Summary:
Summary Statement of Deficiencies D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon interviews with TP (Testing Personnel) #1 and the LD (Lab Director) on 11/14/23, the laboratory failed to prepare LC/MS (liquid chromotography/mass spectrometry) quality control and calibration reagents from different standard stock solutions. Findings: During interview with TP#1 at approximately 9:20 a.m., the TP stated that both quality control and calibration reagents are prepared from the same single preparation of standard stock solution. The LD confirmed this practice during a summation interview at approximately 12:15 p.m. 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 --