Quality manual

4.15 Management Review

1. 
   General
   

All services are subject to annual review. The Annual Management Review, described in MP-GEN-0001 Management of the Laboratory, examines the continuing suitability and adequacy of services and their effectiveness and support of patient care. The need to introduce any necessary changes or improvements may also be identified.

In addition, monthly Quality Meetings, as described in MP-GEN-0021 Quality Meetings, are held to address individual aspects of the Quality Management System on an on-going basis.

The format of meetings is defined in MP-GEN-0001 Management of the Laboratory and MP-GEN-0021 Quality Meetings to ensure that results of the review are incorporated into a plan that includes goals, objectives, action plans, responsible personnel and the dates that actions are to be completed by.

2. 
   Review Input
   

The Annual Management Review, Monthly Quality Meetings and Pathology Governance Committee Meetings cumulatively include information from the results of at least the following:

1. 
   The periodic review of requests and suitability of procedures and sample
   

requirements

2. 
   Feedback from clinicians, patients and other parties
   

3. 
   Staff suggestions
   

4. 
   Outcome of recent internal audits
   

5. 
   Risk management
   

6. 
   Quality indicators for monitoring the laboratory’s contribution to patient care
   

7. 
   Assessment by external bodies, e.g. Health Products Regulatory Authority, INAB
   

8. 
   The outcome of external quality assessment e.g. UK NEQAS, IEQAS, RIQAS, WEQAS, LabQuality
   

9. 
   Monitoring and resolution of complaints
   

10. 
    Evaluation of performance of suppliers
    

11. 
    Identification and control of Non-conformances
    

12. 
    Results of continuous improvement processes including current status of corrective and preventive actions
    

13. 
    Follow up actions from previous management reviews
    

14. 
    Changes in the volume and scope of work, personnel and premises that could affect the quality management system
    

15. 
    Recommendations for improvement, including technical requirements
    

16. 
    Goals for the forth-coming year
    

17. 
    Reports from relevant managerial and supervisory personnel
    

4.15.3 Review Activities
The quality and appropriateness of the contribution of the Department of Pathology to patient care is monitored and evaluated objectively through the Management Review Meeting, Quality Meetings and Pathology Governance Committee Meetings and arising actions are discharged within an appropriate and agreed upon timeframe.
The various meetings analyse the input information for causes of nonconformities, trends and patterns that indicate process problems. It also includes assessing these opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
The quality and appropriateness of the laboratory’s contribution to patient care, is also objectively evaluated.

4. 
   Review Output
   

Minutes of the findings and actions from all meetings are documented. The minute’s document:

1. 
   Improvement of the effectiveness of the quality management system and its processes
   

2. 
   Improvement of services to users
   

3. 
   Resource needs
   

Findings and actions are implemented within the appropriate and agreed upon timeframes and are available for review by laboratory staff.

2. TECHNICAL REQUIREMENTS

5.1 Personnel

5.1.1 General
The laboratory has documented procedures for personnel management and maintains records for all personnel to indicate compliance with requirements. These include MP-GEN-0005 Management of Personnel and MP-GEN-0011 Management of Data and Information.
The reporting and working relationships are demonstrated through the Appendix 1 QF-GEN-0060 Department of Pathology Organisation Chart for Our Lady’s Hospital, Navan.

The Directorate of the Department of Pathology, Consultants, the Chief Medical Scientist, Senior Medical Scientists have responsibility for:

• 
  The testing/advisory and consultative services offered by the Department of Pathology as appropriate
  
• 
  The administration of the department including management of personnel and ensuring that sufficient resources (personnel, material, equipment) are available to meet the requirements of the service as appropriate
  
• 
  Ensuring personnel are suitably qualified, trained and competent and also providing opportunities for continuing education as appropriate
  

The Chief Medical Scientist ensures that sufficient resources are available to meet the requirements of the Quality Management System. This includes a commitment to ensuring that staff resources are adequate for the work performed including Haemovigilance and Traceability.

The Human Resources Department at Our Lady’s Hospital ensure that all personnel working in the hospital, including personnel working within the Department of Pathology have the required qualifications (in accordance with national guidelines and regulations) and experience to carry out the duties relevant to their post within the organisation. See Table 5. Responsibilities of Personnel outlines the personnel responsible for the discharge of key tasks.

Table 5. Responsibilities of Personnel

Task	Description of Responsibility	Responsible
a.	Provide advice on choice of test in the Department of Pathology and interpretation of laboratory results or data	Consultants
b.	Serve as an active member of the medical staff for the hospital	Consultants
c.	Relate and function effectively with: Irish National Accreditation Board (INAB) HIQA Health Products Regulatory Authority General Manager The healthcare community within the Hospital i.e. Clinicians, Clinical Area National Haemovigilance Office (NHO) Infection Prevention & Control	Laboratory Directorate of Department of Pathology: Consultants Chief Medical Scientist Quality Co-ordinator Haemovigilance Officer
d.	Define, implement and monitor standards of performance and quality improvements of the Medical Laboratory Service	Department of Pathology Management Team*
e.	Implementation of the Quality Management System and participation in any quality improvement committees within the hospital	Department of Pathology Management Team*
f.	Monitor all work performed in the Department of Pathology to ensure reliable data is being generated and reported (Internal QC and EQA)	Department of Pathology Management Team*
g.	Ensure personnel performing laboratory tasks are suitably qualified, adequately trained and have the required experience	Chief Medical Scientist
h.	Plan, set goals, develop and allocate resources appropriate to the medical environment	Department of Pathology Management Team*
i.	Provide effective and efficient administration of the Department of Pathology, including budget planning and control with responsible financial management	Chief Medical Scientist
j.	Provide educational programmes for the Medical Laboratory staff and ensuring participation in education programmes provided by the Hospital	Chief Medical Scientist
k.	Plan and direct research and development performed in the Laboratory as required	Consultants Chief Medical Scientist
l.	Select and monitor all referral laboratories for quality of service	Consultants Acting Chief Medical Scientist Quality Co-ordinator
m.	Implement a safe laboratory environment in compliance with legal requirements, hospital policy and laboratory department safety procedures	Department of Pathology Management Team*
n.	Address any complaint, request or suggestion from the users of the Department of Pathology	Department of Pathology Management Team*
o.	Ensure good staff morale	Department of Pathology Management Team*
p.	Ensuring requirements of EU Directive 2002/98/EC are met	Department of Pathology Management Team*

*The Department of Pathology Management Team consists of the Laboratory Directorate of the Department of Pathology.

5.1.2 Personnel Qualifications
Records of the relevant educational and professional qualifications, training and experience, and competence of all personnel are stored in either the Department of Pathology or the Human Resources Department. Copies of all relevant qualifications are requested and checked for veracity by the Human Resources Department prior to the person taking up the post. These records include the following:

1. 
   A certificate or licence is required by a person in order to practice in their profession
   

2. 
   A qualification recognised by the Academy of Medical Laboratory Sciences (AMLS) is required to work as a Medical Scientist.
   

3. 
   A nursing qualifications and registration with the Nursing Body in Ireland, Nursing and Midwifery Board of Ireland for the post of Haemovigilance Officer if the post is filled by a nurse.
   

4. 
   Registration with the Medical Council of Ireland and certificate of the Specialist Register for all Consultants.
   

5. 
   All qualifications or licenses are current and up to date, and are obtained by the HR personnel prior to the person taking up the post. This is implemented through the Public Service Management (Recruitments and Appointments) Act 2004.
   

5.1.3 Job descriptions
Job descriptions are in place for all staff and retained in individual training folders.

Written job descriptions are in place for all grades of personnel including:

• 
  Laboratory Directorate
  
• 
  Consultants
  

• 
  Chief Medical Scientist
  
• 
  Quality Co-ordinator
  
• 
  Senior Medical Scientists
  
• 
  Medical Scientists
  
• 
  Haemovigilance Officer
  
• 
  Phlebotomists
  
• 
  Clerical
  

5.1.4 Personnel Introduction to the Organizational Environment
The laboratory has a programme to introduce new staff to the organisation, the department or area in which the person will work the terms and conditions of employment and staff facilities as per MF-GEN-0044 Laboratory Staff Induction Checklist for all new staff members
5.1.5 Training
MP-GEN-0017 Pathology Training Policy, MP-GEN-0005 Management of Personnel and HP-GEN-0008 Haemovigilance Training are the procedures that describe staff training. There is a training plan in place for all staff which ensures that they are suitably trained in all areas of the Quality Management System.
Only staff that hold the required qualifications, the applicable theoretical and practical background, recent experience and suitable training are authorised to make professional judgements with reference to examinations (scientific staff), Haemovigilance & Traceability and Phlebotomy activities (nursing/scientific staff). Professional judgements can be expressed as opinions, interpretations, predictions, simulations, models and values are in accordance with national, regional and local regulations. Personnel, including Haemovigilance & Traceability and Phlebotomy personnel, take part in regular professional development or other professional liaison.
This is implemented through the following procedures:

• 
  MP-GEN-0017 Pathology Training Policy
  
• 
  MP-GEN-0005 Management of Personnel
  
• 
  HP-GENGEN-0008 Haemovigilance Training
  

The laboratory provides training for all personnel in areas that are relevant to their position. These include:

• 
  The Quality Management System
  

• 
  Assigned Work Processes and Procedures
  

• 
  The Laboratory Information System (Apex). The LIS is managed and controlled by the Laboratory IT Co-ordinator. Design and management of the LIS is cognisant of the clauses of ISO 15189:2012. Procedures have been established that define who may use the LIS including access to patient data and who is authorised to enter and change patient results or modify computer programmes. Refer to MP-GEN-0012 Management and Operation of Apex. The audit trail feature of the LIS ensures that the identity of the staff member requesting and making entries and amendments to entries is recorded
  

• 
  Health and Safety including the prevention or containment of the effects of adverse incidents. Staff are trained to prevent or contain the effects of adverse incidents. This is implemented through MP-GEN-0007 Staff Health & Safety Manual.
  

• 
  Ethics
  

• 
  Confidentiality of Patient Information. Confidentiality of information regarding patients is maintained by all personnel, including personnel involved in laboratory, Haemovigilance & Traceability and Phlebotomy activities as per their contracts of employment and their job descriptions. This is in accordance with MP-GEN-0011 Management of Data and Information.
  

• 
  Haemovigilance & Traceability
  

Personnel that are undergoing training are supervised at all times. The effectiveness of the training is periodically reviewed.

5.1.6 Competence Assessment
A comprehensive Training and Competency programme for all staff ensures that personnel are competent to perform their tasks. Competency testing is carried out on an on-going basis, as described in MP-GEN-0017 Pathology Training Policy,

MP-GEN-0005 Management of Personnel and HP-GEN-0008 Haemovigilance Training. Competency training plans ensure that the competency of each member of routine and on-call staff will be assessed at least once annually, thus ensuring that they are competent to perform individual tasks. Refer to LF-BT-0016 Competency Review for Rotating Blood Transfusion Laboratory Scientist, MF-BIO-0006 Biochemistry Training and Competency Programme for Non-Biochemistry On-call Staff, MF-BIO-0017 Biochemistry Certificate of Competency. LF-HAEM-0019 Annual Competency Review for Haematology Laboratory Scientists, LF-HAEM-0067 Haematology Tests Performance and Authorization: Competency Testing, LF-HAEM-0073 Interpretation of Data for Proficiency Testing, LF-HAEM-0096 Competency Assessment Questionnaire Haematology and LF-MIC-0012 Annual Competency in Gram Staining in Microbiology for On-call Medical Scientists.
Re-training may be required in the corrective/preventative action associated with a non-conformance or complaint, as described in QP-GEN-0005 Control of Non-Conformances. This is organised by the Chief Medical Scientist and recorded in the individuals Training File.
Where a procedure is not fully understood, individual personnel are obliged to complete MF-GEN-0003 Request for Re-Training and discuss retraining needs with the Chief Medical Scientist. Re-training including competency assessment occurs on an annual basis for staff performing emergency on-call duty.
In addition, retraining is carried out when a member of staff returns from a leave of absence of greater than one year.
There is a plan in place for Internal & External Training and for On-going Competency Assessment of Laboratory Personnel. This is implemented through

MP-GEN-0017 Pathology Training Policy and MP-GEN-0005 Management of Personnel. All training is documented and records retained in individual training folders for each laboratory staff member.
Competency of laboratory staff is assessed using a combination of approaches under the same conditions as the general working environment as follows:

• 
  Direct observation of routine work processes and procedures, including all applicable safety practices
  
• 
  Direct observation of equipment maintenance and function checks
  
• 
  Monitoring the recording and reporting of examination results
  
• 
  Review of Work Records
  
• 
  Assessment of Problem Solving Skills
  
• 
  Examination of specifically provided samples, such as previously examined samples, inter laboratory comparison materials or split samples
  

5.1.7 Reviews of Staff Performance
In addition to the assessment of technical competence, the laboratory ensures that reviews of staff performance consider the needs of the laboratory and of the individual in order to maintain or improve the quality of service given to the users and encourage productive working relationships. Ref. MP-GEN-0006 Management of Annual Joint Review.
Staff performing reviews receives appropriate training.
5.1.8 Continuing Education and Professional Development
A continuing education programme is available to personnel who participate in managerial and technical processes. This is in accordance with MP-GEN-0024 Continuing Education and Professional Development. All personnel take part in continuing education. The effectiveness of the continuing education programme is periodically reviewed.
Personnel take part in regular professional development or other professional liaison activities.

9. 
   Personnel Records
   

Records of the relevant educational and professional qualifications, training and experience and assessments of competence of all personnel are maintained. These records are readily available and include the following:

• 
  Educational and Professional Qualifications
  

A copy of the qualifications is held in the individual staff Training folders

• 
  Certificate or License when applicable
  
• 
  Previous Work Experience
  

The Human Resources Department maintains references from previous employment. This is implemented through the Public Service Management (Recruitments and Appointments) Act 2004.

• 
  Job Descriptions
  

Job descriptions are held in individual Training Folders

• 
  Introduction of New Staff to the Laboratory Environment
  
• 
  Training in Current Job Tasks
  

Records of staff training are filed in individual Training folders

• 
  Competency Assessments:
  

Competency assessment records are maintained for laboratory staff as per

MP-GEN-0017 Pathology Training Policy, and MP-GEN-0005 Management of Personnel and are filed in individual Training Folders. Competency evaluations of non-laboratory personnel trained in Haemovigilance procedures/activities and Haemovigilance Officers are carried as per the procedures, HP-GEN-0007 Operation and Function of the Haemovigilance Role and HP-GEN-0008 Haemovigilance Training

Records of competency assessments are held in individual Training Folders.

• 
  Records of Continuing Education and Achievements
  

As defined in MP-GEN-0017 Training Procedure for Laboratory Personnel, MP-GEN-0001 Management of the Laboratory, MP-GEN-0005 Management of Personnel and QP-GEN-0004 Continual Improvement, continuing education programmes are available to staff at all levels involved in the delivery of services.

Scientific, Medical, Phlebotomy and Haemovigilance staff attends National and International meetings and seminars and other professional meetings for continued professional development and records of these are filed in individual Training Folders.

• 
  Reviews of Staff Performance are held in individual files in the Chief Medical Scientist’s Office
  
• 
  Reports of Accidents and Exposure to Occupational Hazards
  

All staff are obliged to attend corporate training in Hand Washing. Manual Handling and Fire Safety Training are mandatory for all staff.

Records of personal incidents / accidents are maintained in accordance with the requirements of MP-GEN-0007 Staff Health & Safety Manual and recorded on Incident, Near Miss and Hazard Report Form. Completed forms are then are forwarded to the Risk Manager at Our Lady’s Hospital who assesses the incident

• 
  Immunisation Status, when relevant to Assigned Duties
  

Other records available to authorized persons relating to personnel health may include records of exposure to occupational hazards – These are maintained individual files in the Occupational Health Department, St. Theresa’s Residence, OLOL Complex, Drogheda, Co. Louth.