Summary:
Summary Statement of 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 upon a review of manufacturer's instructions, a review of patient test logs, observations made during a tour of the laboratory, and through interviews with staff, the laboratory failed to follow manufacturer's instructions for expiration dates of Henry Schein One-Step urine pregnancy test kits. Survey findings follow: A) During a tour of the laboratory, at 10:35 a.m. on 4/10/26, one of one test kit (the only test kit observed) of Henry Schein One-Step urine pregnancy test was observed available for use, stored in the laboratory cabinet. The test kit (lot # 0000717233) had an expiration date, on the package, of 2025-05-13. B) In an interview at 10:35 a.m. on 4/10/26 the laboratory staff member ( # 1 on the form CMS 209) confirmed that the test kit identified above had exceeded the date of expiration and that was the only urine pregnancy test kit available. C) When asked when the most recent urine pregnancy test was performed, the laboratory staff member (# 1 on the form CMS 209) reviewed patient records and said that a urine pregnancy test was performed on patient # 101898 on 2/22/26, after the test kit used to perform the test had expired. 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 --