Advanced Dermatology Of Maryland

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: I. Based on procedure manual and proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory did not ensure that PT was performed at least twice annually for all non-regulated tests performed in the laboratory. Findings: 1. The laboratory performs Hematoxylin and Eosin (H&E) staining procedures to evaluate histopathology slides for Mohs surgery patients. 2. The procedure, "Mohs Quality Assessment Manual" states that a "Mohs proficiency slide review is performed biannually for each Mohs Surgeon by a dermatopathologist." 3. A review of PT records from 2024 to 2026 showed that histopathology PT was performed on 07/01/2024, 01/14/2025, and 01/30/2026. 4. During an interview on 03/19/2026 at 2:00 PM, the LD confirmed that PT slides were not sent out twice annually in 2025. II. Based on procedure manual and proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory did not ensure that PT was performed at least twice annually for all non- regulated tests performed in the laboratory. Findings: 1. The laboratory performs potassium hydroxide (KOH) slide testing to test for fungal elements and scabies infections on skin scrapings. 2. The procedure, "Verification of PPM Test Results," section "6. Procedure: Parasitology and KOH" states, "Twice a year, the testing personnel will select a patient from whom to collect a specimen for competency and proficiency testing." 3. Record review showed that there was no documentation that PT was performed for KOH testing from 2024 through 2026. 4. During an interview on 03/19/2026 at 10:40 AM, the LD stated that PT for KOH testing was not performed at the laboratory. 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: I. Based on procedure manual and histopathology stain maintenance log record review and interview with the histotechnologist (HT) and the laboratory director (LD), the laboratory failed to follow written procedures for filtering and changing the reagents used for histopathology testing. Findings: 1. The laboratory performs Hematoxylin and Eosin (H&E) staining procedures to evaluate histopathology slides for Mohs surgery patients. The laboratory documents histopathology stain maintenance on the "H & E Automatic Staining Log" (stain log). 2. The procedure, "Policy # CP-L 1017: Quality Control Maintenance" stated, "The stains and reagents must be filtered daily and changed weekly following CP-L 2013 Daily Histology Stain control policy and procedures." The procedure, "Policy # CP-L 2013: Histology Stain Daily Surveillance" stated, "Routine histology stains are changed weekly or after 40-hour use". 3. A review of stain logs from 01/15/2025 through 03/18/2026 showed that the stain log lists each of the 12 reagents used on the left side of the log: Hematoxylin (#1), Water (running) (#2), Water (running) (#3), Acid Alcohol (#4), Water (running) (#5), Bluing (#6), Water (running) (#7), 95% Alcohol (#8), Eosin (#9), Alcohol (#10), Alcohol (#11), and Xylene Substitute (#12). 4. On each day of testing the laboratory writes the date at the top of the next available column, then writes a letter next to each reagent to indicate what maintenance was performed using the key at the bottom of the log. The key indicates that "N=NEW", "C=CHANGE", "F=FILTER", AND "R=ROTATE". On two of five stain logs reviewed, the laboratory had hand-written "' T.O' = Top-off". 5. Stain log review showed that on 01/22/2025, 01/29/2025, and 06 /04/2025 reagents #1 through #7 were marked "NA"; on 03/12/2025, 03/19/2025, 05 /21/2025, and 07/12/2025 reagents #1 through #7 were marked "NA" and reagents #8 through #12 were marked "TO"; and on 02/26/2025 reagents #1 through #12 were marked "NA". 6. During an interview on 03/19/2026 at 11:30 AM, the HT stated that "NA" meant that the reagents were "not touched" and confirmed that "T.O" meant that the lab had added more reagent to the stainer without disposing of the old reagent. 7. During an interview on 03/19/2026 at 2:00 PM, the LD confirmed that the laboratory did not follow the written procedure for performing histopathology stain maintenance. II. Based on surveyor observation, procedure manual and reagent log record review, and interview with the histotechnologist (HT) and the laboratory director (LD), the laboratory failed to ensure that the laboratory followed written procedures for documenting histopathology reagent information and labeling the reagents with the date they were opened. Findings: 1. The procedure, "Policy # CP-L 1017" "6. B. Reagents" states "All reagents used within the laboratory will be documented on LF- 0006 Reagent Log". "The reagent name, lot number, date received, expiration date, date opened, disposal date, and initials will be logged when available". "When a reagent bottle or container is opened, the date opened will be written directly on the reagent bottle or container". 2. During a tour of the laboratory on 03/19/2026 at 12:00 PM the surveyor observed that the laboratory stored their histopathology reagents in a flammable cabinet. The flammable cabinet contained the following reagents: two opened bottles of "Gill 3 Hematoxylin" (lot #211102, expiration date 04/30/2026); two bottles (one of two opened) of "Eosin-Y Alcoholic 0.25%" (lot #219662, -- 2 of 5 -- expiration date 01/31/2027); two bottles (one of two opened) of "100% Alcohol" (lot #2600802, expiration date 01/08/2029); two bottles (one of two opened) of "95% Alcohol" (lot #2517003, expiration date 06/19/2028, opened and lot #2603502, expiration date 02/04/2029, unopened); and four bottles (two of four opened) of "XS- 3 Xylene Substitute" (lot #231793, expiration date 06/30/2027). 3. None of the opened and in-use histopathology reagents in the laboratory flammable cabinet were labeled with the date that they were opened and put into use. 4. A review of histopathology stain reagent logs from 2025 and 2026 showed that one of the two bottles of "Gill 3 Hematoxylin" (lot #211102, expiration date 04/30/2026) was documented with a "Disposal Date" of 10/02/2025, however the bottle remained in use and was stored in the flammable cabinet. 5. The unopened bottle of "95% Alcohol" (lot #2603502, expiration date 02/04/2029) was not documented on the reagent log. 6. "XS-3 Xylene Substitute" (lot #231793, expiration date 06/30/2027) was logged once on the reagent log, however the laboratory had four bottles of the reagent in the flammable cabinet at the time of the survey. 7. On the 2025 reagent log the laboratory listed four bottles of "Scotts Bluing" with the same lot number and expiration date (lot #134846N, expiration date 09/23/2025), however the "Date Opened" and "Disposal Date" were not documented. "Scotts Bluing" reagent was listed twice on the 2026 reagent log, however there was no lot number or expiration date documented and no reagent present in the flammable cabinet at the time of the survey. 8. During an interview on 03/19/2026 at 12:25 PM the HT stated that the laboratory had just run out of the "Scotts Bluing" reagent and had ordered more. They confirmed that the last bottles used were not documented on the reagent log. 9. During an interview on 03/19/2026 at 2:00 PM, the LD confirmed that the laboratory did not follow the written procedure for documenting histopathology stain reagent information on the reagent log or labeling the reagents with the date they were opened. D5785

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: I. Based on review of the "Cryostat Cleaning & Temperature Maintenance Log" and interview with the histo tech (HT) and the laboratory director (LD), the LD failed to document monthly review of the worksheet to ensure that the HT was maintaining the quality of the cryostat. Findings: 1. The "Cryostat Cleaning & Temperature Maintenance Log" worksheets from January 2024 through August 2024 were reviewed. The upper left hand corner of the worksheet has a section for documenting the monthly review of the worksheet. There were no initials and dates showing that the worksheet had been reviewed each month of testing. 2. During the exit interview on 09/18/2024 at 10:15 AM, the HT and LD confirmed that there was no documentation on the worksheet showing that the data had been reviewed as required. II. Based on review of the final patient reports and interview with the HT and LD, the LD failed to ensure that the case number was on the final report as required. Findings: 1. Three final reports from 2024 were reviewed for accuracy. One of the three failed to include the case number along with the information transcribed from the Moh's surgical map. 2. During the exit interview on 09/18/2024 at 10:15 AM, the HT and LD confirmed that the case number was missing from one of the three final reports that were reviewed. 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 --