Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and an interview with the General Supervisor on 02/14/2022 at 12:00 p.m., it was determined that the laboratory failed to provide a written procedure manual that described tests, assays and examinations that laboratory personnel could follow. The findings include: 1. The General Supervisor confirmed on 02/14/2022 at 12:00 p.m. that the Quality Control Plan in the laboratory procedure manual was provided by the iStat manufacturer and was not approved by the Laboratory Director. 2. The laboratory Quality Control Plan contained a section "Authorization of the IQCP". The General Supervisor confirmed on 02/14/2022 at 12:05 p.m. that testing personnel performed daily iStat quality control with Level I and Level III controls and that they were unaware of the implementation of an IStat IQCP Plan. 3. Section 2d of the laboratory Quality Control Plan describes the iStat blood gas and lactate test systems. The General Supervisor confined on 02/14/2022 at 12:10 p.m. that testing personnel do not perform blood gas or lactate testing. 4. Testing personnel documented patient iStat hemoglobin and hematocrit test results on the Laboratory Patient Test Log. The General Supervisor confirmed on 02/14/2022 at 12:15 p.m. that the laboratory did not report these results and that a procedure describing what to do with critical or abnormal hemoglobin and hematocrit values was not available for laboratory personnel to follow. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- 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 a review of laboratory iStat records and an interview with the General Supervisor on 02/14/2022 at 12:45 p.m., it was determined that the laboratory failed to verify the performance specifications of the Abbott iStat test system, SN21410420 it introduced prior to reporting patient Chem 8+ test results. The findings include: 1. An Abbott representative performed an iStat System Verification between June 9-10, 2020. The iStat ACT Performance Verification Report summary statement was not reviewed, evaluated or approved by the Laboratory Director for iStat performance specifications to include accuracy, precision, reportable range, verification of manufacturer critical values as appropriate for the laboratory patient population. 2. The laboratory performs an estimated 300 iStat Chem 8+ tests annually. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of laboratory procedure manuals, quality control and iStat maintenance records and confirmation by the General Supervisor on 02/14/2022 at 11: 00 a.m., it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings include: 1. The General Supervisor confirmed the laboratory did not have a written policy or procedures that describes how the following analytic systems are assessed: a. Test procedures b. Specimen and reagent storage conditions c. Equipment maintenance, calibration and function checks d. Quality control results e.