Safety

Be prepared to prepare medications

Ambulatory Safety Monitor, March 10, 2005

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In spring 2004 the JCAHO clarified standard MM.4.20 to allow
nurses to prepare IV admixtures when a pharmacy isn't available. Leaders now face the challenge of making sure that nurses perform this job appropriately.

Although the standard does not detail how to safely prepare medications, it calls for you to have policies and procedures in place to show you use the appropriate care in this area.

In association with this standard, the JCAHO also recognizes the United
States Pharmacopeaia Chapter 797 regulations for compounding sterile
preparations. It is critical for ambulatory facilities to understand which
situations require them to comply with the regulations and which do not (see http://www.mic4.com/regulations/USP-797.pdf for more information).

With these regulations in mind, the JCAHO says that if they apply to you, you must now conduct a risk assessment (or gap analysis) of your compliance for all provisions in the chapter. By July 2005, surveyors
should find a developed renovation plan. And by January 2006, you should certify all laminar-airflow workbenches, isolator machines, and buffer rooms every six months.

Little efforts make a big difference

Although you're looking toward the long term, begin making short-term
changes. Physician's Surgical Center in Norman, OK, works to develop their policies on an ongoing basis, says Jan Allison, RN, compliance
coordinator at the center. Part of creating the organization's policies includes understanding the JCAHO standards and USP 797 regulations, she says. "This is a big patient safety focus because of the possibility of devastating infections in the bloodstream introduced by IVs," she says.

"Many think the USP 797 is only an issue if your ambulatory surgery center [ASC] has a pharmacy, but there are standards that affect you if you go through the JCAHO."

The JCAHO standard says that when an on-site pharmacy is available, the pharmacy must compound all admixtures, and it is the pharmacy that must comply with all the issues in the new USP chapter. When a pharmacy isn't available and staff must mix solutions, the standard recommends using appropriate techniques to avoid contamination during preparation. If you must mix, find a clean and clutter-free space to do so. Allison offers these tips when mixing medications:<BR>Develop specific written guidelines for the environment used for preparation. The area should:

  • be designated for preparation of parenteral medications and not used for any other activities.
  • be easily cleaned with disinfectant and free from clutter.
  • have adequate lighting, reduced noise, and low traffic.
  • when possible, avoid environmental hazards, such as the sink, drain, general waste bin, external air vent, and window. However, a sink should be in a convenient location for handwashing.
  • prohibit eating, drinking, and smoking.
  • not permit personnel with respiratory infections or dermatological
    diseases to handle open solution containers.

If you mix hazardous materials, regularly train and monitor staff about the
use of safety materials and equipment.

Use the metric system and check your calculations and products to prevent dosage errors.

Visually inspect the ingredients for signs of deterioration or contamination
(also a JCAHO element of performance).

Provide competency-based training upon orientation to those who perform IV admixtures for appropriate aseptic manipulation skills. Annual training will reinforce initial instruction and prevent the development of poor
technique.

Call in a consultant pharmacist to assess managers for competency and teach them how to assess their nurses, suggests Allison.

Surveyor watch: Surveyors may focus on competencies for IV admixtures. They want nurses to explain the IV admixture process. Also, surveyors may ask managers how they know their nurses are competent to perform this task.

Also use a checklist to serve as a simple and effective reminder. Post the
checklist next to the preparation areas and include the main points on aseptic technique and the checks required during preparation. Create a manual that provides advice on the preparation and administration of parenteral medicines available and review it regularly.

Perform a regular audit of the areas used for the preparation of parenteral
medicines to confirm compliance with the agreed standards and to highlight any potential risks requiring corrective actions.

Clearing up the confusion

Some organizations find it difficult to understand when the USP 797
regulations apply to them. The regulations will not apply when using the
following helpful tips at your ASC:

  • Use premixed solutions or a closed medication reconstitution/mixture system whenever possible
  • Administer compounded preparations for immediate patient use; it won't have time for bacteria to grow, making use of a laminar flow hood unnecessary
  • You don't need to use a laminar flow hood in emergency situations with stat doses



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