Physician practices have a compelling interest in
receiving their patients' laboratory results electronically. After all,
health systems consistently report that one of the most frequent — and
vocal — requests made by providers is for electronic laboratory results
reporting. It is easy to understand why: Moving away from paper-based
results reporting not only generates substantial administrative
efficiencies within physician practices but also improves physician
decision making and patient outcomes by making results available more
quickly and more accessible.
Yet, a number of issues arise when it comes to the
question of how physician practices can realize the benefits of
electronic results reporting (and, by extension, how laboratories
can move their physician clients toward electronic order entry).
Physicians often find it difficult to choose between competing order
entry and results reporting options, sometimes because they are unsure
about the current functions and capabilities of their ambulatory
electronic medical record (EMR) systems and about what role EMR systems
will play in the future. Therefore, it is essential that labs present
their provider partners with options that accommodate each practice's
current IT reality.
and even that number does not accurately reflect the variety of EMR systems available.
Five years ago, laboratories were focused on
providing physicians with order entry and results reporting by means of
proprietary systems. Today's physician practices, however, increasingly
expect to be able to easily and cost effectively interface their EMR
systems with their lab partners' laboratory information systems (LIS).
As a result, labs are faced with making the transition from stand-alone
and proprietary offerings to providing integrated connectivity
solutions. And, while EMR interfaces clearly are the future of lab order
entry and results reporting, significant challenges are associated with
integrating ambulatory EMR systems and LIS systems.
LIS-EMR interfaces: still a complex process
Many providers (especially small practices) have yet
to deploy an EMR system, which means that focusing exclusively on EMR
integration effectively excludes a large portion of physicians from
electronic order entry and results reporting. Even when addressing
practices with EMR systems already in place, it is essential to
recognize that the technology is far from being at the point of
deploying EMR interfaces with plug-and-play simplicity.
Integrating an LIS with an EMR system continues to be
a complex undertaking. Consider that more than 300 EMR vendors currently
operate within the healthcare space, and even that number does not
accurately reflect the variety of EMR systems available. As a result of
industry acquisitions and mergers, EMR systems from the same vendor can
vary considerably. For example, within a single product grouping,
multiple versions of EMR systems may exist, each with different
capabilities and functionality. This wide variety of available EMR
systems presents unique challenges for the typical LIS vendor, who may
have limited expertise connecting to any particular EMR system. In
addition, providers and laboratories can have unrealistic expectations
for implementing interfaces to their systems — resulting in frustration
for both.
Following are a few of the obstacles commonly
encountered when interfacing an LIS and EMR system:
- Establishing a secure physical connection between
the EMR system and LIS is the first hurdle. A common method is to
create a virtual private network (VPN). Since most practices with an
EMR system do not have a dedicated IT staff, deploying a VPN is not
always a viable option. - Not all EMR systems can place an electronic order
and, of those that can, not every order is output in a format that
can be accepted by the specific LIS. - Some EMR systems are unable to accept discrete
laboratory results. In those cases, the interface needs to have the
capacity to convert the lab's HL7 results data into an Adobe PDF
file or graphic file that the EMR system can accept. - EMR systems do not normally utilize the same
conventions as the LIS or hospital system to identify patients and
orderable tests. - If an EMR system did not generate the test order,
it may be unable to receive the associated “unsolicited” result.
Portals: narrowing the interface divide
Although the rate of deployment of EMR systems is
growing, the issues surrounding the interfacing of EMR systems and LIS
systems will not be solved overnight. Until such time as a critical mass
of providers occupies the same point on the technology spectrum, it is
essential that labs offer their provider partners a technology bridge
that will enable them to benefit from an EMR system interface without
having to invest in interface options that may not meet their
expectations or budget requirements.
Web-based portals are an effective, efficient means
of augmenting a laboratory's EMR interface initiatives and of increasing
the number of providers able to place orders and receive results
electronically. Portals offer labs the means of transitioning beyond two
common, but not always optimal, connectivity options: 1) offering a
stand-alone proprietary solution and 2) developing an EMR system
interface to the LIS. Portals enable laboratories to support all
physicians in the community, regardless of what kind of system (EMR or
not) a practice uses.
Portals can be effective in meeting the needs of both
laboratories and their physician clients. From the lab's perspective,
portals enable physicians to easily and accurately enter lab orders —
helping to ensure that the appropriate tests are performed in a timely
manner. Once a test has been completed and results posted, physicians
can access the portal and retrieve those results from any
Internet-enabled device. This means physicians can review results and
get them to patients more quickly and spend less time calling the lab to
request a resend of results — saving time for the physician practice and
the lab. In addition, in practices using an EMR system, portals can
serve as a back up in cases where the EMR system is down, since
physicians are able to log into the portal and submit an order or access
result information in real time.
Effective portals are designed to complement existing
workflows, promote ease of navigation, and generate useful search
results. It is likely that the vast majority of practice staff have used
consumer search and shopping sites, such as Google and Amazon, which
have distinguished themselves for (among other things) their
user-friendliness and appealing organization of information. Similarly,
the best lab order entry and results reporting portals mirror these
sites in their ease of use and search functions, as well as in limiting
the number of page views that the user must navigate in order to
accomplish a particular task. In addition to improving user
satisfaction, portals featuring these attributes reduce training needs
since the basic user interface is already familiar to staff members.
In terms of data flow, portals can be more flexible
than many EMR systems when it comes to receiving documents that include
digital graphics. An effective portal will support Adobe PDF files, XML,
image formats, ASCII, and electronic print captures, which is essential
as laboratories move toward generating result reports with graphics and
images. Physicians appreciate dynamic reports that include graphs,
charts, and images — making it easier for them to analyze results.
Portals also represent an opportunity for
laboratories to involve other hospital departments in establishing
connectivity with referring physicians. Because portals are uniquely
suited for distributing information — for example, radiology reports,
discharge summaries, cardiology images, and emergency department records
— laboratories can take the lead in establishing electronic connectivity
within their organizations while also spreading some of the costs to
other participating departments. Compared with the costs and staffing
requirements needed to interface with the numerous available EMR
systems, portals are a relative bargain that meet both physician and
health system needs.
Brian Morgan, PMP, MT(ASCP), is vice president of
operations at Halfpenny Technologies in Blue Bell, PA, where he is
responsible for managing the company's project implementation and
customer service teams.
Instrument reliability and QC frequency: a cautionary tale
By John Yundt-Pacheco
Imagine this announcement: “Accuration Instruments
Inc. is proud to announce the release of the Reliabulator 2/500,
a new hallmark in the reliability of clinical diagnostic laboratory
automation.”
Your laboratory will be one of the first
installations of the new Reliabulator 2/500. The manufacturer
claims the “2” in the instrument name stands for an expected two years
between undetected grave malfunctions, and the “500” means it will
process 500 patient specimens per day.
One of the things you need to decide on is a suitable
quality-control strategy for the Reliabulator. If it only fails
every two years, does that mean no quality control (QC) is necessary the
first year? That would certainly help the budget. After a bit more
consideration, you realize that an expected malfunction rate of once
every two years is not the same thing as a malfunction every two years
starting after installation. The instrument could have an expected
malfunction rate of once every two years and still malfunction the day
after it is validated. An expected malfunction rate of once every two
years means that the malfunction could occur at any time; but over the
long term, there will be an average of one malfunction for every two
years of service. Consequently, no QC during the first year is not much
of an option.
What about doing QC once a month? What is the
worst-case scenario? If QC is done on the first of the month and the
system malfunctions on the next sample, that would be the worst case. If
the malfunction was not detected until the next QC, that would mean a
whole month's worth of compromised patient samples — call it 30 days of
500 patients per day: 15,000 compromised specimens! But how likely is it
that a malfunction will occur on the specimen right after a QC event?
The answer is:
“Not very likely.”
What about the best-case scenario? The system might
malfunction after the last patient specimen of the month but before the
QC specimen next month. The malfunction is detected, and no patient
specimens are affected. How likely is that to happen? The answer is “not
very likely” but about the same probability of the system malfunctioning
right after QC. Given that the greatest risk to the laboratory will
occur if a malfunction happens on the first of the month just after the
QC event, and there is no risk to the laboratory if a malfunction
happens at the end of the month after the last patient specimen (but
before next month's QC event), then the middle of the month can be used
to estimate the expected number of patient specimens compromised by a
malfunction — assuming that a malfunction is equally likely to occur on
any day of the month.
It turns out that half the number of patient
specimens between QC events is the expected number of specimens that are
compromised by a malfunction.1 If the malfunction is grave
enough, half the number of patients between QC events will contain an
unacceptable amount of error. In the case under consideration, 15 days
of 500 patients per day would result in 7,500 compromised patient
specimens, every two years, or 3,750 patients per year.
Looking at a strategy of performing QC once a week,
results in 3.5 days of 500 patient specimens per day that are
compromised in the event of a malfunction — 1,750 every two years, an
expected 875 per year.
Evaluating a QC specimen every morning results in 0.5
days of 500 patient specimens per day that are compromised in the event
of a malfunction — 250 every two years, an expected 125 per year, or
about one every three days. This may be manageable, but it requires
doing QC every day, even on an instrument as reliable as the
hypothetical Reliabulator 2/500.
Unfortunately, there is another consideration:
although the expected rate of compromised patient results is one result
every three days, they actually occur as 250 consecutive compromised
results at one point in time, every two years on average — meaning a
major headache when it happens.
The reliability rate can be computed as the number of
uncompromised patient specimens times 100/number of specimens. For a
test system with periodic malfunctions, it is directly related to the
frequency of QC events.
For a QC frequency of once per month over a two- year
period, the reliability rate is calculated as 100*
(365,000-7,500)/365,000 or 97.45% — or sigma value of 3.54.2
QC once per week over a two-year period,
the reliability rate is 99.52% — or sigma value of 4.09
QC once per day over a two-year period,
the reliability rate is 99.93% — or sigma value of 4.70
By way of comparison, airline baggage-handling sigmas
have been reported at a sigma value of 4.15.3 It is evident
that even an instrument as reliable as the Reliabulator 2/500
needs at least daily QC.
John C. Yundt-Pacheco is a technical development
manager at Bio-Rad Laboratories in Hercules, CA.
References
- Parvin CA, Gronowski AN, Effect of analytical run
length on quality-control (QC) performance and the QC planning
process, Clin Chem. 1997;43:11, 2149-2154. - Reliability rates can be transformed to expected
upper sigma bounds using a sigma calculator like the one at:
http://www.isixsigma.com/sixsigma/six_sigma_calculator.asp . - Westgard JO. Six Sigma Quality Design and
Control. Westgard QC Inc.: 2001;29.
