Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on June 11, 2026, at the laboratory of CSL Plasma - North Charleston by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of deficiencies cited as a result of the June 11, 2026 recertification 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 records review, lack of documentation, and staff interview, the laboratory failed to provide documentation of a written personnel competency evaluation procedure. Findings included: 1. Records review of testing personnel listed on the CMS 209 form reveals 21 out of 23 TP had personnel competency documentation. 2. Review of the policy and procedure manual reveals a lack documentation for a policy and procedure for personnel competency evaluation. 3. In an interview on June 11, 2026 at 12:30pm in the laboratory conference room with the Assistant Manager of Quality and the Center Manager, the findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- through 493.1236. This STANDARD is not met as evidenced by: Based on records review, lack of documenmtation, and staff interview, the laboratory failed to provide documentation of a Quality Assurance (QA)Policy and Procedure. Findings Included: 1. During the June 11, 2026 survey, the surveyor requested documentation of the laboratory's written QA policy and procedure. None was provided. 2. Records review of laboratory documentation reveals QA activities were being performed. 3. In an interview on June 11, 2026 at 12:30pm in the laboratory conference room with the Assistant Manager of Quality and the Center Manager, the findings were confirmed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)