Chapter 17 Discussion Questions and Answers

17.1 How would you encourage a quality culture within your laboratory?

  • Set up a quality forum or discussion group
  • Be inclusive of all staff in quality, audit and improvement activities and training
  • Communicate to staff about what ISO 15189 and any other standard and legislation means practically
  • Encourage forward thinking and nurture the idea of continuous quality improvement
  • Competitions, information on notice boards about improvements made

There is no real right answer, just need people to come up with ideas suitable for them

17.2 What are the possible consequences if your laboratory loses CPA accreditation?

  • Very unlikely to be recommended for accreditation with ISO 15189
  • Need to start application process to UKAS again
  • Affects staff morale
  • Implications for activities within the hospital e.g. clinical trials and research work where testing is required to be carried out in accredited laboratories
  • Potential loss of income if service users do not want to stay with a non-accredited laboratory

17.3 What systems need to be in place to ensure compliance with the HTA 2004?

  • The Human Tissue Authority (HTA) as the body to produce codes of practice, the standards for the use of human tissue for scheduled purposes.
  • The HTA aims to create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs
  • HTA licence and a designated individual.

Self check on Quality Section

Define KPIs for your laboratory service (need to encourage evaluation process)

  • Includes both business performance and quality performance
  • TATs where they apply to specific patient pathways e.g. cancers
  • Quality of H&E stains as these are the basic, underpinning slides used for any case
  • IHC quality control as the panels used are for diagnostic and prognostic purposes and the technique can be difficult to get right
  • Budget performance against workload demands (up and down)
  • There will only be a very limited number of really key performance indicators

Explain the difference between EQA and IQC and the value of performing each activity

  • External Quality Assurance is a process by which unknown samples are processed in the laboratory, returned to the scheme organiser for marking and results distributed to all participants. Root cause analysis of any failures is needed to produce corrective action and the process is both a way of reviewing performance and an educational tool.
  • Internal Quality Control is the process of running known value or performance material through an analyser or process to ensure that the procedure involved is performing as expected. Non-conformances need to be investigated and corrected. Correctly performing IQC material gives laboratories confidence to process patient material along the same pathways.
  • There are 3 types of audit: vertical covers a complete pathway e.g. the complete life of a sample and all aspects of managing it. This covers information for patients and users, request forms and sample containers, sample collection methods and consent, transport, spillages / breakages, storage, laboratory reception, sample processing, quality control and records of reagents, equipment and staff competence, reporting of the result and ensuring it reaches the requestor in the same format as issued. Horizontal audit covers any one aspect of a whole system e.g. competence records, transport driver training, document control, equipment maintenance records. Witness audit refers to the observation of someone carrying out a process or activity, discussing this with them, testing their knowledge and understanding and may involve a set range of questions or outcomes being correctly addressed.

Questions for on-line research

1. What are the current regulations for UK procurement processes and their implications?

  • The Public Contracts Regulations 2015 and EU directives

http://www.legislation.gov.uk/uksi/2015/102/contents/made

https://www.gov.uk/guidance/transposing-eu-procurement-directives

Regulations are laws: if the procedures for procurement of goods and services are not followed according to these, and in consideration of the total value of the procurements across it’s life, which varies according to value, the procurer is in breach of the law and at risk of being subject to legal action.

2. Investigate a range of tools for undertaking root cause analysis and trend analysis of errors and incidents.

  • 5 whys, Ishikawa fishbone analysis, Pareto analysis (80:20 analysis), use of scatter grams / Histograms

http://www.institute.nhs.uk/quality_and_service_improvement_tools/quality_and_service_improvement_tools/identifying_problems_-_root_cause_analysis_using5_whys.html

http://asq.org/learn-about-quality/cause-analysis-tools/overview/fishbone.html

https://en.wikipedia.org/wiki/Pareto_analysis

3. Seek out the latest techniques and strategies proposed for staff engagement and assess their usefulness. These are some examples: the researcher will find many options and should write a reflection based on their research and if they feel that the strategies proposed would be successful for them and in their workplace.

https://www.cipd.co.uk/hr-resources/factsheets/employee-engagement.aspx

http://www.industryweek.com/engagement/three-strategies-employee-engagement

http://www.torbenrick.eu/blog/performance-management/20-tips-to-improve-employee-engagement-and-performance

4. Investigate the range of ISO standards and supplementary documents that are relevant to laboratories and assess how your department would comply with them.

They should note the current ISO 15189:2012 standard applicable to medical laboratories:

Medical laboratories — Requirements for quality and competence (ISO 15189:2012)

They should also look at ISO 17025 which applies to calibration and testing of instruments and equipment e.g. pipettes, balances, centrifuges. They should become aware of supplementary documentation such as the LAB and TPS range of documents which UKAS refers to when assessing against ISO 15189: 2012.

ISO/IEC 17000, Conformity assessment —Vocabulary and general principles
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
ISO/IEC Guide 2, Standardization and related activities — General vocabulary
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)

The researcher should write a reflection based on their research into the standards and associated documents. This could be an activity carried out with colleagues, quality leads and managers in the work place as it is required for any department seeking to be accredited under ISO 15189:2012.

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