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

2. Bon Secours Hospital, Cork

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

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

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

6. 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

7. 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’

8. 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

9. 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

10. 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

11. 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

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

13. 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

14. 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

15. 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

16. 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

17. 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

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

19. 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

20. Information Lab manual

21. Thank you! Questions?