Adam C. Welch, PharmD 

Community pharmacies have provided a significant share of COVID-19 vaccines during the pandemic.

For some pharmacy staff, makeshift parameters were put in place to provide this patient care.

Couple that with continually evolving authorization, approval, and recommendations for the vaccines, the risk for vaccine errors can be elevated. This article describes a process to minimize vaccine errors using a COVID-19 vaccine point of distribution as an example.

Establishing a COVID-19 Vaccination Point of Distribution

The Tennessee Department of Health, using a cooperative agreement with the US Centers for Disease Control and Prevention (CDC), supported the formation of a COVID-19 vaccine point of distribution (POD) at East Tennessee State University.

 In establishing a vaccine POD, the university chose a central location that could accommodate large numbers of people with appropriate physical distancing. 

A conference center owned by the university was chosen as the site of the POD. Minor modifications were made to the conference center (e.g., establishing back-up power access) in preparation of vaccine delivery. The result of this multidisciplinary collaborative effort was the establishment of a vaccination clinic in a non-traditional, non-health care setting.

The POD leadership team made the decision to use the Janssen COVID-19 vaccine for reasons of storage, mobility, and fulfilling a perceived gap in the community with, at the time, a 1-dose vaccine option. The Janssen COVID-19 vaccine was initially authorized for use in persons 18 years of age and older.

Early COVID-19 vaccination clinics required an appointment. This requirement was removed in later clinic dates and as the vaccine was recommended for people regardless of risk.

In the initial clinic setup, 6 stations were developed. Station 1 was a welcome station at the door where appointments were confirmed, and temperatures were taken. Station 2 included the distribution of the Emergency Use Authorization and Fact Sheet for Recipients and Caregivers.

Station 3 was a verification of answer choices on the consent form, determination if the patient was an appropriate candidate for the vaccine, and the appropriate observation time (i.e., 15 or 30 minutes). Station 4 was the vaccination.

Station 5 was the observation and issuance of the white vaccination card. Station 6 was documentation in a separate room in the Tennessee Immunization Information System (TennIIS). Patients progressed in a 1-directional flow utilizing hallways and rooms with multiple doors. For each clinic, volunteers, primarily from the university’s health science colleges, staffed the stations.

A core group of professional staff oversaw the operations. For each clinic day, a brief 30-minute orientation occurred immediately before the clinic shift. These orientations outlined responsibilities for the volunteers and provided general information about setup, flow, and day-of tasks.

Vaccine records were reconciled as a part of a separate procedure. In that reconciliation, an error was identified retrospectively in which 3 patients received the Janssen vaccine who were under 18 years of age. After identification of the second administration error, an analysis was done following the Root Cause Analysis framework used by the Veterans Health Administration (VHA).

The VHA National Center for Patient Safety (NCPS) describe a comprehensive systematic approach to address a patient safety event called the Root Cause Analysis (RCA).

It is used to uncover factors that lead to patient safety events, which can ultimately help organizations provide safer care.

It allows for a rapid and accurate assessment of potential and actual causes of patient harm.

 There are 17 total steps in the RCA. The steps of the process are listed in 

. This process was modified and applied to the administration errors found in the vaccine POD.

The staff applied the root cause analysis to the error of vaccinating a person under 18 years of age. The first step in applying this concept was creating a team.

The core group of professional staff involved with the clinics were used to investigate the administration errors. The workflow of the vaccination clinic was known to the staff.

To triage and conduct the safety investigation, the team proposed a series of questions thinking backwards from the endpoint of an underage person receiving the vaccine. By asking a series of questions such as what, where, when, and how, the team was able to pursue a root cause.

A 17-year-old received the vaccine. Why? Because they made it to station 4 without being stopped? How? Because age was not identified at station 3. Why? Because the age was not easily listed on the consent form, rather a date of birth was listed.

The person at station 3 tended to only review the yes/no answers for vaccine contraindications and precautions. Why? Because the training of the volunteer at that station did not address the idea of confirming date of birth. Why? There were only 30 minutes allotted for orientation, and an emphasis was placed on clinical decision making based on contraindications and precautions. Why? Because the clinic advertised the vaccine for those 18 years of age and older and the volume of patients during a clinic shift was high.

At this point in the investigation, the staff determined that education on the responsibilities of station 3 should include verifying the birth date. Training was done on subsequent orientations and volunteers were instructed to verify age as well as risk for vaccine contraindications.

This intervention would be considered a “weaker action” in the safety action hierarchy described by the VHA NCPS. A few weeks later, a third patient under 18 years of age inadvertently received the vaccine, indicating this weaker intervention was not enough.

The safety action hierarchy can be a helpful tool to assist teams involved in identifying root cause analyses. The hierarchy determines which actions would likely have a stronger effect for successful and sustained improvement. The actions are categorized in 3 levels: weaker, intermediate, and stronger.

The strength of the action is inversely related to the reliance on humans to remember to perform a task. Weaker actions require more reliance on humans to perform a task correctly. Examples of the 3 action levels are listed in 

Table 2. Example patient safety actions following the action hierarchy

The intervention initially implemented involved training, which is considered a weaker action. At subsequent orientations, the volunteer was asked to verify the age of the patient in addition to reviewing the consent form for vaccine contraindications. Eventually, that intervention was determined to be ineffective as another 17-year-old received the vaccine.

After reviewing the process again, the POD leadership team made a different intervention that would be classified as intermediate. Rather than relying on training of the volunteers at station 3, many of whom were volunteers spending only 1 day at the station, the team decided on an “enhanced documentation” intervention.

The consent form was modified to include the yes/no question: Are you currently 18 years or older? This intervention was more successful as the clinic did not experience further underage vaccinations now that the patient was explicitly asked if they were old enough to receive the vaccination.

The vaccination POD was developed out of a community need. It was not a traditional health care facility and did not have the traditional medication safety checks and balances that evolve over time.

Applying a root cause analysis and thinking about the hierarchy of actions was helpful to the POD to minimize errors. These same principles can be applied to community pharmacies, which can adapt these processes with the basic understanding that effective error-preventing strategies are more about the system and less about the human. Lastly, it is important to note that vaccine errors should be reported to the Vaccine Adverse Event Reporting System, vaers.hhs.gov.

Schieszer J. COVID-19 vaccinations change the role of community pharmacy. 

https://www.drugtopics.com/view/covid-19-vaccinations-change-the-role-of-community-pharmacy

Opfer C. Pharmacy workers turn to makeshift virus protections on the job. 

https://news.bloomberglaw.com/daily-labor-report/pharmacy-workers-turn-to-makeshift-virus-protections-on-the-job

Centers for Disease Control and Prevention. Interim clinical considerations for the use of COVID-19 vaccines currently approved or authorized in the United States. 2021. 

www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

www.grants.gov/web/grants/search-grants.html

U.S. Food and Drug Administration. Janssen COVID-19 vaccine. 2021. 

www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine

Veterans Health Administration (VHA) National Center for Patient Safety (NCPS). Guide to performing a root cause analysis. 2021. 

https://www.patientsafety.va.gov/docs/RCA-Guidebook_02052021.pdf

Institute for Healthcare Improvement. RCA2: Improving root cause analyses and actions to prevent harm. 2021. 

www.ihi.org/resources/Pages/Tools/RCA2-Improving-Root-Cause-Analyses-and-Actions-to-Prevent-Harm.aspx

Articles

An overview for community pharmacies of a process to minimize vaccine errors using a COVID-19 vaccine point of distribution as an example.