Biolife Plasma Services, Lp

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/21/2025). The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the center manager, quality manager, and technical consultant at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the center manager, the laboratory failed to follow their written policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy titled, "Moderate Complexity CLIA Testing Requirements" stated the following in Section 13.1 "Laboratory Director must evaluate the Technical Consultant initially for approval and assess for competency annually (within 12 months) from the date approved as a Technical Consultant"; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of July 2023 through the current date identified competencies, based on job responsibilities, had not been performed after 07/14/2023 for one of one individual listed as the technical consultant on Form CMS-209; (3) The findings were reviewed with the center manager who stated on 05/20/2025 at 01:30 pm, the policy had not been followed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the center manager, the laboratory failed to perform calibration verification procedures at least once every six months for seven Reichert T5 Digital Refractometers used during the review period of July 2023 through the current date. Findings include: (1) On 05/20/2025 at 11:00 am, the center manager stated Total Protein testing was performed using seven Reichert T5 Digital Refractometers (Serial Numbers 12531-0219, 12546-0319, 12535-0219, 12653-0319, 12534-0219, 12654-0319, and 125454-0319); (2) A review of records from July 2023 through the current date identified no evidence calibration verification had been performed at least once every six months for each of the Refractometers listed above between 09/22/2023 and 02/12/2025; (3) The records were reviewed with the center manager who stated on 05/20/2025 at 12:20 pm, calibration verification procedures had not been performed every six months as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/23/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the group operations manager, quality manager, and the quaility manager for Broken Arrow during an exit conference performed at the conclusion of the survey. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the group operations manager, 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 manager, and the quality manager for Broken Arrow, the laboratory failed to perform calibration verification procedures at least once every 6 months for the refractometer total protein testing performed on 5 Reichert refractometers. Findings include: (1) On 06/23/2023 at 11:55 am, the group operations manager stated the laboratory performed total protein testing on 5 Reichert refractometers. (Serial#'s 12531-0219, 12546-0319, 12535-0219, 12653-0319, and 12534-0219); (2) A review of records from August of 2021 through the current time identified no evidence calibration verification procedures had been performed at least once every six months between 4/08/2022 and 03/20/2023; (3) Interview with the group operations manager, quality manager, and the quality manager for Broken Arrow on 06/23/2023 at 11:55 am confirmed the laboratory had not performed calibration verification at least once every six months between 06/23/2023 and 03/20/2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 07/15/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the quality manager, center manager, and district quality manager at the conclusion of the survey. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the district quality manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for 2 of 6 events. Findings include: (1) On 07/15/2021, the surveyor reviewed the third 2019; first, second and third 2020; and first and second 2021 proficiency testing events. For 2 of 6 events, the attestation statements had been signed approximately 3-4 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2020 Chemistry Event - The sample testing had been completed on 02/14/2020, and the attestation statement had not been signed by the laboratory director/designee until 07/02/2020; (b) First 2021 Chemistry Event - The sample testing had been completed on 02/12/2021, and the attestation statement had not been signed by the laboratory director/designee until 05/25/2021. (2) The surveyor reviewed the findings with the district quality manager who stated 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 -- on 07/15/2021 at 03:00 pm the attestations had been signed approximately 3-4 months after the proficiency samples had been tested. The surveyor explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 2 of 2 --