Classification: Position Paper
Date: July 2012
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 to be performed on a patient. In addition, all results of tests and procedures are reported to the physician who assumes the responsibility of communicating the information to the patient. This model is reinforced by Medicare and Medicaid regulations 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 individuals with diabetes continues to increase, these patients are encouraged to closely monitor 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 focus.1 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. At this time, 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 clinician.2 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 making.4
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 informed consumers who: may not have a personal physician but are willing to pay for extra assurance of their wellness or early signs of health problems, prefer to come armed with data when physician office visits are required, and seek confirmatory data following a physician visit. In addition, patients with chronic health conditions may prefer to track their health status more closely than their insurance will allow.6 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 2,325 original questions per month in 2011, answered by 50 volunteers. An additional collaborative effort with other laboratory professional organizations established Lab Tests Online, a site that “has been designed to help...as a patient or family caregiver, to better understand the many clinical lab tests that are part of routine care as well as diagnosis and treatment of a broad range of conditions and diseases.”8 Voluntary client responses received regularly by the ASCLS team suggest the service is very valuable and fills a void in the communication chasm between patients and their healthcare providers.
DAT is offered by 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 regulations.1 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.14-16 Patients state the following as the most common reasons for having testing performed:
- early data
- doctor visit preparation
- second opinion
- saving money
- privacy, and
- obtain tests for which insurance will not pay.21
Clients will order the desired tests, usually without consultation 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, client pick up, e-mail, company's website or by phone.22 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, medical information databases like Labtestsonline, or MedLine.
From the most recent documented study of the frequency of tests ordered by consumers, the listing of DAT included:
- HIV antibody status
- lipid panels
- allergen-specific IgE
- chemistry panels
- ABO/Rh blood typing
- hepatic function panel
- complete blood count
- thyroid-stimulating hormone
- rapid plasma regain
- prostate specific antigen
- culture and antibiotic sensitivity
- semen analysis, and
- therapeutic drug monitoring.23
Benefits and Concerns
DAT is receiving much media attention, focusing on the perceived advantages and disadvantages.17-19 The benefits of DAT include consumer empowerment, convenience, potential for cost savings, privacy, rapid turnaround time, and early disease detection.1 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.24 It also can create visibility for the clinical laboratory and bring more patients into the healthcare system.
DAT does pose a number of valid concerns, including:
- consumer follow up of results,
- appropriateness of tests ordered,
- reliable interpretation of test results,
- generation of a false security if tests are "normal" or of panic if tests are "abnormal", and
- potential for unscrupulous fear tactics in advertising.1
DAT facilities that offer only waived testing have minimal regulatory oversight and are not required to provide their consumers appropriate consultation and assistance with interpretation of test results.1 Important issues to consider in the development of a DAT program 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 diseases, and
- questioning whether a parent has the right to order a test on a child, or if a child can order a test.1
State and Federal Regulations / Legal Issues
The availability of direct access testing and the different tests offered are governed by state law. As of 2007, twenty-six states either permitted DAT or did not address it, thereby allowing this service to be offered. There are twelve states that allow DAT with some limitations on testing.27
The CLIA regulations and standards do not differentiate between facilities performing DAT and facilities performing provider ordered testing. All facilities that meet the definition of “laboratory” under CLIA must obtain an appropriate CLIA certificate prior to conducting patient testing, including DAT. These CLIA certificates must be maintained and the CLIA laboratory procedures must be followed throughout all phases of testing.
DAT testing using waived test systems are subject to the CLIA provisions on waived testing. DAT testing using moderate or high complexity test systems are subject to the CLIA provisions on non-waived tests.28
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".29 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".30 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".31 This position paper fully supports these earlier positions and offers additional statements in regards to Direct Access Testing. The 2005 position paper on Health Care Reform Resolution states that ASCLS supports “access to accurate and reliable laboratory testing.”
- 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.
- ASCLS supports the role of certified clinical laboratory professionals 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.
- 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.
- ASCLS believes that it is the role of certified clinical laboratory professionals 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.
- 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 results.8 It is fully appropriate for clinical laboratory professionals to partner with other direct access programs such as bone density or heart scans.
- 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.
- 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 laboratory and its owners for accurate consumer information.
- Merlin, T. Direct Access Testing. http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0303/Merlin0303I.pdf
- Direct Access testing from Concept to Reality, AACC/ASCLS Healthcare Forum, July 23, 2003, Philadelphia, PA
- Institute of Medicine, To Err is Human: Building a Safer Health System. Washington DC: National Academy Press, 2000. http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf
- Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century. Washington DC: National Academy Press, 2001. http://iom.edu/~/media/Files/Report%20Files/2001/Crossing-the-Quality-Chasm/Quality%20Chasm%202001%20%20report%20brief.pdf
- Inlander, C. DAT -A Consumer's Perspective. http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0303/Inlander0303N.pdf
- Focus on Direct Access testing, National Intelligence Report, April 21, 2003, p 3-6
- NAME. "Special Report: Consumers face hurdles when trying to access credible health information online". LWW.com Insider, March 2004, vol 3, number 10.
- http:// labtestsonline.org
- Fischman, J. (May 19, 2003). "Testing made easy." U.S. News & World Report.
- 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
- Davis, Robert. (September 17, 2002). "Aches & Claims: Ordering up your own medical tests." The Wall Street Journal, p D4.
- Woods, Michael. "It's not hard to translate your own lab tests." The Reading Eagle, August 2003.
- Langevin, Kate. Commercial Implementation of a Direct Access Testing Program, AACC Teleconference, http://abcnews.go.com/%20sections/%20living/%20DailyNews%20/DTC_marketing021008.html
- Mariani, S. "Laboratory Services: Access, Quality, and Safety". Medscape Molecular Medicine 5(2), 2003.
- Gore MJ. Should consumers be able to order their own tests? Laboratory Industry Report 1997; 6: 5-8.
- Arnold, M., Halsey J.F., Janzen V.K., Soloway H. "Testing on demand". Medical Laboratory Observer, March 2000.
- Schulze, Matthew, 25 Percent More States Allow direct Access Testing, Laboratory Medicine, 2001: #11, Vol 32 page 661-664
- Fundamentals Of Direct Access Testing: How To Get Your Lab Connected To Consumers, Washington G-2 reports, 2001 http://www.g2reports.com/publications.php
- Survey of Direct-to-Consumer Testing Statutes and Regulations, June 2007: Genetics and Public Policy Center, Berman Institute of Bioethics, Johns Hopkins University.
- States permitted to perform DAT: AK, AR, DE, DC, IN, IA, KS, LA, MN, MS, MO, MT, NE, NM, NC,ND, OH, OK, SD, UT, VT, WA,WV, WI, TX, VA,
- States with some limits on DAT: AZ, CA, CO, FL, IL, ME, MD, MA, NV, NJ, OR, NY
- States where DAT is prohibited: AL, CT, GA, HI, ID, IA, KY, MI, NH, PA, RI, SC, TN, WY
- ASCLS Health Care Reform, Position Paper approved ASCLS House of Delegates, July 1995.
- ASCLS Managed Care, Position Paper approved ASCLS House of Delegates, July 1995.
- ASCLS Scope of Practice Position Paper, approved ASCLS House of Delegates, August 2001.