Summary:
Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the failure to follow procedures, availability of procedures and documentation with required information, testing performed prior to lack of the establishment validation\verification, lack of required documentation and interview with Cardiac Practice Manager, the laboratory failed to have a reference range, Analytical Measurement Range (AMR) and panic values located in the i-STAT procedure (refer to D5403); failed to provide any temperature storage documentation (written/electronic) of Quality Controls (QC) and the EG7+ testing cartridge (refer to D5413); failed to provide documentation of validation/verification performed on i- STAT EG7+ tests cartridge prior to patient testing (refer to D5421); failed to perform QC on day of patient testing on the i-STAT EG7+ for arterial blood gases with no established Individual Quality Control Plan (IQCP) for arterial blood gas (refer to D5445). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)