Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on direct observations, review of Safety Data Sheets (SDS), lack of Standard Operating Procedures (SOPs), as well as interview with the Testing Person (TP), the laboratory failed to ensure proper ventilation for conducing all phases of the testing process. FINDINGS: 1. There was no ventilation system in the Mohs processing laboratory where manual hematoxylin and eosin (H & E) staining of patient specimens were performed. 2. It was noted that, although no fume hood or biosafety cabinet was present in the Mohs processing laboratory, the Cryostat and Fume Hood Maintenance Checklist documented fume hood cleaning and filter maintenance. 3. Avantik Cover Mount 2, Toluene Based, lot: 160971, expiration: November 30, 2024, and Avantik Tissue Marking Dye Green, lot: 27320, expiration: January 2016 were stored in a cabinet above the sink in the Mohs processing laboratory. 4. No reagents, stains, or solutions were stored in the flammable Jamco Products Safety Storage cabinet located the Mohs processing laboratory. 5. The current SOPs did not include instructions for safe handling and storage of hazardous and flammable materials including reagents, solutions and stains used in the Mohs processing laboratory for patient testing. 6. The TP confirmed the findings on August 6, 2025, at approximately 10:30 A.M. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 SOPs, personnel competency assessment records, as well as interview with the TP, the laboratory failed to perform and document competency assessments. FINDINGS: 1. There was no documentation of competency assessment performance for the Clinical Consultant (CC), Technical Supervisor (TS), and General Supervisor (GS). 2. The current SOPs did not include instructions for performing CC, TS, and GS competency assessments. 3. It was noted that Histotechnician TP competency assessment was performed and documented. 4. The TP confirmed the findings August 6, 2025, at approximately 1:00 P.M. 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 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)