Dermatologic Surgery Center Of Washington Llc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the procedure manual, staining solutions logs, and the chemical products inventory log, and interview with the histotech (HT), the laboratory failed to ensure that staining reagents were not used beyond their expiration date. Findings: 1. The laboratory performed hematoxylin and eosin staining on Mohs surgery specimen slides. 2. The "Laboratory Procedure Manual Histopathology-Mohs surgery" stated, "Do not use reagent after expiration date." 3. Staining reagent lot numbers were documented on the "Staining Solutions Log" for each day Mohs surgery was performed. 4. The expiration and discard dates for each lot of staining reagent was documented on the "Chemical Products Inventory." 5. Logs showed that the hematoxylin staining reagent lot 180520 expired on 03/31/2025 but was used on patient slides in April 2025. Records showed that the reagent was discarded on 06/30 /2025. 6. Logs showed that the ultraclear staining reagent lot 2306864 expired at the end of 06/2025 but was used on patient slides in July 2025. Records showed that the reagent was discarded on 07/29/2025. 7. During the exit interview on 11/19/2025 at 12:00 PM, the HT confirmed that hematoxylin and ultraclear staining reagents were used for staining beyond their expiration dates. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and 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 -- complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of potassium hydroxide (KOH) testing records and interview with the histotech (HT), the laboratory failed to ensure that testing personnel performing KOH testing procedures were evaluated for competency. Findings: 1. The laboratory personnel report (form CMS-209) listed eight testing personnel (TP) who performed KOH slide preparations and evaluations. 2. During the exit interview on 11/19/2025 at 12:00 PM, the HT confirmed that there were no competency evaluation records for the eight TP performing KOH testing procedures. -- 2 of 2 --

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 (PT) record review and interview with the histotechnician, the laboratory did not ensure that PT was performed at least twice annually. Findings: 1. The procedure, "Quality Control" states that "Twice a year, 4 random selected slides will be sent to (off-site pathologist)." 2. A review of "Quality Control Logs" from 2022 and 2023 showed that eight histology cases were sent out for PT on 03/02/2022 and eight cases were sent out for PT on 06/20/2023. 3. During an interview on 01/11/2024 at 12:00 PM, the histotechnician confirmed that PT slides were not sent out at least twice annually for confirmation by a second pathologist to verify the accuracy of testing. 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 laboratory procedure manual and record review and interview with the histotechnician, the laboratory did not ensure that the procedure for changing and discarding histopathology stains accurately reflected the current practice in the 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 -- laboratory. Findings: 1. The procedure, "Quality Control" states that "All solutions are discarded every other week." The "Mohs Daily Quality Control" procedure states that "all solutions will be discarded at the end of each Mohs procedure day." 2. A review of "Staining Solutions Logs" from 09/11/2023 through 12/18/2023 showed that the "Hematoxylin" was "changed out" (discarded and replaced) 11 out of 27 days of testing; the "100% Alcohol" was changed out 13 out of 27 days; the "95% Alcohol" was changed out 18 out of 27 days; the "Eosin" was changed out 11 out of 27 days; the "Xylene Substitute" was changed out 10 out of 27 days; the "Scotts Tap Water" was changed out 11 out of 27 days; and the "Acid Alcohol" was changed out 9 out of 27 days of testing. 3. During an interview on 01/11/2024 at 12:00 PM, the histotechnician stated that the laboratory does not discard stain solutions after each day of testing and confirmed that the procedure manual needed to be updated. -- 2 of 2 --