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 the staff interview and record review on 03-19-2021, the laboratory failed to ensure the samples collected were transported according to the manufacturers' instructions. Findings include: Sample number one (1) was collected on 2-17-2021 but was not delivered to the reference laboratory until 02-23-2021. The sample was rejected because the patient sample had exceeded the storage stability of the collection kit. Interview with employee # 1 at the laboratory stated at 09:1 5 AM that the laboratory was responsible for calling the courier for sample pickup on the day of collection. Also, the sample would not be picked up by the reference laboratory with out notification. 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 --