Summary of States' Policy toward Disclosure
- • Disclosure to Patient
Ten (10) states since 2002 have implemented public policy that mandates disclosure of adverse events / medical errors to the patient and/or family.
By the Tennessee Governor's signature to the Health Data Reporting Act of 2002 on March 19, 2002 . . .(just one day before the MCARE law [PDF] was signed by Pennsylvania's Governor) . . . , the State of Tennessee became the first of ten States through 2005 to require facilities or physicians to notify patients or family of a reported event. In three of these states, policy has been implemented via promulgation of administrative rules. The legislatures in seven (7) other States have passed laws to require notification of patients and/or family of adverse events.
South Carolina implemented regulations for ambulatory surgery centers only (SC Code Regs. 61-91-601(A)), mandating:
"Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence."
Regulations for Maryland were promulgated for hospitals only. Connecticut DPH began on July 1, 2004 to include a separate space within the Adverse Event Reporting Form [PDF] where facilities indicate 1) whether notification of patients and/or the authorized representative occurred, and 2) the date of notification . Since Public Act No. 02-125, §3(e) requires the Commissioner of the DPH to codify an adverse event reporting form and system in regulations, these questions ultimately reflect DPH regulations.
The 7 States passing statutes to implement this public policy include Florida, with separate requirements for hospitals and physicians, Nevada, New Jersey, Oregon, Pennsylvania, Tennessee, and Washington.
Several states have passed ‘Apology’ / ‘I'm sorry’ laws that permit providers to extend apologies to patients and/or family for adverse events and errors without permitting these statements to be used against providers in potential future medical malpractice actions. In this analysis, these VOLUNTARY ‘Apology’ laws are distinct and separate entities from mandatory notification.
- • Morality: The Most Compelling Argument for Disclosure
A Consensus statement of Harvard Hospitals published in March 2006, "When Things Go Wrong: Responding to Adverse Events" [PDF], makes a strong moral argument for disclosure:
"We are making a moral argument here, not a business case or an evidence-based clinical guideline. Where there are published data or empirical evidence to support a practice, we cite them, but our primary justification is moral. We are committed to full disclosure because it is the right thing to do. The patient and family have the right to know what happened. In addition, honest communication promotes trust between the patient and provider, so that the primary focus of the clinician-patient relationship remains patient care. Further, open discussion about errors can promote patient safety by encouraging clinicians to seek systems improvements that minimize the likelihood of recurrence."
The consensus statement also refines the definition of "disclosure:"
"Disclosure: Providing information to a patient and/or family about an incident. Because this term suggests revealing of privileged information and implies an element of choice, in this document we use instead the term communication, by which we wish to convey a sense of openness and reciprocity"
It is highly likely that most providers believe their health care is guided by strong moral values, and it is fruitless to assume that changes in individual behavior addressing disclosure will result from health policy decrees similar to the 10 states enumerated above. Consequently, it is incumbent upon institutions to implement significant institutional requirements that facilitate the management and communications with patients surrounding adverse events. The Harvard consensus document clearly identifies the key and central role of the clinician / physician in disclosure of adverse events to patients, and it identifies opportunities for improvement and a framework for assuring that disclosure is guided by a moral compass. These changes are consistent with positions advocated by several professional physician societies, and they emphasize the need to integrate clinicians into institutional protocols.