Quality Management ( Chapter 23 )

Question 1

The degree to which a product or service meets requirements

Answer 1

Quality

Question 2

The building blocks of Quality

Answer 2

Quality control , Quality Assurance , Quality Management System

Question 3

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

Answer 3

FDA
Joint Commission
CAP
AABB

Question 4

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

Answer 4

Compliance programs

Question 5

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

Answer 5

Compliance inspections

Question 6

Compliance inspection is also known as

Answer 6

Surveys or Assesment

Question 7

When do usually Compliance Inspection conducted

Answer 7

every 1 to 2 years

Question 8

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

Answer 8

Quality Assurance

Question 9

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

Answer 9

Quality Management

Question 10

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

Answer 10

Joint Commission

Question 11

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

Answer 11

Process

Question 12

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

Answer 12

Process control

Question 13

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

Answer 13

Total Process Control

Question 14

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

Answer 14

cGMP ( current GOOD MANUFACTURING PRODUCT )

Question 15

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

Answer 15

Flow Chart

Question 16

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

Answer 16

Work Process

Question 17

Provide instruction for each activity in the larger process.

Answer 17

Standard Operating Procedures

Question 18

Illustrate the sequence activities in Total Process Control

Answer 18

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

Question 19

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

Answer 19

Validation

Question 20

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

Answer 20

Proficiency Testing

Question 21

Are approved info contained in a written or electronic format.

Answer 21

Documents

Question 22

Defines the QMS for external inspector and internal staff

Answer 22

Documents

Question 23

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

Answer 23

Document Control System

Question 24

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

Answer 24

Forms

Question 25

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

Answer 25

Information Management

Question 26

Give the 6 Types of Nonconformance

Answer 26

``` Accident Adverse rxn Complaint Discrepancy Error Postdonation ```

Question 27

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

Answer 27

Adverse Rxn

Question 28

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

Answer 28

Complaint

Question 29

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

Answer 29

Discrepancy

Question 30

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

Answer 30

Error

Question 31

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

Answer 31

Accident

Question 32

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

Answer 32

Postdonation

Question 33

The immediate action which is the initial quick fix soln.

Answer 33

Remedial Action

Question 34

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

Answer 34

Internal Audit

Question 35

What are the two types of External Assesment

Answer 35

Proficiency testing and External Inspection

Question 36

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

Answer 36

External Inspection

Question 37

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

Answer 37

Prevention cost

Question 38

Give the 4 different Types of Quality cost

Answer 38

Prevention Cost Appraisal Cost Internal Failure Cost External Failure Cost

Question 39

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

Answer 39

Appraisal Cost

Question 40

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

Answer 40

External Failure Cost

Question 41

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

Answer 41

Nonconformance management

Question 42

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

Answer 42

Process improvement team

Question 43

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

Answer 43

Process validation