Beyond a Legislative Disconnect

In the first of several articles, Group Editor Marty Kauchak reviews efforts to improve the US healthcare community’s performance in patient safety.

As many as 400,000 people a year die from preventable medical errors in hospitals.

This July 17, the US Senate’s Health, Education, Labor and Pensions (HELP) Committee’s Subcommittee on Primary Health and Aging conducted a hearing on Patient Safety and Medical Errors entitled “More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety.” The event was touted by the committee’s media team and others inside the Washington, DC Beltway as another opportunity to allow patient safety to move to the policy forefront. And with good reason! As subcommittee chairman, Bernard Sanders of Vermont, reminded the hearing’s attendees during his opening remarks, it is time to “start focusing attention on the third leading cause of death in the United States of America and that will come as the great surprise. The third leading cause of death in this country has to do with preventable medical errors in hospitals.” Emphasizing one estimate that as many as 400,000 people a year may die from preventable medical errors in hospitals, “that could be more than a thousand a day. Tens of thousands also died from preventable mistakes outside the hospital such as that from misdiagnoses or injuries with medication,” he added for effect.

Sanders, who is acclaimed on both sides of the political aisle and on both sides of Capitol Hill as a proponent for patient safety, undoubtedly deserved better in this most recent effort to elevate the topic on the legislative agenda in a bitterly divided Congress. Indeed, of 14 subcommittee members, Sanders was joined by two other Senate colleagues, Elizabeth Warren of Massachusetts and Sheldon Whitehouse of Rhode Island at the approximate one hour and thirty seven minute hearing.

Left unresolved after this important hearing was a suggested legislative roadmap to address a long menu of issues to include: what is the role, if any, of the federal government in reducing the nation’s patient safety rate, and what legislation may be required to improve the community’s performance in this space?

Other members of congress and their staffs with oversight on patient safety were conspicuously absent in this watershed moment on Capitol Hill.

The offices of five HELP subcommittee members who did not attend the hearing: Alexander; Baldwin; Enzi; Harkin; and Kirk did not return this author’s requests by email and telephone messages for interviews for this article. Similarly, the HELP committee’s counterpart office in the US House of Representatives, the Committee on Ways and Means, declined to respond to similar contact efforts, for the committee leadership and staff members.

Advocate Organizations’ Perspectives

While there does not appear to be significant interest on Capitol Hill to allow patient safety to gain traction as a legislative issue until the new Congress is seated this January, other stakeholders continue their efforts to keep patient safety alive as a policy issue.

One insight on patient safety provided at the July 17 hearing was from John James, PhD, the founder of Patient Safety America (patientsafetyamerica. com). The Houston, Texas-based organization seeks to inform primarily non-medical people about the need for vast improvements in patient safety. James told MEdSim on October 7 “I do this by sending a monthly newsletter to about 500 people. The newsletter includes book reviews and summaries of pertinent articles from major medical journals. I also represent the organization through invited talks and publication of studies and books. For example, I have co-edited a book called The Truth about Big Medicine - Righting the Wrongs for Better Health Care. This book is due out in December. At specific times I ask those on distribution to support legislation or a cause that seeks to improve patient safety.”

Another major community actor in the efforts to reduce accidents and mistakes in safety care is the National Patient Safety Foundation (www.npsf.org). The foundation is focusing heavily on encouraging advancements in patient engagement and transparency.

A report published by the NPSF Lucian Leape Institute earlier this year included recommendations for health care policy makers to improve patient and family engagement. (See the Executive Summary.) “Early next year [2015], the Institute will publish a report on transparency, meaning the open exchange of information at all levels: among staff, between caregivers and patients, among institutions, and in clear public reporting that is useful to the lay public and meaningful to incite further improvement,” said Tejal K. Gandhi, MD, MPH, CPPS, president of NPSF and of the Institute.

NPSF’s expanding role of leadership in this policy arena was further advanced this January, when the foundation developed a three-year strategic plan, with one of the goals being to help guide health care leaders and policy makers to advance patient safety in the evolving market. Thus far, however, most of the work NPSF is currently involved in or supporting at the federal level is not necessarily legislative, but rather providing feedback on initiatives coming out of federal agencies such as the Centers for Medicare and Medicaid Services (CMS), the FDA, the Office of the National Coordinator for Health Information Technology (ONC) and others.

Another affirmation of NPSF’s presence as a community leader is Dr. Gandhi’s participation as a member of the ONC’s Health IT Policy Committee Safety Task Force. This group is working to respond to the FDASIA Health IT report and provide recommendations around the formation, structure, and governance of a Health IT Safety Center. This is a joint initiative between the FDA, the ONC, and the FCC.

Any uncertainly about a role for the federal government in improving US patient safety was set aside by James who asserted the federal government has a critical role in forcing change for better patient safety, but it has to start getting things “right”. “The latest example is of the website where patients in principle can learn about the payments of drug companies to specific doctors. The website is awful to try to use. The Centers for Medicare and Medicaid Services could force some improvements. For example, they could declare that all hospitals that want to continue to receive funds from CMS shall adopt a performance review system like 360-degree assessments of all professionals. This had been started at the federal agency from which I just retired and it has been used for a decade in hospitals in Alberta, Canada.” James further noted the approach is that each professional is assessed by patients, subordinates, colleagues, and staff heads using anonymous surveys. “Studies show that these do not have to be onerous. CMS could also demand job-satisfaction assessments of hospital staff,” he suggested and continued, “These would be made publicly available and associated with specific hospitals. If you had a choice, would you seek treatment at a hospital where 20% of the staff are happy with their job, or one where 85% are happy? This would provide strong leverage for hospital administrators to make positive changes.”

For its part the NPSF sees patient safety issues incrementally entering the public policy arena. In one instance the patient safety community is still seeing results from the Patient Protection and Quality Improvement Act of 2005, which established Patient Safety Organizations. PSOs collect, aggregate, and analyze confidential information reported by health care providers, with the goal being to share and learn from others, without fear of discovery.

But most significant is the Affordable Care Act (ACA), passed by Congress and then signed into law by President Obama on March 23, 2010. Under ACA a variety of patient-safety-related requirements and initiatives are coming into play. In one instance value-base purchasing, which began in October 2012, ties Medicare payments to hospitals’ performance in a number of process of care and patient experience measures.

At the annual NPSF Patient Safety Congress in May 2014, a full-day session looked at the challenge of keeping quality and safety on the agenda when health systems are being challenged to reduce the costs of care.

“A big concern of the participants was the need for better metrics to measure and monitor safety across systems and over time, to ensure that organizations are interpreting and reporting the same events in the same way,” Dr. Gandhi said.

In her transcript for this July’s Senate Subcommittee hearing, NPSF president Dr. Gandhi continued to open the aperture on patient safety – by emphasizing patients’ vulnerability during transitions in care. “These transitions occur all the time in health care - hospital to home, nursing home to emergency department, rehabilitation center to visiting nurse. Transitions are high‐risk times, when key pieces of information (such as medication changes, pending test results, additional workups that need to happen) can be lost. For example, one study found that after hospital discharge, within three to five days, one‐third of patients were taking their medications differently than how they were prescribed at discharge” she said.

As any opportunity to advance safety through new legislation in this session of Congress appears to be a non-starter, Patient Safety America’s James, a self-described patient activist, offered several ideas for the new Congress. “Given the inordinate complexity of the health insurance industry, I favor a well-run, single payer system. I know there is a lot of distrust of the federal government running anything. People I know are highly frustrated with the hodge-podge of insurance options. I think that once all are in the same system, there will be more push for improving safety.”

James further suggested that opening up the National Practitioner Data Bank to the public would foster transparency into the possibility that doctors may be unsafe. “A national patient bill of rights like those enjoyed by workers and minorities would help level the playing field between patients and the medical industry. It should be enforced by the Justice Department. A National Patient Safety Monitoring Board, patterned somewhat like the National Transportation Safety Board would also help improve patient safety,” he added.