The Challenges of Regulatory Compliance and Quality Outcomes An OTTR Solution Gene Ridolfi RN BA MHA Administrative Director Introduction The numbers are well known gt100000 people are currently waiting for a life saving transplant ID: 780167
Download The PPT/PDF document "Organ Transplantation Looking Forward:" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Organ Transplantation Looking Forward:The Challenges of Regulatory Compliance and Quality Outcomes: An OTTR Solution
Gene Ridolfi, RN, BA, MHA
Administrative Director
Slide2IntroductionThe numbers are well known:
>100,000 people are currently waiting for a life saving transplant.
>6,000 people per year die while waiting for a life saving organ transplant.
Waitlist for organ transplant grows annually on an average of 19%.
Rate of organ donation from deceased donors in the U.S. has averaged around increases of 3.7% over the last decade.
Only about half of the families of potential organ donors consent to organ donation.
Slide3Solid-Organ Transplantation:Regulatory Oversight
A number of sources for regulatory oversight exist, each with its own perspective regarding solid-organ transplantation activities. Additional agencies oversee bone marrow transplantation, but for programs providing only solid-organ transplantation the important sources are the following:
OPTN
UNOS
Scientific Registry of Transplant Recipients (SRTR)
CMS
HHSESRD NetworkJCAHOOffice of the Inspector General (OIG)ACOT
Progress in Transplantation, Vol 17, No. 2, June 2007
Slide4Solid-Organ Transplantation:What does Regulatory Oversight Look Like
HHS
US Department of Health and Human Services
HRSA
Health Resources and Services Administration
CMS
Centers for Medicare and Medicaid ServicesOPTNOrgan Procurement and Transplantation Network
SRTR
Scientific Registry of Transplant Recipients
Slide5Solid-Organ Transplantation:What does Regulatory Oversight Look Like
OPTN
Organ Procurement and Transplantation Network
UNOS
United Network for Organ Sharing
Kidney Committee
Liver Committee
MPSC
Membership and Professional Standards Committee
Board
Slide6Solid-Organ Transplantation:Regulatory Oversight
For programs providing histocompatibility laboratory services and/or operating their own organ procurement agency, the following agencies provide oversight:
Clinical Laboratory Improvement Amendments
American Society for Histocompatibility and Immunogenetics
Association of Organ Procurement Organizations
Transplant administrators should pay particular attention to the activities of the OPTN, UNOS, SRTR, CMS, HHS, ESRD Network, the OIG, JCAHO, and ACOT with respect to current and future regulations.
Progress in Transplantation, Vol 17, No. 2, June 2007
Slide7Regulatory Compliance in Solid-Organ TransplantationThe risk of non-compliance with policy and by-laws and/or poor outcomes in solid organ transplantation is significant and may lead to:
Probation
Suspension
Loss of Insurance Contracts (COE)
Program closure
Progress in Transplantation, Vol 17, No. 2, June 2007
Any and all of the above outcomes will negatively effect the ability for a program to grow and has the absolute possibility of financial devastation.
Slide8Regulatory Compliance in Solid-Organ TransplantationMost, if not all, regulatory compliance requirements support Patient Safety. Failure in compliance can lead to medical error and risks for patient safety.
Medical error and patient safety issues are, unfortunately, ubiquitous in health care delivery environments
About 1 in 10 patients is harmed while receiving care
44,000 to 96,000 people die each year as a result of preventable errors
Progress in Transplantation, Vol 17, No. 2, June 2007
Slide9Regulatory Compliance in Solid-Organ TransplantationProgress in Transplantation, Vol 17, No. 2, June 2007
Lets put this in perspective. Compare the above statistics to the chances of being harmed in a commercial airliner or in a nuclear power plant;
1 in 1,000,000
Slide10Do errors occur at high profile transplant centers?
Slide11Do errors occur at high profile transplant centers?
Slide12Do errors occur at high profile transplant centers?
Slide13Who is watching us and how?SRTR (mandatory outcomes analysis)MPSC (UNOS/OPTN) (peer review)
CMS (certification)
Who watches the watchers?
SRTR: STAC, HRSA, UNOS committees
MPSC: HRSA, UNOS committees and board
CMS: Congress
The Regulatory Environment
Slide14Use and effectiveness of a QAPI/RCAAdherence to systems guidelines (ABO, etc.)Ability to transplant those in need (access to the waitlist, waitlist outcomes, organ refusals, live-donor programs, innovation)
Short-term outcomes (length of stay, infections)
Patient/referring-provider satisfaction
Patient and Graft Survival
Evaluating Performance
What Could be Evaluated?
Slide15Top Policy Violations Identified During Site Visit
Documenting patient notification
Documenting ABO verification at time of listing
ABO typing x2 prior to listing candidates
Data entry errors of candidate status or errors
i
n documenting status
Not removing recipients from the waiting list within 24 hours of transplant
Communicate multiple listing
Slide16Top Safety Issues Reported / Identified
Errors in ABO typing, verification, and documentation
Data entry, transcription and other discrepancies
ABO/ABO subtyping
HLA
Donor ID
Donor and recipient height and weight
Incorrect packaging and/or labeling of organs or extra vessels
Incorrect organ sent or switched laterality
Failure to submit extra vessel disposition
Slide17Where do we go from here?
Facts:
Reimbursement is declining
Increased scrutiny of center compliance and outcomes
Additional resources will be limited
Charitable care is
increasing
Focused efforts to advance organ availability
Paired Donation
ABO incompatible
Highly sensitized patients
Living liver transplant
These efforts require close scrutiny to detail and increases resource utilization.
Slide18Where do we go from here?
We must enhance efficiency through work force reform. There are multiple avenues to achieve this:
Six Sigma / Lean Transformation
Standardize
Automate
Hard wire
Slide19What can HKS Solutions do to support
our effort?
First and foremost, its users must educate HKS Solutions about our requirements for compliance and measurement.
Simplify interfacing of HKS Solutions with multiple other databases and EMRs.
Automate hard stops around key steps of the transplant process in support of safety and compliance.
Build key process and quality scorecards.
Enhance application functionality to better support outcomes research.
Identify common practice to allow for development of standardization
Slide20HKS Solutions Opportunity (Examples)
Hard stop checklist supporting all documents completed.
Checklist complete confirmation.
Notification of transplanted patients in past 24 hours.
Add missing data to SRTR
Support real time graft and patient survival.
Living donor follow-up.
Drop down for diagnoses, removal codes to match UNOS
Expand statistical tools.
Slide21HKS Solutions Continued
Standardize/automate compliance metric scorecard.
Develop/automate process metric scorecards.
Simplify 1-year graft and patient survival.
Track/alert program specific patient death in 1-year.
Integrate SRTR donor and recipient covariates for risk adjustment.
Slide22HKS Solutions Continued
Block different ABO from being entered without verification step.
Round labs to match UNet form.
Add matching drop down menu from UNOS (ex: Reason removed from waitlist)
Address functionality for tracking patients with multi-organ transplant
Slide23HKS Solutions Opportunity (Examples)
Slide24HKS Solutions Opportunity (Examples)
Slide25HKS Solutions Opportunity (Examples)
Slide26In Closing
Transplant Centers need HKS Solutions help in support of CMS and OPTN policies.
We cannot add more people. We need IT solutions.