Anne Arundel Dermatology

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, the laboratory did not record the humidity of the room where processing and staining of tissue for MOHS surgery was performed. Findings: 1. The laboratory reviewed the humidity readings for the room where processing and staining was performed, but did not document those reading on the log each day when MOHS surgery was performed. The log had a place to document these readings, and of four of four days reviewed, when MOHS surgery was performed in September 2024, the humidity was not documented. 2. This was confirmed with the histotechnologist at 10:30 a.m. on September 26, 2024. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on procedure manual, laboratory patient log, and patient electronic medical record (EMR) review and interview with the laboratory staff, the laboratory did not follow the established policies and procedures to ensure positive identification of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Findings: 1. The laboratory performs histopathology testing on patient specimens from Mohs surgery. The patients are entered on a patient log, where they are assigned a case number. The procedure manual states that the case number must include the last two digits of the current year followed by the next sequence number for that year. 2. A random review of patient records showed that Patient A was listed as "Case # 23-113" in the patient log. Examination of Patient A's histology slides showed that they were labeled correctly with "23-113," however a review of the patient final report in the EMR showed that the case number in the "final visit note" was documented as "22-113." 3. The procedure "Quality Control Program," subheading, "Data Validation" states, "The Mohs physician will review the record for accuracy ensuring that the test results are correctly entered" and "If the information is correct, the Mohs physician will electronically sign the record. Their signature notes that the record was review and that all the data has been validated as correct." 4. During an interview on 02/09/2023 at 10:30 AM, the laboratory staff confirmed that written policies and procedures that ensure positive identification of histology specimens from the time of collection or 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 -- receipt of the specimen through completion of testing and reporting of results were not followed. -- 2 of 2 --

Summary Statement of Deficiencies D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on remote review of laboratory records and interview with the laboratory manager, the general supervisor did not ensure that the histotechs completed the cryostat maintenance worksheets as required. Findings: 1. The control slide logs from January 2020 through May 6, 2021 and the cryostat maintenance sheets for cryostats #1 and #2 were reviewed. 2. The control slide logs showed that testing was performed on February 10, 2020 but there was no cryostat maintenance documented on that date. 3. The records show that control slides were reviewed on July 10 and 14, 2020 but there was no cryostat maintenance documented on those dates. 4. The records show that control slides were reviewed on October 13, 15 and 20, 2020 but there was no cryostat maintenance documented on those dates. 5. The control slide logs showed that testing was performed on December 29, 2020 but there was no cryostat maintenance documented on that date. 6. During the phone interview on 05/26/2021 at 11:55 am, the laboratory manager confirmed that the control slide logs were accurate and the cryostat maintenance sheets were missing maintenance documentation on the days that control slides were evaluated. 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 D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with the laboratory staff, the histopathology laboratory did not document that it checked the Hematoxylin and Eosin (H&E) stain for intended response and predicted characteristics of the stain. Findings: 1. The laboratory performs H&E staining procedures to evaluate histopathology slides made from patient specimens taken during Mohs surgery. Daily stain QC for the H&E stain is recorded on the "Control Slide Log." 2. A review of "Control Slide Logs" from January through October, 2018 showed that the log records the "Date," "Slide Number," "Stain" (marked as "H&E"), and "Reviewed By." There was no documentation of the stain quality of the slides each day of patient testing. 3. During an interview on 10/24/18 at 10:45 AM, the laboratory staff confirmed that daily slide QC was not consistently documented. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require