Pediatric Associates Of Winchester

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates of Winchester on September 9, 2025 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: D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually 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), laboratory policies and procedures, personnel records, lack of documentation, and an interview, the technical consultant (TC) failed to follow their established policy and perform annual microbiology competency evaluations for five (5) of 5 testing personnel (TP) in calendar year 2024. (See Personnel Code Sheet.) The findings include: 1. Review of the CMS 209 form revealed the laboratory director (LD) also performed the duties of TC and identified TP# 1-5 as responsible for moderate complexity testing of throat cultures and urine sediment examinations during the timeframe of November 2023 to September 2025. 2. Review of the laboratory personnel files for November 2023 until September 2025 revealed a lack of documentation of annual competency evaluations of throat cultures and urine sediment examinations for TP #1-5 in calendar year 2024. The surveyor requested to review annual competency assessments for the moderate complexity microbiology testing and urine sediment examinations performed by the above listed TP during calendar year 2024. The laboratory provided no documentation for review. 3. Review of the laboratory's policies and procedures revealed a policy, dated May 15, 2012, with the statements, "All physicians will be monitored annually for competency that includes the following five elements...The following pages for each physician will indicate that they have been observed for the above five elements, and this will be 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 -- signed off by the lab director." 4. In an exit interview with the Laboratory Director and Primary Nurse at 12:30 PM on September 9, 2025, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates of Winchester on November 16, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The deficiencies cited are 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 a 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 Throat Culture PT among testing personnel (TP) responsible for patient testing for three (3) of five (5) events reviewed (survey timeframe: January 2022 to November 16, 2023). The findings include: 1. Review of the CMS 209 form with the testing personnel on November 16, 2023, at approximately 9:15 AM, confirmed 5 testing personnel (TP) were responsible the reading of throat cultures during the review timeframe of January 2022 to November 16, 2023. 2. Review of the laboratory's scored College of American Pathologists (CAP) D1 Throat Culture PT documentation, a total of 5 events (2022 Events 1-3, 2023 Events 1-2), revealed the following (see personnel code sheet): TP D signed attestation and performed CAP 2022 Events 1,and 3 and 2023 Events 2; TP C signed attestation and performed CAP 2022 Event 2; TP B signed attestation and performed CAP 2023 Event 1. 3. In an exit interview with the laboratory director and testing personnel on November 16, 2023, at approximately 12:15 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 2 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates of Winchester on October 24, 2019 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: D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CASPER 096 Laboratory Application and Survey Summary Report, College of American Pathologists (CAP) proficiency testing (PT) records, and interviews, the laboratory failed to participate in one (1) of six (6) Throat Culture PT events reviewed from November 2017 until the date of the survey on October 23, 2019. Findings include: 1. Review of the CASPER 096 Laboratory Application and Survey Summary Report revealed the laboratory received a score of 0% for the 2018 Event 3 for Bacteriology. 2. Review of the CAP PT records from November 2017 through October 23, 2019 revealed the laboratory failed to participate in the 2018 CAP Throat Culture-D Event C and received a result code of "(40) =Results for kit were not received." 3. In an interview with the primary nurse at approximately 10:30 AM, the primary nurse stated: "We didn't submit the 2018 CAP 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 -- Throat Culture-D Event C. We realized we didn't submit the event and contacted CAP. We ordered another set of samples and self-graded the results. The results were 100%." 4. The surveyor requested documentation of the self-grading of the replacement set. The laboratory provided documentation of the self-graded results. The surveyor reviewed the results which were 100% correct. 5. In an exit interview with the primary nurse and laboratory director at approximate 12:30 PM, the findings were confirmed. -- 2 of 2 --