Quality Improvement in
Radiation Oncology
Chapter 17
W/L
1
Quality Improvement
• An approach to the continuous study and
improvement of the processes of providing
health care services to meet the needs of
patients and others.
• AKA “continuous Quality Improvement” or “Total
Quality Management”
– A continuous quality improvement plan integrates
quality assurance, quality control, and assessment
into a complex, system wide improvement program
revolving around the health care organization’s
mission and goals.
• Proactive approach: don’t wait for something to
go wrong.
2
Quality Improvement
• Based on Demings principles of management:
– Delineate the health care organizations mission and
goals, so that there is a reason for improving
– Instead of setting thresholds, which are expected
levels of compliance, always strive for improvement
no matter how good the product or service.
– Improve the process rather than inspect for errors
– Plan for the future by analyzing “long term costs” and
“appropriateness of product or service”
– Allow the employee to contribute to the improvement
process
– Encourage and support employees through education
3
Quality Improvement
– Ensure qualified leaders for the improvement system
– Eliminate fear by encouraging employees to offer
suggestions
– Eliminate staffing barriers by helping employees
understand the needs of other departments or
sections
– Require management to always keep employees
informed of what is happening
– Emphasize qualit6y first rather than quantity
– Promote and encourage teamwork versus individual
performance
– Encourage and support an employees educational
and self-improvement program
– Support and train all employees in the transformation
4
process.
Quality Improvement
• QA should be related to:
– Structure – staff, equipment, facility
– Process – before, during and after treatment
– Outcome
• Morbidity: side effects
• Mortality: death
5
Quality Improvement
• Participation in CQI has been
demonstrated to:
– Decrease costs
– Increase customer satisfaction
– Ensure quality throughout the health care
organization
6
Evolution of Quality
Improvement
• Standards must be developed by which one can
compare, evaluate, and establish quality control.
• Initially focused on the physical aspect of
treatment equipment performance and
standards for radiation measurement.
– SED: skin erythema dose
• In 1928, the roentgen (R) became the
“international unit of x-radiation”
• Now the SI units are used.
7
Evolution of Quality
Improvement
• Standards of patient care began in 1917
with the Hospitalization Standardization
Program, which eventually evolved into
Joint Commission on the Accreditation of
Hospitals (1952).
• 1965 – Medicare was introduced
mandating hospitals to be accredited in
order to receive reimbursement
8
JCAHO
• 1988 – JCAH becomes the JCAHO Joint
Commission on the Accreditation of Health
Organizations, to include ambulatory centers,
group practices, health maintenance
organization, community health centers,
emergency and urgent care centers, and
hospital-based practices.
– Standards established to ensure safety of health care
organizations and assessment of patient outcomes.
•
•
•
•
•
•
Morbidity
Mortality
Recurrence of disease
Survival rates
Patient satisfaction
Quality of life
9
Quality Improvement
• Emphasis: Doing the right thing and doing
the right thing well.
– Doing the right thing refers to delivering
effective and appropriate treatment, and doing
the right thing well refers to providing patient
care effectively, accurately, in a timely
manner, and with respect and caring for the
patient.
10
Regulating Agencies
• Regulations and standards must be met to
ensure high quality patient care and
safety.
– Ensure that equipment is functional and
operates within acceptable limits.
– Operators of equipment are truly qualified.
11
Federal Agencies
• 1974 – NRC: U.S. Nuclear Regulatory
Commission.
• Ensure adequate protection of the public heath
and safety, the common defense and security,
and environment in the use of nuclear materials
in the United States.
– Nuclear power reactors
– Nonpower research, test, and training reactors
– Fuel cycle facilities: medical, academic, and industrial
uses of nuclear materials
– Transport, storage and disposal of nuclear materials
and waste
– Use of radioisotopes in brachytherapy and the cobalt
for external treatments.
12
Federal Agencies
• 1970 – EPA - Environmental Protection
Agency: to protect human health and
safeguard the natural environment – air,
water, and land – upon which life depends.
- Assists the NRC in the regulation of disposal,
storage, and handling of nuclear materials as
it relates to the environment.
• Department of Transportation DOT: assists
NRC in regulating the transportation of
hazardous wastes.
13
Federal Agencies
• 1968 – Congress passes Radiation Control for
Health and Safety Act – set standards to reduce
exposure to radiation from electronic products.
• Now part of the Food and Drug Administration
FDA: requires manufacturers of these products
to keep records in reference to quality testing of
their products and communications to the
dealers, distributors, and purchasers as it relates
to radiation safety issues.
• Regulates:
– Linear accelerators, diagnostic x-ray and ultrasound
machines, microwaves, cell phones
14
Federal Agencies
• 1991 – Safety Medical Devices Act – requires
facilities to report to the FDA any medical device
that caused death or injury to patient or
employee.
– Failure to do so can result in civil penalties to the
medial facility as well as to the health care
professional.
• 1970 – Occupational Safety and Health Act
OSHA: protects workers
– Requires all facilities that come in contact with blood
to have an exposure control plan
– Sets standards for cadmium and lead exposure
15
State Agencies
• NRC may give a portion of its authority to
the state, especially concerning the
licensing and regulation of radioisotopes.
• There are currently 34 agreement states
(including MN) that stay in close contact
with the NRC.
16
Professional Organizations
• Provide standards of practice
• ACR – American College of Radiology –
organization for radiologists, radiation
oncologists, and medical physicists – standards
to produce high quality radiologic care.
• AAPM – American Association of Physicists in
Medicine – come up with QC programs for
equipment and treatment planning
17
Professional Organizations
• ASRT – American Society of Radiologic
Technology – practice standards for radiation
therapists, divided into three sections:
– Clinical performance standards: define activities
related to the care of patients and the delivery of
procedures and treatments.
– Quality performance standards: the activities of the
practitioner in the technical areas of performance
involving equipment safety and TQM.
– Professional performance standards: define activities
in the areas of education, interpersonal relationships,
personal and professional self-assessment, and
ethical behavior.
18
Definitions
• Quality assurance: planned and systematic
actions to ensure that a RT facility consistently
delivers high quality care leading to the best
outcomes with the least amount of side effects.
• Quality assurance has been replaced with
quality assessment or quality improvement to
emphasize the fact that it’s a continuous,
ongoing process.
• Quality control: procedures and techniques
used to monitor or test and maintain the
components of the RT QI program.
19
Quality Indicators
• Quality Indicators: measurement tools used to
evaluate an organization’s performance.
– Consultation and informed consent
• History and physical report in treatment record
• Pathology report
• Consent form signed by patient & radiation oncologist
– Treatment planning
• QC program for equipment and treatment planning computer
• Target volume indicated on target films
• Setup information, diagrams, and photographs in treatment
record
• Calculation and graphic plans double checked.
20
Quality Indicators
– Treatment delivery
•
•
•
•
•
QC program for equipment
Written and signed prescription
Approved treatment plan
Comparison of portal films with sim films
Weekly portal films signed by radiation oncologist and
reviewed by radiation therapist.
– Documentation of Treatment delivery
•
•
•
•
Adherence to prescription
Documentation of weekly physics review
Completeness of treatment record
Incidence/unusual occurrence reports
– Patient Outcomes
• Completion notes/summary and follow up notes filed in chart
• Documentation of treatment outcomes
21
Quality Improvement Team
• Medical Director
– Appoint QI committee
– Ensure that all employees are qualified for their jobs
• Radiation Oncologist
–
–
–
–
–
–
Chart review
Morbidity and mortality conferences
Review and development of departmental procedures
Portal film review
Patient/family education
Completion/review of incidence reports
22
Quality Improvement Team
• Physicist
– Develop and carry out the QC program to meet the
needs of the department
– Conduct weekly and final physics reviews of the
treatment records.
• Nurse:
– Perform an assessment on each now patient to
determine overall physical and psychological status
– Evaluate the educational needs of each patient
– Order, evaluate, and record blood counts and weights
• Support staff
– Gathers pertinent information and prepared the
treatment chart before the patients initial visit
23
Quality Improvement Team
• Therapist
– Perform warm-up procedures
– Perform quality control tests on the simulation and treatment
units
– Verify the presence of completed and signed prescription and
consent forms
– Review the prescription and treatment plan on each patient
before the initiation of treatment
– Deliver accurate treatment adhering to the prescription
– Accurately record treatment delivered
– Take initial and weekly portal films
– Evaluate the health status of the patient daily before treatment
delivery to ensure there are no adverse reactions to treatment or
other impending physical or psychological problems
– Participate in patient/family education
– Provide care and comfort to meet the needs of the patient.
24
Staffing
• According to the “Blue Book” by the Inter-Society
for Radiation Oncology, a RT department should
have:
–
–
–
–
–
One doctor for every 25-30 patients
One physicist for every 400 patients treated annually
One dosimetrist for every 300 patients per year
One supervising RT
2 RT’s per machine up to 25 patients per day or 4 per
machine up to 50 patients per day
– 2 simulation techs per 500 patients per year
– One nurse per every 300 annual patients
25
Development of QI Plan
• Establish the program – what info will be
collected
• Use this info to demonstrate (or not) that
standards are being met; if not, how can
you improve
• Implement a plan of action for
improvement
• Assess the plan for effectiveness
• Report results to appropriate people
26
Dosimetric Accuracy
• Should be +/- 5% due to uncertainties in
equipment calibration, treatment planning
and patient setup:
– Overall uncertainty of beam calibration is
about 2.5% under optimal conditions
– Random and systematic errors
• Random: variation in individual treatment setup.
• Systematic: variation in the translation of the
treatment setup from the simulator to the treatment
unit.
– Human errors
27
Equipment
• Appropriate equipment is essential for high
quality patient care:
– Linear Accelerator (1 per 30 patients) with
dual energies and electrons
– Brachytherapy – both interstitial (Ir-192, I125)
and intracavitary (past: Rd, current: Cs)
– Simulator
• CT:
– Quality DRRs
• Traditional:
– Geometric accuracy – for reproducibility
– Quality image
– fluoroscopy
28
Buying New Equipment
•
•
•
•
•
Justify the need for it
Shop around
Check references
Negotiate price
Responsibility of physicist, physician, and
administrator.
29
Acceptance Testing
• After the vendor installs a new machine,
acceptance testing is done by physicist to
make sure the equipment meets the
performance specifications and safety
standards agreed to in contract
• No treatments can be given until this is
completed
30
Acceptance Testing
• Radiation Survey:
– Once machine is installed and can generate a
beam, a preliminary survey is done to make
sure exposure levels outside of room are
acceptable
– After installation completed, a formal survey is
done which includes:
• Measurement of head leakage
• Area survey
• Tests of interlocks, warning lights and emergency
switches
**Done for conditions that are expected to exist
31
in the clinical use of the machine
Commissioning
• Commissioning a linear accelerator is
done after acceptance testing
– Collecting acceptable and sufficient beam
data to permit treatment planning and dose
calculations for patient treatment (PDD, TMR,
scatter factors, output factors, cGy/MU)
– Sole responsibility of the physicist
– No treatments can be given until finished
32
Quality Control Measures in
Radiation Therapy
• Daily (done by RT)
– Dosimetry checks
• X-ray output constancy (3%)
• Electron output (3%)
– Mechanical checks (also done on simulator)
• Lasers (2mm)
• Distance indicator (2mm)
– Safety checks
• Door interlock (functional)
• Audiovisual monitor (functional)
33
Quality Control Measures in
Radiation Therapy
• Monthly:
– Safety Interlocks
• Emergency off buttons – one tested per month (functional)
– Dosimetry checks
• X-ray output constancy (2%)
• Electron beam flatness constancy (3%)
– Mechanical checks
•
•
•
•
•
Gantry/Collimator angle indicators (1 degree)
Light/radiation field coincidence (2mm or 1% on side)
Wedge position (2mm)
Field size indicators (2mm)
Jaw symmetry (2mm)
34
Field Flatness & Symmetry
• Variation of dose relative to the CA over
the central 80% (penumbra) of the field
size at a 10 cm depth
• A dose of +/- 2% for x-rays, and +/_3% for
electrons is acceptable
• Must be checked monthly, although some
institutions will do it every week
• Symmetry must be within +/- 3% for both
electrons and x-rays
35
Coincidence
• Performed monthly to assure correct alignment
of light beam and x-ray beam
• Some physicists require it after light bulb
changed as well, in case mirror is bumped
• Must be accurate to within 2 mm or 1% on any
side
Wedges
• For wedges placed in the machine, they should
not move more than 2mm when locked in
• Performed monthly
36
Jaw Symmetry
• To make sure jaws open evenly on both
sides
• Uses a machinist’s dial indicator
• Should be accurate to within 2 mm (or 1
mm on each side)
• Checked during acceptance testing and
every month after machine in operation
**Not for MLC which is run by software
37
Quality Control Measures in
Radiation Therapy
• Annual:
– Dosimetry checks
• Wedge transmission factor constancy (2%)
– Mechanical checks
• Isocenter shift (+/-2mm)
• Table top sag (2mm)
• Tennis racket sag (0.5 cm)
38
Mechanical Isocenter
• The intersection point of the axis of rotation of
the collimator and gantry
• Done yearly because the heavy weight of the
gantry frame may flex during rotation = uncertain
position of isocenter
• Checked with graph paper and a sharp pointer
called a center finder or wiggler
• With rotation of gantry or collimator, isocenter
must stay within 2 mm diameter circle.
39
Radiation Isocenter
• Jaws are set to a narrow slit.
• Exposures are made on ready-pack film at
6-7 different collimator angles.
• The processed film will show a star pattern
with a dark central region, which is the
radiation isocenter.
• Dark center should be no more than 2 mm
in diameter.
40
Split-field Test
• To check for misalignment between opposed
fields (yearly??)
• Can simultaneously detect three general causes
of beam misalignment:
– Focal spot displacement
– Asymmetry of collimator jaws
– Displacement in collimator or gantry rotation axes
• Set a square field, block half with lead and
expose, rotate 180*, block opposite side and
expose – the two exposures should match.
41
Other Yearly Tests
• Wedge transmission factors must be
accurate to within 2% and checked yearly.
• Isocenter shift when couch motion up and
sown should not exceed +/- 2mm
• Table-top sag with lateral or longitudinal
travel under a weight of 180 lbs. should
not exceed 2mm
• Tennis racket insert sag should not sag
more than 0.5 cm under 180 lbs.
42
Brachytherapy
• Source identity
– Physical length
– Diameter
– Serial number
– Color coding
**Done by radiographic and visual inspection
43
Brachytherapy QA
• Densitrometer: measures intensity
• Source uniformity and symmetry:
– An autoradiograph will reveal the active length and
the distribution of activity.
– Sources placed on a film for an interval of time – film
is developed and shows area of activity.
• Source calibration:
– All sources should be individually calibrated to check
their strength specified by vendor.
– Done with a well ionization chamber.
– If not within +/- 5% of vendor’s specifications, need to
send back to vendor.
44
Brachytherapy QA
• Applicator (Ex: Fletcher Suit) evaluation:
– Applicators used in intracavitary implants used to hold
sources in a specific geometry
– Need to be checked for integrity – orthogonal
radiographs can be used
• Remote after-loaders
– Check the operation of unit – function and safety
features
– Radiation safety of facility
– Source calibration and transport
– Treatment planning software
45