CMS 30-minute rule: How does this affect your facility?

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After reading this article, you will be able to:

  • Identify CMS' new stance on the so-called "30-minute rule"
  • Discuss changes to CMS' requirements for standing orders

Editor's note: The following article was written by BOJ advisor Elizabeth Di Giacomo-Geffers, RN, MPH, CSHA, a healthcare consultant in Trabuco Canyon, CA, and former Joint Commission surveyor.
In late 2011, CMS issued a memo to its state survey agency directors regarding updated guidance on medication administration. The intent, according to the memo, was to reflect current standards of practices related to timeliness of medication. Hospitals, the memo stated, are expected to establish policies and procedures for the timing of medication that provides a proper balance between patient safety and flexibility for work processes.

"Recognizing that it is no longer the standard of practice in the current hospital environment," CMS wrote in its memo, "we are removing reference to the so-called '30-minute rule' in the survey procedures portion of the guidance, which had established a uniform 30-minute window before or after the programmed time for all scheduled medication administration."

CMS now states that hospitals must adopt policies and procedures for medication administration based on standards of practice. This update allows hospitals more flexibility-they can now establish their own policies and procedures for timing of medication administration that address the nature of the medication involved, such as patient needs and specific clinical applications.

So what does this mean for hospitals and other affected healthcare facilities? Well, our mantra in this space is frequently "make sure policies match practice." In this case, the story is no different. Hospitals must verify that the policies and procedures approved by the medical staff are being followed-and if not, identify the reasons for noncompliance. Are they too restrictive, or too complex for staff and physicians?

Addressing these concerns can be resolved in a five-step process:

  • Review the memo from CMS. (We have provided a link to the memo at the end of this article.)
  • Perform a gap analysis. Where are the missing requirements between existing policies and procedures and current CMS requirements?
  • Review those existing policies and procedures for revisions.
  • Educate physicians and staff and any others involved in medication management process.
  • Finally, audit your processes for compliance and to verify that staff understand and retain the information they need to comply.

 Let's take a step back even further. Take a look at your own state laws and other regulations. Are staff administering drugs or biologicals in accordance with law and regulatory requirements?
So what do these policies and procedures need to cover to be in compliance with CMS requirements? They should address timing of medication administration by identifying those medications that:

  • Are not eligible for scheduled dosing times
  • Are eligible for scheduled dosing times and are time critical
  • Are eligible for scheduled dosing times and are not time critical

 Review your medical records and perform a system review of medication management.
Keep an eye on established windows for medication administration. Looking at the scale above for criticality of medication timing, you should make sure that the following time windows are complied with:

  • Time-critical scheduled medications administered within one hour
  • Medications prescribed more frequently than once per day but not more often than every four hours administered within two hours
  • Medications prescribed for daily or longer intervals administered within four hours

 Place also matters. Determine whether your policy/procedure is clear and whether time-critical medications are covered by the policy hospitalwide. Or does your organization look at them based on unit, patient diagnosis, or clinical situation?
Medical records review

In terms of medical records review, you will want to make sure that your medication administration processes match the physician's order-right medication, right patient, right dose, right route, right frequency, and right timing. This includes verifying that the physician's medication order has not been rescinded (which can be done by medication pass observations and a system interview on medication management).

What should we be looking for in the review?

  • Prescriber's name.
  • Verify that practice and policy match during drug preparation and administration.
  • Verify that patient identification is being done properly. Is the patient's identity confirmed prior to medication administration?
  • Name of the medication, dose, route, and frequency-does your policy/procedure ensure these are properly followed?
  • Timing. Again, verify that policy and procedure for timely medication administration is being followed.
  • Does the nurse or staff member stay with the patient until the medication is consumed? This is a simple step often overshadowed by other processes.
  • Do you monitor and document the effects of the medication administered?
  • An eye toward staff knowledge
  • It is also a good idea to conduct staff interviews to make sure they understand the organization's policies for medication administration timing. Are they:
  • Able to identify time-critical and non-time-critical scheduled medications?
  • Are they aware of medications that are not eligible for scheduled dosing times?
  • Can they describe the requirements for time-critical and non-time-critical medication administration timing in terms of the hospital's medication administration policies and procedures?

 Few tricks work better than a tracer to make sure this knowledge is in place. A medication management tracer, either individual or systemwide, will provide much insight as to what is needed in terms of staff education and gaps in knowledge.
Standing orders

Back in 2008, CMS stated that it is permissible for hospitals to use standing orders to address well-defined medication administration clinical scenarios. This new guidance is being updated so that it will take into account the 2008 memo.

How does your organization handle standing orders? Do current policies and procedures address the process that standing orders are developed, approved, and monitored; initiated by staff; and authenticated by physicians or practitioners who are ultimately responsible for the care of the patient?

Improving your standing orders policies and procedures can come out of collaboration with physicians, nurses, and other care providers during tracers mentioned previously. Such collaboration is a good opportunity to gain feedback as well as take a hard look at your organization's practice versus its policy.
Editor's note: To view the November 18, 2011, CMS memo, visit