Kuchnir Dermatology And Dermatologic Surgery

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview with the histology preparation technician (HPT), the laboratory failed to have a written policy for verifying the function of the eyewash station,and no evidence was found that routine checks were performed. Findings include: 1. Surveyor observation on 5/22/2026 at 11: 00 AM of the laboratory area identified 1 plumbed eyewash station. 2. Record review on 5/22/2026, of the laboratory's procedure manual revealed the manual did not include a policy addressing eyewash maintenance and function checks. 3. Record review on 5/22/2026 of the laboratory's 2024, 2025 and 2026 to date equipment maintenance records revealed a document titled 'Eyewash Station' containing weekly dates. Review further revealed a "Checked By" column that had not been initialed from 7/20/2024 through the time of the survey. 4. Staff interview with the HPT on 5 /22/2026 at 11:15 AM confirmed the above findings. The HPT stated, "I checked it, I just didn ' t get a change to initial the sheet." D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. 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 record review and interview with the histology preparation technician (HPT) the laboratory did not have a written policy for performing preventative maintenance on the laboratory microscopes and did not perform the weekly maintenance as indicated on the laboratory's maintenance worksheets within the specialty of Histopathology. Findings include: 1. Surveyor observation on 5/22/2026 at 10:15 AM of the laboratory and office area identified 2 microscopes. 2. Record review on 5/22 /2026, of the laboratory's procedure manual revealed the manual did not include a policy addressing microscope maintenance and function checks. 3. Record review on 5 /22/2026 of the laboratory's 2024, 2025 and 2026 to date equipment maintenance records revealed a document titled 'Microscope Maintenance' containing weekly dates. Review further revealed a "Checked By" column that had not been initialed from 7/20/2024 through the time of the survey. 4. Staff interview with the HPT on 5 /22/2026 at 10:31 AM: a. Confirmed that microscope cleaning is required to be performed weekly, as indicated on the maintenance sheets. b. The HPT stated, "I was told I didn't need to do weekly maintenance if I did yearly preventative maintenance." 5. The laboratory performs 896 tests annually in the specialty of Histopathology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Kuchnir Dermatology and Dermatologic Surgery laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 interview, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's procedure for twice annual peer slide review of pathology cases on 1/8/2020. The review revealed that laboratory's procedure for peer slide review of pathology cases stated that four (4) to eight (8) cases would be twice annually reviewed by another dermatopathologist to verify the accuracy of the diagnoses. A review of calendar years 2018 and 2019 quality assessment records for pathology revealed that there was no documentation available to verify that the laboratory performed twice annual peer slide reviews for pathology cases for calendar year 2019. The documented reviews were performed on 7 /1/18, 12/15/18 and 1/7/2020. The histotechnician interviewed on 1/8/2020 at 1:11 P. M. verified that the twice annual peer slide review for calendar year 2019 was not performed in 2019. The histotechnician stated it was performed on 1/7/2020 for eight (8) cases from calendar year 2019. This is a repeat deficiency that was cited at the survey performed on 1/6/2016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory director did not ensure that the proficiency testing samples were tested as required under Subpart H of this part as evidenced by the following:. The surveyor reviewed the laboratory's twice annually peer slide review documentation of pathology cases for calendar years 2018 and 2019 on 1/8/2020. The review revealed that the laboratory director failed to ensure that the laboratory performed twice annual peer slide reviews for pathology cases for calendar year 2019. The histotechnician interviewed on 1/8/2020 at 1:11 P.M. verified that the laboratory director did not ensure that twice annual peer slide review of pathology cases was performed for calendar year 2019. -- 2 of 2 --