There’s no argument that compounding sterile products (CSP) is a high risk process. There have been well-documented cases of patient injury or death due to sub-standard practices. Hence, both CMS and accrediting organizations (AO) take a keen interest in assuring that hospitals compound in a safe manner. So what do CMS and AO’ focus on during a survey? The interpretive guidance under Appendix A of the State Operations Manual at §482.25(b)(1) form the basis for this discussion.

What is Compounding?
CMS uses the USP definition, which is: “The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice… including reconstitution or manipulation of commercial products that may require the addition of one or more ingredients”

USP 797
The basis for CMS requirements involving CSP’ is found primarily in industry guidance published by the United States Pharmacopeia (USP) in Chapter 797. USP 797 outlines minimum standards of practice to be followed by all health care personnel in any setting when preparing, storing and transporting compounded sterile preparations. These standards address at least the following:

• The responsibilities of compounding personnel and their supervisors to implement and maintain proper procedures and quality assurance checks.
• Issues specific to “immediate use” CSPs; single- and multiple-dose containers; CSPs containing hazardous drugs; radiopharmaceuticals; allergen extracts; and automated compounding devices used for parenteral nutrition compounding.
• Methods for sterilization, depyrogenation and for verifying compounding accuracy and sterility.
• Specifications for environmental quality and control, including but not limited to:
  • Specifications and related personnel training, including competency assessment and evaluation of skill in aseptically preparing CSPs using visual observation as well as bacterial sampling of glove fingertips and “media-fill testing” at specified intervals.
  • Evaluation and monitoring/testing of the environment in which compounding takes place and, if applicable, the adjacent “ante-” and “buffer” areas, including facility layout, design, environmental controls, restricted access, air quality standards and testing, surface characteristics, furnishings, cleaning and disinfection procedures, and standards for personnel health, attire/cosmetics, cleansing/garbing/gloving, aseptic work practices, etc.
• Suggested standard operating procedures to protect the quality of the environment in which CSPs are prepared.
• Quality control related to ingredients, devices and equipment used in relation to CSPs.
• Quality checks to be performed before CSPs are dispensed or administered.
• Issues related to beyond-use dating and packaging, storage and transportation conditions for CSPs.
• Protecting dispensed and distributed CSPs.
• Patient education issues.
• Monitoring for and reporting adverse patient events related to CSPs.
• Requirements for a formal quality assurance program to be maintained by providers of CSPs

The specific requirements that a hospital must follow depends on the classification of risk relative to the products that are compounded and the subsequent shelf-life. Hospital pharmacies that are classified as low risk may have different requirements than pharmacies classified as high-risk.

Outsourcing CSP
It’s important to note that both CMS and AO’ will expect your hospital to assure that all CSP activities comply with USP 797 guidelines – whether performed in-house of outsourced to a contract service. There are two types of outsourced compounding pharmacies; 503A and 503B. A 503A pharmacy is one that is not registered with the FDA, and hence is not subject to oversight by the FDA. A 503B pharmacy is registered with the FDA and – ostensibly at least – is overseen by that agency to assure that compounding practices are safe.

If your hospital contracts with either type of outsourced pharmacy for CSP, it must demonstrate that it is monitoring the pharmacy’s practices and incorporating said monitoring into the hospital’s QAPI program. This is particularly important when dealing with 503A pharmacies since – depending on your State – there may be little external regulatory oversight.

CSP Outside of Pharmacy
Only your pharmacy should compound or admix sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible (for example, when there is a need for emergency or immediate patient administration of a compounded sterile preparation). If CSP must be performed outside of the pharmacy, then both CMS and AO’ will look to see that the following occurs:

• There is a valid need to CSP outside of the pharmacy
• Staff who perform the CSP have documented training to do on an annual basis
• CSP is done in a functionally clean environment using aseptic technique
• The CSP is for immediate administration – i.e. given within one hour following the time it was prepared.

CSP in the Pharmacy
For CSP that occur in the Pharmacy, CMS and AO’ will assess for at least the following:

• The structural design, environmental controls, air quality levels (based on International Organization for Standardization (ISO) standards for particulate matter in air) and air flow patterns in and surrounding the environment to which the contents of the CSP as well as the surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs are exposed is appropriate for the risk level of CSP being performed.
• Compounding personnel shall perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, at least annually thereafter for low- and medium-risk level compounding, and semiannually for high-risk level compounding. Compounding personnel who fail written tests or whose media-fill test vials result in gross microbial colonization shall be immediately re-instructed and re-evaluated by expert compounding personnel to ensure correction of all aseptic practice deficiencies.

Failure to demonstrate adherence to USP 797 guidance for CSP will almost always result in a condition-level deficiency. The most common citations involve;

• Inadequate documentation of training and proficiency testing for personnel both in and out of the pharmacy
• Inadequate documentation of cleaning and disinfection of the IV room in the pharmacy
• Non-compliance to structural and environmental control requirements in the pharmacy IV CSP area
• Lack of effective oversight of outsourced contract pharmacies
• Lack of oversight and integration of CSP practices into the hospital’s QAPI program

Rick's clinical background is in critical care nursing with a focus in cardiovascular and trauma service lines. He has held both clinical and executive management level positions in Quality, Risk, Education, Infection Control, and Regulatory Compliance.

Rick is a regular speaker at numerous state and national conferences on the federal regulations and accreditation standards, and is host of CIHQ's popular monthly webinars addressing key compliance challenges in today's environment.

Rick is nationally certified in healthcare accreditation, and serves as Chair of the Board of Examiners for the Healthcare Accreditation Certification Program (HACP). Rick has a degree in Nursing with a Master's Degree in Health Services Administration.