Rva Pediatrics, Pc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at RVA Pediatrics, PC on 05/29/24 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: 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 interview, the laboratory failed to retain the "Cell Dyn 18 Plus" manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for three of seven lot numbers used from 10/01/22 up to the date of survey on 05/29/24. Findings include: 1. Review of the laboratory's hematology QC records from 10/01/22 up to the date of survey on 05/29/24 revealed the laboratory received and used seven lot numbers of the "Cell Dyn 18 Plus Hematology Control": 2262, 2340, 3065, 3149, 3233, 3317 and 4036. The following three QC lot numbers lacked documentation of acceptable ranges or manufacturer's package inserts: 3149, 3233 and 4036. The inspector requested to review the package inserts. The documentation was not available for review. 2. An exit interview with the laboratory supervisor on 05 /29/24 at 1530 confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the review of the laboratory's monthly hematology quality control (QC) records, quality assurance (QA) checklists, policy and procedures (P&P), lack of documentation, and an interview, the laboratory failed to provide documentation of an approved QA policy at the date of the survey on 05/29/24. Findings include: 1. Review of the laboratory's monthly hematology QC records revealed a QA checklist that included categories of review for pre-analytical, analytical, and post-analytical categories such as, but not limited to: testing personnel, proficiency testing, quality control materials, and patient test result reviews. 2. The inspector requested to review the QA policy that provided instructions for conducting the reviews and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at RVA Pediatrics, PC on September 21, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID- 19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes one Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. 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 six personnel performing Complete Blood Count (CBC) patient testing during the twenty-three (23) months reviewed (timeframe October 2020 to September 21, 2022). Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified six testing personnel (TP) who were qualified and performed CBC patient testing on the Abbott Emerald hematology analyzer during the 23 months of review. 2. Review of the laboratory's College of American Pathologists (CAP) PT attestation documentation (2020 Event C, 2021 Events A-C, 2022 Event A) a total of five events, revealed TP A performed the following three of five CAP Hematology Automated Differential Survey FH1 module events reviewed: 2020 Event C, 2021 Event A, 2021 Event C. (See Personnel Code Sheet.) 3. An exit interview with the lab supervisor and lead testing personnel on 9/21 /22 at 3:00 PM confirmed the above 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 3 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of manufacturer's operations manual, procedures, 2020 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at RVA Pediatrics, PC on October 21, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 10/05/2020 and virtual record review conducted on 10/19/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. 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 instrument maintenance records, manufacturer's operations manual, lack of documentation, and an interview, the laboratory failed to document performance of Abbott Emerald maintenance as required (twice annually) during the review timeframe of July 2018 to October 2020. Findings include: 1. Review of the laboratory's Emerald hematology maintenance logs from July 2018 to the date of the record review on 10/19/20, revealed one maintenance record of piston syringe lubrication (dated 08/11/19). The inspector requested to review additional documentation of the piston syringe maintenance. No other records were available. The lead testing personnel stated, at approximately 12:30 PM on 10/19/20, "We relied on our Peak field service technician to perform the piston procedures when it was required. I have checked emails for the maintenance reports from Peak Service, but cannot find any other records for the piston syringe procedure". 2. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually". 3. In an interview with the lead testing personnel, on 10/21/20 at approximately 11:00 AM, 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 3 -- 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 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 a review of calibration records, policies and procedures, lack of documentation, and an interview, the laboratory failed to document calibration procedures every six (6) months for Complete Blood Count (CBC) patient testing according to the procedure in calendar year 2019. Findings include: 1. Review of the Abbott Emerald hematology analyzer calibration documentation from December 2018 to the date of the record review on 10/19/20, a total of twenty-two (22) months, revealed the following calibration records: 12/14/18, 05/23/19, 03/20/20, and 09/16 /20. The inspector requested to review additional Emerald analyzer calibration records for calendar year 2019. No additional calibration documentation was available for review. The lead testing personnel stated, at approximately 11:30 AM on 10/19/20, "I do not see any additional calibrations for 2019. It was missed in November. It should have been done at the six month timeframe." 2. Review of the laboratory's procedures revealed a quality assurance policy that stated "calibration frequency for CBC is at least once every six (6) months". 3. In an interview with the lead testing personnel, on 10/21/20 at approximately 11:00 AM, the above findings were confirmed. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, quality assurance (QA) records, lack of documentation, and interviews, the laboratory failed to document a validation or check of their hematology analyzer's automated interface in order to verify transmission of Complete Blood Count (CBC) results from January 2019 to the date of the laboratory tour on October 21, 2020. Findings include: 1. During a laboratory tour, on 10/21/20 at approximately 10:00 AM, the inspector noted a testing personnel (TP) performing a patient CBC test on the Abbott Emerald. The testing personnel -- 2 of 3 -- placed the instrument print out in a bin. The inspector asked the TP to describe how the patient results are sent to the provider and patient record. The TP stated "We do not have to scan the results or manually enter them now. They go automatically over into the EMR." 2. Review of the laboratory's procedures and records revealed no QA records of a validation of the Reli Med electronic interface for the transmission of the Abbott Emerald CBC results from the date of the interface installation in January 2019 to the date of the survey on 10/21/20. The inspector requested to review validation documentation of the Reli Med transmission of patient results. No validation records were available for review. 3. In an interview with the lead testing personnel, on 10/21/20 at approximately 11:00 AM, the above findings were confirmed. -- 3 of 3 --