Beaumont Multi Specialty Services

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to establish a system to ensure the transcribed Mohs' surgical site was accurately transcribed from the "Dermatopathology Report" onto the Mohs' map, Mohs' log, and in the patient's "Mohs' Surgery Progress Note" in the electronic medical record (EMR) for 3 (M21-27, M21-44, and M22-23) of 10 patient test records reviewed. Findings include: 1. A record review revealed for 3 of 10 Mohs' cases reviewed, the surgical site was not accurately transcribed from the "Dermatopathology Report" onto the patient's Mohs' map, Mohs' log, and in the "Mohs' Surgery Progress Note" in the EMR system as follows: M21-27 i. Pathology Report (Path), Mohs' map, and Mohs' log - right inferior central forehead ii. Procedure Note (Note) - right lateral inferior forehead M21-44 i. Path, Mohs' map, and Mohs' log - right forehead ii. Note - right lateral forehead and temple M22-23 i. Path, Mohs' map, and Mohs' log - right leg ii. Note - right lower leg 2. An interview on 10/19/2022 at 11:30 am, the LD confirmed the Mohs' surgical site was not transcribed accurately. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 record review and interview, the laboratory failed to at least twice annually verify the accuracy of 1) the histopathology Mohs' tissue slide examination for four (2nd 2016, 1st and 2nd 2017, and 1st 2018) of four twice annual evaluation events and 2) the twice a year Michigan Dermatological Society examination for four (fall 2016, spring and fall 2017, and spring 2018) of five seasonal exams. Findings include: 1. On November 14, 2018 at 9:52 AM, record review of the "Mohs Case Quality Assurance Form" revealed the laboratory did not perform at least twice a year verification of accuracy for the Mohs' specimens processed on-site as follows: a. 2016 - 2nd event b. 2017 - 1st and 2nd events c. 2018 - 1st event 2. On November 14, 2018 at 10:30 AM, lack of records revealed the laboratory director did not complete and document the twice a year (spring/fall) Michigan Dermatological Society examinations as follows: a. 2016 - no fall b. 2017 - no spring or fall c. 2018 - no spring 3. On November 14, 2018 at 9:52 AM when queried, the specimen processing personnel was unable to provide the surveyor the twice annual verification of accuracy of Mohs' tissue slide examination and the Michigan Dermatological Society examination. 4. During the interview on November 14, 2018 at 9:52 AM, the specimen processing personnel confirmed the twice a year verification of accuracy was not performed and documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --