Risk classification guide for the safety of sperm and ova observations (GUI-0129)

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Organization: Health Canada

Published: 2020-02-04

Updated: 2020-02-04

Author: Regulatory Operations and Enforcement Branch

Date issued: February 4, 2020

Implementation date: February 4, 2020

Disclaimer

This document does not constitute part of the Assisted Human Reproduction Act (AHR Act) or its regulations and in the event of any inconsistency or conflict between the AHR Act or regulations and this document, the AHR Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the AHR Act, the regulations and the applicable administrative policies.

Table of contents

The following table shows the two types of icons used in this document, and the way they are intended to be used.

Important: Key or cautionary information for people to know.

Information: Supplementary information like quotes and legal references.

About this document

1. Purpose

This document is intended for establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of assisted human reproduction (AHR). It is meant to provide guidance on:

It also informs establishments and health professionals of the situations Health Canada considers unacceptable and that may result in a non-compliant (NC) rating for an inspection.

2. Scope

This guide applies to sperm and ova regulated under section 10 of the Assisted Human Reproduction Act (AHR Act) and the Safety of Sperm and Ova Regulations (Safety Regulations). 

The ratings in this guide apply to all establishments, including primary establishments and foreign establishments, and health professionals that are conducting any of the following activities with respect to donor sperm or ova for the purpose of AHR:  

This guide is in support of the AHR Act, the Safety Regulations, the Guidance Document: Safety of Sperm and Ova Regulations, and the Inspection Approach for the Safety Regulations (POL-0125).

3. Introduction

Health Canada inspectors may inspect any regulated party that conducts activities under the Safety Regulations. Health Canada inspections support a national compliance and enforcement program. More information on Health Canada’s inspection approach is available in the Inspection Approach for the Safety of Sperm and Ova Regulations (POL-0125).

During an inspection, an inspector notes deviations or deficiencies from the applicable requirements of the AHR Act and the Safety Regulations. These deviations or deficiencies appear as observations on the inspection Exit Notice provided to the regulated party. 

Three levels of risk for observations

The possible risk ratings for observations are: 

See Appendix A for a list of sample observations Health Canada considers critical (Risk 1), major (Risk 2), and minor (Risk 3). Although the sample observations are assigned a particular rating, the same situation could be assigned a higher or lower rating depending on the nature and extent of the deviation or deficiency. In addition, this list is not exhaustive, and other deviations or deficiencies may be identified during inspections.

All observations recorded on the Exit Notice require corrective action within an appropriate timeframe, regardless of the overall inspection rating assigned to the inspection. The inspector will identify the higher risk observations that require immediate or expedited corrective actions to the regulated party. 

Compliant and non-compliant inspection ratings

When determining the inspection rating, the inspector takes into account the nature and extent of any deviations and deficiencies noted, and provides a rating for the inspection.

The possible overall inspection ratings are:

When an NC rating is under consideration, or the final rating needs further review, Health Canada will review the final rating before the inspector issues the Exit Notice. A non-compliant rating may have serious consequences. These can include:

When a regulated party is given a non-compliant rating, they must immediately address the high risk deficiencies to mitigate the risk to human health and safety.

If you receive a non-compliant rating and there is immediate risk to human health and safety or the safety of sperm an ova, Health Canada will take action in accordance with the Compliance and enforcement policy for Assisted Human Reproduction Act POL-0100.

4. Guidance

Inspectors use the following criteria to rate observations noted during inspections:

The inspector will immediately bring any observations rated as Risk 1, along with any other observations requiring immediate corrective actions, to the attention of the regulated party. A deviation or deficiency that happens again in a subsequent inspection (including a re-inspection) is considered a repeat observation. This includes situations in which:

The inspector may rate a repeated deviation or deficiency at a higher risk level than it was first rated. The inspector will generally consider the following questions when rating a repeat observation:

Assigning an inspection rating

An inspector’s decision to rate the regulated party as compliant or non-compliant with section 10 of the AHR Act and the associated Safety Regulations takes into account the nature and extent of the observations noted during the inspection.

Generally, a compliant rating will be assigned in the following situations:

Situations that may produce a non-compliant rating include:

If the regulated party wants to dispute the results of the inspection or the final rating, methods of dispute will be outlined in the letter accompanying the Exit Notice.

Appendices

Appendix A – Sample observations

The following are sample observations inspectors may note during an inspection. It is not intended to be an all-inclusive list, and inspectors may use other observations (e.g. critical, major or minor) where appropriate.

Although the sample observations are assigned a particular rating, the same situation could be assigned a higher or lower rating depending on the nature and extent of the deviation or deficiency. For example:

  • An inspector may consider that a combination of several minor observations, none of which on their own may be major, but which may together represent a systemic issue and may result in a major observation on the Exit Notice.
  • An inspector may consider an observation that would normally be rated minor or major, be rated a level higher because the same observation was noted during the previous inspection, indicating that corrective actions from the previous inspection were not implemented or not effective.

Distribution, etc. of gametes

Section 10 of AHR Act

Critical

General Requirements

Section 2-3 of the Safety Regulations

Critical

Registration and Notification

Section 4-21 of the Safety Regulations

Critical

Major

Donor Suitability

Sections 22-27, 30-37, and 40 of the Safety Regulations

Critical

Major

Minor                                                                                 

Quarantine

Sections 28 – 29, and 38 - 39 of the Safety Regulations

Critical

Quality Management

Section 41 of the Safety Regulations

Critical

Quality Management System

Sections 42 – 45 of the Safety Regulations

Major

Tracing and Identifying

Sections 46 - 48 of the Safety Regulations

Critical

Labelling and Storage

Sections 49 - 52 of the Safety Regulations

Critical

Major

Minor

Personnel, Facilities, Equipment and Supplies

Sections 53 - 58 of the Safety Regulations

Critical

Major

Errors and Accidents

Sections 59 -68 of the Safety Regulations

Critical

Major

Adverse Reactions

Sections 69 - 85 of the Safety Regulations

Critical

Records

Section 77 - 85 of the Safety Regulations

Critical

Major

Minor

Appendix B − Glossary

Acronyms

AHR Act:
Assisted Human Reproduction Act

Terms

These definitions explain how terms are used in this document. If there is a conflict with a definition in the Assisted Human Reproduction Act or associated regulations, the definition in the AHR Act or regulations prevails.

Compliance – The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.

Enforcement – Actions that may be taken to compel or induce compliance in order to mitigate the risk identified by non-compliance with the Assisted Human Reproduction Act and its associated regulations.

Establishment – A person, partnership, unincorporated entity or a part of any of them that conducts an activity (processing, importing or distributing) but only includes a health professional if the health professional conducts an activity that is not referred to in the definition for health professional.

Health professional – A person who is authorised under the laws of a province to make use of sperm or ova in that province and who:

Human health and safety –means the health and safety of a recipient of sperm or ova or a child created from that sperm or those ova to the extent that their health and safety relate to the safety of the sperm or ova.

Inspection –With respect to verifying compliance or preventing non-compliance with sections 8, 10 or 12, monitoring and assessment against the applicable requirements of the Assisted Human Reproduction Act and its associated regulations. Inspections may also be routinely conducted based on risk to assess compliance.

Inspector – Any person designated as an inspector under section 46 of the Assisted Human Reproduction Act.

Primary Establishment – an establishment that conducts all processing activities in respect of sperm or ova, whether it conducts them itself or another establishment conducts any of the activities on its behalf.

Observation – A deviation or deficiency to the requirements of the Assisted Human Reproduction Act or its regulations that an inspector notes during an inspection, and is confirmed in writing to the regulated party in the inspection Exit Notice. The observations are assigned a risk classification ranging from 1 for “Critical”, to 2 for “Major” and 3 for “Minor”.

Appendix C − References

Laws and regulations

Assisted Human Reproduction Act
https://laws-lois.justice.gc.ca/eng/acts/a-13.4/

Other related documents

Assisted human reproduction on Health Canada’s website
canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/assisted-human-reproduction.html

Compliance and enforcement policy for the Assisted Human Reproduction Act (POL-0100)
canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/compliance-enforcement-policy-assisted-human-reproduction.html

Guidance Document: Safety of Sperm and Ova Regulations
canada.ca/en/health-canada/programs/consultation-safety-sperm-ova-regulations/document.html

Inspection Approach for the Safety Regulations (POL-0125)
canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/inspection-approach-sperm-ova-safety.html

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