Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the BetterMed Urgent Care on July 7, 2021 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 June 26, 2021 with off-site record review of documentation on July 2, 2021. Specific deficiencies cited are as follows: The laboratory is performing COVID- 19 testing and in compliance with the applicable COVID-19 reporting requirements. 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 the review of the manufacturer's product correction, maintenance logs, lack of documentation, and interview, the laboratory failed to document the performance of the weekly bleaching procedures for seven (7) of 52 weeks reviewed. Findings include: 1. Review of the Abbott Product Correction notification (dated 02/21/19) revealed instructions to increase the bleach cleaning procedures from monthly to weekly. 2. Review of the Abbott Cell Dyn maintenance logs from April 1, 2020 through April 30, 2021 revealed lack of documentation of the performance of the weekly bleaching procedures for the following: 05/10-17/20, 10/15-22/20, 10/22-29 /20, 10/29-11/05/20, 11/05-09/20, 11/16-23/20 and 11/23-29/20. Total 7 Weeks. 3. An exit interview with the regional and site managers on 07/07/21 at approximately 1:00 PM 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 --