Biolife Plasma Services Lp

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 16, 2023. Biolife Plasma Services LP clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibration verification for Total Protein testing on the Reichert TS Meter-DSP refractometers at least semi-annually for four (serial number 12249-1118, 12278-1118, 12287-1118, 12298-1118) of five (serial number 12249-1118, 12278-1118, 12287-1118, 12298- 1118, 12303-1118) refractometers currently being used from 10/01/2021 to 03/15 /2023, and failed to perform a calibration verification for one refractometer before putting the refractometer "in service" on 12/02/2022. Findings: Review of the policy titled "Refractometer Calibration Verification, Precision and Specification Testing" read, "Calibration verification will be performed 6 months after precision testing is performed, and semiannually thereafter per applicable steps of SOP" 1. Review of the "Quality Control Record - Refractometer Calibration Verification" record showed 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 -- calibrations were performed on 10/01/2021, 06/09/2022 and 03/15/2023, 9 months between each calibration verification for refractometers serial numbers 12249-1118, 12278-1118, 12287-1118 and 12298-1118. On 03/16/2023 at 10:47, the Quality Manager acknowledged the semi-annual calibration verification was performed only once in 2021. 2. Review of the "Equipment Audit Report" refractometer serial numbers of 12303-1118 showed the instrument was put back in service on 12/02/2022 and the last documentation of a validation being performed was 12/16/2021. The "Quality Control Record - Refractometer Calibration Verification" record showed a calibration was performed on 03/15/2023 for refractometer serial numbers of 12303- 1118. On 03/16/2023 at 12:05, the Quality Manager stated refractometer serial number 12303-1118 was put back in service on 12/02/2022 and the validation was done on 03/15/2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 23, 2021. Biolife Plasma Services LP clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibrations within the laboratory's stated performance specifications for 3 (serial numbers 12287- 1118, 12278-1118, 12295-1118) of 6 (serial numbers 12291-1118, 12303-1118, 12298-1118, 12287-1118, 12278-1118, 12295-1118) refractometers on 03/25/2020. Findings: Review of the calibration documentation showed that calibrations were performed on 09/13/2019, 03/25/2020 and 10/02/2020. Review of the laboratory's Refractometer Calibration Verification documentation dated 03/2/2020 showed that the Refractrol Low Control Lot #K303250 had an acceptable range of 4.0 to 4.8 g/dL (grams per deciliter). Review of the calibration verification document show that refractometers serial numbers (SN) 12287-1118, 12278-1118, 12295-1118 all reported the low control value of 4.9 g/dL. Review of the policy titled "Refractometer Calibration Verification, Precision and Specification Testing" read "If the result is not within the manufacturer's acceptable range or if a fuzzy image/no sample result is obtained, repeat the calibration using the same vial of protein control in the 1st repeat calibration verification section." There was no documentation that the low control was rerun. Review of the daily controls showed controls for refractometer SN12287-1118 were run on 03/25/2020 to 06/10/2020, and controls for refractometers SN 12278- 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 -- 1118 and SN 112295-1118 were run on 03/25/2020 to 10/01/2020. During an interview on 03/23/2021 at 1:10 PM, the Group Quality Manager stated the low level of controls were out of range. During an interview on 03/23/2021 at 1:20 PM, the Group Quality Manager stated controls were run on all instruments where there was the potential for patients to be tested with the refractometer. -- 2 of 2 --