Form B6 B6_HR Heart_Clean

Organ Procurement and Transplantation Network Application Form

B6_Heart_Clean

B Heart (HR) Designated Program Application

OMB: 0915-0184

Document [doc]
Download: doc | pdf

Department of Health and Human Services OMB No. 0915-0184

Health Resources and Services Administration Expiration Date:  xx/xx/xxxx


Part 3: Heart Transplant Program



Table 1: OPTN Staffing Report


OPTN Member Code:

Name of Transplant Hospital:

Main Program Phone Number:


Main Program Fax Number:


Hospital URL: http://www


Toll Free Phone Number for Patients:


Hospital Number:


Refer to the staffing audit sent with this application and complete the table below for staff that are not captured on the staffing audit or to update information for current staff, including deleting (DEL) an individual. If you did not receive an audit with this application, complete the entire staffing report. Add additional rows as necessary. Make sure to use individuals’ full, legal names (middle name/initial also included when possible) to prevent duplicate entries within the UNOS Membership Database and UNet.


Identify the transplant program medical and/or surgical director(s).

DEL

Name

Address

Phone

Fax

Email














Identify the primary surgeon and additional surgeon(s) who perform transplants for the program.

DEL

Name

Address

Phone

Fax

Email




















Identify other surgeon(s) who perform transplants for the program.

DEL

Name

Address

Phone

Fax

Email














Identify the primary physician and additional physicians (internists) who participate in this transplant program.

DEL

Name

Address

Phone

Fax

Email














Identify other physicians (internists) who participate in this transplant program.

DEL

Name

Address

Phone

Fax

Email














Identify the transplant program administrator(s)/hospital administrative director(s)/manager(s) who will be involved with this program. The * denotes the primary transplant administrator.

DEL

Name

Address

Phone

Fax

Email


*












Identify the clinical transplant coordinator(s) who will be involved in this transplant program.

DEL

Name

Address

Phone

Fax

Email














Identify the data coordinator(s) who will be involved in this transplant program. The * denotes the primary data coordinator.

DEL

Name

Address

Phone

Fax

Email


*






Identify the social worker(s) who will be involved with this program.

DEL

Name

Address

Phone

Fax

Email














Identify the pharmacist(s) who will be involved with this program.

DEL

Name

Address

Phone

Fax

Email














Identify the financial counselor(s) who will be involved with this program.

DEL

Name

Address

Phone

Fax

Email














Identify the anesthesiologists who will be involved with this program. The * denotes the director of anesthesiology.

DEL

Name

Address

Phone

Fax

Email


*












Identify the QAPI team members who will be involved with this program.

DEL

Name

Address

Phone

Fax

Email














Identify any other transplant staff who will be involved with this program.

DEL

Name

Title

Address

Phone

Fax

Email








Part 3A: Personnel – Transplant Program Director(s)


1. Identify the transplant program surgical and/or medical director(s) of the heart transplant program and submit a C.V. for each program director. Briefly describe the leadership responsibilities for each individual.



Name

Date of Appointment

Primary Areas of Responsibility








Part 3B, Section 1: Personnel – Surgical – Primary Surgeon


1. Identify the primary transplant surgeon:


Name:

  1. Provide the following dates (use MM/DD/YY):


Date of employment at this hospital:

Date assumed role of primary surgeon:

b) Does the surgeon have FULL privileges at this hospital?


Yes


No



If the surgeon does not currently have full privileges:


Date full privileges to be granted (MM/DD/YY):

Explain the individual’s current credentialing status, including any limitations on practice:




c) How much of the surgeon’s professional time is spent on site at this hospital?


Percentage of professional time on site:

Number of hours per week:


d) How much of the surgeon’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?


Facility Name

Type

Location (City, State)

% Professional Time On Site














e) List the surgeon’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If individual has been recertified, use that date. Provide a copy of certification(s). If the surgeon does not have current American or Canadian board certification, provide letters of recommendation requesting this exception and provide the plan for continuing education as described in the OPTN Bylaws.


Certification Type

Certificate Effective Date

(MM/DD/YY)

Certificate Valid Through Date

(MM/DD/YY)

Certification Number













f) Check the applicable pathway(s) through which the surgeon will be proposed. Refer to the OPTN Bylaws for the necessary qualifications and more specific descriptions of the required supporting documents.


Membership Criteria


Cardiothoracic Surgery Residency Pathway


Twelve-Month Heart Transplant Fellowship Pathway


Clinical Experience Pathway


Alternative Pathway for Predominately Pediatric Programs



g) Transplant Experience (Post Fellowship) and Training (Fellowship): List the name(s) of the transplant hospital(s), applicable dates, program director name(s), and the number of transplants and procurements performed by the surgeon at each transplant hospital.



Training and Experience

ABTS

Approved Program?

Y/N

Date

(MM/DD/YY)

Transplant Hospital

Program Director

# of Transplants as Primary

# of Transplants as 1st Assistant

# of Procurements as Primary or 1st Assistant

Start

End

HR

HL

HR

HL

HR

HL

Residency Training























Fellowship Training























Experience Post Fellowship



































h) Describe in detail the proposed primary surgeon's level of involvement in this transplant program as well as prior training and experience.



Describe Level of Involvement in This Transplant Program

Describe Prior Training/Experience

Pre-Operative Patient Management



Recipient Selection



Donor Selection



Transplant Surgery



Post-Operative Hemodynamic Care



Use of Mechanical Assist Devices



Post-Operative Immunosuppressive Therapy



Outpatient Follow-Up



Coverage of Multiple Transplant Hospitals (if applicable)



Additional Information




Table 2: Primary Surgeon - Transplant Log (Sample)


Complete a separate form for each transplant hospital.


Organ:



Name of proposed primary surgeon:



Name of hospital where transplants were performed:


Date range of surgeon’s appointment/training:

MM/DD/YY to MM/DD/YY



List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#

Date of Transplant

Medical Record/ OPTN ID #

Primary Surgeon

1st Assistant

1





2





3





4





5





6





7





8





9





10





11





12





13





14





15





16





17





18





19





20





21





22





23





24





25





26





27





28





29





30






Director’s Signature

Date

Print Name



Table 3: Primary Surgeon - Procurement Log (Sample)


Organ:



Name of proposed primary surgeon:




List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#

Date of Procurement

Donor ID

Number

Comments

(LD/CAD/Multi-Organ)

1




2




3




4




5




6




7




8




9




10




11




12




13




14




15




16




17




18




19




20




21




22




23




24




25




26




27




28




29




30





Director’s Signature

Date

Print Name



Part 3B, Section 2: Personnel – Additional Surgeon(s)


Complete this section of the application to describe surgeons involved in the program that are not designated as primary, but are credentialed by the transplant hospital to provide transplant services and independently manage the care of transplant patients, including performing the transplant operations and organ procurement procedures. Duplicate this section as needed.


1. Identify the additional transplant surgeon:


Name:


a) Provide the following dates (use MM/DD/YY):


Date of employment at this hospital:


b) Does the surgeon have FULL privileges at this hospital?


Yes


No



If the surgeon does not currently have full privileges:


Date full privileges to be granted (MM/DD/YY):

Explain the individual’s current credentialing status, including any limitations on practice:




c) How much of the surgeon’s professional time is spent on site at this hospital?


Percentage of professional time on site:

Number of hours per week:


d) How much of the surgeon’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?


Facility Name

Type

Location (City, State)

% Professional Time On Site










e) List the surgeon’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the surgeon has been recertified, use that date.


Board Certification Type

Certification Effective Date/ Recertification Date

(MM/DD/YY)

Certification Valid Through Date

(MM/DD/YY)

Certificate Number





Part 3C, Section 1: Personnel – Medical – Primary Physician


1. Identify the primary transplant physician:


Name:


a) Provide the following dates (use MM/DD/YY):


Date of employment at this hospital:

Date assumed role of primary physician:


b) Does the physician have FULL privileges at this hospital? (check one)


Yes


No



If the physician does not currently have full privileges:


Date full privileges to be granted (MM/DD/YY):

Explain the physician’s current credentialing status, including any limitations on practice:




c) How much of the physician’s professional time is spent on site at this hospital?


Percentage of professional time on site:

Number of hours per week:


d) How much of the physician’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?


Facility Name

Type

Location

(City, State)

% Professional Time On Site










e) List the physician’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the physician has been recertified, use that date. Also provide a copy of the certification(s). If the physician does not have current American or Canadian board certification, provide letters of recommendation requesting this exception and the plan for continuing education as described in the OPTN Bylaws.


Board Certification Type

Certification Effective Date/ Recertification Date

(MM/DD/YY)

Certification Valid Through Date

(MM/DD/YY)

Certificate Number










f) Check the applicable pathway(s) through which the physician will be proposed. Refer to the OPTN Bylaws for the necessary qualifications and more specific descriptions of the required supporting documents.



Membership Criteria


Twelve-Month Transplant Cardiology Fellowship Pathway


Clinical Experience


Alternate Pathway for Predominately Pediatric Programs


Conditional Approval



g) Transplant Experience (Post Fellowship) and Training (Fellowship): List the name(s) of the transplant hospital(s), applicable dates, program director name(s), and the number of transplant patients for which the physician provided substantive patient care (pre-, peri- and post-operatively from the time of transplant).


Tr

Training and Experience

Date

(MM/DD/YY)

Transplant Hospital

Program

Director

# Heart

Patients Followed

# Heart/Lung

Patients Followed

Start

End

Pre

Peri

Post

Pre

Peri

Post

Fellowship Training































Experience

Post Fellowship































h) Training/Experience: List how the physician fulfills the criteria for participating as an observer of heart or heart/lung procurements and heart or heart/lung transplants. For procurements, the physician must have observed the evaluation, donation process, and management of the donors.


Date

From - To

(MM/DD/YY)

Transplant Hospital

# of HR/HL Procurements Observed

# of HR/HL Transplants Observed










i) Describe in detail the proposed primary physician's level of involvement in this transplant program as well as prior training and experience.



Describe Level of Involvement in This Transplant Program

Describe Prior Training/Experience

Candidate Evaluation Process



Pre- and Post-Operative Hemodynamic Care



Post-Operative Immunosuppressive Therapy



Long-Term Outpatient Follow-Up



Care of Acute and Chronic Heart Failure



Use of Mechanical Assist Devices



Donor Selection



Recipient Selection



Histologic Interpretation and Grading of Myocardial Biopsies for Rejection



Coverage of Multiple Transplant Hospitals (if applicable)



Additional Information



Table 6: Primary Physician – Recipient Log (Sample)


Organ:



Name of proposed primary physician:



Name of transplant hospital where transplants were performed:


Date range of physician’s appointment/training: MM/DD/YY to MM/DD/YY



List cases in date order. Patient ID should not be name or Social Security Number. Extend lines on log as needed.

#

Date of Transplant

Medical Record/ OPTN ID #

Pre-Operative

Peri-Operative

Post-Operative

Comments

1







2







3







4







5







6







7







8







9







10







11







12







13







14







15







16







17







18







19







20







21







22







23







24







25







26







27







28







29







30








Director’s Signature

Date

Print Name




Table 7: Primary Physician – Observation Log (Sample)

Organ:



Name of proposed primary physician:




In the tables below, document the physician’s participation as an observer in heart or heart/lung transplants and heart or heart/lung procurements. For procurements, the physician must have observed the evaluation, donation process, and management of the donors.


List cases in date order. Patient ID should not be name or Social Security Number. Extend lines on log as needed.


Transplants Observed


#

Date of Transplant

Medical Record/ OPTN ID #

Hospital

1




2




3




4




5





Procurements Observed


#

Date of Procurement

Medical Record/ OPTN ID #

1



2



3



4



5



















Part 3C, Section 2: Personnel – Additional Physician(s)


Complete this section of the application to describe physicians involved in the program that are not designated as primary, but are credentialed by the transplant hospital to provide transplant services and be able to independently manage the care of transplant patients. Duplicate this section as needed.


1. Identify the additional physician:


Name:


a) Provide the following dates (use MM/DD/YY):


Date of employment at this hospital:


b) Does the physician have FULL privileges at this hospital? (check one)


Yes


No



If the physician does not currently have full privileges:


Date full privileges to be granted (MM/DD/YY):

Explain the physician’s current credentialing status, including any limitations on practice:


c) How much of the physician’s professional time is spent on site at this hospital?


Percentage of professional time on site:

Number of hours per week:


d) How much of the physician’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?


Facility Name

Type

Location

(City, State)

% Professional Time On Site










e) List the physician’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the physician has been recertified, use that date. Also provide a copy of the certification(s).


Board Certification Type

Certification Effective Date/ Recertification Date (MM/DD/YY)

Certification Valid Through Date

(MM/DD/YY)

Certificate Number









Table 8: Certificate of Investigation


1. List all transplant surgeons and physicians currently involved in the program.


a) This hospital has conducted its own peer review of all surgeons and physicians listed below to ensure compliance with applicable OPTN Bylaws. Expand rows as needed.


Names of Surgeons









Names of Physicians









  1. If prior transgressions were identified, has the hospital developed a plan to ensure that the improper conduct is not continued?


Yes


No


Not Applicable



If yes, what steps are being taken to correct the prior improper conduct or to ensure the improper conduct is not repeated in this program? Provide a copy of the plan.


I certify that this review was performed for each named surgeon and physician according to the hospital’s peer review procedures.


Signature of Primary Surgeon

Date

Print Name


Signature of Primary Physician

Date

Print Name



Table 9: Program Coverage Plan


1. Provide a copy of the current Program Coverage Plan and answer the questions below. The program coverage plan must be signed by either the:


a. OPTN/UNOS Representative;

b. Program Director(s); or

c. Primary Surgeon and Primary Physician.


Yes

No

Is this a single surgeon program?



Is this a single physician program?



If single surgeon or single physician, submit a copy of the patient notice or the protocol for providing patient notification.

Does this transplant program have transplant surgeon(s) and physician(s) available 365 days a year, 24 hours a day, 7 days a week to provide program coverage?



If the answer to the above question is “No,” an explanation must be provided that justifies why the current level of coverage should be acceptable to the MPSC. Please use the additional information section below.

Transplant programs shall provide patients with a written summary of the Program Coverage Plan at the time of listing and when there are any substantial changes in program or personnel. Has this program developed a plan for notification?



Is a surgeon/physician available and able to be on the hospital premises to address urgent patient issues?



Is a transplant surgeon readily available in a timely manner to facilitate organ acceptance, procurement, and implantation?



A transplant surgeon or transplant physician may not be on call simultaneously for two transplant programs more than 30 miles apart unless circumstances have been reviewed and approved by the MPSC. Is this program requesting an exemption?



If yes, provide explanation:




Unless exempted by the MPSC for specific causal reasons, the primary transplant surgeon/primary transplant physician cannot be designated as the primary surgeon/primary transplant physician at more than one transplant hospital unless there are additional transplant surgeons/transplant physicians at each of those facilities. Is this program requesting an exemption?




If yes, provide explanation:


Additional information:





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