Validation protocol: First step of a lean-total quality management principle in a new laboratory set-up in a tertiary care hospital in India

Indian Journal of Clinical Biochemistry

Volumn 26, Issue 3, 2011, Pages 235-243

  Das, Barnali ^a  

^a KOKILABEN DHIRUBHAI AMBANI HOSPITAL   (India)

Author keywords

Alkaline phosphatase; Lean concept; Total quality management; Validation

Indexed keywords

ALKALINE PHOSPHATASE;

ACCURACY; ADULT; ANALYTICAL MEASUREMENT RANGE; ARTICLE; CINICALLY REPORTABLE RANGE; CLINICAL LABORATORY; CLINICAL PROTOCOL; CONTROLLED STUDY; ENZYME ASSAY; HUMAN; INDIA; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEAR SYSTEM; REFERENCE VALUE; SENSITIVITY ANALYSIS; TERTIARY HEALTH CARE; TOTAL QUALITY MANAGEMENT; VALIDATION PROCESS;

EID: 80052300263     PISSN: 09701915     EISSN: 09740422     Source Type: Journal    
DOI: 10.1007/s12291-011-0110-x     Document Type: Article

References (17)

1. C Kilinc 2009 Laboratory quality management systems: missions, goals and activities in quality assurance Clin Biochem 42 4-5 301 302 19863930 10.1016/j.clinbiochem.2008.09.020
2. Food and Drug Administration, Guideline on General Principles of Process Validation, May 1987.
3. J Cummings TH Ward A Greystoke M Ranson C Dive 2008 Biomarker method validation in anticancer drug development Br J Pharmacol 153 4 646 656 17876307 10.1038/sj.bjp.0707441 1:CAS:528:DC%2BD1cXitVGqu74%3D (Pubitemid 351271750)
4. L Kaminski M Degenhardt J Ermer, et al. 2010 Efficient and economic HPLC performance qualification J Pharm Biomed Anal 51 3 557 564 19801176 10.1016/j.jpba.2009.09.011 1:CAS:528:DC%2BD1MXhtl2jsbfF
5. Linnet K, Boyd JC. Selection and analytical evaluation of methods-with statistical techniques. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. St. Louis: Saunders; 2006. p. 353-403.
6. Cembrowski GS, Sullivan AM. Quality control and statistics. In: Bishop ML, Duben-Engelkirk JL, Fody EP, editors. Clinical chemistry principles, procedures, correlations. 2nd ed. Philadelphia, PA: Lippincott; 1992. p. 63-101.
7. George ML. Lean Six Sigma for service: how to use Lean speed and Six Sigma quality to improve services and transactions. New York: McGraw-Hill; 2003.
8. M Sunyog 2004 Lean management and Six-Sigma yield big gains in hospital's immediate response laboratory. Quality improvement techniques save more than $400, 000 Clin Leadersh Manag Rev 18 255 258 15493100 (Pubitemid 39663958)
9. H de Koning JP Verver J van den Heuvel S Bisgaard RJ Does 2006 Lean Six Sigma for healthcare J Healthc Qual 28 2 4 11 16749293 10.1111/j.1945-1474.2006. tb00596.x
10. Sasse EA, Doumas BT, Miller WG, et al. How to define and determine reference intervals in the clinical laboratory; Approved guideline, 2nd edn. CLSI document EP28-A2, 2008; 15: No. 4, Wayne, PA, USA
11. Carey RN, Anderson FP, George H, et al. User verification of performance for precision and trueness; Approved guideline, 2nd edn. CLSI document EP15-A2, 2008;25:No. 17.
12. Tholen DW, Linnet K, Kondratovich M, et al. Protocols for determination of limits of detection and limits of quantitation; Approved guideline. CLSI document EP17-A, 2008;24:No. 34.
13. LA Currie 1995 Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995) Pure Appl Chem 67 1699 1723 10.1351/pac199567101699 1:CAS:528:DyaK2MXptFGhu70%3D
14. R Dybkaer 1997 Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine Eur J Clin Chem Clin Biochem 35 2 141 173 9056759 1:CAS:528:DyaK2sXhsFaku74%3D (Pubitemid 27129867)
15. McEnroe RJ, Burrit MF, Powers DM, Rheinheimer DW, Wallace BH. Interference testing in clinical chemistry; Approved guideline, 2nd edn. CLSI document EP7-A2, 2008;25:No. 27.
16. S Storari E Lamma R Mancini, et al. 2003 Validation of biochemical laboratory results using the DNSev expert system Expert Syst Appl 25 503 515 10.1016/S0957-4174(03)00091-5
17. Price CP, Christenson RH, editors. Evidence-based laboratory medicine: from principles to outcomes. Washington, DC: AACC Press; 2003.