This bill is based on four principles that describe rights and responsibilities. The numbered references within the text refer to the literature cited near the bottom of the page.
1) Patients have the right to know about unanticipated outcomes of their care and harmful medical errors that have occurred during their care.
Patients expect to be informed of errors that occur during their care. (1, 2) The organizations and individuals who deliver health care have an obligation to recognize the dignity of their patients and to act in the best interest of their patents. Many professional healthcare societies have stated in their codes of ethics that their members have a duty to treat patients with honesty and integrity. (3, 4, 5) But this obligation to inform patients of all aspects of their care has more than just an ethical basis: “Courts have found that patient provider relationships are fiduciary in nature and that providers are therefore required to disclose all pertinent information to patients. Courts have also found that the failure to disclose is tantamount to fraud and fraudulent concealment…”(6)
This bill requires that patients be informed of unanticipated outcomes and harmful medical errors that occur during their care. Transparency is an essential component of high-quality healthcare, but too often institutional, personal factors act against disclosure of information. This bill will establish unambiguously that the responsibility to the patient supersedes all other factors when an issue of disclosure arises.
The content of the disclosure required by this bill (Sections 3(c), 3(i)) reflects the best-practice recommendations by Mastroianni et al. (7).
2) Healthcare workers and administrators of healthcare institutions have the responsibility to have timely and authentic conversations with patients (and their families or representative, as appropriate) about unanticipated outcomes and medical errors.
The bill as currently drafted allows up to seven days from the time an unanticipated outcome or medical error is discovered until it is disclosed (Section 3(i)). The survey by Mastroianni et al. (7) found timeframes for disclosure in other states ranging from 24 hours to 7 days, and we encourage shortening the seven-day timeframe proposed in this bill.
Disclosure is not a one-time event. It will often consist of a series of conversations as the medical team learns more about the event. Initially it may not be clear whether or not an error was made. These conversations should begin early. Risk managers should not act as a gatekeeper in deciding whether to discuss a situation with a patient, but rather as a resource for disclosure conversations.
3) Patients who have been harmed due to medical errors have the right to be treated fairly and compensated appropriately.
Offers of financial compensation following disclosure have been promoted as a way to quickly compensate injured patients and avoid malpractice lawsuits. These settlements can be a good solution for both parties, but there is a danger that patients will be persuaded to settle for far less than the amount necessary to cover future medical expenses, replace lost income, and compensate for pain and suffering (8). Therefore, this bill requires that patients are informed of their right to consult an attorney before accepting a settlement. In addition, this bill follows the recommendation of Gabriel Teninbaum (9) by creating a six month waiting period between the offer of a settlement and acceptance of that settlement if a patient chooses not to consult an attorney (Section 3(m)).
Medical care facilities should be encouraged to financially compensate injured patients for any immediate expenses they feel are appropriate. These may include child care expenses, rent or mortgage payments for patients unable to immediately return to a job, or funeral expenses for a deceased patient. These types of targeted short-term compensation should not be subject to the six month waiting period.
Section 3(o) prohibits information related to a case from being made confidential as a condition of settlement. This clause is based on a recommendation by the Joint Commission. They warn that “… confidential settlement offers may encourage quick resolution, but this is achieved at the cost of forever barring access to potentially important information that could be used to improve the quality and safety of care.” (10).
4) Health care institutions have the responsibility to establish procedures for disclosure of unanticipated outcomes and medical errors to patients and their families.
Unanticipated outcomes and medical errors will occur in even the best of medical care facilities. Therefore, it is to the benefit of both patients and medical care facilities that procedures for disclosure are established so that the responsibilities of health care providers, expectations of administrators of the medical facility, and timelines for action are clear.
Section 3 of this bill sets forth a requirement for medical care facilities to design and implement a disclosure policy. Numerous resources are available to assist in developing disclosure policies, including a series of three monographs published by the American Society of Healthcare Risk Management on the topic of disclosing medical errors and unanticipated outcomes (published in May 2003, Nov. 2003) and Feb. 2004; available as monographs under the category “Patient Safety” on their website. Examples of disclosure policies are available on the Premier website.
- Mazor KM, Simon SR, Yood RA, et al. “Health plan members’ views about disclosure of medical errors.” Annals of Internal Medicine, 2004; 140:40–18. (view abstract in PubMed)
- Witman AB, Park DM, Hardin SB. “How do patient want physicians to handle mistakes: A survey of internal medicine patients in an academic setting.” Archives of Internal Medicine, 1996; 156(22):2565–2569. (view abstract in PubMed)
- American Medical Association, Code of Medical Ethics, Section 8.12. (view document)
- American Nurses Association, Code of Ethics for Nurses, Sections 1.4 and 3.4. (download document)
- American Society for Healthcare Risk Management, Code of Professional Conduct, Section “The responsibility to those we serve.” (download document)
- Porto GG. “Disclosure of medical errors: Facts and fallacies” Journal of Healthcare Risk Management, 2001; 21(4): 67–76. (view citation in PubMed)
- Mastroianni AC, Mello MM, Sommer S, Hardy M, and Gallagher TH. “The flaws in state ‘apology’ and ‘disclosure’ laws dilute their intended impact on malpractice suits.” Health Affairs, 2010; 29(9): 166–1619. (view abstract in PubMed)
- American Association for Justice. “Medical negligence: The role of America’s civil justice system in protecting patients’ rights.” February 2011. (download document)
- Teninbaum GH. “How medical apology programs harm patients.” Suffolk Law School, Legal Studies Research Paper Series, Research Paper 11-30, November 2011. (read abstract and download document)
- Joint Commission on Accreditation of Healthcare Organizations. “Care at the CrossRoads: Strategies for improving the medical liability system and preventing patient injury.” 2005. (download document)
Sources of definitions in the bill
- Health care provider
adapted from K.S.A. 40-3401(f)
- Health care administrator
from Substitute House Bill 2069
- Medical error
from the definition of “error” within To Err is Human: Building a Safer Health System, Committee on Quality of Health Care in America, Institute of Medicine (2000)
- Unanticipated outcome
based on accepted definitions from several sources for “unanticipated outcome” and “adverse event”
- Error of commission, Error of omission, Adverse event, Sentinel event
from “Tackling patient safety taxonomy: A must for risk managers”, a monograph from the American Society for Healthcare Risk Management (February 2008)
- Serious unanticipated outcome or medical error, Minor unanticipated outcome or medical error
adapted from definitions for “minor error” and “serious error” within “Disclosure of unanticipated outcomes”, ECRI Institute, Healthcare Risk Control, (2008) supplement A.
- Less serious unanticipated outcome or medical error
created for this bill to further distinguish between differing severity of unanticipated outcomes and medical errors, so that only the most serious are required to be disclosed in writing
- Patient’s family member, Patient’s representative
adapted from Colorado statute CRS 13-25-135