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: Based on surveyor observation, review of the laboratory's quality assurance policy, and an interview with the laboratory director the laboratory failed to ensure positive patient identification from the time of specimen collection through the completion of testing. 1. Surveyor observation of urine samples in the laboratory revealed four urine samples labeled only with patient name. 2. Review of the laboratory's quality assurance policy states "all specimens will be labeled with the patient's name." 3. Interview with the laboratory director on March 28, 2023 at 10:50 AM confirmed the four urine samples were only labeled with patient name. Interview also confirmed if two patients with the same name were collected the laboratory could not identify which sample belongs to each patient. 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 --