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Umbilical cord blood to provide cells for unrelated use may be collected and banked locally, regionally or nationally and information about CBU and their blood and tissue types is held on registries with worldwide access. Quality standards and accreditation are therefore extremely important in guaranteeing to users that the banked CBU are to be of use in transplantation. Since cord cell transplantation is relatively new there is no single organisation setting international standards for the collection, processing and storage of CBU. Several organisations involved in setting standards for peripheral blood or bone marrow donation have, instead, extended their remit to cover cord cell banking. This section briefly addresses some of the accreditation schemes that exist.

Access to detailed information about the accreditation schemes available requires membership of some of these organisations. As the resources of this project did not extend to such expenditure internet addresses have been provided in case more detailed information is sought than that provided here.

Certification of cord blood registries

The World Marrow Donor Association, in its International Standards for Unrelated Hematopoietic Stem Cell Donor Registries, sets standard for all such registries around the world including cord blood registries. NetCord is represented on the Board of the WMDA by Professor Eliane Gluckman. As its name suggests, WMDA was established to set standards in the area of bone marrow donation but has subsequently extended its remit to cover umbilical cord cell banking. However, the emphasis is on the processes and procedures involved in bone marrow donation. The latest version of the WMDA International Standards (approved October 2002) may be found at Annex 3. The following definitions are based on those found in these Standards.

Registry A registry is a legal entity whose responsibility is to process requests for haematopoeitic stem cells from donors originating within the country and emanating from abroad. The Registry may co-ordinate the activities of Donor, Collection and transplant centres in the respective country.

Donor Centre The Donor Centre is the organisation responsible for recruiting, obtaining consent, and counselling potential donors.

Collection Centre The Collection Centre is the medical facility at which the haematopoietic stem cell (cord blood unit) collection takes place.

Cord Blood Bank A Centre whose sole mission is to collect and maintain umbilical cord blood units. A Cord Blood Bank may combine some or all of the activities of both a Donor Centre and a Collection Centre. It may be responsible for donor recruitment and cord blood collection, processing and storage but the database of donors might be maintained by a Registry. Alternatively, the Cord Blood Bank might include all of these activities and perform searches for Transplant Centres.

The WMDA sets standards for

• the general organisation of a Registry, including its legal status, its location and communication links and the expertise expected of the Director and key personnel;

• donor recruitment including consent procedures;

• donor characterisation, that is tissue and blood typing and disease testing – HLA typing laboratories must be accredited by the relevant professional bodies, in Europe this is the European Federation for Immunogenetics;

• information technology and database management including confidentiality;

• facilitation of search requests;

• collection, processing and transport of haematopoietic stem cells and any other collected cell products intended for therapeutic use – centres must fulfil national, regional or international guidelines for such a facility;

• follow up of patient and donor – registries should collect transplantation outcome data;

• financial and legal liabilities.

Accreditation of Cord Blood Banks

American Association of Blood Banks (AABB)

The AABB has been developing and promoting standards for blood banks and transfusion services since 1957. In 1991 the Association published its first Standards for Hematopoietic Progenitor Cells which covers the collection, processing and transplantation of bone marrow, peripheral blood and umbilical cord blood progenitor cells. The AABB is also developing Model Standards for Blood Banking that incorporate blood banking terminology and are compatible with ISO 9000.

The AABB provides accreditation for banks principally, but not entirely, in North America. Any organisation that performs activities traditionally performed by hospitals and community blood centres including the collection, processing, distribution or transfusion of blood or blood components is eligible for institutional membership of the AABB and AABB accreditation is a requirement for institutional membership. Membership dues for Institutional Members, such as cord blood banks, are $750 ( 641) plus applicable accreditation fees per membership year. The yearly fee for a cord blood service that collects less than 5000 CBU annually is slightly over

$4000 ( 3,420) per year.

The Standards, together with the requirements specified in the Accreditation Information Manual, provide the basis of the AABB Accreditation programme.

(copies of the AABB Standards and Manual may be purchased online at www.aabb.org). A facility that is accredited for cord blood is assessed for compliance to standards every two years through an on-site visit by a team that includes a cord blood subject matter expert. Once a facility is found to be in compliance, accreditation is good for two years. A list of the cord blood banks accredited by the AABB at 30 April 2003 is given in Table 4.1

Table 4.1 AABB Accredited Cord Blood Facilities American Association of Blood Banks

Updated April 30, 2003

State

(or Country) Company City

AZ CBR Systems, Inc. Stem Cell Bank Tucson

CA California Cryobank, Inc Santa Monica

CA San Diego Blood Bank San Diego

CA StemCyte Inc. Arcadia

FL Cryobanks, Inc. Altamonte Springs

FL Cryo-Cell International Inc. Clearwater

FL Florida Blood Services, Inc . St. Petersburg

FL LifeSouth Community Blood Centers Gainesville

LA Children's Hospital New Orleans

MA American Red Cross Blood Services Dedham

MA Viacord, Inc. Boston

MN American Red Cross Blood Services St. Paul

MO Cardinal Glennon Children's Hospital St. Louis

NJ Bergen Community Blood Services Paramus

OR American Red Cross Western Community Portland

WA Puget Sound Blood Center Seattle

BRAZIL Hospital Israelita Albert Einstein Sao Paulo

Accredited - An AABB assessor has been on the facility's premises and the facility practices were found to conform with the AABB standards of practice.

Banks that are going through the accreditation process for the first time are not listed until they have completed the accreditation process and been sent their AABB certificate. There are usually several facilities going through the cord blood accreditation process for the first time. The accreditation process begins when a facility that has expressed an interest in becoming accredited pays their dues. The AABB receives many enquiries about accreditation and some are followed through once the facility is up and running. The premise for AABB accreditation is that a facility is up and running and that all standards are addressed in their Standard Operating Procedure and that these standards are followed. The assessment process ensures that a facility’s quality and operational systems are evaluated to ensure compliance with AABB Standards; Code of Federal Regulations; CLIA ’88 (Clinical Laboratory Improvement Amendments of the CMS and CDC) and Federal guidance and documents.

The AABB is not regulatory and cannot shut a facility down but if a facility is having problems the Association tries to educate them so that standards are met. It is possible for a facility to fail accreditation and there is a process in place for this but the AABB endeavours not to allow this to happen. However, if a facility does not pay its subscription then accreditation is removed. Failure to pay dues is the most common reason for loss of accreditation.

The Foundation for the Accreditation of Cellular Therapy (FACT)

In 1994 a North American Task Force, formed of all the major professional organisations interested in haematopoietic cell therapy including ISHAGE, ASBMT and FACT, was established to develop graft processing standards. There was a consensus that the FACT standards were of sufficiently high standard to serve as a template for the other organisations involved in the field. The FACT Standards were published in 1996 and the first inspections began in September 1997. FACT accreditation has been endorsed by NetCord, a number of whose members now have FACT accreditation. The first Netcord-FACT inspections began in August 2002 and at that time nearly 30 cord blood banks across the United States, as well as internationally, had applied for accreditation. Facilities, including cord blood banks, are invited to apply for accreditation which is voluntary. Any cord blood bank accredited by NetCord- FACT would automatically be accredited by WMDA. It has been impossible to access information about which cord blood banks have been accredited by FACT and the FACT Standards and Manual are only available for purchase. However, information about FACT is available at www.factwebsite.org.

Facilities pay an initial registration fee of $5,000 ( 4,585) and FACT accredited facilities are required to renew their accreditation every three years. The Inspection Fee for cord blood banks is $15,000 ( 13,753).

ISO 9000

The International Organisation for Standardization (ISO) is the world’s largest developer of standards. While ISO’s principal activity is in the development of technical standards, ISO standards also address management, environmental and social issues. ISO was established in 1947 and is a network of the National Standards

Institutes of 146 countries. It is a non-governmental organisation bridging the public and private sectors. ISO standards are voluntary although some, mainly those concerned with health and safety, have been adopted in a number countries as part of their regulatory framework. Although ISO standards are voluntary, they are developed in response to market demand in consultation with relevant experts and based on consensus between the relevant parties. Standards are reviewed at least every five years. ISO 9000 is concerned with quality management and is the standardization system which has been applied to umbilical cord blood banking. The Italian Grace network has been instrumental in developing the ISO 9002 standards to which they adhere. The AABB is also making its standards compatible with ISO.

The Joint Accreditation Committee EBMT-EuroISHAGE (JACIE)

JACIE was established in 1999 with the aim of creating a standardised system of accreditation officially recognised across Europe. It is based on the FACT standards and will eventually substitute the current EBMT accreditation system. While the JACIE Standards were principally established to provide standards for bone marrow progenitor cell collection, processing and transfer, they are also designed to apply to cord blood banks. Their purpose is to foster good medical and laboratory practice in haematopoietic progenitor cell therapy. JACIE Standards, too, are voluntary and provide minimal performance guidelines. Attempts have been made to make them conform with national regulations but compliance with these Standards does not guarantee compliance with all regulations in all cases.

Accreditation is overseen by the JACIE Accreditation Committee. The basis for accreditation is documented compliance with the current edition of the JACIE Standards. Accreditation is determined by evaluation of the written information provided by the applicant facility and by on-site inspection. Inspections are carried out by people with training and experience in haematopoietic cell therapy, who have inspector training and who have a working knowledge of the FACT Standards.

Accredited facilities are to be inspected at regular intervals, as determined by the Accreditation Committee. The Committee may, however, delegate this responsibility to an appropriate national agency. Accreditation may be suspended if a facility fails to comply with the Standards.