Current through Register Vol. 46, No. 39, September 25, 2024
(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.
