N.Y. Comp. Codes R. & Regs. tit. 10 § 405.15

Current through Register Vol. 46, No. 45, November 2, 2024

Section 405.15 - Radiologic and nuclear medicine services

(a)General provisions for diagnostic and therapeutic radiologic services.

The hospital shall maintain or have available diagnostic radiologic services defined for purposes of this subdivision as imaging services utilizing diagnostic radiation equipment or devices which emit radiation by virtue of the application of high voltage. If therapeutic services are provided, they shall meet the requirements established in subdivision (b) of this section in addition to the requirements of this subdivision. In addition, the hospital shall meet the standards of Part 16 of the State Sanitary Code.

(1) The hospital shall maintain or have available radiologic services according to the needs of the patients as determined by the governing body in consultation with the medical staff and the administration.

(2) Radiologic services shall be provided in accordance with generally accepted standards of practice only on the order of physicians or, consistent with State law, of those other practitioners authorized by the medical staff and governing body to order such services.

(3) Safety for patients and personnel.

Written policies and procedures shall be developed and implemented and available for review. The policies and procedures regarding imaging studies for newborns and pediatric patients shall include standards for clinical appropriateness, appropriate radiation dosage and beam collimation, image quality and patient shielding. A policy and a procedure shall be developed to ensure that the practitioner's order for an imaging study is specific as to the body part(s) that are to be imaged.

Quality improvement audits shall verify that these policies and procedures are being followed. Quality improvement activities shall include a review of the adequacy of diagnostic images and interpretations.

(i) Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards and radiation hazards. This includes adequate shielding for patients and personnel, as well as appropriate storage, use and disposal of radioactive materials.

(ii) Any existing or potential hazards identified through periodic inspection by local or State health authorities shall be corrected promptly.

(iii) Personnel shall be instructed in radiation safety principles and practices. The radiation safety principles shall be adequate to ensure compliance with all generally accepted standards of practice as well as pertinent laws, rules and regulations. Policies and procedures shall be developed to minimize the radiation exposure that is necessary to produce high quality imaging studies on patients of all ages.

(iv) Radiologic procedures requiring the use of contrast media or fluoroscopic interpretation and control shall be performed with the active participation of a qualified specialist in diagnostic radiology or a physician qualified in a medical specialty related to the radiographic procedure. Emergency equipment and staff trained in its use shall be available for anaphylactic shock reactions from contrast media.

(4) Personnel.

The hospital shall provide qualified personnel adequate to supervise and conduct the services. For radiologic tests, the following personnel standards shall apply for the purposes of this subdivision:

(i) a full-time or part-time radiologist who is board certified or board admissible in radiology shall direct the clinical aspects of the organization and delivery of radiologic services. That radiologist or another individual qualified by education and experience shall direct the administrative aspects of the services;

(ii) radiologic tests shall be interpreted by a board certified or board admissible radiologist, except that radiologic tests may be interpreted by practitioners within their field of specialization who are granted privileges to interpret such tests by the governing body and the medical staff in consultation with the director of radiologic services pursuant to the credentialing process in the hospital;

(iii) the services of qualified radiologists, qualified practitioners, and licensed radiologic technologists shall be sufficient and available to meet the needs of the patients. A licensed technologist shall be on duty or available at all times and function in accordance with article 35 of the Public Health Law and Part 89 of this Title;

(iv) use of the radiologic equipment and administration of radiologic procedures shall be limited to personnel who are currently licensed and designated as qualified by the hospital in accordance with any applicable licenses and regulations.

(v) The chief of radiology, in conjunction with the radiation safety officer, shall ensure that all practitioners who utilize ionizing radiation equipment within the hospital are properly trained in radiation safety procedures for patients of all ages.

(5) Records.

Records of radiologic services including interpretations, consultations and therapy shall be filed with the patient's record, and duplicate copies shall be kept in the radiology department/service. All films, scans and other image records shall be referenced in the patient's medical record and retained in the patient's medical record, radiology department/service or in another central location accessible to appropriate staff. All electronic images shall have a duplicate storage either offsite or in another area of the hospital separate from the primary storage devices.

(i) Requests by the attending practitioner for X-ray examination shall contain a concise statement of reasons for the examination which shall be authenticated by the requestor.

(ii) The radiologist or other practitioner who performs radiology services shall authenticate reports of his or her interpretations.

(iii) The hospital shall retain films, scans and other image records which have not been incorporated in the medical record for at least six years or three years after a minor patient reaches the age of majority.

(b)Therapeutic radiology or radiation oncology.

Therapeutic radiology or radiation oncology services shall be provided in accordance with the following:

(1) no hospital providing the service shall refuse treatment of a patient on the basis of the referring practitioner or practitioner's facility affiliation, if known;

(2) institutions shall provide services for patients who cannot attend treatment sessions during normal day shift working hours;

(3) therapeutic radiology or radiation oncology services shall utilize six or more megavoltage (MEV) units with a source-axis distance of 100 or more centimeters as the primary unit in a multi-unit radiation oncology service;

(4) a therapeutic radiology service shall be headed by a board admissible or board certified radiation oncologist or a general radiologist who devotes at least 80 percent of his/her time to the practice of therapeutic radiology and who treats not fewer than 175 patients per year;

(5) a therapeutic radiology service shall have on staff:

(i) a full-time New York State licensed radiation therapists sufficient to meet the needs of the service; and

(ii) a full-time registered professional nurse with appropriate education and experience;

(6) a hospital with a therapeutic radiology service shall have on staff or through formal arrangements:

(i) a board admissible or board certified medical oncologist, hematologist or other specialist who devotes at least 80 percent of his/her practice to medical oncology and who treats not fewer than 175 oncology patients per year; and

(ii) A New York State licensed radiation therapy physicist who will be involved in treatment, planning and dosimetry as well as calibrating the equipment. The hospital shall provide for the services of a licensed radiation therapy physicist(s) in sufficient quantity to adequately meet the needs of its patients of all ages.

(iii) A physicist in training must be supervised by a licensed radiation therapy physicist.

(7) the therapeutic radiology service shall be part of a multidisciplinary approach to the management of cancer patients, involving a variety of specialists in a joint treatment program, either through formal arrangement or in the facility;

(8) each patient shall have a treatment plan in his/her medical records;

(9) each therapeutic radiology service shall have access, either through formal arrangements or in the facility, to a full range of diagnostic services, including hematology, pathology, and medical imaging procedures;

(10) each facility providing therapeutic radiology services shall have access to the full range of rehabilitation therapies, including but not limited to physical therapy, occupational therapy, vocational training, and psychological counseling services for its radiotherapeutic patients;

(11) a radiation therapy program operating a linear accelerator with photon or electron beam energies greater than 10 MEV's must be a part of a comprehensive program of cancer care which includes surgical oncology, medical oncology, pathology and diagnostic radiology. In addition such program shall meet the following standards:

(i) there shall be two full-time equivalent radiation oncologists on staff who are board-certified in radiation oncology or have equivalent training and experience and whose professional practices are limited to radiation oncology;

(ii) there shall be a full-time medical radiation physicist assigned to the radiation therapy program for the treatment planning of patients; and

(iii) a CT scanner shall be available within the radiation therapy program that is equipped for radiation oncology treatment planning or arrangements shall be made for access to a CT scanner on an as needed basis.

Provisions shall be made for access to an MRI scanner for treatment planning purposes on an as needed basis.

(c)Nuclear medicine services.

If the hospital provides nuclear medicine services, those services shall meet the needs of the patients in accordance with generally acceptable standards of practice. Nuclear medicine services shall be ordered only by a physician whose Federal or State licensure and staff privileges allow such referrals.

(1) Organization and staffing.

The organization of the nuclear medicine service shall be appropriate to the scope and complexity of the services offered.

(i) The clinical aspect of the organization and delivery of nuclear medicine services shall be directed by a physician who is qualified in nuclear medicine and named in the facility's New York State Health Department or New York City Health Department radioactive materials license as authorized to use radioactive materials in humans. The administrative aspects of these services shall be directed by that physician or another individual qualified for such duties by education and experience.

(ii) The qualifications, training, functions and responsibilities of all nuclear medicine personnel shall be specified by the clinical service director in accordance with applicable regulations and approved by the medical staff and the hospital.

(2) Delivery of service.

Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with generally acceptable standards of practice and pertinent laws, rules and regulations.

(i) In-house preparation of radiopharmaceuticals shall be by, or under the direct supervision of, an appropriately trained registered pharmacist or a physician whose use of radioactive materials is authorized in the facility's New York State Health Department or New York City Health Department radioactive materials license.

(ii) If clinical laboratory tests are performed in the nuclear medicine service, the service shall meet the requirement for clinical laboratories with respect to management, adequacy of facilities, proficiency testing and quality control in accordance with the requirements of section 405.16 of this Part.

(3) Facilities.

The hospital shall provide equipment and supplies which are appropriate for the types of nuclear medicine services offered and shall maintain such for safe and effective performance. The equipment shall be:

(i) maintained in safe operating condition; and

(ii) inspected, tested, and calibrated at least annually by qualified personnel and at the intervals specified in the hospital's quality assurance program.

(4) Records.

The hospital shall maintain authenticated and dated reports of nuclear medicine interpretations, consultations and procedures.

(i) The hospital shall maintain copies of nuclear medicine reports which have not been incorporated into the patient's medical record for at least six years or three years after the patient reaches the age of majority.

(ii) Interpretation of the results of nuclear medicine procedures shall be made by a physician authorized in the facility's New York State Health Department or New York City Health Department radioactive materials license, or a physician under his/her tutelage. Interpretations may be made in consultation with the referring practitioner or other practitioners. The authorized physician, or physicians in tutelage, shall authenticate and date the interpretations of these tests.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.15

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019