LABORATORY REPORT CARD

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

REAGENTS

• Are all reagents within their expiration dates?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

TESTING

• Are specimens collected and handled according to lab protocols?

  Yes

  No

  N/A

• Are all specimens labeled correctly?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is staff complying with policies and procedures?

  Yes

  No

  N/A

• Are all waved testing QC done and documented?

  Compliant

  Non-Compliant

• MARCH, SEPTEMBER - 6 Month Pre-Analytic assessment of specimen, handling, collection & Labeling: Did you do a visual inspection of staff, documentation and policy procedure?

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

PROFICIENCY TESTING

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

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

COMPUTER / IT / LIS

• Are techs using their own log-in?

  Yes

  No

  N/A

• Are techs logging out when leaving the lab?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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)

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

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

  Yes

  N/A

• Were 20 normal patient samples tested for all tests performed in the lab?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  N/A

• What tests ranges were changed?

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

  Yes

  No

  N/A

• Were all physicians notified?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Summary and analysis of findings:

EQUIPMENT:

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

  Yes

  No

  N/A

• Has all monthly maintenance been performed and documented?

  Compliant

  Non-Compliant

• Has supply or vendor problems been documented?

  Yes

  No

  N/A

• Were unscheduled maintenance or service repairs documented?

  Yes

  No

  N/A

• Are monthly calibrations performed as scheduled?

  Compliant

  Non-Compliant

• APRIL, OCTOBER - 6 month analytic instrumentation review:

  Yes

  N/A

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

  Yes

  No

  N/A

• Has calibration and calibration verification been performed on the Piccolos? (Correlation between the two analyzers)

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Has calibration and calibration verification been performed on the Biosite Triage?

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Has calibration and calibration verification been performed on the Clinitek Stratus

  Compliant

  Non-Compliant

  N/A

• Has calibration and calibration verification been performed on the i-STAT?

  Compliant

  Non-Compliant

  N/A

• Has calibration and calibration verification been performed on the Glucometers? (Correlation between the two analyzers)

  Compliant

  Non-Compliant

  N/A

• OTHER:

  Yes

  N/A

• Summary and analysis of findings:

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

CONTROL OF RECORDS

• Are lab results retained for a minimum of 2 years?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

ENVIRONMENT

• JUNE - Is it time for the annual compliance assessment (visual review of laboratory physical environment for safety, patient confidentiality compliance, update of procedure manuals, laboratory licensing and enrollment)?

  Yes

  N/A

• Are fire extinguishers present and service updated, eye wash tested if present and/or within expiration date?

  Compliant

  Non-Compliant

• Is there personal protective equipment present?

  Compliant

  Non-Compliant

• Has biohazard waste disposed of properly into conveniently placed containers?

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• PATIENT CONFIDENTIALITY: Are computer screens and records protected?

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

• Are laboratory records being stored, protected and easily retrievable?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is the temperature appropriate for performing lab tests?

  Yes

  No

  N/A

• Is the lighting adequate to read and perform tests?

  Yes

  No

  N/A

• Is the lab clean and orderly?

  Yes

  No

  N/A

• Are noise levels controlled and within limits?

  Yes

  No

  N/A

EDUCATION

• JANUARY - Is this the annual personnel training evaluation month?

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Summary and analysis of findings:

• Do the techs that are performing tests have documented competency?

  Yes

  No

  N/A

• Is the training documented and readily available?

  Yes

  No

  N/A

• Have staff signed off on this months continuing education?

  Yes

  No

  N/A

• Have staff initialed API result forms?

  Yes

  No

  N/A

• Have staff reviewed this months assigned procedures from MCN?

  Yes

  No

  N/A

• List any additional lab training classes:

QUALITY ASSURANCE

• The percent of CRITICAL VALUES documented correctly was?

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

  Compliant

  Non-Compliant

• MAY, NOVEMBER - 6 month assessment of critical values and turn around times; Did you evaluate 10 patient orders with review of order time to result entry? Did you also evaluate 10 reference lab requisitions with review of time sent to receipt of results?

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Are STAT results for tests performed in-house available to physicians within 1 hour of collection?

  Compliant

  Non-Compliant

• Is the turn-around-time for specimens sent to the reference lab within the reference lab stated times?

  Compliant

  Non-Compliant

• Summary and analysis of findings:

• Percent of QUALITY CONTROLS performed correctly

• The Percent of Quality Controls <98% (Non-Compliantly)

  Compliant

  Non-Compliant

• Are Quality Control ranges updated in LabDAQ?

  Yes

  No

  N/A

• 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)

  Compliant

  Non-Compliant

• Summary and analysis of findings:

• The percent of AMENDED REPORTS documented correctly was

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

  Compliant

  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?

  Yes

  N/A

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

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Were unacceptable specimens documented as rejected?

  Compliant

  Non-Compliant

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

  Compliant

  Non-Compliant

• Are all lab records maintained for 2 years (pathology records for 10 years)?

  Yes

  No

  N/A

• Summary and analysis of findings:

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

  Yes

  N/A

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

  Compliant

  Non-Compliant

• Was there any communication breakdowns with documented possible solutions?

  Compliant

  Non-Compliant

• Have complaints been properly recorded and investigated?

  Compliant

  Non-Compliant

• Has remedial action been documented for all valid complaints?

  Compliant

  Non-Compliant

• Summary and analysis of findings:

UNEXPECTED EVENTS (includes; incidents, complaints or problems)

• Was there any unexpected event this month?

  Yes

  N/A

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

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