BBQA Teamwork

true or false
Quality is the same as compliance

_________ is about doing what is required, meeting the minimum requirements.

Quality includes putting effort into _________.

this works best when people share ownership, otherwise things fall through the cracks.

this is a concrete, realistic statement of how NMCSD intends to implement and monitor QA and current GMP.

biohazard safety falls into what QA system.

this QA system includes:
organizational issues
personnel selection/training/education
validation/calibration/PM/PT
supplier qualification
Process control
Documentation/recordkeeping
label control
incident/error/accident review
internal assessment
process improvement
product recalls
biohazard safety

this QA system includes:
Data entry
Software Development
Change control
operations

which QA system includes:
Sample
Reagent/supply preparation
Equipment
Testing process
Confirmatory Testing

what QA system includes recipient ID?

what QA system includes specimen collection.

what QA system includes Donor ABO/Rh verification?

what QA system includes:
Request form
Recipient ID
Specimen collection
Donor ABO/Rh verification
Patient pre-transfusion compatibility testing
Supervisory notification of problems in providing blood

what QA system includes Recipient ID prior to transfusion.

what QA system includes
dispensing blood components for transfusion
Recipient ID prior to transfusion
Blood component administration
Appropriate blood component usage

what QA system includes detection and recognition of acute adverse effects?

what QA system includes:
Detection and recognition of acute adverse effects
Investigation of acute adverse effects
Investigation of delayed effects
investigation of suspected transfusion transmitted disease
lookback

what QA system includes:
Result review
Component lable verification

what QA system includes:
Quarantine process
Component storage
Distribution/issue
Discard/Destruction process

what QA system includes:
blood components intended for transfusion
Blood components intended for further manufacturing
components modification

what QA system includes Identification of donor and labeling of materials?

what QA system includes:
identification of donor and labeling of materials
collection
donor exceptions
post-collection

what QA system includes:
request form (physicians request)
patient acceptance and screening
ID of patient and collection of unit
Medical review

this form is used for therapeutic phelbotomy and indicates "not for transfusion"

what QA system includes:
request form
donor screening and acceptance
ID of donor and labeling material
Testing and component processing
handling and labeling autologous units
Release of autologous unit for transfusion
medical review

what QA system indicates:
Pre-donation event
Donor registration
Donor screening and accpetance
Donor deferral registry
donor deferral notification process

what QA system includes:
instrument set-up
donor registration and creening interview
donor deferral registry
medical review and donor deferral notification process
apheresis procedure
procedural problems
quality control

this is the performance of a systematic investigation to confirm or negate that established, approved policies and SOPs are being properly implemented.

what are the two types of audits?

true or false
audits are scheduled and use a checklist.