Always dependent on a large number of repetitive, manually intensive tasks, the laboratory department was among the first in healthcare to look to automated equipment for solutions. First it was instruments--some more intelligent than others. Then came laboratory information systems (LIS) to support electronic data entry, storage and retrieval. The preferred technology now, according to Arden Forrey, PhD representing the American Clinical Chemistry Association of Washington, DC, is a clinical information management system (CLIMS).
According to Robin Felder, PhD, professor of pathology at the University of Virginia in Charlottesville, a whopping 80 percent of the numbers generated in a typical medical facility still come from the laboratory. Too often, however, the laboratory generates numbers but few value-added services. "If we embrace automation technology, the laboratory can become an information specialist and manage most of the information generated in healthcare facilities," he advises.
Political and regulatory upheavals have taken their toll on the laboratory. Government regulatory compliance rules have placed new responsibilities and new restrictions on the laboratory doorstep. After the fraud and abuse muddles of the past decade, laboratory reimbursements now are tied to "approved" and "medically necessary" diagnoses and test codes. Meanwhile, the laboratory must rely on cooperative clinicians to provide correct diagnostic codes. A computer-based patient record should eventually assure proper coding, but in the meantime, little short of goodwill can efficiently get those codes to the order entry form.
The government is serious about compliance with its regulations, however, and the laboratory is beginning to see new regulatory compliance IT tools to address compliance. James Small, MD, PhD, associate pathologist and director of IS at UniPath PC, a specialty reference laboratory in Denver, hopes vendors will incorporate such functionality into product updates, but sees little value in a third-party product because access to the data is the important element. "CLIMS vendors need to recognize that users must be able to retrieve information in ways the vendor never envisioned during the design process," he says. Larger vendors are just now beginning to offer the powerful and flexible query tools that users need to address unpredictable problems such as queries for compliance with legal regulations.
Many hospitals are trying to regain lost ground following periods of rampant outsourcing. In addition to bringing back more in-house test procedures, many also are adding services--often teaming with other members of the care team to provide outreach and specialty services. Such tactics are resulting in more direct competition with reference laboratories, long dominant in the outpatient market. And as business edges blur, so do IS needs, resulting in increased markets for hybrid clinical information management systems.
Hybrid hospital/commercial systems may be evolving more rapidly, but overall, changes in laboratory systems are occurring slowly, says Don Lyons, CIO of Bio-Cypher Laboratories of Sacramento, Calif. The director of clinical chemistry at Montefiore Medical Center in Bronx, N.Y., Herb Rose, PhD, agrees. Following extensive research while planning his new laboratory, Rose sees few bright lights--and those he does see are from relative newcomers in the market. By and large, he gives most well-known laboratory systems poor scores. For the two systems Rose thinks capable of standing up to the workloads in today’s laboratory, the common thread is development origins: Both began by developing systems for the reference laboratory. "Their development approaches included the integration of external sites," Rose says, "and that’s where everybody else falls apart."
Closely tied with the greater healthcare IT picture, many CLIMS and laboratory automation trends follow those in other segments of the organization. As Lyons redesigns and rebuilds the IS platforms at Bio-Cypher, the second largest reference laboratory in California, he’s considering the price/performance equation, new operating system and hardware architectures for his large operation. The laboratory can take advantage of other healthcare trends that include interface engines, multi-tiered database engines, HL7 application interfacing and advanced lower level connectivity designs based on open standards such as the TCP/IP protocol. There also are many developments unique to the laboratory. Among them, Lyons cites better specimen management and tracking, specimen processing robotic engines, comprehensive bar coding of specimens and optical archival of requisition information with interfaces to the CLIMS and financial systems.
Maturing and more reliable technologies also are good for decentralization, says Lyons. Internet Protocol supports better remote device connectivity and advanced networking technologies capable of carrying more traffic. Specimen management, too, is benefiting from advanced courier and specimen management tracking algorithms. Although browser technologies have not yet been deployed to any extent in the laboratory, Lyons believes that this will be the next serious development wave for the CLIMS.