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Cell and Tissue Banking

, Volume 11, Issue 4, pp 379–389 | Cite as

Coding and traceability: cells and tissues in North America

  • Scott A. BrubakerEmail author
  • Diane Wilson
Original Paper

Abstract

Cell and tissue banking professionals in North America have long understood the value of labeling their allografts with descriptive names that make them easily recognized. They have also understood that advantages exist in possessing the capability to track them internally and externally to better understand tissue handling from donation through distribution. An added insight that can assist with strategic planning is to know who uses them, how many, and for what purpose or application. Uniquely coding allografts naturally aids tracking in event of recall or the rare need to link them if implicated in an adverse outcome report. These values relate to an ability or inability to sufficiently track specific cell/tissue types throughout the allograft’s lifetime. These concepts easily fit into the functions of a Quality Program and promote recipient safety. It is management oversight that drives the direction taken and either optimizes this knowledge or limits it. How concepts related to coding and tracing human cells and tissues for transplantation have evolved in North America, and where they may be headed, are described in this manuscript. Many protocols are in place but they exist in numerous operational silos. Quality Management System concepts should drive decision-making and include considerations for future planning beyond our own professional lifetimes.

Keywords

Standards Regulations Quality management system Traceability gaps Universal tracking Compliance 

Notes

Acknowledgments

The authors wish to acknowledge assistance from the following colleagues for lending their expertise regarding information used in this manuscript: New York State requirements: Jeanne V. Linden and Thomas Favreau; EBAA information: Patricia Aiken-O’Neill and David Korroch; NMDP Standards: Lisa Phillips Johnson; Standards in Canada: Marc Germain, Mathias Haun; Regulations in the USA: Melissa Greenwald; Requirements in Mexico: Rául Álvarez San Martín; and, Regulations in Canada: Liz Anne Gillham-Eisen.

References

  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 978-90-481-9141-3Google Scholar
  3. 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 77:214–224PubMedGoogle Scholar
  4. Eisenbrey AB, Eastlund T (eds) (2008) Hospital tissue management: a practitioner’s handbook, 1st edn. AABB Bookstore, BethesdaGoogle Scholar
  5. Food and Drug Administration, Bar Code Label Requirement for Human Drug Products and Biological Products (69 Federal Register 9120, February 26, 2004)Google Scholar
  6. 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)Google Scholar
  7. 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 § 1271.60Google Scholar
  8. Guidance Document for Averse Reaction Reporting to the EBAA, Eye Bank Association of America, revised 8/2009Google Scholar
  9. Hospital Accreditation Program Manual, Transplant Safety Chapter, Standard TS.03.02.01, Elements of Performance, at listing 7; The Joint Commission, 2010Google Scholar
  10. Kuehnert M et al (2007) Human tissue oversight in hospitals: an AABB survey. Transfusion 47(2):194–200CrossRefPubMedGoogle Scholar
  11. MedWatch: The FDA Safety Information and Adverse Event Reporting Program http://www.fda.gov/Safety/MedWatch/default.htm. Accessed 17 July 2010
  12. 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
  13. Pearson K, Dock N, Brubaker S (eds) (2008) Standards for tissue banking, 12th edn. American Association of Tissue Banks, McLeanGoogle Scholar
  14. See Records, 56. (1) and (2) at http://laws.justice.gc.ca/eng/SOR-2007-118/20100717/section-.html. Accessed 17 July 2010
  15. 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 326:726–732CrossRefPubMedGoogle Scholar
  16. 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
  17. 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 341Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2010

Authors and Affiliations

  1. 1.American Association of Tissue Banks (AATB)McleanUSA
  2. 2.Community Tissue ServicesDaytonUSA

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