Quality of practice: Clinical Audit To develop a basic understanding of QA and clinical auditing in cardiovascular imaging

Lessons: Personnel

Training Basic training Training on new acquisitions Check if training was complete and effective

Lines of authority Supervisor Procedure

Lessons: Patient

Patient management Supervision Diagnosis

Delay Missing of important transient findings

Patient – carer relationship Trust

At a time when Americans receive far more diagnostic radiation than ever before, two cases under scrutiny in California … underscore the risks that powerful CT scans pose when used incorrectly

Walt Bogdanovich

October 15, 2009

Mad River Community Hospital Case

Technologist performed 151 CT scans on a single 3mm slice in a 23 months old child over 65 minutes

Child suffered radiation burns on a small strip of his face and head

So far, no lasting harm reported

Cedars Sinai Case

Increased radiation burden to 206 patients in a 18 month period during CT brain perfusion scanning due to software misconfiguration

3-4 Gy exposure (FDA Safety investigation of CT brain perfusion scans)

Temporary hair loss and erythema

Quality Assurance

Quality Assurance

www.jeanroberts.com.au/

Without a quality system, quality assurance isat best a guess, with no basis for continuousquality improvement

QM: Deming Cycle

Quality Management System

Quality Planning

Quality Control

Quality Assurance

Quality Improvement

Quality Management

Save Money

Quality Management

Improve Safety

Risk and quality are two sides of the same coin

Why quality management in nuclear medicine?

Improve patient care and safety

Improve satisfaction of customers and staff

Make best use of available resources

Improve visibility of and confidence in nuclear medicine in the local/regional/national medical environment

Quality Management System (QMS)

Organisational structure ProcessesProcedures Resources

QUANUM

Quality Audit

Process of regular and systematic examination of a quality system

By an internal or external auditor/audit team

Essential part of the quality management system

QUANUM: Clinical Auditing Internal Audits

Regular (yearly) Audit Team representing the various professions involved

External Audits Team of international experts trained as auditors and

representing the key professions (physician, medical physicist, radiopharmacist, NM technologist)

What needs to be audited?

What needs to be audited?

Nearly everything!

Quality Management System (QMS)

Organisational structure

Nuclear Medicine Department Organisation chart

DC-004 rev. 00 – Date: - Approved by:

Medical Director

Administration

Nursing staff /team

Medical technical officers

Medical staff Medical physicistsTechnical staff

RadiopharmacistsLaboratory staff

Nuclear Medicine physiciansSecretariat

Reception

Nuclear Medicine technician

Finance

Quality manager

Channels of communicationLines of authority

Nuclear Medicine Department Organisation chart

DC-004 rev. 00 – Date: - Approved by:

Medical Director

Administration

Nursing staff /team

Medical technical officers

Medical staff Medical physicistsTechnical staff

RadiopharmacistsLaboratory staff

Nuclear Medicine physiciansSecretariat

Reception

Nuclear Medicine technician

Finance

Quality manager

Channels of communicationLines of authority

Cardiology Radiology

………

Quality Management System (QMS)

Processes

NMD Process Map

Strategic Planning

CUSTOMER SERVICE

TECHNICAL PROCESSES ADMINISTRATION

Customer relationship

Relationship with Scientific Societies Human Resources Management

review

MANAGEMENT PROCESSES KEY PROCESSES SUPPORT PROCESSES

Customers:

• Patients

• Referring physicians

• Medical Insurance

RECEPTION

Customers:

• Patients

•Doctors

•Medical Insurance

Purchasing Filing system Waste control

REPORT MANAGEMENT

FINANCE CONTROL

IMAGE + REPORT

IMAGE ACQUISITION

PATIENT PREPARATION

Maintenance

Technical Resources

Health and safety Quality system

DC-005 rev. 00 – Date: - Approved by:

THERAPY

Quality Management System (QMS)

Procedures

QM Procedures

Develop standard operating procedures (SOP)

defined as detailed, written instructions to achieve uniformity

of the performance of any specific function

including also Conformity checks Preventive and corrective actions

Download ISO software at www.eanm.uems.org

Download ISO software at www.eanm.uems.org

Download ISO software at www.eanm.uems.org

Quality Management System (QMS)

Resources

Human resources EquipmentFinances

QUANUM Auditing Checklists

Administration and management

Human resources development

Patient radiation protection

Evaluation and assurance of quality systems

QC for imaging equipment

Computer systems & data handling

QUANUM Auditing Checklists

General clinical services

Assessment of imaging diagnostic procedures (up to 5 cases)

Assessment of non-imaging diagnostic procedures (up to 3 cases)

General radionuclide therapy

Assessment of therapy (up to 5 cases)

QUANUM Auditing Checklists

Radiopharmacy operational level 1

Radiopharmacy operational level 2

Radiopharmacy operational level 3

Hormones and tumour markers

General clinical services: 30 items

Standardised procedures, including update and distribution

Requests, including justification, contraindications, pregnancy and lactation

Patient preparation

Radiopharmaceutical –activity, administration, paediatrics

Patient surveillance, including emergency situations, incidence reporting, corrective actions

Reporting and archiving

Scoring

Not applicable

0 - absent or inappropriate

1 - planned or approximate

2 - partially conform or partially implemented

3 - largely conform or largely implemented

4 - fully conform or fully implemented

•Activities based on patient weight, maximal/minimal activities•Special concerns for children (EANM Dosing card, SNM consensus•Dosimetric data (NM and CT)

Nuclear Cardiology: Optimisation of protocols•Adapt protocol to the individual patient•Stress only protocols, prone imaging•Optimise injected activity of Tc-tracers•Progressive abandon of thallium•CT attenuation correction: add calcium scoring•Software, hardware improvements

• Appropriateness of the test for a given patient

• Shared responsibility with referring physician

Assessment of diagnostic imaging in up to 5 cases chosen at random by the auditors:

4 topics with 4-10 questions

1. Clinical

2. Technical/procedure

3. Patient preparation

4. QA/QC

Average and lowest value of all cases presented as radar plots

Nuclear Cardiology: Challenges

Cooperation between departments Written document specifying duties and

responsibilities

Sophisticated instrumentation and processing Hybrid imaging

Reporting in a clinically meaningful manner

Nuclear Cardiology: Particularities

Risks for the patient Radiation Stress tests

Collaboration of two teams: Cross training

Radioprotection issues (staff) Contamination

Conclusions

Introducing a culture of quality assurance with regular and systematic internal and external auditing

favours continuous improvement of nuclear cardiology services to patients and referring physicians

in an environment that is safe for patients, staff and environment