Summary:
Summary Statement of Deficiencies D0000 An unannounced CLIA complaint survey was conducted at Carespot Express Healthcare on 7/29/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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 record review and interview, the laboratory failed to follow the manufacturer's instructions for the Medline Urinalysis reagent strip test by failing to document the performance of required quality control (QC) testing. This deficient practice encompassed the date of the alleged incident (03/07/2026) for 1 of 1 test systems reviewed. Findings include: 1. The Medline Urinalysis Reagent Strip manufacturer's instructions and the laboratory's "Quality Control Log" require liquid quality control testing to be performed and documented for each new lot, each new shipment, each new canister, and monthly for canisters that remain open for more than 30 days. 2. A review of the laboratory's "Quality Control Log" on 07/29/2026 revealed no documented QC testing prior to May 2026. 3. In an interview on 07/29 /2026 at 10:30 AM, Staff #C (Regional Director) confirmed the laboratory was unable to locate documentation of QC testing performed prior to May 2026. 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 --