Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and interview with the testing person, the laboratory did not ensure that the testing personnel documented the PT results in the same manner as patient specimens and that the attestation worksheets were saved. Findings: 1. The chemistry, hematology and microbiology PT records for 2017 and 2018 were reviewed. 2. The PT records for the first microbiology event in 2017 showed that the testing person failed to document the microbiology PT testing results on the patient log along with the patient test results as required by the procedure. 3. Review of the PT records for microbiology in 2018 showed that the laboratory failed to maintain the attestation worksheet for the first event in 2018. 4. During the survey on 03/06/2019 at 12:00 PM the testing person confirmed that the microbiology testing results for the first PT event of 2017 were not documented on the patient log along with the patient test results as required and the attestation worksheet from the first microbiology event in 2018 was not saved. D6016 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 4 -- CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director did not ensure that the proficiency testing samples were tested as required. Cross refer to D2015 for details. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: I. Based on review of the quality assessment (QA) records and interview with the testing person, the laboratory director (LD) failed to ensure that QA records were reviewed in a timely manner to ensure that problems were identified and