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corbin19
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true or false
Quality is the same as compliance
false
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_________ is about doing what is required, meeting the minimum requirements.
compliance
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Quality includes putting effort into _________.
prevention
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this works best when people share ownership, otherwise things fall through the cracks.
accountability
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this is a concrete, realistic statement of how NMCSD intends to implement and monitor QA and current GMP.
QA plan
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biohazard safety falls into what QA system.
System A- quality assurance program
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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
System A-quality assurance program
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this QA system includes:
Data entry
Software Development
Change control
operations
System B- Information Management
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which QA system includes:
Sample
Reagent/supply preparation
Equipment
Testing process
Confirmatory Testing
System C- Donor and Patient Testing
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what QA system includes recipient ID?
System D- Compatibility and Type and Screen Testing
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what QA system includes specimen collection.
System D- Compatibility and Type and Screen Testing
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what QA system includes Donor ABO/Rh verification?
System D- Compatibility and Type and Screen Testing
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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
System D- compatibility and Type and Screen Testing
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what QA system includes Recipient ID prior to transfusion.
System E- Blood Administration
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what QA system includes
dispensing blood components for transfusion
Recipient ID prior to transfusion
Blood component administration
Appropriate blood component usage
System E- Blood administration
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what QA system includes detection and recognition of acute adverse effects?
System F- Investigation of adeverse effects
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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
System F- Investigation of Adverse Effects
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what QA system includes:
Result review
Component lable verification
System G- Review and Labeling
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what QA system includes:
Quarantine process
Component storage
Distribution/issue
Discard/Destruction process
System H-Storage and Distribution
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what QA system includes:
blood components intended for transfusion
Blood components intended for further manufacturing
components modification
System I- Component processing
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what QA system includes Identification of donor and labeling of materials?
System J-blood collection
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what QA system includes:
identification of donor and labeling of materials
collection
donor exceptions
post-collection
System J-blood collection
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what QA system includes:
request form (physicians request)
patient acceptance and screening
ID of patient and collection of unit
Medical review
System K-therapeutic phelbotomy
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this form is used for therapeutic phelbotomy and indicates "not for transfusion"
DD572
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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
System L- autologous blood
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what QA system indicates:
Pre-donation event
Donor registration
Donor screening and accpetance
Donor deferral registry
donor deferral notification process
allogenic donor suitability
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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
System N- apheresis
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this is the performance of a systematic investigation to confirm or negate that established, approved policies and SOPs are being properly implemented.
Audits/assessments
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what are the two types of audits?
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true or false
audits are scheduled and use a checklist.
true
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