Implementation of a quality system (ISO 9000 series) for placental blood banking

Journal of Hematotherapy and Stem Cell Research

Volumn 7, Issue 1, 1998, Pages 19-35

  Sirchia, Girolamo ^a   Rebulla, Paolo ^a   Lecchi, Lucilla ^a   Mozzi, Fulvio ^a   Crepaldi, Roberto ^a   Parravicini, Anna ^a  

^a FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD BANK; HEMATOPOIETIC STEM CELL TRANSPLANTATION; ITALY; PLACENTA CIRCULATION; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;

BLOOD BANKS; FETAL BLOOD; HUMANS; ITALY; MANAGEMENT AUDIT; PLACENTA; QUALITY ASSURANCE, HEALTH CARE;

EID: 0031924042     PISSN: 15258165     EISSN: None     Source Type: Journal    
DOI: 10.1089/scd.1.1998.7.19     Document Type: Article

References (19)

1. Broxmeyer, H.E., Douglas, G.W., Hangoc, G., et al. Human umbilical cord blood as a potential source of transplantable hematopoietic stem/progenitor cells. Proc. Natl. Acad. Sci. USA 86:3828, 1989.
2. Gluckman, E., Broxmeyer, H.E., Auerbach, A.D., et al. Hematopoietic reconstitution in a patient with Fanconi anemia by means of umbilical-cord blood from an HLA-identical sibling. N Engl. J. Med. 321:1174, 1989.
3. Kurtzberg, J., Laughlin, M., Graham, M.L., et al. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N. Engl. J. Med. 335:157, 1996.
4. Wagner, J.E., Kernan, N.A., Steinbuch, M., et al. Allogeneic sibling umbilical cord blood transplantation in forty-four children with malignant and non-malignant disease. Lancet 346:214, 1995.
5. Harris, D.T., Schumacher, M.J., Rychlik, S., et al. Collection, separation and cryopreservation of umbilical cord blood for use in transplantation. Bone Marrow Transplant. 13:135, 1994.
6. Rubinstein, P., Rosenfield, R.E., Adamson, J.W., et al. Stored placental blood for unrelated bone marrow reconstitution. Blood 81:1679, 1993.
7. Progenitor Cell Standards Task Force. Standards for Hematopoietic Progenitor Cells. American Association of Blood Banks, Bethesda, MD, 1996.
8. Standards for Blood and Marrow Progenitor Cell Collection, Processing and Transplantation. Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT), Omaha, NB, 1996.
9. McCullough, J., Clay, M.E., Fautsch, S., et al. Proposed policies and procedures for the establishment of a cord blood bank. Blood Cells 20:609, 1994.
10. Rowley, S.D. Standards for hematopoietic progenitor cell processing. In Hematopoietic Progenitor Cells: Processing, Standards and Practice, eds. Brecher, M.E., Lasky, L.C., Sacher, R.A., et al. American Association of Blood Banks, Bethesda, MD, 1995.
11. Zuck, T.F. The applicability of cGMP to cord blood cell banking. J. Hematother. 5:135, 1996.
12. Smit Sibinga, C.Th. & van der Tuuk Adriani, W.P.A. Definitions in quality assurance and quality management. In Good Manufacturing Practice in Transfusion Medicine. Proceedings of the 18th International Symposium on Blood Transfusion, eds. Smit Sibinga, C.Th., Das, P.C. & Heiniger, H.J. Groningen, Kluwer, Dordrecht, The Netherlands, 1993, p. 13.
13. Krause, M.S. Jr. ISO 9001 benefits and pitfalls: The path to successful certification. Clin. Chem. 42:1561, 1996.
14. Harvey, E., Hewison, C., Nevalainen, D.E., et al. Maintaining quality in blood banking. Blood Rev. 9:15, 1995.
15. Nevalainen, D.E. & Lloyd, H.L. ISO 9000 quality standards: A model for blood banking? Transfusion 35:521, 1995.
16. Nevalainen, D.E. Practice of quality assurance in blood centers - The system and daily work. Vox Sang 70(Suppl. 3):154, 1996.
17. Quality Systems. Model for quality assurance in production, installation and servicing. International Organization for Standardization, Case postale 56, CH-1211 Geneve 20, Switzerland.
18. Locatelli, F., Arcese, G.W., Rebulla, P., et al. GRACE protocol for allogeneic transplant of umbilical cord blood progenitor cells using unrelated donors. Haematologica In press.
19. Sirchia, G., Contreras, M., Garcia, J., et al. NETCORD: A model of network linking placental blood banks. Abstracts Book of the 3rd International Meeting of the ISHAGE. Bordeaux 39, 1997.