The Final Rule: Freedom for Patients, But How Does it Affect Your Lab Compliance?

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Executive War College 2014
April 29-30, 2014 | New Orleans Sheraton| Save the Date

Lab Compliance and The Final Rule - How Does it Affect Your Lab?

Government mandates are among many operational and compliance changes laboratories face as they move into 2014. One of the most significant mandates, known as the “Final Rule,” allows patients direct accessibility to test results.

*According to the American College of Physicians, this final rule amends the Clinical Laboratory Improvement Amendments (CLIA) of 1988 which previously only allowed physicians and labs to view test information.

Now, the Final Rule grants patients, or representatives of patients, the rights to copies of completed test results directly from laboratories, issued within 30 days of the request. An accompanying physician’s interpretation of the results is not required, but is strongly recommended to avoid unnecessary concerns or reassurances.

This mandate provides patients greater accessibility to their health information, empowering them to make educated decisions about diagnoses, and to take a more active role in managing their health.

The Final Rule specifically affects all CLIA and CLIA-Exempt laboratories covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Exceptions to the rule are limited to specific cases in which a licensed health care provider determines that requesting results access would likely endanger the life or physical safety of the individual requesting the information, or of other persons involved.

Lab Compliance—What Your Lab Needs to Do

As with any operational change, you may have questions about how you can help your lab make the smoothest transition possible:

  • How can labs handle requests? Laboratories are granted flexibility in receiving, authenticating, and processing requests according to their own individual operations.
  • How should labs provide test results? Labs are required to provide an individual with a copy of the requested information in the format requested by the individual, unless otherwise agreed upon between provider and patient.
  • Do labs need to provide interpretation? Results interpretations are not required, but a laboratory may provide educational materials to optimize an individual’s understanding of the reports.
  • Does the final rule pre-empt state laws? The Final Rule pre-empts all state laws, except those that require greater access protocols, such as faster results delivery times, than indicated in the final rule.
  • When does this law take effect? Final Rule full compliance for HIPAA-covered laboratories is required by October 6, 2014.

What The New Lab Compliance Requirement Will Cost

Initially to comply, the rule will cost the laboratory industry ~$59 million per year for the first five years.

However, according to an article by Joseph Conn on Modern Healthcare, entitled “HHS Issues Rule Granting Patients Direct Access to Lab Test Results,” you’ll be able to offset those expenses with “a reasonable, cost-based fee” that you can charge patients for lab result copies.

The Executive War College Conference: A Melding of Great Minds for Great Solutions

Among many other discussions on negotiating current dynamic changes affecting lab and pathology management, all matters of government mandates and lab compliance will be covered at this year’s 19th Annual Executive War College Conference, held April 29–30 at the Sheraton Hotel in New Orleans.

About LabMetrics

LabMetrics is a proud sponsor at this year’s Executive War College.

A premier full-service lab and health information technology consulting firm, LabMetrics supplies innovative technology-based business and clinical solutions to our clients in life sciences industries. A respected leader in the field of lab management consulting, LabMetrics provides a 360° approach to improve laboratory and pathology businesses.

Because LabMetrics’ team of experts stays abreast of the most recent business, compliance, operational, technology and scientific trends in the industry, our customized consulting helps you keep your competitive edge honed for success. Enduring today’s rocky healthcare landscape may seem to be survival of the fittest, but with LabMetrics solutions, we give you the lab management tools to thrive.

Check us out at to see how we can help your lab adapt to the new changes in health care.



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