Northern Virginia Carenow Urgent Care Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BetterMed Urgent Care- Mechanicsville on May 12, 2022 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 is in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of instrument performance verification records, manufacturer's user guide, lack of documentation, and interviews, the laboratory failed to evaluate/verify the reportable range of test parameters after installing and initiating patient Complete Blood Count (CBC) testing on the new Abbott Emerald hematology analyzer on July 21, 2021 and up to the date of the inspection on May 12, 2022. Findings include: 1. Review of the laboratory's instrument validation records revealed a new hematology analyzer installation, by an Abbott field service technical specialist, occurred on 7/21 /21. The inspector noted no record of validation for the CBC parameters' reportable range/linearity on the new Abbott Emerald analyzer, Serial Number (SN) 030421- 010111. 2. Review of the Abbott Users Guide for new instrument installation revealed instructions "The patient Reference Range and Linearity must be validated by 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 -- laboratory." 3. The inspector requested to review documentation that the LD validated /approved the Emerald SN 030421-010111 analyzer's reportable ranges prior to patient testing. No documentation was available for review. During the inspection, the practice manager reached out to the field service rep to inquire regarding the linearity study. The manager stated on 5/12/22 at approximately 2:30 PM: "It appears that we never received the linearity study paperwork. It did not get reviewed". 4. An exit interview with the practice site manager on 05/12/22 at approximately 4 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BetterMed Urgent Care on February 13, 2020 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, patient test logs, procedures, lack of documentation, and interviews, the laboratory failed to retain manufacturer's assay information inserts documenting Troponin and D Dimer acceptable ranges for thirteen (13) of nineteen (19) QC lot numbers utilized in the twenty-three (23) months reviewed. Findings include: 1. Review of the laboratory's QC and patient test logs for Troponin and D Dimer from March 2018 to the date of the inspection on 2/13/20 revealed 19 lot numbers of "Quidel Triage Total 5" QC material were utilized to document and evaluate patient testing on the Triage instrument. The following 13 utilized QC lot numbers had no manufacturer's package inserts with acceptable ranges documented: 03349, 03353, 03356, 03364, 03367, 03370, 03371, 03399, 03403, 03407, 03408, 03429, 03434. 2. Review of the policy and procedure manual revealed an approved Troponin and D Dimer Individualized Quality Control Plan (IQCP) with instructions to "retain all control lot inserts". 3. During an interview, at approximately 12:00 PM on 02/13/2020, the inspector requested to review the package inserts with acceptable ranges for the 13 lot numbers listed above. The site manager stated: "I assumed the role as manager in 2019 and realized that the staff was not remembering to retain all of the QC inserts at this site. I have tried to make sure that we are keeping 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 -- them with the QC print outs." 4. In an exit interview with the site manager at approximately 2:30 PM on 02/13/2020, the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the policy and procedure manual, manufacturer's operations manual, instrument maintenance records, field service maintenance records, lack of documentation, and interviews, the laboratory failed to document performance of required Abbott Emerald Cell-Dyn hematology analyzer maintenance (twice annually) in calendar years 2018 and 2019. Findings include: 1. Review of the laboratory's procedure manual revealed that the laboratory utilized a copy from the Abbott Emerald Cell-Dyn User Guide as their hematology maintenance procedure. The maintenance protocol stated: "Every 6 months perform syringe piston lubrication". 2. Review of the Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually". 3. Review of the laboratory's hematology maintenance logs from March 2018 through the date of the survey on 2/13/20, revealed no semiannual piston syringe maintenance was recorded as performed during the twenty-three (23) months reviewed. The inspector requested to review additional documentation of the piston syringe maintenance in 2018 and 2019. No other records were available. The site manager stated, at approximately 1:00 PM on 02/13/2020, "I assumed the role as manager in 2019 and thought that our Peaks Service field representative was completing the required maintenance. We have not been doing this in the lab." 4. The inspector requested to review the Peaks Service record reports for 2018 and 2019. Review of the field service reports revealed no semiannual piston syringe maintenance was recorded as performed by the vendor in calendar years 2018 or 2019. 5. In an exit interview with the site manager at approximately 2:30 PM on 02/13/2020, the above findings were confirmed. -- 2 of 2 --