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Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
What is CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) was established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results. A laboratory is defined to be a facility that performs certain testing on human specimens in order to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body (42 C.F.R. sec. 493.2.). CLIA’s regulatory requirements vary according to the kind of test(s) each laboratory conducts. Tests are categorized as waived, moderate complexity or high complexity. Moderate and high complexity tests are collectively referred to as “non-waived” testing.
What is DAT?
“Direct access testing” (DAT) is generally defined as consumer (as opposed to physician) initiated testing of human specimens. DAT is also known as "direct-to-consumer" or "patient-authorized" testing. Some states do not allow for DAT. Where DAT is permitted, it is commonly ordered by an individual without a prior consultation with a physician or a physician’s request for testing.
DAT/CLIA
Interest in DAT-based issues is growing as trends in the direct marketing of laboratory testing to consumers (including web-based solicitation), consumer privacy concerns, convenience, cost savings, and consumer self-empowerment in managing their health are all leading to greater use of DAT. Interest has also grown in how CLIA affects the availability of DAT. CLIA authorizes regulation of laboratories that conduct testing, not the individuals who order the tests or receive test results. State laboratory laws may regulate that issue, and limit the availability of DAT.
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.
CLIA affects DAT in the same manner in which it affects provider ordered laboratory 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. The following regulatory excerpts are a selection of the CLIA provisions on waived and non-waived testing that should be of particular interest to laboratories providing DAT.
Special Report
25 Percent More States Allow Direct
Access Testing
Matthew Schulze
Senior Manager of State and Professional Affairs, ASCP, Washington Office
The number of states allowing direct access testing has increased substantially in the last 2 years. Several states may expand the list of direct access tests due to new legislation or regulation. In states where direct access testing is not permited, services are often available by other means. As laboratories establish their own policies in regard to direct access testing, they should be aware of their state laws.
In the June 1999 edition of Laboratory Medicine [Vol. 30, No. 6], the ASCP Washington Office wrote an article on direct access, or patient authorized, testing. Because of the significant interest expressed by ASCP members, the public, and the press, the ASCP Washington Office has revisited this issue to provide you with additional and updated information on the topic. The accompanying chart [F1] is a compilation of state (plus Puerto Rico and Washington DC) responses gathered during August and September 2001 interviews on direct access testing. As it turns out, there have been some interesting changes since our 1999 article. The re-examination has uncovered that a number of states that previously identified themselves as either not permitting direct access testing or unsure of the legality of such testing, now indicate they allow it. These states include Arkansas, Illinois, Louisiana, Minnesota, Mon- tana, Nebraska, Oklahoma, Puerto Rico, and Washington DC. The ASCP Washington Office's research has determined that
34 states allow direct access testing and 18 prohibit it. This is a substantial change from our 1999 study, which found that 27 states allowed such access. We note that some states are in the process of expanding
to patients direct authority to order laboratory testing services. Beginning in 2002, California will expand its list of di- rect access tests to include all tests that are approved by the federal Food and Drug Administration for over-the-counter sale without a prescription. Currently, California allows direct access testing for glucose, cholesterol, pregnancy, occult blood, and HIV (FDA-approved home-based blood collection kits only). This change came about as a result of the enact- ment of SB 1131, which was introduced by Senator Michael J. Machado (D-Sacramento) and signed into law by Governor Gray Davis on July 18, 2001. Similar legislation is currently being considered in the New York General Assembly.
Only a few of the states allowing direct access testing specify in-state law that patients can obtain laboratory test services without a medical order. Maine, for example, allows direct ac- cess testing for glucose, cholesterol, urine pregnancy, and fecal occult blood. Other states, such as Illinois, Michigan, and New Jersey, allow waived tests to be provided via direct access. However, most of the states allowing direct access testing do so because their law is silent on the issue of whether patients may authorize laboratory testing for themselves.
2014
Now 43 states offer Direct Access Testing