Sterile Compounding USP 797

The other major news this month is the column entitled Consistent Interpretation. It reinforces our past warnings about TJC applying the exacting standards of sterile compounding USP 797 during the survey process.

Sterile Compounding USP 797

Even though there are no new standards that say this. The Joint Commission provides three detailed examples of competency validation requirements required for sterile compounding.

Staff Competencies

Staff competencies that will perform sterile compounding is the first example. In this case, the hospital required a didactic test but did not establish a passing score for that test. TJC states the organization must identify a passing score on such a test. Also, there must be an observational component to the competency for sterile compounding. This includes proper adherence to hand washing and garbing. Plus, there must be an outcome competency. In this case, a media fill test and gloved fingertip sampling. Lastly, staff that prepares hazardous sterile compounds must have an additional competency. It includes an assessment verifying compliance with those processes for self-protection.

Judging Staff Competencies

The second competency issue described is interesting. The standard is HR.01.06.01, EP 3 that requires staff to be deemed competent by someone with the educational background, experience and knowledge related to the skills being assessed.

This describes the staff assigned to clean the sterile non-hazardous or hazardous medication compounding area. Joint Commission requires the compounding supervisor, not the EVS manager, check this competency.

Preparing Sterile Compounds

The third example TJC discusses covers the staff that prepares sterile compounds. Before preparing sterile products for patient use, supervisors must assess competencies.

The Joint Commission states that they must pass the following:

• Didactic exam
• Visual observation of hand hygiene
• Visual observation of garbing and use of PPE
• Media fill test Gloved fingertip testing X 3
• And, it prepares hazardous sterile compounds additional competencies for that function

But, here’s the key takeaway. Prepare for a thorough evaluation of the sterile compounding USP Chapter 797 the next time TJC arrives at your door. Pharmacy directors should undertake a thorough review of all requirements in USP Chapter 797. Self-assess to identify areas which may need improvement before your next survey. Plus, obtain and use either of these two documents:

• Medication Compounding Certification Standards
• Home Care Medication Compounding chapter

The Sterile Compounding USP 797 covers these requirements but throughout a long narrative. Instead, these tools provide a user friendly EP level detail.

Patton Healthcare Consulting assists organizations as they deal with the exacting standards of sterile compounding USP 797 during the survey process.