Staffing and Skill Building for Biologic Therapy in Alternate Sites of Care
Pamela McIntyre, MSN, RN
As oncology care shifts toward community-based settings, this interview explores how ambulatory infusion centers can prepare clinically and operationally to safely deliver biologic therapies for cancer patients.
Please introduce yourself by stating your name, title, and any relevant experience you’d like to share.
Pamela McIntyre, MSN, RN: My name is Pamela McIntyre, and I have been a nurse for more than 4 decades. I've worked primarily in the field of infusion including oncology and infusion centers for chronic care, both hospital and outpatient. I also have significant experience in the realm of home infusion and have performed operational and clinical functions for these pharmacies.
I now work as a consultant advising home infusion companies and ambulatory infusion centers (AICs) on clinical policy and procedures and accreditation assistance, and with home infusion companies to build infusion nursing programs.
I also work with ambulatory infusion centers helping to bridge the gap in the launch phase as they transition from the business aspect to the patient care phase. They also consult with me to create their clinical policies and procedures and to advise on workflow and staffing models.
Could you provide a brief overview of your session at NICA 2025?
McIntyre: I strongly feel that, as time goes on, independent centers are going to be asked to provide care for oncology patients for biologic therapies—not necessarily chemotherapy, but maintenance regimens using targeted monoclonal antibodies.
Some of these referrals are made because patients request to be seen closer to their home. In others, insurance companies are seeking lower cost sites of care by directing the patients out of the hospital system infusion centers. Additionally, patients are seeking expanded hours, including weekends, because once they have completed their chemotherapy and moved to maintenance therapy they may return to work. If the oncology center is hours away, it is more convenient to receive their infusions closer to home.
What that means for independent AICs is that we need to develop the programs and create the capacity to take care of these patients so that we are ready when the referrals are made.
What are the essential clinical competencies and certifications that AICs must ensure among staff to safely manage oncology patients?
McIntyre: There are different paths nurses can take to care for these patients. In all cases they do need to have oncology training, and I want to make some distinctions between the credentials and competency.
Competency means that you have been observed and meet the criteria needed to take care of this population safely. Certification is proven by continuing education units, years of service, and passing a rigorous test. A competent nurse may apply for certification once they meet the years of experience requirement.
An oncology program for an AIC should be led by an Oncology Certified Nurse (OCN)—a certification through the Oncology Nurse Certification Corporation (ONCC). OCNs have the knowledge to administer the products and monitor for and manage reactions to chemotherapy and targeted biologic therapies. They are also highly trained and experienced in oncology disease processes as well as the detection and management of oncologic emergencies. The OCN leads a team of nurses that administer the drugs, and those nurses should have, at a minimum, a Provider Card.
A Chemotherapy and Immunotherapy Provider Card is also earned through ONCC. The Provider Card is earned by passing a test that is taken after earning 15.25 specialized contact hours and self-directed study, and nurses are eligible if they have 6 months of nursing practice experience.
Course work to study for the provider card can be accessed for 6 months after purchase. Upon passing, you receive the Chemotherapy and Immunotherapy Provider Card, an added qualification and valuable credential.
The distinction between the OCN requirements and a provider card is that the OCN requires an additional level of experience, which is at least 2000 hours of adult oncology nursing practice within 48 months prior to applying for the certification examination, in addition to continuing education units (CEUs). This well-rounded certification provides the comprehensive skill set needed to provide excellent patient care for the oncology population.
What infrastructure or policy updates are most critical for AICs preparing to expand into oncology biologics?
McIntyre: There are payer requirements that you need to fulfill to obtain the contracts needed to be reimbursed for this therapy class. Payers require a system for communication with the ordering physicians to relay information about any services provided in the clinic, patients must be screened for toxicity and complications related to their infusions in coordination with the oncologist’s office, and monitoring of labs and diagnostic studies is required to ensure that patients meet acceptable criteria to have their treatment.
It's important that when you receive these patient referrals you take note of the guidelines for treatment that the prescriber sets. Depending on what the patient's baseline is, sometimes improvement in the values is what they're looking for as opposed to a normal value. These criteria are individualized based on the patient’s condition and may change throughout the course of their disease.
As you look ahead, what changes do you foresee in how payers, providers, and AICs collaborate around oncology biologics?
McIntyre: There are some malignancies that are now treated with these drugs alone, instead of chemotherapy. As oncological treatment evolves, cancer will become increasingly curable, and as the population is aging expansion of service options will be needed.
Insurance companies are encouraging patients to sites of care that are less costly and may direct patients to both independent AICs and, in some cases, home infusion. These drugs are not only being given intravenously but are also being reformulated to be given subcutaneously which expands the ability for alternate sites of infusion to administer these medications. Training for our nurses will be critical so we're ready to care for these patients when the referrals come through the queue.
Is there anything else that you wanted to add that you think is important?
McIntyre: It's really important that we evaluate whether we have the clinical infrastructure needed when we consider providing this therapy, because the oncology practices have the management of these patients dialed in. We need to prove that we are equally equipped to provide a superior level of service in order for us to care for them in our alternate setting. Nurses in ambulatory care and home infusion already provide drugs that have profiles capable of severe reactions and that require close monitoring, but this an entirely different class. The communication with the oncology practice has to be airtight, considering some of these drugs have high potential for toxicity. The prescribers need to be informed when each dose has been administered, how the patient tolerated it, including any reaction and, equally important, if there wasn't a reaction. A systematic approach to comanaging these patients is essential to quality patient care in alternate sites of service.
