Octapharma Plasma Inc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain all proficiency testing (PT) records for at least two years. Findings include: 1. The laboratory's standard operating procedures (QPM-201) for proficiency testing and electronic records for PT events from October 11, 2019 (Event #3, 2019) through September 25, 2021 (Event #3, 2021) were reviewed. 2. The QPM-201 PT retention policy stated the following: "4.6.4. A KwikTag scanned document is a "True and Accurate Copy of the Original". "4.6.5. Original copies may be discarded after scanning into KwikTag and the scanned record is verified according to procedure requirements". 3. The scanned PT documents from event 3 of 2019 through event 3 of 2021 retrieved from the KwikTag electronic system revealed the following: *From event 3 of 2019, the entire PT event packet had been scanned, which included the laboratory's address, date the PT package was received in the laboratory, deadline date for the laboratory to report PT results, PT program instructions, PT program result recording forms, the PT program's attestation statement form, and the laboratory's scores from the PT program for the event. *From events 1, 2, 3 of 2020 and event 1,2, 3 of 2021, the packets included the PT program's attestation statement form, electronic reporting confirmation forms, and the laboratory's PT scores for each event. 4. The laboratory failed to retain all PT records for six out of six events during the years of 2020 through 2021. 5. On a Recertification survey conducted on February 24, 2022 at 4:15 PM, the laboratory Staff managers confirmed the above findings. 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 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based record review and interview with the Quality Assurance Supervisor, the laboratory director failed to ensure that prior to testing patient's specimens, all personnel have the appropriate education and experience. Findings include: 1. There were a total of 13 testing personnel listed on Laboratory Personnel Report (FORM CMS 209). 2. Review of personnel records revealed that 1 of 13 testing personnel lacked educational credentials that show she had at least a high school diploma. See D6065 3. At 10:30 AM on 04/01/2019, the Quality Assurance Supervisor confirmed the surveyor's findings. 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 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 -- 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 high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based record review and interview with the Quality Assurance Supervisor, testing personnel failed to meet the minimum educational requirement for performing moderate complexity testing. Findings include: 1. There were a total of 13 testing personnel listed on Laboratory Personnel Report (FORM CMS 209). 2. On 04/01 /2019 at 10:30 AM, review of personnel records revealed that 1 of 13 testing personnel's educational documents was not legible. The surveyor told the Quality Assurance Supervisor that she must submit a legible copy of the educational document by the close of business, Monday, April 8, 2019. 3. On 04/08/2019 at 8:00 AM, the surveyor received and reviewed a legible copy of 1 educational transcript emailed to her on 04/01/2019. Review of the transcript revealed that that this person lacked the minimum educational requirement of a high school diploma for performing moderate complexity testing. 4. On 04/08/2019 at 8:12 AM, the surveyor relayed this in a follow-up email to the Quality Assurance Supervisor. -- 2 of 2 --