General
What is considered significant damage to a supply shipment?
If significant damage is noted to 20% or more of the supply shipment the supply is rendered unusable, and center management is to decline the shipment and contact corporate management. Under no circumstances is the shipment to be accepted until approval is given by corporate management.
CTR6000 3.5.1
When are trained medical staff required to be onsite?
Trained medical staff are required to be on site during all donation activities. The donation activity parameters are defined as; the start of FDHQ/ADHQ to the last needle removed on the donor floor.
CTR3000 4.2
What is the temperature range in the reception area? What happens if the reception area exceeds the minimum temperature requirement?
15C to 30C
If the temperature is below 15C, the refractometers can not be used. Total protein can not be determined. Impact assessment must be completed.
CTR6004 4.1.1 and CTR6009 6.2
What does the BLAD, DPM, DLAD, and ACAD stand for?
BLAD- Blood Line Air Detector
DPM - Donor Pressure Monitor
DLAD- Donor Line Air Detector
ACAD- Anti-coagulant Air Detector
Within how long must plasma samples be placed into the freezer after disconnect?
Plasma units must be placed int the appropriate area of the freezer within 60 minutes of disconnect.
0-60 minutes : Good
61-120 minutes: Minor Deviation
120> minutes: IIR + Contact Corp QA for unit suitability
CTR5000 3.1.3
What must be completed prior to returning a refractometer back in to service after being sent out for repair?
EI must be completed, validation must be passing, impact assessment must be completed, and TC review must have occurred.
What pulse requires medical review?
40-49bpm : Physician Substitute can discuss athletic donor suitability with the CMD.
≥ 125bpm : Medical evaluation from physician substitute required
CTR2002 4.6.2 and 4.6.6
When should capillary tubes be discarded and require a second fingerstick or deferral?
Hemolysis, air bubbles, leakage, lipemia
CTR2002 4.7.3.1
Which direction should the vent line face for a plasma collection container?
Right
CTR4001WI-aa 3.5.11.2
How many plasma cases are allowed to be out of the freezer during case packing?
When packing plasma units, no more than six cases worth of units may be out at a time and should not be out of the freezer for more than 60 minutes at a time
CTR5000 3.1.5
What should be written on damaged boxes during QA inspection?
Any supply cartons that have visible damage must be inspected by QA to ensure no supply within the carton is damaged. QA will document “OK FOR USE” ,or similar, on the damaged box with their initials and date.
CTR6000 3.5.3.2
What is the process for when a condition is not listed on the MCG?
In instances where the MCG does not provide guidance on a donor’s medical suitability, the Physician Substitute will contact the Responsible Physician for consultation to determine if the donor is eligible to donate or refer the donor to their Primary Care Physician (PCP) for further information
CTR3001 4.1.4
Describe a failed arm check.
If any abnormalities are found on the VP site, outer arms, hands, and between fingers. Abnormalities are defined as bruising, needle marks, open wounds, and signs of infection.
If abnormalities are found, Screeners should fail the arm check and a physician substitute should complete the arm evaluation questionnaire.
CTR2002 4.3
What are the dimensions for both venipuncture prep solutions? When must a scrub be re-performed?
ChloraPrep: 2.5 x 2.5 square in back-and-forth strokes for a minimum of 30 seconds
Iodine: 1" circle directly over the venipuncture site for 30 seconds and then 15 seconds to create outward concentric circles at 3"
Rescrub must occur is the donor bends their arm, non-sterile object touches the site, employee leaves the donor bed prior to venipuncture, or iodine swab touches the pressure cuff or shirt.
CTR4001WI-ab 3.1 and 3.2
When packing, every unit must be inspected to verify the following:
-Volume is documented on the unit and is suitable
-Unit is labeled and the label is legible
-Unit is fully frozen
-Unit has no broken ports
CTR5003 2.2
How frequently should the zebra printer QC be performed? How do you perform?
The Zebra Printers require the printhead and rollers to be cleaned upon changing the media or ribbon. Use the cotton-tipped applicator with 99.7% Isopropyl Alcohol to perform the cleaning. Wipe along the brown strip on the printhead assembly from end to end and the palten roller. Allow the solvent to evaporate.
CTR6014 3.2.2
What topics are required to be covered on the weight loss evaluation?
A Physician Substitute will be required to perform an evaluation on donors that have a 10lb or more weight loss within the past 30 days. The evaluation should include the following: Donor Health History, Diet, Exercise, Medical Diagnostics, Medications, Clothing
CTR3001 10.1
True or False. Donors can be on their phones during screening? This includes phone conversations, facetime, playing games, and texting?
False. Donors can not have their phones out during the screening process. Medical receptionists must ask the donors to put their phones away for the duration of the screen.
What are the different color beacon lights and what do they mean?
White- there's an error that requires your attention or the procedure is in a paused state
Orange: there's a notification on the screen
Green: the procedure is complete
Blue: POST or final return cycle
TM1010
How frequently is the Freezer Thermometer Comparison? If the comparison is not within 2 degrees, what steps should be taken?
-Freezer Thermometer Comparison is a Quarterly Activity.
-If the readings are not within 2 degrees of each other, the equipment activity will fail. A retry of the Freezer Thermometer Comparison Equipment Activity will need to be completed after two hours.
CTR6008 4.5.1
What should be completed if the center experiences a bleed label swap/error?
-Place a temporary management deferral on the donor(s)
- Destroy unit and samples if true label swap occurs
-Send an email to Corp QA
-Initiate an IIR
-Initiate an eDMS ticket
CTR1010 4.7
What type of deferral is placed if a donor decides to self exclude during a health assessment? What do you do if a donor self-excludes with an auditor in the room?
Permanent Deferral.
If other personnel (staff, auditors, etc.) are present during self exclusion, a 2nd opportunity to self-exclude must be completed privately after the signing of the Informed Consent.
CTR3003
What must be performed if a donor is hearing impaired?
After confirming that a donor is hearing impaired, staff must assess the potential donor’s ability to read lips. The impairment must be document in the donor’s chart and specify if the donor is able to read lips or not able to read lips. If unable to read lips ALL communication must be documented as part of the manufacturing records. If a donor is hearing impaired- does not read lips and has been deemed illiterate, they will be unable to donate.
CTR2000 5.5
What are the first 3 things that donor floor should do in the event of a power failure?
1. Push the device power switch to the "Off" position
2. Ensure the blood in the needle set is anticoagulated by pumping 5mL of AC through the tubing
3.If power is NOT restored within 5-7 minutes, gravity reinfuse
NexSys User Manual p.110
Describe the back-up sample destruction process.
Center Ops reviews back-up sample destruction requirements on a bi-weekly basis to determine a clear date.
Back-ups can be destroyed once 60 days aged, test results for the unit have posted, customer requirements are met, and orphan status has been reviewed.
CTR5001 2.11.4 and 2.12