What is a limited reinfusion service?
A limited reinfusion service (LRS) is a site that prepares and/or administers reinfusion products. A reinfusion procedure is the withdrawal of blood, its processing and administration of the product to the same patient for diagnostic or therapeutic purposes. Such processing may include, but is not limited to, separation (e.g. into platelet-rich plasma), radioisotopic tagging, and genetic and immunologic manipulation. Reinfusion procedures do not include presurgical autogeneic collection, normovolemic hemodilution, intraoperative blood recovery or postoperative blood recovery. Please refer to Subpart 58-2 Blood Banks.
What types of facilities/sites provide these services?
Facilities/sites that may provide such services include, but are not limited to, ambulatory surgery centers, dental offices, medical imaging centers, nuclear pharmacies, physicians’ offices, and wound care centers. If hospital-owned and operated, and located on that hospital’s contiguous campus, a facility does not require LRS approval, provided the hospital holds a permit in Blood Services – Transfusion. If hospital-owned and operated, and not located on that hospital’s contiguous campus, a facility does require LRS approval. Questions should be directed to the Blood Resources Program at email@example.com.
How is an LRS approved?
Operation of an LRS requires approval by the Department’s Blood Resources Program. Approval is granted based upon review of the Application Form (DOH-5045) and the Checklist signed by the Director of the Limited Reinfusion Service attesting that written policies and procedures comply with all applicable regulations and standards.
What is required for application?
Applicants are required to submit an Application Form (DOH-5045) and Checklist. The Guide to Developing a Written Procedure is provided to assist in development of written procedures. The application and checklist should be submitted after the policies and procedures are complete and have been approved by the LRS Director.
Are there approval conditions?
Approval is granted for four years, renewable, subject to regulatory compliance. The Department reserves the right to conduct inspections as deemed necessary. The Blood Resources Program must be notified in writing of changes in director, owner, location, or category(ies) of service.
Directions for using digital signatures are provided.