Comment on FR Doc # 2026-14146

I am a Nurse Anesthesiologist (CRNA) who has delivered anesthesia at several Level 1 trauma centers and founded and owned an anesthesia practice serving three ambulatory surgery centers in the Chicago area. I am a licensed clinical psilocybin facilitator in Colorado and CEO and Cofounder of KNEW Integrative Health and CANOE Health Alliance, a rural integrative and behavioral health model. I serve on the Government Relations Committee of the Colorado Association of Nurse Anesthesiologists. I am also a person in long term recovery, including from a fourteen year fentanyl dependence, and I understand controlled substance safety both as a provider and as someone who has lived the consequences when safety systems fail. Central point. HRSA does not need to invent a safety framework. American medicine already delivers high risk interventions safely outside the hospital every day in ambulatory surgery centers, using mature monitoring, rescue, and controlled substance protocols. That model is the right template. The essential task is to calibrate requirements to the pharmacologic risk of each specific compound, so that safety and access are strengthened together. 1. Match requirements to the compound. Psilocybin carries a primarily psychological risk profile. Ibogaine is entirely different: it prolongs the cardiac QT interval and can cause fatal ventricular arrhythmia, including in people with no prior cardiac history. A single standard for all psychedelics would be too heavy for the lowest risk agents and dangerously too light for ibogaine. I urge a tiered framework in which monitoring, staffing, and facility requirements scale with the risk of the specific drug and formulation. 2. Define the qualified provider by competency, not by degree. These procedures require hemodynamic management, real time electrocardiogram interpretation, electrolyte and blood value optimization, airway management, and arrhythmia rescue. These are not general medical skills, and a medical degree alone does not confer them; a psychiatrist may not have interpreted an electrocardiogram in years. This is exactly what anesthesia providers do every day. I recommend HRSA require an anesthesia trained provider, specifically Certified Registered Nurse Anesthesiologists, for the medical safety role with higher risk agents. This serves HRSA's goals directly: CRNAs hold the exact competency, already make up more than eighty percent of anesthesia providers in rural counties, offer a cost effective model with a safety record equivalent to physician anesthesiologists, and have safely managed consciousness altering agents for roughly a century and a half. If we treat this as spiritual surgery, it deserves protocols that match surgery. 3. Require a real safety envelope on the day of administration. For agents with cardiac risk such as ibogaine, require a pre administration electrocardiogram with corrected QT measurement, electrolyte optimization, cardiac exclusion criteria, and continuous cardiac monitoring during administration. The only United States based data showing ibogaine delivered without serious cardiac events achieved that by pairing it with cardiac protection and monitoring. Require genuine rescue capability: emergency medications, a defibrillator, airway equipment, advanced cardiac life support, a written emergency protocol, and a hospital transfer agreement. Separate the psychological support role from the medical safety role, and require at least two trained providers. 4. Apply existing controlled substance safeguards and treat diversion as real. Use the protocols that already govern ambulatory surgery centers: secured and logged storage, chain of custody, witnessed waste, inventory reconciliation, and limited access. Diversion is not abstract. I understand from direct experience how these systems fail and why redundancy matters. Robust diversion prevention should be a core requirement as these agents enter community clinics. 5. Protect rural and underserved access by calibrating requirements, not lowering them. If HRSA imposes uniform hospital grade requirements everywhere, access will concentrate in urban centers and the rural communities this RFI aims to serve will be excluded. Instead, use tiered compound specific standards, hub and spoke models where a medical hub supports smaller clinics, and telehealth for screening, preparation, and follow up while preserving on site presence during administration. CANOE is a working example of telehealth reach paired with disciplined safety standards. 6. Require certification tied to risk and kept achievable for safety net clinics, and use technology to extend the workforce and standardize training, but never to replace the human safety monitor during administration. No algorithm can perform a rescue. Thank you for your consideration. The attached document provides full detail and references. Steph Leopold, CRNA Nurse Anesthesiologist CEO and Cofounder