Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on October 10, 2024. 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: D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) reports and interview with the General Supervisor (GS), the laboratory failed to enroll and participate in proficiency testing (PT) for the subspeciality of urinalysis (microscopic exams). Findings: 1. Review of the 2023 & 2024 API PT reports revealed the laboratory was not enrolled/participating in PT for urine microscopic exams. 2. Interview with the GS (CMS 209) on 10/23/24 at 4:34 p.m on the phone, confirmed the aforementioned finding. 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 4 -- This STANDARD is not met as evidenced by: Based on review of profiency test (PT) records and interview with the laboratory General Supervisor (GS) , the Laboratory Director (LD) failed to attest that PT samples were tested in the same manner as patient specimens. Findings: 1. Review of PT records for 2023 and 2024 revealed the LD did not sign the attestation statement for 10/10 PT events performed through date of the survey. 2. Interview with the GS (CMS 209), on 10/10/24, at 10 a.m, in the laboratory hall area, confirmed the finding above. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and staff interview, the laboratory failed to perform and document required QC for urine microscopic testing. Findings include: 1. Review of QC records revealed the laboratory failed to provide QC documentation for Microscopic Urinalysis 2. Interview with the General Supervisor (CMS 209), in the laboratory hall area, on 10/10/24, at 11:39 a.m., confirmed the lack of QC for aforementioned test. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require