Quality Improvement in Radiation Oncology

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Quality Improvement in Radiation Oncology

• Chapter 17
• W/L

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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 organizations mission and goals.
• Proactive approach dont wait for something to
  go wrong.

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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

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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 process.

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Quality Improvement

• QA should be related to
• Structure staff, equipment, facility
• Process before, during and after treatment
• Outcome
• Morbidity side effects
• Mortality death

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Quality Improvement

• Participation in CQI has been demonstrated to
• Decrease costs
• Increase customer satisfaction
• Ensure quality throughout the health care
  organization

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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.

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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

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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

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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.

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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.

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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.

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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.

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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

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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

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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.

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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

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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.

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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 its a continuous, ongoing process.
• Quality control procedures and techniques used
  to monitor or test and maintain the components of
  the RT QI program.

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Quality Indicators

• Quality Indicators measurement tools used to
  evaluate an organizations 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.

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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

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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

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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
  

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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.

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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 RTs 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

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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

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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

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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

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Buying New Equipment

• Justify the need for it
• Shop around
• Check references
• Negotiate price
• Responsibility of physicist, physician, and
  administrator.

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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

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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
• in the clinical use of the machine

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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

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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)

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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)

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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

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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

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Jaw Symmetry

• To make sure jaws open evenly on both sides
• Uses a machinists 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

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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)

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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.

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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.

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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.

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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.

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Brachytherapy

• Source identity
• Physical length
• Diameter
• Serial number
• Color coding
• Done by radiographic and visual inspection

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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 vendors specifications,
  need to send back to vendor.

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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