Sterile Compounding Coordinator

Site Name:

Via Christi Hospitals Wichita, Inc.

Primary Intended Outcome(s):

1. and who has a four-year University degree.
2. Remove pharmacists from routine IV room processes and procedures, as well as annual testing and employee training, so as to redirect their time to clinical functions.
3. Increase regulatory compliance by having an advanced technician routinely engaged in the IV room workflow, who is able to respond in real time to issues or problems that arise.
4. Standardize the training of new employees.

Site Description:

Via Christi Hospitals Wichita, Inc., part of the Ascension network of hospital systems, comprises three hospitals in the Wichita area: Via Christi St. Francis, Via Christi St. Joseph, and Via Christi St. Teresa. Via Christi St. Francis is a Level 1 Trauma Center with an inpatient Cancer Institute, ambulatory infusion center, seven intensive care units, and 408 beds. Via Christi St. Joseph has a New Life Center with a Level 3 neonatal intensive care unit, two additional intensive care units, and 211 beds. Via Christi St. Teresa is a community hospital with one intensive care unit, an inpatient rehabilitation unit, and 57 beds. Each location produces sterile compounds on demand as well as producing scheduled sterile compounds. Via Christi St. Francis also produces sterile chemotherapy compounds for the Via Christi inpatient Cancer Institute and occasional procedures conducted at the St. Joseph campus. There are five compounding aseptic isolators located throughout the three hospitals, two laminar airflow workbenches and a biological safety cabinet at St. Francis, and two i.v. STATIONsTM at St. Joseph. The IV room at St. Francis includes a non-hazardous clean room with adjacent ante-room and a hazardous clean room with adjacent ante-room. Batched products used at all three campuses are produced by the i.v. STATIONsTM and by technicians working in the non-hazardous clean room at Via Christi St. Francis. The majority of compounds, both hazardous and non-hazardous, are produced by technicians. Pharmacists produce sterile compounds only in emergent situations when a qualified technician is not available.

Advanced Role Description:

The Sterile Compounding Coordinator is responsible for ensuring all compounding rooms, devices, supplies, and personnel are compliant with USP Chapter <797> and USP Chapter <800> regulations as well as any applicable state Board of Pharmacy regulations. This includes ensuring proper airflow in ISO classified areas, verifying products used meet USP requirements for sterile compounding, and confirming devices are working according to manufacturer specifications. The coordinator completes routine environmental sampling of all devices and rooms, coordinates semi-annual recertification with an outside entity, conducts new employee training, writes and reviews sterile compounding procedures, and supervises annual written and didactic competency testing with all employees who engage in sterile compounding. Training and education is provided to technicians and pharmacists at initial hire, on an annual basis, and as needed. Further staffing duties are required to ensure adequate staffing levels, conduct training and education of new employees, and develop policies and procedures that both fit the workflow and meet facility requirements.

How to Start:

Oversight of a sterile compounding program has traditionally been assigned to a pharmacist, who completes necessary requirements in addition to regular staffing duties. With the move to a new model of pharmacist staffing, the goal is to remove the pharmacist from operational duties in the IV room. In order to allow pharmacists to engage in clinical, patient-oriented activities, it is necessary to leverage the power of a trained, competent technician. The following are questions to discuss when implementing this technician role:

1. Will this technician be promoted from within the department, or will an outside applicant be pursued?
2. What kind of training, experience, and education is required for this position?
3. What are the staffing needs of the facility, and how will the staffing needs affect the amount of time allotted for coordinator duties?
4. How will this role interact with pharmacy management and to whom will they report?
5. What expenses, such as pay and/or benefits, will be needed to entice a qualified applicant and remunerate that applicant for their added responsibilities?
6. What are the short-term and long-term goals of this technician?
7. What methods of education will be provided to keep this technician current?

Regulatory and/or Legal Requirements:

1. State license and/or registration.
2. National certification.

Revenue & Expense Parameters:

• Personnel:  One trained technician, paid at the coordinator rate.
• IT and other infrastructure:  Cubicle/office space and dedicated computer.
• Supply Expense:  As needed to maintain compliance.
• Return on Investment: ROI is non-monetary and includes successfully passing all semi-annual recertifications, standardized training for new employees, and improved compounding processes.

Training and/or education requirements:

USP does not require any specific training or education beyond what is needed to be competent at aseptic technique. USP Chapters <797> and <800> state that the individual shall be “qualified,” leaving the interpretation up to each facility. At minimum, the coordinator should have demonstrated mastery over the fundamental principles of sterile compounding and be a Certified Pharmacy Technician (CPhT). Additional training and/or experience in management is preferred, such as the PTCB® Certified Compounded Sterile Preparation Technician™ (CSPT™) Program and/or a bachelor degree. 

Additional training is available through USP, ASHP - such as the Certificate Program in Sterile Compounding, other entities. Though not required, facilities should be willing to provide funding for these courses, to ensure the coordinator remains competent and up to date in the latest regulatory changes and best practices. Several companies also provide free webinars on topics such as procedures for environmental sampling, becoming compliant with cleaning practices, and instituting new regulations. Facilities should be willing to provide the time necessary to attend these valuable educational opportunities.

Outcome Measures:

1. Increase compliance of required cleaning activities to 100% every month.
2. Reform practices and procedures to meet USP regulations and industry best-practices.
3. Pass semi-annual recertification for all devices and rooms.
4. Successful implementation of USP Chapter <800> on or before December 1, 2019.

Lessons Learned:

1. Compliance should be seen as a journey, not a destination. As regulations change, so will the tasks required to continue facility compliance.
2. Organization and documentation is key to successfully transforming a sterile compounding program. If it is not documented, it did not occur.
3. Mistakes will be made, and not every change implemented will end up being successful for the facility. Learning to incorporate lessons learned is vital to ensuring the program continues to move forward.
4. The ability to quickly and efficiently research answers to problems and questions is vital. The coordinator will be required to find information on a variety of topics. Understanding the key terms frequently used in the industry will help in this process.
5. The coordinator will have advanced knowledge of cleaning techniques, regulations, and best practices that will be not be available to most technicians. Educating the staff on this information is the best way of ensuring they follow these practices.
6. Drug shortages are frequent and the coordinator will spend a great deal of time working to discover ways the facility can safely mitigate the impact of these shortages on patient care. Working closely with the purchasing department and being a member of various pharmacy organizations can help the coordinator be proactive rather than reactive.