Risk Classification of Observations to Donor Semen Establishments (Guide-0053)

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Supersedes : August 2003

Date issued : September 13, 2010

Date of implementation : September 13, 2010

Disclaimer :

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions and acronyms
• 5.0 Guidance
  • 5.1 Assigning a risk classification to an observation
  • 5.2 Determining the establishment's overall Compliance rating
  • 5.3 Response to non-compliant rating
• Appendix 1
• Appendix 2

1.0 Purpose

The purpose of Inspectorate Guide-0053 : Risk Classification of Observations to Donor Semen Establishments, is two-fold :

1. To promote uniformity among inspectors of the Health Products and Food Inspectorate (Inspectorate) in the assignment of
   1. a risk classification to observations noted during inspections of semen establishments and;
   2. an overall rating of compliance following an inspection of a semen establishment.
2. To inform semen establishments of situations that the Inspectorate considers :
   1. acceptable and likely to result in an overall rating of Compliant (C) following an inspection; or
   2. unacceptable and likely to result in an overall rating of a Non-Compliant (NC) rating following an inspection.

2.0 Background

Donor Semen used for assisted conception is regulated as a drug under the  Food and Drugs Act and the  Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations). The semen inspection programme applies to all known Canadian semen establishments (semen establishments) that process, import, and/or distribute donor semen used in assisted conception. For more information on the inspection programme related to the processing, importing and/or distributing donor semen for assisted conception, please consult policy 23 Inspection Strategy for Semen Establishments (POL-0023).

During an inspection, the inspector conducting the inspection will note all situations of non-conformity with the Food and Drugs Act and the Semen Regulations including the referenced sections of the Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination (Health Canada Directive). These situations of non-conformity will be recorded in the Inspection Exit Notice as observations. Situations of non-conformity must be well defined, unambiguous and clearly cited against the applicable regulations. The risk classification of each observation is determined by the inspector conducting the inspection. Inspectors use this Guidance Document and other relevant documents and information, the compliance history of the semen establishment, and consideration of the real and/or potential risk involved to objectively and uniformly assign a risk classification to each observation noted.

The attached Appendix describes observations related to each category of risk. Please note that the observations listed in the Appendix 1 serve as examples and are not meant to be an exhaustive list. Additional observations may be added in the future as appropriate. Appendix 2 indicates the particular sections of the Semen Regulations that apply to each of the identified activities for establishments involved in assisted conception. (i.e. processors, importers or distributors) .

3.0 Scope

This Guidance Document applies to all inspections of processors, importers and/or distributors of donor semen used for assisted conception and is based upon the requirements of the Food and Drugs Act, the Semen Regulations and the referenced sections of the Health Canada Directive.

4.0 Definitions and Acronyms

Distributor :

A person or establishment that sells/distributes donor semen for use in assisted conception. A physician who uses donor semen in the performance of assisted conception is also considered a distributor.

Donor :

A man who donates sperm/semen for use in assisted conception.

Donor Semen Special Access Program (DSSAP):

A special access program, via Part 2 of the Processing and Distribution of Semen for Assisted Conception Regulations, that provides access, in exceptional circumstances, to donor semen that has not been processed in accordance with the Regulations. If authorization is granted, Health Canada will provide a Letter of Authorization (LOA) to the exporter, which must accompany the shipment.

Food And Drugs Act:

A federal statute which regulates food, drugs, cosmetics, and medical devices. The Minister of Health is responsible for the administration of the Food and Drugs Act.

Observation:

A deviation or deficiency to the Food and Drugs Act or the Semen Regulations including the referenced sections of the Directive noted during the inspection of a processor, importer or distributor of donor semen for assisted conception and that is documented in the Exit Notice. An observation may be classified as " Risk 1 " , " Risk 2 " or " Risk 3 " .

Processor:

A person or establishment that collects, tests, prepares, preserves, labels and stores donor semen for use in assisted conception.

Quarantine:

Effective restriction of the availability of material or product for use or distribution by the establishment, until released by a designated authority

NOTE: In the case of donor semen, specimen is to be held under quarantine in an establishment for the purposes of an investigation and/or as a regulatory requirement for the collected semen which is to be quarantined for a minimum of 180 days following its collection.

Risk 1 Observation:

An observation which describes a situation that has resulted or has a high probability of resulting in, an immediate or latent health risk to the recipient of donor semen and may include any observation that involves fraud, misrepresentation or falsification of products or records.

Risk 2 Observation:

An observation which describes a situation that has a low probability of resulting in an immediate or latent health risk to the recipient of donor semen.

Risk 3 Observation:

An observation that is neither assigned a Risk 1 nor Risk 2, but is a deviation from the Food and Drugs Act and Semen Regulations including the Health Canada Directive.

Semen Regulations:

The regulations entitled, Processing and Distribution of Semen for Assisted Conception Regulations, made under the Food and Drugs Act.

5.0 Guidance

5.1 Assigning a Risk Classification to an Observation

While it is recognized that it is difficult to predict every possible situation that may generate a risk, the risk classification will be assigned in relation to the impact of the situation on the safety of donor semen. When assigning a risk classification, inspectors must take into consideration the following criteria :

1. the nature of the non-compliance with the Semen Regulations
2. the potential health risk
3. the number of occurrences of a particular non-compliance issue and/or violation
4. the context, the specific situation, and the evaluation by the inspector.

The inspector will attempt to discuss all observations noted during the inspection with the establishment and present them at the closing meeting.

Appendix provides examples of observations that are considered by the Inspectorate to be representative of Risk 1, Risk 2 or Risk 3. The examples presented correspond to specific sections of the Semen Regulations.

Risk 1 observations, represent the highest level of risk and may have different impacts on the safety of donor semen used for assisted conception. The assignment of a Risk 1 observation may be given to a situation that affects a single donation or a situation that impacts a wider range of donations.

If one or more Risk 1 observation (s) is/are noted during an inspection:

1. The situation will be immediately brought to the attention of the Medical Director or the responsible person at the establishment.
2. The affected donor semen will be immediately put under quarantine and/or recalled as appropriate.
3. The establishment must take corrective actions in order to prevent the situation from reoccurring.
4. The Medical Director or the responsible person at the establishment will be informed that the situation may result in an " NC " overall rating.

It is also important to note that, if the situations of non-conformity with the Food and Drugs Act or the Semen Regulations including the Health Canada Directive compromise the safety of the product and/or pose an immediate or potential health risk to the recipient, the establishment must immediately implement reasonable corrective actions to minimize the risk of the implicated products. For example, the establishment may recall and/or place the implicated donor semen under quarantine until investigation of the implicated semen is complete. Inspectorate Policy-0001, Compliance and Enforcement Policy, will be followed when a non-compliance issue is identified.

5.2 Determining the Establishment's Overall Compliance Rating

Based on the inspection of the semen establishment, the inspector will assign an overall rating of compliance in accordance with the following criteria :

1. If, at the time of the inspection, the establishment has demonstrated that it is in control of the regulated activities pertaining to the processing, importation and/or distribution of semen as determined on the basis of the observation (s) found, than an overall compliant (C) rating will be assigned.
2. An establishment will be assigned a rating of non-compliant (NC) if, at the time of the inspection, the establishment has not demonstrated that it is in control of regulated activities pertaining to the processing, importation and/or distribution of donor semen.

An overall rating of C will be assigned in all situations where only Risk 3 observations are noted.

The notation of a Risk 2 observation during an inspection usually will not preclude the assignment of a C overall rating, and in most cases, the inspection will result in an overall C rating, however, an NC overall rating may be assigned in the following situations:

1. numerous Risk 2 observations are noted during an inspection which indicate that the establishment does not control its processes and operations sufficiently; or
2. Risk 2 observations that were noted during previous inspections were also noted during the current inspection indicating that the establishment did not implement the appropriate corrective actions following the previous inspection or did not put in place adequate preventive actions in a timely manner to avoid recurrence of such violations.

An overall rating of NC may be assigned in situations where one or more Risk 1 observations is/are noted.

5.3 Response to Non-Compliant Rating

In response to the issuance of a non-compliant rating, it is expected that the establishment will submit to the inspector an action plan specifying the corrective measures to be taken, as well as the time frame within which they will be completed.

Compliance is normally achieved following a cooperative approach between the regulated party and the Inspectorate; however, when this is not possible, or when the regulated party is unable to correct non-compliance in a timely manner in order to ensure the safety of the donor semen, a number of regulatory measures may be used in accordance with Policy-0001.

References

1.  Processing and Distribution of Semen for Assisted Conception Regulations, June 1996
2. Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination, July 2000
3. POL-0023 Inspection Strategy for Semen Establishments
4. POL-0001 Compliance and Enforcement Policy

Appendix 1

Semen Regulations Part 1 Section 4 - Prohibition :

Risk 1

• Donor semen was distributed when there was no evidence that the exclusion criteria were assessed.
• Donor semen was distributed when it should have been rejected due to a positive infectious disease test result.
• Donor semen that was subject to an open investigation under section 15 of the Semen Regulations was released for distribution.
• Serological testing performed was completed using test kits that were not approved or licensed.
• No validation data was available for a microbiological test developed by the laboratory that was used to release donor semen.
• Donor semen reserved for special access under section 16 was released for distribution without a DSSAP authorization.

Risk 2

• The establishment relies on both manual and electronic systems to track distribution of donor semen and a discrepancy was found between the two systems.
• The clinic's donor semen shipment receipt log did not identify a non-compliant specimen as " under Quarantine " although the specimen was isolated in a designated storage section of the liquid nitrogen tank labeled " Non-compliant Samples ".

Semen Regulations Part 1 Section 5 - Prohibition :

Risk 1

• Donor semen was imported from a donor who had not been screened against all the exclusion criteria outlined in Section 2.1 c of the Technical Directive.
• Donor semen was imported from a donor who had not been tested for infectious diseases.
• Donor semen was imported prior to the donor being re-assessed and re-tested after the 180-day quarantine period.
• Semen sample not compliant with the Semen Regulations was distributed without a DSSAP authorization.

Risk 2

• Although the appropriate testing results were provided, the donor semen was imported without a declaration signed by the foreign processor certifying that the semen had been processed in accordance with the Semen Regulations and quarantined for a minimum of six months.

Risk 3

• Donor semen was imported without the business address of the processor.
• The physician did not record the correct number of vials on the DSSAP application form thus the authorization issued by the Biologic and Genetic Therapies Directorate was for only one vial and when in reality three vials were used for the insemination.

Semen Regulations Part 1 Sections 6-8 - Notice :

Risk 2

• The establishment did not notify Health Canada prior to commencing processing or importing activities.

Risk 3

• The establishment did not notify Health Canada of the cessation of processing or importing activities.

Semen Regulations Part 1 Section 9 and the Referenced Sections of the Directive - Screening :

Risk 1

• Although the processor determined that the donor was not suitable, the donor semen in the possession of the processor was not destroyed or quarantined.
• The donor screening failed to address all of the required exclusion criteria.
• A donor who had a repeat reactive result for a serological test was not rejected.

Risk 3

• Although there was evidence that all required tests were performed, the processor SOP did not include this information.
• Although all of the required criteria were included, the donor questionnaire was approved by someone other than the medical director or physician designate.
• The establishment did not complete an initial discussion with a potential donor prior to donation.
• There was no documentation available to demonstrate that the lab performing the screening tests for infectious diseases met the accreditation requirements.

Semen Regulations Part 1 Section 10 - Laboratory Controls :

Risk 1

• Containers used to collect semen were not sterile.
• Donor semen containers were cracked during processing and did not provide adequate protection against contamination.
• Laboratory supply that comes in contact with donor semen was not maintained to prevent possibility of contamination and cross contamination.

Semen Regulations Part 1 Section 11 - Labelling :

Risk 1

• Each container of donor semen was not marked with the donor unique identification code.

Risk 2

• The processor did not provide their name and business address with each container of donor semen.

Risk 3

• The processor did not provide their business address with each container of donor semen.

Semen Regulations Part 1 Section 12 - Records :

Risk 1

• The number of containers having the same identification number for a donation was not recorded by the processor.
• In the case of donor semen that is used by the processor in the performance of assisted conception, there was no means to identify on which patient a sample of donor semen was used.
• The processor's records did not include a means to link the identification codes of donor semen containers with the person who received the donor semen for further distribution.
• There was no record to identify the lot number (s) and/or donor identification of the donor semen vials used on a patient.

Risk 2

• There was no written consent from the patient to use donor semen for which special access had been granted.
• Procedures in place were incomplete and did not reflect the actual practices of the processor.
• Although the required testing and screening was performed on the donor, the processor did not maintain these records.
• Written procedures related to the processing of donor semen were not in place.

Risk 3

• For donor semen that was destroyed, the reason for destruction was not documented.

Semen Regulations Part 1 Section 13 - Records :

Risk 1

• The distributor did not maintain records of the name of the processor from which they received donor semen samples.

Risk 2

• The distributor's records did not include the dates and results of tests completed for a donor from which semen was distributed.
• Boththe name and business address of the importer from which the donor semen was received were not documented.

Risk 3

• The business address of the processor was not documented for each container of donor semen.
• The test date (s) and results of the tests performed on the donor were not on file for donor semen for which a special access authorization was granted.

Semen Regulations Part 1 Section 14 - Tracing of Semen :

Risk 1

• The distributor did not inform the processor that an infectious agent may have been transmitted using donor semen they processed.
• Donor semen that was believed to be involved in the transmission of an infectious agent was used by a physician.

Risk 3

• A written report of a possible transmission of an infectious disease was not provided to the processor in a timely manner although a verbal report was provided.

Semen Regulations Part 1 Section 15 - Tracing of Semen :

Risk 1

• The processor did not conduct an investigation when there were reasonable grounds to believe that semen has been contaminated with an infectious agent.
• Donor semen involved in an investigation was not quarantined by the processor.
• The processor did not notify all persons who received containers of donor semen that is believed to be contaminated with an infectious agent.
• The notice provided by the processor did not indicate that the semen must be quarantined pending the completion of the investigation.
• A distributor of donor semen did not provide the name and business address of every person to whom he distributed donor semen involved in an investigation as requested by the processor.

Risk 2

• The processor did not report to Health Canada their investigation into the possible contamination of donor semen by an infectious agent.

Risk 3

• The donor was notified verbally but not in writing that an investigation is being conducted to determine whether the semen he donated is contaminated by an infectious agent.

Semen Regulations Part 1 Sections 16 - Tracing of Semen :

Risk 1

• The processor did not destroy donor semen samples in quarantine that were found to be contaminated by an infectious agent.

Risk 2

• Where the results of the investigation were inconclusive, the processor did not provide a notice that these quarantined containers were to be collected and destroyed or reserved for special access.

Risk 3

• Where the results of the investigation demonstrate that the semen is not contaminated, the processor did not notify all persons who received the implicated donor semen to inform them that the semen could be distributed.

Semen Regulations Part 1 Section 17 - Tracing of Semen :

Risk 1

• After a notice of investigation was received from the processor, the implicated containers of donor semen were not quarantined.
• Donor semen that was determined to be contaminated by an infectious agent was not returned to the processor or destroyed.

Risk 2

• A report was not provided to the processor outlining the disposition of donor semen involved in an investigation (distributed, destroyed, reserved for special access, kept in quarantine to be collected by the processor).

Risk 3

• The written report provided to the processor outlining the disposition of donor semen involved in an investigation (distributed, destroyed, reserved for special access, kept in quarantine to be collected by the processor) was incomplete.

Semen Regulations Part 1 Section 18 - Tracing of Semen :

Risk 2

• The processor did not notify the donor of the results of an investigation when the investigation was inconclusive.

Risk 3

• Following the completion of an investigation, the processor did not provide a report to the Minister detailing the results of the investigation.
• The processor did not notify the donor of the results of an investigation when the investigation showed that the donor semen was not contaminated with an infectious agent.

Semen Regulations Part 2Sections 19-21 - DSSAP :

Risk 3

• Special access was granted to a physician for a container of donor semen who then transferred this container to another physician who did not apply for a revised special access authorization in his/her name prior to distributing the donor semen.
• A copy of the authorization was not available for a container of donor semen for which a special access authorization was granted.

Appendix 2

Sections of the Regulations	Processor	Importer	Distributor	Section of Guidance Document on the Processing and Distribution of Donor Semen for Assisted Conception
1 - Interpretation	X	X	X	General Requirements
2 - Application	X	X	X	General Requirements
3 - Food and Drugs Regulations	X	X	X	General Requirements
4 - Prohibition	X	X	X	General Requirements
5 - Prohibition		X		Importer
5 (1) - Exception	X	X	X	General Requirements
6 - Notice	X	X		Processor and Importer
7 - Notice	X	X		Processor and Importer
8 - Notice	X	X		Processor and Importer
9 - Screening	X			Processor
10 - Laboratory Controls	X			Processor
11 (1) - Labelling	X			Processor
11 (2) - Labelling	X	X	X	Distributor
12 - Records	X			Processor
13 - Records		X	X	Distributor
14 - Tracing of Semen			X	Distributor
15 (1) - Tracing of Semen	X			Processor
15 (2) - Tracing of Semen	X	X	X	All
15 (3) - Tracing of Semen	X			Processor
16 - Tracing of Semen	X			Processor
17 - Tracing of Semen	X	X	X	All
18 - Tracing of Semen	X			Processor
19 - Special Access Application			X	DSSAP
20 - Authorization	X	X	X	DSSAP
21 (1) - Documentation	X	X	X	DSSAP
21 (2) - Documentation		X		DSSAP