Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was conducted on June 12, 2018 at Octapharma Plasma-CLIA ID # 19D0669316. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish a laboratory policy and procedure manual that contained complete policies and procedures. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have complete policies for the following: a) Performance specification: detailed procedures for performing accuracy, precision (day-to-day, run-to-run, and within-run variation, as well as operator variance), reportable and reference range studies, acceptability criteria for studies, and actions to take when data from the studies fail to meet acceptability criteria. 2. In interview on June 12, 2018 at 1:10 pm, Personnel 5 stated the laboratory did not have a policy for performance specifications. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D5401. -- 2 of 2 --