New concepts in the design of a clinical laboratory information system (LIS).

Laboratory computers have expanded in potential and are now capable of handling a communication system to support patient care. New technics and interactive software to expand this function are described and were developed because of serious deficiencies discovered in the hospital laboratory operation. New concepts in ordering of tests, collection and identification of samples, reporting of results, and retrieval of data are described.

Clinical laboratory test reference (CLTR).

As the healthcare system undergoes a transformation in scope and funding, there remain many unfinished projects which will be essential for the next generation of automated medical support services. The most demanding and labor intensive tasks for this new frontier deal with the accumulation of knowledge which can be used as a clinical database to support supervisory functions in a physician operated interactive care delivery environment. These databases will contain the worlds accumulated knowledge in specialized areas. They will be organized by topic or clinical service, and have significant impact on the quality of care as well as medical malpractice exposure. This article will describe a clinical pathology database that has been adapted for medical practice. The database contains information about laboratory tests and their interpretation. The data is structured for rapid reading and has references where indicated. The database can be used in a stand alone program or integrated into an information system within an application program. The files are reviewed on a continuing basis and quarterly updates are made available to subscribers.

Metamorphosis of a dinosaur or the future role of the clinical pathologist.

Proposing that pathology reorganize, the author introduces a role model for clinical pathology that contains skills and capabilities not currently offered in the clinical practice of medicine. This proposed rebuilding of a clinical discipline, to avoid continued degradation of the pathologist's role in the practice of medicine, will require teaching institutions to instill a new concept of clinical pathology, and the author pinpoints the tool that will be required to make this urgently needed transition to a new type of practice.

A proposal for laboratory data reporting.

Changes are proposed regarding the presentation of laboratory information. More definitive statements are required for reference limits, sampling variance (the Clinical Delta Range), and multivariate group analysis of large test batteries. To make this transition possible, laboratory reports should be classed so that the practicing physician has some measure of confidence in the product and its compatability with other sources. The proposal extends to the range of financial reimbursement and suggests that class standing be issued by an accrediting agency and support a structured level of payment.

Progress toward a second generation Laboratory Information System (LIS).

A Laboratory Information System (LIS) is a convenient organization of programs and hardware designed to meet the health care delivery needs of a department of pathology. A full service LIS is now a commercially viable product and after 2 years of experience, certain desirable design features are evident for a second generation system. Such variables as hardware configuration, physical plant, libraries, diagnostic algorithms, system usage and surveillance, and manpower and human engineering are now significant operational features and essential for LIS acceptance by a department of pathology as well as the practicing medical staff.

Evaluation tools for hospital computer equipment and systems.

The size and scope of this study for 1983 has been only briefly described by the few summary results that we have been able to put within this single article. Thousands of pages of data exist describing and detailing the complete statistical base of information that now exists on hospital data processing over the past 3 years. One need no longer guess or approximate what the industry is doing. Quantitative data are now available that we hope will lead to good decisions, good products, and good services. The 1982 and 1983 data base is now complete, along with the statistical analysis of information. The 1984 survey is now being distributed, and results should be complete in early 1985. For companies that are involved in this industry, the survey produces 11 volumes of information that are called Market Reports. For hospitals primarily concerned about the acquisition of equipment, there exist 8 volumes covering the major systems areas. For further information on these documents or any of the data elements contained within the survey, please address your questions to the Medical Systems Division at the University of Florida, Gainesville, Florida.

Shopping in the healthcare information systems market--a search for well-camouflaged land mines.

The selection of a healthcare information system is analogous to a big game hunt. The buyers perceive themselves as the hunters while the truth is just the opposite. To strip away the carefully crafted facade of corporate marketing is an art form and requires due diligence on the part of the shopper. Suggestions are offered to the consumer on how to pierce the shell of corporate silence and find the facts that will make a significant difference in product selection. The objectives on the seller's side are to make as much profit as possible and give as little as required to make the sale. The buyer is looking for the best product, the best company, and the most painless installation. The ground between these two vastly different goals is the battlefield of healthcare computer procurement. May the best shopper win! Caveat emptor.

The Health Maintenance Facility.

The Health Maintenance Facility (HMF) is the code name for a space-based medical clinic. The HMF is an integral part of the U.S. sponsored space station program due to be launched in the late 1990s. Contained in this module will be equipment, facilities, and supplies that can be used to support space station crew health. The range of medical care will depend upon the skill of the crew, the tools available, and the support systems that can be used from earth. The design of this system and its heavy dependence upon computer resources provide an excellent model for looking forward into the earth based medical clinics of the future.

Implications of mass automated instruments on medical practice.

The clinical laboratory is in a stage of change which has been the direct result of an influx of technology and the current demand for lower costs and increased productivity. There is no significant trend anticipated in the future which would forestall this particular process. The practicing physician can anticipate a fairly marked reduction in the cost of individual tests and, likewise, a marked increase in the amount of available information. There will be a larger clerical function involved in the review of such information along with a series of relevant problems related to the actual size of the new data base. One of the most significant problems related to this increase in numerical reporting will be the statistical problem of the "abnormal-normal." Statistical misclassification must be considered with each abnormal test and a specific approach must be taken to these tests to minimize the inconvenience to the patient. It is recommended that any unsuspected abnormal test(s) that is discovered be repeated as a single test(s) through a reference method. Reordering of the test battery or screen will only offer another possibility for statistical misinterpretation. If the test on isolated evaluation does appear abnormal, then this should call for the routine evaluation of this particular condition. Multivariate statistical analysis could eliminate this probability dilemma, yet is presently experimental and is not in routine use within any clinical setting. We can look forward to the evolution of such a process through the mechanism of a hospital and laboratory communication system which will allow the physician to work with an evaluation process capable of handling these large volumes of numbers (22). Such programs are on the horizon and should be anticipated within the next five years in some of the larger centers that have this new instrumentation.

National Survey of Hospital Data Processing--1985.

The National Survey of Hospital Data Processing contains a great wealth of information that the hospitals have contributed in respect to the trends and changes that are now occurring within our hospital data-processing environment. 2-5 We wish to thank all of those hospitals that have participated in this study and have been willing to provide the kind of information that is so essential in tabulating these results. It is our hope that this report will provide some measure of return on your investment and that it will supply some answers to you as you face the difficult questions of planning and projecting for the future. A great deal more information is contained within the study, but it cannot be presented because of the sheer volume of information that remains. For this reason, the survey has been structured as an on-line database rather than a report. We ask that those who have interests in seeking more in-depth information from these files contact our publishing office so that we can advise you of ways that this information can be conveniently made available to you for your special project. There will be a follow-up report for 1986 when that database is complete. For those who wish to do longitudinal studies, a parallel volume was published in August 1985 that should provide a 4-year perspective on the field of hospital data processing.

Diagnostic and treatment support for the NASA space program astronauts.

For over 9 years our research unit has been investigating medical databases that would be required to support astronauts on long-term missions. The configuration that has been developed will allow complete separation from earth-based experts and the capability of an on-board stand-alone system for knowledge engineering and medical decision support. Our data processing base of operation has advanced from the early stages on mainframe computers to the now ubiquitous microcomputer. Over this nine-year period we have seen several generations of improvements in every level of technology to the point where we can now package and deliver for space travel a rather broad-based decision support tool for astronauts that can provide the basic needs of medical treatment and diagnostic support which is vital for the proper execution of manned space missions.

The search for the elusive electronic medical record system--medical liability, the missing factor.

Over the past few years, the traditional paper-based medical record system has come under close scrutiny by every participant in the healthcare industry. Some groups, especially federal agencies such as Medicare and Medicaid, HMOs, and other third party payors, have begun to demand changes in medical record documentation, and have become very assertive as to what goals and objectives will be met. In contrast, the medical liability insurance industry has remained almost invisible during this period of transition. At a recent electronic medical records (EMR) conference participants attending a software development workshop were asked if they had their systems reviewed from a medicolegal standpoint by a malpractice insurance carrier. In response to this inquiry, not one software vendor raised their hand to indicate this had been accomplished, or was even contemplated. In the author's opinion, the key missing factor in the current quest for a paperless medical office system rests in the domain of those who represent the medical liability industry. All of these gate-keepers of medical loss and risk prevention will eventually be called upon, either by choice or necessity, to validate every working EMR system that is used in medical practices in the future. This article will explore the best information published from this currently silent sector of the industry, and proposes an active involvement by the medical liability industry in the current EMR design and development processes taking place. In addition, there are 10 minimum EMR design criteria contained in this article that are recommended for implementation based upon 16 years of medical malpractice experience and loss prevention input.

Unlimited volumes of laboratory data: a confusing and diagnostically deceptive product of modern technology.

The large volumes of laboratory data currently available in clinical practice can lead to erroneous conclusions. Our current statistical interpretation of these data is univariate (one variable at a time) and often not age- and sex-corrected. Using an optimal technique of multivariate analysis, a SMAC profile of 19 tests performed on normal subjects resulted in over a 500% improvement in defining the reference range. Using physiologic subsets of the SMAC profile for patients, improvements in interpretation of between 100% and 300% are possible. Results indicate a serious clinical problem that will require modification of laboratory reports using modern technology as an adjunct for diagnostic medicine.