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/path ology/New%20Folder/BSCPATHGDE001%20Ver.%2013.5.p

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Thank you! Questions?