Injecting Standardization into Vaccine Clinics

INTRODUCTION

• Provide host facilities with a preclinic checklist to identify needs related to setup and layout, technology, patient flow, and documentation.
• Optimize the design of forms for documentation, including patient consent and vaccine administration records.
• For clinics administering more than 1 type of vaccine, standardize the approach to patient flow using 1 of the models described.

Vaccinations provided at community-based clinics (e.g., in schools, offices, and community centres) support high immunization rates, thereby helping to prevent the spread of vaccine-preventable disease. ISMP Canada conducted a multi-incident analysis of vaccine errors as well as a recent failure modes and effects analysis after observing several community vaccine clinics. The systemic vulnerabilities identified through these analyses have the potential to lead to errors and highlight opportunities for system improvements. This bulletin shares learnings to help inform safe medication practices in vaccine clinics.

BACKGROUND

Analyses identifying types of errors with vaccines have previously been published.1,2 Vaccine-related medication errors can result in vulnerability to disease, adverse effects, a need to readminister the vaccine, or a loss of trust in the healthcare provider or in the healthcare system.3 Some vaccine clinics are well established, with a permanent setup (e.g., travel clinics). Others are ad hoc clinics set up in non-healthcare settings, commonly referred to as host facilities. These latter clinics operate on a seasonal basis (e.g., influenza vaccine clinics in shopping malls) or in response to an urgent public health need (e.g., temporary vaccine clinics during an epidemic) or episodically (e.g., school-based vaccine clinics). Operational differences among such clinics can result in safety vulnerabilities (see Box 1).

CLINIC SETUP AND ORGANIZATION FACTORS

Clinic Layout

A preclinic checklist should be developed by the vaccine clinic providers to provide the host facility with organizational guidelines and to ensure that clinic staff will be working in an environment with standardized physical conditions, regardless of the specific location.

Recommendations:

• • Provide the host facility with a checklist of clinic needs related to setup and layout, technology, patient flow, and documentation. The checklistshould include the following layout information, ata minimum:
  – Space requirements to accommodate the preferred, standard layout, including furniture and lighting needs, as well as clear signage to help patients navigate the clinic.
  – Clearly defined and separate triage/assessment areas, waiting areas, immunization stations, post-immunization observation areas, and a designated space for emergency care if an adverse reaction occurs.
  – Privacy considerations for patients and providers in the care delivery areas.
  – Reasonable proximity to a washroom and/or hand-washing station.
  – Vaccine storage requirements to maintain the cold chain.
  • Visit the proposed site beforehand to confirm that it can safely accommodate the clinic.

Access to Technology

To support clinic staff, suitable technology must be available to assist in registering patients, identifying potential problems (e.g., vaccine contraindications), and updating health records.

Recommendations:

• Confirm access to uninterrupted internet service for online documentation systems (where applicable). If documentation of vaccination is to be completed online, clinic staff will need uninterrupted access to the internet and suitable electronic equipment, with back-up provisions for unanticipated downtimes.
• If possible, use secure mobile applications for documentation. Staff use of secure internet-enabled mobile devices reduce the clinic’s reliance on the host facility’s internet access.
• If only paper documentation is used, notify the patient’s primary care provider, if available, about which vaccine was administered, to ensure that the patient’s health record is up to date.
• Encourage patients to notify their primary care providers of each vaccination, regardless of the documentation method used

PATIENT FLOW

It is important to have good patient flow, as well as procedures for crowd control, to minimize the chances of errors related to distraction of staff by a potentially noisy, chaotic, or disorganized environment. In a busy clinic, long wait times contribute to patient anxiety and to a perception of time pressure and increased cognitive load for clinic staff. Some clinics administer only 1 type of vaccine (e.g., influenza), whereas travel or school clinics typically offer multiple vaccines. Clinics that administer multiple vaccines can use 1 of 2 models of patient flow:

1. Configure the clinic to provide a separate area for each vaccine to be administered, such that patients needing more than 1 vaccine move from station to station. This approach decreases the likelihood of administering an incorrect vaccine; however, it requires a repetitive patient identification process at each station, which may result in omission of a needed vaccine or increased anxiety for some patients.
2. 2 The alternative model is to administer multiple vaccines at the same station. Each vaccine needs to be checked against the patient’s list prior to administration. This approach eliminates the need for multiple patient identifications and reduces the likelihood that a vaccine will be omitted, but it can increase the possibility that an incorrect vaccine will be selected and administered.

Recommendations:

• To eliminate confusion among patients as they arrive at the clinic, post information about patient intake and consent procedures. • Designate a patient waiting area outside the official clinic area.
• Assign time blocks outlining when patients should arrive for their vaccinations, or schedule individual appointments.
• If the clinic is based in a school or office building, control flow by calling patients to the clinic according to floor or room number. If possible, identify anxious patients so that they can be vaccinated first.
• For clinics offering more than 1 type of vaccine, standardize the approach, using the model selected to streamline workflow and decrease the potential for errors.

DOCUMENTATION PROCESSES

Documentation is an integral part of the vaccination process; however, the required forms (e.g., consent forms, vaccine administration records) often differ between organizations and may not provide the information in the sequence required by the person administering the vaccine.

Recommendations:

• If possible, format the content of each form to fit on 1 side of a single page, to avoid the need for double-sided printing and the requirement for clinicians to flip back and forth to find needed information.
• On all documentation, use both the brand and the generic names of the vaccine to be administered, given that the brand may change from 1 clinic to the next, depending on availability. Using the generic name also reduces the risk of confusion among products, especially when a brand name is associated with more than 1 vaccine.
• When both paper and electronic forms are used, employ the same terminology and present the information in the same order and in a similar format, to the extent possible.
• Provide patients (or their parents/guardians for children) with a record of the vaccine and date administered. Digital tools, such as CANImmunize, ⁴ are available for secure storage of personal vaccine records.
• Whenever possible, pack only 1 lot number of each vaccine per clinic, to assist with correct documentation of the lot number and expiry date, and to reduce staff workload. If only 1 lot number is used, documentation of the lot number and expiry date prior to administration would allow a double check at the time of administration. • Encourage the use of a duplicate label supplied by vaccine manufacturers, containing both the lot number and expiry date of the product, for documentation purposes (i.e., to be applied to the vaccine administration record).

VACCINE-ASSOCIATED CONSIDERATIONS

PROCUREMENT

Vaccines may be procured from a central supply (e.g., the public health department for publicly funded vaccines in some provinces) or from a drug wholesaler or the manufacturer. Each brand of the same generic vaccine may need to be handled differently (e.g., varying expiry dates for opened multi-dose influenza vaccines) and vaccines with similar names (e.g., Priorix-Tetra and Priorix, Varivax and Vaxigrip, Pediacel and Adacel) can be mixed-up.

Recommendations:

• For each clinic, procure only 1 brand of each generic vaccine, where possible. If there is insufficient supply of a single brand, segregate the brands and clearly indicate which product is to be used first.
• Ensure emergency medical supplies are available to manage anaphylaxis and other post-immunization reactions on-site.

STORAGE AND COLD CHAIN REQUIREMENTS

Vaccines have specific cold storage requirements and require temperature monitoring. To maintain the cold chain during transportation and in ad hoc clinics, insulated coolers are often used if a monitored refrigerator is not available.

Recommendations:

• Store vaccines under monitored cold storage conditions in a cooler or a refrigerator, by verifying the container temperature at regular intervals.
• Store each vaccine product separately using labelled compartments (with a picture, where possible), when more than 1 vaccine is stored in the same location.
• Consider using bar code identification to verify product selection and to reduce incorrect vaccine errors due to inadvertent misplacement during storage. Mobile bar code readers are available and can be incorporated into vaccine administration processes for the clinic.

Wrong patient and wrong vaccine are common vaccine administration errors.

Recommendations:

• Before administration of each vaccine, obtain 2 unique identifiers (e.g., first and last [and/or preferred] names, birthdate) to identify the patient.
• To limit confirmation bias, ask patients open-ended questions, for example, “What vaccine are you expecting to receive today?”
• In clinics offering multiple vaccines, select and administer the required vaccine for each patient individually. This method creates a more engaging environment and makes the task less prone to error.

CONCLUSION

Organizations operating vaccine clinics have an opportunity to improve vaccine safety by standardizing all aspects of the clinic, including setup and layout, vaccine procurement and storage, patient flow, and design of forms. Standardization is especially critical for organizations (e.g., school boards, public health departments) that operate or host numerous vaccine clinics over multiple sites and employ a large staff.

The Canadian Medication Incident Reporting and Prevention System (CMIRPS) is a collaborative pan-Canadian program of Health Canada, the Canadian Institute for Health Information (CIHI), the Institute for Safe Medication Practices Canada (ISMP Canada) and Healthcare Excellence Canada (HEC). The goal of CMIRPS is to reduce and prevent harmful medication incidents in Canada.

Funding support provided by Health Canada. The views expressed herein do not necessarily represent the views of Health Canada.

The Healthcare Insurance Reciprocal of Canada (HIROC) provides support for the bulletin and is a member owned expert provider of professional and general liability coverage and risk management support.

The Institute for Safe Medication Practices Canada (ISMP Canada) is an independent national not-for-profit organization committed to the advancement of medication safety in all healthcare settings. ISMP Canada’s mandate includes analyzing medication incidents, making recommendations for the prevention of harmful medication incidents, and facilitating quality improvement initiatives.

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