Csl Plasma, Inc

Summary Statement of Deficiencies 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 review of the laboratory's Technical Consultant Annual Recertification policy, the CMS 209 personnel form, and personnel records, the laboratory failed to establish a written policy and procedure to assess technical consultant competency for technical consultant responsibilities at this laboratory. Findings include: 1. The laboratory's Technical Consultant Annual Recertification policy states that technical consultant competency assessment is to be performed. The policy does not include the identification of the individual, listed on the CMS 209 personnel form, responsible for assessing the competency of the technical consultant. 2. Review of the CMS 209 personnel form and personnel records since the last survey on 8/24/2022 revealed that two of two annual competency assessments of the technical consultant, for both 2022 and 2023, were performed by an individual other than the laboratory director listed on the CMS 209 personnel form. 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 D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of documentation of monthly review of quality control records, to include calibration verification records, since 11/23/20, review of room temperature records, and confirmation by Testing Personnel #17 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, a qualified technical consultant failed to document review of these records since 11/23/20. Findings include: Review of documentation of monthly review of quality control records of total protein testing on nine Reichert refractometers, to include calibration verification records, since the last survey on 11/23/20 and temperature records revealed no documentation of review of these records by a qualified technical consultant since 11/23/20. Testing Personnel #17, listed on the CMS 209 personnel form, confirmed these records were not reviewed by a qualified technical consultant since 11/23/20. THIS IS A REPEAT DEFICIENCY. 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 D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the personnel records and the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to have a technical consultant who meets the qualification requirements of 493.1411 of this subpart. Findings include: Review of the CMS 209 personnel form revealed no technical consultant listed. Review of the laboratory's personnel records revealed the laboratory director does not meet the qualification requirements of 493.1411 of this subpart. Refer to D6049 (Lack of review of quality control records by a qualified technical consultant). Refer to D6053 (Lack of semiannual evaluation of personnel by a qualified technical consultant). Refer to D6054 (Lack of annual evaluation of personnel by a qualified technical consultant). D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of documentation of monthly review of quality control records, to include calibration verification records, since the last survey on 4-12-18, a qualified 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 -- technical consultant failed to document review of these records since 9-4-19. Findings include: Review of documentation of monthly review of quality control records of total protein testing on eight Reichert refractometers, to include calibration verification records, since the last survey on 4-12-18, revealed no documentation of review of these records by a qualified technical consultant since 9-4-19. 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 review of the personnel records and the CMS 209 personnel form, a qualified technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year these individuals tested patient specimens. Findings include: Review of the personnel records and the CMS 209 personnel form revealed a qualified technical consultant failed to evaluate and document the performance of the following testing personnel, responsible for moderate complexity testing, at least semiannually during the first year these individuals performed patient total protein testing: Testing Personnel #3, #14, #15, #16, #24, #26, #28, #29. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the personnel records and the CMS 209 personnel form, a qualified technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually, after the first year these individuals performed patient total protein testing. Findings include: Review of the personnel records and the CMS 209 personnel form revealed a qualified technical consultant failed to evaluate and document the performance of the following testing personnel, responsible for moderate complexity testing, at least annually, after September 2019: Testing Personnel #1, #2, #4, #5, #6, #7, #9, #10, #11, #12, #14, #15, #16, #18, #19, #20, #21, #23, #25. -- 2 of 2 --