November / December 2005
Consumers as Partners
Including Consumers as Reporters to Learning Systems
Enactment of the long-awaited Patient Safety and Quality Improvement Act raises a question we hate to have to ask: Why were patients left out? Signed on July 29, 2005, the new law establishes a federally protected safe harbour for preventing discovery in malpractice litigation of voluntary reports of medical error to Patient Safety Organizations (PSOs). Reports can be made by physicians, hospitals, and other healthcare professionals and entities. PSOs, in turn, would analyze the data to develop patient safety improvement strategies. The fact that consumers may also be the source of information useful to PSOs apparently was not appreciated.
Sadly, the new law reflects a stale paradigm where patients and the public continue to be perceived more as adversaries than as partners in producing optimal treatment results. We understand the goal of increasing the volume of adverse event and near miss reports and appreciate on one level that the public benefits from increased reporting. Yet as co-founders of Consumers Advancing Patient Safety, an organization dedicated to furthering constructive partnerships between all interested stakeholders, we lament the continuing fear-based need for such protection. And, we have difficulty reconciling it with the fundamental goals of encouraging general system transparency and full disclosure to patients when medical errors do cause harm.
We accept, however, that not all movements forward in patient safety are transformational in scope. Sometimes they are incremental, and the most productive course is to identify the next step we can take. With that in mind, we ask those who share our vision for a health system safe for all people to work with us to support the inclusion of consumers as reporters to PSOs. Join us also in advocating that reporting/learning systems implemented internally by healthcare organizations (HCOs) to feed their improvement work extend the opportunity to report to patients and their lay caregivers.
The United Kingdom, Australia, and other nations emerging as leaders in patient safety implementation have recognized that consumer engagement in reporting incidents associated with their own care or a loved one's can bring otherwise unidentified issues and factors to bear on an HCO's ability to understand what the holes in its safety nets are, identify root causes, and mitigate harm (Sheridan, 2005; ACSQHC, 2004; NPSA, 2003). For example, patients may experience injuries that do not manifest until after discharge from an HCO and therefore are not readily captured as reportable incidents. Patients and lay carers who coordinate care may be better positioned than anyone else to identify risks and gaps between providers across the continuum of care, e.g. between clinic and hospital or hospital and pharmacy. They may also witness incidents such as falls that multitasking healthcare workers just miss. Patients and their lay carers may also serve a reminding function to clinicians who work in the same environment day to day and see risk associated behaviour so routinely poor hand hygiene for example that it becomes "normalized" and, therefore, not appreciated as significant enough to report.
In a remarkable exercise of leadership and discernment, the Australian Council for Safety and Quality in Health Care (ACSQHC) has recognized that consumer reports often manifest as complaints. In 2004 it published better practice guidelines to assist providers in looking past the initial unpleasantness of a complaint to "harness the experiences of patients and their carers to drive improvement." As the guidelines explain:
Consumers (including patients and carers) have a unique expertise in relation to their own health and their perspective on how care is actually provided. Consumer complaints are therefore a unique source of information for health care services on how or why adverse events occur and how to prevent them. As well as reducing future harm to patients, better management of complaints should restore trust and reduce risk of litigation, through open communication and a commitment to learn from the problem and prevent its recurrence. (ACSQHC 2004)
Consumer reporting also can play a significant role in the national, regional, or system-wide learning systems facilitated by the PSO legislation. It is well understood that incidents and near misses are now grossly under-reported by providers to external data collection sources (Devers, 2004; Lamb, 2003; Pinkus, 2000). While the Patient Safety and Quality Improvement Act pre-empts some of the state-based legal barriers that chill provider willingness, fear of reporting entrenched in cultures and psyches of providers may still be a discouraging factor. In contrast, consumer reporting faces no such legal or fear-based obstacles. Patients and families who have experienced a medical error report a high desire to see remedial action taken to prevent future harm to others (Gallagher, 2003; Hickson, 1992; Hingorani, 1999; Vincent, 1994). In a recent Swiss study, 94% of patients filling out a hospital experience survey completed an added section on safety concerns and 51% reported an undesirable event (Agoritsas, 2005). If reporting pathways were established and made known to the public, it is reasonable to infer that consumer reports of adverse events and near misses would materialize. They would have to be culled and shaped, of course, but every new reporting initiative faces "priming the pump" work of explaining what is needed and most useful to potential reporting constituencies.
In addition, including consumers in both PSO and internal HCO reporting programs can further the patient safety movement's culture change objectives that currently seem so distant. The very existence of a reporting pathway would help establish a shared mental model with the public that ensuring safety is a continuous challenge for all patient safety stakeholders, consumers included. As in other steps forward toward transparency, it is reasonable to infer that once consumers are engaged in understanding the importance of reporting, their trust in organizations that include them as reporters will increase.
Of course, all of these arguments reflect gaps in existing research. Additional research agenda questions, among others, include (1) whether patients and families actively engaged in reporting systems contribute to achieving better treatment outcomes for themselves or others; (2) whether increased consumer reporting impacts the frequency of litigation or compensation claims; (3) whether consumers have different needs, e.g. the need to report in a narrative format, than providers that must be assessed in actively engaging them; and (4) whether consumers need feedback from a learning/reporting system in order to sustain their interest in contributing to it.
The Australian guidelines were a prelude to a broadly visionary National Patient Safety Education Framework issued by the Council earlier this year, as the foundation of an effort to re-educate every Australian healthcare worker on the basic tenets of transparency, systems-based improvement, and patient-centered care. (ACSQHC, 2005). As coincidence would have it, this education framework was accepted and approved by the Australian health ministers on July 29, 2005 the same day the Patient Safety and Quality Improvement Act was signed into law in the United States. The contrast is striking: Whereas American public policy continues to be driven by provider fear of litigation, Australian government is promoting a real shift in worldview via systemic re-education and increased consumer participation in safety work. By turning our attention to including consumer feedback to our reporting and learning systems, we will take positive steps in the same direction in the United States.
Susan E. Sheridan's introduction to safety issues and her motivation to make a difference came through grave medical errors, which led to her son's permanent disability from untreated newborn jaundice, known as kernicterus, in 1995 and her husband's death in 2002 from failure to communicate a diagnosis of cancer. She is co-founder of Parents of Infants and Children with Kernicterus (PICK), a nonprofit devoted to preventing kernicterus and realizing the full potential of people who have it, and co-founder of Consumers Advancing Patient Safety (CAPS), a 501(c)(3) organization dedicated to fostering the role of consumer as proactive partner. She also chairs the Patients for Patient Safety track of the World Alliance for Patient Safety, launched by the World Health Organization (WHO) in 2004. Sheridan is a member of PSQH's Editorial Advisory Board and may be contacted at email@example.com.
Martin J. Hatlie (firstname.lastname@example.org) is president of Partnership for Patient Safety (p4ps), a patient-centered initiative dedicated to advancing the reliability of healthcare systems worldwide, and co-editor of The Patient Safety Handbook (Jones & Bartlett 2003). Previously, Hatlie was a lobbyist for the American Medical Association (AMA) focusing on tort reform. In 1997, he coordinated the AMA's launch of the National Patient Safety Foundation and served as its founding executive director, and in 2003, Hatlie co-founded CAPS. He currently serves on the Sentinel Event Advisory Group of the Joint Commission on Accreditation of Healthcare Organizations and the Advisory Board of Parents of Infants and Children with Kernicterus. Formerly, he has served on the governing boards of the Anesthesia Patient Safety Foundation and the American Tort Reform Association. Hatlie is a member of PSQH's Editorial Advisory Board.
Agoritsas,T., Bovier, P.A., Perneger, T.V. (2005), Patient reports of undesirable events during hospitalization, Journal of General Internal Medicine 20(10), 922-928.
Australian Council for Safety and Quality in Health Care, Better Practice Guidelines on Complaints Management for Health Care Services (2004), accessed September 11, 2005, at www.safetyandquality.org/articles/Action/complaintfact.pdf
Australian Council for Safety and Quality in Health Care, National Patient Safety Education Framework (2005), accessed September 11, 2005, at www.safetyandquality.org/framework0705.pdf
Devers, K, J., Pham, H. H., & Liu, G., (2004). What is driving hospitals' patient-safety efforts. Health Affairs 23(2), 103-115.
Gallagher, T. H., Waterman, A. D., Ebers, A. G., Frasier, V. J., & Levinson, W., (2003). Patients and physicians attitudes regarding the disclosure of medical errors, Journal of the American Medical Association 289, 8,: 1001-1007.
Hickson, G. B., (1992). Factors that prompted families to file medical malpractice claims following perinatal injuries. Journal of the American Medical Association 267, (10),: 1359-1363.
Hingorani, M., Wong, T., & Vafidis, G., (1999). Patients' and doctors' attitudes to amount of information given after unintended injury during treatment: Cross-sectional questionnaire survey, British Medical Journal 318, 640-641.
Lamb, R., (2003). Hospital disclosure practices: results of a national survey, Health Affairs 2003, 22,(2):, 73-83.
National Patient Safety Agency, Overview of patient involvement activities within NPSA's work: Report to the Board by Peter Mansell, NPSA, December 2004.
Patient Safety and Quality Improvement Act of 2005, Public Law 109-41, 109th Congress of the United States.
Pinkus, R., (2000). Learning to keep a cautious tongue: the reporting of mistakes in neurosurgery, 1890 to 1930, in Zoloth L, (eEd.), Margin of error: The ethics of mistakes in the practice of medicine. Hagerstown, MD:, University Publishing Group, 2000.
Sheridan, S. E., & Hatlie, M. J., (2005). Measured impatience. Patient Safety & Quality Healthcare 2(1), 8-11.
Vincent, C. A., Young, M., & Phillips, A., (1994). Why do people sue doctors? Lancet 343, 1609-1613.