Lifeback Llc

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Toxicology QC used for Toxicology tests performed on the Beckman Coulter AU480 analyzer from 12/17/18 to the date of the survey. The findings include: 1. UTAK Toxicology Controls had no documented evidence that QC verification was performed. 2. The TP confirmed on 8/31/21 at 10: 00 am that assayed QC material was not verified before putting in use. D5783

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 lack of Competency Assessment (CA) records, review of the procedure manual and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on one out of one testing personnel in the calendar year 2017. The TP confirmed on 12/17/18 at 2:05 pm that the CA procedure was not followed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel(TP), the laboratory failed to review and evaluate Urine Drug Screen PT results obtained from the American Academy of Family Physicians (AAFP) in the second quarter of 2017 and 2018. The TP confirmed on 12/19/18 at 1: 30 pm that the laboratory did not review and evaluate all PT results. 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 --