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Blood and Tissue Resources

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Jeanne V. Linden, M.D., M.P.H.
Director
Telephone: (518) 485-5341
Fax: (518) 485-5342
btraxess@health.state.ny.us

The Blood and Tissue Resources Program is responsible for oversight of blood banks and tissue banks operating in New York State. This vital public health responsibility extends to protecting the health and safety of both donors and recipients. Regulations have been developed and implemented to ensure the safe and ethical collection, processing, storage, and distribution of donated blood and tissue for clinical use, as well as the recovery of bodies, body parts, organs, and tissues for use in medical research and education

BLOOD RESOURCES

More than 400 facilities are approved by the department to provide blood services. One and a quarter million blood components are prepared annually. Approximately 90% of the blood is collected at blood centers, with the remainder collected by approximately 42 hospitals and a small number of independent facilities. Oversight is provided through the Blood and Tissue Resources Program support of the New York State Council on Human Blood and Transfusion Services, established in 1973 by Public Health Law (Article 31). The Council enacts and amends regulations affecting the safety of the blood supply in New York State, subject to approval by the Commissioner of Health. These regulations include Blood Banks (Subpart 58-2) and Hematopoietic Progenitor Cell Banks (Subpart 58-5). (hematopoietic progenitor cells are precursors of blood cells found in peripheral blood, umbilical cord blood and bone marrow.) The Council also develops guidelines for the processing and clinical use of blood and blood components, and hematopoietic progenitor cells.

Approval by the Blood and Tissue Resources Program or by the Clinical Laboratory Evaluation Program is required for facilities that perform blood banking activities or offer any blood services in New York State, from collection through clinical use. Through collegial education, inspection, and enforcement of regulations, blood banks are assisted in adhering to acceptable standards of practice and complying with regulations. Hematopoietic progenitor cell banks must be licensed as tissue banks, as described below.

Informational materials on blood services, including guidelines and recommendations, are developed and made available to the public and to regulated parties as appropriate. The Program monitors errors and accidents involving blood for transfusion (more than 50 transfusion-related incidents are reported each year that have significant potential to harm either the donor or the recipient). Guidelines have been developed through review of these incidents, including recommendations for reducing fatalities related to blood recovery during and after surgical procedures and for alerting physicians caring for transfusion recipients of possible transfusion-transmitted infections.

TISSUE RESOURCES

More than 800 entities are licensed to operate tissue banks and nontransplant anatomic banks in New York State. The Blood and Tissue Resources Program oversees all human tissue banking activities and services provided in New York State, from donor solicitation to clinical use. The first comprehensive oversight program for tissue banks in the country, the tissue bank regulatory program has served as a model for development of national and other state oversight programs.

Public Health Law Article 43-B, enacted in 1990, established the Commissioner's authority over tissue banks. Part 52, Tissue Banks and Nontransplant Anatomic Banks, covers such tissues as skin, eye, semen, embryos, and stem cells. Subpart 58-5, "Hematopoietic Progenitor Cell Banks," regulates activities involving hematopoeitic progenitor cells (precursors of blood cells found in umbilical cord blood, peripheral blood, and bone marrow). Licensure is required for all tissue banking activities in New York, including collection, processing, storage, and distribution. Through a comprehensive on-site survey process, facilities are assessed for acceptable standards of practice. Enforcement action is initiated as appropriate.

Regulations also include requirements for licensure of facilities that recover, process, store and/or distribute nontransplant anatomic parts for medical research and health professional education. Program staff oversees the appropriate handling of whole bodies and body segments donated through anatomical gift programs. Over 80 facilities are currently licensed as nontransplant anatomic banks.

Informational materials on tissue banking are developed and made available to the public and to regulated parties as appropriate. The Program's Guide for the Interpretation and Management of Tissue Donor Screening Test Results was developed to assist tissue banks in determining tissue suitability through interpretation of results of infectious disease testing. The program has also developed Guidelines for Collection, Processing, and Storage of Cord Blood Stem Cells, establishing standards for the appropriate handling of cord blood-derived hematopoietic progenitor cells for both family storage (private) and community (public) banking.

The Program responds regularly in depth to inquiries from professionals in the field and the public, distributing regulations, guidelines, applications, and lists of facilities licensed by the department to provide tissue banking services in New York State.

IMMUNOHEMATOLOGY PROFICIENCY SERVICES

Through its Immunohematology Proficiency Testing Program, the Blood and Tissue Resources Program monitors the quality of immunohematology testing, including blood typing for such groups as ABO and Rh, and crossmatching, performed by laboratories serving New York State patients. Each proficiency test event includes five whole blood samples that are tested for ABO group, Rh group, direct antiglobulin (DAT), Rh phenotype, and compatibility testing and includes five serum samples that are tested for unexpected antibodies, antibody identification, and compatibility. A department permit in Picture of racks of test tubes the category of Immunohematology is required for laboratories providing such testing. Oversight is authorized by the Public Health Law (Article 5, Title V) and the Clinical Laboratory Improvement Amendments of 1988.

The Blood and Tissue Resources Program evaluates the proficiency test results from over 300 laboratories and assists laboratories with unsatisfactory performance in developing appropriate corrective actions to ensure that the cause of the unsatisfactory performance is identified and corrected (thus reducing the likelihood of its recurrence). Staff members occasionally conduct on-site investigations. Enforcement action is initiated as appropriate.

HEMOPHILIA EDUCATIONAL SERVICES

The Blood and Tissue Resources Program provides support for the Hemophilia Advisory Panel. The Panel was established in 1983 to advise the department on programs and policies pertaining to hemophilia and related congenital bleeding disorders. It has produced a variety of educational materials, including posters distributed to hospital emergency rooms throughout the state explaining how to provide urgent care to persons with hemophilia and a thirty-four page publication entitled Hemophilia Treatment in New York State: Status Report and Recommendations.