Summary:
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 document review and interview, the laboratory director failed to sign and date three of three procedures reviewed indicating his/her approval of changes and/or updates. Findings Include: 1) The following policy updates from 11/2014 were not signed and dated by the laboratory director: a. "Procedure and Form: Histopathology- Mohs Surgery...Updated 11/2014 b. "Procedure Ectoparasites...Updated 11/2014 c. "Procedure Potassium Hydroxide (KOH) Examination of Skin, Hair, or Nails... Updated 11/2014 2) Medical record review indicated the following patients having laboratory testing performed: PT1=8/7/17 PT2=9/25/17 PT3=10/25/17 PT4=11/13/17 PT5=12/4/17 PT6=5/7/18 PT7=4/4/18 PT8=3/26/18 PT9=2/12/18 PT10=1/8/18 PT11=8/28/17 PT12=8/9/17 2) In interview on 9/4/18 at 12:24 pm, staff member SP-2 confirmed the above procedures had not been signed and dated by the laboratory director indicating approval. 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 --