MPSC Top Violations – OPO

MPSC Top Violations – OPO
Betsy Coleburn
Ann-Marie Leary
Objectives

Describe the MPSC/PCSC review

Identify common OPO 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?
te
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td
us
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,d
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lp
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to
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ho
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4.
1
m
3.
1
sc
ar
e
2.
Who?
They scare me. I don’t
want to go to UNOS jail!
They try to help members
operate safely.
I just delete those letters,
do they matter?
Th
ey
1.
Who are these people?
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
Recipient
Subcommittees

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 outcome
Confidential 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 blind
Where 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 actions
Types of Cases
Site Survey
• On-site
reviews
• Full and
focused desk
reviews
Non-Routine
Issues
• Member
complaints
• Patient
Safety
System
reports
• Disease
transmission
reports
Allocations
• Review of
every
allocation that
results in a
transplant
Site 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, OPO
Non-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 analyses
Allocation 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 trends
All 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 incident
How 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 Policy
Common Policy Violations
Common Policy Violations – OPO

Follow-up donor testing (Policy 2.10)



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Recording flush solution lot numbers in donor record
(Policy 2.12.B)


OPOs must notify transplant centers’ patient safety contacts within 24
hours of receiving positive post-recovery test results.
OPOs must document the communication and time.
Only faxing results to the transplant center is not acceptable
Many OPOs record this information but do not include it in the donor
record
Timely donor feedback submission (Policy 1.1.D)

Just one day overdue is still a violation!
Common Policy Violations – OPO

Archiving serum sample in donor record (Policy 2.2)


Packing, labeling and verification (Policies 16.4 & 16.6)


Kidney laterality; transcription errors;
Informed Consent/Hemodilution (Policy 15.3)


Many OPOs archiving the serum sample but do not document it in the
donor record
Hemodilution calculation errors often caused by not including all
administered fluids
Allocation not following match run (Policy 5.4.B)

Expedited placements
How does the MPSC make
decisions?
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No one knows, it’s a
secret!
Flipping a coin
They do whatever they
can to get people in
trouble!
Using guidelines in the
Bylaws
No
A.
MPSC 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
judgment
What can the MPSC do to me?
1
1
or
m
at
io
n
Ch
Re
q
ue
s
ti
nf
to
m
e
In
vi
te
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yp
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am
an
ts
!
w
Sh
ut
d
4.
it
3.
1
ha
te
ve
r
2.
Whatever it wants!
Shut down my program
Invite me to Chicago
Request information
W
1.
MPSC 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 action
Letters 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 decision
Probation 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 released
MPSC Actions Since 2000
3
8
43
47
283
Member Not in Good Standing
Probation
Letter of Warning
Notice of Uncontested Violation
Letter of Reprimand
Where can I get help?
1
UN
OS
R
es
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fr o
m
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sa
ve
M
y
4.
1
ca
n
3.
ng
2.
Nothing can save you
from the MPSC!
My crystal ball will tell me
what to do
My peers
UNOS Resources
No
th
i
1.
MPSC & 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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