Lab Total Q Mangement

Laboratory Quality Management : 

Laboratory Quality Management

Stages of Quality management: 

Stages of Quality management Quality lnspection, QI (1910) Corrective action and Identify sources of non-conformance Quality Control, QC (1924) SOPs, Performance data, Self-inspection (in lab management), service testing (Demo), Quality planning and use of statistics Paper-work control Quality Assurance, QA (1950) Third-party approvals, Systems audits, Quality planning, Quality manuals, Quality costs, Process control, Failure mode and effect analysis and Non-production operation Total Quality Management, TQM (1980) Add to previous; Focused vision, Continuous improvements, Internal customer Performance measures (KPI), Inter-departmental barriers Management and leadership

Evolution of Quality Management Philosophy: 

Evolution of Quality Management Philosophy 1930 – 60, Q.C. ( Cure )  1970 – 80, Q.A. ( Preventive )  To-day, TQM ( Holistic involvement )

Evolution of Quality Systems: 

Evolution of Quality Systems

Slide 5: 

Leaders of Quality Management (A sample) Business Quality Healthcare Quality Lord Kelvin James Westgard W. Edwards Deming George Lundberg Joseph Juran John Bernard Henry Philip Crosby Ray Gambino Taiichi Ohno Brent James Jim Womack Michael Laposata

Quality in Medical Laboratory Testing: 

Quality in Medical Laboratory Testing The right test result , at the Right time, on the Right specimen, from the right patient, with result interpretation based on Correct reference data , and at the Right price

Why Medical Labs need Quality Management : 

clinical medicine decision making is predicated upon, confirmed, and documented by medical laboratory test results. 70 % Why Medical Labs need Quality Management Medical Laboratories have; Highly complex operations Staff doing complex tasks Absolute need for completion of attributes Absolute need for Accuracy Absolute need for Time Effectiveness Absolute need for Cost Effectiveness

What is Quality?: 

What is Quality? Q uality can have two meanings: (1) the characteristics of a service that bear on its ability to satisfy stated or implied needs ( 2) a service free of deficiencies (Non conformities) It is also defined as: Quality of design Quality of conformance Quality of performance

Quality definitions: 

Quality definitions TQM Report with full data Report meet the diagnosis Patient is satisfied by TAT & test price Cope with the sample volume

Is it Quality of Business or Business of Quality? : 

Is it Quality of Business or Business of Quality?

Fundamental Concepts in Quality Management: 

Fundamental Concepts in Quality Management

Cost in quality (Does Quality cost?) : 

Cost in quality ( Does Quality cost?) Quality of Conformance is profitable not costly POOR QUALITY IS COSTLY ! Companies that measure their “quality costs” for the first time are usually shocked at what they find

Generic Quality Process Road: 

Generic Quality Process Road Monitoring Requirements Specified Requirements Satisfied Effectiveness (Ability to achieve objectives) Efficiency (Achievement of objectives)

Slide 14: 

What is a Process? Activity that transforms input into output Input Activity Output Resources - Money (Budgetary) - Materials - Machinery - Manpower Technicality - Staff skills - Training - Procedures - Monitoring Management (Problem solving mechanism) Services Performance

Slide 15: 

How is a Process Managed? Monitor & Measure the Process make sure the inputs are right, the transformation activities consistently work, and the desired results are achieved, then - improve the process as needed Input Activity Output Right Resources: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Desired Results: Quality Services Customer Satisfaction

Slide 16: 

How is a Process Measured? Efficient No Waste Effective Desired Results Achieved Input Activity Output Right Resources: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Desired Results: Quality Services Customer Satisfaction

Slide 17: 

The QMS must be used for continuous improvement ... Improve Process through DMAIC Cycle QMS Improvement Objective Results Baseline Performance Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results

Slide 18: 

Your Laboratory Other Laboratories . Workload distribution (better centralization) . Growth of workload (Material management) . Important Tests available Structure . Service Sharers Avoid duplicate lab service . Technology Unifying technology to get supplier support Relations . Providers . Patients . Physicians . Government Financial aspects . Trends of costs . Profit (Value) to improve . Reimbursement Elements of regional laboratory analysis

Dimensions of Laboratory Quality: 

Dimensions of Laboratory Quality Quality Management Conformity Process essentials interactions Process essentials

The first dimension of lab quality (Process essentials): 

The first dimension of lab quality (Process essentials) Space & layout Infrastructure Environment Manpower Machinery Material Methods Organization & Management Market Effect Authority Communication/ Time Management

Slide 21: 

Traffic Chemistry (blue) Specimen Processing (red)

Correction of traffic  improve TAT: 

Correction of traffic  improve TAT Proposed design Diff & Kit Testing Bio Haz Cap s Sam ple V950 Label Misys Monitor Label Misys Monitor Misys Monitor Label Misys Monitor

Environmental conditions: 

Environmental conditions Vibration which affect hard desks and sensitive electrical circuits (Lab design and layout modifications, centrifuges in separate areas) Temperature (climatic conditions & in lab AC/Waste Heat) High temperature may cause evaporation of staining or reagents, stress on staff (Large work cells may produce > 15 kW= need of 7-10 fan coolants) Low temperature may cause crystallization of reagents Humidity (climatic conditions & water baths) Photomultipliers or computer screens may damage. Infections of eye or pneumonia may occur Dust Can affect results of Fe or trace elements by contamination of probes Health problems may develop e.g. Allergies or eye diseases

Slide 24: 

5. Light May have an influence on certain analytes like bilirubin Reflection of light on computer screens may lead to bad legibility 6. Magnetic fields Sources like MRT, electric high voltage cables or electric motors. Magnetic fields may cause instrument electro-mechanical malfunction e.g. Stepper motors Distance if not sufficient, ferromagnetic materials may be helpful for protection against effects of magnetic field intensity 7. Electromagnetic fields/ Radio frequency Mobile phones and transmitter antenna could be the source for EMF/RF 8. Noise Outside sources; traffic or construction site In lab sources; centrifuges, refrigerators or air condition This may cause poor concentration or vegetative symptoms The treatment is by soundproofing of windows.

Slide 25: 

9. Harmful substances e.g. Insecticides if used in lab may contaminate samples which impossible to analyze the cholinesterase (anti cholinergic insect spray) and may harm staff 10. Power supply Information systems do not tolerate power failure that last longer than parts of a second. Consequences are loss of data and waste of time and reagents Use of UPS (Uninterrupted power supply) is mandatory for computers and instruments in lab. Emergency power generator are also indicated if frequent power failures lasting more than one hour. 11. Water supply High quality, germ free water is essential for lab analysis 12. Cleanliness Dirty glassware or tubes affect results. Small rodents (e.g. Mice may erode instruments’ cables or tubes

The 2nd dimension of lab quality (Interaction of process essentials & Process implementation) Process Flowchart: 

The 2 nd dimension of lab quality (Interaction of process essentials & Process implementation) Process Flowchart

Slide 27: 

End Result release , reporting and recording Result interpretation and verification Result technical validation Sample analysis Method stability assessment by QC assessment Instrument assessment by checks & Calibration Special prep/Separation Register , enter data on LIMS and assign unique identifier Receive the sample Start Sample identification and processing Pre-analytical stage Instrument/ Material application Analytical stage Reporting and Recording Post-analytical stage

The 3rd dimension of lab quality : 

The 3 rd dimension of lab quality Standardization of the process Documentation Define Process controls & key indices (KPI)s Detect non- conformities

Structure of Quality Documentary: 

Structure of Quality Documentary Quality manual (Policy, Vision, Mission, Objectives & commitment to quality), structure, Job descriptions & Authority Quality procedure (Guidelines to perform quality related activities) Written instructions & Standard Operating Procedures (SOPs) Forms, Results, Reference Standards & Instrument manuals (Installation reports, PM schedule, EM reports)

Example for a quality system: 

Example for a quality system

What’s beyond the 3rd dimension?: 

What’s beyond the 3 rd dimension?

Controlling pre-analytical variables: 

Controlling pre-analytical variables

Controlling pre-analytical variables (cont.): 

Controlling pre-analytical variables (cont.)

Controlling pre-analytical variables (cont.): 

Controlling pre-analytical variables (cont.)

Controlling analytical variables : 

Controlling analytical variables

Controlling analytical variables (cont.) : 

Controlling analytical variables (cont.)

Controlling analytical variables (cont.) : 

Controlling analytical variables (cont.)

Standards and Quality Management: 

Standards and Quality Management Organization & Management Customer Satisfaction Continual Improvement Assessment Technical Documentation & Control Personnel Facilities Quality Management

Standards and Quality Management: 

Standards and Quality Management Organization & Management Customer Satisfaction Continual Improvement Assessment Technical Documentation & Control Personnel Facilities Quality Management Monitor Audit Review Training and Competency Policy Process SOPs Responsibility Authority Supply Chain Inventory Equipment Testing Collection Reporting Environment and Safety

What happens if you focus all your energy on one component?: 

What happens if you focus all your energy on one component? Organization & Management Customer Satisfaction Continual Improvement Assessment Technical Documentation & Control Personnel Facilities Quality Management

The system starts to fall apart QUICKLY: 

The system starts to fall apart QUICKLY Organization & Management Customer Satisfaction Continual Improvement Assessment Technical Documentation & Control Personnel Facilities Quality Management

Slide 44: 

Quality Indicators indicate performance determine quality highlight concerns identify areas needing further study track changes over time

Characteristics: 

Characteristics

Computer Nonsense Indicators: 

Computer Nonsense Indicators [urine culture] * [glucose] * [INR] [NUPA hr ] * [Telephone minutes ] X100 Just because a computer can calculate a value, doesn’t mean that it should.

Give examples: 

Give examples Pre-analytic Analytic Post-analytic End user

Quality Indicators and Timing: 

Quality Indicators and Timing Use an indicator only as long as it provides useful information . Don’t get tied to your indicators.

Thanks: 

Thanks