Form 1 Deceased Donor Registration

Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System

1 Deceased Donor Registration Instructions

OPTN- Deceased Donor Registration Worksheet

OMB: 0915-0157

Document [docx]
Download: docx | pdf

Deceased Donor Registration (DDR) Record Field Descriptions

Deceased Donor Registration (DDR) records are generated and available as soon as the donor organ disposition process (Donor Feedback) is completed in DonorNet®. The Deceased Donor Registration record is to be completed for all consented but not recovered and recovered donors.

A consented (written) but not recovered donor is one in which consent was obtained but the organs were not recovered for transplantation. Information about this donor is entered on the DDR record to determine why the donor's organs may not have progressed to donation.

A recovered organ donor refers to situations where consent was obtained and at least one organ was recovered for the purpose of transplantation.

The DDR record must be completed within 30 days from the record generation date. See OPTN Policy for additional information.  Use the search feature to locate specific policy information on Data Submission Requirements.

To correct information that is already displayed in an electronic record, call the UNetSM Help Desk at 1-800-978-4334.

Donor Information

The donor's ID # will be displayed at the top of this section.

OPO:  Verify the OPO name, code and Medicare provider number of the OPO responsible for the management of the donor.

Donor Hospital: Verify the hospital name and the Medicare provider number of the hospital that originally referred the donor. If this information is incorrect, you may make modifications in the donor record in DonorNet®. The information will then be updated in the DDR record. A list of Medicare provider numbers for your state can be obtained in the Donor Hospitals section of DonorNet®.

Referral Date: Enter the date of the initial donor referral call to the OPO. Use the standard 8-digit numeric format of MM/DD/YYYY. This field is required.

Recovered Outside the U.S.: If the organs were recovered outside of the United States, select Yes. If the organs were not recovered outside of the United States, select No. This field is required.

If Yes is selected, select the name of the Country, from the drop-down list, where the organs were recovered.

Last Name: Enter the donor’s last name. This field is required.

First Name: Enter the donor’s first name. This field is required.

Middle Initial: Enter the donor’s middle initial.

DOB: Enter the date the donor was born using the standard 8-digit numeric format of MM/DD/YYYY or enter the donor's Age in Years or Months.

Gender: Indicate if the donor is Male or Female. This field is required.

Height: Enter the height of the donor in ft (feet) and in (inches) or cm (centimeters). This field is required.

If the donor's height at the time of recovery is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). (List of Status codes)

Weight: Enter the weight of the donor in lbs (pounds) or kg (kilograms).  This field is required.

If the donor's weight at the time of recovery is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). (List of Status codes)

Home City: Enter the name of the city where the donor lived before hospitalization. If the donor did not live in the United States before hospitalization, enter the city and country of the donor's residence in the space provided. This field is required.

Note: If the donor is a non-U.S. resident, complete the Home City field, leave the State and Zip Code fields blank, and complete the Citizenship and Home Country fields located further below..

State: If the donor lived in the United States before hospitalization, select the state from the drop-down list where the donor's home city was located. (List of State codes – See Appendix A)

Zip Code: Enter the U.S. Postal Zip Code of the location where the donor lived before hospitalization.

Ethnicity/Race: Select, as appropriate, to indicate the donor's ethnicity/race. This field is required.

American Indian or Alaska Native: Select for donors who are of North, South, or Central American descent (e.g. American Indian, Eskimo, Aleutian, Alaska Indian). If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select American Indian or Alaska Native: Other. If unknown, select American Indian or Alaska Native: Not Specified/Unknown.

Asian: Select for donors who are of Asian descent (e.g. Asian Indian/Indian Sub-Continent, Chinese, Filipino, Japanese, Korean, Vietnamese). If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select Asian: Other. If unknown, select Asian: Not Specified/Unknown.

Black or African American: Select for donors of African descent (e.g. African American, African (Continental), West Indian, Haitian). If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select Black or African American: Other. If unknown, select Black or African American: Not Specified/Unknown.

Hispanic/Latino: Select for donors who are of Central or South American descent (e.g. Mexican, Puerto Rican (Mainland), Puerto Rican (Island), Cuban). If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select Hispanic/Latino: Other. If unknown, select Hispanic/Latino: Not Specified/Unknown.

Native Hawaiian or Other Pacific Islander: Select for donors who are descendants of the Native Hawaiian, Guamanian or Chamorro, or Samoan peoples. If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select Native Hawaiian or Other Pacific Islander: Other. If unknown, select Native Hawaiian or Other Pacific Islander: Not Specified/Unknown.

White: Select for donors who are of European Descent, Arab or Middle Eastern or North African (non-Black). If the donor belongs to the primary category, but does not belong to any of the subcategories listed, select White: Other. If unknown, select White: Not Specified/Unknown.

Citizenship: Select as appropriate to indicate the donor's citizenship. This field is required.

U.S. Citizen: A United States citizen by birth or naturalization.

Non-U.S. Citizen/U.S. Resident: A non-citizen of the United States for whom the United States is the primary place of residence.

Non-U.S. Citizen/Non-U.S. Resident: A non-citizen of the United States for whom the United States is not the primary place of residence.

Unknown – Citizenship could not be determined

Home Country:  If the donor is a non-U.S. citizen/non-U.S. resident, enter the donor's Home Country from the drop-down list (See Appendix E).  This field is required.

Cause of Death: Select the donor's cause of death from the drop-down list. This field is required. If the cause of death is not listed, select Other Specify, and enter the cause of death in the Specify field. If Other Specify is selected, this field is required.

Anoxia
Cerebrovascular/Stroke
Head Trauma
CNS Tumor
Other Specify

Mechanism of Death: Select the donor's mechanism of death from the drop-down list. If the mechanism of death is not listed, select None of the Above. This field is required.

Drowning
Seizure
Drug Intoxication
Asphyxiation
Cardiovascular
Electrical
Gunshot Wound
Stab
Blunt Injury
SIDS
Intracranial Hemorrhage/Stroke
Death from Natural Causes
None of the Above

Circumstances of Death: Select the donor's circumstances of death from the drop-down list. If the circumstance of death is not listed, select None of the Above. This field is required.

MVA
Suicide
Homicide
Child-Abuse
Non-MVA
Death from Natural Causes
None of the Above
Unknown

Procurement and Consent

Medical Examiner/Coroner: If the donor's death was reported to the medical examiner/coroner, select Yes, Medical Examiner Consented or Yes, Medical Examiner Refused Consent from the drop-down list. If the donor's death was not reported to the medical examiner/coroner, select No. If unknown, select Unknown. This field is required.

No
Yes, Medical Examiner Consented
Yes, Medical Examiner Refused Consent
Unknown

Was the patient legally declared brain dead: If the appropriate personnel legally declared the patient as brain dead, select Yes. If not, select No.

Cardiac arrest since neurological event that lead to declaration of brain death: If cardiac arrest occurred between a fatal brain injury event and organ recovery, select Yes. If cardiac arrest did not occur, select No. If No is selected for “Was the patient legally declared brain dead”, this field is required.

Note: With DCD donors, if cardiac arrest occurred during donor management, then select Yes. Otherwise, select No for DCD donors.

If Yes, Duration of Resuscitation: If cardiac arrest occurred between a fatal brain injury event and organ recovery, enter the total minutes of cardiac resuscitation. If Yes is selected for Cardiac arrest, this field is required.  If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Did the patient have written documentation of their intent to be a donor: If the patient had written documentation of their intent to be a donor, select Yes. If not, select No. If unknown, select Unk. This field is required.

If yes, indicate mechanisms (check all that apply): Select the type of documentation used for consent. This field is required if Yes is selected for written documentation. If the mechanism is not listed, select Other Specify, and enter the mechanism in the Specify field. If Other Specify is selected, this field is required.

Driver's license
Donor Card
Donor Registry
Durable Power of Attorney/Healthcare Proxy

Advanced Directive
Other Specify


Was the consent based solely on this documentation: If consent was based solely on this documentation, select Yes. If not, select No. If Yes is selected for written documentation, this field is required.

Did the patient express to family or others the intent to be a donor: If the patient expressed their intent to be a donor to their family or others, select Yes. If not, select No. If unknown, select Unk. This field is required.

Date and time of pronouncement of death (Complete for brain dead and DCD donors): Enter the date, using the standard 8-digit numeric format of MM/DD/YYYY, and military time of pronouncement of death of the donor. This field is required.

Date and time consent obtained for organ donation: Enter the date, using the standard 8-digit numeric format of MM/DD/YYYY, and military time consent was obtained for organ donation. This field is required. If consent is based solely on first person consent, the time of consent entered should be the time of death.



Clinical Information

ABO Blood Group: The donor's blood type reported in the donor record in DonorNet® displays. Verify the blood type displayed for the donor referred to your OPO.

A
A1
A1B
A2
A2B
AB
B
O
Z (In Utero Only)

Terminal Lab Data: For each of the laboratory tests enter the value, in the units indicated, from tests performed closest to the time of recovery. These fields are required. If a lab value is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Protein in Urine (Yes, No, UNK)

Serum Sodium (mEq/L)

BUN (mg/dl)

Serum Creatinine (mg/dl)

Total Bilirubin (mg/dl)

SGOT/AST (u/L)

SGPT/ALT (u/L)

INR

Hematocrit (%)

Pancreas (PA Donors Only): These fields are required for pancreas donors.

Serum Amylase (u/L)

Serum Lipase (u/L)

HbA1c (%)

Serology: For each of the tests listed, select the results from the drop-down lists (Cannot Disclose, Indeterminate, Negative, Not Done, Positive, or Unknown). These fields are required Enter results of serological tests only, do NOT enter results of NAT testing.

HIV Serology Results

HIV Antigen/Antibody

HTLV Serology Results

RPR-VDRL

Anti-CMV

HBsAg Serology Results

HBc Serology Results

HCV Serology Results

HBsAb

EBV (VCA) (lgG)

EBV (VCA) (lgM)

EBNA

Chagas Serology Results

West Nile Serology Results

Note: For CMV, a titer of >1:4 for the complement fixation or latex agglutination tests, a titer of >1:10 for IgG-immunofluorescence (IF) and a titer of >1:16 for IgM-IF are usually considered positive. If the test(s) are below the threshold considered positive, the result should be marked Negative. If testing was done, but for a rare reason, results are inconclusive, select Indeterminate. If testing was not done, select Not Done. Select Unknown if no results are found. If you cannot disclose the results, select Cannot Disclose.

Note: For Epstein-Barr Virus (EBV (VCA) (lgG), EBV (VCA) (lgM), and EBNA) serologies, a titer level of <1:10 is considered Negative.

NAT Results: For each of the tests listed, select the results from the drop-down lists (Positive; Negative; Unknown; Cannot Disclose; Not Done; Indeterminate). These fields are required.

HBV DNA Results:

HCV NAT Results:

HIV NAT Results:

HTLV NAT Results:

Chagas NAT Results:

West Nile NAT Results:

Donor Management: (Any medication administered within 24 hours prior to crossclamp.) If any of the listed medications were given to the donor within 24 hours prior to crossclamp, select Yes. If not, select No. If unknown, select Unk. If medications are not listed, enter the name of the medication in the Other/Specify field. You may enter as many medications as will fit in the boxes. Do NOT enter paralytics used in the donor OR. Do NOT enter electrolytes such as KCL, KPhos etc. If a medication falls under more than one category (antihypertensives and vasodilators) select Yes for both categories. If Insulin is given as part of a T4 protocol, answer Yes for insulin. These fields are required, except for Other/Specify.

Steroids

Diuretics

T3

T4

Antihypertensives

Vasodilators

DDAVP (synthetically derived vasopressor (e.g. DDAVP or Desmopressin))

Heparin

Arginine Vasopressin (human or animal derived vasopressor (e.g. pitressin, vasopressin, argipressin))

Insulin

Other/Specify

Other/Specify

Other/Specify

Inotropic Medication at Time of Cross Clamp: If any inotropic agents were administered at the time of cross clamp, select Yes. If not, select No. If unknown, select Unk. This field is required.

NOTE: Vasopressin and T4 are NOT inotropes.

If Yes is selected, complete the following:

Medication: Select the medication from the drop-down list. If Yes is selected for Inotropic Medications at Time of Cross Clamp, this field is required. If the medication is not listed, select Other, specify. Enter the medication in the Specify field. If Other, specify is selected, this field is required.

Dopamine
Dobutamine
Epinephrine
Levophed
Neosynephrine
Isoproterenol (Isuprel)
Other, specify

Number of transfusions during this (terminal) hospitalization: Select the number of units, from the drop-down list, for packed red cells or whole blood transfused prior to organ recovery for this hospitalization. Do NOT count other blood products such as FFP or platelets. If the number of transfusions is not known or it is not known if the donor received a transfusion, select Unknown. This field is required.

None
1 - 5
6 - 10
Greater than 10
Unknown

Clinical Infection Confirmed by Culture: If there is documented evidence of any clinical infection (of any positive cultures) during this hospitalization for the donor, select Yes. If there is no documented evidence of any clinical infection during this hospitalization for the donor, select No. If the donor's history of infection is unknown, select Unk. This field is required.

If there is documented evidence of any clinical infection confirmed by culture during this hospitalization for the donor, select whether the Source (Click all that apply) was Blood, Lung, Urine and/or Other, specify. If Yes is selected for Clinical Infection Confirmed by Culture, these fields are required. If Other specify is selected, enter the source in the space provided. If Other specify is selected, this field is required. If there are any positive cultures, the answers will be Yes.

Life Style Factors

Cigarette Use (>20 pack years) - Ever: If the donor has ever used cigarettes for more than 20 pack years, select Yes. If the donor has never used cigarettes or the usage is less than 20 pack years, select No. If cigarette usage is unknown, select Unk. This field is required.

Pack years refers to the number of packs of cigarettes the donor smoked per day multiplied by the number of years. For example, a donor smoking 2 packs of cigarettes per day for 10 years equals 20 pack years. Another example is 11/2 packs per day for 10 years equals 15 pack years.

AND continued in last six months: If the donor used cigarettes for more than 20 pack years and has continued usage within the last 6 months, select Yes. If the donor has not used cigarettes within the last 6 months, select No. If cigarette usage in the last 6 months is unknown, select Unk. If Yes is selected for Cigarette Use, this field is required.

Cocaine Use - Ever: If the donor has ever used or had a dependency to cocaine, select Yes. If not, select No. If cocaine use is unknown, select Unk. This field is required.

AND continued in last six months: If the donor used or had a dependency to cocaine within the last 6 months, select Yes. If not, select No. If cocaine use in the last 6 months is unknown, select Unk. If Yes is selected for Cocaine Use, this field is required.

Other Drug Use (non-IV) - Ever: If the donor has ever abused or had a dependency to Non-IV street drugs, such as crack, marijuana or prescription narcotics, sedatives, hypnotics or stimulants, select Yes. If not, select No. If drug use is unknown, select Unk. This field is required.

AND continued in last 6 months: If the donor abused or had a dependency to non-IV street drugs, such as crack, marijuana or prescription narcotics, sedatives, hypnotics or stimulants within the last 6 months, select Yes. If not, select No. If drug use is unknown, select Unk. If Yes selected for Other Drug Use, this field is required.

Heavy Alcohol Use (heavy = 2+ drinks/day): If the donor has a history of having two or more alcoholic drinks per day, select Yes. If not, select No. If alcohol use is unknown, select Unk. This field is required.

Tattoos: If the donor has any tattoos, select Yes. If not, select No. If unknown, select Unk. This field is required.

According to the OPTN policy in effect on the date of referral, does the donor have risk factors for blood-borne disease transmission?: If the donor meets guidelines for high Risk" for an organ donor, select Yes. If not, select No. If unknown, select Unk. This field is required.

Note: To view the U.S. Public Health Service (PHS) guidelines see:

http://www.publichealthreports.org/issueopen.cfm?articleID=2975

Chagas History: If the donor has a documented history of chagas prior to this hospitalization, select Yes. If the donor does not have a chagas, select No. If the donor’s history is unknown, select Unknown. This field is required.

TB History: If the donor has a documented history of TB prior to this hospitalization, select Yes. If the donor does not have a TB, select No. If the donor’s history is unknown, select Unknown. This field is required.

History of Diabetes: If the donor has a documented history of diabetes mellitus prior to this hospitalization, select Yes and the number of years from the drop-down list. If the duration is unknown, select Yes, Duration Unknown. If the donor does not have a history of diabetes, select No. If the donor’s history is unknown, select Unknown. This field is required.

No
Yes, 0-5 Years
Yes, 6-10 Years
Yes, > 10 Years
Yes, Duration Unknown
Unknown

Insulin Dependent: If the donor has a history of diabetes and is insulin dependent, select Yes and the number of years from the drop-down list. If the duration is unknown, select Yes, Duration Unknown. If the donor is not insulin dependent, select No. If the donor’s insulin history is unknown, select Unknown. If Yes is selected for History of Diabetes, this field is required.

No
Yes, 0-5 Years
Yes, 6-10 Years
Yes, > 10 Years
Yes, Duration Unknown
Unknown

History of Hypertension: If the donor has a documented history of hypertension prior to this hospitalization, select Yes and the number of years from the drop-down list. If the duration is unknown, select Yes, Unknown Duration. If the donor’s hypertension history is unknown, select Unknown. This field is required.

No
Yes, 0-5 Years
Yes, 6-10 Years
Yes, >10 Years
Yes, Unknown Duration
Unknown

If yes, method of control: Select Yes, No or Unk (unknown) for each method of hypertension control listed. If Yes is selected for History of Hypertension, these fields are required.

Diet
Diuretics
Other anti-hypertensive medication

History of Cancer: If the donor has a documented history of any type of cancer prior to this hospitalization, select the primary cancer site from the drop-down list. If the donor has no documented history of any type of cancer prior to this hospitalization, select No from the drop-down list. If the donor’s cancer history is unknown, select Unknown. This field is required. If the primary cancer site is not listed, select Other, Specify. Enter the cancer site in the Specify field. If Other, Specify is selected, this field is required.

No
Skin - Squamous, Basal Cell
Skin - Melanoma
CNS Tumor - Astrocytoma
CNS Tumor - Glioblastoma Multiforme
CNS Tumor - Medulloblastoma
CNS Tumor - Neuroblastoma
CNS Tumor - Angioblastoma
CNS Tumor - Meningioma
CNS Tumor - Other
Genitourinary - Bladder
Genitourinary - Uterine Cervix
Genitourinary - Uterine Body Endometrial
Genitourinary - Uterine Body Choriocarcinoma
Genitourinary - Vulva
Genitourinary - Ovarian
Genitourinary - Penis, Testicular
Genitourinary - Prostate
Genitourinary - Kidney
Genitourinary - Unknown
Gastrointestinal - Esophageal
Gastrointestinal - Stomach
Gastrointestinal - Small Intestine
Gastrointestinal - Colo-Rectal
Gastrointestinal - Liver & Biliary Tract
Gastrointestinal - Pancreas
Breast
Thyroid
Tongue/Throat
Larynx
Lung (Include bronchial)
Leukemia/Lymphoma
Unknown
Other, Specify

Cancer Free Interval: If the donor has a documented history of cancer, enter the number of years the donor has been free of any sign of cancer. Cancer-free interval can be entered in portions of a year by entering a decimal. If data is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). This field is required.

Cancer at time of procurement: If the donor exhibited documented clinical signs of cancer at the time of recovery, select Yes for each of the categories listed. If the donor did not exhibit documented clinical signs of cancer at the time of recovery for any listed category, select No. If unknown, select Unk. These fields are required.

Intracranial: Enter which type of intracranial cancer from the following options. If the primary cancer type is not listed, select Other, Specify. Enter the cancer type in the Specify field. If Other, Specify is selected, this field is required.

Type:

Astrocytoma,

Medulloblastoma,

Glioblastoma Multiforme,

Neuroblastoma,

Meningioma,

Malignant Meningioma,

Benign Angioblastoma,

Unknown

Other specify

Other/Specify text:


Extracranial:
Enter which type of extracranial cancer from the following options. If the primary cancer type is not listed, select Other, Specify. Enter the cancer type in the Specify field. If Other, Specify is selected, this field is required.

Type:


Kidney

Breast

Thyroid

Tongue/Throat/Larynx

Lung

Leukemia/Lymphoma

Liver

Unknown

Other Specify


Other/Specify text:


Skin:
Enter which type of skin cancer from the following options. If the primary cancer type is not listed, select Other, Specify. Enter the cancer type in the Specify field. If Other, Specify is selected, this field is required.

Type

Squamous Cell

Basal Cell

Melanoma

Unknown

Other/Specify


Other/Specify text:

Organ Recovery

Recovery Date (donor to OR): Enter the date the donor entered the operating room for the purpose of organ recovery. Use the standard 8-digit numeric format of MM/DD/YYYY.. Modification can be made in the donor feedback if incorrect. This field is required.

Was this donor recovered under DCD protocol: If this donor was a DCD (Donation after Cardiac Death) donor, select Yes. If this donor was not a DCD donor, select No. This field is required.

If Yes, Controlled: If this was a DCD donor and the DCD donor was controlled, select Yes. If the DCD donor was not controlled, select No. If unknown, select Unk. If Yes is selected for Was this a DCD donor, this field is required.

A controlled DCD donor is a donor whose life sustaining treatment will be withdrawn and whose family gave written consent for organ donation in the controlled environment.  A controlled DCD donor will be defined by the Maastricht classification III [awaiting cardiac arrest; patient on intensive care unit with non-survivable injuries who have withdrawal of life sustaining treatment.]

An uncontrolled DCD donor can be a patient who is declared dead and catheters may be placed in the vessels and/or peritoneum to cool the organs until consent/authorization can be obtained; a patient who suffers a cardiac arrest requiring CPR for rapid procurement of the organs.  As with all donors, an uncontrolled DCD donor is only a donor if at least one organ is recovered for the purpose of transplantation.

If Yes, Date and time of withdrawal of support: Withdrawal of Support is the withdrawal of life sustaining treatments; the actual point where the patient’s attending physician or designee begins the process of removing life sustaining treatments and not when the order is written. Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of the withdrawal of support. The date must be between the referral date and the date and time of death.  If Yes is selected for If Yes, Controlled, this field is required.

If Yes, Date and time agonal phase begins (systolic BP < 80 or O2 sat. < 80%): Agonal Phase begins when one of the following conditions is met and sustained for a minimum of five (5) minutes:

a. Newborn up to 28 days old, with a systolic blood pressure less than 60 mmHg, OR

b. 29 days old up to 12 months old, with a systolic blood pressure less than 70 mmHg, OR

c. 1 year old up to 10 years old, with a systolic blood pressure less than 70 mmHg, plus 2 times the age of the patient in years, not to exceed 79 mmHg, OR

d. 11 years or older, with a systolic blood pressure less than 80 mm Hg, OR when the oxygen saturation is less than 80% at any age.

Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time when the agonal phase begins. The date and time must be up to 60 minutes prior to the date and time of withdrawal of support, but not later than the day after the recovery day. If Yes is selected for If Yes, Controlled, this field is required.

If DCD, Total urine output during OR recovery phase: Total urine output is measured from the point at which life sustaining treatment is withdrawn to the initiation of cold perfusion in situ.  Enter the total urine output (cc). If Yes is selected for If Yes, Controlled, this field is required.

Measure between Withdrawal of Support and Cardiac Death. Provide Serial Data Every 5 minutes Between Withdrawal and Support and Start of Agonal Phase, and Every 1 Minute between Start of Agonal Phase and Cardiac Death.

Date: Enter the date using the standard 8-digit numeric format of (MM/DD/YYYY format).

Time (military time): Enter the time.

Systolic blood pressure: Enter the systolic blood pressure. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).  

Systolic Blood Pressure - The top number in the blood pressure (the 120 in a blood pressure of 120/80) measures the maximum pressure exerted on the vessel wall when the heart contracts.

Diastolic blood pressure: Enter the diastolic blood pressure. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Diastolic Blood Pressure - The bottom number in the blood pressure measurement (80 in a blood pressure of 120/80), indicating the pressure in the arteries when the heart is at rest.

Mean arterial pressure: Enter the mean arterial pressure. The value must be between 0 and 200. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

O2 Saturation: Enter the O2 saturation. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).  

If Yes, Core Cooling Used: If this was a DCD donor, select Yes if core cooling was used. If core cooling was not used for the DCD donor, select No. If Yes is selected for If Yes, Controlled, this field is required.

Core Cooling: the initiation of cold perfusion in situ.

If Yes, Date and time of abdominal aorta core cooling: Enter the date and time of the initiation of abdominal aorta core cooling (the date and time of the initiation of cold perfusion in situ). Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of abdominal aorta cannulation. The value entered cannot be more than 60 minutes after the cross clamp time. If Yes is selected for Was this a DCD Donor, this field is required. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).  

If Yes, Date and time of thoracic aorta core cooling: Enter the date and time of the initiation of thoracic aorta core cooling (the date and time of the initiation of cold perfusion in situ). Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of thoracic aorta cannulation. The value entered cannot be more than 60 minutes after the cross clamp time. If Yes is selected for Was this a DCD Donor, this field is required. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).  

If Yes, Date and time of portal vein core cooling: Enter the date and time of the initiation of portal vein core cooling (the date and time of the initiation of cold perfusion in situ). Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of portal vein cannulation. The value entered cannot be more than 60 minutes after the cross clamp time. If Yes is selected for Was this a DCD Donor, this field is required. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).  

If Yes, Date and time of pulmonary artery core cooling: Enter the date and Time of the initiation of pulmonary artery core cooling (the date and time of the initiation of cold perfusion in situ). Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of pulmonary artery cannulation. The value entered cannot be more than 60 minutes after the cross clamp time. If Yes is selected for Was this a DCD Donor, this field is required. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). -

Clamp Date: Enter the date the aorta was cross clamped. Use the standard 8-digit numeric format of MM/DD/YYYY. This field is required.

Clamp Time: (Military Time): Enter the time the aorta was cross clamped. This field is required. If the time the aorta was cross clamped is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Clamp Time Zone: Select the time zone from the drop-down list which corresponds with the time and location of the recovery. This field is required.

Eastern
Central
Mountain
Pacific
Alaska
Hawaii
Atlantic

All Donors Cardiac and Pulmonary Function:

History of previous MI: If the donor had a history of myocardial infarction, select Yes. If the donor did not have a history of myocardial infarction, select No. If this information is unknown, select Unk. This field is required.

LV ejection fraction (%): Provide the left ventricular ejection fraction, if known. This field is required. If the left ventricular ejection fraction is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Method: Select the left ventricular ejection method from the drop-down list. If a value is entered for LV ejection fraction, this field is required.

Echo (echocardiogram)
MUGA (scan)
Angiogram

If LV, Ejection Fraction < 50%:

Structural Abnormalities: If there were abnormalities, select Yes for each of the affected locations. If there were no abnormalities at the location, select No. If a value is entered for LV ejection fraction, this field is required.

Valves
Congenital
LVH

Wall Abnormalities: If there were abnormalities select Yes for each of the affected type. If there were no abnormalities of the type, select No. If a value is entered for LV ejection fraction, this field is required.

Segmental
Global

Coronary Angiogram: If the donor had a coronary angiogram, select Yes, normal or Yes, not normal from the drop-down list. If the donor did not have a coronary angiogram, select No from the drop-down list. This field is required.

No

Yes, normal

Yes, not normal


If Abnormal, # of Vessels with > 50% Stenosis: If the results of the coronary angiogram were abnormal, select the number of vessels with more than 50% stenosis from the drop-down list. If this information is unknown, select Unknown from the drop-down list. If Yes, not normal is selected, this field is required.

Heart machine perfusion: If the donor received heart machine perfusion, select Yes. If a heart machine was not used, select No. This field is required.

Pulmonary Measurements:

ABG Results

Blood pH – Enter the blood pH level for the donor.

PCO2: Enter the PCO2 in mmHg. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). This field is required.

PO2: Enter the terminal value in mmHg.. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

FiO2: Enter the terminal percent (i.e. 40%) of FiO2. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). This field is required.

PEEP – Enter the PEEP value in mmHg performed closest to the time of recovery. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). This field is required.

Ventilator mode closest to the time of recovery: Select appropriate drop down option

A/C

CMV

SIMV

PRVC

APRV

HFOV

Other, specify


If Other Specify is selected, enter the specific ventilator mode in the Other Diagnosis/Specify field.

Was a pulmonary artery catheter placed: If a pulmonary artery catheter was placed, select Yes. If not, select No. This field is required.

If Yes, Initial (baseline) and Final-Preoperative measurements: If a pulmonary artery catheter was placed, enter the Initial (baseline) and Final (preoperative) measurements for the following fields. All values should be entered from the same reading. For example, if there is no PCWP  - do not enter the PCWP from another reading. If Yes is selected for Was a pulmonary artery catheter placed, these fields are required. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

MAP: (mmHg) (Mean arterial pressure)
CVP: (mmHg) (Central Venous Pressure)
PCWP: (mmHg) (Pulmonary Capillary Wedge Pressure)
SVR: ((dynes/sec/cm)^5) (Systemic Vascular Resistance)
PA Systolic: (mmHg) (Pulmonary Artery Pressure Systolic)
PA Diastolic: (mmHg) (Pulmonary Artery Pressure Diastolic)
CO: (L/min) (Cardiac Output)
Cardiac Index: (L/min/sq. m)

Biopsy (heart donors only): If a biopsy was performed, select Yes with the type of result. If Yes, Other Diagnosis Specify is selected, enter the diagnosis in the Other Diagnosis/Specify field. If a biopsy was not performed, select No. This field is required if the heart was transplanted.

No
Yes, Myocarditis
Yes, Negative Biopsy Result
Yes, Other Diagnosis Specify

Any Extracorporeal Support Given: If any extracorporeal support (i.e. ECMO) was given select Yes. If extracorporeal support was not given, select No. This field is required.

How long: If Yes was entered for extracorporeal support given, enter how long (minutes) the extracorporeal support was supplied. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Flow Rate: If extracorporeal support was provided, enter the flow rate in L/min closest to the time of recovery. If unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).





Left Kidney Biopsy: If a biopsy was performed to evaluate organ histology for assessing organ function/quality of the left kidney, select Yes. And If there was more than one biopsy, enter the results from the final biopsy result. If no biopsy was performed select No. If a biopsy was performed only for other reasons, for example to evaluate a potentially cancerous lesion, select No. This is a required field if the left kidney (or en bloc kidneys) was recovered or transplanted.

Type of biopsy: If a biopsy was performed, select the type of biopsy performed: Needle, Wedge, Other/Specify

Other/Specify: If Other/Specify is selected, provide the type of biopsy in the text field.

Interstitial Fibrosis: Once the type of biopsy performed is selected, enter the amount of interstitial fibrosis

Absent

Minimal

Mild

Mild-moderate

Moderate

Unknown


Vascular Change: Once the type of biopsy performed is selected, enter the amount of vascular change

Absent

Minimal

Mild

Mild-moderate

Moderate

Unknown



Number of Glomeruli Visualized: If the number of the glomeruli was not entered in DonorNet® previously, enter in the number visualized.

Number of Glomeruli sclerosed:

Glomerulosclerosis: If Yes is selected for Left Kidney Biopsy and the organ was recovered or transplanted, select the glomerulosclerosis percentage for the left kidney from the drop-down list. DO NOT enter the number of glomeruli sclerosed. To calculate the percentage of glomerulosclerosis divide the number sclerosed by the number of glomeruli visualized and multiply the answer by 100. E.g. 3 of 30 glomeruli were sclerosed = 3/30X100 = 10 %. This field is required.

0 - 5
6 - 10
11 - 15
16 - 20
20+
Indeterminate

Pump: If a pump was used in preservation of the left kidney, select Yes. If not, select No. If the left kidney (or en bloc kidneys) was recovered or transplanted, this field is required.

Type of Left Kidney Pump/Machine: Enter the type of pump/machine used to perfuse the left kidney

ORS

Waters

Other Specify


If Other/Specify is selected, provide the type of left kidney pump/machine in the text field.


Final Resistance Prior to Shipping: If Yes is selected for Pump, enter the resistance value. If Yes is selected for Pump, this field is required. If data is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Transferred to transplant center on pump: If pump was used in preservation of the left kidney and the organ was transferred to the transplant center on pump, select Yes. If not, select No. If Yes is selected for Pump, this field is required.

Right Kidney Biopsy: If a biopsy was performed to evaluate organ histology for assessing organ function/quality of the right kidney, select Yes. And If there was more than one biopsy, enter the results from the final biopsy result. If no biopsy was performed select No. If a biopsy was performed only for other reasons, for example to evaluate a potentially cancerous lesion, select No. This is a required field if the right kidney (or en bloc kidneys) was recovered or transplanted.

Type of biopsy: If a biopsy was performed, select the type of biopsy performed: Needle, Wedge, Other/Specify

Other/Specify: If Other/Specify is selected, provide the type of biopsy in the text field.

Interstitial Fibrosis: Once the type of biopsy performed is selected, enter the amount of interstitial fibrosis

Absent

Minimal

Mild

Mild-moderate

Moderate

Unknown


Vascular Change: Once the type of biopsy performed is selected, enter the amount of vascular change

Absent

Minimal

Mild

Mild-moderate

Moderate

Unknown



Number of Glomeruli Visualized: If the number of the glomeruli was not entered in DonorNet® previously, enter in the number visualized.

Glomerulosclerosis: If Yes is selected for Right Kidney Biopsy and the organ was recovered or transplanted, select the glomerulosclerosis percentage for the right kidney from the drop-down list.

0 - 5
6 - 10
11 - 15
16 - 20
20+
Indeterminate

Pump: If a pump was used in preservation of the right kidney, select Yes. If not, select No. If the right kidney (or en bloc kidneys) was recovered or transplanted, this field is required.

Type of Right Kidney Pump/Machine: Enter the type of pump/machine used to perfuse the right kidney

ORS

Waters

Other Specify


If Other/Specify is selected, provide the type of left kidney pump/machine in the text field.

Final Resistance Prior to Shipping: If Yes is selected for Pump, enter the resistance value. If Yes is selected for Pump, this field is required. If data is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Transferred to transplant center on pump: If pump was used in preservation of the right kidney and the organ was transferred to the transplant center on pump, select Yes. If not, select No. If Yes is selected for Pump, this field is required.

Liver Biopsy: If a biopsy was performed to evaluate organ histology for assessing organ function/quality of the liver, select Yes. And If there was more than one biopsy, enter the results from the final biopsy result. If no biopsy was performed select No. If a biopsy was performed only for other reasons, for example to evaluate a potentially cancerous lesion, select No. This is a required field.

Type of Liver Biopsy: Enter the type of liver biopsy

Core

Wedge

Other/Specify


If Other/Specify is selected, provide the type of liver biopsy in the text field.


% Macro vesicular fat: If Yes is selected for Liver Biopsy, enter the percentage of macro vesicular fat. This field is required. If data is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Macrovesicular - Large fat droplets balloon the liver cell, displacing the nucleus to the periphery of the cell, like an adipocyte. Triglycerides accumulate most commonly because it has the highest turnover rate of all hepatic fatty acid esters. Liver uptake of FFA from adipose tissue and the diet is unrestrained, whereas FFA disposition by oxidation, esterification, and VLDL secretion is limited.

% Micro/intermediate vesicular fat: If Yes is selected for Liver Biopsy, enter the percentage of micro/intermediate vesicular fat. This field is required. If data is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Microvesicular - Fatty liver, small fat droplets accumulate, cells appear foamy, and nuclei are central. Triglycerides collect in subcellular organelles (i.e. endoplasmic reticulum), reflecting widespread metabolic disturbance. Mitochondrial injury limits FFA oxidation, while apoprotein synthesis necessary for VLDL secretion is depressed, leading to triglyceride accumulation.

Fibrosis: If Yes is selected for Liver Biopsy, enter in the appropriate value using the ISHAK scoring system:


0 = No Fibrosis

1 = Fibrosis expansion of some portal areas, with or without short fibrous septa

2 = Fibrosis expansion of most portal areas, with or without short fibrous septa

3 = Fibrosis expansion of most portal areas, with occasional portal to portal bridging

4 = Fibrosis expansion of portal areas, with marked bridging (portal Cirrhosis to portal as well as portal to central)

5 = Marked bridging with occasional nodules (incomplete cirrhosis)

6 = cirrhosis, probable or definite



Portal Infiltrates: If Yes is selected for Liver Biopsy, enter in the appropriate value for Portal Infiltrates.

0 = None Noted;

1 = Mild, some or all portal areas

2 = Moderate, some or all portal areas

3 = Moderate/Mark, all portal areas

4 = Marked, all portal areas


Type of Liver Machine Perfusion: Enter the type of pump/machine used to perfuse the right kidney

Normothermic

Hypothermic

Other Specify


If Other/Specify is selected, provide the type of left kidney pump/machine in the text field.


Left Lung Bronchoscopy and Right Lung Bronchoscopy: If a lung was recovered or transplanted, select the results of the bronchoscopy procedure from the drop-down list. If the results were abnormal, select Abnormal with the type of abnormality. If a bronchoscopy was not performed, select No Bronchoscopy. If unknown, select Unknown if bronchoscopy performed. This field is required.

No Bronchoscopy
Bronchoscopy Results normal
Bronchoscopy Results, Abnormal-purulent secretions
Bronchoscopy Results, Abnormal-aspiration of foreign body
Bronchoscopy Results, Abnormal-blood
Bronchoscopy Results, Abnormal-anatomy/other lesion
Bronchoscopy Results, Unknown
Unknown if bronchoscopy performed

Left/Right Lung Machine Perfusion: If a lung machine was used for perfusion , select Yes. If not, select No. If a lung was recovered or transplanted, this field is required.

Chest X-ray: If a lung was recovered or transplanted, select the results of the chest x-ray from the drop-down list. If abnormalities were found on the chest x-ray, select Abnormal with the location. If this information is unknown, select Unknown if chest x-ray performed. If a chest x-ray was performed and the results are unknown, select Results unknown. If no chest x-ray was performed, select No chest x-ray. This field is required.

Shape1

Organ Dispositions

No chest x-ray
Normal
Abnormal-left
Abnormal-right
Abnormal-both
Results Unknown
Unknown if chest x-ray performed

Complete the requested information for each displayed organ type listed.

Organ: Verify the final disposition of the organ.

Consent Not Requested
Consent Not Obtained
Organ Not Recovered
Recovered Not for Tx
Recovered for Tx but Not Tx
Transplanted
N/A

If DCD, Date and time [organ] recovered/removed from donor: (when the organ is placed in the basin): Enter the date, using the standard 8-digit format of MM/DD/YYYY format, and military time of organ recovery/removal. If the organ was recovered or transplanted and Yes is selected for Was this a DCD donor, this field is required.

Recipient: The recipient name from the Waitlist removal record displays. Verify that the recipient listed is correct.

SSN: The recipient's social security number from the Waitlist removal record displays. Verify that the recipient's social security number is correct.

TX Center: The recipient’s transplant center displays. Verify that the center is correct.

Reason Code: Select the appropriate reason code from the drop-down list. This field is required. If Other, specify is selected, enter the reason in the space provided. If Other, specify is selected, this field is required.

If consent was not requested, select the appropriate reason from the drop-down list. The remaining questions for this organ will not display.

Donor age
Non-heart beating donor
History of previous cardiac surgery (valid for heart only)
History of severe cardiac disease (valid for heart only)
History of lung disease (valid for lung only)
History of gastro-intestinal disease (valid for intestine only)
History of diabetes mellitus (valid for pancreas only)
Pancreatitis (valid for pancreas only)
Acute/chronic renal failure
Donor quality
Donor ABO
Other specify

If consent was not obtained, select the appropriate reason from the drop-down list. The remaining questions for this organ will not display.

Emotional
Cultural beliefs
Religious beliefs
Family conflict
Other, specify

If the organ was not recovered, select the appropriate reason from the drop-down list. The remaining question for this organs will not display.

Poor organ function
Cardiac Arrest
Infection
Positive Hepatitis
Positive HIV
Diseased organ
Anatomical abnormalities (not valid for PA or PA segments)
Vascular damage
No recipient located
Donor medical history
Donor social history
Positive HTLV - 1
Biopsy findings
Surgical damage in OR
No local recovery team
Organ refused by all regional programs
Organ refused by all national programs
Organ refused by all programs with urgent need
Ruled out after evaluation in OR
Ruled out due to biopsy report
Ejection fraction < 50%
PO
2 < 200 on O2 challenge
Hemodynamically unstable donor
Trauma to organ
Positive (+) gram stain
Time constraints
Medical Examiner restricted recovery
Replaced/aberrant RHA or CHA traversing head of PA
IPDA-SMA junction identified within 5mm from RHA junction
IPDA originating directly from RHA
Other anatomical abnormality
Converted anatomical abnormalities (206 for PA and PA segments) INACTIVE
Other, specify

If the organ was recovered but not for transplant use, select the appropriate reason from the drop-down list.

Recovered for Research
Recovered for Heart Valves
Recovered for Extra-corporeal Liver
Recovered only for purpose Hepatocytes
Recovered Pancreas for Technical Reasons (UNOS-use only)

If the organ was recovered for a transplant but not used for a transplant, select the appropriate reason from the drop-down list.

Recovered for Transplant: Discarded Locally
Recovered for Transplant: Shared and Discarded
Recovered for Transplant: Submitted for Research
Recovered for Transplant: Sent for Heart Valves
Recovered for Transplant:  whole PA/PI, processed for islets, not transplanted or transplant unknown
Recovered for Transplant: Sent for Ex-corp Liver
Recovered for Transplant: Sent for Hepatocytes
Recovered for Transplant: Pancreas sent for Technical Reasons (UNOS-use only)
Exported, not transplanted or transplant unknown

If the organ was transplanted, select the appropriate reason from the drop-down list.

Organ Transplanted Locally
Organ Transplanted Shared
Islet Cells Transplanted
Exported Out of U.S., transplanted

Reason organ not transplanted: If the organ was not transplanted, select the appropriate reason from the drop-down list, the organ was not transplanted. If Other, specify is selected, enter the reason in the Specify field.

Too old on pump
Too old on ice
Vascular damage
Ureteral damage
Inadequate urine output
Donor medical history
Donor social history
Positive CMV
Positive HIV
Positive Hepatitis
Warm ischemic time too long
Organ trauma
Organ not as described
Biopsy findings
Recipient determined to be unsuitable for TX in OR
Poor organ function
Infection
Diseased organ
Anatomical abnormalities
No recipient located - list exhausted
Other, specify

Recovery Team #: Enter the 6-digit Medicare Provider number of the OPO or transplant center procurement team that performed the recovery operation. This field is required.

Initial Flush Solution: For each recovered organ, select the flush solution from the drop-down list, used during the recovery procedure. If unknown, select Unknown. This field is required. If Other, specify is selected, enter the flush solution used in the Specify field. If Other, Specify is selected, this field is required.

Viaspan (UW/Belzer)
Eurocollins
Modified Collins
Cardioplege
Pulmoplege
Saline
Ringers
Celsior
Custodiol
Perfadex
No Flush
Unknown
Other, specify

Initial Flush Solution Volume (mL): If the organ is either a liver or a pancreas and the disposition is recovered for transplant but not transplanted or transplanted, then enter the amount of flush solution used.Back Table Flush Solution: For each recovered organ, indicate the back table flush solution used to preserve each organ. If a back flush solution was not used, select No Flush. If unknown, select Unknown. This field is required. If Other Specify is selected, enter the flush solution used in the Specify field. If Other Specify is selected, this field is required.

No Flush
Viaspan (UW/Belzer)
Eurocollins
Modified Collins
Cardioplege
Pulmoplege
Saline
Ringers
Celsior
Custodiol
Perfadex
Unknown
Other Specify

Back Table Flush Solution Volume (mL): If the organ is either a liver or a pancreas and the disposition is recovered for transplant but not transplanted or transplanted, then enter the amount of flush solution used.

Final Flush/Storage Solution: For each recovered organ, indicate the final flush and storage solution used during the recovery procedure. If unknown, select Unknown. This field is required. If Other Specify is selected, enter the flush solution used in the Specify field. If Other, Specify is selected, this field is required.

Viaspan (UW/Belzer)
Eurocollins
Modified Collins
Cardioplege
Pulmoplege
Saline
Ringers
Celsior
Custodiol
Perfadex
No Flush
Unknown
Other, specify

OPO sent vessels with organ: If vessels (vascular allografts) were sent with the organ, as indicated on the Donor Organ Disposition in DonorNet®, Yes displays. If no vessels were sent, No displays.

Tx center used extra vessels in the tx procedure: If extra vessels (vascular allografts) were used in the transplant procedure, as indicated on the Waitlist Removal record, Yes displays. If the vessels were not used, No displays.

Vessel Donor ID: The Donor ID entered on the Waitlist removal displays.

Note: If the extra vessels used in a transplant procedure are procured from a tissue processing organization, they are not reported in UNetSM.

 





File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAlex Garza
File Modified0000-00-00
File Created2021-01-26

© 2024 OMB.report | Privacy Policy