Summary:
Summary Statement of Deficiencies 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 review of glucose online instructions, interview with the testing person (TP), and the nurse supervisor, the lab failed to follow the manufacturers instructions when performing fingerstick glucose. Findings: 1. The laboratory failed to have the manufacturers instructions onsite when performing fingerstick glucose testing. 2. The TP stated that the laboratory stopped glucose testing last year during the year 2021. 3. The laboratory failed to provide any documentation of patient test results, quality control results, lot numbers and expiration dates. 4. The testing person confirmed on the day of the survey at 1:00 PM that documentation of patient test results, quality control results, lot numbers and expiration dates were not available, and the manufacturer's instructions were not onsite for performing fingerstick glucose testing. 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 --