Summary:
Summary Statement of Deficiencies D0000 An unannounced onsite complaint survey was performed on January 23rd, 2024, and the laboratory was found to NOT be in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1240 Pre-Analytic Systems 493.1250 Analytic Systems 493.1290 Post-Analytic Systems 493.1403 Laboratory Director, (moderate complexity). 493.1409 Technical Consultant 493.1441 Laboratory Director, (high complexity) 493.1447 Technical Supervisor 493.1463 General Supervisor 493.1487 Testing Personnel (high complexity) The laboratory's failure to be in compliance with the CLIA regulations was found to pose immediate jeopardy to the patients served by the laboratory. The laboratory abated the immediate jeopardy by letter signed by the laboratory director dated, 01/25/2024. The complaint was found to be substantiated. 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 laboratory policy, American Proficiency Institute (API) Proficiency Testing (PT) 2023 Chemistry Core events and confirmed in interview, the Laboratory Director (or designee) failed to attest to the routine integration of proficiency samples into the patient workload for one of three Chemistry Core events in 2023. Findings Included: 1. Review of laboratory policy, "Proficiency Testing Protocol" (Approved by the Laboratory Director on 10/19/2023) revealed the following: " ...Reporting PT Results ...Ensure a copy of the signed attestation statement is filed in the manual. ...Retention of PT Records The Laboratory must retain an easily accessible record of proficiency testing processing as follows: ...Copy of signed attestation station [sic]" 2. Review of API instructions provided to the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 51 -- laboratory by the PT agency for Chemistry Core 2nd Event in 2023, revealed the following: "ATTESTATION STATEMENT SIGNATURES REQUIRED- Testing personnel and the laboratory director must physically sign an attestation statement for all PT results and retain the signed statement (or a copy) for a minimum of 2 years. Either the attestation statement below or a printed copy of the form provided online can be used for this purpose." 3. Review of laboratory API PT Chemistry events in 2023 (1st, 2nd, and 3rd events) revealed the Laboratory Director or designee failed to sign the attestation statement for the 2nd Chemistry Core event in 2023. 4. During an interview on 01/23/2024 at 12:45 PM in the laboratory, Testing Person-1 confirmed the Laboratory Director (or designee) failed to attest to the routine integration of proficiency samples into the patient workload for one of three Chemistry Core events in 2023. 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 laboratory policy, American Proficiency Institute (API) Proficiency Testing (PT) Chemistry Core events for 2023, API