Comprehensive Pain Management

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 record review and interview with the Laboratory Director (LD), the LD failed to be present for a reasonable period of each working day in each laboratory for which they were director for 12 of 19 months from 02/12/2024 to the day of survey as required by Pennsylvania (PA) state regulations. Findings include: 1.The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2. On the day of survey, 08 /14/2025 at 9:19 am, review of the "Lab Director Log" used to document the director's site visits revealed the LD failed to visit the laboratory for 12 of 19 months from 02/12 /2024 to 08/14/2025. 3. Further review of the written plan (signed by the LD on 09/18 /2023) for how the director plans to oversee the laboratory stated, "I plan to visit the laboratory monthly to monitor Quality Assessment and Quality Control with the Technical and General Supervisor." 4. During interview with the LD on 08/14/2025 at 9:30 am, the LD confirmed the findings above and stated, "the visits were performed every 3 months (quarterly)". 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 a lack of the laboratory's personnel competency assessment records and interview with the Technical Supervisor (TS), the laboratory failed to establish and follow a competency assessment procedure to assess the competency of 1 of 1 Clinical Consultant (CC) for their supervisory responsibilities in 2023. Findings Include: 1. On the day of the survey, 02/12/2024 at 10:20 am, the laboratory could not provide a competency assessment procedure to assess the competency of 1 of 1 CC (CMS 209 personnel #3) for their supervisory responsibilities in 2023. 2. The laboratory could not provide competency assessment documents for 1 of 1 CC for 2023. 3. The TS confirmed the findings above on 02/12/2024 at 11:01 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 --