Rva Peds

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at RVA Peds on May 1, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The inspection included an offsite follow up interview with the clinical supervisor on 5 /2/25. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include the following Condition under 42 CFR part 493 CLIA Regulation: D6063 -42 CFR. 493.1421 Condition Testing Personnel. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of hematology proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure that the Complete Blood Count (CBC) PT module's hemoglobin (Hgb) analyte results were returned to College of American Pathologists (CAP) for five (5) of 5 challenge samples on one (1) of 5 events reviewed on the date of the inspection, May 1, 2025. Findings include: 1. Review of the laboratory's CAP PT documentation (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of 5 hematology events, revealed that the laboratory failed to submit and received "failure to participate" analyte scores for the following CBC module: 2024 Event 3 - 0% Hgb scores for 5 of 5 challenges (samples- FH-11, FH-12, FH-13, FH- 14, and FH-15). 2. An interview with the clinical supervisor on 5/1/25 at 4 PM confirmed the above findings. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a pre-survey review of the Center of Medicare and Medicaid Services CASPER 0096D Report (CMS CASPER), laboratory's proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to document a review/evaluation of five (5) of 5 Hemoglobin (Hgb) results on their 2024 College of American Pathologists (CAP) Hematology PT Event 3 report as reviewed on the date of the inspection on May 1, 2025. Findings include: 1. During a pre-survey review of the laboratory's CMS CASPER 0096D report revealed unsatisfactory analyte scores reported by CAP for the 2024 Event 3 Hematology Analyte Number 0795: HGB (NON-WAIVED) - Score 0%. 2. Review of the laboratory's CAP hematology PT documentation (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of 5 events, revealed 2024 CAP Event 3's samples Hgb FH-11, Hgb FH-12, Hgb FH-13, Hgb FH- 14, and Hgb FH-15 resulted as zero for "absence of laboratory response". 3. Review of the laboratory's 2024 Event 3 PT records revealed Complete Blood Count (CBC) analyzer reports included printed Hgb results for the PT challenge samples outlined above. The inspector requested to review documentation of a self evaluation for the hemoglobin results. The clinical supervisor stated on 5/2/25 at 3:30 PM, "We submitted the CBC results for that event but we failed to enter the five hemoglobin results. We ran the complete CBC for each PT vial but did not report the hemoglobin. We did not check our results with the peer results." 4. An exit interview with the clinical supervisor on 5/2/25 at 4:00 PM confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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, and interviews, the laboratory failed to retain documentation of education qualifications for one of seven testing personnel responsible for reporting moderate complexity Complete Blood Count hematology patient test results during the twenty-two months reviewed (timeframe: 7/11/23 - 5/1 /25). 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 -- 2 of 3 -- 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), testing personnel (TP) records, and interviews, the laboratory failed to maintain documentation of education qualifications for one (1) of seven (7) TP as noted on the date of the inspection, May 1, 2025. Findings include: 1. Review of the CMS 209 report revealed 7 TP listed as qualified to perform moderate complexity Complete Blood Count (CBC) patient testing utilizing the laboratory's Abbott Emerald hematology analyzer. 2. Review of the laboratory personnel files revealed no documentation of education qualifications for TP A. The inspector requested to review documentation of TP A's diploma of education or official transcript record. The documentation was not available for review. (See Personnel Code Sheet.) 3. An exit interview on 5/1/25 at 4 PM and a follow up offsite interview with the clinical supervisor on 5/2/25 at 11 AM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the RVA Pediatrics on 07/11/23 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 07/11/23). Findings include: 1. Review of the College of American Pathologists (CAP) hematology PT records revealed a lack of the lab director and TP signatures on the attestation statements for the following: 2021 FH1-C, 2022 FH1- A-C and 2023 FH1- A & B. An interview with the primary TP on 07/11/23 at approximately 1400 revealed that the CAP online portal provides an electronic attestation statement. 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 07/11/23 at approximately 1550 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 on August 17, 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 08/17/21 at approximately 11:00 AM 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 08/17/21 at approximately 12:00 PM, the inspector requested to 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 -- review 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 08/17/21 at approximately 1:00 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 08/17/21 at approximately 11:00 AM 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 08/17/21 at approximately 12:00 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 08/17/21 at approximately 1:00 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 on May 1, 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: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of manufacturer's hematology instrument operations manual, maintenance records, and an interview, the laboratory failed to perform and document Abbott Emerald hematology instrument monthly and semi-annual maintenance procedures for twenty-four (24) of 24 months reviewed. Findings include: 1. Review of the Abbott Emerald Operations Manual revealed maintenance instructions that stated: Monthly Maintenance- "Cleaning the system with bleach solution is to be performed monthly using 3.6 percent (%) hypochlorite (bleach) solution"; Semi- annual Maintenance- "For optimal operation, the syringe pistons are to be lubricated every six months". 2. Review of the laboratory's Emerald hematology maintenance logs revealed no documentation of performance of the monthly or semi-annual maintenance during the review timeframe of April 2017 to the date of the survey on 5 /1/19. The inspector requested documentation of the required monthly and semi- annual maintenance procedures. The primary testing personnel stated, "We have had to clean with bleach occasionally but have not documented it. We have never performed the semi-annual maintenance. Our field service representative may have 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 -- performed it on the preventative maintenance in 2017 and 2018". 3. In an exit interview with the primary testing personnel at approximately 1:00 PM, the above findings were confirmed. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and an interview, the technical consultant (TC) failed to document annual competency assessments to include review of intermediate test results or worksheets, quality control (QC) records, and preventative maintenance records for testing personnel A and B in calendar years 2017 and 2018. Findings include: 1. Review of the CMS 209 form revealed that the lab director (LD) performed the duties of TC and that two (2) testing personnel (TP) performed hematology patient testing. 2. During a review of the 2017 and 2018 laboratory personnel files, the inspector noted no Abbott Emerald hematology Complete Blood Count (CBC) competency assessments that included the competency procedures of review of intermediate test results, worksheets, QC records, and preventative maintenance for TP A and B. (See Personnel Code Sheet) The inspector requested to review additional CBC competency documentation. The primary testing personnel stated, "our competency check sheet only includes direct observation of patient testing". 3. In an interview with the primary testing personnel at approximately 1:00 PM, the above findings were confirmed. -- 2 of 2 --