Integrated Dermatology Of 19th Street Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 7/29/26. Standard level deficiencies were cited. 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: Based on a review of the laboratory's procedure, maintenance log, and in an interview with the consultant, the laboratory failed to ensure that cryostat temperature ranges were consistent between their written procedure and logs for 1 of 1 month. Findings included: 1. Review of the laboratory's written procedure included cryostat internal temperature defined as, "Cryostats are kept within a range of -18 to -31 degrees C." 2. Review of "Hematoxylin and Eosin Staining Maintenance Log" from 8/2026 included the following defined temperature range, "Cryostat Temp Value -24C - -30C." 3. During an interview on 7/29/26 at 11:00 am, the consultant confirmed the inconsistent cryostat temperature between the procedure and the log. 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. 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 -- This STANDARD is not met as evidenced by: Based on direct observation and in an interview with the Mohs technician, the laboratory failed to ensure 2 of 2 expired reagents were not available for use when processing Mohs specimens. Findings included: 1. During a tour of the laboratory on 7 /29/26 at 10:19 am, the following expired reagents were observed stored in the flammable cabinet: One gallon bottle of Epredia Clear-Rite 3 (used for prepping specimens), Lot 144586, expiration date 7/10/2026. One gallon bottle of Epredia Bluing Reagent (used for staining), Lot 144447, expiration date 7/11/2026. 2. During an interview on 7/29/26 at 10:22 am, the Mohs technician confirmed the reagents were expired. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observations and interview with the Mohs Technician and a management staff on July 2, 2018 at approximately 1:30 PM and 2:00 PM respectively, the laboratory failed to ensure that an adequate space is provided for staining Mohs surgery slides. The findings included: 1. The laboratory uses a moveable staining station with a table top hood (G-Series Containment Hood). The staff moves the staining station from storage to the laboratory / patient exam room /Mohs room on the days the laboratory performed Mohs procedure. The staining station is placed behind a big unmovable examination chair. 3. The station is on top of a very low table. The Mohs Technician demonstrated to the surveyor how the staff process the slides, by squatting. In addition, due to the height of the table and the position of the exam chair, the lighting inside the hood is inadequate. There is very little room between the chair and the processing station. 4. Interview with the Mohs Technician revealed that he/she had been able to use the station with some difficulty. 5. The lack of adequate space was discussed with management staff at the time of the exit conference. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)