Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted on 6/13/2024, 6/14/2024, and 7/1/2024, the laboratory was found out of compliance with the CLIA regulations. The following conditions were not met: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6108 - 42 C.F.R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of oxygen (O2) saturation performed on the AVOXimeter in 2023 and 2024. Findings include: 1. Review of 2023 and 2024 proficiency testing records revealed the laboratory did not participate in proficiency testing for O2 saturation. 2. The laboratory could not provide documentation at the time of survey that it had verified accuracy two times in 2023 and in 2024. 3. Interview on 6/14/24 at 8:20 a.m. with the Technical Supervisor (TS) of Point of Care Testing confirmed the laboratory did not perform proficiency testing on the AVOXimeter. The TS revealed that the laboratory did not verify twice annually the accuracy of O2 saturation performed on the AVOXimeter in the cardiac catheterization laboratory. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 record review and staff interview, the laboratory (lab) failed to meet chemistry, general immunology, and hematology analytic systems requirements in 2022, 2023, and 2024. Findings include: 1. The lab's procedure manual for i-STAT CG8+ testing failed to include reference ranges for capillary whole blood, venous cord blood, and arterial cord blood in use and available on 5 of 5 test reports reviewed from November 2022, July 2024, and March 2024. Refer to D5403. 2. The lab failed to establish performance specifications for a FDA-modifed i-STAT CG8+ test system. Refer to D5423. 3. The lab's control procedure for coagulation testing on the TEG6S failed to include two materials of different concentration. Refer to D5447. 4. The lab's control procedures for rupture of membrane (ROM) failed to document control test results. Refer to 5481. 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)