The mission of BIS and why it needs barcoding
Bio Implant Services Foundation (BIS) intermediates between the donation and transplantation of tissues such as corneas, heart valves, bone and skin. When the physician in charge reports a possible donor, a medical history is taken with emphasis on risk factors for transmissible diseases.
After acceptance of a donor, explantation is performed of one or more tissues, and these are transported to the tissue banks where preparation and preservation occurs. Thus usually more than one, in case of a bone donation sometimes even several thousands of pieces of tissues of one donor can be transplanted into a corresponding number of different recipients. Thus traceability of the tissues while on route is important and the donor-recipient combinations have to be tracked.
During explantation of tissues, also bloodsamples are withdrawn for determination of serological markers of transmissible diseases, such as hepatitis and AIDS. When screening tests are performed, sometimes false positive results occur and if that is the case, additional, so called confirmatory testing is performed. A decision tree is then applied to finally decide on the safety of the tissue.
Nevertheless, it is impossible to exclude completely the risk for transmission of diseases, since a so-called window phase exists, during which a donor can transmit disease but is serologically completely negative. Therefore, in addition, serum needs to be stored for extra testing or future control during several years.
Finally, when tissue is delivered and used for a recipient, a follow up is required which boils down to the return of a duly completed form by the implanting surgeon which combines the data of donor and recipient. This in short explains why BIS foundation is in need of a bar coding system, in order to work efficiently, to prevent writing errors and to secure the quality level which is, for understandable reasons, imposed by governmental bodies and European GMP-requirements.
Current and possible future uses of barcoding at BIS
BIS accepts approximately 2500 donors per year and it is expected that this number will increase in the years to come. Donors are given a unique identification number, which together with the date of birth is barcoded, to enable efficient labeling of forms, blood samples and tissues when they are being processed.
Moreover, BIS is internationally active which necessitates the use of an interchangeable barcode standard for identification of donor, of the type of tissue and its expiration date, of the results of the tests applied and of the banks where the tissue has been processed. Thus barcode-stickers should be able to provide this information too.
When tissue is implanted, a surgeon should be able to complete the follow-up form merely by sticking the barcode label, with this information, from the packaging insert onto the form to be returned, together with some additional clinical data about the recipient and date of implantation as requested. Ideally, the identification of the recipient should be in barcode too, and both codes should allow to be concatenated (they should act electronically as if they belong together) upon arrival into the computersytem of BIS, to secure the storage of the corresponding donor-tissue-recipient combinations.
One can easily calculate that within 10 years, at least over 500.000 of such combinations need to be traceable, preferably with a single touch of a button and with a possibility to trace back all the ramifications mentioned. May the following example convince you that this is not a luxury: When the news came that an Abbott test for AIDS turned out to be false negative under certain circumstances, BIS was asked to trace those donors (and recipients who received tissue from them) whose blood was tested with this type of test in order to retest the blood if necessary with a test from another fabricate, and we were able to solve this satisfactorily.
Although no international barcode standard exists, tailored to the needs of tissue procurement and banking, it is envisaged that the use of code 128 as proposed by the International Society of Blood Transfusion (ISBT 128) can be adapted to suit this purpose relatively easy and BIS will embark on an initiative to form a working party with this purpose.
The need for distributed electronic communication
The information about donors gathered from the laboratories and stored by BIS should preferably arrive by electronic means and simultaneously be transferred to tissue banks via the same route. This calls for a distributed electronic communication with a distributed database system, and this will be expanded upon below.
From CLIS to CLAUS: Communication by means of a 2-dimensional barcode system
So far, the application of barcoding by BIS is relatively new for its setting in patient- and healthcare, but comparable to several other applications, for identification of products to be delivered, albeit that in this case especially the privacy of the donor and recipient have to be guaranteed. As explained above, a relatively complicated screening cascade for serological markers of viral infections is required, which varies per type of tissue.
The developments in this area are very dynamic, and it is almost impossible to work error free if all personnel involved needs to be trained with every new adaptation in this field. Moreover, the laboratory results, sometimes together with additional results of confirmatory testing and with a medical authorization, need to be received in a single document that is readable and understandable for any medical personnel involved in the chain from processing to implantation. Crucial however, is that information has to be provided with the bloodsample about the type of tissue(s) concerned which should trigger both the actions to be taken by the laboratory and the exact information in the authorized letter with the results thereafter.
To enable this we currently use a modification of the barcode system as it is applied at the Central Laboratory of The Netherlands Red Cross Blood Transfusion Service, Amsterdam (CLB), called CLIS (Central Laboratory Information System), and we will embark on the system currently being developed, called CLAUS (Central Laboratory Aanvragen (Requests) and Uitslagen (Results) System). In the current system (CLIS) a special form is developed for BIS which has to accompany the blood sample.
The employees at BIS only have to identify the donor on the form and on the bloodsample by barcode stickers and tick the appropriate boxes on the form to indicate for which tissue(s) the testing has to be performed. The computer at the CLB reads the corresponding barcodes which are concatenated with the donor-ID-barcode and this then determines the workflow and the content of the authorized letter with the results.
Previously, this process was much more complicated and error prone, since all necessary tests had to be selected and marked by hand by the employee at BIS from a long list of many possibilities. Moreover, it is preferred to have one single document per donor with both the type of tissues donated and the corresponding results of the relevant tests - together with additional testing if necessary - plus an authorized interpretation.
Since the amount of information which accompanies each form, and/or blood sample, increases, and the type of actions to be taken varies per item too, a need for a 2-dimensional barcode system is recognized, which may contain 1000 characters of information. To make all of the above requirements possible, a special Claus-computer will be installed at the central office at BIS, programmed in Lotus-Notes and operating under Windows, which contains several databases, i.e. one for on-line help, one to describe all possible blood determinations and what type of blood sample is required, one to store all results which come from the CLB, one to store the complete authorization letter with the results, and so on.
When a donor is accepted by BIS, the corresponding donor identification and tissues available, plus additional actions to be taken and special requests can then be entered into the CLAUS computer and a customized form will be printed, to go with the blood to the laboratory. This form will then have all the information about the donor and the requested testing printed on the 2-dimensional barcode and removable stickers with a barcode, identifying the donor, will be on the form too. These will then be used to stick on the blood samples. Both, blood samples and corresponding form then arrive at the CLB which can automatically take the appropriate action.
At BIS, but also at the tissue banks if they are connected, one can see automatically in the CLAUS computer that the samples have arrived and when the results can be expected. Alternatively, to work cost effective, a blood sample can be processed for storage only until a tissue has been approved by the bank, and thereafter the tests can be ordered via the system.
For several reasons it is not logical to send a message directly to the CLB computer that blood is on its way and to order tests, instead of doing so via the above mentioned method. This would disturb a natural and efficient workflow at the CLB and confusion will exist about the samples, which were announced but have not been sent after all or did not arrive for other reasons.
With the advent of increasing numbers of tissue-donors and of increasing quality requirements to trace all donor-recipient combinations and to perform sophisticated cascades of testing for serological markers, which vary per tissue, an increasing need exists to use barcoding at BIS. This is not only for coding the tissues, but also to convey information to the laboratory, needed to initiate the right workprocess and the correct authorized letter with the results.
For the coding of tissues it is envisaged that a modified form of ISBT code-128 will be developed. For the error-free communication with the laboratory it is envisaged that a 2-dimensional barcode will be initiated and printed (from a specialized CLAUS computer), which will contain all necessary information and through which the right workprocess is ordered, resulting in the correct authorized letter with all pertaining donor/tissue information and the laboratory results.
This letter will arrive electronically at several places where this information is needed in a total data transmission process that rests upon distributed electronic communication.
by Eric Kalter, Bio Implant Services Foundation