WK15: QA & QC

Question 1

Is the degree to which a product or service meets the requ irem ent

Answer 1

Quality

Question 2

Operational techniques and activities used to fulfill the requirements for quality

Answer 2

Quality Control

Question 3

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

Answer 3

Quality Assurance

Question 4

Provides a framework for applying quality principles and practices uniformly across all blood bank operations

Answer 4

Quality Management

System

Question 5

QC Activities

Answer 5

Collection Equipment
Blood Components
Reagents
Lab Equipment

Question 6

Sequential flow of the elements of the total process control

Answer 6

Flowcharts

Question 7

Work process involves one or more persons who perform a sequence of activities over a period of time

Answer 7

SOP

Question 8

Ensure that new processes will work as intended, they must be validated before being put into use

Answer 8

Validation

Question 9

Process controls involve review of _____ and _____

Answer 9

work and QC records

Question 10

Essential to monitor the process to ensure that they are

performing as required

Answer 10

Process controls

Question 11

Routine process controls include

Answer 11

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

Question 12

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

Answer 12

Proficiency testing

Question 13

disease transmitted to blood transfusions is sent by _____

Answer 13

RITM

Question 14

nformation about events involving the blood bank that deviate from accepted policy, process, or procedure need to be captured and acted upon

Answer 14

Nonconformance reporting

Question 15

Nonconformance attributable to a human or system problem

Answer 15

error

Question 16

Measures the state of the facilities quality program with respect to the applicable requirements at a single point in time

Answer 16

Assessment

Question 17

monitor the effectiveness of its QMS

Answer 17

Internal assessment

Question 18

2nd type of assessments; performed by regulatory and accreditation organizations for the purposes of obtaining and maintaining the facility’s license or accreditation

Answer 18

External inspection

Question 19

Cost of implementing the process and the control to prevent the occurrences of the non-conformances

Answer 19

Prevention Cosst

Question 20

Cost of implementing the process and controls to appraise or evaluate the blood bank or transfusions service

Answer 20

Appraisal cost

Question 21

Wastage of reagents, supplies in donation

Answer 21

Internal Failure Costs

Question 22

expensive and hard to measure because they include both the actual and intangible cost incurred to correct an nonconformance that has reached a customer

Answer 22

External Failure Costs

Question 23

Define the quality management system for external inspectors and internal staff

Answer 23

documents

Question 24

Alarms must be checked _____

Answer 24

periodically

Question 25

True or False:

Ref temp must be recorded every 3 hours

Answer 25

False (4 hrs)

Question 26

low temp alarm

Answer 26

1.5C

Question 27

high temp alarm

Answer 27

5.5C

Question 28

True or false:
Any spike in low or high temp must be
documented for any reason

Answer 28

True

Question 29

Temp of PLT rotator

Answer 29

RT - 20-24C (with constant agitation)

Question 30

Expired reagents can be used when:

Answer 30

rare
difficult to obtain
documented
stated in SOP

Question 31

detects HgB

Answer 31

Copper Sulfate

Question 32

perform during use

Answer 32

Minor blood group

Copper Sulfate

Question 33

Used for donor screening by observing the behavior of drops of blood of known hemoglobin concentration

Answer 33

Copper Sulfate Solution

Question 34

Sg of copper sulfate

Answer 34

1.053

Question 35

Sg of copper sulfate is equivalent to _____ g/dL of HgB

Answer 35

12.5g/dL HgB

Question 36

90% of units sampled contain ≥5.5x10^10 platelets

Answer 36

pooled PLTs

Question 37

True or False

Blood banks are inspected quarterly

Answer 37

False (yearly)

Question 38

All antisera should be stored at ___ when not in use

Answer 38

2-6°C

Question 39

Rh view box: provide sufficient heat so the temp of Anti-D antisera and the red blood
cells are approximately ____

Answer 39

37°C temp

Question 40

The glass surface of the viewing box must remain between ____

Answer 40

45-50 °C