Csl Plasma, Inc

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on September 10, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of the completed CMS-209 form listing the laboratory testing personnel, a review of the State of Nevada Division of Public and Behavioral Health personnel certification records, and an interview with the Senior Center Manager, the Assistant Manager of Quality, and the Assistant Manager, the director failed to ensure that testing personnel ceased donor testing between the time of the Office Laboratory Assistant certification expiration and reinstatement as required by the State of Nevada. Findings include: 1. A review of the laboratory testing personnel records revealed that two of 33 testing personnel continued performing donor testing during a lapse in the Office Laboratory Assistant certification required by the State of Nevada. 2. Testing personnel number nine listed on the CMS-209 failed to maintain the State of Nevada Office Laboratory Assistant certification required to perform donor testing. The certification expired on December 26, 2023. The personnel applied for a new certification that was issued on May 6, 2024. 3. Testing personnel number 29 listed on the CMS-209 failed to maintain the State of Nevada Office Laboratory Assistant certification required to perform donor testing. The certification expired on July 16, 2024. The certification was reinstated on September 4, 2024. 4.. The findings were 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 -- confirmed that the personnel continued to perform donor testing while the certification was expired during an interview conducted with the Senior Center Manager, the Assistant Manager of Quality, and the Assistant Manager on September 10, 2024 at approximately 2:00 PM. The laboratory performs approximately 81,936 chemistry tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on April 7, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 laboratory training and competency assessment records for 2018, 2019, 2020, and 2021, and an interview with the Plasma Center Manager, Assistant Center Manager, and Assistant Quality Manager, and a telephone conversation with the Assistant Quality Manager, the Technical Consultant failed to ensure that the semi-annual training and competency assessments of testing personnel were performed and documented. Findings include: 1. A random audit of 39 of 54 testing personnel records revealed that the semi-annual training and competency assessment was not performed and documented for four of the testing personnel in 2019. 2. This was confirmed during an interview with the Center Manager, the Assistant Center Manager, and the Assistant Quality Manager conducted on April 7, 2021 at approximately 4:15 pm., and during a telephone conversation with the Assistant Quality Manager on April 8, 2021 at approximately 1:15 pm. The laboratory performs approximately 102,245 Chemistry tests annually. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- 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 a review of laboratory training and competency assessment records for 2018, 2019, 2020, and 2021, and an interview with the Plasma Center Manager, Assistant Center Manager, and Assistant Quality Manager, the Technical Consultant failed to ensure that the annual training and competency assessments of testing personnel were performed and documented. Findings include: 1. A random audit of 39 of 54 testing personnel records revealed that the annual training and competency assessment was not performed and documented for four of the testing personnel during 2019. 2. This was confirmed during an interview with the Center Manager, the Assistant Center Manager, and the Assistant Quality Manager conducted on April 7, 2021 at approximately 4:15 pm. The laboratory performs approximately 102,245 Chemistry tests annually. -- 2 of 2 --