MPSC Top Violations - TXC - Betsy Coleburn Ann-Marie Leary
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MPSC Top Violations – TXC
Betsy Coleburn
Ann-Marie Leary
Objectives Describe the MPSC/PCSC review Identify common transplant center policy violations Identify common MPSC actions Emphasize MPSC and compliance resources
Membership and Professional
Standards Committee
The MPSC is charged with making sure that members
meet and remain in compliance with the criteria for
institutional membership
Develop and review membership criteria
Review applications and make recommendation for Board
action
Review living donor adverse events
Projects – suggest improvements to Bylaws, Policies, or review
procedures
Review transplant program and OPO donor yield performance
Review member compliance with OPTN Policies and Bylaws
What do you think of the MPSC?
1. Who? 1 1 1 1
2. They scare me. I don’t
want to go to UNOS jail!
3. They try to help members
operate safely.
4. I just delete those letters,
do they matter?
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Committee Makeup 38 members, 2 HRSA reps Chair and Vice Chair 11 Regional Representatives 25 At Large Representatives
Committee Makeup
Physicians and Surgeons Transplant Coordinators
OPO Administrators OPO Procurement and
Quality staff
Transplant Administrators Lab Directors
Living donor RecipientSubcommittees
MPSC has two standing subcommittees
Performance Analysis and Improvement Subcommittee (PAIS)
reviews outcomes and inactivity
Policy Compliance Subcommittee (PCSC) reviews potential policy
violations and other noncompliance
We work with the PCSC to review case information
related to potential policy violations, and determine
the appropriate outcomeConfidential and Protected
MPSC members are considered Medical Peer
Reviewers and use the peer review process to
conduct Committee work
Confidential – Protected by Virginia & Illinois state
peer review laws
Compliance reviews are also blind up to a point
Allows for discussion without fear of bias
Once an issue requires face to face interaction, no longer blindWhere does the PCSC get the
information?
Two UNOS departments support the MPSC –
Membership and Evaluation and Quality
Evaluation and Quality includes three teams that
investigate and summarize potential issues
Membership includes analysts that facilitate the
review by MPSC members and provide historical
context for actionsTypes of Cases
Site Survey Non-Routine Allocations
Issues
• On-site • Member • Review of
reviews complaints every
• Full and • Patient allocation that
focused desk Safety results in a
reviews System transplant
reports
• Disease
transmission
reportsSite Surveys
Every three years, or more often for checking
continued compliance
Set list of policies for each program or OPO based
on data required in UNetSM
Heart, Intestine, Kidney, Liver, Lung, Pancreas,
Living Donor Kidney, OPONon-Routine Issues
Reported to Safety Analysts through complaints,
self-reports, patient safety portal reports
Screened for potential policy violations and patient
safety risks
Inquiry to get full story, any corrective actions or
root cause analysesAllocation Analysis
All allocations resulting in a transplant are reviewed
Extenuating circumstances (time constraints, donor
quality) taken into account
Potential patient safety issues sent to Safety
Analyst
Other potential violations presented cumulatively
for each program and OPO once a year to look for
specific issues and possible trendsAll review types
For all cases, letters from the MPSC should have
specific Bylaw or Policy references
Want to be clear on reason for action
Policy changes (including the plain language
rewrite) have complicated these references
All investigations are considered using the Policy
language in effect at the time of the incidentHow can you make the process
smooth?
Respond to any inquiries/requests by the deadline
Provide specific details on circumstances of issue,
any corrective actions, and training
Have a specified staff member to keep up with
Policy and Bylaw changes. Many of the common
issues we see are due to members not knowing
about changes to PolicyCommon Policy Violations
Common Policy Violations – TXC
Data entry errors (Policy 18.1)
TXCs must enter accurate data in Tiedi forms
Vessel storage and monitoring (Policy 16.7)
TXCs must destroy vessels within 14 days of recovery date
TXCs may not store HCV or HBsAg positive extra vesselsCommon Policy Violations – TXC
ABO verification upon receipt of an organ, prior to
implantation (Policy 1.2)
Many TXCs do this verification, however the documentation does not
show that it occurred after the organ arrived but before implantation
TXCs may not document verification of donor ID
Patient notification of listing or removal (Policy 3.5)
Listing letters need to include correct date of listing in body of letter
Letters must include and refer to the OPTN Contractors Patient
Information Letter
Letters must be sent within 10 business days of listing or removalCommon Policy Violations – TXC
Packaging and labeling errors (Policies 16.4 &
16.6)
When TXCs repackage or label organs for reallocation, TXCs are
responsible for correctly packaging and labeling
Disease transmission reporting errors (Policy 15.4)
Have to report any suspected disease transmission within 24 hours to
Host OPO and the Patient Safety Portal
Accepting an organ for one person and
transplanting someone else (Policy 5.7)
Should release organ back to Host OPO for reallocationHow does the MPSC make
decisions?
A. No one knows, it’s a 1 1 1 1
secret!
B. Flipping a coin
C. They do whatever they
can to get people in
trouble!
D. Using guidelines in the
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ThMPSC Decision Making
Severity of issue, including any risk to patient
health or public safety and risk to integrity of or
trust in OPTN
Previous compliance history
Corrective action plans
Evidence of mitigating factors based on medical
judgmentWhat can the MPSC do to me?
1. Whatever it wants! 1 1 1 1
2. Shut down my program
3. Invite me to Chicago
4. Request information
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ShMPSC Monitoring On-site or desk monitoring Root cause analysis Corrective action plan Plan for quality improvement Peer visit External expert consultants
MPSC Actions Close with no action Notice of Uncontested Violation Letter of Warning Letter of Reprimand Probation Member Not in Good Standing
Close with no action
Notice of Uncontested Violation
Notice of Uncontested Violation
Everyone makes mistakes!
Problem identified and appropriately corrected
No likelihood of recurrence
Substantial evidence of mitigating factors based on
medical judgment
Final actionLetters of Warning and Reprimand
Letters of Warning and Reprimand
More severe issues
Previous compliance history
Little or no evidence of mitigating factors based on
medical judgment
Final actions
Letter of Reprimand entitles member to an
interview before MPSC makes decisionProbation and Member Not in Good Standing
Probation and Member Not in Good
Standing
Right to an interview and a hearing
Must be approved by the Board of Directors
Notice to the public, including all OPTN members
and certain patients
At least one year monitoring
Member Not in Good Standing loses right to vote in
OPTN matters and serve on OPTN committees
until releasedMPSC Actions Since 2000
3
8
43
47
283
Member Not in Good Standing Probation Letter of Reprimand Letter of Warning Notice of Uncontested ViolationWhere can I get help?
1. Nothing can save you 1 1 1 1
from the MPSC!
2. My crystal ball will tell me
what to do
3. My peers
4. UNOS Resources
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MMPSC & Compliance Resources Membership Staff OPTN Bylaws, Appendix L OPTN Policies Evaluation Plan Public Comment Proposals Transplant Administrators List Serve UNOS Regional Administration
Questions?
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