Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 4, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 records for a minimum of two years as required. Findings include: 1. American Academy of Family Physicians (AAFP) PT document review revealed the lack of PT log sheets available at the time of survey for the following Hematology PT events: 2019 and 2020 -- Events A, B, and C. 2. An interview with Staff #2 (CMS 209) on 11/4/2020 in the conference room at approximately 11:45 a.m. confirmed the lack of PT event log sheets available at the time of survey for the aforementioned dates. D5401 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), testing personnel (TP) document review, and staff interview, the laboratory failed to follow policies and procedures as required. Findings include: 1. Review of the laboratory SOP and TP document review revealed the lack of TP initial training documentation in 2019 and six-month competency documentation in 2020 as required by the policy and procedure for TP competency performance. 2. An interview with Staff #2 (CMS 209) in the conference room on 11/4/2020 at approximately 11:00 a.m. confirmed the SOP competency policy and procedure was not followed for TP evaluation of performance in 2019 and 2020. 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