Sovah Family Medicine Gretna

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at SOVAH Family Medicine Gretna on 09/11/24 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), proficiency testing (PT) records, policy and procedures (P&P) and an interview with the office manager and testing personnel (TP), the lab failed to follow the established P&P for rotating the PT events among all TP for five of five events reviewed from 01/01/23 up to the date of survey on 09/11/24. Findings include: 1. Review of the CMS-209 personnel form revealed three TP performing hematology procedures in the calendar year 2023 and up to the date of survey on 09/11/24. 2. Review of the American Proficiency Institute (API) PT records revealed that the same TP personnel performed all three events in 2023 and the first two events in 2024 (TP- A). 3. Review of the P&P, "Proficiency Testing", revealed the following statement, "The testing of proficiency material is rotated among all staff members who normally perform the patient testing." 4. An exit interview with the office manager and TP on 09 /11/24 at 1200 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 1 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sovah Family Medicine Gretna on January 31, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS- CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, manufacturer's package insert, and interviews, the laboratory failed to label three of three hematology quality control (QC) vials with appropriate expiration date, observed in use to monitor patient Complete Blood Count (CBC) performance, on the date of the survey January 31, 2023. Findings include: 1. A laboratory tour on 1/31/23 at approximately 10:00 AM revealed three vials of CDS Boule Con-Diff Quality Control(Low-Lot Number # 22209-31, Normal- Lot # 22209- 32, High- Lot # 22209-33) stored in a reagent refrigerator outside of the manufacturer's package (placed within a specimen cup). The inspector noted the three QC vials did not have an open date with revised expiration date. 2. The inspector inquired regarding the laboratory's protocol for monitoring hematology QC open stability. The lead testing personnel stated at approximately 10:30 AM, "The CBC controls are good for 14 days after opening and our procedure is to write the date on each along with the expiration date." 3. Review of the Boule Con-Diff Tri-Level QC 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 -- package insert revealed a manufacturers defined open vial stability of fourteen (14) days. 4. The inspector inquired if the identified/observed control materials, outlined above, were currently in use for the monitoring the laboratory's Medonic hematology analyzer. The facility's lead testing personnel stated on 1/31/23 at approximately 11: 00 AM, "Yes, the CBC machine's QC tubes that you checked are the opened ones in use. The QC should have been labeled with the date they were opened and expiration date." 5. An exit interview with the practice manager and lead testing personnel on 01 /31/23 at approximately 11:30 AM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Family Medicine Gretna on October 25, 2018 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: 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 interviews, the laboratory director and testing personnel (TP) failed to sign two (2) of the five (5) attestation statements reviewed. Findings include: 1. Review of the American Academy of Family Physicians (AAFP) hematology PT records for all three (3) events in 2017 and the first two (2) events in 2018 revealed lack of the laboratory director's and TP signature of the attestation statements for the following: 2017 Event A- no signature by the laboratory director, 2017 Event C- no signature by the TP. 2. Interview with the office manager and primary TP at approximately 12:30 PM confirmed the findings. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are 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 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require