16 Del. Admin. Code § 3340-13.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3340-13.0 - Laboratory and Radiologic Services

13.1 The FSED shall provide on-the-premises clinical laboratory services and diagnostic radiology services during all hours of operation.

13.2 Laboratory Services

13.2.1 Clinical laboratory services shall include collection, processing and provision of results to meet a patient's emergency laboratory needs.

13.2.2 Laboratory Services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in 42 Code of Federal Regulations §§ 493.1 - 493.1780.

13.2.3 When blood and blood components are stored, the FSED shall have written procedures readily available containing directions on how to maintain the blood and blood components within permissible temperatures and including instructions to follow in the event of a power failure or other disruption of refrigeration.

13.2.3.1 Blood transfusions shall be prescribed in accordance with facility policy and administered in accordance with a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.

13.2.3.2 Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to adopted, implemented, and enforced facility policy.

13.2.3.3 Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.

13.2.3.4 Facility staff must observe the patient for potential adverse reactions during the transfusion and for an appropriate time thereafter, and document the observations and patient's response.

13.2.3.5 Pre-transfusion and post-transfusion vital signs shall be recorded.

13.2.3.6 Following the transfusion, the blood transfusion record or copy shall be made a part of the patient's medical record.

13.2.4 The FSED shall establish a mechanism for ensuring that the patient's physician or other licensed health care professional is made aware of critical lab value results, as established by the medical staff, before or after the patient is discharged. A physician or non-physician practitioner shall read, date, sign and authenticate all laboratory reports.

13.3 Radiology Services

13.3.1 The FSED shall provide radiological services including but not limited to: x-ray, computed tomography scan and ultrasound.

13.3.2 The radiology department shall meet all applicable federal, state and local laws, codes, rules, regulations and ordinances.

13.3.3 The FSED must adopt and implement policies and procedures that provide safety for patients and personnel, including but not limited to:

13.3.3.1 Adequate shielding for patients, personnel and surrounding areas;

13.3.3.2 Labeling of radioactive materials, waste and hazardous areas;

13.3.3.3 Transportation of radioactive materials between locations within the FSED;

13.3.3.4 Security of radioactive materials, including determining who may have access to radioactive materials and controlling access to radioactive materials;

13.3.3.5 Testing of equipment for radiation;

13.3.3.6 Maintenance of personal radiation monitoring devices;

13.3.3.7 Proper storage of radiation monitoring badges when not in use;

13.3.3.8 Storage of radio nuclides and radio pharmaceuticals as well as radioactive waste; and disposal of radio nuclides, unused radio pharmaceuticals, and radioactive waste; and

13.3.3.9 Methods of identifying pregnant patients.

13.3.4 Policy and procedure manuals shall include procedures for all examinations performed, infection control for the facility, treatment/examination rooms, dress codes of personnel, and cleaning of equipment.

13.3.5 The FSED must have policies and procedures in place to ensure that periodic inspections of radiology equipment are conducted and current, and that problems identified are corrected in a timely manner. The FSED must ensure that equipment is inspected in accordance with manufacturer's instructions, federal and state laws, regulations, guidelines and FSED policy.

13.3.6 Employees/contractors must be checked periodically, by use of exposure meters or badge tests, for amount of radiation exposure.

13.3.7 Radiology services shall only be performed upon a written order of a physician or non-physician practitioner.

13.3.8 A physician shall read, date, sign and authenticate all examination reports.

16 Del. Admin. Code § 3340-13.0

24 DE Reg. 692( 1/1/2021) (final)