Spiking Fluids in Advance of Administration

Since Spiking Fluids In Advance of Administration is Not Allowed – How Do You Comply with USP 797 Standard

The newest USP 797 guidance states that spiking IV fluids in advance of administration is outside the scope of the standards. Instead, we need to create policy grounded in evidence-based guidelines and manufacturer’s instructions for use. However, we use several different brands of IV fluids, some of which do not have any specification on pre-spiking. Looking up this information or referring to each package insert is burdensome and time consuming. What are other hospitals doing to comply with this changed standard?

The Answer Lies in a Team Risk Assessment

Most hospitals have previously eliminated the pre-spiking fluids in advance of administration process. This included removing the Christmas tree devices, or the wall of coat hooks designed to accommodate all the pre-spiked bags. If you have already eliminated pre-spiking, we suggest not reintroducing the concept. If you were not previously successful in eliminating the process, we suggest a team risk assessment process to design how to do this with reasonable safety. 

As you mentioned, different manufacturers have different guidance. Some may reference spiking and hanging, others mention removal of the outer plastic wrap immediately prior to use. Your team conducting the risk assessment has to evaluate why the manufacturers provide this guidance. In the case of the outer wrap, they are concerned about evaporation. Your risk assessment team may decide that evaporation of less than one ml from a 1000 ml bag is acceptable in a X hour timeframe. 

They may also want to evaluate the contamination risk by conducting some observer studies to determine if hand hygiene and aseptic technique is perfect, thus reducing the risk of contamination. Another validation method is to take some pre-spiked bags and incubate them to determine if any microbial growth develops.

Patton Healthcare Consulting

Patton Healthcare Consulting provides a complete range of Joint Commission and CMS Compliance Assistance and a full range of pre-survey and post survey services.

We serve more than 400 hospitals, behavioral health care organizations, ambulatory clinics and home care companies nationwide—hospitals ranging from critical access hospitals to the largest health systems. Contact us at (888) PHC-INC1 for more information.