Octapharma Plasma, Inc

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form CMS-209 "Laboratory Personnel Report (CLIA)" and personnel records and interview with the center director, the laboratory did not have documentation showing one of six new testing personnel reviewed met the academic qualification requirements for moderate complexity testing personnel at 493.1423. Findings include: 1. The laboratory did not have documentation before June 7, 2022 showing one of six reviewed new testing personnel had met the academic qualification requirements for moderate complexity testing. See D 6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a 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 -- high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form CMS-209 "Laboratory Personnel Report (CLIA)" and personnel records and interview with the center director, the laboratory did not have documentation showing one of six reviewed new testing personnel met the qualification requirements for moderate complexity testing personnel at 493.1423 from March 26, 2022 through June 7, 2022. Findings include: 1. Review of academic credentials for six of the new testing personnel identified on the Form CMS-209 submitted for the survey showed the high school transcripts for one testing person (staff A) did not show the individual received a high school diploma and did not include a graduation date. 2. Review of training and competence evaluation records for staff A showed the techical consultant signed the competence evaluation for staff A on March 26, 2022. 3. The center director (staff B) emailed a copy of Staff A's diploma on June 9, 2022 at 2:00 PM . The diploma showed staff A was given the diploma on June 7, 2022. 4. Interview with the center director on June 7, 2022 at approximately 1:45 PM confirmed staff A had performed moderate complexity testing since March 26, 2022. Further interview confirmed the transcript did not show staff A had earned a high school diploma. -- 2 of 2 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of Certification and Surveyor Provider Enhanced Reporting (CASPER) records and proficiency testing (PT) results, and interview with the quality assurance supervisor and assistant manager, the laboratory did not authorize the proficiency test program to release to Health and Human Services (HHS) the laboratory's proficiency test results. Findings include: 1. Review of the CASPER report 0155D (Individualized Laboratory Profile) for the laboratory on January 7, 2021 shows no proficiency testing data was available for review. 2. Review of the PT records showed the report for the laboratory did not include the Clinical Laboratory Improvement Amendments (CLIA) identification number for the laboratory. 3. Interview with the quality assurance supervisor and assistant manager, Staff A and Staff B, on January 7, 2021 at 1:35 PM, confirmed the laboratory did not provide the CLIA identification number to the PT provider to authorize the program to release the laboratory's results to HHS. 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 --