Starting a Spravato® clinic:
the compliance checklist.

1 · Certify the setting

The practice enrolls with the SPRAVATO® REMS as a certified healthcare setting — the entity accountable for supervised administration, post-dose monitoring, and session reporting. Certification is paperwork plus attestation: that you can supervise self-administration, monitor patients for the required period, and document sessions to the program. Your dispensing channel (typically a certified specialty pharmacy shipping to the site) hangs off the same certification, so start it early — it gates everything downstream.

2 · Enroll prescribers and patients

• Prescribers complete their own REMS enrollment before writing the first prescription.
• Every patient enrolls before first treatment — acknowledging the monitoring requirement and the no-driving-until-tomorrow rule. Build enrollment into your intake so a first-timer can't reach a treatment chair without it; their enrollment form must be on file before their first session is run.

3 · Shape the space

You need somewhere for a monitored patient to spend two comfortable hours — a recliner in a quiet room beats a busy bay — plus a blood-pressure cuff per active room and a sight-line (or call path) from wherever staff actually are. Most practices start with one or two rooms; the constraint that matters isn't square footage, it's that someone can always answer: what phase is each room in, and what's due next? Design for that question from day one and the floor scales; design around it and every added room multiplies the chaos.

4 · Staff the day

• An administering clinician (RN/NP/MD per your state's scope rules) supervises dosing, takes vitals, and assesses discharge readiness.
• A prescriber is reachable for the judgment calls — out-of-range baseline vitals, early endings, adverse events.
• The front desk owns arrivals, the schedule, and — in well-run clinics — the filing backlog. Make that ownership explicit; orphaned paperwork is how deadlines die.
• Train against the session sequence (checklist → pre-dose vitals → supervised dosing → observation → SAE review → discharge) until it's boring. Boring is the goal.

5 · Decide how the record gets made

Before the first patient, decide where vitals, times, and observations live during the session — because that decision is really the decision of how hard your Patient Monitoring Forms will be to produce. The options are honest paper (cheap, fragile, transcribed later), a spreadsheet (searchable, still manual, still no timestamps anyone can defend), or purpose-built tooling that captures the session as it happens and hands you the finished form at discharge. Whichever you choose, two tests matter: can you prove a monitoring window ran its full length, and will every session's form demonstrably meet its seven-day deadline?

6 · Rehearse, then open

• Run a full dress rehearsal on synthetic patients — open the day, sign staff in, run a room through every phase, file the practice form. The first real session should be your second time through, not your first.
• Bookend the day deliberately: open with the schedule and yesterday's unfiled forms; close only after today's are filed or consciously batched.
• Expect the first weeks to surface edge cases — the early ending, the elevated baseline, the patient without a ride. Each one is a process decision; write the answer down and the next occurrence is routine.

The shape of the whole thing

Certification makes you accountable; enrollment makes patients eligible; the space and staffing make the two-hour window humane; the record-keeping makes all of it provable. Practices that struggle usually skipped straight from certification to treating, and let the proof become an after-hours job. Practices that thrive treat the record as a by-product of a well-run day — which is also, not coincidentally, the day that feels calm to be a patient in.

Related guides

• Spravato® REMS requirements, explained
• The two-hour monitoring window: what it actually requires