Sterile Medication Compounding – New FAQs

There are 11 new FAQ’s about sterile medication compounding.

We warned readers in our July 2017 newsletter that the subject became a focus on hospital surveys.

Then, in the September issue of Perspectives, TJC published its most frequently scored standards. This included the most frequently scored issues in its new Medication Compounding Certification program.

Sterile Medication Compounding

Next, in its October 2017 edition of Perspectives, Joint Commission published tips on survey preparation. We also heard at the January Consultants Forum, hosted by TJC, that they hired a pharmacist in the Standards Interpretation Group. Their role is to assist in interpretation and application of requirements. The genesis of this new focus is interesting. The source is a document called USP Chapter 797.

The USP is a standards setting body for pharmaceutical products including sterile compounds. The standards for sterile compounding have existed since 2004. And, in terms of oversight, Joint Commission has taken a circuitous route to where we are today.

Initially TJC was going to enforce USP 797. Had this occurred, it would require only a gap analysis. And in addition, enforcement would occur only in states that adopted USP Chapter 797 as part of their state board of pharmacy regulations. However, the article in the October Perspectives and these 11 FAQ’s make clear a new position. It will now enforce all expectations of USP Chapter 797.

In the past, it was challenging to find enough knowledgeable surveyors that understood the technical requirements. Reportedly, TJC trained the entire hospital surveyor cadre this year. And, as we mentioned in July newsletter, they have pharmacist surveyors assigned to hospital teams in some facilities. When one of these content experts participates on the survey, you can expect a close examination of USP Chapter 797 standards.

We encourage our readers to print and discuss the:

• New FAQ’s
• October 2017 Perspectives article on sterile compounding.
• September listing of most frequently scored standards in medication compounding certification

They will help you determine your preparedness for sterile compounding surveys. In addition, to gain further understanding about TJC’s precise expectations, we encourage readers to obtain a copy of the home infusion standards 2018, or the optional medication compounding certification standards. These documents have significant similarity to each other. In fact, the EP format makes it easier to understand than the narrative format of USP Chapter 797. While you may not have home infusion services, and you may not have volunteered for certification, these are very useful documents. They help you understand issues that may be explored on your next hospital survey.

Why is TJC applying requirements not stated in the hospital accreditation manual? Remember the CMS memo SC 16-01, dated 10/30/15? It stated that hospitals comply with “accepted professional pharmacy standards and principles including USP 797.” The TJC hospital accreditation manual then states in LD.04.01.01 that the hospital shall be compliant with law and regulation. In addition, IC.01.05.01 requires the hospital to use evidence based national guidelines to prevent the spread of infection, and USP 797 is one example.

The 11 New Sterile Medication Compounding FAQ’s

FAQ 1 – Pharmacy Compounding Requirements

Requirements for pharmacy compounding staff competency verification include:

• Annual media fill testing
• Fingertip sampling
• Didactic testing
• Competency evaluation of hand washing and donning of PPE

Organizations that perform high risk compounding must perform media fill and fingertip testing every 6 months.

FAQ 2 – Urgent Sterile Compounding

Nursing staff who perform urgent sterile compounding are exempt from media fill and fingertip testing. Thus, the ICU or ED staff involved in code or other emergency procedures, will not need this competency.

FAQ 3 – Closed System Transfer Device

The FDA will not approve a closed system transfer device (CSTD) to extend the beyond- use-date of a single dose medication vial. Or, beyond a 6-hour maximum when compounded inside of a laminar flow hood. Remember these are single dose item medications for one use only. Plus, the requirement calls for discarding any residual amount when drawn up outside of a laminar flow hood.

FAQ 4 – Hazardous Medication Permissible Practices

This FAQ explains permissible practices for hazardous medications. It permits sterile compounding outside of a negative pressure room. But two levels of protection are required, such as a CSTD and a biological safety cabinet (BSC) or compounding aseptic isolator (CAI). With the release of the new USP chapter 800 in December 2019, this will become a more intense focus. This chapter focuses exclusively on compounding of hazardous medications. Drafts and guidance publications from USP and ASHP and JCR are already available to help you start preparations.

FAQ 5 – Personal Cleansing and PPE Exemptions

This is an important one. You might think part of personnel cleansing and PPE are exempt when using a compounding aseptic isolator (CAI) or compounding aseptic containment isolator, (CACI). However, this FAQ states that nothing is exempt from the same requirements similar to using a laminar flow workbench. That is unless, the manufacturer of the CAI or CACI specifically states what can be eliminated. Furthermore, unless the manufacturer of the device states that it is not needed, TJC requires double gloving when preparing hazardous medications in the CAI or CACI,

FAQ 6 – Testing Data Primary Engineering Control

This FAQ defines the testing data required every 6 months for the primary engineering control, (PEC) including your laminar air flow workbench, CAI or BSC. Remember also to include this data with your day one documents. TJC requires:

• ISO level of the PEC
• Viable particle testing on the surface of the PEC
• Viable particle testing of the air within the PEC
• HEPA filter leak test for the PEC
• Evidence of remediation and retesting if assessed levels were not in compliance

 FAQ 7 – Testing Data Secondary Engineering Control

This FAQ details the 6-month testing requirements for the secondary engineering control, or the room surrounding room environment. TJC requires:

• Air exchanges per hour of the buffer area
• Pressure differentials between buffer and ante area, and ante to non-classified area
• ISO level of the buffer and ante area
• Viable particle testing of the surface of the buffer and ante area
• Viable particle testing of the HEPA filtered air and leak test
• Evidence of remediation and retesting in the event of a failure

FAQ 8 – Low Risk Compounding

This FAQ describes that low risk compounding can still take place in a segregated compounding area with a hood. But, the beyond use date cannot exceed 12 hours.

FAQ 9 – Cleaning During Sterile Compounding

This FAQ states that a single alcohol swab used during sterile compounding to clean a critical point such as a vial septum, ampule neck or injection port on an IV. Use the swab clean one item only. Cleaning multiple items or areas is not allowed. Since surveyors may be observing sterile compounding, this becomes an important compliance issue. But, some staff may see this as a somewhat trivial point.

FAQ 10 – Failing PEC Testing & Certification

This FAQ is interesting in that it addresses an issue about what to do if your PEC fails its testing and certification. The advice provided seems unusual to us. It says determining to continue using the compounding area is up to the organization. Our advice is to immediately remediate and retest. In addition, discuss appropriate steps with infection control and risk management. Proceed with extreme caution or stop compounding in that location until that remediation is complete.

FAQ 11 – PEC Or SEC Results

Like FAQ 10, it addresses using the PEC when testing/certification results show that either the PEC or SEC is outside of the acceptable range. The advice here is to remediate and retest. In addition, examine all issues including cleaning processes, products and air filtration efficiency.