The “Praxis für Strahlentherapie” in Singen is a radiotherapy practice. We treat around 140 people a day with a staff of more than 20 people. The institution was built new from scratch in 2007, so we had the advantage of no inherited bad habits and were able to define our workflow without inherited burden. A good workflow is essential for every radiotherapy institution. Nearly all of the patients who come to us for treatment have had some other previous treatments (surgery, chemotherapy…). They come to us with a pile of papers describing treatments, actual blood values and diagnostic findings. Using the information we get we make a therapy plan, the therapy is carried out and in the end a letter is sent to every clinic or physician involved.
Radiation therapy is document-intensive. The print of a therapy plan alone takes about 15 to 20 pages. To this you have to add reports, laboratory prints, x-rays, CT or MR pictures and a lot more. This all adds up to 50 or more pages of documentation that one has to maintain for every patient during his time in the institution. This paper has to be stored and someone has to search for it when the patient comes back after several weeks or after a year for examination or further treatment.
At the moment we treat around 1500 patients a year. Easy math tells that we face some 75,000 pages of paper and pictures. Keeping in mind that we are forced to maintain these documents for 30 years gives a glimpse of the mass of documents that has to be created, stored and maintained.
Documentation maintenance is costly in terms of room, personal and time. More and more storage room is needed over the years – room that is normally not available. Searching takes more and more time and in the end a lot of records will not be found. A rule of thumb says that 10 to 15% of all records will “disappear”.
Lost records consume time twofold. Firstly, the search time used until a record is accepted as “lost” is wasted – and then more time is needed to reconstruct the basic patient history.
An electronic health record solves most of the above-mentioned problems. Everything is instantly accessible, and the room for the old archive can be used otherwise. A picture that is not stored in the database cannot be found, regardless of how hard we search, so we don’t need to bother searching at all. We therefore decided that a complete electronic health record was the logical step.
But the digital solution leads to new problems. What about the records’ 30 year life span and how does the digital record compare to the real one in the event of a lawsuit? How can we be sure that a document created in 2009 can be read in 2029?
From 1980 to 2010: 30 years of progress
30 years are a long time. Considering hardware progress over that time, one comes to the conclusion that the hardware has evolved, but most of the components that made a state-of-the-art computer in 1980 can also be found in a brand new machine. CPU, hard disk, video card: all are faster, bigger and better but are essentially the same. Imagine a file that made it’s way from a 5 ¼” over a 3 ½” disk, a big and clunky hard disk to a brand new 5 TB raid array. Hardware evolved in small, comprehensible steps. There is no great problem to transfer the file from one medium to another to the next and so on. So we think we can state that – if some care is taken – all files can make their way over the years.
But chances are good that the 30 year old file that we managed to transfer through the different hardware was written with DisplayWrite on a IBM-PC. Or with WordStar. Or with some other ancient program that has vanished into the blue. Even now, where most documents are written with MS-Word which has emerged as a standard word processor, it is not that easy to open a document that was written with an older Word version. The problem is not which software to use. The problem is, that the next update of the same software might change the storage format and over time drops support for the old format. The only way to prevent this is the strict use of a standardised storage format. Working in radiotherapy involves working with standards: everything is standardised. There is ISO, there is DIN, and everything is regulated. So we searched for a standard long-term storage friendly file format and found PDF/A.
Our hardware strategy for the next years is to follow the evolution and keep our hardware state-of-the-art. And we use PDF/A for our documents – at least for the critical ones.
All letters and documents that accompany the patient on his first visit are scanned and added to the patient’s electronic record. In the moment there is no automatic PDF/A conversion of the scanned files that are usually TIFFs. But we don’t really need to convert them because the patient comes with a copy; the original document is kept by the attending physician.
We use PDF/A to store the documents that we ourselves create and might be needed in case of a later legal battle, or might be needed if the patient comes back to us some ten years later for further treatment. Furthermore, we also use PDF/A to store the proof-of-quality documentation that we have to keep for the appropriate authorities.
The following documents are stored in PDF/A:
- consent forms
- radiation plans
- documentation of the first treatment
- discharge letters
- accelerator’s daily lists
- accelerator’s quality check printouts
In total we have about 10 different document types that are stored in PDF/A format.
Storing documents in PDF/A format gives us the best chance to be able to access and display them in 10 or 20 years. But we also have to consider some legal aspects. In earlier times patients and physicians signed a consent form. The physicist signed the print of the radiation plan, physicians and physicists signed the daily lists of the accelerators and so on. Signing was mandatory, and still is for nearly all documents we store in PDF/A format. So we had to go a step further.
More than a document
A fundamental point in medical treatment is the patient’s informed consent. The physician and the patient fill out a standardised form while the physician explains all steps needed for the desired treatment. At the end, the document is signed. In the moment we are on our way to translate this process in the digital world. We are defining a similar standard PDF/A document. The physician will be able to write into the document, check some checkboxes, draw some marks to clarify a special point or even start a short animation of some kind. Certain parts of the document may only be visible if specific preconditions apply.
The actual time spent filling out the document could be stored by the document’s history function. With this, the physician can prove that the patient’s information did not happen in passing but took a specific time with several actions on the form.
To mimic the paper form as close as possible, a WACOM touch sensitive flat screen is used. Physician and patient sit at a desk where the tablet is mounted, similar to sitting in front of a sheet of paper, and in the end the document is signed.
In the digital world, physically signing a paper means a qualified signature. For us, digital signatures opened a new field of regulations and laws we did not know and did not previously need. In the end, everyone who must be able to sign a document had to get a digital signature card from a trusted supplier together with a checked and sealed card reader and with approved signing software.
Our signature cards are from the Sparkassenverlag, look like a normal bank card and are handled in a similar way. Every physician and every physicist has his own signature card. Our computers are equipped with a KOBIL card reader and the SignLive! software from intarsys for the qualified signature.
Putting it all together, our document workflow is as follows:
- document creation (scan, print to PDF, …)
- convert to PDF/A (SignLive!)
- qualified signature (SignLive!)
- document import into the digital patient file (Mosaiq)
Our consent form will be signed by the patient with a pen on the WACOM tablet and signed with a qualified signature by the physician. After the possible introduction of a health card for all insured persons, the patient could sign the form with his own card and his pin number.
The combination of PDF/A and qualified digital signatures is a secure and court-proof way for long-term medical data storage. Handling is easy and becomes a routine process over time. The PDF/A conversion however is done manually, taking time (and therefore money…). A better integration of the PDF/A storage format into the big standard applications would be the next logical step in establishing PDF/A.