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BCTXP > Regulatory > Flashcards

Regulatory Flashcards

1
Q

What did the National Organ Transplant Act in 1984 Establish?

A

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

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2
Q

What is OPTN? Their role?

A

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

  1. Create policies for hospitals, OPOs, HLA labs
  2. Establish membership requirements for organizations to participate in US txp network
  3. Evaluate each organization via UNOS
  4. Reports program findings to CMS
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3
Q

What is UNOS? Their role?

A

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
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4
Q

What is SRTR? Their role?

A

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
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5
Q

What is role of CMS in txp?

A

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
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6
Q

Who holds SRTR contract?

A

Chronic Disease Research Group (Private, non-profit)

Division of HHRI - Hennepin Healthcare Research Institute

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7
Q

How many OPOs in the US

A

57

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8
Q

Role of OPOs

A
  1. Increase # of donors

2. Coordinate donation product

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9
Q

Who oversees OPOs?

A

CMS (regulated by CMS CoPs)

OPTN (OPO under membership of OPTN, must follow policies and report data)

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10
Q

Where does SRTR get their data?

A
  1. OPTN
  2. CMS
  3. Nat’l Tech Info Service death master File
  4. Nat’l Cancter Instit Txp Cancer Match Study
  5. Pharmacy claims database
  6. CF Foundation registry
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11
Q

To whom does SRTR provider data?

A
  1. Federal government
  2. Private insurance providers
  3. OPTN
  4. External investigators
  5. Public
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12
Q

What are the publicly released data reports by SRTR

A
  • Program-specific reports
  • OPO-specific reports
  • Annual data report
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13
Q

How often is the program specific report produced by SRTR

A

Twice annually

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14
Q

Time points evaluated for survival by SRTR as part of PSR

A

1 month
1 year
3 months

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15
Q

How does SRTR adjust for risk level of transplants done within program?

A

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

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16
Q

How does SRTR PSR express observed survival vs expected survival?

A

Hazard Ratio
Ratio >1 = more deaths vs national experience
Ratio <1 = less deaths

17
Q

What is UNet & what is its role

A

Data collection system (transmitted to SRTR)

  1. Access and complete electronic data collection form
  2. Manage list of waiting txp candidates
  3. Add donor info
  4. Run donor-recipient matching lists
  5. Access various txp data reports and policies
18
Q

What is the purpose of OPTN Bylaws

A

Outline membership requirements

19
Q

OPTN - do the Bylaws specify including pharmacists on team?

A

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

20
Q

OPTN - what does Bylaws say about role of pharmacists

A
  • 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
21
Q

OPTN/MPSC criteria for evaluating txp program performance to identify programs for review

A

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

22
Q

What must a txp program do to obtain CMS approval

A
  1. Be located within hospital that has Medicare provider agreement
  2. Meet all hospital CoPs
  3. Meet all transplant CoPs
23
Q

CMS - does the CoP specify including pharmacists on team?

A

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.

24
Q

CMS - what does the CoP say about role of pharmacists

A

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)
25
Q

Pharmacist role in transplant and discharge phase per CMS

A

None, txp program must have written patient management policies tho. Same for living donor (evaluation, donation, discharge)

26
Q

Per CMS, how often much each discipline meet with the patient during transplant & discharge phase

A
  • Initial eval (do not need to see again unless identified needs)
  • After surgery
  • As often as needed by identified issues
  • Prior to discharge
27
Q

What must be included in medical record for documentation of post-txp care - CMS

A

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

BCTXP (11 decks)

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