Coding and traceability: Cells and tissues in North America

Cell and Tissue Banking

Volumn 11, Issue 4, 2010, Pages 379-389

  Brubaker, Scott A ^a   Wilson, Diane ^b  

^a American Association of Tissue Banks   (United States)

^b Community Tissue Services ^*  (United States)

Author keywords

Compliance; Quality management system; Regulations; Standards; Traceability gaps; Universal tracking

Indexed keywords

CELL TRANSPLANTATION; DONOR; HEALTH CARE FACILITY; HEALTH CARE QUALITY; HUMAN; INFORMATION PROCESSING; LEGAL ASPECT; MEDICAL RECORD; NORTH AMERICA; REVIEW; SAFETY; STANDARD; TISSUE TRANSPLANTATION; TRANSPLANTATION;

AUTOMATIC DATA PROCESSING; CELL TRANSPLANTATION; HUMANS; MEDICAL RECORDS; NORTH AMERICA; QUALITY ASSURANCE, HEALTH CARE; SAFETY; TISSUE AND ORGAN PROCUREMENT; TISSUE BANKS; TISSUE DONORS; TISSUE TRANSPLANTATION; TRANSPLANTS;

EID: 79952738636     PISSN: 13899333     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10561-010-9219-z     Document Type: Review

References (18)

1. ALABAT Tissue Banking Management Guide (Taller de buenas prácticas en procesamiento y producción en bancos de tejidos. Proyecto RLA/6/062 ARCAL CVIII. ANEXO III), see Chapters 4, 7, 8, and 9. www.alabat.org
2. Brubaker S (2010) Chapter 12 - establishing a quality system. Essentials of tissue banking. Galea G (ed) (in print). Springer, Berlin, pp 191-216, ISBN 978-90-481-9141-3
3. CBSCustomer letter #2008-06. http://www.blood.ca/CentreApps/Internet/UW- V502-MainEngine.nsf/resources/CustomerLetters08/$file/CL2008-06.pdf. Accessed 21 Aug 2010
4. Conrad EU, Gretch DR, Obermyer KR, Moogk MR et al (1995) Transmission of the hepatitis-C virus from tissue transplantation. J Bone Joint Surg Am 77:214-224
5. Eisenbrey AB, Eastlund T (eds) (2008) Hospital tissue management: a practitioner's handbook, 1st edn. AABB Bookstore, Bethesda
6. Food and Drug Administration, Bar Code Label Requirement for Human Drug Products and Biological Products (69 Federal Register 9120, February 26, 2004)
7. Food and Drug Administration, Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement, Final Rule, November 24, 2004. See preamble and 21 CFR 1271.290 Tracking, §1271.370 Labeling, § 1271.320 Complaint file, and §1271.350 Reporting (Adverse reaction reports)
8. Food and Drug Administration, Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice, May 25, 2004, 69 FR 29786. See preamble and 21 CFR 1271.55 and § 1271.60
9. Guidance Document for Averse Reaction Reporting to the EBAA, Eye Bank Association of America, revised 8/2009
10. Hospital Accreditation Program Manual, Transplant Safety Chapter, Standard TS.03.02.01, Elements of Performance, at listing 7; The Joint Commission, 2010
11. Kuehnert M et al (2007) Human tissue oversight in hospitals: an AABB survey. Transfusion 47(2):194-200 (Pubitemid 46146551)
12. MedWatch: The FDA Safety Information and Adverse Event Reporting Program http://www.fda.gov/Safety/MedWatch/default.htm. Accessed 17 July 2010
13. New York Code, Article 43-B - (4360-4368) Organ, Tissue and Body Parts http://www.wadsworth.org/labcert/regaffairs/article43b/index.htm. Accessed 14 July 2010
14. Pearson K, Dock N, Brubaker S (eds) (2008) Standards for tissue banking, 12th edn. American Association of Tissue Banks, McLean
15. See Records, 56. (1) and (2) at http://laws.justice.gc.ca/eng/SOR-2007- 118/20100717/section-.html. Accessed 17 July 2010
16. Simonds RJ, Holmberg SD, Hurwitz RL et al (1992) Transmission of human immunodeficiency virus type 1 from a seronegative organ and tissue donor. N Engl J Med 326:726-732
17. Title 10 of New York Codes, Rules and Regulations, Part 52 Tissue Banks and Nontransplant Anatomic Banks http://www.wadsworth.org/labcert/regaffairs/ clinical/Part52.pdf. Accessed 14 July 2010
18. Ministry of Health, General Health Law, Fourteenth Part, Donation, Transplantation and Loss of Life, in Chapter I., Common Provisions, Articles 313 and 317; and in Chapter III., Transplant, Articles 337, 338, 339, 340, and 341