Sovah Family Medicine - Mt Hermon

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SOVAH Family Medicine - Mt Herman on January 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. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D6063 -42 CFR. 493.1421 Condition Testing Personnel. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interview, the laboratory failed to document review/evaluation for one (1) of six (6) hematology PT modules reviewed (timeframe March 2023 to January 30, 2025). Findings include: 1. Review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) hematology PT records, a total of 6 events (2023 Events 1-3, 2024 Events 1-3), revealed no retained scored results or documentation of review /evaluation for 2024 WSLH Hematology Module Complete Blood Count and Auto Differential Event 1. 2. The inspector requested to review the WSLH scored results and evaluation documentation for the hematology module event outlined above. No documentation of review/evaluation was available. 3. An interview with the office manager at 2 PM on 1/20/25 confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet 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 -- qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, testing personnel records, lack of documentation, and interview, the laboratory failed to retain documentation of education qualifications for one new testing personnel during the review timeframe of 3/29/23 to the date of the inspection on January 30, 2025. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of education qualifications for one (1) of seven (7) testing personnel (TP) reviewed during the review timeframe of March 29, 2023 to the date of the inspection on January 30, 2025. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified 7 TP qualified to perform patient hematology Completed Blood Count testing during the twenty-two months of review. 2. Review of the laboratory personnel records revealed a new personnel (TP A) completed initial laboratory training on 3/5/24 with semi- annual competency assessment documented on 9/20/24. The inspector noted that TP A's personnel file lacked documentation of required education qualification. (SEE PERSONNEL CODE SHEET.) 3. The inspector requested to review an official transcript or diploma as documentation of TP A's education qualifications. Neither record was available for review. 4. An interview with the office manager at 2 PM on 1 /30/25 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Family Medicine- Mt Hermon on 03/28/23 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 is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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 hematology PT events among all five TP in 2022. Findings include: 1. Review of the CMS-209 personnel form revealed five TP performing hematology procedures in the calendar year 2022. 2. Review of the American Academy of Family Physicians (AAFP) PT records revealed that the same TP personnel performed all three events in 2022 (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 03/28/23 at approximately 1300 confirmed the findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- 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, lack of documentation, and interview with the office manager and testing personnel (TP), the lab director failed to review and sign four of four PT attestation statements reviewed. Events of record review include all three PT events in 2022 and the first event in 2023. Findings include: 1. Review of the American Academy of Family Physicians (AAFP) PT 2022 records and the Wisconsin State Laboratory of Hygiene (WSLH) first PT event in 2023 records revealed the lack of documentation by the lab director for review and signature of the following: AAFP- 2022 Hematology 1-3 event attestation statements, and WSLH- 2023 Hematology 1st event attestation statement. 2. An exit interview with the office manager and TP on 03/28/23 at approximately 1300 confirmed the findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of 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 investigating the score of 60% for the White Blood Cell count (WBC) and the WBC Differential parameters for the 3rd event in 2022. Findings include: 1. Review of the American Academy of Family Physicians (AAFP) PT records for the 3rd event in 2022 revealed the lab received a score of 60% for the WBC and WBC Differential parameters (unsatisfactory performance). In addition, there was no documentation of investigation by the lab director or TP for the event. 2. Review of the P&P, "Proficiency Testing", revealed the following statements, "Results outside of the acceptable range require remediation as determined by the lab director or designee. Failures will be reviewed as an opportunity to correct problems, educate staff, and improve the quality of services. All failures will be investigated, even if remediation is not required." 3. An exit interview with the office manager and TP on 03/28/23 at approximately 1300 confirmed the findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as -- 2 of 4 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the review of manufacturers operator's guide, hematology records, and an interview, the lab failed to perform the Medonic M-series calibration procedures every six months for the 22 months reviewed. Dates of record review include 05/21/21 up to date of survey on 03/28/23. Findings include: 1. Review of the manufacturers operator's guide for the Medonic M-series hematology analyzer, "Section 7: Calibration", revealed recommendations for performing calibration procedures every six months. 2. Review of hematology records, to include calibration documents, for the Medonic M-series hematology analyzer from 05/21/21 up to date of survey on 03 /28/23 revealed calibration procedures performed on 10/22/21 and 10/31/22. The inspector requested to review additional calibration procedures for the abovementioned time frame. The documents were not available for review. 3. An exit interview with the office manager and TP on 03/28/23 at approximately 1300 confirmed the findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), hematology quality control (QC) records, lack of documentation, and an interview with the office manager and testing personnel (TP), the lab failed to follow the established P&P for verifying new lot numbers of hematology QC materials prior to use for seven lot numbers received and utilized from 01/01/22 up to date of survey on 03/28/23. Findings include: 1. Review of the P&P, "Quality Control", revealed the following statements, "Each new lot number of controls is validated before placing the lot number in service. This is accomplished by assaying new control in an analytical run that includes previously tested and validated control materials." 2. Review of hematology QC records for the Medonic M-series analyzer revealed the lab received and utilized the following seven lot numbers from 01/01/22 up to date of survey on 03/28/23: 22111, 22204, 22206, 22208, 22210, 22211 and 22212. In addition, the record review revealed lack of documentation of the lab staff verifying the new lot numbers of QC materials as specified by the abovementioned P&P. 3. An exit interview with the office manager and TP on 03/28/23 at approximately 1300 confirmed the findings. -- 3 of 4 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview with the office manager and TP, the technical consultant (TC) failed to perform and document the semi-annual competency assessment for two of two TP in 2022. Findings include: 1. Review of the CMS-209 form revealed the lab director performs the duties of TC. 2. Review of the TP records revealed lack of documentation by the TC of performance and review of a semi-annual competency assessment for TP A and B. See attached TP code sheet. 3. An exit interview with the office manager and TP on 03/28/23 at approximately 1300 confirmed the findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Family Medicine Mt Hermon on January 31, 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: D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), quality control (QC) data and interview with the office manager, the laboratory failed to follow the established P&P for performing verification of each new lot number of QC material prior to use for three (3) of 3 lot numbers received in the calendar year 2018. Findings include: 1. Review of the P&P for "Quality Controls" revealed the following statement: "III. Procedure- 3. Each new lot number of quality controls is validated before placing the lot number in service." 2. Review of the Boule hematology QC records for the CDS Medonic M-series hematology instrument revealed the following lot numbers 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 -- received in 2018: 21802-31, 21802-32, 21802-33 expiration date 06/26/2018- in use 03 /26/2018, 21806-31, 21806-32, 21806-33, expiration date 09/24/2018- in use 06/25 /2018, 21808-31, 21808-32, 21808-33, expiration date 12/24/2018- in use 09/24/2018. The inspector requested to review documentation of the verification of the new lot numbers of QC prior to use. The documentation was not available for review. 3. An interview with the office manager at approximately 12: 30 PM confirmed the above- specified findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, the quality assurance (QA) policy and an interview, the technical consultant failed to perform and document annual competency assessments for three (3) of 3 TP in 2017. Findings include: 1. Review of the CMS- 209 form revealed that the lab director also performs the duties of technical consultant that there were 3 TP performing patient testing in 2017. (See attached personnel list.) 2. Review of the TP records revealed no documentation of competency assessments performed by the technical consultant in 2017 for TP A, B and C. The inspector requested the competency assessments for the 3 TP. The documentation was not available for review. 3. Review of the QA policy revealed the following statement: "5. Personnel Assessment- III. Procedure- 3. All testing personnel will be evaluated for competency on an annual basis." 4. An interview with the office manager at approximately 12:30 PM confirmed that the above-specified findings. -- 2 of 2 --