Quality Flashcards
What is Health Canada responsible for?
Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.
What does the ‘Regulated Health Professions Act’ do?
regulates health professionals to provide health services in a safe, professional, and ethical manner in the public interest.
What does the ‘College of American Pathologists’ (CAP) Laboratory Accreditation Program provide?
provides an on-site inspection to assess compliance with program requirements using discipline specific CAP Accreditation Checklists
What is the ‘Manitoba Quality Assurance Program’?
Manitoba Quality Assurance Program (MANQAP) establishes standards for diagnostic facilities, investigates and inspects diagnostic facilities for accreditation, and monitors compliance with established Manitoba Laboratory Standards and the Manitoba Patient Service Center Standards.
What is ISO 15189?
ISO 15189 Medical laboratories – Requirement for quality and competency is an international standard that specifies the quality management system requirements particular to medical laboratories developed by the International Organization for Standardization.
What is the ‘Clinical Laboratory Standards Institute’?
Clinical Laboratory Standards Institute promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
What is a Quality Management System?
Overseeing all activities and tasks to achieve excellence
Includes quality assurance and quality control
What is Quality Assurance?
Activities and processes implemented to ensure quality through every stage of the process (prevention of errors)
Auditing
What is Quality Control?
Operational techniques to fulfill quality requirements (detection of errors)
Includes statistical monitoring and proficiency testing
Quality control ensures that laboratory tests produce accurate and precise results using a statistical control system for recognizing and minimizing analytical errors
Name at least four quality system essentials?
Organization Process Management Customer Focus (e.g. patient) Facilities and Safety Documents and Records (e.g. standard operating procedures, maintenance records) Information Management Personnel (properly trained) Purchasing and Inventory Equipment Nonconforming Event Management Assessments (e.g. analyze patient data vs control - validation) Continual Improvement
What is risk management?
Risk management is the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
What is one way to reduce risk in the lab mentioned in this class?
Development of a comprehensive quality plan for the:
Prevention of laboratory testing errors
Ensures that correct results are reported
What are potential areas for risk pre-analytical, i.e. before testing?
Patient preparation Fasting or time of day Collection of sample and handling Patient ID, posture, warming site, order of draw, proper tubes for proper test, tube inversions, hemolysis, Transport On ice, type of container, time to lab Accessioning Entered into LIS correctly, labelled correctly Processing of sample prior to testing Centrifuging, aliquoting Storage
What are potential areas for risk during the analytical phase?
Testing
Reliable methods
Water quality, temperature monitored, pipettes calibrated, instrument maintained and checked
Standard Operating Procedures (SOPs) clear
Staff thoroughly trained
What are the potential areas for risk during the post-analytical phase?
Following testing Interpretation of results Repeat testing if necessary Delta checks Reporting results Correcting errors Turn around time Sample arrives in lab until results are sent out
Describe the risk management process?
See slide 13 of Quality Presentation
- Hazard Identification, begins with process map of lab process steps,
- Risk estimation of each step, likelihood of failure, severity of patient harm from failure
- Risk controls (labs), and lastly,
- Risk monitoring and failure investigation
What is a NCEs (non-conformance event)?
Deviation from established policies and procedures. Within a QMS NCEs are documented, investigated, and used to improve the quality of laboratory services
Learn from them and change policies or procedures to prevent future NCEs
What are some examples for non-conformance events in a lab setting?
Unlabeled and/or mislabeled samples
Specimen processing errors
Incorrect results reported
Reports faxed to incorrect office
What is done at a quality assessment? Why is it important.
Update the Risk Assessment/Management and modify the Quality Control Plan (QCP) based on information obtained from the Quality Assessment
Important for accreditation
What is used to decrease waste and errors in the lab while increasing value?
A combination of Lean and Six Sigma principles.
Lean: Streamlining or modifying to reduce cost
Errors cost money and time
Does this process or step need to exist?
Six Sigma or 6SDs
Test with a determined 6SD performance will be very precise and produce only 3.4 occurances for every million opportunities performed or a 99.9997% yield
What are some examples of wastes in the lab (name at least two)?
Waiting – time between processes and tests
Excess motion – unnecessary movements
Overproduction – excess work in progress (specimens piling up in processing area)
Defect correction – time and resources to correct issues
Excess processing – unnecessary steps in process that doesn’t add value
Excess movement of materials – moving materials from one place to another
Inventory – over-ordering or keeping excess items on hand that will not be used
What are the 5S’ of the lean process?
Sort – remove unnecessary items
Straighten – arrange items so they are easily accessible
Shine – maintaining a clean space
Standardize – organization with clear/detailed procedures and proper training
Sustain – time commitment and effort by employees and employer
