Nationwide Children's Hospital

Non-Sterile Compounding Accreditation within a Pediatric Outpatient Pharmacy Hospital Setting

Submitted by Trenton Soukup, PharmD

Site Description

Nationwide Children’s Outpatient Pharmacy is located within Columbus Ohio. Our organization, Nationwide Children’s Hospital, has been named the U.S. News & World Report’s Best Children’s Hospitals Honor Roll at #6 in 2023. We offer a variety of outpatient services at our Blue, Orange and Yellow pharmacy locations, including influenza (flu) vaccines, non-sterile compounding and meds-to-beds services for discharging patients. The Pharmacy Department at Nationwide Children’s provides pharmacy services to achieve best medication-related outcomes for all our patients and is committed to providing the highest quality of care to all children and their families regardless of ability to pay.

Program Description

The purpose of this case study is to highlight the successes and challenges in our journey as an outpatient pharmacy department to attain PCAB non-sterile compounding accreditation status through ACHC. The process was initiated to ensure our outpatient pharmacy was able to maintain the highest quality services for our pediatric patient population as well as meet payor requirements for financial reimbursement. The financial barriers would have been immense for our patients if they were unable to receive assistance related to their compound medications.

Primary Intended Outcomes

The primary objectives for obtaining non-sterile compounding accreditation within the outpatient pharmacy at Nationwide Children’s Hospital include:

1. Achieve key benchmarks set forth by ACHC
   • Ensuring compliance with the standards set forth by ACHC demonstrates our commitment as a department to provide the highest quality of care to our patients. Also demonstrates are ability as a department to remain agile and innovative with updates related any non-sterile compounding procedures.
2. Meet payor requirements for financial reimbursement.
   • A growing portion of prescription insurance plans are now requiring accreditation status to provide reimbursement for compounded medications. It was our goal to mitigate the financial and medication accessibility barriers patients and families would ultimately face without coverage from their prescription insurance plans.

Key Elements of Success

Key steps that led to a successful accreditation survey include:

1. Gap Analysis Development
   • Allowed for a structured approach when reviewing the full list of ACHC Standards. Our team was able to determine where the pharmacy was currently compliant as well as identify where the biggest risks remained. Once all risks were outlined and identified, we designated a responsible person and deadline for each action item.
2. Team Collaboration
   • A key driver to our success revolved around collaboration as a Pharmacy Department. With assistance from Pharmacy Administration, Medication Safety, Pharmacy Inventory, and Special Pharmacy, we were able to successfully ensure all standards set forth by ACHC were attained.
3. Staff Preparation
   • In preparation for the survey, mock interview questions were created with education materials to help educate all staff members. At monthly staff meetings, these topics would be reviewed to ensure that every team member could confidently and correctly answer questions related to the standards set forth by ACHC.

Outcomes, Measures, or Evaluations for Program

To maintain accreditation status, our outpatient pharmacy will be required to submit a yearly process improvement (PI) plan. Activities are intended to ensure that as an accredited pharmacy, we are maintaining an effective, on-going organization-wide quality improvement mentality. Ongoing monitoring of our program will be conducted by the following:

• Review of all safety event reports related to any non-sterile compound preparations
• Review of patient complaints submitted to Patient Relations related to any non-sterile compound preparations
• Review of non-sterile compound potency results from new trainee quality control samples submitted to an outside sourced (third-party) lab.

Lessons Learned

• Have an organized strategic plan from the beginning identifying responsible person(s) and prioritizing the action items that pose the biggest risk to success
• Maintain effective and ongoing communication throughout the process with all individuals directly involved 
• Seek out individuals or organizations that are willing to share from their experiences and assist with underlying questions/concerns
• Maintain an open mindset when unexpected issues or failures arise during the process. These present an opportunity to improve problem solving and critical thinking skills

Future Goals

Goals for the future with highest priority include achieving successful completion and approval of our process improvement plan on a yearly basis and ensuring pharmacy staff member and patient satisfaction by gathering feedback related to any non-sterile compound preparations or procedures. This will allow us to maintain the highest levels of efficiency and mitigate and medication errors from arising.