Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Individualized Quality Control Plan (IQCP) review and interview with staff, the laboratory's IQCPs failed to include documentation of data review results to support performing external quality control at a reduced frequency (less that each day of testing) for 2 of 2 IQCP plans reviewed (Istat and EZ Cup). Finding include: 1. The IQCP plan for testing performed on the Istat analyzers stated they reviewed quality control (QC) results from testing since 2014. The Plan did not include documentation of what and how many results were reviewed, what the results showed, or a copy of the results reviewed to demonstrate they could perform external quality control at the reduced frequency identified in the plan (which states to perform QC with each new shipment/lot number of Istat cartridges and every month). 2. The IQCP plan for urine drug screen using the EZ Cup failed to include any reference to the data reviewed to support doing QC at the reduced frequency of with each shipment and once a month. 3. Staff stated during the survey on 02/12/2018 at approximately 2:00 p.m. they were not aware of the necessity of including the results of the data reviewed, used to justify reduced frequency QC, in the IQCP plans. 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 --