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Quality Assurance, Quality Control and Accreditation

Article in Vox Sanguinis · February 2000

DOI: 10.1046/j.1423-0410.2000.79402531.x · Source: PubMed

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 International Forum

Vox Sang 2000;79:253–264

Quality Assurance,
Quality Control and Accreditation

(2) If there is a systematic control of your based on the ISO 9000 series, the Council of
C.P. Engelfriet quality system, who or which body/bodies is/ Europe guidelines or both, or on EN 45001,
H.W. Reesink are responsible? which will be replaced by ISO/IEC 17025 (all
G.G. de Lange (3) If there is no quality assurance system three in one country) and in the USA on the
in your country (obligatory or voluntary), is FDA guidelines for blood transfusion labora-
Quality assurance and quality control such a system envisaged in the near future? tories/centres. For a survey, see table 1.
have become important aspects of transfu- If so, on which system will it be based Question 2. In nearly all countries where
sion medicine. Licensing and accreditation (see question 1)? quality assurance is compulsory, the ulti-
of blood transfusion laboratories and centres (4) Is accreditation of blood transfusion mate responsibility rests with the govern-
is gaining importance. In some countries, laboratories/centres required or advocated ment. However, often the practical aspects
quality assurance and control are compulso- in your country? If so, by whom or which of quality assurance are delegated to other
ry, and accreditation of blood transfusion body and on which system will it be based bodies, e.g. the National Blood Transfusion
services is required. It seemed of interest to (1)? Service, the Red Cross and even to a foreign
obtain information on the present situation Which body is responsible for granting or institution (Hong Kong, see Lin).
concerning this aspect of transfusion medi- refusing accreditation? Question 3. Because there is obligatory
cine in various countries as well as on the What are the consequences if accredita- quality assurance in nearly all countries from
systems on which quality assurance and con- tion is refused? which a contribution was received, there
trol are based. To obtain such information, (5) Is your centre accredited or are there were only two direct answers to this ques-
the questions outlined below were sent to 27 centres in your country which are accredit- tion. In Italy (see Mozzi et al.), new national
experts in the field, in 24 countries, and ed? And if so, since when? and regional laws on blood transfusion are
answers were obtained from 22 of them, cov- under discussion and include accreditation
ering 18 countries. We give a survey of the Comments and thus quality assurance of blood transfu-
information obtained but the reader is ad- Question 1. It is clear that in virtually all sion services. In Sweden (Åkerblom and
vised to examine the individual answers in countries from which a contribution was re- Messeter), although there are two quality
order to fully appreciate the developments in ceived, quality assurance and control are assurance systems for blood centres, a dis-
this field. obligatory for all or some aspects of blood cussion has started on creating a new ‘Swed-
transfusion. In all countries but one, quality ish Quality System for Blood Services’ based
Questions assurance of blood products and their prepa- on GMP, the new ISO 17025 (which replaces
(1) Is there an obligatory or voluntary, ration is mandatory. It is, nearly everywhere, EN 45001) and including relevant elements
organized form of quality assurance in your based on GMP and, in many countries, also from the new ISO 9001 series.
country? on the ‘Guidelines to the preparation, use Question 4. Accreditation, certification
If so, on which system is it based? (GMP, and quality assurance of blood components’ or a license are required in most countries
GLP, GCP, ISO 9000 series, EN 45001, of the Council of Europe (1999). and are under discussion in others. In three
FDA, AABB, Council of Europe: Guide to In many countries, quality assurance of countries accreditation is required for the
the preparation and quality assurance of blood transfusion services is also compulso- preparation of blood products but not for
blood components) or other. ry, although it is still voluntary in some. It is blood transfusion laboratories (Czech Re-

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 Table 1. Quality assurance

Country Products Based on Services Based on

Austria obligatory GMP, CLP, CoE voluntary ISO 9000, EFI,

EN 45001
Brazil obligatory GMP, CoE, obligatory ISO 9000, CoE, GLP
(not evaluated yet) AABB, FDA
Canada obligatory GMP voluntary
Czech Rep. obligatory CoE, GMP obligatory CoE
Germany obligatory GMP, CoE, partly obligatory, CoE, GLP, EN 45001
German guidelines partly voluntary + German guidelines
Hong Kong obligatory CoE, AABB obligatory ISO 9002, CoE
Hungary obligatory GMP, CoE obligatory CoE
Ireland obligatory GMP, cGamp, CoE voluntary CoE, CPA, EFI
Italy being established voluntary ISO 9000
Japan obligatory GMP obligatory national system
Netherlands voluntary, in progress GMP voluntary, in progress ISO 9001 (2000), EFQM
New Zealand obligatory Medicines Act obligatory GLP
Norway voluntary GMP not required
Poland obligatory GMP, CoE obligatory GLP, CoE
Spain voluntary ISO 9000, CoE voluntary ISO 9000, CoE
Sweden obligatory GMP voluntary EN 45001, CoE,
Swedish guidelines
UK (England, obligatory GMP voluntary ISO 9000, CPA,
Scotland) EN 45001, CoE
USA obligatory GMP of FDA obligatory + FDA guidelines
voluntary (AABB standards)

CoE = Council of Europe, Guide to the preparation, use and quality assurance of blood components, 1999.

public, Sweden and the UK). Mostly again, GMP and the Council of Europe ‘Guide to
the ultimate responsibility rests with the gov- the preparation, use and quality control of Peter Flanagan
ernment. Refusal of accreditation may lead blood components’, and on the ISO 9000
to severe measures and ultimately to closure series, GLP, the Council of Europe guide- In New Zealand, blood and blood prod-
of the unit. lines and the EN 45001 series, which will be ucts that are intended for therapeutic use are
Question 5. In some countries there are replaced by ISO/IEC 17025 and in the USA defined as medicines and are therefore sub-
blood transfusion centres that have been or on the FDA guidelines for blood transfusion ject to the requirements of the Medicines
are in the process of being officially accred- laboratories/centres for the quality assurance Act 1981, the Medicines regulations 1984
ited. To obtain a full picture of the present of laboratories and centres. and subsequent amendments. These specific
situation, the reader is advised to read the statutory requirements define the environ-
answers to questions 4 and 5. Prof. Dr. C.P. Engelfriet ment in which quality systems for the as-
In conclusion, it is clear that quality as- Dr. G.G. de Lange surance of safe blood and blood products
surance and control have become an integral Central Laboratory of the Blood Transfusion have been developed.
Service (Sanquin)
part of blood transfusion. In nearly all coun- Plesmanlaan 125
New Zealand Blood Service (NZBS) was
tries, official, obligatory quality assurance NL–1066 CX Amsterdam (The Netherlands) established in July 1998 as the sole provider
systems are in force, mostly for both blood of blood and blood products within New
products and their preparation as well as the Ass. Prof. Dr. H.W. Reesink Zealand. A national quality system is being
laboratory procedures connected with blood Blood Bank North Holland (Sanquin) established that will conform to the require-
transfusion. In the few countries where there Plesmanlaan 125 ments of both GMP and ISO 9000. The de-
NL–1066 CX Amsterdam (The Netherlands)
is, as yet, no obligatory quality assurance, its sirability of moving to formal ISO certifica-
institution is under discussion. Accredita- tion remains under review.
tion, certification of, or a license for transfu- Blood centres within the country are re-
sion laboratories is required in several coun- quired to be licensed by Medsafe, the regula-
tries or is being discussed. Quality assurance tory arm of the Ministry of Health. This
systems for blood products are based on requirement has been in place since approxi-

254 Vox Sang 2000;79:253–264 International Forum

mately 1993. Licenses to manufacture are plied to laboratory testing, methods for the
issued on an annual basis following formal
Bjarte G. Solheim preparation of blood components, and meth-
audit inspections. These external quality au- ods for compatibility testing and the issuing
dits are undertaken against two main stan- Questions 1 and 2 of blood components for transfusion.
dards. In Norway, both cellular and plasma The Swedish National Board of Health
(1) The New Zealand Code of Good blood products are defined as medicinal and Welfare (NBHW) has issued directives
Manufacturing Practice for Manufacture products and are thus regulated by GMP. and recommendations for the activities at
and Distribution of Therapeutic Goods part Medicinal inspectors from the Norwegian the blood centres. The NBHW strongly en-
2: manufacture of blood and blood products. Health Department performed initial in- courages all centres to implement quality
This document is based on the Australian spections at all blood banks in the period assurance in their activities, but does not
Code with some minor modifications. Utilis- 1994–98, and by now the majority have been prescribe how this should be done.
ing a GMP based approach it identifies the GMP-certified. However, the Department The Guide to the preparation, use and
key elements of an effective quality system. has not given priority to regular control/ quality assurance of blood components
It also includes technical standards. insepction of GMP-certified blood banks. (Council of Europe) and the Handbook for
(2) The New Zealand Minimum Stan- This is particularly serious because the blood Blood Centres (Swedish Society for Transfu-
dards for the Collection, Processing and banks lack experience with the quality con- sion Medicine) are used as guidelines in all
Quality Assurance of Blood and Medicines trol procedures and responsibility require- blood centres.
derived from Human Plasma. This docu- ments inherent in GMP.
ment initially produced in 1996 provides Question 2
comprehensive technical standards. The Question 3 Inspectors from the MPA inspect the
Ministry of Health initially produced the We hope that the National Institute of blood centres every second year. Based on
Minimum Standards. In 1998, following its Health together with a new Transfusion their reports (and after acceptance of correc-
establishment as the single national entity Council will introduce quality assurance sys- tions undertaken by the blood centres) the
for the supply of blood and blood products, tems for blood banks. MPA gives the blood centre a licence, au-
responsibility passed to NZBS. Formal sys- thority accreditation, to produce blood com-
tems for change control have been agreed Question 4 ponents (plasma) for the manufacturing of
with Medsafe. The Council of Europe We have no requirements for accredita- medicinal products.
‘Guide to the Preparation and Quality As- tion of transfusion laboratories/centres. The manufacturer receiving blood com-
surance of Blood Components’ is utilised as ponents as starting material for production
an external standard for the review process. Question 5 of medicinal products has to inspect the
NZBS is responsible for provision of None of the Norwegian transfusion lab- blood centres regularly with regard to com-
blood services from ‘vein to vein’. This oratories/centres are accredited today. How- pliance to GMP.
involves responsibility for hospital-based ever, several of the larger transfusion labora- Based on yearly inspections, the Swedish
blood transfusion in addition to the manu- tories have recently started preparations for Board for Accreditation and Conformity As-
facturing role. NZBS directly manages the ISO 9000 and/or ISO/IEC 17025 accredita- sessment (SWEDAC) may declare the blood
larger blood banks. The smaller blood banks tion. At Rikshospitalet we are in the state of centre to be accredited as a testing laboratory
are operated by the local hospital under a having transplantation immunology accre- according to EN 45001. For blood centres,
contract with NZBS. The contract defines dited by EFI and the haematopoietic stem this is a voluntary procedure.
the requirements and standards that the cell work by EBMT and ISHAGE.
blood bank must maintain. One specific re- Question 3
Prof. Bjarte G. Solheim, MD, PhD, MHA
quirement is that the laboratory is accredited Although there are two quality assurance
Institute of Immunology
by International Accreditation New Zealand Rikshospitalet systems for blood centres in our country, we
(IANZ). IANZ is an external independent N–0027 Oslo (Norway) have started discussions on creating a new
organisation that audits against the New Swedish ‘Quality System for Blood Services’,
Zealand Code of Laboratory Management based on GMP, the new ISO 17025 (replac-
Practice (NZCLMP). ing the EN 45001), and including relevant
The blood transfusion sector in New elements from the new ISO 9001.
Zealand is highly regulated with require- Olof Åkerblom
ments for accreditation of both the manufac- Lisbeth Messeter Question 4
turing and blood banking sector. The expec- In order to issue blood products (plasma)
tations of the accreditation authorities con- Question 1 to be used as starting material for the manu-
tinue to increase. At this stage, however, The obligatory form of quality assurance facturing of medicinal products, the blood
there is no instance where a blood centre or is based on GMP and controls the prepara- centre must have a licence from the MPA.
blood bank has been refused accreditation. tion of blood components to be used as start- The MPA can withdraw a licence in case of
ing material for the manufacturing of me- non-compliance to GMP. Without a licence,
Dr. Peter Flanagan dicinal products. The Swedish Medical plasma from the blood centre may not be
New Zealand Blood Service
Product Agency (MPA) has issued the appro- used for the manufacturing of medicinal
Level 1/110 Symonds Street
PO Box 26611 priate provisions. products.
Epson A voluntary form of quality assurance is If the quality of performance in a blood
Auckland (New Zealand) based on EN 45001 (ISO 17025) and is ap- centre does not comply with EN 45001,

Quality Assurance, Vox Sang 2000;79:253–264 255

Quality Control and Accreditation
SWEDAC will not give or will withdraw the role to play in the quality systems: National by the UK Medicines Control Agency
accreditation certificate. Since the accredita- Institute of Clinical Excellence (NICE) and (MCA). Therefore, it follows there is an
tion is voluntary, the blood centre can still Commission for Health Improvement (CHI) obligatory requirement for a formal quality
serve hospitals without accreditation (how- in England and similar bodies in Scotland. A assurance system. From the regulatory per-
ever, this means ‘loss of face’ and is therefore new concept called ‘Clinical Governance’ spective, this is based on GMP [1, 2]. Addi-
avoided at all costs). has been introduced and Chief Executives of tionally, the UK Blood Services also comply
Statutory Bodies are responsible for ensuring with Guidelines for the Blood Transfusion
Question 5 the quality of all work, including clinical Services in the UK [3]. This is a best practice
All of the 90 plus blood centres and blood work, carried out in their organisations. guide that is based on the combined princi-
and plasma collection sites in Sweden have ples of GMP and ISO 9000 and takes ac-
received a licence from the MPA, allowing Question 3 count of the Council of Europe guidance in
them to issue recovered and source plasma Not applicable. this area [4].
to be used as starting material for the manu- It is generally accepted that the term
facturing of medicinal products. The MPA Question 4 ‘blood banking’ refers specifically to the pro-
inspections started in 1994 and licensing in All Blood Transfusion Centres in the UK vision of such services as pretransfusion test-
1995. have to be licensed by MCA for the pro- ing, supply of blood for patients and antena-
SWEDAC started in 1995 to accredit duction of blood components. This is man- tal/investigative serology, i.e. it is the provi-
blood centres according to the EN 45001. datory. sion of a clinical laboratory service for pa-
Today, 28 blood centres have applied for, Accreditation by CPA for the diagnostic tients.
and received, such accreditation. laboratories is still voluntary, but under the Currently there is no legislation govern-
new systems of clinical governance may be- ing quality standards in blood banking (or
Dr. Olof Åkerblom come mandatory. other pathology discipline) in the UK. How-
Department of Clinical Immunology and MCA and CPA are responsible for grant- ever, blood banks are required to participate
Transfusion Medicine ing or refusing licenses or accreditation, re- in National (UK) External Quality Assur-
University Hospital
spectively. ance proficiency testing exercises for blood
S–75105 Uppsala (Sweden)
If the MCA refuses to issue a license then group serology.
the Centre cannot produce or issue any A voluntary accreditation scheme for
blood components, if the CPA refuses ac- UK pathology laboratories has been estab-
creditation then the Centre will continue to lished [5] and is contributing to a significant
function carrying out the diagnostic work raising of standards. This scheme is not
V. James but hospitals might soon stop referring sam- based on any established quality system but
ples. requires compliance with a number of de-
Question 1 fined standards that embrace the general
The Quality systems in the UK are based Question 5 principles of good and safe laboratory man-
on ISO 9000; the principles of EN 45001 are All Transfusion Centres in the UK have agement and service provision.
incorporated into the Quality systems. GMP been licensed (mandatory) by the MCA since
is compulsory. 1991. Question 2
The United Kingdom Blood Transfusion Most diagnostic laboratories in centres Blood component manufacturing quality
Services/National Institute of Biological have CPA accreditation since approximately systems are controlled at various levels, i.e.:
Standards and Control: Guidelines for the 1990. – by MCA regulatory inspections which,
Blood Transfusion Services in the United as a minimum, take place every two years or
Kingdom (the Red Book) are compatible Dr. V. James whenever there has been a significant change
with the Council of Europe Guide and also Consultant Haematologist or problem;
appropriate EU Directives. Trent Centre – the Scottish National Blood Transfu-
Longley Lane
sion Service (SNBTS) has a Quality Directo-
Sheffield S5 7JN (UK)
Question 2 rate which plays a lead role in monitoring
There are several layers of systematic performance (e.g. through audit, review of
control with internal (individual Transfu- performance vs. key performance indicators
sion Centre based) and external quality au- and incident reporting); controlling change
dits. (e.g. SOPs, validation and implementation
The Medicines Control Agency (MCA) plans, recall) and promoting continuous
is responsible for licensing Transfusion improvement (e.g. through target setting;
Centres for the production of components Martin Bruce corrective/preventative action; sharing best
and Fractionation Centres for the produc- practice);
tion of plasma derivatives. Question 1 – all staff have a responsibility to control
Clinical Pathology Accreditation (CPA) In the UK, manufacturing and provi- the quality of their own work.
is responsible for accrediting the diagnostic sion of blood components are undertaken The SNBTS cross-matches around half
laboratory work at the Transfusion Centres. at Blood Centres (BCs) and is considered of the blood that is used in Scotland, there-
New bodies have recently been created a pharmaceutical manufacturing activity. fore, the quality system elements listed
by the UK Government which will all have a These activities are regulated and licensed above apply equally to blood banking in

256 Vox Sang 2000;79:253–264 International Forum

SNBTS (although at present these principles ISO 9000; The King’s Fund; Chartermark;
are less well established in the blood bank CPA, etc.).
Joan O’Riordan
environment). Most pathology services in the UK would William Murphy
For other hospital blood banks, there is acknowledge that CPA offers the most ap-
no independent Quality Department/Per- propriate scheme. However, as participation Question 1
sonnel. In these establishments, the extent in the scheme presently is voluntary, failure The Irish Blood Transfusion Service
and control of the quality system is largely to secure accreditation does not result in (IBTS), formerly known as the Blood Trans-
based on the standards established by Clin- withdrawal of the right to provide the ser- fusion Service Board, is regulated by the
ical Pathology Accreditation UK Ltd vice. That said, it is hoped that such a posi- Irish Medicine’s Board (IMB) who inspect
(CPA). tion would result in a redoubling of that to cGMP and cGAMP standards and the
In the past year, the UK Departments of establishment’s efforts to correct the prob- Council of Europe Guide to preparation, use
Health have issued an instruction [6] notably lems identified and secure accreditation. and quality assurance of blood components.
to hospital Chief Executives, Medical Direc-
tors etc. drawing their attention to the im- Question 5 Question 2
portance of safe blood transfusion practice. In the UK, the NHS and Community The IMB grants the IBTS its Manufac-
Amongst the recommendations made was a Care Act (1990) resulted in the removal of turing Licence which covers the collection
requirement to establish Hospital Transfu- ‘Crown Immunity’ on 31 March 1991. For and processing of whole human blood and
sion Committees. This, of itself, has brought Blood Transfusion Services, this meant their human plasma for use in the manufacture of
an increased level of control. Further control manufacturing activities would be governed medicinal products. The IMB also grants a
and improvement are envisioned as the phi- by the same rules which applied to the Wholesaler’s Licence in respect of the distri-
losophy of Clinical Governance is imple- broader pharmaceutical industry. BCs were bution of medicinal preparations. There are
mented into the routine working of hospi- given 5 years to obtain a license from MCA. twice-yearly inspections to the above stan-
tals. This was achieved and all Centres continue dards.
to be licensed.
Question 3 Question 4
The quality system requirements in Scot- References Accreditation is not required, but it is an
land have been described in some detail in aspiration to seek accreditation from rele-
1 Rules Governing Medicinal Products in The
responses 1 and 2. vant bodies: CPA for Diagnostic Laborato-
European Union, vol IV: Good Manufacturing
Significant change is not envisaged in the Practice for Medicinal Products. Luxembourg,
ries and European Federation for Immuno-
near future. Office for Official Publications of the European genetics (EFI) accreditation for the National
Communities, 1997. Tissue Typing Reference Laboratory.
Question 4 2 Rules and Guidance for Phamraceutical Man-
As has been described, blood component ufacturers and Distributors. London, the Sta- Question 5
tionery Office, 1997. The IBTS has two transfusion centres;
manufacture in the UK is regulated by the 3 Guidelines for the Blood Transfusion Services
MCA. BCs submit and maintain a license the National Blood Centre is located in Dub-
in the United Kingdom. Sheffield, National
application and site master file. The MCA Blood Authority, 1997. lin and the second centre is in Cork. Both
Inspector will consider the contents of these 4 Guide to the preparation and quality assurance centres are inspected to cGMP and licensed
documents and his findings at one or more of blood components, ed 5. Strasbourg, Council by the IMB. In addition, ISO 9000 accredita-
audits when determining whether a license of Europe Press, 1999. tion and CPA have been granted to the
5 Bruce M: Managing change through quality regional blood centre.
should be awarded.
systems; in Quality Around the World. Bethes- Failure to maintain the required stan-
The BC normally will be given a period da, AABB, 1997, pp 29–63.
of time to correct non-conformances identi- dard by the IMB would lead to not being able
6 Better Blood Transfusion. The Scottish Office,
fied at audit, the more serious the problem/s, Department of Health. Management Executive to export plasma for blood derivative manu-
the shorter the time given to effect corrective Letter, 1999. facture. The consequences in terms of pub-
action. 7 Departments of Health. Strategic Review of lic/political disapproval would be very se-
Withdrawal of a license would be pur- Pathology Services. ISBN-011-Reorder 321- vere. However, the transfusion service is the
9334. London, HMSO Publication Centre, sole supplier of allogeneic labile blood com-
sued only if the problems identified could
1995.
not be resolved within an agreed time scale ponents, and as such would continue in this
and/or the MCA considered there was a sig- Dr. Martin Bruce
capacity pending renewal of licence. ISO
nificant risk to patient safety. National Quality Director 9000 and CPA accreditation are voluntary.
With regard to Blood Banking, as has Scottish National Blood Transfusion Service Other activities that require an accreditation
been mentioned, there is a voluntary system Ellen’s Glen Road framework in the future are tissue banking
of accreditation. To date, the strongest indi- Edinburgh EH17 7QT (UK) and tissue typing.
cation that this will become a prerequisite
for service provision appeared in a 1995 Dr. Joan O’Riordan
Irish Blood Transfusion Service
Department of Health (England and Wales)
Pelican House
report [7]. This recommended that purchas- 40 Mespil Road
ers of pathology services use ‘accredited’ lab- Dublin 4 (Ireland)
oratories, but fell short of defining which
system of accreditation should be used (e.g.

Quality Assurance, Vox Sang 2000;79:253–264 257

Quality Control and Accreditation
 1999: Laboratory and blood deposit, Question 4
D. Schönitzer Krankenhaus Krems (NÖ) In the near future, accreditation will only
1999: Blutzentrale Klagenfurt be required for laboratories performing tests
Question 1 Plasmapheresis Facilities with ISO 9000 on in vitro diagnostics for bulk release in the
In Austria the ISO 9000 series for quality certificate: European Union. In general, Austria’s as
assurance is voluntary. GMP is obligatory 1997: Human Plasma GmbH, Wien well as the European Union’s philosophy
for facilities producing blood products (Arz-
1998: Seruman Humanplasmagewin- tends to promote accreditation in the fu-
neimittelgesetz). nung, Linz ture.
Since January 1st, 1999, the blood safety 1999: Plasmaspendedienst Graz
law (Blutsicherheitsgesetz) has been in ac- Two centres expect certification during Question 5
tion, which regulates in detail donor selec- the course of the year 2000. In total there are The Blood Donation Center for Vienna,
tion and blood donation. The law is mainly 11 plasmapheresis centres in Austria. Lower Austria and Burgenland of the Aus-
based on the Recommendation No. R (95) In Austria there are 12 blood banks, trian Red Cross is not yet accredited, but we
15 on the preparation, use and quality assur-
where blood or blood components are col- are planning to get accreditation for the
ance of blood components.
lected. In smaller hospitals there are blood Blood Group Serology Laboratory. There are
deposits and transfusion laboratories, which centers that have already passed accredita-
Question 2 order the blood products from the blood tion, for example the HLA Laboratory of the
Systematic control of ISO 9000 norms is banks. Department for Blood Group Serology at the
performed by organisations like ÖQS, TÜV, University Hospital Vienna.
DNV, Süd Cert and others. Prim. Doz. Dr. D. Schönitzer
GMP is controlled by the Federal Minis- Zentralinstitut für Bluttransfusion und Dr. Gabriela Henn
try for Labour, Health and Social Affairs and Immunologische Abteilung Blutspendezentrale
by Public-health officers under supervision Landeskrankenhaus Innsbruck Wiedner Hauptstrasse 32
of the government. Anichstrasse 35 Postfach 39
A–6020 Innsbruck (Austria) A–1041 Wien (Austria)
Question 3
Not applicable.

Question 4
Obviously, there is no clear-cut distinc- W.R. Mayr
tion between certification and accreditation. Gabriela Henn Petra L’Herminez
However, GMP certification is required by
the Federal Ministry for Labour, Health and Question 1 Question 1
Social Affairs. This body is responsible for In Austria both systems of quality assur- The executive board of Sanquin (the
granting or refusing certification. If certifica- ance are installed: an obligatory one, based Dutch foundation for blood supply) has vol-
tion is refused, a certain period of time will on the Law on Blood Safety (Blutsicherheits- untarily decided that every division of San-
be given for corrective measures. If correc- gesetz), corresponding to GMP and GLP quin has to fulfill the requirements of GMP,
tion cannot be achieved, the laboratory or which is under the surveillance of the Minis- ISO 9001 (2000) and – finally – EFQM. The
centre has to be closed (so far, this has never try of Health, and a voluntary one, which is implementation of these quality systems will
been the case). If the laboratory of a transfu- based on ISO 9001 at our blood donation be performed stepwise. Total implementa-
sion service performs tissue typing, EFI ac- center. Our center is also interested in ac- tion time is estimated to be at least 5 years
creditation is required, if services are to be creditation following EN 45001 for some (depending on the division).
considerd acceptable within the framework activities. The ISO 9001 certification and
of Eurotransplant. the EN 45001 accreditation, however, are Question 2
voluntary. The Dutch Inspectorate of Health per-
Question 5 forms GMP inspections in the blood bank
Transfusion centres with ISO 9000 cer- Question 2 divisions on a 2-yearly basis. STERLAB ac-
tificate: The body responsible for systematic con- creditation is inspected by the ‘Raad voor
1995: Transfusionsmedizinisches Zen- trol of the obligatory part of the quality sys- Accreditatie’.
trum Wien (Dr. Scholda) tem in our country is, as mentioned above, Within Sanquin, an internal inspection
1996: Blood deposit and laboratory Wil- the national health authority (Ministry of systemis is in place for the blood bank divi-
helminen Spital, Wien Health). For the voluntary part, certification sions. This system is being enlarged to cover
1997: Zentralinstitut für Bluttransfusion is done by accredited companies; concerning all parts of Sanquin.
und Immunologische Abteilung Innsbruck the accreditation, we have to contact the
1998: Laboratory of Landeskinderklinik Ministry of Economic Affairs or ‘Notified Question 3
Linz Bodies’ (e.g. TÜV) within the European See above.
1998: Blutzentrale für Wien, NÖ und Union.
Burgenland Question 4
1998: Krankenhaus der Barmherzigen Question 3 No, the accreditation is not required or
Schwestern Wels (Blutbank) (OÖ) Not applicable. advocated by others than Sanquin self.

258 Vox Sang 2000;79:253–264 International Forum

Question 5
All blood bank divisions fulfill the re- P. Kühnl Fulvio Mozzi
quirements of GMP (as stated by the Dutch A. Kluge Paolo Rebulla
Inspectorate of Health). One blood bank di- Girolamo Sirchia
vision has an AABB accreditation. Some We submit our statement from Germany
parts of Sanquin have an ISO 9001 : 1994 in the form of a table (see below). Question 1
certificate and some parts are accredited by Health care structures willing to supply
STERLAB. Prof. Dr. P. Kühnl health services in Italy must pass two different
Department of Transfusion Medicine
steps: (a) authorization and (b) accreditation
University Hospital Eppendorf
Dr. Petra C. L’Herminez [1]. The first is based on the compliance to
Martinistrasse 52
Quality Assurance structural technologic and organizational re-
D–20246 Hamburg (Germany)
Sanquin
quirements fixed by the national law [2] (only
P.O. Box 9892
NL–1006 AN Amsterdam (The Netherlands)
Prof. Dr. A. Kluge for health structures with in-patients) and
Institute of Immunology regional regulations. Authorization is granted
University of Heidelberg by the regional administrations and allows
Im Neuenheimer Feld 305
public or private health structures to supply
D–69120 Heidelberg (Germany)
health services, but not on behalf of the Na-

QMS Collection and Laboratory control (a) Other laboratory Clinical transfusion
production of of blood recipients activities medicine
blood components (b) Except control (application of
Laboratory control of medical devices, blood components)
of blood donors IVD

Question 1 Obligatory; Obligatory; (a) Voluntary Obligatory;

AMG, GMP, GLP, TFG, RiLiBlut, (b) Obligatory; TFG, RiLiBlut
CoE Guide GLP, CoE Guide MPG, EN 45001,
IVD-RiLi
Question 2 PEI, regional officersa Regional officersb (b) ZLG or other Regional officersb
notified body
Question 3 (a) No
Question 4 No accreditation, No accreditation, (a) In discussion No accreditation,
supervision by AMG supervision by RiLiBlut (b) Essential for supervision by
is required is required special activities RiLiBlut is required
Stop of production (IVD, AMG)
and/or distribution
Question 5 Accredited: 0 Accredited: 0 Accredited: 0 Accredited: 0
Certified: ? Certified: ? Certified: ? Certified: ?

IVD = in vitro diagnostics; AMG = Arzneimittelgesetz; CoE = Council of Europe; TFG = Transfusionsgesetz;
RiLiBlut = Richtlinien zur Gewinnung und Anwendung von Blut und Blutprodukten (Hämotherapie); MPG = Medi-
zin-Produktegesetz; IVD-RL = In Vitro Diagnostika-Richtlinie; PEI = Paul-Ehrlich-Institut (Federal Agency for (im-
muno)biological drugs); ZLG = Zentralstelle der Länder für Gesundheitsschutz.
a Of States’ Ministries of Health.
b In several States (e.g. Baden-Württemberg).

Quality Assurance, Vox Sang 2000;79:253–264 259

Quality Control and Accreditation
tional Health Service (NHS). To do this, Question 4
accreditation is required, which is granted by As mentioned before, accreditation is not
F. Carbonell-Uberos
the regional administrations following the as- yet mandatory for blood transfusion labora-
Question 1
sessment of the compliance to additional tories/centres, as stated in the answer to
In Spain there is a voluntary program for
structural, technologic and organizational re- question 1, but it will with the new law.
quality assurance of blood establishments
quirements, specific for each health-care area. The Regional Administrations, directly or
based mainly on the Council of Europe
These ‘additional requirements’ have been through independent bodies, will assess the
Guide. This guide has been translated into
established by each regional administration compliance with the accreditation require-
Spanish by the Ministry of Health as the ref-
for its own territory. They include, as in the ments, in view of granting or refusing accre-
erence book. Several centres have been cer-
case of the region Lombardia [3, 4], in a more ditation. The initial assessments will be fol-
tified by ISO 9000 series and others are in
detailed way than the national law, the imple- lowed by regular surveillance.
preparation to meet these requirements.
mentation and the regular application, in each In cases in which accreditation is refused,
structure, of a Quality Assurance System the organization will not be allowed to sup-
Question 2
based and certified on the ISO 9000 series. ply products and/or services on behalf of the
Licensing of blood establishments and
Following the institutional accreditation, NHS [3] and, consequently, to be paid.
mandatory inspections are the responsibility
health structures become potential suppliers
Question 5 of regional health authorities. Voluntary ac-
of health services on behalf of the NHS.
creditation is based on the program co-
The National Blood Transfusion Service The quality system of the Centro Trasfu-
developed by the AEHH (Spanish Associa-
is regulated by a particular legislation [5–7], sionale e di Immunologia dei Trapianti,
tion of Haematology and Haemotherapy)
which defines most of the product and ser- based on the EN ISO 9002 : 1994 standard,
and the SETS (Spanish Society of Blood
vice standards, but does not require the ac- was the first system to be awarded a certifi-
Transfusion). There is a Committee of Ac-
creditation for the blood banks. Only the new cate of approval in Italy (18th July, 1997).
creditation in Transfusion (CAT), formed by
national and regional laws concerning blood Other Italian blood transfusion centres
members of both societies, which is in charge
transfusion, now under discussion [8, 9], will have been certified since. We expect that we
of publishing the standards in transfusion,
include the accreditation principle and de- and others will undergo accreditation in the
defining the areas of accreditation and the
fine the requirements and the authorities for next few months or years, according to pre-
rules for the inspections of blood establish-
the accreditation, harmonizing the transfu- scriptions of the forthcoming blood transfu-
ments.
sion service with the NHS regulations. sion law.
In the meantime, many blood banks have
started the implementation of their quality References Question 4
assurance systems based on the ISO 9000 Accreditation of blood transfusion estab-
1 Legislative decree No 502. Gazzetta Ufficiale lishments is advocated by the two profes-
series [10, 11]. In the last few years, the 1992;305(suppl 137, and following modifica-
Società Italiana di Medicina Trasfusionale sional societies previously mentioned. The
tions).
ed Immunoematologia (SIMTI) strongly CAT is responsible for giving or not accredi-
2 Presidential decree Jan 14, 1997. Gazzetta Uf-
promoted and supported this activity, also ficiale 1997;42(suppl 37). tation which is valid for 3 years. After this
with the cooperation of the Italian National 3 Region Lombardia, law No 31. Bollettino Uffi- time, one needs to ask for a reaccreditation.
Institute of Health (Istituto Superiore di ciale 1997;28(suppl 2). The centre needs to be accredited in order to
4 Region Lombardia, decree No 6/38133. Bollet- receive post-graduate doctors to specialise in
Sanità, ISS) through specific training courses tino Ufficiale 1998;35(suppl 4).
and/or consultancy. haematology and transfusion medicine.
5 Law No 107. Gazzetta Ufficiale 1990;108:5–
At present, several blood banks have in 18.
place a running quality assurance system cer- Question 5
6 Health Ministry decree Dec 27, 1990. Gazzetta
tified on the ISO 9000 standards. Ufficiale 1991;20:6–11. Our centre and most of the blood transfu-
7 Health Ministry decree Jan 15, 1991. Gazzetta sion centres and hospital-based transfusion
Question 2 Ufficiale 1991;20:12–16. services are accredited. The voluntary sys-
8 Law project No 2112 (unified version 1999). tem of accreditation in Spain has started in
The ISO 9000 certification process usual- Web site www.camera.it.
ly includes an initial comprehensive external 1975 and has been implemented progres-
9 Region Lombardia, law No 20 (IV regional
audit, followed by a 3-year surveillance peri- sively.
blood and plasma plan 1999/2001). Bollettino
od during which external audits are per- Ufficiale 2000;13(suppl 2).
10 EN ISO 9001 : 1994: Model for quality assur- Dr. F. Carbonell-Uberos
formed every 6 months. Audits are per-
ance in design, development, production in- Chief Immunohematology Service
formed by independent organizations, which Centro Transfusión Comunidad Valencia
stallation and servicing.
have to be accredited by the respective na- Av. Cid 65
11 EN ISO 9002 : 1994: Model for quality assur-
tional bodies (Sincert in Italy). The national ance in production installation and servicing. E–46014 Valencia (Spain)
accrediting bodies, as well as the certifica-
tion bodies, have to comply with common Fulvio Mozzi, DSc
international standards. This allows the in- Paolo Rebulla, MD
ternational mutual recognition of the certifi- Girolamo Sirchia, MD, FRCEdin
cation procedures. Centro Trasfusionale e di Immunologia
dei Trapianti
IRCCS Ospedale Maggiore di Milano
Question 3 Via Francesco Sforza, 35
See answer to question 1. I–20122 Milano (Italy)

260 Vox Sang 2000;79:253–264 International Forum

 Question 5
György Medgyesi M. Pı́sačka 67 transfusion centres are accredited by
now (registered by the Ministry of Health, in
Before answering the specific questions, Question 1 cooperation with SUKL), but the accredita-
it might be appropriate to give some general In the Czech Republic there is an obliga- tion of each centre will be re-evaluated (only
information about the Hungarian Blood tory system of quality assurance, based on by SUKL) in the near future – following the
Transfusion Service. The law on health care GMP and GLP. The national GMP and
process of harmonisation of national legisla-
adopted by the Hungarian parliament in GLP regulations are based on Council of tion with the European Union.
1997 declared the provision of blood and Europe Recommendation No. R (95)15 and
blood derivatives to be a governmental re- its Appendix: ‘Guide to the Preparation, Use Dr. M. Pı́sačka
sponsibility. According to this decision, and Quality Assurance of Blood Compo- Reference Laboratory for Immuno-
blood transfusion centres have been orga- nents’. haematology
nised into a National Blood Transfusion Ser- Institute of Haematology and Blood
vice. At present the Service consists of six Question 2 Transfusion
regional and 22 local centres co-ordinated The responsible body for the quality con- U. nemocnice 1
CZ–128 20 Prague 2 (Czech Republic)
and supervised by the Headquarters. trol of blood component production in the
Czech Republic is the State Drug Control
Question 1 Institute (SUKL). Inspectors of SUKL con-
The law on health care (law CLIV of trol all procedures of transfusion production
1997) mandates the application of quality and fulfilment of GMP and GLP require-
assurance on health services. In accordance ments is necessary for the accreditation M. Letowska
with this law, the Decree of the Hungarian (= state registration) of all transfusion
Minister of Health (decree 43/1999, EuM) centres. The external quality assurance sys- There are 21 Regional Centers for Trans-
states that the Hungarian National Blood tem is based on proficiency testing. The im- fusion Medicine (RCTM) in Poland, 16 of
Transfusion Service operates a quality assur- munohematology part is organized by the which are located in main cities. Each
ance system to control: National Reference Laboratory for Immuno- RCTM has its local blood bank (6–32) in
– the quality of the materials and re- hematology, which is part of the Institute of smaller towns of the region. Within the scope
agents used in blood banking activity, Hematology and Blood Transfusion. The of activity of each local blood bank lies: qual-
– the adherence to professional guide- proficiency test samples are distributed four ification of donors, blood collection and dis-
lines and regulations, and times a year. The participants provide their tribution of blood components. 95% of the
– the fulfilment of requirements concern- results of ABO/RhD typing, further red cell local blood banks also deal with blood com-
ing personnel and equipment. antigens phenotyping, direct Coombs, anti- ponent preparation. This activity is super-
The quality assurance system adopted is body screening and identification (the extent vised by the National Center for Transfusion
based on GMP and the Council of Europe of testing depends on the diagnostic range of Medicine (NCTM) with its seat in Warsaw.
‘Guide to the Preparation, Use and Quality each participant laboratory).
Assurance of Blood Components’. Further transfusion-related proficiency Question 1
testing systems are organized by the respec- Polish RCTMs are obliged to adhere to
Question 2 tive National Reference Laboratories (NRL the quality assurance system organized ac-
The Headquarters of the National Blood for HIV, hepatitis, syphilis, hematology, bio- cording to the regulations prepared and is-
Transfusion Service regularly supervises the chemistry), which are independent of the sued by the NCTM. This system of regula-
quality system within the blood transfusion transfusion service. tions is mainly based on the regulations of
centres. the Council of Europe as issued in ‘Guide to
Question 3 the Preparation and Quality Assurance of
Question 4 Not applicable. Blood Components’ as well as on the princi-
Accreditation of blood transfusion ple of GMP and GLP.
centres by bodies beyond the Headquarters Question 4
of the National Blood Transfusion Service is The accreditation of blood transfusion Question 2
currently under consideration at govern- laboratories involved in blood component Quality assurance is supervised by the
mental level. preparation (transfusion centres) is part of Quality Assurance Divisions of each RCTM.
the licensing process by SUKL. Refusal of They bear responsibility for SOP, systematic
György Medgyesi, PhD, DSc accreditation should lead to cessation of audits of all divisions and local blood banks,
Scientific Adviser blood component preparation by the respec-
National Blood Transfusion Service
staff training and current quality control of
tive centre. blood components. Every month, employees
PO Box 44
The accreditation of other blood transfu- of the Quality Assurance Division analyze
H–1518 Budapest XI (Hungary)
sion laboratories (blood banks – pretransfu- quality control documents sent in by the
sion testing) is not required by national legis- local blood banks and at least once a year
lation, but the registration by state authori- audits of each local blood bank are orga-
ties and participation in the external quality nized. All RCTMs are supervised by the
assurance system is obligatory. NCTM. At least once in 2 years every
RCTM plus one selected local blood bank

Quality Assurance, Vox Sang 2000;79:253–264 261

Quality Control and Accreditation
are audited by representatives of the Question 2 and blood component manufacturing are in
NCTM. During such inspections, atten- In the US, the FDA is respnsible for the place and define the requirements for opera-
tion is paid mainly to the functioning of federal regulation of blood establishments, tions. Also, New National Blood Safety Stan-
Quality Assurance Divisions. including quality requirements. Voluntary dards have been drafted and will be refer-
organizations that have accreditation pro- enced in legislation in the near future.
Question 3 grams, such as the AABB, also oversee quali-
Not applicable. ty in their members’ facilities. Question 2
Yes there is a system control of quality
Questions 4 and 5 Question 3 systems. Canada’s blood system operators
In Poland the public blood transfusion Not applicable. (CBS and HQ) are responsible for having
service constitutes an integral part of the these systems in place and the federal gov-
public health service. The Polish blood Question 4 ernment (Therapeutic Products Programme)
transfusion service functions according to In the US, blood establishments that is responsible for ensuring that it meets regu-
the regulations introduced with the govern- transfer blood and blood components from latory standards.
mental law of January 1st 1999. According one US state to another must be licensed by
to this law, blood may be collected in public the FDA. All blood establishments, whether Question 3
blood transfusion centers only. All RCTMs they share blood or not, are inspected by the Not applicable given response to ques-
are funded by the Ministry of Health while FDA against cGMP standards. There are tion 2.
their functioning is supervised by the federal civil court penalties for failure to
NCTM. Such supervision is conducted by adhere to cGMP. In addition, voluntary or- Question 4
way of regular audits and inspections of the ganizations, such as the AABB, have accredi- Blood transfusion centres in Canada are
regions. If serious faults in the activity of the tation programs for their members. licensed by the federal government and thus
regional unit are found during inspections, do not need to be accredited since existing
the Ministry of Health may be approached Dr. Mary Gustafson federal licensing represents the ultimate de-
for a change of director or the closure of the Division of Blood Applications gree of regulatory oversight. Some transfu-
blood bank. CBER, FDA, HFM-370 sion centres are, however, accredited by
1401 Rockville Pike
AABB or Canadian Society of Transfusion
Rockville, MD 10852-1448 (USA)
Dr. Magdalena Letowska Medicine, but these are voluntary.
Institute of Hematology and
Blood Transfusion Question 5
ul. Chocimska 5
Refer to answer in question 4. It is neces-
PL–00-957 Warszawa (Poland)
sary to contact CBS and HQ to seek out
information about their respective accredita-
Peter Ganz tion status.

Before responding specifically to your Dr. Peter Ganz

questions, let me preface our answers by Chief, Blood & Tissues, Division
Mary Gustafson emphasizing that these answers are offered Bureau of Biologics and Radio-
pharmaceuticals
as those of the national regulatory authority.
Tunney’s Pasture
Question 1 In Canada this is the federal government, Ottawa, Ont. K1A 0L2 (Canada)
The Food and Drug Administration’s specifically, the Therapeutic Products Pro-
(FDA) current good manufacturing practices gramme of the Health Protection Branch
(cGMP) regulations for blood and blood which is responsible for regulation of the
components [in Title 21, Code of Federal blood system. Operators of the blood system,
Regulations, Part 606 (21 CFR 606)] and Canadian Blood Services (CBS) and Héma-
drugs (21 CFR 211) apply. These are manda- Québec (HQ) should be requested to provide J. Wesley Rees
tory requirements for blood establishments. answers for some questions for which they
FDA’s Center for Biologics Evaluation and have authority, i.e. question 2 and/or ques- Question 2
Research (CBER) prepared a guideline for tion 4. Our Regulator, the Bureau of Biologics
industry to assist blood establishments in and Radiopharmaceuticals (BBR) is respon-
conducting quality programs consistent with Question 1 sible for ensuring that all firms engaged in
the applicable regulations. The guideline is Yes there is an organized form of quality the collection of blood and the manufacture
‘Guideline for Quality Assurance in Blood assurance. The quality options in place fol- of blood components have a quality system
Establishments’, July 11, 1995 (Docket No. low GMP requirements defined in legisla- that satisfies minimum requirements. The
91N-0450). This guideline is available on the tion (Division 2 of Canada’s Food and Drugs BBR ensures the systematic control of the
world wide web (http://www.fda.gov/cber/ Act and Regulations). Blood is regulated as a quality system through routine annual in-
gdlns/gde_qa). drug in Canada and parts of this federal spections.
In addition, there are several voluntary legislation require that quality systems be in In addition, each firm is responsible for
quality programs, including the AABB’s place within the Canadian Blood System. deciding the quality standards (in excess of
quality system and ISO 9000. The Drugs Directorate Guidelines for blood the minimum) it wishes to achieve and for

262 Vox Sang 2000;79:253–264 International Forum

ensuring that its quality system produces this Training and Audits are all sections under which is responsible for evaluating only the
level of quality. CBS is currently working Regulatory Affairs. Quality assurance is re- private sector (currently with 46 members,
with Canada’s National Quality Institute to sponsible for non-conformance manage- collecting approximately 600,000 donations/
establish a quality system that is based on ment, our material acceptance and the quali- year) launched a mandatory programme in
the criteria of the Canadian Framework of ty control of blood products. Compliance June 2000. On the other hand, for the SBHH
Business Excellence. and licensing is responsible for submissions programme, this is a voluntary activity from
to the Regulatory Agency including SOPs the services that would like to be continuous-
Question 4 manufacturing changes, error/accident re- ly evaluated. Both programmes (ABBS and
Transfusion Centres, such as those oper- ports and adverse events reports. The Train- SBHH) are based on different international
ated by CBS and Héma-Québec, that collect, ing section is responsible for the trainer pro- organisations (AABB, Council of Europe,
test, manufacture and distribute blood and gramme, GMP training programme and ac- ISO 9000 series, GMP, GLP, FDA) and the
blood components are required to obtain a cessing other training programme. The Au- Brazilian Acts 1376 and 121 [2]. In addition
licence from the government of Canada. (Dr. dits section is responsible for internal audit to that, the Brazilian Ministry of Health,
Ganz heads the government agency respon- programme, supplier audits and facilitation launched in 1998 the National project
sible for this licensing process.) The require- of regulatory agency audits. ‘Blood, 100% of Quality Assurance in all
ments for licensing are defined in the Food steps’, will be responsible for assuring quali-
and Drugs Act (Canada) and in Regulations Question 4 ty to all public Blood Services (with approxi-
and Guidelines published pursuant thereto. Yes we are licensed by the Therapeutic mately 1,400,000 collections/year) by the
If ‘accreditation’ is refused or revoked, a Product Programme of Health Canada ac- year 2003.
centre may not legally operate. Violations of cording to GMP.
the legal requirements may be prosecuted in The Bureau of Biologics and radiophar- Question 2
criminal court. maceutical is responsible for granting licens- Since either the ABBS and SBHH pro-
Currently, accreditation of hospital ing. If ever licensing is refused, we would grammes were launched in 2000, and the
blood banks (which store blood and blood have to cease operations. Brazilian Ministry of Health programme has
components and manage their actual trans- not been put in practice yet, there are some
fusion to patients) is not required on a na- Dr. Francine Décary speculations of which organisation (a single,
tional basis. The federal government has Héma-Québec multiple?) will definitely be responsible for
been considering a national program for sev- 4045 boulevard Côte-Vertu the systematic control. The ABBS pro-
Saint-Laurent, PQ H4R 2W7 (Canada)
eral years. Provincial governments, often in gramme has taken the own responsibility of
concert with the provincial college of physi- controlling its mandatory quality assurance
cians, maintain personal professional accre- programme, under the responsibility of the
ditation programs. ABBS Quality Department; a group enroll-
ing the staff from all associates is now un-
Question 5 dergoing a training programme, and it is
The Canadian Red Cross Society, which expected that all aspects of control and ac-
previously operated Canada’s blood system, Silvano Wendel creditation will be fully implemented by
was ‘accredited’ (i.e. licensed by the federal Paulo T. Rodrigues Almeida June 2001. On the other hand, the SBHH
government) in September 1989, the point at programme will be under the responsibility
which the requirement became effective. Ca- Question 1 of the National Accreditation Organisation
nadian Blood Services (and Héma-Québec) In Brazil, the Brazilian Ministry of (ONA), an external organisation with experi-
have maintained this status since taking over Health, under the National Vigilance Agen- ence in the field of Hospital Accreditation,
the role of operator in September 1998. cy, is responsible for enacting all guidelines though this is going to be the first project in
which have to be followed by all Blood Ser- the Blood Transfusion field.
Dr. J. Wesley Rees vices in the national territory. Currently, Act
Vice President, Safety & Performance 1376 [1] is the one in practice in Brazil and it Question 3
Management is mandatory that all services involved with Not applicable, since it has already been
Canadian Blood Services
blood transfusion activity must have a sys- answered in questions 1 and 2.
1800 Alta Vista
Ottawa, Ont. K1G 4J5 (Canada)
tematic programme of quality concerning all
aspects of collection, processing and transfu- Question 4
sion of blood products. A Blood Service license in Brazil (either
The Brazilian Act 1376 does not state public or private) is granted by the Brazilian
with precision how this programme should Ministry of Health, through each State Sani-
be performed, nor which organisation is re- tary Secretary. Only certain aspects are re-
Francine Décary sponsible to evaluate the performance of quired, and granting is allowed once the Ser-
each Brazilian Blood Service, however, there vice fulfils the requirements of Act 1376,
Question 2 are two organisations currently involved in although a specific accreditation programme
The Regulatory Affairs Department is re- defining programmes for that: the Brazilian is not necessary as far as quality assurance is
sponsible for the systematic control or our Association of Blood Banks (ABBS) and the concerned. Thus, the first step of any Blood
quality system. Quality Assurance (including Brazilian Society of Haematology and Hae- Service to have a license is to be inspected by
Quality control), Compliance and Licensing, motherapy (SBHH). The first organisation, the Local State Sanitary Agency. Without it,

Quality Assurance, Vox Sang 2000;79:253–264 263

Quality Control and Accreditation
regardless of any accreditation programme, ing as the Management Representative; (c) cilities of Manufacturing Plants for Biologi-
no service is allowed to be operative. How- monitoring the overall effectiveness of quali- cal Preparations (GMP for Biological Prepa-
ever, if these services, once initially licensed, ty system implemented and compliance to rations) were issued with notifications in
later submit to one of the aforementioned ac- ISO 9002 requirements; (d) controlling qual- October 1997. Blood collection that is regu-
creditation programmes (ABBS or SBHH) ity documents; (e) supervising instrument lated by Blood Collectors and Blood Dona-
and are refused, there is no legal power from calibration and blood component QC activi- tion Mediators Control Law (enacted June
such organisations to revoke the already es- ties; (f) coordinating internal and external 1956) was linked with GMP by Regulations
tablished license to supply blood products audits and the Management Review activi- for Proper Collection of Blood for Produc-
to the public, although in the ABBS pro- ties. tion of Blood Products (issued in November
gramme, if the accreditation is refused, the 1980). Therefore, every process from blood
service will be excluded as an ABBS mem- Question 3 collection through distribution in blood cen-
ber. Not applicable. ters is required to comply with GMP or man-
aged by the quality assurance (QA) system.
Question 5 Question 4
Since the national accreditation pro- No. There is an ongoing discussion lo- Question 2
grammes are in the early phase, there are no cally. In Japan, the Japanese Red Cross Society
services which have already been accredited (JRCS) is the only organization conducting
(at least one year is expected until the first Question 5 blood programs. JRCS has 77 blood centers.
accreditations are fully implemented). On Not applicable. MHW establishes regulations and standards
the other hand, there are some Brazilian ser- for quality assurance. The Pharmaceutical
vices that have submitted to the AABB or Dr. C.K. Lin Affairs Bureau (PAB) of each prefecture in-
ISO 9002 accreditation, the first one in late Hospital Chief Executive spects its covering blood centers in com-
1998. Hong Kong Red Cross Blood Transfusion pliance with GMP, orders improvements if
Service
necessary, and decides about the establish-
15 King’s Park Rise
References Kowloon, Hong Kong, SAR (China) ment license. JRCS Headquarters set up In-
ternal Standards for Operating Procedures.
1 Ministério da Saúde, Brasil-Portaria 1376,
1993. According to GMP and the Standards, each
2 Ministério da Saúde, Brasil-Portaria 121, blood center must have its own product mas-
1995. ter codes, standard operating procedures and
manuals. In addition, each blood center has
Dr. Silvano Wendel Kenji Tadokoro a quality assurance section, which is in
Hospital Sı́rio Libanês Blood Bank charge of quality control of blood products/
Rua Adma Jafet 91
Question 1 raw materials and to ensure the blood center
BR–01308-050 São Paulo (Brazil)
The GMP for drugs, that was imple- to comply with GMP.
Dr. Paulo Tadeu Rodrigues Almeida mented in April 1976 under the administra-
Hemobanco tive guidance of the Ministry of Health and Question 3
Rua Capitão Souza Franco 290 Welfare (MHW) based on the recommenda- Not applicable.
BR–80730-420 Curitiba (Brazil) tion of WHO, was published by MHW Ordi-
nance under the Pharmaceutical Affairs Law Question 4
amendments made in September 1980. Al- Blood centers are inspected by PAB offi-
though GMP hardware (buildings, facilities, cials and accredited by the prefecture gover-
equipment) needed to follow the guidance nor depending on the results of their inspec-
C.K. Lin for the accreditation, implementation of tion. Blood centers receive orders/instruc-
GMP software was not yet required for the tions for improvement, if any, after the in-
Question 1 accreditation, implementation of GMP soft- spection and follow them. So far, no blood
Yes. ISO 9002 series, AABB standards ware was not yet required for the establish- center has been refused accreditation. In
and Council of Europe: Guide to the prepa- ment license. With the subsequent Law 1999, the contents of the inspection were
ration and quality assurance of blood com- amendments in April 1993, GMP has been standardized among prefectures throughout
ponents. implemented as licensing standards for the Japan. In current regulations, a blood center
software as well as the hardware to be met by that is refused accreditation must be closed.
Question 2 manufacturers since April 1994. It was fur- In 1998, an internal audit section was set up
Yes. (1) We are ISO 9002 certified. (2) ther defined by Regulations for Manufactur- under the Blood Program Task Force at the
We have a Contract Manufacturing Agree- ing Control and Quality Control of Drugs JRCS HQs and started the educational au-
ment with the CSL Bioplasma, Australia, and Regulations for Buildings and Facilities dit.
which in turn is under the Australian cGMP for Pharmacies (amended March 1997). Be-
regulatory ordinance of Therapeutic Goods cause of the necessity of higher levels of Dr. Kenji Tadokoro
Administration, Australia. (3) We have a manufacturing control for biological prepa- Director, Tokyo Western Blood Center
Quality Assurance Department which is re- rations Standards for Manufacturing Con- Japanese Red Cross Society
3256 Midoricho, Tachikawa-shi
sponsible for: (a) identifying needs and de- trol and Quality Control of Biological Prepa-
Tokyo 190-0014 (Japan)
veloping targets, plans and budgets; (b) serv- rations and Standards for Buildings and Fa-

264 Vox Sang 2000;79:253–264 International Forum

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