Community-based point-of-care testing policy

Publication date: July 22, 2020

Effective date: May 1, 2020

Policy context

Point-of-care testing (POCT) is a form of patient-centric health care and refers to diagnostic tests performed at, or near, the site of a patient, with the result leading to a possible change in care for the patient¹.

POCT is performed to guide treatment decisions and support medical care, and is often provided by health-care professionals, other qualified health-care providers, and in some cases by individuals themselves. POCT can be performed in hospitals, clinics, laboratories, pharmacies, physician offices, ambulances, nursing and long-term care facilities, patient residences, or other community-based point-of-care settings².

The British Columbia Ministry of Health (the Ministry) regulates and influences the provision and utilization of POCT in specific medical/clinical domains (e.g., medical laboratories) using accreditation standards for diagnostic service providers and scope of practice regulations that authorize which health professionals can administer and interpret tests, provide a diagnosis, and manage treatment. This is done to ensure the quality and safety of care in these settings.

POCT performed outside of an accredited laboratory environment, or that does not follow best practice procedures for quality and safety, may lead to inconsistent or unreliable results.

Therefore, in the interest of safety and service quality, the Ministry has prepared this policy to guide appropriate implementation by community-based health-care providers that fall outside the laboratory accreditation authority such as those administered by the College of Physicians and Surgeons of B.C. (CPSBC). The policy supports quality assurance, safety, access, and efficient, culturally safe and appropriate POCT.

Policy objectives

This policy provides Ministry guidance to enable quality and safe access to POCT for British Columbians, seeks to provide assurance that effective and consistent processes are in place to help mitigate adverse events and service issues, and provides a foundation for health profession regulatory colleges (“Colleges”) seeking to establish POCT standards of practice.

Health-care providers performing POCT in a community-based setting should establish a process to review test results and have reasonable arrangements in place to follow up with the individual. If health-care providers are unable to provide result interpretation as well as clinical instruction to the individual, individuals must be referred to a medical health clinic or a practitioner’s office for result interpretation and, where applicable, to confirm a diagnosis. POCT for suspected infectious diseases should be avoided in community-based settings except where recommended by the Ministry of Health, and providers should instead refer individuals to a health professional for a differential diagnosis.

Expected impact on health outcomes and service attributes

It is anticipated that providers of community-based POCT will facilitate meaningful health outcomes and quality-of-care experiences (respect, safety, accessibility, appropriateness, effectiveness, equity and efficiency).

Scope

	This policy applies to	This policy does not apply to
Test Settings	All community-based point-of-care settings where POCT is provided or deployed (e.g., a clinic, physician's office, pharmacy, or long-term care facility outside of a health authority³ Virtual care settings (i.e., where an individual consults virtually with a health-care provider)	Facilities that are health authority governed or subject to the CPSBC’s accreditation programs^4,5 POCT provided as direct-to-consumer testing
Type of Testing	POCT involving biologic specimens	POCT that does not involve the testing of biologic specimens (e.g., measurements using a blood pressure cuff, or instruments to measure weight, height, and temperature) Diagnostic imaging or screening services administered under the Medicare Protection Act
Self-Testing	Self-testing under guidance by a health-care provider at the time of testing (i.e., guided self-testing)	Self-testing and direct-to-consumer testing

Policy direction

The Health Professions Act provides a common regulatory framework for health professions in B.C. The health profession regulatory colleges (Colleges) establish standards of practice for their registrants. In the interest of safety, this guideline provides a foundation for Colleges seeking to establish POCT standards of practice to enhance the quality of care provided by their registrants. In the absence of specific POCT standards developed by Colleges, the Ministry of Health has developed the following Community-Based Point-of-care Testing Policy Guidelines for health-care providers:

1. Safety and training

Providers requesting, interpreting, and/or performing POCT must do so within their scope of practice. They should also do this in accordance with organizational policies and procedures when available.
Providers are responsible for the safe and competent use of POCT devices, and to undertake training designed to attain, maintain and demonstrate the competency required to perform POCT.
When appropriate, providers need to maintain and update skills and training when significant changes are made to POCT procedures and/or devices.
It is recommended that providers are familiar with the purpose, accuracy, precision, reliability and quality control procedures of the test, including equivalent laboratory testing, how/if POCT values may differ from laboratory values, and if POCT is the best suited procedure.
When appropriate, written procedures, and instructions on training requirements and safety protocols, should be developed and implemented that concern the health and safety of the individual and/or provider, personal protective equipment, safety of those handling biological specimens (e.g., blood or urine), proper disposal of contaminated material or specimens, and the cleaning of contaminated surfaces and equipment.
It is recommended that health-care staff complete San'yas Indigenous Cultural Safety Training or other cultural safety training.

2. Care environments

POCT should be delivered in a culturally safe and appropriate manner, recognizing the unique needs of diverse patient populations.
POCT should be delivered in a manner that emphasizes relationship-based care (i.e., an intentional caring relationship between health-care professionals and the people they serve). Relationship-based care requires attention to key elements of cultural safety and humility and the ways in which these concepts can be integrated into professional practice.
An appropriate level of privacy should be provided, and protocols established to ensure testing is appropriately, effectively, and safely performed.
In a multi-disciplinary care setting, it is recommended that a suitably qualified health-care provider be delegated to oversee POCT services.

3. Reporting results

It is recommended that results and testing data are recorded in a permanent record, including details of POCT device used and reported to the appropriate health-care practitioner(s) and to the patient.
Where applicable, written procedures, guidance and/or instructions should be developed to guide reporting and documentation of results.
When applicable, appropriate federal and provincial regulation on data collection, privacy, security, storage and use requirements are met and align with the information and privacy legislation, data stewardship and information privacy and security policies set by the Ministry.

4. Follow-up care

Individuals performing POCT should have a system in place to review the test results, and reasonable arrangements should be in place to follow up with the individual and appropriate health-care provider. If health-care providers are unable to provide result interpretation as well as clinical instruction to the individual, individuals must be referred to a medical health clinic or a practitioner’s office for result interpretation and, where applicable, to confirm a diagnosis.
Where applicable, written procedures, guidance and/or instructions may be developed to guide individual and/or specimen referrals to an accredited laboratory for further testing if required.

5. Proficiency and quality control

It is recommended that individuals providing or overseeing POCT have a framework in place that actively manages the safety and quality risks in the delivery of POCT. Quality systems ensure test results are reliable and accurate, and typically encompass the preparation and sample collection (pre-analytical), testing process (analytical), and reporting of results and sample disposal (post-analytical) phases of the test/treatment cycle. Quality system monitoring and evaluation may be provided by an accredited third- party service provider (e.g., DAP accredited laboratory).
It is recommended that individuals providing POCT consult the International Organization for Standardization (ISO) Point-of-care testing (POCT) – Requirements for quality and competence (ISO 22870), and the Accreditation Canada standards for point-of-care testing, and implement those standards where possible.

6. Device and equipment

All POCT devices should be approved for use by Health Canada.
It is recommended that routine evaluation of POCT services and devices be performed to ensure they are providing quality testing to individuals, including evaluation to ensure that devices have not been withdrawn by U.S. Food and Drug Administration, Health Canada, or the Ministry of Health.
When appropriate, all devices and materials are inspected and verified prior to use to ensure they are functioning as intended, and that manufacturer specified quality control and calibration procedures are followed and, when appropriate, failures are documented and rectified.
Trends and continued problems with POCT devices, including adverse events, should be reported to Health Canada.
Where applicable, written procedures, guidance and/or instructions for use of POCT may be developed and implemented for: the purpose of the test, quality control procedures, reference intervals (“normal values”) for populations being treated, remedial action for out-of-range readings, test limitations, and preparation of reagents and other materials.

7. Specimen collection considerations

It is recommended that specimen collection, including volume, handling and storage of samples, is in accordance with requirements specified by the device or equipment manufacturer.
Where applicable, written procedures, guidance and/or instructions for use of POCT may be developed for specimen collection and handing.

8. Education

Providers may consider providing education to individuals regarding POCT. Education provided should fit within the provider scope of practice, education and training, and include details on where POCT testing may be performed, any potential costs to the individual, and information on where testing may be provided at no cost to the individual when available as a publicly funded service.

Additional Resources:

College of Physicians and Surgeons of British Columbia, Non-Hospital Medical and Surgical Facilities Accreditation Program, Accreditation Standards, Point-of-care Testing, July 2018
College of Physicians and Surgeons of Alberta, Performance of Point-of-care Testing in Unaccredited Settings: A Guide for Non-Laboratorians, June 2017
Alberta College of Pharmacy, Guidance for Pharmacists and Pharmacy Technicians, Laboratory and Point-of-care Testing (POCT), October 2018
Alberta College of Pharmacy, Standards of Practice, Laboratory and Point-of-care Testing (POCT), October 2018
International Organization for Standardization, ISO 22870:2016 Point-of-care testing (POCT) - requirements for quality and competence, November 2016
Accreditation Canada, Standards, Point-of-Care Testing, January 2017

Review and quality improvement

The policy will be refreshed as needed, and reviewed three years from May 1, 2020 and following completion of the summative evaluation.
The policy may also be reviewed as determined through consultation between Ministry and external stakeholders.
Information from the policy review/evaluation will be used to understand the performance of the strategic initiative, areas of success and areas for continuous quality improvement.
The Ministry will work to develop a quality improvement plan where necessary and manage the review and quality improvement process.
The Ministry will lead any monitoring of outcome measures that are identified in the quality improvement plans developed.

Glossary and definitions

Community-based point-of-care settings: A setting where point-of-care testing is provided and not subject to accreditation by the College of Physician and Surgeons of British Columbia’s Diagnostic Accreditation Program (DAP) or administered by a health authority. Examples include physician offices, medical clinics, pharmacies, long-term care, and home and community care outside of a health authority. Community-based point-of-care settings include virtual care settings where an individual performs guided self-testing and consults virtually with a regulated health professional.

Diagnosis: The process of identifying a disease, condition, or injury from its signs and symptoms. Health history, exams, and medical tests may be used to make a diagnosis.

Direct-to-consumer testing: Tests available for purchase without health-care provider involvement in testing (e.g., pregnancy tests).

Cultural humility: A process of self-reflection to understand personal and systemic biases and to develop and maintain respectful processes and relationships based on mutual trust. Cultural humility involves humbly acknowledging oneself as a learner when it comes to understanding another’s experience.

Cultural safety: An outcome based on respectful engagement that recognizes and strives to address power imbalances inherent in the health care system. It results in an environment free of racism and discrimination, where people feel safe when receiving health care.

Guided self-testing: Self-testing overseen by a health-care provider.

Health-care providers: Includes all regulated and non-regulated care providers.

Self-testing: Where a person performs a self-test for the purpose of identifying, self-diagnosing, screening or monitoring a disease or condition and interprets the results in private (e.g. blood glucose monitoring).

Point-of-care testing (POCT): Testing that is performed near or at the site of a patient with the result leading to possible change in the care of the patient.

Health profession regulatory colleges (Colleges): In British Columbia, health profession regulatory Colleges have been delegated the authority under provincial legislation to govern the practice of their registrants in the public interest. The primary function is to ensure their registrants are qualified, competent, and follow clearly defined standards of practice.

Result interpretation: Medical tests provide data/results that can be used in health monitoring, screening and diagnosis. Results are compared to a reference sample to distinguish between “health” and “disease.”

Virtual care: The delivery of health-care at a distance using information and communications technologies and processes when not provided under a health authority/Diagnostic Accredited Program (e.g., video-conferencing, phone, text, email).

¹ International Organization for Standardization, ISO 22870:2016 Point-of-care testing (POCT) - requirements for quality and competence, November 2016

² CADTH, Environmental Scan Point-of Care Testing, September 2017

³ Health-care providers offering POCT should be familiar with College of Physician and Surgeons of BC accreditation programs and requirements, as accreditation may be required.

⁴ The College of Physicians and Surgeons of BC Diagnostic Accreditation Program (DAP) evaluates and monitors performance standards in diagnostic healthcare, and administers accreditation programs for diagnostic services, including laboratory medicine. The scope of the DAP includes public and private diagnostic facilities within British Columbia: www.cpsbc.ca/programs/dap.

⁵ The DAP Non-Hospital Medical and Surgical Facilities Accreditation Program establishes accreditation and performance standards, procedures and guidelines for private facilities, and includes a standard for point-of-care testing. https://www.cpsbc.ca/programs/nhmsfap

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