Quality management PRELIM lab Flashcards

1
Q

facility outside of the hospital

A

blood center

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2
Q

same with the blood centers but it is within the
hospital

A

hospital blood bank

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3
Q

4 governing agencies

A
  • united states food and drug administration
  • the joint commission
  • college of pathologist
  • Association for the Advancements of Blood and biotherapies
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4
Q

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

A

United States Food and Drug Administration (FDA)

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5
Q

Compliance inspections is conducted every

A

2 years

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6
Q

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

A

Compliance program

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7
Q

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

A

Compliance inspections

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8
Q

Compliance inspections also called as

A

surveys or assessment

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9
Q

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

A

Quality management

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10
Q

(3) foundation of a quality
management system

A

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

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11
Q

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

A

Association for the Advancement of Blood and Biotherapies

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12
Q

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

A

Individualized Quality Control Plan (IQCP)

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13
Q

The three parts of IQCP

A
  • laboratory risk assessment
  • pre-analytical, analytical, post-analytical process
  • customize its QC program
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14
Q

parts ofRisk Assessment (RA)

A

Specimen
Reagents
Test system
Environment
Testing personnel

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15
Q

Part of specimen

A

PSS
- patient preparation
- specimen collection
- specimen labelling

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16
Q

Part of reagent

A

PSS
- Preparation
- shipping and receiving
- storage conditions

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17
Q

Part of test system

A

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

18
Q

Part of environment

A

HAT
- humidity
- airflow/ventilation
- temperature

19
Q

Part of testing personnel

A

CST
- competency
- staffing
- training

20
Q

temperature for plasma

A

room temperature - 20-24 degrees

21
Q

routine blood bank QC procedures

A
  • daily testing of reactivity of blood typing reagents
  • time checks
  • regular performance of QC
  • manufacturers package insert
  • calibration of serologic centrifuge
  • monitor temperature
22
Q

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

A

quality assurance

23
Q

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

A
  • frequency of testing
  • criteria for acceptable QC results
  • number and type of QC testing materials
24
Q

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

A

quality assessment

25
Q

Quality assessment monitors could include

A

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

26
Q

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

A

quality assurance

27
Q

Common QC Activities

A
  • blood component
  • donor collection
28
Q

Part of donor collection

A
  • microhematocrit instrument control
  • hemoglobin instrument control
  • apheresis equipment function check
  • blood weighing scale accuracy
29
Q

Part of blood component

A

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

30
Q

What are the reagents control

A

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

31
Q

Laboratory Equipment Function
Checks

A
  • freezer
  • thawing device
  • water bath
  • ph meter
  • cell counter
  • cell washer
  • centrifuge
  • platelet incubator
32
Q

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

A

Quality management system

33
Q

Quality Management System Essentials

A

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

34
Q

quality essentials and blood bank operation

A

quality essential
- organization
- resources
- equipment
- process control
- documents and records

blood bank operation
- autologous donor qualification
- apheresis donor qualification
- blood collection

35
Q

Organization

A

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

36
Q

Facilities and Safety

A

part of facilities
TEF
- temperature control
- electrical safety
- fire protection

part of safety
ICE
- infections control
- chemical hygiene
- emergency preparedness

37
Q

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.

A

process control

38
Q

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

A

total process control

39
Q

blood bank path workflow

A

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

40
Q

QMS building block

A
  • the blood bank
  • the work
  • the performance