Patient First-East York

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted by the Pennsylvania Department of Health at the Patient First-East York laboratory on 07/09/2025. The laboratory was found out of compliance with the following conditions: 42 CFR. 493.1409 Technical Consultant-Moderate Complexity. 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 Technical Consultant (TC) #1, the laboratory failed to establish a competency assessment procedure to assess 2 of 13 testing personnel (TP) for their supervisory responsibilities performed from 8/22/2023 to 7/9/2025. Findings Include: 1. On the day of survey, 7/9/2025 at 12:30 pm, the laboratory failed to provide a competency assessment procedure to assess the competency of TP #3, and #9 (CMS 209 form dated 6/3/2025) for their supervisory responsibilities performed in the laboratory from 8/22/2023 to 7/9/2025. 2. The laboratory failed to provide CA records for TP#3 and #9 for their supervisory responsibilities performed from 8/22/2023 to 7/9/2025. 3. The Technical Consultant (TC)#1 confirmed the findings above on 7/9/2025 at 12:45 pm. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with Technical Consultant (TC) #1, the laboratory failed to follow established written polices for an ongoing mechanism to monitor, assess, and correct problems identified for postanlytical systems specified in 493.1291(k) when errors were found for 1 of 1 patient test report reviewed from 8/22 /2023 to 7/9/2025. Findings include: 1. On the day of survey, 7/9/2025 at 12:30 pm, review of the Quality Assurance: Deficiency/

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 technical consultant #1 (TC), 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 tests were performed from 06/17/2021 through the day of survey. Findings include: 1. The PA regulation (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. On the day of the survey, 08/22/2023 at 01:45 pm, review of the laboratory personnel report (PA State), personnel credentials and personnel schedules revealed the laboratory failed to ensure that the PA regulations were met regarding having a qualified supervisor on site during all normal scheduled working hours in which tests were performed for the following days in November 2021, August 2022, and February 2023: - 13 of 30 days in November 2021 - 16 of 31 days in August 2022 - 22 of 28 days in February of 2023 3. TC#1 confirmed the above findings on 08/22/2023 at 02: 45 pm D5783