Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc on 8/21-8/25/2025 The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, review of reagent safety data sheets, and staff interview, the laboratory failed to ensure protection from chemical hazards from 08/25/2023 through 08/21/2025. Findings included: 1. Observations were conducted during a tour on 08/18 /2025 beginning at 10:40 a.m. There was no fume hood over the staining work station. Reagents Clear-Rite 3 and 100% Dehydrant were observed stored in the safety cabinet with a respiratory hazard symbol on the labels. 2. Interview with the Laboratory Manager on 08/21/2025 at 10:54 a.m. confirmed the laboratory had no fume hood or monitoring of air quality. 3. Manufacturer Safety Data Sheets (SDS) were reviewed for chemicals the laboratory utilized. a. The SDS for Clear-Rite 3 with a revision date of 03/01/2009 stated if inhaled remove to fresh air and avoid inhalation. b. The SDS for 100% Dehydrant with a revision date of 01/26/2015 stated use outdoors or only in a well-ventilated area, do not breath fumes, gas or vapors, and the vapor is harmful. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain analytic records from 8/25/2023 to 3/10/2025 for the speciality of Mycology (KOH) testing. Findings included: 1. Proficiency Testing Log Sheet for KOH was reviewed which listed date of testing, patient name, sample location, result, and provider. The earliest date of KOH analytic records available for review was 3/10/2025. The laboratory was unable to provide analytic records for 8/25/2023 to 3/10/2025. 2. During an interview on 8/25/2025 at 12:30 p.m., the Laboratory Manager confirmed the laboratory had performed patient KOH testing between 8/25/2023 to 3/10/2025 and the absence of analytic records KOH from 8/25/2023 to 3/10/2025. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to follow a policy to be onsite once every six months and document the onsite visits from 1/1 /2025-8/21/2025 Findings included: 1. The laboratory's policies and procedures were reviewed and approved by the Lab Director on 6/20/25. There was a policy to reflect the Laboratory Director would be onsite at least once every six months and have detailed documented records of onsite visits. 2. The Laboratory Manager confirmed on 8/21/2025 at 12:30 p.m., there was no documentation of the Laboratory Director's 6 month visit. The Laboratory Director was questioned via email on 8/21/2025 at 3:05 p.m. with a request to have a response by 8/25/25 at 8:00 a.m. No response from the Laboratory Director was received to confirm or deny lack of documentation. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that prior to testing patient specimens, all personnel had demonstrated that they could perform all testing operations reliably to provide and report accurate results for one of one newly hired Testing Personnel (TP#B) from 3/10/25 to 8/21/2025 who performed Moderate Complexity Mycology (KOH) testing. Findings included: 1. The CMS-209 -- 2 of 3 -- Laboratory Personnel Report, signed by the Laboratory Director on 8/18/25, listed one Testing Personnel (TP#B) who performed Moderate Complexity KOH testing. The Laboratory Manager stated on 8/21/25 at 11:15 a.m. that TP# B's date of hire in the laboratory was 3/10/2025. 2. The Laboratory policy manual approved by the Laboratory Director on 6/20/25, included a Personnel Competency Assessment Policy which stated initial competency to be documented within the first 90 days. The policy did not indicate training and initial competency was to be documented prior to testing patient samples. 3. TP#B's personnel records included a six month competency signed and dated by the Laboratory Director on 7/19/2023, and annual competencies signed and dated by the Laboratory Director on 7/30/24 and 8/5/25 . There was no initial competency or training for TP#B conducted by the Laboratory Director prior to TP#B performing patient testing on 3/10/2025. 4. The Laboratory Manager confirmed on 8 /21/2025 at 12:30 p.m. there was no documentation of an initial competency or training for TP#B performed by the Laboratory Director prior to performing patient KOH testing on 3/10/2025. 5. On 8/21/2025 at 3:05 p.m. via E-mail, the Laboratory Director was questioned as to why there were competencies for TP#B prior to date of hire in the laboratory and if there was training and initial competency on or before 3/10 /2025. The E-mail included a request to have a response by 8/25/25 at 8:00 a.m. No response was received from the Laboratory Director to confirm or deny the lack of documentation. . -- 3 of 3 --