MLAB 147 - UNIT 6 & 7 Better
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190 Terms
Q: What is Total Quality Management (TQM)?
A: A continuous improvement philosophy applied to all laboratory services.
Q: What is the main goal of TQM?
A: Continuous improvement of quality, efficiency, and patient outcomes.
Q: What does TQM cover?
A: All quality processes including QM, QA, QC, CQI, and inspections.
Q: What is Quality Management (QM)?
A: Developing and improving laboratory policies and procedures.
Q: What is Quality Assurance (QA)?
A: Standards for performance, monitoring compliance, and tracking outcomes.
Q: What is Quality Control (QC)?
A: Monitoring quality and accuracy of analytical procedures.
Q: What is Continuous Quality Improvement (CQI)?
A: Ensuring standardized procedures are efficient, timely, and cost
Q: What is the difference between QM and QA?
A: QM develops/improves systems while QA monitors whether requirements are met.
Q: What is the difference between QA and QC?
A: QA is proactive and covers the whole process; QC monitors analytical testing.
Q: What is the QA memory trick?
A: Quality All
Q: What is the QC memory trick?
A: Quality Check = checking analytical testing.
Q: Is QA proactive or reactive?
A: Proactive.
Q: When does QA establish standards?
A: Before work happens.
Q: What phases does QA monitor?
A: Pre
Q: What is the goal of QA?
A: Consistent performance and positive patient outcomes.
Q: What does QA identify and correct?
A: Problems that may affect quality in all testing phases.
Q: What are QA indicators and tools?
A: Incident reports, equipment malfunction reports, variable tracking, TAT monitoring, competency assessments, and external proficiency testing.
Q: What are incident reports used for?
A: Documenting errors or events affecting quality.
Q: What are equipment malfunction reports used for?
A: Tracking problems with laboratory equipment.
Q: What does TAT stand for?
A: Turnaround Time.
Q: Why is TAT monitored?
A: To evaluate efficiency and timely reporting.
Q: What are competency assessments?
A: Evaluations that confirm staff can perform procedures correctly.
Q: What is external proficiency testing?
A: Testing performance using samples compared with outside standards.
Q: What is the goal of QC?
A: Alert technologists when corrective action is needed to prevent inaccurate results.
Q: What phase does QC mainly focus on?
A: Analytical phase.
Q: What does QC ensure?
A: Accuracy, precision, and reliability.
Q: What are QC materials?
A: Internal and external control materials.
Q: What is external QC?
A: Materials with specific target ranges.
Q: What is internal QC?
A: Known positive and negative samples.
Q: What is the purpose of internal QC?
A: To monitor testing performance and detect problems.
Q: What is the QC memory trick?
A: Accuracy + Precision + Reliability = good QC.
Q: What is CQI’s main goal?
A: Maximize efficiency in time and cost for the best patient diagnosis.
Q: What is the CQI cycle?
A: Assess → Plan → Improve → Repeat.
Q: What does CQI focus on?
A: Improving processes continuously.
Q: What is the relationship between TQM and CQI?
A: CQI is a major part of TQM.
Q: What is quality phlebotomy?
A: Applying quality management principles to blood collection and specimen handling.
Q: What does quality phlebotomy focus on?
A: Consistent high
Q: What is the objective of quality phlebotomy?
A: Reduce errors and improve efficiency.
Q: What is a policy?
A: Overall intentions and directions from management.
Q: What is an SOP?
A: Standardized step
Q: What is the difference between a policy and SOP?
A: Policy explains what should happen; SOP explains how to do it.
Q: What is the purpose of SOPs?
A: To ensure standardized procedures.
Q: Why are SOPs important?
A: They reduce variation and improve quality.
Q: What information must SOPs include?
A: Principle/purpose, specimen type, collection method, equipment, supplies, procedure, QC, calibration, references, and critical ranges.
Q: What is included in the principle and purpose section of an SOP?
A: Why the procedure is performed and its basic concept.
Q: What does the specimen section of an SOP include?
A: Specimen type and collection method.
Q: What does the equipment section of an SOP include?
A: Required supplies and equipment.
Q: Why are QC and calibration details included in SOPs?
A: To ensure accurate and reliable testing.
Q: What is the Quality Manual?
A: A document describing the laboratory’s commitment to quality standards.
Q: What is the Quality Manual standard?
A: Right test, right patient, right time; right result, right person, right time.
Q: Who reviews policies annually?
A: The Quality Council.
Q: How often must policies be reviewed?
A: Annually.
Q: What is the SOP photocopy rule?
A: Never keep photocopies; use the current digital version.
Q: Why are SOP photocopies prohibited?
A: They may expire and contain outdated information.
Q: What is the maximum number of venipuncture attempts per phlebotomist?
A: Two attempts.
Q: What is the two
strike rule?
Q: What is the rule for foot veins in diabetic patients?
A: Physician consultation is required first.
Q: Why are foot veins risky in diabetic patients?
A: Increased infection risk.
Q: What is required before using foot veins in non
diabetic patients?
Q: What is the foot vein memory rule?
A: Foot = last resort.
Q: What is the Medical Director responsible for?
A: Overall QC oversight and monthly sign
Q: What is the Technical Specialist responsible for?
A: Developing QC programs, selecting materials, and monthly sign
Q: What is the Supervisor/Manager responsible for?
A: Assisting development, ensuring corrective actions, and monthly sign
Q: What is the Quality Manager responsible for?
A: Developing support systems, auditing, and preparing indicator reports.
Q: What is the Technologist/Technician responsibility in QC?
A: Performing QC and documenting corrective actions.
Q: What is the MLA/Technologist memory rule?
A: Perform QC → document actions.
Q: What are the 12 Quality System Essentials (QSEs)?
A: The framework that organizes all laboratory quality activities.
Q: What are the three main categories of the 12 QSEs?
A: The Lab, The Work, and Measurement.
Q: What are the QSE categories memory tricks?
A: The Lab = Resources, The Work = Processes, Measurement = Success.
Q: What does the “The Lab” category include?
A: Organization, Personnel, Equipment, Purchasing/Inventory, and Facilities/Safety.
Q: What does the “The Work” category include?
A: Process Control, Documents/Records, Information Management, and Customer Service.
Q: What does the “Measurement” category include?
A: Occurrence Management, Process Improvement, and Assessment.
Q: What is the purpose of the QSEs?
A: To maintain a complete quality system in the laboratory.
Q: What is the shared responsibility for equipment maintenance?
A: Both MLTs and MLAs are responsible for daily equipment upkeep.
Q: Why is daily equipment maintenance important?
A: It prevents equipment problems and protects patient results.
Q: What should be checked when receiving supplies?
A: Breakage, expiry dates, and product integrity.
Q: What should supplies be compared with during receiving?
A: The purchase order.
Q: What should happen before storing supplies?
A: Label supplies with the date received.
Q: What does FIFO stand for?
A: First
Q: What is the FIFO rule?
A: Old stock goes to the front and new stock goes to the back.
Q: Why is FIFO used?
A: To use older supplies before expiration.
Q: How should temperature
sensitive supplies be stored?
Q: What is risk assessment?
A: Identifying what could go wrong, the likelihood of occurrence, and consequences.
Q: What are the three questions in risk assessment?
A: What can go wrong? How likely is it? How severe is the impact?
Q: What are physical hazards?
A: Hazards such as slippery surfaces, repetitive movements, bending, stretching, or prolonged sitting.
Q: What are biological hazards?
A: Hazards involving infectious materials.
Q: How are biological hazards controlled?
A: Standard precautions, PPE, and immunizations.
Q: What is the purpose of inspections?
A: To observe techniques and check equipment.
Q: What is the sharps availability rule?
A: Sharps containers must be readily available at point of use.
Q: Can sharps containers be overfilled?
A: No.
Q: When should safety features on sharps devices be activated?
A: Before disposal.
Q: Why should sharps containers not be overfilled?
A: To prevent needlestick injuries.
Q: What are the four stages of an audit?
A: Preparation, Performance, Reporting, Follow~up/Closure.
Q: What happens during audit preparation?
A: The laboratory gets ready for evaluation.
Q: What happens during audit performance?
A: Staff, equipment, and processes are tested.
Q: What happens during audit reporting?
A: Compliance and non
Q: What happens during audit follow~up/closure?
A: Problems are corrected and improvements are planned.
Q: What is a first~party audit?
A: An internal audit where the organization checks itself.
Q: What is a second~party audit?
A: A customer audit, such as checking a supplier.
Q: What is a third~party audit?
A: An independent external audit that may lead to certification or penalties.