Putting Together A Program Tuned To Patient, Staff
(Part 2 of a 2-part series)
by Dr. Sheila Dunn
Reprinted with Permission from Washington G-2 Reports,
Physician Office Testing, March 1999
If you manage a physician
office laboratory, you're perfectly suited to administer a patient self-testing
program. In Part I of this article,
we looked at the boom in the home testing market, with consumers keen
on exercising a more active role in managing their own health, aided
by test kits and instruments that are relatively simple to master and
produce reliable results when used correctly. Here, we'll examine how
a patient self-testing program can put your in-office lab at the forefront
of this movement.
Taking The Plunge
Start with the idea of customizing the program to fit your physician
practice: the diverse categories of patients seen and your clinical,
outreach, and coordination capabilities. What works for one practice
may not work for another. Design the education and training you plan
to offer to match test complexity, system types, intended use (self-testing
vs. self-management), and professional disciplines.
Apart from training patients to use the testing devices,
your program must account for several other variables that can affect
- Pre-analytical: specimens are collected properly;
patient performs the test at the right time; patient has taken proper
preparations (fasting, etc.).
- Post-analytical: clerical errors such as transposing
numbers, recording results wrongly or in the wrong place; sending
the results to the wrong caregiver; results not appropriately acted
on; wrong patient data used to calculate reference ranges (age, gender);
self-monitoring of diet and other lifestyle changes; noticing and
reporting signs of adverse outcomes (for example, bleeding indicators
for prothrombin time testing).
Prior to developing your
program (Figure 1), ask the following questions:
- Justification: Why is
the program needed? What are the advantages/disadvantages of offering
it? What are the clinical applications?
- Logistics: Which groups
of patients will be targeted and accepted? Who in the office will
coordinate the program (documentation, instrument maintenance, training)?
Where and how will results be recorded?
- Technical issues: Which
quality control/quality assurance measures are needed (internal/external
controls, ongoing proficiency checks)? At what frequency should patients
test? When and how should test results be transmitted to caregivers?
For patients who will manage their disease at home, at what point(s)
should the physician be consulted?
The next step is to assess your costs, both direct and
indirect. Factor in projected savings associated with the program, such
as improved timeliness of patient assessment and intervention. Compare
the program's total cost with that you now incur with existing test
Direct costs for home-based testing are: instruments,
reagents, supplies, waste from repeat testing (assume 5% repeat rate),
personnel, training, and program coordination. Indirect costs include
medical interventions, computer resources, telephones or pagers.
Consider which reimbursement resources can help support
your program. Medicare, for example, covers certified diabetes self-management
training (in both group and individual sessions) as well as related
monitoring devices and supplies under certain conditions (Physician
Office Testing, June, July '98, pp. 2-3). At this time, Medicare
does not, however, cover other forms of patient self-testing education/training,
such as prothrombin time testing.
Managed care plans advocate programs that help enrollees
stay healthy, manage disease conditions at home, and avoid costly hospitalization
or other institutional care. Check your managed care contracts to determine
whether they reimburse such patient education/training. Your program
could be an excellent "selling point" to health plans which
emphasize outcomes-oriented care and heightened involvement of patients
in activities to maintain their own health.
Criteria to consider
when evaluating instruments for your program are summarized in Figure
2. Here are some added considerations.
- Manufacturer support: Obtain
references about the instrument's reliability and quality of support.
Find out where the nearest distributor is located and the approximate
lead-time once orders are placed. Investigate the possibility of obtaining
a year's worth of a single lot number of reagents. Be sure the manufacturer
or distributor has a toll-free 24-hour, 7 days a week technical support
department. Will the manufacturer supply a replacement instrument
while repairs are performed? Offer training for medical facility staff?
Provide easy-to-read, quality educational materials for patients?
The manufacturer should provide an instruction/operator's manual and
cue cards outlining critical steps. Finally, the instrument's specifications
and limitations should be clearly indicated.
- Instrument characteristics: The
testing procedure should be acceptable to both the patient and the
in-office lab. Speed, ease, simplicity, and user-friendly operation
are essential. Assess the functional turnaround time capability, including
patient preparation, sample collection, test performance, and result
Low sample volume requirements are less invasive and less painful
for the patient. This is also important for patients who require frequent
blood glucose sampling and may have poor peripheral circulation.
Calibration and maintenance should be fast and simple. Regents and
supplies should be easy to store, preferably not require refrigeration,
and have a long shelf life. Error messages should be easy to interpret
by operators. Assess the size of the print on the display screen,
because small print may be hard for some operators to read. The size
of the instrument, amount of test supplies, and storage should afford
easy handling and access for most operators.
The instrument must be rugged enough to survive home use, including
all kinds of conditions and accidents, as well as travel. It should
include a "low battery" indicator that can be tested routinely.
Possible sources of error should be minimal and be identified on cue
Determine the method for documenting test results. Is the instrument
capable of interfacing with the laboratory/patient care information
- Instrument reliability: Assess
accuracy and strive for results within 10% of laboratory values, or
define acceptable limitations for imprecision at each specific medical
decision limit. A number of interferences, such as lipemia, hemolysis,
hyperbilirubinemia, and abnormal hematocrit, must be evaluated.
Operating The Program
For your program to be successful, comprehensive patient training is
essential. Your aim is to educate and motivate. According to the American
Diabetes Association (ADA), well-trained patients who perform their
own glucose tests at home are much more likely to avoid or delay the
serious consequences of diabetes. Better outcomes have also been reported
for those who self-test and self-manage anticoagulation therapy.
ADA provides guidelines for a comprehensive training
program for diabetes self-management. The program contains 20 standards
which any self-testing program should strive to achieve. For more information,
contact ADA's Education Recognition Department at 1-888-232-0822.
Training of both patients and program staff should address
the following issues:
- Patient preparation
- Sample handling
- Test performance
- Preventive maintenance, troubleshooting, and calibration
- Reagent storage and stability
- Knowledge of pertinent pre-analytic and post-analytic
- Test result evaluation, including proper follow-up
- Quality control and evaluation of results
- Reporting results, along with steps to take if results
indicate further action
- Therapy adjustment
In addition to initial training, both patients and program
staff require periodic competence evaluations. Any one (or a combination
of) the following may be used:
- Blind samples
- Testing a sample in the presence of another trained
- Checklists to ensure conformance with the proper procedures
You'll find your program is not only a boon to current
patients, but also will attract others who value close, ongoing collaboration
with healthcare professionals in staying as healthy as they can be,
for as long as possible.
Figure 1: Steps In Devising Patient
(Return to text.)
- Analyze need
- Analyze cost/reimbursement
- Make "Go" or "No Go" decision
- Select instruments
- Design, implement education/training of patients,
- Establish results reporting system; if patient is
to self-manage, establish when interaction with caregiver is required
Source: Dunn, S. "Home-Based Testing." In
Point Of Care Testing: Principles, Management, and Clinical Practice,
in press. Ed: Gerald J. Kost, MD, PhD. New York: McGraw-Hill.
Figure 2: What To Look For When
Selecting Instruments For Your Patient Self-Testing Program
(Return to text.)
- Device warranty and repair policies
- Training for staff/patients (interactive, video, CD-ROM,
- Instructions for meeting CLIA/JCAHO requirements
- Therapeutic turnaround time
- Number & efficiency of pre-analytical, analytical,
- Flexibility, modularity, expandability, upgrade capability
- Networking or interfacing capability
- Information system, data storage, archiving capability
- Small sample volume
- Automated calibration
- Interrupt capability
- Short analysis cycle
- Compact, reliable, durable, lightweight, mobile, power-efficient
with battery operation
- Reagent stability, shelf life, lot size
- Accuracy, precision, bias, resolution, reproducibility,
stability, response time
- Linearity in both high and low extremes of measurement
- Consistency and relationship to tests performed in
the parent lab
- Artifact elimination, error detection, interference
warning, specimen flagging
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