Total Quality Assurance in a Distributed Point-of-Care Testing Laboratory Organization in Primary Health Care

Plastic Surgical Nursing

Volumn 3, Issue 3, 2004, Pages 99-114

  Fremner, Eva ^a   Kalerud, Bo ^a   Larsson, Lasse ^a  

^a LINKÖPING UNIVERSITY HOSPITAL   (Sweden)

Author keywords

management; medical decision; point of care testing; practicability; quality assurance

Indexed keywords

EID: 33845477089     PISSN: 07415206     EISSN: 15501841     Source Type: Journal    
DOI: 10.1097/01.poc.0000138642.33358.07     Document Type: Article

References (26)

1. Witte DL. Medically relevant performance goals: a listing of the complexities and call for action. Clin Chem. 1993;39:1530-1535.
2. Freedman DB. Clinical governance: implications for point-of-care testing. Ann Clin Biochem. 2002;39:421-423.
3. Rainey P. Outcomes assessment for point-of-care testing. Clin Chem. 1998;44:1595-1596.
4. Price CP. Delivering clinical outcomes. Point of Care. 2003;2:151-157.
5. Guiliano KK, Grant ME. Blood analysis at the point of care: issues in application for use in critically ill patients. AACC Clin Issues. 2002;13:204-220.
6. England JM, Hyde K, Lewis SM, et al. Guidelines for near-patient testing: haematology. Clin Lab Hematol. 1995;17:300-319.
7. National Committee for Clinical Laboratory Standards. Point-of-care in vitro diagnostic (IVD) testing: proposed guidelines. NCCLS document no. AST2-P. Villanova, PA: NCCLS; 1995.
8. Briedigkeit L, Muller-Plathe O, Schlebusch H, et al. Recommendations of the German Working Group on medical laboratory testing (AML) on the introduction and quality assurance of procedures for point-of-care testing (POCT) in hospitals. Clin Chem Lab Med. 1999;37:919-925.
9. Fuentes-Arderiu X. Variability of the biological variation. Scand J Clin Lab Invest. 2002;62:561-563.
10. Westgard JO, Barry PL, Hunt A. A multi-rule Shewchart chart for quality control in clinical chemistry. Clin Chem. 1981;15:493-510.
11. Schultz SG, Holen JT, Donohue JP, et al. Two-dimensional centrifugation for desk-top clinical chemistry. Clin Chem. 1985;31:1457-1463.
12. Ehrmeyer SS, Laessig RH. Regulatory requirements (CLIA'88, JCAHO, CAP) for decentralized testing. Am J Clin Pathol. 1995;104:S40-S49.
13. SOSFS. Socialstyrelsens föreskrifter och allmänna råd om kvalitetssystem i hälso- och sjukvården [in Swedish]. 1996:24.
14. Kost GJ. ed. Principles & Practice of Point-of-Care Testing. Philadelphia: Lippincott Williams & Wilkins; 2002.
15. Price CP, Hicks JM. eds. Point-of-Care Testing. AACC Press; 1999.
16. Ehrmeyer S. Quality assurance. Point of Care. 2002;1:180-182.
17. Fraser CG, Hyltoft Pedersen P, Ricos C, et al. Proposed quality specifications for imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem. 1992;30:311-317.
18. Diabetes Control and Complication Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.
19. Nichols JH. Management of point-of-care testing. Blood Gas News. 1999;8:65.
20. Blick KE. The essential role of information management in point-of-care/critical care testing. eJIFCC 2000;12. http://www.ifcc.org/ejifcc/vol12no4/vol12no4al.htm.
21. Theodorsson E, Norheim S. Mätosäkerhetsberäkning med patientprover [in Swedish]. Klin Kem. 2001;4:142-152.
22. Wiebe DA, Westgard JO. Cholesterol-a model system to relate medical needs with analytical performance. Clin Chem. 1993;39:1504-1513.
23. Ehrmeyer S, Laessig RUS. POCT quality assurance regulations: a model for the EU to follow? Clin Lab Int. 2002;26:20-24.
24. Auxter S. Moving to one quality control standard for non-waived testing: final CLIA QC rule raises the bar for moderate complexity labs. Clin Lab News. 2003;29:1-6.
25. Laessig RH, Ehrmeyer SS, Leinweber JE. Interlaboratory performance requirements necessary to pass proficiency testing: CAP-1990 vs CLIA 1967 (March 14, 1990) formats compared. Clin Chem. 1992;38:895-903.
26. Bullock DG. Quality control and quality assurance. In: Price CP, Hicks JM, eds. Point-of-Care Testing. AACC Press; 1999:157-173.