Pharmacist had right to refuse quality assurance assessment by Pharmacy Board: NL Court of Appeal

Quality assurance committee, not provincial regulator, has authority to conduct QA assessments

Pharmacist had right to refuse quality assurance assessment by Pharmacy Board: NL Court of Appeal

The Newfoundland and Labrador Court of Appeal has ruled that only assessors properly appointed by a duly designated quality assurance committee can conduct practice site assessments at pharmacies, to ensure patient records are protected.

In Vey v. Newfoundland and Labrador Pharmacy Board, 2022 NLCA 55, Beverley Vey applied to the Newfoundland and Labrador Pharmacy Board for approval of renovations to provide for a private consulting area in her pharmacy. Her application was approved and, once the renovations were completed, the board assigned a person to conduct a practice site assessment. Vey refused to comply with the assessment, arguing that only an assessor appointed by a quality assurance committee had authority to conduct a practice site assessment. Since the board had not appointed the necessary committee, Vey asserted that it did not have the authority to appoint a person to conduct the assessment. She also expressed concern about client confidentiality, which could be prejudiced by the assessment.

Vey was then subjected to disciplinary proceedings under the Pharmacy Act. An adjudication tribunal ruled that Vey had engaged in conduct deserving of sanction based on her refusal to allow a practice site assessment in her pharmacy. Vey elevated the matter to the NL Court of Appeal, arguing that the complaint dealt with by the adjudication tribunal was grounded in conduct by the board for which it lacked authority.

Quality assurance committee

The appeal court noted that under the Pharmacy Act, the board is required to establish a quality assurance program and to appoint a quality assurance committee. That committee will, in turn, appoint quality assurance assessors who will be authorized to enter the pharmacy to make necessary inspections, access patient records without consent of the patients, and require additional information relating to the care administered to patients.

The adjudication tribunal ruled that under the act, it was not mandatory to appoint a quality assurance committee, and that if no committee was appointed the board retained the authority itself to conduct quality assurance assessments. The appeal court, however, disagreed with this interpretation of the law.

According to the appeal court, a review of the purpose and scheme of the Pharmacy Act led to the conclusion that the board’s authority to appoint a quality assurance committee was intended by the legislature to be coupled with a duty to make that appointment. The court explained that quality assurance is an integral component of the board’s responsibility to promote high standards of practice and to ensure protection of public interest. Appointment of a quality assurance committee was the vehicle adopted in the legislation for that purpose.

Only quality assurance committee has authority to conduct assessments

The court further said that the act gives the appointed quality assurance committee the authority to appoint assessors for purposes of the quality assurance program. The assessors appointed by the committee have the power to enter the pharmacy at any time and to inspect patient records without the patient’s consent. The court emphasized that it is the quality assurance committee, not the board, which has the authority to conduct quality assurance assessments. In the absence of a quality assurance committee, the board has no authority to conduct quality assurance assessments.

The court further said that this rule under the Pharmacy Act must be interpreted to operate harmoniously with the policy that underpins the Personal Health Information Act – that is, protecting the confidentiality of personal health information.

The court ultimately ruled that Vey could not be considered to have engaged in “conduct deserving of sanction” when she refused to allow the practice site assessment because the person designated by the board to conduct the assessment was not properly authorized to do so under the Pharmacy Act.

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