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 procedure manual, review of peer review records and interview with the office manager, the Laboratory failed to ensure that testing personnel #1 (TP#1) performed in the verification of accuracy for Mohs micrographic examination at least twice annually in 2019 and 2020. Findings Include: 1. The Proficiency testing, Mohs micrographic surgery skin specimen policy states, "The tech or risk manager send twice a year Mohs cases and biopsy or 1 every 6 months for proficiency testing/peer review reporting". 2. On the day of survey, 07/08/2020, the office manager could not provide TP#1 twice annual performance of accuracy for Mohs micrographic examination performed in 2019 and 2020. - In 2019, no cases were sent for review from 01/01/2019 to 06/01/2019. - In 2020, no cases were sent for review from 01/01/2020 to 06/01/2020. 3. The office manager confirmed the findings above on 07/08/2020 around 09:45 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on observation of reagents and interview with the office manager, the laboratory failed to indicate the expiration dates of 5 of 5 bottles of Davidson Tissue Marking dyes, (black, blue, red, green and yellow) proper to use. Findings include: 1. On the day of survey, 07/08/2020, observation of laboratory reagents revealed, 5 of 5, 59 ml Davidson Tissue Marking dyes of 5 bottles (black, blue, red, green and yellow), did not indicate their expiration dates. 2. The office manager could not provide a policy for the laboratory's protocol for reagents used without expiration dates. 3. The office manager confirmed the findings above on 07/08/2020 around 10:15 am. -- 2 of 2 --