Pennsylvania Dermatology Group, Pc

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 documentation and interview with the Histotechnician, the laboratory failed to establish and follow a written policy to assess the competency of 2 of 3 Clinical Consultants (CC), 2 of 3 General Supervisors (GS) and 2 of 3 testing personnel (TP) for their responsibilities performed in the Histopathology laboratory in 2022 and 2023. Findings Include: 1. On the day of the survey, 05/07/2024 at 1:00 pm, the laboratory could not provide a competency assessment policy to assess the competency of the 2 of 3 CC and GS (CMS 209 personnel #2 and #3) for their supervisory responsibilities, and the 2 of 3 TP (CMS 209 personnel #2 and #3) who performed microscopic examinations in the Histopathology laboratory in 2022 and 2023. 2. The laboratory could not provide competency assessment records for the following personnel: - CC #2, GS #2, TP #2 (CMS 209 personnel #2) for 2022 and 2023 - CC #3, GS #3, TP #3 (CMS 209 personnel #3) for 2023 3. The Histotechnician confirmed the findings above on 05/07/2024 at 02:00 pm. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) log, Mohs procedure manual and interview with the Histotechnician, the laboratory failed to establish criteria for intended reactivity to ensure acceptable staining characteristics of Hematoxylin & Eosin (H&E) stains used in Histopathology from 09/06/2022 to the date of survey. Findings include: 1. On the day of survey, 05/07/2024 at 1:30 pm, a review of the laboratory's Quality Control Log for Slide Preparation and the Mohs procedure manual revealed the laboratory did not establish or document criteria for intended reactivity to ensure acceptable H&E staining characteristics when Histopathology slides were examined from 09/06/22 to 05/07/24. 2. The Histotechnician confirmed the findings above on 05/07/24 at 2:00 pm. -- 2 of 2 --

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 procedure and interview with the Histotechnician, the laboratory failed to establish a competency assessment procedure for Testing Personnel (TP) 1 of 2 who performed Moh's histopathology examination from 7/17 /2020 to the day of survey. Findings Include: 1. On the day of the survey, 09/06/2022 at 11:10 AM, the laboratory could not provide a competency assessment procedure to assess competency for 1 of 2 TP (CMS 209 Personnel #2) from 07/17/2020 to 09/06 /2022. 2. The laboratory failed to provide any competency assessment record for TP#2. 3. The Histotechnician confirmed the findings above on 09/06/2022 around 11: 45 AM. 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 histopathology technologist (HT), the laboratory failed to establish a competency assessment policy to assess the competency 1 of 2 testing personnel for their supervisory responsibilities form 2018 to 2020. Findings include: 1. On the day of survey, 07/17/2020, the laboratory could not the provide a competency assessment policy or documented competency assessment perform on 1 of 2 TP (On the CMS 2019 Testing Personnel form, listed as, a clinical consultant, technical supervisory, general supervisor and TP) in 2018, 2019 and 2020. 3. The HT confirmed the findings above on 07/17/2020 around 09:30 am. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on observation of the mohs laboratory and interview with the histopathology technologist (HT), the laboratory failed to establish a maintenance policy to assess the maintenance/function for 1 of 1 Extech Big Digital Hygo-thermometer used to monitor the mohs laboratory temperature from 2018 to the day of survey. Findings Include: 1. On the day of survey, 07/17/2020, the surveyor observed 1 of 1 Extech Big Digital Hygo-thermometer in use to monitor the temperatures of reagents stored in the mohs laboratory from 01/19/2018 to 07/17/2020. 2. The laboratory could not provide a maintenance policy for the thermometer, or maintenance documents performed on the thermometer from 2018, 2019 and 2020. 3. The HT confirmed the findings above on 07/17/2020 around 10:15 am. D5781

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of