Compounding Sterile Preparations

Compounding Sterile Preparations: The
Infection Preventionist Role

Breaches related to compounding sterile preparations (CSPs) can receive national media attention, such as the alarming 2012 multistate fungal meningitis outbreak originating from the New England Compounding Center. When an infection or outbreak is related to a CSP breach, Infection Prevention and Control (IPC) will be involved in the investigation and mitigation activities. Yet, their involvement often comes after a patient has been harmed.

Which begs the question:

What opportunities do Infection Preventionists have before a breach occurs to prevent or halt the process before a contaminated medication reaches the patient?

Understanding the key stakeholders in preventing a breach

Before we know where Infection Preventionists have the opportunity to take action, it’s important to understand that a multidisciplinary approach is critical to achieving intended patient outcomes associated with CSPs. This includes a number of key stakeholders:

  • Pharmacy
  • Leadership
  • Environment of care/facilities/engineering
  • IPC
  • Medical and nursing staff

Of these stakeholders, it’s important to build and sustain a partnership between IPC and the pharmacy that is focused on patient safety. Together, they should be reviewing and approving environmental cleaning and disinfection, as well as engineering control testing policies. A routine review of the following is advised:

  • Buffer and ante rooms
  • Cleaning, disinfection, and sterilization techniques utilized with CSPs
  • Staff hand hygiene
  • Donning and doffing of personal protective equipment (PPE)

To ensure a safe environment is maintained when compounding medications, the Infection Prevention and Control Program should be driven by a comprehensive risk assessment that includes the pharmacy and all satellite locations as a high-risk area under its surveillance. It’s important to understand the level of compounding that is being performed in the pharmacy setting, as requirements differ based on level of risk.

Infection Control Committee (ICC) meetings should have pharmacy representation to include documentation in the ICC meeting minutes of pharmacy testing report results as appropriate. As a best practice, include both primary and secondary engineering controls (PECs and SECs) for viable particle testing for air and surfaces. This report submission does not replace contacting key stakeholders in real time if testing values are out of range or do not pass, which would warrant remediation activities.

One final group to consider is any regulatory body or authority that the pharmacy may be subjected to. This includes a full understanding of two quality standards:

  • Pharmacy and United States Pharmacopeia (USP) 797 – Pharmaceutical Compounding–Sterile Preparations
  • USP 800 Hazardous Drugs–Handling in Healthcare Settings

All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities. Additionally, state pharmacy regulatory bodies are responsible for pharmacy oversight. Nearly all boards of pharmacy either require full compliance with USP 797 or incorporate USP 797 into their state regulations in some manner. (You can learn more here.) Revisions to USP 797 and USP 800 compliance are anticipated on December 1, 2019.

Preventing contamination in CSPs

Now that we better understand the key stakeholders in this process and their relationship with each other, we can now look at some of the key components of CSPs for the Infection Preventionist to focus on, with associated CMS Conditions of Participation and Joint Commission Standards/EPs. Not all activities fall entirely under the Infection Preventionist’s realm; however, they are worth noting and understanding as they all ultimately relate to providing safe CSP practices and preventing potential patient harm.

PEC/SEC CERTIFICATION OR TESTING FREQUENCY

CMS Condition of Participation:

  • §482.41 TAG: A-0700
  • §482.41 Condition of Participation: Physical Environment

Joint Commission Standard/EP:

  • EC.02.04.01 EP4 (PEC)
  • EC.02.06.01 EP1 (SEC)

Each component must be tested and certified every six months by a qualified individual (this is to include any time a PEC is moved or relocated). Request testing report results from the Director of Pharmacy.

CLEANING FREQUENCY FOR PEC

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: IC.02.01.01 EP1

Confirm that pharmacy staff education and training includes cleaning frequency, and that it is monitored for compliance:

  • At the beginning of each work shift
  • Before each batch preparation is started
  • Every 30 minutes during continuous compounding periods with individual CSPs
  • When a spill occurs
  • When surface contamination is known or suspected from procedural breaches

CLEANING FREQUENCY FOR SEC

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: IC.02.01.01 EP1

Confirm the cleaning frequency is occurring and is monitored for compliance:

  • Daily: Floors and work surfaces
  • Monthly: Walls, ceiling, and storage shelves

PEC ISO LEVEL

CMS Condition of Participation: §482.23(c) TAG: A-0405 (c) Standard: Preparation and administration of drugs

Joint Commission Standard/EP: MM.05.01.07 EP4

Must be ISO 5 or less.

SEC ISO LEVEL

CMS Condition of Participation:

  • §482.41 TAG: A-0700
  • §482.41 Condition of Participation: Physical Environment

Joint Commission Standard/EP: EC.02.06.01 EP1

Buffer area must be ISO 7 or less. Ante area must be ISO 8 or less.

PEC HEPA FILTER LEAK TEST

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: IC.02.01.01 EP1

Must show proof of pass or evidence that holes were patched. Request testing report results from the Director of Pharmacy.

AIR FLOW MONITORING

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: EC.02.05.01 EP15

Must have continuous monitoring. SEC must have 30 air exchanges per hour. Compounding hood may contribute up to 15 of the 30 air exchanges.

BACTERIAL ENDOTOXIN (PYROGEN) AND STERILITY TESTING

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: IC.02.01.01 EP1

Review testing results with the Director of Pharmacy as appropriate for these high-risk CSPs:

  • Prepared in groups of more than 25 identical individual single-dose packages
  • Multi-dose vials for administration to multiple patients
  • Exposed longer than 12 hours at 20-80 and longer than 6 hours at warmer than 80 before they are sterilized, dispensed, or administered

MEDIA-FILL TEST, GLOVED FINGERTIP TEST, OBSERVATION COMPETENCY, AND DIDACTIC WRITTEN TEST

CMS Condition of Participation: §482.28(a)(3) TAG: A-0622 (c) Standard: Organization

Joint Commission Standard/EP:

  • HR.01.06.01 EP5 (initial assessment of competency)
  • HR.01.06.01 EP6 (ongoing assessments of competency)

Each test has different requirements:

  • Media-Fill Test: Must meet complexity level of low/medium risk (conducted annually) or high risk (conducted every six months) compounding.
  • Initial Gloved Fingertip Test: Requires three separate tests. To pass test, cannot exceed zero colony forming units (CFU).
  • Ongoing Gloved Fingertip Test: Requires one test. To pass test, cannot exceed 3 CFUs.
  • Observation Competency: Includes PPE garbing and aseptic technique.
  • Didactic Written Test: Organization defines the passing score. Must include high-risk compounding if applicable.

STAFF HANDWASHING AND PPE

CMS Condition of Participation:

  • §482.42 TAG: A-0747
  • §482.42 Condition of Participation: Infection Control

Joint Commission Standard/EP: IC.02.01.01 EP2

Confirm that pharmacy staff education and training includes handwashing and PPE, and that they are monitored for compliance:

  • Handwashing up to the elbow for 30 seconds at minimum
  • Order of donning PPE is from dirty to clean
  • No jewelry, make-up, or outer garments are to be worn
  • Observation Competency: Includes PPE garbing and aseptic technique.
  • Didactic Written Test: Organization defines the passing score. Must include high-risk compounding if applicable.

STERILIZATION PROCESS PERFORMED

CMS Condition of Participation: §482.23(c) TAG: A-0405 (c) Standard: Preparation and administration of drugs.

Joint Commission Standard/EP: MM.05.01.07 EP1

Any product which is classified as high-risk compounding must go through a sterilization process. Confirm with the Director of Pharmacy that sterilization processes are performed for all high-risk compounding.

  • Sterilization by filtration: Must have test of filter after sterilization completed based on manufacturer instructions for use.
  • Sterilization by other methods: BI included with every load/batch, along with temperature sensing device, which may be part of sterilizer.

EVIDENCE OF ACTION WHEN ANY ITEM IS OUT OF RANGE

CMS Condition of Participation: §482.11(a) The hospital must be in compliance with applicable federal laws related to the health and safety of patients.

Joint Commission Standard/EP: LD.04.01.01 EP3

Evidence of remediation actions taken when items do not pass, along with re-testing to ensure compliance is required.