Chp-Cvfp - Internal Medicine

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CHP-CVFP-Internal Medicine on February 4, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(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 (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review manufacturer's user guide, hematology calibration records, lack of documentation, and interviews, the laboratory failed to document calibration procedures every six (6) months for Complete Blood Count (CBC) testing according to their policy during the review timeframe of May 4, 2023 to the date of the inspection on February 4, 2025. Findings include: 1. Review of the Beckman Coulter DxH 600 user guide protocols revealed instructions "calibrate every 6 months, after major maintenance, and as needed". 2. Review of the laboratory's calibration records during the twenty-two month review timeframe (05/04/23 - 02/04/25) revealed the following three calibration records: 05/10/23 01/05/24 01/31/25 The lab inspector 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 -- requested to review additional calibration procedures completed in November 2023 and July 2024. No additional calibration documentation was available. 3. An exit interview with the lead testing personnel and Director of Ancillary Services on 2/4/25 at 2:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Initial survey was conducted at the CVFP Internal Medicine on July 24, 2019 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: D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the entrance tour of the laboratory, review of policy and procedures (P&P), quality control (QC) records, lack of documentation, patient data logs, and interviews with the lab supervisor and testing personnel (TP), the laboratory failed to follow the established Individualized Quality Control Plan (IQCP) for performing external QC materials every 30 days for the Troponin I, Creatine kinase-MB (CK-MB), D-Dimer, Myoglobin and brain natriuretic peptide (BNP) analytes from March 30, 2019 to May 9, 2019 and reporting twenty-two (22) patients. Findings include: 1. Entrance tour of the laboratory at approximately 9:45 AM revealed that the lab utilizes three (3) Alere Triage Meters (Serial Numbers 75282, 75266, and 68929) to assay patient samples for Troponin I, CK-MB, D-Dimer, Myoglobin and BNP analytes. 2. Review of the P&P revealed an established IQCP (signed by the lab director on 12/30/2015 and by the new lab director on 02/05/2019) that included the following statements: "Triage 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 -- Shortness of Breath Panel for the Troponin I, CK-MB, D-Dimer, Myoglobin and BNP analytes" "Quality Control- IQCP is utilized with this test system to perform QC as required to satisfy the manufacturer and individual lab needs. External liquid QC is performed with each new lot of reagent and/or shipment and every 30 days. External electronic QC is performed daily to ensure that the meter is functioning properly. Each meter is set to lock out patient testing if the Electronic QC is not performed daily and External Liquid QC is not performed every 30 days." 3. Review of the external QC records from October 1, 2018 and up to June 30, 2019 revealed external QC performed on 02/28/19 and on May 10, 2019 and the lack of documentation of performance of external QC between those dates. An interview with the lab supervisor at approximately 2:30 PM revealed that according to the current IQCP for the test system, the laboratory was to perform external QC assays on March 30, 2019 and April 29, 2019. The inspector requested to review documentation of external QC for timeframe specified. There was no documentation available for review. The inspector asked the lab supervisor and testing personnel to demonstrate if the 3 meters were set to lock out patient testing as specified in the IQCP. No meters had the lock out function enabled. 4. Review of the LabDaq Laboratory Information System (LIS) revealed that 22 patients assayed for the Troponin I, CK-MB, D-Dimer, Myoglobin and BNP analytes for the above-specified timeframe. 5. An interview with the lab supervisor and testing personnel at approximately 4:15 PM confirmed the findings. -- 2 of 2 --