Sovah Pediatrics

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Pediatrics on 07/09/24 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: D6054 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 annually, after the first year. 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 interviews, the technical consultant (TC) failed to perform and document the annual competency assessments for two of three TP in 2023. Findings include: 1. Review of the CMS-209 form and an interview with the market quality manager and primary TP on 07/09/24 at 1100 revealed the lab director performs the duties of TC and three TP performed patient testing in calendar year of 2023. 2. Review of the TP records revealed a lack of documentation by the TC of performance and review of the annual competency assessments in the calendar year 2023 for the following: TP A and TP B. The surveyor requested to review annual competency assessments and the documents were not available for review during the survey. 3. An exit interview with the market quality manager and primary TP on 07/09/2024 at 1300 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 unannounced CLIA complaint investigation (VA00058886) was conducted at SOVAH Pediatrics on 06/05/23 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 was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5800 - 42 C.F. R. 493- 1290 Condition: Postanayltic Systems, D6000- 42 C.F.R. 493-1403 Condition: Moderate Complexity Laboratory Director. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, review of the policy and procedures (P&P), lack of documentation, and interview, the laboratory failed to have procedures established for the staff to follow related to protection from physical, chemical, electrical hazards and biohazardous materials at the date of survey on 06/05/23. Findings include: 1. The inspector observed testing personnel (TP) #1 placing two patient complete blood count (CBC) sample tubes next to a jar of strawberry preserves and drink container on the counter at approximately 11:45 AM on 06/05/23. At approximately 1230, TP#1 was observed placing two "UTM-RT 3ml w/o beads" viral transport medium tubes, that included the patient swabs in the tubes, at the same counter next to the jar of strawberry preserves and drink container . 2. Review of the P&P revealed lack of documentation of safety procedures available for the staff. In an interview with the market quality manager on 06/05/23 at approximately 1240, the inspector requested to review safety procedures. They stated, "I know we had a policy but it's not in the manual today." 3. An exit interview with the market quality manager on 06/05/23 at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 1330 confirmed the laboratory did not have safety procedures established and available to the staff. 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)

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at SOVAH Pediatrics on 10/13/22 by the Virginia Department of Health's Office of Licensure and Certification. The surveyor performed a focused SARS-CoV-2 Test Reports survey on 10/13/22. 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: D3000 - 42 C.F.R. 493-1100 Condition: Reporting of SARS-CoV-2 Test Reports. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a tour of the facility, record review and interviews, the lab failed to report 146 SARS-CoV-2 (COVID-19) positive test results for 163 of 163 testing dates from 04/04/22 up to date of survey on 10/13/22. Findings include: 1. A tour of the facility and interview with the registered nurse (RN) coordinator on 10/13/22 at 11:30 AM revealed the facility had six Quidel Sofia readers that were utilized to perform to COVID-19 patient testing. During the same interview, the inspector requested to review a log sheet or mechanism in which the facility tracks COVID-19 testing and reporting positive results to the State agency. The RN coordinator stated "We do not 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 -- have log sheets and we report results directly into our electronic medical records. We have not been reporting positive results." Patient testing data were retrieved from the six Sofia readers and the Athena electronic medical records. 2. 146 positive results were not reported as required during the period of review (163 testing dates). 3. The laboratory performed 1,108 COVID-19 tests during the period of review. 4. An exit interview with the RN coordinator on 10/13/22 at approximately 1330 confirmed the findings. 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)

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Pediatrics on 10/13/22 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: D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a tour of the facility, record review and interviews, the lab failed to report 146 SARS-CoV-2 (COVID-19) positive test results for 163 of 163 testing dates from 04/04/22 up to date of survey on 10/13/22. Findings include: 1. A tour of the facility and interview with the registered nurse (RN) coordinator on 10/13/22 at 11:30 AM revealed the facility had six Quidel Sofia readers that were utilized to perform to COVID-19 patient testing. During the same interview, the inspector requested to review a log sheet or mechanism in which the facility tracks COVID-19 testing and reporting positive results to the State agency. The RN coordinator stated "We do not have log sheets and we report results directly into our electronic medical records. We have not been reporting positive results." Patient testing data were retrieved from the six Sofia readers and the Athena electronic medical records. 2. 146 positive results 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 -- were not reported as required during the period of review (163 testing dates). 3. The laboratory performed 1,108 COVID-19 tests during the period of review. 4. An exit interview with the RN coordinator on 10/13/22 at approximately 1330 confirmed the findings. 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)

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at SOVAH Pediatrics on December 15, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on November 16, 2020 with off-site record review of documentation on December 11, 2020. Specific deficiencies cited are as follows: 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 a review of quality control (QC) records, lack of documentation, and primary testing personnel (TP) interview, the laboratory failed to retain the "Coulter AcT Diff Control Plus" manufacturer's package inserts (PI) documenting Complete Blood Cell (CBC) count QC acceptable ranges for four (4) of 5 lot numbers utilized from January 1, 2020 up to December 15, 2020. Findings include: 1. Review of the laboratory's end of the QC lot instrument printouts from January 1, 2020 through December 15, 2020 revealed the laboratory received and utilized 5 lot numbers of the "Coulter AcT Diff Control Plus". The following QC lot numbers lacked documentation of acceptable ranges or manufacturer's PI: 360120 (370120, 380120), 360320 (370320, 380320), 360520 (370520, 380520) and 360720 (370720, 380720). 2. An interview with the primary TP at approximately 10:30 AM on December 15, 2020 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 Pediatrics on September 21, 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: D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of proficiency testing (PT) records, hematology quality control (QC) records, instrument maintenance records, quality assessment (QA) policy, testing personnel (TP) records, and interviews, the laboratory director failed to (1) sign attestation statements (Refer to D6016); (2) review PT results (Refer to D6018); (3) follow written policy for hematology QC record review (Refer to D6020); and (4) perform and sign the competency assessments of TP (Refer to D6030). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; 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 -- This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and interviews, the laboratory director failed to review and sign the attestation statements for five (5) of the five (5) PT events reviewed. Findings include: 1. Review of the American Academy of Family Physicians (AAFP) hematology PT events, a total of 5 events, revealed a lack of the laboratory director's signature on the attestation statements for the following: 2016 Event C, 2017 Event A, B, and C, 2018 Event A. 2. Interviews with the office manager and primary testing personnel at approximately 12:00 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 reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require