MONTHLY QUALITY ASSURANCE CHECKLIST
QUALITY SYSTEMS ASSESSMENT
Columbus County Health Department Laboratory
❑ Select one or more systems each month and evaluate components or processes for compliance.
❑ Place a check mark by item if acceptable/within limits.
❑ Write ‘N/A” if item is not applicable at the time of evaluation.
❑ Write “C” if item requires a comment and/or corrective action
❑ Write “QAS” if a QA study was generated.
PATIENT CONFIDENTIALITY:
________ Was patient information kept confidential throughout all phases of testing?
COMPLAINT INVESTIGATIONS:
________ Have complaints been documented and investigated according to protocol?
________ If a complaint was investigated, was resolution documented?
________ Was the resolution monitored to show improvement? (in 3 – 6 months)
COMMUNICATIONS:
________ Has the laboratory received information necessary for efficient and effective operation?
________ Have clinical staff received information necessary for efficient and effective patient care?
________ Have problems been documented with corrective action and follow-up evaluation?
PERSONNEL COMPETENCY ASSESSMENT:
________ Was training and education documented for all testing personnel?
________ Has Lab director/designee reviewed assigned duties for all testing personnel?
________ Have testing personnel performed each assigned test at least once per quarter?
________ Have testing personnel completed required annual continuing education?
________ Were competency assessments performed and documented by appropriate personnel?
________ Were competency assessment results reviewed with appropriate personnel?
________ Were competency assessment failures investigated and remedial action taken?
PROFICIENCY TESTING:
________ Was proficiency testing rotated among testing personnel?
________ Were proficiency samples treated like patient samples?
________ Were copies of all submitted proficiency results retained?
________ Were all summary reports reviewed by the lab manager and lab director/designee?
________ Were incorrect results (graded and ungraded) investigated and corrective action taken?
PERSONNEL SAFETY:
________ Was the laboratory director/designee notified of any situation that could affect the lab’s performance or the safety of employees?
________ Were Universal precautions used when applicable?
________ Have lab personnel received annual OSHA Bloodborne Pathogen training?
________ Have lab personnel documented annual review of safety manuals?
________ Have new lab personnel:
1. Received safety training?
2. Been offered the Hepatitis B vaccine?
PATIENT IDENTIFICATION & PREPARATION:
________ Were patients properly identified prior to specimen collection?
________ Were patients properly instructed prior to specimen collection?
________ Were interpreters available to instruct Spanish-speaking clients?
SPECIMEN COLLECTION & INTEGRITY:
________ Were specimens collected and handled according to protocol?
________ Were specimens labeled legibly and correctly?
________ Were specimens processed, transported, and stored properly?
________ Was positive identification of each specimen maintained throughout testing?
________ Were specimens collected outside the lab received in a timely manner?
________ Was “received time” documented for all laboratory specimens tested in-house?
________ Were specimen rejection policies followed?
TEST REQUEST:
________ Did the lab have written/electronic requests or standing orders from authorized individuals for all tests performed?
________ Did test requests/requisitions contain all necessary information?
PROCEDURE MANUAL:
________ Are laboratory policies/procedures current and complete?
________ Have lab personnel documented annual review of policies/procedures?
________ Has lab director/designee documented annual review of policies/procedures?
________ Do new/updated procedures reflect the dates put in to use/revised?
________ Were discontinued procedures dated and kept for two-year minimum?
VERIFICATION OF PERFORMANCE:
________ Were method changes verified and approved by the lab director/designee before implementation?
MAINTENANCE & FUNCTION CHECKS:
________ Was scheduled instrument/equipment maintenance properly performed and documented?
CALIBRATION & CALIBRATION VERIFICATION (non-waived instruments):
________ Was calibration performed according to manufacturer’s instructions?
________ Was calibration performed at least every six months, with reagent lot changes, and after major maintenance or service?
QUALITY CONTROL:
________ Were environmental controls (temperature, humidity, etc.) recorded and within acceptable limits prior to testing?
________ Were only in-date reagents, controls, kits, media, etc., used?
________ Was procedural QC performed, documented, and within acceptable limits before patient test results were reported?
________ Were appropriate Levy-Jennings charts plotted and evaluated for trends or shifts each day of testing?
________ Were QC failures (i.e., out-of-range results) documented, along with corrective action?
________ Was performance of QC rotated among testing personnel?
COMPARISON OF TEST RESULTS:
________ Were instrument comparisons conducted twice a year?
________ Were wet mount results compared among all testing personnel twice a year?
TEST RECORDS:
________ Were records of testing, including worksheets and instrument printouts, retained and complete?
________ Was the identity of testing personnel documented for each intermediate step in testing (i.e., oxidase, gram stain)?
TEST REPORT:
________ Were test reports reviewed for completeness and accuracy?
________ Did multi-part requisitions reflect all information on each copy?
________ Was turnaround time for in-house specimens appropriate?
________ Was turnaround time for referred specimens appropriate?
________ Were panic values reported according to lab policy?
________ Were corrected/amended reports issued according to lab policy?
DATA STORAGE & RETRIEVAL:
________ Were exact copies of in-house test reports maintained and accessible?
________ Was lab documentation (i.e., QC records, worksheets, package inserts, and instrument printouts) retained for a minimum of two years?
COMMENTS:
COMPLETED BY: _______________________________________________________________DATE: ___________________________
LAB MANAGER REVIEW: ________________________________________________________DATE: ___________________________
LAB DIRECTOR/DESIGNEE REVIEW: ______________________________________________DATE: ____________________________
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POSTANALYTIC SYSTEMS
ANALYTIC SYSTEMS
PREANALYTIC SYSTEMS
GENERAL LABORATORY SYSTEMS
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