The United States Pharmacopeia, or better known as USP, is a non-governmental, official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States. CMS recognizes USP guidelines when reviewing your ASC. We have referred to them frequently during our discussions. Below are a few of the questions recently asked and you will note directly answered by USP:

Question: Is there a limit of how many times a vial can be entered by a nurse using a single dose vial within 24 hours?

Answer: This practice qualifies as an Immediate-Use CSP. A maximum of two stopper entries is permitted within one hour from when the preparation began for administration to the same patient.

Question: I can only find direction on the expiration dates for single-dose and multi-dose vials. What is the appropriate expiration date for eye drops and for multi-dose vials of oral solutions if commercially made?

Answer: For ophthalmics, the expiration date is labeled by the manufacturer. Multi-dose vials of oral solutions are not required to be sterile; thus, <797> does not apply thereto.

Question: If a commercially available IV fluid (i.e., Lactated Ringers or Normal Saline) is spiked in anticipation of emergent administration, for example an OR room, does the 1 hour expiration time apply to this situation?

Answer: Yes. Since the spiking of an IV bag is considered sterile compounding, administration within the one hour time limit would be applicable. The individual performing this task should use appropriate aseptic technique and should perform a thorough hand sanitization.

Question: What current citations do you most frequently hear about?

Well the really good news we are no longer hearing about facility closures. It appears the word is out regarding theses Infection Control Surveys and facilities are getting prepared. We are seeing and hearing is a propensity towards environmental issues. This continues to be a heavy focus for citations. Check your ceiling tiles, look high and low for dust, check all equipment for tears such as mattresses, and this is that time of the year when insects may become a real issues. If you are not using a check list for your cleaning inspections you should consider one. See our attached link.

Coming in second place seems to be training. While this is still and obscure number for all of us, be sure to have handy information on what the training involved. Certificates are not necessarily enough. And the concept of " ongoing" training will take on new meaning as we head into a new year. It would be best to look for 2011 opportunities and at least be able to show your planning process. And you must figure out a way to share all this information with your surgeons so that they have training as well.

Having a QA/PI program is a requirement of accrediting and regulatory agencies. The facility's program must meet requirements of external agencies but should meet the internal needs of your facility. The overall goal of an Infection Prevention program is to provide high quality services that provide for the safety of patients and staff by reducing the risk of Health Care Acquired Infections. Measurements of the performance of the Infection Prevention program are a part of the facility's measurements of performance.

Surveillance and monitoring activities lend themselves to documenting the integration of the Infection Prevention program with the facilities QA/PI activities. Review what your facility is monitoring for performance improvement measures and make sure to include your surveillance reports. From that point, include the record of activities you have put in place for ongoing monitoring or correction.

QA/PI projects you choose should be meaningful for your facility, the procedures performed, your patient population, should measure outcomes of care, measure compliance with infection control requirements, and be congruent with your facility's QA/PI plan. Although you are probably doing overall surveillance for health care acquired infections, a total infection rate will be less meaningful than the infection rates for specific procedures. Data for infections related to specific procedures can guide performance improvement initiatives to reduce the incidence of infection related to a procedure. Monitoring and improving compliance with infection prevention requirements is important. Monitoring of compliance with hand hygiene guidelines, safe injection practices, timing of pre-operative antimicrobial prophylaxis, compliance with disinfection and sterilization guidelines would be examples of monitoring for compliance. Data from monitoring can reveal areas where compliance should be improved.

Collection of data and preparing reports is not useful without reporting of the information to key persons. Of course the governing body must receive this information but the information must be shared with other stakeholders, particularly the facility employees. As you go forward with performance monitoring and improvement for your Infection Prevention program, continue to look for opportunities to tie the activities of your Infection Prevention program with the performance goals of your facility.

Be looking for Excellentia Advisory Group, soon to be on Facebook. This will be a quick way for us to keep you updated on industry information, new things we learn, and new ways we can help you. We, of course, hope that you will "like" us, and that will allow us to stay in touch with you on a regular basis.

Excellentia will be hosting 4 two day events in 2011 with the purpose of providing infection control training with focus in the ASC and ambulatory care healthcare niches.

Our first venue will be in St. Charles (St. Louis), Missouri on March 4-5, 2011.

This fantastic 2-day training opportunity will be at the St. Charles Convention Center/Embassy Suites Hotel & Spa.

This will be an opportunity to earn 14 hours of continuing education credit and provide strong evidence of training to your CMS surveyors.