What is a Limited Transfusion Service?
A Limited Transfusion Service (LTS) is a facility, home care services agency, physician’s office, or other entity that administers blood components, but relies on a blood bank holding a permit in Blood Services – Transfusion to perform pretransfusion testing and provide the blood components. A hospital’s permit in Blood Services – Transfusion covers transfusions performed at any location that is owned and operated by, and physically attached to, the hospital. Non-hospital sites and satellite sites that do not meet these criteria, and do not hold a laboratory permit in the Blood Services – Transfusion Storage Only category, must be approved as a Limited Transfusion Service in order to perform transfusions.
What types of facilities/sites provide these services?
Sites that may provide such services include, but are not limited to, ambulatory surgery centers, dialysis centers and other Diagnostic & Treatment Centers, physician’s offices, and home care agencies. Inquiries regarding Limited Transfusion Services should be directed to the Blood Resources Program at (518) 485-5341.
An LTS must have a written agreement with a facility that holds a New York State permit in Blood Services – Transfusion. The agreement must specify the division of responsibilities for ensuring compliance with the provisions of 10 NYCRR, Subpart 58-2, Blood Banks.
What is required for application?
Applicants must submit an Application Form (DOH-2761), a Checklist and an agreement. The checklist is included to ensure that required policies and procedures are in place. The model agreement is intended as a guide; this format and specific content are not required. However, all of these elements must be addressed.
How is a Limited Transfusion Service approved?
The Director of the Blood Bank and the Director of the LTS must sign both the Checklist and the agreement. If the applicant LTS is a hospital satellite site, and the Director of the Blood Bank and the Director of the LTS are the same person, another responsible person at the LTS should also sign the agreement on behalf of the LTS. Mail the completed Application Form (DOH-2761), and the signed checklist and agreement to the address on the form.
Are there approval conditions?
Departmental approval is granted for four years, conditioned upon ongoing regulatory compliance and satisfactory completion of periodic update forms issued by the Blood Resources Program. 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 blood bank. Prior to implementation, any modification of the agreement must be submitted to the Blood Resources Program for approval. Termination of the agreement by either party will void the LTS approval.
Directions for using digital signatures are provided.