Advanced Dermatology Of Maryland

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the office manager (OM), the laboratory did not ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory currently has two TP listed on the "Laboratory Personnel Report" (CMS-209) who perform histopathology testing. 2. During an interview on 09/20/2024 at 10:50 AM, the OM stated that TP #2 began testing on 09/29/2023. 3. PT record review showed that TP #2 did not participate in the PT program in 2023. 4. During an interview on 09/20/2024 at 1:48 PM, the OM confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on procedure manual review and interview with the office manager (OM), the laboratory did not retire histopathology procedures that were no longer in use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Findings: 1. A review of the approved procedure manual showed that it included the procedures, "Automatic Staining Procedure - Toluidine Blue" and "Manual Staining Procedure - Toluidine Blue". 2. During an interview on 09/20/2024 at 11:30 AM, the OM stated that the laboratory staff told them that the laboratory did not perform staining of histopathology slides with the Toluidine Blue stain. The OM confirmed that the procedures were not removed from the procedure manual nor were they labeled with the date of discontinuance. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: I. Based on record review and interview with the office manager (OM), the laboratory did not ensure that a copy of all quality system assessment (QA) records were maintained by the laboratory for a minimum of two years. Findings: 1. Monthly QA records were reviewed from March 2023 through August 2024. 2. The laboratory stores the following monthly logs in a QA binder: "Laboratory Temperature/Humidity Log"; "Monthly Meeting Notes"; "H E Staining Log"; "Cryostat Temperature Log"; "Cryostat(s) Cleaning and Maintenance Log"; and "Microscope Cleaning and Maintenance Log". 3. QA record review showed that there were no "Laboratory Temperature/Humidity Logs" present for March through December 2023; there were no "Monthly Meeting Notes" present for March through December 2023 and April through July 2024; and the "H E Staining Log" for June 2024 was present, however the log was blank. 4. None of the six QA logs listed above were present for March, May, June, or August 2023. 5. During an interview on 09/20/2024 at 1:48 PM, the OM confirmed that the laboratory failed to maintain a copy of all QA records for at least two years. II. Based on patient record review and interview with the office manager (OM), the laboratory did not retain a copy of all patient test records for a minimum of two years. Findings: 1. Random review of patient records showed that for one of two patients reviewed, (case # DS23-123, performed on 10/14/2023) the Mohs map which is used to document the surgical process was missing from the electronic medical record. 2. During an interview on 09/20/2024 at 1:48 PM, the OM confirmed that they were unable to find a copy of the Mohs map for case # DS23-123. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual and proficiency testing (PT) record review and interview with the office manager (OM), the laboratory did not follow the written procedure for performing PT. Findings: 1. The procedure, "Attachment B: Proficiency Testing Mohs Histopathology Procedure Reference Guide" states that the laboratory should perform -- 2 of 5 -- PT "Bi-annually" and that "Between Jan. 1 - June 30th - first set of 5 slides should be sent" and "Between July 1st - December 30th - second set of 5 slides should be sent." 2. The laboratory currently has two TP listed on the "Laboratory Personnel Report" (CMS-209) who perform histopathology testing. 3. A review of PT records from 2023 and 2024 showed that the laboratory sent out its first set of PT slides for TP #1 on 09 /10/2024, and the PT slides for TP #2 on 01/26/2024 and 04/19/2024. 4. PT slides were not sent out for TP #2 in 2023. Cross-refer to D2007. 5. During an interview on 09/20/2024 at 1:48 PM, the OM confirmed that the laboratory did not follow its procedure for performing PT. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review and interview with the office manager (OM), the laboratory failed to ensure that the laboratory's procedure manual was approved by the current laboratory director (LD) before use. Findings: 1. During an interview on 09/20 /2024 at 9:30 AM, the OM stated that the current LD took over as LD on 08/30/2023. 2. Procedure manual review showed that the laboratory's procedure manual was signed and approved on 02/25/2023 by the previous LD. The laboratory's written procedure manual was not approved by the current LD. 3. This was confirmed by the OM during the exit interview on 09/20/2024 at 1:48 PM. D5781

Summary Statement of Deficiencies D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of the slide labeling procedure, slide review and interview with the supervisor, the testing personnel (TP) failed to label the patient slides with the patient's last name as required in the labeling procedure. Findings: 1. The "Analytical" section of the "Mohs Quality Assurance Manual" states: "The slide is labeled with the patient's last name, case number, stage and piece, and dated." 2. The supervisor pulled the slides for patient #FA22-008 slides for review and one of the four slides did not have the last name of the patient. The slide was labeled with "QC[quality control]" instead of the patient's last name. 3. Review of the slides from 05/15/2021 through 02 /25/2023 showed that the first slide of the day of patient testing was labeled with "QC" and not the last name of the patient which is required by the "Mohs Quality Assurance Manual." 4. During the survey on 02/27/2023 at 11:30 am, the supervisor confirmed that the TP were not labeling the patient slide with the last name of the patient as required by the "Mohs Quality Assurance Manual." 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 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 procedure manual and proficiency testing record review and interview with the regional manager, the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The procedure, "Proficiency Testing Mohs Histopatholgy" states that "Proficiency testing will be performed bi-annually. It is to be sent out and returned by end of June and Dec." 2. A review of PT records showed that no PT slides had been sent out in 2020. In an email on 4/27/2021 the regional manager stated that "with the change in lab directors and the pandemic proficiency testing was not done last year." 3. During an interview via email on 4/30 /2021 at 11:30 AM , the regional manager confirmed that PT slides were not sent out in 2020. 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 --