New Rule Proposes to Put Lab Reports Directly in Hands of Patients

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October 7, 2011

A new rule proposed by the U.S. Department of Heath and Human Services (HHS) may soon give patients direct access to their laboratory results.

HHS Secretary Kathleen Sebelius announced the proposal at the first HHS Consumer Health Information Technology (IT) Summit on September 12. Allowing patients to obtain their test results directly from the laboratory is part of a larger movement towards expanding the use of health information technology. The reforms are intended to empower patients, coordinate better care, and improve health care quality.

The rule was proposed by the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Office for Civil Rights (OCR), all within the HHS. The rule would amend regulations that oversee laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule by removing exceptions that restrict patients from accessing their laboratory test results.

Under the proposed rule, all patients or their representatives will be able to directly access their laboratory tests after having their identities verified, regardless of state restrictions. Currently, many states require patients to go through their health care provider to receive their test results or for permission to receive them from laboratories, as do current federal regulations.

The proposed rule is open for comment 60 days after its publication in the Federal Register. A final rule is due to be published later this year, after consideration of comments received.

The rule is intended to allow patients to take a more active role in their health care decisions. According to a 2009 study from the Archives of Internal Medicine, up to 7% of abnormal test results are not shared with patients. HHS believes that test result access will enable patients to monitor their own results and ask the right questions of their doctors, and will provide greater assurance that an abnormal result is not overlooked. The rule encourages patients to act as partners with their health care providers, rather than passive health care consumers. Studies have shown that greater availability and understanding of personal medical information such as laboratory results can promote buy-in from patients in following treatment protocols and making the healthy choices recommended by their doctors.

More ready access to test results, however, places patients in a position of greater responsibility. Patients may encounter complex test results and will need to recognize that there is a context in which providers use results to make treatment decisions. This may require that patients educate themselves about their tests in order to understand why certain tests were ordered and the references intervals used in laboratory results. (See the article Reference Ranges and What They Mean) The availability of Lab Tests Online and other credible health information online can assist those looking for a better understanding of their medical information. Patients should still look to their doctors as the ultimate informed partner for understanding test results and providing treatment options.

The new HHS rule is part of a general drive towards using health information technology to improve patient care. Electronic health care databases will simplify information transfer between patients and their primary care doctors and specialists, improving coordinated care and reducing redundancies in medical tests and procedures. Providing laboratory tests directly to patients is one step in the cycle of information access, enhancing doctor and patient dialogue to improve medical care.

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

Casalino LP, et al. Frequency of failure to inform patients of clinically significant outpatient test results. Archives Intern Med 2009; 169 (12). Available online at http://archinte.ama-assn.org/cgi/content/full/169/12/1123 through http://archinte.ama-assn.org/. Accessed September 2011. 

U.S. Department of Health and Human Services (September 12, 2011). Secretary Sebelius spotlights new efforts to empower patients to increase secure access to their health information. Available online at http://www.hhs.gov/news/press/2011pres/09/20110912a.html through http://www.hhs.gov. Accessed October 1, 2011.

Centers for Medicare and Medicaid Services (September 12, 2011). HHS proposes broad patients rights to access clinical laboratory test result reports. Accessed online through https://www.cms.gov/. Accessed September 2011.