Pilot studies

Three pilot studies have been undertaken with the objective of expanding this technology into other healthcare processes, patient categories and organisations. These pilots provided a testing ground within the AMC where experience could be built up on the application of RFID standards.

The pilots focused on the following RFID applications:

-Identification and location of persons within the operating theatre;
-Tracking and tracing of operating theatre equipment;
-Tracking and tracing of blood products.

The advantage of launching several pilots within a single institution was that direct connections could be made between them. For instance the same processes and patient categories were used in intensive care and in the administration of blood to patients in the operating theatre . The concentration of the pilot studies within a single institution also delivered practical advantages and cost savings, since this allowed RFID solutions to be realized using the same infrastructure.

Individuals
Individual persons were monitored during the pilot study in the AMC, including patients and the operating theatre team. Both groups took part on a voluntary basis.

Patients were approached by a member of the project team on the day before their operation. The project team member explained the RFID project and asked if the patient would be willing to wear a tag band for the next 24 hours. The verbal explanation was also available as a patient information document. This document was then left with the patient.

If the patient was taken to the operating theatre the following day, the tag would be picked up at the entrance and exit to the recovery room, the entrance and exit to the operating wing and in intensive care if applicable. This allowed the "patient logistics" to be mapped out.

The operating theatre team were asked to wear a badge during the operation. The badges were linked to functions, for example surgeon, operating theatre assistant, anaesthetist. This allowed the number of movements during the operation to be monitored retrospectively.

Materials

A limited number of items of materials were tracked. The selected items were suture materials forming a standard component of specialized trays (trays used for a particular type of treatment) and vascular prostheses. These items were chosen on considerations of rate of turnover and the costs of the materials.

The aim was to automatically scan the introduction and removal of these materials to and from the operating theatre using the RFID infrastructure. A different solution was chosen following problems with interference (see Technology → Interference with medical equipment). Prior to the operation the specialized trays were manually scanned using a portable scanner. The hand scanner was then synchronized with the database.

Following the completion of the operation the used materials were taken in a refuse bag to the clinical waste section. An RFID reader had also been installed in the clinical waste section so the refuse bag was scanned there. This allowed the materials used to be identified.

As a check on the scans carried out in the clinical waste section, staff dealing with pre-stocking were asked to scan each returning tray using a hand scanner. This allowed identification of the materials that had not been used during the operation. This method also made it possible to measure how often specific articles continued to be returned unused in the specialized tray. This information is significant in view of issues such as shelf life.

Blood products

European legislation requires blood and blood components to be traceable from donor to recipient and vice versa. The use of temperature-sensitive RFID tags offered a solution here: The tags can easily be attached to blood bags and can easily be read . The use of active RFID tags also contributed to patient safety by allowing the localization of a blood bag. This combination of active and temperature-sensitive tags allows continuous objective monitoring of the entire chain passed through by a product, from the transfusion lab right through to the administration to the patient or the return of the product to the transfusion lab. By Following the use in the operating theatre or in intensive care the actual use of blood products was easily determined , improving the completeness and reliability of transfusion records.

This continuous monitoring allows a better assessment of quality preservation, so that with greater certainty can be established with whether a product should be written off as unusable or not. Linking this system to a warning system could also lead to a reduction in the quantity of products returned as unusable. The effects are expected to be magnified when the technique is extended to cover the entire transfusion process.

The introduction of RFID technology would also allow the computerization of a number of administrative procedures, further reducing the risk of errors. The logistical process can also be optimized thanks to a better understanding of the actual consumption of blood products. Further investigation is however required into the relationships between ambient temperature, temperature as recorded by the RFID tags and the actual (core) temperature of the blood products, since comparative measurements have produced a variety of results

	Further research The outcomes of this project have led to a number of recommendations for further research: •  Investigation into the risks of WiFi in high-risk hospital departments like operating theatres and intensive care departments (in terms of interference risks and the maximum permissible safe power capacities) •  The development of standards for the application of RFID in combination with medical technology (in collaboration with NEN & TNO). •  Tests should be carried out to determine whether high-risk medical equipment which is also used outside the health care setting is interfered with by RFID installations. •  The developments in the area of RFID in the medical equipment and medication supply chain should be mapped out and shared with relevant parties in the supply chain within the Netherlands. •  The user requirements and the possibilities of carrying out measurements in relation to product temperature, quality and storage conditions for sensitive products with a high risk profile in patient care should be investigated.

Business case

The objective of the business case is to provide a financial analysis of the feasibility of implementation of RFID technology, based on the results of the pilot studies, without taking into account the limited scope of the pilots. That is to say: the business case considers a broad roll-out of the tried and tested functionality, and in contrast with the pilots there will be no limitations with regard to patient categories, equipment types, number of operating theatres or blood product types. Taking into account the necessary assumptions, the business case has been worked through in detail with regard to both the quantitative and qualitative benefits. A good estimate of the anticipated costs can be made based on the experiences of the pilot studies. An analysis of the costs and benefits results in the picture as set out below. According to these calculations, the widespread application of RFID in the area of the operating theatre would have a pay-back period of less than three years.

Lessons learned

The pilot studies suffered from a few technical setbacks and other useful experiences . The most useful learning points which emerged from the pilots are described below.

Hazardous interference
The traditional passive RFID technology selected for the
project did not appear to be useable in the immediate environment of medical equipment. The newer active RFID technology however is useable, provided it is implemented carefully. It is not possible to rule out hazardous interference between RFID signals and medical equipment on the basis
of the technical and scientific literature. Specific tests have therefore been carried out in order to investigate this interference. The understanding of the hazardous interference led to the taking of both technical and organizational measures. This allowed the RFID signals to be kept at a safe distance from the medical equipment. The various measures taken meant that no interference of any kind occurred between the RFID equipment and medical equipment. (see also the article on the risks of RFID in hospitals). Further information can be found under Technology → Interference with medical equipment

Shifts in levels of acceptability
The wearing of an RFID tag did not prove to be a problem for patients, partly due to the level of information provided to them. Only one or two declined to take part in the pilot study. The position was more complex in the case of the hospital staff. There was a certain level of suspicion in some groups about what would be done with the data obtained. Others took part enthusiastically right from the start. It was the part played by their own colleagues rather than the project team that appeared to be significant in overcoming the suspicion.

Latest technology demands extra care
The use of the latest technology demands extra care during installation, testing and commissioning. Unexpected
problems can arise due to lack of experience. Fault identification and rectification was complicated by the
restricted access to the operating theatre complex. There was also a lack of a representative test area to allow the entire
RFID installation to be subjected to thorough testing. On occasion this led to an appreciable lengthening of the period between the introduction of modifications and the observation of their effects.

Tight project management indispensable
This project would have been impossible without the active involvement of a good internal Project Leader, with a sound grasp of the organizational structure and culture. Often acting
in an informal way, the internal Project Leader was also in a position to encourage the different groups involved in the process to bring the project to a successful conclusion. Support from the upper levels of the organization, including
the medical staff, the Works Council and the Management Board was also essential, particularly when the pilot involving individual persons was concerned. Other crucial factors in the success of the project were the anticipation of the possible consequences and early and well-judged communications about the project and the specific roles to be played by the people involved. (see also the article "RFID:veni, vidi, vici!").