Quality Management Systems

In Radiotherapy

Based on ISO 9001 principles

Val Antoff

Accreditation against the National Safety and Quality Health Service (NSQHS) Standards will be mandatory for all hospitals and day surgeries from 1 January 2013. In WA this includes both public and private facilities.

Why do we need to know about Quality Management Systems

(QMS)?

1.Definitions2.Documentation requirements of QMS3.Importance of organisation chart 4.Measuring quality5.Making improvements6.The documentation pyramid7.Summary

Scope of this presentation

Quality Management

System

Measurements&

ImprovementsDefinitions

Documentation Requirements

Procedure

Process

Quality Policy

Quality

Work Instructions

Quality Manual

System Documented

Control of Records

Control of Documents

Analysis

Monitoring

Internal Audit

Patient Satisfaction

Corrective Action

Preventive Action

Non-conformance

What to document?

Quality“Quality is fitness for use“, the service should meet its specifications

Quality PolicyThe quality policy is a general statement made by top management that it intends to achieve quality as a result of the company's operation.

Process A series of activities, actions or functions designed to bring about a specific result.

Definitions

ProcedureThe procedure documents the step-by-step detail for the process activities andactions that must be executed in the same manner in order to always obtain the same result under the same circumstances.

They typically include what, when, where, and who should do the activity identified.

We are committed to Total Patient Satisfaction by providing services which meet or exceed our patients expectations. It is our policy to ensure that all patients undergoing simulation have a signed treatment consent.

Definitions

Quality ManualThe quality manual outlines the policies, procedures, work instructions and requirements of the Quality Management System and describes the interactionbetween the processes.

Work instructionWhilst a procedure documents the step-by-step detail for the process, a work instruction defines further details of one or several process step(s) that the business has put in place.Work instructions are for work performed in one area or function and typically tell you “how” to do the activity.

“Without documentation, all your tasks, functions, processes, and procedures

the way that we habitually do everything – are nothing more than good

intentions. Processes that have not been documented are only rumours about

the way we do things”.

“If the process is not written down, how can you train others to create the same

results? How do you ensure that everyone does it the same way? How do you

know if that way is the best way? If it is not written down it did not happen”.

Michael Gerberwww.e-myth.com

System Documented

Why do we need to document our procedures and work instructions?

What to document?

Warm up CT

Make a vac bag

Capture fee codes

Sim RT roleUpdate database

TasksRole Warm up CT

Database

Vac bag

Capture

Procedure

Define the roles

Define tasks and functions for each role

Ensure that a procedure covers each task and function

Shut down CT CT

CT

Principle – “Say what you do and do what you say”

Task and Functions of Treatment RT

Task or Function/What is done When or how often is this function done

Key Area Sub element this function relates to

Role responsible for this function

Linac warm up Daily QA RTCheck Dr’s notes Daily QA RTCheck images Daily QA RTCheck all new starts are ready Daily QA RTTreat patients Daily Treatment RTAuthorise new files Daily QA RTIcom/iView new files Daily QA RTLoad reference data new files Daily QA RTPerform imaging requirements Daily QA RTWeekly chart checks Daily QA RTSummarise finished patients Weekly QA RTEnsure all accessory equipments is safe

Weekly Supplies RT

Order new supplies Weekly Supplies RTEnsure linen stocked in room Weekly Supplies RTPerform monthly QA films Monthly QA Senior RTPerform monthly QA MLC checks Monthly QA Senior RT

Use the form below to workshop individually the tasks that each person carries out. These will make up the headings of the future content of policies & procedures that will be written in full later. It is important to ‘drill down’ into the tasks so that the headings are all micro parts of a large process.

Organisation Chart

Chief RT

Senior Treatment RT

Senior Sim RTSenior Planner

RT

Sim RT Treatment RT Planner RT

General Manager

Nursing Manager

Control of Documents What Control? Approval, review and

update, status, version, obsolete documents

How? Document Control Procedure

Control of Documents and Records

Control of Records

What Control? Identification, storage, protection, retrieval, retention time and disposition of records

How? Records Control Procedure

What Records? Patient health and accounting records and others including calibration, maintenance, training, survey, audit, licensing, certifications, and other competency records.

Why? To assure legibility and accuracy of data and records, to assure that records are identifiable and retrievable

What Documents? Meeting minutes, procedures, pathways or protocols, work instructions, forms, equipment operating instructions, regulations, local treatment programs

Measurements &

Improvements

Analysis

Monitoring

Internal Audit

Patient Satisfaction

Corrective Action

Preventive Action

Measurements and Improvements

Thank you cards, chocolates, cakes etc

Surveys and opinion polls

Audit Policies and Procedures

E.g. calibration, incident reporting

Data

Review nonconformities

Determine the causes

Implement action needed

Record the results

Review effectiveness

Determine potential

Need for action

Implementation action

Record results

Review effectiveness

Documentation Pyramid

What are your responsibilities in relation to the QMS?

1) Quality Policy – management2) Processes – you & your supervisor3) Procedure – you & your supervisor4) Work instruction – you & your

supervisor5) Quality Manual – management to

ensure that there is a seamless interaction between the processes.

A quality management system (QMS) is the organisational structure, procedures, processes and resources needed to implement quality management

What is a QMS?

Summary• Accreditation will become mandatory from 1

January 2013 – a QMS is a prerequisite;

• Unless a QMS is documented the procedures that we followare only rumours about the way we do things;

• It is essential that every role has a list of tasks and functionsassigned to it;

• The results from the analysis of the measurements and reporting data are the main indicators for quality;

• Improving the way we do things can be achieved only after we analyse any nonconformities and take action;

• It is everyone’s responsibility to follow an up-to-date set ofprocedures and work instructions and participate in the maintenance and development of the QMS;