Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Mohs micrographic surgery (Mohs) quality control (QC) slides for two (PT#1 and PT#4) out of six patients reviewed. Findings included: 1. "Mohs Laboratory Procedure Manual", signed by laboratory director on 1/2/23, under section "Daily Quality Control for Hematoxylin and Eosin Stains" states "All slides are retained and kept on file at the facility." 2. Review of Mohs patient reports and slides revealed the following: a. PT#1 had no QC slide with 15 slides read on 4/1/2021. b. PT#4 had no QC slide with three slides read on 9/2/2021. 3. During interview on 1/31/2023 at 12:44 PM, SP-1 (Histotech) indicated the previous dermatologist would throw QC slides in the trash after review. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. 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 record review, lack of documentation, and interview, the laboratory failed to verify the accuracy of Mohs testing for one (2022) of two years reviewed. Findings included: 1. Review of "Quality Assurance Review", signed by laboratory director on 8/24/22, revealed peer-review was performed January 2022 to June 2022 on 8/24/22 for 23 Mohs cases. There was no documentation that peer-review was completed for Mohs cases the second half of 2022. 2. Review of the "Mohs Laboratory Procedure Manual", signed by laboratory director on 1/2/23, indicated the laboratory had no policy on how twice annual verification will be performed. 3. During an interview on 1 /31/2023 at 2:49 PM, SP-1 (Histotech) confirmed peer-review was not performed for the second half of 2022 for Mohs testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to define and maintain temperatures for two (Leica CMS 1850 and Leica CMS 1860) of two cryostats in use for Mohs slides from October 2020 to January 2023. Findings include: 1. During tour of the laboratory on 1/31/23 at 11:18 AM, the following equipment was observed: Leica CMS 1850 Cryostat Machine and Leica CMS 1860 Cryostat Machine. 2. The manual "Leica CM1510S", version 08/2003, under 6.7 "Temperature selection chart required the following temperatures: a) Skin with fat -25 degrees Celsius (C) - -35 degrees C) Skin without fat -15 degrees C - 25 degrees C. 3. Review of policy "Cryostat Maintenance", signed by laboratory director on 1/2/23, read "If temperature is ever below -30 degree C or higher than -20 degree C