FACT
FACT requirements
N10 Protocols
Transplant Questions
Misc
100
What does FACT stand for?
Foundation for the Accreditation of Cellular Therapy
100
Fact requires CIT to have support services beyond the consulting specialist (cardiology, nephrology, infection disease, etc)
Can you name one of the services?
Services: Dietary, social services, psychology, and PT.
100
For use during downtime, where are the hard-copy of the SOP binders located?
Red binder at the nurses station, above the ASCOM phones
100
What does it mean if a donor is “ineligible”?
The donor may have positive infectious disease markers (IDM’s), or the donor may have health history, physical assessment, or medical records may indicate risk factors for communicable diseases, but it is still in the patient’s best interest to proceed with this donor.
What is needed when we proceed with an “ineligible” donor? The donor and recipient must be informed of the reason for ineligibility and sign a Declaration of Urgent Medical Need (DUMN) consent. Cellular products obtained from the donor must be stored in quarantine and labeled appropriately.
100
True or False:
N10 Nurses must ensure the cell tech filled out the preparation and technique section
TRUE: This is a FACT standard that indicates our machine was cleaned and is working properly. If you notice that this information was not filled out, please fill it out prior to the end of your shift.
200
How often do we complete a FACT inspection?
Every 3 years
200
How often do our critical documents need to be reviewed?
At minmum every 2 years!
Examples of "critical documents"
-Policies, protocols, SOPs, guidelines
-Worksheets
-Forms
-Labels
200
What CIT-Specific training and competency have you had to perform a transplant? Name at least 2
- Cellular infusion validation quiz
- Annual CIT knowledge quiz
- CAR-T module on workday
- BMT fundamentals
- Chemotherapy certification
- National Marrow Donor Program Confidentiality training
- CIT medication quiz
200
What is the maximum amount of DMSO in cryopreserved cell products that a patient can receive in a single day?
50 mL or 1 mL/kg, whichever is smaller
200
How long do you pre-medicate the patient prior to a stem cell transfusion?
Medications should be given PER ORDER. If your order states they are to be given one hour prior, they should be given as ordered. It is important to minimize the risk of reaction for stem cell infusions.
300
True or False:
FACT is the only accrediting agency that addresses all quality aspects of cellular therapy and cord blood banking, including collection, processing, and administration.
TRUE :)
300
Which endpoints of clinical function do we monitor to evaluate CAR T products?
Cytokine Release Syndrome - Neurotoxicity
Complete Response Rate - Relapse Rate
(the percentage of patients who show no signs of cancer after treatment)
300
What is in the back of every patient's chart?
In the back of each chart, you will find the circular of information. This is a FACT requirement and should be in EVERY chart of a patient who receives a stem cell transplant.
Its a detailed document that provides crucial information regarding the use, indications, contraindications, side effects, dosage, and administration instructions for cellular therapy products, essentially acting as an extended product label due to limited space on the container itself
300
Which SOP speaks to the safe administration of Cell Therapy products?
CIT.CLIN-3.02 Cellular Therapy Product Infusion (Policy Manager)
300
TRUE or False: A copy of the release and transport of cells is scanned into a patients chart after stem cell infusion.
True! This should be scanned into your patient's chart after stem cell transplant. The physical copy and the digital should be in your patient's chart by end of shift.
400
How do patients benefit if we are FACT accredited?
For patients, a FACT-accredited HSCT center signifies a higher likelihood of receiving safe and high-quality care during their stem cell transplant procedure.
400
True or False: All examples below are events that should be entered into the CIT AE icon
- The wrong dose of tacrolimus was given.
- Patient starts to experience rigors and a fever during a stem cell infusion.
- Patient is transferred to the ICU at D+50.
True!
400
How does our unit protect patients from airborne microbial contamination?
5 answers total :)
1. HEPA filters
2. Positive pressure
3. Isolation
4. Masking
5. Visitation guidelines
400
Who co-signs your stem cell infusion?
The CELL TECH or APP
ideally, the cell tech signs off on your stem cell infusion; at times, the APP is the only other person in the room.
Without a cosign, it could be assumed that you did not have a second individual in the room, even if their name is listed. Please ensure you request a cosign from your cell tech or APP and follow up with a secure chat before the end of your shift if this is not completed.
400
TRUE or False: The FDA definition of an Adverse Event is “any undesired experience associated with the use of a medical product in a patient.”
True :)
500
What is the purpose of FACT?
FACT (Foundation for the Accreditation of Cellular Therapy) is a non-profit organization that sets standards and provides accreditation for cellular therapies, including hematopoietic stem cell transplants (HSCT)
When a facility is FACT-accredited for HSCT, it means they meet rigorous standards for patient care, laboratory practices, and procedures related to stem cell collection, processing, and transplantation.
500
How many transplants does FACT require us to perform?
Adult: average of 5 new autos and 5 new allos per year.
500
What is our visitation policy? (Hours, age, masking, hand hygiene, etc)
- Visitors hours are 8-8
- Two adult visitors are permitted, no one under age 18
- Visitors should not have been exposed to chicken pox or any live virus vaccinations in the last 3 weeks
- All visitors MUST wear a mask while visiting on the unit
- Wash your hands prior to entering and after exiting the room with soap/water or hand sanitizer
- If the patient is on contact or droplet, visitors are required to use a gown and gloves as indicated
500
How often do you obtain vitals on a stem cell infusion?
Pre infusion VS
5 minute VS
15-minute VS (if applicable)
End of infusion VS
1-hour post infusion VS
500
Name ONE thing that recipient follow-up includes after the stem cell infusion. DON'T THINK TO HARD. What do we monitor for?
Management of nausea, vomiting, pain, etc
Monitoring blood counts and transfusions
Monitoring infections and antimicrobials
Monitoring organ dysfunction
Monitoring graft failure, instituting treatment
Assessing GVHD (acute and chronic), instituting treatment