Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 14, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 audit of patient laboratory testing in the areas of routine chemistry and toxicology between 7/20/17 and 5/18/19 and an interview with the laboratory manager, the laboratory failed to follow the director approved policy to ensure positive identification of a patient's specimen from the time of collection through the reporting of the test results. Findings include: 1. A random audit of patient laboratory testing in the areas of routine chemistry and toxicology between 7/20/17 and 5/18/19 found that the laboratory failed to ensure the positive identification of one of ten patient's specimens from the time of collection through the reporting of patient results. 2. The random audit found a specimen collected on 10/25/18 with a unique identification of the patient birth date of 5/23/82 had routine chemistry and toxicology testing performed on 11/03/18 with a unique identification of the patient birth date as 5 /23/83 on the patient final report. This was confirmed by the laboratory manager on June 14, 2019 at approximately 3:30 PM. The laboratory performs approximately 225,000 routine chemistry and toxicology patient 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 --