University Of California Irvine,

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 on February 23, 2026, at approximately 12:30 p. m., the laboratory failed to establish and follow written policies and procedures to assess employee competencies in 2023, 2024, and 2025. The findings included: 1. It was practice of the laboratory to perform mycology and Mohs Micrographic Surgery. The laboratory had eleven testing personnel (TP) responsible for performing KOH skin preparations, and seven TP who reviewed histopathology slides. 2. On February 23, 2026, the laboratory failed to provide documentation of competency evaluations for 11 of 11 TP who conducted KOH testing and 7 of 7 TP who performed histopathology testing. The laboratory requested an extension to locate and submit the required documentation via email to the surveyor. The documents were not submitted within the extended timeframe. 3. The laboratory's testing declaration form, signed by the laboratory director on February 13, 2026, stated that the laboratory performed approximately 2,185 tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manuals and an interview with the laboratory staff on February 23, 2026, it was determined that the laboratory director failed to approve and sign the procedure manuals before laboratory began using it. The findings included: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery and mycology testing. 2. On February 23, 2026, at approximately 12:00 p.m., the laboratory staff confirmed that the director had not reviewed, signed, or dated the histopathology procedure before it was used in the lab. 3. The laboratory's testing declaration form, signed by the laboratory director on February 13, 2026, stated that the laboratory performed approximately 2,100 histopathology tests annually. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manuals and an interview with the laboratory staff on February 23, 2026, the Laboratory Director failed to ensure that there were approved procedure manual available to all personnel responsible for mycology testing process. The findings included: 1. It was the practice of the laboratory to perform histopathology testing including Mohs Micrographic Surgery and mycology testing. 2. On February 23, 2026, at approximately 12:30 p.m., the laboratory failed to provide policies or procedures manuals regarding preanalytic, analytic or postanalytic testing for KOH prep procedures that are performed on site. 3. The laboratory's testing declaration form, signed by the laboratory director on February 13, 2026, stated that the laboratory performed approximately 85 mycology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the laboratory's Cryostat temperature records, and interview with the laboratory staff, it was determined that the laboratory failed to follow the laboratory 's stated performance specification for Cryostat acceptable temperature range in a manner that provided test results as determined. The findings included: a. The laboratory failed to follow the laboratory's stated performance specification for Cryostat acceptable temperature range. b. The laboratory performed Mohs surgery and employed two outside histology laboratory services, A and B. c. The A and B histology laboratory services has established its Cryostat acceptable temperature ranges. d. The A established the acceptable temperature for its operation between - 29 to -15 o C e. The B established the acceptable temperature for its operation between --35 to -18 o C f. The laboratory's Cryostat temperature records indicated the acceptable temperature range is between - 30 to -18 o C which is inconsistent between the A or B services' acceptable temperature range. h. The laboratory failed to be consistent with the histology laboratory services' policies and procedures stated. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Policy 2.06 and the laboratory's BIANNUAL QUALITY ASSESSMENT (Mohs slides), and interview with the laboratory staff, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and to ensure the accuracy of the patient test result reports. The findings included: a. The laboratory has established "MOHS MICROGRAPHICSURGERY NEGATIVE SLIDE REVIEW" (POLICY 2.06) b. It states V. PROCEDURES 1. Five random patients' slides from a Bi-Annual period of procedures are selected. 2. For each of four patients, one positive and one negative slide are selected for review. 3. All slides for the fifth patient are selected. 4. The selected patients' slides ... .(Form# MMS-02) c. Review of the MMS-008 (no MMS- 01 and MMS-02) records for the period of Month/Year: June 2022 and July-Dec 2022 (BIANNUAL QUALITY ASSESSMENT/Mohs slides), they indicated six patients' cases worksheets and slides were selected in each MMS-08, d. Review of the copies of Biannual assessments of June 2022 and July-Dec 2022, there were SIX patients selected and attached all the slides including positive and negative slides in the review records which were inconsistent with its written procedures above. e. Review of MMS-08 record, the case identified as M22-118, specimen collected on 03/02/22 with a diagnosis of BCC, showed NO signature and date under "Initial/Date Reviewer indicated that this particular case selected was missed and NOT been assessed by a second qualified testing personnel among the six cases/slides selected. f. The laboratory failed to follow its written policies and procedures to monitor, assess, and to ensure the accuracy of patient test result reports. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, Biannual Assessment policies and procedures (P&P), Cryostat temperature records and the histology laboratory's policies and procedures, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided. The findings included: a. The laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided. b. The laboratory performed Mohs surgery and qualified dermatopathologists performed diagnoses of tissue slides prepared by outside histology laboratory services onsite. c. The laboratory failed to follow its written P&P to perform Bi-annual review (Policy 2.06) see (D-5891) d. The laboratory failed to follow histology laboratory services' P&P in recording the Cryostat temperature, see D-5411 -- 2 of 2 --