ACHC Announces Distinction in Ig Therapy

By: Angie Loch, PharmD, IgCP, Pharmacy Surveyor & Caroline Girardeau, PharmD, MBA, PMP, BCPS, Program Director

Angie Loch has served as a Pharmacy Surveyor with ACHC since 2023. Her background includes home infusion, community, and health system pharmacy practice, with expertise in complex therapies such as IVIG, TPN, IV antibiotics, and sterile compounding. Angie is committed to advancing standards-driven practice and patient-centered pharmaceutical care.

Caroline Girardeau brings more than 30 years of pharmacy experience to her position as Program Director for ACHC Pharmacy and PCAB (Compounding Pharmacy) Accreditation. She combines clinical expertise with a passion for education, quality, and performance improvement to help pharmacies strengthen their practices and deliver safe, patient-centered care.

Posted: March 26, 2026

ACHC is excited to introduce a new Distinction in Immunoglobulin Therapy. This specialty recognition is the result of two years’ development in close partnership and collaboration with the Immunoglobulin National Society (IgNS), the premiere organization for education, certification, and research on immunoglobulin therapy. The IgNS Standards of Practice were used as the framework for building the distinction which can be awarded to organizations with either ACHC Specialty or Infusion Pharmacy Accreditation.

What is immunoglobulin therapy?

Immunoglobulin therapy is a plasma-derived therapy from a minimum of 1000 donors to a maximum of 60,000 donors per batch. Donors are screened and undergo testing for viral diseases and must donate at least twice before their plasma is considered safe. The plasma is processed, purified, stabilized, and sterilized. It is administered either intravenously or subcutaneously at regular intervals. There are clinical complexities involved in pairing patients with the most appropriate formulation. Clinicians have to take product risk factors into account, oversee patient tolerance to therapy, mitigate potential adverse reactions, and stay current with evidence-based innovations and best practices.

Why develop a distinction now?

The distinction evaluates a pharmacy’s infusion specialty against evidence-based standards for quality and safety. Achieving distinction is a mark of excellence, giving payors and manufacturers confidence in your operation’s quality of care. With ACHC’s Distinction in Ig Therapy, organizations will gain credibility that sets them apart, validation that their practices meet standards for consistency, quality improvement, and reductions in compliance risk.

There has been an increase in the number of indications for immunoglobulin therapy due to an aging patient population, better awareness through diagnostic methods, and increased FDA approvals. Immunoglobulin is used to treat over 70 conditions. The Hogan Lovells Roundtable Report in May 2022 reported that there were approximately 275,000 patients in the US treated with immunoglobulin. Forecasts project that the global Ig market will grow by 48% in the next eight years.

Why should my pharmacy add the distinction?

Because immunoglobulin therapy has certain risk factors and monitoring parameters that often warrant clinical intervention, training and competencies for both pharmacy and nursing staff are imperative. The IgNS Standards of Practice and the ACHC Accreditation and Distinction requirements complement each other, ensuring that patients are treated by expert teams. Thorough care plans must be assessed and documented at treatment initiation and ongoing maintenance. The distinction involves additional training, competencies, and certifications to minimize adverse effects and maximize therapy effectiveness.

Standards were developed with small and large pharmacies in mind. Requirements to obtain the distinction are attainable by ACHC-accredited infusion and specialty pharmacies.

What do the standards cover?

The distinction includes compliance with IgNS Standards including clinical staff certification (IgCN®/IgCP®), ethical and compliant business operations, clinical risk management, and addresses outcomes and healthcare costs. At minimum, each site should have two Immunoglobulin Certified Nurses (IgCN®) and two Immunoglobulin Certified Pharmacists (IgCP®). There is a strong mentorship component promoted in the standards for Ig certified clinicians to support and coach non-Ig certified personnel. For large practices, at least 10% of nursing staff should be IgCN mentors and 25% of pharmacists should be IgCP mentors. As part of performance improvement and multi-disciplinary collaboration, the standards promote a Professional Advisory Committee, which requires a minimum of three different people to fulfill nine roles. Achieving compliance with these standards ensures alignment with nationally recognized best practices and promotes optimal patient outcomes.

How does my pharmacy obtain the IG distinction?

Are you already ACHC-accredited for either Specialty or Infusion Pharmacy?

If so, you may add the distinction either at your next renewal survey, or you may opt to add it mid-cycle with a one-day onsite survey for the distinction requirements.

If not, apply for ACHC Specialty or Infusion Pharmacy Accreditation and for the distinction at the time of your initial survey.

References

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