Regulations Dictate Market Trends

It's back to the future for lab trends in the sense that federal government and industry regulatory mandates guide many aspects of the business.


"The hospital infrastructure was mostly built in the 1960s and '70s from the stimulus of Medicare which arrived in 1965. The population is increasing in most parts of the country. The demand for laboratory services is increasing as well and the way these tests are done and the way they use their staff has all changed. So the layouts of the laboratories have to adapt too," said Gary Reich, President, Reich Consulting Services, Inc. "Looking forward, if there is more money spent on infrastructure in this country, you are looking at even more changes because that's been the history. When the government announces a major program, there are sometimes positive implications."

Meanwhile, other recently imposed guidelines, known as USP 797, require compliance on a wide range of hospital pharmacy policies and procedures to cut patient infections and protect staff. Issued by U.S. Pharmacopoeia (USP.org), the regulation governs any pharmacy that prepares "compounded sterile preparations" (CSPs), according to USP797.org, an informative web site.

"USP 797 is forcing pharmacies to rethink and upgrade how they are handling their product so we are seeing hospitals building clean rooms where they never had them before," said Tony Gandy, owner of SRS, Inc. "Now hospitals are buying the correct hoods-one for chemo, another for critical IV mixtures. Drugs need to be sterile to protect patients (as antibiotics) or are dangerous to those preparing (nuclear medicine)." He noted that the requirements call for separate bench areas for different types of preparations. This requires special hoods, air locks, room design, air flow and pressure and monitoring equipment.

"It's expensive. This is like insurance. No one wants to buy it unless they are forced to," Gandy said.

Another regulatory demand, resulting from FDA inspection requirements, is for laboratory monitoring equipment that keeps tabs on the temperature of refrigerators and freezers, ensuring that they don't power down. These devices are now wireless and feed computer databases which print reports for inspectors to ensure that chemical preparations and biologics have been kept safe.

Other Industry Forces

Reflecting broader trends in health care and other industries, consolidation of labs and automation of histology and other functions are becoming pervasive. Meanwhile, companies are acquiring others to provide full product ranges. For example, Leica Microsystems has acquired Surgipath, which makes pathology consumables.

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