ISO 15189 in Histopathology Louise O’Callaghan MSc FAMLS Histology Department Bon Secours Hospital, Cork

Bon Secours Hospital, Cork

Bon Secours Hospital, Cork Private hospital 340 Bed hospital 18,000 in patients; 29,000 outpatients /year Endoscopy Theatres Breast Unit Dermatology Oncology

Histopathology 16,000 cases/yr 60,000 Blocks/yr 7500 IHC slides/yr 1 CBMS 1.6 SBMS 6.3 BMS 1 MLA

Histopathology First accredited ISO15189 – 2004 April 2015 – ISO15189: 2012 Cross discipline audits - annually Quality manager + Document Controller + Validation Technician Currently paper based Quality System

ISO 15189 - Where to start??? The standard: Read / review/ interpret Section 4 – Management requirements Section 5 – Technical requirements Identify road blocks/ obstacles gap analysis Create a plan

Assessments Accrediting body – INAB / UKAS Pre assessment Assessment Accreditation for 5 years, with annual surveillance visits – allow extension to scope ‘Surprise’ visits ‘Only answer what you are asked’

4 Management Requirements 4.1 Organization and management responsibility Covers: legal entity / ethical conduct/ Lab director / Quality policy / needs of users/ communication/ quality manager 4.2 Quality Management System Covers: general requirements/ documentation requirements/ quality manual 4.3 Document control

4 Management Requirements 4.4 service agreements Establish & review service agreements 4.5 Examination by referral laboratories Select/ review/ maintain list of referral labs & expert opinions Keep record of periodic reviews

4 Management Requirements 4.6 External services and supplies Procedure for selecting and purchasing equipment/ external services/ reagents and consumable supplies Select and approve suppliers – may need to collaborate with other organizational departments List of selected and approved suppliers maintained Monitor performance of suppliers

4 Management Requirements 4.7 Advisory services Arrangements for communicating with users- sample requirements/ advice on clinical cases/ effective utilisation of lab services / logistical issues 4.8 Resolution of complaints 4.9 Identification and control of non conformities

4 Management Requirements 4.10 Corrective Action 4.11 Preventative Action 4.12 Continual Improvement 4.13 Control of records

4 Management Requirements 4.14 Evaluation and audits Review of requests/ user feedback/ staff suggestions/ internal audit/ risk management/ quality indicators 4.15 Management review

5 Technical Requirements 5.1 Personnel qualifications/ job descriptions/ introduction to organization/ training/ competence/ review of performance/ continuing education and professional development/ personnel records 5.2 Accommodation and environmental conditions Lab and office facilities/ staff facilities/ storage/ sample collection facilities/ facility maintenance and environmental conditions

5 Technical Requirements 5.3 Lab equipment reagents and consumables Equipment acceptance testing/ instructions/ calibration and metrological traceability/ maintenance and repair/ adverse incident reporting/ records Reagent and consumables reception and storage/ acceptance testing/ inventory management/ instructions for use/ adverse incident reporting/ records

5 Technical Requirements 5.4 Pre examination processes Information for patients and users – lab manual Request form, information/ sample collection and handling/ sample transport/ reception 5.5 Examination processes Verification of examination procedures/ validation/ measurement uncertainty of measured quantity values/ biological reference intervals/ documentation of examination procedures

5 Technical Requirements 5.6 Ensuring quality of examination results Quality control materials/ data Inter lab comparisons – Participation/ alternative approach 5.7 Post examination processes Review of results/ storage retention of samples

5 Technical Requirements 5.8 Reporting results Report attributes/ content 5.9 Release of results Critical values Automated selection and reporting of results

5 Technical Requirements 5.10 Laboratory Information Management Confidentiality of patient information Define authorities and responsibilities of all personnel System should be validated/ protected/ safeguarded

Information Lab manual http://www.bonsecours.ie/contentFiles/files//Cork/pathology/New%20Folder/BSCPATHGDE001%20Ver.%2013.5.pdf

Thank you! Questions?