Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of policies and procedures, lack of competency assessment records, and an interview with the laboratory personnel on March 30, 2026, the laboratory failed to establish and follow written policies and procedures to assess employee competencies in 2024 and 2025. The findings included: 1. It was practice of the laboratory to perform Mycology using Potassium Hydroxide (KOH) testing. The Physician Assistants (PA) were responsible for preparing Wet Mount and reporting the results. The laboratory had three testing personnel (TP) responsible for performing KOH skin preparations. 2. On March 30, 2026, at approximately 2:15 pm, the laboratory's office manager affirmed that the laboratory did not possess written policies or procedures regarding the assessment of employee competency. Furthermore, no documentation existed to demonstrate competency assessment for either of the two Physician Assistants (PA) who performed Potassium Hydroxide (KOH) testing. 3. The laboratory's testing declaration form, signed by the laboratory director January 15, 2026, stated that the laboratory performed approximately 90 microbiology tests annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of Proficiency Testing (PT) records and an interview with the laboratory staff on March 30, 2026, it was determined that the Laboratory did not verify the accuracy of the Histopathology tests at least twice annually for the year 2024. The findings included: 1.It was the practice of the laboratory to perform Histopathology testing which is not listed in subpart I of the 42 CFR part 493. For test procedures not listed in subpart I, the laboratory must verify the accuracy of the test procedure twice annually. In accordance with the laboratory procedure manuals, the laboratory ensures the accuracy of its histopathology test procedures through a biannual verification process. Specifically, at least one case is selected and sent for peer review during each verification event. 2. On March 30, 2026, at approximately 1: 00 p.m., the surveyor conducted a review of the laboratory's peer review documentation associated with histopathology testing procedures. The documentation revealed that, for the second verification event in 2024, one case was sent out for accuracy verification. However, this case had not been initially reviewed by the laboratory itself. Instead, the initial review was performed by BARR dermatopathology and subsequently peer reviewed by a laboratory holding CLIA ID: 05D0870989. As a result, the laboratory did not perform the required accuracy verification for the second event in 2024, thereby failing to meet the biannual verification requirement for that year. 3. On March 30, 2026., at approximately 1:00 p. m., the laboratory staff confirmed that the laboratory did not verify the accuracy of the Histopathology testing twice annually for 2024. 4. The laboratory's testing declaration form, signed by the laboratory director on January 15, 2026, stated that the laboratory performed approximately 1000 histopathology tests annually. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) (c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on review of specimen grossing records, an interview with the laboratory personnel and review of five (5) randomly selected patient test results on March 30, 2026, it was determined that the laboratory failed to ensure that the reference laboratory for specimen grossing maintains a current CLIA certificate. The findings included: 1. It was the practice of the laboratory to perform dermatopathology testing. 2. On March 30, 2026, at approximately 12:40 p.m., the laboratory personnel confirmed that specimen grossing is referred to Harris Histology Service. 3. Harris Histology Service does not possess a CLIA certificate to perform high complexity testing and, therefore, is not authorized to perform specimen grossing. 4. The laboratory's testing declaration form, signed by the laboratory director on January 15, 2026, stated that the laboratory performed approximately 1,000 histopathology tests including dermatopathology annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for -- 2 of 4 -- specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)