This section includes examples of tools to help TS with the validation process. Many resources have been generously shared by colleagues.
As with all TraQ resources, the standard disclaimer applies. No one model fits all sizes and TS need the experience and expertise to adapt models to their particular needs.
Validation SOPs, protocols, checklists
1. Stem Cell and Bone Marrow Transplant Program, Hamilton Health Science Centre, Hamilton, ON, Canada (shared by
- Handout provided by Shirley Gregway, Blood Bank Supervisor, Holmes Regional Medical Center, FL at AABB 2005 meeting: The Quality Diet: Back to Basics (shared by Kate Gagliardi, Hamilton HSC)
4. AABB. The AABB has many validation documents to help its members. For example:
- Validation protocol (The James Cancer Hospital & Solove Research Institute Bone Marrow Transplant Laboratory Ohio State University Medical Center)
- Validation protocol (H. Lee Moffitt Cancer Center Blood Bank Tampa, FL )
- Validation checklist (IDQM16A)
- American Red Cross Blood Services. Equipment and process validation (90.000.90.300)
- Validation & Implementation of New Procedures & Methodology (Laboratory Corporation of America)
- many more....
Visit the AABB website, conduct a search for validation, and have your username and password handy.
Resources for specific validation procedures
1. Vancouver Island Health Authority - South Island, Victoria, BC, Canada: Ortho Provue (Shared by Betty-Ann Vesala)
2. Providence Health Care, Vancouver, BC, Canada: LIS validation (shared by Darryl Gouthro)
- Validation protocol: Patientregistry (validation script)
- Validation protocol: Group and Rh test entry - Invalid test case #1 (validation script)
- System Error Log Report + Software/Hardware Modification Report
Adams MR, Dumont LJ, McCall M, Heaton WA. Clinical trial and local process evaluation of an apheresis system for preparation of white cell-reduced platelet components. Transfusion 1998 Oct; 38(10):966-74.
Aulesa C, Pastor I, Naranjo D, Piqueras J, Galimany R. Validation of the Coulter LH 750 in a hospital reference laboratory.,Lab Hematol 2003; 9(1):15-28.
Burgstaler EA, Pineda AA. Plateletapheresis: instrumentation validation. Transfus Sci 1999 Oct;21(2):153-61.
Cowan DF, Gray RZ, Campbell B. Validation of the laboratory information system. Arch Pathol Lab Med 1998 Mar;122(3):239-44.
Dumont LJ, Dzik WH, Rebulla P, Brandwein H. Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfusion 1996 Jan;36(1):1120.
Dunne W M, Case L K, Isgriggs L, Lublin D M. In-house validation of the BACTEC 9240 blood culture system for detection of bacterial contamination in platelet concentrates. Transfusion 2005 Jul;45 (7): 1138-42.
Fritsma GA, Marques MB. The top ten problems in coagulation. Advance for Med Lab Professionals, 2004 June 28. - see Problem 10: How to validate point-of-care (POC) coagulation tests
Malone T. Bacterial Detection. Experience In the blood center. (44 slide presentation at USA Advisory Committee on Blood Safety and Availability)
Owens MA, Vall HG, Hurley AA, Wormsley SB. Validation and quality control of immunophenotyping in clinical flow cytometry. J Immunol Methods 2000 Sep 21; 243(1-2):33-50.
Schaffner G, Kayser T, Tonjes A, Volkers P. Validation of flow cytometry to quantify the potency of anti-D immunoglobulin preparations. Vox Sang 2003 Feb; 84(2):129-36.
Seghatchian J, Beard M, Krailadsiri P. The role of in process qualification in quality improvement of the haemonetics MCS plus leucodepleted platelet concentrate. Transfus Sci 2000 Jun;, 22(3):165-9.
Yazer MH, Triulzi DJ. Use of a pH meter for bacterial screening of whole blood platelets. Transfusion 2005 Jul;45(7):1133-7.
- Part 1: Introduction to terminology
- Part 2: Types of validation
- Part 3. Determining when and how extensively to validate a method
- Part 4: Regulations and standards
- Part 5: Validation examples (tools and resources) <--You are here