60 Safety Situation_Form.xlsx

			Safety Situation
			Fields to be completed by members
			Form Section	Field Label	Notes
			Situation Information	Reporting Institution
			Situation Information	Type of Safety Event (Choose all categories and subcategories that are applicable)
			Situation Information	The issue reported involved the following (choose all categories that are applicable)
			Situation Information	Communication
			Situation Information	Data Entry
			Situation Information	Data Entry - DonorNet
			Situation Information	Data Entry - Waitlist
			Situation Information	Data Entry - Other
			Situation Information	Transportation
			Situation Information	Transportation - Airline (commercial)
			Situation Information	Transportation - Airline (charter/private)
			Situation Information	Transportation – Ground
			Situation Information	Transportation - Other (please describe in the description field below)
			Situation Information	Packaging/Shipping
			Situation Information	Labeling
			Situation Information	Recovery Procedure/Process
			Situation Information	Transplant Procedure/Process
			Situation Information	Testing
			Situation Information	Testing – ABO
			Situation Information	Testing – HLA
			Situation Information	Testing - Infectious Disease
			Situation Information	Testing – Other (Please describe in the description field below)
			Situation Information	Organ Allocation/Placement
			Situation Information	Other (please describe in description field below)
			Situation Information	The issue reported involves the following (choose all categories that are applicable): Recipient/Candidate
			Situation Information	Waitlist ID
			Situation Information	SSN
			Situation Information	Donor Organ/Extra Vessels
			Situation Information	Donor ID associated with the event
			Situation Information	Did this event involve the entire donor or were only specific organs involved?
			Situation Information	Organ Type
			Situation Information	Did this safety situation cause or contribute to
			Situation Information	The discard of any organ(s)?
			Situation Information	A delay (prologue ischemic time) for any organ(s) transplanted?
			Situation Information	Other (please describe in the description field below)
			Situation Information	Date Event Occurred
			Situation Information	Detailed description of the event
			Situation Information	Has a root cause analysis (RCA) been completed?
			Situation Information	Please specify additional details regarding the RCA
			Contact Information	Who at your institution should OPTN contact about this case?
			Contact Information	First Name
			Contact Information	Last Name
			Contact Information	Phone contact (Enter at least one)
				Office
			Contact Information	ext.	Optional
			Contact Information	Pager/Beeper	Optional
			Contact Information	ext.	Optional
			Contact Information	Mobile	Optional
			Contact Information	ext.	Optional
			Contact Information	Email
			Contact Information	Other contact info	Optional
			Contact Information	ext.	Optional
			Contact Information	Submit
			PUBLIC BURDEN STATEMENT:
			The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0157 and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.7 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or [email protected].