Preview Sept. 14 OPTN data collection changes

Data definition clarifications:

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity
• Gender replaced by Birth Sex

• Gender replaced by Birth Sex
• TX Date replaced by Transplant Date and Time
• PCW(mean) mm/HG replaced by PCWP mm/Hg

This data collection will be collected for both 24 and 72 hours post-transplant (+/- 4 hours):

• Is Primary Graft Dysfunction Present?
  • PGD – Left Ventricular Dysfunction (PGD-LV)
  • PGD – Right Ventricular Dysfunction (PGD-RV)
• Left Ventricular Ejection Fraction (LVEF)
• Left Atrial (LA) Pressure
• Pulmonary Capillary Wedge Pressure (PCWP)
• Right Atrial (RA) Pressure
• Pulmonary Artery (PA) Systolic Pressure
• Pulmonary Artery Diastolic Pressure
• Cardiac Output (CO)
• Patient on Life Support?
  • Extra Corporeal Membrane Oxygenation
  • Intra-Aortic Balloon Pump
  • Inhaled NO
• Patient on Ventricular Assist Device (includes device type)
• Epoprostenol following transplant
• Epinephrine dosage, if any
• Milrinone dosage, if any
• Dobutamine dosage, if any
• Dopamine dosage, if any
• Norepinephrine – Levophed dosage, if any
• Phenylephrine – Neosynephrine dosage, if any
• Vasopressin – Pitressin dosage, if any

• Airway dehiscence (removed from Heart TRR only)

Added data collection:

• Organ check-in date and time: Organ check in must be completed any time an organ is recovered outside the facility where the transplant will take place. Organ check in must be competed upon arrival at the transplant hospital prior to opening the organ’s external transport container.

• First name, last name: If the donor identity is unknown, enter the hospital-generated alias.

• Home City, Zip Code: Status field now available for selection if the data is Missing, Unknown, N/A, or Not Done.
• Race/Ethnicity: Race and Ethnicity are now collected separately as two different questions.
  • Race
  • Ethnicity

• Did the OPO notify the medical examiner/coroner?
  • If yes, did the medical examiner/coroner accept the case?
    • If yes, were there any restrictions? (list of organs restricted)
• Was authorization obtained for organ donation?
  • If yes, method of authorization used (First Person, Heirarchy)
  • If no, what was the reason organ donation authorization was not obtained (Declined, Not Requested)

• Medical examiner/coroner question
• Did the patient have written documentation of their intent to be a donor? (and all child questions regarding mechanism of authorization).
• Did the patient express to family or others the intent to be a donor?

• Weight: Enter the first measured weight of the donor after hospital admission in lbs (pounds) or kg (kilograms). This field is required.
• Terminal lab data: For each of the laboratory tests enter the value, in the units indicated, from tests performed during donor management and prior to the donor entering the operating room closest to the time of recovery.

• Inotropic medications at time of cross-clamp: Inotropic medications at time of cross-clamp or at time of withdrawal of life-sustaining medical support:

• Serology section renamed to ‘Infectious disease testing’ and NAT results are now incorporated into this section to mirror how data is collected in DonorNet. ‘Indeterminate’ value for infectious disease testing results now changed to ‘Indeterminate/Equivocal’

• Transfusions prior to ABO determination (Yes/No)
  • If yes, Total volume (CCs)

• Transfusions following ABO determination (Yes/No)
  • If yes, Total volume (CCs)

• Number of transfusions during this terminal hospitalization (dropdown)

• Ever use or take drugs, such as steroids, cocaine, heroin, amphetamines, opioids, or marijuana (Yes/No)
  • If yes, select all drugs used. For each drug selected, provide:
    • Last used on date (or status if not available)
    • Duration of use (in years or months, or status if not available)
    • Frequency of use (free text or status if not available)
    • Drug use route (Inhaled, Needles, Ingested, Unknown)

• According to the OPTN policy in effect, does the donor have risk factors for blood-borne disease transmission: This field will now be calculated from 10 child questions – an answer of ‘Yes’ to any child question will result in an answer of ‘Yes’ to this question.
  • Sex (i.e., any method of sexual contact, including vaginal, anal, and oral) with a person known or suspected to have HIV, HBV, or HCV infection
  • Man who has sex with another man
  • Sex in exchange for money or drugs
  • Sex with a person who had sex in exchange for money or drugs
  • Drug injection for nonmedical reasons
  • Sex with a person who injected drugs for nonmedical reasons
  • Incarceration (confinement in jail, prison, or juvenile correction facility) for 72 or more consecutive hours
  • Child breastfed by a mother with HIV infection
  • Child born to a mother with HIV, HBV, or HCV infection
  • Unknown medical or social history

• Other Drug Use (non-Iv) Ever
• Cocaine Use – Ever
• Tattoos
• Cancer free interval

• LV Ejection fraction (%%): Provide the left ventricular ejection fraction, if known. This should be the final measurement collected prior to the donor entering the operating room.

• Left/Right Lung Bronchoscopy: If a lung was recovered or transplanted, select the results of the bronchoscopy procedure from the drop-down list. If multiple bronchoscopies are performed, enter the results from the last bronchoscopy performed prior to the donor entering the operating room. 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.

• Lung machine perfusion intended or performed: Lung machine perfusion intended or performed

• DCD – If Yes, Controlled
  • ‘Unknown’ no longer an option
• ‘Flush’ label changed to ‘Core cooling’
• Core Cooling date/times are now collected for both DCD and brain dead donors if core cooling was used
• Coronary angiogram: Options changed
  • No
  • Yes, normal (no evidence of coronary artery disease)
  • Yes, not normal abnormal but non-obstructive (all stenosis determined to be < 70%)
  • Yes, abnormal and obstructive (presence of any stenosis >= 70%)
• Left/Right Lung Bronchoscopy: options changed
  • No Bronchoscopy
  • Bronchoscopy Results normal
  • Bronchoscopy Results, Abnormal-other
    • Other specify text
  • 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
• Date/time organ recovered or removed from donor
  • Now collected for both DCD and brain dead donors
• Recovery team #
  • Now collected as recovery OPTN center code/center type

• ‘Was a pulmonary artery catheter placed?’ is being replaced with ‘Were advanced hemodynamic parameter data obtained?’
  • If yes, indicate the method (pulmonary artery catheter or minimally invasive monitoring) and report one set of measurements

• Left/Right Kidney biopsy: More information is now collected for left and right kidney biopsy including
  • Number of globally sclerotic glomeruli
  • Tissue preparation technique
  • Nodular mesangial glomerulosclerosis
  • Interstitial fibrosis and tubular atrophy (IFTA)
  • Vascular disease
  • Arteriolar hyalinosis
  • Cortical necrosis
  • Fibrin thrombi
  • % Globally sclerotic glomeruli is now calculated from Number of glomeruli and Number of globally sclerotic glomeruli

• DCD donor serial data (DCD measures)
• Biopsy (heart donors only)
• Initial flush solution volume (solution is still collected)
• Back table flush solution volume (solution is still collected)

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity

• Left/Right Kidney biopsy: More information is now collected for left and right kidney biopsy including
  • Number of globally sclerotic glomeruli
  • Tissue preparation technique
  • Nodular mesangial glomerulosclerosis
  • Interstitial fibrosis and tubular atrophy (IFTA)
  • Vascular disease
  • Arteriolar hyalinosis
  • Cortical necrosis
  • Fibrin thrombi
  • % Globally sclerotic glomeruli is now calculated from Number of glomeruli and Number of globally sclerotic glomeruli

• History of myocardial infarction (MI): Now collected in donor medical social history
• According to the OPTN policy in effect, does the donor have risk factors for blood-borne disease transmission: This field will now be calculated from 10 child questions – an answer of ‘Yes’ to any child question will result in an answer of ‘Yes’ to this question.
  • Sex (i.e., any method of sexual contact, including vaginal, anal, and oral) with a person known or suspected to have HIV, HBV, or HCV infection Tissue preparation
  • Man who has sex with another man
  • Sex in exchange for money or drugs
  • Sex with a person who had sex in exchange for money or drugs
  • Drug injection for nonmedical reasons
  • Sex with a person who injected drugs for nonmedical reasons
  • Incarceration (confinement in jail, prison, or juvenile correction facility) for 72 or more consecutive hours
  • Child breastfed by a mother with HIV infection
  • Child born to a mother with HIV, HBV, or HCV infection
  • Unknown medical or social history

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity
• Gender replaced by Birth Sex

Added data collection:

• Did the OPO notify the medical examiner/coroner?
  • If yes, did the medical examiner/coroner accept the case?
  • If yes, were there any restrictions?
  • If yes, list of organs restricted (checkboxes)

• Was authorization obtained for organ donation?
  • If yes, method of authorization used (First Person, Hierarchy)
  • If no, what was the reason organ donation authorization was not obtained (Declined, Not Requested)

Removed data collection:

• Medical examiner/coroner question
• Did the patient have written documentation of their intent to be a donor? (and all child questions regarding mechanism of authorization).
• Did the patient express to family or others the intent to be a donor?

Donor information

Candidate Demographic Information

Data definition clarifications:

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity

• Gender replaced by Birth Sex

Data definition clarification:

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity

Data definition clarifications:

• Transplant time: An organ transplant begins at the start of anastomosis or the start of an islet infusion

Added data collection:

• Transplant time
• Transplant time zone

Data definition clarification:

• Race/Ethnicity replaced by:
  • Race
  • Ethnicity