Summary:
Summary Statement of Deficiencies D0000 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 a random patient audit of nine specimens tested between the dates of January 7, 2020 and February 14, 2022, and an interview with the Director of Operations and the Compliance Manager, the laboratory failed to ensure that positive patient identification was maintained from the time of collection of the specimen through completion of testing and reporting of results. Findings include: 1. A random patient audit of nine patient specimens tested between the dates of January 7, 2020 and February 14, 2022 revealed that, for the record reviewed for the patient ID number 81541 tested on May 22, 2020, there was a discrepancy in the spelling of the patient's first name between the test requisition and the final test report. 2. The findings were confirmed during an interview with the Director of Operations and the Compliance Manager on April 27, 2022 at approximately 10:30 AM. The laboratory performs approximately 900 chemistry tests annually. 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 --