Quality in the Laboratory

100問 • 1年前

問題一覧

Total Quality Management (TQM): A management _________ and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements.

PHILOSOPHY

: A management PHILOSOPHY and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements.

Total Quality Management (TQM)

QLP (Quality Laboratory Processes) - include___________processes and the general policies, practices, and procedures that define how all aspects of the work are done

ANALYTICAL

- include ANALYTICAL processes and the general policies, practices, and procedures that define how all aspects of the work are done

QLP (Quality Laboratory Processes)

QC (Quality Control) - emphasizes _________control procedures (QC procedures), but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors

STATISTICAL

- emphasizes STATISTICAL control procedures (QC procedures), but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors

QC (Quality Control)

as currently applied, is concerned primarily with broader measures and monitors of laboratory performance

QA (Quality Assessment)

referred to as total quality control (QC)

Total Quality Management (TQM)

referred to as total quality leadership

Total Quality Management (TQM)

referred to continuous quality improvement

Total Quality Management (TQM)

referred to quality management science

Total Quality Management (TQM)

referred to industrial quality management

Total Quality Management (TQM)

referred to turnaround time

QA (Quality Assessment)

referred to specimen identification

QA (Quality Assessment)

referred to patient identification

QA (Quality Assessment)

referred to test utility

QA (Quality Assessment)

provides a structured problem-solving process to help identify the ROOT cause of a problem and a CAUSE for that problem

QI (Quality Improvement)

is necessary to standardize the remedy

QP (Quality Planning)

is necessary to establish measures for performance monitoring

QP (Quality Planning)

is necessary to ensure that the performance achieved satisfies quality requirements

QP (Quality Planning)

is necessary to document the new QLP

QP (Quality Planning)

Clinical and Laboratory Standards Institute (CLSI) document describes a quality management system (QS) as a "set of _____________________ that must be in place for an organization's work operations to function in a manner to meet the organization's stated quality objectives."

KEY QUALITY ELEMENT

Clinical and Laboratory Standards Institute (CLSI) document describes a ?as a "set of KEY QUALITY ELEMENT that must be in place for an organization's work operations to function in a manner to meet the organization's stated quality objectives."

quality management system (QS)

? document describes a ?as a "set of KEY QUALITY ELEMENT that must be in place for an organization's work operations to function in a manner to meet the organization's stated quality objectives."

Clinical and Laboratory Standards Institute (CLSI)

A comprehensive program in an institution in which ALL areas of operation are monitored to ensure quality with the aim of providing the highest quality patient CARE.

Quality Assurance / Assesment

Standard operating procedure (SOP) - Set of __________ for methods used in the laboratory. Also known as procedure manual

instructions

- Set of instructions for methods used in the laboratory. Also known as procedure manual

Standard operating procedure (SOP)

Standard operating procedure (SOP) - Set of instructions for methods used in the laboratory. Also known as

procedure manual

2 Costs of Conformance

Prevention Costs Appraisal Costs

2 Quality Cost

Costs of Conformance Costs of Nonconformance

2 Costs of Nonconformance

Internal Failure Costs External Failure Costs

Quality Cost Training

Prevention Costs

Quality Cost Calibration

Prevention Costs

Quality Cost Maintenance

Prevention Costs

Quality Cost Inspection

Appraisal Cost

Quality Cost Quality control

Appraisal Cost

Quality Cost Scrap

Internal Failure Costs

Quality Cost Rework

Internal Failure Costs

Quality Cost Repeat runs

Internal Failure Costs

Quality Cost Complaints

External Failure Costs

Quality Cost Service

External Failure Costs

Quality Cost Repeat Request

External Failure Costs

are increasingly used to reduce error and waste

Lean Six Sigma

Lean was designed to eliminate non–____-adding steps

VALUE

was designed to eliminate non–VALUE -adding steps

Lean

Lean seeks to streamline the process by eliminating _________ excess, and barriers for a more optimized flow. The major measurement for Lean is generally _______

DUPLICATION TIME

seeks to streamline the process by eliminating DUPLICATION excess, and barriers for a more optimized flow. The major measurement for Lean is generally TIME

Lean

Six Sigma is a performance improvement program, the goal of which can be summarized by the mantra “improvement by eliminating process ________”: improved performance, improved quality, improved bottom line, improved customer satisfaction, and improved employee satisfaction . it is oriented toward process identification and process improvement

VARIATION

is a performance improvement program, the goal of which can be summarized by the mantra “improvement by eliminating process VARIATION”: improved performance, improved quality, improved bottom line, improved customer satisfaction, and improved employee satisfaction . it is oriented toward process identification and process improvement

Six Sigma

Six Sigma Process Improvement:

DMAIC Define Measure Analyze Improve Control

ISSUES TO IMPROVE

Define

DATA COLLECTION

Measure

IDENTIFY OF id of root cause

Analyze

changes to adapt (solution / remedy)

Improve

Ensures of changes are maintained/ followed

Control

What is the goal of Six sigma? i. improved performance ii. improved quality iii. improved precision iv. Improved accuracy a. I,ii b. i.iii,v c. iii,iv d. I, ii, iii, iv

a. I,ii

Quality Control A system ensuring __________ and ____________

accuracy precision

A system ensuring accuracy and precision

Quality Control

used to monitor the analytic variations that can occur with a new instrument or with new lots of control

Quality Control

.Sensitivity - measure the _________ concentration

smallest

. - measure the smallest concentration

Sensitivity

.Specificity – ability to measure _______ the analyte of interest.

ONLY

. – ability to measure ONLY the analyte of interest.

Specificity

Sensitivity IS THE

SCREENING TEST

IS THE SCREENING TEST

Sensitivity

.Specificity IS THE

CONFIRMATORY TEST

. IS THE CONFIRMATORY TEST

Specificity

Accuracy – __________________________ of the assayed value to the true value

CLOSENESS

– CLOSENESS of the assayed value to the true value

Accuracy

Precision/Reproducibility – ability to give____________ results on the same Sample that agree w/one another.

REPEATED

– ability to give REPEATED results on the same Sample that agree w/one another.

Precision/Reproducibility

CLOSENESS OF AGREEMENT

Precision/Reproducibility

IS AFFECTED BY RANDOM ERROR

Precision/Reproducibility

Precision/

Reproducibility

/Reproducibility

Precision

refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time

RELIABILITY

– ability to detection proportion of individuals w/that disease

Dx Sensitivity

Dx Sensitivity FORMULA

TP / (TP + FN) × 100

Dx Sensitivity – ability to detection proportion of individuals

w/that disease

TP / (TP + FN) × 100

Dx Sensitivity

Is the percentage of people with positive test results who have the disease.

Positive predictive value

– ability to detect the proportion of individual w/o the disease who test negatively for the disease

Dx specificity

Dx specificity FORMULA

TN / (TN + FP) × 100

Dx specificity

is the percentage of people with negative test results who do not have the disease

Negative predictive value

determines the lowest and highest values that can be accurately measured by a particular method.

Linearity check

Kinds of QC

Intralab (internal QC) Intralab (internal QC)

Intralab (internal QC) ● analyses of ________ w/patient sample

CONTROL

● analyses of CONTROL w/patient sample

Intralab (internal QC)

lyophilized or liquid materials that have the same matrix as patient specimens

Control material

handled exactly like patient specimen

Control material

provide both negative and positive results

Control material

A quality program in which specimens are submitted to laboratories for analysis and the results of an individual laboratory are compared with the results for the group of participating laboratories.

External Quality Assessment:

Interlab (external QC)

PROFICIENCY TESTING PROGRAM

External Quality Assessment

FOR LONG TERM ACCURACY

External Quality Assessment

Specimens that have known concentrations of an analyte for the test of interest. The testing laboratory does not know the targeted concentration when teste

PROFICIENCY samples

3 Types of Error

Random error Systematic error Clerical error

Random error – due to _____________.

CHANCE

100

– due to CHANCE.

Random error

other names parasitology

Yves Laure Pimentel · 70問 · 2年前

other names parasitology