Limitations of Paper-Based Data
While the banking, healthcare and airline industries have made great strides in electronic data processing and storage technologies, most analytical laboratories continue to cling to paper-based record keeping systems. But paper records have many critical limitations:
- Paper is far more expensive than disk space or CD/DVD jukeboxes as a medium for data storage and (even with state-of-the-art high density storage systems) occupies a much larger “footprint” in the lab (i.e., valuable square footage);
- Filing systems are rarely centralized or standardized across an entire organization;
- Records within each filing system are impractical to cross-reference and most often catalogued (and therefore retrieved) by a single file label only (e.g., patient record number, name or analysis date range);
- Paper records are highly susceptible to damage and loss;
- Sharing and distributing paper documentation is inefficient and usually leads to proliferation of additional photocopies;
- Maintaining security, traceability and confidentiality of paper records (and all photocopies) is costly, and if compromised, exposes the organization to significant ethical and legal risks.
In a recent paper presented at the October 2002 Society of Forensic Toxicologists (SOFT) conference, we examined the “hard” costs for paper-based laboratories; even a small laboratory generating only 500 pages/copies per day will spend over $10,000 per year simply printing, photocopying and storing hardcopy records. Factor in the actual labor, overhead and “soft” costs (e.g., environmental impact, damage to business/reputation if critical, paper-based data is lost), and very little additional number-crunching is necessary to produce a relatively immediate ROI for most paperless record keeping technologies.
Limitations of Electronic Record Keeping Systems
Most document management systems are based on digital scanning technology; paper records are scanned into an electronic filing system and indexed for later retrieval. While a digital image of the record can now be viewed by any user with access to the document management system, the user still needs to know how the records are filed and searched. A scanned chain of custody record, for example, will most often be “attached” to the donor name or social security number in the electronic record keeping system. If the record has a barcode, or optical character recognition (OCR) software is used, the scanned record will be stored with a filename generated from some or all of the characters embedded in the barcode or scanned image itself. If the laboratory is blessed with a sophisticated laboratory information management system (LIMS), the image may then be accessed via a link from the relevant record identifier(s) in LIMS to the image file stored on the document management system on the network.
There are a number of critical shortcomings with this approach. If the original hardcopy record is generated by an outside entity (independent from the laboratory), the originator provides the lab with little choice but to scan the paper. The original paper must still be filed and stored, often for seven or more years, depending on the regulatory requirements. The scanned record is usually only searchable by its filename, or by the identifier (e.g., social security number) extracted from the filename. With OCR, additional identifiers (and “real” data) may be extracted from the record in order to populate the document management system database and/or LIMS.
To avoid the scanning/OCR method for laboratory-generated records, third-party software or custom programming is usually required to process the data electronically (for example, to parse data from an instrument report into a database). This solves two key problems by (1) eliminating the need to print the output to paper in the first place, and (2) avoiding manual transcription of data into a LIMS for further analysis, validation and reporting. There is at least one scientific data management system (as distinguished from a document management system) on the market that provides sophisticated (and patented) print-to-database technology, using a virtual print driver to capture the output and store its image in a database. An Excel®-generated benchsheet, GC/MS chromatogram, or accounting system invoice, for example, can all be printed directly to the database for review by any user in the enterprise. This same software provides powerful text searching capabilities to instantly locate, for example, all instrument data containing any instance of the word “cocaine”—even when printed vertically at the top of a chromatogram peak. Scientists can reuse data in desktop applications (one click sends columns of numbers in a quantitation report to Excel, for further analysis or graphing, for example) and collaborate by e-mailing hyperlinks that send the recipient directly to the image of interest in the database. Built-in “extraction template” technology is used to extract numbers from the “printed” report and store them in the LIMS for computing reportable results.
The software described above also allows a data reviewer to attach a comment to the record or apply an electronic signature, approving the record for final reporting. But the cynic in each of us would be quick to point out that paper is still better for this purpose on at least two counts: (1) handwritten signatures and notes on paper have a long history of defensibility in a court of law, and (2) annotations are usually easier to make on paper than attaching a comment to an electronic record. While the aforementioned Part 11 standards have gone a long way in addressing the former criticism, it wasn’t until quite recently that technology stepped in to offer a solution to the latter—in the form of the tablet PC.
There are currently more than a dozen manufacturers of tablet PCs—essentially handheld, portable PCs (most are about the size of your laptop screen) with wireless connections to your network. The tablet PC uses a stylus and handwriting recognition software (far superior, incidentally, to the handwriting recognition you might be accustomed to using on your Palm or other PDA device), for data entry and for freehand note-taking. Used in conjunction with the scientific data management software described above, and the online images are easily annotated in the same manner as any paper-based laboratory record.
Electronic Records and Reporting
The line between scanning/document management systems, scientific data management systems, instrument data systems, financial systems and LIMS is becoming more and more blurred. In the most highly automated laboratories, the LIMS is the ultimate Swiss Army knife of laboratory software—providing integration with all of these systems, along with a report writing and data delivery platform. Once scanned and “printed” images are captured and stored in a database, the reporting tool should be able to access the images for integration into a final data report or litigation package. In a paper-based organization, the pages are retrieved from files and collated by hand, then integrated into a word-processed document for submittal by snail mail or fax. In the paperless laboratory, the individual documents are all retrieved, collated and paginated by the LIMS report writer. The table of contents and cover page are applied, and the final report is transmitted electronically or accessed through the laboratory’s secure Web site.
LIMS Requirements for a Paperless Lab
From a practical standpoint, in order to replace paper in a regulated environment, a full-featured scientific data management system must be tightly integrated with the laboratory’s LIMS/LIS. The integrated solution must be capable of:
- Storing all laboratory-generated output, including scanned documents, instrument reports and benchsheets, in a fully indexed, searchable database;
- Capturing an electronic version of the output, identical to the original output that would have otherwise been printed to, or written on, paper;
- Allowing data reviewers to view, accept, reject, qualify, annotate and apply electronic signatures to these stored records, and to intelligently update the LIMS based on the action(s) of the reviewer;
- Providing secure and permanent storage of electronic records, such that each record is readily retrieved at any point in the future, independent of the operating system, database version or hardware infrastructure in use at that time;
- Applying date- and time-stamped electronic signatures with a full audit trail, compliant with 21 CFR Part 11 requirements; and
- Querying stored records and electronically collating and paginating a complex data report, with little or no human intervention, in a manner that replaces the manual assembly of paper-based reports.
The FDA’s acceptance of electronic records through the 1997 Final Rule on Electronic Records/Electronic Signatures (21 CFR Part 11) and the 1998 Government Paperwork Elimination Act slashed the regulatory barriers confronted by laboratories aspiring to convert from paper-based to paperless organizations. Technological and financial hurdles followed; up until the past few years, the cost of digital storage media and the computing power necessary to efficiently retrieve electronic records made commercial solutions cost-prohibitive for all but the largest institutions. The final barriers to fall have been of an operational and practical nature—providing scientists with the ability to retrieve, reuse, approve and report electronic data from a single, unified repository—the Laboratory Information Management System.
Robert J. Whitehead and Conor J. Ward, ChemWare, Inc., Raleigh, NC, U.S.A.
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References 1. Implementing a Regulatory-Compliant Electronic Records Strategy in the Clinical Chemistry Laboratory; Robert J Whitehead, ChemWare Inc., Raleigh, NC, October 2002. 2. Laboratory Information Systems. A Novel Approach for Designing your Laboratory; Kathryn Francis, Clinical Laboratory News; November 2001. 3. Electronic Lab Notebooks: Paving the Way of the Future of R&D; Rich Lysakowski, Records Management Quarterly; April 1998.
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