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