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 review of the patient logs, observation of the slides, and interview with the senior location manager (SLM), the laboratory failed to document when slides were sent offsite for outside proficiency testing (PT) review. Findings: 1. Physical slides prepared on 03/16/2023 were reviewed for comparison to the patient logs. 2. Slides for case M23-038 were missing from the storage box. 3. Slides had recently been sent to another location for PT review, but the list of slide numbers included in the PT shipment were not available at the time of the survey. 4. In an email received on 02/14 /2024 at 1:10 PM, the SLM confirmed that they were "not able to find the list of what was sent out" to be able to verify if the missing slides for case M23-038 could be accounted for. 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: 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 -- Based on review of the proficiency testing (PT) policy and interview with the senior location manager (SLM), the laboratory failed to document biannual peer review PT for the Mohs surgeons for 2022 and 2023 as stated in the policy. Findings: 1. The "Mohs Histopathology & Proficiency Testing Policy" stated "Peer review proficiency testing for all Mohs surgeons and histopathologists will be performed bi-annually. Proficiency testing is to be sent out and returned by June 30th and December 31st each year" and "Results of the peer review proficiency testing will be recorded on the Mohs Proficiency Form (LF-0024) and maintained in the CLIA manual." 2. Patient testing began on 05/20/2022. There were no completed Mohs Proficiency Forms. 3. During the survey on 02/08/2024 at 12:55 PM, the SLM confirmed that there were no records that biannual peer review PT for the Mohs surgeons was performed for 2022 and 2023. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the procedure, patient logs, and slides and interview with the senior location manager (SLM), the laboratory failed to assign patient case numbers as defined in the procedure. Findings: 1. The "Mohs Quality Assurance Manual" stated that "The case number will consist of the Mohs surgeon's first initial of their last name, the first initial of the office location, the last number of the year, a hyphen and then starting with the number one continue in numerical order." 2. Patient testing began on 05/20/2022. 3. The Mohs surgeon from 05/20/2022-07/23/2023 had the initials AF, the Mohs surgeon from 09/12/2023 to the present had the initials SD, and the practice location was La Plata, MD. 4. From 05/20/2022 to the end of 2023, the case numbers were assigned as "M" followed by the last two digits of the year, followed by a hyphen, followed by a sequential numerical designation (e.g., M23-001, M23-002 ...). 5. Starting in 2024, the case numbers were assigned as "SD" (the initials of the present Mohs surgeon), followed by "24", followed by a hyphen, followed by a sequential numerical designation (e.g., SD24-001, SD24-002 ...). 6. During the survey on 02/08/2024 at 12:55 PM, the SLM confirmed that the patient case numbers were not assigned as defined in the quality assurance manual. D5781