South Hill Family Medicine

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at South Hill Family Medicine July 29-30, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations and included a follow up off-site interview with the laboratory manager on 7/31/25. South Hill Family Medicine was not in compliance with applicable Standards and Conditions under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Conditions: D2016 - 42 CFR. 493.803 Condition: Successful Participation D5400 - 42 CFR 493.1250 Condition: Analytic Systems **REPEAT DEFICIENCY D6000 - 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This CONDITION is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155 report, the laboratory's proficiency testing records and interviews, the laboratory failed to successfully participate within the Chemistry specialty for the Carbon Dioxide analyte. The laboratory had unsatisfactory scores for the first and third event of 2024 and the first event in 2025. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's proficiency testing (PT) records, and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Carbon Dioxide (CO2) for two (2) out of three (3) consecutive chemistry events in calendar year 2024 resulting in unsuccessful PT performance as reviewed on the dates of the inspection July 29-31, 2025 (review timeframe August 2023 through July 2025). Findings include: 1. A review of the American Proficiency Institute (API) PT records (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of five events, revealed CO2 scores of less than 80% for the following 2 out of 3 consecutive chemistry events: 2024 API Event 1: CO2 scored 60% (challenge sample 2 reported as 24 with acceptable range 14-22, challenge sample 5 reported as 26 with acceptable range 16-25); 2024 API Event 3: CO2 scored 60% (challenge sample 14 reported as 23 with acceptable range 23-38, challenge sample 15 reported as 17 with acceptable range 20-30); resulting in an unsuccessful PT performance noted by API. 2. Interviews with the Technical Consultant on 7/29/25 at 3:00 PM and an off-site follow up exit interview on 7/31/25 at 2:00 PM with the lab manager confirmed the above findings. B. Based on a pre-survey review of the Center for Medicaid and Medicare Services CASPER 0155 report (CMS 0155), PT records, and interviews, the laboratory failed to attain a score of at least 80% for CO2 for 2 consecutive chemistry module testing events resulting in a non-initial unsuccessful PT performance as reviewed on the dates of the inspection July 29-31, 2025 (review timeframe August 2023 through July 2025). Findings include: 1. A pre-survey review of the CMS 0155 report revealed the laboratory received an unsatisfactory score of 60% for the regulated analyte #0351, CO2, in the Chemistry 2025-1st Event. 2. A review of American Proficiency Institute (API) PT records (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of five events, revealed the following unsatisfactory scores: 2024 API Event 1: CO2 scored 60%; 2024 API Event 3: CO2 scored 60%; 2025 API Event 1: CO2 scored 60% (challenge sample CH 02 reported as 24 with acceptable range 14-22, challenge sample CH 05 reported as 26 with acceptable range 16-25); resulting in a non-initial unsuccessful PT performance noted by API. 3. Interviews with the Technical Consultant on 7/29/25 at 3:00 PM and an off-site follow up exit interview on 7/31/25 at 2:00 PM with the lab manager confirmed the above findings. D2127 HEMATOLOGY CFR(s): 493.851(d) -- 2 of 8 -- (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 receiving unsatisfactory scores for one (1) of five (5) events reviewed (timeframe of review: August 2023 through July 2025). Findings include: 1. During a pre-survey review, the CMS CASPER Report 0096D revealed zero percent (0%) scores were reported on 2023 Event 3 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 Proficiency Institute (API) PT hematology module event results (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of 5 events, revealed unsatisfactory scores for the following event: API 2023 Event 3: PT samples ABT 11, ABT 12, ABT 13, ABT 14, and ABT 15 received 0% scores for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit. API reported "results not reported 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 South Hill Family Medicine on July 21, 2023 and August 1, 2023 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: D5400 -42 C.F.R. 493-1250 Condition: Analytic Systems **REPEAT DEFICIENCY** and D6033- 42 C.F.R. 493-1409 Condition: Technical Consultant. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of policy and procedures (P&P), the

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at South Hill Family Medicine on 10/13-14/21 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: D5400 - 42 C.F. R. 493-1250 Condition: Analytic Systems ***REPEAT DEFICIENCY*** D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity Laboratory Director ***REPEAT DEFICIENCY*** The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of manufacturer's operator manual, lack of documentation and interviews, the lab failed to retain documentation of the daily, weekly and monthly maintenance procedures for six of six months from November 2019 and up to April 2020. Findings include: 1. Review of the Abbott Architect 4100 chemistry analyzer revealed required maintenance procedures to include but not limited to: Daily- check 1 ml syringes and check DI water purity. Weekly- clean probe, clean mixers, pipettorWZ probe cleaning. Monthly- check dispense components, clean cuvette washer nozzles, check syringe and valves and clean ICT drain tip. 2. Review of instrument maintenance records and interview with the technical consultant on 10/14 /21 at 11 AM revealed there was a failure with the backup of instrument data and the maintenance records could not be retrieved for review. The technical consultant stated that the lab was not using paper logs to document the instrument maintenance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- procedures during the specified six month timeframe. 3. An exit interview with the technical consultant on 10/14/21 at approximately 2:00 PM confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), manufacturer's instructions for use (IFU), policy and procedures (P&P), performance verification records, operator's manual, instrument maintenance records, lack of documentation, and interviews, the laboratory failed to: 1. have a written policy for reporting patient SARS-CoV-2 (COVID-19) positive and negative results to the State agency (Refer to D5403) REPEAT DEFICIENCY, 2. verify the reference (normal) ranges for Complete Blood Cell counts (CBC) (Refer to D5421), 3. perform the quarterly maintenance for the Abbott Emerald 22 AL hematology analyzer (Refer to D5429 part A), 4. document the Abbott Architect 4100 monthly maintenance procedures 10 of 16 months reviewed (Refer to D5429 part B), 5. follow the established P&P for performing the pipette calibration procedure annually (Refer to D5433) REPEAT DEFICIENCY, and 6. follow the established P&P for performing calibration verification procedures twice yearly for 24 of 24 months reviewed in the subspecialty of chemistry (Refer to D5439). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)