Dermatologic Surgi Center

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of maintenance records and interview with the histotechnician, the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 Extech thermometer/humidity monitor used in the Histopathology laboratory from 10/25/2022 to the day of survey. Findings Include: 1. On the day of survey, 08/27/2024 at 1:15pm, during observation of the laboratory the surveyor discovered 1 of 1 Extech hygro-thermometer clock (model number 445702), calibration due March 2024. 2. The laboratory could not provide maintenance/function check records after March of 2024 for the thermometer /humidity monitor. 3. Interview with the histotechnician on 08/27/2024 at 1:25 pm confirmed the 1 of 1 Extech hygro-thermometer clock was used to record room temperature and relative humidity in the Histopathology laboratory from 10/25/2022 to 08/27/2024. 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 --

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 lack of competency assessment records and interview with the Mohs Histotech (MH), the Laboratory failed to assess the competency of 1 of 2 Clinical Consultant (CC), 1 of 2 Technical Supervisor (TS), and 1 of 1 General Supervisor (GS) (on the CMS-209 form listed as personnel 2) for their supervisory responsibilities in Histopathology from 09/02/2020 to 10/25/2022 Findings include: 1. On the day of survey, 10/25/2022 at 09:40am, the MH could not provide competency assessment records for 1 of 2 CC, 1 of 2 TS, and 1 of 1 GS for their supervisory responsibilities from 09/20/2020 to 10/25/2022. 2. The MH confirmed the finding above on 10/25/2022 at 10:45am. *Repeated deficiency. 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 --

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 the laboratory policies and interview with the histotechnologist (HT), the laboratory failed to establish a competency assessment policy to assess the competency for 2 of 3 personnel for their regulatory responsibilities from 2018 to the day of survey. Findings include: 1. On the day of survey, 09/02/2020, the HT could not provide a competency assessment policy for 2 of 3 personnel for their regulatory responsibilities (On the CMS 2019 Testing Personnel form, listed as a clinical consultants (CC) technical supervisors (TS) and general supervisors (GS)) in 2018, 2019 and 2020. 2. The HT could not provide documentation of regulatory competency for 2 of 3 CC, TS and GS from 2018, 2019 and 2020. 3. The HT confirmed the findinga above on 09/02/2020 around 09:40 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)