Midlothian Family Practice Villiage

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Midlothian Family Practice-Village Office on 09/21/22 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: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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 manufacturer's instructions for use (IFU), maintenance logs, and lack of documentation, and interviews, the laboratory failed to document performance of required monthly calibration checks for the Quidel Sofia 2 analyzer utilized for COVID-19 testing for seven of twenty-one months reviewed. Dates of record review include 01/01/21 up to date of survey, 09/21/22. Findings include: 1. An entrance interview with the technical consultant (TC) on 09/21/22 at approximately 09:10 AM revealed the facility performed COVID-19 testing. A tour of the exam room designated for patient testing on 09/21/22 at approximately 09:15 AM revealed one Quidel Sofia 2 analyzer in use for COVID-19 testing. 2. Review of the Quidel Sofia 2 SARS Antigen IFU revealed the following statement: Quality Control: "The Calibration Check is a required function that checks the Sofia 2 optics and calculations systems using a specific calibration cassette. The Calibration Check should be performed every 30 days." 3. Review of the Quidel Sofia analyzer maintenance log book revealed lack of documentation of calibration checks for the following months: April, May and June 2021, February, April, June and July 2022. 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 -- Total of seven months. The inspector requested documentation for the above-specified months. The documentation was not available for review. 4. An exit interview with TC on 09/21/22 at approximately 10:30 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification remote-site survey was conducted at the Virginia Physicians Inc Midlothian Family Practice Village on December 8, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on November 17, 2020 with off-site record review of documentation and a follow-up phone conference on December 3, 2020. Specific deficiencies cited are as follows: D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of two patient test reports, lack of documentation, and interview with the technical consultant, the Harvest Laboratory Information System (LIS) final patient report failed to contain reference intervals or normal values for one (1) patient vaginal wet preparation examination and one (1) patient potassium hydroxide (KOH) examination at the date of survey on December 8, 2020. Findings include: 1. Review of patient test reports generated from the Harvest LIS revealed lack of documentation of reference intervals or normal values for 1 patient vaginal wet preparation examination and 1 patient KOH examination. 2. An interview with the technical consultant at approximately 10:30 AM on December 8, 2020 confirmed the findings. 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 --