WK15: QA & QC Flashcards
Is the degree to which a product or service meets the requ irem ent
Quality
Operational techniques and activities used to fulfill the requirements for quality
Quality Control
Set of planned actions that ensure that the system and the elements that influence the quality of the product or the service are working as expected individually and collectively
Quality Assurance
Provides a framework for applying quality principles and practices uniformly across all blood bank operations
Quality Management
System
QC Activities
Collection Equipment
Blood Components
Reagents
Lab Equipment
Sequential flow of the elements of the total process control
Flowcharts
Work process involves one or more persons who perform a sequence of activities over a period of time
SOP
Ensure that new processes will work as intended, they must be validated before being put into use
Validation
Process controls involve review of _____ and _____
work and QC records
Essential to monitor the process to ensure that they are
performing as required
Process controls
Routine process controls include
quality control of test
methods of the reagent
the review of the work and quality control records
capturing the occurrences when the process did not work as expected
One laboratory’s methods and procedures are compared with those of other laboratories for the ability to get the same result on a set of unknown specimens
Proficiency testing
disease transmitted to blood transfusions is sent by _____
RITM
nformation about events involving the blood bank that deviate from accepted policy, process, or procedure need to be captured and acted upon
Nonconformance reporting
Nonconformance attributable to a human or system problem
error
Measures the state of the facilities quality program with respect to the applicable requirements at a single point in time
Assessment
monitor the effectiveness of its QMS
Internal assessment
2nd type of assessments; performed by regulatory and accreditation organizations for the purposes of obtaining and maintaining the facility’s license or accreditation
External inspection
Cost of implementing the process and the control to prevent the occurrences of the non-conformances
Prevention Cosst
Cost of implementing the process and controls to appraise or evaluate the blood bank or transfusions service
Appraisal cost
Wastage of reagents, supplies in donation
Internal Failure Costs
expensive and hard to measure because they include both the actual and intangible cost incurred to correct an nonconformance that has reached a customer
External Failure Costs
Define the quality management system for external inspectors and internal staff
documents
Alarms must be checked _____
periodically
True or False:
Ref temp must be recorded every 3 hours
False (4 hrs)
low temp alarm
1.5C
high temp alarm
5.5C
True or false:
Any spike in low or high temp must be
documented for any reason
True
Temp of PLT rotator
RT - 20-24C (with constant agitation)
Expired reagents can be used when:
rare
difficult to obtain
documented
stated in SOP
detects HgB
Copper Sulfate
perform during use
Minor blood group
Copper Sulfate
Used for donor screening by observing the behavior of drops of blood of known hemoglobin concentration
Copper Sulfate Solution
Sg of copper sulfate
1.053
Sg of copper sulfate is equivalent to _____ g/dL of HgB
12.5g/dL HgB
90% of units sampled contain ≥5.5x10^10 platelets
pooled PLTs
True or False
Blood banks are inspected quarterly
False (yearly)
All antisera should be stored at ___ when not in use
2-6°C
Rh view box: provide sufficient heat so the temp of Anti-D antisera and the red blood
cells are approximately ____
37°C temp
The glass surface of the viewing box must remain between ____
45-50 °C
