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CLINICAL QUALITY ASSURANCE-
REQUIREMENTS & RESOURCES
Dr. Bharti Devnani
Department of Radiation Oncology
AIIMS, New Delhi
PHILOSOPHY OF RADIOTHERAPY QUALITY
ASSURANCE
 Improve the quality of clinical practice minimizing the
risk of errors.
 Promotion of consistency between centers
 Ensuring accuracy and integrity of data
 Validity of clinical trial results
 Evaluation and correlation of radiotherapy parameters
with treatment outcome
INTEGRATED PROCESS OF PLANNING &
DELIVERY INCLUDES
MANY ERRORS THAT OCCUR IN RADIATION
ONCOLOGY ARE NOT DUE TO FAILURES IN DEVICES
AND SOFTWARE; RATHER THEY ARE FAILURES IN
WORKFLOW AND PROCESS
QA- PREPLANNING
PREPLANNING
To ensure the quality -
 Assessment of the patient based on clinical/Radiological
Parameters- Intent of treatment should be clear
 Full & detailed explanation of the procedure/precautions/Side-effects/
Dental prophylaxis
 Follow a uniform departmental protocol and explain to the patient
 Gyn-Bladder/ Rectal protocol
 Lung- Still/ Normal breathing
 Oral and or Iv contrast
 Written informed Consent
 Identification of correct patient by name, photo, RT no
 Correct site and laterality
IMMOBILIZATION
 Get patient accustomed to the mouth bite or stent, if possible, prior to
making the mask to decrease the set-up errors
 Temprature of the mask should be checked before placing on pts skin
 Documentation of the fixed positions of all immobilisation devices
performed by RTT should be checked by clinician.
 Any additional supports required for the procedure, such as knee rests
or shoulder retractors should be indexed to the couch
 Mask selection
Low neck-5 point mask/3 point mask with shoulder retractor
 Ensure that the patient’s airway is not compromised during the
procedure. This may necessitate enlarging the gap for the nasal and
mouth areas slightly.
 For post-operative patients with tracheostomies in situ, care should
be taken to avoid airway obstruction. This will necessitate placing
petroleum-based gauze over the stoma, which will not obstruct
breathing, as well as making an appropriate sized gap in the material
to clear the tracheostomy site.
 Any dentures, hearing aids, toupees, earrings and wallet etc should
be removed.
 If possible, the patient should be provided with a gown, which can be
removed, as the procedure commences.
 The patient should be positioned on the treatment couch, in the
prescribed treatment position as comfortably and reproducibly as
possible.
 The sagittal laser should be used to ensure straightness, checking
that it bisects the nasal septum, sternal notch, xiphisternum and
symphysis pubis as much as is possible. This aids in the minimisation
of rotations.
 All immobilisation devices must be indexed and fixed to the couch, to
minimise rotational and translational errors.
 Neck rests should provide adequate support for the head and neck
and gaps should not be present underneath the head of the patient
nor at the top of the neck rest.
Immobilization CT scan (3D data) Target delineation Tr Planning Evaluation Verify / Deliver
QUALITY ASSURANCE DURING
SIMULATION/CT PROCEDURE
 Identification of correct patient by name, ID and photo
 Site and laterality
 Marking of scars/Nodal regions
 Contrast administration
 Check the creatinine clearance
 Screen for potential contrast anaphylaxis
 Emergency trolley is prepared and fully stocked
 Contrast is heated to body temperature 37 degree
 Under supervision of Oncologist preferably by injector
 Positioned / re-positioned accurately
 Bolus placement
 Correct scanning protocol/ localization protocol
 Patient orientation and the orientation of the topogram
should be correctly entered at the CT console.
 Appropriate axial slice thickness
 To ensure sufficient anatomic detail for target and
organ at risk delineation.
 To minimize the partial volume effect
 For adequate anatomic details on DRRs from the
TPS for treatment verification procedures.
 The dose length product , number of axial slices and scan
length should be documented in the patient chart.
 Export the data to TPS/ virtual simulation correctly.
 If contrast has been administered, the departmental
protocol in relation to observation should be adhered to
prior to the patient leaving the department.
QA- VOLUME DETERMINATION
 Fusion uncertainties
 GTV- Physician training for interpretation of imaging
/Help of radiologist or nuclear medicine/ correct window
selection/HU setting
 CTV- follow std guidelines/peer review/uniform
department protocol/educational courses by
ASTRO,ESTRO
 PTV- Institutional data for individual site to quantify their
own population- based errors and regular audits
 Peer review/Shadowing experience person
VARIABILITY IN DOSE- DIFFERENCE IN
CONTOURING
IJROBP, Vol 82, No 1, 368-78, 2012
2
http://skynet.ohsu.edu/tactics/http://skynet.ohsu.edu/tactics/
TIME , DOSE , FRACTIONATION
Radiation dose specification/ Fractionation
schedule
 45Gy/25#/1.8 Gy per# over 5 weeks
 OAR constrains- Uniform standard guidelines
QA- PLAN EVALUATION
PLAN EVALUATION TOOL: DVH
• A. Quantitative analysis of
DVH
• Hot spots/cold spots
• ? Location of hot/cold spots
• B. Examine homogeneity:
HI/CI
• C. Dose to OARs
• D. RVR (Remaining volume
at risk)
• E. Comparison of different
plans
DVH DOES NOT SHOW LOCATION OF HOT
SPOT
PLAN EVALUATION: MULTIPLE
SECTIONS
Plan1 Plan2
95%
All three planes
TREATMENT VERIFICATION &
DELIVERY
 1st day set up should be monitored by Radiation
Oncologist regarding patient positioning and
immobilization.
 Mask too loose / too tight- evaluate
 Patient weight should be monitored weekly
If significant weight loss or gain----Re-plan
TUMOR SHRINKAGE ON IMAGING
 Imaging modalities- Resource dependent
Orthogonal Planar MV Imaging
Orthogonal Planar kV Imaging
kV Cone Beam CT (CBCT)
MVCT (MegaVoltage Computed Tomography)
MATCH STRUCTURES FOR IMAGE VERIFICATION
 Bony match structures/regions of interest (ROIs) for image
verification should be a surrogate for the target.
 Depending on the tumour location, may include nasal septum,
vertebral bodies and processes, maxilla, angle of mandible,
base of skull, head of clavicle.
 It may be useful to define primary and secondary match
structures at planning for use during image verification.
RELOCATION ACCURACY FOR FEMALE PELVIS
 Primary match structures
Structures whose anatomy are in close proximity to the
target ,most useful for position comparison and, for 3D
volumetric imaging using CBCT, will determine the
position of the clipbox.
 Secondary match structures
Structures whose presence are useful for guidance
purposes only.
Verify / Deliver
CORRECTION PROTOCOLS
 Online corrections
 Offline corrections
No action level (NAL)
Shrinking action level (SAL)
PortalVision aS500 images showing
day-to-day setup uncertainty
Immobilization CT scan (3D data) Target delineation Tr Planning Evaluation Verify / Deliver
QA- FOLLOW-UP
 Weekly monitoring of acute radiation reactions
Standard protocol- RTOG/CTCAE
 Out of field reactions??
Sometimes exit beam of IMRT/ wrong side
 Dietary counseling/ Nutrition/Need of Ryle’s tube
 Documentation of toxicities/ Supportive care
IMPORTANCE OF AUDIT FOR QA
AUDIT TO IMPROVE THE QUALITY
 Promotes learning by addressing the following (A method of self
evaluation)
 What am I doing?
 How am I doing it?
 Why did I do it that way?
 Can I do it better?
 Audits allow a critical review of current information (being up to date)
 Highlights the need for specific knowledge / information, acquisition of
new skills / development of existing ones
 Improves communication skills and flexibility in attitudes with other
members of the same team
 Improves patient safety and quality of care
THE AUDIT CYCLE
Identify the need for change:
e.g. a problem identified in daily
practice-something that could /
should have been done better. 3
basic areas:
Structure:
manpower/premises/facilites
Process: provision of care
Outcome: Results in patients
Set a criteria:
i.e. an item of care used to assess
quality
Needs a standard of reference
(invent one - minimum, ideal,
optimum)
Collect data:
What data?
How and in what form?
Who collects it?
Assess performance against
criteria / standards:
Identify an area of care below
predetermined levels—develop an
action plan
Implement recommendations:
And then re-audit
THANKS

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Clinical quality assurance in Radiotherapy

  • 1. CLINICAL QUALITY ASSURANCE- REQUIREMENTS & RESOURCES Dr. Bharti Devnani Department of Radiation Oncology AIIMS, New Delhi
  • 2. PHILOSOPHY OF RADIOTHERAPY QUALITY ASSURANCE  Improve the quality of clinical practice minimizing the risk of errors.  Promotion of consistency between centers  Ensuring accuracy and integrity of data  Validity of clinical trial results  Evaluation and correlation of radiotherapy parameters with treatment outcome
  • 3. INTEGRATED PROCESS OF PLANNING & DELIVERY INCLUDES
  • 4. MANY ERRORS THAT OCCUR IN RADIATION ONCOLOGY ARE NOT DUE TO FAILURES IN DEVICES AND SOFTWARE; RATHER THEY ARE FAILURES IN WORKFLOW AND PROCESS
  • 6. PREPLANNING To ensure the quality -  Assessment of the patient based on clinical/Radiological Parameters- Intent of treatment should be clear  Full & detailed explanation of the procedure/precautions/Side-effects/ Dental prophylaxis  Follow a uniform departmental protocol and explain to the patient  Gyn-Bladder/ Rectal protocol  Lung- Still/ Normal breathing  Oral and or Iv contrast  Written informed Consent  Identification of correct patient by name, photo, RT no  Correct site and laterality
  • 8.  Get patient accustomed to the mouth bite or stent, if possible, prior to making the mask to decrease the set-up errors  Temprature of the mask should be checked before placing on pts skin  Documentation of the fixed positions of all immobilisation devices performed by RTT should be checked by clinician.  Any additional supports required for the procedure, such as knee rests or shoulder retractors should be indexed to the couch  Mask selection Low neck-5 point mask/3 point mask with shoulder retractor
  • 9.  Ensure that the patient’s airway is not compromised during the procedure. This may necessitate enlarging the gap for the nasal and mouth areas slightly.  For post-operative patients with tracheostomies in situ, care should be taken to avoid airway obstruction. This will necessitate placing petroleum-based gauze over the stoma, which will not obstruct breathing, as well as making an appropriate sized gap in the material to clear the tracheostomy site.  Any dentures, hearing aids, toupees, earrings and wallet etc should be removed.
  • 10.  If possible, the patient should be provided with a gown, which can be removed, as the procedure commences.  The patient should be positioned on the treatment couch, in the prescribed treatment position as comfortably and reproducibly as possible.  The sagittal laser should be used to ensure straightness, checking that it bisects the nasal septum, sternal notch, xiphisternum and symphysis pubis as much as is possible. This aids in the minimisation of rotations.  All immobilisation devices must be indexed and fixed to the couch, to minimise rotational and translational errors.  Neck rests should provide adequate support for the head and neck and gaps should not be present underneath the head of the patient nor at the top of the neck rest.
  • 11. Immobilization CT scan (3D data) Target delineation Tr Planning Evaluation Verify / Deliver
  • 13.  Identification of correct patient by name, ID and photo  Site and laterality  Marking of scars/Nodal regions  Contrast administration  Check the creatinine clearance  Screen for potential contrast anaphylaxis  Emergency trolley is prepared and fully stocked  Contrast is heated to body temperature 37 degree  Under supervision of Oncologist preferably by injector
  • 14.  Positioned / re-positioned accurately  Bolus placement  Correct scanning protocol/ localization protocol  Patient orientation and the orientation of the topogram should be correctly entered at the CT console.  Appropriate axial slice thickness  To ensure sufficient anatomic detail for target and organ at risk delineation.  To minimize the partial volume effect  For adequate anatomic details on DRRs from the TPS for treatment verification procedures.
  • 15.  The dose length product , number of axial slices and scan length should be documented in the patient chart.  Export the data to TPS/ virtual simulation correctly.  If contrast has been administered, the departmental protocol in relation to observation should be adhered to prior to the patient leaving the department.
  • 17.  Fusion uncertainties  GTV- Physician training for interpretation of imaging /Help of radiologist or nuclear medicine/ correct window selection/HU setting  CTV- follow std guidelines/peer review/uniform department protocol/educational courses by ASTRO,ESTRO  PTV- Institutional data for individual site to quantify their own population- based errors and regular audits  Peer review/Shadowing experience person
  • 18. VARIABILITY IN DOSE- DIFFERENCE IN CONTOURING
  • 19. IJROBP, Vol 82, No 1, 368-78, 2012
  • 21. TIME , DOSE , FRACTIONATION Radiation dose specification/ Fractionation schedule  45Gy/25#/1.8 Gy per# over 5 weeks  OAR constrains- Uniform standard guidelines
  • 23. PLAN EVALUATION TOOL: DVH • A. Quantitative analysis of DVH • Hot spots/cold spots • ? Location of hot/cold spots • B. Examine homogeneity: HI/CI • C. Dose to OARs • D. RVR (Remaining volume at risk) • E. Comparison of different plans
  • 24. DVH DOES NOT SHOW LOCATION OF HOT SPOT
  • 25. PLAN EVALUATION: MULTIPLE SECTIONS Plan1 Plan2 95% All three planes
  • 27.  1st day set up should be monitored by Radiation Oncologist regarding patient positioning and immobilization.  Mask too loose / too tight- evaluate  Patient weight should be monitored weekly If significant weight loss or gain----Re-plan
  • 29.  Imaging modalities- Resource dependent Orthogonal Planar MV Imaging Orthogonal Planar kV Imaging kV Cone Beam CT (CBCT) MVCT (MegaVoltage Computed Tomography)
  • 30. MATCH STRUCTURES FOR IMAGE VERIFICATION  Bony match structures/regions of interest (ROIs) for image verification should be a surrogate for the target.  Depending on the tumour location, may include nasal septum, vertebral bodies and processes, maxilla, angle of mandible, base of skull, head of clavicle.  It may be useful to define primary and secondary match structures at planning for use during image verification.
  • 31. RELOCATION ACCURACY FOR FEMALE PELVIS
  • 32.  Primary match structures Structures whose anatomy are in close proximity to the target ,most useful for position comparison and, for 3D volumetric imaging using CBCT, will determine the position of the clipbox.  Secondary match structures Structures whose presence are useful for guidance purposes only.
  • 34. CORRECTION PROTOCOLS  Online corrections  Offline corrections No action level (NAL) Shrinking action level (SAL)
  • 35. PortalVision aS500 images showing day-to-day setup uncertainty Immobilization CT scan (3D data) Target delineation Tr Planning Evaluation Verify / Deliver
  • 37.  Weekly monitoring of acute radiation reactions Standard protocol- RTOG/CTCAE  Out of field reactions?? Sometimes exit beam of IMRT/ wrong side  Dietary counseling/ Nutrition/Need of Ryle’s tube  Documentation of toxicities/ Supportive care
  • 39. AUDIT TO IMPROVE THE QUALITY  Promotes learning by addressing the following (A method of self evaluation)  What am I doing?  How am I doing it?  Why did I do it that way?  Can I do it better?  Audits allow a critical review of current information (being up to date)  Highlights the need for specific knowledge / information, acquisition of new skills / development of existing ones  Improves communication skills and flexibility in attitudes with other members of the same team  Improves patient safety and quality of care
  • 40. THE AUDIT CYCLE Identify the need for change: e.g. a problem identified in daily practice-something that could / should have been done better. 3 basic areas: Structure: manpower/premises/facilites Process: provision of care Outcome: Results in patients Set a criteria: i.e. an item of care used to assess quality Needs a standard of reference (invent one - minimum, ideal, optimum) Collect data: What data? How and in what form? Who collects it? Assess performance against criteria / standards: Identify an area of care below predetermined levels—develop an action plan Implement recommendations: And then re-audit