Upc-Pediatrics Associates

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at UPC-Pediatrics Associates on March 11, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at UPC- Pediatrics Associates on May 25, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the FederaL Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D5781

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at UPC Pediatric Associates on April 19, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the daily environmental condition logs, the laboratory policies and procedures (P&P), and an interview with the laboratory manager, the laboratory failed to monitor and document (3) humidity for the ACT Diff analyzer. Findings: 1. Review of 2020 and 2021 environmental condition logs identified no humidity level was recorded for 15 of 15 months reviewed. 2. Review of P&P revealed a CLIA Compliance Manual that contained defined environmental criteria: "the ACT Diff series analyzer operates at ambient temperature of 16-35 degrees Celsius and 30-85% humidity without condensation." 3. During an interview with the laboratory manager, on 4/19/21 at approximately 11:45 AM, the laboratory manager stated that the humidity for the room where the ACT Diff analyzer was located was not being monitored or documented. 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 --

Summary Statement of Deficiencies 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 proficiency testing records and interview with testing personnel, the laboratory failed to ensure proficiency testing was rotated among all qualified testing personnel. Findings: 1. Review of proficiency testing attestation statements for event 3 of 2017, events 1, 2, and 3 of 2018, and event 1 of 2019 found that proficiency testing has only been performed by two of the five testing personnel (testing personnel 1 and 2). 2. Interview with Testing Personnel #1 (TP1) on 5/30/2019 at approximately 12:30PM confirmed that only two personnel have been performing proficiency testing. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and interview with testing personnel, the laboratory failed to provide the necessary personal protective equipment (PPE) to guard the testing personnel from exposure to biohazardous materials. Findings: 1. A tour of the laboratory area found that there were no lab coats, face shields, or splash guards Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- available to protect from splashing or aerosols when opening sample containers. 2. Interview with TP1 on 5/30/2019 at approximately 11:25AM confirmed that none of the required PPE was available or used. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)