Quality manual

Department of Pathology, Our Lady’s Hospital

QMn-GEN-0001

Rev. No. 16
Quality Manual

Page of

Effective Date:

14/02/2017

Author: Kathleen Callan

Authoriser: Mr Ray O’Hare Dr. Mike Louw

QUALITY MANUAL

Contents

1. INTRODUCTION 4

2.QUALITY MANAGEMENT SYSTEM 6

3.TERMS AND CONDITIONS 7

4.MANAGEMENT REQUIREMENTS 7

4.7 Advisory Services 32

4.8 Resolution of Complaints 33

4.10 Corrective Action 36

4.11 Preventative Action 37

4.12 Continual Improvement 38

4.13 Control of Records 38

4.14 Evaluation and Audits 41

4.15 Management Review 45

5.TECHNICAL REQUIREMENTS 47

5.1 Personnel 47

5.2 Accommodation and Environmental Conditions 54

5.3 Laboratory Equipment, Reagents and Consumables 58

5.4 Pre-examination Procedures 66

5.5 Examination Procedures 73

5.6 Ensuring Quality of Examination Results 79

5.10 Laboratory Information Management 88

6.APPENDICES 93

1. INTRODUCTION

1. Purpose

The purpose of this document is to define in clear terms, the policies, practices and procedures that control the effective delivery of the services provided, as it relates to the Department of Pathology, Our Lady’s Hospital, Navan. This document forms the organisations response/approach to the requirements of the following regulations and standards:

• 
  Blood Directive – Directive 2002/98/EC ~ “Setting the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood products and amending Directive 2001/83/EC”.
  
• 
  EU Directive 2004/33/EC Annex IV titled “Storage, Transport and Distribution Conditions for Blood and Blood Products”.
  
• 
  SI 360 / 05 - European Communities (Quality and Safety of Human Blood and Blood Products) Regulations 2005. This is the statutory instrument which adapts the EU Directives as defined above Into Irish law.
  
• 
  Traceability SI 547/06 - Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC”.
  
• 
  AML-BB current version titled “Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events ) of EU Blood Directive 2002/98/EU
  
• 
  Directive 2005/61/EC ~ “Implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events”.
  
• 
  Directive 2005/62/EC ~ “Implementing Directive 2002/98/EC of the European Parliament and of the Council as regards community standards and specification relating to a quality system for blood establishments”.
  
• 
  Directive 98/79/EC – “In Vitro Medical Devices Directive”
  
• 
  SI No 304/2001 European Communities (In vitro Diagnostic Medical Devices) Regulations 2001
  
• 
  S.I. No. 158/2006 - European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006
  
• 
  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
  
• 
  ISO 15189:2012(E) - International Standard ~ Medical Laboratories – Particular requirement for Quality and Competence.
  
• 
  HIQA May 2010 – ‘National Standards for the Prevention and Control of Healthcare Associated Infections’.
  
• 
  INAB Regulations, Terms and Conditions
  
• 
  S.I. 707/03 - Infectious Diseases Regulations 2003
  
• 
  Ethics in Public Office Acts 1995 and 2001
  
• 
  Public Service Management (Recruitments and Appointments) Act 2004
  
• 
  Disciplinary Procedure for Employees of the Health Service Executive (January 2007)
  

Health Products Regulatory Authority has been designated by the Department of Health and Children (DOHC) as the competent authority for overseeing the implementation of these regulations in all Hospital Blood Banks in Ireland.

2. Overview of Our Lady’s Hospital

Governance Background
In 1997, Our Lady’s Hospital, Navan became part of the North Eastern Health Board (NEHB). In 2005, it then became part of the Health Service Executive Dublin North East (HSE DNE) with the amalgamation of Health Boards. It was nominated as one of the hospitals in the Louth/Meath Hospital Group, the other two hospitals being Louth County Hospital, Dundalk and Our Lady of Lourdes Hospital, Drogheda. In 2013, Professor Higgins in “The Establishment of Hospital Groups as a Transition to Independent Hospital Trusts” recommended that Our Lady’s Hospital, Navan be included with the Ireland East Group. This group included the Mater Misericordiae University Hospital, St Vincent’s University Hospital, Midland Regional Hospital, Mullingar, St Luke’s Hospital, Kilkenny, Wexford General Hospital, National Maternity Hospital, St Columcille’s Hospital, St Michael’s Hospital, Dun Laoghaire, Cappagh National Orthopaedic Hospital and the Royal Victoria Eye and Ear Hospital. The Academic Partner nominated is University College, Dublin.
The Department of Pathology in Our Lady’s Hospital, Navan is no longer linked to the Department of Pathology of Our Lady of Lourdes Hospital. The Laboratory Directorate is comprised of Dr Michael Louw, Consultant Chemical Pathologist, Mr Ray O’Hare Chief Medical Scientist and Mr Ken Fitzgibbon General Manager. Dr Anne Fortune as the Consultant Haematologist with responsibility for the Blood Bank, Dr Agneiska Blum, Locum Consultant Haematologist, Dr Jeremy Sargent, Consultant Haematologist with responsibility for Haematology, Dr Rosemary Curran, Consultant Microbiologist with responsibility for Microbiology, Dr Michael Louw, Consultant Chemical Pathologist to provide advisory services to Biochemistry and Mr Ray O’Hare as Chief Medical Scientist in charge.
Capacity
Our Lady’s Hospital, Navan has a capacity of 136 beds.

Services Provided
Our Lady’s Hospital, Navan provides a general acute hospital service to the catchment area of Meath and an orthopaedic service to the region as a whole. Services provided at the hospital are detailed in Table 1. Services Provided at Our Lady’s Hospital
Table 1. Services Provided at Our Lady’s Hospital, Navan

General Medicine	Pathology
Emergency Medicine	Radiology
Orthopaedics	Physiotherapy
Gynaecology Day Surgery	Pharmacy
Palliative Care	Cardiology
General Surgery	Occupational Therapy

3.