Quality Improvement in the Laboratory

QUALITY IMPROVEMENT IN THE LABORATORY

• Quality in pathology is about service driving a process.

QUALITY IN PATHOLOGY

• The quality standards include:
  • ISO 9001
  • ISO 17025
  • ISO 15189
• Quality as a concept.
• Quality cycles.
• Quality improvement systems.
• Process review.
• Holistic quality.

ISO QUALITY STANDARDS

• ISO 9001: Quality management systems – Requirements.
• ISO 17025: General requirements for the competence of testing and calibration laboratories.
• ISO 15189: Medical laboratories – Requirements for quality and competence.

ISO 9001:2015

• ISO 9001:2015 is an internationally recognized standard for creating, implementing, and maintaining a Quality Management System for a company.
• It is intended for organizations of any size or industry.
• It serves as the basis for a company to create a system ensuring customer satisfaction and improvement, often required by corporations from their suppliers.
• It is based on the Seven Quality Management Principles.

THE QUALITY “CYCLE” ISO 9001:2015 (PDCA)

• PLAN
  • Identify goals and baseline.
  • Assemble internal resources.
  • Determine quality standards and requirements.
  • Determine procedures to ensure criteria are being met.
  • Organize supporting documentation (ISO documentation, policies, procedures, training materials, work instructions, etc.) in a document management system.
• DO
  • Train employees on new process(es).
  • Deploy the quality management system.
• CHECK
  • Control, measure, and monitor outputs to ensure they meet expected criteria.
• ACT
  • Identify areas where there is opportunity for improvement.
  • Re-evaluate both the processes and the product.
  • Review the findings of your quality management system.
  • Begin the quality management process again.

TESTING AND CALIBRATION LABORATORIES

• Testing laboratories determine the characteristics of an item of interest for conformity assessment. For example, testing a cereal sample to see if the level of pesticide it contains meets the legislated limits.
• Calibration laboratories compare a measurement instrument of unknown accuracy to one of known accuracy. For example, calibrating the scale at the airport to accurately weigh luggage by comparing readings against certified mass pieces.

ISO 17025:2017

• ISO 17025:2017 is the international standard that sets out the general requirements for the competent, impartial, and consistent operation of testing and calibration laboratories.
• Certification according to ISO 9001 is recognition that an effective management system is in place, ISO 17025 includes recognition of the technical competence of laboratories.
• It specifies the activities that must be included in laboratory operations to promote confidence in its ability to produce valid and consistently reliable testing, calibration, and sampling results.

ISO/IEC 17025: 2017 - Management System

• The standard emphasizes customer feedback and management review.
• It covers structural requirements, impartiality, and confidentiality.
• It includes risk and opportunities assessment, corrective action, and internal audit.
• It addresses nonconforming work, complaints, requests, tenders, and contracts.
• It focuses on the selection, validation, and verification of methods.
• It includes sampling, handling, and reporting.
• It details technical records, measurement uncertainty, and quality control.
• It requires management of resources including personnel, IT, facilities, equipment, traceability, and environmental conditions.
• It also covers purchasing, subcontracting, control of data, document control, and records management.

MEDICAL TESTING LABORATORIES

• Medical laboratory services are essential to patient care and must be available to meet the needs of all patients and the clinical personnel responsible for their care.
• Services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing, and examination of clinical samples, along with interpretation, reporting, and advice, in addition to safety and ethics considerations.

ISO 15189:2023

• ISO 15189:2023, based upon ISO 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories.
• It is acknowledged that a country could have its own specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain.

LABORATORY ACCREDITATION

• NATA is the accrediting body.
• NATA: National Association of Testing Authorities, Australia.
• Apply ISO 17025 and ISO 15189 principles.
• Scope of testing: Each area/technical part of pathology needs to be cleared.
• It is a statutory requirement to attract Medicare rebates.
• Accreditation may be necessary to obtain some contracts.

OTHER DOCUMENTS AND GUIDELINES

• Other Australian/ISO Standards (AS/NZS 4308, AS/NZS 4760).
• NATA Documents:
  • Technical Notes
  • Application Documents
• NPAAC Documents (Department of Health | National Pathology Accreditation Advisory Council (NPAAC)).
• State Guidelines (Victoria).
• Association (AMA, RCPA) Best Practice Documents (NICE).
• International Guidelines.
• Therapeutic Goods Administration (TGA).

ASSESSING ISO COMPLIANCE

• Fully ISO 9001 Compliant.
• Probably ISO 17025 Compliant.
• Traceability?
• ? ISO 15189 Compliant.
• What is the intent?
• What is the risk?
• Effect on Product.

17025:2017 & 15189:2023 Changes

• 17025:2017 Changes
  • Impartiality
  • Confidentiality
  • Risk
  • Evidential Documentation
  • Organisational Context
• 15189:2023 Changes
  • Governance
  • Resources
  • Risk
  • Process
  • POCT (Replaces ISO 22870:2016)

QUALITY SYSTEMS

• Standards and Requirements give a Medical Laboratory:
  • A Quality System Framework
  • The Legislative Framework
  • An Assessment Framework
  • A Governance Framework
  • A Process Framework
• It does not state what “Quality” is for any entity.

QUALITY AS A CONCEPT

• How do we Improve Quality in a Medical Laboratory?
• First, we would need to understand what Quality is for a Medical Laboratory.
• Medical Laboratories are a service provider and a Healthcare entity.

QUALITY AS A CONCEPT - Definitions of Quality in Healthcare

• Definitions of Quality in Healthcare (hundreds of definitions).
• The degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. (Institute of Medicine US).
• The assessment and provision of effective and safe care, reflected in a culture of excellence, resulting in the attainment of optimal or desired health. (UK).

QUALITY AS A CONCEPT - Definitions of Quality in Service

• Definitions of Quality in a Service Organisation (thousands of definitions).
• Service quality generally refers to a customer’s comparison of service expectations as it relates to a company’s performance.
• Service quality is generally viewed as the output of the service delivery system, especially in the case of pure service systems. Moreover, service quality is linked to consumer satisfaction.

QUALITY AS A CONCEPT - Definitions for a Medical Laboratory

• Definitions for a Medical Laboratory (2 definitions).
• Laboratory quality can be defined as the accuracy, reliability, and timeliness of the reported test results. (WHO).
• Quality in laboratory medicine should be defined as the guarantee that each and every step in the total testing process (TTP) is correctly performed, thus ensuring valuable decision making and effective patient care. (AACC).

QUALITY DEFINITION

• The Quality Medical Testing Laboratory: Providing the service required by their customers in a consistent and timely manner.

QUALITY IN PATHOLOGY

• Providing the service required by their customers in a consistent and timely manner.
• The Quality cycle for a Pathology Service is more than just the quality of the results.
• Customer complaints, KPIs, Clinical Interpretations.
• Clinical Guidance.

QUALITY IMPROVEMENT

• Now we know what Quality is:
  • We can monitor that quality (Quality Management Systems).
  • We can IMPROVE that Quality if we:
    • Act on issues
    • Review processes
    • Audit systems
    • Listen to customers/users

QUALITY IMPROVEMENT - Goals

• What do we want to improve?
  • The Pathology Service
  • The Patient interface (ACCs)
  • The Diagnostic Process
  • Clinical Interpretation/Advice
  • The Clinical Interface
  • Outcome and Evidence based Laboratory Medicine
  • Education and Training
  • Clinical Practice and Interaction
  • Listening to customers/users

QUALITY IMPROVEMENT - Monitoring

• What do we monitor to identify improvement?
  • Feedback
  • Complaints/Compliments/Clinical Requests
  • Dynamic Communication
  • Process Review
  • Investigations of failures/problems
  • Quality Improvement Initiatives
  • Understanding your Customer’s Business
  • Keeping up to date with developments

FEEDBACK

• Dynamic Communication
  • Don’t wait to be told
  • Seek out information
• Patient Feedback
  • Their experience and view of your service
• Clinician Feedback
  • Their experience and view of your service
  • Where are they going / what is new?
• Staff Feedback
  • Staff are good at picking process issues and getting feedback from users
• Vendor Feedback
  • Vendors are useful for how you are perceived in the marketplace and how easy your organisation is to work with.

PROCESS IMPROVEMENT

• Efficiency vs Productivity

PROCESS REVIEW

• Systematic
  • Quality embedded in the process
  • Audit
  • Feedback (Dynamic)
  • Review
• Responsive
  • Act on complaints/issues
  • Targeted Audit
  • Resolution
  • Change Management

QUALITY IMPROVEMENT IN CLINICAL LABORATORIES: A SIX SIGMA CONCEPT

• KALRA J, KOPARGAONKAR A. QUALITY IMPROVEMENT IN CLINICAL LABORATORIES: A SIX SIGMA CONCEPT. PATHOL LAB MED OPEN J. 2016; 1(1):
• GOOD DATA IS EVERYTHING
  • Take a systematic approach to Quality Improvement
    • Observe
    • Verify
    • Challenge
    • Collate

GOOD DATA IS CHALLENGING

• Talk to People
  • The “right” people
  • At the “coal face” the people who perform that function
  • What is the expected procedure vs the reality
  • Why is it different?
  • Have we set ourselves up for failure
• Evidential data
  • Data that is relevant and helpful (can it be interpreted a different way)
  • That supports what you hear
  • Why is it different?
• Open and Transparent

HOLISTIC VIEW FOR MEDICAL LABORATORIES

• Consider every change you make in the context of the patient journey.
• View feedback as an opportunity to reflect.
• Pathology should not be discipline-driven since it produces a “silo mentality” and you lose customer focus.
• Efficiency is not the same as productivity.

STAFF REQUIREMENTS FOR IMPROVEMENT

• Ability to understand your customer.
• Ability to understand your processes.
• Ability to challenge current processes.
• Evidence based approach to change (not knee-jerk).
• Continual review of problems and complaints.
• Keep systems as simple as possible.
• Make sure communication is constant and relevant.

THE NON-CONFORMING FISH

• Mistakes are opportunities to improve.
• Complaints are opportunities to learn
• Quality Systems should not stifle innovation.
• Non-Conformance is not always bad
• There is no dumb question. Every question is an opportunity to learn.Just because you feel you are swimming against the tide doesn’t mean you are wrong.

INTRODUCING A NEW TEST - Group Assignment

• Introduction of a New Test (Group Assignment)
• Single Final Written Document (seamless flow so I can’t tell who did what)
• This is where the detail of your service is
• This is where you discuss the options available to the laboratory and the client

INTRODUCING A NEW TEST - Presentation

• Introduction of a New Test (Group Assignment)
• Seamless Presentation (use handovers and a wrap up)
• This is a sales pitch, so be careful of information overload.
• Doesn’t have to have everything in the document.
• Consider the allocated time.
• Last Slide: Say who investigated what part of the assignment (not how much was done, common in medical papers)
• Be prepared for Questions
• Don’t use palm cards
• Don’t read out exactly what is on the slide