Layton Avenue Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyor observation of reagents in the laboratory and interview with testing personnel, testing personnel used expired Gill 3 hematoxylin stain four of the last four months. Findings include: 1. Observation of stains in the laboratory on April 24, 2023 at 1:25 PM revealed an opened bottle of Gill 3 hematoxylin, lot 122924, expiration date December 31, 2022. Continued observation showed no other opened hematoxylin stain in the laboratory. 2. Interview with testing personnel (staff A) on April 24, 2023 at 1:25 PM confirmed testing personnel stained all patient Hematoxylin & Eosin slides made after December 31, 2022 using the expired hematoxylin reagent. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the laboratory did not document the testing of the hematoxylin and eosin (H&E) stain 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 -- for intended reactivity for four of four Mohs cases reviewed. Findings include: 1. Random review of records for four Mohs cases performed in 2022 showed no record of stain quality documentation for each day of testing. 2. Interview with testing personnel (staff A) on April 24, 2023 at 1:30 PM confirmed testing personnel had not evaluated and documented the H&E evaluation for intended reactivity each day of use. -- 2 of 2 --

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of testing personnel records and interview with the practice manager, staff A, the technical supervisor did not evaluate the semiannual competency for one of one new testing personnel performing high complexity testing. Findings include: 1. Review of testing personnel records showed initial training performed in June 2020 for staff B. Further review showed no evaluation of semiannual competency for staff B. 2. Interview with staff A on August 30, 2021 at 10:05 AM confirmed the technical supervisor did not evaluate the semiannual competency for one of one new testing personnel performing high complexity testing. 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 --