Two sets of hands. One record that has to close.

Most ambulatory surgery centers track their own procedural stock in a paper binder. Countra is a digital option built for surgery centers that handle controlled substances in-house, with no hospital pharmacy, no dispensing cabinet and no staff pharmacist: it replaces the binder, keeps a reconciled record from delivery into inventory through witnessed waste, and exports that record as a PDF on demand. And because the record is data rather than ink, Countra can also read it: built-in analytics flag unusual patterns early, so a quiet question gets asked in days, not at the next count. It covers the drugs a center actually stocks for sedation and anesthesia, such as fentanyl (Schedule II), ketamine (Schedule III) and midazolam (Schedule IV). It does not require a dispensing cabinet or a staff pharmacist, and it runs on the smartphone, tablet, desktop or laptop your team already uses.

The federal set: your inventories, a continuing record of every controlled substance received, delivered or otherwise disposed of, an administration record naming the person who gave each dose, executed order forms kept separately, and any theft or loss reports. Federal rules require those records to be available for inspection and copying for at least two years (21 CFR 1304.04(a)), and they expressly allow them to be kept on an in-house computer system, with no notification to DEA required (21 CFR 1304.04(c)). A CMS surveyor works from a different document: the State Operations Manual, Appendix L, tag Q-0181, under 42 CFR 416.48(a), which asks whether the center's record system tracks scheduled drugs in a readily retrievable manner and whether discrepancies in count are reconciled promptly. Countra keeps the records it holds in one place, from delivery into inventory through witnessed waste and the reconciliation, and exports them as a PDF on demand. It does not hold or file your order forms or your theft and loss reports. Filing forms and maintaining compliance remain the registrant's responsibility, and state requirements vary, so confirm yours with counsel and your state board of pharmacy.

Federal rules require the wastage to be recorded, but they do not impose the two-person witness. 21 CFR 1304.21(e) says the destruction of a controlled substance dispensed for immediate administration at your registered location, when it is not fully exhausted, is recorded under 21 CFR 1304.22(c) and need not be maintained on a DEA Form 41. The two-employee witness rule at 21 CFR 1317.95(d) attaches to on-site destruction of stock the center still holds, which is a different record. The witness requirement on procedural waste comes from state rules, accreditation standards and your own facility policy, and it varies from state to state. In Countra, the waste and the witnessed co-signature are captured as a single record, with a time stamp the entry carries for good. Confirm every requirement with your own counsel and your state board of pharmacy before you rely on it.

No. Compliance with the Controlled Substances Act and DEA recordkeeping rules is the registrant's own responsibility, and no software can take it over. Countra supports those obligations by helping you document, track, and reconcile controlled substances and keep audit-ready records. Its analytics also flag unusual patterns for your review, which can shorten the time between a discrepancy and someone noticing it. But Countra does not make a facility DEA compliant, does not file your DEA forms, and does not prevent or guarantee the detection of diversion. Monitoring surfaces questions; answering them remains your program's job.

No. Countra is built for the way surgery centers without a hospital pharmacy actually handle controlled substances: from a locked safe or cabinet, without an automated dispensing cabinet, and without an on-site pharmacist. Federal survey guidance says the same thing. CMS State Operations Manual Appendix L, tag Q-0180, says a pharmacist is ideally available to an ASC but that this is not required by the regulation, unless the center performs activities that under state law may only be performed by a licensed pharmacist. What 42 CFR 416.48 requires is that drugs and biologicals be provided under the direction of an individual designated responsible for pharmaceutical services. Pharmacist presence and its cadence come from state rules and accreditation standards, and they vary. Your existing clinical staff document each step as part of the routine they already run.

No new record is being created. The anesthesia record stays in the patient's chart, exactly where it is. Countra holds the other record, the center's own controlled-substance record that a binder holds today, and the entries it asks for are the ones that record already requires: the checkout, the administration entry, the witnessed waste, the count. Each is a short digital entry on a device the person already has, instead of a line written onto paper between cases. And for centers that run an EHR, Countra connects to modern EHR systems, so an administration documented in the chart carries into the controlled-substance record without being typed twice. Whoever documents a step in your workflow today documents that same step in Countra, once.

The center's governing body carries it. Under 42 CFR 416.41, the center must have a governing body that assumes full legal responsibility for determining, implementing and monitoring the policies governing the center's total operation. Where a service is provided through a contract with an outside resource, 42 CFR 416.41(a) requires the center to assure that the service is provided in a safe and effective manner. Contracting the anesthesia service does not move that duty. In practice the work is shared, and the split varies: the ordering, stocking and counting often sit with the center's own staff, and in Countra the dose is documented by the center's own rotating OR nurses. Controlled-substance records trace back to a registrant, so it is your registration and your name on the line, whoever is holding the vial.

Yes. Your records are yours. You can export them as PDF reports at any time, for an inspection, a survey, or your own files, and you can take your complete controlled-substance history with you if you ever leave the platform.

Yes, and your anesthesia providers do not need access to Countra. The controlled-substance documentation in Countra is done by your center's own rotating OR nurses, not by your anesthesia providers. Anesthesia providers keep logging their information in the anesthesia record the way they do now, and Countra does not change that flow or the way anesthesia records are kept. Countra is only for controlled-substance documentation. If your center has an EHR, Countra can pull information from it to avoid documenting the same thing twice. Whether your anesthesia group is employed or contracted, the people entering the record are your own staff.