July 2002

Clinical Lab Information Management in the Dawning Age of Consumerism
Jay B. Jones, Ph.D. DABCC

With the continuing explosion of affordable information processing hardware in the market place, distribution of medical information to the laboratory’s customers is becoming more widely spread. With the advent of HIPAA, patients will have a rising expectation for having access to their own personal medical information. After all, the “P” in HIPAA stands for portability - not privacy. Predictably, the demand for greater access to personal medical information will be more than enabled by connectivity hardware’s ability of to deliver it. In the laboratory we may expect to be stressed by these capabilities, demands and expectations. Since laboratory data is one of the consumer’s most popular kinds of medical information to look at, we may need to distribute it rapidly with appropriate levels of confidentiality.

The laboratory information systems and medical informatics division (LISMI) was aptly named a year ago to focus attention on its informatics role. We must be increasingly job-oriented towards information management. Certainly many of us have continued roles in operating laboratory information systems (LISes);however, a greater demand by our customers will be placed upon us to configure systems to deliver and manage information. Delivery and management of information will not be only to our provider customers, but increasingly to our ultimate customers - patients. The old notion of verifying a laboratory result to an LIS as being the end of our testing process is clearly obsolete. As information managers we must think of where our valuable results are delivered. They may be delivered to a provider customer via a hospital information system (HIS) or electronic medical record (EMR). Or, in the future they may be to the patient him or herself. It is important to think “on the horizon” as new paradigms for laboratory information delivery arise. This horizon includes delivery of lab test results to the patient by the Internet.

In the Geisinger Health Care System lab test results are already being delivered via Internet by an EMR tool called “MyChart.” Laboratory results distributed to the EMR (in our case EpicCare) are available via Internet browser to patients after physician review. The laboratory has written and/or vetted explanations to accompany lab test results viewed by patients. In this case our informatics expertise was applied to creating understandable explanations of what lab values mean to patients (not an easy task).

It doesn’t stop here. Patients can email questions to their provider, renew prescriptions, and arrange appointments via the same internet browser interface. This makes me happy since besides being a clinical chemist and informaticist, I am also on occasion a consumer. Now for the clincher. How about patients doing their own home lab test and resulting it to the LIS and/or the EMR via the internet? Does that sound far- fetched? How about a single use disposable double beam spectrophotometer enzyme immunoassay (EIA) with data port that is FDA approved for home use? Even more far-fetched, you say?

Recently a new point-of-care/home test for HbA1c has been FDA approved for prescribed home use called “A1cNow” (www.Metrika.com). A cut away diagram for this POCT cartridge shows:

Although connectivity is not initially available for this device, it certainly gets one thinking about the near horizon. LISMI Division members must envision the impact of such novel devices. Will home testing devices connect to the LIS or EMR from the home via MIB game ports? Are “home testing appliances” a new genre for lab systems? Such horizon thinking is almost enough to make one wish they were horizontal. As an information industry we must foresee such new developments and possibilities or we surely will collectively become horizontal. Shouldn’t lab testing for patients be a two way street and a shared informatics task? Is the internet secure? These are but a few questions that we as medical informatics practitioners will need to answer in the not too distant future.

In summary, hardware connectivity has become a universal fact of life in our culture. Classic LIS/EMR systems of delivering information to and from the patient will certainly change and the laboratory must participate in this change. The question that only we can answer remains – “Can the laboratory keep pace with all this change and maintain quality and affordability in the process?” Dynamics of change will certainly control the market place. We as both provider and consumer of information only know what a stimulating marketplace it will be.

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