Epiphany Dermatology, Pa

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.1412 Testing Personnel, moderate complexity D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 policy, patient final reports, and confirmed in interview, the laboratory failed to follow its own written policy for reporting patient KOH (potassium hydroxide) results for one of five patients in August 2023 (random review) and one of three patients in January 2025. Findings included: 1. Review of the laboratory's policy titled "Potassium Hydroxide Procedure Protocol" stated: "PROCEDURE ... Clinical Staff ... CLIA Required Paperwork ... Diagnosis (Positive or Negative)" 2. A random review of patient final reports from 2023 and 2025 revealed the following: 08/17/2023 Patient MRN: MM0001145827 Plan: KOH Prep "Examination of the slide showed: branching hyphae." 01/24/2025 Patient MRN: MM0003228674 Plan: KOH Prep "Examination of the slide showed: branching hyphae." The above results were not documented on the patient final reports as positive. The laboratory failed to follow their own written policy for reporting patient KOH results. 3. During an interview on 03/26/2025 at 11:59 a.m., the laboratory representatives after a review of the records confirmed the laboratory failed to follow their own written policy for reporting patient KOH results. Word Key: MRN- medical record number Prep- preparation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of CMS 209 form, laboratory policy, personnel records, and confirmed in interview, the Technical Consultant (who is also the laboratory director) failed to evaluate and document the performance of one of four Testing Persons (TP- 3) who perform moderate complexity testing, at least semiannually during the first year the Testing Person tested patient specimens in 2023. Findings included: 1. Review of the CMS 209 form listed TP-3 as an individual who performed moderate complexity testing, which included microscopic procedures. 2. Review of the laboratory's policy "Laboratory: Quality Assessment, Competency Assessment" stated: "PROCEDURE ... 2. The following individuals are required to have competency assessments: Clinical consultant (if applicable) Technical consultant (if applicable) Technical Supervisor (if applicable) General Supervisor (if applicable) Testing personnel Dermatologists Dermatopathologists ... 4. Anyone who performs testing on patient specimens is required to have documented competency assessments on file including the following 6 categories: Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing Monitoring the recording and reporting of test results Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observations of performance of instrument maintenance and function checks Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples Assessment of problem-solving skills 5. The Laboratory Director or Technical Supervisor (if applicable) is responsible for performing all competency assessments ... Physicians ... 2. Competency shall be assessed semiannually the first year and annually after that." 3. Review of personnel records for TP-3 revealed the following: Hire date 10/10/2022 There was no record of semiannual competency evaluations for TP-3. The technical consultant did not ensure semi-annual competency assessments were evaluated and documented for TP-3. 4. During an interview on 03/26/2023 at 11:40 a.m., the laboratory representatives confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of CMS 209 form, laboratory policy, personnel records, and confirmed in interview, the Technical Consultant failed to evaluate and document the annual competency assessments for two of four Testing Persons (TP-3, TP-4) who perform moderate complexity testing in 2024 and 2025. Findings included: 1. Review of the CMS 209 form listed TP-3 and TP-4 as individuals who performed moderate complexity testing, which included microscopic procedures. 2. Review of the laboratory's policy "Laboratory: Quality Assessment, Competency Assessment" -- 2 of 4 -- stated: "PROCEDURE ... 2. The following individuals are required to have competency assessments: Clinical consultant (if applicable) Technical consultant (if applicable) Technical Supervisor (if applicable) General Supervisor (if applicable) Testing personnel Dermatologists Dermatopathologists ... 4. Anyone who performs testing on patient specimens is required to have documented competency assessments on file including the following 6 categories: Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing Monitoring the recording and reporting of test results Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observations of performance of instrument maintenance and function checks Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples Assessment of problem-solving skills 5. The Laboratory Director or Technical Supervisor (if applicable) is responsible for performing all competency assessments ... Physicians ... 2. Competency shall be assessed semiannually the first year and annually after that." 3. Review of personnel records for TP-3 and TP-4 revealed the following: TP-3: Hire date 10/10/2022 There was no record of annual competency evaluations for TP-3 in 2024. The technical consultant did not ensure an annual competency assessment was evaluated and documented for TP-3. TP-4 was also delegated as the Laboratory Director and Technical Consultant. His personnel records revealed annual competency assessments performed on 02/21 /2024 and 02/28/2025 by TP-2. TP-2 was NOT delegated as a Technical Consultant. 4. During an interview on 03/26/2023 at 11:00 a.m., the laboratory representatives confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) 209 form, laboratory policy, personnel records, and confirmed in interview, the laboratory failed to have documentation that one of three testing persons (TP-3) met the qualifications required to perform moderate complexity testing prior to performing patient testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 -- 3 of 4 -- weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) 209 form, laboratory policy, personnel records, and confirmed in interview, the laboratory failed to have documentation that one of three testing persons (TP-3) met the qualifications required to perform moderate complexity testing prior to performing patient testing. Findings included: 1. Review of the CMS-209 form included TP-1 through TP-4 listed to perform moderate complexity testing. 2. Review of the laboratory's policy titled "Quality Assessment, Competency Assessment" stated: "QUALITY ASSURANCE ... 2. Personnel files are maintained for each employee to include a record of the employees' formal education (high school diploma or equivalent, college degree, medical degree), record of certification or licensure if applicable, documentation of continuing education, proficiency evaluations, and competency assessments." 3. A random review of personnel records revealed the laboratory did NOT have educational documentation to ensure TP-3 was qualified to perform moderate complexity testing. The laboratory was asked to provide documentation of TP-3's education on 03/26/2025 at 11:16 a.m. No documentation was provided. 4. During an interview on 03/26/2025 at 11:25 a.m., laboratory representatives confirmed the laboratory failed to have documentation that one of three testing persons (TP-3) met the qualifications required to perform moderate complexity testing prior to performing patient testing. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory records, patient records, and confirmed in interview, the laboratory failed to ensure 1 of 6 patient KOH (potassium hydroxide) preparation results were transcribed accurately to the final test report in 2022 (random review September 2022 through April 2023). The findings include: 1. Review of the laboratory's policy titled "KOH Protocol" revealed: "RESULTS: There should be no air bubbles under the coverslip that might obscure the dermatophytes. A correctly prepared slide will allow the physician and/or mid-level provider to render a fast and correct diagnosis of a specimen. A normal, or negative, KOH test shows no evidence of fungi. Dermatophytes or yeast seen on a KOH test indicate that the person has a fungal infection. Fungi causing ringworm infections produce septate (segmented) hyphae, or long branch-like tubular structures. Yeast cells appear round and oval. Budding forms may be seen. KOH cannot identify the specific organism. If necessary, a biopsy can be procured and submitted for permanent pathologic processing, or a second scraping may be taken and submitted for culture." 2. Review 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 -- of the laboratory's "Mycology Log" and corresponding patient final reports revealed the following: 12/15/2022 MRN: MM0002499334 Mycology Log: "(+)" Final report: "Examination of the slide showed: +/- results" The laboratory failed to accurately transcribe results of KOH preparations to the final reports. 2. During an interview on 05/16/2023 at 10:34 a.m., the Office Manager confirmed the above findings. -- 2 of 2 --