Radiation oncology practice accreditation: The American College of Radiation Oncology, Practice Accreditation Program, guidelines and standards

Critical Reviews in Oncology/Hematology 55 (2005) 93–102

Radiation oncology practice accreditation: The American College of Radiation Oncology, Practice Accreditation Program, guidelines and standards Gregory W. Cotter a,∗ , Ralph R. Dobelbower Jr. b a

Division of Radiation Oncology, The University of South Alabama College of Medicine, 307 University Blvd., CC/CB Room 135, Mobile, Alabama36608, USA b Department of Radiation Oncology, Medical College of Ohio, CS 10008, Toledo, OH 43699, USA Accepted 10 March 2005

Contents 1.

2.

3.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1. History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2. Quality of care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3. Accreditation assessment methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4. Standards and guidelines in radiation oncology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5. Governmental requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The ACRO PAP structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2. Radiation therapy personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3. Radiation therapy equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4. Process of radiation therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5. Continuous Quality Improvement Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6. Radiation Safety Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7. Education program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary and perspectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Biographies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

94 94 94 94 94 95 95 96 96 97 98 99 100 101 101 101 101 101 102

Abstract The American College of Radiation Oncology Practice Accreditation Program (ACRO PAP) is a process by which a medical practice is evaluated through an in depth external review to ascertain whether or not key components of the practice comply with existing regulations, rules, laws, practice guidelines and professional practice standards. In radiation oncology, like other fields, it is driven by the need or desire to demonstrate an identified level of patient care.The accreditation process adopted by the American College of Radiation Oncology (ACRO) is based on the parameters of quality care assessment outlined by the National Academy of Science’s Institute of Medicine. Those practices that meet these criteria are eligible for recognition and accreditation by ACRO. © 2005 Elsevier Ireland Ltd. All rights reserved. Keywords: Radiation therapy; Treatment guidelines; Standards; Accreditation; Facilities; Personnel; Equipment; Continuous quality improvement

∗

Corresponding author. Tel.: +1 251 460 7160; fax: +1 251 460 6531. E-mail address: [email protected] (G.W. Cotter).

1040-8428/$ – see front matter © 2005 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.critrevonc.2005.03.002

94

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

1. Introduction 1.1. History Accreditation of medical services is based on the need or desire to demonstrate an identified level of medical care. The need to demonstrate an identified level of medical care may be driven by a variety of reasons. Some governmental agencies may require accreditation for licensure or other regulatory purposes. Governmental and private third party payors for healthcare services may desire to reference payment to standardized care. Also a medical practice may desire to seek accreditation to demonstrate an identified level of care to its patients or community. The American College of Radiation Oncology (ACRO) Practice Accreditation Program (ACRO PAP) was initiated in 1996 as a service to ACRO members to achieve the above goals. At the time of this writing the ACRO has received 237 applications for radiation oncology practice accreditation over about a 6-year time period. The ACRO has awarded accreditation to 196 of those practices during this time and 126 practices carry active ACRO accreditation. Sixty-seven radiation oncology practices are currently going through the ACRO PAP examination process. Twenty-eight practices have sought reaccreditation and four practices have thrice sought accreditation. Approximately 75% of first-time applicant practices achieve full (3-year) ACRO accreditation. Approximately 20% of such applicant practices are awarded provisional ACRO accreditation and approximately 5% of applicant practices fail to achieve ACRO accreditation. 1.2. Quality of care The goal of the ACRO PAP is to provide a method of assessing quality in the practice of radiation oncology. Quality of care is defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge [1]. Inherent in this definition is the public health aspect of medical care. This is an important aspect because substantial amounts of healthcare services are funded through governmental sources in the United States and other countries today. The reality in this acknowledgement is that medical care can only be delivered to a population within the economic limits of the funding source. 1.3. Accreditation assessment methods The method of assessment of quality of care is important to the value of the recognition or accreditation at the completion of the process. In this regard the methods of assessment should provide a reasonable review of aspects relevant to patient care. The Institute of Medicine (IOM) and the National Research Council established the National Cancer Policy Board (NCPB) in 1997 [2]. One of the questions

tasked to the NCPB was to address “What is quality cancer care and how is it measured.” The NCPB outlined a method for quality assessment of cancer care. “Quality assessment is the measurement of quality by expert judgment (implicit review) or by systematic reference to objective standards (explicit review).” While implicit review is used as an accrediting method its supplementation by explicit review allows for a broader and perhaps more meaningful assessment to be performed. The ACRO PAP utilizes both types of review. The explicit review method provides a systematic approach to quality assessment and incorporates three dimensions of assessment. The three dimensions of assessment are structure, process and outcome. “Structural quality” refers to health system characteristics, “process quality” refers to what the provider does and “outcome quality” refers to the patient’s ultimate health. Structural quality alone, while often easy to assess, is not an adequate measure of quality of care. Outcome quality is the best measure of quality however adequate outcome data is often lacking for a variety of reasons. As such process quality is often used as a surrogate or proxy for assessing quality of care. Process quality relies on technical quality and interpersonal quality. “Technical process” can be measured according to appropriateness criteria, practice guidelines or professional standards. Evidence-based practice guidelines for patient care is often useful for assessment particularly when they are linked to a defined outcome. “Interpersonal quality” refers to whether the care is provided to the patient in a humane manner. Interpersonal quality is often evaluated using patient surveys. Assessment of interpersonal quality may include aspects such as was the patient provided sufficient information to make an informed decision regarding their medical care. In the radiation oncology setting the patient comes in contact with a variety of personnel providing care. Assessment of the aspects of non-physician care may be appropriate and useful to the practice. 1.4. Standards and guidelines in radiation oncology Initiatives to define standards for radiation oncology treatment date back to at least the 1950s. In 1950 the National Cancer Institute of Canada published a booklet entitled “Minimum standards of radiation therapy centres” [3]. This was followed in 1957 with a revision entitled “Standards for radiation therapy centres recommended by the National Cancer Institute of Canada.” In the United States the Committee for Radiation Therapy Studies (CRTS) was formed in 1959 through the combined efforts of the National Cancer Institute (NCI) and the Radiation Study Section [4]. In 1967 the CRTS submitted a paper to the NCI in which the requirements for major and satellite cancer centers were outlined. In 1968, the CRTS submitted another report to the NCI entitled “A prospect for radiation therapy in the United States.” This report also referred to as the “blue book” described in some detail the current practice of radiation therapy as well as staffing and facility require-

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

ments. The “blue book” was periodically updated and was last published in 1991. It is now out of print. Other initiatives have strived to develop guidelines or standards for medical practice including radiation therapy. Debate continues as how best to characterize those elements that form the basis of current mainstream medical practice. While the terms guideline and standard are often used interchangeably there are significant differences in them. The term guideline is defined as a principle by which to determine a course of action [5]. The term standard is defined as something established for use as a rule or basis of comparison in measuring quality. In essence a guideline points us in the right direction while a standard is our ultimate goal. Both terms have utility in trying to define acceptable practice parameters and are not mutually exclusive. Another useful concept is “scope of practice.” This term perhaps begins the effort to define acceptable practice parameters by limiting or defining the realm of medical practice one is focusing on. The process of first defining the scope of practice and next developing or identifying meaningful practice guidelines in the defined area of interest hopefully leads to the establishment of acceptable standards for medical care, in this case for radiation therapy. Different methods of developing guidelines and standards in medical practice have been utilized. Two common methods are expert opinion and consensus. Neither method unto itself insures that the guideline or standard developed will in fact achieve the desired level of credibility. Another method involves surveying the practice patterns of physicians as performed in the Patterns of Care Study supported by the National Institutes of Health [6,7]. While information of this latter type is a useful profile of current practice it does not in unto itself establish scientifically proven standards of care. For this reason, The Patterns of Care Study incorporated Donabedian’s model of quality of care assessment to try to compare practice patterns to quality of care endpoints [8]. In order to improve credibility in guideline or standard development some authors have incorporated evidencebased guidance into their process. The tern evidence-based medicine first appeared in the medical literature in 1991 [9]. Clinical practice guidelines (CPGs) are defined a systematically developed statements aimed to assist in health care decisions made by clinicians, policy-makers and patients for specific clinical circumstances [10]. This concept was developed by clinical epidemiologists at McMaster University in Canada beginning in the 1970s [11]. It led to the formation of an international Evidenced-based Medicine Working Group whose work was subsequently published in the Journal of the American Medical Association [12]. Today various groups have published evidence-based guidelines and standards in the area of oncology and more specifically in the field of radiation oncology. The standards utilized by the ACRO PAP have been selected and reviewed by the ACRO Standards Committee and the ACRO Board of Chancellors. These include standards for external beam radiation therapy, external beam medical physics, brachytherapy

95

and pharmacologic agents [13–16]. The ACRO PAP also utilizes various practice guidelines from the medical literature for evaluation of patient care and physics aspects of the practice. 1.5. Governmental requirements In addition to the guidelines and standards in the field of radiation oncology governmental regulations play an important role in defining acceptable practice in the field of medicine today. Examples of this are regulations applying to health and safety, persons with disabilities, patient privacy and safety codes.

2. The ACRO PAP structure The ACRO PAP has been structured to incorporate aspects of quality of care assessment discussed in the above paragraphs. The steps in the ACRO PAP are the application process, the survey process, the review process and practice accreditation. The paragraphs that follow describe these steps in more detail and are adapted from the ACRO Red Book Guidelines for the ACRO Practice Accreditation Program [17]. Likewise, the parameters reviewed during the ACRO PAP are described: • Application Process: The practice seeking ACRO PAP accreditation will initially communicate their interest to the ACRO office in Bethesda, MD. The ACRO will then send an application form to the practice. Once the ACRO receives the application form and the 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 infor mation. • 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. • Practice 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.

96

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

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. Throughout this report the use of the terms “shall” or “must” indicate a requirement to be met. The terms “should” or “recommended” indicate an important practice standard or guideline, but one that may be modified to fit individual practices needs provided that safety and effectiveness are not compromised. During the above steps in the ACRO PAP process the following aspects of the practice are reviewed. 2.1. 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. Aspects of facility review include the following: 1. Parking: There should be adequate parking for patients and their families including a sufficient number of handicapped designated spaces. 2. Accessibility: The facility should be accessible for patients including those with handicaps or disabilities. 3. Waiting area(s): There should be a comfortable waiting area sufficient for the needs of patients and their families. 4. Reception/business areas: There should be sufficient space for a reception area, record storage and business functions of the practice. 5. Restrooms: There should be a sufficient number of restrooms for patients, their families and the staff including access for handicapped and disabled individuals. 6. Examination Rooms: There should be adequate examination rooms for patient care and, ideally, an area for examination of stretcher- and wheelchair-bound patients. 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. 8. Treatment planning/physics/dosimetry areas: There should be adequate space for Treatment Planning, Physics and Dosimetry functions performed on site. 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 manufacturer, 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 review of the treatment room should be available for review. 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. 11. Offices: There should be sufficient office space for physicians, physicists and other supervisory personnel to carry out their functions. 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. The practice should demonstrate compliance with the applicable rules of the Americans with Diasabilities Act (ADA), the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Occupational Safety and Health Administration (OSHA) and local fire codes. 2.2. 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. 1. Radiation Oncologist: A Radiation Oncologist must have (1) satisfactorily completed a radiation oncology residency in an American Council of Graduate Medical Education (ACGME) 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. 2. Conservatively a Radiation Oncologist can manage 30–40 patients/day under treatment. Considering consultations, on treatment visits, simulation and follow-up visits, this translates to approximately 65–90 patient encounters per week and allow 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-h basis, 365 days/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. Medical Physicist in Radiation Oncology: A Medical Physicist should be (1) board certified or board eligible in

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

the appropriate medical physics subfield and must be (2) licensed in those states where licensure exists. The following board certifications or eligibilities 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 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. Practices without a full-time physicist must have regular on-site physics support during hours of clinical activity, at least weekly. Chart checks by the physicist or his/her designate should be performed at least once each week. 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 or by a Medical Physicist or his supervised designee under the supervision of a Radiation Oncologist. A practice shall demonstrate a sufficient number of Medical Dosimetrists, Medical Physicists and/or other individuals as noted above to fullfill the dosimetry requirements for the patient population under treatment. In general, there should be at least one FTE dosimetry person per 40 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. 4. Radiation Therapy Technologist (RT(T)): Radiation Therapy Technologists 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 ideal to have two RT(T)s per megavoltage treatment unit under a standard schedule 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.

5.

6.

7.

8.

97

If only a single RT(T) is assigned to a treatment unit 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. 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 Therapy Technologist(s). Simulation Staff: Simulation 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 are similar to those of megavoltage treatment units. 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. Clerical Staff: The practice should demonstrate a sufficient number and type of Clerical Staff sufficient for the needs of the practice.

2.3. Radiation therapy equipment Radiation therapy equipment should include, but not be limited to: 1. Megavoltage radiation therapy equipment for external beam therapy (e.g., linear accelerator or 60 Co teletherapy unit). If the 60 Co machine is the only megavoltage radiation treatment unit, it must have a treatment distance of 80 cm or more. 2. Electron beam or superficial X-ray equipment suitable for treatment of superficial (e.g. skin) lesions or access to such equipment. 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. 4. Brachytherapy equipment for intracavitary and interstitial treatment or arrangements for referral to facilities with appropriate capabilities for such treatment. 5. Computer dosimetry equipment capable of calculating and displaying external beam isodose curves as well as brachytherapy isodose curves. Three-dimensional (3D) dosimetry capability is desirable. 6. Physics calibration devices for all equipment.

98

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

7. Treatment aides: • Beam-shaping devices. • Immobilization devices. • Additional treatment aides as deemed appropriate by the practice. 8. Maintenance and Repair: Regular maintenance and repair of equipment is mandatory. 2.4. Process of radiation therapy As noted above, the process of radiation therapy treatment consists of a series of steps as noted in Fig. 1. 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. The typical procedures for external beam radiation therapy are as follows: 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. Informed Consent: Informed consent must be obtained and documented. This should include a discussion of the

Fig. 1. The process of radiation therapy.

proposed treatment, its rational, options for treatment if appropriate and a review of the logistics, risks and side effects of treatment. 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/day, number of fractions/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, the Radiation Oncologist must select the radionuclide(s); select the method of intracavitary, interstitial or systemic administration (oral or intravascular); ensure applicators are properly in place; obtain localization radiographs; calculate dose distributions and review these dose distributions; and complete the prescription, which 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. 4. Simulation: The establishment of the area(s) of treatment is termed simulation. Simulation is carried out by an RT(T) or RT under the direction of the Radiation Oncologist. Simulation is used for both external beam treatments and brachytherapy as well as combination treatment. Today simulation may be accomplished on the treatment machine, with radiographic units, fluoroscopic units, or 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. 5. Dose calculation and/or Computer planning: Dose calculations may be carried out by hand or by computer by the

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

6.

7.

8.

9.

10.

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. 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.). Radiation treatment delivery: The next step in external beam radiation therapy is the actual treatment. The Radiation Therapy Technologist, 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. 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, at least every other week 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 simulator 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. 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. 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 taken to address issues related to treatment.

99

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. 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.

2.5. Continuous Quality Improvement Program Continuous Quality Improvement Plan: The practice shall have a Continuous Quality Improvement (CQI) Plan that includes a Continuous Quality Improvement Committee. This may be combined with the Radiation Safety Program. The following items should be included in a CQI program: 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: • diagnosis; • stage of disease; • pertinent histopathologic report(s); • pertinent history and physical examination performed by the responsible Radiation Oncologist; • diagram(s) and/or photograph(s) of lesion(s), examination, operative and radiographic reports; • documentation of informed consent to treatment; • radiation therapy treatment records; • diagram(s) and/or photograph(s) documenting each treatment field; • dosimetry calculations; • graphic treatment plan (e.g. isodose distribution) signed and dated by a Radiation Oncologist, when applicable; • dose verification records; • documented periodic (at least weekly) examinations of patient, while under active treatment, by a Radiation Oncologist; • documentation that chart was checked at least weekly during the course of radiation treatment by a Medical Physicist; • treatment summary (completion of therapy note); • follow-up plan.

100

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

2. General Practice Review: The CQI Committee shall establish a review processes for the following: • Physics Review. The practice should have a process for review of regular physics quality reports. • 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 should review include any case in which mathematical dose corrections of 10% or more are made as a result of any dose verification or recalculation procedure. • New Procedure Review. When any new treatment modality or technique is introduced at the facility, the procedures, results, problems, complications, etc., should be reviewed by the QA committee in a timely fashion consistent with patient safety. • Incident Report Review. The practice should regularly review all cases in which incident reports are filed or in which there are reports of accidents or injuries to patients. • Morbidity and Mortality Review. The practice should regularly review all cases in which any of the following occur: ◦ Unplanned interruptions during the course of radiation treatment. ◦ Unusual early or late complications of radiation treatment. ◦ Severe early or late complications of radiation treatment. ◦ Unexpected deaths. • Outcome Studies Review. The practice should review pertinent outcome studies from the Cancer Committee, Tumor Registry or any other section, department or committee of an associated hospital or healthcare entity. • Radiation Oncologist Peer Review. At least ten percent (10%) of all cases managed within a radiation oncology practice must be regularly examined via a physician (Radiation Oncologist) peer review mechanism. Such peer review activities shall occur no less frequently than once each quarter. • Review of Patient Outcome Data. Radiation Oncologists must, at appropriate intervals, follow all radiation therapy patients treated with curative intent (and patients treated with palliative intent where appropriate) in order to document the outcomes of therapy including tumor control, survival and significant treatment-related sequelae. • 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:

◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦

Number of consultations. Number of new patients treated. Number of patients retreated. Number of patients treated with curative intent, palliative intent, and for local tumor control. Number of simulations. Number of external beam treatments. Number of brachytherapy procedures. Anatomic sites and stages (AJCC, UICC, etc.) of diseases treated. Stage-related patient survival rates and local tumor control rates. Treatment-related complications and complication rates.

2.6. Radiation Safety Program Radiation safety measures should include the following: 1. Radiation Safety Program: The practice shall have a written Radiation Safety Program that will include a Radiation Safety Committee. 2. Charting system(s) appropriate for the prescription, definition and delivery of radiation treatment, as well as for daily dose recording and dose summation(s), including appropriate charting system(s) for brachytherapy procedures shall be maintained. 3. Physics program(s) for calibration of equipment so as to ensure accurate dose delivery via both external beam radiotherapy and brachytherapy shall be in effect. 4. System(s) for independent verification of initial dose calculations prior to administration of the third treatment (or 20% of the total prescribed dose for treatment schedules with less than 10 fractions) and for weekly checks of all delivered doses shall be in place. 5. System(s) for independent verification of initial dose calculations prior to administration of any treatment in the case of single or two-fraction treatment regimens (e.g. intraoperative, stereotactic, hemi-body irradiation, etc.) shall be in place. 6. System(s) for the Radiation Oncologist and Radiation Physicist to independently verify all parameters for each brachytherapy procedure (source, isotope, activity, dose rate, total dose, point(s) of dose specification, time of application, proper patient identification, etc.) shall be in effect. 7. Program(s) to prevent mechanical injury caused by the radiotherapy machine(s) and/or accessory equipment shall be in place. 8. Systems for visual monitoring and communication with patients during radiation therapy. 9. Program(s) and equipment to establish and maintain personnel safety should include: • Radiation exposure monitoring program(s), as required by the Nuclear Regulatory Commission (NRC) and/or the appropriate state regulatory agencies.

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

• Visual and auditory warning devices as required by the Nuclear Regulatory Commission (NRC) and/or the appropriate state regulatory agencies. • Program(s) to ensure systematic inspection of interlock systems. • Appropriate shielding of radiation therapy treatment rooms. • Program(s) to ensure routine leak testing of all sealed radioactive sources as required by federal and state regulatory agencies. • Appropriate safety equipment for the use of sealed (and unsealed, as the case may be) radiation sources. 2.7. Education program Continuing medical education (CME) programs are required for Radiation Oncologists and physicists as well as the physics, dosimetry, nursing and radiation therapy technology staffs. This program shall include: 1. Access to information, as appropriate to each individual’s responsibilities, pertinent to safe operation of all equipment within the facility. 2. Access to information pertinent to radiation treatment techniques and new developments in the field(s) of radiation oncology.

3. Summary and perspectives In summary, accreditation has become a means of demonstrating and documenting that medical practices meet existing standards of patient care. Demonstrating that medical care meets existing quality standards may be important from a variety of standpoints including consumer awareness, providing legal documentation and/or meeting regulatory requirements. The ACRO Practice Accreditation Program was initiated in 1996 and is designed to assess the various aspects of medical care in the radiation oncology practice requesting review. A number of methods of assessment are employed to evaluate the various elements of the practice under review. Through this structured approach a balanced assessment of the radiation oncology practice is achieved. The American College of Radiation Oncology then recognizes those practices meeting the established standards of medical care through accreditation of the practice. In addition to the reasons for attaining accreditation noted above, the ACRO Practice Accreditation Program provides a way for the collaborators of the service to think together, to improve the efficiency and satisfaction of their work and understand and respect the work of each other. Ideally, this process provides a dynamic way to continuously assess the use of medical technology, services and thinking for the benefit of the patient.

101

Acknowledgements The author wishes to thank the American College of Radiation Oncology, Jeanne M. Carroll, ACRO PAP Administrator and E. Ishmael Parsai, Ph.D., ACRO PAP Physics Consultant. Reviewers Jean-Calude Horiot, Professor, Directeur, Centre de Lutte contre le Cancer G.F. Leclerc, 1, Rue Marion, F-21079 Dijon, France. Dr. Dominique Schneider, D´epartment de Radiooncologie, Clinique de Genolier, 1 rte du Muids, CH-1272 Genolier, Switzerland. Jacques Bernier, M.D., P.D., Chairman, Department of Radio-Oncology, Oncology Institute of Southern Switzerland, San Giovanni Hospital, CH-6504 Bellinzona, Switzerland. Christopher S. Walsh, M.D., President & CEO, Virginia Radiation Therapy and Oncology, P.C, 12000 Kennedy Lane Suite 104, USA. References [1] Institute of Medicine. Volume 1. Committee to Design a Strategy for Quality Review and Assurance in Medicine, Institute of Medicine. Lohr K, editor. Medicare: A Strategy for Quality Assurance. Washington, DC: National Academy Press, 1990. [2] Institute of Medicine and Commission on Life Sciences, National Research Council. In: Hewitt M, Simone JV, editors. Ensuring quality cancer care. Washington, DC: National Academy Press, 1999, p. 1–115. [3] Walton RJ. Cancer centres. In: Vaeth JM, editor. Frontiers of Radiation Therapy and Oncology, vol. 8. Baltimore: University Park Press: Radiation Therapy and the Cancer Center; 1973. p. 36–41. [4] Kramer S. Radiation therapy and the cancer center. In: Vaeth JM, editor. Frontiers of Radiation Therapy and Oncology, vol. 8. Baltimore: University Park Press: Radiation Therapy and the Cancer Center; 1973. p. 26–8. [5] Webster’s New World Dictionary. Warner Books. New York; 1990. [6] Kramer S. The study of patterns of care in radiation therapy. Cancer 1977;39:780–7. [7] Kramer S. The patterns of care study: A nationwide evaluation of the practice of radiation therapy in cancer management. Int J Radiat Oncol Biol Phys 1976;1:1231–6. [8] Donabedian A. Evaluating the quality of medical care. Milbank Meml Fund Quart 1966;44:166–206. [9] Guyatt GH. Evidence-based medicine. ACP J Club 1991;114:A-16. [10] Browman, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995;13:502–12. [11] The Evidence-based Medicine Working Group. In: Guyatt G, Rennie D, editors. User’s guide to the medical literature: a manual for evidence-based clinical practice. Chicago, IL: AMA Press; 2002, p. xiii–xvi. [12] Evidence-based Medicine Working Group. Evidence-based medicine: a new approach to the teaching of medicine. JAMA 1992;268:2420–5. [13] American College of Radiation Oncology. Standards for radiation oncology; 2002 http://www.acro.org/pages/programs/radiation standards.cfm.

102

G.W. Cotter, R.R. Dobelbower Jr. / Critical Reviews in Oncology/Hematology 55 (2005) 93–102

[14] American College of Radiation Oncology. Physics standards – external beam radiation therapy; 2002 http://www.acro.org/pages/ programs/radiation standards physics.cfm. [15] American College of Radiation Oncology. ACRRO standards for the use of pharmacologic modifying, adjunctive and supportive agents in radiation oncology; 2002 http://www.acro.org/pdf/standards/ pharmacologic.pdf. [16] Nag S, et al. Inter-society standards for the performance of brachytherapy: a joint report from ABSACMP and ACRO. Crit Rev Hematol/Oncol 2003;48:1–17. [17] American College of Radiation Oncology Red Book: Guidelines for the ACRO Practice Accreditation Program, Bethesda: American College of Radiation Oncology; 2004.

Biographies Gregory W. Cotter, M.D., FACRO is Adjunct Professor, Director of the Division of Radiation Oncology and Philip

Rubin Scholar in Radiation Oncology at the University of South Alabama College of Medicine in Mobile, Alabama, USA. He is also Chairman of the American College of Radiation Oncology’s Standards Committee. His interests include practice standards development, breast cancer treatment and neurological oncology. Ralph R. Dobelbower, MD, PhD, FACR, FACRO is Professor Emeritus & Founding Chairman Department of Radiation Oncology and Professor of Neurological Surgery Medical University of Ohio, Toledo, Ohio. He is the Medical Director of the American College of Radiation Oncology Practice Accreditation Program and Past Chairman of the Standards Committee. His interests include practice standards development, intraoperative radiation therapy and gastrointestinal oncology.