3. • Explain the difference between an
incident/complaint and a nonconformance
• Learn methodology of proper investigation
techniques
• Identify and implement effective corrective and
preventive actions, to include effectiveness
checks
• Learn when an occurrence requires reporting to
regulating entities
Learning Objectives:
By the end of this training segment, the participants
will be able to …
4. { {Incident/Complaint
• Any written or oral
communication concerning
dissatisfaction with the service
the OPO provided through the
process of organ donation
including but not limited to:
• donor identity
• quality
• packaging, durability, reliability
• safety, effectiveness
• donor families, affiliated agencies,
healthcare professionals,
representatives of community
services (i.e. funeral homes),
coroners, and Medical Examiners
Nonconformance
• An unplanned variation
from a Policy and/or
Standard Operating
Procedure (SOP)
• Occurrence with an
unexpected outcome, error,
accident, discordant
transplant suitability result
• Variance found during the
auditing process, or an out-
of-the ordinary event
Now let’s define...
5. { Incident/Complaint or Nonconformance
Now you identify…
Scenario #1 – During chart review a quality staff member
has identified that a urinalysis was not completed within
24 hours of cross-clamp.
6. {
• Now that you have
identified a
Nonconformance
(NC), the next step
requires
documentation of
the event in your
Quality
Management System
(QMS)
• Q-Pulse
The next step…
7. {
General Information screen
• Enter Raised by Person
• The person entering the NC
• Use drop down arrow to see
alpha list by last name or type
last name
• Enter Occurrence Date
• Date the NC occurred
• Source
• Select the Location by clicking
on the plus sign. Select
“Nonconformance Unplanned”
• Enter Identification
• If none, enter N/A
Q-Pulse entry…
OPO – Nonconformance
8. {
The Nonconformance
Description screen
• Enter Event Type
• Location
• The event that best describes the
deviation
• Staff Responsible
• Enter Details
• This is a free text field to record
as much information and detail
that is known at this point
regarding the NC
• Any staff member names
involved in the NC should be
listed here
• Include the Policy, SOP, or WI
with document number and title
for which the NC in violation of
• Attachment (if applicable)
• Upload any attachments that
support the initial NC entry
• i.e.: emails, SOPs, pictures,
etc…
Q-Pulse entry…
OPO
9. {
• Related Items screen
• Select the Regulation or Standard
(if known) the NC was in violation
of
• Once ‘Next’ is selected the
initiated NC is submitted
• Q-Pulse will assign a unique
tracking number for each NC
or event
Q-Pulse entry…
11. {
• Review information recorded in the
NC record
• Begin investigation by asking
who/what/when/why/how
• Depending on severity, a Root Cause
Analysis (RCA) may be required
Start your investigation…
12. Missing UA investigation…
• Held meeting with staff
responsible for
occurrence
• It was revealed the staff
did not communicate
during shift change for
completion of UA
• Violation: internal SOP
and OPTN policy 2.8
13. {5 WHYs iterative technique
Explore cause and effect
Root Cause Analysis…
14. Problem: UA not performed within 24 hours of cross-clamp
1st Why:
2nd Why:
3rd Why:
4th Why:
5th Why & Root Cause:
Root Cause Analysis…
OPO staff member did not confirm with hospital staff
to ensure UA was performed
Hospital staff performed UA at 0800 on 09/05/15;
The OR was originally set for 09/06/15 at 0500
OR time change due to transplant center request:
09/06/15 at 0800
OR time change resulted in missed UA due to OPO
staff/donor already in OR
Current OPO Donor Management Order Set: UA to
be performed Q24
15. {
• Corrective action for staff members involved for
failing to complete UA within specified time
frame/violating OPTN policy
• Revise OPO Donor Management Order Set to
have UA performed Q12 to ensure its completed
within the 24 hour time frame
Start your corrective and preventive action…
16. { Department Director & Quality Director review for
completion, accuracy, and final approval
Investigation review & approval…
17. {
• Verify that all actions taken were timely, effective and
adequate
• If satisfactory, close stage and overall Nonconformance
Effectiveness check…
• Depending on donor activity:
• Effectiveness Checks over next 3-6
months review donor charts to ensure
UA completed within 24 hours of
cross clamp as specified in the newly
implemented donor management
order set
18. { Incident/Complaint or Nonconformance
Now you identify…
Scenario #2 – Transplant Center “A” Surgeon informed
OPO that incorrect kidney was received.
19. {
• When an
Incident/Complaint
is received, the next
step is to document
the event in your
Quality
Management System
(QMS)
• Q-Pulse
The next step…
20. {
General Information screen
• Customer
• Enter the complainant
• Source
• Select the Location by clicking
on the plus sign. Select
“Complaint”
• Event Type
• Determine applicable category
for complaint
• Raised Against Department
• The department that the
complaint applies to
Q-Pulse entry…
21. {
The Complaint Description
screen
• Identification
• Enter information (if applicable)
• Product to be Returned?
• Select “No” indicating no
distributed organs and/or tissues
will be returned.
• Select “Not Applicable” if the
complaint is not relevant to
distributed organ and/or tissues.
• Select “Yes” if distributed organs
and/or tissues will be returned
• Enter Details
• This is a free text field to
document as much information
and details at this point regarding
the complaint
• Attachment (if applicable)
• Upload any attachments that
support the initial entry
• i.e.: emails, SOPs, pictures, etc…
Q-Pulse entry…
22. {Q-Pulse will assign a unique
tracking number for each
Incident/Complaint
Q-Pulse entry…
23. {
So what happens next…
Transplant Center Surgeon informed OPO that incorrect kidney was received
C-24
OPO - Complaint
Shipping/Transport
OPO
Gauger, Lauren
24. {
• Review information recorded in
Complaint record
• Begin investigation by asking
who/what/when/why/how
Start your investigation…
Summarize the investigation and attach supporting documentation
25. Complaint investigation…
• Originally Transplant Center “A” accepted
the left kidney and Transplant Center “B”
accepted the right kidney
• During the investigation it was revealed
the courier agency, failed to deliver each
organ to its designated transplant center.
• Transplant Center “A” received the kidney
accepted by Transplant Center “B”
• Transplant Center “B” received the kidney
accepted by Transplant Center “A”
• Review OPO’s documentation
• OPO was compliant in
packaging/labeling/logistics to internal SOP
and OPTN Policy
• A conference call was held between the
OPO and courier agency revealing a
breakdown in transportation process
• The courier was unfamiliar with OPTN
transplant center codes/final destination
26. {
• CAPA not required of OPO
• However, process and opportunity for improvement was
identified
• Organ(s) for local transplant centers will be hand delivered by
OPO staff
• Organ(s) for non-local transplant centers will utilize a courier
service (if necessary)
• Courier agency provided a corrective action plan
• Revised internal SOP for OPO account
• Retrained call center and all couriers
• Report to OPTN as a Safety Situation
Develop your corrective action plan…
Document corrective action plan. Upload supporting documentation, if applicable.
27. {
Approval & customer follow up…
Review and approve.
Response letter sent to Transplant Center “A” Surgeon in regards to the investigation and corrective action plan.
28. {
• Verify that all actions taken were timely, effective and
adequate
• If satisfactory, close stage and overall Complaint
Effectiveness check…
• OPO Recovery Surgeon follow up with
each transplant center post recovery and
pre-transplant
• Depending on OPO donor activity:
• Effectiveness Checks over next 3-6
months to review donor charts where
organs are shipped outside of OPO DSA
to ensure no transport incidences
occurred
29. • Explain the difference between an
incident/complaint and a nonconformance
• Learn methodology of proper investigation
techniques
• Identify and implement effective corrective and
preventive actions, to include effectiveness
checks
• Learn when an occurrence requires reporting to
regulating entities
Learning Objectives:
By the end of this training segment, the participants
will be able to …
30. [Put text here]All issues are not created equal…
Transplant center calls to report
death of a recipient
Partner hospital calls,
complaining your recovery
staff were rude to their OR
staff
Call from the funeral home that
estimated completion time for
recovery wasn’t met
Sharps injury during
recovery
When packaging organs, staff
catch transcription error on blood
tube labels
31. [Put text here]Establishing severity levels
• Severity levels give a frame of reference for the
impact of the occurrence on your organization.
• Each severity level is associated with specific
required actions.
• Assists with reviewing reports for trends.
33. [Put text here]
Who assigns the severity level?
When is it assigned?
A single, responsible individual
or
A small team of reviewers
At the time the report is initially filed
or
During review by a manager or the quality
representative
Who:
When:
34. [Put text here]
Severity Level Designations
Level I severity - occurrences with no to very low
risk of harm to a patient, person, or organization.
• generally corrected in real time by the reporting
party; therefore, may not require a root cause
analysis (RCA).
• An RCA may be completed at the discretion of
the Director or Manager for any Level I
occurrence, but is required for three or more
Level I occurrences of the same condition as this
constitutes a trend.
35. [Put text here]
Severity Level Designations
Level II severity - occurrences with low risk of harm
to a patient, person, or organization.
• easily rectified; therefore, may not require an
RCA.
• RCA may be completed at the discretion of the
Director or Manager for any Level II occurrence,
but is required for three or more Level II
occurrences of the same condition which
constitutes a trend.
36. [Put text here]
Severity Level Designations
Level III severity - occurrences have the potential to
adversely affect product or service quality, put the facility,
patients, recipients or employees at risk, jeopardize industry
certification or government regulations or cause great harm to
other operations in the organization.
• is inclusive of regulatory body and accrediting agency
definitions for adverse events and will be reported per their
respective guidelines.
• requires a Root Cause Analysis (RCA) be conducted.
• Reported by the Director or Manager to the Incident
Response Team via e-mail and/or by telephone.
Notification should occur as soon as possible, but not to
exceed 2 hours. Within 18 hours of initial receipt of this
report, the Incident Response Team will meet in person or
via conference call to review the occurrence.
37. [Put text here]
Severity Level Designations
Level IV severity - have adversely affected product or
service quality, put the facility at risk, caused death or serious
injury to patients, recipients or employees, jeopardized
industry certification or government regulations or caused
great harm to other operations in the organization.
Additionally, occurrences will be rated Level IV if two of the
following three Level III events occur simultaneously:
• Risk of significant injury to staff, donors/potential donors
or recipients/potential recipients.
• Violation of policies, procedure or regulations.
• Loss or potential loss of public confidence in NDN.
.
38. [Put text here]
Severity Level Designations
Level IV severity
• inclusive of regulatory body and accrediting agency
definitions for adverse events and will be reported per their
respective guidelines.
• Level IV occurrences require an RCA be conducted.
• The responsible Director or Manager will report all Level IV
incidents to the Incident Response Team by telephone.
Notification should occur as soon as possible, but not to
exceed 2 hours. Within 12 hours of initial receipt of this
report, the Incident Response Team will meet in person or
via conference call to review the occurrence.
39. [Put text here]
• Is there a need to report the incident/
non-conformance to:
• OPTN?
• recovering transplant centers?
• tissue or ocular bank?
• tissue processing partners?
External Reporting
Requirements
40. [Put text here]
OPTN Guidance for Reporting of
Potential Donor Derived Disease
Transmission Events (PDDTE)
http://optn.transplant.hrsa.gov/SharedContentDocuments/Guidance_DTAC_PDDTE.pdf
“…any suspected donor derived transmission event
(infection, malignancy, or other condition) should be
reported per OPTN Policies 15.4 (Reporting of Potential
and Proven Disease) and 15.5 (Requirement for Post-
Transplant Discovery of Donor Disease or Malignancy).
While an exhaustive list cannot be compiled, this document
is meant to provide guidance regarding what and when to
report to the OPTN’s Improving Patient Safety reporting
portal for members in Secure Enterprise SM.”
41. [Put text here]
OPTN 2.13.A Reporting Requirements
The host OPO is responsible for timely follow up and reporting of any new or
changed deceased donor test results to the relevant transplant programs.
The host OPO must report to the transplant programs all of the following:
1. Updates, such as the identification of any potential disease-causing
organism and the sensitivity of the deceased donor to that organism, as
the host OPO receives the information.
2. Medical-social history, testing, and laboratory assessments that
identify malignant or infectious conditions that may adversely affect a
potential transplant recipient.
3. Any known or suspected infectious or neoplastic conditions that may
be transmitted to transplant recipients.
The host OPO must report to the OPTN Contractor’s Patient Safety Portal
any new disease or malignancy in the deceased donor that may be
transmitted to transplant recipients.
Is this incident/non-conformance
reportable to OPTN?
42. [Put text here]
Is this incident/non-conformance
reportable to OPTN?
OPTN 15.4 Reporting of Potential and Proven Disease Transmissions
15.4.B Requirements for Living Donor Recovery Hospital and
Host OPOs
The living donor recovery hospital or host OPO is responsible for all the
following:
1. Communication of the suspected donor’s and affected recipient’s test
results and diagnosis that may be relevant to acute patient care as
soon as possible, but no more than 24 hours after receipt, to any
transplant programs, patient safety contacts, and tissue banks that
received organs or tissue from the donor. This includes any test results
that were not available at the time of procurement or that were
performed after recovery. The living donor recovery hospital or host
OPO must document that this information is shared with all receiving
transplant programs and tissue banks.
2. Notification of the event to the OPTN Improving Patient Safety Portal
as soon as possible, but no later than 24 hours after receipt of test
results or diagnosis.
43. [Put text here]OPTN 15.4.B Requirements for Living Donor
Recovery Hospital and Host OPOs (cont.)
3. Potential disease transmission follow up communication as follows,
including:
a. For deceased donors, completion and submission of the Potential Disease
Transmission Report Form no later than 24 hours after reporting the event
through the OPTN Improving Patient Safety Portal. This must include:
• i. The specific receiving transplant program patient safety contact and tissue bank
staff that were notified of the potential transmission
• ii. Disposition of all organs, tissues, and vessels
• iii. Any preliminary information available regarding any remaining deceased donor
samples for additional testing, notification to state or local health department as
appropriate for nationally notifiable infectious diseases, and whether an autopsy
was performed on the deceased donor.
4. A follow up review of the event, in partnership with OPTN patient
safety staff, to determine whether the deceased or living donor was
diagnosed with a potentially transmissible disease or condition.
48. [Put text here]
Is this incident/non-conformance
reportable to OPTN?
Disease Transmission Event:
An efficient avenue for members to report
cases of malignancy and infectious disease. All
transmissible diseases and medical
conditions (including malignancy) that are
detected by an OPO in a donor after organs
are procured or by a transplant center before
or after organs have been transplanted must
be submitted. All reported events will be
reviewed immediately by UNOS staff.
49. [Put text here]
Is this incident/non-conformance
reportable to OPTN?
Safety Situation:
A voluntary and confidential system that
provides members the opportunity to report
situations or activities that could have affected
patient safety. These situations may be related to
patient safety, organ placement/availability,
communications, clinical information accuracy, or
risk of disease transmission that was prevented.
Situations that may not directly impact safety,
availability, or utilization but cause concern from a
transplantation, donation and/or quality perspective
may also be reported.
50. [Put text here]Complaint investigation…
• Originally Transplant Center “A” accepted
the left kidney and Transplant Center “B”
accepted the right kidney
• During the investigation it was revealed the
courier agency, failed to deliver each organ
to its designated transplant center.
• Transplant Center “A” received the kidney
accepted by Transplant Center “B”
• Transplant Center “B” received the kidney
accepted by Transplant Center “A”
• Review OPO’s documentation
• OPO was compliant in
packaging/labeling/logistics to internal SOP
and OPTN Policy
• A conference call was held between the
OPO and courier agency revealing a
breakdown in transportation process
• The courier was unfamiliar with OPTN
transplant center codes/final destination
Organs delivered to
wrong transplant
centers…report as a
Safety Situation.
51. [Put text here]
Missing UA
investigation…
• Held meeting with staff
responsible for
occurrence
• It was revealed the staff
did not communicate
during shift change for
completion of UA
• Violation: internal SOP
and OPTN policy 2.8
situation or activities that
could have affected
patient safety…
report as a Safety
Situation.
52. [Put text here]
• Was this a shared donor with your own or
another tissue/ocular recovery
organization?
• Consider needs for reporting to AATB
• Consider needs for reporting to EBAA
• Consider needs for reporting to FDA
Consideration for reporting an
occurrence to other accrediting
agencies or regulatory bodies.
53. [Put text here]
If you are unsure whether a specific situation
should be reported, it is recommended that
you report in order to promote patient safety.
