Preferred Primary Care Physicians Inc

Summary Statement of Deficiencies D0000 A recertification survey conducted by the Pennsylvania State Agency on 09/10/2025 found the Preferred Primary Care Phys Inc laboratory to be out of compliance with the following condition: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 lack of documentation and interview with the Technical Supervisor (TS) #1, the Laboratory Director (LD) failed to be present for a reasonable period of each working day in each laboratory for which he is director for 23 of 23 months from 10 /18/2023 to the day of the survey as required by Pennsylvania (PA) state regulations. Findings Include: 1. Pennsylvania State Clinical Laboratory 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 the survey, 09/10/2025, the laboratory could not provide documentation of the director's onsite visits to the laboratory from 10/18/2023 to 09/10/2025. 3. Interview on 09/10/2025 at 9:13 am with TS #1 (PA State Laboratory Personnel #2) revealed the LD did not visit the laboratory for 23 of 23 months from 10/18/2023 to 09/10/2025 as required by PA regulations. 4. TS #1 confirmed the findings above on 09/10/2025 at 12:17 pm. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance 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 -- with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute proficiency testing records, lack of documentation and interview with the technical supervisor, the laboratory director failed to provide overall management and direction in accordance with 493.1445. The laboratory director failed to ensure proficiency testing samples were tested as required under subpart H in 2024. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation and interview with the Technical Supervisor (TS), the laboratory director (LD) failed to ensure PT samples were tested as required under subpart H in 2024 for 5 of 5 PT events performed for Chemistry, 3 of 3 PT events performed for Microbiology and 1 of 3 PT events performed for Hematology. Findings include: 1. On the day of the survey 09/10/2025, review of the laboratory's API PT records revealed, the laboratory director (LD)/designee failed to document the attestation of the routine integration of samples into the patient workload for the following API PT events in 2024: - Chemistry Core: 1st, 2nd and 3rd Events of 2024 API. - Chemistry Miscellaneous: 1st and 2nd Events of 2024 API. - Microbiology 1st, 2nd and 3rd Events of 2024 API. - Hematology/Coagulation: 3rd Event of 2024 API. 2. The TS confirmed the findings above on 09/10/2025 at 12:31 pm. **Repeat Deficiency** -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with technical supervisor (TS) #3, the laboratory director (LD) /designee and testing personnel (TP) failed to sign 17 of 17 API PT attestation statement documents for microbiology, hematology and chemistry testing performed in 2022 and 2023. Findings include: 1. On the day of the survey, 10/18/2023, review of API PT records revealed the following 17 of 17 API PT attestation statements were not signed by the LD/designee and TP for microbiology, hematology, and chemistry testing performed in 2022 and 2023: - 2023, Event #1 and Event #2, Chemistry Core. - 2023, Event #1, Hematology/Coagulation. - 2023, Event #1 and Event #2, Microbiology. - 2023, Event #1, Chemistry Miscellaneous. - 2022, Event #1, Event #2, and Event #3, Hematology/Coagulation. - 2022, Event #1, Event #2, and Event #3, Microbiology. - 2022, Event #1, Event #2, and Event #3, Chemistry Core. - 2022, Event #1, and Event #2, Chemistry Miscellaneous. 2. TS #3 confirmed the findings above on 10/18/23 at 9:17 am. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. 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 Supervisor (TS) #3, the laboratory failed to ensure that a qualified general supervisor was on-site during all normal scheduled working hours in which tests were performed from 08/26/2021 through the date of the survey, as required by Pennsylvania (PA) state regulations. 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, 10/18/23 at 10:10 am, review of the laboratory personnel report revealed that a qualified general supervisor was not on- site during all hours of patient testing from 08/26/2021 to 10/18/2023. 3. The hours of operation for this facility are Monday to Friday, 07:00 to 21:00 (CMS 116). 4. TS #3 confirmed the above findings on 10/18/23 at 10:10 am. 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's competency assessment records and interview with Technical Supervisor (TS) #3, the laboratory failed to establish a competency assessment procedure to assess the competency of 2 of 2 technical consultants (TC), 3 of 4 technical supervisors (TS), and 1 of 1 general supervisor (GS) for their supervisory responsibilities in 2022. Findings include: 1. On the day of the survey, 10 /18/2023, the laboratory could not provide a competency assessment procedure to assess the competency of the following personnel for their supervisory responsibilities in 2022: - 2 of 2 TC (CMS 209 personnel #4, and #6) - 3 of 4 TS (CMS 209 personnel #3, #5, and #6) - 1 of 1 GS (CMS 209 personne # 7) 2. The laboratory could not provide competency assessment documentation for 2 of 2 TC, 3 of 4 TS, and 1 of 1 GS for 2022. 3. TS #3 confirmed the findings above on 10/18/2023 at 11:06 am. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, and interview with Technical Supervisor (TS) #3, the laboratory failed to document the evaluation and verification activities for PT testing performed in hematology and chemistry in 2022. Findings include: 1. On the date of survey, 10/18 /2023, review of API PT records revealed that the laboratory did not document the review and

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: A. Based on review of personnel competency assessment records and interview with the Technical consultant (TC), the laboratory failed to follow the Laboratory's Competency Assessment Policy to assess the competency for 1 of 6 Testing personnel (TP) twice during the first year of patient testing in 2018. Findings Include: 1. The Laboratory Competency Assessment Policy, under III Interval, #2 states, "New personnel must demonstrate competency in performing each test procedure twice during the first year in which they perform the procedure. 2. Testing personnel #6 started in February of 2018 and was assessed on 04/13/2018. 3. On the day of survey, 03/27/2019, the laboratory provided 1 of 2 competencies assessed for TP #6 during the first year in which they perform the procedure. 4. The TC confirmed the findings above on 03/27/2019 around 8:30 am. B. Based on review of Laboratory procedure manuals and interview with the TC, the laboratory failed establish a complete procedure to include how to assess the competency of 1 of 1 consultants responsibilities from 07/11/2017 to the date of survey. Findings include: 1. On the day of survey, 03/27/2019, review of the Laboratory Competency Assessment Policy lacked the technical consultant's competency assessment procedure. 2. The TC competency was not assessed in 2018. 3. The TC confirmed the finding above on 03 /27/2019 around 8:38 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 --