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Discussion - Part
5
(Validation Examples - Tools & Resources)
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.
*
If you have documents to share, please
e-mail Pat
*
** Resources are
**
GENERAL:
Validation SOPs, protocols, checklists
1. Stem Cell and Bone Marrow
Transplant Program, Hamilton Health Science
Centre, Hamilton, ON, Canada (shared by
2.
Process control: Validation checklist for new / changed processes
- 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)
3. Transfusion Medicine Laboratory, Moncton
Hospital, Moncton, NB, Canada (shared by Anne Robinson,
Transfusion Medicine supervisor
South-East Regional Health Authority - for more information:
e-mail Anne)
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.
SPECIFIC: 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)
LITERATURE / STUDIES
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):11–20.
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.
FURTHER READING:
See case homepage
*
If you have comments on information included in this section, please
e-mail Pat.
DISCUSSION...
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