Applying an error prevention process to a COVID-19 vaccination clinic
An overview for community pharmacies of a process to minimize vaccination errors using a COVID-19 vaccine distribution point as an example.
Community pharmacies provided a significant portion of COVID-19 vaccines during the pandemic.1 For some pharmacy staff, makeshift settings have been put in place to provide this care to patients.2
Add to that ever-changing vaccine licensing, approval and recommendations, the risk of vaccination errors can be high. This article describes a process to minimize vaccine errors using a COVID-19 vaccine distribution point as an example.
Establish a COVID-19 vaccine distribution point
The Tennessee Department of Health, using a cooperative agreement with the United States Centers for Disease Control and Prevention (CDC), supported the formation of a COVID-19 vaccine distribution point (POD) at the ‘East Tennessee State University.4 In establishing a vaccine POD, the university chose a central location that could accommodate large numbers of people with appropriate physical distancing.
A university-owned conference center was chosen as the POD site. Minor modifications were made to the conference center (for example, the establishment of emergency electrical access) in preparation for the delivery of vaccines. The result of this multidisciplinary collaborative effort was the establishment of an immunization clinic in a non-traditional, non-medical care setting.
The POD leadership team made the decision to use the Janssen COVID-19 vaccine for reasons of storage, mobility and to fill a perceived gap in the community with, at the time, a vaccine option at a dose. The Janssen COVID-19 vaccine was initially licensed for use in people 18 years of age and older.5
Early COVID-19 vaccination clinics required an appointment. This requirement was removed at later clinical dates and as the vaccine was recommended for people regardless of risk.
In the initial configuration of the clinic, 6 stations were developed. Post 1 was a gate reception post where appointments were confirmed and temperatures taken. Item 2 included the distribution of the emergency use authorization and information sheet for beneficiaries and caregivers.
Station 3 was a verification of the response 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 vaccination.
Item 5 was 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 one-way flow using multi-door hallways and rooms. For each clinic, volunteers, mostly from the university’s health science faculties, manned the stations.
A core of professional staff supervised the operations. For each clinic day, a brief 30-minute orientation took place immediately prior to the clinic shift. These guidelines outlined the responsibilities of the volunteers and provided general information on the setup, flow and day of the tasks.
Vaccination records were reconciled in a separate procedure. In this reconciliation, an error was identified retrospectively in which 3 patients under the age of 18 received the Janssen vaccine. After the second administration error was identified, an analysis was performed according to the root cause analysis framework used by the Veterans Health Administration (VHA).
Root cause analysis
The VHA National Center for Patient Safety (NCPS) describes a comprehensive systematic approach to addressing a patient safety event called root cause analysis (RCA).6 It is used to uncover the factors that lead to patient safety events, which can ultimately help organizations deliver safer care.
It enables rapid and accurate assessment of potential and actual causes of harm to patients.6 There are 17 stages in total in the RCA. The process steps are listed in Table 1. This process has been modified and applied to administration errors found in the vaccine POD.
Table 1. Steps in a Root Cause Analysis
Staff applied root cause analysis to the error of vaccinating a person under 18 years of age. The first step in applying this concept was to create a team.
Core professional staff involved in the clinics were used to investigate administration errors. The workflow of the vaccination clinic was known to the staff.
To sort out and conduct the safety investigation, the team came up with 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 arrived at station 4 without being arrested? How? Because the age was not identified at station 3. Why? Because age was not readily indicated on the consent form, a date of birth was listed instead.
The person in station 3 tended to only review yes/no responses for vaccine contraindications and precautions. Why? Because the training of the volunteer at this station did not address the idea of confirming the date of birth. Why? There was only 30 minutes allotted for the orientation, and the emphasis was on clinical decision-making based on contraindications and precautions. Why? Because the clinic advertised the vaccine for people 18 and older and the volume of patients during a shift was high.
At this point in the investigation, staff determined that training on Job 3 responsibilities should include birth date verification. Training was provided on subsequent referrals and volunteers were instructed to verify age as well as risk of vaccine contraindications.
This intervention would be considered a “weaker action” in the hierarchy of security measures described by the VHA NCPS. A few weeks later, a third patient under the age of 18 inadvertently received the vaccine, indicating that this weaker intervention was not sufficient.
Security Action Hierarchy
The Safety Action Hierarchy can be a useful tool to help teams involved in identifying root cause analyses. The hierarchy determines which actions would likely have a stronger effect for successful and lasting improvement. Actions are classified into 3 levels: weakest, intermediate and strongest.
The strength of the action is inversely proportional to the reliance on humans to remember to perform a task. Weaker actions require greater trust in humans to perform a task correctly. Examples of the 3 levels of action are listed in Table 2.
Table 2. Example of patient safety actions following the hierarchy of actions.7
The intervention initially implemented was training, which is considered a weaker action. During subsequent referrals, the volunteer was asked to verify the patient’s age in addition to reviewing the consent form for vaccine contraindications. Ultimately, this intervention was deemed ineffective because another 17-year-old received the vaccine.
After reviewing the process, the POD leadership team made a different intervention that would be classified as intermediate. Rather than relying on the training of Station 3 volunteers, many of whom were day-long volunteers at the station, the team opted for an “enhanced documentation” intervention.
The consent form has been modified to include the yes/no question: Are you currently 18 or older? This intervention was more successful as the clinic did not experience any further vaccinations of minors now that the patient was explicitly asked if they were old enough to receive the vaccination.
The vaccination POD was developed based on a community need. It was not a traditional health care facility and lacked the traditional checks and balances on medication safety that evolve over time.
Applying root cause analysis and thinking about the hierarchy of actions has been helpful to 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 prevention strategies are more about the system and less about the human. Finally, it is important to note that immunization errors should be reported to the Vaccine Adverse Event Reporting System, vaers.hhs.gov.
- Schieszer J. COVID-19 vaccinations are changing the role of community pharmacy. Drug topics. December 3, 2021. Available at https://www.drugtopics.com/view/covid-19-vaccinations-change-the-role-of-community-pharmacy. Accessed April 7, 2022.
- Opfer C. Pharmacy workers turn to makeshift virus protection at work. Bloomberg Law. April 9, 2020. Available at https://news.bloomberglaw.com/daily-labor-report/pharmacy-workers-turn-to-makeshift-virus-protections-on-the-job. Accessed April 7, 2022.
- Centers for Control and Prevention of Disasters. Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Licensed in the United States. 2021. www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. Accessed November 23, 2021.
- CDC-RFA-IP19-1901 2020. www.grants.gov/web/grants/search-grants.html. Accessed August 17, 2021.
- US 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. Accessed November 23, 2021.
- 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. Accessed August 17, 2021.
- Institute for Health Care Improvement. RCA2: Improve root cause analyzes and actions to prevent damage. 2021. www.ihi.org/resources/Pages/Tools/RCA2-Improving-Root-Cause-Analyses-and-Actions-to-Prevent-Harm.aspx. Accessed August 17, 2021.