Epiphany Dermatology Of Oklahoma, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/26/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the clinic supervisor at the conclusion of the survey. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 a review of a written procedure and interview with the clinic supervisor, the laboratory failed to ensure one of one written procedure had been approved, signed, and dated by the laboratory director. Findings include: (1) On 03/26/2025 at 10:30 am, the clinic supervisor stated scabies testing was performed as a PPM (Provider Performed Microscopy) procedure; (2) A review of the procedure titled, "KOH Protocol/Scabies" identified no indication it had been approved, signed, and dated by the laboratory director; (3) The findings were reviewed with the clinic supervisor who stated on 03/26/2025 at 10:55 am, the procedure had not been signed and dated by the laboratory director. 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 The recertification survey was performed on 04/04/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the office manager at the conclusion of the survey. 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 a review of a written procedure and interview with the office manager, the laboratory failed to ensure a written procedure had been approved, signed, and dated by the laboratory director. Findings include: (1) On 04/04/2023 at 11:50 am, the office manager stated KOH (Potassium Hydroxide) testing was performed as a PPM (Provider Performed Microscopy) procedure; (2) A review of the procedure titled, "KOH Protocol" identified no indication it had been approved, signed, and dated by the laboratory director; (3) The findings were reviewed with the office manager who stated on 04/04/2023 at 01:50 pm, the procedure had not been signed and dated by the laboratory director. 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 The initial survey was performed on 04/15/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the clinical manager at the conclusion of the survey. 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 a review of procedure manual and interview with the clinical manager, the laboratory failed to ensure written policies and procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) On 04/15/2021 at 10:30 am, the clinical manager stated to the surveyor the laboratory performed microscopic interpretations on skin specimens, obtained from Mohs surgery; (2) The survey reviewed the "Quality Assessment Manual", which contained written policies and procedures. There was no indication the manual had been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the clinical manager, who stated on 04/15/2021 at 12:40 pm, the manual contained the policies and procedures and had not been signed and dated by the laboratory director. 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 --