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 the laboratory's policies and procedures and review of 2022 and 2023 laboratory records 4/15/24, the laboratory failed to verify the accuracy of the KOH (potassium hydroxide) and scabies preps at least twice a year in 2022 and 2023. Findings: Review of the laboratory's policies and procedures revealed "Contract Agreement for Quality Assurance and Proficiency Testing In ordinance with the Center for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments regulation regarding quality assurance and proficiency testing of non- regulated analyte, not covered under Subpart I, biannual verification is necessary. This biannual verification will be done using the split sample technique using another laboratory that performs the same testing procedures. Semi-annually, (the laboratory), Moderate Testing Personnel will have reviewed two or three cases containing the original slides or photographs from the microscope for KOH and Ectoparasite testing ...". 1. KOH Review of the"KOH Examination and QC" procedure revealed "... Accuracy: 1. Verification of the accuracy of the KOH prep is completed with each Provider Performed in Microscopy (PPM). Each physician and mid-level provider uses clinical correlation, along with collecting and reading each test. 2. Provider shall maintain KOH quality assurance (peer review) done bi-annually. The Proficiency testing will be done bi-annually with CAP, WSLH, ACMS, ASMS or other accredited organization, or split sampling (quiz) done annually." Review of 2022 and 2023 laboratory records revealed: a. The accuracy of KOH was verified only once in 2022. On 7/12/22, two providers read a patient KOH prep and documented their results. There was no documentation of any other activity to verify the accuracy of the KOH testing performed by the laboratory. b. The accuracy of KOH was verified only once Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in 2023. In January 2023, all providers participated in a "quiz" consisting of a review of blind samples, including KOH. There was no documentation of any other activity to verify the accuracy of the KOH testing performed by the laboratory. 2. Scabies Review of the "Ectoparasite/ Wet Mount Examination" procedure revealed "... Accuracy: 1. Verification of the accuracy of the ectoparasite prep is completed with each Provider Performed Microscopy (PPM). Each physician and mid-level provider uses clinical correlation, along with collecting and reading each test. 2. ... Twice yearly, quality assurance via peer review will be completed and maintained in Quality Control Logbook." Review of 2022 and 2023 laboratory records revealed: a. The accuracy of scabies preps was not verified in 2022. There was no documentation of any activity to verify the accuracy of the scabies preps performed by the laboratory. b. The accuracy of scabies preps was verified only once in 2023. In January 2023, all providers participated in a "quiz" consisting of a review of blind samples, including scabies preps. There was no documentation of any other activity to verify the accuracy of the scabies preps performed by the laboratory. 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)