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Regulatory Data Submission (1.07)

Regulatory Data Submission (1.07) - Policies, Administrative, UWHC, Department Specific, UW Organ and Tissue Donation

1.07



POLICY
Established Date: December 2009
Effective Date: January 2018
Title: Regulatory Data Submission Policy Number: 1.07

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 1 of 2
PURPOSE

The purpose of this policy is to ensure University of Wisconsin Organ and Tissue Donation (UW OTD) fulfills
regulatory requirements for data submission for the Centers for Medicare and Medicaid Services (CMS),
United Network for Organ Sharing (UNOS), and Association of Organ Procurement Organizations (AOPO).
UW OTD will comply with all applicable data submission regulatory requirements for patients evaluated for
organ donation potential in the UW OTD designation service area (DSA). Timeliness of data submissions
will be evaluated by various regulatory agencies.

POLICY

A. UW OTD organ procurement coordinator (OPC) will complete the following UNOS electronic
submissions:
1. Deceased Donor Feedback – The form will be automatically generated in UNET (a UNOS
provided website) for any patient of which a UNOS ID was created. The form will be
submitted within four business days after the cross clamp date for patients that have a
cross clamp date. For patients that do not have a cross clamp date, the form will be
submitted by the deadline automatically assigned by UNET.
2. Deceased Donor Registration (DDR) – The form will be automatically generated in UNET
based on data entered in the deceased donor feedback form. The form will be
submitted within 30 calendar days after the deceased donor feedback form was
submitted. The deadline will be automatically assigned by UNET.
3. Potential Transplant Recipient Data (PTR) – The PTR form will be submitted for every
match run that is created by UW OTD staff. The form will be submitted within seven
calendar days after the cross clamp date for patients that have a cross clamp date. For
patients that do not have a cross clamp date, the form will be submitted by the deadline
automatically assigned by UNET.
4. Death Notification Registration (DNR) – For imminent or eligible deaths as defined by
UNOS in which the patient also has a cross clamp date, the form will be submitted within
seven calendar days after cross clamp date. For imminent or eligible deaths in which the
patient does not have a cross clamp date:
i. If the patient was referred to UW OTD, the form will be submitted by the senior
OPC on or before the first Thursday of the following month after the referral was
made.



POLICY
Established Date: December 2009
Effective Date: January 2018
Title: Regulatory Data Submission Policy Number: 1.07

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 2 of 2
ii. If the patient was not referred to UW OTD (i.e. a missed referral), the form will be
submitted by the senior OPC timely after the senior OPC is notified.
B. The senior OPC will review and verify DNR submissions. This review will be completed by the
first Thursday of the following month after the referral was made for patients that were referred
to UW OTD.
C. The UW OTD operations manager, clinical and donor family services or designee will oversee the
timeliness of data submissions completed by OPC staff. The operations manager, clinical and
donor family services or designee will monitor the deadline information available on UNET at
least twice weekly and will complete the appropriate follow-up action to ensure all data
submissions are completed on or before the deadline.
D. The UW OTD data coordinator will complete the following UNOS electronic submissions:
1. Monthly Donation Data Report – Data for all deaths reported by a DSA hospital 30
calendar days after the end of the month in which a DSA hospital reported a death to
UW OTD. The Statline Referral Statistics Hospital Analysis report will be used to identify
reported deaths.
2. Monthly Deceased Donor Conformation Report – The data coordinator will confirm
organs recovered for transplantation data from deceased donors.
E. The UW OTD data coordinator will verify the accuracy of the following Scientific Registry of
Transplant Recipients (SRTR) data tables semi-annually and as needed:
1. Measures of donation rate
2. Measures of donation rates by hospital
3. Organ utilization
4. Observed and expected organ yield
5. Organs recovered per donor
6. Trends in organs transplanted per donor
7. Trends in organ donation
F. The UW OTD data coordinator will notify senior OPC to verify accuracy. Senior OPC will correct
any discrepancies in submitted data.
G. The UW OTD data coordinator will complete the AOPO electronic submission of the monthly
profile survey data 30 calendar days after the end of the month that is being reported.