Assessments conducted by PEP
Quality improvement approach
CPSBC recognizes that all licensees are dedicated to providing the highest standard of care. The pursuit of quality is a continuous process. Quality improvement focuses on a culture of reflection, learning, and continual practice improvement to strengthen patient care. Under Practice Enhancement Program (PEP), there are several assessments intended to support our licensees’ quality improvement.
Medical device reprocessing assessment
Medical device reprocessing assessments support, educate and assess community-based licensees who reprocess reusable semi-critical and/or critical medical devices on-site or off-site. A medical device assessment is needed if devices are used that require sterilization before being reused on another patient.
The goal of these assessments is to ensure licensees meet expected standards of practice and promote safe patient care. Assessments are based on the best practice requirements and recommendations established by the Ministry of Health for standard reprocessing of reusable medical devices.
Assessment process
Medical device reprocessing assessments apply to licensees as well as long-term and short-term locum tenens who practise in community-based settings.
This includes:
- a solo office
- multi-licensee clinics
The identified medical director of the office/practice is responsible for participating in the assessment.
Medical device reprocessing assessments do not apply to
- clinics or outpatient clinics that are under the direct jurisdiction of a health authority or hospital, and where reprocessing practices are monitored and evaluated by the health authority
- clinics accredited by the Non-Hospital Medical and Surgical Facilities Accreditation Program, where reprocessing practices are assessed by that program
Participants may be selected through:
- the annual licence renewal form
- a peer assessor referral
- an office assessment referral
- random selection
Licensees selected to participate in an assessment will receive an email to complete a pre-assessment questionnaire (PAQ).
The PAQ confirms eligibility and helps identify both the processes used in the clinic as well as any deficiencies related to the reuse and reprocessing of medical devices in the office.
If reprocessing deficiencies are identified, recommendations for improvement are provided to the participant in an action plan, including guidance on how to correct the identified deficiencies.
Participants must correct any deficiencies identified in the action plan and return the action plan for final review. A program assessor then reviews the submitted action plan and schedules a site assessment.
The time allotted to correct a deficiency depends on the level of risk. High-risk deficiencies that require immediate attention may require the office to cease reprocessing immediately until the matter is corrected. During this period, the licensee may be required to obtain disposable devices to continue performing procedures.
Current medical device reprocessing standards state that the reprocessing of reusable medical devices must occur in a dedicated physical space. In smaller clinical offices that may not have dedicated space, reprocessing can take place in a dual-purpose or multi-purpose room with some requirements. For example, a patient exam room is acceptable for that process provided no patients are present when the steps of reprocessing occur. A staff kitchen and washroom are not appropriate areas for reprocessing due to the risk of cross-contamination.
A medical device reprocessing assessor conducts the site assessment, which can take place at the office or remotely. The site assessment allows the assessor to gather detailed information on the physical set-up for reprocessing, sterile storage practices, and sterilizer function. Clinic staff are encouraged to ask questions during the site assessments.
The site assessment may identify further deficiencies and requirements for improvement that must be addressed by the licensee. A completed signed copy of the assessment tool report must be returned to CPSBC once those deficiencies are resolved. This is the final step of the assessment process.
CPSBC does not close clinics based on reprocessing deficiencies, but significant issues may be referred to the Practice Enhancement Program Committee for further review.
What is considered a critical or semi-critical medical device?
| Device | Definition | Examples |
|---|---|---|
| critical | Devices that puncture the skin or mucous membrane, enter the vascular system or a sterile cavity, or through which sterile fluids run |
|
| semi-critical | Devices that contact intact mucous membranes or non-intact skin |
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PEP evaluation and development
Program evaluation provides information on the effectiveness, efficiency, and impact of a program, enabling informed decision-making and continuous improvement.