Summary:
Summary Statement of Deficiencies 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: . Through a review of the laboratory policy and procedure manual, patient medical records, lack of documentation and interview with laboratory personnel, it was determined the laboratory failed to follow its own policy for resolving flags prior to their release to the healthcare provider. A. A review of the laboratory's policy and procedure manual for Complete Blood Count (CBC) revealed the Differential Parameter Flag Policy for resolving "R Code Flags: For flag codes (1,2,3,4,M,*) 1. Check specimen for clots or agglutination. 2. Repeat the specimen after 20 minutes of collection, redraw if necessary. 3. If flag persists, at the discretion of the physician, send specimen to reference lab for confirmation, and provider will order send out differential if wanted." B. A review of patient Complete Blood Count (CBC) results revealed three of ten patient's results, had (*) flag that were not resolved prior to their release to the healthcare provider. Patient # 343594 Flag: (*) CBC results were released to electronic medical record (EMR) without the approval of physician and specimen was not sent to reference laboratory. Patient #206863 Flag: (*) CBC results were released to (EMR) without the approval of physician and specimen was not sent to reference laboratory. Patient: #52179 Flag: (*) CBC results were released to (EMR) without the approval of physician and specimen was not sent to reference laboratory. C. In an interview on 02/04/2020 at 11:45, laboratory personnel #3 (as listed on form CMS 209) confirmed the findings and that the specimens were not sent to the reference laboratory for confirmation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --