Rva Peds - Southside

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the RVA Pediatrics- Southside on 7/12/23 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: 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, lack of documentation and interviews, the lab director and testing personnel (TP) failed to sign six of six attestation statements reviewed (September 2021 through date of survey 07/12/23). Findings include: 1. Review of the College of American Pathologists (CAP) hematology PT records revealed lack of the lab director and TP signature of the attestation statements for the following: 2021 FH1-C, 2022 FH1- A-C and 2023 FH1- A & B. In an interview with the primary TP on 07/12/23 at approximately 11:00 AM, it was revealed that the CAP online portal provides an electronic attestation statement for each event. Individual names can be typed into the statement page but there is no individual secure electronic signature available via CAP. The names on the CAP attestation statements are entered by one individual and then printed. Each individual performing the PT event and the lab director did not review and sign the above- specified events. 2. An interview with the primary TP on 07/12/23 at approximately 1215 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 the RVA Peds Southside on August 16, 2021 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 in compliance with the applicable COVID-19 reporting requirements. 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: A. 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), lack of documentation, and interviews, the laboratory failed to provide documentation of required training for the use and interpretation of results for the Quidel Sofia SARs Antigen FIA test kits for twelve (12) of 12 months reviewed. Findings include: 1. Review of the CMS 116 form revealed the laboratory performs COVID-19 testing. An interview with the laboratory supervisor on 08/16/21 at approximately 1:30 PM revealed the lab began patient testing with the Quidel Sofia SARs Antigen FIA kits on 07/10/20. 2. Review of the manufacturer's IFU's revealed the following statement: Quidel Sofia SARs Antigen FIA (nasopharyngeal or nasal swab) - "Conditions of Authorization for Laboratory and Patient Care Setting", "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 3. On 08/16/21 at approximately 2:25 PM, the inspector requested to review 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 -- documentation of the training for the Quidel Sofia SARs Antigen FIA test kit on or before 07/10/20 up to 07/10/21 (12 months). The documentation was not available for review. 4. An exit interview with the laboratory supervisor on 08/16/21 at approximately 4:00 PM confirmed the above findings. B. 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), lack of documentation, and interviews, the laboratory failed to provide documentation of required training for the use and interpretation of results for the Abbott ID Now COVID-19 test kits for ten (10) of 10 months reviewed. Findings include: 1. Review of the CMS 116 form revealed the laboratory performs COVID-19 testing. An interview with the laboratory supervisor on 08/16/21 at approximately 1:30 PM revealed the lab began patient testing with the Abbott ID Now COVID-19 kits on 10 /08/20. 2. Review of the manufacturer's IFU's revealed the following statement: Abbott ID Now COVID-19 (Antigen nasopharyngeal or nasal swab) - "Conditions of Authorization for Laboratory and Patient Care Setting", "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 3. On 08/16/21 at approximately 2:25 PM, the inspector requested to review documentation of the training for the Abbott ID Now COVID-19 test kit on or before 10/08/20 up to 08/10 /21 (10 months). The documentation was not available for review. 4. An exit interview with the laboratory supervisor on 08/16/21 at approximately 4:00 PM confirmed the above 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 RVA PEDS-Southside on May 2, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The specific deficiency cited is 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records and an interview, the laboratory failed to rotate PT among the two (2) personnel performing Complete Blood Count (CBC) patient testing during the twenty-four (24) months reviewed. Findings include: 1. Review of the CMS 209 form revealed 2 testing personnel (TP) performed CBC patient testing on the Abbott Emerald hematology analyzer during the review timeframe of April 2017 to the date of the survey on 5/2/19. 2. Review of the laboratory's College of American Pathologists (CAP) PT attestation documentation, a total of six (6) events, revealed TP A performed the following five (5) of six (6) hematology events reviewed: 2017 Event 2, 2018 Event 1, 2, 3 and 2019 Event 1. (See Personnel Code Sheet) 3. In an exit interview with the lead testing personnel at approximately 12:00 PM, the above findings were confirmed 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 --