Summary:
Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to meet requirements for the specialty of Hematology as specified in 493.1251, 493.1253, 493.1254, 493.1256, 493.1282 and 493.1291. Findings are as follows: 1. The laboratory failed to establish written procedures for staff to follow when flagged values are obtained on patient testing. See D5403 2. The laboratory failed to perform a complete performance verification of the Hematology analyzer prior to putting it into production in May 2022. See D5421 3. The laboratory failed to perform and document required maintenance on a Hematology analyzer during five month in 2023. See D5429 4. The laboratory failed to verify criteria for quality control (QC) material prior to putting it into production for all QC lot changes since May 2022. See D5469 5. The laboratory failed to ensure