Despite rigorous safeguards in place, non-infectious complications of transfusion can still occur. The risk of error associated with the dispensation and administration of blood products to a particular patient is a persistent concern. A mistransfusion, the failure to give the correct blood to the intended recipient, is the worst preventable human error that can result in major ABO incompatibility with potential subsequent immune hemolysis, renal failure, and death.
To prevent potential mistransfusions and other potential transfusion risks, AABB, CAP, FDA, and Joint Commission regulations require that the Transfusion Medicine Division is actively involved in capturing, assessing, investigating, and monitoring events that deviate from accepted policies, processes, and procedures. The Johns Hopkins Hospital Transfusion Medicine Division has been monitoring and instituting change to prevent recurrence of deviations for many years. These deviations are documented on an internal variance. There are several discovery routes that ensure errors are captured prior to blood products being dispensed from the blood bank:
(1) The Transfusion Medicine computer system has been carefully designed to warn staff of potential risk areas preventing the release of nonconforming blood products. Technologists are forced to enter reasons for exceptions to these warnings into the computer system prior to dispensing. Exceptions are captured by a report that is generated and reviewed daily by the Quality Assurance Specialist. Each exception is reviewed to ensure that it was acceptable by policy to release the product for transfusion.
(2) The UHC Patient Safety Net, used by the Hospital, allows for staff outside the blood bank to report errors or deviations recognized prior, during, or after the transfusion of a blood product.
(3) Hemovigilance, a component of the Biovigilance program developed by the National Healthcare Safety Network (NHSN), was designed for transfusion services to track adverse events, including recipient adverse reactions and quality control incidents related to blood transfusion. Hemovigilance monitoring, which began a year ago, allows Transfusion Medicine staff to anonymously report issues, errors and deviations to the Quality Assurance Specialist. These incidents are entered into a database where they are tracked, trends are identified and process improvements are initiated.
A review of variance summaries from 2002-2004 showed alarming totals of greater than 100 variances per year with a maximum of 142. The management of variances prior to 2005 involved staff counseling, implementation of corrective action and staff retraining. In 2005, an analysis showed that deviations with the greatest impact to patient care involved the processes of dispensing and testing. The Transfusion Medicine Quality Assurance Committee set an initial performance improvement goal of a 50% reduction in the number of deviations involving these processes. In order to reduce the number of dispensing and testing variances, three objectives were initiated. First, educational sessions with medical director participation were presented to the staff to provide an awareness of the severity associated with dispensing and testing deviations. Second, quality systems were enhanced so that deviations in either category included a procedure review and direct observation of the process with the technologist involved. Last, monthly staff quality assurance meetings included a review of each variance, excluding staff names, to clarify the process for all staff, thereby reducing the chance of recurrence. After initiating the performance improvement goal, dispensing deviations decreased by 53% and testing deviations decreased by 56%. By 2008, the total number of documented variances was 75, representing a 40% overall reduction in 5 years.
Variances are continuously reviewed and performance improvement goals are set when upward trends are identified, thereby ensuring the provision of the highest quality of patient care.
Christi Marshall, Lisa Shifflett, Joan Boyd, Paul Ness, M.D.
Transfusion Medicine Division
Johns Hopkins Hospital