Assessment of the Analytical Phase of Selected Biochemical Testsat the UP-PGH Central Laboratory: Application of Six Sigma Metricsto Internal and External Quality Control Data
Amado O. Tandoc III, MD
Principal Author
Ariel M. Vergel De Dios, MD, FPSPNelson T. Geraldino, MD, MSPH, FPSPMa. Carmen L. Cagampan, MD, FPSPJoselyn A. Mendoza, RMT
Co-Authors
UNIVERSITY OF THE PHILIPPINES-PHILIPPINE GENERAL HOSPITAL
DEPARTMENT OF LABORATORIES
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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
ABSTRACT.
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.
I
NTRODUCTION
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.
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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.
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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.
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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
Six Sigma
.
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FIG. 1.
THE SIX SIGMA PERFORMANCE GOAL.
Six standarddeviations of process variation should fit within the tolerancelimits for the process.FIG. 2. Two ways of deriving the Sigma Metric.
Six Sigma
is a process improvementstrategy that has been hailed as an “evolutionin quality management.”
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It is the universaland objective way of quality measurement asit measures the degree to which any processdeviates from its goal. How well the processworks is analyzed and measured as the firststep towards improving quality. It has beenimplemented initially–and successfully–in business and industry starting in the early1990’s by companies such as Motorola and General Electric and espouses a performance goal that“Six sigmas or 6 standard deviations of process variation should fit
within the tolerance limits
for the process.”
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As a universal measure of process performance, any process can be evaluated in terms of a
Sigma Metric
that describes how many “sigmas” fit
within the tolerance limits
. Of the two ways of assessing performance, the measurement of variation is applicable in the laboratory setting. It makesuse of the information on precision and accuracy that laboratories derive from internal and externalquality control programs.
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The
sigma-capability
of the process tells us where and what level of improvement isnecessary. A high quality process strives to achieve a sigma value of 6. Processes of acceptablequality have a sigma value of 4-5. Most processes are sigma 3, which connotes great opportunity for improvement. As Sigma increases, process reliability improves, operating costs go down andcustomer satisfaction increases.
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In 2000, Nevalainen et al evaluated laboratory performance of quality indicators with the SixSigma Scale.
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This is the first application of Sigma metrics to laboratory data. In this study, the
preanalytic, analytic
and
postanalytic phase
of laboratory operations in 3 clinical laboratories in the
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MEASUREOUTCOMEMEASUREVARIATIONInspectOutcomes &CalculateDefect PerConvert DPMto SigmaMeasureVariation of aCalculate SDand ProcessConvertCapability to
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