July 30, 2018

As part of its new series of monthly updates entitled “4-1-1 on Survey Enhancements” the Joint Commission has identified sterile medication compounding as its first high-risk area of focus for the accreditation and certification standards it administers for nearly 21,000 health care organizations and programs in the United States. Driven in large part by the 2012 multistate meningitis outbreak (caused by contaminated compounded injectable medications), the Joint Commission began offering Medication Compounding Certification in January 2017.

As part of its risk-based heightened sterile compounding focus, the Joint Commission has ramped up its on-site evaluation process of sterile medication compounding in hospitals, critical access hospitals and home care organizations; administering a more comprehensive assessment of these complex sterile compounding processes. Because this highly-technical process has been targeted as one that, if not performed correctly, could lead to patient harm, the Commission has implemented an approach affording expanded dialogue during tracer activities and additional designated surveyor time spent in physical compounding areas of practice for observation purposes.  These requirements will apply to any compounding pharmacy seeking either initial accreditation or triennial reaccreditation.

Additionally, for home care organizations, the Joint Commission announced that it will now utilize the new “Medication Compounding” chapter in the “Comprehensive Accreditation Manual for Home Care” for accreditation purposes. Adapted from the Joint Commission’s Medication Compounding Certification requirements, these new standards align with current United States Pharmacopeial Convention (USP®) requirements for sterile and nonsterile preparations and augment current Home Care Pharmacy accreditation standards. With a focus on preventing the microbial contamination that occurs through direct contact with (or exposure to) moisture or particles in the air generated by personnel, objects and other mechanisms, the areas of focus for quality improvement include:

  • People—Training, competency, proper use of personal protective equipment, aseptic technique
  • Product—Sterility of base products, beyond-use dates, labeling
  • Environment—Airflow, buffer areas, guidelines for cleaning and documentation, storage

The Commission has indicated that all hospitals engaged in sterile compounding activity (including critical access hospitals) should focus on the following areas to best prepare for heightened engagement:

  • Environmental assessment (including testing and certification reports for engineering controls) to ensure all required components are tested and within acceptable ranges.
  • Product preparation assessment.
  • Appropriate completion of competency assessment for all pharmacy compounding staff.

If you have any questions about these enhanced accreditation standards or to learn more about the challenging co-regulatory environment of pharmacy compounding, please contact Hancock Daniel’s Life Sciences team.

The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

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