New Standards Set for 'Wild West' Infusion Centers

Marcia Frellick

June 25, 2019

AUSTIN, Texas — The first minimum standards of care for in-office infusion providers, which will help set the bar for safety and care quality in the industry, have been issued by the National Infusion Center Association (NICA).

The standards come as the outpatient infusion and injection market is rapidly expanding and as the number of "med-spas," "hydration clinics," and mobile services promising hangover cures and vitamin-cocktail drips is escalating.

"It's the wild, wild west on the vitamin-infusion side," Reece Norris, JD, cofounder of NICA, told Medscape Medical News. "We wanted to make sure there are at least some guidelines for our constituency."

That core constituency is providers who deliver biologic and infusion therapy and treat autoimmune diseases in nononcology, nonhospital clinics, he explained here at the NICA 2019 Meeting.

By establishing standards when the outpatient side of the industry is still young, the organization has a chance to be proactive, rather than having to react after a tragedy, said Kaitey Morgan, RN, an infusion nurse and director of clinical operations at OI Infusion Services in Portsmouth, New Hampshire, who helped develop the standards.

"I feel that we got ahead of that in this case. We're not always able to do that in healthcare. The concern is that, in the absence of standards, we would have one of those tragic events and that would create access barriers and excessive regulation or the wrong regulation in response to that," she told Medscape Medical News.

The goal is to remove discrepancies in care, regardless of the setting in which the infusion happens. The best practices are based on current evidence and industry standards, Morgan said.

Preparation, Storage, and Skills

One thing the standards address is where medications should be prepared.

"I've seen that done next to lab specimens, next to sinks," she explained. "The standards say it has to be done in a separate area free from possible contaminants, like water from a sink, fluid specimens, food, or drink."

Prepared medications should not be stored for future use, the standards state, and administration should begin within 1 hour of preparation. If extenuating circumstances make that impossible, manufacturer guidelines on stability and storage must be followed, but storage should never exceed 4 hours.

The standards require that medications, supplies, and equipment be immediately available in the case of a hypersensitivity reaction.

They also address the ratio of clinicians to patients and the skills and proficiencies every provider should have. For instance, all personnel involved in preparing or administering the medications must have current Basic Life Support certification, the document states.

The standards will help insurers know which infusion centers are committed to following basic best practices, and that could help when contracts are negotiated, said Norris.

Because infusion centers do not go through an accreditation process, proof of excellence rests mostly with the individual licenses of the providers, he explained.

The hope is that providers who are operating centers, or plan to, will see where a particular center falls behind and address the shortcomings, said Morgan.

Now that basic standards have been established, the next step is to develop standards for excellence, she reported.

"There's never a ceiling to quality, but these would be a way for infusion centers to provide the highest levels of care," she said.

As stated in the standards, they are meant as a reference and do not supersede state regulations, including scope of practice, insurance demands, or boards of nursing rules.

Morgan and Norris have disclosed no relevant financial relationships.

National Infusion Center Association (NICA) 2019 Meeting. Released June 20, 2019.

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