Genesis Dermatology

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 7/28/22 at Genesis Dermatology, a clinical laboratory in Jupiter, Florida. Genesis Dermatology is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to include the address of the laboratory for five of five patients' Mohs surgical procedure Visit Notes (#1, #2, #3, #4, #5). The findings included: Review of patients' Visits Notes showed the address of the laboratory was not listed on the reports. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 08/01/2022, the laboratory's annual test volume was 280 tests. On 07/28/2022 at 11:07 AM, Practice Administrator confirmed the Visit Notes was given to patients who requested a report of their Mohs surgical procedure and that the address of the laboratory was not on the Visit Notes. 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 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/2/20 at Genesis Dermatology, a clinical laboratory in Jupiter, Florida. Genesis Dermatology is not in compliance with 42 Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the technical supervisor evaluated performance of one of two testing personnel. The findings included: Review of competency records on 9/2 /20 revealed that there were competencies documented for the histotechnician in 2018 and 2020, but not 2019. During an interview with the practice administrator on 9/2/20 at 10:30 a.m., she confirmed they must have missed performing the competency in 2019. 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 --

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 observation, record review, and interview with laboratory personnel, there was an expired reagent in the flamable cabinet in the laboratory. Findings include: During tour of the laboratory at 11:30 a.m. on 07/25/2018, the surveyor found a bottle of Gill 3 Hematoxylin that expired on 04/18. The bottle was received on 01/18/2018 and opened on 01/28/18. The surveyor reviewed the reagent logs, and this lot of hematoxylin was not logged in. During an interview with the office manager at 12:05 p.m. on 07/25/2018, she said that it was probably the bottle that a neighboring laboratory borrowed when they ran out, and maybe that was why it had not been logged in. 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 --