wk 10- organisation and career progression

• Laboratory Scientist


  • Biomedical Scientist: analyse blood, bodily fluids and tissue samples from patients in order to identify, monitor and treat diseases and evaluate effectiveness of treatments
  • Research Scientist: Often found in Higher Educational institutes. Plan, gain funding for and carry out projects/experiments into novel areas for the purpose of publication and expansion of scientific knowledge
  • Development scientist: Often found in industry. Translation of Scientific principles to develop tests/kits/equipment for use
• Pathology Disciplines


  • Sharing resources
  • Scope of testing
  • Equipment
  • Organisational structure
  • Shift patterns
• Multidisciplinary


  Working across different disciplines or areas of expertise
• Roles within a clinical laboratory

  • Laboratory based/HCPC registration required
  • Laboratory and specimen reception based
  • MSc/HSD required
• 2022/23 Biomedical Scientist Pay Banding

  • Band 3 – 21,730-23177
  • Band 4 - £23949-£26,282
  • Band 5 - £27055-£29,180
  • Band 6 - £33706-£35572
  • Band 7 - £41659-£43,806
• Roles within a clinical laboratory

  • MLA/Healthcare science assistant
  • Associate practitioners (non-accredited degree)
  • Accredited Degree
  • + Specialist Portfolio
  • + MSC and/or Higher Specialist Diploma
• HCPC Registration - Ensuring Quality


  • Good Professional Practice (GPP)
  • Continual Professional Development (CPD)
  • Good Laboratory Practice (GLP)
  • Health and Safety (H&S)
  • Quality Control (covered in a separate lecture)
• Professionality


  Professionalism is the conduct that characterises or marks a profession or professional person. It describes the qualities, skills, competence and behaviours you are expected to demonstrate.
• Professionalism in Practice


  • Responsibility
  • Integrity
  • Behaviour
  • Conduct
  • Performance
  • Knowledge
  • Consequences
  • Professional Skills
• HCPC registered professions


  • Art Therapists
  • Speech and Language Therapists
  • Many professions deal directly with patients
• HCPC Generic Standards of Proficiency (StoPs)

  • practise safely and effectively within their scope of practice
  • practise within the legal and ethical boundaries of their profession
  • look after their health and wellbeing and seeking appropriate support when necessary
  • practise as an autonomous professional, exercising their own professional judgement
  • recognise the impact of culture, equality and diversity on practice and practise in a non-discriminatory and inclusive manner
  • understand the importance and be able to maintain confidentiality
  • 7 . communicate effectively
  • 8 . work appropriately with others
  • maintain records appropriately
  • 10. reflect on and review practice
  • 11. assure the quality of their practice
  • 12. understand and apply the key concepts of the knowledge base relevant to their profession
  • 13. draw on appropriate knowledge and skills in order to inform practice
  • 14. establish and maintain a safe practice environment
  • 15. promote health and prevent ill health
• Quality in the laboratory


  The standard of something as measured against other things of a similar kind; the degree of excellence of something
• Quality


  Quality is about consistency and reproducibility, that is, getting it right first time and every time
• Why is quality important?

  • Compliance with legislation and regulations
  • Reputation of laboratory
  • Quality standards in lab related to patient care
  • Improved efficiency
  • Maintain standards/innovation
  • Reduced errors
• Quality Assurance (QA)


  The overall process/program undertaken ensuring the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time
• QA comprises 5 main elements

  • Quality Control (comprises IQC and EQA)
  • Quality Management
  • Documentation (governance)
  • Training & Competency
  • Health & Safety
• Quality Control


  A procedure intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer
• Internal Quality Control (IQC)


  Measures that must be included during each assay run to verify that the test is working correctly
• Continuous Professional Development (CPD)


  Activities undertaken in order to demonstrate continual learning and development during their career. Means of staying up to date with changes
• Quality Assurance (QA)


  A procedure intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer
• QA comprises 5 main elements

  • Quality Control
  • Quality Management
  • Documentation (governance)
  • Training & Competency
  • Health & Safety
• Quality Control


  Comprises IQC and EQA
• Internal Quality Control (IQC)


  Measures that must be included during each assay run to verify that the test is working correctly (e.g. Shewhart/Levey-Jennings control charts, assessment of positive and negative controls, sample ID/patient data checking, with immediate corrective action)
• Continuous Professional Development (CPD)


  Activities undertaken in order to demonstrate continual learning and development during their career, means of staying up to date with changes, as per HCPC Standards of CPD
• How to undertake CPD

  1. Reflection

  2. Continual process

  3. Requires co-operation of all staff

  4. Quality of processes should be continually improved
• Quality Management System (QMS)


  A formalized system that documents processes, procedures and responsibilities for achieving quality policies and objectives. Includes governance (documentation), audits, training & competency assessment of staff. Aims to prevent non-conformity (any deviation from that which is required). If a non-conformity arises, root cause analysis (RCA) is performed and corrective and preventive actions (CAPA) are assigned.
• External Quality Assurance (EQA)

  Assesses quality of a lab's tests comparable to others and to known 'gold standards'. Samples of known positivity/results are sent out to labs to stain/test with their in-house method. Each lab is anonymised, results peer-assessed against a defined set of criteria (score). Highlights good & poor practice and trends.
• Governance


  Hierarchy of documentation in a QMS: a) Evidence (e.g. records, forms, worksheets), b) 'How?' (e.g. SOPs), c) 'Why?' (e.g. Policies), d) Scope/objectives (QM)
• Audits


  Check processes & procedures and highlight good practice and areas of weakness/required improvement. 3 categories: 1) Internal audit (conducted by lab itself; audit schedule), 2) External audit (conducted by external organisation/Dept e.g. UKAS), 3) Co-operative audit (conducted between lab and another party for mutual benefit e.g. clinical audit)
• Training and Competency assessment

  High quality training of staff leads to high quality results, reduces errors. IBMS training approval for registration and specialist training. Competency assessments ensures training still valid, re-training if required. CPD to maintain competency and registration.
• Regulatory and governing bodies


  • HCPC (Health Care Professions Council)
  • UKAS (United Kingdom Accreditation Service)
  • MHRA (Medicines & Healthcare products Regulatory Agency)
• No matter how hard we try – things do go wrong!
• QM is about how we minimise these and prevent recurrence; Learn from our mistakes – continual improvement
• Errors can occur in any part of the laboratory test cycle

  • Pre-analytical phase (most errors)
  • Analytical phase (testing errors)
  • Post-analytical phase (e.g. transcription errors when typing reports)
• Pre-analytical errors


  • No labels/mix-up of barcodes between patients
  • Timing error (sending in a blood sample too early after the administration of a drug)
  • Delay in transport of a frozen tissue sample will cause autolysis
  • Sample collection contamination
• Good Laboratory Practice (GLP)


  A quality system covering the organisational process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP ensures the quality and integrity of safety test data submitted to the government for the issuance of research permits.
• The 10 Good Laboratory Practice principles

  • Test Facility Organization and Personnel
  • Quality Assurance Programme
  • Facilities
  • Apparatus, Material, Reagents
  • Test Systems
  • Test and Reference Items
  • Standard Operating Procedures
  • Performance of the Study
  • Reporting of Study Results
  • Storage and Retention of Records and Materials
• Health and Safety in the Workplace

  • Health and Safety at Work Act 1974 (Main UK Legislation)
  • Health and Safety Executive (UK governing body that enforces the above legislation)
  • COSHH (Control of Substances Hazardous to Health)
  • RA (Risk Assessment)
  • RIDDOR (Reporting of Injuries, Diseases and Dangerous Occurrence Regulation 1995)
• To perform a risk assessment

  1. Identify potential hazards

  2. Evaluate risk

  3. Describe how these are mitigated in the lab
• Laboratory Safety and Infection Control

  • Waste disposal streams (e.g. sharps bins, clinical waste, confidential waste)
  • Manual Handling (how to move items safely)
  • First Aid (Nominated first aiders, first aid kits)
  • Safety signs
  • PPE (Personal Protective Equipment)
  • Infection control