Pediatric Specialists Of Va

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 --