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Patient Self-Testing:

Putting Together A Program Tuned To Patient, Staff Needs
(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 test reliability:

  • 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).

Analyzing Opportunities
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 methods.

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.

Selecting Instruments
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 documentation.

    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 cards.

    Determine the method for documenting test results. Is the instrument capable of interfacing with the laboratory/patient care information system?
  • 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 variables
  • Test result evaluation, including proper follow-up procedures
  • 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 observer
  • 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 Self-Testing Program
(Return to text.)

  • Analyze need
  • Analyze cost/reimbursement
  • Make "Go" or "No Go" decision
  • Select instruments
  • Design, implement education/training of patients, staff
  • 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.)

Manufacturer Support

  • Device warranty and repair policies
  • Training for staff/patients (interactive, video, CD-ROM, virtual, Internet)
  • Instructions for meeting CLIA/JCAHO requirements


Instrument Characteristics

  • Therapeutic turnaround time
  • Number & efficiency of pre-analytical, analytical, post-analytical steps
  • 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


Instrument Performance

  • 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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