Piercing the Dermis for Demonstration and Point-of-Care Tests
This guideline outlines legislative requirements and expectations for pharmacy professionals performing a procedure on tissue below the dermis, specifically the act of piercing a patient’s dermis with a lancet-type device to obtain blood, as authorized under the Pharmacy Act and enabled by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). It is meant to be used alongside the Code of Ethics, Standards of Practice and Standards of Operation.
Informed Consent: Consent to treatment is informed if, before giving it, the person received the information about the nature, expected benefit, potential risks or side effects, other options and consequences of not having the treatment (or any information that a reasonable person in the same circumstances would require in order to make a decision about the treatment) and the person received responses to their request for additional information (Health Care Consent Act).
Pharmacist: For the purposes of this document where the term ‘pharmacist’ is used it is inclusive of pharmacy interns and students, and subject to any terms, conditions and limitations on their certificates of registration. Where this is not the case, it will be clearly identified.
Point-of-care test (POCT): a test that employs a medical device authorized by the Minister of Health for Canada for point-of-care use (O. Reg. 202/94)
The Pharmacy Act authorizes pharmacy professionals to carry out the controlled act of “performing a procedure on tissue below the dermis” in accordance with the requirements of O. Reg. 202/94 and the terms, conditions and limitations on their certificate of registration. A pharmacist or pharmacy technician may perform the act of piercing a patient’s dermis with a lancet-type device to obtain blood for the following purposes:
- Demonstrating the appropriate use of lancet-type devices for:
- The patient’s self-care and education, or
- The patient’s self-monitoring of their chronic disease
- Administering a point-of-care test if:
- The test is listed in subsection 28 (2) of O. Reg. 45/22 under the LSCCLA
- Hemoglobin A1C
- Prothrombin time and International Normalized Ratio (INR)
- It is performed exclusively to assist patients with the management of their medication to treat chronic disease.
Pharmacy technicians must be under the direction of a Part A pharmacist who is physically present on the premises at the time they perform the act. After performing a point-of-care test, a Part A pharmacist interprets the results of the test and makes any professional decision(s) arising from those results.
If any conditions of the regulations cannot be met, delegation of authority, such as a medical directive or direct order, from another regulated health professional would be required to perform a controlled act.
Pharmacy professionals must ensure they possess the knowledge, skill and judgment with respect to performing this controlled act, and understand the medical condition of the patient, to ensure the procedure is carried out safely and effectively.
Expectations for pharmacy professionals piercing a patient’s dermis with a lancet-type device to obtain blood for either purpose:
1. Assess patient
The pharmacy professional will only consider performing the procedure:
- For demonstration purposes, if they understand the value and limitations of the self-care device or self-monitoring tool and educate the patient on how to self-monitor and when to contact a health professional.
- For the purposes of point-of-care testing, if the pharmacist assesses the patient to determine it is appropriate for the test to be performed, based on the individual’s need, history, current health status, follow up and care plan or as part of a medication monitoring program for chronic disease management and professional judgment exercised accordingly.
2. Obtain Informed Consent to Treatment
Prior to piercing a patient’s dermis, a pharmacy professional must explain the purpose and receive informed consent from the patient or their agent/substitute decision maker.
- There is no minimum age of consent in Ontario; it is contingent on an individual’s capacity to understand why and for what the consent is being sought.
- Consent may be express (provided verbally or in writing) or implied (such as when a patient extends their finger to allow the use of a lancing device to obtain a blood sample).
3. Store Devices and Supplies Appropriately
Procedures must be in place to properly receive and store devices and related supplies according to manufacturer’s instructions. Prior to use, the device should be calibrated if required to ensure it functions as intended.
To protect patient safety, inventory must be monitored for the identification and disposal of outdated, deteriorated, recalled or obsolete products. Medical device users are encouraged to report device-related incidents directly to Health Canada by completing a Health Product Complaint Form.
4. Ensure Safe and Appropriate Environment
The act of piercing the dermis must only be performed in an environment that is clean, safe, private, and comfortable for the patient. Pharmacy professionals must consider the known risks and benefits to the patient and have the safeguards and resources available to safely manage the outcome and any other emergent circumstances. The pharmacy professional should be alert for any signs of an adverse reaction experienced by the patient.
6. Follow Infection Prevention and Control Procedures
Pharmacies must have evidence-based Infection Prevention and Control (IPAC) measures in place to prevent or reduce the risk of transmission of microorganisms.
- A ‘routine precaution’ approach should be undertaken at all times, with all patients, including proper hand washing and, when appropriate, use of personal protective equipment
- In the hospital setting, pharmacy professionals should adhere to the organization’s IPAC policies and procedures
- Devices used for multiple patients must be cleaned and disinfected as per the manufacturer’s instructions
- The pharmacy must have procedures in place for the safe handling, collection and disposal of medical sharps (i.e., lancets)
- As recommended in the Canadian Immunization Guide, pharmacy professionals should have their immunizations up-to-date and receive an annual influenza vaccination
7. Document and Notify
Pharmacy professionals are expected to review and adhere to the College’s Record Retention, Disclosure and Disposal Guideline and Documentation Guidelines.
The pharmacy professional must maintain a patient record that includes:
- the name and address of the patient,
- the name and work address of the pharmacy professional
- the date the act was performed,
- the circumstances relating to the performance of the act and any adverse reaction experienced by the patient,
- confirmation that an informed consent was given
If the act was performed to administer a point-of-care test, the record must also include:
- The results of the test, and
- The pharmacist’s professional decision arising from the results of the test and the rationale for the decision.
- Pharmacy technicians may gather and document the results of the point-of-care tests in the patient record to inform the pharmacist’s decision.
- The patient’s primary care provider (if any) must be notified of the above within a reasonable time.
If the act is performed for education or demonstration purposes, the patient’s primary care provider (if any) may be notified if, based on professional judgment, it is important for continuity of care or if the pharmacist identifies a clinically significant result.
Documentation sent to a primary care provider must be concise and include pertinent details respecting the act to ensure the patient record is complete in both locations.
- Pharmacy professionals do not have the authority to perform the controlled act of “Communicating to the individual or his or her personal representative a diagnosis identifying a disease or disorder as the cause of symptoms of the individual in circumstances in which it is reasonably foreseeable that the individual or his or her personal representative will rely on the diagnosis.”
- In Ontario hospitals, the licensed laboratory provides policies, procedures and processes for the oversight of POCT and is subject to mandatory quality requirements for accreditation.
- Pharmacy Act
- PART VII.3, O. Reg 202/94
- O. Reg 45/22 under the Laboratory and Specimen Collection Centre Licensing Act
- Medical Devices Regulations
- Standards of Practice for Pharmacists
- Standards of Practice for Pharmacy Technicians
- Guideline – Initiating, Adapting and Renewing Prescriptions
- Infection Prevention and Control (Public Health Ontario)
- Infection Prevention and Control for Clinical Office Practice (Provincial Infectious Diseases Advisory Committee (PIDAC))
- Top Five High Risk Practices: Recommendations and occupational health and safety responsibilities
- Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Healthcare Settings (Public Health Agency of Canada)
- Guideline C-4: The Management of Biomedical Waste in Ontario (Ministry of Environment and Climate Change)
- Medical devices active licences search (Health Canada)
Published: December 18th 2020
Version #: 2.00
College Contact: Pharmacy Practice
|1.00||December 18th, 2020||Removed from Administering Substance by Injection or Inhalation policy and turned into stand alone guideline.|
|2.00||July 1, 2022||Revised to include point-of-care testing scope changes.|