Epiphany Dermatology, Pa

Summary Statement of Deficiencies D0000 . An onsite survey conducted on 1/18/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. . 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 review of laboratory final reports and confirmed in interview, the laboratory failed to include the address of the laboratory location where the test was performed on six of six Mohs maps, included in the patient final report, reviewed in 2020 and 2021. The findings include: 1. Review the following six patient final reports from 2020 and 2021 included a 'Mohs Micrographic Map' worksheet that did not include the address of the laboratory location where the testing was performed; 2020 - Three patient final reports reviewed: M20-566 M20-580 M20-535 2021 - Three patient final reports reviewed: M21-628 M21-636 M21-601 2. In an interview on 1/18 /2022 at 11:30 hours, testing personnel (TP) 4 confirmed the above findings. . 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of laboratory procedures, testing personnel competency verification documentation and staff interview, the laboratory had no written procedure for performance of parasite identification examinations. Findings: 1. Review of testing personnel education and training documents showed notations of competency verification for potassium hydroxide (KOH) fungal/mineral oil scabies examinations. 2. In an interview at the site on 10-07-2019, testing person 3 (CMS form 209) stated that mineral oil preps for scabies identification were occasionally performed by providers. 3. While the laboratory policy manual included a procedure for KOH fungal examinations, it did not include a procedure for scabies identification testing. This finding was confirmed in the exit interview on 10-07-2019 by testing person 3 and shared with the laboratory director at that time. 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 --