Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Dermatology and Cosmetic Surgery on 4/22/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 observation, record review, and interview, the laboratory failed to ensure that the ventilation system was maintained to properly remove chemical vapors for the testing performed, when the facility lacked a chemical fume hood required by the manufacturer of the histopathology reagent (100% Dehydrant by Cardinal Health) found in the laboratory's storage area and marked for primary use on 4/22/2026. Findings include: 1. During an observation of the laboratory on 4/22/2026, it was noted that the facility lacked a chemical fume hood. An Epredia Linistat Linear Stainer was observed situated on a workbench. There was no local exhaust ventilation, fume hood, or containment system present above or around this equipment to remove chemical vapors. 2. On 4/22/2026, a one-gallon container of 100% Dehydrant (Manufacturer: Cardinal Health, Cat No. C4305-10) was stored within the laboratory flammable cabinet. The label on the bottle included a "When using, the following safety precautions are recommended" section which pictured a "VENT HOOD" icon. There was also a pink sticky note attached to the container labeled "Use 1st - Alcohol". 3. A review of the Safety Data Sheet (SDS) for the Cardinal Health 100% Dehydrant on 4/22/2026 revealed mandatory manufacturer instructions regarding ventilation: Section 7 (Handling): "Use only under a chemical fume hood." Section 8 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 -- (Engineering Measures): "Use only under a chemical fume hood." 4. In an interview on 4/22/2026 at 12:45 PM, Office Manager #1 confirmed the laboratory did not have a chemical fume hood. Office Manager #1 stated that the laboratory had recently run out of 100% alcohol and had just received a shipment of another brand. Office Manager #1 was unable to confirm when the Cardinal Health 100% Dehydrant was last used. 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 record review and interview, the laboratory failed to ensure that competency assessments were performed for 2 of 3 testing personnel (TP #2 and #3) reviewed who performed high-complexity Mohs histopathology testing on 9/4/2025 and 9/11/2025. Findings include: 1. A review of the laboratory's written policy, CP-L 1018, titled "Competency Assessment for Testing Personnel" (Revised 7/31/2025 and approved by the Laboratory Director on 8/27/2025), stated: "Advanced Dermatology Laboratories that perform moderate to high complexity testing participate in competency assessments upon hire, at 6 months, and annually thereafter." The policy explicitly identifies "Mohs Surgeons" as testing personnel subject to this requirement. 2. A review of the Form CMS-209, Laboratory Personnel Report (CLIA), signed by the Laboratory Director on 4/13/2026, identified three individuals authorized to read and interpret Mohs slides: Testing Person #1 (primary Mohs surgeon), Testing Person #2, and Testing Person #3. 3. A review of the laboratory's personnel files on 4/22 /2026 revealed no documentation that competency assessments had been conducted for TP #2 and TP #3. 4. A review of the laboratory's patient testing records confirmed that high-complexity Mohs surgery and histopathology interpretation were performed by these individuals on the following dates: TP #2: 9/4/2025 TP #3: 9/11/2025 5. In an interview on 4/22/2026 at 1:00 PM, Office Manager #1 confirmed that the laboratory did not have documented competency assessments for TP #2 or TP #3. Office Manager #1 stated that these individuals were only "filling in" for TP #1 on the specific dates noted. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure that reagents were labeled with accurate and appropriate dates to monitor stability and expiration for 1 of 1 reagent container (1 gallon 100% Dehydrant) observed in the laboratory flammable cabinet on 4/22/2026. Findings include: 1. During an observation of the laboratory on -- 2 of 3 -- 4/22/2026, a one-gallon container of 100% Dehydrant (Manufacturer: Cardinal Health, Cat No. C4305-10) was observed stored in the flammable cabinet. 2. A pink sticky note was attached to the front of the container which stated, "Use 1st Alcohol", indicating that this specific reagent was currently designated by staff as the primary alcohol for use in the staining process. 3. Handwritten notations on the shoulder of the 100% Dehydrant bottle observed on 4/22/2026 identified the following dates: "R: 6/21 /23" (Received Date) "O: 5/16/26" (Opened Date) The documented "Opened" date of 5 /16/2026 was recorded three weeks in the future from the actual date of the survey (4 /22/2026). 4. In an interview on 4/22/2026 at 12:45 PM, Office Manager #1 was unable to explain why it was labeled with an "Opened" date that had not yet occurred. -- 3 of 3 --