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EVOLVING ASPECTS OF QUALITY ASSURANCE IN LABORATORY TESTING Patrick St.Louis, PhD, Dip Clin Chem Sainte-Justine Hospital Montreal, Canada Congress SCPC, 2004

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Quality the total characteristics of a process or procedure that affect its ability to satisfy its intended application To appreciate the need for quality we must understand the impact of poor quality automobile: safety/accidents, repairs - time and cost cigar: taste, low satisfaction, poor reputation - sales laboratory test result: inappropriate treatment delays in treatment direct harm - repeat punctures social and economic harm

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Quality Assurance (QA) the systematic activities needed to ensure that the requirements of quality will be met. An efective laboratory QA program will provide reliable test results with a minimum of delay and the efficient use of resources, taking care to address patient safety and to minimise laboratory errors.

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Select processes and identify steps for improvement Need objectives with measurable quality indicators; objectives should have clinical, patient care relevance. For example: To reduce the number of unlabelled specimens received measurable patient care relevance: number of repeat sticks time delay to results and treatment

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The laboratory QA program must consider all phases of the laboratory testing process and the steps that can benefit from quality improvement pre-analytical, analytical and post-analytical

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Pre-analytical phase patient identification specimen: collection, identification laboratory: reception and verification pre-test handling: separation decanting aliquotting ( labelling )

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Patient identification: (CRITICAL) Armbands No specimen shall be drawn from a patient who is not wearing an armband Double identification: name (ask), number Special situations: newborns, patients in the ER Sample identification: care should be taken to correctly identify the specimen at this time.

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Specimen collection: proper procedure; repeat punctures; correct samples - no omissions; needlestick injuries identification: label must be affixed transport: delays ( time-stamping, tube systems ) inappropriate and un-protected samples Sample volume issues

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Pre-analytical phase patient identification specimen: collection, identification laboratory: reception and verification data/order entry pre-test handling: separation decanting aliquotting ( labelling ) delay or loss in laboratory ( this occurs more often than we would like )

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Studies on laboratory errors pre-analytical errors 30%-75% of total errors patient/specimen ID errors 34 - 58% of pre- analalytical errors Bonini et al. Clin Chem 2002; 48:691-698 Astion et al. Am J Clin Pathol 2003; 120:18-26 CAP-Q Probes study Order entry errors can be as high as 5% of tests entered; most frequent test request not entered Valenstein & Meier, Arch Pathol Lab Med 1999; 123:1145-1150

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Analytical phase need well-written protocols (methods; format) ensure reliability of test (NCCLS, ISO): establish or verify linearity verify limits of detection and analytical range evaluate precision and accuracy establish institution-specific reference ranges reagent handling: storage, expiry dates; fridge temperatures instrument breakdown and repair logs: down time causes loss of effective working time and delays in results

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Quality control (QC) operational techniques and activities that are used to fulfill requirements for quality QC for the analytical phase : traditional automatic electronic Continuous system monitoring: total system; remote sensing and monitoring

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use of split samples and other means of internal assessment and monitoring concordance between analysers External QC programs (proficiency testing) External QC results and proficiency testing material as tests of trueness

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Post-analytical phase Result validation: automatic, absurd results (contamination by IV fluids, saline, glucose,) Reflex testing eg TSH and T3, T4 Reports and interpretations ( HbS, tumor markers ) Managing critical and unusual results: l protocols defining critical values and actions l calls and read backs Problems inherent in manual entry of results Sample storage and retrieval for supplementary testing; a good system saves time

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The total QA process can benefit from the laboratory information system (LIS): time stamps identity tags traceability from specimen collection to test result previous results and delta checks format of laboratory reports; reference values and comments

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Approach to QA program Develop protocols and policies Identify intervention points Use Risk Reports: laboratory and/or hospital; government mandated reporting Prepare regular QA reports; ensure distribution and follow up.

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Preparation of QA reports and follow up statistical analysis: by period, by clinical unit explain/understand the consequences of particular problems and the reason for actions: eg improper sample identification leading to sample rejection or certification; real or potential harm to the patient avoid blame and seek support interdisciplinary problems

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Some policies at HSJ patient identification specimen identification and certification specimens delayed in transport (use of pneumatic tube system) adequate filling of specimen tubes (anti- coagulation) instrument maintenance, breakdown and repair log sheets temperature logs for refrigerators and freezers critical values protocols: values and actions

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Specimen ID errors: HSJ protocol rejection Specimen not identified/labelled no requisition identification errors: wrong patient, wrong label on specimen, wrong requisition, sample and requisition do not match Are all mis-labelled samples rejected? Some samples are hard to replace Certification by someone responsible on the clinical side

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HSJ 2003/2004: from Certification Forms l 132 sample-related incidents 64 - no identification 36 - wrong identification number of rejections = 90 number of certifications and acceptances = 8 We have noted a marked decrease in the number of events; under-reporting of problem cases ? What about when the test is already done and the report sent; removing results from the patient chart; do not transfer results

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Responsibility for QA: Everyone An institutional issue, having administrative support Uses analytical and statistical tools Two aspects identify and resolve any current problems long range anticipation to improve processes

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Publications: NCCLS documents ISO 15189: Standards for Medical Laboratories Relating to Quality and Competence