Summary:
Summary Statement of Deficiencies D0000 . Based on record review and interview with the laboratory director, the laboratory failed to notify the state agency prior to performing and reporting results for its high complexity dermatopathology microscopic tissue examinations, in accordance with 493.53 Notification requirements for laboratories issued a certificate for provider- performed microscopy (PPM) procedures, for 10 (January 2024 to October 2024) of 10 months the laboratory was performing microscopic tissue examinations prior to notifying the state agency. Findings include: 1. A review of the CMS database showed the laboratory had applied for a certificate of compliance and had a certificate of registration, which was effective 10/1/24. 2. A review of the laboratory's patient biopsy logs revealed documentation starting 1/4/24. A total of 199 patients had biopsies collected between 1/4/24 and 10/1/24. 3. A review of five test reports for patients listed on the patient biopsy logs between January 2024 and October 2024 confirmed patients listed on the biopsy logs had received dermatopathology microscopic tissue examinations at the laboratory. a. Patient #3 received testing on 01 /25/2024. b. Patient #4 received testing on 03/14/2024. c. Patient #5 received testing on 05/30/2024. d. Patient #6 received testing on 07/25/2024. e. Patient #7 received testing on 09/04/2024. 4. A review of the laboratory's certification history showed the laboratory had an active certificate for provider-performed microscopy (PPM) procedures from 7/24/23 to 9/30/24. A CMS-116 form was received to perform the change in certificate type indicated to be effective on 10/1/24. The laboratory failed to notify the state agency in accordance with 493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures, which states, "Laboratories issued a certificate for PPM procedures must notify HHS or its designee-- (a) Before performing and reporting results for any test of moderate or high complexity, or both, in addition to tests specified as PPM procedures or any test or examination that is not specified under 493.15(c), for which it does not have a registration certificate as required in subpart C or subpart D, as applicable, of this part." 5. An interview on 9/25/25 at 11:16 am with the laboratory director acknowledged the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 the laboratory director, the laboratory failed to follow its competency assessment policies for one (2024) of two years reviewed. Findings include: 1. A review of the laboratory's "CLIA Certification Exam" policy revealed a section stating, "To ensure twice annually the laboratory must verify the accuracy of testing for each provider using the Michigan Dermatological Socity [sic]. Physicians performed microscopy/DTM interpretation and/or dermatopathology examination." 2. A review of the laboratory's Michigan Dermatological Society exam records for testing personnel #1 revealed a lack of documentation for any performed in 2024. 3. An interview on 9/25/25 at 11:16 am with the laboratory director acknowledged the above findings. 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: . A. Based on record review and interview with the laboratory director, the laboratory failed to verify the accuracy of it's Potassium Hydroxide (KOH) and Scabies preparations at least twice annually for two (September 2023 to September 2025) of two years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy data revealed a lack of verification of accuracy data for its KOH and Scabies preparations between September 2023 to September 2025. 2. An interview on 9/25/25 at 11:16 am with the laboratory director acknowledged the above findings. B. Based on record review and interview with the laboratory director, the laboratory failed to verify the accuracy of its dermatopathology testing at least twice annually for one (2024) of two years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy data revealed a lack of verification of accuracy data for its dermatopathology testing prior to 3/15/25. 2. An interview on 9/25/25 at 11:16 am with the laboratory director acknowledged the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as -- 2 of 4 -- established or verified in 493.1253. (b)(7) Control procedures. (b)(8)