Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory records and interviews with laboratory personnel; the laboratory failed to demonstrate it can obtain performance specifications established by the manufacturer for troponin I testing on I-Stat analyzer. Findings Include: 1. During tour of the laboratory facility on 01-09-2018, with TC#1 at 11:35 am, TC#1 confirmed the facility began testing for troponin I on the I-Stat analyzer, serial number 382618, on 03-01-2017. 2. Review of verification of performance documentation provided by TC#1 for troponin I testing on the I-Stat analyzer failed to document the accuracy and precision of troponin I testing prior to use for patient testing. 3. On survey date 01-09-2018, at 1:35 pm, the above findings were confirmed by TC#1 and TC#2. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interviews with laboratory personnel; the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing before reporting patient test results for troponin I on the I-Stat analyzer. Findings include: 1. Interview with TC#1 at 11:35 am, on 01-09-2018, confirmed quality controls for troponin I testing on the I-Stat analyzer are performed with each lot/shipment and every 30 days. 2. Interview with TC#2 at 12:25 pm on 01-09-2018 confirmed no Individual Quality Control Plan was in place for troponin I testing on the I-Stat analyzer. 3. Review of patient testing performed on the I-Stat analyzer found that two levels of control materials were not documented each day of testing for troponin I for 3 of 4 dates reviewed when patient test results were reported. Patient Identification Test Date QC Ran Date T1 12-21-2017 12-08-2017 T3 05-01-2017 04- 07-2017 T4 12-29-2017 12-08-2017 4. On survey date 01-09-2018, at 1:35 pm, TC#1 and TC#2 confirmed that two levels of quality control material were not performed each day of patient testing for troponin I on the I-Stat analyzer. -- 2 of 2 --