Joslyn Pribble, MS, MT(ASCP), CSSBB(ASQ)

Methodist Dallas Medical Center

» Member of CAP LAP Checklist Committee

» NOT a paid staff inspector from the CAP, only a volunteer inspector with 506 inspections completed to date

» Do’s and Don’ts of preparing for an inspection

» Identify the top six cited checklist questions

» Know how IQCP fits into a CAP inspection

» Know when and how to challenge a cited deficiency from your inspection

» Know how to respond to a deficiency cited from your inspection

» Do’s ˃ Go over checklist questions with staff to prepare them for the

inspection

˃ Make sure someone knows where to find all relevant materials in case you are not there for the inspection

˃ Prepare a “morning of” checklist for staff so that everything is in place when the inspectors arrive

˃ Complete the free CAP Online inspector training module and encourage staff to do so as well

˃ Get area cleaned up as much as possible – floors, walls, bench tops, etc.

» Dont’s ˃ Do not expect staff to know how to behave during an inspection

without any prior coaching

˃ Food and drinks in the work areas (true for ALL times, not just during an inspection). Discard any food or drink items outside of the work area or in “Clean areas”.

˃ PPE being improperly used (sleeves on lab coats pushed up, no gloves, face shields worn upside down, etc.)

˃ Messy lab – general cleanliness goes a long way to impress!

˃ Failing to follow manufacturer’s directions without proper validation of changed process

Phase I : Typically non-patient impacting standards which do not require a response to CAP if cited. Corrections are to be made on-site and be made available during next inspection . Phase II : Most serious standards which require response to CAP if cited during an inspection.

Read ALL notes and evidence of compliance in each checklist question! Most questions require proof of compliance (logs, records, etc.) as well as a written procedure. It is not good enough to just be “doing it”.

» QC: Review of records, signatures, corrective actions

» Morphological Observation Assessment

» Media QC

» Blood Culture Examination (Manual Back-up)

» Activity Menu

» Comparability of Instruments

MIC.11020 (Phase II): Quality Control data are reviewed and assessed at least monthly by the Laboratory Director of designee. MIC.11018 (Phase II): There are records of corrective action when control results exceed defined acceptability limits

•Missing signatures/no review • Incomplete records/blank

spots •Review taking longer than one

month • Temperatures out of range

with no corrective action taken

MIC.11350 (Phase II): The microbiology laboratory at least annually assesses morphological observations among personnel performing Gram, trichrome and other organism stains, to ensure consistency

• Failure to include all shifts in review • Having techs review different slides rather

than everyone looking at the same one • Not including all slide/stain types in the

review • Failure to grade assessments and assign a

passing score expectation • No follow-up retraining with techs no

passing assessment • No reviewed by signature/date on

assessment documents

MIC.21240 (Phase II): An appropriate sample from each lot and shipment of each purchases medium is checked before or concurrently with initial use for each of the following: • Sterility • Ability to support growth • Biochemical reactivity

• No established IQCP for the acceptance of QC performed by the media supplier for “Exempt” media

• No Media QC on all AST Media (Mueller-Hinton, Haemophilus media, GC media, etc.)

• Failure to perform QC on Campylobacter agar, Chocolate agar or other selective media for isolation of Neisseria species

• Trace of media on hand and in-use not listed on current QC logs (unable to confirm QC testing was done).

MIC.22620 (Phase II): Blood cultures are examined (macroscopically if manual method) for evidence of growth at least twice daily for the first two days of incubation, then at least daily for the remainder of the incubation period.

• No plan for handling manual blood cultures (if system is down, different bottles received, samples that keep flagging positive on automated system, etc.)

• If a plan for manual blood cultures is written, failure to have documented examination twice a day on the first two days.

COM.01200 (Phase I): The laboratory’s current CAP activity menu accurately reflects the testing performed.

• Performing tests that are NOT included on the CAP Activity Menu

• Tests on the activity menu that are no longer performed

• Remember to check your proficiency testing against the activity menu. If you are not doing PT for an analyte that was not on the activity menu but is being performed, you can be cited for COM.01300 regarding PT Participation (Phase II)

COM.04250 (Phase II): If the laboratory uses more than one non-waived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results.

• Applies to automated instruments such as Vitek, MicroScan, Sensititre and Phoenix

• Also applies to identical tests which are done on two different platforms or test kits (Anaerobic ID by automated instrument and by Rapid Kit for example)

• Must include back-up methods in the comparability study

• You may use QC isolates for comparison testing

• Testing MUST be done on same day using same isolate

COM.50200 (Phase II): The laboratory has identified all tests using an IQCP and completed the CAP’s forms for laboratories using an individualized quality control plan. COM.50300 (Phase II): The IQCP for a test/device/instrument includes a risk assessment to evaluate potential sources of error to include all of the following: • Pre-analytic, analytic and post-analytic phases of the testing process • Intended medical uses of the test and impact if inaccurate results are

reported (Clinical risk) • Components of the tests including reagents, environment, specimen,

testing personnel and test system • Variations in the components based on use of the tests (e.g. use in

different environments, by different personnel or multiple identical devices)

• Data from the laboratory’s own environment, instrument/equipment performance and testing personnel

• Manufacturer’s instructions and recommendations

COM.50400 (Phase II): The IQCP includes a written quality control plan approved by the laboratory director prior to implementation COM.50500 (Phase II): The individualized quality control plan must define all aspects monitored based on the potential errors identified during the risk assessment, including the following parameters as applicable • The number, type (external and internal quality control systems) and

frequency of quality control • Criteria for acceptable performance • Monitoring of the testing environment and reagents • Specimen quality • Instrument calibration, maintenance and function checks • Training and competency of testing personnel • Provisions for multiple identical devices and variation for uses

covered under one IQCP

COM.50600 (Phase II): Ongoing quality assessment monitoring is performed by the laboratory to ensure that the quality control plan is effective in mitigating the identified risks for the IQCP and includes the following: • Review of quality control and instrument/equipment maintenance

and function check data at least monthly • Evaluation of errors relating to pre-analytic, analytic and post-

analytic phases of the testing process • Review complaints from clinicians and other healthcare providers

regarding the quality of testing to confirm the clinical efficacy of testing

• Evaluation of corrective action taken if problems are identified • Reapproval of the quality control plan by the laboratory director or

designee at least annually

• Supporting data showing that the lab was in compliance AT THE TIME OF THE INSPECTION has been located

• Lab believes that they were in compliance with a standard and wants to provide CAP with the supporting documentation and data for review

• Lab believes the inspector acted in a biased manner in citing the deficiency

• Inspector and lab did not see eye-to-eye on the deficiency and lab wants CAP to decide if the supporting documentation meets the intent of the standard