Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 12, 2019. 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: 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 proficiency test (PT) records and interview with the laboratory technical supervisor , the laboratory testing personnel and lab director (LD) failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of Hematology PT 2019 events #1 & #2 revealed no attestation statements available for review. 2. Review of Serology PT 2019 events #1 & #2 revealed attestation statements were not signed by the LD. 3. Interview with the technical supervisor (CMS 209 form) on 9/12/19 at approximately 2:50 PM in the breakroom, confirmed the aforementioned attestation discrepancies. 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 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 -- 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 review of proficiency test (PT) records and interview with the laboratory technical supervisor , the laboratory failed to retain original analyzer printouts for hematology. Findings include: 1. Review of Hematology PT 2019 event #1 revealed no original analyzer printouts were available for review. 2. Interview with the technical supervisor (CMS 209 form) on 9/12/19 at approximately 2:50 PM in the breakroom, confirmed the original analyzer printouts were not available for review. 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 procedure manual (SOP) review and staff interview, the laboratory failed to include procedures for all testing performed.. Findings: 1. Review of the SOP revealed the lack of written procedures for Complete Blood Counts (CBC), manual differential, urine microscopic exam, Rapid Plasma Reagin (RPR), Proficiency Testing (PT),