Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with the Mohs Technnologist and Office Coordinator, the laboratory failed to establish a competency assessment procedure to assess 1 of 2 Testing Personnel (TP) for their grossing and inking responsibilities from 7/30/2020 to the day of survey. Findings Include: 1. On the day of survey, 08/01/2022 at 09:59 am, the laboratory could not provide a competency assessment procedure to assess the competency for 1 of 2 TP (CMS 209 Personnel #2) from 07/30/2020 to 09/01/2022. 2. The Mohs Technologist could not provide competency assessment documentation for 1 of 2 TP from 07/30/2022 to 09 /01/2022. 3. The Mohs Technologist confirmed the findings above on 09/01/2022 around 11:00 am. 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 lack of documentation, and interview with the MOHS Technologist and Office Coordinator, the laboratory failed to ensure that 1 of 2 TP performed the verification of accuracy for MOHS micrographic surgery slides examined from 07/30 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 -- /2020 through the date of survey. Findings Include: 1. On the day of survey, 09/01 /2022 at 09:42 am, the laboratory could not provide documentation of twice annual verification of accuracy for Hematoxylin and Eosin (H&E) stained slides examined from 07/30/2020 to 09/01/2022 for 1 of 2 TP (CMS 209 personnel # 1). 2. The laboratory performed 158 MOHS micrographic surgery slide examinations in 2021. 3. The MOHS Technologist confirmed the findings above on 09/01/2022 around 11:00 am. -- 2 of 2 --