Summary:
Summary Statement of Deficiencies 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: D5401 PROCEDURE MANUAL 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 record review and staff interview laboratory failed to follow written policies and procedures in the specialty of Hematology. Findings include: 1. Record review on 3/11/2020 of the laboratory's policy and procedure (page -14) for running quality control (QC) for complete blood count (CBC) tests revealed, "XN CHECK (all 3 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 -- control vials) will be run twice per day before patient testing." 2. Record review on 3 /11/2020 of the QC peer evaluation Insight reports (for analyzers with serial number # 17784 and #17778) from Sysmex for CBC, revealed the laboratory personnel did not run QC materials twice on the following days when patient samples were tested and reported. 6/21/19- No second shift QC performed. 6/22/19- No QC performed all day. 8/4/19- No second shift QC performed. 8/6/19- No first shift QC performed. 10/10/19- No second shift QC performed. 1/27/20- No second shift QC performed. 2/21/20- No second shift QC performed. 3. Record review on 3/11/2020 of the Insight report referenced in #2 above revealed the lack of