Highly publicized instances of patient complications associated with compounded sterile preparations (CSPs) have increased scrutiny of safe medication practices in ambulatory surgery centers. Citations are being issued related to safe medication preparation and administration. There is confusion, even among surveyors, on the use of some multi-dose medications, such as eye drops.

In CfC 416.48, Centers for Medicare and Medicaid Services (CMS) clarifies that ASCs must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual the ASC has designated responsible for provision of the ASC’s pharmaceutical services. In the same CfC, CMS indicates drugs must be prepared and administered according to established policies and acceptable standards of practice. To meet the standard set forth in CfC 416.48, ASC Clinical Directors will want to consider this list of safe medication practice guidelines.

Safe Medication Standards of Practice

1. Designate a licensed staff member to oversee your pharmacy program. Make sure this individual is routinely present in your facility. Follow your state regulations as they relate to the need for a registered pharmacist. Regulations vary from state to state. Some states do not require a registered pharmacist and some, like Texas, require a weekly consult.
2. Maintain appropriate records for the ordering, receipt, and disposition of scheduled II, III, IV, and V drugs.
3. Understand that single-dose medications/vials (SDV) are to be used immediately upon opening, on one patient only, and then discarded. Once opened, they cannot be stored for any period of time.
4. Date multiple-dose medications/vials (MDV) upon opening with the beyond use date. Do not take a MDV into an immediate patient care area. If this occurs, that MDV becomes a SDV for that particular patient.
5. Ensure staff are aware of the definition of a MDV – “A vial of liquid medication intended for parenteral administration that contains more than one dose of medication.”This does not apply to eye drops. Adherence to this guideline will prevent confusion in a survey.
6. Create a policy and procedure for the administration of eye drops. Conduct staff training on the process.
7. Review and be knowledgeable of the questions on the CMS infection control surveyor worksheet found in Exhibit 351.

United States Pharmacopeia Chapter 797 (USP 797) provides guidelines on compounding sterile preparations in ASCs. It is acceptable for a center to compound for immediate use, but the following rules apply:

1. The compound sterile product (CSP) must be intended for immediate use or an emergency.
2. The CSP cannot be stored for the purpose of anticipated need or batch compounding.
3. No more than three (3) commercially available sterile products in original container and no more than two (2) entries into any container/package/device can occur.
4. Continuous process must be completed within one (1) hour.
5. Adhere to aseptic technique.
6. Administer within one (1) hour, or discard CSP.

Examples of immediate use CSPs are antibiotic solutions, blocks, and irrigating solutions. Dilating solutions may also fall into this category. The development of best practices for immediate use CSPs is important and should be included in training and competencies for licensed staff involved in the preparation, transportation, and/or administration of CSPs.

The area where CSP preparation takes place should be quiet and free from distractions. The designated staff member should disinfect the area, complete proper hand hygiene, and wear appropriate personal protective equipment (PPE). The entry ports must be disinfected. Calculations should be verified to ensure accurate mixing takes place. Proper labeling must occur prior to removing the CSP from the preparation area and administering it to the patient.

To ensure safe medication practices and compound sterile preparations are compliant with CMS regulations, ASC clinical leaders may find it helpful to refer to the lists above. Additional information on CMS guidelines is available via the CMS infection control surveyor worksheet and the CMS website.

Jovanna Grissom, Vice President of Operations