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

Process Control: Quality Control of Qualitative and Semi-Quantitative Procedures 1 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 fo...

Process Control: Quality Control of Qualitative and Semi-Quantitative Procedures 1 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 2 2 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 3  The Quality Management System Organization Personnel Equipment Purchasing Process Information & Control Management Inventory Documents Occurrence & Assessment Management Records Process Customer Facilities Improvement Service & Safety Process Control: Qualitative and Semi-Quantitative QC-Module 8 4 Qualitative or semi-quantitative tests - Examples ◼ microscopic examinations ◼ dipsticks ◼ serologic procedures ◼ microbiological procedures ◼ any reaction that produces non-numeric results Process Control: Qualitative and Semi-Quantitative QC-Module 8 5 5 Important Concepts ◼ sample management ◼ staff competency ◼ equipment maintenance ◼ control materials ◼ stains, media and reagents management ◼ record keeping Process Control: Qualitative and Semi-Quantitative QC-Module 8 6 6 Quality Control Materials ◼ built-incontrols ◼ control materials that mimic patient samples ◼ reference organisms Process Control: Qualitative and Semi-Quantitative QC-Module 8 7 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 8 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 9 Using Traditional Controls ◼ 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 Process Control: Qualitative and Semi-Quantitative QC-Module 8 10 10 Stock Cultures for QC ◼ reference strains ◼ in-house developed strains ◼ predictable reactions in stains and media ◼ ensure media, reagents and supplies work as intended Process Control: Qualitative and Semi-Quantitative QC-Module 8 11 11 Sources for Obtaining Reference Strains ▪ ATCC-American Type Culture Collection ▪ NTCC-National Type Culture Collection (UK) ▪ CIP- Pasteur Institute Collection (France) Process Control: Qualitative and Semi-Quantitative QC-Module 8 12 12 Stains are important— take care of them! Continued Attention No Attention Process Control: Qualitative and Semi-Quantitative QC-Module 8 13 13  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 14 14 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 15 15 Gram Stain Good Quality Poor Quality Process Control: Qualitative and Semi-Quantitative QC-Module 8 16 16 QC of Microbiology Media ◼verifyperformance 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 17 17  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 18 18 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 19 19 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 20 20 Key Messages ◼ QC procedures followed by ALL staff ◼ always record QC results and corrective actions ◼ If QC results are not acceptable, do not report patient results! Process Control: Qualitative and Semi-Quantitative QC-Module 8 21 21  Organization Personnel Equipment Questions? Purchasing Process Information & Control Management Inventory Comments? Documents Occurrence & Assessment Management Records Process Customer Facilities Improvement Service & Safety Process Control: Qualitative and Semi-Quantitative QC-Module 8 22