Organ Labeling and Packaging System

OMB No. 0915-0157; Expiration Date: XX/XX/202X

Organ Labeling and Packaging

Enter donor data into organ labeling and packing system to generate labels

A logged in user has the ability to enter donor data into the organ labeling and packing system to print labels for organs and other donor items related to transplantation (i.e. blood, spleen, nodes, extra vessels).

Donor Setup – Donor Hospital

Hospital Name: Donor hospital name. This field is required.

City: Donor hospital city.

State: Donor hospital state.

Zip: Donor hospital zip code.

Time Zone: Donor hospital time zone.

Eastern

Central

Mountain

Pacific

Alaska

Hawaii

Atlantic

DST Observed: Donor hospital time zone observes daylight savings time.

Donor Setup – Donor Info

Donor ID: OPTN assigned donor identification. This field is required.

ABO: Donor blood type and subtype. This field is required.

O

A

A1

A2

B

AB

A1B

A2B

Date of Birth: Donor’s date of birth. Format: MM/DD/YYYY. This field is required.

Donor Initials: Donor’s initials. This field is required.

Local ID: Organ procurement organization assigned donor identification.

Verified Donor ID: Verified OPTN assigned donor identification. This field is required.

Verified ABO: Verified donor blood type and subtype. This field is required.

Verified Date of Birth: Verified donor date of birth. Format MM/DD/YYYY. This field is required.

Verified Donor Initials: Verified donor’s initials. This field is required.

Verified Local ID: Verified organ procurement organization assigned donor identification.

Blood & Culture Labels – Blood Tubes With ABO

Draw Date: Donor blood draw date for labels with ABO. Format: MM/DD/YYYY. This field is required.

Draw Time: Donor blood draw time for labels with ABO. Format: HH:MM. This field is required.

Initials: Initials of personnel drawing donor blood for labels with ABO. This field is required.

Comments: Optional comments for labels with ABO.

Blood & Culture Labels – Blood Tubes Without ABO

Draw Date: Donor blood draw date for labels without ABO. Format: MM/DD/YYYY.

Draw Time: Donor blood draw time for labels without ABO. Format: HH:MM.

Initials: Initials of personnel drawing donor blood for labels without ABO.

Comments: Optional comments for labels without ABO.

Blood & Culture Labels – Cultures

Draw Date: Donor culture draw date. Format: MM/DD/YYYY.

Draw Time: Donor culture draw time. Format: HH:MM.

Initials: Initials of personnel drawing culture.

Type: Type of culture drawn.

Site: Location of culture drawn.

Infectious Disease Results

Anti-HBc: Infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Anti-HIV I/II: Infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

HIV Ag/Ab Combo: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

HIV NAT: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

HBsAg: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

HBV NAT: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

Anti-HCV: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

HCV NAT: Infectious disease test result (Values: Positive, Negative, Not done, Indeterminate, Pending).

Positive

Negative

Not done

Indeterminate

Pending

PHS Increased Risk Donor?: Predetermined set of conditions that put a donor at an increased risk for disease transmission status.

Yes

No

Verified Anti-HBc: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified Anti-HIV I/II: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified HIV Ag/Ab Combo: Infectious disease result.

Positive

Negative

Not done

Indeterminate

Pending

Verified HIV NAT: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified HBsAg: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified HBV NAT: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified Anti-HCV: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified HCV NAT: Verified infectious disease test result.

Positive

Negative

Not done

Indeterminate

Pending

Verified PHS Increased Risk Donor?: Predetermined set of conditions that put a donor at an increased risk for disease transmission status.

Yes

No

Procurement Plan

Heart: Organ type selected for donation.

Left Lung: Organ type selected for donation.

Right Lung: Organ type selected for donation.

Lungs Enbloc: Organ type selected for donation.

Liver: Organ type selected for donation.

Liver Split Left: Organ type selected for donation.

Liver Split Right: Organ type selected for donation.

Pancreas: Organ type selected for donation.

Left Kidney: Organ type selected for donation.

Right Kidney: Organ type selected for donation.

Kidneys Enbloc: Organ type selected for donation.

Intestine: Organ type selected for donation.

Procurement

Date: Date donor aorta was cross clamped. Format: MM/DD/YYYY. This field is required.

Time: Time donor aorta was cross clamped. Format: HH:MM. This field is required.

Procurement – Organ Detail

­Ice Date: Date the donor organ was put on ice. Format: MM/DD/YYYY. This field is required.

Ice Time: Time the donor organ was put on ice. Format: HH:MM. This field is required.

Initials: User initials who entered the ice date/time. This field is required.

Ice Date 2: Second date the donor organ was put on ice. Format: MM/DD/YYYY.

Ice Time 2: Second time the donor organ was put on ice. Format: HH:MM.

Initials 2: User initials who entered the second ice date/time.

Tissue/Extra Vessel Labels

Ice Date: Date the donor organ was put on ice. Format: MM/DD/YYYY.

Ice Time: Time the donor organ was put on ice. Format: HH:MM.

Initials: User initials who entered the ice date/time.

Ice Date 2: Second date the donor organ was put on ice. Format: MM/DD/YYYY.

Ice Time 2: Second time the donor organ was put on ice. Format: HH:MM.

Initials 2: User initials who entered the second ice date/time.

VCA Packaging

­Excision Date (Right): Date the VCA organ was excised. Format: MM/DD/YYYY.

Excision Time (Right): Time the VCA organ was excised. Format: HH:MM.

Excision Date (Left): Date the VCA organ was excised. Format: MM/DD/YYYY.

Excision Time (Left): Time the VCA organ was excised. Format: HH:MM.

Ice Date: Date the donor VCA organ was put on ice. Format: MM/DD/YYYY.

Ice Time: Time the donor VCA organ was put on ice. Format: HH:MM.

Initials: User initials who entered the ice date/time.

Ice Date 2: Second date the donor VCA organ was put on ice. Format: MM/DD/YYYY.

Ice Time 2: Second time the donor VCA organ was put on ice. Format: HH:MM.

Initials 2: User initials who entered the second ice date/time.

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 0.27 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 Information Collection Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857 or [email protected].   

OPTN Restricted

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