Virginia Pediatric Group

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Pediatric Group on May 8, 2024 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 include the condition: D6063 -42 CFR. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) documentation, lack of documentation, and an interview, the laboratory failed to retain PT result evaluations and attestation statements signed by the laboratory director (LD) and testing personnel (TP) for nine (9) of ten (10) PT events from September 2022 until May 2024. The findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) and Wisconsin State Laboratory of Hygiene (WSLH) PT documentation, a total of 10 events (AAFP 2022 Event 3, WSLH 2023 HemeReg Events 1, 2, & 3, 2023 Bacti/Viral Event 1, 2023 ChemEndoTx Events 1, 2, & 3, 2024 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 -- HemeReg Event 1 and 2024 ChemEndoTx Event 1) revealed the laboratory failed to retain signed PT result evaluations and attestation statements for the following PT events: AAFP 2022 Event 3 result evaluation lacked LD signature. WSLH 2023 Event 1 HemeReg attestations lacked TP signature. WSLH 2023 Event 1 Bacti/Viral attestations lacked TP signature. WSLH 2023 ChemEndoTx attestations lacked TP signature. WSLH 2023 Event 2 HemeReg attestation lacked LD and TP signatures. WSLH 2023 Event 3 HemeReg result evaluations and attestations lacked LD and TP signatures. WSLH 2023 Event 3 ChemEndoTx result evaluations and attestations lacked LD and TP signatures. WSLH 2024 Event 1 HemeReg result evaluation and attestation lacked LD and TP signatures. WSLH 2024 Event 1 ChemEndoTx result evaluation lacked LD signature. A total of 9 events. The surveyor requested to review the signed PT result evaluations and attestation documentation for the PT events listed above. The laboratory provided no documentation for review. 2. In an exit interview with the technical consultant and testing personnel at approximately 12:30 PM on May 8, 2024, the findings were confirmed. 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 (CMS-209), available testing personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of personnel qualifications for one (1) of two (2) new testing personnel responsible for reporting Complete Blood Cell (CBC) counts and neonatal bilirubin (NBil) from March 2023 until December 2023 (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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(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), available testing personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of personnel qualifications for one (1) of two (2) new testing personnel responsible for -- 2 of 3 -- reporting Complete Blood Cell (CBC) counts and Neonatal Bilirubins (NBil) from March 2023 until December 2023 (See Personnel Code Sheet). The findings include: 1. Review of the CMS 209 form revealed the laboratory director identified two new testing personnel (TP), that included TP A, as responsible for resulting CBCs and NBils from March 2023 until December 2023. 2. Review of the available personnel documents for TP A revealed no foreign education equivalency evaluation. Review of the laboratory personnel records revealed TP A was hired in March 2023 with initial training and sign off for patient testing verified/signed by the technical consultant on April 1, 2023. The surveyor requested to review a foreign education equivalency evaluation for TP A. The laboratory provided no documentation for review. 3. In an exit interview with the technical consultant and testing personnel at approximately 12: 30 PM on May 8, 2024, the findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Virginia Pediatric Group on November 5, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 09/29/2020 and virtual record review conducted on 10/29/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, a review of the Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) website, review of available patient and quality control (QC) logs, and lack of documentation and interviews, the laboratory failed to document performance of negative and positive external quality control (QC) materials for one (1) non FDA approved COVID-19 IgG/IgM test methods while reporting eighty-four (84) patient COVID-19 antibody results from June 22, 2020 until October 28, 2020. Findings include: 1. In a video conference interview with the primary testing personnel on October 29, 2020 at approximately 9:30 AM, it was revealed that the laboratory had been utilizing a COVID-19 Antibody test kit labeled as "COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) manufactured by Zhejiang Orient Gene Biotech CO, Ltd during the timeframe of June 22, 2020 until October 28, 2020. 2. Review of the FDA website's published listing of COVID-19 EUA's granted for SARS CoV-2 antibody testing as of November 5, 2020 revealed no EUA granted for 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 -- the "COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) manufactured Zhejiang Orient Gene Biotech CO, Ltd. 3. During the video conference with the primary testing personnel on October 29, 2020 at approximately 9:30 AM, the inspector asked for a description of the laboratory's QC protocols and patient test logs for the test methods outlined above. The primary testing personnel stated "We use the internal built in QC. We did not use external quality control materials." 4. Review of available patient and QC logs revealed that the facility reported 84 COVID- 19 IgG/IgM results while performing zero (0) negative or positive external controls for each day of patient testing from June 22, 2020 until October 28, 2020. The inspector requested documentation of the performance of a negative and positive controls each day of patient testing from June 22, 2020 and October 28, 2020. The laboratory provided no documentation of the performance of controls. 5. An interview with the primary testing personnel on November 5, 2020 at approximately 10:15 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Virginia Department of Health's Office of Licensure and Certification conducted an announced CLIA recertification survey at Virginia Pediatric Group, Ltd on June 20, 2018. The laboratory was surveyed under 42 CFR part 493 CLIA Requirement. Specific deficiencies cited are as follows: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, quality control (QC) package insert, QC records and an interview, the laboratory failed to follow manufacturer's instructions to confirm recovered QC values are within the expected results or establish new laboratory means before the current control lots expire. Record review was from June 2016 to June 2018. Findings include: 1. Review of the laboratory's procedure manual revealed no procedure for the verification of Coulter 4C QC utilized for the Coulter AcT diff. 2. Review of the Coulter 4C QC package insert revealed manufacturer's instructions that state: "Before your current cell control lot(s) expire perform the following on your new lot(s): Confirm that recovered values are within the TABLE OF EXPECTED RESULTS or establish your own laboratory mean." 3. Review of laboratory's Coulter AcT diff QC records from June 2016 to June 2018 revealed no records of new lot numbers of QC being confirmed prior to current lot numbers of quality control expiring. 4. An interview with the Technical Consultant at approximately 12:15 PM on 6/20/18 confirmed that the laboratory failed to verify new lot numbers of Coulter 4C quality control prior to the expiration of current 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the Beckman Coulter 4C control package insert, and an interview, the laboratory failed to ensure that three (3) of three (3) hematology control (QC) vials in use were within the manufacturer's expiration date. Findings include: 1. During a laboratory tour at approximately 10:15 AM on 6/20/18, it was noted that three (3) of three (3) vials of Beckman Coulter 4C QC were opened and stored in the refrigerator. The open vials were: Abnormal Low (lot number 062300 expiration date 6/22/18); Normal (lot number 070000 expiration date 6/25/18); Abnormal High (lot number 081800 expiration date 6/23/18). When asked, the technical consultant confirmed the open vials were in use for the AcT Diff. The inspector asked when the testing personnel opened the control vials. The technical consultant stated: "The vials were put in use on 5/10/18. Our new controls should be here any day now. We had trouble with our shipment this month." The inspector noted that three (3) of three (3) vials did not have the "date of use" on the vials. The surveyor inquired what the protocol for labeling QC was and how the lab could confirm how long the the three (3) QC vials had been opened and in use. The technical consultant stated, "The QC box is tabled with the date of use." The surveyor observed the hand-written date of "5/10/18" on the outside of the Coulter 4C QC box. 2. Review of the Beckman Coulter QC package insert revealed manufacturer stability and storage instructions that state: "Open vial stability (Days) 35. **Assumes that the Instructions for Use section of the package insert is performed a maximum of 31 times within 35 days." 3. During an interview with the technical consultant at approximately 10:15 AM on 6/20/18, the technical consultant confirmed that the laboratory failed to ensure that the QC materials listed above were not used beyond their expiration date. -- 2 of 2 --