Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was conducted at approximately 12:16 pm on February 1, 2023 at Burke Dermatology, Dover. The laboratory was surveyed according to 42 CFR part 493 CLIA requirements. Specific deficiencies are as follows: D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: lack of documentation and during the interview, the laboratory failed to have a qualified person assigned as the Testing Personnel (TP) for high complexity testing. 1. During document review of new personnel at approximately 12:25 pm on February 1, 2023 for training and education documentation, the laboratory provided a copy of a Certificate of Training that states she "completed a 2 day training in Mohs Micrographic Technology 12 CEU Hours" on the "21st day of October, 2022". 3. Durting the interview, at approximately 12:30 pm the Practice Manager (PM) could not provide further documention for the TP pertaining to high complexity testing qulifications. 2. By the end of the survey at approximately 1:56 pm on February 1, 2023, no other documentation was provided that indicated the TP was qualified. 3. After the survey, the State Agency (SA) requested transcripts documenting training and education for the TP. On February 16, 2023, an email that included a High School transcript for the TP was provided, but no documentation for high complexity testing qualifictions. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --