Carolinas Fertility Institute

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 laboratory's procedures, review of the 2019, 2020, and 2021 AAB(American Association of Bioanalysts) PT (proficiency testing) records and interview with the LD(laboratory director) and TP(testing personnel) 8/6/21, the laboratory failed to maintain all PT records and failed to ensure the laboratory director and testing personnel signed the attestation statement. Findings: The laboratory's Proficiency Testing policy states, "7. Primary records related to PT and alternative assessment testing are retained for 2 years. These include all instrument tapes, work cards, computer printouts, evaluation reports, evidence of review, and documentation of followup/

Summary Statement of Deficiencies D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedures, and laboratory director (LD) interview 09/28/18, the laboratory director failed to establish a quality assessment program to assure the quality of laboratory services provided. Review of laboratory policy and procedures revealed a quality assessment notebook containing multiple outlines and policies regarding quality assessment practices. Review of quality assessment notebook revealed the laboratory director had not established the quality assessment program for the laboratory services provided. Interview with laboratory director at approximately 11:00 a.m. confirmed the laboratory quality assessment program was not established. He stated that he has been working on an effective quality assessment program, but it was not complete and has not been enacted. 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 --