Critical steps and independent double checks

Background

A critical step is a step within a process that must be checked by a pharmacist or pharmacy technician, as it cannot be reliably confirmed or easily corrected during a final check.

Critical steps vary between tasks but may include

• performing calculations,
• verifying the selection of drugs or ingredients,
• verifying quantities of ingredients, or
• verifying techniques.

Each practice site may have critical steps unique to their site due to variation in workflows and technologies used. Critical steps are mandatory checkpoints within a process where an error could result in patient harm, product loss, workflow delays, or other significant consequences.

One way to verify a critical step is through an independent double check. Because some errors cannot be identified once a process has moved past a certain point, critical steps and independent double checks provide an opportunity to catch errors that may not be possible to detect during a final check. When an unregulated employee performs a critical step, that step must be independently double checked by a regulated member before proceeding.

For example, when performing compounding activities, mixing in the wrong amount of a product may not result in a detectable change and could be hidden when performing a visual check of the final product. Identifying critical steps and performing independent double checks reduces the likelihood that practice incidents such as these occur.

As outlined in the Standards for the Operation of Licensed Pharmacies (SOLP) and Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT), an independent double check involves a regulated member confirming that the critical step completed by another individual at the practice site has been performed accurately. Regulated members performing independent double checks should use their own judgement and any original sources of information (e.g., the written prescription, master formula, stock bottles, or the patient profile) before relying on the work or conclusions of others.

Examples of critical steps that an unregulated member may perform include, but are not limited to

• selecting drug products to fill a prescription,
• reconstituting commercial products as per the manufacturer’s instructions, and
• activities related to non-sterile compounding such as weighing ingredients.

Under Standard 2.5 of the SPPPT, regulated members are accountable for any patient care provided not only by themselves but also any unregulated staff members working under their supervision.

Identifying critical steps and completing independent double checks are two quality assurance mechanisms that ensure patients are receiving safe and appropriate care.

Advice to protect you, your patients, and your profession

1. Identify critical steps.
   1. Review each step in the procedures at your workplace and ask yourself the following questions. Answering “yes” to any of them may indicate that the step is a critical step.
      1. Potential for patient or public harm – Could a mistake result in patient harm? Would a mistake impact multiple patients, the public, or other workers?
      2. Product integrity – Could a mistake affect the quality or effectiveness of the final product?
      3. Recurring concern – Is this step recognized as a high-risk part of the process or has this step been associated with a practice incident, close call, audit finding, or trend at the practice site?
      4. Workflow – Once this step is completed, would the evidence needed to verify accuracy no longer be available? Would it be difficult or impossible to correct the mistake after proceeding to the next step? Would the steps performed be difficult or impossible to confirm during the final check by a pharmacist or pharmacy technician? Could this consume significant resources and create challenges if done incorrectly? Does this step require a specific value, setting, calculation, interpretation, or professional judgement that could substantially change the outcome?
   2. Examples of critical steps in pharmacies may include the following:
      1. Blister packaging – Using the incorrect medication when making blister packs for patients may be difficult to detect later, result in patient harm, or create significant time delays to amend the assembled packs. Requiring a critical step where a regulated member checks the DINs of the products selected against the information on the patient’s profile prior to returning stock to the shelf reduces the likelihood of this occurring.
      2. Reconstituting medications – Improper methods of reconstituting medications cannot be undone, may be difficult or impossible to detect later, and may impact patients or result in the loss of product. Prior to mixing products such as amoxicillin suspensions, having a regulated member check any calculations and verify the amount of water measured against the manufacturer’s instructions ensures that the correct product is reconstituted in the correct way.
      3. Filling an automated dispensing system (e.g., ScriptPro, PACMED) – An incorrect medication being placed in an automated dispensing system may have the potential for significant patient harm and result in delays or loss of product. Before adding new stock, a regulated member should check the name, strength, and DIN of the medication against the cell label and information in the dispensing system to ensure that the correct medication has been selected.
      4. Performing non-sterile compounding – Selecting the wrong product or measuring the wrong amount of the correct product may be difficult or impossible to detect later, result in patient harm and the loss of product. A regulated member should check the selected product and the amount weighed out against the master formula at a point before the preparation is finalized while the accuracy of the ingredient selection and measurement can still be independently confirmed.
2. Create policies and procedures that
   1. define critical steps so it is clear to all staff which steps are considered critical steps within a process and therefore require an independent double check when performed by an unregulated employee;
   2. explain
      1. who performs the independent double check,
      2. what information they are checking,
      3. what must be documented
      4. when in the process the check occurs, and
      5. how the check is to be performed; and
   3. ensure accountability and quality assurance by incorporating steps within the independent double check such as having the regulated member document their check (this could be as simple as initialling beside calculations or the DIN on other documentation).
3. Review policies and procedures
   1. following practice incidents or close calls, and
   2. when new workflows are introduced or updates are made to existing workflows.
4. Regulated members involved in critical steps or independent double checks, should
   1. Be familiar with site-specific procedures – Know the procedures that contain critical steps and the policies on independent double checks.
   2. Ensure the quality of the work they provide – When performing critical steps, extra care should be taken to ensure that they are completed properly.
   3. Ensure independent double checks occur for critical steps performed by unregulated employees – Independently double check critical steps performed by unregulated employees, or ensure another regulated member does so before the activity proceeds.
   4. Consider an independent double check by another regulated member for their own work – Although not required when a critical step is performed by a regulated member, an independent double check by another regulated member is considered a best practice when resources permit.
   5. Reduce the risk of bias whenever possible – The original information should be independently checked, rather than simply confirming that the work appears to have been done correctly. For example,
      1. check the amount counted or measured before verifying with the manufacturer’s instructions, the compound formula, or other sources of information such as your colleague;
      2. perform calculations separately before reviewing any work that was already done or use an alternative method of calculating the required information; and
      3. review one piece of information at a time and compare it to the source document when possible.

Further reading

ACP resources

• Critical steps and independent double checks
• Standards for the Operation of Licensed Pharmacies
• Standards of Practice for Pharmacists and Pharmacy Technicians

External resources

• Lowering the Risk of Medication Errors: Independent Double Checks – ISMP Canada
• Tools and Support – ISMP Canada