Ada West Dermatology

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, transcripts and an interview with the lead histotechnician on 9/24 /2025, the laboratory failed to have one of two testing personnel meet educational requirements for performing Mohs mechanical procedures. See D6171 D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, 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 -- biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, diplomas, transcript and an interview with the lead histotechnician on 9/24/2025, the laboratory failed to have one of two testing personnel meet educational requirements for high complexity testing. The findings include: 1. A review of the CMS 209 form identified two testing personnel performing Mohs mechanical procedures including inking. 2. A review of diplomas and a transcript identified that the laboratory failed to ensure testing personnel two met minimal educational requirements for performing Mohs mechanical procedures including inking of patient tissue. 3. An interview with the lead histotechnician on 9/24/2025 at 1:15 pm confirmed that one of two histotechnicians performing Mohs mechanical procedures failed to have minimum qualifications for high complexity testing. 4. The laboratory reports performing 1900 Mohs slide examinations annually. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a record review of the Staining Quality Control (QC) log and an interview with the testing personnel (TP), the laboratory failed to ensure that the TP did not use expired stains. Findings include: 1. Record review of the Staining QC log revealed that the laboratory failed to document any reagents in use, replaced, and/or expired for 01/04/2022 through 06/28/2023. 2. Interview with the TP on 06/28/2023 at 03:30 PM stated, "I was told that I did not have to log that information anymore." 3. The laboratory reports performing approximately 1600 histopathology tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on laboratory tour, record review, and interview with the laboratory manager, the laboratory failed to perform annual preventative maintenance (PM) service for 1 of 1 Avantik cryostat in 2022 and 2023. Findings include: 1. Laboratory tour revealed that 1 of 1 Avantik cryostat had an annual PM service due date of 08/2022. 2. Record review revealed that the laboratory failed perform annual PM service for 2022 and 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 -- 2023. 3. Interview with the laboratory manager on 06/28/2023 at 04:00 PM confirmed that the laboratory did not perform annual PM on Avantik cryostat for 2022 and 2023. 4. The laboratory reports performing approximately 1600 histopathology samples annually. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. This STANDARD is not met as evidenced by: Based on review of competency assessment and interview with laboratory manager, the technical supervisor (TS) failed to include the 6 competency assessment (CA) criteria found in CLIA regulation 42 CFR 493.1451(b)(8) for testing personnel (TP) Findings include: 1. Review of 1 of 1 TP CA for dates 7/21/21, 9/9/2022, and 1/9 /2023, revealed that the TS failed to perform CA in accordance with CLIA regulations. 2. Interview with the laboratory manager on 6/28/2023 at 02:05 PM confirmed that the TS failed to include the 6 CA criteria found in CLIA regulations for TP-1 CA. -- 2 of 2 --