Improving Patient Safety: Potential Donor-derived Disease Transmission Event
The goal of the Improving Patient Safety system is to collect information about safety related incidents occurring system-wide, in order to increase organ utilization and reduce the morbidity and mortality of transplant patients.
Disease Transmission Event:
All events involving unexpected, suspected or proven transmission of a medical condition, including infections and malignancies, discovered after procurement of a donor organ must be reported through the OPTN Patient Safety System.
For OPO's:
OPTN policy specifies when OPOs must report potential disease and malignancy transmission through this portal. OPOs must report the following to the OPTN:
Results that indicate a disease or condition defined on Pathogens of Special Interest list
Malignancy or other findings highly suggestive of malignancy recognized post-procurement
Substantial concerns for donor derived disease or malignancy received from a transplant hospital
OPOs must also report these items within 24 hours, as well as others defined in policy, to transplant hospital patient safety contacts.
For Transplant Programs:
When an organ recipient is suspected to have, is confirmed positive for, or has died from a potential transmissible disease or medical condition for which there is substantial concern that it could be from donor origin, the transplant program must notify the Host OPO by phone and provide available documentation to the Host OPO as soon as possible, and not to exceed 24 hours of this knowledge/concern. The transplant center that suspects potential transmission should not wait for all medical documentation that may eventually be available, but must inform the Host OPO and the OPTN through the “Improving Patient Safety” portal, to transfer this knowledge/concern as soon as possible to all other centers that received organs from the same donor.
For Living Donor Recovery Centers:
When a transmissible disease or medical condition (including malignancy) is recognized in a living donor after organ procurement and relevant to acute patient care (defined as requiring clinical observation, diagnostic testing or therapeutic intervention to diagnose, prevent or treat a potentially transmitted disease), the center must notify the living donor transplant program and submit a report through the OPTN Improving Patient Safety Portal as soon as possible but no later than seven days after receipt of the new information.
Learn more about the required disease transmission event reporting in OPTN/UNOS policy.
Learn more about recent changes to this policy that changed on September 1, 2016
Policy notice
Webinar
Pathogens of Special Interest
To report a potential donor-derived disease transmission event, complete the information below and select the submit button. Please note the incidents are consider confidential and will only be viewable with member and patient identified entered by the user that initially submitted the information and UNOS staff.
Reporting Event for: This field is required.
Donor (Living or Deceased)
Recipient
Donor ID: The unique alphanumeric value assigned by the system when a donor is registered. This field is required if checkbox “Donor (Living or Deceased)” is selected.
Have all of the recipient centers been notified at this time?: This field is required if checkbox “Donor (Living or Deceased)” is selected.
Yes
No
Recipient SSN: The recipient’s social security number. Numeric format XXXXXXXXX. This field is required if Recipient is selected.
Waitlist ID: The system-generated number assigned after a candidate is added to the waiting list. Numeric format XXXXXXXX. This field is optional if Recipient is selected.
Donor ID of donor involved: The unique 6- or 7-character alphanumeric value assigned by the system when a donor is registered. This field is required if Recipient is selected.
Has the Host OPO been notified regarding this report?: This field is required if Recipient is selected.
Yes
No
Reporting Institution: Reporting member institution 4-digit code and name selected from the drop-down list. This field is required.
Detected by: This field is required.
OPO before organs procured
OPO after organs procured
TX before organs procured
TX after organs procured
Date Occurred: Date the disease transmission occurred. MM/DD/YYYY format. This field is required.
Infection/Malignancy/Other Medical Condition: More than one may be selected.
Add Infection
Add Malignancy
Add Other Medical Condition
Specify Type: Values selected from a drop-down list. This field is required.
Infection: Value selected from a drop-down list. Up to four types may be selected. This field is required.
Specify Type:
Amoebic
Bacterial
Fungal
Parasitic
Viral
Infection:
Encephalitis (All Types)
Endocarditis
Fever of Unknown Origin (FUO)
Meningitis (All Types)
Pneumoniae
Unknown Infection
Other Specify
Acinetobacter baumanii
AFB-other
Bacterial Emboli
Brucella
Citrobacter
E. coli
Ehrlichia
Endocarditis
Enterobacter asburiae
Enterococcus (not VRE)
Enterococcus (VRE)
Gram Positive Cocci (GPC)
Klebsiella
Legionnaires Disease
Listeria monocytogenes
Lyme Disease
Methicillin-resistant Staphylococcus aureus (MRSA)
Methicillin-sensitive Staphylococcus aureus (MSSA)
Mycobacterium Avium Complex (MAC)
Mycobacterium Kansaii
Mycobacterium (unknown)
Mycobacterium abscessus
Mycobacterium gordonae
Mycobacterium intracellulare
Mycoplasma hominis
Mycobacterium tuberculosis (TB)
Mycotic Aneurysm
Neisseria meningitides
Nocardia
Pneumoniae
Pseudomonas
Salmonella
Serratia
Staphylococcus
Streptococcus
Syphilis
Veilonella
Aspergillus
Blastomycosis
Candida albicans
Candida glabrata
Candida tropicalis
Candidiasis (unknown)
Cryptococcus
Coccidioides immitis (Valley Fever)
Histoplasma/Histoplasmosis
Rhizopus
Zygomycete
Amoebiasis
Babesia
Balamuthia mandrilli
Chagas (T.cruzi)
Leishmaniasis
Schistosomiasis
Strongyloides
Toxoplasmosis
Adenovirus
Cytomegalovirus (CMV)
Epstein-Barr virus (EBV)
Hepatitis B (HBV)
Hepatitis C (HCV)
Hepatitis E
Herpes Simplex Virus (HSV)
Human herpesvirus 8 (HHV8)
Human Immunodeficiency Virus (HIV)
Human T-cell lymphotropic virus I (HTLV-I)
Human T-cell lymphotropic virus II (HTLV-II)
Influenza A – H1N1
Influenza A (Not H1N1)
Lymphocytic Choriomenigitis virus (LCMV)
Parvo B19
PIV3 ParaInfluenzaVirus
Rabies
Rhinovirus
Viral Myocarditis
West Nile Virus (WNV)
Date Detected: Date the infection was detected. MM/DD/YYYY format. This field is required.
At this time the diagnosis is: This field is required.
Confirmed
Suspected
Malignancy: Value selected from the drop-down list. Up to four types may be selected. This field is required.
Adenocarcinoma
Adenocarcinoma Colon
Adenocarcinoma Prostate
Astrocytoma
Basaloid CA
Basal Cell
Bladder CA
Brain CA-Spindle Cell
Breast Cancer
Breast mass Bronchi-Aviolar CA
Cholangiocarcinoma
Chronic lymphocytic leukemia (CLL) Dermatofibrosarcoma Protuberans
Epithelioid Angiomyolipoma
Gastrointestinal stromal tumor (GIST)
Glioblastoma
Hepatocellular Carcinoma (HCC)
Kaposi’s Sarcoma
Leukemia
Liposarcoma
Liver CA
Lung CA
Lymphoma Non-Hodgkins
Malignant T-cell Lymphoma
Medullablastoma
Melanocytic Lesion
Melanoma
Mesothelioma
Neuroendocrine CA
Non-Small Cell Carcinoma
Oncocytoma
Ovarian CA
Pancreatic CA
Paraganglioma
Pineoblastoma
Prostate Cancer
Renal Cell Carcinoma (RCC)
Sarcoma Squamous Cell CA
Small Bowel CA
Small Cell CA
Thyroid CA
Unknown CA
Urothelial Cell CA
Other Specify
Date Detected: Date the malignancy was detected. MM/DD/YYYY format. This field is required.
At this time the diagnosis is: This field is required.
Confirmed
Suspected
Other Medical Condition: Value selected from the drop-down list. Up to four types may be selected. This field is required.
Amyloidosis
Creutzfeldt-Jakob Disease (CJD)
Hemochromatosis
Ornithine Transcarbamylase (OTC) Deficiency
Peanut allergy
Sarcoidosis
Other – Specify
Date Detected: Date the condition was detected. MM/DD/YYYY format. This field is required.
At this time the diagnosis is: This field is required.
Confirmed
Suspected
Please attach any relevant documents, including lab or diagnostic testing results: Choose File: To upload supporting documentation to the event form. This is optional. Maximum file upload size: 20 MB.
Was an assay or other test used to identify organism disease?: This field is required.
Yes
No
Unknown
Assay/Test Type: This field is required if checkbox “Yes” is selected in response to “Was an assay or other test used to identify organism disease?”.
Ab
Acid Fast Smear
Aerobic Cx
AFB Cx
BAL
Blood Cx
Bone Marrow Bx
Bronchial Bx
Bronchial Lavage
Bx
Cell block
Cell Ct & Diff
CMV Stain
CT of abd
CT of chest
CT of head
CT of pelvis
CXR
Cytology
DNA testing
FISH
Fluid Cx
Fungal Cx
Fungal stain
GMS stains
Gram stain
IgG
IgM
Legionella DFA & Cx
Molecular Fingerprinting
MRI of abd
MRI of chest
MRI of head
MRI of pelvis
NAT
PCR
Pneumocystic IFA
Pheumocystis Stain
PPD
Silver Stain
Smear
Sputum Cx
Surface Antigen
Urinalysis
Urine Cx
US of abd
US of pelvis
Viral Cx
RNA
Other – Specify
Results: Value selected from drop-down menu. This field is required if checkbox “Yes” is selected in response to “Was an assay or other test used to identify organism disease?”.
Positive
Negative
Indeterminate
Other
Date of test: Date the test was completed. MM/DD/YYYY format. This field is required if checkbox “Yes” is selected in response to “Was an assay or other test used to identify organism disease?”
Was the donor blood sample obtained pre or post transfusion?: This field is required if checkbox “Yes” is selected in response to “Was an assay or other test used to identify organism disease?”
Pre
Post
Unknown
What donor specimens remain for further testing? (Please indicate type and amount): A free-text field to describe specimens available for testing. 5000 character limit. This field is required.
Was tissue recovered from this donor?: This field is required.
Yes
No
Unknown
Was an autopsy completed on this donor? (Please upload a copy of the autopsy report if available): This field is required.
Yes
No
Unknown
Have local/state public health authorities been contacted regarding this event? (If appropriate for nationally notifiable infectious diseases as defined by the US Public Health Services): This field is required.
Yes
No
Unknown
Enter narrative description of the event: A free-text field to enter a detailed description of the event or to explain any other choices selected elsewhere on the form. 5000 character limit. This field is required.
Who is the patient safety contact at your institution for this event?
First Name: First name of the institution’s patient safety contact. 50 character limit. This field is required.
Last Name: Last name of the institution’s patient safety contact. 50 character limit. This field is required.
Phone contact (enter at least one): Office: The office phone number of the institution’s patient safety contact. Numeric format XXX-XXX-XXXX or XXXXXXXXXX. This field is required.
ext.: The extension of the office phone number. 10 character limit. This field is optional.
Pager/Beeper: The pager/beeper number of the institution’s patient safety contact. Numeric format XXX-XXX-XXXX or XXXXXXXXXX. This field is optional.
ext.: The extension of the pager/beeper number. 10 character limit. This field is optional.
Mobile: The cell phone number of the institution’s patient safety contact. Numeric format XXX-XXX-XXXX or XXXXXXXXXX. This field is optional.
ext.: The extension of the mobile number. 10 character limit. This field is optional.
Email: The email address of the institution’s patient safety contact. 100 character limit. This field is required.
Other contact info: A free text field. 50 character limit. This field is optional.
ext.: The extension of the other contact info. 10 character limit. This field is optional.
Person Submitting the Report:
First Name: First name of the person submitting the report. 50 character limit. This field is required.
Last Name: Last name of the person submitting the report. 50 character limit. This field is required.
Email: The email address of the person submitting the report. 100 character limit. This field is required.
Submit: Select to submit form when entry is complete.
Cancel: Select to exit form before submitting an event. Any information entered on the form will be lost.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Disease Transmission Event_Instructions |
| File Modified | 0000-00-00 |
| File Created | 2023-07-29 |