IOM Calls for Better Collaboration to Fight Diagnostic Error

Physicians, nurses, laboratory medicine professionals, and others in the healthcare system must do a better job working as a team to avoid errors in diagnosis, a poorly understood problem that contributes to 10% of patient deaths, according to a report from the Institute of Medicine (IOM), part of the National Academy of Sciences. The report, Improving Diagnosis in Healthcare, is a continuation of the IOM’s Quality Chasm Series, which includes the landmark To Err Is Human: Building a Safer Health System, released in 2000.

According to the new report, efforts to improve diagnosis and reduce diagnostic errors have been limited, and more research is needed to understand it. The IOM also called for more enhanced training for healthcare professionals; more emphasis on identifying and learning from diagnostic errors and near misses in clinical practice; and a payment and care delivery environment that supports the diagnostic process.

“AACC strongly supports initiatives to improve patient care by reducing diagnostic errors and the cost, suffering, and loss of life that stems from these errors. We fully agree with the National Academies that taking a team approach to the diagnostic process is central to accomplishing this goal, and laboratory medicine professionals will be a key player on any successful team,” said AACC President David Koch, PhD. “Laboratory medicine professionals hold a wealth of knowledge on clinical tests and, if involved more in day-to-day clinical consulting, can provide vital insight to help physicians find better, faster, and more precise answers to challenging patient health problems.”

Proposal Would Update Rules on Research Study Participants

The Department of Health and Human Services (HHS) is proposing revised regulations that govern research involving human subjects. The current regulations, in place since 1991, are referred to as the Common Rule.

The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and other advances in technology, created the need to update the regulatory framework, according to HHS.

The proposed changes include: strengthened informed consent provisions; requirements for administrative or institutional review boards (IRB) that would align better with the particular risks of research; tighter data security and information protection standards; requirements for written consent for use of a person’s biological samples for research, with the option to consent to their future use for unspecified studies; and the requirement, in most cases, to use a single IRB for multisite research studies.

The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from one of 18 federal agencies that follow the Common Rule. HHS will take public comment on the proposal through December 4.

Proposed Affordable Care Act Rules Protect Against Discrimination in Healthcare

A proposed rule from the Department of Health and Human Services (HHS) aims to reduce disparities in healthcare by expanding the scope of civil rights protections that ensure equal access to healthcare services. Previously, civil rights laws enforced by HHS only barred discrimination based on race, color, national origin, disability, or age.

The proposed rule establishes that the prohibition on sex discrimination includes discrimination based on ­gender identity, and it sets new requirements for effective communication with individuals who have disabilities, as well as language assistance for people with limited English proficiency. The proposed rule also states HHS’s commitment to preventing discrimination based on sexual orientation.

The rules would apply to Health Insurance Marketplaces, any health program that HHS itself administers, and any health program or activity that receives federal funding, such as hospitals that accept Medicare patients. HHS has more information about the rule on its Office for Civil Rights website,