Advanced Dermatology & Cosmetic Surgery

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Dermatology & Cosmetic Surgery from 4/16/2024 to 4/24/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the established quality assessment (QA) program was maintained for one (2023) of two years (2022-2024) reviewed. Findings included: Review of the "Mohs Laboratory Quality Assessment" policy revealed: The Laboratory Director was responsible for compliance with all policies and procedures of the laboratory. The Laboratory Director reviews all quality control (QC) charts and logs on a routine basis. Review of the monthly meeting notes, which included review of QA/QC for 2023, revealed no evidence of review by the Lab Director. On 4/16/2024 at 11:40 AM, the Office Manager confirmed there was no documentation the Laboratory Director reviewed QC for 2023 in accordance with the Mohs Quality Assessment policy. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure Testing Personnel (TP) had competency evaluations prior to reporting patient results for 1 (TP #A) of 2 Testing Personnel (TP #A & #B). Findings included: 1. Record review of the policy titled "Job Duties of Laboratories Performing Testing of High to Moderate Complexity" showed the duties of the Laboratory Director included ensuring all personnel have demonstrated they can perform testing reliably prior to testing patients' specimens. 2. Record review of the "Competency Assessment for Testing Personnel" procedure showed competency assessments were to occur at hire, at six months, and then annually. 3. Review of the Form CMS-209, Laboratory Personnel Report, signed by the Laboratory Director on 04/16/2024 revealed the laboratory had 2 TP (#A & #B). 4. Review of competency evaluations revealed only one competency was completed for TP #A. Review of the document for TP #A showed it was an annual competency dated 3/28/24, signed by TP #A on 4/16/24, and no evidence the Laboratory Director had performed this competency. 5. On 4/16/24 at 11:40 AM, the Office Manager confirmed there was no competency evaluations for TP #A signed by the Laboratory Director. The Office Manager was not sure when TP #A started patient testing but thought it was in the middle of 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Advanced Dermatology and Cosmetic Surgery on 07/20/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Office Manager, the laboratory failed to have an expiration date on the mineral oil reagent used to perform one of one Scabies test between 11/05/21 and 07/20/22. Findings included: During a tour of the laboratory on 07/20/22 at 10:10 a.m., one bottle of mineral oil reagent used for Scabies testing (subspecialty of Parasitology) with no expiration date was observed. Review of the "KOH" Log and the "Bi-annual KOH and/or Scabies Competency and Proficiency Testing for Laboratory Testing Personnel" revealed that one Scabies test had been performed from 11/05/21 through 07/20/22. On 7/20/22 at 12:05 p.m., the Office Manager confirmed the mineral oil bottle did not have an expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- 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 observation, record review, and interview with the Office Manager, the laboratory failed to ensure the Potassium Hydroxide (KOH) reagent used for the subspecialty mycology (Fungi) testing was not expired prior to performing 10 patient tests from 11/05/21 to 07/20/22. Findings Included: A tour of the laboratory on 07/20 /22 at 10:10 a.m. revealed a bottle of KOH reagent with an expiration date of 04/09 /20. Review of the "KOH" Log and the "Bi-annual KOH and/or Scabies Competency and Proficiency Testing for Laboratory Testing Personnel" revealed that 10 Fungi tests had been performed from 11/05/21 through 07/20/22. On 07/20/22 at 12:05 p.m., the Office Manager stated she was unaware the KOH reagent was expired. -- 2 of 2 --