By Robert Campbell, PharmD, BCSCP, Director, Clinical Standards Interpretation and Medication Management for Hospital/Ambulatory Programs and Maura Naddy, MSN, RN, Associate Director, Standards Interpretation Group
More than one in 10, Americans have diabetes. Many of these people rely on personal insulin pumps and continuous glucose monitoring (CGM) systems to improve their overall glycemic control and reduce the risk of experiencing hypoglycemic or hyperglycemic episodes.
Many patients prefer continuing to use their personal insulin pump or CGM system when hospitalized. The American Diabetes Association endorses this practice but it can create risk for the organization.
The Joint Commission outlined seven safety considerations for hospitals to implement if they choose to allow patients to continue using their personal insulin pumps and CGM systems in Quick Safety 59.
1. Contingencies. The team creating policies and procedures surrounding personal insulin pump and CGM system use needs to be multi-disciplinary, including but not limited to:
- nursing
- pharmacy
- risk management
- physician leadership
Contingency planning can’t be overlooked when developing these policies . Patients should be aware that there are important contingencies in place if they are allowed to utilize their own equipment during hospitalization such as:
- patient’s condition changes, especially if the patient can no longer safely manage the infusion
- availability of batteries if the patient does not have replacements
- availability of replacement medication for the infusion device
- failure or damage of the infusion device , rendering it unusable
Remember, per Environment of Care Standard EC.02.04.03, element of performance (EP) 1, The Joint Commission requires that all medical equipment must be inspected prior to being used. This inspection includes safety, operational, and functional checks. At a minimum, organizations should conduct a visual inspection of the device to determine that there are no obvious defects such as:
- cracks
- broken or missing dials
- other components
Hospital staff can have patients demonstrate use of the device to both develop familiarity and gauge whether the device is operational.
2. Evaluation of home medication usage and storage. It’s common for patients to prefer to use their own insulin (i.e., insulin that is brought to the hospital from the patient’s home). Organizations need to define the circumstances under which medications brought in by the patient or family may be used and implement a process to identify and visually evaluate the medication’s integrity.
The process should be completed by an individual deemed qualified by the organization. Additionally, safe storage practices should be evaluated, including the following:
- ensuring security to protect from theft, tampering and diversion
- complying with the product manufacturer’s instructions for use, such as refrigeration and protection from light sources
- warning labels or alerts used to support safe use of the medication (i.e., high alert or look-alike/sound-alike)
- any segregation of medications brought by the patient from those provided by the pharmacy for use on other patients
3. Process for medication self-administration. When an organization permits a patient to self-manage their insulin administration via a personal infusion device, a written process is needed to guide safe and accurate self-administration of medication. Patients with diabetes are often well-versed on managing their insulin infusion and operation of their infusion and CGM devices, but it’s still important to educate the patient on your organization’s policies and procedures regarding use and self-administration of medication brought from home. For example, patients need to communicate to staff:
- the results of glucose testing
- any changes to the rate of infusion, including basal and/or bolus rate adjustments
- any event that may require an increase or decrease in the insulin infusion rate
- any signs or symptoms that suggest that glycemic control may be unstable
- any signs the device is malfunctioning and not delivering the insulin infusion
4. Insulin orders. As with all medication, an insulin order from the licensed practitioner is required. Policies that address the type of medication orders permitted and the required elements of medication orders should include self-administered medication via an infusion device.
When comparing medication information on home medications against the medication orders, practitioners need to be informed of the baseline basal rate and bolus settings in order to determine whether to continue the same treatment regimen or if any modifications are needed during the hospital encounter.
Specific to glucose testing devices, there needs to be a process to verify the patient’s personal glucose testing device is working appropriately. Consider verifying device functionality by performing a blood glucose with the approved multi-use hospital glucometer to ensure the results from both devices are within a range defined by the organization.
If the organization allows a patient to use a CGM device, the process must comply with the manufacturer’s instructions for use related to calibration of the device to ensure accurate results are provided.
5. Documentation requirements for medical records. While the organization determines where and how the use of a personal medical device is documented within the patient medical record, such documentation needs to include:
- medication dose, frequency, and route of administration
- orders from a licensed practitioner
- assessments and reassessments
- patient response to treatment.
- any complications encountered during self-administration
6. Patient and family education. Educate patients and families on applicable policies and procedures. This education should be based on the learning needs assessment, taking into consideration any treatment and/or environmental factors that may be a barrier to safe, self-administration (e.g., a patient receiving narcotic analgesics that may impair cognition).
Staff need to be educated on the organization’s policies and procedures that apply to self-administration of medication via an infusion device. Such education may include requirements such as:
- assessment and reassessment of the device
- assessment and reassessment of the insertion site
- documentation
- responding to critical test results
- provider notification of critical test results.
- ongoing assessment of the patient’s ability to safely self-manage their insulin administration and pump programming.
- contingency plan if the device fails.
It’s important to remember there is no requirement that staff be trained on the actual use of a personal infusion device as the intent is that the patient is responsible for managing the device. The organization determines any staff training or competency requirements.
7. Risk Assessment. When developing policies and procedures around self-administration of medications via an infusion device, it’s helpful to conduct a risk assessment to identify risks associated with various options being considered.
A proactive risk assessment examines a process in detail including:
- sequencing of events
- actual and potential risks
- failure
- points of vulnerability
This prioritizes, through a logical process, areas for improvement or mitigation based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
An area of risk that organizations may consider when conducting a risk assessment should be whether use of these devices are permitted during high-risk or invasive procedures, such as surgical cases, interventional procedures, or imaging studies.
Specific to surgical cases, the American Association of Nurse Anesthetists reports that continuation of the patients own personal insulin pump has been reported as a safe and more consistent method to maintain the blood glucose level over other means of insulin administration.
During an imaging study, organizations would be required to follow the manufacturer’s instructions for use on how to manage personal devices when an MRI, CT or other imaging studies are performed. Therefore, evaluating these areas as part of a risk assessment can reduce the potential for adverse patient outcomes.
Note: The introductory section of the Leadership (LD) chapter in Joint Commission accreditation manuals provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not required as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, or combinations and variations of these.
If you have specific questions on Joint Commission standards and requirements with regard to insulin and glucose monitoring device usage, please feel free to contact our Standards Interpretation Department directly via this form.
Robert Campbell, PharmD, BCSCP, is director, Clinical Standards Interpretation Hospital/Ambulatory Programs and director, Medication Management. Prior to these roles, he served as the pharmacist for Clinical Standards Interpretation in the Division of Healthcare Improvement at The Joint Commission. Campbell also surveys as a field representative for The Joint Commission in the Hospital Accreditation and Critical Access Hospital Accreditation Programs and is a reviewer in the Medication Compounding Certification Program. Prior to joining The Joint Commission, Campbell worked in health care organizations and held leadership positions with oversight responsibilities for performance improvement, accreditation readiness, risk management, infection control, medical staff services, as well as inpatient and outpatient pharmacy services.
Maura Naddy, MSN, RN, is Associate Director of the Standards Interpretation Group. Prior to this position, she worked in various obstetrical roles at Amita Health and Northwestern Memorial Hospital.