Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of peer review documentation and operation manager interview 11/30/18, the laboratory failed to verify the accuracy of the Mohs histology testing at least twice a year in 2017 and 2018. The laboratory employs 4 testing personnel (TP) which perform Mohs histology testing, 2 TP began employment in January of 2018. Review of laboratory policies revealed the laboratory performs quarterly peer reviews as part of their quality assessment program to verify the accuracy of the Mohs histology testing performed. Review of laboratory policy "Quality Improvement Plan Mohs Surgery" revealed ..."3. Identify Important Aspects of Care...Mohs Surgery Peer Case Review-A retrospective peer review of selected cases conducted quarterly." Review of laboratory policy "General Information and Routine Procedure for Mohs Surgery Peer Review Cases" revealed "1. The reviewers receive case reports and slides, and complete the Peer Review Quality Assurance (QA) Report form as cases are reviewed. The concordance of clinical history and final tumor eradication are assessed and results recorded on the form....3. Upon the completion of your review, return the forms and all reviewed material to ....." Review of "Peer Review Quality Assurance (QA) Reports revealed the following: 1. Peer review documentation for TP #1 revealed no documentation of peer reviews for 2017 and 2018. 2. Peer review documentation for TP #2 revealed a peer review for the 1st quarter of 2017. There was no documentation of peer reviews for the 2nd, 3rd and 4th quarters of 2017. There was also no documentation of peer reviews for 2018. 3. Peer review documentation for TP #3, who began employment in January of 2018, revealed no documentation of peer reviews for 2018. 4. Peer review documentation for TP #4, who began employment in January of 2018, revealed no documentation of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- peer reviews for 2018. Interview with operations manager at approximately 1:00 p.m. confirmed peer reviews were used to verify the accuracy of the Mohs testing performed and peer reviews were to be performed quarterly as per laboratory policy. She also confirmed that the peer reviews were not performed in 2017 and 2018 as required. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)