CMS Lifts its “30-minute rule” Related to Medication Administration

The Centers for Medicare and Medicaid Services (CMS) have notified state survey directors that effective immediately, they have eliminated the 30-minute rule for medication administration. In a memo dated November 18, 2011, the CMS states that “the change in these guidelines is the result of findings from the Institute for Safe Medication Practices survey, which showed that nurses were developing unsafe practices and ’work-arounds‘to the 30-minute rule.” These “work-arounds” threatened patient safety and diluted medication error tracking efforts.

The CMS, instead, will require hospitals to put in place, medication administration policies and procedures that are consistent with accepted practice standards and are required by CMS regulation 42 CFR 482.23(c). Hospitals will need to identify medications that require exact or precise timing for administration and are not eligible for scheduled dosing times.

Medication that may be eligible for scheduled dosing times will be identified by hospitals as time-critical or non-time-critical.

Hospitals must establish policies regarding the timing of medication administration accordingly. Time-critical scheduled medications are those in which early or late administration longer than 30-minutes may cause harm or have a significant impact on the intended therapeutic or pharmacologic effect. Non-time-critical scheduled medications are those in which the dosing time would not significantly alter the medication’s therapeutic effect.

Hospital policies must:

• Identify the categories of licensed personnel and the types of medications they are permitted to prepare and administer according to state law. It must also identify the education and training for all persons preparing and administering medications.
• Reflect the accepted standards of practice that confirm:
  • The patient’s identity
  • The correct medication
  • The correct dose
  • The correct route
  • The appropriate time
• Define those medications that are not eligible for scheduled dosing times and those that are eligible.Define time-critical and non-time-critical scheduled medications.
• Identify actions that need to be taken when medications eligible for scheduled dosing are not administered within their permitted timeframe.
• Identify guidelines for the administration and timing of new medications which are initiated between standardized dosing times.
• Identify parameters within which nurses are allowed to use professional judgment regarding the rescheduling of missed or late doses and when notification of the prescribing healthcare provider caring for the patient is required prior to doing so.

Hospitals are also expected to periodically evaluate their administration timing policies, including staff adherence to policies, to determine whether they are safe and effective medication administration. Medication errors related to the timing of medication administration must be tracked and analyzed to determine their cause.

Finally, included in this memo from the CMS was a statement related to standing orders. Hospitals may have policies and procedures related to standing orders to address well-defined clinical scenarios related to medication administration. The policies for standing orders must address the process in which a standing order is developed, approved, monitored, initiated by authorized staff, and subsequently authenticated by a prescribing healthcare provider.