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, and there is confusion, even among surveyors, on the use of some multi-dose medications, such as eye drops.
Centers for Medicare and Medicaid Services (CMS) clarifies with CfC 416.48 that we must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice and under the direction of an individual that we have designated responsible for our pharmaceutical services. In addition, CMS adds in the same CfC that drugs must be prepared and administered according to established policies and acceptable standards of practice. Below is a list of safe medication practice guidelines to prepare ASC Clinical Directors to meet the standard set forth in CfC 416.48.
Safe Medication Standards of Practice:
- Designate a licensed staff member to oversee your pharmacy program, and make sure this individual is routinely present in your facility. You must also follow your state regulations as it relates to the need for a registered pharmacist, as regulations vary from state to state. Some states do not require a registered pharmacist and some, like Texas, require a weekly consult.
- Keep the appropriate records for the ordering, receipt of, and disposition of scheduled II, III, IV, and V drugs.
- 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.
- For multiple-dose medications/vials (MDV) – date upon opening with the beyond use date and do not take a MDV into an immediate patient care area; if this occurs, that MDV becomes a SDV for that particular patient.
- Make sure that 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.
- Create a policy and procedure for the administration of eye drops and conduct staff training on this process.
- Review and be knowledgeable of the questions on the CMS infection control surveyor worksheet. Exhibit 351.
United States Pharmacopeia Chapter 797 (USP 797) provides you with guidelines on compounding sterile preparations in your ASC. It is acceptable for a center to compound for immediate use, but the following rules apply:
- The CSP must be intended for immediate use or an emergency situation.
- The CSP cannot be stored for the purpose of anticipated need or batch compounding.
- No more than (3) commercially available sterile products in original container and no more than (2) entries into any container/package/device can occur.
- Continuous process must be completed within (1) hour.
- Adhere to aseptic technique.
- Administer within (1) hour, or discard CSP.
Examples of immediate use CSPs are antibiotic solutions, blocks, irrigating solution, and even dilating solutions may fall into this category. The development of best practices for immediate use CSPs is important and should be included in training and competencies for those licensed staff that are involved in the preparation, transportation, and administration of CSPs.
The area where CSP 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). Make sure the entry ports are disinfected and calculations are verified so that accurate mixing takes place. Proper labeling must also be done prior to taking the CSP for administration.
ASC clinical leaders may refer to the lists above to ensure safe medication practices and compound sterile preparations are compliant with CMS regulations. For further information on CMS guidelines, visit the CMS infection control surveyor worksheet referenced above or the CMS website.
Part two of this blog series will focus on compounding pharmacies – problems and understanding the differences between the types of compounding pharmacies.