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 the surveyor's review of the laboratory records, manuals, and an interview with the laboratory administrator, the laboratory failed to document a complete IQCP for testing performed in the subspecialty of Routine Chemistry. Findings: 1. A review of the IQCP documentation showed that the laboratory's plan does not include a quality control (QC) plan which defines the reduced QC procedure to be performed on the new Blood Gas test system in-use, prior to testing patients. 2. The records reveal that patient testing began on 03/31/2016. 3. The Quality Assessment (QA) plan reviewed does not include a routine review of the manufacturer's instructions for the Blood Gas Cartridges used for patient testing. 4. On a Validation survey conducted on 01/30/2018 at 1:15PM, the laboratory administrator and staff confirmed the above findings. D5779