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

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Presentation on theme: "ISO 15189 in Histopathology Louise O’Callaghan MSc FAMLS Histology Department Bon Secours Hospital, Cork."— Presentation transcript:

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

2

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

4  16,000 cases/yr  60,000 Blocks/yr  7500 IHC slides/yr  1 CBMS  1.6 SBMS  6.3 BMS  1 MLA Histopathology

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

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

7  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’ Assessments

8  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

9  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

10  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

11  4.7 Advisory services  Arrangements for communicating with users- sample requirements/ advice on clinical cases/ effective utilisation of lab services / logistical issues  4.8Resolution of complaints  4.9Identification and control of non conformities 4 Management Requirements

12  4.10Corrective Action  4.11Preventative Action  4.12Continual Improvement  4.13Control of records 4 Management Requirements

13  4.14 Evaluation and audits  Review of requests/ user feedback/ staff suggestions/ internal audit/ risk management/ quality indicators  4.15Management review 4 Management Requirements

14  5.1 Personnel  qualifications/ job descriptions/ introduction to organization/ training/ competence/ review of performance/ continuing education and professional development/ personnel records  5.2Accommodation and environmental conditions  Lab and office facilities/ staff facilities/ storage/ sample collection facilities/ facility maintenance and environmental conditions 5 Technical Requirements

15  5.3Lab 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

16  5.4Pre examination processes  Information for patients and users – lab manual  Request form, information/ sample collection and handling/ sample transport/ reception  5.5Examination processes  Verification of examination procedures/ validation/ measurement uncertainty of measured quantity values/ biological reference intervals/ documentation of examination procedures 5 Technical Requirements

17  5.6Ensuring quality of examination results  Quality control materials/ data  Inter lab comparisons – Participation/ alternative approach  5.7Post examination processes  Review of results/ storage retention of samples 5 Technical Requirements

18  5.8Reporting results  Report attributes/ content  5.9Release of results  Critical values  Automated selection and reporting of results 5 Technical Requirements

19  5.10Laboratory Information Management  Confidentiality of patient information  Define authorities and responsibilities of all personnel  System should be validated/ protected/ safeguarded 5 Technical Requirements

20  Lab manual ology/New%20Folder/BSCPATHGDE001%20Ver.% p df Information

21 Thank you!Questions?


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