Hospital labs are often viewed
as a stepchild—those ancillary services in the
basement that have to be charged against a
diagnosis related group (DRG). In fact, laboratory
data is part and parcel of three-quarters of all
health care decisions, and advanced diagnostic
testing now in the works will make labs even more
crucial to medical care.
Increasing workloads and
shortages of skilled lab technicians, as well as
pressure from doctors for faster turnaround on lab
tests, have prompted significant advances in
automation and computerization. That’s led to more
standardized quality and results and lower
per-test costs. Point-of-care testing is pushing
some traditional lab functions out to the patient
bedside.
But breakthroughs in lab
technology don’t inspire the same hoopla as a
spanking new MRI or surgical robot, and many labs,
especially in community hospitals, have trouble
making a case for sophisticated computer systems
and automated testing equipment. The result is
what clinical consultancy Sg2 calls “the lab of
the ’60s.”
“Hospitals need to move from
focusing on just what’s going on within the four
walls of the lab and more on how lab-based
diagnostic testing improves patient flow
throughout the whole organization,” says Leslie
Wainwright, vice president and head of lab
operations at Chicago-based Sg2.
Automation is the key. Systems
that resemble a modern manufacturing plant move
blood samples from the emergency department and
patient floors to the lab. Bar codes on specimen
tubes are read by computers, which then direct
them to the right instrument for testing. Results
are automatically entered into the laboratory
information system, and electronic reports are
sent to physicians. For many routine tests that
don’t require a pathologist’s analysis, human
hands never touch the specimen.
Because the lab of the future
resembles an assembly line, lab directors are
turning to process improvement tools such as Six
Sigma and Lean Manufacturing. Process redesign
can improve productivity, but experts caution that
a top-to-bottom analysis should be done before
opening the checkbook for any new equipment. “The
most powerful way to get the most out of any type
of automation initiative is to incorporate the
process redesign part of it,” Wainwright says.
“There’s no sense in automating a bad process.
Without doing a combined, very detailed workflow
analysis, automation will only get you part of the
way.”
Automation and sophisticated
testing instruments pay off financially, as well.
More accurate testing that leads to more detailed
diagnoses can help boost Medicare prospective
payment or insurer per diems. For example, a
significant number of hospital patients are
discharged with a diagnosis of DRG 420, fever of
unknown origin. But if improved testing such as
automated bacterial culture systems can identify
the cause of those fevers, more detailed coding
can be made on a claim—and that means more
reimbursement.
An Sg2 report analyzing clinical
lab operations shows how: If lab testing reveals
that a fever resulted from septicemia, DRG 416
(septicemia) can be coded. Medicare’s base
reimbursement for DRG 416 in 2005 was $7,192,
while DRG 420 paid $2,709—an additional $4,483 for
each case. Moreover, since DRG 416 is one of the
codes that CMS is especially watchful of for
upcoding, lab documentation makes it easier to
show medical necessity.
Point-of-care testing is another
advance that’s helping physicians make better,
faster decisions. Rapid test results in such
critical areas as the emergency department can
save lives, says Tony Kurec, lab administrator for
University Pathologists Laboratories, Syracuse,
N.Y., which is affiliated with the State
University of New York.
“Thirty-five years ago, if you
could get lab results back to a physician in two
or three hours, that was pretty good. Today, they
want the results in 10 or 15 minutes,” says Kurec,
who also is editor of the Clinical Laboratory
Management Association’s scientific journal. Even
so, certain complex tests can’t be done at the
bedside and must still be sent to the lab. “So
you’re still going to have to wait a half-hour or
45 minutes for the rest of the lab results before
you can start treating the patient,” Kurec says.
Few can argue with success,
though. After Boston’s Massachusetts General
Hospital established a point-of-care satellite
testing lab in its ED to perform routine tests
such as urinalysis, glucose levels, cardiac
markers and tests for strep and pregnancy,
turnaround times were reduced by 87 percent and
patient stays fell by 41 minutes. An added bonus
for the bottom line: ED diversions dropped.
Point-of-care testing can be a
touchy subject among lab managers. Some resent the
loss of the testing volume, while others question
the accuracy of results of tests performed by
non-lab staff who are not intimately familiar with
the equipment. Others, however, say anything that
improves the patient care process is good.
“We can sit all we want in our
ivory tower in the lab and say the only test
that’s good is the one you send to the lab,” says
Rick Panning, administrative director of Fairview
Laboratories, part of Fairview Health System,
Minneapolis. “But that’s not true anymore. There’s
very good technology out there that gives
high-quality results in real time.”
Sg2’s Wainwright acknowledges
that point-of-care testing performed by other
staff can put the lab in an awkward position.
“There are a lot of quality and regulatory hurdles
the lab is responsible for, and in some cases it
might not be the certified lab techs who are
actually performing the tests,” she says. “That
means while you can lose some control over the
process, you’re still responsible.”
One of the fastest-growing
segments in the lab business—molecular
diagnostics—could prove to be one of its most
challenging. Research scientists have fully
sequenced more than 120 bacterial and viral
genomes, and are working on dozens more. That data
quickly turn into novel diagnostic tools that will
drive growth in molecular diagnostics.
Molecular diagnostic testing
today is done largely in outpatient settings such
as physician offices. But Sg2 predicts that within
two years, most hospitals will need to to be able
to perform molecular testing. For instance,
cancerous tumors will no longer be designated as
breast, lung or prostate, but instead on their
genetic or proteomic profiles. Targeted medical
therapies will be prescribed based on molecular
signatures.
Reimbursement poses perhaps the
most vexing challenge to progress in the clinical
lab. Payment already is dismal for routine lab
tests, says Don Young, M.D., vice chair of
laboratory medicine at the University of
Pennsylvania Health System, Philadelphia, and the
outlook is even more bleak when it comes to
molecular diagnostics, proteomics and similar
tests. While academic medical centers like Penn
lead the charge into new medical frontiers such as
genetic testing, they’re usually impelled more by
the science, not the money, at least initially.
Medicare and Medicaid refuse to reimburse for new
services such as molecular testing, and commercial
payers often take the government’s lead, says
Young.
“It becomes a never-ending
loop,” he says. “There’s no reimbursement until a
new test shows clinical utility. But how do you
get to the point of showing clinical utility when
you can’t get paid for doing it?”
Workforce issues could prove
even more daunting. Demand for qualified lab techs
is growing rapidly. Many current staff members are
approaching retirement age, and the number of
people entering the profession is much lower than
the number leaving. Money is short, and lab
directors complain that lab salaries haven’t kept
up with pay increases in other health care
professions such as nursing and pharmacy.
Employees also are demanding more job satisfaction
in an environment that can be monotonous.
“We can do all the automation
and process improvement we want,” says Panning.
“but we still need people.”
Some see molecular diagnostics,
proteomics and other advanced testing as a ray of
hope for workforce concerns. Kurec says these
developments will allow lab experts to become more
involved with caregivers and elevate lab staff to
a role of adviser, much the way pharmacists’ roles
have evolved. “There is a level of respect that’s
beginning to grow for laboratorians,” he says.
“That’s better than years past, when we were
basically locked up in the basement and nobody
knew who we were or what we did.”