american college
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TRANSCRIPT
AMERICAN COLLEGE
OF
RADIATION ONCOLOGY
RED BOOK ©
Guidelines for the ACRO
Practice Accreditation Program
2006 - 2007
Table of Contents
SECTION Preface 1. The Use of Radiation Therapy 2. The Accreditation Process
2.1 Introduction 2.2 Practice Demographics 2.3 Facilities 2.4 Radiation Therapy Personnel 2.5 Radiation Therapy Equipment 2.6 Radiation Therapy Physics 2.7 Process of Radiation Therapy 2.8 Pharmacologic Adjunctive and Supportive Therapy 2.9 Continuous Quality Improvement Program 2.10 Safety Program 2.11 Education Program
3. References 4. Application for Accreditation Review
Preface AMERICAN COLLEGE OF RADIATION ONCOLOGY
PRACTICE ACCREDITATION PROGRAM 2006 – 2007 Edition
Radiation Oncology is the independent field of medicine that deals with the therapeutic applications of radiant energy and its modifiers as well as the study and management of cancer and other diseases. The American College of Radiation Oncology (ACRO) is a nonprofit professional organization whose primary purposes are to advance the science of radiation oncology, improve service to patients, study the socioeconomic aspects of the practice of radiation oncology, provide information to and encourage continuing education for Radiation Oncologists, Medical Physicists, and persons practicing in allied professional fields. As part of its mission, ACRO has developed a Practice Accreditation Program, part of which consists of Standards for Radiation Oncology. Each ACRO Practice Standard requires extensive peer review and the approval of the ACRO Standards Committee as well as that of the ACRO Board of Chancellors. The Standards recognize that the safe and effective use of ionizing radiation requires specific training, skills and techniques. Accreditation is a voluntary process that recognizes entities that meet these high professional Standards. The Standards outlined in this publication are for the use of Radiation Oncologists and their Practices for the purpose of attaining accreditation by ACRO. Additional information useful to the Radiation Oncologist is available at the ACRO website: www.acro.org. The ACRO Standards are not absolute rules, but rather attempts to define principles of practice that are indicative of high quality care in radiation oncology. It is important to note that the ACRO Standards should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. Similarly, the ACRO Standards should not be considered a substitute for compliance with federal, state, and local laws or medical licensing board requirements. The ACRO cannot, and does not, guarantee, warrant, endorse, or otherwise make representations with regard to the ability of any accredited practice or its practitioners or staff to perform adequately or to meet its patients’ needs. The Radiation Oncologist in light of all circumstances presented by the individual situation must make the ultimate judgment regarding the propriety of any specific procedure or course of conduct.
The ACRO Board of Chancellors Gregory W. Cotter, M.D., FACRO Chairman, ACRO Standards Committee Ralph R. Dobelbower, M.D., Ph.D., FACRO Director, ACRO Practice Accreditation Program E. Ishmael Parsai, Ph.D. Chairman, ACRO Physics Commission
Guidelines for the ACRO
Practice Accreditation Program
1. THE USE OF RADIATION THERAPY
Radiation therapy is an important modality in the treatment of neoplastic disease. In the United States, the age-adjusted 1998-2002 SEER incidence rate of new cancer cases is estimated to be about 4.70 cases per 1,000 population. There is significant variation by locale, depending on the population mix. Today radiation therapy is used as part of the initial treatment in approximately thirty-two percent of newly diagnosed cancer cases according to the American College of Surgeons National Cancer Data Bank 2002 -2003 data (TABLE 1). Additionally, 15 to 25 percent of patients will receive further radiation therapy treatment during the course of their disease. TABLE 1 Analysis for Radiation Oncology Usage, American College of Surgeons National Cancer Data Base 2002 - 2003 SITE % Total Cases % XRT AVG % Cases XRTHead and Neck Sites 5.8% 56.9% 3.3% Digestive System 18.3% 18.3% 3.6% Respiratory System 14.4% 41.2% 5.9% Soft Tissue/Bone 0.8% 34.7% 0.3% Skin 3.7% 4.0% 0.2% Breast 17.7% 47.1% 8.3% Gynecologic 6.9% 23.1% 1.6% Genitourinary System 20.8% 30.4% 6.3% Nervous System 2.1% 49.5% 0.9% Hematologic/Lymphoid System
7.1% 16.5% 1.2%
Other/Unknown 2.8% 20.8% 0.6% TOTAL 100.00% 31.9%
The general distribution of new radiation oncology cases is shown in TABLE 2. TABLE 2 Distribution of New Radiation Therapy Patients, American College of Surgeons National Cancer Data Base 2002 - 2003 Site % Cases Breast 26.2% Genitourinary System 19.8% Respiratory System 18.6% Digestive System 10.5% Head and Neck Sites 10.3% Gynecologic 5.0% Hematologic/Lymphoid System 3.7% Nervous System 2.8% Skin 0.5% Soft Tissue/Bone 0.9% Other 1.8% In estimating the number of radiation therapy cases for a population a practice should carefully define its service population and the population growth. It is also important to note the age distribution of that population. In 2000, the U.S. census found that approximately 12.4 percent of the population was 65 years of age or older, yet 56.2 percent of cancer cases occurred in this same age group according to the 1998 – 2002 SEER cancer statistics. In the past the increase in cancer incidence was also considered, but today it appears that age-adjusted cancer incidence has stabilized or may be decreasing according to the Center for Disease Control (CDC). As an example, it would be estimated that an average population of 500,000 persons would have approximately 2,360 new cancer cases per year (500,000 X 0.0047). Of these 2,350 new cases about 752 (2,350 X 0.32) would receive radiation therapy as part of their initial course of treatment. Perhaps 25 percent would receive a second course of treatment (752 X 0.25) for an additional 188 courses of treatment. In total this population would yield about 940 courses of radiation therapy per year. Radiation therapy treatment can be administered today in a variety of forms including external beam therapy (teletherapy) and brachytherapy (via radioisotopes). External beam treatment can be given in fractionated, single dose, hyperfractionated and accelerated fraction forms. Treatments delivered five days per week remains the most common schedule of radiation therapy. Increasing numbers of Practices are utilizing
more complex forms of treatment including Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT). While the time of treatment may vary from patient to patient and from practice to practice, it is reasonable to use 15 minute intervals as a general guide to patient scheduling for patients treated with conventional external beam radiation therapy. IMRT and/or IGRT treatments typically require longer delivery times than conventional treatments and this should be incorporated into the daily treatment schedule. Assuming a workday of 7:30 AM to 4:30 PM for a single treatment unit facility a sample schedule may be as follows: 7:30 – 8:00 Treatment unit warm-up and quality assurance checks 8:00 – 12:00 4 patients per hour X 3 hours = 12 patients 3 IMRT/IGRT patients per hour X 1 hour = 3 patients 12:00 – 1:00 lunch 1:00 – 4:30 4 patients per hour X 2.5 hours = 10 patients 3 IMRT/IGRT patients per hour X 1 hour = 3 patients Total 28 patients per day under treatment Assuming treatment five days per week for 52 weeks per year (less five holidays per year) it can be estimated that this example facility with one megavoltage treatment unit could potentially administer (51 X 5 X 28) 7,140 radiation treatments per year. Assuming a 95 percent operational status of the treatment unit (7,140 X 0.95) 6,783 treatments per year per megavoltage treatment unit per year could be administered. The average number of treatments that a patient receives can vary from practice to practice depending on the patient mix and treatment preferences of the Radiation Oncologist. If a practice treats mostly metastatic disease, the average number of treatments per patient may be lower. Similarly, if a practice treats a large proportion of early breast and prostate cancer, the average number of treatments per patient may be higher. General estimates of an average of 25 treatments per patient have been used in the past, but again this may be variable from practice to practice. It is important for each practice to be aware of its own particular case mix and the impact that this has upon utilization of the resources. Using our sample population above and using an average of 25 treatments per course of radiation therapy a total of 23,500 treatments per year (940 X 25) would be estimated. If the capacity of each megavoltage treatment unit is 6,783 treatments per year, then a minimum of 3.5 units (23,500 / 6,783) would be needed to treat the sample population. Assuming some under-utilization, four or five megavoltage external beam treatment units should adequately serve this population.
2. THE ACCREDITATION PROCESS
2.1 Introduction
The American College of Radiation Oncology Practice Accreditation Program (ACRO PAP) process consists of the following steps:
Application Process: The Practice seeking ACRO PAP Accreditation will initially communicate their interest to the ACRO office in Bethesda, MD (See contact information in Section 3). The ACRO will then send an application form to the Practice. Once the ACRO receives the application form and fee, the ACRO PAP Office will be contacted to initiate the accreditation process.
Survey Process: The ACRO PAP Office will then send on-line data entry instructions to the Practice. In addition, specific data will be requested from the Practice for review. Requested data include personnel, facility information, equipment, physics data and patient treatment information.
Review Process: The survey information and Practice data are then turned over to the assigned reviewers. The reviewers may request additional information of the Practice. After completion of the review the reviewers return their findings and recommendation(s) to the Practice Accreditation Committee. Once the initial off-site review is completed a Site Verification Visit is performed.
Facility Accreditation: After completion of the review process the ACRO PAP will inform the Practice of its findings. If the Practice meets the requirements of the ACRO PAP, Accreditation will be issued by the ACRO. Accreditation will normally be for a period of 3 years. If minor issues are noted, the Practice may receive a Provisional Accreditation with a defined time to address the issue(s). Once the issues are resolved by the Practice then full Accreditation may be received. If major issues are identified during the ACRO PAP review process, Accreditation may be deferred allowing the Practice to more fully address the issues. As the identified issues are resolved, the Practice may then move forward through the remaining parts of the review process. During the above steps in the ACRO PAP process the aspects of the practice in the sections below are reviewed.
2.2 Practice Demographics During the ACRO PAP review demographics of the practice will be examined to help define the nature of the patients treated and the services offered. Requested demographic aspects of the Practice include the following:
2.2.1 Contact person, address, telephone number, fax number and
email address.
2.2.2 Type of practice and affiliations.
2.2.3 Number of consultations.
2.2.4 Number of new patients treated.
2.2.5 Number of patients retreated.
2.2.6 Number of patients treated with curative intent, palliative intent, and for local tumor control.
2.2.7 Number of simulations.
2.2.8 Number of external beam treatments.
2.2.9 Number of brachytherapy procedures.
2.2.10 Anatomic sites and stages (AJCC, UICC, etc.) of diseases treated.
2.2.11 Types of special treatment procedures.
2.2.12 Other.
2.3 Facilities During the practice review the facilities are scrutinized to determine if patient care is being given in a reasonable manner consistent with applicable laws, regulations and standards. Aspects of facility review include the following:
2.3.1 Parking: There should be adequate parking for patients and their families, including a sufficient number of handicapped-designated spaces.
2.3.2 Accessibility: The facility should be accessible for patients including those with handicaps or disabilities.
2.3.3 Waiting area(s): There should be a comfortable waiting area
sufficient for the needs of patients and their families. 2.3.4 Reception/Business areas: There should be sufficient space for a
reception area, record storage, and business functions of the Practice.
2.3.5 Restrooms: There should be a sufficient number of restrooms for
patients, their families and the staff, including access for handicapped and disabled individuals.
2.3.6 Examination rooms: There should be adequate examination
rooms for patient care and, ideally, an area for examination of stretcher- and wheelchair-bound patients.
2.3.7 Simulation areas: There should be an area for simulation of
patient treatment fields. This may be a separate simulation room or may be incorporated into other areas in the facility.
2.3.8 Treatment Planning/Physics/Dosimetry areas: There should be
adequate space for Treatment Planning, Physics and Dosimetry functions performed or reviewed on site.
2.3.9 Megavoltage treatment room(s): There should be an
appropriately shielded area for each megavoltage treatment unit in use. These areas should meet all applicable, state and/or federal requirements. Each treatment room should be equipped with door interlocks, radiation monitors, video observation equipment and voice communication equipment. Documentation of the radiation safety survey of the treatment room should be available for review.
2.3.10 Treatment aide fabrication areas: There should be areas for
fabrication of treatment aides for the Practice. These areas may be in separate rooms or incorporated into other areas within the facility. When utilizing potentially hazardous materials, appropriate facilities should be available and utilized.
2.3.11 Offices: There should be sufficient office space for physicians,
physicists and other supervisory personnel to carry out their functions.
2.3.12 Other areas: In addition to the above areas, the practice facility should have space for storage, a break room (lounge) for staff and space for other needs of the practice.
2.3.13 Legal issues: The practice should demonstrate compliance with
the applicable rules of the Americans with Disabilities Act (ADA), the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Occupational Safety and Health Administration (OSHA) and local fire codes.
2.4 Radiation Therapy Personnel
The process of radiation therapy consists of a series of steps and often involves a number of different individuals. Each practice should establish a staffing program consistent with patient care, administrative, research and other responsibilities. It is recognized that talent, training and work preferences may vary from individual to individual. It is appropriate to factor these aspects into the staffing program. Personnel involved in the radiation oncology process are as follows:
2.4.1 Radiation Oncologist: A Radiation Oncologist must have (1) satisfactorily completed a radiation oncology residency in an ACGME (American Council of Graduate Medical Education) approved program, or (2) be certified in radiation oncology or therapeutic radiology by the American Board of Radiology, the American Osteopathic Board of Radiology, or the Royal College of Physicians and Surgeons of Canada.
Conservatively a Radiation Oncologist can manage 30 to 40 patients per day under treatment. Considering consultations, on treatment visits, simulation and follow-up visits, this translates to approximately 65 to 90 patient encounters per week and allows sufficient time for treatment planning, record keeping and other clinical physician functions. As noted above, the number of Radiation Oncologists available for a practice or facility should be consistent with patient care, administrative, research and other responsibilities.
A Radiation Oncologist should be available for patient care and quality review on a daily basis. The Radiation Oncologist, facility, and support staff should be available to initiate urgent treatment within a medically appropriate response time on a 24-hour basis, 365 days per year. When not physically present within the facility, the Radiation Oncologist should be available by phone, beeper, or
other designated means. When unavailable, the Radiation Oncologist is responsible for arranging appropriate coverage.
2.4.2 Medical Physicist in Radiation Oncology: A Medical Physicist
should be (1) board certified in the appropriate medical physics subfield and must be (2) licensed in those states where licensure exists. The following board certifications meet criterion (1) above: the American Board of Medical Physics, the American Board of Radiology, and the Canadian College of Physicists in Medicine. The Radiation Oncology Physicist shall be available when necessary for consultation with the Radiation Oncologist and to provide advice or direction to technical staff when treatments are being planned or patients are being treated. When a Medical Physicist is not immediately available on site, clinical needs shall be fulfilled according to documented procedures and the Radiation Oncology Physicist should be available by phone, beeper, or other designated means. Authority to perform specific clinical physics duties shall be established by the Radiation Oncology Physicist for each member of the physics staff in accordance with individual competencies. The Radiation Oncologist shall be informed of the clinical activities authorized for each member of the staff. In general, there should be at least one FTE Radiation Oncology Physicist per forty patients under treatment for general radiation oncology care. If the Practice is engaged in a large proportion of higher-complexity care, more Radiation Oncology Physicist personnel may be required. Practices without a full-time Medical Physicist must have regular on-site physics support during hours of clinical activity, at least weekly. Chart checks by the Medical Physicist or his/her designate should be performed at least once each week.
2.4.3 Medical Dosimetrist: A Medical Dosimetrist shall meet the following criteria. (1) Be eligible for the Medical Dosimetrist Certification Board Examination or (2) be certified by the Medical Dosimetrist Certification Board. Medical dosimetry functions may be carried out by a Medical Dosimetrist as defined above under the supervision of a Radiation Oncologist and/or Medical Physicist. Alternatively, medical dosimetry functions may be carried out by a Medical Physicist or his supervised designee. In either case, the Medical Physicist should oversee the medical dosimetry functions of the Practice, function as a technical supervisor of medical dosimetry services and oversee medical dosimetry quality assurance activities.
A Practice shall demonstrate its access to a sufficient number of Medical Dosimetrists, Medical Physicists and/or other individuals as noted above to fulfill the dosimetry requirements for the patient population under treatment. In general, there should be at least one FTE dosimetry person per forty patients under treatment for general radiation oncology care. If the Practice is engaged in a large proportion of higher-complexity care, more dosimetry personnel may be required. If dosimetry services are performed off-site, the Practice shall provide documentation that these services are performed by qualified individuals.
2.4.4 Radiation Therapist [RT(T)]: Radiation Therapist(s) must fulfill state licensing requirements, if they exist, and should have American Registry of Radiologic Technology (ARRT) certification in Radiation Therapy. Generally about one RT(T) is needed per twenty patients under external beam treatment. It is recommended to have two RT(T)s per megavoltage treatment unit under a standard schedule to ensure optimal quality of care, and to allow for vacations, meetings or absences. Additional RT(T)s per treatment unit may be required if there are longer than standard work hours or larger than average patient load for the treatment unit. It is not recommended that a single RT(T) be assigned to a treatment unit alone. In circumstances where he/she is, he/she should be assisted by other Radiation Therapy Support Staff trained in the aspects of radiation safety and emergency care of patients under treatment.
2.4.5 Radiation Therapy Support Staff: Included in these personnel are Radiology Technologists and Treatment Aides. Individuals involved in the treatment of patients should have training and experience in the care of radiation therapy patients as well as in radiation safety and certain aspects of emergency care of patients under treatment. They should work under the supervision of the Radiation Oncologist, Medical Physicist and Radiation Therapist(s).
2.4.6 Simulation Staff: Simulation Therapists or Technologists must fulfill state licensing requirements and should have American Registry of Radiologic Technology (ARRT) certification in Radiation Therapy [RT(T)] or Radiography (RT). Staffing requirements may be similar to those of megavoltage treatment units depending on simulation volume. If applicable, cross competency training in CT, PET or MRI is recommended.
2.4.7 Patient Support Staff: Included in these personnel are Nurses, Physician Assistants, Nurse Practitioners and Clinical Aides. Individuals involved in the nursing care of patients should have
training and experience in the care of radiation therapy patients. Certification as an Oncology Nurse (OCN), Advanced Oncology Nurse (AOCN), or Pediatric Oncology Nurse (POCN) is desirable.
2.4.8 Clerical Staff: The practice should demonstrate a sufficient number and type of Clerical Staff sufficient for the needs of the practice.
2.5 Radiation Therapy Equipment Radiation therapy equipment should include, but not be limited to:
2.5.1 Megavoltage radiation therapy equipment for external beam therapy (e.g., linear accelerator or 60Co teletherapy unit). If the center has a 60Co machine it must have a treatment distance of 80 cm or more with the exception of cranial stereotactic radiosurgery.
2.5.2 Electron beam or superficial X-ray equipment suitable for treatment of superficial (e.g. skin) lesions, or access to such equipment.
2.5.3 Simulator capable of duplicating the treatment setups of the megavoltage unit(s) and capable of producing images representative of the radiotherapy fields to be employed. Fluoroscopic simulation capability and/or CT treatment planning capability is highly desirable.
2.5.4 Brachytherapy equipment for intracavitary and interstitial treatment, or arrangements for referral to facilities with appropriate capabilities for such treatment.
2.5.5 Computer dosimetry equipment capable of calculating and displaying external beam isodose curves as well as brachytherapy isodose curves. Three-dimensional (3-D) dosimetry capability, when beneficial to the patient, is recommended for conventional radiation therapy. Inverse planning capability is desirable for intensity modulated radiation therapy.
2.5.6 Physics calibration devices for all equipment.
2.5.7 Treatment aides:
2.5.7.1 Beam-shaping devices.
2.5.7.2 Immobilization devices. 2.5.7.3 Additional treatment aides as deemed appropriate by the
Practice. 2.5.8 Maintenance and Repair: Regular maintenance and repair of
equipment is mandatory.
2.6 Radiation Therapy Physics
2.6.1 Radiation Safety Program: Each Practice shall have a written Radiation Safety Program incorporating the elements described in the following subsections:
2.6.2 Radiation room surveys: Each facility should have documentation
of radiation exposure shielding calculations, surveys and licensure from the appropriate regulatory agency for operation.
2.6.3 Radiologic equipment licensure/registration: The practice should
have documentation of licensure/registration for all radiotherapeutic or radiologic equipment used for therapeutic purposes.
2.6.3.1 Linear accelerator licensure or registration. 2.6.3.2 Other external beam or radiographic equipment licensure
or registration. 2.6.3.3 Individuals authorized to use the equipment.
2.6.4 Brachytherapy licensure/registration: The practice should have
documentation of licensure/registration for all radioisotopes used for therapeutic or calibration purposes.
2.6.4.1 Radioisotope licensure. 2.6.4.2 Individuals authorized to use the brachytherapy
equipment.
2.6.5 Radiation exposure monitoring program: The Practice shall a have radiation exposure monitoring program, as required by the Nuclear Regulatory Commission (NRC) and/or the appropriate state regulatory agencies.
2.6.6 Major equipment operating procedures: The Practice should
have documentation of major equipment operating procedures. The following documents should be available on site:
2.6.6.1 Operating procedures for all major equipment.
2.6.6.2 Procedures for preventive maintenance and repair. 2.6.6.3 Emergency procedures. 2.6.6.4 Radiation safety procedures.
2.6.7 Major equipment records: The Practice should have documentation of the following:
2.6.7.1 Initial acceptance testing and commissioning documents. 2.6.7.2 Calibration records. 2.6.7.3 Maintenance records including preventive maintenance
and repairs. 2.6.7.4 Machine fault log book
2.6.8 Radiation safety and quality assurance procedures: The Practice should have radiation safety and quality assurance procedures, when applicable, for all radiotherapeutic or radiologic equipment including:
2.6.8.1 Visual and auditory warning devices as required by the
Nuclear Regulatory Commission (NRC) and/or the appropriate state regulatory agencies.
2.6.8.2 Program(s) to ensure systematic inspection of interlock systems.
2.6.8.3 Systems for visual monitoring and communication with patients during radiation therapy.
2.6.8.4 Warmup procedures for all radiotherapeutic or radiologic equipment.
2.6.8.5 Morning QA procedures for all radiotherapeutic or radiologic equipment.
2.6.8.6 Monthly QA procedures for all radiotherapeutic or radiologic equipment.
2.6.8.7 Annual calibration for all radiotherapeutic equipment. The Practice must document that the annual calibration or the therapeutic external beams is performed in accordance with AAPM TG-51 and TG-40 protocol guidelines or their equivalents.
2.6.9 Dosimetry reference: Each Practice must demonstrate a
dosimetric reference for physics calibration purposes. 2.6.10 Physics calibration equipment: Each Practice must show access
to adequate physics calibration equipment including:
2.6.10.1 Ionization chambers appropriate for the equipment and procedures within the Practice.
2.6.10.2 Appropriate equipment for in-vivo dosimetry (e.g., diodes, TLDs, films, etc.) for clinical use if applicable.
2.6.10.3 Tissue equivalent buildup material. 2.6.10.4 Water phantom with beam scanning equipment. 2.6.10.5 Documentation of other physics equipment and uses.
2.6.11 Treatment planning: Each Practice shall demonstrate the
following:
2.6.11.1 Access to a computerized treatment planning system, on site or remote.
2.6.11.2 Records of system commissioning, acceptance testing and beam data.
2.6.11.3 Concordance of beam data with British Journal of Radiology – 25 data for 5x5cm, 10x10cm, 20x20cm and 30x30 cm fields.
2.6.12 Record and verify systems: The Practice should demonstrate the
following when applicable:
2.6.12.1 Records of acceptance testing and commissioning of the record and verify system.
2.6.12.2 Backup records, either computerized or hard copy. 2.6.12.3 Computer system security. 2.6.12.4 Program of ongoing data accuracy monitoring.
2.6.13 Treatment Quality Assurance: the Practice shall demonstrate the following: 2.6.13.1 Weekly physics checks including verification and quality
assurance of prescription, administered dose, review of patient treatment documentation and assessment of treatment parameters.
2.6.13.2 Second monitor unit (MU) check done within 72 hours, including method.
2.6.13.3 Port film(s) or image(s) checked within 72 hours. 2.6.13.4 Physics checks of computerized dosimetry treatment
plans. 2.6.13.5 Physics checks of record and verify entries. 2.6.13.6 Check of valid in-vivo dosimetry measurements for
concordance with calculated values (e.g. external diode or TLD measurement).
2.6.13.7 Rechecks for any revision(s) in treatment parameters. (i.e. field, energy, treatment distance, field shape, etc.).
2.6.13.8 Check of appropriate use of treatment aides as prescribed.
2.6.14 Brachytherapy Procedures: The Practice shall demonstrate the following when applicable:
2.6.14.1 Quality assurance program for brachytherapy
procedures. 2.6.14.2 Security in storage of available radioisotopes used for
therapeutic purposes or calibration. 2.6.14.3 Appropriate safety equipment for the use of sealed (and
unsealed, as the case may be) radiation sources. 2.6.14.4 Incoming/outgoing package surveys/wipe tests
completed and recorded according to recommended policies of respective regulatory bodies.
2.6.14.5 Quarterly inventory of all radioisotope sources. 2.6.14.6 Semi-annual wipe-tests of stored sealed radioisotopes
used for therapeutic purposes. 2.6.14.7 Completed documentation of measurement tests and
safety procedures for source exchange for high-dose-rate (HDR) units.
2.6.14.8 Availability of policy and procedure for calibration method for HDR source, and quality management program (QMP) for brachytherapy practice.
2.6.14.9 Quality assurance program for HDR unit and treatment. 2.6.14.10 Emergency procedures for HDR unit. 2.6.14.11 Record of brachytherapy procedures. 2.6.14.12 Procedures for use and safe handling of other unsealed
radioisotopes such as 131I, 153Sm, 89Sr, etc. 2.6.14.13 Method of exposure monitoring and records. 2.6.14.14 License application procedures and/or Department of
Transportation rules (Title 49 CFR). 2.6.14.15 Availability of procedural menus for all radioisotope
assays in accordance with recognized standards such as AAPM TG-43.
2.6.15 Posting and availability of information: Each Practice must
demonstrate appropriate posting or availability of the following in an easily readable and accessible method: 2.6.15.1 Radiation safety officer and other contacts in case of a
radiation-related emergency. 2.6.15.2 Any state or other regulatory agency signage such as
“Notice to Employees”. 2.6.15.3 Personnel radiation exposure readings are available
upon request to the radiation safety officer or their designee.
2.7 Process of Radiation Therapy
As noted above, the process of radiation therapy treatment consists of a series of steps. In the case of external beam radiation therapy, these steps typically follow in a logical order. When brachytherapy is utilized, the sequence is similar but may be more or less complicated depending on the specific type of treatment. Figure 1 outlines the general process of radiation therapy. The typical procedures for external beam radiation therapy are as follows:
2.7.1 Consultation: A Practice must demonstrate that it performs an adequate clinical evaluation by taking a patient history, performing a physical examination, reviewing pertinent diagnostic studies and reports, determining the extent of the tumor for staging purposes, and communicating with the referring physician and certain other physicians involved in the patient’s care.
2.7.2 Informed Consent: Informed consent must be obtained and documented. This should include a discussion of the proposed treatment, its rational, options for other treatment if appropriate and a review of the logistics, risks and side effects of treatment.
2.7.3 Treatment Planning: When ionizing radiations are to be used, a Practice must demonstrate that processes are in place to allow a Radiation Oncologist to plan treatment, including selecting the beam characteristics and/or the radionuclide sources, method of delivery, doses, sequencing with other treatments, communication with and supervision of the Radiation Physicist and dosimetrist.
The prescription by the Radiation Oncologist should include: Volume (site) to be irradiated, description of portals [i.e., anteroposterior (AP), posteroanterior (PA), lateral, oblique, etc.], radiation modality, dose per fraction, number of fractions per day, number of fractions per week, total number of fractions, total tumor dose, and the point or isodose line of dose specification. The prescription should be signed by the Radiation Oncologist no later than prior to the second treatment. Brachytherapy: If the Radiation Oncologist determines brachytherapy is appropriate, he/she must select the radionuclide(s) and select the method of application; intracavitary, interstitial or systemic administration (oral or intravascular, etc.). The Radiation Oncologist should ensure that applicators are properly in place and obtain localization radiographs, if applicable, should review the dose calculations and in the case of computerized planning the dose distributions. The completed
prescription should be signed and dated. This prescription should specify the radionuclide source(s) and strength(s), the dose to clinically relevant points and/or minimum dose to the target volume, and the time course for the brachytherapy administration. Combined Modality Therapy: If the Radiation Oncologist determines that other treatment modalities (e.g., chemotherapy, hyperthermia, radiation sensitizers, radioprotectors, immunotherapy, etc.) should be combined with external beam irradiation or brachytherapy, the Radiation Oncologist must document such procedures in the radiation therapy chart, including such critical factors such as drug(s), dose(s), route(s) of administration and timing of such therapy in relation to the delivery of the radiation therapy.
2.7.4 Simulation: The establishment of the area(s) of treatment is termed simulation. Simulation is carried out by an RT(T) or RT(R) under the direction of the Radiation Oncologist. Simulation is used for both external beam treatments and brachytherapy as well as combination treatment. Simulation may be accomplished on the treatment machine, with radiographic units, fluoroscopic units, CT, MRI or PET scanners. Similarly it may be carried out on a computer planning system with virtual simulation using data from some of the above sources.
2.7.5 Dose calculation and/or Computer planning: Dose calculations may be carried out by hand or by computer by the Radiation Oncologist, Medical Physicist, Dosimetrist or RT(T). These calculations must be independently checked (by another person or another method of calculation) and clearly documented before administration of the third radiation treatment and at any time that any changes are made.
2.7.6 Treatment Aids: A Practice must be able to determine when or if to use devices to aid in positioning and immobilizing the patient, shield normal tissue, or improve the radiation dose distribution. Such devices include, but are not limited to, beam attenuators (e.g., wedge filters, compensating filters, etc.), beam shapers (e.g., custom-molded or generic metal blocks), and various devices to aid in patient positioning (e.g., breast boards, belly boards, treatment chairs, etc.) and/or immobilization (e.g., bite blocks, custom-molded masks, cradles, etc.).
2.7.7 Radiation treatment delivery: The next step in external beam radiation therapy is the actual treatment. The Radiation Therapist, following the prescription and plan of the Radiation Oncologist, should carry out daily treatments. The radiation therapy treatment parameters should be verified by the RT(T) to
ensure proper treatment and recorded daily as the treatments are administered.
2.7.8 Treatment verification: To permit proper delivery of radiation therapy, radiographic images produced by each treatment beam with the patient in the treatment position (portal verification images) should be performed at the initiation of treatment, and a representative sample or orthogonal images should be taken weekly thereafter, and at such times that any of the radiation fields are modified, or when any new radiation fields are applied. These images should be compared with simulation images to verify that the treatment beams and the fields planned at simulation are well matched. Verification of the administered dose should be performed for each field at the initiation of treatment with that field. These procedures should be repeated if a treatment area or dose prescription changes. Dosimeters may be used in vivo to measure and record actual doses at specific anatomic sites.
2.7.9 Continuing Medical Physics consultation: While a patient is undergoing active radiation therapy the Medical Physicist should evaluate the execution of the Radiation Oncologist’s treatment plan to ensure that the treatment is being administered properly. The Medical Physicist should review the patients’ records on a regular schedule (such as weekly or after, for example, every five treatments). Each Practice shall document this procedure in its Quality Management Program.
2.7.10 Radiation treatment management: Each patient should be evaluated by the Radiation Oncologist at least weekly while receiving treatment. The patient should be assessed for response to treatment and treatment-related sequelae. These evaluations should be documented and measures should be taken to address issues related to treatment. Any changes in the planned treatment that require new calculations, or even a new treatment plan, must be documented in the radiation therapy record.
The patient and/or referring physician should be informed of the progress of treatment whenever deemed appropriate by the Radiation Oncologist. At the time of completion of a course of radiation therapy, the Radiation Oncologist must assess the patient’s progress, tumor response, and sequelae of treatment and communicate his/her assessment to the referring physician.
2.7.11 Follow-up medical care: Upon completion of the prescribed course of radiation therapy the Radiation Oncologist should
arrange for ongoing follow-up care of the patient. This may be performed by the Radiation Oncologist, in conjunction with other physicians, or may be delegated to other physicians as appropriate for the individual patient.
2.7.12 Clinical Performance Measures:
2.7.12.1 histopathologic diagnosis.
2.7.12.2 site of disease or ICD – 9 code.
2.7.12.3 stage of disease.
2.7.12.4 pertinent history and physical examination performed by the responsible Radiation Oncologist.
2.7.12.5 treatment plan.
2.7.12.6 simulation record, when applicable.
2.7.12.7 dosimetry calculations.
2.7.12.8 documentation of informed consent to treatment.
2.7.12.9 graphic treatment plan (e.g. isodose distribution) when applicable.
2.7.12.10 daily/weekly/total radiation therapy dose and treatment volume records.
2.7.12.11 weekly record of treatment management.
2.7.12.12 continuing weekly medical physics review for external beam treatment.
2.7.12.13 port image(s) documenting each treatment field, when applicable.
2.7.12.14 record of brachytherapy or radionuclide therapy procedure(s), when applicable.
2.7.12.15 treatment summary note.
2.7.12.16 follow-up plan.
Figure 1.
Consultation
Treatment Planning
The Process of Radiation Therapy
ConsultationReport
Brachytherapy
External Beamand
Brachytherapy
External Beam
PharmacologicalAgent
Simulation
DoseCalculation
TreatmentAdministration
TreatmentReport
Followup
DoseVerification
PatientData
TreatmentData
OutcomeData
2.8 Pharmacologic Adjunctive and Supportive Therapy
The use of pharmacologic modifying, adjuvant and supportive agents in conjunction with radiation treatment is well established. Further, research continues in this area with the primary goal being improvement in patient care. A wide variety of pharmacologic modifying, adjunctive and supportive agents are available for general clinical use or use in the investigational setting. These agents can be categorized as follows:
A. Radiation protectors B. Radiation sensitizers C. Hormonal agents D. Cytotoxic agents E. Photosensitizers F. Immunologic agents G. Biologic agents H. Molecular therapeutic agents I. Antiemetics
J. Pain medications K. General medications
2.8.1 Facility: Those Practices that administer pharmacologic modifying, adjuvant and supportive agents should have adequate facilities to safely care for patients including:
2.8.1.1 The Practice facility should comply with sections 2.3.1 –
6 with regard to parking, accessibility, waiting room, business area restrooms and examination rooms. Similarly, the Practice should demonstrate compliance with the applicable rules of the Americans with Disabilities Act (ADA).
2.8.1.2 The practice facility should have satisfactory treatment
areas (e.g., chairs, recliners, and/or beds, as appropriate to patient needs) including treatment areas that can afford privacy when needed.
2.8.1.3 Treatment areas should be within immediate nurse or
physician access. 2.8.1.4 A “crash cart”, oxygen and other materials for
management of cardiopulmonary resuscitation and anaphylactic reaction should be readily available within the administration area.
2.8.1.5 Antineoplastic and other hazardous drugs should be
stored and prepared in adherence with Federal OSHA requirements.
2.8.1.6 There should be access to a laboratory, either within the
office or through another facility. This laboratory should be able to report the results of the patients’ laboratory tests to the physician quickly enough to permit evaluation for treatment on the same day. The laboratory should comply with state licensure and federal certification requirements.
2.8.2 Personnel: Those Practices that administer pharmacologic modifying, adjuvant and supportive agents should have adequate trained personnel as follows:
2.8.2.1 Physicians who order, administer, and/or supervise the administration of antineoplastic agents should be qualified to administer such agents.
2.8.2.2 Professional staff specifically trained in chemotherapy
procedures should administer chemotherapy. Licensure as a doctor of medicine, doctor of osteopathy, registered nurse, or physician assistant should be in compliance with applicable state and federal regulations. Certification as an oncology nurse (OCN), advanced oncology nurse (AOCN), or pediatric oncology nurse (POCN) is desirable.
2.8.2.3 Physicians and nursing staff should have cardio-
pulmonary resuscitation training.
2.8.3 Process for use of Pharmacologic Agents
2.8.3.1 Clinical Evaluation: A Practice must demonstrate that it performs an adequate clinical evaluation by taking a patient history, performing a physical examination, reviewing pertinent diagnostic studies and reports, determining the extent of the tumor for staging purposes, and communicating with the referring physician and certain other physicians involved in the patient’s care.
2.8.3.2 Documentation: There should be documentation in
patient records of all patient interactions, including evaluation and management services; dosage, route, and type of antineoplastic chemotherapy; and supportive-care treatments.
2.8.3.3 Establishing Treatment Goals. A Practice must have a
process for clearly defining the goal of treatment (curative, palliative, achievement of local tumor control or symptom relief), including discussing with the patient the relative merits and risks of various treatment options.
If the physician determines that pharmacologic treatment modalities (e.g., radiation sensitizers, radioprotectors, chemotherapy, immunotherapy, etc.) should be part of the patient’s treatment, the physician must document the treatment plan in the patient’s chart. Critical factors, such as drug(s), dose(s), route(s) of administration and timing of such treatment along with any changes in the planned
treatment, must be documented in the medical record.
2.8.3.4 Informed Consent. Prior to treatment, informed consent must be obtained and documented.
2.8.3.5 Support Services: In addition to access to laboratory
services, the Practice should also have access to diagnostic and therapeutic radiology services. Similarly, referral for psychosocial and nutritional counseling services should be available.
2.8.3.6 Physician Supervision: There should be appropriate
physician supervision of all professional staff that provide patient care.
2.8.3.7 Pharmacologic Administration: The Practice shall
demonstrate the following:
2.8.3.7.1 The administration of chemotherapy should comply with federal and state requirements regarding occupational safety and health.
2.8.3.7.2 Procedures to ensure that antineoplastic and
supportive-care drugs are properly labeled for identity and dosage should be established.
2.8.3.7.3 Procedures to ensure that antineoplastic and
supportive-care drugs are mixed properly should be established.
2.8.3.7.4 The date of administration of an antineoplastic
or supportive-care drug should fall within the date of expiration on the manufacturer’s label.
2.8.3.7.5 Procedures to ensure that antineoplastic and
supportive-care drugs are properly handled before and after preparation should be established.
2.8.3.7.6 Procedures to ensure that antineoplastic and
supportive-care drugs and their containers are not contaminated or diluted should be established.
2.8.3.7.7 Antineoplastic and supportive-care drugs
should be available on a schedule that meets
treatment needs. 2.8.3.7.8 Antineoplastic and supportive-care drugs
should be furnished soon enough after mixing to comply with the manufacturer’s preparation instructions.
2.8.3.7.9 Materials for patient education regarding
diagnosis, treatment, and drugs administered should be available.
2.8.3.7.10 An appropriately trained physician should be
physically present in the facility when a drug or biologic therapy that is known to cause anaphylaxis is being administered.
2.8.3.7.11 Medications for the treatment of anaphylaxis,
including oxygen, should be immediately available.
2.8.3.7.12 The Practice should have review procedures to
detect and prevent both over- and under-dosing of antineoplastic and supportive care drugs.
2.8.3.7.13 The Practice should have procedures to
manage chemotherapy extravasation
2.8.3.8 Patient Evaluation During Treatment.
2.8.3.8.1 The physician should monitor the patient's progress, check entries in the medical chart, and discuss the plan of therapy, as well as any changes thereto, with appropriate team members during the course of pharmacologic treatment.
2.8.3.8.2 Regular evaluations of the patient must be done during the course of treatment. Pertinent laboratory and imaging studies should be periodically ordered and reviewed.
2.8.3.8.3 Patients should be monitored for treatment-related side effects. The physician should institute appropriate treatment for side effects
or the patient should be referred to a medical specialist for consultation or treatment.
2.8.3.8.4 The patient and/or referring physician should be informed of the progress of treatment whenever deemed appropriate by the physician.
2.8.3.9 Follow-up Evaluation. At the time of completion of a course of pharmacologic treatment and periodically after treatment, the physician must follow the patient’s progress and assess tumor response and sequelae of treatment.
2.9 Continuous Quality Improvement Program
Continuous Quality Improvement Plan: The practice shall have a continuous quality improvement (CQI) plan. This may be combined with the radiation safety program. The following items should be included in a CQI program:
2.9.1 Chart Review: Designated chart reviewer(s) will audit all radiation therapy charts opened during the period of time under review. Chart reviews must be performed on a regular (weekly is recommended) basis to ensure ongoing quality management. A chart audit should include review (and corrective action, if necessary) of the following:
2.9.1.1 diagnosis.
2.9.1.2 stage of disease.
2.9.1.3 pertinent histopathologic report(s).
2.9.1.4 pertinent history and physical examination performed by the responsible Radiation Oncologist.
2.9.1.5 diagram(s) and/or photograph(s) of lesion(s).
2.9.1.6 examination, operative and radiographic reports.
2.9.1.7 documentation of informed consent to treatment.
2.9.1.8 radiation treatment records.
2.9.1.9 diagram(s) and/or photograph(s) of field(s).
2.9.1.10 dosimetry calculations.
2.9.1.11 graphic treatment plan (e.g. isodose distribution) signed and dated by a Radiation Oncologist, when applicable.
2.9.1.12 port image(s) documenting each treatment field.
2.9.1.13 dose verification records.
2.9.1.14 documented periodic (at least weekly) examinations of patient, while under active treatment, by a Radiation Oncologist.
2.9.1.15 documentation that chart was checked at least weekly during the course of radiation treatment by a Medical Physicist.
2.9.1.16 treatment summary (completion of therapy note).
2.9.1.17 follow-up plan.
2.9.2 General Practice Review: The CQI Plan shall establish a review processes for the following:
2.9.1.1 Physics Review. The Practice should have a process for review of regular physics quality reports.
2.9.1.2 Dose Discrepancy Analysis. The Practice should have a process for review of all cases in which there is found a variation of delivered dose from prescribed dose greater than 10% of the intended total dose. This review should include any case in which mathematical dose corrections of 10% or more are made as a result of any dose verification or recalculation procedure.
2.9.1.3 New Procedure Review: When any new treatment modality or technique is introduced to the Practice or to the facility, the procedures, results, problems, complications, etc. should be reviewed by the QA committee in a timely fashion consistent with patient safety.
2.9.1.4 Incident Report Review: The Practice should regularly review all cases in which incident reports are filed and in
which there are reports of accidents or injuries to patients.
2.9.1.5 Morbidity and Mortality Review: The Practice should regularly review all cases in which any of the following occur:
2.9.1.5.1 Unusual early or late complications of radiation treatment.
2.9.1.5.2 Unplanned interruptions during the course of radiation treatment.
2.9.1.5.3 Severe early or late complications of radiation treatment.
2.9.1.5.4 Unexpected deaths.
2.9.1.6 Outcome Studies Review: The Practice should review pertinent outcome studies, including tumor control, survival and significant treatment-related sequelae, from the Cancer Committee, Tumor Registry or any other section, department or committee of an associated hospital or healthcare entity, if applicable.
2.9.1.7 Radiation Oncologist Peer Review: At least ten percent (10%) of all cases managed within a radiation oncology practice must be examined via a physician (Radiation Oncologist) peer review mechanism. Such peer review activities shall occur no less frequently than once each quarter.
2.9.1.8 Record Maintenance and Data Collection: Appropriate patient records should be kept in the radiation therapy department or facility, consistent with state and local requirements and/or by maintenance of a tumor registry. Each radiation therapy Practice and/or facility should collect data permitting the compilation of an annual summary of activities including data necessary for Section 2.2.
2.10 Safety Program
The provision of a safe environment for patients, staff and the public is tantamount for each Practice. The Practice shall demonstrate that it provides safety measures including the following:
2.10.1 Safe entrance and exit from the facility consistent with the rules of the Americans with Disabilities Act (ADA).
2.10.2 A written Radiation Safety Program as described in Section 2.6.
2.10.3 Adherence to the rules of the Occupational Safety and Health Administration (OSHA).
2.10.4 Adherence to local fire codes, including clearly marked exits, fire extinguishers and the ability to contact the local fire department in the case of emergency.
2.10.5 Program(s) to prevent mechanical injury caused by the radiotherapy machine(s) and/or accessory equipment shall be in place.
2.11 Education Program
Continuing medical education (CME) programs are required for physicians and physicists as well as the physics, dosimetry, nursing and radiation therapy technology staffs. This program shall include:
2.11.1 Access to information, as appropriate to each individual’s responsibilities, pertinent to safe operation of all equipment within the facility;
2.11.2 Access to information pertinent to radiation treatment techniques, new developments in the field of radiation oncology and related medical care;
2.11.3 Adherence to local licensing agency requirements for CME.
3. REFERENCES
1. Halvorsen, P.H.,Das I.J., Fraser, M.,D. Freedman, J.,Rice III, R. E.,Ibbott,
G.S.,Parsai, E.I.,Robin Jr., T.T., and Thomadsen, B.R.; AAPM Task Group 103 report on peer review in clinical radiation oncology physics; Journal of Applied Clinical Medical Physics, 6(4): 50-64, Fall 2005.
2. Cotter, G.W., Dobelbower, R.R., The American College of Radiation Oncology Practice Accreditation Program, Critical Reviews in Oncology/Hematology, Volume 55(2): 93 – 102, August 2005.
3. Dobelbower, R.R., Cotter G.W., Parsai E.I., Vaisman, I., Carroll, J.M.; Acreditacion y Mecanismos de Estudiod Cooperativa. Abstract CD of CRILA Congress, Lima, Peru: 30 March -02 April, 2005.
4. Radiation Oncology Practice Management Guide, American College of Radiation Oncology, Bethesda, Maryland, 2004. Editors: Gillette, A., Kagan, R.A., Schilling, P., Cotter, G.W., Currier, J., and DiGiaimo R.
5. NAG, S., Dobelbower, R.R., Glasgow, G., Gustafson, G., Syed, N., Thomadsen, B., Williamson, J.F.; Inter-Society Standards for the Performance of Brachytherapy: A Joint Report from ABS, ACMP, and ACRO. Crit Rev Oncol/Hematol 48:1-17, 2003.
6. Parsai E.I., Dobelbower, R.R., Accreditation of Radiation Oncology Practices by the American College of Radiation Oncology. Newsletter of the American College of Medical Physics. pp. 6-7, August 2002.
7. Dobelbower, R.R., Cotter, G.C., Schilling, P.J., Parsai, E.I., Carroll, J.M.; Radiation Oncology Practice Accreditation. Rays (Italy), 26(3):191-8, Jul-Sep 2001.
8. Criteria for Facilities and Personnel for the Administration of Parenteral Systemic Antineoplastic Therapy, American Society of Clinical Oncology (ASCO) Clinical Practice Committee, Journal of Clinical Oncology, 22:22, 4614 - 4615, 2004.
9. Hensley, M.L., et al., American Society of Clinical Oncology Clinical Practice Guidelines for the Use of Chemotherapy and Radiation Therapy Protectants, Journal of Clinical Oncology, 17(3): 333 – 3355, 1999.
10. The Americans with Disabilities Act of 1990 (Public Law 101-336) 42 U.S.C. 12101-12213, www.access.gpo.gov.
11. The Americans with Disabilities Act of 1990 (Public Law 101-336), 28 C.F.R. Parts 35 and 36, www.access.gpo.gov.
12. Americans With Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities; Architectural Barriers Act (ABA), 36 CFR Part 1191. www.access.gpo.gov.
13. The Clinical Laboratory Improvements Act (CLIA) 42 C.F.R. Part 493. www.access.gpo.gov.
14. The Occupational Safety and Health Administration (OSHA) of the US Department of Labor, 29 C.F.R. Part 1910. www.access.gpo.gov.
15. Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), 45 C.F.R. Part 164. www.access.gpo.gov.
4. APPLICATION FOR ACCREDITATION REVIEW
A Practice desiring to apply for Accreditation Review may contact the ACRO office in Bethesda, MD or the ACRO PAP office at the following address: The American College of Radiation Oncology 5272 River Road Suite 630 Bethesda, MD 20816 Tel: (301) 718-6515 Fax: (301) 656-0989 Email: [email protected]: www.acro.org or Jeanne M. Carroll, Program Administrator Department of Radiation Oncology Medical University of Ohio 3000 Arlington Ave Toledo, OH 43614 419 383-4462 Email: [email protected]: www.acro.org
FEES:
Initial accreditation review
• Single Practice, ACRO Member, Fee = $7,000 • Single Practice, Non-Member, Fee = $9,000 • Additional Local Practice Sites = $3,000/ second site, $2,500/ third site,
$1,500 /each additional site (satellite sites must be within 30 miles of the Primary Practice Site)
Re-accreditation review
• Single Practice Site, ACRO Member, Fee = $6,000 • Single Practice Site, ACRO Member, payment option $2,000 per year X 3
years = $6,000 • Single Practice Site, Non-Member Fee = $9,000
Additional Local Practice Sites = $2,500/ second site, $1,500 /each additional site (satellite sites must be within 30 miles of the Primary Practice Site).
The American College of Radiation Oncology 5272 River Road
Suite 630 Bethesda, MD 20816
(301) 718-6515 (301) 656-0989 Fax
Email: [email protected]: www.acro.org