The Importance of Management Reviews€¦ · Module Objectives At the end of this module, participants will be able to: Describe he format needed for t reviews; Discuss who should

The Importance of Management Reviews

Module Presented By: Henry Julius

Welcome

Welcome to the The Importance of

Management Reviews Module

Module Objectives

At the end of this module, participants will be able to: Describe the format needed for reviews; Discuss who should attend the review meeting; Discuss the Agenda created for reviews; Discuss the role of the Quality Manager in the review process; Review statistical information tables; Discuss the indicators to develop so that goals of compliance are met; Describe the characteristics of good metrics; Discuss the essentials required for implementation; Discuss what leadership commitment entails; Describe the activities for quality improvement.

What and Why Management Review

ISO – 15189 Requirement

“Laboratory Management shall review the Quality Management System at planned intervals to ensure its continuing suitability, adequacy and effectiveness and support of patient care” – ISO15189:2012

Regular review of “Quality System” – [organisational structure, procedures and resources in place to ensure provision good quality service]

Thorough audit of entire laboratory operational system

No greater than 12 months (ISO 15189:2012)

Management Review Process

Changes in volume and turnaround time

Previous man review

Health and safety e.g. number of IODs

Quality Indicator improvement

One or more meetings, Depending on availability of management team

Depending on the maturity of the quality system

Formal agenda to be created and sent out well in advance

All records must be available

Format Of Review

Quality Manager Head of facility / HOD Pathologist-in-charge per division Laboratory Manager per division Laboratory Supervisors (if applicable) Quality Assurance Officer (if applicable) Health and Safety Officer Representative from Lab Support Services Representative from Customer Services Representative from Information Technology All trial specific personnel (if applicable)

Attendees

Ensure that the meeting takes place

Responsible for minutes of meeting

Identify corrective action required responsible person

timeline

ensure compliance & follow up

Maintain all review documentation

Based on discussions the Quality Manager and Laboratory Head may formulate plans for the following year

These must be in line with the overall objectives and strategies of the organization

Role Of Quality Manager

Follow-up actions from previous management review Changes in the volume and scope of work, personnel

Staff movements - number and category of staff

Year on Year comparison of Volumes

Changes in test repertoire

Changes in Test TAT

Identification and control of nonconformities Internal audits Assessment of User feedback including of complaints

Risk assessment Quality Indicator

Agenda

Agenda Items

Continual improvement including Corrective Actions and Preventive Actions.

Review of requests, suitability of procedures and sample requirements

Reviews by external organizations - External Audits

Inter-laboratory comparison programmes (PT/EQA)

Health and Safety and environment

Assessment of user feedback and monitoring and resolution of complaints

Equipment issues

Agenda (continued…)

Agenda Items

Performance of suppliers

Information Technology

Recommendations for improvement, including technical requirements

Staff suggestions

Agenda (continued…)

Agenda Items

Developing Successful Indicators

1. Objective 2. Methodology 3. Limits 4. Interpretation 5. Limitations 6. Presentation 7. Action plan 8. Exit plan

Quality indicators, commonly called metrics, are the specific targets examined using objective methods, in order to ascertain if the goals of compliance are being met.

Ensure the following when developing indicators:

Developing Successful Indicators (continued…)

Objective What are you trying to measure? 1. Why am I collecting this information? Be specific

Methodology

How to capture the data 1. What data needs to be captured 2. Who (or what) to capture the data 3. How often to capture the data 4. Is it achievable (time, resources, revenue)?

Limits Can I preset levels for: 1. Acceptable, Concern, Unacceptable, Critical

Presentation Graphic or Text

Interpretation 1. What does it mean? 2. Does it reflect on YOUR quality? 3. Can I compare it? 4. Can I trend it?

Limitations 1. Unintended variables 2. What does it not mean?

Action Plan 1. What will I do if it indicates acceptable performance? 2. What will I do if it does not?

Characteristics of Good Metrics

Implementation Essentials

Commitment: Commitment from all levels of the laboratory staff is critical. Improvement requires continual awareness and activity.

Planning: To achieve goals, careful planning must take place and points, such as root causes of error; failures, potential failures and “near misses” need to be considered.

Structure: An organizational structure that supports the improvement activities must exist.

Leadership: Top management must be involved and supportive. Participation and engagement: The staff who know and understand what

is done on a daily basis must be involved because without their contribution, improvement programs have little chance of succeeding.

Implementation Essentials (continued…)

Consider the following when planning: Root causes of error Risk management Failures and potential failures and near-misses Costs, benefits, and priorities Costs of inaction

Leadership & Participation

Leadership committed to performing management reviews Leadership commitment that improvement will occur Leadership give opportunity for staff participation

Management does not always know what workers know and do Continual improvement requires leadership and team participation

Leadership

Participation

Quality Improvement Activities Summary

Use team approach

Use quality tools

Correct or prevent poor practices

Report progress to management and laboratory

Use available information to study customer's suggestions or complaints, errors identified from occurrence management program and problems identified from internal audits

Design a study so that results can be statistically measured

Use indicators only as long as they provide useful information

Summary

Laboratory Management shall review the Quality Management System at planned intervals.

Regular review of “Quality System” – [Organizational structure, procedures and resources in place to ensure provision good quality service]

Thorough audit of entire laboratory operational system is critical.

Correct or prevent poor practices Leadership must be committed to performing management reviews Leadership must ensure that improvement will occur

References & Links

WHO: Quality Management Toolkit

ISO 15189:2012: Quality management in the clinical laboratory

Guidance for Laboratory Quality Manuals (Ontario Laboratory Accreditation Division)

Exploring the Medical Laboratory Quality Toolbox-A by Michael Noble

References

Wrap Up

Participants are now be able to: Describe the format needed for reviews; Discuss who should attend the review meeting; Discuss the Agenda created for reviews; Discuss the role of the Quality Manager in the review process; Review statistical information tables; Discuss the indicators to develop so that goals of compliance are met; Describe the characteristics of good metrics; Discuss the essentials required for implementation; Discuss what leadership commitment entails; Describe the activities for quality improvement.

Questions