Family Physicians Of Marion

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Family Physicians of Marion on October 8, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, quality assurance check list, PT manufacturer's instructions, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the testing personnel (TP) for four (4) of five (5) events reviewed (survey timeframe of December 13, 2023 to October 8, 2025). Findings include: 1. Review of the CMS 209 personnel form revealed that the Laboratory Director (LD) identified two TP as responsible for performing non-waived hematology Complete Blood Count (CBC) during the review timeframe of 12/13/23-10/08/25. 2. Review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) hematology PT documentation (2024 Events 1-3, 2025 Events 1-2), a total of 5 events, revealed no signed TP attestation statements for the following Hematology modules: 2024 Event 2, 2024 Event 3, 2025 Event 1, 2025 Event 2. 3. Review of the laboratory's PT Event Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- quality assurance checklist forms for each of the events outlined above revealed instructions: "Answer Yes or No for the following prompts". The inspector noted that prompt "All testing personnel and lab director have signed the attestation sheet?" was marked as "Yes" for all events. 4. Review of AAB-MLE PT instructions for each of the events outlined above revealed the following instructions, "Be sure to keep the attestation statements printed from your online reporting form. The attestation statements must be signed for each analyte by the analyst performing the procedures and kept in your files for your inspection purposes." 5. The inspector requested to review TP attestation signatures for the 4 events listed above. The documentation was not available for review. 6. An exit interview with the laboratory's two TP on 10/8/25 at 2:00 PM confirmed the above findings. D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Centers of Medicaid and Medicare Services CLIA Survey Summary Report (CMS CASPER Report 0096D), proficiency testing (PT) records, and interviews, the laboratory failed to submit hematology PT results resulting in unsatisfactory scores for one (1) of five (5) events reviewed (timeframe of survey: December 13, 2023 through October 8, 2025). Findings include: 1. During a pre- survey review, the CMS CASPER Report 0096D revealed zero percent (0%) scores were reported on 2024 Event 2 for the following speciality and six (6) analytes: 0760 HEMATOLOGY 0765 CELL ID- Automated Diff 0775 RBC - Red Blood Cell Count 0785 HCT - Hematocrit 0795 HGB - Hemoglobin 0805 WBC -White Blood Cell Count 0815 PLT - Platelets 2. Review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT hematology module event results (2024 Events 1-3, 2025 Event 1-2), a total of 5 events, revealed unsatisfactory scores for the following event 2024 Hematology Event 2: PT challenge samples HD 06 through HD10 received 0% scores for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit. AAB-MLE reported "results not submitted to API resulting in score of zero". 3. The inspector inquired regarding

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Family Physicians of Marion on 01/13/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D2000 - 42 C.F. R. 493-803 Condition: Enrollment and Testing of Samples. **REPEAT DEFICIENCY** D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the testing personnel, the lab director failed to review and sign three (3) of 3 attestation statements in 2020. Refer to D2009 **REPEAT DEFICIENCY** 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 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 -- laboratory's routine methods. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the testing personnel, the lab director failed to review and sign three (3) of 3 attestation statements in 2020. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) PT results revealed the lack of documentation of the attestation statements by the lab director for review and signature of all three events in 2020 for the Hematology module. 2. An exit interview with the testing personnel on 01/13/22 at approximately 12 PM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Family Physicians of Marion on September 24, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on the review of lab temperature logs, tour of the lab testing area, manufacturer requirements, and an interview with the primary testing personnel, the lab failed to follow manufacturer's instructions for the storage of the Alere Triage BNP Quality Control (QC) materials Levels 1 and 2 for twenty (20) of 20 months reviewed. Dates of record review include January 1, 2018 and up to August 30, 2019. Findings include: 1. Review of the temperature logs for the laboratory revealed documentation of freezer temperatures January 1, 2018 and up to August 30, 2019 (20 months). The temperature range listed at the bottom of the pages were less than or equal to -30 degrees Celsius. 2. Tour of the lab testing area and an interview with the primary testing personnel at approximately 11:30 AM revealed that the lab stores the Alere Triage BNP QC materials (Levels 1 and 2) in the freezer. 3. Review of the manufacturer requirements for storage of the above-specified QC materials revealed the temperature range of - 20 degrees Celsius or colder. The recorded freezer temperatures was warmer than -20 Celsius for the 20 months reviewed. 4. An interview with the primary testing personnel at approximately 12:15 PM confirmed the findings. 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 -- 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 the review of proficiency testing (PT) records and an interview the primary testing personnel, the laboratory director failed to sign one (1) of five (5) attestation statements reviewed. PT record review included 2018 and 2019 (First and second) testing events. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) PT records for all three events in 2018 and the first and second events in 2019 revealed that the laboratory director did not sign the 2018 MLE 2nd event (M2) attestation statement. 2. An interview with the primary testing personnel at approximately 12:15 PM confirmed the above-listed findings. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --