RFID and Smart Packaging in healthcare

Case Study: RFID in Action - the Massachusetts General Hospital START project

by Sunny Dzik, Co-Director Blood Transfusion Service, Massachusetts General Hospital, USA

“To err is human”

In the year 2000, the Institute of Medicine published it’s landmark report, “To err is human: Building a Safer Healthcare System”. This report detailed current long-standing structural problems in the safe delivery of healthcare to patients. Drawing largely on data concerning medication errors in hospitals, the IOM report estimated that as many as 96,000 Americans may die each year as the result of errors in the delivery of healthcare. The report generated enormous attention to the problem of medical error and galvanized governmental, regulatory, and professional groups to respond. Proper patient identification—a critical requirement to give the right treatment to the right patient-- has become widely understood as the fundamental infrastructure of safe patient care. Organizations such as the Joint Commission on the Accreditation of Hospitals (JCAHO) have clearly signaled proper patient identification as a basic requirement of good healthcare and a starting point for the assessment of any hospital. While at first glance the identity of the patient seems a simple matter, current practice demonstrates that much improvement is needed. We describe herein an example of the problem of patient identification at the time of blood transfusion and describe our initial steps to explore an improved method of patient identification using RFID technology currently under study at Boston’s Massachusetts General Hospital.


Blood Transfusion Errors

While the general public associates blood transfusion with the risk of exposure to infectious hazards, transfusion of blood to the wrong patient (mis-transfusion) is the most important serious hazard of transfusion.(1-4) The risk of mis-transfusion is more than 100 times greater than the risk of HIV or HCV transmission by blood.(1) Mis-transfusion typically results from an error made during the bedside check just prior to transfusion.(1,3) Studies have documented that such errors are most likely to occur among surgical patients.(3) Currently, the bedside check is done by humans using eye-readable information in a manner little changed in fifty years and without the advantage of any new technology.

Data from multiple sources worldwide document that mis-transfusion errors are serious and unacceptably frequent. In the United States, mis-transfusion has consistently been the leading cause of death from transfusion reported to the FDA since such reporting began. (3) Similar results are found in other nations. The frequency of serious adverse events related to blood transfusion is assessed in England through an organized national program of hemovigilance called the Serious Hazards of Transfusion (SHOT) program. Figure 1 categorizes all adverse transfusion events reported to the SHOT program including not only those attributed to errors but also those resulting from unavoidable blood reactions. When the data from SHOT are further analyzed to only include those events that result in either death or substantial morbidity to the recipient, mis-transfusion remains the most important hazard. The most recent data from the SHOT program identified 213 incidents of incorrect blood transfused in the year 2002.(4) When analyzed in detail, the most common cause of error was improper bedside check.

Figure 1: Serious Hazards of Transfusion (SHOT) national data from the UK(4)
 

Other sources report very similar results. Linden et al calculated that the risk of ABO mis-transfusion was 1 in 12,000 units. (5) Pierre Robillard reports that the hemovigilance program in Quebec identified mis-transfusion as the most common major adverse event occurring at a rate of 1 in 12,000 transfusions.(6) Andreu reports similar findings from the hemovigilance program in France.(7)

Current safety checks against mis-transfusion are inadequate and getting worse

Current patient safeguards to prevent mis-transfusion are inadequate. JCAHO has identified better patient identification at the time of blood transfusion as a top priority for improved patient safety. Previous published studies have repeatedly documented weaknesses in performance of the final bedside clerical check.(9-11) Of particular concern is the suggestion that the process is getting worse. The College of American Pathologists recently published results of two large observational audits— one conducted in 1994 and one in 2000.(12) These audits assessed the frequency with which basic elements of the bedside check were performed including positive patient identification, matching wristband identification to the blood compatibility label, matching patient identifiers with the blood request, and review of compatibility and expiration date information. In each category, there was a substantial decline in the percentage of transfusions that were correctly checked at the bedside between the years 1994 and 2000. Equally disturbing was the actual frequency that checks failed to be performed. For example, in the year 2000, the audit of over 4,000 transfusions revealed a failure to match wristband identification with the compatibility label in 25% of transfusions. Nationally, this translates into literally millions of episodes in which patients are not provided basic safeguards against the most common serious hazard of transfusion.

Technology support is appropriate for the bedside check:
Since most ABO incompatible transfusions (5) and most acute fatal blood reactions (3) result from giving blood to the wrong recipient, the process of the bedside check is the central target for improving patient safety related to transfusion. The bedside check is a repetitive task subject to “slip or lapse” type errors. (13) The essential features of the check are to verify that the patient identifiers written on the compatibility label attached to the blood bag match the identifiers of the actual patient about to be transfused. Because different patients may have similar names and medical record numbers, wrong units may be delivered to the bedside. The final bedside check requires careful comparison of names and medical record numbers of the patient and the blood label. Currently, the bedside check is performed without the aid of any supportive technology-- even though previous research has documented that the performance of repetitive task functions is aided through the use of technology.(14)

Radio-frequency identification (RFID) for patient and blood identification

Two machine-readable technologies—bar code technology and RFID—are candidates for application to the bedside transfusion check. Bar code technology has been available for decades, but has not gained acceptance for blood checks at the bedside despite the fact that all blood containers have been bar coded for many years. We believe the failure to adopt bar code technology for the bedside transfusion check reflects its unsuitability for bedside use. Bar coding requires line-of-sight so that a hand held laser can read a flat surface with the code. The laser light must be oriented by the user to cross the barcode. These simple constraints may represent important practical obstacles to bar-coding especially in operating rooms where the patient is covered with surgical drapes. Lack of acceptance of bar coding suggests the need to develop other identification technologies.

START: Safer Transfusion with Advanced Radiofrequency Technology

Massachusetts General Hospital has begun to study RFID “smart tag” technology to improve the bedside check. Working with Precision Dynamics Corporation, a major supplier of hospital wristbands and with Lattice Corporation, a software company focused on improved patient safety, we have begun to develop an RFID solution to the problem of transfusion error in the Operating Room.

Radiofrequency technology

Passive smart tags can be engineered to use several different ranges of radiofrequency from 125 kilohertz to 5.8 gigahertz. We propose to use tags operating at 13.56 megahertz as these provide the following advantages: low energy, low cost, no need for battery source in tag, small, will not interfere with other medical equipment.

RFID technology is well-suited to rapid reading of the blood label in the OR. RFID tags have been already employed in industrial applications requiring fast read-rates such as checking products on conveyor lines and at loading docks in supply chain management. Reading and writing data to the RFID tags is fast and accurate, with the time required to transmit at less than 100 milliseconds. Of particular importance for this proposal, data transfer is automatic (does not require action by the user) as soon as the tag enters the field of the reader device.

Making it “easy to do the right thing”

Correct reader design is critical to the success of the implementation project. Failure to use the reader removes the patient-safety advantage provided by the technology. In this application we propose an initial pilot study under controlled conditions that will permit us to optimize our existing reader design based on field experience, feedback, and data obtained on user acceptance. Our goal is a reader design which is seamlessly integrated into the process of administering a blood transfusion.

Why study this technology in the Operating Room?

We propose to pilot study the RFID check in the operating rooms (ORs). Data from Sazama document that mis-transfusion events are most likely to occur in surgical patients.(3) The OR is an ideal location for the implementation of technology to assist in the pre-transfusion check for the following reasons:

REASONS TO USE RFID BLOOD CHECKING IN THE OR

• A large proportion of the blood supply is transfused in the OR
• Patients are unconscious during the transfusion and cannot state their name.
• Caregivers in the OR have limited contact-time with the patient and may not “know” the patient as well as nurses on non-surgical floors.
• OR staff have experience with the use of technology designed for patient safety.
• Blood is often given under urgent circumstances.
• Distraction in the OR is commonplace

At MGH, 25 % of red blood cell transfusions are administered in the ORs. No other hospital location (patient floor, emergency room, outpatient area, etc) transfuses more red blood cells than the OR. The opportunity for error is particularly high as patients are unconscious and thus cannot state their name at the time of the bedside check. (Asking the patient to state his name is a standard part of the bedside check outside of the OR.) Unlike the nurse outside the OR who may have cared for the patient over the course of several days, nurses and anesthesiologists in the OR have not “known” the patient for a prolonged period of time. The OR environment is “friendly” to the use of technology to assist in patient safety. Indeed patient-safety devices developed in conjunction with human factors research have been long applied in anesthesia. (15,16) Finally, blood transfusions are often given in the OR under circumstances of extreme urgency and distraction—two key elements that may contribute to lapse errors at the time of the bedside check. Thus, from both a perspective of need and acceptance we are confident that the OR is the ideal hospital location to implement technology that assists in the bedside transfusion check.

A simplified view of the system (a design showing reader input to LCD monitor) is shown below:

Data Collection during the START study

The primary endpoints are user acceptance and system performance:

User acceptance

User acceptance will be measured as the proportion of units which were checked by the users in the Operating Room with the RFID system. The hospital blood bank data base records each unit issued, transfused, and returned to the laboratory for each patient. The blood bank system also records the date and time of issue and return, the type of product (RBC, FFP, etc), the unit’s unique number, and the patient to whom the unit was issued. By comparing blood bank records on each unit issued to the patient (and each unit transfused) with the data recorded on the tablet computer attached to the RFID reader in the OR reader, we can determine the proportion of issued units (and proportion of transfused units) that were checked in the OR by the RFID reader.

System performance

System performance will be measured by the ability of users to recognize that the intended recipient of a labeled unit does not match the actual recipient in the room. Because such errors are infrequent under routine conditions, we propose to measure the performance of the system using “test tag” units that act as a surrogate for mis-labeled units.

“Test Tag” units (surrogate mislabeled units) to test the system:
Test tag units will contain deliberately encoded information that does not match the recipient and therefore act as surrogate mislabeled units. We have developed a technique for applying these test tag units that will not compromise patient safety during the evaluation.

Obstacles to RFID in the OR bedside check of blood-- Future Opportunities for RFID

We envisage three potential obstacles to the success of RFID technology applied to the bedside check of blood units in the operating room:

a. Failure to wrist-band the patient (this obstacle will evaporate if MGH decides to apply RIFD wrist-bands to all patients);
b. Failure to initialize the reader; or
c. Failure to use the reader.

Our study will be able to measure with high precision the rates of each of these three failure modes and permit us to analyze which part of the process should be improved. For example, if failure to use the reader emerges as a common obstacle, then “automatic readers” placed at the OR doorway would be explored in a subsequent study.


Literature Cited:

1. Dzik WH. Emily Cooley Lecture 2002: Transfusion Safety in the Hospital. Transfusion 2003; 43: 1190-99.
2. Minz PD. Nishot: on target, but there's no magic bullet. Am J Clin Pathol. 2001 Dec;116(6):802-5
3. Sazama K. Reports of 355 transfusion-associated deaths: 1976 through 1985. Transfusion 1990; 30: 583-590.
4. Love EM, Soldan K and the Serious Hazards of Transfusion Steering Group. SHOT Annual Report 2000-2001, 2002, pp 1-239.
5. Linden JV, Wagner K,Voytovich AE, Sheehan J. Transfusion errors in New York State: an analysis of 10 years’ experience. Transfusion 2000;40: 1207-1213.
6. Robillard P, Itaj NK, Corriveau P. ABO incompatible transfusions, acute and delayed hemolytic transfusion reactions in Quebec hemovigilance system – Year 2000 (abstract). Transfusion 2002; 42: 25S.
7. Andreu G, Morel P, Forestier F, et al. Hemovigilance network in France: organization and analysis of immediate transfusion incident reports from 1994 to 1998. Transfusion 2002; 42: 1356- 64.
8. Baele PL, De Bruyere M, Deneys V, et al. Bedside transfusion errors. A prospective survey by the Belgium SAnGUIS group. Vox Sang 1994; 66:117-21.
9. Shulman IA, Saxena S, Ramer L. Assessing blood administering practices. Arch Pathol Lab Med 1999; 123: 595-598.
10. Zimmermann R, Linhardt C, Weisbach V, et al. An analysis of errors in blood component transfusion records with regard to quality improvement of data acquisition and to the performance of lookback and traceback procedures. Transfusion 1999; 39: 351-356.
11. Miller KA. Transfusion errors. Q Probe09. Q-Probes 2000. College of American Pathologists.
12. Novis DA, Miller KA, Howanitz PJ, Renner SW, Walsh MK. Audit of transfusion procedures in 660 hospitals. Arch Pathol Lab Med 2003; 127: 541-48.
13. Leape LL. Error in medicine. JAMA 1994; 272: 1851-1857.
14. Bates DW, Cohen M, Leape LL, Overhage JM, Shabot MM, Sheridan T. Reducing the frequency of errors in medicine using information technology. J Am Med Inform Assoc 2001; 8: 299-308.
15. Cooper JB, Newbower RS, Lond CD, McPeek B. Preventable anesthesia mishaps: a study of human factors. Qual Saf Health Care 2002; 11:277-82.
16. Cooper JB. Accidents and mishaps in anesthesia: how they occur, how to prevent them. Minerva Anesthesiol 2001; 67: 310-3.
17. Dumont LJ. Sampling errors and the precision associated with counting very low numbers of white cells in blood components. Transfusion 1999; 31: 428-32.

 

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