1. 1 Quality Improvement in Radiation Oncology Chapter 17 W/L

2. 2 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.

3. 3 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

4. 4 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.

5. 5 Quality Improvement QA should be related to: –Structure – staff, equipment, facility –Process – before, during and after treatment –Outcome Morbidity: side effects Mortality: death

6. 6 Quality Improvement Participation in CQI has been demonstrated to: –Decrease costs –Increase customer satisfaction –Ensure quality throughout the health care organization

7. 7 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.

8. 8 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

9. 9 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

10. 10 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.

11. 11 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.

12. 12 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.

13. 13 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.

14. 14 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

15. 15 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

16. 16 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.

17. 17 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

18. 18 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.

19. 19 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.

20. 20 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.

21. 21 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

22. 22 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

23. 23 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

24. 24 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.

25. 25 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

26. 26 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

27. 27 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

28. 28 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

29. 29 Buying New Equipment Justify the need for it Shop around Check references Negotiate price Responsibility of physicist, physician, and administrator.

30. 30 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

31. 31 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

32. 32 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

33. 33 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)

34. 34 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)

35. 35 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

36. 36 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

37. 37 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

38. 38 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)

39. 39 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.

40. 40 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.

41. 41 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.

42. 42 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.

43. 43 Brachytherapy Source identity –Physical length –Diameter –Serial number –Color coding **Done by radiographic and visual inspection

44. 44 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.

45. 45 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