1. AMERICAN COLLEGE
Guidelines for the ACRO
Practice Accreditation Program
2006 - 2007
2. Table of Contents
1. The Use of Radiation Therapy
2. The Accreditation Process
2.2 Practice Demographics
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
4. Application for Accreditation Review
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
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
4. 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.
Analysis for Radiation Oncology Usage, American College of Surgeons
National Cancer Data Base 2002 - 2003
SITE % Total Cases % XRT AVG % Cases XRT
Head 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%
7.1% 16.5% 1.2%
Other/Unknown 2.8% 20.8% 0.6%
TOTAL 100.00% 31.9%
5. The general distribution of new radiation oncology cases is shown in TABLE 2.
Distribution of New Radiation Therapy Patients,
American College of Surgeons National Cancer Data
Base 2002 - 2003
Site % Cases
Genitourinary System 19.8%
Respiratory System 18.6%
Digestive System 10.5%
Head and Neck Sites 10.3%
Hematologic/Lymphoid System 3.7%
Nervous System 2.8%
Soft Tissue/Bone 0.9%
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
6. 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.
7. 2. THE ACCREDITATION PROCESS
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.
8. 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
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
2.2.11 Types of special treatment procedures.
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
9. 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
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
10. 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
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
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
11. 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
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.
12. 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
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
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
13. 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
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 60
Co teletherapy unit). If the
center has a 60
Co machine it must have a treatment distance of
80 cm or more with the exception of cranial stereotactic
2.5.2 Electron beam or superficial X-ray equipment suitable for
treatment of superficial (e.g. skin) lesions, or access to such
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
2.5.6 Physics calibration devices for all equipment.
2.5.7 Treatment aides:
184.108.40.206 Beam-shaping devices.
14. 220.127.116.11 Immobilization devices.
18.104.22.168 Additional treatment aides as deemed appropriate by the
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
22.214.171.124 Linear accelerator licensure or registration.
126.96.36.199 Other external beam or radiographic equipment licensure
188.8.131.52 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.
184.108.40.206 Radioisotope licensure.
220.127.116.11 Individuals authorized to use the brachytherapy
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:
18.104.22.168 Operating procedures for all major equipment.
15. 22.214.171.124 Procedures for preventive maintenance and repair.
126.96.36.199 Emergency procedures.
188.8.131.52 Radiation safety procedures.
2.6.7 Major equipment records: The Practice should have
documentation of the following:
184.108.40.206 Initial acceptance testing and commissioning documents.
220.127.116.11 Calibration records.
18.104.22.168 Maintenance records including preventive maintenance
22.214.171.124 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
126.96.36.199 Visual and auditory warning devices as required by the
Nuclear Regulatory Commission (NRC) and/or the
appropriate state regulatory agencies.
188.8.131.52 Program(s) to ensure systematic inspection of interlock
184.108.40.206 Systems for visual monitoring and communication with
patients during radiation therapy.
220.127.116.11 Warmup procedures for all radiotherapeutic or radiologic
18.104.22.168 Morning QA procedures for all radiotherapeutic or
22.214.171.124 Monthly QA procedures for all radiotherapeutic or
126.96.36.199 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:
188.8.131.52Ionization chambers appropriate for the equipment and
procedures within the Practice.
16. 184.108.40.206Appropriate equipment for in-vivo dosimetry (e.g., diodes,
TLDs, films, etc.) for clinical use if applicable.
220.127.116.11Tissue equivalent buildup material.
18.104.22.168Water phantom with beam scanning equipment.
22.214.171.124Documentation of other physics equipment and uses.
2.6.11 Treatment planning: Each Practice shall demonstrate the
126.96.36.199Access to a computerized treatment planning system, on
site or remote.
188.8.131.52Records of system commissioning, acceptance testing
and beam data.
184.108.40.206Concordance 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:
220.127.116.11Records of acceptance testing and commissioning of the
record and verify system.
18.104.22.168Backup records, either computerized or hard copy.
22.214.171.124Computer system security.
126.96.36.199Program of ongoing data accuracy monitoring.
2.6.13 Treatment Quality Assurance: the Practice shall demonstrate the
188.8.131.52Weekly physics checks including verification and quality
assurance of prescription, administered dose, review of
patient treatment documentation and assessment of
184.108.40.206Second monitor unit (MU) check done within 72 hours,
220.127.116.11Port film(s) or image(s) checked within 72 hours.
18.104.22.168Physics checks of computerized dosimetry treatment
22.214.171.124Physics checks of record and verify entries.
126.96.36.199Check of valid in-vivo dosimetry measurements for
concordance with calculated values (e.g. external diode
or TLD measurement).
188.8.131.52Rechecks for any revision(s) in treatment parameters.
(i.e. field, energy, treatment distance, field shape, etc.).
184.108.40.206Check of appropriate use of treatment aides as
17. 2.6.14 Brachytherapy Procedures: The Practice shall demonstrate the
following when applicable:
220.127.116.11 Quality assurance program for brachytherapy
18.104.22.168 Security in storage of available radioisotopes used for
therapeutic purposes or calibration.
22.214.171.124 Appropriate safety equipment for the use of sealed (and
unsealed, as the case may be) radiation sources.
126.96.36.199 Incoming/outgoing package surveys/wipe tests
completed and recorded according to recommended
policies of respective regulatory bodies.
188.8.131.52 Quarterly inventory of all radioisotope sources.
184.108.40.206 Semi-annual wipe-tests of stored sealed radioisotopes
used for therapeutic purposes.
220.127.116.11 Completed documentation of measurement tests and
safety procedures for source exchange for high-dose-
rate (HDR) units.
18.104.22.168 Availability of policy and procedure for calibration
method for HDR source, and quality management
program (QMP) for brachytherapy practice.
22.214.171.124 Quality assurance program for HDR unit and treatment.
126.96.36.199 Emergency procedures for HDR unit.
188.8.131.52 Record of brachytherapy procedures.
184.108.40.206 Procedures for use and safe handling of other unsealed
radioisotopes such as 131
220.127.116.11 Method of exposure monitoring and records.
18.104.22.168 License application procedures and/or Department of
Transportation rules (Title 49 CFR).
22.214.171.124 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:
126.96.36.199 Radiation safety officer and other contacts in case of a
188.8.131.52 Any state or other regulatory agency signage such as
“Notice to Employees”.
184.108.40.206 Personnel radiation exposure readings are available
upon request to the radiation safety officer or their
18. 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
19. 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
20. ensure proper treatment and recorded daily as the treatments are
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
21. 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:
220.127.116.11 histopathologic diagnosis.
18.104.22.168 site of disease or ICD – 9 code.
22.214.171.124 stage of disease.
126.96.36.199 pertinent history and physical examination performed
by the responsible Radiation Oncologist.
188.8.131.52 treatment plan.
184.108.40.206 simulation record, when applicable.
220.127.116.11 dosimetry calculations.
18.104.22.168 documentation of informed consent to treatment.
22.214.171.124 graphic treatment plan (e.g. isodose distribution) when
126.96.36.199 daily/weekly/total radiation therapy dose and treatment
188.8.131.52 weekly record of treatment management.
184.108.40.206 continuing weekly medical physics review for external
220.127.116.11 port image(s) documenting each treatment field, when
18.104.22.168 record of brachytherapy or radionuclide therapy
procedure(s), when applicable.
22.214.171.124 treatment summary note.
126.96.36.199 follow-up plan.
22. Figure 1.
The Process of Radiation Therapy
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
F. Immunologic agents
G. Biologic agents
H. Molecular therapeutic agents
23. 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:
188.8.131.52 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).
184.108.40.206 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.
220.127.116.11 Treatment areas should be within immediate nurse or
18.104.22.168 A “crash cart”, oxygen and other materials for
management of cardiopulmonary resuscitation and
anaphylactic reaction should be readily available within
the administration area.
22.214.171.124 Antineoplastic and other hazardous drugs should be
stored and prepared in adherence with Federal OSHA
126.96.36.199 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
2.8.2 Personnel: Those Practices that administer pharmacologic
modifying, adjuvant and supportive agents should have adequate
trained personnel as follows:
24. 188.8.131.52 Physicians who order, administer, and/or supervise the
administration of antineoplastic agents should be qualified
to administer such agents.
184.108.40.206 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.
220.127.116.11 Physicians and nursing staff should have cardio-
pulmonary resuscitation training.
2.8.3 Process for use of Pharmacologic Agents
18.104.22.168 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.
22.214.171.124 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
126.96.36.199 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
25. treatment, must be documented in the medical record.
188.8.131.52 Informed Consent. Prior to treatment, informed consent
must be obtained and documented.
184.108.40.206 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.
220.127.116.11 Physician Supervision: There should be appropriate
physician supervision of all professional staff that provide
18.104.22.168 Pharmacologic Administration: The Practice shall
demonstrate the following:
22.214.171.124.1 The administration of chemotherapy should
comply with federal and state requirements
regarding occupational safety and health.
126.96.36.199.2 Procedures to ensure that antineoplastic and
supportive-care drugs are properly labeled for
identity and dosage should be established.
188.8.131.52.3 Procedures to ensure that antineoplastic and
supportive-care drugs are mixed properly should
184.108.40.206.4 The date of administration of an antineoplastic
or supportive-care drug should fall within the
date of expiration on the manufacturer’s label.
220.127.116.11.5 Procedures to ensure that antineoplastic and
supportive-care drugs are properly handled
before and after preparation should be
18.104.22.168.6 Procedures to ensure that antineoplastic and
supportive-care drugs and their containers are
not contaminated or diluted should be
22.214.171.124.7 Antineoplastic and supportive-care drugs
should be available on a schedule that meets
26. treatment needs.
126.96.36.199.8 Antineoplastic and supportive-care drugs
should be furnished soon enough after mixing
to comply with the manufacturer’s preparation
188.8.131.52.9 Materials for patient education regarding
diagnosis, treatment, and drugs administered
should be available.
184.108.40.206.10 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.
220.127.116.11.11 Medications for the treatment of anaphylaxis,
including oxygen, should be immediately
18.104.22.168.12 The Practice should have review procedures to
detect and prevent both over- and under-
dosing of antineoplastic and supportive care
22.214.171.124.13 The Practice should have procedures to
manage chemotherapy extravasation
126.96.36.199 Patient Evaluation During Treatment.
188.8.131.52.1 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
184.108.40.206.2 Regular evaluations of the patient must be
done during the course of treatment.
Pertinent laboratory and imaging studies
should be periodically ordered and reviewed.
220.127.116.11.3 Patients should be monitored for treatment-
related side effects. The physician should
institute appropriate treatment for side effects
27. or the patient should be referred to a medical
specialist for consultation or treatment.
18.104.22.168.4 The patient and/or referring physician should
be informed of the progress of treatment
whenever deemed appropriate by the
22.214.171.124 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
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:
126.96.36.199 stage of disease.
188.8.131.52 pertinent histopathologic report(s).
184.108.40.206 pertinent history and physical examination performed
by the responsible Radiation Oncologist.
220.127.116.11 diagram(s) and/or photograph(s) of lesion(s).
18.104.22.168 examination, operative and radiographic reports.
22.214.171.124 documentation of informed consent to treatment.
126.96.36.199 radiation treatment records.
28. 188.8.131.52 diagram(s) and/or photograph(s) of field(s).
184.108.40.206 dosimetry calculations.
220.127.116.11 graphic treatment plan (e.g. isodose distribution) signed
and dated by a Radiation Oncologist, when applicable.
18.104.22.168 port image(s) documenting each treatment field.
22.214.171.124 dose verification records.
126.96.36.199 documented periodic (at least weekly) examinations of
patient, while under active treatment, by a Radiation
188.8.131.52 documentation that chart was checked at least weekly
during the course of radiation treatment by a Medical
184.108.40.206 treatment summary (completion of therapy note).
220.127.116.11 follow-up plan.
2.9.2 General Practice Review: The CQI Plan shall establish a review
processes for the following:
18.104.22.168 Physics Review. The Practice should have a process for
review of regular physics quality reports.
22.214.171.124 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.
126.96.36.199 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
188.8.131.52 Incident Report Review: The Practice should regularly
review all cases in which incident reports are filed and in
29. which there are reports of accidents or injuries to
184.108.40.206 Morbidity and Mortality Review: The Practice should
regularly review all cases in which any of the following
220.127.116.11.1 Unusual early or late complications of radiation
18.104.22.168.2 Unplanned interruptions during the course of
22.214.171.124.3 Severe early or late complications of radiation
126.96.36.199.4 Unexpected deaths.
188.8.131.52 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.
184.108.40.206 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
220.127.116.11 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
2.10 Safety Program
30. 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
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
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
2.11.2 Access to information pertinent to radiation treatment techniques,
new developments in the field of radiation oncology and related
2.11.3 Adherence to local licensing agency requirements for CME.
31. 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
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.
11.The Americans with Disabilities Act of 1990 (Public Law 101-336), 28 C.F.R.
Parts 35 and 36, www.access.gpo.gov.
32. 12.Americans With Disabilities Act (ADA) Accessibility Guidelines for Buildings and
Facilities; Architectural Barriers Act (ABA), 36 CFR Part 1191.
13.The Clinical Laboratory Improvements Act (CLIA) 42 C.F.R. Part 493.
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.
33. 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
Bethesda, MD 20816
Tel: (301) 718-6515
Fax: (301) 656-0989
Jeanne M. Carroll, Program Administrator
Department of Radiation Oncology
Medical University of Ohio
3000 Arlington Ave
Toledo, OH 43614
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)
• 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).
34. The American College of Radiation Oncology
5272 River Road
Bethesda, MD 20816
(301) 656-0989 Fax