Assessment of the Analytical Phase of Selected Biochemical Tests at the UP- PGH Central Laboratory: Application of Six Sigma Metrics to Internal and External Quality Control Data
A.O.Tandoc III, MD; A.M.Vergel De Dios,MD,FPSP; N.T.Geraldino,MD,MSPH,FPSP;M.C.L.Cagampan,MD,FPSP; J.A.Mendoza,RMT
UNIVERSITY OF THE PHILIPPINES-PHILIPPINE GENERAL HOSPITALDEPARTMENT OF LABORATORIES
Ten (10) common biochemical tests (Glucose, BUN, Creatinine, Uric Acid, Total Protein, Albumin, Cholesterol, Sodium, Potassium and Chloride) performed at the ChemistrySection of the UP-PGH Central Laboratory were analyzed by reviewing available paired Internal and External QC (EQAS, AQAS, PCQACL & NRLB) data in 2007 & 2008 and subjecting these datato Six Sigma principles. With a benchmark for world class quality of 6 sigma and acceptable process quality of 4-5 Sigma, only Uric Acid testing achieved an acceptable average Sigma metricat 4.69 using EQAS data. Creatinine, Total protein, Albumin and Potassium testing were within 3-4 Sigma. Glucose, Cholesterol, BUN, Sodium and Chloride testing all fall below 3-Sigma which isunacceptable quality. Using AQAS data, no analyte tested above 4-Sigma. Using PCQACL and NRLB data, only Potassium was within 4-5 Sigma.
Medical laboratory work is composed of the technical activities that produce laboratoryresults for patient care. Preanalytic (blood sample collection, receiving, accessioning), analytic(testing, examinations, interpretation) and postanalytic activities (reporting results, archiving samples,charging) transform a clinician’s order for a laboratory examination into the results used by theclinician to diagnose and treat patients.Central to every laboratory is its obligation to assure that the whole testing process isaccurate, reliable and ultimately, useful to the clinician. It is mandated by the Department of Health(DOH) Administrative Order No. 2007-0027
Revised Rules and Regulations Governing the Licensureand Regulation of Clinical Laboratories in the Philippines
that every clinical laboratory shall beorganized to ensure the quality of laboratory results.
Quality control mechanisms, both internal and external, are put in place just for this purpose.
Internal QC procedures
are performed regularly through assaying QC materials for which the correctresult is known in advance in order to verify that a measurement procedure is performing asexpected.
External quality control programs
, in the form of proficiency testing, is one way by whichlaboratory performance is evaluated against those of its peers that use the same instruments and principles within the country and between countries. Such assessments allow a laboratory to verifythat its results are consistent with those of other laboratories using the same or similar methods for ananalyte.
As will be demonstrated in the present study, a step further towards a more meaningfulinterpretation of the data gleaned from both internal and external QC data may be achieved throughthe use of the principles of