Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2018 and interview with the facility personnel, one of the testing personnel failed to sign the PT attestation statement. Findings include: 1. The PT attestation statement presented for review for the third event of 2018 in the specialty of Chemistry lacked the testing personnel's signature for PT sample 1B13 for i-Stat blood gas testing. 2. The sample indicated above was tested by operator ID:171724 according to the i-Stat test strip retained by the laboratory 3. The facility personnel confirmed that the PT attestation statement was not signed by the testing personnel for 1 out of the 5 samples tested. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of i-Stat Blood Gas test records and interview with the facility 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 -- personnel, the laboratory failed to indicate the correct operator ID on the i-Stat print out for the testing personnel that performed the test for 1 out of 3 test reports reviewed: 1. The i-Stat Blood Gas test result strips indicate different operator ID numbers depending on which testing personnel performed the test. 2. The laboratory maintains a reference sheet that indicates each individual testing personnel's name and their specific operator ID that is associated with their name. 3. Each test result sheet had a signature of the testing personnel, but the test result strip for patient #17376 from October 18, 2018 at 05:51 indicated a different operator ID than what was indicated on the reference sheet for that testing personnel. 4. The facility personnel acknowledged that another testing personnel's operator ID was indicated on the i-Stat test result strip. -- 2 of 2 --