Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, observations made during a tour of the laboratory, and interviews with staff, it was determined the laboratory failed to establish procedures to ensure positive identification of urine specimens. Survey findings include: A. During a review of laboratory policies and procedures, the surveyor determined there were no policies for labeling of urine specimens. B. During a tour of the laboratory, at 1:35 p.m. on 1/17/2023, the surveyor observed one McKesson Drugs of Abuse Test Cup, on the laboratory counter beside the sink. The patient's name was on the lid of the cup instead of on the container. During a tour of the laboratory, at 3:05 p.m. on 1/17/2023 the surveyor observed four McKesson Drugs of Abuse Test Cups, on the laboratory counter beside the sink. Four of four specimens were labeled on the container lid instead of on the specimen container. C. In an interview, at 3:05 p.m. on 1/17/2023, laboratory employee #3 (as listed on the form CMS-209) confirmed the four McKesson Drugs of Abuse Test Cups were labeled on the lid and not on the actual container. 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 --