Quality

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.

regulates health professionals to provide health services in a safe, professional, and ethical manner in the public interest.

provides an on-site inspection to assess compliance with program requirements using discipline specific CAP Accreditation Checklists

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.

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.

Clinical Laboratory Standards Institute promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.

Overseeing all activities and tasks to achieve excellence Includes quality assurance and quality control

Activities and processes implemented to ensure quality through every stage of the process (prevention of errors) Auditing

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

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

Risk management is the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.

Development of a comprehensive quality plan for the: Prevention of laboratory testing errors Ensures that correct results are reported

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

Testing Reliable methods Water quality, temperature monitored, pipettes calibrated, instrument maintained and checked Standard Operating Procedures (SOPs) clear Staff thoroughly trained

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

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

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

Unlabeled and/or mislabeled samples Specimen processing errors Incorrect results reported Reports faxed to incorrect office

Update the Risk Assessment/Management and modify the Quality Control Plan (QCP) based on information obtained from the Quality Assessment Important for accreditation

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

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

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

Defined Standard Operating Procedures (SOPs) and policies Identify and control variables in the system Pipette and instrument calibrations, water quality, etc. Proficiency testing Frequency and evaluation method for quality control data Detection, troubleshooting, and corrective actions Schedule for routine maintenance Record keeping and record retention Maintenance Logs, Calibrations, QC Charts, refrigerator/freezer temps, etc.

Determine frequency of QC testing Type and number of QC samples that will be tested Statistical QC limits Corrective actions if QC is not acceptable