Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted on October 26, 2021. Tarantola Dermatology clinical laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. 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 record review and interview with laboratory staff, the laboratory director failed to sign the policy and procedure manual since 2019. Findings included: Review of the policy and procedure manual revealed that it was last signed May 7, 2019. During interview with laboratory staff at 11:45 on 10/26/2021, it was confirmed the policy and procedure manual had not been signed since 2019. 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 --