Direct Access Testing
Document: Consumer Access to Laboratory Testing and Information
Classification: Position Paper
Date: July 2004
Status: Approved by ASCLS House of Delegates July, 2004
The traditional healthcare model in this country places the physician (or appropriate ordering provider) in control of determining what diagnostic and therapeutic monitoring (including laboratory tests) are performed on a patient. In addition, all results of tests and procedures are reported to the physician who assumes the responsibility of relaying the information to the patient. This model is reinforced by Medicare and Medicaid regulation and the laws of a number of states. The general public, however, was introduced to the concept of being directly involved in their own laboratory testing as early as the 1950’s with the availability of over-the-counter urine glucose and ketone tests. As the number of diabetics continues to increase, these patients are encouraged to monitor closely their glycemic status in an attempt to decrease the incidence of complications. With diabetes mellitus leading the way, an expansion of over-the-counter testing technology, and a movement for more empowerment of consumers to take responsibility for their own healthcare, has created a major paradigm shift in healthcare, moving from a physician focus to a consumer focus1. One manifestation of this has been direct access testing (DAT) for laboratory services. DAT is also known by a variety of other names including consumer ordered tests, patient-directed testing, direct access to lab services, consumer driven testing, self-ordering, direct-to-consumer and consumer self-orders. It is characterized by the individual paying up-front and out-of-pocket for the service. As of 2004, most insurance companies and other payers are not offering reimbursement. Tests are usually purchased without physician consultation, and the consumer/patient is responsible for any follow up with their clinician2. This is in contrast to the over-the-counter home testing kits available for purchase in pharmacies and other retail outlets. DAT places the clinical laboratory professional in a direct provider relationship with that consumer/patient.
The American public has come to expect and demand the highest quality in the delivery of health care. However, there is overwhelming evidence that there are safety3 and quality4 flaws in the healthcare system which requires substantive changes. The Institute of Medicine, in its 2001 publication “Crossing the Quality Chasm: A New Health System for the 21st Century”, suggested a redesign of the system which would include (a) the patient as the source of control, (b) unfettered access for patients to their own medical information and to clinical knowledge, and (c) evidence-based decision making4.
Television, the print media and the internet, coupled with an aging, more educated and informed population of healthcare consumers, has produced consumers with access to a great deal of medical information. These consumers want control of their medical care and are willing to pay for the service. A representative of the People’s Medical Society, a medical consumer advocacy organization, provided a perspective at a March 2003 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). He described today’s healthcare consumer as “empowered, educated, demanding, critical of the healthcare system and providers, and the driving force for changes in healthcare”5. A National Intelligence Report Focus article from April 2003 adds that aging boomers bring a new set of attitudes to the healthcare system. They are less willing than previous generations to cede control of their care to physicians. They research their health conditions on the internet. They are the worried well, who may not have a personal physician but are willing to pay for extra assurance of their wellness or early signs of health problems. They are those who must see a physician but prefer to come armed with data, and others who just saw a physician and want confirmatory data. Patients with chronic health conditions may prefer to track their health status more closely than their insurance will allow6. This desire for becoming involved in their own healthcare, however, can be thwarted by the consumers having difficulty distinguishing credible health information from information that is not trustworthy.7
While many patients may ask for their laboratory test results, some either fail to ask what they mean or are not given enough time with their physician to have their questions addressed. Recognizing this, ASCLS created the Consumer Information Webpage (CIW) in 1999 with a team of volunteers who respond to questions from both lay consumers and other professionals (physicians, lawyers, nurses, etc), covering all aspects of the Body of Knowledge. The CIW averaged 385 questions per month between August 2003 and January 2004, and has replied to 11,000 questions since 1999. An additional collaborative effort with other lab professional organizations established Lab Tests Online, as a “peer-reviewed, non-commercial, patient-centered resource on clinical lab testing from the laboratory professionals who do the testing”8.
As of 2004, DAT is estimated to be offered by 10-15% of hospital and commercial laboratories, either by internet or in face-to-face encounters, with a broad range of test menus often defined or limited by state regulations9. In these instances, the facility advertising the DAT is itself the facility where the testing will take place10-14. In contrast to this, “virtual” laboratories serve as internet brokers for DAT, providing the link between the consumer and the facility actually performing the tests 15-17. DAT is receiving much media attention, focusing on the perceived advantages and disadvantages18-20. For example, using the internet, consumers can choose tests as simple as a blood glucose or as complex as analyzing DNA for 21 specific mutations associated with colorectal cancer16. A 2003 survey of direct access testing patients from Quest Diagnostics showed the following reasons for having testing done:
Clients will order the desired tests, usually without intervention from the online resource as to appropriateness, and receive a form authorizing the specimen collection at a local site. The specimen is sent to the participating clinical laboratory and results are available within 48-72 hours. Communication of the results can be by conventional mail (45%), client pick up (27%), e-mail (12%), company’s website (5%) or by phone (less than 5%).23 Most online resources have a mechanism to provide more immediate follow up if a test result is in the critical range. Some web companies will provide an interpretation for an additional fee, while most will only provide links to dictionaries or MedLine scientific literature databases.
Acknowledgement of the benefit of face-to-face encounters between consumers and laboratory professionals are increasingly occurring with the full backing of some employers. For example, HealthEast Care System in St. Paul, Minnesota has agreed to allow the hospital’s “Lab Tests Direct” program to use employee wellness Flex spending accounts24. Those belonging to the Louisiana Office of Group Benefits will make the Wellness Program of http://www.directlabs.com, available to all plan members, covered dependents and retirees at no cost15.
|The most frequently requested DAT in 1997 included
Benefits and Concerns
The benefits of DAT include consumer empowerment, convenience, potential for cost savings, privacy, rapid turnaround time, and early disease detection1. It provides a cost-effective alternative for the consumer, the laboratory and the health care industry and would allow for direct marketing to the consumer.26 It also can create visibility for the clinical laboratory and bring more patients into the healthcare system.
|AT does pose a number of valid concerns, including
DAT facilities offering only waived testing have minimal regulatory oversight and are not required to provide its consumers appropriate consultation and assistance with interpreting test results9. An example of inadequate pre-test guidance information about why a test should be ordered can be found at one online DAT provider, where the explanation of the $325 “cystic fibrosis DNA test” link is “A simple and painless cheek swab test kit you can use in the privacy of your own home”.
Important issues to consider in the development of a DAT program might include any or all of the following:
- advice from legal counsel,
- consumer-friendly reports,
- customer service,
- communication of program availability to the primary care provider community,
- health department reporting protocols,
- limitation of the testing menu because some tests are deemed inappropriate for self-ordering,
- ethics involving communication of genetic testing and reportable infectious disease,
- questioning whether a parent has the right to order a test on a child, or if a child can order a test9.
CLIA ’88 regulations address test interpretation, and require the individual serving as the laboratory’s clinical consultant to have appropriate qualifications9. As of February 2003, these qualifications include a doctoral degree, a defined amount of laboratory experience, and successfully passing a board certification exam. For some states, the interpretation of test results by laboratory staff may be considered an unauthorized practice of medicine25. Instructions for establishing a DAT program are also available28.
State Regulation / Legal Issues
The availability of direct access testing and the different tests offered are governed by state law. For example, Arkansas prohibits hospital labs from performing DAT, while Missouri only prohibits its hospitals from performing DAT for in-patients. Michigan allows only CLIA-waived tests to be on the DAT menu, and Maryland only allows cholesterol testing. Interestingly, Utah limits hospital-based DAT to tests that “patients can understand.”27. As of 2001, 34 states either permitted DAT or did not address it, thereby allowing this service to be offered27, 29-31. On the federal level, CLIA 88 does not address DAT. Online DAT providers avoid the variances of state law by performing the testing in those states permitting DAT1. Legislation addressing this issue is continually being updated from state to state, making it imperative to obtain verification from one’s state health department before providing DAT. Online and hospital laboratory DAT providers usually include, within their ordering process, statements about HIPAA guidelines for patient confidentiality and provide disclaimers concerning the diagnostic usefulness of the tests performed.
In January 2003, the Direct Access Testing Association (DATA) was formed to establish standards of excellence for providers of DAT. The standards include
- maintenance of records for 5 years,
- formation of a screening committee for membership,
- utilization of CLIA certified labs only,
- highest standards for confidentiality of results,
- physician reviewed test results,
- mandatory follow-up on “out of range” results,
- adherence to all CLIA, HIPAA and OSHA regulations,
- highest standards in phlebotomy including certification,
- recommendations to DAT customers to have results referred to their healthcare provider, and
- DAT members cannot practice medicine, diagnose or give treatment or medical advice32.
Previous ASCLS Positions
The ASCLS 1995 position paper on Health Care Reform states that “ASCLS supports access to accurate and reliable laboratory testing. ASCLS supports direct access to clinical laboratory services for screening tests, tests used for monitoring purposes, and tests that do not require consultation. Direct access can greatly increase the availability and usage of preventive services. Furthermore, substantial cost savings can be achieved by elimination of office visits and prior approval of appropriate, preventive laboratory services”33. The ASCLS 1995 position on Managed Care supports “clinical laboratory scientists’ participation in patient-interactive and physician-consultative roles” and “clinical laboratory scientists having the authority to order initial and/or reflexive testing to achieve appropriate and cost-effective clinical laboratory test orders”34. In addition, the Scope of Practice 2001 position paper stated that “clinical laboratory scientists are bound by applicable laws and regulations, as well as by standards of good practice and sound professional ethics, in their relationships with consumers and with practitioners of medicine”35. This position paper fully supports these earlier positions and offers additional statements in regards to Direct Access Testing.
1. ASCLS supports the recommendation of the Institute of Medicine pertaining to the consumer’s right to have unfettered access to their own medical information and to clinical knowledge in a manner which he/she can understand.
2. ASCLS supports the role of certified clinical laboratory scientists in the development of a DAT program. Important features of a DAT program should include, but not be limited to, a pre-analytical phase that collects pertinent information on the consumer, and a post-analytical phase that incorporates an explanation of the results using a variety of strategies from pre-determined interpretive comments to one-on-one consultation with the consumer ordering the test which may include additional counseling by appropriate healthcare professionals..
3. ASCLS supports the establishment of a standard of care that requires direct access testing be performed only within CLIA-certified moderately and highly complex laboratories, using FDA approved methods, staffed by individuals with appropriate education and expertise.
4. ASCLS believes that it is the role of certified clinical laboratory scientists to consult with consumers about the purpose of laboratory tests and the general meaning of laboratory results in whatever setting those test results are generated, including direct access testing.
5. ASCLS encourages consumer communication with other healthcare team members so that together they can integrate pertinent information, such as age, ethnicity, health history, signs and symptoms, and other procedures (radiology, endoscopy, etc.) when interpreting their laboratory test results36. It is fully appropriate for clinical laboratory practitioners to partner with other direct access programs such as bone density or heart scans.
6. ASCLS believes that consumer-driven laboratory services are best provided by clinical laboratories in which reside the expertise to ensure the appropriate menu of tests and quality performance standards as well as to interpret and explain test results when needed.
7. ASCLS believes that clinical laboratory professionals have an ethical responsibility to monitor DAT to ensure its appropriate performance and claims to protect the public good and consumer/patient safety, by providing direct feedback and suggestions to the lab and its owners for accurate consumer information.
1. Merlin, T. Direct Access Testing. http://www.phppo.cdc.gov/cliac/cliac0303.asp#t16
2. Direct Access testing from Concept to Reality, AACC/ASCLS Healthcare Forum, July 23, 2003, Philadelphia, PA
3. Institute of Medicine, To Err is Human: Building a Safer Health System. Washington DC: National Academy Press, 2000.
4. Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century. Washington DC: National Academy Press, 2001.
5. Inlander, C. DAT -A Consumer’s Perspective. http://www.phppo.cdc.gov/%20cliac/%20cliac%2003%200%203.asp#t16
6. Focus on Direct Access testing, National Intelligence Report, April 21, 2003, p 3-6
7. NAME. “Special Report: Consumers face hurdles when trying to access credible health information online”. LWW.com Insider, March 2004, vol 3, number 10.
9. Merlin, T. Direct Access Testing. http://www.ascls.org/position/.%20http://www.phppo.cdc.gov/cliac/cliac0903.asp#t16
18. Fischman, J. (May 19, 2003). “Testing made easy.” U.S. News & World Report.
19. Judd, J. and Willis, M. (October 8, 2002). “Consumer care: Medical test marketing appeal to consumers, freezes out physicians.” http://abcnews.go.com/%20sections/%20living/%20DailyNews%20/DTC_marketing021008.html
20. Davis, Robert. (September 17, 2002). “Aches & Claims: Ordering up your own medical tests.” The Wall Street Journal, p D4.
21. Woods, Michael. “It’s not hard to translate your own lab tests.” The Reading Eagle, August 2003.
22. Langevin, Kate. Commercial Implementation of a Direct Access Testing Program, AACC Teleconference, http://abcnews.go.com/%20sections/%20living/%20DailyNews%20/DTC_marketing021008.html
23. Mariani, S. “Laboratory Services: Access, Quality, and Safety”. Medscape Molecular Medicine 5(2), 2003.
25. Gore MJ. Should consumers be able to order their own tests? Laboratory Industry Report 1997; 6: 5-8.
26. Arnold, M., Halsey J.F., Janzen V.K., Soloway H. “Testing on demand”. Medical Laboratory Observer, March 2000.
27. Schulze, Matthew, 25 Percent More States Allow direct Access Testing, Laboratory Medicine, 2001: #11, Vol 32 page 661-664
28. Fundamentals Of Direct Access Testing: How To Get Your Lab Connected To Consumers, Washington G-2 reports, 2001 http://www.g2reports.com/publications.php
29. States with no limits on DAT: AK, WA, MT, CO, NM, SD, NE, KS, OK, TX, MN, WI, LA, IN, OH, WV, VA, VT, NH, DE, DC27
30. States with some limits on DAT: CA, NV, UT, MO, AR, IL, MS, MI, NY, ME, NJ, MD, PR27
31. DAT is prohibited in AL, AZ, CT, FL, GA, HI, ID, IA, KY, MA, NC, ND, OR, PA, RI, SC, TN, WY27
33. ASCLS Health Care Reform, Position Paper approved ASCLS House of Delegates, July 1995.
34. ASCLS Managed Care, Position Paper approved ASCLS House of Delegates, July 1995.
35. ASCLS Scope of Practice Position Paper, approved ASCLS House of Delegates, August 2001.