Information
-
Document No.
-
Audit Title
-
Client / Site
-
Conducted on
-
Prepared by
-
Location
-
Personnel
REAGENTS
-
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?
SAMPLE COLLECTION & HANDLING
-
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:
PROFICIENCY TESTING
-
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:
COMPUTER / IT / LIS
-
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:
EQUIPMENT / TEST SYSTEMS
-
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:
CONTROL OF RECORDS
-
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?
ENVIRONMENT / SAFTY
-
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:
EDUCATION
-
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:
QUALITY ASSURANCE
-
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 </= 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:
-
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 </= 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:
EMPLOYEE FOLLOW UPS FROM PREVIOUS AUDITS (EIN'S ONLY)
-
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.
MEDIA / PICTURES
-
Add media
COMPLETED BY
-
Add signature
-
Select date