Quality manual


Overview of Department of Pathology



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Overview of Department of Pathology

The Department of Pathology provides a comprehensive service to Our Lady’s Hospital, Navan. It includes:




  • Blood Bank (Blood Transfusion Laboratory & Haemovigilance)

  • Haematology

  • Biochemistry

  • Microbiology

Pathology Governance meetings are held on site every 2 months.



  1. QUALITY MANAGEMENT SYSTEM


The Quality Management System is produced to direct and control the Department of Pathology with regard to quality. The Management Team includes the Consultant Haematologist, Dr Anne Fortune (Clinical Responsibility for the Blood Bank), Dr Jeremy Sargent, Consultant Haematologist (Clinical Responsibility for Haematology), Dr Agneiska Blum Locum Consultant Haematologist (Clinical Responsibility for Haematology/Blood Bank), Dr Rosemary Curran (Clinical Responsibility for Microbiology) and Dr Michael Louw, Consultant Chemical Pathologist (Clinical Responsibility for Biochemistry). The Laboratory Directorate is composed of Dr Michael Louw, Consultant Chemical Pathologist, Mr Ray O’Hare Chief Medical Scientist and Mr Ken Fitzgibbon General Manager.
Ray O’Hare the Acting Chief Medical Scientist is responsible for the Day to day operations in the Laboratory including responsibility for Scientific and Administration Issues and he reports directly the General Manager.
Appendix 1 Organisational Chart for Our Lady’s Hospital, Navan clearly defines the lines of communication and responsibility within each laboratory in the Pathology Department.
All personnel are required to follow these lines of communication and authority without exception.

  1. TERMS AND CONDITIONS


For the purpose of this document the terms and conditions will be taken from ISO 15189:2012

  1. MANAGEMENT REQUIREMENTS

    1. Organisation and Management Responsibility


      1. Organisation

4.1.1.1 General
The Department of Pathology is committed to performing its activities in accordance with the requirements of the International Standard ISO 15189 (current version). All work in the Department of Pathology relevant to the scope of ISO 15189 accreditation is carried out in the permanent facility.
The Department of Pathology consists of a Chief Medical Scientist, Senior Medical Scientists, Basic Medical Scientists, a Haemovigilance Officer, Phlebotomists, a Clerical Officer and Laboratory Aides. Medical Scientists participate on a voluntary basis on the multi-discipline on-call rotation which includes all departments.
The Blood Bank in Our Lady’s Hospital, Navan has been accredited to ISO 15189 since 17th February 2009. The scope of the accreditation is detailed in Registration Number 215MT. All work relevant to the scope of ISO 15189 (current version) accreditation is carried out in the permanent facility Appendix 2 List of Test Methods and the Respective EQA and IQA includes a list of the tests that are included in the scope of ISO15189 accreditation for the Blood Bank in Our Lady’s Hospital, Navan.
The Haematology and Biochemistry Departments have been accredited since 2016 following initial inspection in October 2015. Appendix 7 includes the Schedule of Testing for the Haematology Department and Appendix 8 includes the QF-BIO-0007 Schedule of Testing for the Biochemistry Department.
An application for an extension to scope to include the Microbiology Department is planned for 2017.

4.1.1.2 Legal Entity
The Department of Pathology in Our Lady’s Hospital, Navan is held legally responsible for its activities within the Health Service Executive. The Department of Pathology of Our Lady’s Hospital, Navan is situated on the first floor of the main hospital building.


Address: Department of Pathology,

Our Lady’s Hospital,

Navan,

Co. Meath.



C15 RK7Y

Telephone: Hospital Switchboard 046 9021210

Laboratory Office 0469078701

Blood Bank 046 9078573

Haematology 0469078575

Biochemistry 0469078574

Fax: Laboratory Office 046 9098016
4.1.1.3 Ethical Conduct
All aspects of ethical conduct in the Department of Pathology, Our Lady’s Hospital, Navan are managed in accordance with the ED-GEN-0132 Ethics in Public Office Acts 1995 and 2012 and MP-GEN-0026 Code of Conduct for Laboratory Personnel & Confidentiality Statement.

Laboratory management has arrangements in place to ensure the following:




  1. It is the Department of Pathology policy not to be involved in any activity that would diminish confidence in its competence, impartiality, judgement or operational integrity. This is achieved through adherence to procedures, with any deviations being reported and investigated as non-conformances as described in QP-GEN-0005 Control of Non-Conformances.




  1. Management and personnel are free from any undue internal and external commercial, financial or other pressures and influences that may adversely affect the quality of their work. This is implemented through adequate provision of resources as defined in MP-GEN-0001 Management of the Laboratory and MP-GEN-0026 Code of Conduct for Laboratory Personnel & Confidentiality Statement.




  1. The Department of Pathology ensures that there can be no conflict of interest for personnel involved in or with influence on the examination of primary samples. This is achieved through the maintenance of contracts of employment and job descriptions identifying responsibilities for each position which identify, manage and prevent a conflict of interest when testing. This is implemented through the ED-GEN-0134 Public Service Management (Recruitments and Appointments) Act 2004 and ED-GEN-0132 Ethics in Public Office Acts 1995 and 2012 and MP-GEN-0026 Code of Conduct for Laboratory Personnel & Confidentiality Statement.

Where potential conflicts in competing interests may exist, they shall be openly and appropriately declared.




  1. There are appropriate procedures to ensure that staff treats human samples, tissues or remains according to relevant legal requirements.




  1. Our Lady’s Hospital policy with regard to patient confidentiality is strictly adhered to. Each employee is contractually bound to ensure patient confidentiality and data protection as described in ED-GEN-0003 HSE Codes of Standards and Behaviour and MP-GEN-0011 Management of Data and Information. Breaches of confidentiality are dealt with as defined in ED-GEN-0131 Disciplinary Procedure for Employees of the Health Service Executive (January 2007).



4.1.1.4 Laboratory Directorate
The Laboratory is directed by a laboratory Directorate.
The responsibilities of the Laboratory Directorate include professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered by the laboratory
The Laboratory Directorate delegates selected duties and/or responsibilities to qualified personnel; however, the Laboratory Directorate maintains the ultimate responsibility for the overall operation and administration of the laboratory.
The duties and responsibilities of the Laboratory Directorate are documented in the roles and responsibilities of the Laboratory Directorate.
The Laboratory Directorate [or the designates for delegated duties] have the necessary competence, authority and resources to fulfil the requirements of ISO 15189.
The Laboratory Directorate [or designate/s] is responsible for the following:


  1. To provide effective leadership of the medical laboratory service, and delegating to the Chief Medical Scientist budget planning and financial management, in accordance with institutional assignment of such responsibilities according to MP-GEN-0001 Management of the Laboratory;




  1. To relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community and the patient population served and providers of formal agreements, when required according to MP-GEN-0001 Management of the Laboratory;




  1. To ensure that there are appropriate numbers of staff with the required education, training and competence to provide medical laboratory services that meet the needs and requirements of the users described according to MP-GEN-0017 Pathology Training Policy;




  1. To ensure the implementation of the quality policy;




  1. To implement a safe laboratory environment in compliance with good practice and applicable requirements according to MP-GEN-0007 Staff Health and Safety Manual, MP-GEN-0004 Management of Clinical Material and LP-GEN-0016 Cleaning in the Laboratory.




  1. To ensure that Consultants serve as a contributing member of the medical staff for those facilities served, if applicable and appropriate according to QP-GEN-0007 Advisory Services.




  1. To ensure the provision of clinical advice with respect to the choice of examinations, use of the service and interpretation of examination results according to QP-GEN-0007 Advisory Services.




  1. To select and monitor laboratory suppliers according to MP-GEN-0016 Management and Review of Contracts;




  1. To select referral laboratories and monitor the quality of their service according to MP-GEN-0016 Management and Review of Contracts;




  1. To provide professional development programmes for laboratory staff and opportunities to participate in scientific and other activities of professional laboratory organizations according to MP-GEN-0017 Pathology Training Policy;




  1. To define, implement and monitor standards of performance and quality improvement of the medical laboratory service or services according to

QP-GEN-0004 Continual Improvement;


  1. To monitor all work performed in the laboratory to determine that clinically relevant information is being generated according to QP-GEN-0004 Continual Improvement;




  1. To address any complaint, request or suggestion from staff and/or users of laboratory services according QP-GEN-0008 Complaints Procedure.




  1. To delegate to the Chief Medical Scientist responsibility to design and implement a contingency plan that essential services are available during emergency situations or other conditions when laboratory services are limited or unavailable. Refer to MP-GEN-0001 Management of the Laboratory;




  1. To delegate to the Chief Medical Scientist the responsibility to plan and direct research and development, where appropriate according to MP-GEN-0001 Management of the Laboratory;

4.1.2 Management Responsibility

4.1.2.1 Management Commitment
Laboratory management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by:


  1. Communicating to laboratory personnel the importance of meeting the needs and requirements of users as well as regulatory and accreditation requirements according to MP-GEN-0001 Management of the Laboratory;




  1. Establishing the quality policy ensuring the quality objectives and planning are established;




  1. Defining responsibilities, authorities and interrelationships of all personnel according to MP-GEN-0001 Management of the Laboratory;




  1. Establishing communication processes according to MP-GEN-0001 Management of the Laboratory and MP-GEN-0020 Management Review Procedure;




  1. Appointing a Quality Co-ordinator;




  1. Conducting management reviews according to the MP-GEN-0020 Management Review Procedure




  1. Ensuring that all personnel are competent to perform their assigned activities according to the MP-GEN-0017 Pathology Training Policy;




  1. Ensuring availability of adequate resources to enable the proper conduct of pre-examination, examination and post-examination activities according to MP-GEN-0001 Management of the Laboratory;



4.1.2.2 Needs of Users

The Department of Pathology in Our Lady’s Hospital provides the services outlined in section 1.2. Laboratory management ensures that laboratory services, including appropriate advisory and interpretative services, meet the needs of patients and those using the service. The services of the Department of Pathology include appropriate interpretation and advisory services, and are designed to meet the needs of patients and all hospital personnel responsible for patient care. Refer to Table 2. Department of Pathology Services.

Table 2. Department of Pathology Services


SERVICE NAME

SERVICE DESCRIPTION

Blood Bank


The Blood Bank comprises of the Blood Transfusion Laboratory and Haemovigilance service.

Opening hours: 8.30-18.30 Monday – Friday.

Emergency on-call service operates outside these hours.


  • The Blood Transfusion Laboratory offers comprehensive laboratory service including:

  • Blood Grouping and Antibody Screening, Antibody Identification (Inconclusive antibody panels are referred to the Irish Blood Transfusion Service for investigation)

  • Routine cross-matching of blood daily before 15:30 and urgent requests outside these hours

  • Direct Coombs Test (DCT), Phenotyping/Antigen Typing

  • Suspected Transfusion Reaction Investigation (if necessary)

  • Blood products include Plasma, PCC and Fibrinogen and other clotting factors. Platelets are ordered from the Irish Blood Transfusion Service when requested by a clinician. Clotting Factors are ordered from TCP.

  • PCC is ordered from United Drug Wholesalers.

  • Routine Cross-matching

  • Cross-matched blood is made available for routine transfusions and for operation cover in accordance with the HF-GEN-0003 Maximum Blood Ordering Schedule in place for Orthopaedics and General Surgery.

  • Emergency Cross-matching

  • Cross-matched blood may be made available in an emergency if the blood group has already been processed in the laboratory or if no irregular red cell antibodies are present. HF-GEN-0004 Minimum Timeframes to Prepare & Issue.

Two emergency O Rh (D) Negative, K, C, E negative units are available for emergency transfusion if necessary (LP-BT-0016 Emergency Release of Blood). These units will be issued with labels and reports stating “Uncross-matched blood at request of Medical Doctor”.

Re-routing of blood to Our Lady of Lourdes Hospital, Drogheda occurs on a regular basis.



  • Blood Bank Schedule of ISO 15189 accredited tests is detailed in Appendix 2.1.

  • Routine hours are 08:30hrs to 18.30hrs Monday to Friday (excluding Bank Holidays)

  • An emergency on call service is available at all other times

The Haemovigilance service provides the following:

  • Haemovigilance and Traceability of all Blood Products

  • A reporting service to the National Haemovigilance Office as described in HP-GENGEN-0006 The Reporting of SAEs/SARs/Near Misses to the National Haemovigilance Office.

  • Education and training to all clinical staff involved in the blood transfusion chain.

Haematology

The Haematology Department provides routine and emergency testing of samples. (Refer to Appendix 7 Haematology Schedule of Testing.

  • Routine hours are 08.30-18.30 Monday to Friday (excluding Bank Holidays)

  • An emergency on-call service is available at all other times.

Biochemistry

The Biochemistry Department provides routine and emergency testing of samples. (Refer to Appendix 8 Biochemistry Schedule of Testing, Routine hours are 08.30-18.30 Monday to Friday (excluding Bank Holidays)

  • An emergency on-call service is available at all other times.

Microbiology

The Microbiology Department provides routine and emergency testing of samples. It is planned to have these tests added to the scope of ISO 15189 by the end of 2017.

  • Routine hours are 08.30-18.30 Monday to Friday (excluding Bank Holidays)

  • An emergency on-call service is available at all other times.

Phlebotomy

The Phlebotomy Service is provided by personnel trained in phlebotomy techniques and is located in the Out-Patient’s Department. The service operates from Monday to Friday 9.00am – 4.45pm taking samples from hospital patients. On week-ends and bank holidays, samples are taken by the phlebotomist on mornings only. Outside this time, trained nursing and medical staff perform phlebotomy.

Consultant

Advisory services are provided by a Haematologist (Dr Anne Fortune) for Blood Bank. Advisory services are provided by a Consultant Haematologist (Dr Jeremy Sargent) for Haematology and advice on-call is provided by a Haematology rota including Dr Agneiska Blum Locum Consultant Haematologist. Contact with the Haematologists is through Our Lady’s Hospital Switch board.

Advisory services are provided by Microbiologist (Dr Rosemary Curran) for Microbiology.

Advisory Services for Biochemistry are provided by a Consultant Chemical Pathologist (Dr Michael Louw).


4.1.2.3 Quality Policy

Our Lady’s Hospital Navan plays an important role in the provision of health services in the North East region. The Department of Pathology is committed to providing a service of the highest quality and shall be aware and take in to consideration the needs and requirements of its users.

The Mission Statement of the Department of Pathology is:

Our purpose is to contribute to improvement of the health and well-being of the people in the North-East’

In order to ensure that the needs and requirements of users are met, the Department of Pathology implements the Quality Policy by:


  • Ensuring the policy is appropriate to the purpose of the organisation;

  • Including a commitment to good professional practice, examinations that are fit for intended use, compliance with the requirements of ISO 15189 and continual improvement of the quality of the laboratory services;

  • Providing a framework for establishing and reviewing quality objectives;

  • Ensuring that the policy is communicated and understood within the organisation;

  • Treating Health and Safety as a prime focus for users and staff of the Department of Pathology;

  • Upholding professional values and good professional practice through the provision of continuing education, training and professional development;

  • Recruiting of staff, training and development at all levels to provide an effective and efficient service to its users;

  • Providing and managing resources to ensure that laboratory examinations are processed to produce the highest quality results possible;

  • Reporting results in ways which are timely, confidential, accurate and are supported by clinical advice and interpretation when required;

  • Implementation of internal quality control, external quality assessment, audit and assessment of user satisfaction to continuously improve the quality of the service.

  • Complying with all environmental legislation;

  • Complying with all regulatory standards including ISO 15189, EU Directive 2002/98/EC, AML-BB including Article 14 and 15, INAB Regulations for the services and tests defined in the Quality Manual;

  • Reviewing for continuing suitability

Signed: ________________________________________ Date: ____________________

Acting Chief Medical Scientist (Ray O’Hare)

Signed __________________________________________Date: ____________________

Consultant Chemical Pathologist (Dr Mike Louw)

Signed __________________________________________Date: ____________________

General Manager (Mr Ken Fitzgibbon)

4.1.2.4 Quality Objectives and Planning

Laboratory management shall establish quality objectives, including those needed to meet the needs and requirements of the users, at relevant functions and levels within the organisation in accordance with MP-GEN-0001 Management of the Laboratory. The quality objectives shall be to measure aspects of the pre-examination, examination and post-examination processes and shall be consistent with the quality policy.

Laboratory management shall ensure that planning of the quality management system is carried out to meet the requirements and the quality objectives in accordance with QP-GEN-0004 Continual Improvement.

Laboratory management shall ensure that the integrity of the quality management system is maintained when the changes to the quality management system are planned and implemented in accordance with MP-GEN-0019 Management of Change Control.


        1. Responsibility, Authority and Interrelationships

The responsibilities, authorities and inter-relationships of each department are defined, documented and communicated within the Department of Pathology. The Department of Pathology Management consists of Directorate of the Department of Pathology, Laboratory Consultants, General Manager and the Chief Medical Scientist. The Laboratory Directorate is composed of Dr Michael Louw, Consultant Chemical Pathologist, Mr Ray O’Hare Chief Medical Scientist and Mr Ken Fitzgibbon General Manager.


The Chief Medical Scientist reports to the General Manager on governance issues and operational issues. The Chief Medical Scientist reports to the Laboratory Directorate of the Department of Pathology and the relevant Laboratory Consultants on clinical matters.


Department of Pathology Management Team


  • Laboratory Directorate of the Department of Pathology

  • Consultants

  • Chief Medical Scientist


Department of Pathology Quality Teams



  • Consultants

  • Chief Medical Scientist

  • Quality Co-ordinator

  • Medical Scientist Representatives (if required)

  • IT Co-ordinator (if required)

  • Senior Phlebotomist (if required)

  • Haemovigilance Officer (Blood Transfusion)

The Consultants are responsible for:


  • Directing/advising clinical issues

  • Communicating directly with the Chief Medical Scientist

  • Providing advice on the choice of tests

  • Providing advice on the use of laboratory services

  • Interpretation of laboratory data

  • Overseeing Haemovigilance/Traceability (Consultant Haematologist)

  • Infection Prevention & Control (Microbiology)



The Chief Medical Scientist is responsible for:


  • Reporting to the General Manager on management and governance issues

  • Directing scientific issues

  • Providing advise on the development of scientific tests

  • Providing advise on the use of laboratory services

  • Interpretation of laboratory data

  • Implementing the Quality Management System

The Department of Pathology Management Team ensures that policies and procedures are in place to define responsibility, authority and interrelationships.

The organizational and management structure of the Department of Pathology and interrelationships of personnel in relation to the Quality Management System are illustrated in Appendix 1. Organisational Chart for Our Lady’s Hospital, Navan.



The Department of Pathology Management Team ensures that policies and procedures are in place to address the following:




    1. The responsibilities of personnel involved in the examination of primary samples are defined by formal job descriptions. Signed job descriptions are in place for each position and are located in individual training folders. Department of Pathology personnel are provided with the appropriate authority and resources to carry out their duties as specified in their job descriptions. This is implemented through MP-GEN-0001 Management of the Laboratory and MP-GEN-0005 Management of Personnel.




    1. The Chief Medical Scientist is responsible for preparing, reviewing and updating relevant job descriptions in conjunction with the Human Resources Department. Table 3. Key Functions of Personnel in the Department of Pathology outlines the role, responsibility and deputy for key personnel.



    1. It is the Department of Pathology policy to ensure that personnel are adequately trained to perform procedures that have an impact on the quality of service supplied, as described in MP-GEN-0017 Pathology Training Policy.

    2. The Department of Pathology Management Team has overall responsibility to ensure adequate resources are in place to ensure the required quality of service is provided.


4.1.2.6 Communication
There are established communication processes within the Department of Pathology which ensures that communication takes place regarding the effectiveness of the Quality Management System. This is carried out through the following:


  • Pathology Governance Meeting

  • Quality Meetings

  • Annual Management Review Meeting

  • General Laboratory Meetings

  • Department Meetings

  • Training and Development Meetings

  • Haemovigilance Meetings

  • Hospital Transfusion Committee Meetings

  • Infection Prevention & Infection Control Meetings (Microbiology)

Laboratory pre-examination, examination and post examination processes are discussed at all of these meetings. Quality indicators are used to track the effectiveness of these processes and reports are produced periodically by the Quality Co-ordinator to track and trend progress.


Records are kept in hard copy of items discussed in communications and meetings and managed by the Quality Co-ordinator.

Table 3. Key Functions of Personnel in the Department of Pathology

Role

Role Description

Responsibility within the QMS

Deputy

General Manager

Ultimate responsibility for the administrative management of the department.

Provide resources for the Quality Management System

Senior Manager

Laboratory Directorate

Ultimate responsibility for clinical governance of the department.

Provide effective leadership and clinical direction. Chairs the Pathology Governance Meetings.

Consultant

Consultant

Clinical Advisor

Clinical advice and direction on departmental issues. Attendance at Pathology Governance Meetings, Quality Meetings and Annual Management Review and other individual department meetings.

Consultant

Chief Medical Scientist

Manages the local governance and administrative activities in the Department of Pathology

Development & implementation of the Quality Management System, ensures adherence to the Quality Management System by all staff

Senior Medical Scientist/

Medical Scientist



Senior Medical Scientist

Manage technical matters on a daily basis as directed by the Chief Medical Scientist

Ensure adherence to the Quality Management System by all staff

Medical Scientist

Quality Co-ordinator

Fulfils the roles and responsibilities of a quality manager. Is responsible for the overall management of the Quality Management System

Development & implementation and maintenance of the QMS.

Chief Medical Scientist

Medical Scientist

Day to Day work-load

Adheres to the Quality Management System.

Medical Scientist

IT Co-ordinator

Manages the Laboratory Information System and any IT Issues.

Ensure that all requirements of Annex B of ISO 15189 are met

Chief Medical Scientist

Laboratory Aides

Specimen reception and any other duties specified by the Chief Medical Scientist

Adheres to the Quality Management System.

Medical Scientist

Haemovigilance Officer

Haemovigilance/Traceability


Ensures compliance with AML-GEN, Articles 14 & 15.


Senior Medical Scientist Blood Bank


Senior Phlebotomist

Manages the phlebotomy service

Specimen collection and dispatch of samples to the laboratory.

Phlebotomist

Ref.: MF-GEN-0072 List of Names of Personnel in the Department of Pathology and Laboratory Medicine in Our Lady’s Hospital, Navan




        1. Quality Manager

The Quality Co-ordinator fulfils the roles and responsibilities of the Quality Manager in Our Lady’s Hospital, Navan. The Quality Co-ordinator is responsible for ensuring that processes needed for the quality management system are established, implemented and maintained across the Department of Pathology.


The Quality Co-ordinator reports directly to the Acting Chief Medical Scientist who has the authority to make or recommend changes on policy and resources, in conjunction with the Directorate of the Department of Pathology.
The Quality Co-ordinator ensures the promotion of awareness of users’ needs and requirements throughout the laboratory organisation.


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