Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, review of seven electronic medical records, lack of documentation, and interviews with laboratory personnel, it was determined the laboratory performed urine drug screens without a request from an authorized person. Survey findings include: A. A review of the laboratory policy and procedure manual revealed the following policy for test orders: The laboratory must perform test only at a written or electronic request from an authorized person (a physician). B. During a review of seven patient electronic medical records, the surveyor requested to see the physicians orders for the urine drug screens. During the review (11:21 on 11/19/2021) surveyor was told, by laboratory employee #3 (as listed on form CMS-209), that there are no orders for the patient drug screens, in the electronic medical records. C. In interview, at 11:21 a.m. on 11/19/2021, laboratory employee #3 stated that she performs drug screens on patients based on a protocol hand written on a sheet of paper from a note pad, which was posted on the wall in the laboratory. The hand written protocol was not signed by the physicians to indicate it was a standing order for patient laboratory testing. She further stated that a drug screen would be performed on any patient presenting in the waiting room with any behavior to suggest impairment. 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 --