Pediatric Partners Of Stafford, Pc

Summary Statement of Deficiencies D0000 An announced Clinical Laboratory Improvement Amendments (CLIA) recertification survey was conducted at Pediatric Partners of Stafford, PC on September 8, 2022 by a Medical Facilities Inspector from the Virginia Department of Health, Office of Licensure and Certification. The surveyor performed a focused COVID-19 Reporting Survey which concluded on September 12, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. During the recertification survey, the inspector found that the laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulation: D3000- 42 CFR. 493.1100 Condition Facility Administration (Reporting of SARS-CoV-2 test results). 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 laboratory tour, manufacturer's instruction for use (IFU), SARS CoV-2 patient test records, lack of documentation and interviews, the laboratory failed to report positive SARS-CoV-2 Antigen test results as required for two hundred forty- two (242) patients on one-hundred ten (110) of 110 testing dates reviewed (timeframe April 4, 2022 to September 8, 2022). Findings include: 1. During a tour of the laboratory on September 8, 2022 at approximately 9:00 AM, the inspector noted the 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 -- laboratory performs SARS CoV-2 Antigen testing using the Quidel QuickVue SARS Antigen Test. 2. Review of the package insert for the Quidel QuickVue SARS Antigen Test revealed the following statement, "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 3. Review of the laboratory's SARS CoV-2 patient test records revealed 242 patients with positive SARS CoV-2 Antigen tests were performed and resulted on 110 testing days from April 4, 2022 to September 8, 2022. The inspector requested to review documentation of the reporting of the positive SARS CoV-2 Antigen test results to the Virginia Department of Health. The laboratory provided no documentation for review. In an interview with the nurse manager and testing personnel on September 8, 2022 at approximately 12:00 PM, the nurse manager stated, "I didn't realize we were required to report positive SARS CoV-2 Antigen test results to the Virginia Department of Health." 4. 242 positive SARS CoV-2 Antigen test results were not reported as required during the timeframe of review (110 testing dates). The laboratory performed nine-hundred fifty- nine (959) SARS-CoV-2 Antigen tests during the timeframe of review. 5. In an exit interview with the nurse manger on September 12, 2022 at approximately 11:15 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Partners of Stafford, PC on September 8, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 review of policies and procedures, quality control (QC) records, and an interviews, the laboratory failed to follow their policy for QC statistics review in order to monitor, assess and correct problems with the hematology analyzer and complete blood count (CBC) QC materials for twenty-two (22) of 22 months (timeframe reviewed November 2020 until date of survey, September 8, 2022). Findings include: 1. Review of the laboratory's policies and procedures revealed a "Triannual Quality Assurance Checklist" to monitor, assess and correct problems with the Horiba Micros 60 hematology analyzer that stated "Quality Control-the required controls, calibrations and maintenance have been performed and reviewed." 2. Review of the "Triannual Quality Assurance Checklist" for January 2021, May 2021, September 2021, January 2022 and May 2022 revealed documentation of a "Y (yes)" response for "Quality Control-the required controls, calibrations and maintenance have been performed and reviewed." 3. Review of the laboratory's CBC QC records from November 2020 until the date of survey, September 8, 2022, revealed a lack of documentation of review of CBC QC records for 22 of 22 months reviewed. The inspector requested to review documentation of the CBC QC review from November 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 -- 2022 until the date of the survey, September 8, 2022. The laboratory provided no documentation to review. At approximately 11:30 AM on September 8, 2022, the nurse manager stated they did not realize they needed to print-out CBC QC records for the laboratory director's review. 4. In an exit interview with the nurse manager and testing personnel on September 8, 2022 at approximately 12:15 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Pediatric Partners of Stafford on October 27, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 09/22/2020 and virtual record review conducted on 10/21/2020. The laboratory was surveyed under 42 C.F.R. part 493 CLIA Regulations. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems and D6000 - 42 C.F.R. 493.1403 Condition: Moderate complexity laboratory director. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to document remedial /

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Partners of Stafford, PC on June 13 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the hematology instrument performance verification documentation, manufacturer's user guide instructions, patient test logs, and an interview, the laboratory director (LD) failed to evaluate and verify the normal values for Complete Blood Count (CBC) testing prior to reporting two thousand two hundred ninety-three (2,293) patient CBC panels from June 5, 2016 to the date of the survey, June 13, 2018. Findings include: 1. Review of the laboratory's instrument validation records revealed a new hematology analyzer installation, by a Horiba field service technical specialist, occurred on 6/5/16. The inspector found no record of a CBC patient normal value (reference range) validation for the new Horiba Micros 60 (Serial Number 603CS95729). The inspector requested to review documentation that the LD validated the new Horiba analyzer's patient normal value ranges prior to patient testing. No documentation was available for review. 2. Review of the Horiba Users Guide for new instrument installation revealed instructions "The patient Reference 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 -- Range must be validated by the Lab Director". The manufacturer provided instructions and data logs for the client to perform prior to patient testing. 3. Review of the patient test logs revealed that the lab had reported two thousand two hundred ninety-three (2,293) CBC reports from 6/5/16 to the date of the survey on 6/13/18. 4. In an interview with the nurse manager and primary testing personnel at approximately 1:45 PM, it was confirmed that the LD failed to evaluate and validate the patient reference range for CBC testing prior to reporting patient results from the new Micros 60 hematology instrument as outlined above. 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, and interviews, the laboratory failed to document hematology instrument weekly preventative maintenance for eighty-five (85) of one hundred four (104) weeks in the reviewed timeframe of June 2016 to the date of the survey on 6/13/2018. Findings include: 1. Review of the laboratory's Horiba Micros 60 hematology maintenance logs revealed a preventative maintenance procedure for Concentrated Cleaning Cycle listed as "perform on a weekly basis". The inspector noted that the available logs from 6/5/16 (the date of the analyzer's installation) to 2/1/18, a total of eighty-five (85) weeks, revealed no weekly maintenance was documented as performed. The inspector requested to review the missing documentation. The primary testing personnel stated "A former employee had been assigned to document and retain those records and we cannot locate them. We do have documentation from February 2018 up to now." 2. Review of the Horiba Micros 60 Operations Manual revealed manufacturer's instructions which state: "a concentrated cleaning cycle must be performed with Minoclair solution once weekly". 3. In an interview with the nurse manager and primary testing personnel at approximately 1:45 PM, it was confirmed that the laboratory failed to document performance of the Horiba hematology weekly Concentrated Cleaning Cycle for the timeframe outlined above in calendar years 2016, 2017, and up to February of 2018. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the procedures and policies, hematology calibration records, and interviews, the laboratory failed to document Horiba Micros 60 calibration procedures for hematology Complete Blood Count (CBC) patient testing according to their written procedure in calendar year 2017. Findings include: 1. Review of the laboratory's procedure manual revealed a Quality Assurance (QA) policy that outlined to calibrate CBC testing on the Horiba Micros 60 hematology analyzer at a frequency of every six (6) months. 2. Review of the Micros 60 hematology instrument calibration documentation from July 2016 to the date of the inspection on 6/13/18, a total of twenty-three (23) months, revealed a lapse in the six month calibration: The inspector noted documentation that calibration procedures were performed once in calendar year 2017 (on 6/26/17). No other calibration documentation in 2017 was available for review. The inspector requested to review additional calibration records for 2017. The primary testing personnel stated, "We cannot find any other documentation of a calibration in 2017". The inspector noted that the lab documented a calibration on 5/2/18, a four (4) month lapse in the protocol. 3. In an interview with the nurse manager and primary testing personnel at approximately 1:45 PM, it was confirmed that the laboratory failed to document calibration procedures for CBC testing, in calendar year 2017, according to their written QC policy. -- 3 of 3 --