Testing on demand.
Patient-directed testing appears to be a force that will only grow stronger in the 21st century. In a number of states, patients are legally free to request at least some of their own laboratory tests without a physician's order, a phenomenon that has been called direct laboratory access (DLA). In one view, DLA is a win/win scenario, empowering healthcare consumers and offering laboratories a new revenue source: individuals willing to pay out-of-pocket for testing services. In another view, it's a recipe for disaster: worried and ill-informed patients getting more information than they can handle without a physician's guidance on choice of tests or interpretation of results.
Which opinion should you heed? If your state permits DLA, should your laboratory offer it-and if so, what makes a DLA program successful? This article presents the experience and advice of 2 leading providers in the young but burgeoning field of DLA services, along with some notes from a consultant on DLA legislation and a strong note of caution by a family physician with a laboratory background. Their combined expertise provides a good primer on the risks and opportunities involved when laboratories provide services straight to the consumer.
Fulfilling a need
There's nothing new about patients bypassing their physicians to get test results, according to Henry Soloway, MD. The laboratory he directs, Associated Pathologists Laboratories, Las Vegas, NV, has offered a limited menu of tests directly to consumers for more than a decade. Direct-access testing is already available at health fairs and, most importantly, at the local drugstore, where the proliferation of home tests and collection kits now runs the gamut from glucose in blood and urine to pregnancy and ovulation detection. The availability of such testing saves insurers the cost of otherwise unnecessary physician visits and may provide vital information to patients who would avoid testing if it involved the cost and inconvenience of an office visit. Uninsured patients or those desiring absolute anonymity may find the option particularly attractive.
Direct access to a clinical laboratory offers the same benefits as home testing, as well as those of professional specimen collection and test performance. Optimally, patients should also reap the benefits of rapid turnaround time, easily comprehensible test reports, physician review of test data, and prompt communication about critical laboratory values.
The demand for DLA, typically from health-conscious consumers, is a reflection of broader trends--the shift away from a paternalistic, physician-patient relationship to a more self-directed model; the quest for speed and convenience; the widespread lack of health insurance (which often excludes screening tests); and concerns about privacy. In an age of do-it-yourself healthcare research on the Internet, the market for "cash-and-carry" testing on demand may become quite profitable, according to some laboratory market analysts.
State laws vary widely in regard to DLA. Some states, such as New York, don't permit any clinical testing without a physician's order, not eventests that patients themselves can perform with drugstore kits. Others allow only a restricted test menu, while some have no restrictions on the books whatsoever. At least 30 states permit some degree of direct-access testing (See Table 1). It's not uncommon for laboratory professionals, and even health officials, to be murky on the details of their state's regulatory status. If you encounter conflicting opinions on the status of DLA in your state, the only way to ascertain it may be to look up the pertinent laws and regulations.
Even in states where it is permitted, however, clinical laboratories have been slow to offer DLA and even slower to actively market it to consumers. Beyond mere inertia, there are several valid reasons. Liability is one major concern, although none of the authors of this article was aware of any lawsuits arising to date from DLA testing. A laboratory that accepts test requests from consumers and delivers test results to them must develop protocols for every step of the process, including sensitive issues regarding anonymity and reporting. And by entering into a direct relationship with patients, clinical laboratories run the risk of alienating their core clientele--physicians, who may perceive DLA as undermining their role as the primary healthcare provider.
Indeed, it takes considerable forethought, careful planning, and hard work to establish a smooth-running and responsible program for direct-access testing--one that protects the interests of consumers, the laboratory itself, and its physician clients. The DLA testing program at Dr. Soloway's laboratory, located in a major tourist area, arose to meet the needs of travelers requiring testing services, such as patients taking warfarin who needed a prothrombin time. Rather than forcing patients to endure an physician's office visit, with all that might entail, the laboratory decided to allow its own pathologists, all state-licensed physicians, to order any test requested by "walk-in" individuals. The program was never marketed to the public but has grown by word of mouth; most DLA clients are now local residents, characterized by Dr. Soloway as "anxious, educated, and somewhat affluent."
To deal directly with patients, the laboratory developed formal guidelines that include the following essentials:
1. A physician orders all tests on behalf of the individual requesting testing and then reviews all results promptly.
2. No samples are drawn unless the requesting individual provides an address or phone number for contact in the event of abnormal results.
3. Each DLA laboratory report includes a disclaimer reminding patients that physicians don't diagnose diseases based on laboratory tests alone and names the county medical society as a source for physician referrals.
4. Only the patient picks up reports (with photo identification required).
5. Letters are sent out whenever an abnormal result (as defined by protocol) triggers a physician response. In these letters, the tested individual is invited to call the pathologist for assistance in obtaining a physician's appointment. All such letters are maintained in a permanent file.
In the case of life-threatening critical values, the tested individual receives an immediate telephone call. 
The DLA program at Associated Pathologists had to resolve a number of practical considerations. All clients must pay for testing at the time of service, and Medicare-eligible patients must sign a release acknowledging that testing is not a covered benefit. To avoid antagonizing area physicians, the program has never been advertised, and the laboratory will not send copies of reports to designated physicians. (This is to spare doctors the dilemma of receiving an abnormal value on an unknown patient or one whom they haven't seen for years.)
All direct-access clients are assigned an identification number for reporting purposes, and their records are kept separate from the laboratory's physician-ordered testing records. Any critical values on a predetermined schedule are communicated directly to the individual who requested the test. Dr. Soloway lists the following abnormal test results as those that will trigger a phone call and follow-up letter to a patient:
* blood lead, elevated;
* fasting glucose [greater than] 130 mg/dL;
* random glucose [greater than] 250 mg/dL;
* cholesterol [greater than] 300 mg/dL;
* prothrombin time [greater than] 30 seconds;
* urinalysis showing pus, blood or protein [greater than or equal to] 2+;
* total protein [greater than] 9.0 gm/dL;
* positive tuberculosis skin test;
* elevated therapeutic drug levels;
* urine cultures positive for single organism [greater than] 50,000 colonies/mL; or
* respiratory cultures with heavy growth of pathogenic organism.
Testing for human immunodeficiency virus (HIV) presents its own set of challenges; many local residents seek HIV antibody testing directly from Associated Pathologists, notes Dr. Soloway. [HIV testing is readily available through the Las Vegas health department's sexually transmitted disease (STD) clinic, a setting that may discourage some individuals from showing up.] The medical, legal, and emotional stakes of HIV testing are high, so the laboratory gives tested individuals a US Public Health Service pamphlet entitled What about AIDS testing? and asks whether they wish to receive free, pre-test counseling by a pathologist. (Most decline, Dr. Soloway has observed.)
Patients with a positive HIV antibody test, as confirmed by Western blot, receive a letter requesting them to call the pathologist reviewing the report as soon as possible. The letter refers only to a "significantly abnormal result." Those picking up their test results in person also receive a letter recommending free counseling by a pathologist.
In contrast to the conservative, no-marketing approach of Associated Pathologists, a more assertive strategy is used by the Personal Diagnostic Center (PDC), a direct-access laboratory in Overland Park, KS. The laboratory's director, John Halsey, PhD, is also director of IBT Reference Laboratory, a national clinical immunology laboratory; but PDC is operated independently as a consumer-friendly, direct-access testing service. The PDC facility, which advertises in the local media, is located in a shopping area, nor a medical building, with a suite of offices for counseling, specimen collection, and testing. The staff members are dedicated personnel trained to work directly with the public. Medical reference books, diabetes care and allergy control products, and other related services are available, and a pathologist is accessible by telephone at all times.
In states that permit direct-access testing, the options range from offering only CLIA-waived tests to providing an unlimited menu. Like Dr. Soloway's laboratory, PDC faced the initial task of developing a test menu appropriate for ordering on demand. According to Dr. Halsey, such a menu should include at the very least waived, home- use, and mail-in tests. Additional basic tests typically offered at health fairs such as thyroid-stimulating hormone, prostate specific antigen, complete blood count, and wellness chemistry panels, are also on the menu.
Under appropriate circumstances, additional tests may be ordered, including blood typing, hepatic function, rapid plasma reagin, STD tests, rubella and hepatitis immunity, and some therapeutic drug monitoring. Certain tests at PDC do require a physician order, and staff members are trained to refuse requests that seem inappropriate. The tests consumers most frequently request at both the Kansas and Las Vegas laboratories are HIV antibody status and blood cholesterol tests (see Table 2). Chlamydia, allergy testing, blood chemistry panels, and blood typing also rank high.
Patients are apparently not the only ones who appreciate the convenience of direct-access testing. At PDC, direct and indirect ordering by local physicians makes up a significant part of the workload. About 10% of the tests performed are generated by written orders from physicians, and another 25% stem from patients' requests for tests recommended by their physicians, such as hepatic function or thyroid monitoring. The remainder are initiated and ordered by patients themselves.
Both laboratories have had to grapple with a host of sensitive issues that arise when consumers have direct access to laboratory testing. Some of these issues surround testing for STDs and drugs of abuse, especially when such testing is requested by minors or by parents for minors; toxicology testing for pre-employment drug screens; maintaining confidentiality when providing reports by phone; identifying individuals picking up test reports; counseling individuals seeking testing services; proper handling of critical test values; and requests for inappropriate tests from emotionally disturbed individuals.  The development and enforcement of clear and consistent formal protocols is essential to handling these issues.
On balance, despite the inherent risks and costs of offering tests on demand, Drs. Soloway and Halsey contend that DLA, whether advertised or not, is a worthwhile endeavor for consumer and laboratory alike. It provides consumers with a service they desire and one that is difficult or impossible to obtain in most communities. It keeps healthy but anxious patients out of physicians' offices and makes quality testing available at a fair price, while providing test results with a doctor's oversight. It also provides an additional income source to the laboratory, one that doesn't depend on marketing to physicians, offering discounts to managed care organizations, or billing third-party payers.
A strong note of caution
Thus far, the growth of testing on demand has been scattered and sporadic, largely because of restrictive regulation. A recent attempt in California to legalize a wide range of direct-access testing met with powerful and well-organized opposition from the state's medical and hospital associations, according to Michael Arnold, a lobbyist who represents the California Clinical Laboratory Association, which sponsored the bill. After the list of permissible direct-access tests was sharply curtailed, the bill was further stalled when a provision to curb physician liability for test results met with opposition from trial lawyers. Ultimately, the bill was redrafted to remove all reference to DLA and to address the issue of exempt status under CLIA. The California initiative, which was expected to be a harbinger of DLA growth if successful, was disappointing to advocates of broader laboratory access to consumers.
Some observers, however, stress the dangers inherent in a direct-access testing boom, with the risk of scare-tactic advertising and unscrupulous practitioners entering the field. Verlin Janzen, MD, a family physician in Kansas who also trained as a medical technologist, is an outspoken critic of unfettered direct access to laboratory testing. Some tests may be reasonably performed on demand, such as pregnancy, HIV, cholesterol, and blood sugar, he asserts, but such tests should be the exception, not the rule.
One of Dr. Janzen's main concerns is whether consumers, even well-educated ones, can be trusted to interpret laboratory test results in a meaningful context. Will a patient understand that the difference between, say, a serum cholesterol value of 230 mg/dL 6 months ago and a current value of 220 mg/dL isn't clinically significant? Even if his or her lipid panel falls within a low-risk range, will the patient take into account the broader profile for cardiovascular risk, including age, gender, smoking status, family history, blood pressure, and more? If the patient has already suffered a myocardial infarction, will the standardized test report specify that total serum cholesterol should ideally be in the 160-180 mg/dL range, not just under 200? And, perhaps most importantly, will a patient understand that laboratory tests, despite their high-tech appeal, aren't infallible?
Dr. Janzen also questions the wisdom of allowing patients to avoid "unnecessary" physician visits for routine screening tests. Often, it is precisely during these encounters that a conscientious physician may evaluate the patient's global health status and offer important interventions as needed, such as counseling on smoking cessation or weight loss. Because the consumers served by direct-access testing tend to be relatively young and healthy and thus not frequently in contact with a physician, DLA may further limit or delay their opportunities for such counseling and, perhaps, detection of unsuspected medical problems.
Normal test results may lead to a false sense of security, and even knowledgeable patients are not always qualified to know what tests are most appropriate to evaluate a particular symptom. Dr. Janzen relates the case of a 39-year-old female patient who requested-blood glucose testing without an office visit, suspicious that she had diabetes because of frequent urination. (A friend of hers had recently been diagnosed with diabetes after experiencing the same symptom.) Had she obtained such testing on demand, she would have been falsely reassured that all was well. As it happened, when she reluctantly scheduled an office visit, her physician reviewed her history and performed a Pap smear, which revealed an early and treatable cervical malignancy.
The authors agree that direct access to basic screening tests such as those currently available for home use has been generally a boon to healthcare consumers, provided that the information can be readily confirmed and appropriately acted on by a physician. They also believe that direct laboratory access, while presenting enormous opportunities to laboratorians as well as consumers, must be handled with extreme care and sensitivity to avoid creating more problems than it solves. If it is indeed inevitable, as Dr. Soloway suggests, that physicians will no longer be the sole gatekeepers to medical testing services, then the responsibility of the laboratory must broaden to serve the special needs of consumers as their direct clients.
Michael Arnold is a legislative advocate and consultant at Michael J. Arnold & Associates, Inc., Sacramento, CA; John F. Halsey, PhD, is president and laboratory director at IBT Reference Laboratory, Lenexa, KS; Verlin K. Janzen, MD, is a family physician at the Hutchinson Clinic, Hutchinson, KS; and Henry Soloway, MD, is director, Associated Pathologists Laboratories, Las Vegas, NV.
(1.) Soloway HB. Establishing a direct laboratory access program. Clin Cbem. 1995;41:809-812.
Soloway HB. Patient-initiated laboratory testing: Applauding the inevitable (editorial). JAMA. 1990;264:1718.
States allowing direct-access testing
In general, states regulate who may order laboratory tests. Many authorize only physicians, dentists, and certain other practitioners to do so. New York state permits no direct-access testing. The following states permit it, although with various restrictions:
Source: Schwartz K and Cohen CG. Patient direct access to testing. Laboratory Medicine. 1990;21:9. Cited by: Gore MJ. Should consumers be able to order their own tests? Laboratory Industry Report. 1997;6:5-8.
The most frequently requested direct-access tests
HIV antibody status
Cholesterol and lipid pane
ABO/Rh blood typing
Hepatic function panel.
Complete blood count
Rapid plasma reagin
Prostate specific antigen
Culture and antibiotic sensitivity
Therapeutic drug monitoring
Source Gore MJ. Should consumers be able to order their own tests? Laboratory Industry Report. 1997;6:5-8.
Online tests for consumers
A full menu of diagnostic testing and screening products have been available to consumers in drugstores for some time, but they are now being offered online as well. HealthCheck, an e-commerce site recently launched by Technical Chemicals and Products, inc. (TCPI) of Pompano Beach, FL. (www.health-check.com) sells an array of tests that are already sold over the counter that can be bought and used in the privacy of one's own home.
Cybershoppers can select from either "health screening products," which include tests to screen for diabetes, urinary tract infections, kidney and bladder disease, and total cholesterol (awaiting FDA marketing approval); "health monitoring products," which include systems to assess vision, skin growths, and blood pressure; or "family planning diagnostic products," which include pregnancy and ovulation detection tests. TCPI also plans to add an HDL cholesterol screening test to its test menu.
Prices for the tests are moderate, ranging from $7-20 (with the exception of a $50 blood pressure monitoring cuff). TCPI advertises its products as being "easy to use" and having results that are" comparable to clinical labs"; it claims an accuracy rate of more than 95% for its health screening products and 99% for its family planning tests. (Accuracy rates are based on clinical trials done for FDA approval.) In tests that determine levels of a substance, such as cholesterol, inserts in the test kit packages encourage consumers to see a physician if their test results approach certain cutoff points.
Since its launch early this year, the HealthCheck site has been well attended, with 250,000 "hits" during its first 4 weeks of business, according to Howard Goldman, TCPI's vice president of investor relations. He believes direct-to-consumer, diagnostic test marketing will be a significant time and money saver for both patients and doctors because patients can test themselves for certain basic conditions before going to a doctor's office, thereby avoiding unnecessary visits and tests.
HealthCheck also offers consumers health education information through a program with Amazon.com, plus links to various health and medical organizations for details about different medical conditions.
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|Author:||Arnold, Michael; Halsey, John F.; Janzen, Verlin K.; Soloway, Henry|
|Publication:||Medical Laboratory Observer|
|Date:||Mar 1, 2000|
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