Octapharma Plasma, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/25/2022. The findings were reviewed with center director, quality assurance back-up, and laboratory director during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the center director, the laboratory failed to ensure materials were not used beyond the open vial stability for one of one bottle of control material. Findings include: (1) On 04/25/2022 at 10:15 am the center director stated the following to the surveyor: (a) Plasma Total Protein was tested at five stations using the Reichert TS Meter DSP analyzers; (b) KOVA Refractrol SP high control material (green top) was used for monthly calibrations. (2) An observation at 10:20 am revealed the high control (lot# K304827), had been dated as open on 04/01 /2022 with an expiration date of 04/14/2022; (2) A review of the manufacturer's package insert for the control material stated, "KOVA Refractrol SP has an open vial stability of up to 14 days"; (4) The findings were reviewed with the center director, who stated on 04/25/2022 at 12:45 pm, that although the LIS (laboratory information system) would not allow the high control material to be used, it had not been discarded on or before the expiration date. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with center director and quality assurance back-up, the laboratory failed to evaluate the relationship between test results using seven different analyzers at least twice a year for one of three evaluations. Findings include: (1) On 04/25/2022 at 10:15 am, the center director stated to the surveyor: (a) Total protein testing was performed using seven different Reichert refractometers identified as R001, R002, R003, R004, R005, R006, R007. (2) A review of the written procedure manual titled, "Donor Center SOP" contained a policy titled, "Refractometer Semi-Annual Equipment Comparison". Under the section titled, "5. PROCEDURE" it stated: (a) "5.1 Review Requirements" (i) "5.1.1 At least twice per year, at six (6) month intervals, the refractometer semi-evaluation must be completed to perform a comparison of all active refractometers QC results when different refractometers are utilized to perform total protein test in the Donor Center.". (3) A review of the comparison records between 06/20/2020 through the day of the survey (04/25/2022) revealed a comparison had not been documented as performed after 03/11/2021; (4) The records were reviewed with the center director and quality assurance back-up. Both stated on 04/25/2022 at 11:52 am, a comparison of all the refractometers had not been documented as performed since 03/11/2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/06/20 The findings were reviewed with the center director, quality assurance supervisor, and quality assurance technician at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the quality assurance supervisor and quality assurance technician, the laboratory failed to ensure analyzers were stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the quality assurance supervisor stated the following to the surveyor: (a) Total Protein testing was performed using 7 Reichert TS analyzers (serial #: 10925-0817, 10938-0817, 10943-0817, 10932-0817, 10941-0817, 10933- 0817, 10939-0817); (2) Later during the survey, the surveyor reviewed the manufacturer's environmental requirements for the Reichert TS analyzer which required a humidity of less than 80%; (3) The surveyor reviewed laboratory records from July 2019 through December 2019. There was no evidence that the humidity, where the analyzers were maintained, had been monitored; (4) The surveyor asked the 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 -- quality assurance supervisor and quality assurance technician if the humidity, where the analyzers were maintained, was being monitored. The quality assurance supervisor and quality assurance technician both stated the humidity was not being monitored. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records, policy, and interview with the quality assurance supervisor and quality assurance technician, the technical consultant failed to to ensure that persons performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records. The following was identified: (a) Testing Person #2 - The initial training for this person was completed on 02/14/18. The 6 months competency assessment was completed on 12/11/18, 10 months after the initial training; (b) Testing Person #6 - The initial training for this person was completed on 10/24/18. The 6 months competency assessment was completed on 08 /20/19, 10 months after the initial training; (c) Testing Person #8 - The initial training for this person was completed on 01/04/18. The 6 months competency assessment was completed on 12/11/18, 11 months after the initial training; (d) Testing Person #17 - The initial training for this person was completed on 08/28/18. The 6 months competency assessment was completed on 04/18/19, 8 months after the initial training. (2) The surveyor reviewed the policy titled, "Training Policies - NexLynk" which required a semiannual competency be performed at 6 months; (3) The surveyor reviewed the records and policy with the quality assurance supervisor and quality assurance technician. Both stated there were no records to prove the above testing persons had been evaluated at 6 months according to laboratory's policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the QA Supervisor by phone after the conclusion of the survey. 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 a review of records, interview with the quality assurance supervisor, and consultation with the proficiency testing program customer support, the laboratory failed to ensure the proficiency testing program released all data to CMS and to the State Agency for 2017 and 2018. Findings include: (1) Prior to the survey, the surveyor printed the facility's proficiency testing scores for review from the Federal database on 05/21/2018. The scores for 2017 and 2018 did not print. Therefore, it appeared that the laboratory did not participate in proficiency testing; (2) At the survey, the surveyor asked the quality assurance supervisor when the laboratory began patient total protein testing using the Reichert TS Meter DSP. The quality assurance supervisor stated to the surveyor that patient testing began on 09/20/17; (3) The surveyor then asked the quality assurance supervisor about the proficiency testing. The quality assurance supervisor explained that for 2017, the laboratory performed an off-cycle testing event. The surveyor reviewed the proficiency testing records, which verified the laboratory participated in proficiency testing for the off-cycle event on 10 /17/17 and for the first 2018 event on 01/31/18; (4) The surveyor asked the quality assurance supervisor if the laboratory had authorized the proficiency testing program to release its scores to CMS and to the State Agency. The quality assurance supervisor contacted the facility's corporate office via email. The corporate office emailed a copy 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 -- of the "2018 Order Confirmation" form. Although the proficiency testing order form included the note, "Results to be sent to CLIA/State," the laboratory's CLIA number was not included on the order confirmation form; (5) After the survey, the surveyor contacted the proficiency testing program customer support, who verified the proficiency testing confirmation form would include the laboratory's CLIA number if it had been provided to the proficiency testing program and the scores would only be released to CMS and to the State Agency if the laboratory's CLIA number had been provided; (6) The surveyor contacted the quality assurance supervisor for the laboratory and explained in order for the proficiency testing program to provide testing scores to CMS and to the State Agency, the laboratory's CLIA number must be provided to the proficiency testing program. -- 2 of 2 --