Document:
Consumer Access to Laboratory Testing and Information
Classification: Position Paper
Date: July 2004 Status: Approved by ASCLS House of Delegates July, 2004
Introduction
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.
Background
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:
early
data (18%)
doctor
visit preparation (18%)
convenience
(13%)
second
opinion (10%)
saving
money (10%)
privacy
(6%)
obtain
tests for which insurance will not pay (4%), and
"other" (21%)22.
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
HIV
antibody status
lipid
panels
Chlamydia
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 monitoring25.
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
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
the
potential for unscrupulous fear tactics in advertising1.
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 IssuesThe
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 PositionsThe
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. Position
Statements1.
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. Footnotes1.
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/
cliac/ cliac 03 0 3.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.
8. http://www.labtestsonline.org
9. Merlin, T. Direct Access Testing. http://www.phppo.cdc.gov/cliac/cliac0903.asp#t16
10. http://www.homeaccess.com
11. http://www.directaccesslabs.com
12. http://www.novatx.com/menu.html
13. http://www.results-direct.com
14. http://www.questest.com/ch/minihome/Home.jsp
15. http://www.health-tests-direct.com/What_is_Direct_Access_Testing_DAT.htm
16. http://www.directlabs.com/DAT.php
17. http://www.healthcheckusa.com/home.html
18. Fischman, J. (May 19, 2003). "Testing made easy." U.S.
News & World Report
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