Quality

• Quality Control:

  • Evaluate the uniformity of specific processes and basic functions to assure that they are operating within acceptable parameters
  • These processes include the ways in which labs accession, process, interpret, report and retain submitted specimens
  • QC monitors are designed to compare the actual performance of the process with the process set forth in the departmental procedure.
• Quality Assurance:

  Term used to indicate a system designed with:

  • Internal quality checks
  • Encompasses a higher level of oversight
  • Relies upon the collection of outcome data

  Outcomes encompass multiple processes and procedures:

  • Monitor report timeliness
  • Diagnostic error rates
• Quality Improvement:

  Activities seek to improve outcomes:

  • Reducing diagnostic error rates
  • Shortening turnaround times
  • Improving customer satisfaction

  Use QA monitors to determine the effectiveness of an intervention.

   
• Maintaining Quality

  Many systems operate reasonably well until stresses are placed. Those stresses may come in forms:

  • Inc workload
  • Unexpected absences
  • Unfamiliar situations

  These increase the chance that employees, in their diligence to keep up with work, will make mistakes

  This fallibility can be mitigated with knowledge and training, most experts agree that this approach must be accompanied by system enhancements and modifications
• Managing Quality

  Lab staff, incl. pathologists, should embrace system enhancements that reduce errors, inc efficiency, reduce costs, improve accuracy and improve timeliness and completeness.

  Intro and acceptance of synoptic reports is one example of a successful system enhancement that improve patient care by reducing the chance of error.

  QI activities consume a significant amount of lab resources

  Since resources are limited, QI activities for any given year must be selected prudently.
• Risk

  Every lab has to have an effective risk management policy. In the lab, it is important that the chances of something going wrong is either negated or minimised. The risk management process involves:

  • Identifying all risks that exist within the environment
  • Assessing risks for likelihood and severity
  • Eliminating those risk that can be removed
  • Reducing the effect of risks that cannot be eliminated
  • Medicine itself is a risky business, which requires careful clinical management
• External Audits

  An integral part of the modern laboratory's quality system is the roles played by external organisations that develop the standards that the laboratory operates under, certify and accredit the lab in respect to the standard and that provide training and QA programs to monitor the lab performances 

  1. International Organisation for Standardisation (ISO)
  2. Standards Australia
  3. National Pathology Accreditation Advisory Council (NPAAC)
  4. NCS International (NCSI)
  5. National Association of Testing Authorities Australia (NATA)
  6. Royal College of Pathologists of Australasia (RCPA)
• ISO

  ISO15189 = Medical Laboratories

  • Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to med labs.

  ISO helps to make industry more efficient and effective. They are developed through global consensus

  The world's largest developer of voluntary international standards. Give state of the art specifications for: products, services and good practice.
• A standard is a doc that provides requirements, specs, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

  Pathology practice in Aus is covered by:

  • ISO standard 15189 Med Labs - particular requirements for quality and competence.

  The standard which labs are accredited by NATA and certified by NCSI

   
• Standards Australia

  An independent, not-for-profit organisation, recognised by AUS government as the peak non-government standards body in AUS.

  Develops internationally aligned AUS standards that deliver net benefit to AUS.

  Enhances the nation's economic efficiency, international competitiveness and contributes to community demand for a safe and sustainable environment.

  Leads and promotes a respected and unbiased standards development process ensuring all competing interests are heard, their points of view considered and consensus reached.

   
• NPAAC

  Advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology labs.

  Plays a key role in ensuring the quality of AUS pathology services and is responsible for the development and maintenance of standards and guidelines for pathology practice.

  Comprised of representatives from all states and territories, nominees from peak professional bodies and the Department of Health and Ageing.
• NATA

  Authority responsible for:

  • Accreditation of labs
  • Inspection bodies
  • Calibration services
  • Producers of certified reference materials
  • Proficiency testing scheme providers throughout Aus

   

  Provides independent assurance of technical competence through a proven network of best practice industry experts for customers who require confidence in the delivery of their products and services

  Not-for-profit company operating as an association owned and governed by its members and representatives from industry, government and professional bodies.
•  

  British Standards Institution

  A subsidiary of NATA. One of Australia's largest certification bodies and provides a wide array of auditing, training and accredited certification solutions.
• RCPA

  Leading organisation representing pathologists in Australasia

  The mission is to train and support pathologists and to improve the use of pathology testing to achieve better healthcare

  Roles:

  • Continuing professional development
  • Professional practice standards
  • Government relations: liaising with government on issues relating to professional practice, medical, economic and other medico-political issues.
  • Training and examinations