M D Express Urgent Care - Newport News

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care-Newport News on December 8, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 of procedures, hematology calibration records, lack of documentation, and an interview, the laboratory failed to document calibration procedures every six (6) months for hematology Complete Blood Count (CBC) testing according to their written procedure in calendar year 2020. Findings include: 1. Review of the laboratory's procedure manual revealed a Hematology Quality Control (QC) policy that outlined to calibrate the CBC testing on the Medonic M Series hematology analyzer at a frequency of every 6 months. 2. Review of the hematology instrument calibration documentation for calendar year 2020 revealed calibration 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 -- procedures were documented on 04/23/20. The inspector requested to review additional calibration records for calendar year 2020. No additional documentation was available. 3. In an exit interview with the Lab and X-ray Coordinator on 12/08/21 at approximately 1:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care-Newport News on July 10, 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 deficiency cited is as follows: 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 tour, a review of manufacturer's analyzer user guides, daily temperature logs, and an interview, the laboratory failed to monitor the daily relative humidity percent (RH%) to ensure manufacturer's operating requirements were followed for two (2) analyzers utilized in patient hematology and chemistry testing from August 2017 to June 2019. Findings include: 1. During a tour of the laboratory, the inspector noted a Medonic M Series hematology analyzer in use for patient hematology Complete Blood Count (CBC) testing and an Alere Biosite Meter in use for patient chemistry Creatine Phosphokinase MB (CK-MB), Troponin, Myoglobin, D-dimer, and B Type natriuretic peptide (BNP) testing. 2. Review of the manufacturer's users guides for ambient operating requirements revealed: Medonic M Series humidity requirement less than or equal to 80%, Biosite humidity requirement 10-85%. The hematology and chemistry manufacturers' users guides stated maintenance instructions for daily humidity monitoring listed as "record daily". 3. Review of the 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 -- daily temperature logs from 08/01/17 to 06/30/19, revealed no record of laboratory humidity monitoring for twenty-two (22) of the 22 months reviewed. 4. In an interview with the clinical coordinator at approximately 2:00 PM the above findings were confirmed. -- 2 of 2 --