Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing performance, and interview with the laboratory staff on 3/21/2024 at 3:30 PM, laboratory failed to verify the accuracy of Mohs surgery histopathology testing at least twice annually. The finding includes: 1. The laboratory performed Mohs surgery, which included histopathology examination for skin tissues. The laboratory did not verify the accuracy of histopathology examination. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2. On 3/21/2024 at 3:30 PM, the laboratory staff confirmed that there was no evaluation of histopathology proficiency testing performance or peer review documents available at the time of survey. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/2024 stated that the laboratory performed 800 tests in histopathology, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 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 -- 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing performance, and interview with the laboratory staff on 3/21/2024 at 3:30 PM, the laboratory director failed to assure compliance with the applicable regulations and potentially may have harmed patients. The finding include: See D5217 -- 2 of 2 --