According to the American Clinical Laboratory Assn., lab results influence more than 70% of clinical decisions. Putting those results in electronic health records (EHRs) will clearly enrich the data available for physicians, hospitals, health plans and patients. This enriched data enhances the value of EHRs for treatment, quality improvement, disease management and wellness.
But the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the state laws implementing CLIA pose barriers to clinical labs providing that data for EHRs. Those barriers are not often discussed but are a legal challenge to populating EHRs with results from clinical labs.
CLIA is a federal law that regulates the operations of clinical labs. Among other things, CLIA limits to whom a clinical lab may release the results of tests. An "authorized person" is one permitted recipient of those results. CLIA defines an authorized person as an "individual authorized under state law to order tests or receive test results, or both."
States vary in defining who is an authorized person. Many define an authorized person as the clinician ordering the lab test. Others take no position, defaulting to CLIA. A clinical lab regulated by such a silent state may release lab results only to those whom the state's statutes or regulations allow to order lab tests or receive lab results.
That means a variety of state laws in silent states must be reviewed to determine who is permitted to receive results from clinical labs. For example, physicians order lab tests, so under a silent state's medical practice act, physicians in that state would thus qualify under CLIA to receive results from a clinical lab.
Some states allow clinical labs to release results to patients, but most don't. In fact, several states expressly prohibit clinical labs from releasing results to patients. This contrasts with most other laws that regulate health information disclosure. Those laws, like the HIPAA Privacy Rule, give patients near absolute right to their health information.
Under the CLIA scheme then, clinical labs usually cannot release the results of tests for EHRs, except as directed by the ordering clinician or other authorized person. That constrains the ability of non-ordering clinicians, institutional providers, health plans, patients and others to receive lab results to populate EHRs.
The CLIA laws only regulate clinical labs, so they are not a barrier to all who hold lab results. If a non-ordering clinician, institutional provider, health plan or other non-lab party already has the lab results, CLIA and its state implementing laws do not regulate their releasing the results to populate EHRs.
Tennessee took legislative action in 2007 to ease the CLIA barrier by permitting clinical labs to release results to entities that assist providers, payers or patients in creating EHRs. The laws do not need to pose a continuing barrier.
It remains unclear what happens next for CLIA—whether other states will follow Tennessee's lead or whether the Department of Health and Human Services (HHS) will revisit CLIA and its implications for putting lab results in EHRs. HHS revision of the CLIA regulations is the way to go if the federal government is serious about promoting robust, effective EHRs.
Kathryn A. Roe is a partner in the Health Law Practice Group at Neal, Gerber & Eisenberg LLP.