Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the onsite initial CLIA certification survey conducted at your facility on June, 1, 2023. 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. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a random audit of patient test reports from January 1, 2023, through May 31, 2023, the laboratory failed to include relevant information to interpret the test result in the report. Findings include: 1. A review of one of one patient reports from January 1, 2023, through May 31, 2023, revealed that the report of patient SH from February 16, 2023, did not include the reference ranges necessary for interpretation of the Vitamin D results. 2. An interview with the public health nurse on June 1, 2023, at approximately 1:00 PM confirmed these findings. The laboratory performs approximately 12 chemistry tests annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require