Oakland Hills Dermatology

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to retain the original test report for 1 (Patient M22-114) of 10 patient test reports reviewed. Findings include: 1. A review of the 10 patient test reports revealed Patient M22-114 had whiteout and "Right Nasal Sidewall" written over it on the patient's mohs map for their surgery date on 7/6/22, indicating the report had an error that was corrected. 2. A review of Patient M22-114's 6/10/22 visit note revealed a biopsy was collected and indicated the site as "Right Medial Malar Cheek." 3. An interview on 5 /31/23 at 11:02 am with the Office Manager revealed the site was incorrectly identified during the 6/10/23 visit where the biopsy was collected. The laboratory had updated the documentation to a site that better reflected the actual location. The Office Manager confirmed the original report for mohs on 7/6/22 where it indicated "Right Medial Malar Cheek" was not available. 4. A review of the laboratory's "Lab Paperwork & patient Chart Quality Assurance" revealed a section stating, "The lab director is in charge of the Mohs map and any paperwork within the patient chart. The Mohs tech will be in charge of maintaining the Mohs log sheet. When a change is made to any of the above paperwork the lab director will do the following: 1. Put a line through what has changed. 2. Write "Amended or Error" next to the change. 3. Notify the Mohs histotech of the change. 4. Sign and date on all paperwork that was corrected or changed." 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 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: A. Based on record review and interview with the Laboratory Liaison (LL), the Mohs' surgeon failed to record on the Mohs' map that the specimen margins were clear and /or negative for the Mohs' tissue specimen for 1 (#116) of 14 final Mohs' maps reviewed. Findings include: 1. A record review for 1 (#116) of 14 final Mohs' maps reviewed collected on 7/14/2021, the Mohs' map in the patients electronic medical record (EMR) system revealed the Mohs' surgeon did not record that the specimen margins were clear and/or negative for that tissue specimen on the Mohs' map. 2. An interview on 12/01/2021 at 10:57 am, the LL confirmed the final Mohs' maps did not contain the clear and/or negative margins recorded on the Mohs' map. B. . Based on record review and interview with the Laboratory Liaison (LL), the laboratory failed to ensure the location of the Mohs' surgical site was maintained consistently throughout the Mohs' process for 2 (#58 and #11) of 14 final Mohs' map reviewed. Findings include: 1. Record review revealed for 2 ( #58 and #11) of 14 final Mohs' map the surgical site was not consistently labeled throughout the Mohs' process as follows: a. Mohs' case #58 performed on 5/06/2020 - the original Pathology report and the Mohs' surgical site was labeled as left upper back, the final report in the patient's electronic medical record (EMR) was labeled left superior upper back. b. Mohs' case #11 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 -- performed on 1/20/2021 - the original Pathology report and the Mohs' surgical site was labeled as right eyebrow, the final report in the patient's EMR was labeled right central eyebrow. 2. During the interview on 12/01/2021 at 10:57 am, the LL confirmed the surgery site location was not consistently used throughout the Mohs' reporting process. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to document cryostat operating temperatures, room temperature, and humidity for 1 (patient #1 tested on 12/20/17) of 13 patient testing days reviewed. Findings include: 1. A patient chart audit revealed patient #1 had Mohs Micrographic Surgery performed on 12/20/17. 2. A record review of the "Master Log for Thermometer" room temperature and humidity log revealed a lack of documentation of room temperature and humidity on 12/20/17. 3. A record review of the "Cryostat Temperature Check Log" revealed a lack of documentation of cryostat operating temperatures for 12/20/17. 4. An interview on 10/30/19 at 1:35 pm with the Mohs Technician confirmed cryostat operating temperatures, room temperature, and humidity was not recorded on 12/20/17 when patient testing was performed. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a 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 -- maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to document maintenance activities for 1 (patient #1) of 13 patient testing days reviewed. Findings include: 1. A patient chart audit revealed patient #1 had Mohs micrographic surgery performed on 12/20/17. 2. A record review of the "Routine Maintenance" log revealed the daily maintenance includes "changing reagents /solutions" and "clean dishes, stainer case and covers." 3. A record review of the "Routine Maintenance" log revealed a lack of documentation of daily maintenance on 12/20/17. 4. An interview on 10/30/19 at 1:35 pm with the Mohs Technician confirmed documentation of daily maintenance was not available. D5781