Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at BPC Plasma, Inc on May 06, 2025 through May 12, 2025 . The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 record review and staff interview, the Laboratory Director had not signed the laboratory procedure manual since May of 2023. Findings included: 1-Review of the CMS 209 form signed by the Laboratory Director on 05/06/2025 listed current laboratory director (LD) for the laboratory who is also Clinical Consultant (CC) and Technical Consultant (TC) for the for moderate complexity laboratory. 2-Review of the Medical Department Qualifications and Responsibilities MED-002 procedure for the Laboratory Director responsibilities did not list the approval of the procedure manual. 3- During an interview 05/06/2025 at approximately 2:07 PM, the center Quality Manager (CQM) confirmed that the laboratory procedure manuals were not signed by the current laboratory director. 4- Email on 5/12/2025 at 10:05 AM from the CQM confirmed current laboratory director since November 18, 2022. 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 --