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 the manufacturers package insert for urine drug screen testing cup, observation of the testing personnel (TP) and interview with the office manager determined that the laboratory failed to follow manufacture package insert for timing the urine drug test. The findings include: 1. Review of the manufacturers package insert for urine drug screen testing cup states "wait 5 minutes to determine a positive result" the laboratory failed to follow manufacturers package insert instructions by not using a timer. 2. Observation of the TP determined that the TP did not following the manufacturers package insert instructions for urine drug screen testing by not using a timer before resulting patient results. 3. Interview with the office manager on June 21, 2018 at 11:30 confirmed that the laboratory failed to follow manufacturers package insert instructions for timing urine drug screens. 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 --