• Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel


  • Are all reagents within their expiration dates?

  • Do the reagents packs for Triage & I-STAT that have been removed from the refrigerator, have an expiration date on them?

  • Are there open dates on all reagents and disposables that have been opened?

  • Are there adjusted expiration dates on reagents after they are opened?

  • Is there an adequate supply of reagents and disposables on hand?

  • Are the reagent lot numbers and expiration dates updated in LabDAQ?


  • Are patients identified by name and second identifier by phlebotomist?

  • Are specimens collected, handled and stored according to lab policy?

  • Are specimens adequately labeled following established protocol (at patient bd side)?

  • Did the patient identifier remain with the sample throughout the testing process?

  • Is the specimen quality/integrity adequate to perform testing?

  • Is staff complying with policies and procedures?

  • Are referred specimens labeled, stored and shipped according to protocol?

  • Are all laboratory staff following standard precautions at all times?

  • Is there a policy in place for unacceptable specimens and possible recollection?

  • Do patients receive written information for testing with special requirements?

  • Summary and analysis of findings:


  • VARIOUS MONTHS - Was there a proficiency test done or results received this month?

  • Have all proficiency testing been performed according to CLIA guidelines?

  • Is all proficiency testing performed in the same manner as patient testing?

  • Are all testing documentation, submission forms, and attestation forms retained?

  • Was there a review of graded results conducted and documented?

  • Are unsuccessful PT events investigated and has corrective action been taken?

  • For testing using two different methods; were split studies / alternate survey documented? (i.e. cardiac enzymes)

  • Summary and analysis of findings:


  • Are techs using their own log-in?

  • Are techs logging out when leaving the lab?

  • PATIENT CONFIDENTIALITY: Are computer screens and records protected?

  • Do the electronic requisitions (e-req for reference lab tests) contain all necessary information?

  • FEBRUARY, AUGUST - Every 6 months - Did you assess the pre analytic test tracking by reviewing 10 requisitions to verify that all pertinent data is documented? (If Electronic Medical Record, verify the EMR)

  • Was the name & address of the healthcare provider ordering tests and performing lab present?

  • Was the patients' name and a second identifier (i.e.MR#, DOB) on the requisition?

  • Was there a date and time of specimen collection, & phlebotomist initials on the requisition?

  • Was there other pertinent information such as sex, date of birth, source of culture and/or diagnosis on the requisition?

  • Review 10 send out records (reference lab tests) for all required information; Is all required information present?

  • Summary and analysis of findings:

  • AUGUST OR AS NEEDED - Is this an annual or physician requested review of patient population reference ranges?

  • Were 20 normal patient results reviewed for all tests performed in the lab?

  • Were these results compared against current normal ranges established in manuals?

  • Were there any normal ranges that needed to be adjusted?

  • What tests ranges were changed?

  • Did the Lab Director sign for her/his approval?

  • Were all physicians notified?

  • Are the updated normal ranges posted within the laboratory and in the LIS?

  • Summary and analysis of findings:


  • Are all analyzers / test systems operating properly?

  • Are maintenance logs, calibration records, and I-STAT analyzer tapes/reports up to date and easily accessible?

  • Has all monthly maintenance been performed and documented?

  • Has supply or vendor problems been documented?

  • Was unscheduled maintenance or service repairs documented?

  • Are monthly calibrations performed as scheduled?

  • APRIL, OCTOBER - 6 month analytic instrumentation review:

  • Has calibration and calibration verification been performed on all necessary equipment?

  • Has calibration and calibration verification been performed on the Hematology analyzer?

  • Has calibration and calibration verification been performed on the Biosite Triage? (Correlation between Triage & iSTAT tests)

  • Has calibration and calibration verification been performed on the Qualigen FastPack IP

  • Has calibration and calibration verification been performed on the i-STAT? (Correlation between iSTAT & Triage tests)

  • Any other equipmnt

  • Summary and analysis of findings:

  • Has the daily, weekly and monthly maintenance been performed and documented?

  • Is quality control being performed according to policy and procedure?

  • Has the QC been reviewed at least monthly by the lab director or designee?

  • Has corrective action been documented and patient results reported only with acceptable quality control values?

  • Is corrective action taken and documented when analyzers do not meet performance specifications?

  • Summary and analysis of findings:


  • Are lab results and other records being retained and easily retrievable for a minimum of 2 years, 10 years for Blood Bank & Pathology?

  • Are maintenance & calibration records retained for the life of the analyzer plus 2 years after removed from service?

  • Are the disposition of records documented when they have been disposed of?


  • Is TempTrack operating properly and being audited daily by facility staff?

  • Is the temperature appropriate for performing lab tests?

  • Is the lighting adequate to read and perform tests?

  • Is the lab clean and orderly with no food or drinks present?

  • Are noise levels controlled and within limits?

  • Is biohazard waste disposed of properly into conveniently placed containers (sharp & non-sharp)?

  • Are fire extinguishers present and service updated?

  • Is eye wash tested if present and/or within expiration date?

  • Is there personal protective equipment present (gloves, lab coat, glasses)?

  • Is staff using PPE appropriately?

  • Is the biohazard trash picked up regularly and documented with receipts?

  • Are the OSHA, Safety, and MSDS manuals present and updated?

  • Is the lab procedure manual up to date and signed by the lab director/designee annually?

  • Is the lab CLIA, COLA, & State Licensure current? Is the enrollment in API Proficiency Testing current?

  • Are all instrument and test records retained for established time? (Test electronic records)

  • Summary and analysis of findings:


  • Is there documentation of initial, six month or annual competency assessment?

  • Has assessment of competency by proficiency testing and other skills checklist been utilized?

  • Is there documentation of continuing education (at least one per year)?

  • Is there proof of education (H.S., A.A., B.S., Certifications, Diplomas and other as necessary) in their employee folder/

  • Is there annual documentation of Blood Born Pathogen, Safety, and OSHA training?

  • Have staff signed off on this months continuing education?

  • Have staff initialed API result forms?

  • Have staff reviewed this months assigned procedures from MCN?

  • Is there evidence of Hepatitis B Vaccine options or vaccination documentation in the lab employee file?

  • List any additional lab training classes: Is the training documented and readily available?

  • Summary and analysis of findings:


  • Was the critical value documented and reviewed by supervisor to include patient name, result, date & time of notification and person notified?

  • The percent of CRITICAL VALUES documented correctly was?

  • The percent of Critical Values </= 95% (Non-Compliant)

  • Are routine results available to physicians within 4 hours of collection?

  • Are STAT results for tests performed in-house available to physicians within 1 hour of collection? (Review at least 10 patient orders)

  • Is the turn-around-time for specimens sent to the reference lab within the reference lab stated times? (Evaluate at least 10 reference lab requisitions from time sent to receipt of results)

  • Summary and analysis of findings:

  • Percent of QUALITY CONTROLS performed correctly

  • The percent of Quality Controls </= 98% (Non-Compliant)

  • Are Quality Control ranges updated in the LIS?

  • Are all waved testing QC done and documented?

  • Monthly analytic QC assessment; Were the QC records and logs reviewed weekly by lab staff or designee and monthly by the lab director or designee? (QC done as required, QC log complete & LJ Charts present)

  • The percent of AMENDED REPORTS documented correctly was

  • The Percent of Amended Reports </= 90% (NON-COMPLIANT)

  • MAY, NOVEMBER - 6 months post analytic review of result reporting; Did you review 10 lab reports against patient charts, review of rejection logs and corrected reports?

  • Did the reports contain test name, results, units, normal ranges, patient name, lab name and address, testing personnel?

  • Did the lab record and patient chart contain the same results?

  • Were unacceptable specimens documented as rejected?

  • Was the policy for corrections followed; physician notified, original and corrected report retained for two years?

  • Summary and analysis of findings:

  • FEBRUARY, MAY, AUGUST, NOVEMBER - Quarterly: Is this a month for our quarterly communication complaint investigation?

  • Was there a quarterly meeting held to evaluate communication and complaints between lab staff, patients, physicians and other facility staff?

  • Were there any communication breakdowns with documented possible solutions?

  • Have complaints been properly recorded and investigated?

  • Has remedial action been documented for all valid complaints?

  • Summary and analysis of findings:


  • What is the employees EIN and purpose of follow up?

UNEXPECTED EVENTS (includes; incidents, complaints or problems)

  • Was there any unexpected event this month?

  • Document: Problem or Event Description, Cause of Event, Problem Resolution & Implementation Date.


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