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Process Control: Q uality Control of Qualitative and Semi-Quantitative Procedures. Learning Objectives. At the end of this module, participants should be able to: Differentiate between built-in and traditional controls. Describe how to use stock cultures for microbiology QC.

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Process Control: Quality Control of Qualitative and Semi-Quantitative Procedures


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Learning Objectives

At the end of this module, participants should be able to:

Differentiate between built-in and traditional controls.

Describe how to use stock cultures for microbiology QC.

Discuss the use of quality control procedures for stains used in microscopic examination.

Describe methods for verifying performance of microbiological media.

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Scenario

Laboratory A performs a culture, and Pseudomonas aeruginosa is identified.

What QC measures can you use to confirm that the isolate is correctly identified?

Process Control: Qualitative and Semi-Quantitative QC-Module 8


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The Quality Management System

Organization

Personnel

Equipment

Process Control

Purchasing & Inventory

Information Management

Assessment

Documents& Records

Occurrence Management

Process Improvement

Customer Service

Facilities & Safety

Process Control: Qualitative and Semi-Quantitative QC-Module 8


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Qualitative or semi-quantitative tests - Examples

Process Control: Qualitative and Semi-Quantitative QC-Module 8

microscopic examinations

dipsticks

serologic procedures

microbiological procedures

any reaction that produces non-numeric results

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Important Concepts

Process Control: Qualitative and Semi-Quantitative QC-Module 8

sample management

staff competency

equipment maintenance

control materials

stains, media and reagents management

record keeping

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Quality Control Materials

built-in controls

control materials that mimic patient samples

reference organisms

Process Control: Qualitative and Semi-Quantitative QC-Module 8


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Built-in Controls

integrated into the design of a test kit device

automatically run with each test performed

assess certain aspects of kit performance

may not assess entire testing process

Process Control: Qualitative and Semi-Quantitative QC-Module 8


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Traditional Controls

materials with known reactivity

mimic patient samples

assess the integrity of the entire test system

Process Control: Qualitative and Semi-Quantitative QC-Module 8


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Using Traditional Controls

Process Control: Qualitative and Semi-Quantitative QC-Module 8

test as per patient samples

use a positive and negative control

include a weak positive control for immunological procedures

choose positive controls close to the cut-off value

include control to monitor extraction phase

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Stock Cultures for QC

reference strains

in-house developed strains

predictable reactions in stains and media

ensure media, reagentsand supplies work as intended

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Sources for Obtaining Reference Strains

Process Control: Qualitative and Semi-Quantitative QC-Module 8

  • ATCC-American Type Culture Collection

  • NTCC-National Type Culture Collection (UK)

  • CIP- Pasteur Institute Collection (France)

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Stains are important— take care of them!

Continued Attention

No Attention

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Stain Management

use established procedure for preparation or reconstitution

label: content, concentration, date prepared and placed in service, expiration, initials

store appropriately

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Quality Control for Stains

As appropriate for particular stain:

check with known organisms or cells

examine for crystal shards or for precipitation

examine for contaminants such as bacteria and fungi

Left: Wright stain

Right: Gram stain

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Gram Stain

Good Quality

Poor Quality

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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QC of Microbiology Media

verify performance of all media

in-house prepared: all batches

commercially prepared: new lot only

MacConkey Agar

QC

Left: non-lactose fermenter

Right: lactose fermenter

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Media Problems to Avoid

  • out-dated

  • dried-out

  • contaminated

  • Human blood should not be used because:

  • too much batch to batch variation

  • may include inhibitory substances, including antimicrobials

  • may contain biohazards (e.g., hepatitis virus)

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Quality Control of Growth Media

keep records for media prepared in-house

record outcomes in a dedicated media logbook for:

pH, sterility, ability to support growth using stock cultures, biochemical response of stock cultures

frequency

test each new batch or lot number

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Summary

qualitative tests produce non-numerical results

semi-quantitative tests give an estimate

establish a QC program for qualitative and semi-quantitative tests

Process Control: Qualitative and Semi-Quantitative QC-Module 8

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Key Messages

Process Control: Qualitative and Semi-Quantitative QC-Module 8

QC procedures followed by ALL staff

always record QC results and corrective actions

If QC results are not acceptable, do not report patient results!

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Organization

Personnel

Equipment

Process Control

Purchasing & Inventory

Information Management

Assessment

Documents& Records

Occurrence Management

Process Improvement

Customer Service

Facilities & Safety

Questions?Comments?

Process Control: Qualitative and Semi-Quantitative QC-Module 8