Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a review of laboratory policies and procedures for hematology, a review of the hematology summary sample records, and interviews with laboratory staff, the laboratory failed to follow written procedures for Hematology IP messages of the Sysmex flags. Survey findings include: A) The laboratory policy and procedure titled, "IP Messages of the Sysmex" states the following, "It is necessary to review all flagging by the analyzer prior to reporting the patient results. 1.Check the specimen for clots or agglutination. Recollect if clots are found. 2. If not clots are detected, the specimen will be re-mixed and retested. (Limit flags =/- will only need to be repeated if the value is critical.) 3. If flag persists, at the discretion of the provider, send the sample to the reference laboratory for a manual differential." Twenty-one out of seventy-one samples had flags. The flag noted with the twenty-one sample states, "Display symbol * meaning low reliability. Indicates that the reliability of the data is low." Twenty-one samples with the flag "*". List of sample numbers with this flag: 180441559, 180632295, 180720162, 180877796, 180975768, 181145087, 181163838, 181221168, 181491572, 181572846, 181579132, 181723020, 181751562, 181755866, 181815887, 181854342, 181854805, 181855812, 181905591, 181949899, and 181963598. B) Review of the laboratory policy and procedure titled 1. Standard Relationship of patient information to patient's results states, "Patient test results are reviewed with pertinent patient data at the time the test is performed by testing personnel. B.