Quality management PRELIM lab

Question 1

facility outside of the hospital

Answer 1

blood center

Question 2

same with the blood centers but it is within the
hospital

Answer 2

hospital blood bank

Question 3

4 governing agencies

Answer 3

• united states food and drug administration
• the joint commission
• college of pathologist
• Association for the Advancements of Blood and biotherapies

Question 4

who mandates and inspect the different anticoagulants that we use for blood
preservation

Answer 4

United States Food and Drug Administration (FDA)

Question 5

Compliance inspections is conducted every

Answer 5

2 years

Question 6

Evaluate how effectively the facility meets regulatory and accreditation a requirement by detecting errors, deficiencies, and deviations.

Answer 6

Compliance program

Question 7

measure the state of the facility’s program with respect to the applicable requirements

Answer 7

Compliance inspections

Question 8

Compliance inspections also called as

Answer 8

surveys or assessment

Question 9

actively and continuously practiced by blood bank leaders, managers, and staff throughout all blood bank operations

Answer 9

Quality management

Question 10

(3) foundation of a quality
management system

Answer 10

Quality Control (QC), Quality Assurance (QA), and the Quality Management System (QMS)

Question 11

who is responsible to mandates
the different guidelines, the standardization, the policies that we have in every procedures

Answer 11

Association for the Advancement of Blood and Biotherapies

Question 12

allows each laboratory to customize its QC program, but it must be still within the AABB guidelines

Answer 12

Individualized Quality Control Plan (IQCP)

Question 13

The three parts of IQCP

Answer 13

• laboratory risk assessment
• pre-analytical, analytical, post-analytical process
• customize its QC program

Question 14

parts ofRisk Assessment (RA)

Answer 14

Specimen
Reagents
Test system
Environment
Testing personnel

Question 15

Part of specimen

Answer 15

PSS
- patient preparation
- specimen collection
- specimen labelling

Question 16

Part of reagent

Answer 16

PSS
- Preparation
- shipping and receiving
- storage conditions

Question 17

Part of test system

Answer 17

FDT
- failure of system checks
- detection of clots, hemolysis, and lipemia
- transmission of data to LIS

Question 18

Part of environment

Answer 18

HAT
- humidity
- airflow/ventilation
- temperature

Question 19

Part of testing personnel

Answer 19

CST
- competency
- staffing
- training

Question 20

temperature for plasma

Answer 20

room temperature - 20-24 degrees

Question 21

routine blood bank QC procedures

Answer 21

• daily testing of reactivity of blood typing reagents
• time checks
• regular performance of QC
• manufacturers package insert
• calibration of serologic centrifuge
• monitor temperature

Question 22

planned, systematic activities implemented within the quality system to provide confidence that requirements for the quality to be fulfilled

Answer 22

quality assurance

Question 23

To monitor the accuracy and precision of patient testing, QCP must include

Answer 23

• frequency of testing
• criteria for acceptable QC results
• number and type of QC testing materials

Question 24

requires monitoring for effectiveness of the IQCP as well as for potential changes that could introduce risk

Answer 24

quality assessment

Question 25

Quality assessment monitors could include

Answer 25

PPCT - proficiency testing record - personnel competency record - corrective action report - turnaround time

Question 26

set of planned actions that ensure that systems and elements that influence the quality of the product or service are working as expected, individually and collectively

Answer 26

quality assurance

Question 27

Common QC Activities

Answer 27

- blood component - donor collection

Question 28

Part of donor collection

Answer 28

- microhematocrit instrument control - hemoglobin instrument control - apheresis equipment function check - blood weighing scale accuracy

Question 29

Part of blood component

Answer 29

PCRBR - platelet count in platelet unit - Cryoprecipitate antihemophilic factor - red blood cell hematocrit - bacterial contamination of platelets unit - residual leukocyte count

Question 30

What are the reagents control

Answer 30

CRRT - copper sulfate - reagent red blood cell - reagent antisera - test kits for infectious disease testing

Question 31

Laboratory Equipment Function Checks

Answer 31

- freezer - thawing device - water bath - ph meter - cell counter - cell washer - centrifuge - platelet incubator

Question 32

Provides a framework for applying quality principles and practices uniformly across all blood bank operations, starting with donor selection and proceeding through transfusion outcomes

Answer 32

Quality management system

Question 33

Quality Management System Essentials

Answer 33

PHMD - physical facilities - hire qualified personnel - materials and equipment - documents for work performance

Question 34

quality essentials and blood bank operation

Answer 34

quality essential - organization - resources - equipment - process control - documents and records blood bank operation - autologous donor qualification - apheresis donor qualification - blood collection

Question 35

Organization

Answer 35

Relationships among blood bank personnel by job title  The blood bank’s link to the laboratory  The blood bank’s link to the hospital  How the blood bank links to the hospital’s quality function

Question 36

Facilities and Safety

Answer 36

part of facilities TEF - temperature control - electrical safety - fire protection part of safety ICE - infections control - chemical hygiene - emergency preparedness

Question 37

a set of activities that ensures a given work process will keep operating in a state that is continuously able to meet process goals without compromising the process itself.

Answer 37

process control

Question 38

is the evaluation of process performance, comparison of actual performance to a goal, and action taken on any significant difference

Answer 38

total process control

Question 39

blood bank path workflow

Answer 39

component collection > preparation > testing > labelling > distribution > compatibility testing > issue > administration

Question 40

QMS building block

Answer 40

- the blood bank - the work - the performance