Quality Management

67問 • 1年前

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The act of overseeing all activities and tasks that must be accomplished to maintain a desired level of excellence -Administrative side - It focuses more on the client/patient satisfaction, feedback,

Quality Management

- Focuses on the overall process - The maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production - Pre-analytical, Analytical, Post-Analytical

Quality Assurance

A measure of precision, or how well the measurement system (tests) reproduces the same result over time and under varying operating conditions

Quality Control

The quality assurance monitors the performance of?

Quality Control Process

• Focus on the analytical phase • Method Evaluation

Quality Control

Reproducibility of the results

Precision

- The correctness of the value you will able to reach or achieve. - How accurate are your methods to your other competitors.

Accuracy

Will judge the performance of each laboratory. To provide the recommendation on the test kits that you should use. Provide a limit to sensitivity and specificity Provides level or brand

National Reference Laboratory

Ability of your instrument or your method to detect the lowest possible concentration of an analyte. -Kahit gaano pa kaonti, kaya niya magprovide ng measurement

Analytical Sensitivity

Ability of your instrument to detect the analyte of interest only, less prone to cross reactions. Uric Acid = Elevated glucose level Uric acid = gout

Analytical Specificity

Lowest error from 4-32% is? - Transportation -> Analysis -> Data flow

Analytical

Second highest error, from 9 to 55%? - Error in reporting - Interpretation by M.D. -> Diagnosis and treatment -> Healthy patient

Post-analytical

Most error were come from the? - 32 and 75% - Sick patient -> M.D. orders -> Collection

Pre-analytical

In quality control: Systematic approach of monitoring the _____ of the laboratory analysis

Analytical

Material analyzed only for QC purposes

Control

Use of controls, run as samples and plot the results in a chart

Levey Jennings, Westgard

Each charts has a specific range of acceptable values known as?

Control limits

Minimum runs per QC:

20 samples (1/day)

In Calibration, you should adjust the? To measure the level of measurement. Absorbance and concentration.

Linearity

In calibration, the material used is?

Calibrators

When do we usually perform calibration? The machine should be?

Newly purchased, Newly installed, Not used in a very long time, Machine underwent repair, QC run inhibits continuous errors

In quality control, the material used is?

Control

In quality control, when do we perform QC?

Everyday or Every after calibration

In immunoassay (3 sets) you have?

Low Control, Normal Control, High Control

Two quality control

Normal Control, Pathologic Control (Increase)

Three pairs of limits, Levey Jennings Chart

+- 1, +- 2, +- 3

Levey Jennings warning part?

+-1

Part of limit, adjustment? Pag lumabas ng 2, troubleshoot

+-2

Pairs of limits -> immediate attention

+-3

- Pioneered by stewhard - Assess the determination of control materials over time - Within or not within the control limits - Control charts can detect errors in accuracy and imprecision over time

Levey Jennings Chart

Can be used to detect errors

QC Charts

In laboratory (QC), there are two main types of errors...

Random Error, Systematic Error

One time error, difficult to troubleshoot

Random Error

Variations in technique, Fluctuations (UPS, AVR), Temperature, Instrument instability

Continuous error Exhibits continuous pattern

Systematic Error

Detoriating reagents, Improper technique, Calibration and instrument/equipment error, Poorly written SOP (Standard Operating Procedures) and laboratory procedures manual

All of the control limits in significant based on the rules to determine violations

Westgard Rules

One control exceeding the mean +-2s. A warning rule that initiates testing of control data by other rules.

1(2s)

One control observation exceeding the mean +-3s. Allows high sensitivity to random error.

1(3s)

Two control observations consecutively exceeding the same +2s or -2s. Allows high sensitivity to systemic error.

2(2s)

One control exceeding the +2s and other exceeding the -2s. Allows detection of random error.

R(4)s

Four consecutive control observations exceeding +1s or -1s. This allows the detection of systemic error.

4(1)s

Ten consecutive control observations falling on one side or the other of the mean (no requirement for SD size). This allows the detection of systemic error

10x

QC Monitoring

Interlab QC (Internal), Intralab QC (External)

Compilation of QC charts, and logbooks

Interlab QC (Internal)

It has proficiency testing is either conducted by a international accreditor or local (CAP), NEQAS (Natural External Quality Assurance Scheme)

Intralab QC (External)

Intralab Accreditations:

Laboratory Inspection, Chemical Utilization, Internal QC

- Assessing the integrity of the entire testing process from sample receipt to releasing of test results. - Comparison of the laboratory's testing to the performance of a peer group and/or the national reference laboratory. - Laboratory's overall quality assurance program.

NEQAS

Moreover, participation in ____ as part of an overall laboratory quality assurance program is required under local regulatory policies for securing a license to operate.

EQAS

Who administers NEQAS?

National Reference Laboratories

National Reference Laboratories: HIV and STD

SLH (San Lazaro Hospital) - STD AIDS Cooperative Central Laboratory (SACCL)

National Reference Laboratories: - Transfusion Transmissible Infections (Serology) - Virology: Dengue, Arboviruses, Measles, Rubella, Polio - Malaria and Tuberculosis - Mycology

RITM (Research Institute for Tropical Medicine)

National Reference Laboratories: Clinical Chemistry

Lung Center of the Philippines (LCP)

Environmental, Occupational Health, Toxicology, Micronutrients Assay and Associated social problems related to drug abuse and malnutrition - Drug Testing, Water Testing

East Avenue Medical Center (EAMC)

National Reference Laboratories: Hematology Clinical Microscopy Immunohematology Anatomic Pathology (Histopathology)

National Kidney and Transplant Institute (NKTI)

Bio Rad (EQAS): <2

Passed

>2, <3

Warning

Failed

Another quality improvement system that performs in some corporate

Lean Sigma Six Methodology

Purpose of Sigma Six Principles:

Identification Error, Improve

Lean Principle: (Purpose)

Decrease of Waste, Cost

Lean Sigma Six Methodology: Which is right? I. Increase error, Increase waste, Increase cost II. Decrease error, Decrease waste, Decrease cost

Focus on continuous process improvement

Implementation of Six Sigma

Six Sigma Three Roles:

Black Belt, Green Belt, Yellow Belt

A role which dedicate as much as 100% of their time to Quality Improvement (QI) projects, proactively addressing process and quality opportunities for improvement

Black Belts

A role is to contribute approximately 20% of their job to improvement projects while delivering their normal job functions

Green Belts

Includes a full day basic Lean Six Sigma training, including interactive and didactic training program, as a perquisite for all participation

Yellow Belts

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Almira Coleen · 28問 · 1年前

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