At the beginning of a new century with a virtual explosion of computer automation, the question is why the healthcare industry has not fully adopted routine bar code technology and common automatic data capture systems used in many industries to reduce errors. Average Americans purchase hundreds of items from supermarket shelves stocked with thousands of different products every week with 100% certainty that each item will be correctly identified. UPS, Federal Express, auto manufacturers, most major retailers and other industries move, assemble and track items around the world with great accuracy using bar code technology. At the same time, using what are considered conservative reports of life threatening medical errors, between 44,000 and 98,000 Americans die from preventable medical mistakes each year. Has automatic data capture and bar coding technology missed the mark in the healthcare market or have those responsible for maintaining the highest quality healthcare in the world neglected the life-saving potential such technology offers?

The very same technology that tracks packages, checks out groceries and assembles parts for your car has been applied by companies like Digi-Trax to healthcare problems that could make most medical errors a thing of the past. There are systems available now that will measurably improve our healthcare at reasonable costs, but they are not being used aggressively by a medical industry that prides itself as being the "best" in the world.

The reasons are as interesting as they are complex; however, the bottom line is that a national resolve to address the problem of medical errors has not been there. In the JCAHO's publication "Sentinel Event Alert", September 1999 a comprehensive three year study was profiled. It was titled "Blood Transfusion Errors: Preventing Future Occurrences". The article recommends the use of bar code readers with bar coded patient wristbands and bar code labeled components for a positive confirmation between the component and the patient ID-band before the healthcare worker can proceed with the transfusion. What we find unacceptable is that this technology exists and is not being aggressively adopted.

The rather unique complexity and operational characteristics of the American Healthcare delivery system, coupled with a politically charged and hotly debated reimbursement system, has made data capture automation difficult to introduce to our healthcare institutions. Clinical imperatives that are perceived to be essential for patients or competitively necessary do get adopted, while most automation utilizing bar code technologies for patient safety remain difficult to introduce.

Improving healthcare through innovative automation has been at the core of the Digi-Trax mission, along with our strategic alliance partners, Immucor Inc. of Norcross, Georgia and Healthcare-ID of Buffalo Grove, Illinois.

To illustrate our point, we would like to discuss a collective group of products designed to reduce medical errors through automation of the entire donor to patient (vein to vein) transfusion process.

Our products support an improved blood collection and delivery process in all areas through the use of automation so that a donated unit of life-saving blood received in the hospital blood bank/transfusion service will be reliably correct. Properly cross-matched product is essential to the Emergency Room (ER), Operating Room (OR), Intensive Care Unit (ICU) or Hem/Onc area. Bar coding programmed into new Palm Computing devices with integrated bar code readers from Symbol Technologies can ensure that the properly labeled blood reaches the right patient at the right time. All of these products utilize proven bar code accuracy and commonly used computer technology to improve accuracy and reduce cost.

Let's begin with the Blood Donation Center where the cost of a unit of blood has risen dramatically due to newly required testing procedures resulting from AIDS and other blood born diseases and the number of donations continues to decline. Across the country a safer and more cost effective collection process is needed. The dollars of reimbursement to the hospital utilizing blood for life-saving transfusions have been cut. Digi-Trax has an automation system which will reduce lost blood units due to incomplete information on Blood Donor Record Forms (BDRF's).Our Donor-IDT will improve quality and safety while lowering the cost of collecting blood.

Over the past three years, Digi-Trax and Healthcare-ID have developed this 510(k) cleared product called Donor-IDT. This true process control oriented product utilizes PC's, lap tops, and a new Palm Computing platform to automate donor registration, health history, physical exam and phlebotomy. Donor-IDT interfaces to the blood center's host data base for donor deferral, eligibility information, demographics, deferral codes and many other data files for access during the collection process. We are even employing new wireless Radio Frequency (RF) technology to consolidate data. Donor-IDT includes full reporting functions. We are currently installing the first such system at the Gulf Coast Regional Blood Center in Houston, Texas.

It has been calculated that Donor-IDT will effectively save almost $3.00 per donation, thus making this automation improvement very cost effective. As U.S. donations drop, a system such as Donor-IDT ensures that all units drawn can be used thus increasing Donor-ID's value. This product forces the capture of all critical data: new donor demographics or changes, health history responses, screener comments and physical exam elements (e.g. temperature, weight, pulse, blood pressure, and hemoglobin). Phlebotomy data including phlebotomist ID, time, date, lot number, scale ID, weight, reactions, completion codes and more are captured by the Palm Computing device.

Also, for the past ten years the International Society of Blood Transfusion (ISBT) and the American Association of Blood Banking (AABB) have been developing a new bar code symbology, ISBT 128, to replace the old more error prone 1970's technology called CODABAR. But, believe it or not, the U.S. Code of Federal Regulations (CFR's) today does not require the use of any automated symbology (bar code). If we cannot even get the FDA, who actively supports the new ISBT 128 bar coding scheme, to change the CFR's to require the use of safer bar code technology, how can we expect automation in healthcare to go forward. When the government mandates seat belts, is it not reasonable to ask why we can't help ensure blood quality by requiring the use of bar codes?

The new ISBT 128 bar code labeling scheme will go a long way toward improving and standardizing blood labeling worldwide. This label standardization shortcoming was exposed during Desert Storm, when duplicate numbered units showed up along with improperly labeled blood that could not be used. The Department of Defense's Blood System (DBSS) now employs Digi-Trax's Hema Trax.LPST on-demand Windowsr labeling system. Hema Trax.LPST helps to provide accurate labeling and ensures that properly printed labels are easily available from stock blank labels. Computer controlled bar code labeling satisfies the need for secure, informative, consistent labeling with complete reporting audit trails that facilitate total label reconciliation.

This first step toward worldwide standardized labeling is very important and has the support of the American Red Cross (ARC), AABB and the FDA. Moving on to the hospital transfusion service, where blood products are delivered to patients in the OR, ER,ICU, etc. there is new automation that completes the (vein to vein) cycle. Here Digi-Trax and its software development partner for the Palm Computing Platform, Healthcare-ID, have teamed up with Immucor Inc., a major provider of blood banking automation and reagents. I-Trac PlusT, our portable data terminal product closes the loop by providing a unique bedside system to ensure that the properly cross-matched blood unit number reaches the correct patient.

This product, "I-Trac PlusT", addresses the expert's recommendations from the JCAHO's three year review of "Blood Transfusion Errors"; "use a hand-held bar code reader to read both bar coded wristbands on every patient and a bar code identifier on the tag of the components. If the bar code reader fails to confirm the identity between the wristband and the tag, then the healthcare worker cannot proceed with the transfusion."

I-Trac PlusT from Immucor combines a modular automated system for the tracking and verification of transfused blood. I-Trac PlusT is at the heart of Immucor's sample management and testing products. The patient ID band, phlebotomist ID and a specimen bar code label printed at bedside identify the blood sample to be cross-matched on any one of Immucor's automated bar code reading blood analyzers. The cross-matched results are then electronically transferred to the hospital's Laboratory Information Service (LIS). Properly matched and compatibility labeled blood is then issued to the patient. The next module of I-Trac PlusT controls the administration of the blood or blood components to the patient. Again using the Symbol Technologies portable Palm Computing terminal with an integrated bar code reader, the same patient wristband is scanned and compared electronically to the compatibility label on the component to be transfused to ensure a proper match. All activity is recorded. No steps can be skipped or missed, otherwise the process cannot be completed. All of this forced data compliance is electronically recorded and reported. I-Trac PlusT has now been successfully installed at Georgetown University Medical Center.

Our joint venture partner Healthcare ID Corporation utilizes the same Symbol Technologies Palm Computing hardware for a family of other highly reliable Automatic Data Capture products that includes the tracking of laboratory specimens, controlling of automated medication administration, and creation of the bar coded patient wristband.

Digi-Trax has worked cooperatively with several companies to make bar coded ID wristbands easily available through most any admissions system or emergency room. By employing a specially designed small, economical, dedicated thermal bar code printer from Cognitive Solutions Inc., with either self adhesive or lanyard locking patient ID bands from Precision Dynamics Corporation, all hospitals can easily utilize bar coded patient ID wristbands. Many U. S. hospitals including all VA hospitals have already employed these wristbands.

We believe that there is overwhelming evidence pointing to the fact that the technology exists today to improve the U.S. health system by reducing errors through the use of automation.

In summary, Digi-Trax and its partners would like to propose a few positive ideas that might help bring the U.S. health system in harmony with commercial businesses like Federal Express, UPS, GM, Safeway and many others.

1. Mandate the use of bar codes in the Code of Federal Regulations (CFR's) to identify patients, label blood and blood products, identify and control specimens, medications, etc.

2. Demand that the use of computerized verification becomes a part of the standard process in healthcare facilities by asking accrediting bodies like JCAHO, AABB, FDA etc. to make error reduction part of their required processes.

3. Support legislation to make reporting of medical errors a compulsory process while installing some level of legal insulation.

4. Resolve to reduce human intervention and handwriting in all medical administration procedures while recommending that insurance costs be reduced for those who introduce automatic data capture into their facilities.

5. Get the support of the insurance industry for the above suggestions. Reducing medical errors should be just as supportable as seat belts.

6. Encourage a change at medical schools, educating doctors to utilize various electronic means for communicating medical notes and prescriptions. We need to change the practice of medicine to utilize the currently available technology at the education level.

7. Government must provide some of the means to finance these changes since they will result in lowered medical costs and improved health outcomes.

Digi-Trax Corporation
650 Heathrow Drive
Lincolnshire, IL 60069
Phone: 847-613-2100
Fax: 847-465-9055
email:  info@digi-trax.com