Dermatology Associates Of Cny Pllc

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observations, review of the Safety Data Sheets (SDS), reagent manufacturer's storage requirements, approved standard operating procedures (SOPs), as well as interview with the Testing Person (TP), the laboratory failed to properly store flammable reagents in the Mohs processing laboratory and Storage Closet as required by the SDS and reagent manufacturer's storage requirements. FINDINGS: 1. The surveyors' observations in the Mohs processing laboratory and Storage Closet confirmed on July 31, 2024, at approximately 11:30 A.M. the following reagents and processing materials were not properly stored in the flammable materials storage cabinet as required by the SDS and the reagent manufacturer's storage requirements: a. Avantik Gill3 Hematoxylin lot: 178237 expiration: January 31, 2025, was retained in a lower cabinet in the Mohs processing laboratory and Storage Closet. Lot: 193125 expiration: September 30, 2025, was retained in the Storage Closet. b. Avantik Eosin Working Solution lot: 43050631 expiration: May 22, 2025, was stored in a lower cabinet in the Mohs processing laboratory. Lot: 44010010 expiration: January 29, 2026, was retained in the Storage Closet. c. Avantik Xylene lot: KMH22XYL was stored in a lower cabinet in the Mohs processing laboratory. d. EKI SafeClear Xylene Substitute lot: 2405176 was retained in in a lower cabinet in the Mohs processing laboratory and Storage Closet. e. Avantik 95% Reagent Alcohol lot: 2329612 expiration: October 25, 2026, was retained in a lower cabinet in the Mohs processing laboratory and Storage Closet. Lot: 2316716 expiration: June 19, 2026, was retained 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 -- in the Storage Closet. f. Avantik 100% Reagent Alcohol lot: 2327242 expiration: October 3, 2026, was retained in a lower cabinet in the Mohs processing laboratory and Storage Closet. Lot: 2410303 expiration: April 16, 2027, and lot: 2415111 expiration: June 4, 2027, were retained in the Storage Closet. g. CareMount2 lot: 196904 expiration: April 30, 2026, was stored in an overhead cabinet in the Mohs processing laboratory. 2. The current, approved 4.3 "Storage, Use and Handling" SOP did not include such instructions. 3. The TP confirmed the findings on July 31, 2024, at approximately 1:30 P.M. 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 direct observations, review of SDS and approved SOPs, lack of room temperature records, as well as interview with the TP, the laboratory failed to monitor and document ambient room temperatures in the areas where on-site laboratory testing was performed and reagents, processing materials were stored. FINDINGS: 1. There was no documentation of ambient room temperatures in the Mohs processing laboratory and Storage Closet where on-site laboratory testing was performed and reagent and processing materials were stored. 2. This is contrary to instructions included in the current, approved "Temps" section 4.3.2 SOP. 3. The Avantik Gill3 Hematoxylin, Eosin Working Solution, 95% Reagent Alcohol, and 100% Reagent Alcohol SDS included instructions for reagent storage in a "cool, well-ventilated place". 4. The TP confirmed the findings on July 31, 2024, at approximately 1:30 P. M. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor's review of the competency assessment policies, lack of the current competency records and an interview with the Mohs' technician/office manager, the laboratory failed to follow its written policies for competency assessment for two of two Mohs technicians as evidenced by the lack of written competency assessment evaluations for calendar years 2018 and 2019. FINDINGS: 1. The Mohs' technician /office manager confirmed on January 24, 2020 at approximately 10:30 AM, that the laboratory failed to follow the written competency assessment policies, that requires an annual evaluation for the Mohs' technicians based on their duties and responsibilities. 2. The laboratory director, acting as the technical supervisor, failed to perform the annual evaluation for two of two Mohs' technicians for the calendar years 2018 and 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. 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 a surveyor's review of Quality Assessment (QA) policy and confirmed in an interview with the Mohs' technician/office manager at the time of this survey, the laboratory failed to follow the laboratory's written QA policy and perform an annual QA review for the calendar years 2018 and 2019. FINDINGS: The Mohs technician /office confirmed on January 24, 2020 at approximately 10:00 AM the laboratory director failed to ensure that the annual QA reviews were performed and documented, as required by the QA policy, for the calendar years 2018 and 2019. 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: Based on surveyor's review of the laboratory records, QA policy and an interview with the Mohs technician/office manager, the laboratory director failed to ensure the laboratory quality assurance policies were maintained. Refer to D5291. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory polices and procedures, Mohs' technicians personnel records and an interview with the Mohs technician/office manager, the laboratory director failed to ensure written competency assessment policies and procedures were maintained for the calendar years 2018 and 2019. Refer to D5209. -- 2 of 2 --