donation Camps
Voluntary agencies, who can get the services of recognized
blood banks, should be encouraged to conduct blood donation
camps. This will especially be useful in educational institu
tions (colleges), factories, police camps and various other
places.
Yours sincerely,
Dr. C.M. Francis,
Community Health Cell.
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759 197, D, Shanti Bhuvan,
Prabhat Rd. Lane No. 2, Pune-411 004
Telephone No : 373173 (ofT)
Contact Nos.: 341230,436981,334816
LOK VIDNYAN SANGHATANA
HEALTH COMMITTEE
2.9.98
Co-ordination
Committee
Dear friend.
Greetings from Pune
Dr. Anant Phadke
1
Some of us in Pune (myself, Dr Ashok Kale of NMO,
Convenor
Pathologist
Dr.S.V. Gore of Sevadham TrusOan<i Dr
Tongaonkar of
Dondaicha, Dhule district , have been lobbying against
some of elitist, anti-people existing rules and the new
draft rules related to blood banking. Enclosed herewith
Dr. Praveen Bharatiya
is a consensus note that emerged out of a discussion of
Dermatologist
various experts, convened by the health-committee of the
Lok-Vidnyan Sanghatana. This note gives an idea about
the issue. I hope, you would broadly agree with this
Dr. Arun Phadnis
Gynaecologist
Dr. Mandar Paranjpe
Dr. Sanjeev Gupta
Physician
Dr. Shishir Modak
Paediatrician
Dr. Vinay Kulkami
Dermatologist
Advisory
Committee
note.
This is to request you to send a letter to Dr. D.v.
Saldhana, Chairman, National Blood Transfusion Council,
Ministry of Health, Nirman Bhawan, New Delhi, pointing
out that the proposed draft rules would further drprive
the rural poor from access to blood, by making the blood
or its components unnecessarily more costly and even phy
sically more inaccesible.
Dr. Arun Kinare
Sonologist
You may demd the following »-
Dr. Makarand Paranjpe
Surgeon
1)
Dr.Raghunath Godbole
in
registered Village Blood Transfusion Centres,
legally valid.
Surgeon
Dr. Sanjay Gupte
Gx naccologist
Dr. Shirish Gulawani
Paediatrician
Make Unbanked Directed Blood Transfusion to be done
2)
Scrap the requirement of (a) separate rooms for
group serology, and infectious diseases serology.
(b) air-conditioning the bleding room and the
laboratory, (c) A space of a minimum 150 Sq.metres,
(d) A full time post-graduate medical person to
superwise blood component manufacturing.
.2.
3)
Change on scientific basis, the period of deferement
of blood donation in case of certain illness/condition
of donars.
4)
Make it mandatory for blood banks to print Maximum
Retail Price of the blood on the blood-bag.
You may mention that you endorse/agree with the LokVidnyan note as published in the July-August issue of BODHI.
I am sure, you would certainly find time out of your
busy schedule to send such a letter to Dr. Saldhana. If
many many rural health-organizations oppose these new draft
miles, it is only then that there will be some change.
Please do send me a copy of your letter to Dr. Saldhana.
Last week, there was news in all papers that NGOs, people's
Organization should send their comments to Dr. Saldhana
within two months. By the time this letter reaches you,
almost a month would have already gone.
With best wishes and regards.
Thanking you,
Sincerely yours,
Enc; as above.
( ANANT PHA3KE ) .
Draft Rules for Blood Banks Suggested Modifications
The Health - Committee of the Lok-Vidnyan Sanghatana is a sub-committee of doctors of
the Lok-Vidnyan Sanghatana, a registered body. The Health Committee works for public
interest. It discussed in a specially convened meeting on 27th January 1998, the “draft
rules” of the Drugs and Cosmetics (Amendment) Rules, 1997, as published in the Extra
Ordinary Gazette, of the Central Government of India, dated 15th December 1997.
Different experts - surgeons, obstetricians, physicians, paediatricians, dermatologists,
haematologists blood-transfusion officers, community health experts, pathologists and
other doctors participated in this meeting.
The overall opinion of this group of experts about these draft rules was that some of the
provisions in these rules would unnecessarily increase the cost of the blood with hardly
any increase in its quality and that some of the important issues in the blood-transfusion
sector have not been dealt with at all. We deal below, with the latter aspect first.
1. ISSUES MISSING IN THE DRAFT RULES
1.1
- Unbanked Directed Blood Transfusion (UDBT)
1.11- UDBT - a safe procedure - UDBT involves, first selecting an appropriate donor of
a compatible blood group, carrying out mandatory screening tests (for malaria, syphilis,
HTV, Hepatitis - B) on the donor as well as major and minor cross-matching and then to
transfuse his/her blood to the patient, without storing it in a blood bank.
UDBT is as safe as giving banked blood and was widely practised. After the advent of
blood banks, it has become out of fashion especially in cities, partly because it is an easier
option for a city-based surgeon/physician, as the whole responsibility about safety of the
blood is taken over by the blood banks. But rural surgeons, obstetricians, physicians have
continued to practice UDBT. However, with the onset of HIV-epidemic, UDBT had
stopped, partly because single test kits for HIV-test J were not available in the early
nineties and partly due to official disapproval. Now single test kits for HIV-test are
available and yet the official disapproval for UDBT continues.
1.12 - Advantages of UDBT-
UDBT has several advantages over banked blood i) It avoids the metabolic problems caused by storage of blood e.g. (hyper kalemia,
depletion of 2-3 DPG levels and hence oxygen carrying capacity) as well as avoids
depletion of platelets and coagulation factors, which are necessary in certain cases.
ii) It makes blood available to the patient at the earliest; saves precious human power,
time (up to 6-8 hours) travel-costs, loss of wages for the relative who has to go to the
city to fetch blood.
1
iii)
It avoids commercial donors. Though commercial donors have been banned, if a
villager is asked by the blood-bank to bring a replacement donor, the villager would
resort to the commercial donor hovering around the blood bank, as s/he has no friends,
relatives in the alien city, to give replacement donation. UDBT would avoid this
scenario and would be one of the chief measures to stop commercial blood donation.
1.13- Blood Transfusion Centres for UDBT Given the safety and the advantages of UDBT, it should be explicitly legalized and
controlled. We propose the following -
There should be a section in the Drugs and Cosmetics (Amendment) Rules 1977, on
UDBT. This section should lay down the requirements and the procedure to be complied
with for setting up of Unbanked Directed Blood Transfusion Centres (UDBTCs).
There is a precedence of legal Medical Termination of Pregnancy Centres (MTP-centres)
under certain conditions.
The hospital applying for UDBT registration should have a qualified doctor who is also
trained / has the experience of working as a Blood Transfusion Officer in recongnised
Blood banks for say a month, so that s/he has sufficient experience in matching and cross
matching ofblood and the aseptic precautions needed for collecting blood.
The UDBTC need not have its own laboratory to do the mandatory screening test on the
donor. But a qualified pathologist’s test-report, done within say 48 hours prior to blood
transfusion certifying that the tests for all the 4 blood-borne, infectious diseases are
negative must be given. The report should also specify the haemoglobin level and blood
group of the donor. This report should be mandatory.
The UDBTC should be required to keep record in an approved format specifying name,
age, sex, address, and results of the blood-tests etc. This record should be available for
inspection by the concerned officials.
2. Testing the donor’s blood before bleeding Under the existing protocol, a donor’s blood sufficient for blood transfusion is collected
and then the mandatory screening tests are done on a sample from this collected blood. If
any of the tests turns out to be positive, this blood is naturally rejected. But in the process,
the drawn blood is wasted. A better option would be to test the donor’s blood first and
bleed him/her only if all the tests are negative. This would avoid unnecessary wastage of
blood. The donor must be tested within a week preferably within 48 hours prior to
bleeding, so that the chances of the donor getting infected within these two to seven days
are minimal. It may be pointed out that testing any way is not fool - proof, especially in
view of the ‘Window Period’ and there is no point in wasting blood in the pursuit of the
unattainable mirage of zero-risk blood.
2
We, therefore, propose that the following be inserted as clause 1 in section K, in the draft
rules titled ‘Testing of Whole Blood’.
1 Mandatory screening tests to detect common blood-borne infectious diseases and tests
for Hb-Ievel, blood-group of the donor may be conducted within a week and preferably
within 48 hours before bleeding the donor. .The donor should be bled if his/her blood is
found suitable after these tests.
Existing sub-clause 1,2,3 in section K in the draft-rules would become sub-clause 2,3,4
respectively.
It may be pointed out that the existing rules focus attention exclusively on the on the
product, i.e. the blood stored in the pack. By allowing the tests to be done on the donor’s
blood before collecting it in the pack, safety or responsibility is not compromised. If the
basic aim of making rules is achieved, flexibility must be allowed and a blinkerd view
should be avoided.
3. Honouring the Blood Donation Cards Blood donation cards given to voluntary donors are honoured only by the same institution
and not by others. The donor later on may require blood in some other area or institution
and feels frustrated when s/he can not get blood when needed, even after having donated
blood earlier, in many cases several times. This dampens the tendency to donate blood
regularly and people prefer to donate only when a specific need arises in their family or
against friends.
There is absolutely no rationale for not honoring the donor - cards of other blood banks,
since the blood bank doesn’t incur any loss in doing so. All the expenses of testing and
banking are borne by the patient. The blood-bank gets blood free and hence does not incur
any loss by honouring the donor-card of any other blood bank.
We therefore propose that these should be a clause in the draft rules making it mandatory
for blood banks to honour the donor-cards of other blood-banks. (This will be of course
subject to the availability of suitable blood in the bank at that time.)
4) EXEMPTION FOR AUTOLOGOUS BLOOD TRANSFUSION (ABT)
ABT is the safest mode of blood transfusion and is the most preferred mode whenever
feasible for planned surgery. In section 122-EA, in para a, autologaus blood transfusion
has been defined. But no reference has been made through out the draft rules. In case of
ABT, there is no need to conduct any tests on the blood since the patient’s own blood is
to be transfused back to the patient. This exemption should be specifically granted in
section K of Part XII B of the draft-rules. Similarly, in section M, titled ‘Labels’, a para
should be added.
3
In case of autologous blood transfusion, the label need not contain the group or the results
of screening tests since these tests are unnecessary in such instance. The label shall contain
the classification ‘Autologous Blood Donor.’
2)
MODIFICATIONS NEEDED IN THE DRAFT - RULES -
*
In the interests of the patients and of public health, we feel that the following
modifications are required in the draft - rules -
2.1- Part XIIB, subsection B, titled - Accommodation for a blood bank A total of 150 sq. metres’ space stipulated in this sub-section is excessive. This
unnecessarily increases the overheads without enhancing quality. Good quality blood
banks were operating with lesser space.
Two separate rooms for blood group serology and for testing for blood-transmissible
diseases, is quite unnecessary. Similarly, for smaller blood banks with a turnover of say
less than a thousand bottles per year, a separate stores-cum record room is not needed.
2.12 - This section B specifies that the bleeding room and the laboratory should be airconditioned. This would unnecessarily increase the cost of the blood without enhancing
the quality.
This section should specify that entry to the bleeding room and the laboratory should be
highly restricted & it should have self-closing doors, and that they should be assiduously
kept clean by daily wet mopping of the floor and tables and weekly cleaning of the walls
and the top.
Experience shows that this much precaution is sufficient. Reagents etc. can be stored in a
fridge and there is no need to air-condition the whole laboratory for that purpose. (A.C.
temp, is in any case means higher than 2 to 8°c)
2.2
- Deferment of blood donation -
In section H, the table titled ‘Deferment of blood donation’ specifies conditions afflicting
the donor, for which blood-donation should be defered for the safety of the donor or the
recipient. Some of the restrictions specified in the table are unnecessary and hence
unnecessarily reduce the already limited pool of voluntary donors in India.
4
The table below gives our suggestions along with the rationale, about changes needed in
the draft - rules.
Deferment of blood donations - modifications suggested
Modifications suggested with rationale
No.
Condition
1.
Abortions
Period of
deferment as per
draft-rules
6 months
2.
Minor surgery
3 months
3.
Major surgery
6 months
4.
Typhoid
5.
Breast feeding
6 months after
recovering
6 months after
delivery
2.3
- Tests to be conducted on the donor’s blood -
6 weeks. The average blood loss is 100 to
200 ml. In any case a person can loose
blood up to 300 ml every 3 months without
risk.
No restriction needed. There is hardly any
blood-loss in minor surgery.
6-12 weeks. Effects of surgical trauma are
overcome within this period.
12 weeks after the attack. There is no
rationale for deferment after full recovery.
6 weeks after the delivery. The mother
fully recovers from the stress of delivery.
The stress of breast-feeding is no scientific
bar on blood-donation.
Under section K of the draft-rules, tests for only HIV-1, HIV - II antibodies and for HBs
Ag have been mentioned. This is welcome since tests for malarial parasite and for VDRL
have been found to be of no practical value. Malarial parasite is extremly difficult to detect
and both malarial parasite and spirochaetes die within 48 - 72 hours of stored blood.
VDRL can act as a surogate indicator of sexually transmitted disease including HIV and
may be retained. However, in the section L - (‘Records’) in para 2, the master record
includes these two tests. This inconsistency should be corrected by deleting at least the
test for malaria from this para.
These two tests should be mandatory in case of UDBT since malarial parasites and
spirochaetes in fresh blood can cause infection in the recipient.
2.4
- Blood Donation Camps -
In section II of Part XII, B, the draft rules specify that only designated Regional Blood
Transfusion Centres or Indian Red cross banks or licensed Government blood banks can
organise blood-donation-camps. We propose that any blood bank approved by the
government and which complies with the requirements of holding a blood donation camp
5
as specified in this section 11, should be allowed to hold blood-donation-camps. These is
no reason why a recognised bank should not held a blood-donation-camp.
2.5
- Training of the personnel in charge of Blood Component Manufacturing -
Part XII C, subsection C, gives qualification required for directing and supervising
manufacture of blood components; The provision of One year’s working experience in the
manufacture of blood products/ plasma fractionation is quite necessary. But in the next
para, the draft-rules specify that such a person should have a post - graduate degree in
medicine I microbiology / pathology etc. In our view, these post-graduate qualifications do
not directly enable the person to handle the manufacture of blood-components and a
special training is required for it. An MBBS doctor from a recognised university has
sufficient broad based knowledge to enable him/her to learn directing, supervising blood
component manufacture, by undergoing a year’s training I working experience.
The requirement that at least one of the supervising personnel should be a full-time
employee is also superfluous. Blood-banks with limited output do not require a full-time
medical director / supervisor for blood-component manufacture. We therefore, propose
the following stipulation - “The blood-component manufacturing must take place under
the direct, personal supervision, guidance of the personnel in charge.” If the volume of
work is more, this would mean a full-time job for the supervisory person.
2.6
- Maximum Retail Price (MRP) on the blood pack - label -
Subsection I in part XII C deals with labelling of the blood-pack. It does not mention the
need to mention MRP on the blood-pack. Such mention should be mandatory.
Legally, stored blood I blood component is a manufactured drug and hence its label should
mention MRP as in the case of all other drugs. Such mention is necessary as a blood pack
is today sold at varying prices from Rs. 300 to Rs. 1800 per pack! When MRP is printed,
the blood-bank will have to justify the MRP with the ministry of chemicals and fertilizers.
This would stop the exploitation of the needy, helpless patients.
3. CONCLUSION
The draft rules for blood- banks as specified in the extra-ordinary gazette, of 15lh
December 1997, need the above modifications so that safe blood and blood-components
would be available to ordinary Indians at reasonable rates. In absence of these
modifications, blood would unnecessarily become mere costly, beyond the reach of most
Indians.
It is hoped, that due, serious consideration would be given to the above suggestions. We
would be happy to provide further clarifications to the points made above.
6
rv. x
1 URGENT
Dale : 4th Aug. 2001
Dear Colleagues,
You are aware of our fight for making available safe Blood wherever & whenever
required. Unfortunately our demand to legalise ‘Unbanked Directed Blood
Transfusion (UDBT) has been turned down by the Government & National Blood
Transfusion Council, but because of our efforts, the Government has at least started ’
thinking to meet the peripheral Blood demands & has come out with the idea of
‘Satellite Biood Transfusion Centre' & now published the ‘Draft Rules' to amend the
Blood Banking Rules.
We have to take objections or suggestions to these ‘Draft Rules’ which should reach ■
Delhi Before 16U1 Aug. 2001.
Therefore you have to hurry up and send on your ‘Letter Head’ the suggestions &
objections to Delhi.
I am enclosing the proposed Draft Rules & a genera! outline of objections & .
suggestions.
Yon may modify, add or subtract any of the matter.
On the face of it the Draft Rules appeal' acceptable in toto, but I have been given the
Confidential information that most of the policy makers want that these centres should .
bo run only by Government Agencies, this will deprive most of us working in shall
private hospitals getting these centres & therefore the urgent need to send our
objections.
Please send the letter to concerned authorities with copies to relevant people
immediately.
Thanking you,
. Your sincerely,
Dr. R. R. Tongaonkai'.
President, Association of Rural Surgeons of India,
Dr. Tongaonkar Hospital, Dondaivha, Dist - Dhulu
Pin code - 425 408. Maharashtra
'*?tt
4
0
THE GAZETTE OF INDIA EXTRAORDINARY
part n- s.e 3 ®j
DRAFT RULES
1. (1) These rules may be called the Drugs and OosmeticsfAmendment Rules
2001.
(2) They shall be published in the Official Gazette.
2. In the Drug and Cosmetics Rules, 1945, in Schedule K, after serial number 5A
and entries
relating thereto the following shall be inserted namely
Class of Drugs
“5B. Whole Human Blood I.P.
and/or its components, stored for
transfusion by a First
Referal Unit, Community Health
Centre, Primary Health Centre
and a Hospital
Extent and Conditions of Exemptions
The provision of Chapter IV of the Act and the rules
.
made thereunder which require obtaining of a licence
for operation of a blood bank or processing Whole
Human Blood for components, subject of the . >
following conditions, namely.
1) The First Referal Unit, Community Health •
Centre, Primary Health Centre and/or other ■
Hospital shall be approved after satisfying the
conditions and facilities through inspection.
2) The captive consumption of Whole Human Blood
I.P. or its components in the First Referal Unit,
Community Health Centre, Primary Health Centre
and/or other Hospital shall not be more than 500 •.
units annually.
3) The Whole Human Blood and/or its components
,
shall be procured only from Government Blood
Bank and/or Regional Blood Transfusion Centre ,
licensed for the purpose.
4) The approval shall be valid for a period of two
years from the date if issue unless sooner
suspended or cancelled and First Referal Unit,
Community Health Centre, primary Health Centre
or
the Hospital shall apply for renewal to the State
- •
Licensing Authority three months prior to the date .
of expiry of the approval.
5) The approval shall be automatically deemed to be
■
cancelled if the licence of the Government blood
bank or of the Regional Blood Transfusion Centre
from where the Whole Human Blood IP. or
1
Blood Components procured is cancelled.
6) The First Referal Unit, Community Health
Centre, Primary Health Centre and Hospital shall
have the following technical staff for storage of
Blood or its components
(a) A trained Medical Officer for proper
procurements, storage and matching of blood
■
and/or its components. He/ She shall also be
responsible for identifying haemolysed blood
and ensure non-supply of date expired blood or
its components.
(b) A blood bank Technician with the
qualification and experience as specified in
part XII B of Schedule F or persons having
experience of not less than two years in a
licensed blood bank for blood grouping and
cross matching.
7) 'lhe First Reieral Unit, Community Health
Centre, Primary Health centre and Hospital shall
have a minimum areas of not less than 10 sq.
meters of covered area. It shall well lighted,
clean and preferably air-conditioned. Blood bank
i
refrigerators fitted with alarm device
and
recording thermographs of appropriate capacity
shall be provided to store blood units between 4 C
to 6 C and if the components are proposed to be
stored, specialized equipments as specified in
part XIIB of Schedule F shall also be provided.
8) Tne First Referai Unit, Community Health
I • Centre, primary Health Centre and Hospital shall
i
maintain records and registers including details of
i
procurements of Whole Human Blood I.P. and/or
j
blood components, as required under Part XHB of
Schedule F.
j 9) The First P„eferal Unit, Community Health
I
Centre, primary Health Centre and Hospital shall
■
store samples of donors blood as well as patients
i
sera for a period of seven days after transfusion''.
,
I
|
I
I
i
[No. X-l 1014/3/2001-DMS A. PrAj
j
DEEPAK GUPTA, jt. Secy.
_______________________________________ I__________________________________________________________ *
Foot Note The Principal Rules were published in the Official Gazette vide notification No. F. 28 -10/45-H(!)
dated 21-12-1945 and last-amended vide G-S R. 242 (E) dated 3-4-0! The Drugs and Cosmetics Rules, 1945 as
amended up to 1-5-1979 is contained in the publication of the Ministry of Health and Family Welfare
(Department of Health) containing ths Drugs and cosmetics Act. 1940 (PDGHS-61)
4
ft
Sir, Please also fmd our some more suggestions which are based on our Country
wide studies & detailed study of a District in State of Maharashtra regarding Satellite
Blood Transfusion centres.
A questionnaire was sent to 100 Surgeons/small hospitals working in Rural &
peripheral areas all over the country & 40 Doctors working at periphery
in District
Dhule of Maharashtra were interviewed in October 2000. Out of 100 Rural Surgeons
we received answers fiom 29 surgeons.
We also did detailed study of Dhule JDistrict regarding use of Blood at peripheral
areas in 1998
The outcome & conclusion from these studies were as under
:
1) Across the country from Jammu & Kashmir to Tamiinadu out of 29 respondents
27 were still collecting Blood themselves by what is know as ‘Unbanked Directed
Blood Transfusion’ (UDBT), So also out of 40 Doctors in Dhule District 39 were
doing UDBT.
2) The Satellite Blood Transfusion centre should be placed where UDBT is being
practised.
3)
It should be given to private Doctors also.
4)
All agree that minimum two bottles of each group should be stored at the centre at
a given time
5)
Il should be responsibility of the Govt, or Licensed Blood Bank or Regional
B.T.C. to supply the blood to these centres maintaining the cold chain.
6)
If the blood is not used in time, it should be taken away by the Licensed Blood
Bank or Regional Blood Transfusion centre before its expiry, otherwise it will go
waste.
7)
Tnis centre should have communication & transport facilities.
The argument that the satellite Blood transfusion centre should be given to ‘Private
Smail Hospital’ and where there is a competent ‘Doctor’ who can use the blood
- effectively can vary well be exemplified by the following table, which is taken from
supplement to our Booklet on ‘Unbanked Directed Blood Transfusion’.
❖ Table No. H ❖
Status Of Blood Transfusions Given In Peripheral Areas
Name of Taluka
Blood Transfusions Given
Government Semi-Govt
Private
0
1. Akkalkuva
o
o
l 2. .Akrani
0
0
0
Study not done
3. Dhule
0
795
4. Nandurbar
0
r xr
----- ....
J.
iNavapui
460
0
o
3.68
0
585
6. Sakri
0
3 23
40
212
i 7. Shahada
0
154
2.94
38
0
8. Shindakheda
(154)
(0.35)
(30)
(Dondaicha)
(0)
3.060
118
9. Shirour
0
1.10
0
0
10
10. Taloda
38
40
2334
Total
28.99
Total Blood Transfusions at Periphery
2412
Population
in Lac
1.45
1.08
7.45
2.80
The Chart gives the distribution of blood used is various peripheral Talukas in our
District. In Akkalukuva and Akrani Talukas with combined population of 2.5 Lacs not
a single bottle was used. In TalodaTaluka with population of one Lac ten thousand, only 10 bottles were used. In Navapur Taluka with population of 2.5 Lacs not a
single bottle was used in the Navapur Town but - 460 bottles were used in one centre,
a Christian Mission Hospital placed in a distant village of Chinchapada. In rest of the
Tahikas depending on the availability of competent clinicians Blood was used.
The Notable feature was that of the total 2412 bottles used at periphery only 38 were
used in Govt, sector, 2334 bottles i.e. 97% blood was used in Private sector even
though in each Taluka there is either a Rural or Cottage hospital in Govt, sector. This
emphasises the fact that the Utility of Blood depended not on the population or a mere
presence of a Government Hospital but on the availability of a competent clinician
who could use the blood.
All these facts should be taken in consideration when formulating the Rules &
implementing the policies, regarding “Satellite Blood Transfusion Centre”.
^^Jnha-nccl IFwd: Fw: Blood Transfixion Draft Rules.]
V
»
Subject: [phn-ncc] [Fwd: Fw: Blood Transfusiion Draft Rules.]
Date: Mon, 13 Aug 2001 09:48:06 -t-0500
From: CEHAT <cehatpun@vsnl.com>
To: pha-ncc@yahoogroups.com, mfricndcnclc@yahoogroups.com
SubjScn: 1 ...a: xw: tjcccc. Transfusiion Draft Rules.]
Date; Sat, 11 Aug 2GG1 17:30:29 tO53G
From: CEHAT <cehatpun@vsni.com>
s
To: pha-ncc@yahoogroups.com, mfriendcircle@yahoogroups.com
Dear PHA and mfc members,
I am forwarding a very important letter about the proposed changes in
tils t2.ood—Josm k 2tii2.gs. Pl. S9nd It to tils Hssitli SGOJTstcizry on JooliHlf of
ycziz OcMafkiZaLio?: zz you fosl ziivGa.vGG zn tLxic zsszo.
Sincerely yours,
Ananc Phadke
Subject: Fw: Blood Transfusiion Draft Rules.
n=‘-=- m.-= 7 i-ir.f.’n xnsnn
From: "Dr.R.R.Tongaonkar" <rrtong@sancharnst.in>
To: kashtekareoomG. vsnx. net. in>, <cehatpun@ph3. vsnl. net. in>
-------- Original Message-------From: Dr.R.R.Tongaonkar <rrtong@sancharnet.in>
To: dali_f23@yahco.com <dali_f23@yahoo.com>; drshivde@rediffmail.ccm
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kashoKpkaieSreditfmail.com>; shomik@dte.vsnl.net.m
<shomik@dte.vsnl .net.in>; masalekar. shriramisredif rmail .com
kmasalekar. shriramisrediffmail. com>; baifBvsnl. com <baif@vsnl. com>;
ibp@pnvsnl.net.in <ibp@pnvsnl.net.in>; dhrutis@im.eth,net
<dhrutis@im.eth.n.et>; frchpune@giaspn.01. vsnl. net. in
<frchpune@giaspn01 .vsnl.net. ir>; f rchbom@bom2.. vsnl.net. in
<frchbom@bom2.vsnl.net.in>; zarsol@bom5 .vsnl .net-, in
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<bloodbnk@pn3.vsnl.net.in>; ereubenScclan <ereuben@cclan>;
ashtekaregiasbmul.vsnl.net.in <ashtekar@giasbmul.vsnl.net.in>
Date: 05 Adustos 2001 Pazar 22:02
Subject: Blood Transfusiion Draft Rules.
>From Dr.R.R.Tongaonkar,
President,Association of Rural Surgeons of India,
Dondaicha Dist.Dhule Maharashtra 425408.
ukGm i KnQuc.51.
Dear Colleagues,
This is an urgent work you have to do regarding the New Draft Rules about
'Satellite Blood Transfusion centres.
Please find attached herewith1)
n
^JY
COV92?illCT L9’t’t’92?
OJFormat cf letter you have tc send tc concerned authorities on your letter
head (and/or letter—heads or other organasatxons like IMA,Your
Association,Rotary or similar clubs or NGOs)
3)Draft Rules Published in the Gazette.
4)Additional information I have sent to Delhi besides the "2)Format of
letter"
Please act quickly,Time is very short.
Yours since'rely,'
Dr.R.R. Tongaonkar:
Gc-lP-
™1:35PM
[pha-ncc] [Fwd: Fw: Blood Transfusiion Draft Rules.]
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Safe blood starts
with me
Blood saves lives
World Health
Organization
International Federation
of Red Cross and Red Crescent Societies
FOREWORD
Safe blood starts
with me. Blood saves lives
At the beginning of this new millennium, we should like to ask peo
ple everywhere to safeguard their health by caring for that precious life
source, their blood. Cood nutrition, a clean and healthy lifestyle,
proper prevention and early treat mein of disease all contribute to
healthy blood. We should like to emphasize the importance of man
aging blood properly, at the individual and at the global level.
Throughout the world, people have generously given their blood to
save the lives of others, and they continue to do so. We thank all
blood donors on behalf of those millions of recipients whose lives have
been saved through the gift of blood - a unique gift from one person to
another, where the donor hardly ever hears a word of thanks from the
recipient. We especially express our gratitude to all voluntary, non
remunerated donors who give their blood on a regular basis, thereby
providing the strongest foundation for a safe and sustainable blood
supply.
We invite you to reflect on this year’s World Health Day slogan,
"Safe blood starts with me”. The global community shares a com
mon life source: blood. The needfor voluntary donors is a permanent
requirement - blood is used round the clock, year in year out.
We urge you to think carefully about this slogan, “Safe blood starts
with me”. Each one of us can apply this maxim to our own lifestyle
and thus contribute to a global culture ofquality and a continuous
improvement in critical health-related areas.
Director-General
World Health Organization
Secretary General
International Federation
of lied Cross and Red Crescent Societies
1^0©©^
(Wd© feed]
@(f DofF©
The life force in all human beings, regardless of their colour,
race or belief, flows through their arteries and veins: it is a red
liquid which - depending on whether they are well or ill bears good and bad tidings. Its various components form a
highly developed defence and transport system which gives
and saves life.
Blood is a whole world in itself, each component having a
specific job - red blood cells transport oxygen throughout the
body; plasma transports proteins, including antibodies and
clotting factors, and nutrients like glucose for energy around
the body; white blood cells constitute a defence mechanism
against disease; and platelets ensure that bleeding stops. Blood
also carries waste products from all the organs to be evacuated
from the body.
SJc blood ttlrts
with inc
Some 40-4596 of blood is
made up of red blood cells
which cany oxygen. The
remaining 55-60% is plasma with a
small proportion of white blood cellsfor
defending the body, clotting factors and
Blood is living matter, which can be transfused to save lives.
Serious loss of blood due to an accident or disease can cause
shock. When oxygen is lacking, the brain cannot function and
the heart cannot pump. Blood is also the first life link between
a mother and a child. A person’s health can be determined by
the state of his or her blood, which reveals rhe innermost
workings of the body. Scientists today can diagnose and inves
tigate complex diseases by examining blood. Blood can also
transmit diseases from one person to another.
A healthy person has healthy blood. Healthy blood can and
does save lives.
platelets. All the different components
of blood can be used and each compo
nent plays ait important role in saving
the lives of different individuals in the
community.
The human body mounts its defence through blood. Blood
flows through the various organs and. during its course,
detects the presence of foreign elements and identifies any
change from normal healthy conditions. Internal biological
signals trigger reactions to attacks by viruses and other micro
organisms in order to protect the body. Different kinds of
white blood cells, each with a specific function, attack and
destroy the invaders; blood also transports the waste to other
organs for disposal. Antibodies, which protect from disease
and infection, are present in the plasma.
Since blood reflects the overall state of health of the body,
analysis of the blood can reveal illness and chronic disease.
Illnesses can affect different blood cells, harming the body’s
defence system and sometimes leading to death. In the case
of some genetically transmitted blood diseases, the shape of
blood cells and their functioning are affected.
Sofr blood uarli
with me
The average volume of
blood in an adult is 4-5
*_x
litres, or about 89b of the
This highly developed defence system needs right conditions
in order to function at peak performance. Healthy lifestyles,
adequate nutrition, and good sanitation all contribute to
maintaining every individual’s blood quality as well as global ^1)
blood quality.
body weight. Blood contains 4-5 mil
lion red blood cells per mm', 400011 000 white blood cells per inmJ,
and 150 000-400 000 platelets per
mm'. Red blood cells live for about
120 days and white blood cells normal
ly last 3-9 days. New blood cells are
constantly generated in the body.
4
U/e M 'i&A/ix, l&t wwa
M’ 4^oX-
^©m wmfe to
From the day that human life is conceived, blood fulfils a life
giving and nurturing role. In the womb, the mother’s blood
ensures that the fetus is supplied with crucial oxygen and
nutrients and benefits from the mother’s antibodies against
diseases. Outside the womb, blood has another critical func
tion for the newborn, that of defence against health risks as it
begins to produce its own antibodies.
Around 500 000 women die in childbirth each year, mainly
in the developing world. In some cases, at birth there can be
heavy loss of blood and the mother may suffer distress and
even die. Blood may then be needed for transfusion to save
her life. Many women do not have access to safe blood, and as
a consequence they run the risk of receiving contaminated
blood. If only healthy individuals gave sufficient safe blood
and if all the blood were systematically tested, many women
who die in childbirth could be saved.
^y©Gto
Safe blood suns
Every tunc a person's heart
\ beats, 20% of the heart's
output goes directly to the
brain, carryifig oxygen which
is vitalfor survival. The average person
has 25 million million red blood cells.
A pregnant woman's blood volume
expands by about 45% near the time
The better a mother’s health, the less likely that she will need
blood. Proper care from the outset of pregnancy, identifica
tion of risk factors and, if required, early treatment reduce the
risks and increase the likelihood that transfusion can be
avoided.
of delivery. .Many blood products are
given every minute of the day to people
exposed to risk due to disease
or injury.
Wtetb fe gaff®
b)0©@(o]?
Safe blood is blood that does not contain any viruses, para
sites, drugs, alcohol, chemical substances, or other extra
neous factors that might cause harm, danger or disease to the
recipient. People who donate blood should be in good health
and should not suffer or have suffered from any serious ill
nesses. The recipient should not be harmed by receiving
blood; the donor should not be put at risk by giving blood.
The world relies on safe blood, yet only 20-30% of the
world’s health systems are able to provide a safe and adequate
blood supply. There are a limited number of healthy people
donating blood. Ever.- year, over 100 million blood units are
collected from blood donors. Many millions more are still
needed to fulfil global requirements and ensure availability of
blood when and where it is needed.
Although blood can be screened for infectious agents such as
viruses, it cannot be treated to kill viruses and micro-organ
isms because the red blood cells would be destroyed by the
methods currently available. Supplies of blood tests for
screening blood are sometimes interrupted in poor countries.
Honesty in answering the donor questionnaire and at inter
views is critical for the safety of blood transfusion. Blood
donors take on a remarkable responsibility when offering
themselves as life-savers.
Governments should take every opportunity' to review the
requirements of all health authorities and see that they are
committed to supporting the blood services with sufficient
funding. The health authorities should also ensure
that all necessary safety procedures are available and
in place, are supported financially, and are protect
ed and enforced by national legislation.
8
Safe blood start
*
with me
/ >4
Safety of blood and blood
(
products depends on many
zrJZ '
factors, starting with the
recruitment and recall (at safe intervals)
of voluntary, non-remunerated blood
donors who have been eliminatedfrom
any risk. Safety is ensured by provid
ing clean conditions for blood collection,
appropriate screening of donors, exten
sive testing, proper storage, and appro
priate clinical use of transfusion.
9
b)O©©d
Sale blood sum
with me
Up to 596 ofHIV iiifec-
lions in the developing
at"
world may still be due to
transfusion of HIV-contaminated blood.
Some diseases that affect the lives of millions of people are
caused by viruses passing from one person to another through
the blood. These risks can be decreased by ensuring safe
blood supplies.
The human immunodeficiency virus (HIV), which is carried
in the blood and body fluids, already affects over 33 million
people, causing about 2.5 million deaths each year. In some
countries, one in every four persons carries HIV, which can
be passed to another person during sexual intercourse. The
virus can also be transmitted from mother to child, inside the
womb, or through breastfeeding. Hepatitis viruses, leading to
liver disease and even cancer, can also be transmitted through
the blood.
HIV infection by blood transfusion is
almost 10096 effective in each case.
This can easily be prevented by safe and
sustainable blood programmes.
There are ways to prevent transmission of bloodborne dis
ease. Simple tests can detect the presence of antibodies against
such viruses in a person’s blood. Tests for HIV and hepatitis
viruses and for other infectious diseases are used in many
countries, but still not widely enough. WHO and UNAIDS
have worked with the diagnostics manufacturers to develop
and make available cost-effective, simple and rapid tests to
screen donated blood for infectious disease markers.
Testing of all donated blood should be systematic. This will
result in only safe blood being available for transfusion.
Systems for pre- and post-donation counselling should be
established so that donors, where necessary, can be referred
for further counselling and care.
In addition, safe and appropriate use of injections and skin
piercing procedures should be applied. Whenever possible,
alternatives to injections, such as oral medication, should be
given, and sterile procedures respected in all cases to avoid
transmission of bloodborne pathogens.
10
Some genetic diseases affect the blood, such as haemophilia,
thalassacmia and sickle-cell disorder. Persons with these dis
eases require regular supplies of safe blood to replace their
deficient blood.
Haemophilia, which affects mainly men and occurs in about
I in 5000 male births, is caused by a shortage of clotting fac
tors: when a person is injured, there is a risk of bleeding.
Accurate identification of haemophilia is made by measuring
the level of specific clotting factors in the blood. Blood tests
need to be carried out in a laboratory which has appropriate
facilities and experience with these tests. To date, with com
prehensive care and by using products containing the missing
clotting factors, made from blood donations or biotechnology,
even people with severe haemophilia lead nearly normal lives.
In most developing countries, blood is the only source of
treatment available.
SJc blood '.(arts
with me
fIf every capillary, vein and
artery in a person’s body
ivere lined up end to end,
they would cover a distance of 150 000
kilometres. All the iron in an average
person’s blood could make a
5-centimetre nail; two-thirds of this
iron is in the red blood cells.
In sickle-cell disorder and thalassacmia the red blood cells are
unable to carry enough oxygen. Thalassacmia may lead to
mild or severe anaemia and premature death. Blood transfu
sion is currently the main treatment for thalassaemia, which
gives the person optimal chances of survival; blood is also
needed for patients with sickle-cell disorder.
A strong health service infrastructure is essential to ensure
continued monitoring of populations for the early detection
and treatment of these diseases.
11
(cOS
Many parasites and viruses which affect hundreds of millions
of people worldwide are transmitted from person to person by
bloodsucking insects (vectors), and are then transported in
the body via the blood. These diseases include malaria, filaria
sis, dengue fever, Chagas disease, leishmaniasis and African
sleeping sickness. Some of these diseases cause severe anaemia
or blood loss and may require the use of blood products or
transfusions in order to save lives. Malaria, which affects some
300 million people a year, may cause miscarriages, stillbirths
or underweight, anaemic children.
Simple preventive measures such as sleeping under a bed net
can provide protection against night-biting malaria mosquitos
and from carriers of certain other insect-transmitted diseases.
Appropriate insecticides, good environmental sanitation to
reduce vector breeding places, and biological control methods
are commonly used to combat these diseases.
Schistosomiasis and the hookworms are worm infections,
affecting some 1400 million people worldwide. Both diseases
cause blood loss, resulting in damage to tissues and anaemia.
Cost-effective drugs exist to treat these infections effectively
and safely, thereby reducing the need for blood and blood
products. It has been demonstrated that regular treatment of
women and children with anthelminthic drugs in endemic
areas increases their haemoglobin levels.
12
(<s©©(q] [rfl©©D^[ki
Good health depends on lifestyle and disease prevention.
Eating a balanced diet with an adequate vitamin and micro
nutrient supply, keeping a clean environment, and avoiding
risk situations help to keep people, and their blood, healthy.
A healthy society means more safe blood and a reduced need
for blood transfusions.
Safe biood iun»
with me
Red blood cells werefirst
Iron-deficiency anaemia is one of the most widespread
micronutrient deficiencies in the world. It affects about 50%
of pre-school-age children and pregnant women in developing
countries. In children, it affects growth and impairs cognitive
performance. In pregnant women, it increases the risk of dis
eases and maternal mortality. Additional iron in the form of
iron supplements combined with a diet containing iron-rich
food can improve iron status.
described in 1658. Over
—
250 years later, thefirst
four human blood groups, .4, B, /IB
and O, were identified, followed by the
Rhesus (Rh) factor which separated
people into Rh positive and Rh nega
tive. Today, experts can determine
blood groups very precisely, with over a
hundred subtypes.
Cancer patients are frequently recipients of blood transfusions,
especially in industrialized countries. Reducing the overall
number of cancer patients through prevention measures would
reduce the need for heavy treatment schedules and thus the
need for transfusions. This would have many benefits includ
ing an overall gain in health and quality of life, and in eco
nomic terms as well.
Education, from primary schools onwards, plays an important
part in maintaining a healthy society and promoting risk-free
behaviour, and in cultivating positive attitudes towards volun
tary, non-remunerated blood donation. Raising people’s
awareness about the importance of unpaid blood donation
should increase the number of regular, safe blood donations.
Safe Hoed aarts
with roe
Transfusion was used
during the First World War
(1914-18) when blood was
transported to the battlefront in modi
fied, clean, sterilized milk bottles. The
first mobile blood bank was set up in
the 1930s during the Spanish civil war.
The need for an effective health service is felt most during
emergencies of any kind, whether war. natural disasters, largescale accidents or human conflicts. Yet. it is at such times that
the system often breaks down, being unable to cope with the
magnitude of the demand. Internal conflicts or war may
destroy hospitals and clinics, while power shortages often dis
rupt their work and can ruin medical stocks that require
refrigeration, including blood. Caring for large numbers of
wounded people puts an added burden on already strained
systems.
Whenever such events occur, the need for blood donation and
transfusion services increases. Many people spontaneously
donate blood during a crisis, but when the crisis is over, the
countries are left without a sustainable blood supply. Such
situations can be avoided by setting up systematic and efficient
blood services with lists of regular donors.
Safe blood starts
uithme
Blood can safely be donated by a healthy person
three orfour times a year.
After each withdrawal of blood it takes
36 hours for the body to reconstitute
thefluid volume and 21 days for the
blood cell count to return to a normal
level. Blood donors are key players in
medical and surgical treatment, and
save their communities millions of dol
lars.
routine or while travelling, with the loss of blood in life
threatening quantities. It is therefore in everyone’s interest to
have safe blood supplies available worldwide.
Thanks to the people who give safe blood anonymously, lives
arc saved. All blood donors must know that they can save lives
only if the blood given is safe (that is, free of infection).
Likewise, each person should understand that when giving
unsafe blood (disease-carrying) he or she will be responsible
for transmitting potentially life-threatening infection to, and
even killing, another person.
Experience has shown that the safest donor is one who gives
blood at least twice a year without receiving money or goods
in exchange, understands the principle of altruism, answers
questions for donor selection honestly, and will defer or
exclude him/herself from donation if there is any risk to the
recipient.
Governments and health authorities must put into place sys
tems for the proper selection and deferral/exclusion of poten
tial donors so that only safe blood is collected, and for the test
ing of all donated blood. These systems will include effective
infrastructures to collect, process and store the blood; training
for health care workers to deliver blood in sterile conditions;
and promotion and implementation of appropriate clinical use
of blood.
An individual in need ofblood should receive blood that is as
safe as possible: it is the privilege of an individual to give safe
blood.
An integrated national health policy should aim at self-suffi
ciency in blood supplies, an important component of which is
blood safety. In many countries, access to health services pro
viding safe blood, diagnostic imaging and laboratory services,
and appropriate medical practices is limited. More than 60%
of the world’s population lacks access to these basic require
ments. The need for a safe and adequate blood supply requires
the commitment and support of the national health author
ities, various organizations, blood donors, specialist labora
tories, and blood and blood product service infrastructures.
A comprehensive strategy to ensure safe blood will include:
Thefirst recorded blood
transfusion into a vein or
P
commitment and support for a comprehensive blood pro
gramme by the national health authorities;
lists of voluntary, non-remunerated blood donors from
low-risk populations;
high priority to eliminate family, replacement and paid
blood donor systems;
screening of donated blood and blood products to avoid
transfusion-transmitted infections;
safe injection technique;
safe and appropriate clinical use of blood;
implementation of quality control systems throughout the
blood chain;
education of physicians, health workers, and the commu
nity at large.
artery took place in France
in 1667 - and was unsuccessful. A
cupful of lamb's blood was transfused
into a man via a silver tube. The man
survived two transfusions and then
died. It was only in the twentieth cen
tury that blood transfusions became safe
medical practice.
46
©fF [bD©©(o]00o
In many cases, blood transfusion may not be the most appro
priate, cost-effective or safe therapeutic intervention. It is
important to minimize the number of inappropriate blood
transfusions through the effective clinical use of blood or
blood products and the assessment of existing alternatives.
This implies a respect for the use of blood, which should only
be transfused if no alternative treatment is possible.
WHO recommends three key strategies:
• Developing national guidelines for giving transfusions
• Training people who prescribe blood to avoid unnecessary
or inappropriate transfusions
• Ensuring accessibility and availability of volume replace
ment fluids, such as crystalloids and colloids, for use where
appropriate.
Safe blcid JUrtt
with me
fCrystalloids and colloids
arc used to restore blood
volume when there arc
enough red blood cells circulating, but
not enough fluid (plasma).
Crystalloids are a sterile salt solution
which can be used for fluid replacement
without harming the cells or the tis
sues. Colloids are sterile, complex
sugar solutions which can remain
longer in the circulation.
To date, there is no available man-made substitute for red
blood cells. Although considerable progress has been made in
both preventive and curative blood-derived products, red
blood cells remain a rare commodity.
Progress in technology has made it possible to separate all the
components of blood and to store them at temperatures
which are best suited to maintain their viability.
Biotechnology research has increased our knowledge and
enables some of the different components of blood to be
identified and purified. Research is continuing into new
blood-derived products and technologies.
Blood tests have become more sophisticated and are
faster and more cost-effective, yet in many coun
tries blood is still not screened systematically.
More resources have to be identified and allocated
to ensure continuous screening programmes.
18
M gD@b©D ©©§©©©§©
"£© Id© © j©©l
Blood, the life source that flows in every person, can be
shared to help others. Blood saves lives; safe blood begins
with each one of us. This unique resource upon which all
lives are dependent can be shared. It is up to each and every
one of us, as global citizens, to help others.
Contact your local blood transfusion service if you are healthy
and can donate blood, and commit yourself to helping an
other person by donating blood regularly.
Safe blood ttaru
with me
What you can do!
People around the world need blood.
How often luwe you seen a situation where you wondered what
YOU can do to help!
You CAN think about giving blood and take positive steps to see
whether you are eligible to give blood. Contact your local blood
transfusion service/blood bank.
If you have already given blood, become a regidar/repeat donor.
Advocating
safe blood
services
and
systems
In 1975, the World Health Assembly
passed a resolution (WHA28.72) urg
ing Member States of WHO:
w
a) to promote the development of
national blood services based on volun
tary non-remunerated donation of
blood;
b) to enact effective legislation govern
ing the operation of blood services and
to take other actions necessary to pro
tect and promote the health of blood
donors and recipients of blood and
blood products.
Safe blood turn
with ntr
Even today, up to 13 mil
lion blood donations glob
ally are not testedfor HI V
and hepatitis B and C viruses. This
occurs mainly in developing countries,
where 80% of the blood supply comes
from paid or replacement donors and
where there are a high number of
infected persons in the donor popula
tion. Wherever blood transfusion ser
vices screen for HIV, counselling for
voluntary testing ofpersons should be
available.
In recent years, the serious threat oflfe'
infection by such agents as HIV and
hepatitis 13 and C viruses to recipients
of blood and blood products has high
lighted the urgency of the need to
develop safe and effective blood trans
fusion services. Underlying the advo
cacy efforts of both WHO and the
International Federation of Red Cross
and Red Crescent Societies is the push
for quality blood transfusion. There is a
global need for more safe blood and
^tainable, comprehensive blood pro
grammes. WHO and the International
Federation recommend that:
• all adults consider whether they are
eligible to donate blood and, if they
are, to become regular donors;
• transfusion therapy should be acces
sible, without discrimination, to all
those in need;
• civic education should be taught in
schools at all levels and include edu
cation on blood donation;
^lealth authorities should implement
strategics and programmes of educa
tion and promotion for preventive
health care, provide alternatives to
blood for volume replacements, and
provide access to essential drugs
which may reduce the need for
transfusion;
• all blood supplies should be system
atically tested prior to use;
• blood transfusion services should be
allocated sufficient funds to imple
ment training programmes for
developing quality systems and to
maintain sustainable systems;
• all blood programmes of the
International Federation of Red
Cross and Red Crescent Societies
should be familiar with the quality
concepts and the Federation’s qual
ity manual, and become advocates
for developing quality systems in
blood centres;
• in a true spirit of capacity-building,
special assistance should be given to
develop strong blood programmes
systematically in countries that are
in most urgent need of a safe and
sustainable blood supply.
World Health
Organization
Internationa’ Federation
of Red Cross and Red Crescent Societies
For more
information...
AFRICA_______________________________
The World Health Organization
Regional Office for Africa (AFRO)
Parirenyatwa Hospital
P.O. Box BE 773
HARARE
Zimbabwe
Tel.: (001) 4.70.69.51 or 4.70.74.93
Fax: (001) 4.79.01.46
Email: regafro@whoafr.org
Website: www.whoafr.org/
AMERICAS____________________________
The World Health Organization
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Safe blood starts
with me
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J
Safe blood starts
wfith me
BO©©©] saves Boves
World Health
Organization
Injection
Safety
WORLD HEALTH ORGANIZATION
AIDE-MEMOIRE
tW G
’A:"
. i'T i>@ SS/ife
appropriate use of injections
A safe injection does not harm the recipient, does not expose the
provider to any avoidable risks and does not result in any waste
that is dangerous for other people.
Worldwide, each year, the overuse of injections and unsafe
injection practices combine to cause an estimated 8 to 16 million
hepatitis B virus infections, 2.3 to 4.7 million hepatitis C virus
infections and 80,000 to 160,000 HIV infections
.
*
Among unsafe
practices, the re-use of syringes and/or needles without
sterilization is of particular concern.
Injection-associated transmission of bloodborne pathogens can be
prevented through the development of a strategy to reduce
injection overuse and achieve injection safety and its
implementation by a national coalition, with the assistance of a
coordinator.
The three elements of a strategy for the safe and appropriate use
of injections are described in detail overleaf:
□ Behaviour change among patients and healthcare workers to
decrease injection overuse and achieve injection safety
E The availability of necessary equipment and supplies
□ The management of sharps waste.
Words of advice
■ Conduct an initial assessment
■ Secure government commitment and support for the safe
and appropriate use of injections
■
Establish a national injection safety coalition,
coordinated by the Ministry of Health
■
Develop a national policy and plan
■
Develop a systematic strategy for behaviour change
among patients and healthcare workers to decrease
injection overuse and achieve injection safety
■
Ensure the continuous availability of injection equipment
and infection control supplies
■
Set up a waste management system for the safe disposal
of sharps
■
Monitor the impact of activities on injection frequency,
injection safety and injection-associated infections
• Kane A el al. Bull World Health Organ 1999; 77: 801-807.
National policy on the safe and
appropriate use of injections
□
□
□
□
□
□
Assessment of injection practices
Coordination of injection safety
Multidisciplinary national coalition
National policy and plan
Costing, budgeting, and financing
Three-point strategy for the prevention
of unsafe injection practices
□ Monitoring and evaluation
Behaviour change
□ National behaviour change strategy
□ National standards for injection safety
□ Incorporation of safe injection practices
into minimum standards of care
□ Promotion of safe technologies
□ Promotion of rational use of injections
□ Other components of behaviour change
Equipment and supplies
□ Auto-disable (AD) syringes for
immunization
□ Appropriate types of syringes and
needles for curative care
□ Norms and standards for equipment
□ Central bulk procurement, including
safety boxes
□ Central management of storage
□ Efficient distribution system
Management of sharps waste
□ Policy for sharps waste
□ Assessment of waste management
system
□ Selection of appropriate waste disposal
systems
□ Regulatory framework
□ Adequate resources
□ Implementation of waste management
system
□ Training and supervision
Key elements
National policy on the safe and appropriate use of injections
It is the responsibility of
governments to ensure the safe
and appropriate use of injections.
The coalition should be coordinated
by a Ministry of Health team and
should receive political support,
adequate funding and trained staff.
Important activities include:
□ Initial assessment of injection
frequency, breaks in injection
safety and adverse events
associated with injections,
including a behavioural and
systems analysis
□ Establishment of an injection
safety unit to coordinate
departments of the Ministry of
Health, including health
promotion, immunization,
family planing, essential drugs
programmes, healthcare service
delivery, nosocomial infections,
blood transfusion service and
waste management
□ Establishment of a national
coalition, including WHO,
universities, non-governmental
organizations, behaviour change
specialists and associations
(e.g. consumers, public and
private healthcare workers,
traditional practitioners)
□ Development of a national
policy and plan (including
costing, budgeting, and
financing) by the national
coalition, within the Ministry of
Health's overall plan of action
□ Prevention through behaviour
change to reduce injection
overuse and achieve injection
safety; provision of sufficient
quantities of injection
equipment and infection
control supplies; and
management of sharps waste
□ Monitoring of the impact
through process indicators
(injection frequency and
injection safety) and outcome
indicators (incidence of
injection-associated infections,
rational use of injections)
Behaviour change
Equipment and supplies
Management of sharps waste
The foundation for the safe and
appropriate use of injections is a
behaviour change strategy targeting
consumers as well as public, private
and lay healthcare workers.
Important activities include:
□ Development of a national
communication and behaviour
change strategy on the basis of
behaviour and systems analysis
a Definition of national standards
for safe injection practices
H Incorporation of injection safety
into minimum standards of
care
□ Promotion of safe technologies
□ Promotion of the rational use of
injections within essential drug
programmes (e.g. restriction of
unnecessary injectable drugs)
and with the private sector
E Addressing issues that may
lead to poor injection practices,
including attitudes, emotions,
incentives, beliefs, power
relationship, norms and
systems
Eradication of the re-use of syringes
and needles without sterilization
requires the continuous, sufficient
availability of injection equipment
and infection control supplies in all
healthcare facilities.
Important activities include:
□ Adoption of auto-disable
(AD) syringes for
immunization
□ Selection of appropriate types
of syringes and needles for
curative care (sterilizable,
disposable or auto-disable)
□ Enforcement of international
norms and standards by the
national regulatory authority
□ Central bulk procurement of
injection equipment and
infection control supplies,
including safety boxes
□ Central management of storage
□ Efficient distribution system to
ensure continuous, sufficient
availability in all healthcare
facilities nationally
The efficient, safe and
environmentally-friendly
management of sharps waste is the
only means of ensuring that
disposable syringes and needles
are not re-used and do not lead to
accidental needlestick injuries.
Important activities include:
□ Formulation of a policy stating
that disposal is part of the
syringe lifecycle and that
healthcare services have a duty
to manage sharps waste
□ Assessment of the waste
management system, including
expressed and real needs
□ Selection of appropriate waste
disposal systems for all levels
of healthcare facilities
□ Implementation of a regulatory
framework
□ Identification of human and
financial resources required
□ Implementation of a waste
management system
□ Training and supervision
The achievement of this goal
requires the establishment of a
national multidisciplinary
coalition involving different
departments of the Ministry of
Health and other stakeholders,
such as non-governmental
organizations and associations,
and private healthcare providers.
Additional information on the safe and appropriate use of injections can be obtained on the World-Wide Web at
www.injectionsafety.org and on the Safe Injection Global Network internet forum at sign@who.int
Secretariat of the Safe Injection Global Network
Department of Blood Safety and Clinical Technology
World Health Organization
20 Avenue Appia, CH-1211 Geneva 27, Switzerland
Fax: +41 22 791 4836. Email: sign@who.int
Global Database on Blood Safety
Summary Report
1998-1999
World Health Organization
Blood Transfusion Safety
Department of Blood Safety and Clinical Technology
20 Avenue Appia, 1211 Geneva 27, Switzerland
Tel: +41 22 791 4385
Fax: +41 22 791 4836
http://www.who.int/HTP/BCT/BTS
E-mail: bloodsafety@who.int
WHO Global Database on Blood Safety
Following the launch of the Global Collaboration for
Blood Safety, it became apparent that baseline
information was required about blood transfusion
services in Member States to identify the exact nature
of problems and develop appropriate strategies.
Background
Millions of lives are saved each year through blood
transfusions. In most developing countries, however,
people still die due to an inadequate supply of blood
and blood products. This has a particular impact on
women (as a consequence of pregnancy-related
complications), children (malnutrition, malaria and
severe life-threatening anaemia), trauma victims and,
especially, the poor and disadvantaged. It is estimated
that up to 150 000 pregnancy-related deaths each year
could be avoided with adequate transfusion therapy.
The WHO Global Database on Blood Safety (GDBS)
w;is therefore established to obtain data on blood
transfusion services in all Member States of the World
Health Organization, with the following objectives:
♦ To assess the global situation on blood safety
♦ To obtain best available information on blood
transfusion services in each Member State
♦ To identify' problems and needs in order to
provide appropriate technical support
♦ To identify countries for priority assistance
♦ To monitor progress and trends in blood safety.
The emergence of HIV in the 1980s highlighted
the importance of ensuring the safety, as well as the
adequacy, of national blood supplies. In many
countries, even where blood is available, many
recipients remain at risk of transfusion-transmissible
infections (TTIs) as a result of poor blood donor
recruitment and selection practices and the use of
untested units of blood.
A questionnaire, based on the Aide-Memoire, was
developed in 1997 as a tool for the standardized
collection of data from Member States and was sent to
national heath authorities for completion. The status
of blood transfusion services in selected countries was
also assessed during field visits by WO consultants,
whose observations assisted in the analysis of the data.
WHO strategy for blood safety
The World Health Organization (WHO) has identified
blood safety as a health issue requiring high priority
and launched the Global Collaboration for Blood
Safety (GCBS) as a worldwide effort to improve blood
safety' by building on knowledge, utilizing existing
expertise, promoting dialogue and suggesting realistic,
Data analysis
Data was obtained from 175 of the 191 Member States
and was analysed on a regional and global basis.
Since significant differences were revealed between
some countries in the same regions, a common factor
was sought to enable meaningful analysis. The
Human Development Index (HDI), devised by the
United Nations Development Programme (Human
Development Report, UNDP, 1999), satisfied this
requirement.
effective and practical mechanisms.
WHO has developed the following strategy for global
blood safety, which is described more fully in the WHO
Aide-Memoire: Blood Safety.
Organization and management
The establishment of well-organized, nationallycoordinated blood transfusion services with quality
systems in all areas.
The Human Development Index classifies countries
as having a low, medium or high HDI, based on the
following criteria;
0 Life expectancy
♦ Educational attainment
♦ Adjusted income.
Blood donors
The collection of blood only from voluntary non
remunerated donors from low-risk populations.
Blood screening
The screening of all donated blood for transfusiontransmissible infections, including HIV, hepatitis
viruses and syphilis; blood grouping; compatibility
testing; blood processing.
In the majority of developing countries (low and
medium HDI), there is little systematic collection of
data at national level due to a lack of coordination of
blood transfusion services. The data obtained from
these countries was therefore limited to information
from the main centres, usually based in cities.
The clinical use of blood
A reduction in unnecessary transfusions through
tlie appropriate clinical use of blood.
2
Key observations
Global blood supply
Globally, more than 75 million units of blood are
donated each year. Although the majority of the
world's population live in low or medium HDI
countries, around 60% of the global blood supply is
donated in countries with a high HDI, as shown in
Table 1.
Table 1: Global annual blood donations, analysed according to HDI criteria, 1998-1999
Low HDI
countries
(n=41)
Medium HDI
countries
(n=89)
High HDI
countries
(n=45)
Blood supply, in millions of
units and by percentage
1.3m
1.7%
28.9m
38.5%
44.9m
59.8%
Estimated blood donation
rates per 1OOO population
Average
Range
2
0.3-5.3
Average
Range
10
1.7-50.3
Average
Range
40
10.4-74.0
Analysis of the blood supply in
relation to die population reveals
that 83% of the world's population
has access to only 40% of the global
blood supply (Figure 1).
Figure 1: Global population and global blood supply, 1998-1999
The blood donation rate per
1000 population is almost 20 limes
higher in developed countries
(high HDD than in countries with
a low HDI (Map 1).
countries
countries
Map 1: Number of whole blood donations per 1000 population, 1998-1999
Organization and management
commitment and support reported the
implementation of a national blood policy and plan.
In comparison, national policies have been
implemented in only 59% of l°w
medium HDI
countries, particularly those with hospital-based
services. Only 20% of countries reported that all
aspects of a well-organized BTS were in place.
Tlie safety and adequacy’ of the blood supply is
dependent on the commitment of each national
health authority to the establishment of a wellorganized. nationally-coordinated blood
programme. This requires official recognition of
a specific organization with sole responsibility for
blood transfusion services, an adequate budget and
a national blood policy' and plan, supported by
a legislative and regulatory' framework that governs
all activities.
A key indicator of a well-organized and coordinated
national blood programme is a successful programme
for the recruitment and retention of voluntary non
remunerated blood donors. Using this indicator, a
marked difference is evident between countries with a
nationally-coordinated blood transfusion service and
those without, regardless of HDI classification.
GDBS data indicates marked differences globally
in the formulation and implementation of national
blood policies. In the developed world (high HD1),
94% of countries with strong government
Regular, voluntary non-remunerated donors
from low-risk populations are the safest blood
donors. A number of studies have shown that
family/replacement and paid donors have a
higher incidence and prevalence of transfusiontransmissible infections than voluntary non
remunerated donors.
Unfortunately, the World Health Assembly
Resolution has not been translated into reality'
in many low and medium HDI countries since
it was adopted more than 25 years ago, as
indicated by Table 2 and Map 2.
In low and medium HDI countries
less than 40% of blood donations were
from voluntary non-remunerated
blood donors. In contrast, 98% of
donations in high HDI countries were
from voluntary non-remunerated
blood donors.
Blood donors
In 1975, the World Health Assembly passed
Resolution WHA 28.72 urging all Member States
to promote the development of national blood
transfusion services based on voluntary non
remunerated blood donation.
Table 2: Estimated number (in millions) and percentage of donations, by type of donation, 1998-1999
Low HDI
countries
Medium HDI
countries
High HDI
countries
Voluntary non-remunerated donations
0.4m
31%
11.6m
40%
43.9m
98%
Family/replacement donations
0.8m
61%
11.7m
41%
1.0m
2%
Paid donations
0.1m
8%
5.6m
19%
0.03m
n/a
Total donations
1.3m
100%
28.9m
100%
44.93m
100%
4
Map 2: Percentage of voluntary, non-remunerated blood donations, 1998-1999
The analysis clearly illustrates that the lack of a
well-organized blood donor programme based on
voluntary non-remunerated blood donation leads to
dependence on family/replacement blood donors. This
paves the way for a 'hidden' paid and unsafe donation
system since families may pay other's to donate.
the seroprevalence of HIV and other infectious agents,
such as hepatitis B and hepatitis C, is relatively high.
Best practice has shown that, even in high
prevalence areas for infections such as HIV, a wellorganized programme of voluntary non-remunerated
blood donation and effective donor selection
procedures can achieve a low prevalence of infectious
disease markers in the blood donor population. This is
clearly demonstrated by model blood transfusion
services such as those in Zimbabwe (Figure 2) and
South Africa.
Globally, there were about 6 million donations
from paid donors and 13-5 million from family/
replacement donors. Up to 60-70% of donations in
the developing world were given by family/
replacement or paid donors, often in countries where
Figure 2: HIV prevalence in blood donors compared with the general adult population in Zimbabwe,
1998-1999
I
I
HIV prevalence: general adult population
[___ 1
HIV prevalence: new blood donors
I
HIV prevalence: regular blood donors
Blood screening
The WHO strategy for blood safety recommends that
all donated blood should be tested for HIV, hepatitis B
and syphilis. Where feasible and appropriate, all
donated blood should also be screened for hepatitis C,
I
malaria and Chagas disease. Screening for transfusiontransmissible infections, coupled with appropriate
donor selection, has a major impact on reducing the
risk and further spread of these infections.
5
major programme initiatives by the WHO Blood
Transfusion Safety Team, including the GOBS and the
Quality Management Project, and will assist in
monitoring progress, setting priorities and allow for
re-planning of activities to achieve global blood
safety. The data has also been used extensively in the
preparation of WHO guidelines, recommendations,
learning materials and other documents.
available universally; despite a recognition of training
needs in both the developed and developing world.
Globally. /’% of countries cannot meet identified
training needs and many workers remain unfamiliar
with quality1 concepts and the application of quality'
management tools that can improve efficiency
without extra effort or resources.
A new initiative by WHO
Recognizing the need for capacity-building, WHO
initiated the Quality' Management Project (QMP) for
Blood Transfusion Services in 2000.
The Global Database on Blood Safety is a dynamic,
ongoing project. WHO has recently modified the
GDBS questionnaire to widen its scope and it is being
distributed to national health authorities for data
collection for the period 2000-2001.
This global project aims to improve blood safety
through regional training programmes in quality'
management, the establishment of Regional External
Quality Assessment Schemes and the creation of
Regional Quality' Networks.
Acknowledgements
WHO wishes to thank the Ministry of Health and
Welfare, Government of Japan, for its continued
support to the GDBS project.
Conclusions
The invaluable effort of all WHO regional and
country offices, national health authorities, directors
of blood transfusion services and national blood
programme managers is also fully acknowledged.
The data generated from the GDBS has been
invaluable in assisting countries to prioritize their
needs in strengthening their blood safety
programmes. It has also been an important tool for
Copyright © World Health Organization, 2001
This document is issued by WHO for general distribution.
regard of non-infringement of third party proprietary rights.
Thus, WHO does not accept any responsibility or liability in
regard of the reliance on, or use of, such data and information.
The views expressed in this report do not necessarily reflect
the views, decisions or stated policy of WHO.
This document is not a formal publication of the World Health
Organization (WHO), and all rights are reserved by the
Organization. Subject to due acknowledgement to WHO, the
document may, however, be freely reviewed, abstracted,
reproduced or translated, in part or in whole, but not for sale or
for use in conjunction with commercial purposes.
The designations employed and the presentation of the
material in this report do not imply the expression of any
opinion whatsoever on the part of the Secretariat of the World
Health Organization concerning the legal status of any country,
territory, city or area or of its authorities, or concerning the
delimitation of its frontiers or boundaries. Dotted lines on maps
represent approximate borderlines for which there may not yet
be full agreement.
This report is the result of contributions made by various
national health authorities and experts in the field of blood
transfusion safety. The data and information contained herein
are being provided as is and WHO makes no representations or
warranties, either express or implied, as to their accuracy,
completeness or fitness for a particular purpose. Similarly,
WHO does not provide any representations or warranties in
8
WORLD HEALTH ORGANIZATION
Diagnostic
imaging
AIDE-MEMOIRE
for Diagnostic Imaging Services
Diagnostic imaging is a prerequisite for the correct and successful
treatment of at least a quarter of all patients worldwide.
Diagnostic imaging services (DIS) should be:
■ Developed as an integral part of national health care systems,
according to the needs and social and economic structureof the
country; region and area
b Regulated by governments in accordance with international
standards
■ Appropriate to the level of the health care system at which they
are provided
n Appropriate to the therapeutic capabilities that are available.
Approximately two-thirds of patients needing diagnostic imaging can
be diagnosed by' the use of simple X-ray examinations and ultrasound
examinations, either singly or in combination. Every hospital, from
district level to university hospital level, should have the capacity to
perform these techniques.
Checklist
National level
□ Government commitment and
support
□ National plan for diagnostic imaging
services
□ National Radiation Protection
Control Authority
□ National regulations on radiation
protection
□ Specialist DIS advisory groups
□ Inventory and needs assessment
□ Upgrading, repair and maintenance
of existing facilities and
establishment of new services, as
appropriate
Referral hospitals and larger medical institutions should be able to
provide more sophisticated techniques and procedures, in accordance
with local needs.
□ National quality system
Regardless of the type of equipment and procedures used, the following
infrastructure is required.
□ Equipment and procedures relevant
to each hospital’s needs and the
therapeutic capabilities available
1 Trained medical, technical and engineering staff.
2
Radiation protection.
3
Reliable supplies of clean water, electric power, X-ray films,
chemicals and spare parts.
4
Adequate air quality control.
Words of advice
■
Secure government commitment and support for the national
diagnostic imaging programme
■
Establish a National Radiation Protection Control Authority to
develop and enforce national regulations in accordance with
international standards
■
Plan diagnostic imaging services in accordance with national
and local needs and the available therapeutic capabilities
■
Ensure that every hospital has the capacity to perform X-ray
examinations and ultrasound examinations
■
Establish the necessary infrastructure for safe and effective
diagnostic imaging services
■
Establish a national quality system for diagnostic imaging
services
■
Train all medical, technical and engineering staff involved in
diagnostic imaging
Local level
□ Training of all medical, technical
and engineering staff involved in
diagnostic imaging
□ Suitable infrastructure, including
radiation protection, clean water,
stable power supply and air quality
control
□ Adequate and reliable supply of
films, chemicals and spare parts
□ Correct, safe functioning of
equipment
□ Regular maintenance of equipment
by trained technical maintenance
staff
□ Radiation protection
measurements, in accordance with
national regulations
□ Correct image handling,
development of films and
interpretation of examinations
□ Quality assurance and quality
control programme, including
standard operating procedures
Key elements
Develop and maintain diagnostic imaging services
It is the responsibility of governments
to ensure safe and adequate
diagnostic imaging services (DIS) as
part of national health systems. The
operational responsibility may be
divided between governmental and
private institutions, but the overall
responsibility remains with
governments.
Important activities include:
■ The formalization of government
commitment and support
■ Tire development of a national plan
for diagnostic imaging sendees
■ The establishment of a National
Radiation Protection Control
Authority to develop and enforce
national regulations in accordance
with international standards
■ The appointment, when necessary,
of specialist DIS advisory groups
■ An inventory of current availability
and assessment of future needs:
— buildings and facilities
— medical and technical
equipment
-— staff
— education and training
Develop national guidelines and
regulations
within a hospital, region or country,
in accordance with an overall,
national health plan.
A national strategy should be
developed that ensures that diag
nostic imaging services at all levels
adhere to national and international
regulations and standards.
■ National and international regul
ations and guidelines for
radiation protection should be
followed at all times
■ An adequate number of trained
staff should be available, in
accordance with the needs of the
hospital
■ Tire technical and medical quality
of examinations should conform
with generally accepted
international practice and
recommendations
■ Examinations should be
performed in accordance with
medical considerations.
They should also be developed in
close collaboration between national
health authorities and relevant
hospital clinical and technical staff.
Plan appropriate services for
each level of the health care
system
Diagnostic imaging sendees should
be established as an integral part of
each hospital and adapted to local
needs. These will be determined by:
■ TTie type and size of the hospital
■ The number and type of patients:
disease burden, inpatients and
outpatients
■ Therapeutic capabilities.
The structure and capacity of each
diagnostic imaging facility or depart
ment should be based on existing or
planned therapeutic capabilities
Every hospital, from district level to
tertiary level, should have the
capacity to perform:
■ Simple X-ray examinations
■ Ultrasound examinations.
Referral hospitals and larger medical
institutions should be able to provide
more sophisticated techniques and
procedures, including:
■ Specialized X-ray based
techniques, such as:
— Contrast media enhanced
examinations (gastrointestinal
tract, angiography, urography)
— Computed tomography (CT)
— Mammography
— Combined diagnostic and
therapeutic procedures
(interventional radiology)
■ Doppler Teclmique ('ColourDoppler')
■ Magnetic Resonance Imaging (M RI)
■ Nuclear medicine examinations,
including Single Photon Emission
(Computed) Tomography (SPECT)
■ Positron Emission Tomography
(PET).
Establish an infrastructure for
DIS
A minimum of infrastructure should
be in place for all DIS, as follow's.
■ The upgrading, repair and maint
enance of existing facilities and the
planning of new services, according
to national and local needs
■ Tire appointment and training of
staff, as appropriate
■ The procurement, supply, storage
and distribution of films,
chemicals and spare parts to
ensure continuity of services
■ The establishment of a national
quality system, including guide
lines, standard operating pro
ced tires (SOPs), accurate records,
monitoring and evaluation.
Department/facility
■ Adequate medical and technical
knowledge and skills for:
— correct image handling
— development of X-ray films
— interpretation and reporting
of examinations
■ Adequate engineering
knowledge and skills for:
— equipment installation and
maintenance
— radiation protection,
including construction
requirements and regulations
■ Accessible supply of spare parts
■ Reliable supply of clean water
■ Reliable, stable power supply
■ Adequate air quality control:
pollution, temperature, humidity
■ Suitable location:
— accessible to operating rooms
and relevant departments
— convenient for transportation
of beds and stretchers
■ Adequate facilities for patients,
accompanying persons and staff
■ Quality control system.
Examination room and equipment
■ Radiation protection in accordance
with national regulations
■ Correct, safe and efficient use of
equipment in accordance with
operation manuals and SOPs
■ Regular maintenance of
equipment in accordance with
operation manuals and SOPs
■ SOPs for:
— patient identification
— documentation
— archiving
■ Quality' control system.
Diagnostic Imaging and Laboratory Technology, World Health Organization
20 Avenue Appia, CH-1211 Geneva 27, Switzerland
Fax: +41 22 791 4836
WORLD HEALTH ORGANIZATION
Blood Safety
AIDE-MEMOIRE
for National Blood Programmes
A well-organized blood transfusion service (BTS) is a prerequisite
for the safe and effective use of blood and blood products.
The HIV/AIDS pandemic has focused particular attention on the
importance of preventing transfusion-transmitted infections
(TTIs). Between 5% and 10% of HIV infections worldwide are
transmitted through the transfusion of contaminated blood and
blood products. Many more recipients of blood products are
infected by hepatitis B and C viruses, syphilis and other infectious
agents, such as Chagas disease.
Transfusion-transmitted infections can be eliminated or
substantially reduced through an integrated strategy for blood
safety which includes:
■ Establishment of a blood transfusion service
■ Collection of blood only from voluntary non-remunerated blood
donors from low-risk populations
■ Screening of all donated blood for transfusion-transmissible
infections, including HIV, hepatitis viruses, syphilis and other
infectious agents
■ Reduction in unnecessary transfusions through the effective
clinical use of blood, including the use of simple alternatives to
transfusion (crystalloids and colloids), wherever possible.
Words oif advice
■
Secure government commitment and support for the
national blood programme
■
Establish a blood transfusion service as a separate unit
with responsibility and authority, an adequate budget, a
management team and trained staff
■
Educate, motivate, recruit and retain voluntary non
remunerated blood donors from low-risk populations
■
Screen all donated blood for HIV and other transfusiontransmissible agents and ensure good laboratory practice
in blood grouping, compatibility testing, component
preparation and the storage and transportation of blood
products
■
Reduce unnecessary transfusions through the effective
clinical use of blood, including alternatives to transfusion
■
Establish a quality system for the BTS
■
Train all BTS and clinical staff to ensure the provision of
safe blood and its effective clinical use
©hedklisS
Blood transfusion service
□ Government commitment and support
□ National blood policy/plan
□ Legislation/regulation
□ Organization with responsibility and
authority for the BTS
□ BTS management committee
□ BTS medical director
□ BTS quality manager
□ Specialist BTS advisory groups
□ Trained BTS administrative and technical
staff
□ Adequate budget
□ National quality system
Blood donors
□ National blood donor programme officer
□ Blood donor unit
□ Blood donor recruitment officer
□ Standard operating procedures
□ Training of staff in blood donor unit
□ Low-risk donor populations
□ Educational materials
□ Register of voluntary non-remunerated
blood donors
□ Donor selection, deferral, care and
confidentiality
□ Donor notification and referral
□ Monitoring of TTIs
Blood screening
□ Technical officer
□ Screening strategies and protocols
□ Training of laboratory technical staff
□ Screening of all donated blood for TTIs
□ Good laboratory practice, including
standard operating procedures
□ Continuity in screening
□ Effective blood cold chain
Clinical use of blood
□ National policy and guidelines on the
clinical use of blood
□ Training of clinicians and BTS staff
□ Prevention, early diagnosis and treatment
□ Alternatives to transfusion (crystalloids
and colloids)
□ Effective clinical use of blood
□ Monitoring and evaluation
Key elements
Establish a blood transfusion service
It is the responsibility of
governments to ensure a safe and
adequate supply of blood. This
responsibility may be delegated to a
non-profit non-governmental
organization, but the BTS should be
developed within the framework of
the country's health care
infrastructure.
Important activities in establishing a
blood transfusion service include:
■ Formalization of government
commitment and support
■ Development of a national blood
policy and plan
■ Development of necessary
legislation/regulation for the
BTS
■ Formation of an organization
with responsibility and authority
for the BTS
■ Formation of a BTS management
committee
■ Appointment of a medical
director
■ Appointment of a quality
manager
■ Appointment, when necessary,
of specialist BTS advisory groups
■ Appointment and training of
staff experienced in each key
aspect of the BTS
■ Development and implement
ation of a budgeting and finance
system to ensure a sustainable
blood programme through cost
recovery and/or annual budget
allocation
■ Establishment of national quality
system, including guidelines,
standard operating procedures
(SOPs), accurate records,
monitoring and evaluation.
Educate, motivate, recruit and
retain low-risk blood donors
Screen all donated blood for
infectious agents
Reduce unnecessary transfusions
by effective clinical use of blood
High priority should be given to
the elimination of family/
replacement and paid blood donor
systems, which are associated with
a significantly higher prevalence of
Ills. Voluntary non-remunerated
blood donors from low-risk
populations who give blood
regularly are the foundation of a
safe and adequate blood supply.
The BTS should develop and
maintain a national strategy for
the screening of donated blood
and blood products for TTIs, using
the most appropriate and effective
tests, and for good laboratory
practice in all areas of blood
grouping, compatibility testing,
component preparation, storage
and transportation of blood
products.
Blood transfusion has the potential
for acute or delayed complications
and the transmission of infection.
The risks associated with
transfusion can be reduced by
minimizing unnecessary
transfusions through the effective
clinical use of blood and blood
products and the appropriate use
of simple alternatives to
transfusion which are safer and
more cost-effective.
The BTS requires government
commitment and support and
recognition as a separate unit with
an adequate budget, management
team and trained staff.
Important activities include:
■ Appointment of an officer
responsible for the national
blood donor programme
■ Establishment of a BTS unit
responsible for donor
education, motivation,
recruitment and retention
■ Appointment of a designated
blood donor recruitment officer
■ Preparation of SOPs in
accordance with BTS guidelines
■ Training of staff in the blood
donor unit
■ Identification of donor
populations at low risk for TTIs
■ Development of educational
materials
■ Establishment of a register of
voluntary non-remunerated
blood donors
■ Assurance of safe blood
collection procedures, including
donor selection and deferral,
donor care and confidentiality
■ Donor notification and referral
for counselling
■ Monitoring of TTIs in the donor
population.
Important activities include:
■ Appointment of a designated
technical officer
■ Development of protocols for
the testing, selection and
evaluation of appropriate
screening assays to be used at
each site
■ Training of BTS laboratory
technical staff
■ Screening of all donated blood
for TTIs, including HIV,
hepatitis viruses, syphilis and
other infectious agents, such as
Chagas disease
■ Good laboratory practice,
including the preparation of
SOPs in accordance with BTS
guidelines
■ Procurement, supply, central
storage and distribution of
reagents and materials to
ensure continuity in screening
at all sites
■ Maintenance of an effective
blood cold chain for the storage
and transportation of blood
and blood products.
Important activities include:
■ Development of a national
policy and guidelines on the
clinical use of blood
■ Training in the clinical use of
blood for all clinicians involved
in the transfusion process and
for BTS staff
■ Commitment to the prevention,
early diagnosis and treatment
of conditions that could result
in the need for transfusion
(obstetrical complications,
trauma and other causes of
anaemia)
■ Availability of intravenous
replacement fluids (crystalloids
and colloids) for the correction
of hypovolaemia, and
pharmaceuticals and devices to
minimize the need for blood
■ Effective clinical use of blood
and blood products in
accordance with national
guidelines
■ Monitoring and evaluation of
the clinical use of blood.
Blood Safety Unit, World Health Organization
20 Avenue Appia, CH-1211 Geneva 27, Switzerland. Fax: +41 22 7914836
Just Published!
The Clinical Use of Blood
Handbook
World Health Organization
2001, 219 pages
ISBN 92 4 154539 9
Swiss francs 15.—
In developing countries:
Fr.s. 10.50
Order no. 1150485
The handbook introduces the principles of the
appropriate use of blood and blood products and
outlines the characteristics and indications for use of
intravenous replacement fluids, whole blood, blood
components and plasma derivatives. It provides a
detailed guide to clinical transfusion procedures
and the recognition and management of transfusion
reactions. Comprehensive guidance is given on
transfusion and alternatives to transfusion in the
areas of general medicine, obstetrics, paediatrics &
neonatology, surgery & anaesthesia, trauma & acute
surgery, and burns. Key points, tables and algorithms
are highlighted for easy reference and a comprehen
sive index is included.
The Clinical Use of Blood Handbook, provides a
handy guide to the appropriate use of blood and
blood products for prescribers of blood at all levels of
the healthcare system. It is designed to provide a
quick reference to transfusion, particularly when an
urgent clinical decision is required. It summarizes key
information from a more extensive module of learning
material: The Clinical Use of Blood (see front page).
Both the module and handbook have been prepared
by an international team of clinical and blood transfu
sion specialists and reviewed by relevant WHO
departments and critical readers from a range of
specialties from all regions of the world.
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JUST PUBLISHED!
blood transfusion specialists and has been exten
sively reviewed by relevant WHO departments and
critical readers from a range of specialists from all
regions of the world.
World Health Organization
The Clinical Use of Blood
in Medicine, Obstetrics, Paediatrics,
Surgery & Anaesthesia, Trauma &
Burns
World Health Organization
2001,337 pages
ISBN 92 4 154538 0
Swiss francs 40.—
In developing countries:
Fr.s 28 —
Order no. 1150484
This module has been developed for prescribers of
blood at all levels of the health system, particularly
clinicians and senior paramedical staff at first referral
level (district hospitals) in developing countries. It has
been designed for use in undergraduate and post
graduate programmes, in-service training and
continuing medical education programmes, but can
also be used for independent study. Its interactive
style, with learning objectives, activities and case
studies, encourages users to focus on the use of
transfusion in their own clinical environment and
promotes the development of local guidelines on
clinical blood usage. Key points, tables and algo
rithms are highlighted for easy reference and a
comprehensive index is included.
Part 1: Principles, Products and Procedures
introduces the principles of the appropriate use of
blood and outlines the characteristics and indications
for use of intravenous replacement fluids, whole
blood, blood components and plasma derivatives. It
also provides a detailed guide to clinical transfusion
procedures and the recognition and management of
transfusion reactions.
Blood transfusion is an essential part of modern
health care. Used correctly, it can be a life-saving
intervention. Inappropriate use can endanger life
because of the potential risk of acute or delayed
complications, including the transmission of infectious
agents, such as HIV, hepatitis viruses, syphilis,
malaria and Chagas disease. The decision to trans
fuse blood or blood products should therefore always
be based on a careful assessment of clinical and
laboratory indications that transfusion is necessary
to save life or prevent significant morbidity.
The Clinical Use of Blood is an accessible learning
tool that will assist prescribers of blood to make
appropriate clinical decisions on transfusion and
contribute to wider efforts to minimize the unneces
sary use of blood and blood products. It has been
prepared by an international team of clinical and
Part 2: Transfusion in Clinical Practice summa
rizes factors to consider in making clinical decisions
on transfusion and provides comprehensive guid
ance on transfusion and alternatives to transfusion in
the areas of general medicine, obstetrics, paediatrics
& neonatology, surgery & anaesthesia, trauma &
acute surgery, and burns.
Part 3: The Appropriate Use of Blood — Putting It
into Practice explores how individual clinicians and
blood transfusion specialists can make a practical
contribution to achieving the appropriate use of
blood, both within their own hospitals and more
widely.
A companion handbook (see reverse side), contains
a summary of key information from the module to
provide a quick reference when an urgent decision
on transfusion is required.
Publications
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WHO/BCT/BTS/01.3
Distr.: Limited
Orig.: English
Developing
a National Policy
and Guidelines
on the Clinical Use
of Blood
■EE
Recommendations
World Health Organization
Blood Transfusion Safety
GENEVA
Developing
a National Policy
and Guidelines
on the Clinical Use
of Blood
Recommendations
World Health Organization
Blood Transfusion Safety
GENEVA
This document is not issued to the general public, and all rights are reserved by the World Health Organization (WHO).
The document may not be reviewed, abstracted, quoted, reproduced or translated, in pan or in whole, without the prior
written pennission of WHO. No part of this document may be stored in a retrieval system or transmitted in any form or
by any means - electronic, mechanical or other - without the prior written permission of WHO.
The views expressed in documents by named authors are solely the responsibility of those authors.
Contents
Preface
Acknowledgements
Introduction
1
1
Steps in developing a national policy and guidelines on
the clinical use of blood
3
2
National policy on the clinical use of blood
5
3
National guidelines on the clinical use of blood
6
4
National Committee on the Clinical Use of Blood
11
5
Hospital transfusion committees
13
6
Education and training
14
7
Monitoring and evaluation
15
ANNEXES
1
Standard blood request form
19
2
Blood ordering schedule
21
3
Monitoring the transfused patient
23
4
Investigating and recording acute transfusion reactions
24
5
Possible organizational structure for a National Committee on
the Clinical Use of Blood
25
6
Indicators for monitoring and evaluation
26
Acknowledgements
WHO/BCT/BTS wishes to acknowledge with thanks the efforts of all participants in
the expert group meeting at which these Recommendations were formulated — Dr
Paul Fenton, Associate Professor, Department of Anaesthesia, College of Medicine,
Malawi; Dr Jorge Fernandez, National Adviser, ETS/SIDA Department, Secretariat for
Health, Honduras; Dr Peter Ranagan, Clinical Director, Northern Zone, National
Blood Service, UK; Dr Brian McClelland. Regional Director, Edinburgh and South-East
Scotland Blood Transfusion Service, UK; Dr Patricia Rivera, Consultant, BID/OPS/
SSH Project, Honduras; Dr Maria de los Angeles Rodriguez, Head of the Blood Bank,
Hospital Naval, Vina del Mar, Chile; and Dr Elizabeth Vinelli, Medical Director, National
Blood Programme, Honduran Red Cross, Honduras.
Special thanks are due to Ms Jan Fordham, Director, Open Learning Associates, UK,
for her assistance in the preparation of this document.
Introduction
Blood transfusion is an essential part of modern health care. Used correctly, it can
save life and improve health. However, as with any therapeutic intervention, it may
result in acute or delayed complications and carries the risk of transmission of
infectious agents, such as HIV, hepatitis viruses, syphilis and Chagas disease. It is
also expensive and uses a scarce human resource.
The risks associated with transfusion can only be avoided by close collaboration
between the blood transfusion service and clinicians in managing the components
of the transfusion process for which they are each responsible:
■
An adequate supply of safe blood and blood products
■
The effective clinical use of blood and blood products.
Safe blood and blood products
A prerequisite for the effective clinical use of blood is a well-organized blood transfusion
service (BTS) that is able to provide blood and blood products that are safe, accessible
at reasonable cost and adequate to meet national needs.
Only blood which has been obtained from appropriately selected donors and has
been screened for transfusion-transmissible infectious agents, in accordance with
national requirements, should be issued for transfusion, other than in the most
exceptional life-threatening situations.
Low-risk blood donors
Voluntary non-remunerated blood donors from low-risk groups who give blood regularly
are the foundation of a safe and adequate blood supply. A reliance on family/
replacement and paid blood donors should be phased out as these donors are
associated with a significantly higher prevalence of transfusion-transmissible infections.
The education, motivation, recruitment and retention of voluntary non-remunerated
blood donors requires the following activities to be undertaken.
1
The establishment of a blood donor unit within the BTS, with an officer
responsible for the national blood donor programme and a designated
donor recruitment officer.
2
The training of staff responsible for donor education, motivation,
recruitment and selection.
3
The identification of donor populations at low risk for transfusiontransmissible infections.
4
Educational and media campaigns in workplaces, communities and
educational institutions.
5
The maintenance of a register of voluntary non-remunerated blood
donors.
6
Safe blood collection procedures, including donor selection and deferral,
donor care and confidentiality.
7
Donor notification and referral for counselling.
8
The monitoring of transfusion-transmissible infections in the blood
donor population.
1
Screening and processing of donated blood
Quality assurance and good laboratory practice are essential in all areas of blood
screening and processing. Important activities include:
1
The development and implementation of a national strategy for the
screening of all donated blood for transfusion-transmissible infections,
using the most appropriate and effective assays to test for HIV, hepatitis
viruses, syphilis and other infectious agents, such as Chagas disease.
2
The training of BTS laboratory technical staff in all aspects of blood
screening, blood grouping, compatibility testing, component preparation
and the issue of blood for transfusion.
3
Good laboratory practice, including the use of standard operating
procedures, in all aspects of blood screening and processing.
4
Compatibility testing of all whole blood and red cells transfused even
if, in life-threatening emergencies, this is performed after they have
been issued.
5
The procurement, supply, central storage and distribution of reagents
and materials to ensure continuity in testing at all sites.
6
The maintenance of an effective blood cold chain for the storage and
transportation of blood and blood products.
The effective clinical use of blood
The decision to transfuse blood or blood products must be based on a careful
assessment of clinical and laboratory indications that a transfusion is necessary to
save life or prevent significant morbidity.
Responsibility for the decision to transfuse must ultimately rest with individual
prescribers of blood, although this will often be made in consultation when specialist
transfusion advice is available. However, consistently effective clinical transfusion
practice cannot be achieved unless the following elements are in place.
1
A national policy on the clinical use of blood, with appropriate supportive
regulations.
2
National guidelines on the clinical use of blood to aid prescribers of
blood in their clinical decisions about transfusion.
3
A National Committee on the Clinical Use of Blood and hospital
transfusion committees at local level to implement, regularly review
and update the national policy and guidelines.
4
The training of all clinical and blood transfusion service staff involved
in the transfusion process, based on the national guidelines.
5
The availability of simple alternatives to transfusion (crystalloids and
colloids) for the correction of hypovolaemia, and pharmaceuticals and
medical devices to minimize the need for transfusion.
6
Monitoring and evaluation of the implementation of the national policy
and guidelines and the use of monitoring data in a quality improvement
and education programme to assist clinicians to improve their practice.
2
Steps in Developing a National
Policy and Guidelines on the
Clinical Use of Blood
1
The primary responsibility for the development of a national policy and guidelines on
the clinical use of blood lies with clinicians, although the process may be initiated
either by clinicians or by the BTS. Close collaboration between them is essential
since the effective clinical use of blood is dependent on the availability of safe and
adequate supplies of blood and blood products from the BTS.
Where there is a national blood transfusion policy and plan and a National Blood
Transfusion Committee (NBTC) with required legislative support has already been
established, the development of a national policy and guidelines on the clinical use
of blood could be undertaken within the same framework.
In countries where an effectively functioning NBTC or similar body does not exist, a
small Working Group may be initiated by the BTS or individual clinicians to prepare
a draft policy and organize the drafting of the clinical guidelines.
The establishment of a National Committee on the Clinical Use of Blood will
subsequently be required to ensure the effective implementation of the national
policy and guidelines.
Steps
Developing and implementing a national policy and guidelines on the clinical use of
blood requires systematic planning and extensive consultation. The following steps
are recommended, although the sequence and timing of these steps will be determined
by national circumstances.
1
Sensitization of the Ministry of Health/national health authority to the
need for a national policy and guidelines on the clinical use of blood.
2
Preparation of a draft national policy on the clinical use of blood by a
select Working Group comprising clinical specialists and senior personnel
from the BTS.
3
Submission of the draft policy to the Ministry of Health/national health
authority for approval, endorsement and support.
4
National workshop to plan and draft national guidelines on the clinical
use of blood, involving:
■ Clinical specialists
■ Senior BTS personnel
■ Senior pharmacists.
5
Further development of the draft national guidelines by specialist working
groups from major clinical blood use specialties and the blood transfusion
service.
6
Consolidation and editing of the draft national guidelines by the select
Working Group.
3
7
Circulation of the draft guidelines nationally for review by clinicians.
8
Incorporation of comments and amendments and preparation of the
final draft of the national guidelines by the select Working Group.
9
Second national workshop to finalize the guidelines and plan a national
strategy and workplan for their dissemination and implementation.
10
Submission of the revised guidelines to the Ministry of Health/national
health authority for approval and endorsement and the preparation of
a legislative framework, if required.
11
Establishment of a National Committee on the Clinical Use of Blood.
12
Establishment of a hospital transfusion committee in each hospital to
implement and monitor the national policy and guidelines.
13
Dissemination of the national policy and guidelines to the providers
and prescribers of blood.
14
Integration of education and training on the effective clinical use of
blood into undergraduate, postgraduate, in-service and continuing
education programmes for clinical and blood transfusion service staff.
15
Development of indicators for monitoring and the establishment of a
national system to monitor and evaluate the implementation of the
national policy and guidelines.
4
2
National Policy on the
Clinical Use of Blood
A national policy on the clinical use of blood is an essential component of a strategy
to ensure that blood and blood products are transfused only to treat conditions
leading to significant morbidity or mortality that cannot be prevented or treated
effectively by other means.
Key elements
A national policy on the clinical use of blood should define the strategy for the
effective clinical use of blood, blood products and alternatives to transfusion. This
should include the following key elements.
1
A commitment by health authorities, health care providers and clinicians
to the prevention, early diagnosis and effective treatment of conditions
that could lead to the need for transfusion by strengthening public
health and primary health care programmes.
2
A blood transfusion service that is able to provide adequate and timely
supplies of safe blood and blood products.
3
4
The promotion and availability of:
■
Intravenous replacement fluids (crystalloids and colloids) for the
correction of hypovolaemia
■
Pharmaceuticals and devices to minimize the need for transfusion
■
Sterile disposable equipment for blood samples, injection and
infusion.
The availability of national guidelines on the clinical use of blood, which
include:
■
A standard blood request form
■
A model blood ordering schedule
■
Standard operating procedures for all stages of the clinical
transfusion process
■
Information on the specific characteristics of blood products, plasma
derivatives, intravenous replacement fluids and pharmaceuticals
■
Clinical indications for transfusion.
5
The establishment of a National Committee on the Clinical Use of
Blood and hospital transfusion committees at local level.
6
Education and training in the effective clinical use of blood and blood
products for all clinical and blood bank staff involved in the transfusion
process.
7
Effective clinical transfusion practice in accordance with the national
guidelines on the clinical use of blood.
8
Monitoring and evaluation of the clinical use of blood.
5
National Guidelines on the
Clinical Use of Blood
3
Guidelines on the clinical use of blood should represent a national consensus by
clinicians, the BTS and pharmacists on the most effective treatment for specific
clinical conditions, in the context of local conditions, and should be based on the
best available information. The objectives of developing and implementing clinical
guidelines are as follows.
1
To define clinical and BTS requirements for the appropriate use of
blood, blood products and simple alternatives to transfusion, including
intravenous replacement fluids, and pharmaceuticals and medical
devices to minimize the need for transfusion.
2
To make available standard operating procedures for all stages of the
transfusion process.
3
To facilitate the monitoring and evaluation of transfusion practice
nationally and locally in order to improve the clinical use of blood.
Principles of the clinical use of blood
The following principles should be considered in the formulation of national guidelines
on the clinical use of blood.
1
Transfusion is only one element of the patient’s management.
2
Prescribing decisions should be based on the national guidelines on
the clinical use of blood, taking individual patient needs into account.
3
Blood loss should be minimized to reduce the patient’s need for
transfusion.
4
The patient with acute blood loss should receive effective resuscitation
(intravenous replacement fluids, oxygen, etc.) while the need for
transfusion is being assessed.
5
The patient’s haemoglobin value, although important, should not be
the sole deciding factor in starting transfusion. The decision to transfuse
should be supported by the need to relieve clinical signs and symptoms
and prevent significant morbidity and mortality.
6
The clinician should be aware of the risks of transfusion-transmissible
infection in the blood and blood products that are available for the
individual patient.
7
Transfusion should be prescribed only when the benefits to the patient
are likely to outweigh the risks.
8
The clinician should record the reason for transfusion clearly.
9
A trained person should monitor the transfused patient and respond
immediately if any adverse effects occur.
6
Key elements
Guidelines on the clinical use of blood should be practical, comprehensive and
relevant to local circumstances for use by clinicians who need to make urgent
decisions on whether or not to transfuse a patient.
1
Standard blood request form
All requests for blood and blood products should be accompanied by a blood
request form that has been completed by the prescribing clinician. Ideally, a
standard blood request form, developed by the blood transfusion service and
reviewed and agreed by the National Committee on the Clinical Use of Blood,
should be used throughout the country to promote effective clinical transfusion
practice and aid in the monitoring and evaluation of clinical blood use.
Annex 1 summarizes the information that should be provided on a blood request
form. It also contains a simple checklist that could be printed on the reverse
of the form to assist clinicians in applying the principles of the clinical use of
blood when making decisions about transfusion.
2
Blood ordering schedule
It is unnecessary for blood to be crossmatched routinely for every surgical
procedure since many operations rarely require transfusion. Considerable time
and expense can be saved by analysing the usage of blood and developing a
blood ordering schedule as a guide to the number of units of blood and blood
products that should normally be ordered for common procedures. The use of
a blood ordering schedule minimizes unnecessary crossmatching and reduces
the amount of blood that becomes outdated. It also makes it possible to ensure
that blood is readily available for all patients who need it.
National guidelines on the clinical use of blood should therefore include a blood
ordering schedule with guidance on its adaptation by clinicians, in conjunction
with the hospital blood bank, in each hospital at different levels of the health
system, including national, provincial/regional and district hospitals.
Each hospital's blood ordering schedule should reflect the clinical team's usual
use of blood for common procedures, depending on their complexity and expected
blood loss, and should take account of both local clinical conditions and the
supply of blood, blood products and alternatives to transfusion that are available.
It should also include guidance on the use of the group and screen policy for
patients undergoing procedures for which red cell transfusion is occasionally,
but rarely, required. If no clinically important antibodies are detected, fully
crossmatched blood can quickly be made available using a rapid crossmatch
technique. If the antibody screening test is positive, antigen negative blood
should be crossmatched and reserved for the patient, even when there is little
likelihood that transfusion will be needed.
Each hospital transfusion committee should agree a procedure for the prescribing
clinician to override the blood ordering schedule when it is probable that a
patient will need more blood than is stipulated: for example, if the procedure
is likely to be more complex than usual or if the patient has a coagulation defect.
In such cases, additional units of blood should be crossmatched as requested
by the clinician.
Annex 2 outlines the process for developing a blood ordering schedule and
contains an example of a blood ordering schedule for surgical procedures in
adult patients.
3
Standard operating procedures
National guidelines on the clinical use of blood should include standard operating
procedures for the following stages in the clinical transfusion process and, ideally,
standard documentation such as a transfusion reaction report form.
1
Ordering blood and blood products in routine and emergency situations.
2
The issue of blood and blood products.
3
The transportation of blood and blood products and storage in the clinical
setting.
4
The administration of blood and blood products.
5
Recording all transfusions in patient records.
6
Monitoring the patient before, during and after transfusion.
7
The management, investigation and recording of transfusion reactions.
Annexes 3 and 4 include guidance on monitoring the transfused patient and
investigating and recording acute transfusion reactions.
4
Blood, blood products and alternatives to transfusion
The guidelines should contain information on indications, dosage, risk of transmission
of infection, storage conditions, means of administration, contraindications and
precautions for the blood products and alternatives to transfusion that are available.
Blood components
■
■
■
■
■
Whole blood
Red cells
Platelet concentrates
Plasma
Cryoprecipitate
Plasma derivatives
■
■
■
Albumin
Coagulation factors
Immunoglobulins
Intravenous replacement fluids
■
■
Crystalloid solutions
Colloid solutions
Pharmaceuticals
■
■
■
5
Drugs
Medical devices for blood salvage and to maximize blood volume
Sterile disposable equipment for blood samples, injection and infusion
Clinical indications for transfusion
The guidelines should include clinical and laboratory indications for the use of blood
and blood products in:
■ Anaemia
■ Chronic blood loss
■ Acute blood loss
■ Supportive treatment: e.g. haemophilia, thalassaemia and immunodeficiency
disorders.
8
Listed below are some clinical disciplines for which indications for transfusion
might be included.
General medicine
■
Anaemia
— Malaria
— HIV infection
— Haemolytic anaemias
■
Oncology
■
Bone marrow dysfunction
■
Haemoglobinopathies
— Sickle cell disease
— Thalassaemias
■
Disorders of haemostasis
— Congenital
— Acquired
■
Thrombocytopenia
Paediatrics
Neonatology
■
Neonatal anaemia
■
Haemolytic disease of the newborn
■
Exchange transfusion
■
Vitamin K deficiency
■
Thrombocytopenia
General paediatrics
■
Severe paediatric anaemia
— Nutritional anaemia
— Malaria
— Other infections
■
■
Oncology/malignancies
Haemoglobinopathies
— Sickle cell disease
— Thalassaemias
■
Disorders of haemostasis
— Congenital
— Acquired
■
Thrombocytopenia
Obstetrics
■
■
Anaemia in pregnancy
Major obstetric haemorrhage/complications
■
Disseminated intravascular coagulation
■
HIV infection
9
Surgery and trauma
■
Elective surgery
■
Acute surgery and trauma
■
Disorders of haemostasis
— Congenital
— Acquired
■
■
Thrombocytopenia
Burns
— Children
— Adults
10
National Committee on the
Clinical Use of Blood
4
A National Committee on the Clinical Use of Blood requires authority and support in
order to ensure the effective implementation of the national policy and guidelines.
Role
The principal functions of a National Committee on the Clinical Use of Blood are to:
1
Ensure the national policy and guidelines on the clinical use of blood
are disseminated to hospitals at all levels of the health system.
2
Provide guidance on the establishment of hospital transfusion
committees and their roles and responsibilities in implementing and
monitoring the national policy and guidelines.
3
Ensure that a standard blood request form, developed by the blood
transfusion service, is available and used uniformly in all hospitals.
4
Promote the development and use of an appropriate blood ordering
schedule in each hospital in which surgical procedures are performed.
5
Ensure that standard operating procedures for all stages of the clinical
transfusion process are available and used uniformly in all hospitals.
6
Promote the development of an education and training programme for
personnel at all levels who are involved in the prescription and
administration of blood and blood products.
7
Establish a system to monitor and evaluate the pattern of blood usage,
the implementation of the national policy and guidelines, and the
effectiveness of the education and training programme.
8
Regularly review and, where necessary, update the national policy and
guidelines and the strategy for their implementation.
Membership
The effectiveness of a National Committee on the Clinical Use of Blood will depend
on the careful selection of a small number of dedicated, enthusiastic individuals with
specialist expertise in clinical transfusion practice who are able to meet on a regular
basis.
While the most appropriate composition of the committee will be determined by
national circumstances, it should include senior representatives of both the providers
and prescribers of blood and blood products, including:
1
2
A senior professional officer from the Ministry of Health/national health
authority.
Representatives of clinical blood use specialties, such as:
■
Accident and emergency/casualty
■
Anaesthesia/intensive care
3
4
■
Surgery
■
Obstetrics and gynaecology
■
Paediatrics
■
General medicine
■
Haematology/oncology
■
Nursing.
Representatives of hospital transfusion committees.
Senior personnel from the blood transfusion service, such as:
■
Medical director
■
Manager/finance officer
■
Quality manager
■
Senior laboratory technologist.
5
Senior officer (pharmacy or supplies) responsible for the supply of
intravenous replacement fluids, pharmaceuticals, medical devices and
sterile disposal equipment.
6
Representatives of relevant organizations involved in the clinical aspects
of blood transfusion, such as:
■
Education and training institutions
■
Non-governmental organizations:
— National Red Cross or Red Crescent Society
— Voluntary blood donor organizations
— Associated voluntary organizations: e.g. Haemophilia
Association, Thalassaemia Association.
Annex 5 shows a possible organizational structure for a National Committee on the
Clinical Use of Blood.
Hospital Transfusion
Committees
5
A hospital transfusion committee should be set up in each hospital to implement
the national policy and guidelines on the clinical use of blood and monitor the use
of blood and blood products at the local level. The hospital transfusion committee
should have authority within the hospital structure to determine hospital policy in
relation to transfusion and resolve any problems that have been identified.
Role
The principal functions of a hospital transfusion committee are to:
1
Monitor the safety, adequacy and reliability of the supply of blood,
blood products and alternatives to transfusion.
2
Develop systems and procedures for the implementation of the national
guidelines on the clinical use of blood within the hospital, including the
development of a hospital blood ordering schedule.
3
Promote the effective implementation of the national guidelines through
the education and training of all clinical and blood bank staff involved
in the transfusion process.
4
Monitor the usage of blood and blood products in the hospital.
5
Monitor the implementation of the national guidelines in the hospital
and take appropriate action to overcome any factors hindering their
effective implementation.
6
Review incidents of severe adverse effects or errors associated with
transfusion, identify any corrective action required and refer them to
the National Committee on the Clinical Use of Blood.
Membership
A hospital transfusion committee should be multidisciplinary and involve all
departments in the hospital that are involved in providing and prescribing blood and
blood products. These may include:
1
Senior representatives of clinical specialties that prescribe blood in the
hospital.
2
The responsible officer from the hospital blood bank and, where
applicable, a representative of the blood transfusion service that supplies
blood and blood products to the hospital.
3
The hospital staff member responsible for the supply of intravenous
replacement fluids, pharmaceuticals, medical devices and sterile
disposable equipment.
4
The senior nurse.
The membership of the hospital transfusion committee will be primarily clinical but,
on occasions, may also need to involve other personnel, such as the hospital
administrator/finance officer and the medical records officer.
13
Education and Training
6
The effective implementation of the national policy and guidelines requires the
development of a national programme of education and training in the clinical use
of blood. This should be incorporated into pre-service, postgraduate and in-service
training programmes for clinicians, blood bank staff and other personnel involved in
the transfusion process and into continuing medical education programmes.
Undergraduate and postgraduate programmes
■
■
■
■
Medical schools and teaching hospitals
Medical laboratory technology training institutions
Schools of nursing
Paramedical schools
In-service training
■
■
■
Clinicians
Nurses
Blood transfusion service/hospital blood bank technical staff
Continuing medical education
■
■
■
Hospital clinical meetings
Seminars and conferences
Medical publications
WHO training materials
Each country’s national policy and clinical guidelines should be the principal resource
for education and training in the clinical use of blood. The following learning resources
are also available from WHO.
Aide-Memoire: Blood Safety
The Clinical Use of Blood
■
■
Learning materials
Pocket handbook
Safe Blood and Blood Products
■
■
■
■
Introductory Module: Guidelines and Principles for Safe Blood Transfusion
Practice
Module 1: Safe Blood Donation
Module 2: Screening for HIV and Other Infectious Agents
Module 3: Blood Group Serology
Establishing a Distance Learning Programme in Blood Safety: A
manual for programme coordinators
■
Manual
■
Toolkit
The Blood Cold Chain (in preparation)
■
■
Guide for Managers of Blood Cold Chain Equipment
Guide for Users of Blood Cold Chain Equipment
14
Monitoring and Evaluation
7
A simple system of monitoring and evaluation is essential to assess patterns of
blood usage and the impact of the national policy and guidelines on the clinical use
of blood. This requires a systematic approach to data collection and analysis at all
levels of the health system.
The responsibility for establishing a system of monitoring and evaluation should be
shared by the blood transfusion service, the National Committee on the Clinical Use
of Blood and the department responsible for the supply of intravenous replacement
fluids, pharmaceuticals, medical devices and sterile disposable equipment.
Monitoring and evaluation should also be undertaken in each hospital by the hospital
transfusion committee and the results reported to the National Committee on the
Clinical Use of Blood.
Key elements
The following elements should be included in a system for the monitoring and
evaluation of clinical blood use.
1
The safety, adequacy, and reliability of the supply of blood and blood
products.
2
The adequacy and reliability of the supply of intravenous replacement
fluids (crystalloids and colloids) and pharmaceuticals to avoid
unnecessary transfusion, and sterile disposable equipment for blood
samples, injection and infusion.
3
Differences in blood usage within hospitals and between similar hospitals
at national, provincial/regional and district level.
4
The availability of the national guidelines on the clinical use of blood
at all levels of the health system and the establishment of education
and training programmes in their use.
5
The establishment of systems needed to ensure the effective use of
the guidelines by the providers and prescribers of blood.
6
Compliance with the national guidelines in the clinical use of blood,
blood products and alternatives to transfusion.
Indicators for monitoring and evaluation
The following indicators provide a simple framework for the monitoring and evaluation
of the clinical use of blood by hospital transfusion committees. Annex 6 provides a
more comprehensive list of indicators.
1
Are adequate, reliable supplies of safe blood and blood products
available to meet demands?
Indicator
Percentage of unfilled requests, by product
15
Annex 1
Standard blood request form
A standard blood request form should provide the following information:
■
Date of request
■
Date and time the blood is needed
■
Where the blood should be delivered
■
Patient’s full name
■
Patient’s date of birth
■
Patient’s sex
■
Patient's hospital reference number
■
Patient’s ward
■
Provisional diagnosis
■
Reason why transfusion is requested
■
Number of units of blood or blood products required
■
Whether patient’s serum should be grouped, screened and held
■
Standard or emergency request
■
Name and signature of the person requesting the blood
Where previous records or a reliable history are available, the following information
should also be provided:
■
Patient's blood group, if known
■
Presence of any antibodies
■
History of any previous transfusions
■
History of any previous transfusion reactions
■
Females: number of previous pregnancies and maternal/infant incompatibility
■
Other relevant medical history or condition
The simple checklist on p. 20 could be printed on the reverse of the blood request
form to remind clinicians of factors that need to be considered in the management
of patients who may require transfusion.
19
EXAMPLE
Blood ordering schedule: a guide to expected normal blood usage
for surgical procedures in adult patients
Procedure
Action
Procedure
G & S
G & S
Termination of pregnancy
Normal delivery
Caesarean section
Placenta praevia/retained
placenta
Antepartum/postpartum
haemorrhage
Dilatation & curettage
Hysterectomy: abdominal or
vaginal: simple
Hysterectomy: abdominal or
vaginal: extended
Myomectomy
Hydatidiform mole
Oophorectomy (radical)
General surgery
Cholecystectomy
Laparotomy: planned
exploration
Liver biopsy
Hiatus hernia
Partial gastrectomy
Colectomy
Mastectomy: simple
Mastectomy: radical
Thyroidectomy: partial/total
Obstetrics & gynaecology
G & S
X-M 2
G & S
X-M 2
G & S
X-M 2
X-M 2 (+ 2)
Cardiothoracic
Angioplasty
Open heart surgery
Bronchoscopy
Open pleural/lung biopsy
Lobectomy/pneumonectomy
G & S
X-M 4 (+ 4)
G & S
G & S
X-M 2
Vascular
Aortic-iliac endarterectomy
Femoral endarterectomy
Femoro-popliteal bypass
llio-femoral bypass
Resection abdominal aortic
aneurysm
X-M 4
G & S
G & S
X-M 2
X-M 6 (+ 2)
Neurosurgery
Craniotomy, craniectomy
Meningioma
Head injury, extradural
haematoma
Vascular surgery (aneurysms,
A-V malformations)
Action
G & S
X-M 4
G & S
X-M 3
G & S
G & S
G & S
X-M 4
X-M 2
G & S
G & S
X-M 2
X-M 2
X-M 2
X-M 4
Orthopaedics
Disc surgery
Laminectomy
Removal hip pin or femoral
nail
Total hip replacement
Ostectomy/bone biopsy
(except upper femur)
Nailing fractured neck of
femur
Laminectomy
Internal fixation of femur
internal fixation: tibia or
ankle
Arthroplasty: total hip
Spinal fusion (scoliosis)
Spinal decompression
Peripheral nerve surgery
G & S
G & S
G & S
X-M 2 (+ 2)
G & S
G & S
G & S
X-M 2
G & S
X-M 3
X-M 2
X-M 2
G & S
Urology
Ureterolithotomy
Cystotomy
Ureterolithotomy & cystotomy
Cystectomy
Open nephrolithotomy
Open prostatectomy (RPP)
Transurethral resection
prostatectomy (TURP)
Renal transplantation
G & S
G & S
G & S
X-M 4
X-M 2
X-M 2
G & S
X-M 2
X-M = Crossmatch
G & S = ABO)/Rh
Z
group and antibody screen
(+ ) indicates additional units may be requirred, depending on surgical complications
22
Annex 3
Monitoring the transfused patient
1
For each unit of blood transfused, monitor the patient at the following
stages:
2
■
Before starting the transfusion
■
As soon as the transfusion is started
■
15 minutes after starting transfusion
■
At least every hour during transfusion
■
On completion of the transfusion
■
4 hours after completing the transfusion.
At each of these stages, record the following information on the patient’s
chart:
■
Patient’s general appearance
□
Temperature
■
Pulse
■
Blood pressure
■
Respiration
■
Fluid balance:
— Oral and IV fluid intake
— Urinary output.
3
4
Record:
■
Time the transfusion is started
■
Time the transfusion is completed
■
Volume and type of all products transfused
■
Unique donation numbers of all products transfused
■
Any adverse effects.
Monitor the patient particularly carefully during the first 15 minutes of
the transfusion to detect early signs and symptoms of adverse effects.
23
Annex 4
Investigating and recording acute transfusion reactions
1
Stop the transfusion and keep the IV line open with normal saline while
making an initial assessment of the acute transfusion reaction and
seeking advice.
2
Immediately report all acute transfusion reactions, with the exception
of mild urticarial reactions, to a medical officer and to the blood bank
that supplied the blood.
3
Record the following information on the patient’s notes:
■
4
Type of transfusion reaction
■
Length of time after the start of transfusion that the reaction occurred
■
Volume and type of blood products transfused
■
Unique donation numbers of all products transfused.
Immediately the reaction occurs, take the following samples and send
with a request form to the blood bank for laboratory investigations:
■
Immediate post-transfusion blood samples (1 clotted and 1
anticoagulated: EDTA/Sequestrene) from the vein opposite the
infusion site
■
Blood culture in a special blood culture bottle, if septic shock due
to a contaminated blood unit is suspected
■
The blood unit and giving set containing red cell and plasma residues
from the transfused donor blood
■
The first specimen of the patient's urine following the reaction.
5
Complete a transfusion reaction report form.
6
After the initial investigation of the transfusion reaction, send the
following to the blood bank for laboratory investigations:
■
Blood samples (1 clotted and 1 anticoagulated: EDTA/Sequestrene)
taken from the vein opposite the infusion site 12 hours and 24
hours after the start of the reaction
■
All patient’s urine for at least 24 hours after the start of the
reaction.
Annex 5
Possible organizational structure for a National Committee on the Clinical Use of Blood
NATIONAL COMMITTEE ON THE CLINICAL USE OF BLOOD
Chairman
Representatives of
Ministry of Health/
Health Authority
<n
Representatives of
Clinical Specialties
For example:
For example:
■
Representative of
Minister of Health
■
■
Finance
■
■
Pharmacy
Anaesthesia/lntensive
Care
■
Nursing
■
Surgery
Primary Health Care
■
■
Accident &
Emergency/Casualty
Obstetrics &
Gynaecology
■
Paediatrics
■
General Medicine
■
Haematology/Oncology
■
Nursing
■
Hospital Transfusion
Committees
Representatives of
Pharmacy
Representatives of
Blood Transfusion
Service
Representatives of
Other Relevant
Organizations
For example:
For example:
For example:
■
Medical Director
■
Senior Pharmacists
■
■
Manager/Finance
■
Senior Officer Stores/
Supplies
Education and Training
Institutions
■
Non-governmental
Organizations, such as:
Officer
■
Quality Manager
■
Senior Laboratory
Technologist
- National Red Cross/
Red Crescent Society
- Voluntary blood donor
organizations
- Associated voluntary
organizations: e.g.
Haemophilia
Association,
Thalassaemia
Association
Annex 6
Indicators for monitoring and evaluation
1
2
Adequacy and reliability of supply of safe blood and blood products
■
Number of units requested
■
Number of units crossmatched
■
Number of unfilled requests for blood
■
Number of elective surgeries cancelled because of blood shortages
■
Number of units issued for transfusion
■
Number of units issued and returned unused
■
Number of units discarded
■
Number of units issued without screening for infectious disease
markers (HIV, hepatitis, syphilis and other nationally-required tests)
■
Number of units issued without compatibility testing
Adequacy and reliability of supply of:
Intravenous replacement fluids
■
Crystalloid solutions, including normal saline (0.9% sodium chloride)
■
Colloid solutions
Drugs used in:
■
Anaemia
■
Malaria
■
Labour and delivery
■
Shock
■
Child-spacing (to reduce pregnancy-associated anaemias)
■
Haemolytic disease of the newborn (immunoglobulin anti-D )
Medical devices for:
■
Blood salvage
■
Maximization of intravascular volume (pressure cuffs)
Sterile disposable equipment:
3
4
■
Needles
■
Syringes
■
Blood sample tubes
■
Blood giving sets, including cannulae/needles
Proportion of blood and blood products used by each clinical
specialty
■
Requests for blood and blood products by patient category
■
Transfusion of blood and blood products by patient category
Use of national guidelines on the clinical use of blood
■
Percentage of clinicians trained in the use of the guidelines
■
Percentage of clinicians using the guidelines as a basis for clinical
decisions on transfusion
26
5
Establishment of a system and procedures to support the
implementation of the guidelines
■
Availability of blood request form
■
Availability of blood ordering schedule
■
Efficient system for transportation and storage of blood and blood
products in the clinical setting
■
Availability of transfusion reaction report form
■
Availability of standard operating procedures for:
— Ordering blood and blood products in routine and emergency
situations
— Issue of blood and blood products
— Storage and transportation of blood and blood products
— Administration of blood and blood products
— Recording all transfusions in patient records
— Monitoring the patient before, during and after transfusion
— Management, investigation and recording of transfusion
reactions
6
Compliance with national guidelines on the clinical use of blood
■
Number of transfusions given in accordance with national guidelines
■
Number of transfusions not given in accordance with national
guidelines
■
Outcome of transfusions:
— Acute complications of transfusion
— Delayed complications of transfusion
— Mortality
27
World Health Organization,
Geneva
WHO HIV Test Kit —
Bulk Procurement Scheme
"ensuring access to high quality, low cost HIV test kits"
The Issue
HIV test kits are essential for:
Z Diagnosis of HIV infection
Z Screening of donated blood
Z Surveillance
Z Voluntary counselling and testing
Z Prevention of mother-to-child transmission
However...
s HIV test kits account for a substantial proportion
of the budgets of most National AIDS Control
Programmes.
E National and local blood transfusion services in
many countries do not have the financial
resources to purchase the required number of
test kits.
□ Many countries have interrupted supplies of test
kits.
□ Many countries require additional information to
ensure that the kits they do purchase are of high
quality and are suitable for their particular
situation.
The Response
■ UN agencies
■ Nongovernmental organizations
■ Donor supported HIV/AIDS projects
■ Other recognized groups
High Quality
All HIV test kits available through the Bulk
Procurement Scheme have been evaluated by WHO.
These evaluations assess the operational
characteristics of the tests i.e. sensitivity, specificity,
ease of performance and storage conditions. To be
eligible for inclusion in the Bulk Procurement
Scheme, the evaluated test kits must meet current
standards. All test kits included in the Bulk
Procurement Scheme are reviewed annually.
The Bulk Procurement Scheme encompasses the
main types of tests used to detect HIV antibodies
today - Enzyme Linked ImmunoSorbent Assays
(ELISAs), Simple/Rapid assays and Confirmatory
assays. There are 22 tests on the current Bulk
Procurement Scheme List of Available Assays,
including a greater number of Simple/Rapid Assays
than ever before.
WHO established the HIV Test Kit Bulk Procurement
Scheme in 1989. The goals of the scheme are to:
When selecting a test kit, the following issues
should be considered:
■ Facilitate access to:
Z high quality test kits
Z at a lowcost
•/ through an easy purchase procedure
□ The number of samples to be tested
□ The laboratory facilities available
□ The level of laboratory staff training
□ The objective of the testing
□ The testing strategy being followed
■ Provide additional information and assistance to
those selecting/purchasing test kits to ensure
that the chosen kits will be appropriate for the
conditions in which they will be used and will
meet the overall testing objectives.
The Bulk Procurement Scheme is directed towards
and assists:
■ National AIDS Control Programmes
■ Blood transfusion services
No single test is suitable for all testing objectives in
all settings. It is important to choose the test kit
which will produce the best working performance
in actual, routine use.
In addition to the Bulk Procurement Scheme,
recommendations and guidelines have been
developed by WHO to assist with the selection of
appropriate kits.
Low Cost
WHO negotiates prices for all assays in the Bulk
Procurement Scheme directly with the
manufacturers. This process enables WHO to offer a
per test cost approximately half that of the open
market price.
Main types of
tests
Range -
Average -
Open Market Price
Bulk Procurement Price
(USS)**
(US$)»
ELISA
1.00 to 2.00
0.50
Simple/Rapid
2.00 to 8.00
1.00
Confirmatory
20.00 to 30.00
11.00
© Step 2: Submit this request to one of the
appropriate offices for your category:
• WHO Headquarters, Geneva (Category A)
• WHO Regional Office (Category A, B)
• WHO Country Representative (Category B)
• UNAIDS Representative (Category B, C)
• Ministry of Health (Category C)
Step 3: Payment will be debited from your account
(Category A) or a proforma invoice will be issued to
you (Category B and C). Goods must be paid for in
full before purchase is initiated.
Step 4: Procurement Services purchases the
requested kits.
‘Prices as of2000
The resulting savings are substantial, enabling
countries with limited resources to buy more HIV
test kits with their funds, or to channel more
resources into other areas of need, such as HIV
care. The savings for 1999-2000 amounted to
USS 5 million.
Step 5: WHO ships the goods to the airport of
destination.
Step 6: The consignee is responsible for customs
clearance and delivery of the goods.
Further fliraffoirBirBation ~^)
HIV Bulk Purchase 1989-2000
Further information on the WHO HIVTest Kit Bulk
Procurement Scheme is available from the
following sources:
WHO Headquarters —
for procurement assistance:
Procurement Services
Tel:+41 22 791 2801 Fax:+41 22 791 4196
Email: procurement@who.int
Easy Purchase Procedure
The HIVTest Kit Bulk Procurement Scheme accepts
purchase requests from programmes/institutions/
organizations in 3 categories:
■ Category A - WHO programmes & UN agencies
■ Category B - WHO Member States & NGOs in
official relations with WHO
■ Category C - Other clients ie. Donor supported
AIDS projects, regulatory bodies
The HIVTest Kit Bulk Procurement Scheme provides
an easy-to-follow purchase procedure. Simply
complete the steps indicated by this symbol © and
let WHO do the rest!
© Stepl: Prepare a request which includes the
following information:
• Name of requesting programme
• Contact person (ie. name, telephone)
• Test kit name & manufacturer
• Order code
*
• Number of test kits required (indicate number
of tests per kit where necessary)
‘as on the Bulk Procurement List
for technical assistance:
Blood Safety and Clinical Technology
World Health Organization
Avenue Appia 20,1211 Geneva 27
Switzerland
Internet —
Visit the BCT section of the WHO website at
www.who.int/bct and follow the links to Key
Initiatives, HIV Diagnostics, HIV Test Kit Bulk
Procurement Scheme. In addition to general
information, PDF versions of the WHO HIV Test Kit
Bulk Procurement Scheme Information Booklet,
several fact sheets, and this brochure are (or will
soon be) available for downloading. In addition,
information on Test Kit Evaluation is available on
this website.
Regional Offices/Country Representatives —
Contact your WHO Regional Office, WHO Country
Representative, or nearest UNAIDS representative.
If you are a manufacturer and wish to submit your
kit for evaluation by WHO to become eligible for
inclusion in the Bulk Procurement Scheme, please
visit our website or contact Blood Safety and
Clinical Technology:
Fax:+41 22 791 4836
Email: bloodsafety@who.int
Augwttooi
W HO Department of Blood Safety and Clinical 'Technology
Diagnostic Support
for diagnosis, treatment and care
Responding to the HIV Initiative
Providing diagnostic support is an essential part of ensuring quality health care in the fight against the
HIV/AIDS epidemic. There has been a strong call for access to drugs to help in this fight; however, it must be
remembered that this battle is a process which not only requires access to treatment, but also access to accurate
diagnostics, quality of care and follow up. The diagnostic support activities of the Blood Safety and Clinical
Technology (BCT) department of WHO play a vital role in all three phases of this process.
Using appropriate diagnostic technology for screening and diagnosis is the starting point in the process. In
addition to the actual diagnosis of patients’ HIV status,
APPROPRIATE DIAGNOSTICS SUPPORT
diagnostic technology must be used for screening of
with an emphasis on HIV and related diseases & collaboration
donated blood to prevent transmission through
with partners
transfusion. Diagnostic tests are also instrumental for
surveillance, providing epidemiological data to monitor
• Diagnostics: screening & diagnosis
the spread of the HIV/AIDS epidemic. Use of reliable
tests and appropriate testing strategies are important in the
• Treatment/ ARV’s, TB: Monitoring
prevention
of mother-to-child transmission, and for
efficacy
voluntary counselling and testing services. In these
settings, simple/rapid diagnostic tests can provide
• Care and follow up : Improving
Quality of care
accurate, same-day diagnosis resulting in timely treatment
where needed.
Once individuals are identified as being infected with
HIV, and/or related opportunistic infections, diagnostics are used to determine the appropriate treatment
intervention. For example, diagnostic tests may indicate resistance to certain drugs and thus provide guidance
on appropriate drug regimes. Subsequent diagnostic technologies are required to monitor the safety and effec
tiveness of treatment on a continuing basis. Additional diagnostic imaging and basic clinical laboratory tests
will provide information to ensure the ongoing quality care and support provided to those infected with HIV
and suffering from associated infections and illnesses such as TB.
Several key activities within BCT contribute to the provision of high quality, cost-effective health care as
related to the HIV epidemic. BCT aims to ensure that the diagnostic technologies used in diagnosis and screen
ing meet the highest standards, and that they are available and used appropriately. The operational characteris
tics of HIV test kits are evaluated, and reports providing technical information on their quality are issued
regularly. Alternative HIV testing strategies for the various testing objectives have been developed, and are
updated as required. The WHO HIV Test Kit Bulk Procurement Scheme facilitates access to high quality, low
cost diagnostic tests to Member States and UN agencies.
BCT is assessing the available technologies for monitoring the efficacy of HIV treatment (CD4, p24, and viral
load testing) that are suitable for countries with limited facilities and resources. Tool kits for clinical laboratory
monitoring at the district hospital (1st referral) and centralized referral hospital (2nd referral) levels are currently
being developed. To ensure reliable results, existing schemes for monitoring laboratory performance will also
be expanded to cover all HIV related diagnostic areas.
BCT is also providing guidance and training to support and improve health care services in areas of blood
safety, clinical laboratory and diagnostic imaging, all of which contribute to improved quality of care. Capacity
building to improve skills and knowledge at all levels for appropriate diagnostic support is an overarching
aspect of BCT’s activities.
Many of these activities are carried out in collaboration with other WHO departments and with UN agencies
such as UNAIDS and UNICEF, WHO Collaborating Centres and key international partners. These partnerships
are, and will continue to be, an integral part of BCT’s response to the HIV Initiative.
Blood Safety and Clinical Technology * World Health Organization
1211 Geneva k Switzerland • Fax: +41 22 791 4836 ° www.who.int/bct
HIV and YOUTH
Pledge 25 Club
Zimbabwe's youth realized that their future was in their own hands. This is why, some
years ago, a project was launched by youth themselves which has significantly contributed
to the success of the nation’s safe blood supply. The project, already being emulated in
neighbouring countries, is called the “Pledge 25 Club".
HIV caused Blood Transfusion Services across the world to rethink seriously their blood donor recruitment
strategies and, in 1989, Zimbabwe started targeting an as yet untapped pool of low-risk donors: school
children aged 16-19. However, history proved that - successful as the programme was - most school blood
donors ceased to donate regularly upon leaving school. The Pledge 25 Club was therefore created by and
for school leavers, who pledge to make at least 25 donations of blood. Members also actively share
information and knowledge with other current and prospective donors and, in this way, help to promote
healthy lifestyles, and reduce the level of HIV prevalence in peer groups and the amount of infected blood
collected. Club members were honoured on World Health Day in April 2000, and the first group of Club
members had their graduation ceremony - to mark their 25th donation at the Annual General Meeting of the National Blood Transfusion
Service (NETS) on 6 September 2000. Many of the pioneers are
considering the formation of a “Pledge 50” division.
The Club elects national and provincial administrative committees to
ensure the running of their affairs. Selected Peer Donor Promoters now
assist the NBTS with the recruitment of voluntary, non-remunerated,
regular donors from low-risk groups and in turn, the NBTS supervises
and counsels the Club.
It is critical to reiterate the self-motivated commitment of the pupils themselves that has led to a window
of hope for the national blood bank. It is thanks to the students, who instituted a National Youth Blood
Donors Day, that the availability of safe blood at peak times of the year such as Christmas, has gone from
50% to 80% and is still rising. Other statistics speak for
themselves: HTV sero positivity among blood donors has
HIV rates in donated blood (1989 - 1999)
fallen from an average of 4.45% in 1989 to 0.7% in 1999
(compared to sero prevalence in the sexually active
population in general: 25.8%); 99.3% of all blood
collected in 1999 was HIV-negative; and nearly 70% of
the 82,365 units collected in this same year were donated
by pupils.
“...and we have about 1,000 [Pledge 25 Club members] who have already reached their certificate, so
that's how successful the programme has been”.
(Dr T.J. Stamps, Minister of Health and Child Welfare, Zimbabwe
during an interview for World Health Day 2000 on Safe Blood Starts With Me)
\2
.a practical answer
to a vital need
The Haemoglobin Colour Scale
is a simple, reliable and inexpensive tool
developed by the World Health Organization
to screen for anaemia in the absence of
laboratory-based haemoglobinometry.
Anaemia
is the most serious complication of iron de
ficiency and a significant cause of death.
More than half of the pregnant women in
developing countries suffer from anaemia.
The accurate estimation of haemoglobin lev
els is an essential prerequisite in a variety of
other health issues, such as trauma care, se
lection of blood donors, epidemiological
studies, and general primary health care.
Detection and management
of anaemia
The measurement of haemoglobin has long
been recognized as fundamental in routine
health checks, for the diagnosis and treat
ment of disease and, given the global inci
dence of anaemia, in public health care.
The measurement of haemoglobin in blood
as an indicator of anaemia has traditionally
relied on the services of a well-equipped
clinical laboratory'. Simple techniques do of
course exist, but even these are relatively ex
pensive and require commercial reagents, a
good degree of technical skill and are not
readily available in peripheral health clinics
or at point of care for clinicians and mid
wives.
In primary' health care centres, when labo
ratory facilities are not available, anaemia is
usually' diagnosed from clinical signs (pallor
of the conjunctiva, tongue, palms and nail
beds, using anaemia recognition cards if
available), although accurate interpretation
of these signs depends a great deal on effec
tive training. However, in rural areas where
anaemia is common and where appropriate
prevention and treatment strategies may be
most beneficial, an alternative method is
needed to screen for anaemia easily and eco
nomically'. The less sophisticated the device,
the more easily we can respond - in a sus
tained way - to the needs of primary’ health
care centres in developing countries.
Revisiting a
powerful concept
The idea is not new.Tallqvist, among others,
tried in vain as long ago as 1900 to substan
tiate the theory' that the colour of a drop of
blood could reliably indicate anaemia.
The blood would be matched against pre
determined hues of red, telling the health
care worker whether the patient is anaemic
and, if so, the severity' of the condition The
colour printing technology and test-strip pa
per available at that time were such that the
results were inaccurate and the concept
shelved.
It has taken modem technology to perfect
the material on which blood can be absorbed,
and computerized spectrometric analysis to
identify' colours that can accuratelv match
shades of haemoglobin at different concen
trations.
Following many y'ears of development by
WHO, the Haemoglobin Colour Scale will
be available from May 2001 as a simple and
effective medical device for the accurate es
timation of haemoglobin levels in blood.
This will indicate whether the patient is
anaemic and, if so, the severity of anaemia
in clinical terms (see diagram below). It will
not identify minor changes in haemoglobin
during treatment, but rather assist in the
management of any patient with suspected
anaemia, e.g. to decide whether a patient
may require a blood transfusion/' a blood
count, be referred for laboratory tests or to a
hospital or clinic for treatment7.
14
12 g/dl or more:
not anaemic
12
10
8-11 g/dl: mild to
moderate anaemia
8
The less sophisticated the device,
the more easily we can respond...
For severe anaemia, the Scale shows a sen
sitivity' of 95% and a specificity of 99.6%.To
distinguish normal Hb levels from mild
anaemia, the sensitivity and specificity are
98% and 86% respectively, results that are
well above the reliability of any clinical meas
urement.4-8
Using a photometer (HemoCue©) as a ref
erence, the Scale was compared with the
copper sulphate specific gravity method that
is traditionally' used to screen blood donors
for anaemia.The scale was accurate to 98%
in distinguishing among 2,800 volunteer
blood donors those with normal Hb from
those rejected because of anaemia.The Scale
was more reliable than copper sulphate, the
tests giving 2.4% and 5.4% false readings re
spectively'1. Moreover the copper sulphate
presents a potential environmental hazard
in the disposal of used solutions.
As a result, it was shown that a half-hour
training session was sufficient for health
workers to estimate haemoglobin to within
Ig/dl, and assess levels of anaemia much
more effectively than by traditional clinical
diagnosis.
Important: clear instructions for use accompany
the scale, which must be followed.
Haemoglobin Colour Scale
starter kit:
• booklet of 6 shades of red;
• instructions for use,
• dispenser of 200 specially absorbent test
strips in handy box;
• 4 spare dispensers (800 tests).
Refill kits contain dispenser boxes of test
strips only.
6-7 g/dl: marked anaemia
N.B. Use only the approved test strips provided.
4-5 g/dl: severe anaemia
The Starter Kit will be available in English
and French, followed by Spanish, Russian,
Arabic, Chinese, Portuguese, and other lan
guages as appropriate.
6
4
less than 4 g/dl: critical
N.B. Colour and size of the Scale arc approximate
and for illustration only. Whilst g/1 is acknowledged
as the standard measurement, g/dl is still in com
mon use for clinical and public health purposes.
How does it work ?
The Haemoglobin Colour Scale comprises a
small card with six shades of red that repre
sent haemoglobin levels at 4, 6, 8, 10, 12 &
14 g/dl respectively'. The device is simple to
use:
• place a drop of blood on the test strip pro
vided
• wait about 30 seconds
• match immediately' the colour of the blood
spot against one of the hues on the scale.
Sensitivity and specificity of the Scale to
screen for anaemia
Validation in the field
Since the early series of studies carried out
by WHO in 1995 and the first published data
describing the device in the same year1, ex
tensive testing and field trials have been car
ried out on the performance of the Scale. An
international validation study' and recent
published papers have confirmed its reliabil
ity when used in general health centres and
antenatal clinics, and in blood transfusion
centres for donor selection (see comprehen
sive bibliography).
Training
In a validation study, most results were ac
curate to within 1-1.5 g/dl. Further analysis
showed that the discrepancies in the results
of the original study were largely' due to a
lack of training and thus incorrect technique,
e.g. not waiting for 30 seconds, reading in a
shadow or not having an adequate sized
drop of blood.78
How much is it?
The Starter Kit with approved test strips for
1,000 tests will cost about USS 20.This works
out at less than 2c per test - cheaper than
copper sulphate and considerably less than
a laboratory test - with the cost per test fall
ing at each purchase of refills.
The Scale was much more
reliable than copper sulphate
Summary
After several years of development and field
trials, the Haemoglobin Colour Scale will
move to production and distribution in May
2001, pnmarily to assist developing countries
in the detection and management of anae
mia. The device is not intended to compete
with existing laboratory haemoglobinometry,
but rather increase access to health tech
nology for peripheral health services in
resource-poor settings.
The clinical utility' of the Scale has been dem
onstrated in the screening of blood donors
for anaemia, malaria management, antena
tal and child health programmes, iron
therapy' control, m hookworm infection and
in decisions to refer severe anaemia patients
for hospital treatment. It will also be an ex
tremely useful tool for point of care anaemia
checks anywhere, mainly for women and
children suspected of being anaemic.
Use of this medical device requires no spe
cialized training. It doesn't depend on elec
tricity or batteries and needs no mainte
nance. It is portable and the results are im
mediate.
The Haemoglobin Colour Scale is a practi
cal answer to a vital need, a need contained
in the first strategic direction of WHO: to
reduce mortality and morbidity, particularly
of the world's poor and marginalized
populations.
The Haemoglobin Colour Scale
requires no specialized training,
electricity or battery ... It's portable,
and the results are immediate
Bibliography
1.
Stott GJ, Lewis SM. A simple and reliable method for estimating
haemoglobin. Bulletin of the World Health Organization, 1995,73:369373
2.
Munster M et al. Field evaluation of a novel haemoglobin
measuring device designed for use in rural setting. South African
Medical Journal, 1997, 87:1522-1526
3.
Beales PE Anaemia in malaria control: a practical ap-proach./bitmfc
ofTropical Medicine & Parasitology, 1997,91: 713-718
4.
Lewis SM, Stott GJ, Wynn KJ. An inexpensive and reliable new
haemoglobin colour scale for assessing anaemia. Journal of Clinical
Pathology, 1998, 51: 21-24
5.
Van den Broek NR et al. Diagnosing anaemia in pregnancy in
rural clinics: assessing the potential of the Haemoglobin Colour
Scale. Bulletin of the World Health Organization, 1999, 77:15-21
6.
Montresor A et al. Field trial of a haemoglobin colour scale: an
effective tool to detect anaemia in preschool children. Tropical
Medicine and International Health, 2000, 5:129-133
7.
Gosling R et al. Training health workers to assess anaemia with
the WHO haemoglobin col-our scale. Tropical Medicine and
International Health, 2000, 5: 214-221
8.
Ingram CF, Lewis SM. Clinical use of WHO haemoglobin colour
scale: validation and critique. Journal of Clinical Pathology, 2000, 53:
933-937
9.
Lewis SM, Emmanuel J. Validity of the haemoglobin colour scale
in blood donor screening. Vox Sanguinis, 2001, 80: 28-53
Find out more...
For further information on how to procure
the Haemoglobin Colour Scale,
please contact the WHO Secretariat
at the following address:
The Scale does not replace a
laboratory test. It is a clinical device
for use near the patient at point
of care, where no immediate
laboratory facility exists
Department of Blood Safety and Clinical Technology
World Health Organization
20 avenue Appia
1211 Geneva 27
Switzerland
Fax: +41 22 791 4836
Email: hbcolourscale@who.int
Web page: www.who.int/technology/
Blood Safety and
Clinical Technology
This document was produced by the Department of Blood Safety and Clinical Technology
Ordering code:WH0/BCT/01.01
Printed: May 2001
Copies may be requested from:
World Health Organization
Department of Blood Safety and Clinical Technology
CH-1211 Geneva 27, Switzerland
Fax:004122-7914836
E-mail: velazquezi@who.int
© World Health Organization 2001
This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by
the Organization.The document may, however, be freely reviewed, abstracted, quoted, reproduced and translated,
in part or in whole, but not for sale nor for use in conjunction with commercial purposes.
Maps: The designations employed and the presentation of material on maps included in this document do not
imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the
legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers
or boundaries. Dotted lines represent approximate border lines for which there may not yet be full agreement.
Design & Layout: L'lV Com Sari, Morges, Switzerland
WHO/BCT/01.01
Original: English
Distribution: General
Blood Safety
and Clinical
Technology
2000-2003
Strategy
Department of Stood Safety and
Clinical Technology
World Health Organization,
Geneva
Contents
Abbreviations
IV
Preface
V
Introduction
1
1
2
2
5
BCT and WHO's corporate strategy
Organization of the BCT Department
Main areas of work
Main activities
The Blood Safety and Clinical Technology Strategy
Policy
Target 1. Formulation, implementation, monitoring, and updating of national policies and plans
Target 2. Global collaborations
Target 3. Global systems to monitor impact
Quality and Safety
Target 4. Development and establishment of norms and standards: guidelines and reference materials
Target 5. Research, development, and evaluation of new technologies and methods
Target 6. Development and implementation of national quality system
Access
Target 7. Continuous and sufficient quantities of appropriate equipment and supplies
Use
Target 8. Appropriate collection, processing, and clinical use of blood and blood products
Target 9. Appropriate use of diagnostic imaging and laboratory technologies
Target 10. Safe and appropriate use of injections
Target 11. Appropriate use of devices and clinical technologies
Key Initiatives
Global Collaboration for Blood Safety
Safe Injection Global Network
Quality Management Project for Blood Transfusion Services
General Background
Quality Management Training for Blood Transfusion Services
Establishing a Regional Quality Training Centre in each WHO Region
Establishment of Regional External Quality Assessment Schemes
Establishment of Regional Quality Network in Blood Transfusion Services
Providing Appropriate Diagnostic Support in HIV/AIDS Control
7
7
7
9
10
10
10
13
15
16
16
18
18
20
21
22
27
27
30
32
32
33
35
35
36
37
Information, Education, Communication and
Resource IVlobilization Strategy
39
Information, Education and Communication
a9
Resource Mobilization
39
Annex: Summary Budgetary Figures
41
WHO
Blood Safety* and
Clinical Technology:
2000-2003 Strategy
Abbreviations
ABO
AD (syringes)
AFRO
AMRO
BCC
BRM
BTS
BTTI
CBER, USA
CLB, NL
DSS
ECBS
EHTP
EQAS
FDA
GHTF
HbCS
HCWM
HIV/A1DS
HTMM
IAEA
IBGRL, UK
IEQAS
IREQAS
ISBT
ISO
ISTH
NAT
NEQAS
NIBSC, UK
O.i.
PAHO
PIC/S
REQAS
SADC
SEARO
SOGAT
TB
SUP
TSE
TTI
UNAIDS
WHO ECBS
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
WPRO
WSH
blood group serology
autodisable (syringes)
African Regional Office of WHO
/American Regional Office of WHO
blood cold chain
biological reference material
blood transfusion service
blood time temperature indicators
Central Bureau for Evaluation and Research WHO Collaborating
Centres for Biological Standards. USA
Central Laboratory of Biological Standards, who Collaborating Centres
for Biological Standards, the Netherlands
district surgical services
Expert Committee on Biological Standardization
essential health care technology package
external quality assessment schemes
Food and Drugs Administration US
Global Harmonization Task Force
haemoglobin colour scale
health care waste management
human immunodeficiency virus/acquired immunodeficiency syndrome
health care technology management and maintenance
international Atomic Energy Agency
International Blood Group Reference Centre. WHO Collaborating
Centre for Blood Grouping Reagents
international external quality assessment scheme
interregional external quality assessment schemes
International Society for Blood Transfusion
International Organization for Standardization
International Society on Thrombosis and Hemostasis
nucleic acid amplification technology nucleic acid-based tests
national external quality assessment schemes
National Institute of Biological Standards and Control. WHO
Collaborating Centres for Biological Standards
opportunistic infections
Pan American Health Organization
pharmaceutical inspection co-operation scheme
regional external quality assessment schemes
Southern African Development Community
South-East Asia Regional Office of who
WHO Working Group for the Standardization of Gene Amplification
Technology
tuberculosis
supplies service
transmissible spongiform encephalopathy
transfusion transmissible infection
Joint United Nations Programme on H1V/AIDS
WHO Expert Committee for Biological Standards
Western Pacific Regional Office of WHO
water, sanitation, and health
Preface
illions of lives are saved each year through blood transfusions. However.
M
in many developing countries people still die owing to a lack of blood
and blood products while many millions more are at risk of being infected by untest
ed blood transfusions. In many countries, the lack of adequate blood donor recruit
ment services, combined with the high prevalence of infectious agents, leads to high
prevalence rates of infections in donated blood Overuse and inappropriate use of
blood are also factors to be addressed. There is a need to work globally to ensure
that blood and blood products are safe, accessible, available at reasonable cost.
used appropriately and are provided within a sustainable health care system This
impacts mostly on women, children and trauma victims, especially the poor.
Equitable and safe blood transfusion and injections are not readily available. This is
why they are the core of a vital, renewed programme within WHO. which we want to
strengthen to respond to the needs of all populations, and particularly the poor and
marginalized populations in the developing countries.
In most developing countries a lack of quality management for the safety of
blood and blood products, injections, diagnostic imaging, clinical and laboratory tech
nology services adversely affects the quality of care to the patients.
Furthermore. Blood Safety and Clinical Technology in most developing countries
suffer from a lack of finance, skilled manpower, inappropriate equipment and poor
quality management: medical equipment and devices are either not available, not
used or malfunctioning; consumables and reagents are lacking: and there is a dearth
of infection control and waste management systems
Thus, within the overall goal of ensuring equitable access to safe blood, quality
care and affordable technology, particularly in developing countries. WHO's objec
tives are to:
■ Increase access to safe blood, blood products and safe health care
technologies
■ Promote quality health care services that are supported by safe and costeffective technologies.
In the following pages, the global Blood Safety and Clinical Technology Strategy
is laid out. Included are brief descriptions of the key activities proposed tn the areas
of quality and safety of blood and blood products, injection safety, diagnostic imag
ing. clinical and laboratory technology services and medical devices. These activities
will result in:
✓ National, regional and global policies, plans and strategies which will improve
access, quality and safety of blood and blood products, injections, diagnostic
imaging and clinical laboratory services
/ Systems developed leading to better coordinated, organised, managed and
funded blood transfusion programmes
/ Access to safe blood in all main hospitals in more than 6O'.'o of developing
countries
Z Reduction of diseases attributable to unsafe blood, unsafe injections, or lack of
access or unsafe use of diagnostic and health care technologies
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
V Validated norms, standards and biological reference preparations
✓ Upgraded technical expertise of national regulatory authorities for the
evaluation and control of blood products anil related biologicals
✓ Knowledge and skills in the areas of blood transfusion medicine and clinical
technology including laboratory services and diagnostic imaging
■/ Information systems to monitor impact
Z Global collaboration to build consensus on effective strategies to improve
blood safety and injection safety.
Under the key cross-cutting themes of policy, quality and safety, access and use.
we believe these activities are integrally coherent within the strategy, and that they
best respond to the expressed needs in the countries. The BCT Strategy is a compo
nent of the new Health Technology and Pharmaceuticals Strategy, which is in turn
coherent and consistent with WHO’s overall corporate strategy, as will be described
below.
In many cases these activities are the very first steps on the long road to ensure
blood safety. Thus, they are designed as being progressive. There is a need to lay
down a foundation for the major efforts that are yet to come before everyone tn the
world has access to safe blood, blood products and safe health care technologies.
and to quality health care services that are supported by safe and cost-effective tech
nologies.
, / ,
Dr. Jean C Emmanuel
Director. Blood Safety and Clinical Technology
Health Technology and Pharmaceuticals
Geneva. May 2001
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Introduction —
Blood Safety and Clinical
Technology
he department of Blood Safety
T
and Clinical Technology was
established in 1998 as part of WHO'S
new cluster on Health Technology and
Pharmaceuticals (HTP). Its mission is to
promote the safety, quality and adequa
cy' of blood and blood products, injec
tions. diagnostic and clinical technolo
gies. and medical devices that are
essential for the provision of health
care.
BCT anrf WHO's
corporate strategy
an effective health dimension to
social, economic, environmental
and development policy.
The following figure illustrates how
tiie priority activities in the BCT Stra
tegy contribute to WHO's four strategic
directions.
BCT contribution in WHO’s four strategic directions
1. Reduce excess mortality of poor
and marginalized populations:
by increasing access to safe blood, blood products, injections,
clinical and diagnostic technology and medical devices.
Blood safety has been accorded a high
priority by the Director General, and is
an issue of concern to many WHO
Member States in the developed worlci
and all of the developing countries.
Acknowledging the importance of blood
safety, the World Health Day theme for
the year 2000 was “Safe Blood Starts
witii Me - Blood Saves Lives”.
WHO’s four corporate strategic direc
tions arc.
□ To reduce excess mortality.
morbidity and disability.
especially in poor and
marginalized populations
□ To promote healthy lifestyles and
reducing factors of risk to human
health that arise from
environmental, economic, social
and behavioural causes
□ io develop health systems that
equitably improve health
outcomes, respond to peoples’
legitimate demands, and are
financially fair
Q To develop an enabling policy
and institutional environment in
the health sector, and promoting
2- Reducing the leading
risk factors to
human health:
3. Developing
sustainable
health systems:
by creating a safe environment for the
by building sustainable management
use of blood and blood products,
capacity in the technologies involved in
injections, thus reducing the risk of
blood and blood products, injections, as
blood-transmissible and
fundamental components of sustainable
transfusion-related disease.
health systems.
4- Developing an enabling policy and institutional
environment, and promoting an effective health
dimension in development policies:
by developing global norms and standards and support national policies for
blood products and appropriate health technology, and within the framework of
agreed plans of action.
I his same summary’ diagram can
lie drawn lor each ol the departments
in the Health Technology and
Pharmaceutical Cluster, and is a con
vincing statement of the coherence of
BCT Strategy' witli that of HTP and WHO
as a whole.
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
In achieving its strategic objectives.
BCT is acutely conscious of the need to
forge strong partnerships to ensure that
blood safety and clinical technology is
included in wider health and develop
ment agendas. This includes such
major international initiatives that are
being steered by the department as the
Global Collaboration for Blood Safety,
the Safe Injection Global Network.
Regional Programmes lor Quality
Management for Blood Transfusion
Services . all of which are described
later in this document.
Organization of the
BCT Department
rhe Department has four teams that
address the following health issue
areas:
■ Blood transfusion safety
■ Quality and safety of plasma
derivatives and other related
substances
■ Safety of Injections
■ Diagnostic imaging technology
■ Laboratory technology
■ Clinical technology
■ Medical devices.
2 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
There are several overarching
themes that may be identified through
out the work of the department as a
whole. These include policy issues.
such as the promotion of sustainable
national programme, setting global
norms and standards for quality and
safety of blood products and related
biologicals. areas of research and
development and promotion of the
equity of access and use of blood.
blood products, injections, diagnostic
and clinical technology and medical
devices. Activities such as capacity
building and the facilitation of technolo
gy transfer are included among the key
strategies.
Of the three departments in the HTP
cluster, the department of Blood Safety
and Clinical Technology is the smallest.
It has limited manpower and budgetary
resources, despite the very important
role that it has been assigned. In order
to meet the concerns of Member states
and cany out its responsibilities, the
department is seeking to strengthen
manpower where required, outsource
activities where it is cost efficient, and
seek extra-budgetary' funds to cany' out
agreed strategic activities.
Main areas of work
Blood Transfusion Safety
The mission of the Blood Transfusion
Safety (BTS) team is to "promote the
formation of national blood programmes
which ensure the safely, quality and
adequacy of "blood and blood
components" to meet the needs of all
patients, transfused only when
necessary' and are provided as pan of a
sustainable blood programme within
the health care system"
Blood safety activities should be
seen in the context of promoting
sustainable national blood programmes
which ensure the safety, quality and
adequacy of "blood and blood
components", free from all transfusion
transmissible infections which include
among others: HIV. hepatitis B and C.
and Chagas disease.
Among tile strategic activities of
BTS are to:
1. Strengthen “blood transfusion
services" with necessary' guidelines
and national regulatory' authorities
with necessary guidelines.
recommendations, training materials
and technical support in the areas of:
national policies and plans for
establishment of organized nationally'
coordinated bt services, and
legislation/regulations.
2. Promote blood donor
programmes based on voluntary non
remunerated blood donors from lowrisk populations.
3. Promote the implementation of
quality management in blood
transfusion services.
4. Ensure the testing of all donated
blood for relevant transfusion
transmissible infections, blood
products using good manufactured
practices
5. Promote appropriate clinical use
of blood to prevent unnecessary
transfusions
6. improve the quality and safety of
blood transfusion services, especially
in developing countries
7. Further develop the Global
Collaboration for Blood Safety (GCBS).
B Expert Committee on Biological
Standardization (ECBS), the WHO
Committee responsible for setting
global physical and written stan
dards for biological substances
used in human medicine:
Subcommittee for Blood Products
and related Biologicals.
Safe Injection Global Network
(SIGN) Project
The B I S team works in close
collaboration with other clusters such
as FHS/AIDS /child and adolescent
health (CAH), HIV/AIDS (HSI), Making
pregnancy safer. (HSI) and Nutrition
(CDS).
duality and Safety of Plasma
Derivatives and Other Related
Substances
its mission is to “develop, establish and
promote WHO international Standards.
Guidelines and Technical
Recommendations to support
implementation of quality and safety
systems for the production and control
of blood products and related
biologicals. Main duties of the team
form an integral part of the WHO’s
normative functions tn the area of
quality, safety and biological
standardization of blood products and
related biologicals. including
biotechnology products, used in the
prophylaxis, therapy or diagnosis of
human diseases.
The strategic activities of QSD are to:
B Assess, apply and promote rele
vant new technologies and meth
ods for the standardization and
control of blood products and
related biologicals
□ Development of WHO Guidelines
and Recommendations for the
production and control of Blood
Products and Related Biologicals
n Provide technical advice/assistancc on quality assurance and
safely of blood products and
related biologicals to National
Regulatory Authorities and their
Control Laboratories
The Safe Injection Global Network
(SIGN) Project is an international coali
tion of stakeholders that share a com
mon interest in the safe and appropriate
use of injections. The SIGN coalition is
coordinated by a WHO secretariat
housed in the department of Blood
Safety and Clinical Technology. In addi
tion to housing the SIGN secretariat.
BCT conducts its own activities for the
safe and appropriate use of injections.
The strategic objectives of BCT for
the safe and appropriate use of injec
tions worldwide include.
B Policy: To strengthen the capacity
of countries to formulate, imple
ment, monitor, and update nation
al policies for safe and appropri
ate use of injections
B Quality and Safety: To ensure quali
ty and safety of injection devices
B Access: To ensure equitable avail
ability and affordability of injec
tion devices
B Use: To promote appropriate.
rational, and cost-effective use of
injections and other percutaneous
or permucosal procedures per
formed in medical and other
settings.
Diagnostic Imaging and
Laboratory Technology
The Diagnostic Imaging and Laboratory
Technology (DIL) team plays tin impor
tant role in strengthening the quality of
performance of health laboratory servic
es and imaging technology in countries.
with emphasis on the intermediate
level. It is comprised of a Diagnostic
imaging group and a Laboratory
Technology group.
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WHO
Blood Safety and
Clinical Technology:
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The mission of the Diagnostic
Imaging group is to promote quality.
quantity, and equity of diagnostic imag
ing services according to local needs".
and its main strategic activities include:
■ Preparing guidelines for effective
choices in diagnostic imaging
■ Creating educational programmes
and learning material for appropri
ate and adequate use and main
tenance of diagnostic imaging
equipment and procedures
■ Providing global guidance for
radiation protection in medicine
and global quality control of
radiotherapy itistallations.
The mission of the Laboratory
Technology group is to “promote and
advocate standards for establishing
appropriate medical diagnostic laborato
ry sendees to ensure quality of health
care and prevention of diseases’, and
its strategic activities include:
■ Global standardisation of labora
tory procedures and reagents for
the diagnosis, prevention and
monitoring of disease
■ Development and implementation
of internal quality control and
external quality assessment pro
cedures
■ Supporting countries by develop
ing strategies for the improve
ment of diagnostic laboratory
services, with emphasis on the
primary health care level
■ Facilitating transfer of appropriate
diagnostic laboratory technology
to countries in need through
capacity building and develop
ment. assessment and distribu
tion of information on technology.
Devices and Clinical
Technology
4 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
The Devices and Clinical Technology
(DCT) team facilitates the transfer of
techniques and devices for the clinical
treatment of patients. The team is com
prised of a group dealing with Devices
and one dealing with Clinical
Techi io!ogy (District Surgical Services;.
The Clinical Technologies group has
the mission to “promote the quality of
clinical care through identification, pro
motion and standardisation of proce
dures. equipment and materials panicu
larly at first referral level (district hospi
tal)". Its main strategic activities include.
■ The development of guidelines
on effective clinical procedures
particularly at the district level
(surgery, obstetrics, anaesthetics.
orthopaedics, etc.)
■ To advocate and promote the
development and use of selected
appropriate innovative equipment
and materials (oxygen concentra
tor. haemoglobin colour scale.
etc.)
■ To promote and facilitate the train
ing of health care providers to
improve clinical care and support
capacity building.
The Devices group has the mission to
“advocate and provide technical sup
port for appropriate health technology
to enable the expansion or develop
ment of sustainable and cost-effective
health services", and its strategic activi
ties include:
■ Supporting research and develop
ment of appropriate technology
for health services for countries in
need
■ Strengthening capacity building.
improving the process of equip
ment donations and technology
transfer in developing countries in
regard to the safety and efficacy
of devices (i.e.. selection, use and
disposal of skin-piercing medical
devices to ensure safety)
■ Supporting countries in the
application of health technology
for safe and efficient waste
management
■ Strengthening countries capacity
to improve health care technolo
gies management and mainte
nance within a broad context of
health systems and services
development.
in order io perform some of these
DCT activities, we are collaborating
intensively with departments in other
clusters. Worthy of note are the inter
cluster collaborations: BCT and the
Evidence and information for Policy
cluster's Organization of Health Services
Delivery (OSD) department for activities
on health technology management and
maintenance. Development of technical
guidelines and distance learning materi
al will be part of the management and
maintenance project for developing
countries: and also child and adoles
cent health (CAH). HIV/A1DS (HSI).
Emergency preparedness and response
(EHA). Making pregnancy safer (HSI).
(1-HI) Diagnosis of Tuberculosis
This activity will consider such
issues as: needs assessment (with the
assistance of a software based planning
and management tool called the
Essential Health care Technology
Package), spare parts, training, preven
tive maintenance, repair of existing
equipment and guidelines on medical
equipment donations. Based on WHO's
past experience on health technology
management, national projects will be
implemented or improved in selected
countries.
The second inter-cluster collabora
tion is between BCT and the Sustainable
Development and Healthy Environments
cluster's Protection of the Human
Environment (PHE) department, for activ
ities on health care waste management.
The strategy relies on the following ele
ments Development of a database.
preparation of guidance material, avail
ability of waste management options
and development of country plan.
SVUaiBB-D acfin'tyi'Sees
Each of the main activities of BCT are
described in the context of the BCT
Strategy in the next section, by primary
objective, overall target and giving the
critical indicators of performance. A fur
ther chapter lists the principal special
initiatives currently being undertaken or
I iroposed.
The BCT Strategy hinges on four
key primary objectives- policy, quality
and safety, access, and use. These
terms have a particular significance to
the Strategy, and often a particular
meaning, and thus it is worth providing
a description and rationale for the
choice of these primary objectives.
Policy
An absence of policies based upon the
quality cycle - in which action plans are
formulated, implemented, evaluated.
and updated - limits the ability to
progress tn blood and injection safety
as well as in diagnostic and clinical
technology. Thus our first objective is to
strengthen the capacity of countries to
formulate, implement, monitor, and
update national policies and plans for
blood, blood products, injections, diag
nostic. clinical technologies, and med
ical devices. This includes policies,
global collaborations, and global sys
tems to monitor impact.
Quality and Safety
Blood products and technology can
only reach the quality and safety
required for their intended use if the
necessary guidelines and systems are
in place to optimise processes, in addi
tion, appropriate controls must be
applied on the production and on the
product, as applicable. Thus, our objec
tive is to assist countries in ensuring the
quality and safety of blood and blood
products and related substances, injec
tions. diagnostic and clinical technolo
gies. and medical devices. This
includes the development of norms.
standards, establishment of guidelines.
and international reference preparations:
research, development, and evaluation:
and national quality systems through
comprehensive training and creation of
networks and strengthening the techni
cal expertise of national regulatory
authorities.
Access
rhe global database on blood safety
indicates that 80% of the world's
■ 5
WHO
Blood Safety and
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2000-2003 Strategy
population does not have access to reli
able and safe blood. Thus, a primary
objective of the BC.'l Strategy is to sup
port countries in ensuring equitable
availability and affordability of blood.
blood products, injections, diagnostic.
clinical technologies, and medical
devices. This includes ensuring continu
ous and sufficient quantities of appropri
ate equipment, reagents and supplies.
and strengthening their capacity to pro
duce basic supplies locally.
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Use
Access to appropriate health technolo
gy, including safe blood and safe injec
tions. can only be ensured to the extent
that they are used appropriately and in
a reliable manner. Thus a primary objec
tive is to promote the appropriate and
cost-effective use of blood, blood prod
ucts. injections, diagnostic, clinical tech
nologies. and medical devices. Use also
involves maintenance of equipment.
appropriate use of test kits and reagents
tn order to produce reliable results. An
additional aspect is training and building
the necessary skills to correctly use the
available health technology.
The Blood Safety and
Clinical Technology
Strategy
he four primary objectives of the
T
Blood Safety and Clinical
Technology relate to policy, quality and
safety, access and use. In this chapter, the
relevant targets within each objective
are discussed These are then illustrat
ed by the main activities proposed for
2000-2003. their expected outcomes.
and the ways in which we aim to meas
ure performance.
Policy
Target 1: Formulation, implementation, monitoring, and updating of
national policies and plans
Advocacy for nationally coordinated blood
transfusionprogrammes
Blood transfusion services in countries are often
given low priority and many are still very poorly
organized. Government commitment and sup
port for a well organized nationally coordinated
service is the first step to ensure sustainability,
and is a prerequisite to ensuring safe blood and
blood components.This commitment should
include financial support.
Thus, WHO aims to carry out a programme of
high-level advocacy with national governments,
ministries of health, ministries of finance and
ministries of education in respect of blood trans
fusion services. Each country should make the
political and financial commitment to establish
and maintain a nationally coordinated blood
transfusion service. WHO will achieve this by pro
ducing and distributing guidance materials on
developing national policies and plans, and by
holding workshops and undertaking personal
meetings with relevant government ministries
and health service officials.This activity also
relates in providing advocacy to the Ministry of
Health to ensure:
■ Availability of adequate trained staff at all
level in BTS
■ Economy of scale by centralising activities
■ Development of costing procedures
■ Regulation by competent national regulatory
authorities
■ Development of ability to handle disaster
situations.
WHO can act as a adviser and provide technical
assistance for bilateral or multilateral financial
support; contact ministries to discuss restructur
ing their blood programmes; organize a regional
workshop on national blood programmes,
including policies and plans; and expect to find
the restructuring of blood transfusion services in
progress in 2-3 countries.
The result of this programme will be a communication/advocacy/funding strategy on blood safe
ty (to build on the World Health Day on Blood
Safety launched in 2000).
The success of this activity will be measured by
the number of countries that have shifted
towards a nationally coordinated blood transfu
sion service, and the number of countries with an
appropriate financing system to ensure the sus
tainability of the blood programme and an
improvement in the Safety Quality and adequacy
of Blood Supply.
WHO
Blood Safety and
Clinical Technology;
2000-2003 Strategy
Strengthening diagnostic laboratories
through appropriate national policies
The majority of developing countries lack experi
ence both in the creation of national policies for
health laboratory services, and in the manage
ment of the national health laboratory services
network. As a result of the lack of national poli
cies, countries have not ensured that laboratories
meet the minimal requirements needed in order
to provide authorities with information for dis
ease surveillance and to support clinical services
in patient care effectively.
The objectives of WHO's activities are thus to for
mulate, implement and update national policies
and plans for clinical diagnostic laboratory servic
es and technologies to meet requirements for
disease surveillance and patient care. We ? aim to
create a generic policy and plan (i.e., standard
ised items that should be included in national
policies) to enable well functioning laboratories
within the health structure.
Steps in the process include the staging of two
inter-country workshops to prepare plans of
action;organizing an informal consultation on
the role of public health laboratories; and assess
ing the national laboratory network in four coun
tries, and providing them with advice on appro
priate strategies for the establishment of labora
tory quality systems.
staff at all levels receive proper training, and that
steps should be taken to avoid properly trained
staff members being tempted to leave govern
mental institutions.
Working with ministries of health to discuss the
structure and future development of diagnostic
imaging services, and organize regional work
shops on appropriate use of such services.
Among the indicators of performance will be the
number of countries with properly functioning
diagnostic imaging services, and the number of
countries with sufficiently trained staff.
Figure 1:
Regulation of the BTS
Policy/plan and legislation 37%
■ Policy/plan or legislation 37%
■ None 26%
Clearly, the success of this activity will be meas
ured by the number of countries with a national
policy, plans, for laboratory services; developed
and/or implemented.
Safe and appropriate use of injection
policies
Nationally coordinated use of appropriate
and safe diagnostic imaging services
8■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
In at least one third of all patients, diagnostic
imaging is an absolute requirement for proper
diagnosis and treatment, and the need increases
as the life expectancy of the population is
improving. In several developing countries, such
services are either insufficient, or not at all avail
able, and national coordination is often lacking.
The main reason for this is the lack of properly
trained staff.The salaries offered to properly
trained personnel in governmental institutions
are generally too low compared with those
offered by private institutions. We advocate that
The aim of this activity is to strengthen the
capacity of countries to formulate, implement,
monitor and update national policies for safe and
appropriate use of injections.
Key areas of work include (1) advocacy for
national policies and plans for injection safety, (2)
global monitoring system for injection safety
(including estimation of the global burden of dis
ease attributable to unsafe injection practices
and standardized tools to assess and evaluate
injection practices), and (3) maintenance of the
Secretariat of the Safe Injection Global Network
(see also the section on Key Initiatives below).
Indicators of the performance of this activity
include (1) the number of countries with policies
and plans for safe and appropriate use of injec
tions, (2) the availability of a Global Database on
Injection Practices and (3) the number of associ
ates in the Safe Injection Global Network.
Advocacy for national policies and plans
for district surgical services
Many patients presenting at district hospitals
require surgical treatment for trauma, obstetric,
orthopaedic and abdominal emergencies, but
often surgery cannot be safely postponed to
allow the transfer of the patient to a secondary
or tertiary-level hospital. In many developing
countries, acute surgical and anaesthetic care in
district hospitals is provided by inadequatelytrained, non-specialist medical, nursing and para
medical personnel, with limited facilities, equip
ment and supplies. The poor organization and
inadequate resourcing of district surgical services
contributes to unacceptable rates of mortality
resulting from trauma, obstetric complications,
non-traumatic surgical disorders and disability
resulting from injury.
The objective of this activity is to improve stan
dards of surgical and anaesthetic care at firstreferral level, particularly in general surgery,
anaesthesia, obstetrics and gynaecology, trauma
tology, orthopaedics and rehabilitation. WHO will
provide advocacy to Ministries of Health to pro
mote government commitment and support for
the development of effective district surgical
services, with adequate human and financial
resources. It will also promote the development
of policies and plans at both national and district
level to strengthen district surgical services,
including:
■ Organization and management of district
surgical services
■ Education programmes for all personnel
involved in surgical and anaesthetic care, in
conjunction with academic institutions and
professional bodies
■ Upgrading, repair and maintenance of district
hospitals to required standards
■ Appropriate physical facilities and clinical
support services for surgical, obstetric and
acute care
■ Appropriate equipment and instruments
■ National systems for the supply of essential
drugs, surgical supplies and other consum
ables required for common surgical and
obstetric emergencies
■ National quality systems for surgical services,
including standards, clinical guidelines, stan
dard operating procedures, records and audit.
The activity will include the preparation of guide
lines and recommendations on the organization
and resourcing of essential surgical services at
first-referral level.This will be followed by region
al workshops to promote the development of
national policies and plans for district surgical
services and continuing education for all person
nel involved in acute surgical care.
Indicators for monitoring this activity will include
the number of countries that develop and imple
ment national policies and plans to strengthen
district surgical services; the number of countries
that establish continuing education programmes
in acute surgical care; the number of countries
that establish systems to ensure adequate and
reliable supplies of drugs, surgical supplies and
other consumables; the number of countries that
establish national quality systems in surgical
services.
Policy
Target 2: Global collaborations
WHO will participate actively in world-wide net
working through the Global Collaboration for
Blood Safety (GCBS) and the Safe Injection Global
Network (SIGN), both of which are described
among the key initiatives of the Strategy in
Chapter 3. Success in these endeavours is meas
ured by the number of countries joining the col
laborations as associates.
K 3
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Policy
Target 3: Global systems to monitor impact
Global Database on Blood Safety
Information on blood and blood products safety
and on blood transfusion services in countries
and regions needs to be collected and analysed
in order to assess needs, formulate strategies,
plan, implement and evaluate activities, and con
duct research and assist the various bilateral and
multilateral agencies to coordinate and effective
ly implement support projects. The objective of
this activity is to collect and analyse data from all
countries on blood and blood product safety as
the basis for effective action to improve safe
blood transfusion capabilities globally
Questionnaires on blood and blood products
safety and on blood transfusion services have
been developed and are being sent out
bi-annually. Based on the replies received, the
questions have been refined in order to enhance
the scope of data collection. Questionnaires are
being translated into the main WHO languages
and additional background information will be
provided to facilitate the completion of the ques
tionnaire. Data are analysed per region and glob
ally; a summary of the findings are made avail
able through the WHO web-site, and printed
reports are issued bi-annually.
Among the expected outcomes of this activity
are a global database for blood safety and a
global database for injection practices (with
annual updates). Indicators to measure perform
ance include the number of countries for which
complete information required for progress
indicators is available.
Quality and Safety
Target 4: Development and establishment of norms and standards:
guidelines and reference materials
The principal activities undertaken in support of
this target are given below. In general, a range of
results is expected, including WHO recommenda
tions and guidelines for the quality and safety of
blood, blood products, and related substances,
WHO biological reference preparations for blood
products, related substances, WHO reference doc
uments on diagnostic imaging and laboratory
diagnostics, international standards on medical
devices, the harmonisation of medical devices
regulations, and strengthen national regulatory
authorities for devices and biologicals.
1O|
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
These are measured by reviewing the number of
countries implementing WHO recommendations
and guidelines on quality and safety of blood,
blood products, and related substances, the num
ber of institutions with improved efficiency and
quality of diagnostic imaging and laboratory
services, the number of standards and WHO
international biological reference preparations
developed and used, and the number of coun
tries implementing regulations on medical
devices and biologicals based upon international
standards.
International Biological Reference
Materials for Blood Products and Related
Biologicals
This activity aims to develop, establish, and pro
mote international biological reference materials
(physical standards) which form the basis for
global comparability of biological activities in
blood products and related biologicals used in
prophylaxis, therapy and diagnosis of human dis
eases.The production of these materials involves
considerable international collaboration and
coordination of laboratory work, in both devel
oped and developing countries as appropriate,
through WHO international collaborative studies,
the results of which are considered by the Expert
Committee on Biological Standardization, and if
acceptable established.The following activities
are included under this item:
■ Biological Standardization in thrombosis and
haemostasis
■ International Biological Standards for in vitro
diagnostic procedures
■ Review and update of the WHO International
Standards for Blood Grouping Reagents
■ WHO Reference Preparations for Diagnostic
Kits used for the detection of HBsAg, anti-HCV
and anti-HIV antibodies
■ Standardization of Nucleic Acid Amplification
Techniques (NAT) for virological safety testing
■ WHO Biologicals web site:a catalogue of WHO
international biological reference prepara
tions established by the WHO Expert
Committee on Biological Standards is pub
lished via Internet at the following address:
http://www.who.int/technology/biological.ht
ml.This Catalogue is updated annually to
include the new adoptions and discontinua
tions of materials by the Expert Committee. At
the request of the Expert Committee, web
hyperlinks will be developed with available
web sites of the WHO International
Laboratories for Biological Standards, national
regulatory authorities and relevant interna
tional pharmacopoeias. A database for nation
al biologicals regulatory control laboratories is
also under development so that we can
assure the widest promotion of WHO guide
lines and technical recommendations and
international reference materials world-wide.
documents and form the basis of national stan
dards and technical regulations. The norms and
standards established by WHO form the basis for
harmonization of biological products world-wide.
Among the indicators measuring the perform
ance of this activity are: the increase in the level
of harmonization on regulation between coun
tries; the number of countries implementing reg
ulatory programmes for the evaluation and con
trol of blood products and related biologicals
according to WHO Guidelines and recommenda
tions. The following activities are included under
this item:
■ Guidelines on viral inactivation/removal pro
cedures for plasma and plasma derivatives
■ Guidelines for the control and standardization
of Factor VIII and Factor IX biological meas
urements
■ Guidelines on technical issues regarding plas
ma contract fractionation
■ Guidelines for the collection of plasma for
manufacture of plasma derived products.
Biological
Substances
International Standards and Reference Reagents
WHO guidelines and recommendations for
the production and control of blood
products and related biologicals
WHO recommendations and guidelines on the
production and quality control of biological
products, including blood products, constitute an
authoritative guidance for national regulatory
authorities and for manufacturers. The nature of
blood products and related substances raises
complex issues surrounding standardization,
quality control and safety, which require coordi
nated research and consideration on an interna
tional level. In practice, WHO standards, guide
lines and recommendations serve as advice to
Member States for incorporation in to guidance
■11
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Expert Committee on Biological
Standardization
The programme for developing WHO internation
al biological reference materials, guidelines and
recommendations for blood products and relat
ed biologicals is approved by the WHO Expert
Committee on Biological Standardization.The
WHO Expert Committee on Biological
Standardization is supported and assisted by the
interdepartmental biologicals cross-cutting quali
ty assurance group, located in the departments
of Vaccines and Biologicals and Blood Safety and
Clinical Technology. A subcommittee structure
specific to the areas covered by the Committee,
including blood products and related biologicals,
aims to ensure best interactions with national
regulatory authorities and systematic consensus
building regarding international standards,
guidelines and recommendations.
This activity aims at 1) ensuring the adoption of
guidelines on the quality assurance of blood
products and related substances, 2) the establish
ment of WHO international biological reference
preparations, 3) providing guidance for the
preparation, characterization and establishment
of international and other standards and refer
ence reagents for biological substances, 4) sup
porting regulatory research to ensure quality and
safety of plasma and plasma derived products,
and 5) technical coordination with medicines
control authorities, pharmacopoeias, WHO labo
ratories for biological standards and
Collaborating Centres, NGOs, international scien
tific societies, manufacturers associations and
other interested parties.
Harmonization on the regulation of
medical devices
The regulation of medical devices is an increas
ingly important component of health care that is
growing in complexity. At a time when developed
countries have installed quality systems and qual
ity control, only a few developing countries have
functional systems to regulate imported or locally
manufactured medical devices (which would
assure their safety and effectiveness), or the tech
nical capacity to implement these.
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
The objective of this activity is to cooperate with
WHO regions for the development of regional
projects in the area of medical device regulation.
This would include joint activities with the Global
Harmonization Task Force (GHTF), a multinational
consortium formed in 1992, and its study groups
to unify international regulatory requirements.
WHO would encourage more countries to join
the Task Force, in order to benefit from the expe
riences of its participant nations and avoid the
further proliferation of disparate regulatory
regimes for medical devices.
The specific activities include: the translation and
circulation of the existing documents (the revised
FDA Model program for medical devices:an
international guide, and the Guideline for the
development of medical device regulation pre
pared for PAHO) for comments; the revision of
the existing documents and the development of
a new draft on medical device regulation to
come with our WHO guideline by 2002; the par
ticipation at the GHTF conferences and contribu
tion to the work of study group 2 on vigilance
and post market surveillance (devices problem,
recalls, and alerts to the global community).
Regional workshops on the regulation of medical
devices will be staged. We will promote and iden
tify information sources for medical devices regu
lation, establish a uniform format to certify that
product exported by countries comply with their
domestic regulatory requirements.
Among the indicators measuring the perform
ance of this activity are: the increase in the level
of harmonization on regulation of medical
devices between countries; the number of coun
tries implementing regulatory programs for med
ical devices according to WHO guidelines and
recommendations; the number of countries with
national external medical devices quality assess
ment schemes increased.
Quality and safety of injection devices
Quality and safety of medical devices starts with
good quality systems and controls during the devel
opment and manufacturing phase of the device.
This aim of this activity is to ensure the quality
and safety of injection devices by working in
close relation with the industry on the organiza
tion of clinical trials for evidence based decision
on recommendation for new technology and
improvement of the existing one.
Key areas of work include (1) providing safer
injection device by carrying our field evaluations
of newer, safer injection devices and (2) establish
ing an international vigilance system for injection
devices.
Indicators of the performance of this activity
include (1) the number of appropriate new
devices and equipment that have been evaluated
and (2) the existence of an operational system to
control the quality of injection devices.
Establishing norms and standards for
medical devices
Norms and standards are essential tools to
ensure the quality and safety of- medical devices.
An important part of this activity will be to pro
vide coordination for the better control of the
application of international norms and standards.
Ensuring the greater participation of all the
stakeholders will be our major objective.The
International Organization for Standardization
(ISO), and federation of national standards bod
ies, will be assisted by WHO to build more
bridges for a better medical devices standardiza
tion throughout the world.
To achieve this WHO will Establish or reinforce
liaison status with ISO and provide comments
on the work of some ISO technical committees
(TC 84,TC 210..... ), for the better control of the
application of international norms and stan
dards and finally to ensure a greater participa
tion of all the stakeholders.The development of
norms and standards will be a join activity
between medical device manufacturers, regula
tors, users of the medical device, the Global
Harmonization Task Force (GHTF) and ISO. Our
activity will focus on some target groups as the
autodisable (AD) syringe manufacturers to
begin the process of drawing up norms and
standards on AD syringes for therapeutic appli
cations, as a contribution to the injection safety
project. An aide-memoire on medical device
quality and safety will be prepared.
The success of this activity will be measured by
the number of national regulations referring to
norms and standards; the availability of interna
tional standard for AD syringes; the number of
syringe manufacturers producing safe syringes
according to international standards.
Quality and Safety
Target 5: Research, development, and evaluation of new technologies
and methods
Among the principal results of the activities
aimed at achieving this target are: 1) internation
al reference preparation for new technologies for
the diagnosis of infectious agents representing
an emerging threats to blood safety (e.g., trans
missible spongiform encephalitis), 2) the evalua
tion of reagents, procedures, and equipment for
laboratory services, including new tests for trans
fusion-transmitted infections, 3) the evaluation
and post market surveillance for new medical
devices, including syringes supporting safer use
of injections, 4) the evaluation of new waste dis
posal options, and 5) collaboration with partners
for the development of equipment, including
equipment related to safe processing of blood.
Specific activities are given below.
Evaluation of HIV test kits
Blood transfusion saves millions of lives but is
unfortunately also an efficient route of transmis
sion of HIV and other transfusion transmissible
infections (TTIs).Today, a new generation of test
kits for HIV are available (which are, for example,
able to detect simultaneously HIV antigen and
HIV antibody), enabling the early detection of
infection.This is a crucial line of defence in blood
safety. Increasing numbers of HIV test kits are
produced in developing countries, requiring an
independent organization such as WHO to assess
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their quality. Data on locally produced test kits
are lacking.The capacity of test kits to detect dif
ferent variants and strains is not uniform.
Therefore our evaluations are performed on
panels of more than 1000 well characterized
specimens from diverse geographical origins.
This activity, which is carried out with our WHO
Collaborating Centre in Antwerp, is thus aimed at
providing Member States, UN agencies and other
partners with technical information and advice
on the quality of HIV test kits, in order to enable
them to select screening tests most appropriate
for HIV testing strategies in different settings.
Specific activities include: the preparation, publi
cation and wide distribution of an evaluation
report on the operational characteristics of HIV
test kits; the initiation of evaluations of HIV
Ag/Ab tests, ongoing evaluation of new HIV
ELISA tests, including local produced kits, and the
publication of a report on these activities, cover
ing operational characteristics.
improve these testing technologies by evaluating
their operational characteristics and comparing
their intrinsic accuracy with current standards.
We will facilitate and increase access to informa
tion on the quality of simple HIV tests based on
new technology (serum, whole blood and saliva),
and define their appropriateness for particular
settings - for example blood transfusion centres,
antenatal clinics, voluntary testing and coun
selling settings.The evaluations will be carried
out in field sites in different WHO regions. Among
the indicators used to measure the performance
of this activity are: the increased accessibility of
WHO/UNAIDS information and technical guide
lines for HIV testing: independent data to enable
rational selection of the most appropriate whole
blood and/or saliva HIV tests in different settings;
improved HIV testing in antenatal clinics, volun
tary testing and counselling centres; the number
of saliva assays evaluated; the number of whole
blood tests evaluated; reports published; updated
recommendations issued.
Evaluation of test kits for the detection of
Evaluation of saliva and whole blood tests
hepatitis B and hepatitis C
for HIV
Saliva and whole blood tests are among the new,
simple HIV tests used in prevention and care
interventions for HIV/AIDS.This activity seeks to
Figure 3:
Blood safety
Developed countries
Developing countries
(high HOI)
(low and medium HDI)
It has been determined that, world-wide, 17 % of
all blood donations are not reliably tested for
transfusion transmissible infections (TTIs). This
number increases to 43% if we consider only the
non-industrialised countries. Very few non-industrialised countries test all blood donations for
either hepatitis B or C infection on a continuous
basis. Existing test kits are often inappropriate for
situations in developing countries and test kits
are often not affordable due to exorbitant prices
(particularly for hepatitis C). Recently new, appro
priate technology has become available for the
detection of hepatitis B and hepatitis C infection,
some of which are produced in developing coun
tries. However, comparative data on these new
test kits are lacking.
The capacity of test kits to detect different vari
ants and strains is not uniform.Therefore our
evaluations are performed on panels of wellcharacterised specimens (over 1,800 specimens)
from diverse geographical origins, including sero
conversion and low titre performance panels.
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Quality assessment of test kits are performed at
the WHO Collaborating Centre in London and at
various field sites in the different WHO regions.
Our aims are therefore to provide Member States
and agencies with technical information and
advice on the quality of test kits, so as to enable
them to select screening tests most appropriate
for their particular needs, and to develop appro
priate testing strategies for hepatitis B and
hepatitis C infection.
The indicators for this activity include the num
ber of high quality hepatitis C rapid tests identi
fied, the number of high quality hepatitis C EIA
tests identified, the number of high quality hepa
titis BsAg S/R tests identified, and the number of
high quality hepatitis BsAg EIA tests identified.
Appropriate testing technologies and
strategies for Chagas Disease
In geographical areas where Chagas Disease is
endemic,all blood donations should be screened
for infection with Trypanosoma Cruzi (T.cruzi).
Although T.cruzi infection is most important in
Latin America, other countries (USA, Europe) are
considering testing all blood donations forT.
cruzi due to migrant populations and increased
tourism. Available test kits, of which most are pro
duced in Latin America, will be evaluated and
guidelines and appropriate and reliable testing
strategies will be developed. Discussions with
industry will be held to improve current technol
ogy. Partnerships include the WHO Collaborating
Centre in Sao Paulo, as well as the University of
Iowa and international experts.
Indicators include number of test kits evaluated
and evaluation reports distributed.
Biological reference preparations for the
development of diagnostic tests for trans
missible spongiform encephalopathies
This activity envisages creating a WHO repository
to facilitate the development of improved diag
nostic tests for transmissible spongiform
encephalopathies (TSEs) based on available
research methods. Internationally agreed-upon
biological reference materials (BRMs) will be used
for the assessment and validation of assay sys
tems to be applied in diagnostic procedures of
TSEs and for a global harmonization in evaluating
process validation data (clearance of TSE agents
from biological products).
The specific activities include the identification of
priorities for development of BRMs relevant to
public health, the development of a WHO reposi
tory for positive and control materials derived
from humans and animals with TSEs (selection
and characterization of appropriate candidate
materials, development of protocols for WHO
Collaborative studies), the development of inter
nationally agreed-upon parameters for classifica
tion of human TSEs (harmonization of procedures
and reagents used for the classification and
nomenclature of PrPSc typing in human TSE
cases), the consideration of issues concerning the
appropriate uses of the BRMs, and follow-up of
scientific developments with potential public
health impact in the field.
Quality and Safety
Target 6: Development and implementation of national quality
system
Quality assurance of plasma-derived
medicinal products and plasma
fractionation activities
WHO has long recognized the importance of
capacity-building and improving the perform
ance of national regulatory authorities and manu
facturers in meeting appropriate international
standards. Considerable effort is planned for
strengthening developing country regulatory
activities in the area of plasma-derived medicines,
the goal being to upgrade their technical expert
ise for the evaluation, control and national stan
dards setting so that all plasma derivatives used
would be of assured good quality and safety.
This activity aims at preventing the transmission
of blood-borne viral diseases via plasma
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products, upgrading the expertise of national
control authorities and laboratories in quality
assurance of plasma derived products, promoting
closer regional collaborative links among nation
al control authorities, and facilitating the transfer
of information and technology.
The activity will be carried out in collaboration
with the WHO Regional Advisers at the Regional
Offices and upon the request of the countries.
Partners in the project will form part of a Task
Force, including WHO Collaborating Centres,
experts in the quality assurance of plasma prod
ucts and plasma fractionation (from national con
trol authorities and industry or other institu
tions); international scientific societies;
Pharmaceutical Inspection Co-operation Scheme
(PIC/S),and the Expert Committee on Biological
Standardization.
Specific tasks include setting up the Task Force
on Quality Assurance of Plasma Derived
Medicinal Products, multi-country and regional
seminars and workshops (on quality and safety of
plasma for fractionation, strategies to meet the
requirements for producing safe plasma prod
ucts, viral inactivation or removal procedures and
their validation, control tools to assure quality
and safety in plasma products),the development
of guidelines on viral inactivation or removal pro
cedures and validation that are established by
the Expert Committee on Biological
Standardization.
Increased safety and quality of radiotherapy
Radiotherapy is increasingly being used world
wide for curative as well as palliative treatment of
malignant diseases. Especially in poor, develop
ing countries without proper access to modern
oncological treatment, radiotherapy often is the
only treatment available for such patients.
However, the lack of sufficient trained personnel
and the absence of proper maintenance and cali
bration of equipment may reduce the effect of
radiotherapy,or cause severe and life-threatening
side-effects to the patients..
Therefore, our main objective is to have as many
radiotherapy installations as possible included in
the WHO/IAEA quality assurance programme.
Specifically, we will start by having at least one
radiotherapy institution in each of the African
countries included, eventually extending this to
include all countries in the former Soviet Union.
We will develop a complete knowledge base on
radiotherapy installations in the African Region
(to be collected together with the African
Regional Office) and in the former Soviet Union
(to be collected together with the European
Regional Office).
Among the indicators will be the number of
radiotherapy institutions included in the
WHO/IAEA quality assurance programme, and
the number of radiotherapy institutions with
improved quality and safety.
Access
Target 7: Continuous and sufficient quantities of appropriate
equipment and supplies
WHO bulk procurement of test kits for HIV,
hepatitis B and hepatitis C
WHO
Blood Safety and
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2000-2003 Strategy
The risk of transfusion transmissible infections
(TTIs) can be substantially reduced by screening
for all main TTI's, HIV, hepatitis B and hepatitis C.
Although a large number of screening tests with
varying characteristics have been developed, the
cost of these test kits is often prohibitive
for many developing countries.Countries and UN
organizations can make considerable savings
through the bulk procurement of test kits. In
1999, for example, the total savings on all HIV test
kits purchased amounted to USS 2.7 million.This
means that funds are freed to buy an increased
number of test kits, or can be used to cover other
indispensable purchases.
The main activity proposed is (in collaboration
with WHO's procurement services, other interest
ed parties in WHO. and UNAIDS) to promote and
negotiate the availability of high quality HIV, hepa
titis B and hepatitis C test kits at a reasonable cost.
strengthening the capacity to produce laborato
ry diagnostic materials locally. Workshops on
local production of diagnostic laboratory materi
als organised in at least two Regions.The activity
will be assessed in terms of the number of coun
tries with local capability to produce laboratory
reagents.
Minimum requirements for district surgical
services
Based on an updated selection of high-quality
HIV test kits (ELISAs, simple/rapid and confirma
tion tests), a new tender will be organized for bulk
procurement of HIV test kits, and develop and
publish an information booklet on the bulk pro
curement programme for UN agencies, govern
ments, national AIDS programmes,and NGOs.We
will also select and organize a tender for bulk pro
curement of hepatitis B and hepatitis C test kits.
Among the indicators that can be used to moni
tor this activity are the number of test kits pur
chased in each category, and the cost savings as
compared to the market (catalogue) prices,
analysed by regions.
Access to technology for laboratory
diagnostics
With a view to supporting countries in ensuring
equitable availability and affordability of diag
nostic laboratory technology, this activity aims at
District hospitals in developing countries per
form a wide range of surgical procedures, often
with inadequately trained, non-specialist staff,
poor facilities and limited, low-technology appa
ratus and equipment.
WHO will promote the provision of safe surgical
and anaesthetic care through:
■ Development of recommendations on mini
mum requirements for district surgical services
■ Assistance to national health authorities in
the development of national lists of essential
equipment and supplies required at firstreferral level
a Advocacy to promote the development and
use of appropriate innovative equipment and
materials
■ Feasibility study on the bulk purchasing of
essential surgical and anaesthetic equipment
and instruments (oxygen concentrator).
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Ensuring equitable availability and
affordability of injection devices
This aim of this activity is to ensure equitable
availability and affordability of injection devices.
Key areas of work include (1) decision-making
guide for the choice of injection devices, (2)
guidelines on financing of injection devices for
countries and donors, (3) bundling financing plan
for injection devices, and (4) technology transfer
for the production of safer injection devices.
Indicators of the performance of this activity
include (1) the number of countries using the
guidelines to make choices of injection devices,
(2) the number of countries increasing the avail
ability of injection devices, (3) the number of
donors adopting the "bundling" policy statement
and (4) the set-up of local production of safer
injection devices.
Use
Target 8: Appropriate collection, processing, and clinical use of
blood and blood products
Promotion of blood donor programmes
based on voluntary non-remunerated
blood donors
Although regular, voluntary, non-remunerated
blood donors from low-risk populations are con
sidered as the safest donors, blood donation sys
tems in many developing countries are still
dependent predominantly on replacement/family/paid donors.There is lack of properly organ
ized blood donor programmes in most of the
developing countries. Similarly, there is no data
base of regular blood donors and only a very
small fraction of voluntary donors are regular
blood donors. Most of the blood transfusion
centres do not have trained donor recruiters.
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There is a great need for advocacy and providing
technical support for developing national blood
donor programmes.The activities aim at devel
oping and/or strengthening the national blood
donor programmes in WHO Member States
based on voluntary, non-remunerated blood
donors from low-risk populations, depending on
the local situation, requirements and available
work force.This includes organization of training
workshops at country level for training of blood
donor organisers, donor recruiters and blood
transfusion personnel involved in donor recruit
ment and retention activities.
Indicators to monitor and evaluate the outcome
of this activity include increase in total number of
voluntary, non-remunerated donors, number of
staff trained in donor recruitment, reduction in
number of paid donors and reduction in preva
lence of transfusion transmissible infections
among blood donors.
Safe blood collection systems and
component production
Procedures for safe and effective blood collection
are required to reduce the risk of bacterial con
tamination of donated blood and to ensure the
quality and efficacy of blood components pre
pared from the donated blood unit.
The activity aims at developing learning materi
als on safe and effective blood collection and
production of quality blood components.The
learning materials will be developed in two phases.They will be developed as a supplement to
the existing distance learning materials on "Safe
Blood and Blood Products"and will promote the
use of standardized procedures for safe blood
collection and, ultimately, the production of highquality blood and blood components.
Indicators to evaluate the utilization of learning
material include a decrease in the number of
discarded blood units due to inappropriate
blood collection, a reduction in the rate of bacte
rial contamination of blood components,
improved traceability of plasma and serum used
for processing, improvements in the quality and
efficacy of blood components and in the quality
of plasma for processing and fractionation.This
will lead to greater safety and efficacy of blood
products and also minimizing the risk to both
donors and recipients.
Distance learning programme for safe
blood and blood products (DLP)
Blood transfusion staff, especially those in small
hospital blood banks in developing countries,
often lack opportunities for further training and
to participate in refresher courses. Distance learn
ing offers a flexible, cost-effective way of provid
ing training in blood safety for larger numbers of
staff, at lower cost and with less disruption to
services than is possible with conventional cours
es. In promoting the use of distance learning in
transfusion medicine, WHO/BTS has published
five modules of learning materials, Safe Blood
and Blood Products, for staff with responsibility
for donor recruitment and for the collection, pro
cessing and issue of blood for transfusion. It has
also trained senior blood transfusion service per
sonnel from over 100 countries in establishing
distance learning programmes (DLP) in blood
safety supported by the learning materials enti
tled Establishing a Distance Learning Programme
in Blood Safety: A Guide for Programme
Coordinators.This activity aims at increasing the
quality and coverage of training for blood trans
fusion service staff within the workplace as part
of the process of improving the quality and safety
of national blood supplies.
English, French, Spanish, Chinese, Russian and
Portuguese editions of the modules are now
available. An Arabic edition is being produced
and several countries are translating the modules
into their national languages.
Priorities for the future development of the dis
tance learning programme include the evalua
tion of successful national distance learning pro
grammes and technical support to countries that
plan to start programmes, notably China and
India.
Clinical use of blood
A large proportion of transfusions are given inap
propriately. The appropriate clinical use of blood
is critical, particularly in areas with a high preva
lence of transfusion transmissible infections and
in areas where there is a shortage of blood units
and resources for health are limited.The objec
tive of this activity is to develop and promote
good transfusion practice to ensure that the right
patient receives the right blood for safe adminis
tration at the bed side, as well as the right reason,
in accordance with national guidelines on the
clinical use of blood.This will be achieved
through the dissemination of WHO learning
materials as well as training of prescribers of
blood and blood products (nurses, surgeons and
anaesthetists and others).
Regional workshops using the clinical use of
blood learning materials (English version) have
been organized. Learning materials are being
translated into French and Spanish, Chinese,
Russian, Arabic and other languages.
Haemoglobin Colour Scale
The Haemoglobin Colour Scale was developed by
WHO as a simple, accurate,and cost effective clin
ical device for the detection and management of
anaemia for use in areas where laboratory facili
ties are not readily available, and for haemoglo
bin surveys to identify populations at risk.
It was developed in response to such situations
and will be important in a variety of areas includ
ing blood donations, primary health care, antena
tal, paediatric and trauma care.The Scale would
be invaluable in peripheral health services, espe
cially in developing countries, and in the screen
ing of blood donors. It is ideal for determining
blood donor suitability, particularly as a replace
ment for the copper sulphate specific gravity (SG)
method).
WHO has evaluated the device extensively in lab
oratory and field conditions. Over the past four
years, the field evaluations were carried out in all
six WHO regions, in developed and developing
countries, in blood transfusion services, antenatal
clinics, primary health care settings, and nutri
tional survey/research studies.The results of
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these trials have led to minor modifications in
the instructions to ensure correct use.
After the production of several batches of the
Scale we now have achieved the required quality
in the printing of the colours in the Scale. Limited
quantity of the WHO Haemoglobin Colour Scale
has been allocated to selected sites in all regions.
The objective is to transfer the production, mar
keting, logistic for distribution and sales to a
commercial partner ready to finance the initial
cost to bring the product to the market. A licence
Agreement has been signed with a German com
pany, COPACK.
The work will include: the control of the manu
facturer activity in accordance with the licence
agreement signed for the production and distri
bution of the scale, the coordination of the vali
dation of the scale by a WHO collaborating cen
tre; the identification of new donors to facilitate
the access to the device; the development of flier
and other information tools; development of the
HbCS starter kit; the largest dissemination of the
scale to the public sector will still require work
with the manufacturer and development of tools
for promotion and training.
A second generation of the Haemoglobin Colour
Scale will be developed and other non-invasive
haemoglobin monitoring technologies will also
be investigated to help detecting anaemia, par
ticularly of pregnant women.
The starter kit will be first available in English and
French; other language editions of the Scale will
be prepared to respond to the worldwide needs.
Monitoring and evaluation will be provided by
the number of countries currently using the scale
as a screening tool for blood donors and other
application; the increase in anaemia detection
programmes using the scale,The quantity of the
haemoglobin colour scale produced and distrib
uted by the manufacturer.
Use
Target 9: Appropriate use of diagnostic imaging and laboratory
technologies
Among the expected outcomes related to this
target are 1) Regional external quality assess
ment schemes (EQAS) for transfusion-transmissi
ble infections, immuno-haematology, and select
ed laboratory disciplines, 2) educational material
and training programmes on use and mainte
nance of diagnostic imaging facilities and equip
ment, 3) guidelines for the use and cost-effective
strategies for laboratory methods and diagnosis
of transfusion-transmitted infections, and 4)
guidelines for good diagnostic practices.
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The associated critical indicators include 1) The
number of countries participating in External
Quality Assessment Schemes (EQAS) for transfu
sion-transmissible infections, immuno-haematol
ogy, and other laboratory disciplines, 2) the num
ber of countries with improved, safe, and appro
priate imaging services, 3) the number of coun
tries with established standard operating proce
dures in laboratory services, and 4) the number
of countries implementing good diagnostic
practices.
Regional external quality assessment
schemes for transfusion transmissible
infections (HIV hepatitis B and hepatitis C)
There are many steps and procedures required
between blood being drawn from the donor and
the patient receiving the transfusion. An ade
quate quality system should be in place to moni
tor each step. In many countries there is a need
and demand for technical guidance and didactic
material on how to implement a quality system.
The principal objective of this activity is thus to
promote the concept of quality systems and to
assist blood transfusion services and national
authorities in implementing quality systems,
including quality assurance, quality control, stan
dard operating procedures and external quality
assessment for testing and safe blood supply.
Regional external quality assessment schemes
(REQAS) for transfusion transmissible infections
will be established covering four WHO regions:
two in Africa (one for anglophone countries and
one for francophone countries) and for SouthEast Asia and the Western Pacific.
Partners include the CPHLS, London; NRLs,
Melbourne; Hopital Le Dantec, Dakar, and NBTS,
Harare.
A Newsletter discussing issues related to quality
assurance and quality management will be dis
tributed to participants of the scheme.
As indicators to measure the performance of
these activities we may use the number of coun
tries participating in regional EQAS for the main
TTIs, the number of countries of newly imple
mented or improved quality systems, the number
of countries with a NEQAS.
Development of Regional External Quality
Assessment Schemes (REQAS) in Blood
Group Serology
Adequate testing of all donated blood units in
blood group serology is an important strategy for
ensuring safe blood transfusion. Quality manage
ment in blood transfusion laboratory has
attained a greater significance in view of the risks
associated with blood transfusion due to poor
quality. Establishment of External Quality
Assessment Scheme (EQAS) is required to ensure
quality testing in blood group serology for all
donated blood units.
The activity aims at assisting WHO Member
States in promoting the concept of quality sys
tems and in implementing national quality sys
tems. Activities include organizing regional EQAS
in Blood Group Serology, conducting regional
training workshops, identifying areas for further
training and providing support in the areas of
need. Regional external quality assessment
schemes in Blood Group Serology will be estab
lished covering four WHO regions: two in Africa
(one for anglophone countries and one for fran
cophone countries) and for South-East Asia and
the Western Pacific.
Indicators to measure the performance of these
activities include development of WHO guide
lines for organizing a National EQAS, number of
countries participating in regional EQAS in Blood
Group Serology, number of training workshops
and educational activities carried out during the
specified period and number of personnel
trained in concept of Quality Assurance and
External Quality Assessment.
Establishing regional training centres for
quality management
These will be discussed below (under Key Issues)
in detail.
Use
Target 10: Safe and appropriate use of injections
Appropriate, rational and cost effective use
of injections
This aim of this activity is to ensure appropriate,
rational and cost effective use of injections and
injection devices.
Key areas of work include (1) pilot projects in
each WHO region, (2) injection safety standards,
(3) guidelines for universal precautions, (4) tool
box for behaviour change and implementation.
Indicators of the performance of this activity
include (1) availability of evaluation for pilot proj
ects, (2) availability of injection safety standards,
(3) availability of universal precautions guide
lines, and (4) the availability of a behaviour
change and implementation toolbox.
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Use
Target 11: Appropriate use of devices and clinical technologies
Improving blood safety by ensuring
reliable and appropriate HIV testing
In many non-industrialized countries, HIV trans
mission through blood is still occurring.
Assistance will be given to countries to develop
and implement national HIV testing policies, pro
vide updated operational guidelines on appropri
ate and reliable testing for HIV and training of
staff. Educational material will be made available
for training staff on these concepts.
The specific objectives are to assist and encour
age countries to develop and implement national
testing strategies to ensure safe blood, and to
provide technical advice and training on opera
tional aspects of reliable testing of HIV and other
TTls.The content of the advice will cover princi
ples of screening assays, selection of assays and
automated systems and good laboratory practice.
We will produce an educational set (document
and slides) on principles of screening assays,
selection of appropriate assays, and on quality
systems in BTS. After a workshop and field test
ing, we will produce these educational materials
in English, French, Spanish and Russian. Follow-up
actions will include assessment visits, and further
intercountry workshops.
Blood cold chain
An effective blood cold chain (BCC) from dona
tion to transfusion is an essential part of a nation
al blood transfusion service if it is to ensure safe
blood for the patient.
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Thus DCT aims to carry a programme: to deter
mine the specifications of selected blood cold
chain equipment; to perform laboratory and field
evaluation of devices and indicators for the safe
storage of blood or blood product in all environ
ments; to inform and educate users of cold chain
equipment on specifications of appropriate
equipment and devices for use in the mainte
nance of the blood cold chain by producing a
publication with specifications for BCC equipment
and devices and by developing learning materials
for the maintenance of the blood cold chain .
The result of this programme will be: the estab
lishment of WHO specifications for selected BCC
equipment; the development of protocols for
laboratory and field evaluations; the production
of reports on the laboratory evaluations done on
CFC-free refrigeration equipment for BCC, and on
blood time temperature indicators, by specialized
testing centres. Accordingly, we will produce a
publication with specifications for BCC equip
ment and devices evaluated in the laboratory
and in the field, and will develop learning materi
als for the maintenance of the blood cold chain.
Additional essential equipment for the blood
cold chain has been identified (e.g., plasma shock
freezers, platelet agitators), laboratory and field
evaluations will be conducted and appropriate
specifications will be determined in order to
expand the range of equipment and devices nec
essary to further improve the blood cold chain:
The work will also include: the collection of BCC
equipment and material for the preparation of a
product information sheet book; the field evalua
tion and final editing of learning material; the
development of a specific project with a Swiss
school of engineers on the management of the
logistics of the blood cold chain.
Longer-term activities include the production of
a practical manual on the management of blood
inventory, the establishment of minimal stan
dards for blood cold rooms, concept develop
ment of a mobile unit for blood collecting,
improved "hold over time"for refrigerators and a
review of alternate energy sources for refrigera
tor and freezers.
Indicators to measure performance include the
number of countries or health care centres ensur
ing safe blood transmission to patient by imple
menting a BCC service; the numbers of BCC
equipment tested; the numbers of blood trans
portations done with blood time temperature
indicators.
Essential surgical procedures at district
hospitals
District surgical services should be able to man
age the majority of patients with trauma and
obstetric,orthopaedic and abdominal emergen
cies. Many first-referral level facilities in develop
ing countries do not have specialist surgical
teams and are staffed by medical, nursing and
paramedical personnel who perform a wide
range of surgical procedures, often with inade
quate training.This contributes to unnecessarily
high rates of maternal mortality and death and
disability resulting from trauma.
This project aims at ensuring that medical offi
cers and other personnel responsible for surgical
and anaesthetic care at first-referral level receive
appropriate training in the skills required for the
management of trauma and common surgical
and obstetric emergencies.
The activity will include:
■ Identification of future requirements in train
ing in surgery and anaesthesia at first-referral
level in developing countries
■ Development of a global strategy for
essential surgical care
■ Development of a comprehensive set of
learning materials for use in in-service train
ing, short courses, basic and continuing edu
cation programmes for medical, nursing and
paramedical personnel
■ Advocacy to promote the development of
national standards and clinical guidelines on
acute surgical care
■ Capacity-building through the establishment
of a team of Regional Facilitators to promote
and support the development of national
training activities in acute surgical care
■ Organization of regional and inter-regional
workshops to promote both the recognition
of the special training needs of surgical and
anaesthetic personnel at first-referral level
and the provision of appropriate training in
both basic and continuing education
programmes
■ Establishment of an Expert Panel on Essential
Surgical Services
■ Strengthening of collaborative partnerships
between WHO, non-governmental organiza
tions and WHO Collaborating Centres in the
development of integrated approaches to
training.
Indicators for this activity include the number of
countries that develop national standards and
clinical guidelines; the number of countries that
establish specialized training programmes in
acute surgical care; and the number of countries
that use the WHO learning materials as part of
their overall training strategy.
Information technology in transfusion
safety
The objectives of this activity are to provide
national blood transfusion services with tools to
help in the implementation of computerized
information management systems. Such tools
will help to reduce transcription errors, improve
records and traceability and increase effective
ness of donor recruitment and management. We
will also develop guidelines on evaluating the
relevance of computerized information manage
ment and implementation in blood transfusion,
as well as specifications for blood transfusion
software and a guide for validation.
Training programmes and training material
in diagnostic imaging
A major reason for the non-functioning or mal
functioning of diagnostic imaging services in
many countries is the lack of proper education
and training, both medically and technically, of
those involved.The objective of this activity is
thus is to improve local knowledge and skills by
developing and implementing adequate training
programmes and training materials.This would
be done in close collaboration with international
and national experts, and with the concomitant
establishment of regional and national centres of
excellence for diagnostic imaging services.
Specific targets include: the establishment of
centres of excellence for education and training
in diagnostic imaging (two in the WHO African
Region, two in Central and South America, one in
South-East Asia, and one in the Western Pacific
Region); the further development, distribution
and implementation of both medical, technical
and managerial training material and pro
grammes targeting the need of small hospitals
and clinics with limited resources as well as
updated material for the proper use of the World
Health Imaging System for Radiography.
Among the indicators for this activity are the
number of hospitals/institutions with properly
functioning diagnostic imaging, and the number
■ 213
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
of hospitals/institutions with sufficiently trained
staff.
Access to medical devices, R&D and
technology transfer to developing
production of distance learning materials for
essential surgical care for district surgical services
at first referral hospital (manuals for district level
surgical procedures on anaesthetics, surgery,
trauma, orthopaedics, and obstetrics).
countries
Since about 90% of the world's medical devices
are produced in Europe, Japan and the United
States of America, we could improve the access
to medical devices by facilitating the transfer of
technology so that local production is stimulated
in the rest of the world.
The objective is to work with manufacturers, gov
ernments, and users to allow developing coun
tries to have more equity and better access to
safe and effective medical devices and clinical
technologies.This activity includes a range of
technical and educational projects, some of
which are more "product-oriented" (relating to
the evaluation, and research and development,of
new medical devices in partnership with indus
try), while the other projects are more "serviceoriented" (involving the provision of tools for a
better access to technology, learning material,
and guidelines for an appropriate and safe use of
technology).
24 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Specific activities include: the harmonization of
the relevant nomenclature and device classifica
tion systems by using for the Global Medical
Device Nomenclature System (GMDN); regional
information-gathering and needs assessment
meetings; guidelines for the procurement of
medical devices; the elaboration of a communication/advocacy/funding strategy for medical
devices; the development and evaluation of new
technologies (e.g., a low-cost blood transporta
tion box); the measure of the impact of the reuse
of medical devices (including safer use of injec
tions, safe refurbishment of medical devices); the
strengthening of local capacity to produce
equipment and supplies (WHO bulk procure
ment system for medical devices including AD
syringes; the technology transfer for local pro
duction of medical devices, including AD
syringes, meeting with manufacturers on tech
nology transfer to developing countries); the pro
motion of appropriate technologies for district
surgical services (oxygen concentrators,
orthopaedic appliances, skills training) and the
Among the indicators available to measure this
activity are the number of countries implement
ing WHO guidelines and recommendations for
selection, use, and maintenance of technologies;
the number of new devices developed; and the
number of new devices and new techniques
evaluated (including a "universal blood trans
portation box" to be developed in partnership
with a Swiss school of engineers).
Management and maintenance of health
care technology
This activity will be carried out in collaboration
with the Department for the Organization of
Health Services Delivery to help health authori
ties in the process of needs assessment, planning,
selection and acquisition of health care technolo
gies. It includes the development of technology
management toolkits, one of which is a software
based planning and management tool called the
Essential Health care Technology Package (EHTP).
A pilot project on Health care technology man
agement and maintenance started in
Mozambique including a country situation analy
sis and first sensitization of the MOH to the EHTP.
This activity aims at:
■ Supporting the field testing of this software
based planning and management tool in
some selected countries: Mozambique,
Tunisia,China and others
■ Contributing to the finalization and imple
mentation of the EHTP.
The other part of the project will be built on the
WHO Guidelines for Health care Equipment
Donations.The specific activities include the sup
port and promotion of the improved process of
technology transfer, particularly with regard to
equipment donation, through application of the
WHO Guidelines on Equipment Donation.The
maintenance information system developed in
Mozambique will also be tested for exportation
to other countries.
Among the other activities are: the development
of learning materials on management of health
care equipment (guidelines on safety, care, main
tenance and use of medical equipment at district
hospital level); the support on specific preventive
maintenance including blood bank, laboratory
and X-ray equipment.
The impact of the project will be measured by:
the number of appropriate equipment dona
tions; the reduction of the number of unused
equipment, the number of countries using a
management and maintenance information
system; the number of countries using the EHTP.
Health care waste management
In many countries, the improper management of
wastes generated in health care facilities has a
direct impact on the health of the community, of
the personnel working in health-care facilities,
and on the environment. In addition, pollution
caused by the inadequate treatment of waste
can also have indirect effects on community
health.The disposal of certain types of clinical
devices should follow specific safety rules. For
example, a syringe is a common item that
requires safe disposal.
Health care waste management (HCWM) includes
the management of discarded blood, blood
transfusion bags, laboratory sample, sampling
equipment, waste generated by diagnostic imag
ing, and devices (e.g., syringes and needles).
There has been an increasing demand for WHO
to take an active role in implementing safe
HCWM on a larger scale.
Waste management options need to be efficient,
safe and environment-friendly in order to protect
people from voluntary and accidental exposure
to waste when collecting, handling, storing, trans
porting, treating or disposing of waste.
The main objective of this activity is to determine
how health care waste management is being car
ried out and how to improve it.The activity will
include: the identification of centralized waste
management and disposal resources available;
the proposal of a choice of management and dis
posal options (which will depend on their afford
ability, sustainability, environmental friendliness,
efficacy, on the worker’s safety and in order to
assure the prevention of re-use); and the identifi
cation of appropriate options for all levels of
health care facilities.
This activity, which is the result of collaboration
with the WHO cluster on Sustainable
Development and Healthy Environments, aims to
focus on waste blood and any waste materials
containing,or which have contained, blood
regarded as hazardous waste for a specific contri
bution to global blood safety
Steps in the process require a comprehensive
approach and considerable resources. A global
action plan for the implementation of the strat
egy to reduce disease burden caused by inad
equate HCWM will have the following targets:
■ Evidence and information for policy (a data
base on health care waste management will
be organized to evaluate practices and
options available and for the monitoring of
country progress)
■ Reference and guidance material (including
guide, a primary health care decision making
guide, an aide-memoire on HCWM)
■ Safety and availability of waste management
options (an Internet-based database, with
field tests for health care waste management
options)
■ Country plans (implementation of waste
management system, national workshops).
Our contribution to this activity will include: the
development of literature search and a review of
health impacts from microbiological hazards in
health care wastes; the preparation of a guidance
document for the appropriate management of
blood waste and waste contaminated with blood
and a primary health care decision-making guide.
The medical device industry is expected to be
among the partners in this activity, and encour
aged to develop more environmentally friendly
health care products.
Indicators for the success of this activity will
include the number of countries with safe waste
management systems implemented; the number
of primary health care centres currently using the
decision-making guide; the number of options
available for safe health care waste management;
the number of successful cases of technology
transfer in waste disposal. 3
■ 25
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Key Initiatives
Global Collaboration
for Blood Safety
Each national government has the
responsibility to ensure a safe and ade
quate supply of blood and blood prod
ucts for its citizens. However, there are
many parts of the world where the safe
ty and adequacy of the blood supply is
lacking. Global blood safety requires
urgent attention, and it is only through
improved collaboration between organi
zations and institutions involved in the
area of blood safety that the safety of
the global blood supply can be
improved.
The recommendations made at the
AIDS Summit of December 1994 tn this
respect were reinforced by a resolution
of the World Health Assembly in 1995
(WHA 48.27). Taking up the initiative.
WHO proposed that a broadly constitut
ed forum in which to communicate and
to propose joint and complementary
action would lead to the required
improved collaboration. This forum
could include national and international
organizations involved in blood and
blood product safety: manufacturers of
plasma, plasma derivatives and blood
devices: users and prescribers of blood.
blood donor organizations, source plas
ma donors and recipients of blood and
blood products.
The collaborative mechanism will
build on existing knowledge and con
ventional wisdom in the area of blood
safety: utilize existing expertise: pro
mote dialogue on blood safety issues:
and suggest realistic, effective and prac
tical mechanisms to improve blood and
blood product safety. The collaboration
should be one of representation offering
the opportunity to discuss and suggest
viable solutions to resolve blood safety
issues. Fundamental to improving col
laboration on blood safety will be the
issue of improving collaboration
between the developed and developing
regions of this world. Developing coun
tries will have representation in the
mechanism to help identify and offer
realistic approaches to priorities in
blood safety.
In October 1995. WHO held the First
Preparatory Meeting for the Formation of
a Task Force for Global Collaboration for
Blood Safety tn Geneva, to prepare a pro
posal. The meeting involved most of the
major organizations and institutions
involved in the area of blood safety and
it reviewed the WHO proposal and for
mulated recommendations for a mecha
nism to improve global blood safety. The
first full meeting of the Global
Collaboration of Blood Safety (GCBS) was
held in November 2000 and the follow
up Working Group meeting and Annual
meeting will be held in 2001. During dis
cussions. the meeting agreed on a title
for tlie collaborative mechanism and on
the following recommendations:
Recommendations for the
formation off the Global
Collaboration for Blood Safety
(GCBS)
Goaf; Promote and strengthen international
collaboration on safety of blood products and
transfusion practices.
On 1 December 1994, the Paris AIDS
Summit declared the GCBS should he
established. and consequently the forty
eighth World Health Assembly. held tn
■ 27
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
May 1995, produced resolution W'HA
48.27 covering the formal establishment
of GCBS. l ite following mission was
adopted:
To improve collaboration among organi
zations and institutions involved in the
area of transfusion safety with a view to
encouraging and facilitating information
exchange, promoting standards for good
manufacturing practices for blood and
related products for transfusion, and fos
tering the establishment and implemen
tation of cooperative partnerships to
ensure donor and recipient safety in all
countries.
GCBS (structure and functions)
It is recommended that to ensure an
effective and efficient GCBS. it should
be made up of a small number of spe
cialists and representatives of interna
tionally recognized organizations and
institutions involved in the area of trans
fusion safety, as well as national repre
sentatives of different global regions.
The GCBS should ideally comprise
the following organizations:
Participants
1. American Association of Blood
Banks (AABB);
2. European Plasma Fractionation
/Association (EPEA):
3. Federation Internationale des
Organisations de Donncurs de Sang
(FIODS);
4. international Federation of Red
Cross and Red Crescent Societies (IFRCRCS);
5. international Plasma Products
industry Association (IPP1A):
6. international Society of Blood
Transfusion (ISBT):
7. world Federation of Hemophilia
(WFH):
8. world Health Organization (WHO)
(Blood Safety unit. Biologicals unit.
Health Laboratory Technology unit):
9. Participants from developing coun
tries to ensure appropriate regional rep
28 ■
WHO
Blood Safety and
Clinical Technology.
2000-2003 Strategy
resentation:
IO. Representation of relevant health
industry manufacturcrs/medical devices:
and
11- Representation of prescribers of
blood and blood products.
Observer Participants
1. Commission of the European
Communities (CEC):
2. Council Of Europe (CE);
3. Food and Drug .Administration (FDA).
United States of -America: and
4. National Institute of Health (N1H).
Japan.
Key points related to the constitution
and operation of GCBS are as follow:
■ Subject to sufficient funds being
made available for that purpose,
the GCBS Secretariat will be pro
vided by the Blood Safety unit of
the World Health Organization
■ The GCBS will elect a chairman
for a one-year to two-year term.
The functions and activities of the
chairmanship will be decided at
the first meeting of the GCBS
■ The GCBS will hold at least one
to two meetings per year, with
dates agreed by a majority deci
sion of the members
■ The GCBS will produce and dis
seminate documents which.
among other things, analyze
problems and advocate research
to find solutions relating to trans
fusion safety. The GCBS will form
and utilize the expertise of ad hoc
working Groups to debate specif
ic issues relating to blood and
blood product safety and to pro
vide recommendations and guid
ance to the GCBS. In some
instances, the Working Groups
may need to be formally consti
tuted and required to meet to
reach consensus on particular
issues. In other cases, a Working
Group may be constituted less
formally and carry out its task by
correspondence
■ The GCBS will make the decision
on the functions and activities of
each Working Group and make
appropriate provision for the
costs involved in each task
Figures:
GCBS-WHO Secretariat
Figure 6:
GCBS - Partners and WHO Secretariat
assigned, (i.e.. a particular organi
zation such as WHO. 1FRCRCS.
1SBT. etc., may be able to carry
out the necessary task through its
plan of work and budget for
blood safely activities, in other
cases a project proposal may
need to be developed to seek
funding for a specific Working
Group activity).
GOBS funds
Funds will need to be raised to support
tlie GGBS activities, i.e., from govern
ments. non-governmental organizations
and. if necessary and appropriate, from
lite private sector. With regard to poten
tial financial support from the private
sector, care should be taken, however.
to avoid tlie risk of actual or perceived
conflicts of interest. Commercial donors
should not seek promotion of the fact of
their donations. In this regard, the partic
ipants in the GCBS will need to ensure
that all fund raising efforts are in accor
dance with their respective policies and
principles. Under the direction of the
GCBS. the WHO Blood Safety unit will
administer financial contributions intend
ed to support the activities of the GCBS
through a trust fund entitled Global
Collaboration for Blood Safety. This trust
fund will be administered in accordance
with WHO's financial regulations, rules
and practices and be subject to WHO's
normal programme support costs.
Periodic financial reports will be provid
ed by the Secretarial to the membership
of the GCBS. justifying how funds desig
nated to support the activities of GCBS
have been used.
The formation of. and participation
tn. the GCBS may. however, dependent
on how much funding is available in the
above-mentioned trust fund, require
financial commitments from some or all
of the participants.
GCBS objectives
The GCBS objectives are as follow
□ to promote international consen
sus on essential principles of
global blood safety:
C
^ Decision formulating \
in blood safety for
policy makers
J
Traceability of
plasma
-------------------- s
QualityManagment k
working group
C
)
•-----------
GCBS '
Functions
Issues in selection of
safe blood donors
Rights of Patients'
working group
■ to promote the improvement of
global blood safety and encour
age governments to recognize
and establish national blood pro
grammes;
□ to assist countries, upon request.
to identify national blood safety
priorities and prevent transfusion
transmitted disease;
□ to assist countries, upon request.
in the implementation of appropri
ate and recognized transfusion
practices to ensure donor and
recipient safety and freedom from
discrimination;
□ to promote effective recruitment
of safe donors through the use of
appropriate selection criteria;
S to promote the appropriate prepa
ration and utilization of blood and
blood products;
>2S
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
■ to encourage safe international
practices for the collection, stor
age and transport of plasma and
the preparation and distribution of
its derivatives;
■ to promote the bi-directional
traceability of blood products
between donor and recipient
whether in-country or across
national borders; and
■ to facilitate the exchange and use
of information by encouraging
data collection, management and
dissemination.
The development of GCBS
The Department of Blood Safety and
Clinical Technology continues to host
the secretariat of the GCBS. bringing
together national and international
organizations involved in blood and
blood product safety, and associations
of manufacturers of plasma, plasma
derivatives and blood devices and diag
nostics. of prescribers, users, and recipi
ents of blood and blood products as
well as blood donor organizations.
In the shon term, a review of exist
ing safety interventions along the trans
fusion chain will be carried oui with a
view to devising and agreeing on an
objective assessment framework. This
will constitute a tool for developed and
developing countries to prioritize inter
vention strategies, and it will help deci
sion-makers.
Safe Injection Global
Network
30 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
While it is the responsibility of each
national government to ensure safe and
appropriate injections, prevention of
adverse events associated with injec
tions will require improved collaboration
between organizations and institutions
sharing a common interest in this goal.
The Safe Injection Global Network
(SIGN) is a new mechanism for coordi
nating activities aimed at the safe and
appropriate use of injections worldwide.
Unsafe injections waste pre
cious health care resources
A literature review published in 1999
indicated that, of all medical proce
dures. injections are probably the most
common. About 12 OOO million injec
tions are administered each year
throughout the world. Less than io?i> are
for immunizations. Many of the thera
peutic injections, the widest application.
could be avoided. In many countries.
both patients and health care workers
prefer medicines to be administered by
injection. Reportedly, patients ask for
injections because they believe that
medication is more efficacious by that
route and that the pain of the injection
is a marker of that efficacy. Reasons for
health care workers to inject excessive
ly include the desire to respond to a
perceived patient preference, the wish
to monitor compliance directly and. in
some instances, the possibility of charg
ing a higher fee for service. Overall.
unnecessary injections lead to high outofpocket health care expenses for
patients and their families
Poor injection practices cause
a high burden of disease
Many injections administered in the
world are unsafe. Of particular concern
is the reuse of injection equipment with
out sterilization - a frequent practice in
developing countries and those in transi
tion. where it is common simply to rinse
syringes and needles in containers of
tepid water between injections. In these
countries, injections account for a high
proportion of new infections due to hep
atitis B and hepatitis C viruses. Eacli
year, globally, reuse of dirty injection
equipment causes an estimated eight to
16 million infections with hepatitis B
virus. 2.3 to 4.7 million infections with
hepatitis C virus, and 80 OOO to 160 ooo
infections with HIV. Together, these
chronic infections are responsible for an
estimated 1.3 million early deaths and 26
million of years of life lost, and lead to
LISS 535 million in direct medical costs.
Figure 7:
SIGN Associates and SIGN Secretariat
Figure 8:
Cross Cluster Collaboration within WHO
Poor injection practices can be
eliminated
To reduce overuse of injections and io
assure safe injection practices, multidis
ciplinary strategies comprising three ele
ments should be implemented. First.
there needs to be a change in behav
iour: patients and health care workers
should be encouraged to adopt safe
practices and to avoid unnecessary
injections. Second, sufficient quantities
of clean injection equipment should be
available in each health care facility.
Third, mechanisms should be in place
so that “sharps" (i.e. needles and
syringes) are so disposed of as to
ensure that dirty injection equipment is
not reused and the risk of accidental
needle-stick injuries is minimized.
Interventions based on each of these
three elements have proven to be suc
cessful and demonstrated that poor
injection practices can be eliminated.
For example, in Indonesia, behavioural
change interventions have resulted in a
substantial and sustained decrease in
the overuse of injections. In Burkina
Faso, increasing the availability of
clean, disposable injection equipment
through community pharmacies has
almost eliminated unsafe injection prac
tices. tn a pilot project in Cote d'Ivoire.
the introduction of small-scale, locallybuilt incinerators and at the same time
training of health care workers have
successfully eliminated dangerous nee
dles and other sharps waste from the
environment.
Safe and appropriate use of
injections does not require a
new programme
In every country, efforts to ensure safe
and appropriate use of injections require
collaboration between all partners.
Because multidisciplinary interventions
are needed, the basis of preventive
activities should be careful coordination
of already existing initiatives rather than
the creation of new programmes.
National health authorities responsible
for health promotion. HIV prevention.
integrated management of childhood ill-
nesses and blood transfusion services
should promote safer behaviour among
patients and health care workers.
Similarly, national authorities responsi
ble for access to essential drugs, immu
nization services and family planning
should increase the availability of clean
injection equipment It is recommended
that responsibility for safe management
of health care waste should be
assigned to health care sen ic es.
VUHO activities for the safe and
appropriate use of injections
Because unsafe injections waste pre
cious health care resources, transmit
bloodborne pathogens on a large scale
and can be eliminated. WHO has
increased its activities to improve injec
tion safety. First, wi io hosts the secre-
■ 3'2
WHO
Blood Safety and
Clinical Technology;
2000-2003 Strategy
lariat of the Safe Injection Globa)
Network, a coalition, created in 1999. of
stakeholders who strive lor sale and
appropriate use of injections worldwide.
working within a common strategic
framework, the secretarial coordinates
the activities of the network Second,
WHO lias coordinated its relevant activi
ties. which include safety of immuniza
tion injections, rational use of medi
cines. blood transfusion safety, labora
tory safely, medical devices, manage
ment of health care waste, prevention
of viral hepatitis, and prevention of
injection drug use.
Quality Management
Project for Blood
Transfusion Services
General Background
32 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Quality management in all areas of
blood transfusion is crucial for the provi
sion of safe blood for all those requiring
transfusion In most developing coun
tries. there is a lack of quality manage
ment for tiie safety of blood and blood
products which adversely affects the
quality of care to the patients. WHO has
identified that urgent attention and
action needed to be devoted to quality
in the blood transfusion services
In order to implement a quality sys
tem. the capacity of the Blood
Transfusion Services (BTSs) needs to be
improved through comprehensive train
ing. There is an acute shortage of
trained manpower in blood transfusion
in developing countries Quality man
agement has therefore been identified
as a key strategy for global blood safety
and has been targeted by WHO as a pri
ority for training.
WHO has developed the Quality
Management Project (QMP) as a new initia
tive to be carried out tn all regions start
ing from 2001 as a part of a strategy lor
building capacity at global level. The
project addresses the need to adopt the
principles of quality management in all
areas of the blood transfusion services
in order to ensure good organization
and management, donation from safe
blood donors, testing of all donated
blood for HIV and other transfusion
transmissible infections (TT1). quality
component production and appropriate
clinical use of blood This project aims
to ensure the safely of blood transfu
sions to significantly reduce mortality.
morbidity, and the global disease bur
den due to the transfusion of infected
blood and blood products.
QMP has been developed as a long
term collaborative and sustainable proj
ect with effective co-operation and col
laboration with other international organ
izations already involved in quality man
agement such as the American
Association of Blood Banks.
International Federation of Red Cross
and Red Crescent Societies, and the
International Society of Blood
Transfusion.
Activities have been planned for all
the WHO regions, focusing on promot
ing the principles of quality systems
and assisting blood transfusion services
and national authorities in implementing
quality systems.
Figure 9:
Quality Management Project
Goal
To build capacity in the area of quality
management for blood transfusion
services covering all aspects of blood
transfusion, through an integrated
approach of training and assessment, in
all member states of WHO with regional
cooperation.
Objectives
■ To assist WHO Member Stales in
improving the quality, safety and
adequacy of blood
■ To upgrade national capacity,
knowledge and skills of WHO
member states in all aspects of
quality management in blood
transfusion through regional train
ing courses
■ To establish regional quality train
ing centre(s) for ongoing training
for BTSs in each WHO region
■ To develop regional external qual
ity assessment schemes (REQzXS)
tn coordination with international
external quality assessment
scheme for TTI and blood group
serology
■ To upgrade the facilities and build
a Quality z\reti Desk in BTS at
national level
■ To establish a sustainable nation
al quality system in B I S in each
Member State.
Activities
■ Identify quality training centre(s) in
each of the WHO region which
will be responsible for organizing
regular Quality Management
Training (QMT) courses in all
aspects of blood transfusion
■ Organize QMT courses for blood
transfusion services
■ Establish REQAS with the coun
tries participating in the training
course for TTI and blood group
serology integrated within the
training courses in quality man
agement for B I S
■ Develop an effective quality net
work for BTS between the region
al quality training centre and the
participating centres.
Quality Management Training
Figure 10: Components of QMP
Replication of Regional Activities at National Level
4-week training courses and post-train
ing support and follow up to the partici
pants of the courses to assist them in
implementing their plans of action for
establishing quality systems in their
blood transfusion services. The partici
pants will also be a resource for estab
lishing the national quality systems in
BTSs.
Objectives
□ To assess current status of quali
ty system in blood transfusion
services in the participating
countries
□ To develop the participants'
knowledge and skills in quality
assurance
□ To improve knowledge and skills
in good laboratory practices
□ To develop a plan of action for
implementation of quality system
for the participants' BTS/Blood
Bank
□ To suggest future requirements
for continuous training and
staff development in quality
management.
for Blood Transfusion Services
Considering the need to train stalf in
blood transfusion services. Quality
Management Training (QM T) constitutes
an important component of the project.
QMT essentially includes organization of
Participants' profiles
The profiles of the participants attending
tlie courses organized by the training
will be adapted to the different types of
courses organized Two categories of
■ 33
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
participants from the countries in the
region should be nominated for each of
these courses, f lic basic requirements
are:
■ a qualification in Medical
Laboratory Sciences preferably
with specialized training in
immuno-haematology/Blood
Transfusion
■ the participants should be current
ly working full-time in a Blood
Transfusion Service or a Blood
Bank with sufficient supervisory
experience in blood transfusion
safety/blood transfusion
service/blood bank
■ it would be an added advantage
if the participant has experience
in management skills and quality
assurance and a basic know!
edge of tlie aspects of blood
transfusion science other than
laboratory/technical matters i.e.
blood donation practices, compo
nent production, and the techni
cal aspects of use of blood in
clinical situations.
The number of participants in each
course will depend on the number of
countries in the region as well as the
size of the countries. At least, two par
ticipants will be selected initially from
each country. However in large coun
tries. there would be a need for a coun
try-specific QMT.
Participants should be able to take
on the role of quality manager/officer
after attending the course. The partici
pants will be expected to initiate and
strengthen the implementation as well
as monitoring of the quality systems in
their own B I S as well as contribute in
developing national quality systems.
A curriculum has been developed
lor the QMT courses after several con
sultative discussions and appropriate
training materials is being developed
according to the final curriculum, con
sidering the different level of knowledge
and skills of the participants. Back
ground material for the case studies and
group activities is also being prepared.
The training courses consist of for
mal lectures, case study exercises and
group activities. In addition to the staff
of the training centre and WHO's techni
cal assistance, external facilitators will
be used to cover specific topics within
their area of expertise. Prior to the train
ing course participants will receive a
questionnaire to assess their BTSs. The
knowledge of participants will be
assessed at the beginning, during and
at the end of the course. Sufficient time
will be devoted to enable participants in
developing a one-year follow up action
plan to improve their BTSs. The con
cept of regional external quality assess
ment schemes (REQAS) will be intro
duced to the participants and centres
participating in REQzXS will be identified.
Depending on ihe evaluation of the
4-week course and the participants'
needs, one or two 2-week refresher
course(S) will be organised dealing with
specific aspects of quality in blood
transfusion such as intensive courses in
TT1. blood group serology, quality in
blood component produc lion. etc.
Considering the regional variations, the
training courses could be adapted to
the regional needs for training.
Mechanisms will be developed to
assess the implementation of action
plan by the participants as well as to
assist them in overcoming the problems
faced in implementation of the action
plan.
Methodology of work
34|
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Each year, two or three 4-week courses
will be organized. Participants from the
countries in the region could be nomi
nated each year for the training course.
The training course will be organized in
a modular form, covering general quali
ty context and quality principles applied
to specific areas in BTS.
Expected outcome
■ Participants will acquire the
knowledge and skills to establish
quality system for blood transfu
sion services/blood banks
■ Knowledge and skills in good lab
oratory practices will be
improved
■ rhe currem status of the quality
system in blood transfusion serv
ices will be assessed in the par
ticipating countries
■ A plan of action for implementa
tion of quality system for the par
ticipants’ BTS/Blood Bank will be
developed
■ Future requirements for continu
ous training and staff develop
ment in quality management will
be proposed.
Establishing a Regional Quality
organizing quality assessment schemes
will take the opportunity to establish the
regional EQAS and assist in establishing
national external quality assessment
scheme.
The training centre will not only also
act as a regional resource training cen
tre but also hold annual meetings of
quality managers and be seen as an
instrument to promote networking in the
region in the area of blood transfusion
safety.
Establishment of Regional
Training Centre in each WHO
External Quality Assessment
Region
Schemes
In most of the WHO regions, one of the
WHO collaborating centres in blood
transfusion or one of the national institu
tions working in the area of blood safe
ty has been identified by WHO to under
take training in quality management (or
blood transfusion services. The identi
fied centres should have facilities for
training such as lecture rooms, office
space for facilitators, communication
means, including Internet access, dis
tance teaching, multimedia, a laboratory
for trainees and dedicated staff to take
over the responsibility of organizing the
training courses. Ideally, the centre
should also have facilities for accommo
dation for the trainees. For those
regions where such a training centre
does not exist, a centre may need to be
upgraded to carry out this task.
Depending on the requirements of the
centre, the facilities may need to be
upgraded for ongoing training activities
with the assistance of WHO. rhe centre
would be strengthened through upgrad
ing its training facilities, provision of lab
oratory equipment and appointing fulltime training facilitators. An area in the
centre should be dedicated for the
preparation of REQAS materials and
training of B IS staff from the countries
identified for the project.
In addition to providing training for
the participants from the blood transfu
sion services in the region, the regional
quality training centre or another identi
fied centre will) previous experience of
Regional External Quality Assessment
Schemes (REQzXS) will be established
which would be introduced within the
quality management training and have
been integrated within the quality man
agement project. The aim of this inte
grated approach of providing training
courses and introducing REQAS at the
same time, is to enable participating
BTS in upgrading their knowledge and
expertise and at the same time provid
ing them with the information about the
need and role of EQAS in improving the
performance of their laboratories.
Objectives
□ io develop regional external qual
ity assessment schemes which
would be integrated with interna
tional external quality assessment
scheme (or transfusion transmis
sible infections and in blood
group serology
□ To improve national quality sys
tems by assisting WHO Member
States to establish national EQ.\S
□ To assess the quality of laborato
ry performance on a
tlational/regioilai level.
The participants in the QMT course
will be identified as the focal points for
participating tn the WHO regional exter
nal quality assessment schemes tor
transfusion transmissible infections iHIV.
hepatitis B. hepatitis
and blood group
serology (ABO & Rh 1) grouping and
■ 35
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
cross- matching), rhe 1EQA panels will
be sent by WHO/HQ to REQ.XS organis
ers who in turn will send their panels
initially to participating laboratories, two
or three times a year. Subsequently the
capacity o( the organizing centres will
also be strengthened to enable them to
prepare their own proficiency panels
and bring thorn into conformity with the
international standards.
Methodology of work
At the refresher training course the
results of the REQAS will be discussed.
and special emphasis will be given to
the identified problem areas in addition.
the plan of action will be reviewed with
each of the participating BTS and an
evaluation of the progress (failures and
achievements) will be made. Possible
solutions for the problems and difficul
ties encountered will be sought, rhe
Plan of Action will be revised based on
the evaluation results of REQ.-VS. and
the establishment of the national quality
system will be promoted.
Establishment of Regional
Quality Network in Blood
Transfusion Services
Today, most blood transfusion services
in the developing countries work in iso
lation. There is a need for mutual com
munication and access to information
through newsletters and networks for
B I S. Training in quality management
and provision of necessary information
technology packages will make it possi
ble to achieve the goal for blood safety
and will substantially contribute to
improving blood safety globally. This is
one of the seven priorities of WHO
Objectives
36 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
■ To develop a formal structure for
interaction between Regional
Quality Training Centres and
blood transfusion services in
countries in the region, tn partner
ship with collaborating centres
experts and non-governmental
organisations, for the effective
implementation of quality man
agement systems at the national
level
■ To develop and upgrade the facili
ties of information technology for
interaction between BTS at
regional, sub-regional and country
level, including policy makers.
WHO collaborating centres and
non governmental organizations
■ To create effective electronic
national networks to enable the
sharing of critical resources in
blood transfusion services such
as the blood donor database.
information on blood collection.
testing of blood units, inventory
of blood and its components.
availability of technical expertise.
and information on issuing and
utilization of blood
■ To provide on-line assistance to
BTS and facilitate training in
blood safety.
Activities
■ Equip major blood transfusion
services with hardware (desktop
computer, printer, continuous
power unit), software and internet
access
■ Train the participants in computer
skills: development of skill for
information access and manage
ment, application of information
technology to blood transfusion
services, and its utilization for
developing an effective electronic
network system
■ Provide access to have informa
tion on the Internet, download rel
evant technical knowledge, use email for exchange of information
and for problem solving, and use
voice/telephone facilities to
encourage teleconferencing.
Given access to information on the
Internet, participating centres will be able
to communicate with the regional quality
training centre, download relevant techni
cal material, receive newsletters and
training materials, get information on
EQAS and receive the results of EQAS.
rhe establishment of a regional quality
network in blood transfusion services
will lead to improvement in the safety.
accessibility and quality of blood supply.
Expected outcomes
■ The Quality Management Project
for Blood Transfusion Services is
developed as a six-year project
(2000-2005) and expected out
comes are reviewed every year
■ At least two persons from each
country in every region will have
been trained every year as quality
managers/officers
■ The regional quality training cen
tre(s) will be established for ongo
ing quality management training
for BTSs. Based on the needs.
the identified regional quality
training centre will be strength
ened in terms of infrastructure.
equipment and staff in order to
improve the capacity for training
■ Member States in each WHO
region will participate in Regional
External Quality Assessment
Schemes
■ Member States will have estab
lished a sustainable national qual
ity system including a national
EQAS
■ rhe facilities in a Quality Area
Desk in BTS will be upgraded
■ All donated blood will be ade
quately tested for Htv and other
TTls, blood group serology.
processed using good laboratory
and manufacturing practices in at
least 80% countries of the region
by 2005. on a consistent basis
□ The quality, safety and adequacy
of blood will be improved in all
Member States.
Monitoring and evaluation
Among the indicators used to assess
the performance of this project will be
the following
■ Number of participants trained
per country
□ Proportion of countries trained in
the region
■ Number of training courses held
as per plan
■ Quality of the training course
developed
■ Participants’ satisfaction with the
course
■ Use of the centre as a resource
■ Improvement in quality of work at
the BTSs of the participants’ after
6 month/1 year of training
■ Number of centres participating in
the REQAS and of centres show
ing satisfactory performance
■ Number of centres taking correc
tive measures
■ Number of centres provided with
the facilities for electronic net
working
■ Number of centres using electron
ic network facilities.
Providing Appropriate
Diagnostic Support in
E-3DV/A503S Control
Providing diagnostic support is an
essential part of ensuring quality health
care in the fight against the HIV/AIDS
pandemic. There has been a strong call
for access to drugs to help in the fight
against HIV. however, it must be remem
bered that this battle is a process which
does not only require access to treat
ment. but also access to accurate diag
nostics. quality of care and follow up
The diagnostic support activities of the
BCT play a vital role in all three phases
of this process.
Using appropriate diagnostic tech
nology for screening and diagnosis is the
starting point in the process. In addition
to the actual diagnosis of patients’ HIV
status, diagnostic technology must be
used for screening of donated blood to
prevent transmission through transfu
sion. Diagnostic tests are also instru
mental for surveillance, providing epi
demiological data to monitor the spread
of the HIV/AIDS epidemic. Use of reli
able tests and appropriate testing strate
gies are important tn the prevention of
mother-to-child transmission, and for
voluntary counselling and testing
■ 37
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Figure 11: Appropriate diagnostic support with an emphasis
on HIV and related diseases, and collaboration with
partners
Diagnotics:
screening and diagnosis
Treatment of HIV,TB and o.l.:
monitoring efficacy
,
Care and follow-up:
improving quality of care
services. In these settings, simple/rapid
diagnostic tests c an provide accurate.
same-day diagnosis resulting in timely
treatment where needed.
Once individuals are identified as
being infected with HIV. and/or related
opportunistic infections, diagnostics
are used to determine the appropriate
treatment intervention. For example.
diagnostic tests may indicate resistance
to certain drugs and thus provide guid
ance on appropriate drug regimes.
Subsequent diagnostic technologies are
required to monitor the safety and effec
tiveness of treatment on a continuing
basis. z\dditional diagnostic imagine and
basic clinical laboratory tests will pro
vide information to ensure the ongoing
quality care and support provided to those
infected with HIV and suffering from
associated infections and illnesses such
as TB.
Several key activities within BCT
contribute to the provision of high quali
ty cost effective health care as related
to the Hiv epidemic.
BCT aims to ensure that the diag
nostic technologies used in diagnosis
and screening meet the highest stan
38 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
dards. and that they are available and
used appropriately. The operational
characteristics of HIV test kits are evalu
ated. and reports providing technical
information on their quality are issued
regularly. Alternative HIV testing strate
gies for the various testing objectives
have been developed, and are updated
as required. The WHO HIV Test Kit Bulk
Procurement Scheme facilitates access
to high-quality, low-cost diagnostic tests
to Member States and UN agencies.
BCT is assessing the available tech
nologies for monitoring the efficacy of
HIV treatment (CD4. p24. and viral load
testing) that are suitable for countries
with limned facilities and resources.
Tool kits for clinical laboratory monitor
ing at the district hospital (T referral)
and centralized referral hospital (2'"1
referral) levels are currently being devel
oped. To ensure reliable results, existing
schemes for monitoring laboratory per
formance will also be expanded to
cover all HIV related diagnostic areas
BCT is also providing guidance and
training to support and improve health
care services, in areas of blood safety.
clinical laboratory' and diagnostic imag
ing. all of which contribute to improved
quality of care. Capacity building to
improve skills and knowledge at all lev
els for appropriate diagnostic support is
an overarching aspect of BCTs activities.
Many' of these BCT activities are car
ried out in collaboration with other who
departments to improve synergies and
with UN agencies such as UNAIDS and
UNICEF WHO Collaborating Centres and
key' international partners These part
nerships are. and will continue to be. an
integral part of BCTs response to the
HIV/AIDS pandemic.
O [Information, Education,
Communication and
Resource Mobilization
Strategy
Information, Education
and Communication
The Department of Blood Safety and
Clinical Technology has a challenging
programme of work over the four-year
period covered by this Strategic Plan to
achieve the objectives and targets set.
The success of our endeavours will
depend, to some extent on available
resources - both human and financial and on a coherent communications
strategy.
A small communications team has
been formed within the department to
enhance awareness and visibility of the
work of BCT, to promote the mission
and key messages of the teams, and to
strengthen links between existing and
potential donors and partners at all
levels.
They will focus on ensuring that the
information disseminated is consistent.
credible and communicated effectively
to all relevant audiences in an appropri
ate format, and using the various chan
nels available, such as:
□ the written medium (technical
documents and guidelines, meet
ing reports, information sheets
and other advocacy papers.
learning materials, etc.)
□ audiovisual support (standardized
presentations, graphic images.
audio and video cassettes)
□ electronic mail and Internet
facilities
El personal contact.
The Department will place increas
ing emphasis on passing information
through its Internet pages and by using
individual and thematic electronic mail
addresses. This endeavour in no way
replaces the need for the printed page.
especially in resource-poor settings
where equipment is often unavailable or
inappropriate. It will however, be an
extremely useful tool to access credible
information, and even fulfil an interactive
role in information sharing - for example
through restricted, extranet pages - or in
distance learning techniques.
The communications strategy will
also target appropriate major interna
tional events and other types of meet
ing as valuable opportunities to share
information and enlist support for the
priority activities of the Department.
Networking will also be undertaken
broadly to ensure that government and
nongovernmental organizations alike
have the tools they need to reach their
national objectives in areas related to
blood safety and clinical technology.
Resoui-ce Mobilization
The resource mobilization objective of
the Blood Safety and Clinical
Technology department is ultimately to
secure that the department receives
adequate funding from appropriate
donor sources to allow it to carry out its
planned activities.
BCT’s activities have largely been
funded by WHO's regular budget and
the department has historically had only
a few government donors such as
Belgium. Italy. Japan. Luxembourg.
Netherlands and United Kingdom,
providing extrabudgetary support.
Given the scaling up of department
activities, the urgency in addressing
global challenges such as IUV/AIDS or
poor quality management and the
■ 38
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
increased internal and external
demands made on the department, a
comprehensive resource mobilization
strategy is needed to meet the. current
and expected funding gap.
The BCT resource mobilization strat
egy will form part ol the HTP cluster
strategy and build on the experience
and lessons learned from sister depart
ments. Special attention will be given
to:
40 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
■ maintaining and increasing extrabudgetan' contributions from
existing donor governments:
■ identifying potential new donors
in the public and private sectors:
■ finding innovative ways of posi
tioning department projects in
funding requests within and out
side WHO: and
■ raising awareness about the
department's activities within and
outside WHO.
Annex: Summary
Budgetary Figures
he budget and unmet needs
quoted in this section are as at
January 2000. BCTS 2000-2001 budget
will be adjusted during its implementa
tion to reflect the actual income.
Changes to tire original core budget will
be reflected in a working budget, and
reported at the 2001 session of the
Meeting of Interested Parties.
Figure 12: Additional income required for three priority areas
Figure 13: Income expected and unfunded priorities
HI Gap
Total gap USS 8.7 m
■ Unfunded three priorities 58%
Regular budget 23%
□ Expected income specified 19%
collaboration
capacity
training
■ 41
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
Table 1:
Planned cost, core budget and unfunded priorities by objectives and target, and by source of funds, 2000-2001, excluding department
director's office, as at January 2000, (all amounts in US$ thousand, inclusive of programme support cost on voluntary contribution)
WHO regular
Area of work ■ Objective ■ Target
Policy: To strengthen the capacity of
Total core
Unfunded
budget
Voluntary
Planned cost
budget
priorities
allocation
contributions
Unspecified
(a)
(b)
(c=b-a)
(d)
(t=f+j)
(f)
19)
6,399
2,274
•4,125
1,479
795
0
795
4,044
1,043
-3,001
771
272
0
272
2,192
1,186
-1,006
663
23
163
45
-118
45
0
0
0
523
0
4,473
2,509
-1,964
1,255
1,254
0
1,254
2,028
1,188
■840
793
395
0
395
2,212
1,078
-1,134
219
859
0
859
233
243
10
243
0
0
0
S12
230
-282
230
0
0
O
512
230
-282
230
0
0
0
6,362
1,788
■4,574
787
1,001
0
1,001
3,923
943
-2,980
454
489
0
489
1,075
336
-739
295
41
0
41
Specified
countries to formulate, implement, monitor,
and update national policies and plans for
blood, blood products, injections, diagnostic,
clinical technologies and medical devices
T1
Formulation, implementation,
monitoring and updating of national
policies and plans
T2
Global collaborations
T3
Global systems to monitor impact
Quality and safety: To assist
countries in ensuring the quality and safety
of blood, blood products, injections,
diagnostic, clinical technologies and medical
devices
T4
Development of norms, standards,
guidelines and reference materials
T5
Research, development and
evaluation of new technologies and
methods
T6
Development and implementation of
national quality systems
Access: To support countries in ensuring
equitable availability and affordability of
blood, blood products, injections, diagnostic,
clinical technologies and medical devices
T7
Continuous and sufficient quantities
of appropriate equipment and
supplies
Use: To promote appropriate and costeffective use of blood, blood products,
injections, diagnostic, clinical technologies
and medical devices
T8
Appropriate collection, processing and
clinical use of blood and blood
products
T9
Appropriate use of diagnostic imaging
and laboratory technologies
T10 Safe and appropriate use of injections
616
171
■445
0
171
Til Appropriate use of devices and clinical
748
338
-410
38
300
0
0
171
300
17,746
6,801
-10,945
3,751
3,050
0
3,050
3,078
2,209
-869
685
1,524
0
1,524
4,436
4,574
0
4,574
technologies
Sub-total
Departmental management, advocacy &
coordination
Programme support costs on unmet needs
Grand total
42 ■
WHO
Blood Safety and
Clinical Technology:
2000-2003 Strategy
-1,536
20,824
9,010
-13,350
Position: 712 (6 views)