Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of CASPER Report 155D Individual Proficiency Testing report, laboratory policy, proficiency testing (PT) records, and confirmed in interview, the laboratory failed to report PT results for three of three regulated analytes reviewed in 2024. Findings include: 1. Review of CASPER Report 155 determined the laboratory did not have a PT score for pH, pCO2 and pO2 for Routine Chemistry for the first testing event of 2024. 2. Review of the laboratory policy titled "Proficiency Testing Protocol" determined the laboratory failed to have a policy in place for PT result reporting. 3. Review of the laboratory's API PT Chemistry Core performance summary in 2024 (first event) determined the following analytes as not reported to the PT program: Chemistry Core 1st Event 2024 Method: i-STAT Analytes: pH PCO2 pO2 4. The laboratory director stated the laboratory is reporting pH, pCO2, and pO2 for patient results. The laboratory director also stated the laboratory is performing proficiency testing for the above analytes but did not report them to the proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- testing provider during an interview on 08/11/2024 at 1055 hours in the conference room. The proficiency testing provider, API, confirmed the laboratory is enrolled in proficiency testing for pH, pCO2, and pO2 but did not submit results during an interview on 08/22/2024 at 1046 hours over the phone. Key: API - American Proficiency Institute pH - potential of hydrogen (measurement of acidity or alkalinity) pCO2 - partial pressure of carbon dioxide pO2 - partial pressure of oxygen 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 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)