Baladermatology

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 Office Manager, the laboratory failed to establish a competency assessment procedure to assess 1 of 2 General Supervisors (GS) for their supervisory responsibilities performed in 2024. Findings Include: 1. On the day of survey, 07/31/2025 at 9:50 am, the laboratory failed to provide a competency assessment procedure to assess the competency of GS #2 (CMS 209 personnel #2, dated 07/21/2025) for their supervisory responsibilities performed in the laboratory in 2024. 2. The laboratory failed to provide competency assessment documentation for the supervisory responsibilities of GS #2 when overseeing histopathology slide examinations performed in 2024. 3. The laboratory reported 4,500 histopathology examinations in 2024 (CMS 116, estimated annual volume, dated 07/30/2025). 4. The Office Manager confirmed the findings above on 07/31/2025 at 10:52 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 D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor record review and interview with the office manager, the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which histopathology tests are being performed from 09/27/2021 to the date of the survey. Findings include: 1. The PA regulations (5.23 (b)(1)) states: "A general supervisor who meets all the requirements of subsection (a) (1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. The laboratory performs patient testing Monday through Friday from 08:00 am to 04:00 pm according to the information in the CMS-116 form. 3. Review of the CMS-209 form on 08/15/2023 showed that the laboratory director acts as the only general supervisor for the laboratory. 4. On the day of the survey, 08/15 /2023 at 09:48 am, during an interview, the office manager stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing according to chapter 5 section 5.23 of the Pennsylvania State regulations for clinical laboratories. 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 Laboratory's procedures and interview with the laboratory director (LD), the laboratory failed to establish a procedure that includes the six components required for competency assessment for 1 of 1 testing personnel (TP) who performed Hematoxylin and Eosin (H&E) microscopic examinations from 07/01/2021 to the date of survey. Findings include: 1. On the day of survey, 09/27/2021 at 09:40 a.m., the LD could not provide a policy that reviews how to assess the competency for 1 of 1 TP who performed H&E microscopic examinations from 07/01/2021 to the date of survey. 2. The LD could not provide a policy for peer review. 3. The LD confirmed the findings above on 09/27/2021 around 10:25 a.m. 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 --