Calais Dermatology Assoc

Summary Statement of Deficiencies D0000 A Recertification survey was conducted January 30, 2025 at Calais Dermatology Assoc - CLIA ID # 19D0683673. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and proficiency testing records as well as interview with personnel, the laboratory failed to verify the accuracy of performance for Potassium Hydroxide (KOH) testing at least twice per year in 2023. Findings: 1. Review of the laboratory's proficiency testing/competency policy revealed "This process is performed to ensure the accuracy and competency of microscopic potassium hydroxide (KOH) preparation and reading by the facilities testing personnel. This evaluation will be performed on a semiannual basis. If insufficiencies are detected, additional training and education will be provided by the Laboratory Director." 2. Review of the laboratory's proficiency testing records for 2023 revealed the laboratory verified their performance of KOH testing on June 27, 2023, but did not perform a second verification in 2023. 3. In interview on January 30, 2025 at 9:45 a. m., office personnel confirmed the laboratory did not verify KOH performance twice per year as identified above. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for 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 -- accurate and reliable results; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5217. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on August 13, 2021 at Calais Dermatology, CLIA ID # 19D0683673. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 with personnel, the laboratory failed to have a complete policy for competency assessments for testing personnel who perform Histopathology testing. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director performs Histopathology testing and a testing personnel for KOH. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a written policy detailing the use of following six (6) procedures to establish competency: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on August 13, 2021 at 10:30 am, the laboratory personnel confirmed that the laboratory uses outside verification of 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 -- cases to verify competency of the laboratory director's Histopathology reading but the policy did not detail annual competency assessment. Further, the laboratory personnel confirmed competency for KOH was also not detailed in the procedure manual. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure an approved policy and procedure manual was available to all personnel. Refer to D5209. -- 2 of 2 --