Summary:
Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory manager (LM), the laboratory failed to record the room temprature for parafin blocks storage to ensure proper preservation from 10/21/2020 to the day of survey. Findings include: 1. On the day of survey 01/06/2023 at 14:07 pm, the LM could not provide the room temprature records for parafin blocks storage from 10/21/2022 to the day of survey. 2. The LM confirmed the finding above on 01/06/2023 at 14:07 pm. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with the Laboratory Manager (LM), the Technical Supervisor (TS) failed to assess the competency of 3 of 4 Testing Personnel (TP) who performed Mohs micrographic 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 -- examinations and Dermatopathology examinations from 10/21/2020 to the day of survey. Findings include: 1. On the day of survey 01/06/2023 at 12:39 pm, the laboratory could not provide the annual competency assessment records for 2 of 4 TP (CMS 209 personnel #3 and #4) who performed Mohs micrographic examinations from 10/21/2020 to the day of survey. 2. The laboratory could not provide the annual competency assessment records for 1 of 4 TP (CMS 209 personnel #2) who performed Dermatopathology examinations from 10/21/2021 to the day of survey. 3. The Laboratory Manager confirmed the findings above on 01/06/2023 at 12:39 pm -- 2 of 2 --