Pediatric Specialists Of Va

Summary Statement of Deficiencies D0000 An announced recertification CLIA survey was conducted at Pediatric Specialists of VA on July 28-29, 2026 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 deficiencies cited are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 interviews, the laboratory failed to rotate twenty-three (23) of thirty-three (33) PT events among the three testing personnel (TP) during the 25 months of review (timeframe June 6, 2024 to July 29, 2026). The findings include: 1. Review of the CMS 209 form revealed 3 TP listed as testing personnel in the specialties of Chemistry and Hematology during the twenty five months reviewed. 2. Review of the laboratory's College of American Pathologists (CAP) PT documentation revealed the laboratory participated in the following CAP PT modules: C-Chemistry 2024 B, C, 2025 Events A, B, C 2026 A, B FH9-Hematology 2024 B, C, 2025 Events A, B, C and 2026 A, B RT 4-Reticulocyte Events 2024 B, 2025 A, B, 2026 A BCP-Blood Cell Identification, Photomicrographs 2024 B, C, 2025 A, B, C and 2026 A, B ESR-Erythrocyte Sedimentation Rate 2024 B, 2025 A, B and 2026 A CM-Urinalysis and Clinical Microscopy 2024 B, 2025 A, B and 2026 A. A total of 33 events. 3. Review of the laboratory's College of American Pathologists (CAP) PT documentation, a total of 33 PT events, revealed that TP A signed the following PT event attestation statements: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CAP C General Chemistry and Therapeutic Drugs - 2024 B, C, 2025 A, B, C and 2026 A, B = 7 events CAP FH9 Hematology/Auto differential - 2024 B, C, 2025 A, B and 2026 A, B = 6 events CAP RT-4 Reticulocyte - 2024 B, 2025 A, B, and 2026 A = 4 events CAP BCP Blood Cell Identification, Photomicrographs-2024 B, C, 2025 A, C and 2026 A, B = 6 events TP A performed 23 of 33 PT events reviewed. (See Personnel Code Sheet). 4. In an exit interview with the Laboratory Director, Laboratory Manager, and Technical Supervisor on July 29, 2026 at 12:30 PM, the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 the manufacturer's operations manual, chemistry analyzer maintenance records, lack of documentation, and interview, the laboratory failed to document performance of the required monthly, twice-monthly and semi-annual Vitros XT 3400 Chemistry Analyzer preventative maintenance for 14 of 14 months reviewed (timeframe: May 2025 until July 29, 2026). The findings include: 1. Review of the Vitros XT 3400 Chemistry System Maintenance & Troubleshooting Guide Chapter 4 revealed a statement "The Key Operator should perform monthly maintenance procedures as listed on the Periodic Maintenance-Monthly screen ...The following maintenance procedures are the default activities on the monthly maintenance list: Clean PM Discard Chute, Clean PM Incubator Slot and Insert Blade Channels, Clean/Replace PM Evaporation Caps, Clean MicroSensor Cover, Perform System Backup, Inspect/Clean Master Computer Filter (2 months), Perform Correction Factors (6 months), Perform Pad Reflectance Test (6 months)." 2. Review of the laboratory's available Vitros XT 3400 daily maintenance logs from May 2025 until July 29, 2026, revealed a lack of documentation of the required monthly, twice- monthly and semi-annual maintenance listed above from May 2025 until July 29, 2026. The surveyor requested to review documentation of the required Vitros monthly, twice-monthly and semi-annual maintenance from May 2025 until the date of the survey, July 29, 2026. The laboratory provided no documentation for review. 3. In an interview with the Technical Supervisor (TS) on July 29, 2026 at 9:00 AM, the surveyor inquired with the TS what Vitros XT 3400 monthly, twice monthly and semi- annual maintenance the laboratory performed. The TS stated, "We clean the instrument. I asked the service engineer and he said to look at the filters to see if they need changed. I haven't been documenting. I perform Correction Factors and Pad reflectance but I don't have documentation of their performance." 4. In an exit interview with the Laboratory Director, Laboratory Manager, and Technical Supervisor on July 29, 2026 at 12:30 PM, the above findings were confirmed. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, quality assurance (QA) records, lack of documentation, and interview, the laboratory failed to perform the twice annual comparison evaluation of the two (2) methodologies utilized for patient white blood cell (WBC) differential determinations twice annually in two of two calendar years, 2024 and 2025 (Review timeframe: January 2024 until the date of the survey, July 29, 2026). The findings include: 1. Review of the laboratory's policy and procedure manual revealed the following 2 procedures for determination of WBC differential counts: Sysmex XS-1000 Complete Blood Count with automated White Blood Cell Differential; PSV Peripheral Blood Smear Examination Procedure 2. Review of the laboratory's QA documentation revealed a lack of twice annual comparison of the automated and manual White Blood Cell (WBC) differential. The surveyor requested to review the twice annual comparison of automated and manual WBC differential for calendar year 2024 and 2025. The laboratory provided no documentation for review. 3. Review of the laboratory's policy and procedure revealed a lack of a policy for the twice annual comparison of automated and manual White Blood Cell Differentials. The surveyor requested a policy for the comparison of the different methodologies. The laboratory provided no policy for review. 4. In an exit interview with the Laboratory Director, Laboratory Manager, and Technical Supervisor on July 29, 2026 at 12:30 PM, the above findings were confirmed. D5781

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Specialists of VA on June 4-5, 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 includes the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6076 -42 CFR. 493.1411 Laboratory Director. 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: Based on a tour, review of the manufacturer's package insert, and interview, the laboratory failed to follow manufacturer's instructions for two (2) of 2 boxes of Sure- Vue Signature Strep A Test kits stored in the laboratory beyond expiration date as observed on the date of the inspection on June 4, 2024. The findings include: 1. During an entrance tour on June 4, 2024 at 9:00 AM, the surveyor noted 2 boxes of Sure-Vue Signature Strep A test kits in the laboratory's cabinet. The 2 boxes were labeled with lot number 13231034/expiration date of 04/20/2024. One kit was open/in use with 37 test strips remaining and the other kit was sealed and unopened. 2. Review of the Sure-Vue Signature Strep A Test kit's package insert revealed the following instructions, "The test strips and the reagents are stable through the expiration date printed on the box. Do not use beyond the expiration date." 3. The surveyor inquired with the Technical Supervisor (TS) regarding the Strep A test kit. The TS stated on June 4, 2024 at 9:15 AM, "I thought the kit was still within the expiration date." 4. In an exit interview with the current Laboratory Director, new Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Laboratory Director, TS, and Clinic Manager on June 5, 2024 at 11:30 AM, the above findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, policies and procedures, lack of documentation, and interview, the laboratory failed to follow their established policy and record an evaluation of six (6) unacceptable chemistry specimen scores reported on one (1) of four (4) Chemistry PT events from January 2023 until the dates of the survey on June 4-5, 2024. The findings include: 1. Review of the laboratory's College of American Pathologists (CAP) PT records (2023 Events A, B & C and 2024 Event A), a total of 4 events, revealed a lack of evaluation evidence for each of the following analyte specimens reported as unacceptable: 2023 CAP Event A: Lactate Dehydrogenase (CHM-11, CHM-12, CHM-13, CHM-14 and CHM-15) and Cholesterol (CHM-15). A total of 1 out of 4 events reviewed with unacceptable analyte results reported with no evaluation/

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Specialists of VA on December 20, 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: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 review of the laboratory's proficiency testing (PT) records, lack of documentation and interviews, the laboratory failed to evaluate non-graded hematology module PT results for two (2) of five (5) events reviewed for Blood Cell Identification (BCI) . Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) PT records, a total of 5 hematology events (2021 Events 1-3 and 2022 Events 1-2), revealed no documentation of an evaluation or verification of accuracy for the following non-graded responses: CAP Hematology Auto Differentials, FH-9 Module: 2021 FH9-A 2022 BCP-06, 07, 08, 09, and 10, 5 of 5 responses scored as "not graded"; 2022 FH9-B 2022 BCP-16, 17, 18, 19, and 29, 5 of 5 responses scored as "not graded". The surveyor requested to review documentation of the evaluation of the non-graded hematology specimens listed above. The laboratory provided no documentation to review. 2. In an exit interview with the laboratory director and laboratory supervisor on December 20, 2022 at approximately 1:00 PM, the 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 1 --