Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on July 2, 2019. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to ensure examination of the PT samples by testing personnel (TP) who routinely perform laboratory testing as required. Findings include: 1. American Proficiency Institute (API) PT document review and staff interview revealed the same TP/technical consultant (TC) performed 2018 Chemistry Core (Events two and three). 2. The API 2018 Core Chemistry (Event one) attestation statement was not available at the time of the survey. 3. An interview in the laboratory on 7/2/2019 with the TC at approximately 3:00 p.m. confirmed the aforementioned lack of TP rotation for PT testing. 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. 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 -- This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) and the testing personnel (TP) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the LD and TP did not sign the 2018 Core Chemistry (first event).attestation statement. 2. An interview with the technical consultant in the laboratory on 7/2/2019 at approximately 3:00 p.m. confirmed the aforementioned PT attestation statement was not signed by the TP or LD. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the following required documents were not available at the time of survey: Attestation statements -- 2018: Chemistry Core - Event One; 2019: Miscellaneous Chemistry - Event One; PT reports -- 2018: Chemistry Core -- Event Three. 2. An interview in the laboratory with the technical consultant on 7/2/2019 at appoximately 3:00 p.m. confirmed the aforementioned missing PT documents. 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)