Vanderbilt University Medical Center

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: Based on surveyor record review the laboratory failed to ensure that staff perform second person check when issuing blood products. The findings include: 1. Review of the Vanderbilt University Medical Center Diagnostic Laboratories Issue of Blood Products procedure stated a second tech confirms orders and verifies labeling on all products that leave the Blood Bank. The second tech documents the verification by initialing the physician order. 2. Review of the laboratory records revealed that on 9/17 /2019 an order for Patient B was received and issued by TP4. The TP4 left the blood product on the counter and left the laboratory. The blood product was sent to the proper location where Patient B was located before a second check was completed. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on surveyor review of emergency release records and review of emergency release procedures, the laboratory failed to ensure Emergency Release Forms were signed by the requesting physician before or after blood was obtained. The findings include: 1. Review of the Vanderbilt University Medical Center Diagnostics Laboratories Emergency Release of Blood Products procedure stated that any unit emergency issued before any required testing, including ABO/RH compatibility testing or infectious disease testing is complete requires an Emergency Release Form to be signed by the patient's physician. 2. Review of 2018 Transfusion Service Request for Exceptional Release of Blood Components forms from January to December included 325 out of a total of 1,694 that were not complete with physician signature. 3. Review of 2019 Transfusion Service Request for Exceptional Release of Blood Components forms from January to August included 156 out of a total of 1,073 that were not complete with physician signature. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor record review and interview with laboratory personnel, the laboratory failed to correct problems identified in the Issuing of Blood Products procedures. The findings include: 1. The Vanderbilt University Medical Center Diagnostic Laboratories Issue of Blood Products procedure stated to record any special messages relevant to product order i.e. antibodies, notes to tech, and transfusion restrictions (Autologous, Directed Donors...) on requisition. 2. Review of the laboratory records indicated that on 10/9/2019 at 8:57 AM an order was received for Patient A. Patient A had special restrictions to only transfuse O negative blood. TP1 reviewed the order and the special restrictions in SoftBank. TP1 recorded the special restrictions onto the Physician Order Form incorrectly as O positive. TP2 performed a second check by verifying the information TP1 recorded on the Physician Order Form not the information in SoftBank. 3. Interview with TP3 the morning of 12 /4/2019 confirmed the special restrictions in SoftBank for Patient A were recorded by TP1 incorrectly onto the Physician Order Form which resulted in the wrong blood product being transfused. 4. Interview with QA1 on 12/4/2019 confirmed the special restrictions in SoftBank for Patient A were recorded incorrectly by TP1 resulting in the wrong blood products being issued, but no change to the Issue of Blood Products procedure was made when this error was discovered. -- 2 of 2 --

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on interview with the Transplant Coordinator, interview with the Blood Bank Manager, review of Blood Bank Unit History print outs, it was determined that the Laboratory Director did not ensure that an effective Quality Assessment Program was in place when the Transplant Team received notification from the OPO (Organ Procurement Organization) concerning an ABO mismatch between Patient #2 and a transplanted liver and then failed to notify the Blood Bank of this issue prior to them issuing blood products. (Refer to D6094) D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on interview with the Transplant Quality Coordinator, interview with the Blood Bank Manager, and review of the Blood Bank Unit History print outs, it was determined that the Laboratory Director did not ensure that an effective Quality Assessment Program was established to ensure that the Blood Bank issued ABO compatible blood products to Patient #2 after receiving an ABO mismatched liver Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- transplant. The findings included: 1. Interview with the Transplant Quality Coordinator on April 11, 2019 at 1:00pm verified that the Transplant Team received notification on 11/28/18(day after transplant) that the liver they received for Patient #2 was not type O but instead type A. 2. Interview with the Blood Bank Manager on April 11, 2019 at 11:00am verified that on 11/28/18 type O plasma was sent to the floor for Patient #2. The Floor Nurse refused the plasma units and returned them to the Blood Bank because of an ABO mismatch with a transplanted liver. The Blood Bank staff was not aware of the ABO issue with Patient #2 prior to the plasma being returned. The Floor Nurse then called the Blood Bank and told them of the ABO issue with the recently transplanted liver of Patient #2 after sending the type O plasma back to the Blood Bank. 3. Review of the Unit History print outs for Patient #2 indicated the following plasma units were issued on 11/28/18 at 13:13: Units refused by the floor and returned at 15:04 included: O pos W201918571147 O pos W204118444116 O pos W201918867812 O pos W201918567647 O pos W201918554446 O neg W201918572106 O neg W204118444104 O pos W201918572109 O pos W201918867507 O pos W204118443301 O pos W201918571167 O neg W201918572069 Units refused by the floor and returned at 15:04: O neg W204118444099 O pos W204118885295 O pos W204118888073 O pos W201918866255 O pos W204118885319 O pos W204118885159 O pos W201918866196 O pos W201918564276 O pos W201918867669 O pos W201918572073 -- 2 of 2 --