Guidance on classification of observations for inspecting cells, tissues and organs establishments (GUI-0101): Sample observations with risk ratings

On this page

• About the sample observations
• Prohibition
• Registration
• Source establishment
• Processing – general
• Processing – donor suitability assessment
• Processing – retrieval
• Processing – testing
• Processing – packaging and labelling
• Processing – quarantine
• Storage
• Exceptional distribution
• Error, accident and adverse reaction investigation and reporting
• Records
• Personnel, facilities, equipment and supplies
• Quality assurance system

About the sample observations

The following list of observations is only a guide to give you an idea of what an inspector may note during an inspection. Note that the exit notice may word an observation differently.

These sample observations may be limited to 1 specific type of cell, tissue or organ (CTO) but could apply to other types of CTOs depending on the regulatory requirements.

We have assigned a specific risk rating to the following examples of observations. Please note that similar observations could be classified as higher or lower in risk depending on the nature and extent of the deficiency and if it is a reoccurrence.

Also, an inspector will exercise discretion when determining compliance with the Food and Drugs Act (act) and Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations). Each case is assessed based on the facts at hand. For example, observations that are repeated from previous inspections may be assigned a higher risk depending on the corrective actions taken by the establishment at the time of inspection.

Prohibition

(Section 4)

Critical

• An establishment transplanted tissues that were not determined safe by the source establishment before transplantation.
• An establishment transplanted tissues that were processed by an establishment that is not registered with Health Canada.
• An establishment imported tissues that were processed by an establishment that is not registered with Health Canada.

Registration

(Sections 5 to 14)

Minor

• The establishment did not notify Health Canada of a change to the information provided in its application for registration in the required 30-day timeline.

Source establishment

(Section 15)

Critical

• The source establishment did not take responsibility for determining that the organ was safe for transplantation prior to distribution.

Processing – general

(Sections 16 to 17)

Major

• There was no documentation to demonstrate that technical procedures would consistently lead to the expected results.

Processing - donor suitability assessment

(Sections 18 to 23)

Critical

• Physical exams were not performed on the donors.
• There were no test results available for a required infectious disease marker in a donor file that would lead to the exclusion of the donor.
• There was no documentation to demonstrate that a donor was assessed against a number of exclusion criteria.

Major

• The physical exam did not address all required high-risk behaviours.
• Responses were not recorded for required information pertaining to donor history and no follow-up was performed by the establishment.

Processing – retrieval

(Section 24)

Critical

• The maximum interval time between the cardiac asystole of the donor and the retrieval of the tissue had not been established.

Major

• The retrieval time for 1 donor file exceeded the established maximum interval time between the cardiac asystole of the donor and the retrieval of the tissue.

Processing – testing

(Sections 25 to 27)

Critical

• The serological test kit used for donor testing was not licensed.

Major

• The serological test kit used for testing tissue donors was licensed as a diagnostic test kit rather than a screening test kit.

Processing - packaging and labelling

(Sections 28 to 33)

Critical

• The donor identification code did not appear on the interior label and package insert, and the tissues could not be linked to the donor.

Major

• There was no process to verify the packaging was not damaged and was capable of maintaining the integrity of the cells.

Minor

• The registration number of the source establishment was not included on the exterior label.

Processing – quarantine

(Section 34)

Critical

• Tissues were not quarantined until all the processing activities were completed.
• Initial testing performed on a living donor blood specimen did not include nucleic acid testing (NAT), yet the tissues from living donors were not quarantined for at least 180 days and retested prior to release.

Major

• Although the donor suitability assessment was done, not all of the documentation was reviewed for completeness before the tissues were released from quarantine.

Storage

(Sections 35 to 39)

Critical

• The establishment did not take action following a significant temperature deviation in the freezer where released tissues were stored and the safety of tissue was impacted.

Major

• The system in place was not sufficient to ensure that autologous tissues would not be issued as allogeneic tissues.
• The tissue storage area was not secured to prevent unauthorized persons from entering.
• Tissues were stored in a room that was not monitored to ensure the temperature requirements on the label of the tissue were maintained.

Exceptional distribution

(Sections 40 to 42)

Critical

• The establishment released organs that met exclusion criteria, but did not complete the required notices of exceptional distribution.

Major

• The notice of exceptional distribution did not list all applicable exclusion criteria for which the organ was not in compliance at the time of distribution.

Minor

• The notice of exceptional distribution did not include the name of the transplant establishment.

Error, accident and adverse reaction investigation and reporting

(Sections 43 to 54)

Critical

• Implicated tissues were released from quarantine during the ongoing investigation of a serious error and/or accident involving the transmission of an infectious disease and the investigation results showed that implicated tissues were contaminated or compromised.
• The source establishment did not initiate an adverse reaction investigation which potentially involved the transmission of an infectious disease.

Minor

• Although errors and accidents related to transmissible disease testing were thoroughly investigated and followed up, the source establishment did not report to Health Canada within the required timelines.

Records

(Sections 55 to 63)

Critical

• There were no records that showed to which establishment the tissues were distributed, thus resulting in a loss of traceability.

Major

• Although a unique identification code was assigned to each donor, this code was not included on all of the establishment's donor suitability assessment records.

Minor

• An incorrect identification number was recorded for the equipment serial number, however, the equipment was still traceable.
• An incorrect year was recorded for the date on which the temperature of the refrigerator was checked.

Personnel, facilities, equipment and supplies

(Sections 64 to 69)

Critical

• There was no training system in place for either initial or ongoing training of staff performing processing activities.

Major

• There was no documentation to demonstrate the training of staff.
• The number of personnel was insufficient, resulting in many deficiencies within the quality assurance system.
• There was no documentation to demonstrate qualification of new critical equipment was completed prior to use.
• Microbiological monitoring was not adequately conducted in the room where aseptic processing activities took place.
• An expired critical supply was used in the processing of tissues.
• There was no documentation to demonstrate regular maintenance was completed on the refrigerator used to store tissue.

Minor

• The training records for 1 employee were incomplete.
• The training on a new version of a standard operating procedure was performed after its implementation date even though activities relevant to the changes in this procedure were carried out.

Quality assurance system

(Sections 70 to 76)

Critical

• The establishment did not have any written standard operating procedures for the activities that it carries out with respect to the safety of the organs.

Major

• There was no standard operating procedure to describe when testing of both the infant donor and the mother is required.
• There was no standard operating procedure to describe the process of investigating and reporting errors and accidents.
• There was no standard operating procedure to describe the process of investigating and reporting adverse reactions.
• The establishment did not conduct an audit of their regulated activities.
• There was no documentation that demonstrated that the establishment reviewed the standard operating procedures every 2 years.
• Contrary to updated Canadian Standard Association requirements that are referenced in the CTO regulations, the establishment had not updated their donor medical social history questionnaire and associated donor screening standard operating procedures to include the new exclusion criteria.
• Standard operating procedures were not always available at the location where the activities were conducted.

Minor

• The record retention time section of the standard operating procedure did not state that records must be kept for 10 years.