18.1 General
1. If the healthcare organization provides diagnostic radiology services, this service shall meet professionally approved standards. In addition, the healthcare organization shall meet or exceed standard of care for radiation safety.
2. The scope of radiological services offered shall be specified in writing and approved by the medical staff and Governing Body. These services shall be effectively associated with the clinical operationsof the healthcare organization and be readily available as required.
3. The healthcare organization’s radiological services, including any contracted services, shall be integrated into its healthcare organization management system.
4. If the healthcare organization provides nuclear medicine services, this service shall meet professionally approved standards for administration, nuclear medicine safety, and patient care. This shall include training and credentialing requirements for associated staff.
5. The scope of nuclear medicine services offered shall be specified in writing and approved by the medical staff and Governing Body. These services shall be effectively associated with the clinical operations of the healthcare organization and be readily available as required.
6. Therapeutic services shall be in accordance with acceptable standards of practice defined above as well as any standards and recommendations defined by the medical staff.
NOTE 1 Radiological or nuclear medicine services may be provided by the healthcare organization directly or through an outsourced arrangement. Outsourced diagnostic radiology or therapeutic or nuclear medicine services may be provided either on premises or in a remote facility. Credentialing and quality control of outsourced services is described in STANDARD 8.6.11.
18.2 Safety for Patients and Staff
1. The healthcare organization shall develop and implement policies and procedures to assure a safe environment for patients and staff specifically in areas where ionizing medical procedures are performed.
2. Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice as defined by the medical staff under the direct supervision of an appropriately trained registered pharmacist or Doctor of Medicine. The nuclear medicine services shall be free from unacceptable and uncontrolled hazards for patients and personnel.
3. The healthcare organization policies and procedures shall address the safety standards for at least but not limited to:
a) adequate shielding for patients, staff and facilities;
b) labeling of radioactive materials, waste, and hazardous areas;
c) transportation of radioactive materials between locations within the healthcare organization;
d) securing radioactive materials, including determining limitations of access to radioactive materials;
e) testing, maintenance, and calibration of equipment according to manufacturer’s or healthcare organization’s requirements and standards for prevention of radiation hazard to patients, all staff, and other personnel;
f) maintenance, monitoring, and calibration of all critical measuring devices for equipment function;
g) proper storage of radiation monitoring badges when not in use;
h) storage and disposal of radio nucleotides and radio pharmaceuticals as well as radioactive waste;
i) screening and restriction methods to protect patients and staff who may be pregnant;
j) any other real or potential, unacceptable, uncontrolled hazards for patients and personnel.
4. Proper radiation safety precautions shall be developed and maintained to address adequate shielding for patients, staff, and facilities. This shall include periodic testing or appropriate screening of all personal shielding to assure shielding competence and to prevent use of any non-conforming products. Included in this requirement is the responsibility of the appropriate authority to maintain and accurate inventory and location of all personal shielding to be tested. Records of the results of this testing and any corrections and corrective actions undertaken shall be maintained and retained as documented information in accordance with the needs of the healthcare management system.
5. Staff who work in radiation areas shall be monitored continually for radiation exposure by the use of meters or badge dosimeters. Policies and procedures relating to this requirement shall include at least but are not limited to:
a) time, place and position of radiation badges to be worn on relevant staff;
b) methods for monitoring, measuring, and analysis of data collected including a specified timeframe for the appropriate and regular accomplishment of this requirement;
c) appropriate and timely consultation with individuals to inform them of their degree of exposure;
d) corrections and corrective actions indicated as result of b) and c) above;
e) investigation of any high radiation exposure readings. This investigation shall be reported to healthcare organization management system oversight.
6. Aggregate objective monitoring, measurement, and analysis of the requirements herein shall be reported to the healthcare management system as required by STANDARD 4.7.4. Results of these investigations shall also be reported to the pharmacy and therapeutics committee of the medical staff.
18.3 Facilities
1. Physical and work environment, equipment, and supplies shall be appropriate for the types of radiologyand nuclear medicine services offered. They shall be maintained for safe and efficient performance.
2. The healthcare organization shall have policies and procedures in place to ensure that periodic inspections of radiology and nuclear medicine equipment are conducted as required.
3. Timely and regular inspection of equipment shall be performed according to manufacturer’s recommendations and/or as indicated by the functional condition of the equipment in question.
4. Inappropriate equipment functions and hazards shall be identified and promptly corrected. When periodic inspections have identified that equipment is not operating appropriately or malfunctioning, this equipment shall be removed from service, repaired, and verified prior to be replaced in operation for patient care. Equipment which does not conform to requirements shall be identified and controlled to prevent its unintended use without appropriate review. The healthcare organization shall take action appropriate to the potential impact on patient risk and safety care when the failure is detected after care has been previously delivered.
5. Records of preventive maintenance, repairs, corrections and/or corrective actions resulting from nonconforming product and processes, and calibration of radiology equipment shall be maintained as documented information as determined necessary by the healthcare organization.
18.4 Order
1. Radiology and nuclear medicine services shall be provided only on the order of practitioners with clinical privileges and consistent with national and regulatory requirements.
2. The healthcare organization shall develop and implement policies that have been approved by the medical staff to designate which radiology tests require interpretation by a radiologist.
18.5 Personnel
1. The healthcare organization shall ensure that appropriate medical and other required staff personnel are provided to meet the needs of radiology and/or nuclear medicine department.
2. A qualified full-time radiologist or nuclear medicine specialist shall supervise these services specified in the standard. Medical staff who interpret radiology tests shall be appropriately credentialed by the medical staff and Governing Body.
3. This supervisor shall be a member of the pharmacy and therapeutics committee and attend all meetings. Another departmental physician delegate may be appointed as required by circumstance.
18.6 Records
1. Records of medical imaging and nuclear medicine services shall be maintained in accordance with regulations. The organization shall maintain the following patient records for at least 5 years:
a) copies of reports;
b) films, scans, and other image records;
c) documents and patient records relating to ongoing care specific to the nuclear medicine department.
2. The radiologist or other practitioner who interprets radiology images and outcomes shall sign, date, and time the written or otherwise documented reports of his/her interpretations.
3. The healthcare organization shall maintain records of the receipt and disposition of radio- pharmaceuticals in accordance with applicable standards. Significant deviations of accounting shall be reported to the service Director, the Top management of the healthcare organization, and any other regulatory authority as required.
- Thêm trang cùng cấp
- Đăng nhập để gửi ý kiến