Northwestern Michigan Dermatology

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the Mohs Technician, the laboratory failed to label one paraffin-sealed flask containing reagent to identify its contents. Findings include: 1. During a tour of the laboratory on 08/26/2025 at 1:10 pm, the surveyor observed an unlabeled sealed flask containing reagent dated 08/25/2025, stored in a cabinet beneath the stainer. The flask was not labeled in a manner that identified the contents, preparation date, or expiration date. 2. In an interview conducted on 08/26 /2025 at 1:10 pm with the Mohs Technician, she stated the reagent was Hematoxylin and confirmed the flask was not labeled appropriately. 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 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 observation and interview with the Mohs' Tissue Tech (MTT), the laboratory failed to perform and document thermometer calibrations and/or replace an expired thermometer for 1 (S/N 170829833) of 1 thermometer in use. Findings include: 1. During a tour of the laboratory on 4/08/2023 at 10:21 am, the surveyor observed a Fisherbrand memory-loc traceable thermometer sitting on top of the freezer with an expiration date of 11/28/2019. 2. When queried on 4/08/2023 at 10:25 am the MTT was not able to provide the surveyor documentation to show the thermometer had been re-calibrated. 4. An interview on 4/08/2023 at 10:25 am, the MTT confirmed the laboratory failed to perform and document thermometer calibrations and/or replace the expired thermometer for the freezer readings. 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 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 the Laboratory Director (LD), the laboratory failed to assess the competency of testing personnel performing potassium hydroxide (KOH) and Scabies preparations for 2 (Testing Personnel #2 and #4) of 4 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency assessment records revealed a lack of documentation of competency assessments for Testing Personnel #2 and #4 performing KOH and Scabies preparations in 2020. 2. A review of the laboratory's "KOH Quality Control" policy revealed a section stating, "Other NWMD testing personnel will undergo periodic peer review by the Laboratory Director. 1% of annual KOH tests performed by each testing personnel will be reviewed and the results recorded in the 'KOH Log'. Competency assessment will include review of patient information, recording of results as well as interpretation of results. Annual documented review of the KOH log will ensure the above competency guidelines for each laboratory testing personnel will be performed." 3. An interview on 10/26/21 at 11:17 am with the LD confirmed Testing Personnel #2 and #4 did not have competency assessments performed in 2020 for KOH and Scabies testing. 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs' Technician (MT), the laboratory failed to have an electronic request for patient testing from an authorized person for the mycology potassium hydroxide (KOH) testing for 1 (#1) of 10 patient charts audited. Findings include: 1. Record review revealed for 1 of 10 patient charts audited, the patient did not have an electronic request for the KOH testing in the patient's electronic medical record (EMR) and that the office did not have a patient on file by that name. 2. On October 2, 2019 at approximately 1:00 pm when queried, the MT was not able to find the patient in question in the data base of their EMR system and the patient was not on the daily schedule for October 31, 2017. 3. During the interview on October 2, 2019 at approximately 1:00 pm, the MT acknowledged no electronic order or patient file was available in the EMR system. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs' Technician (MT), the laboratory failed to maintain a record system that included the specimen receipt time into the laboratory for each stage/level of tissue specimen for 13 (M09-634, M17-469, M17-659, M18-101, M18-159, M18-311, M18-445, M18-582, M19-35, M19-193, M19-368, M19-541, and M19-648) of 13 Mohs' patient charts audited. Findings include: 1. Record review for 13 of 13 Mohs' cases reviewed, the laboratory failed to include the specimen receipt time into the laboratory for processing on each stage /level on the final Mohs' map as follows: a. M09-634 - no time for levels 1 and 2 b. M17-469 - no time for levels 1 and 2 c. M17-659 - no time for level 1 d. M18-101 - no time for level 1 e. M18-159 - no time for level 1-3 f. M18-311 - no time for level 1 and 2 g. M18-445 - no time for level 1 and 2 h. M18-582 - no time for level 1 i. M19- 35 - no time for level 1-3 j. M19-193 - no time for level 1 k. M19-368 - no time for level 1 and 2 l. M19-541 - no time for level 1 m. M19-648 - no time for level 1-3 2. During the interview on October 2, 2019 at approximately 1:45 pm, the MT acknowledged the final Mohs' map scanned into the patient's chart did not contain the specimen receipt times for each stage/level. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Mohs' Technician (MT), the laboratory failed to have the final mycology potassium hydroxide (KOH) result maintained as part of the patient's chart in the electronic medical record (EMR) system for 1 (#1) of 10 patient charts audited. Findings include: 1. Lack of documentation for 1 (#1) of 10 patient charts audited revealed the final test report for the KOH testing was not maintained in the patient's EMR system. 2. The EMR database did not contain a patient with the name written on the "KOH Log". 3. During the interview on October 2, 2019 at approximately 1:00 pm, the MT acknowledged the lack of documentation for the KOH testing in the patient's chart as that patient did not exist in the EMR system. 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 lack of documentation, record review, and interview with the Mohs' Technician (MT), the laboratory failed to provide the patient's potassium hydroxide -- 2 of 3 -- results on the "KOH Log'" for 2 (#8 and #10) of 10 patient charts audited. Findings include: 1. Lack of documentation on the "KOH Log" of the final KOH test result prompted further investigation into 2 of 10 patient charts audited. 2. Record review of the patient's electronic medical record (EMR) revealed the laboratory reported out a final result for the KOH testing for 2 (#8 and #10) of 10 patient charts. 3. During the interview on October 2, 2019 at approximately 1:00 pm, the MT acknowledged there was no documentation on the "KOH Log" of the test result and that a result was entered into the patient's EMR. -- 3 of 3 --