Epiphany Dermatology, Pa

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory's policy and procedure, patient testing log, and interview, the laboratory failed to document the internal controls for the hCG (Human Chorionic Gonadotropin) Pregnancy Test Strip for 21 of 21 months reviewed. Findings follow. A. Review of the Medline hCG Pregnancy Test Strip (urine) package insert (V2 RB22WON) under Quality Control stated, "Internal procedural controls are included in the test. A red band appearing at the C line is the positive procedural control if the proper testing procedure is followed. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test results." B. Review of the laboratory's policy and procedure titled hCG Urine Pregnancy Test, effective 2021, under Results, stated "Interpretation of results: Positive: Two distinct red lines should appear. One line should be in the control region (C) the other line should be in the test region (T). Negative: One red line should be in the control region (C). No apparent red or pink line appears in the test region (T). Invalid: Control line fails to appear (C)." The procedure did not have a section for quality control. C. Review of the Urine Pregnancy Test Log from 07/12/21 - 05/01/23 showed no results for the red band control line or the clear background internal quality controls. Review of the log showed 66 patient tests were performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- from 07/12/21 - 05/01/23. D. Interview with the medical assistant on May 2, 2023 at 1510 hours in the hall where the pregnancy tests were stored acknowledged she was not aware of the control line until explained, and confirmed it was not documented on the pregnancy log. 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 review of accuracy assessments, laboratory's policy and procedure, patient testing logs, and interview, the laboratory failed to perform twice a year accuracy assessments of its Frozen Section Biopsies for the dermatopathology interpretations for one of two years reviewed. Findings follow. A. Review of accuracy assessments from 2021 and 2022 for the dermatopathology interpretations of Frozen Sections Biopsies showed none available for review for 2021. B. Review of the laboratory's policy and procedure titled Proficiency Testing and Peer Review, effective January 2020, under Procedure stated, "...2. Proficiency shall be assessed at least semiannually. 3. Proficiency for Epiphany Dermatology Mohs Surgeons shall be assessed using one of the following methods. The Laboratory Director shall choose and implement whichever option works best for their particular laboratory. Laboratories will be required to pay for External Quality Control. Internal Peer Review and Epiphany Dermatology Company Peer Review are provided at no cost to the Mohs laboratories. External Quality Control Program Semiannually the Mohs technician shall randomly select a minimum of 2 cases per each Mohs surgeon. If the Mohs surgeon also performs biopsies for frozen section analysis, sample frozen cases should also be selected..." C. Review of the Frozen Biopsy Log showed from 01/22/21 - 11/29/21 there were four cases reported. D. Interview with the Clinical Operations Manager on May 2, 2023 at 1445 hours in the breakroom confirmed accuracy assessments for Frozens were not performed in 2021. 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 the Mohs map and interview, the laboratory failed to include the correct date of birth on the Mohs map for one of ten cases reviewed from 05/25/21 - 02/20/23. A. Random review of 10 Mohs cases from 05/25/21 - 02/20/23 showed one Mohs map compared to the chart notes showed the date of birth was incorrect, as listed by case number and date of service: K21-97 from 12/13/21. B. Interview with -- 2 of 3 -- the Clinical Operations Manager on May 2, 2023 at 1730 hours in the breakroom confirmed the date of birth on the Mohs map was incorrect. -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, testing logs, and interview, the laboratory director failed to approve, sign, and date 18 of 18 laboratory policies and procedures prior to use. Findings follow. A. Random review of the laboratory's policies and procedures contained in the Policy and Procedure Manual and the Quality Assessment Manual showed the laboratory director had not approved, signed and dated any of the policies and procedures. 1. Review of the Policy and Procedure Manual included the following policies and procedures: a. Mohs Surgery Policy b. Mohs Surgery; Criteria for Rejection of Specimens c. Mohs Surgery and Frozen Section; Cryostat Maintenance d. Mohs Surgery and Frozen Section; Specimen and Record Retention e. Mohs Surgery and Frozen Section; Microscope Use Protocol f. Frozen Section Procedure g. KOH Protocol 2. Review of the Quality Assessment Manual included the following policies and procedures: a. Mohs Surgery and Frozen Section Analysis, Quality Assessment; Communications b. Mohs Surgery and Frozen Section Analysis, Quality Assessment; Competency Assessment c. Mohs Surgery and Frozen Section Analysis, Quality Assessment; Complaint Investigation d. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Proficiency Testing e. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Specimen Identity and Integrity f. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Environment, Instruments, Reagents, Materials, and Supplies g. Mohs Surgery and Frozen Section Analysis, Quality Assessment; Histopathology Quality Control h. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Procedure Manual i. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Slide Quality Assessment j. Mohs Surgery and Frozen Section Analysis; Quality 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 -- Assessment; Comparison of Test Results k. Mohs Surgery and Frozen Section Analysis; Quality Assessment; Test Reports B. Interview with the receptionist on November 10, 2021 at 1425 in the laboratory confirmed the findings. C. Review of the Mohs Surgery Log Sheet showed the laboratory began testing Mohs on 6/06/2020. 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, review of patient testing logs, and interview, the laboratory failed to ensure stains used for the Hematoxylin and Eosin stain used to prepare slides for Mohs were not used when they had exceeded their expiration date and tested 10 patient cases. Findings follow. A. On November 10, 2021 at 1500 in the laboratory the surveyor observed the following expired reagents in the flammable cabinet: 1. Leica Surgipath Harris Hematoxylin, Lot 042420, expired 10/24/2021, and 2. Leica Surgipath Hematoxylin Gill III, Lot 032420, expired 09/24/2021. B. Review of the Mohs Surgery Log Sheet showed 10 Mohs cases had been performed on 10/26/2021, accession number K21--78 to K21-87. C. Interview with the receptionist on November 10, 2021 in the laboratory confirmed the stains were expired, and no other Hematoxylin was available in the laboratory for slide preparation. -- 2 of 2 --