Highline Dermatology& Skin Cancer

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 record review and an interview with the practice manager (not listed on the CMS 209 Laboratory Personnel Report form), the laboratory did not perform one of the two required twice yearly accuracy verifications of its Mohs testing procedure for the years 2024 and 2025. Findings: 1. A review of the "QA Slide Review Check In /Out" log and the "Mohs Case Quality Assurance Form" lacked documentation of a second half accuracy verification for the years 2024 and 2025. a. In 2024, slides were sent for review on 1/23/24; no slides were sent for review during July-December 2024. b. In 2025, slides were sent for review on 1/2/25; no slides were sent for review during July-December 2025. 2. The laboratory failed to follow its procedure for "Verification of Test Accuracy" to send at least two cases every six months. 3. An interview on March 17, 2026, at 10:30 AM with the practice manager (not listed on the CMS 209 form) confirmed the laboratory did not perform one of the two twice yearly accuracy verifications of its Mohs testing procedure for the years 2024 and 2025. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) (b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and an interview with the practice manager (not listed on 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 -- CMS 209 Laboratory Personnel Report form), the laboratory did not document the time it received 11 out of 11 excised tissue specimens for six patients from February 19, 2024, to February 26, 2026. Findings: 1. A review of the Mohs Micrographic Surgery Operative Map revealed that six patient files (11 excised tissue specimens) did not include the time the laboratory received each specimen. M24 120 - date of service (DOS) February 19, 2024; three excised tissue specimens M24 295 - DOS May 6, 2024; one excised tissue specimen M24 685 - DOS October 22, 2024; one excised tissue specimen M25 441 - DOS July 22, 2025; four excised tissue specimens M25 702 - DOS October 23, 2025; one excised tissue specimen M26 165 - DOS February 26, 2026; one excised tissue specimen 2. An interview on March 17, 2026, at 1:00 PM with the practice manager (not listed on the CMS 209 form) confirmed the laboratory did not document the time it received 11 out of 11 excised tissue specimens for six patients from February 19, 2024, to February 26, 2026. -- 2 of 2 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of procedures, patient records and slides, and interview with Testing Personnel (TP) # 3, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the preanalytic systems from January 1, 2021 to June 29, 2022. Findings: 1. Review of Specimen Handling, Storage, Preservation and Identification procedure revealed, "3.4.9 Slides are labeled with the Mohs number, patient name, date, stage (roman numeral), piece # (numbers) and slide # (numbers)." 2. Review of patient slides revealed inconsistent labeling:. M22-229, M21-178 labels lacked stage #, piece # and slide #; M22-117(II), M22-234 (II) labels lacked piece # and slide #; M22-126 (III)1, M22-126 (II)2, M22-126(II)1, M21-176(II)1-3, lack slide #; and M20-81(I)C, M20-81 (I)B lack piece #. 3. No documentation of

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 failed to record temperature and humidity at the frequency described in their Quality Assurance Program. Findings: 1. Review of Quality Assurance Program, General Laboratory Cleaning and Safety, Equipment Quality control for Cryostats procedure revealed "1) Room temperature and humidity is checked and recorded daily." 2. Review of Room Temperature & Humidity Log documents for August through December of 2020, revealed temperature and humidity values recorded only on days of Cryostat use. 3. Confirmed during interview with Laboratory Director (LD) on 12/10/2020 at 11:50 am, the Room Temperature & Humidity Logs lacked daily record of temperature and humidity as described in the Quality Assurance Program. 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 --