|
By Ken Blick
10/09/07
Technology: The Key to Survival in Today’s Medical Laboratory
To compete successfully with regional and national reference labs for outreach
business, hospital-based laboratories require a technology-based approach.
All steps in the testing process—from test order to results to billing—must
be automated. This article will look at the instrumental role technology plays
in all aspects of building a successful hospital outreach program.
 Why Invest
in Outreach?
The Oklahoma University Medical Center (OUMC) is a sprawling
campus that includes three teaching hospitals, several ambulatory care centers,
and one lab that handles all testing—including testing for a Level 1
trauma center. There are currently six larger labs in the area that conduct
testing, including high-end boutique labs. “At one time, there were 16
labs in the Okalahoma City area,” says Kenneth Blick, PhD, ACS, ABCC,
NACB, Professor and Director of Chemistry at the University of Oklahoma Health
Sciences Center and UO Medical Center. “Today, it’s all about survival.”
To transport specimens
across its sprawling campus, OU has invested in real-time collections and electronic
order-entry systems. “In fact, we even have
some physicians doing electronic order entry on wireless pads. Approximately
20 percent of our orders are direct physician orders in real time. We print
a local bar code right at the patient’s area that contains all the specimen-collection
instructions and appropriate identifiers. Thus, we have real-time collection
and real-time transport of samples over a three-block radius anywhere on our
campus to the core lab. It has cost millions of dollars to get this implemented.”
The obvious question is, why did they invest so much money? “In the old
days when we ran labs we were able to pick what we would do,” he explains. “Now,
however, market forces are deciding for us. We have to compete, especially
for outreach business, to survive.”
According to Blick, another issue
is that physicians perceive that most laboratory data arrives too late to assist
them in clinical decision-making. “In
my view, laboratory testing is worthless if it doesn’t get there in time,” he
says. Because of recent focus on patient safety, hospitals are also often perceived
as increasingly “dangerous places” to be.
Another issue is that
the average age of medical technologists in the OUMC lab is 53. “We have
no BS/ASCP medical technology training programs in central Oklahoma. In addition,
the cost of medical insurance in Oklahoma is going up to the tune of about
12 percent a year and malpractice insurance has gone up substantially in the
last several years, more than doubling for some specialities,” he says.
“The
specimens that we take out of the human body are packed with thousands and
thousands of little bits of information, and we need to start treating specimens
like information systems. We spend a lot of money on computers in the laboratory
business, making large investments and probably only getting 20 or 30 percent
of the value back.”
Many of the errors are on the front
end in the pre-analytical stage. “A
lot of mistakes are made in the traditional laboratory because of reliance
on outdated manual processes and often, in part, and frequently the lower skill
level of people working in the front-end. We simply have to do better,” Blick
emphasizes. The errors include missing pre- and/or post-draw instructions,
illegible or missing collection data on the label, wrong patient drawn, wrong
container used, sample collected at the wrong time or drawn in wrong order,
missing labels and orders, wrong and misaligned labels, lost specimens, and
no tracking … to name a few.
In addition, laboratory reporting still
generates a lot of paper, which creates a host of problems, including too much
raw data, (i.e., physicians want to have data “cooked”), batch
reporting instead of real-time reporting, the inability to add data electronically
to patient’s electronic medical
records, and data from multiple labs and/or methods.
All of these issues add
up to a tremendous challenge for labs. “We need
to look at our hospitals—they are struggling and they need to survive,” Blick
says. “We need to have specimens flow through laboratories in real time
since up to 70 to 80 percent of the information that physicians need to make
clinical decisions is generated within the laboratory.”
Automation Is
the Solution
The solution, he says, is to use technology and implement
a more automated approach using computer system, robotics, biosensors, point-of-care
testing, robust databases, and expert systems. “We need to take the existing
laboratory concept and totally reengineer the sections and ‘roboticize’ them.
Make IT the showstopper in all decisions relative to purchase of instruments.
In fact, buy instruments that are really designed to be information systems
themselves.”
The key is in developing a core lab to handle all testing while being able
to decentralize some or part of the critical care using smart point-of-care
testing devices. “I estimate that approximately 40 percent of testing
will be done at the patient’s bedside, especially critical-care testing,” Blick
says. “In addition, you need to retrain yourself and your staff and develop
the new IT skills that are required because the system of the future is going
to be computerized with lots of extra capacity—capacity that you want
to sell to outreach clients.”
However, Blick notes that it’s important
not to let an outreach program affect the care of critical in-patients in the
move to automation. “You
need to free up tech time and take the heat off your laboratory staff and eliminate
racks and batch processing. Finally, you have to be able to handle increased
outreach volume without increasing staff.”
The following chart illustrates
the automation process in the “new” OUMC
lab.
One of the goals of the new system, according to Blick, was to minimize manual
handling of samples. “If we touch the samples in an automated lab, we
delay their processing. The idea is to have everything flow without being handled.” The
instruments in the OU lab are connected with load-balancing software that figuratively
provides traffic control and delivery.
The lab also has a “refrigerated
stockyard” so that when physicians
want to add a test they can use the specimen as a biochemical hard drive. “The
ideal system, like the one we are developing, is where physicians can just
dial in with their mobile order-entry system and order a test. The automated
system will take the sample from the stockyard, take the lid off, take it to
the appropriate instrument to conduct the test, and then auto-validate and
auto-release the results.” Essentially all the steps required are accomplished
without human intervention.
Another key component at the OU lab is its pneumatic
tube system. “With
a pneumatic tube system, we can run a sample and have the results back in less
than 40 minutes for most chemistries—with even thyroid testing and other
immunoassays taking only slightly longer. If someone drove to us from 100 miles
away, the lab results would be on our computer before the patient presents
to the doctor. If a customer can get real-time testing from us and not have
to wait three days, they are going to use us. Lab data has great value, but
only when it’s in real time—no queues and no racks.
“Seventy to eighty percent of samples flow through our automated laboratory
mostly untouched; we don’t even look at most results,” Blick says. “Our
system has decision logic that recognizes data events and an expert system
can trap data events. A potassium result or a hemolytic sample will be referred
to a technologist. That referral will be an alert and include instructions
on handling the situation. In fact, we have a number of rules firing that in
order to identify, in real time, potential problems with samples and results.
Indeed, the sample is the least controlled part of the process and this system
detects problems with specimens and tells us that we need to get involved.”
Selecting
the Right Technology
“Many people will buy a computer that’s
great with calculations but slow off the disk,” Blick says. “However,
you need to remember that the lab is an input/output (IO) application. You
need to look for systems that conduct great record retrieval and have process
control.” In short,
the most important features are speed, reliability, connectivity (with exiting
systems, as well), adaptability, flexibility, and standards.
The lab areas that
are traditionally computerized are chemistry, hematology, microbiology, urinalysis,
and serology. The others, especially business applications, are often not computerized
because they do not contribute to profit. “However,
billing is as important as anything else we do in the lab and it is critical
to automate the business side and connect with your customers.”
At the
OUMC lab, the testing process automated from start to finish:
• Test
Order
• Phlebotomy/Transport/Pneumatic
Tube
• Specimen
Logging and Processing
• Specimen
Analysis
• Reporting/Inquiry/Tracking
• Billing/Management
The following table illustrates the flow of a queueless
core lab with no batch processes.
In the areas of patient care, having electronic
physician orders helps the lab trap errors early on. “We want to make
sure physicians get alerts telling them that the patient doesn’t really
need a transfusion because the hemoglobin is 14. It seems we are always on
the back end trying to correct orders because physicians are hand writing them
on the chart and do not have the benefit of a rules-based order-entry system.
Our goal is to get 100 percent compliance with physician order entry so they
can get these kinds of alerts and we can eliminate these pre-analytical errors.”
To
run the automation, you also need to have great vendors to ensure that the
instruments are always running effectively and efficiently. “In fact,
we treat the vendors of these instruments like reference labs. We pay for the
tracks and the instruments—we don’t own them, rather we contract
for results. Every month the vendor dials up the instruments, sees how many
patient results we produced, and bills based on that number. The vendor is
able to do this because they have extremely stable instruments that don’t
need a lot of recalibration. We have also cut down on the number of dilutions,
repeats, and quality-control samples because of overall system stability and
increased linear range of assays.”
To automate the front-end of the lab,
samples are automatically entered in real time and the results are back mostly
within 40 minutes. The system can even auto-receive the samples from the same
tube that was used for collection (eliminating the need to pour off a sample
and risk mislabeling it), and since all the instruments are attached to the
track, the lab has largely eliminated the need for specimen splitting, or pour-offs.
Before implementing the system, the lab was pouring off up to 45 percent of
its chemistry samples.
Automated Billing
“Billing is a dime-store business—it’s high volume and low
charge per item,” Blick says.
“It costs most hospitals that do billing about $30 to send out one statement.
In addition, small balances on many bills encourage write-offs. The hospital
billing systems are usually not very efficient and you can count on them writing
off small bills that you would normally make money on in a laboratory outreach
program, such as Pap smears, as bad debt.” The OUMC lab uses the Meditech
Reference Module, a no-frills, low-cost billing system designed for laboratory
billing in the outreach arena.
There are as many as 13 different kinds of laboratory
billing and multiple codes—in one word, it’s complicated. “You
need a system that can be modified and changed to adapt to billing rules. We
approach billing in the same way that we do patient results,” he notes. “The
less complicated bills will go through often automatically untouched by human
hands. However, we have expert software to identify those accounts that, for
example, might not be paid when sent to Medicare. “We have rules built
in that will even stop a claim that will not be paid from being submitted.
We try to identify issues before we even file.”
Contract billing, which requires discount billing, is another key area. Bills
need to be 100 percent accurate or you risk not being paid. “You can
send an occasional problem lab result and your customers might forgive you.
However, send them a bad bill and they’ll never forgive you,” he
notes. “You need to have a totally accurate billing system for contract
bills because those are return customers. It has to handle any discount that
it takes to get the business. You can’t have a rigid system—it
has to be automated to handle virtually any discount.”
Point-of-Care Testing
Point-of-care testing and core laboratory automation are the two key
technologies that are changing the nature of lab testing. “Point of care
has literally taken over blood gas testing,” Blick says. “You don’t
want to ship blood gases through a pneumatic tube—you want to do gases
at the point of care. If you need a real-time coagulation test in the operating
room, you don’t ship it to the lab, you do it on a handheld testing device.
According to Blick, “it’s point-of-care testing when it makes sense.”
He
notes that a number of esoteric tests are being done at point of care that
can help save lives—for example, rapid testing for cardiac markers and
congestive heart failure. “The testing devices are totally interfaced
and automated and you can get results on a couple of drops of whole blood in
less than 20 minutes. The results are accurate although they may not be as
precise as in the lab. However, when a patient needs immediate intervention,
having the decimal place three places to the right of zero is not the critical
issue.”
One of the issues in accounting for point-of-care testing and
automation is that many of these devices were not designed for IT. “Now
is a good time to replace those devices with ones that are designed to be part
of a data network,” Blick
suggests. “We have a lot of very special database requirements for point
of care. We organize and run all the point-of-care testing out of our core
lab—managing training, quality-control data, results review, the interfaces,
the billing/charge capture, CAP requirements, reagent implementation and stocking,
etc. We also make sure that all the nurses meet quality testing and training
requirements under the Joint Commission.”
A good point-of care computerized
system is going to be costly and you need to be prepared for that. “You
also need to consider standards and have a point-of-care device that doesn’t
need a lot of go-between boxes to help it communicate—and if you have
multiple similar POC testing devices, you clearly need a common data-management
system.”
Middleware is also key for an expert system that is able to trap
infrequent data events and ensure that the correct test is run. “We are
putting a lot rules into our middleware to ensure that the same mistake is
never made twice,” Blick says. “In fact, 90 percent of lab errors
are non-analytical. Hard-coded programs on lab computer systems only handle
what is routine and predictable. You need middleware, an expert system, that
can handle those types of functions and reduce workarounds (i.e., people deal
with exceptions).”
In short, the requirements of an expert system include
the following:
• Easily
modifiable program
• Database
driven
• Handle
multiple actions
• Must
not degrade system performance
Expert systems can handle all the functions that
were previously handled manually, including reflex testing. “You need
a system that gathers data so you can have a real-time quality system approach,” Blick
says. “Quality
assurance is an absolute College for American Pathologists (CAP) requirement
and, these days, you need to be ready for a CAP inspection on a 24/7 basis.”
Because
people’s lives hang in the balance, the OU lab also uses decision-making
expert software along with their expert track system to identify “critical
results.” To handle this in real time, expert decision-making software
is in use on the track, the instrument checking the result, and the data link
middleware software, with further verification checks on the Meditech LIS mainframe. “We
want to make sure that we touch all the bases and get those results to the
attending physician as rapidly as possible.”
Quality-control logs are
also important. We make sure we collect data in real time so if we have a problem
we can monitor processes,” he says. “If
you can’t measure it, you can’t fix it. We collect data prospectively
rather than retrospectively. You want your system to trap discrepant results
before they are sent out.”
Automation in Practice
According to Blick, one area his lab’s
automation has an impact on is cardiac care. In fact, the lab has helped cut
two days off the length of stay in the hospital’s CCU.
“We closed
the two stat labs at the hospital when we went on our track system and have
improved the overall service,” he says. “The physicians
have self-regulated themselves from 53 percent stat requests down to less than
5 percent. We are getting less than 5 percent stat orders because physicians
are no longer concerned about whether we can deliver the service. Centralizing
into an efficient, highly automated core lab is good business since it costs
$2 million or so to keep a stat lab open and equipped with staffing on a 24/7
basis.”
In another area, the lab went from 20 percent outliers to less
than 3 percent—thereby
improving the service and cutting as much as an hour from the wait in the Emergency
Department (ED). “If you plot out a delay in the lab it has almost a
direct relationship to delays in the ED. The only way to improve patient flow
in the ED is to have a real first-class laboratory. Sometimes it takes as long
to get the sample collected and get it to the lab as it does to run the test.
For cardiac marker testing, it has been estimated that for every 30 minutes
of delay, we have potentially another 15 percent damage to the heart. Hence,
delays in interventions due to a slow laboratory turnaround time of one-and-a-half
hours or more could be associated with as much as an additional 30 percent
or more damage to the heart. Indeed, the recently proposed 2004 National Academy
of Clinical Biochemistry guidelines recommend 30 minutes or less for cardiac
marker testing.”
Striving for Success
“Technology and automation are the most significant things that have
happened to the laboratory,” Blick concludes. “Through laboratory
reorganization, automation, and computerization, data can be available sooner
and in a predictable manner. As a result, it has much greater value in the
real-time evidence-based care of patients. Expert systems have great potential
to improve overall quality and eliminate errors—serving to improve outcomes
throughout the hospital.”
|
