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Fundamentals in Blood Bank > Quality Management ( Chapter 23 ) > Flashcards

Quality Management ( Chapter 23 ) Flashcards

1
Q

The degree to which a product or service meets requirements

A

Quality

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2
Q

The building blocks of Quality

A

Quality control , Quality Assurance , Quality Management System

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3
Q

Blood bank compliance with federal regulations and accreditation standards is required by the ff. organizations

A

FDA
Joint Commission
CAP
AABB

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4
Q

Evaluate how effectively the facility meets the requirements by detecting errors , deficiencies , and deviations .

A

Compliance programs

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5
Q

Measure the state of the facility’s program with respect to the applicable requirements at a single point in time

A

Compliance inspections

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6
Q

Compliance inspection is also known as

A

Surveys or Assesment

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7
Q

When do usually Compliance Inspection conducted

A

every 1 to 2 years

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8
Q

Planned actions that ensure that systems and elements that influenced the quality of the product or service are working as expected , individually and collectively.

A

Quality Assurance

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9
Q

Is actively and continuously practiced by the blood bank leaders , managers and staff throughout all blood bank operation.

A

Quality Management

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10
Q

Mandates an environmental control program that addresses all significant environmental issues for facility management and maintenance such as temp control , electrical safety, fire protection, and so forth

A

Joint Commission

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11
Q

Can be defined as a set of interrelated resources and activities that transform inputs into outputs

A

Process

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12
Q

Is 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

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13
Q

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

A

Total Process Control

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14
Q

Requires that facilities design their processes and procedure to ensure that blood components are manufactured consistently to meet the quality standards appropriate for their intended use

A

cGMP ( current GOOD MANUFACTURING PRODUCT )

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15
Q

Graphically represents the sequence of activities in a process and show how the inputs are converted into outputs.

A

Flow Chart

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16
Q

Involves one or more persons who perform a sequence of activities over a period of time.

A

Work Process

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17
Q

Provide instruction for each activity in the larger process.

A

Standard Operating Procedures

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18
Q

Illustrate the sequence activities in Total Process Control

A

Process is Flow Charted —>
Procedures are Identified —>
Procedures are drafted —> Process are validated –>
Procedure are finalized –> Training is performed –>
Initial competence is assested –> Process performance is monitored

19
Q

Test all activities in a new process to ensure that the process will work in the living environment

A

Validation

20
Q

An example of a process control wherein one laboratory methods and procedures are compared with those of other laboratories for the ability to get the same result on a set of unknown specimens

A

Proficiency Testing

21
Q

Are approved info contained in a written or electronic format.

A

Documents

22
Q

Defines the QMS for external inspector and internal staff

A

Documents

23
Q

Links a facility’s policies , process and procedures and ensure that only the latest approved copies of documents are available for use.

A

Document Control System

24
Q

Are specially design documents either paper or electronic on which are recorded the results or outcomes of performing a given procedure

A

Forms

25
Q

Activities include using and manipulating the donor or patient information and test results in facility’s paper and electronic information system

A

Information Management

26
Q

Give the 6 Types of Nonconformance

A 
Accident
Adverse rxn
Complaint
Discrepancy
Error
Postdonation
27
Q

A type of Nonconformance . Complications that occured to the donor during or after the donation process or to the recipient of transfused blood component

A

Adverse Rxn

28
Q

A type of Nonconformance . Expression of dissatifaction from internal customers ( Physician , employess) or external customers ( donor , px )

A

Complaint

29
Q

A type of Nonconformance . Difference or inconsistency in the outcomes of a process, procedures or test results

A

Discrepancy

30
Q

A type of Nonconformance attributable to a human or system problem , such as a problem from failure to follow established procedure or a part of a process that did not work as expected

A

Error

31
Q

A type of Nonconformance generally not attributable to a persons mistake such as a power outage or an aged instruments malfunction

A

Accident

32
Q

A type of Nonconformance the receipt of information ( call or information letter) from donor with additional details regarding his or her donation such as subsequent illness or neglecting to mention illness or medication

A

Postdonation

33
Q

The immediate action which is the initial quick fix soln.

A

Remedial Action

34
Q

A very effective assessment tool that review a specific facility process and determine by examining documents and records , interview and observations whether the facility is meeting the applicable requirements

A

Internal Audit

35
Q

What are the two types of External Assesment

A

Proficiency testing and External Inspection

36
Q

Performed by regulatory and accreditation organization for the purposes of obtaining and maintaining the facility license or accreditation

A

External Inspection

37
Q

The cost of implementing processes and controls to prevent the occurrence of nonconformances

A

Prevention cost

38
Q

Give the 4 different Types of Quality cost

A

Prevention Cost
Appraisal Cost
Internal Failure Cost
External Failure Cost

39
Q

The cost of implementing process and controls to appraise or evaluate blood bank, tranfusion service or medical laboratory’s performance

A

Appraisal Cost

40
Q

Bad Quality Cost that expensive and hard to measure because they include both actual and intangible cost incurred to correct a nonconformance.

A

External Failure Cost

41
Q

Is a name for processes that detect , report , evaluate and correct events in blood bank operations that do not meet the facility’s or othere requirements

A

Nonconformance management

42
Q

Is a group of people who represents different activities in a given process and who have been brought together to identify and implement ways to solve process problems

A

Process improvement team

43
Q

Challenges all activities in a new process before implementation to provide a high degree of assurance that the process will work as intended

A

Process validation

Fundamentals in Blood Bank (17 decks)

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