Summary:
Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on interview with the regional clinic manager (Staff A) and review of the laboratory procedure manual, for one of one discontinued procedures, the laboratory did not record the date of discontinuance. Findings include: 1. Interview with Staff A on August 20, 2025, at 2:30 PM, revealed that the laboratory discontinued potassium hydroxide (KOH) testing effective August 1, 2023. 2. Review of the procedure manual revealed procedure titled "KOH Examination and QC" was not marked with the date that the testing was discontinued and showed no indication that the procedure was discontinued. 3. Further interview with Staff A on August 20, 2025, at 2:30 PM, confirmed that the "KOH Examination and QC" procedure had not been marked with the discontinued date and that it showed no indication that the procedure was discontinued. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on test result and laboratory record review, and interview with the regional clinic manager (Staff A), the laboratory did not ensure all records accurately reflected site of collection for one of four Mohs surgery patient's records reviewed. Findings include: 1. Review of Visit Note in patient's (Patient 1) electronic medical record (EMR) dated July 30, 2024, revealed scanned copies of two Mohs Micrographic Surgery Maps with the same case number, containing exactly the same information except for the site; the first indicated "(L) Inferior lateral malar cheek", and the second, written over white out tape, indicated "(R) Medial zygoma". 2. Review of "Mohs Patient Log" revealed one record for Patient 1 on July 30, 2024, with site recorded as "(R) Medial zygoma" written over white out tape. 3. Interview with Staff A on August 20, 2025, at 3:15 PM, confirmed Patient 1 had the Mohs procedure performed for the right medial zygoma site only and that the laboratory did not ensure all records accurately reflected site of collection for Patient 1. This is a repeat deficiency, previously cited on October 3, 2019. 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 review of the procedure manual, laboratory records, and interview with regional clinic manager (Staff A), the laboratory did not conduct accuracy verifications for frozen section biopsies in 2024 for two of two accuracy checks required annually. Findings include: 1. Review of the laboratory policy, M-721-C-I version 2 "Frozen Section Biopsies & Mohs Micrographic Surgery Slides" revealed the laboratory policy stated: "Bi-annually, the Mohs tech or Regional Clinic Manager will send three random cases of frozen section skin biopsies and Mohs micrographic surgery slides containing the original slides, and send internally or externally for a microscopic examination by a Board Certified Pathologist / Mohs surgeon", and use "Log 721-C-iv Frozen Section Peer Review Form" to record the results. 2. Review of the laboratory records revealed no evidence that the laboratory had completed twice annual accuracy checks for 2024. 3. Interview with Staff A on August 20, 2025, at 3: 50 PM, confirmed that the laboratory did have at least one frozen section biopsy case, and had not conducted twice annual accuracy checks for frozen section biopsies in 2024. D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the regional clinic manager (Staff A), after identifying a test report error, the laboratory did not correct the patient -- 2 of 3 -- test report for one of one reports reviewed that required correction. Patient 1 had a single Mohs procedure on July 30, 2024, the electronic medical record (EMR) included reference to two Mohs procedures performed on two different sites. Findings include: 1. Review of Visit Note in Patient 1's EMR dated July 30, 2024, revealed scanned copies of two Mohs Micrographic Surgery Maps, "Mohs Maps", with the same case number, containing exactly the same information except for the site; the first indicating "(L) Inferior lateral malar cheek", and the second indicating "(R) Medial zygoma". Neither Mohs Map was notated as "corrected". 2. Further review of Patient 1's EMR Visit Note, revealed multiple entries including two Mohs Surgery plans identified as #2 and #4. Entry #2 listed "Location: right medial zygomatic" and included the results of the sample evaluation. Entry #4 listed "Location: right superior lateral malar cheek" and did not include results of the sample evaluation. There was no evidence in the Visit Note that the laboratory had corrected the report and no indication the laboratory identified entry #4 as an error. 3. Interview with Staff A on August 20, 2025, at 3:15 PM, confirmed Patient 1 had one Mohs procedure performed on July 30, 2024, on the right medial zygoma site, confirmed that the Mohs Map indicating "(L) Inferior lateral malar cheek" was not correct, and confirmed the report had not been corrected to remove entry #4. Further interview with Staff A confirmed that the laboratory had identified the problem with the patient report but had not made the corrections in the EMR. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on surveyor review of competence assessment records and interview with the regional clinic manager (Staff A), the laboratory director, who is also the technical consultant, did not document the evaluation of competence for one of two testing personnel authorized to perform scabies testing, a moderate complexity microscopy test, in 2024. Findings include: 1. Review of the 2024 competency assessment forms revealed no evidence that the laboratory director, who is also the technical consultant, had evaluated the competency of testing personnel (Staff B) in performing scabies testing. 2. Interview with Staff A on August 20, 2025, at 2:45 PM, confirmed the laboratory director, who is also the technical consultant, did not document evaluation of competency for Staff B in 2024. This is a repeat deficiency, previously cited on July 28, 2023. -- 3 of 3 --