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Adverse Event Reporting and Review Process for Transplant (3.19)

Adverse Event Reporting and Review Process for Transplant (3.19) - Policies, Administrative, UWHC, Department Specific, Transplant, QAPI

3.19



POLICY & PROCEDURE
Effective Date: July 2011
Revised Date: October 2016
Title: Adverse Event Reporting and Review Process
for Transplant
Policy Number: 3.19

Page 1 of 4
I. PURPOSE
The purpose of this policy is to continuously improve patient care by delineating a process for the prompt
reporting, investigation, analysis and action for unexpected events; to comply with the reporting
requirements of external regulatory agencies and applicable state and federal laws. Areas with a culture of
safety see larger volumes of reported events, which ultimately results in a safer environment for patients.

II. POLICY
UW Transplant strives to provide high quality, safe patient care to achieve excellent outcomes. This policy
applies to all transplant organ programs and within any phase of transplant or living donation. All adverse
events will be identified, tracked, analyzed, and reported to identify trends, evaluate opportunities for
improvement, and prevent future events.

III. DEFINITIONS
A. Adverse event: any undesirable variation in a health care delivery process or environment that results in
patient, staff or visitor harm, has the potential to cause harm, or could have resulted in harm if it had not
been intercepted (i.e. “close call”, or “near miss”).
B. Thorough analysis: an analysis that identifies the root causes of an adverse event and provides actions to
prevent or decrease the possibility of the adverse event re-occurring.
C. PSN: Patient Safety Net, an internal reporting system to report and document adverse events.

IV. PROCEDURE
A. Event Identification
1. The types of events to be reported include, but are not limited to the following:
i. Centers for Medicare & Medicaid Services (CMS) specific examples:
• Serious medical complication or death caused by living donation
• Unintentional transplantation of organs of mismatched blood types
• Transplantation of organs into unintended recipients
• Unintended transmission of disease (ex. infections or malignancy) to a recipient
• Medication error contributing to graft loss or delayed function
• Surgical site infection or other hospital acquired infection
• Unplanned return to the operating room for a surgical complication
ii. United Network of Organ Sharing (UNOS) specific living donor adverse events:
• Living donor organ recovery procedure is aborted after the donor has begun to
receive anesthesia
• Living donor organ is recovered but not transplanted
• Living donor organ is recovered and transplanted into someone other than the
intended recipient
• Living donor dies within two years after the organ donation
• Living liver donor is listed on the liver waitlist within two years after organ
donation



POLICY & PROCEDURE
Effective Date: July 2011
Revised Date: October 2016
Title: Adverse Event Reporting and Review Process
for Transplant
Policy Number: 3.19

Page 2 of 4
• Living kidney donor is listed on the kidney waitlist within two years after organ
donation
iii. Additional UW Health reportable adverse events:
• Graft loss or patient death within the first year of transplant
• Patient care events that put the patient at risk of harm, or other undesirable
variations in process, per UW Health Policy 4.22
B. Event Reporting
1. Refer to UW Health Policy 4.22 for the event reporting process.
2. Additional transplant-specific reporting may include:
i. UNOS/OPTN through the Patient Safety Portal for a suspected disease transmission or
living donor adverse event (see UW Transplant Policy 3.21)
ii. Organ Procurement Organization if the event involved a potential disease transmission
event
iii. Institutional Review Board (IRB) if the event occurred within the context of an approved
transplant study
3. Patient safety issues can also be reported during daily leadership and transplant team huddles.
However, the event should also be documented according to UW Health Policy 4.22.
C. Thorough Analysis
1. Once an adverse event is reported, the Patient Safety Net (PSN) system sends an email
notification to the location manager and other representatives across the organization, based on
the nature of the event.
2. The manager reviews the PSN event for accuracy and assigns consultants for review as necessary.
3. The below steps are followed, depending on the harm score of the event:
i. Low Harm Events (1-4)
a. Manager investigates event, near miss, or unsafe condition and takes action
depending on event. Actions may include:
• Service recovery, involving Patient Relations as necessary
• Action to prevent future event or resolution of unsafe condition, depending
on level of potential risk
• No immediate action, track and trend
b. Manager responds in the PSN system with results of investigation and action taken
within 30 days after notification, per UW Health Policy 4.22.
c. Low harm event data is tracked and trended within PSN dashboard system, and
aggregate data is communicated to program-specific quality leadership teams,
Transplant QAPI Steering Committee, and UW Health Patient Safety and Quality
Committee.
i. A process improvement project may be initiated at the direction of one of the
above committees.
d. One low harm score case is highlighted each quarter for learning purposes, and
posted on the UW Health UConnect Transplant page.




POLICY & PROCEDURE
Effective Date: July 2011
Revised Date: October 2016
Title: Adverse Event Reporting and Review Process
for Transplant
Policy Number: 3.19

Page 3 of 4
ii. Medium Harm Events (5-6)
a. Thorough analysis is initiated by the manager, involving other team members,
hospital quality, risk management, and transplant leadership as necessary.
i. All level 6 events are also discussed by the multidisciplinary hospital Healthcare
Event Evaluation Team (HEET).
b. An action plan is established, based on the results of the thorough analysis. Actions
may include:
• Service recovery, involving Patient Relations as necessary
• Change in clinical protocol or practice
• Change in administrative policy
• Complete formal root cause analysis
• Initiate process improvement project
• No immediate action, track and trend
c. Manager responds in PSN system with results of investigation and action taken
within 30 days after notification.
d. Medium harm event data is tracked and trended within PSN dashboard system, and
aggregate data is communicated to program-specific quality leadership teams,
Transplant QAPI Steering Committee, and UW Health Patient Safety and Quality
Committee.
i. A process improvement project may be initiated at the direction of one of the
above committees.
iii. High Harm Events (7-9)
a. Thorough analysis is initiated by the manager, involving other team members,
hospital quality, risk management, and transplant leadership.
b. Event is reviewed by the multidisciplinary hospital Healthcare Event Evaluation Team
(HEET) to determine next steps. For events with harm scores of 7-9, HEET may decide
a formal Root Cause Analysis (RCA) is necessary.
c. For one-year post transplant graft losses or deaths, the timeline and medical record
is reviewed by program clinicians to determine root causes and opportunities for
improvement.
i. The case is presented in detail at the program-specific quality leadership
meeting.
d. An action plan is established, based on the results of the thorough analysis. Actions
may include:
• Change in clinical protocol or practice
• Change in administrative policy
• Complete root cause analysis
• Initiate process improvement project
• No immediate action, track and trend
e. Manager responds in the PSN system with results of investigation and action taken
within 30 days after notification.



POLICY & PROCEDURE
Effective Date: July 2011
Revised Date: October 2016
Title: Adverse Event Reporting and Review Process
for Transplant
Policy Number: 3.19

Page 4 of 4
f. High harm event data is tracked and trended within PSN dashboard system, and
aggregate data is communicated to program-specific quality leadership teams,
Transplant QAPI Steering Committee, and UW Health Patient Safety and Quality
Committee.
i. A process improvement project may be initiated at the direction of one of the
above committees.

V. CONFIDENTIALITY
All information related to the identification, reporting, evaluating, documenting, and recording adverse or
sentinel events is considered privileged under Wisconsin statutes 146.37 and 146.38. All material related to
an adverse event is considered strictly confidential.

VI. REFERENCES
UW Health Policy 4.22 – Event Reporting
UW Health Policy 4.40 – Reporting Unexpected Events and Sentinel Event Status
UW Health Policy 4.45 – Disclosure of Unanticipated Outcomes to Patient and Families
UW Transplant Policy 3.21 – Transplant Disease Transmission Reporting Policy

VII. COORDINATION
University of Wisconsin Transplant Program
UW Health Quality, Safety and Innovation Department

VIII. APPROVED BY



___________________________________ ___________________________________
Jill Ellefson, MBA Dixon Kaufman, MD, PhD
Administrative Director, UW Transplant Medical Director, UW Transplant