Summary:
Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on Immunohematology procedures manual, quality control records, blood unit returned records, compatibility testing records review and interview with the Blood Bank technical supervisor and testing personnel # 1 on May 17, 2018 at 10:10 AM, it was determined that the blood bank facility failed to ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. The findings include: 1. On May 17, 2018 at 1:40 PM, the 4 blood unit returned sheets records showed that 4 out of 4 blood units were issued from the blood bank on January 9, 2018 and returned on January 12, 2016; the 4 blood units were stored in the "Cardio Refrigerator" (out side the blood bank). All blood units were returned to the general blood inventory, reissued and transfused: a. Unit W236417078410 released from the transfusion service on January 9, 2018. Returned on January 12, 2018. Temperature recorded 5C. Accepted to be used. Transfused on January 16, 2018 (patient #1). b. Unit W236517358481 released from the transfusion service on January 9, 2018. Returned on January 12, 2018. Temperature recorded 5C. Accepted to be used. Transfused on January 15, 2018 (patient #2). c. Unit W236517356800 released from the transfusion service on January 9, 2018. Returned on January 12, 2018. Temperature recorded 5C. Accepted to be used. Transfused on January 15, 2018 (patient #3). d. Unit W236517358364 released from the transfusion service on January 9, 2018. Returned on January 12, 2018. Temperature recorded 5C. Accepted to be used. Transfused on January 16, 2018 (patient #4). 2. The SOP for the blood unit returned did not include the instructions to store out side the blood bank the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- blood unit returned. 3. The Blood Bank technical supervisor confirmed on May 17, 2018 at 1:40 PM, that those blood unit were issued from the blood bank on January 9, 2018 and returned on January 12, 2016. He stated that the four blood units were returned to the general blood inventory, reissued and transfused. He stated that those blood units were stored in the "Cardio Refrigerator" (out side the blood bank). 4. On May 17, 2018 at 1:40 PM, the blood bank did not have records for the Temperature monitoring of the "Cardio refrigerator" from January 1, 2018 to May 17, 2018. At 3: 00 PM, the Blood Bank technical supervisor brought the temperature chart of the "Cardio refrigerator". D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Immunohematology procedures manual, quality control records, blood unit returned records, compatibility testing records, direct observation, Refrigerator # 1 temperature chart records review and blood bank technical supervisor interview on May 17, 2018 at 1:40 PM, it was determined that the blood bank failed to meet the quality control requirements for the subspecialty of Immunohematology. Refer to D 5403 ( (The blood bank failed to have and follow written procedures describing how the blood bank verifies the internal temperature of the returned blood units). Refer to D 5405 (The blood bank failed to follow written procedures to verify the temperature of all blood units that were issued from the blood bank but not transfused in order to determine if those products can be returned to the general blood inventory to be later reissued safely or discarded). Refer to D 5555 (The blood bank failed to assure that the blood units were stored under appropriate conditions from January 6, 2017 to May 17, 2018). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)