Regulatory Flashcards
What did the National Organ Transplant Act in 1984 Establish?
Organ Procurement and Transplantation Network (OPTN) to maintain a national registry for organ matching.
The act also called for the network to be operated by a private, non-profit organization under federal contract. (UNOS)
& SRTR
What is OPTN? Their role?
Organ Procurement and Transplantation Network
Public-private partnership under Dept of. HHS
Role: Inc # of txp, provide fair and equitable access to transplantation, promote donor and recipient safety, improve patient outcomes
- Create policies for hospitals, OPOs, HLA labs
- Establish membership requirements for organizations to participate in US txp network
- Evaluate each organization via UNOS
- Reports program findings to CMS
What is UNOS? Their role?
United Organ Sharing Network
Contractor for OPTN
Role:
- Manage waitlist
- Maintain transplant database
- Monitoring each organ allocation for policy compliance
- Perform site surveys of participating organizations
- Educating public and transplant professionals about organ donation and txp processes
What is SRTR? Their role?
Scientific Registry of Transplant Recipients
Role: Collect, analyze and report transplant data: 1. Program-specific reports 2. OPO-specific report 3. Annual Data Report Other analyses
What is role of CMS in txp?
Largest insurance payor for organ transplantation
- Establishes Conditions of Practice (CoPs) for txp programs to part icipate in Medicare
- Provides quality and safety oversight
- Collect data from OPTN/UNOS to evaluate for compliance to CoPs
- Performs onsite evaluations to ensure compliance
Who holds SRTR contract?
Chronic Disease Research Group (Private, non-profit)
Division of HHRI - Hennepin Healthcare Research Institute
How many OPOs in the US
57
Role of OPOs
- Increase # of donors
2. Coordinate donation product
Who oversees OPOs?
CMS (regulated by CMS CoPs)
OPTN (OPO under membership of OPTN, must follow policies and report data)
Where does SRTR get their data?
- OPTN
- CMS
- Nat’l Tech Info Service death master File
- Nat’l Cancter Instit Txp Cancer Match Study
- Pharmacy claims database
- CF Foundation registry
To whom does SRTR provider data?
- Federal government
- Private insurance providers
- OPTN
- External investigators
- Public
What are the publicly released data reports by SRTR
- Program-specific reports
- OPO-specific reports
- Annual data report
How often is the program specific report produced by SRTR
Twice annually
Time points evaluated for survival by SRTR as part of PSR
1 month
1 year
3 months
How does SRTR adjust for risk level of transplants done within program?
Risk Adjusted Models - refit every PSR and rebuilt Q3 years
Predicts expected survival –> fraction of recipients at txp program who would be expected to be alive or have functioning graft at each time point based on the national experience for similar patients
How does SRTR PSR express observed survival vs expected survival?
Hazard Ratio
Ratio >1 = more deaths vs national experience
Ratio <1 = less deaths
What is UNet & what is its role
Data collection system (transmitted to SRTR)
- Access and complete electronic data collection form
- Manage list of waiting txp candidates
- Add donor info
- Run donor-recipient matching lists
- Access various txp data reports and policies
What is the purpose of OPTN Bylaws
Outline membership requirements
OPTN - do the Bylaws specify including pharmacists on team?
Yes D.9. Other txp program personnel
“Txp programs must have other support personnel on staff to ensure quality patient care”
Which goes on to include…
Clinical Transplant Pharmacist
OPTN - what does Bylaws say about role of pharmacists
- Provider pharmaceutical expertise to txp recipients
- Provide comprehensive pharmaceutical care to txp recipients as part of txp team
- Work with patients, families, txp team
- Should be licensed pharmacist with experience in transplant pharmacotherapy
OPTN/MPSC criteria for evaluating txp program performance to identify programs for review
Programs doing 10+ txps in 2.5 year (either A or B for death or graft failure)
A. Probability HR >1.2 is >75%
B. Probability HR >2.5 is >10%
Programs doing 9 or less txps in 2.5 years –> program has 1+ events
What must a txp program do to obtain CMS approval
- Be located within hospital that has Medicare provider agreement
- Meet all hospital CoPs
- Meet all transplant CoPs
CMS - does the CoP specify including pharmacists on team?
Nope. Under “Transplant Team” states there must be an individual with appropriate qualifications, training and experience in relevant areas including pharmacology.
AKA Other disciplines may be qualified to provide pharmacology services - physician, NP, PA.
CMS - what does the CoP say about role of pharmacists
Phases of care in which patient should have multidisciplinary care
- Patient: txp (eval to surg), discharge (surg to hosp DC)
- Living donor: eval (eval to surg), donation (OR to hosp DC), discharge (hosp admit to hosp DC)
- Waitlist management/ updating clinical information
- Patient records (from evaluation to txp)
Pharmacist role in transplant and discharge phase per CMS
None, txp program must have written patient management policies tho. Same for living donor (evaluation, donation, discharge)
Per CMS, how often much each discipline meet with the patient during transplant & discharge phase
- Initial eval (do not need to see again unless identified needs)
- After surgery
- As often as needed by identified issues
- Prior to discharge
What must be included in medical record for documentation of post-txp care - CMS
Documentation of multidisciplinary care planning; may include but are not limited to:
- F/u appt
- Contact info for staff
- S/sx of complication
- Nutrition plan
- Psychosocial plan
- Activity restrictions and limitations
- Need for coordination of other health services
- Med and med administration
