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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