Why & When Clinical Quality Improvement Does Not Require IRB

By Kevin D. Jackson

 

When it comes to improving patient care, doctors, hospitals, and medical device companies want to be involved. After all, positive patient outcomes are what the healthcare industry strives for. Many understand that utilizing Clinical Quality Improvement (CQI) can lead to meaningful and positive changes in the healthcare setting, but the process seems complicated, and given the bureaucracy involved with the Institutional Review Board (IRB), it oftentimes doesn’t seem worth the hassle.

But there is no hassle. When implementing CQI projects and analysis, no IRB is required, and the process is federally regulated. Also, patient consent is not required. Here’s how it works.

What Is CQI?

At its core, Clinical Quality Improvement (CQI) is the process of examining data regarding medical practices and procedures and using that data to find new, innovative ways to improve the process and healthcare. The ultimate goal is to improve the quality of patient care and outcomes, including safety, satisfaction, and profitability, through a systematic review of objective criteria.

The Institute of Medicine “defines quality in health care as a direct correlation between the level of improved health services and the desired health outcomes of individuals and populations” [1]. That’s precisely what CQI sets out to do. By utilizing data about real patient care, CQI can:

• Improve patient satisfaction
• Increase medical efficiency
• Decrease risks
• Decrease costs
• Create fewer complications

Are There Differences Between CQI & Research?

Research is a systematic scientific investigation in which a researcher either observes or intervenes with the subjects and records the results. In research, there is typically some sort of patient risk involved, and there is always a control group that provides a baseline to compare the intervention.

Although CQI is similar, it is intrinsically different. In CQI, the medical procedure, medication, or device is already established in the healthcare industry, so there is no risk to the patient. CQIs involve looking at treatments the FDA has approved and regulated and trying to find ways to make those treatments more efficient. And unlike research studies, no one is excluded. Although this makes some data locally varied and less generalizable than traditional research, it is based on real-world outcomes and accurately represents the full cycle of care, making it available for immediate application.

Why Is CQI Needed?

Healthcare, as we know, is a complex system. But it can be broken into basic pieces and interactions. It is at this level that CQI works. Focusing on one aspect of the system at a time and examining it in detail provides usable data that helps improve efficiency and the healthcare system overall.

CQI Benefits for Medical Providers

CQI offers a range of benefits to medical providers. For example, it creates a teamwork environment by involving each person in the evaluation process and the improvement of the work environment. It creates a single goal—the improvement of the quality of care—that the entire team is united to reach.

CQI projects increase the effectiveness of both procedures and staff, improve patient satisfaction, maximize health outcomes, and minimize resource utilization, saving both money and time. It also allows doctors, hospitals, and other healthcare providers the flexibility to meet the demands of today’s medical world while preparing for tomorrow’s.

CQI Benefits for Medical Device Companies

By utilizing objective CQI data and analysis, common medical device errors are addressed and reduced, making CQI beneficial for medical device companies. This data can also be used while adapting and developing products and procedures.

Beyond better product usage and development, CQIs give medical device companies an evidence-based approach to compare their own devices and procedures with their competitors’ devices and procedures. When CQI data shows unbiased benefits, it takes the focus off of price and redirects it toward efficiency – i.e., “Which device is cheaper?” becomes “Which one works better?” This benefits the company in both profit and reputation, increases doctors’ trust in the device, and improves patients’ satisfaction and outcome.

CQI Benefits for Patients

Patient benefit is perhaps the most important aspect and the fundamental purpose of CQI. When the healthcare industry improves, patients’ healthcare improves. They receive better care faster, and medical care becomes more efficient and more affordable.

Where Does CQI Come From?

Humans have engaged in quality improvement since we began inventing things, but the concept of CQI didn’t arise until relatively recently.

The American Industrial Era

During the industrial era, companies were determined to shorten the time and lower the cost of making products without having to sacrifice quality. In the mid-1920s, Walter A. Shewhart, W. Edwards Deming, and Joseph M. Juran, set into motion what eventually became known as the science of quality improvement.

Desiring to find a way to increase the efficiency of American industries, these men set out to streamline the production process. By breaking down information, using that data to make decisions, and asking employees to commit to improve work practices, they were able to reduce human error, increase standardization, and make efficiency an achievable industry goal.

Quality Improvement in Healthcare

Soon, the idea of quality improvement began to spread beyond the manufacturing industries. In 1951, the beginnings of CQI were initiated when the American College of Surgeons, the American College of Physicians, the American Hospital Association, the American Medical Association, and the Canadian Medical Association joined forces to establish the Joint Commission on Accreditation of Hospitals, a not-for-profit organization that provides voluntary accreditation to hospitals and, now, other healthcare facilities and institutions.

In 1988, the National Committee for Quality Assurance started to focus on health plans, and in 1993, it published its first Health Plan Report Card, introducing quality assurance to the public.

Peter Pronovost and IRB

In the December 2006 edition of the New England Journal of Medicine, Peter Pronovost reported a study in which he and a group of Michigan-based physicians reduced bloodstream infections in ICU patients, saving an estimated 1,500 lives and the Michigan healthcare system nearly $200 million. An intensive care specialist at Johns Hopkins Hospital and a professor at Johns Hopkins University School of Medicine, Pronovost and his team introduced a five-step intensive care checklist for doctors administering IV catheters. The checklist, which included washing hands with soap and using sterile drapes, was administered in the majority of Michigan ICUs and data was obtained from 103 hospitals [2].

Although Pronovost should have been congratulated for decreasing infection rates by two-thirds in only three months, he was chastised for neglecting to submit to the local IRB and was brought before the Office for Human Research Protections (OHRP). The OHRP stated that Pronovost’s project must be halted until he obtained approval from each hospital’s IRB and consent from each patient.

Atul Gawande to the Rescue

Physician Atul Gawande expressed his discontent with the OHRP, which seemed to be doing the opposite of protecting, in a New York Times op-ed. In this article, Gawande stated that Pronovost’s work “has already saved more lives than that of any laboratory scientist in the past decade”[3]. Gawande explained that there was no need to gain patient consent since no identifying information was used in the study and that, due to the need for approval from every local IRB, many hospitals would have opted out of the CQI.

After deliberation and a push from the medical community, the OHRP backed down, and Pronovost was able to continue implementing his checklists in ICUs. In 2008, he was named one of the 100 most influential people in the world by Time magazine.

Now, neither the U.S. Department of Health and Human Services (HHS) nor the Agency for Healthcare Research and Quality (AHRQ) require an IRB submission or approval.

Why Doesn’t CQI Need IRB?

According to the Institute of Medicine (IOM), an IRB is not required when: [4]

• The data collection is part of actual patient care, and there is no increased risk to the patient;
• All equipment, devices, techniques, or procedures are FDA approved, post market, and evidence-based;
• Data analysis is primarily for CQI;
• Patients are included in the decision process (per the IOM’s recommendation); and
• Secondary goals only consist of selling or sharing the data results with other medical professionals.

CQI Is Not Research

CQI data collection involves gathering raw data, not information about specific individuals. This means the data is absent of all identifying information. Therefore, by definition, CQI is not considered research on a human subject. According to the Department of Heath and Human Services:

Whether or not [CQI] activities are research, they do not involve ‘human subjects.’ The regulation defines a ‘human subject’ as ‘a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information… Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects” [5].

CQI Was Intended by HIPAA

To some, it may seem like CQI tries to avoid regulations and perhaps even violate best practices concerning privacy and patient confidentiality, but that is not the case. These issues have been addressed in current federal healthcare policies. For instance, Health Insurance Portability and Accountability Act of 1996 (HIPAA) states: “The Privacy Rule permits a covered entity to use and disclose protected health information, with certain limits and protections, for treatment, payment, and health care operations activities” [6]. The HIPAA document goes on to explain where CQI fits into the privacy act: “‘Heath care operations’ are certain administrative, financial, legal, and quality improvement activities of a covered entity that are necessary to run its business and to support the core functions of treatment and payment.” It also defines these operations, noting the following: “Conducting quality assessments and improvement activities, population-based activities relating to improving health or reducing health care costs, and case management and care coordination.”

Patient Consent Is Not Needed

The Department of Health and Human Services explains that even though CQI is typically not considered research, it sometimes fits the requirements. Even when that happens, IRB submission and patient consent aren’t needed. HHS regulations protecting human subjects allow an IRB to waive the requirements for obtaining informed consent of the subjects of the research when: [7]

(a) the risk to the subjects is minimal;

(b) subjects’ rights and welfare will not be adversely affected by the waiver;

(c) conducting the research without the waiver is not practicable; and

(d) if appropriate, subjects are provided with additional pertinent information after their participation.

Analyzing Data

Even though CQI data is analyzed, it still does not need IRB approval. Some may argue that because it is not official research, the data is not appropriate for analysis. But this is not the case. Although data collected through CQI is non-identifiable to individuals, it is still solid healthcare data collected by medical professionals.

Publishing

Even if the intent behind CQI data collection and implementation is to publish the results, it is still not considered research. Research, according to the Department of Health and Human Services is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” [8]. Since people publish all types of medical- and healthcare-related documents that are not research, publication or the intent to publish, neither changes nor challenges the need for IRB submission and approval.

Clinical Insights for Optimal Outcomes

At Qualitee 360, LLC, we understand the intricacies of CQI and use evidence-based approaches to help determine best practices when it comes to people, processes, products, and devices. If your practice, institution, or company would like to learn more about how CQI can improve your healthcare outcomes, contact us today at www.qualitee360.com or by calling (877) 905-Q360 or (877) 905-7360.

References:

[1] U.S. Department of Health and Human Services, Quality Improvement Methodology

[2] New England Journal Med (2007 June 21). An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU. 356 (25): 2660.

[3] Gawande, Atul. A Lifesaving Checklist. New York Times. 2007 June 30.

[4] The Institute of Medicine (US) Roundtable on Evidence-Based Medicine. The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary. Eds. Yong PL, Saunders RS, Olsen LA.

[5] Department of Health and Human Services. FAQ.

[6] U.S. Department of Health & Human Services. The Health Insurance Portability and Accountability Act of 1996.

[7] Department of Health and Human Services. FAQ.

[8] Department of Health and Human Services. FAQ.