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Disclosure of Unanticipated Outcomes,

Including Medical Errors


Risk Management

Admin. 12-10

Published: 09/16/2014
Page 1 of 7

PURPOSE:
This policy addresses the Parkland philosophy and practices regarding patient
communications when an unanticipated outcome, including medical error, occurs. While
recognizing the importance of timely and truthful disclosure, Parkland maintains the
confidentiality of peer review, root cause analysis and associated processes and
documents as required by law.
Disclosures of unanticipated outcomes are made for the following reasons:
Ethics- it's the right thing to do.
Outcome - patients are entitled to information affecting their care and enabling
their involvement in their ongoing treatment.
Patient Satisfaction - the more patients are communicated with, the more they
can be involved and kept informed about their care.
Public Confidence - helps maintain the public trust.
Quality Improvement - helps improve patient care by actively pursuing
performance improvement.
External Requirements - The Joint Commission and other regulatory,
standards, and accreditation agencies require disclosure of unanticipated
outcomes.
Provider Satisfaction, Confidence & Education- helps mitigate recrimination
about personal performance.

SCOPE:
All Parkland Health & Hospital System (Parkland) facilities, including but not limited to
hospitals, ambulatory surgery centers, clinics, and all corporate departments/divisions.

PROCEDURE:

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 2 of 7

1. Steps
A. Upon discovery of an unanticipated outcome, the hospital, clinic or medical staff
member will provide for the safety/stability of the patient.
B. If an unanticipated outcome is discovered by a hospital or clinic staff member,
the appropriate staff member will notify the patients treating/primary physician of
the unanticipated outcome.
C. If the treating physician is not the attending physician, the treating physician will
immediately notify the attending physician.
D. If the unanticipated outcome is discovered by a member of the medical staff, the
discovering provider will notify the appropriate care team members involved or
affected by the unanticipated outcome.
E. If an unanticipated outcome is deemed by the Patient Safety Officer to be
clinically significant, the hospital, clinic or medical staff member will follow the
Disclosure Communication Procedure
F. The attending physician will:
1) Determine if risk management assistance is needed prior to disclosure or if
disclosure may proceed without assistance.
2) If risk management assistance is needed, notify the Risk Management
Department of the hospital/clinic responsible for the patient's care (Risk
Management on call through the page operator) and the Risk Management
Department of University of Texas Southwestern Medical School (214-6486905).
3) If appropriate or requested, page Chaplain Services at 214-786-8108.
4) Notify the patient's primary care physician of the unanticipated outcome and
plan of care.
G. The hospital/clinic staff member discovering the unanticipated outcome will
secure, or direct the appropriate care team members to secure, any and all
equipment, documentation, or other material related to the event and/or

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 3 of 7

unanticipated outcome that will allow subsequent analysis of system errors that
may have contributed to the event as directed by institutional procedure.
2. Recommendations:
A. The attending physician, in conjunction with the primary caregivers involved in
the unanticipated outcome, should be involved in the communication with the
patient/family/patient authorized representative(s).
B. When the unanticipated outcome involves a support service or consulting
service, the attending physician at his or her discretion will include other medical
staff members as needed.
C. The nurse caring for the patient should always be informed of the plan for
disclosure, and invited to participate.
D. If the unanticipated outcome results in a transfer of care to another service, level
of care or treatment team, the original attending physician should still lead the
disclosure. The attending physician will introduce the appropriate team
member(s) of the receiving service to the patient/family/patient authorized
representative(s).
E. Disclosure should take place as soon as possible or within 24 hours after the
unanticipated outcome or occurrence is discovered and ideally when the patient
is medically stable enough to understand the information. However, disclosure
should usually not be significantly delayed for improvement in the patients
condition. If there is concern that the patient's condition may interfere with his or
her understanding, disclosure to the patient's family or patient authorized
representative(s) is appropriate.
F. Additional or follow-up disclosures should be made to the patient/family/patient
authorized representative(s) as requested or necessary to ensure the patient
understands the unanticipated outcome or occurrence.
G. If the patient is an adult with decision-making capacity, an emancipated minor, or
a mature minor (a minor receiving confidential care for sexually transmitted
disease, alcohol or drug abuse, or pregnancy-related conditions), the disclosure
is made directly to the patient. In this case, the patient may determine whether

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 4 of 7

family members, relatives, friends, other non- relatives, or other persons involved
in the patient's care should be included in the disclosure.
H. If the patient is a minor, disclosure is made to the patients parent or other legally
authorized representative.
I. If the adult patient lacks decision-making capacity (including a patient who is
comatose, incapacitated, or otherwise mentally or physically incapable of
communication) and has not previously declared a medical power of attorney,
disclosure is made to the adult who has decision-making capacity, in the
following order of priority:
1) the patient's spouse
2) an adult child of the patient who has the waiver and consent of all other
qualified adult children of the patient to act as the sole decision-maker
3) a majority of the patient's reasonably available adult children
4) the patient's parents
5) the individual clearly identified to act for the patient by the patient before the
patient became incapacitated, the patient's nearest living relative, or a
member of the clergy.
J. Although the patients representative will usually be the patients legal next-of-kin,
disclosures to non-relatives who have been actively involved in the incapacitated
patient's care prior to the unanticipated outcome may be permissible in
accordance with this procedure.
3. Communication and Documentation:
A. Disclosures should be accurate, factual and avoid assessing blame. Simple, nontechnical language should be used. Appropriate steps to assuring understanding
(e.g., use of an interpreter) are critical. The communication should generally
follow the outline below:
1) Apologize for the error if a clear error or system failure without
assigning blame or criticizing the care or response of others

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 5 of 7

2) Empathize with the patient and family in an open and honest way
3) Explain the facts of the event, including error or system failure, if clearly
understood
4) Explain the unanticipated outcome:
a) current condition,
b) future developments,
c) what treatments will be necessitated and accompanying information on
medications, treatment, etc.
d) A known complication or side effect is not an unanticipated outcome, but
information about such outcomes should also be disclosed to patients
during the routine course of their treatment and care.
5) Accept responsibility for follow up with further information as it becomes
available
6) Inform the patient/family that an investigation of what happened will take
place to prevent a reoccurrence and improve care in the future
7) Offer to meet with patient/family again to ensure that the patient/family fully
understand and comprehend all care/treatment options
8) Ask the patient/family to reflect back what they have heard, to assure that
effective understanding of the explanation has been achieved
9) Ease later communication by offering a business card with the contact
information of the attending physician
4. As soon as possible, document in the medical record all facts pertaining to the
unanticipated outcome and associated medical response(s) as well as discussion
with the patient/family, including the date and time of the discussion, and the names
of all present during the discussion.

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 6 of 7

A. Include a description of the patient/family/patient authorized representatives


understanding of the discussion, questions asked, and responses to the
questions.
B. Factually record further plans for follow up as indicated
C. Avoid recording any information unrelated to the care of the
D. Patient such as 'incident report filed' or 'risk management notified
E. Do not alter any prior documentation or insert backdated information

EQUIPMENT:
N/A

DEFINITIONS:
Unanticipated Outcome: A result that differs significantly from what is anticipated to be
the result of a treatment, procedure or delay in diagnosis. Medical errors, adverse
events and sentinel events are all types of unanticipated outcomes.
Medical Error: An act or omission with potential or actual negative consequences for a
patient that is considered to be an incorrect course of action.
Adverse Event: Any event involving a patient that is not consistent with routine patient
care or the routine operation of the facility, and which adversely affects or has the
potential to adversely affect the health, life or comfort of the patient and is not caused by
the patient's underlying disease.
Disclosure: Communication of information to a patient or patients representative
regarding results of a diagnostic test, diagnosis, medical, surgical or other interventional
treatment that resulted in an unanticipated outcome.

Disclosure of Unanticipated Outcomes,


Including Medical Errors
Risk Management

Admin. 12-10

Published: 09/16/2014
Page 7 of 7

Sentinel Event: A reportable event as defined by The Joint Commission and/or


regulatory agencies as an adverse event or unanticipated outcome or occurrence
associated with death or serious physical or psychological injury or the risk thereof.

REFERENCES:
American Society for Healthcare Risk Management series on Disclosures: Part I, II, III
2004.
When things go wrong. Responding to adverse events. A Consensus statement of the
Harvard hospitals. March 2006.
Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients.
N Engl JMed 2007;356:2713-9.
Disclosure of Health Care Information, Texas Health & Safety Code, Chapter 241.
Consent to Medical Treatment Act, Texas Health & Safety Code, Chapter 313.

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