QSE 7 — Deviations, Nonconformances, and Adverse Events

Key Concepts

Key Concepts: This QSE focuses on the need to ensure capture of, management of, and response to deviations, nonconformances, or adverse events. This also includes the need to maintain records of resolution.

Key Terms
Adverse Event: A complication. Adverse events may occur in relation to organization-defined activities.

Conformance: Fulfillment of requirements. Requirements may be defined by customers, practice standards, regulatory agencies, or law.

Deviation: A departure from policies, processes, procedures, applicable regulations, standards, or specifications.

Disaster: An event (internal, local, or national) that can affect the safety and availability of the organization’s products or the safety of individuals.

Near-Miss Event: An unexpected occurrence that did not adversely affect the outcome but could have resulted in a serious adverse event.

Nonconformance: Failure to meet requirements.

Root Cause(s): The underlying cause(s) of an event or nonconformance that, if eliminated, would prevent recurrence.

Traceability: The ability to follow the history of a product or service from source to final distribution or disposition using records.

Examples of Objective Evidence:

• Policies, processes, and procedures related to this chapter.
• Records and evaluation of deviations, nonconformances, and adverse events.
• Notification to customer(s) following investigation, if appropriate.
• Records of evidence that measures were taken to ensure deviations, nonconformances, and adverse events do not recur.
• Planned deviation records, if any.
• Records of deviation reporting to appropriate parties [eg, Food and Drug Administration (FDA)].

7.0 Deviations, Nonconformances, and Adverse Events

The organization shall capture, assess, investigate, and monitor failures to meet specified requirements. The responsibility for review and authority for the disposition of nonconformances shall be defined. These events shall be reported in accordance with specified requirements and to outside agencies as required.

Guidance

Standard 7.0 requires that the facility establish a process to capture, assess, investigate, and monitor events that deviate from the requirements. Implicit in this standard is the requirement that the facility has a standardized approach for managing deviations, nonconforming products, and adverse events. That approach should include problem identification, investigation classification, application of data collection, and analysis tools. The facility should have a method for tracking and trending these events.

Failure to meet a requirement results in a nonconformance. It should be recognized that nonconformances can occur even when processes and procedures are followed and performed correctly. One example would be the breaking of a collection bag during centrifugation.

In a nonpunitive atmosphere, employees should be encouraged to submit error and accident reports to foster a culture of documenting nonconformances. If management views nonconformance as an opportunity to improve processes rather than punishment, employees are more likely to embrace the concept and be an integral part of the data collection and investigation.

The process or procedure for controlling nonconformances should be followed even when the nonconformance appears to be minimal or insignificant.

The following steps may be helpful in developing methods to manage nonconformances:

1. Identify the nonconformance.
2. Create a record of it.
3. Evaluate its significance.
4. Determine required action.
5. Perform the action.
6. Create a record of the actions taken in response to the nonconformity.
7. Communicate the issue to the customer, if necessary.
8. Determine what, if anything, will be done to prevent the nonconformance or adverse event in the future. (SS)

​The committee revised standard 7.0 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for capturing, assessing, and investigating deviations, nonconformances, and adverse events.
  • Include procedures for problem identification and investigation classification.
  • Specify data collection and analysis tools to be used.
• Define roles and responsibilities for review and disposition of nonconformances.
  • Ensure authority for disposition is clearly documented.
• Establish a nonpunitive reporting culture to encourage error and accident reporting.
  • Conduct training sessions to reinforce the importance of documentation.
• Implement a tracking and trending system for deviations and nonconformances.
  • Regularly review trends and identify areas for process improvement.
• Maintain records of all actions taken in response to nonconformities.
  • Use a standardized form or log for documentation.
• Communicate significant issues to customers and relevant agencies as required.
  • Document all communications and follow-up actions.

7.1 Deviations

[F]

The organization shall capture, assess, investigate, and report events that deviate from accepted policies, processes, or procedures. The assessment shall ensure timely and appropriate clinical management of the recipient, if applicable.

Guidance

Standard 7.1, Deviations, is a commonly cited standard for nonconformances. Examples of the reasoning behind the nonconformances include the following:

1. There is no process to capture, investigate, assess, and report events classified as deviations by the facility.
2. When deviations are identified, there is no review of previous records of products or outcome data.
3. When products or recipients may have been adversely affected, there is no corrective or preventive action plan. (SS)

​The committee revised standard 7.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for capturing, assessing, investigating, and reporting deviations.
  • Include criteria for classifying events as deviations.
  • Define roles and responsibilities for managing deviations.
• Establish a deviation log to document all identified deviations.
  • Ensure the log includes details such as date, description, and corrective actions taken.
• Conduct a review of previous records and outcome data when deviations are identified.
  • Document findings and any trends observed in a deviation analysis report.
• Implement a process for timely clinical management of recipients affected by deviations.
  • Include procedures for notifying clinical staff and recipients, if applicable.
• Develop a corrective and preventive action (CAPA) plan for deviations affecting products or recipients.
  • Track the implementation and effectiveness of CAPAs in a CAPA log.
• Schedule regular training sessions for staff on deviation management procedures.
  • Maintain training records and competency evaluations for all relevant personnel.

7.1.1

Deviations shall be reported as soon as possible after detection.

☑ Actionable Checklist

• Implement an SOP for reporting deviations immediately upon detection.
  • Train all staff on the deviation reporting SOP and document completion.
• Establish a deviation log to record all reported deviations with timestamps.
• Designate a responsible individual to review deviation reports daily.
• Conduct regular audits to ensure compliance with deviation reporting timelines.
• Include deviation reporting compliance in management review meetings.
• Develop a CAPA plan for addressing any delays in deviation reporting.

7.1.2

Deviations shall be evaluated to determine the need for corrective and preventive action. Standards 9.1 and 9.2 apply.

☑ Actionable Checklist

• Develop and maintain an SOP for evaluating deviations to determine the need for CAPAs.
  • Include criteria for assessing the impact and risk of deviations.
• Train staff on the deviation evaluation SOP and document training records.
• Implement a deviation log to record all deviations and their evaluations.
• Conduct regular reviews of deviation logs to identify trends and areas for improvement.
• Ensure all CAPAs resulting from deviation evaluations are documented and tracked to completion.
• Perform periodic audits to verify compliance with the deviation evaluation process.

7.1.3

For deviations having the potential to adversely affect the safety, purity, or potency of a product; donor safety; employee safety; or the safety of a patient, approval of an individual qualified to evaluate the deviation shall be obtained before final release of the product.

☑ Actionable Checklist

• Identify and document all deviations with potential impacts on safety, purity, or potency.
  • Use the designated Deviation Reporting Form for documentation.
• Assign a qualified individual to evaluate each identified deviation.
  • Reference SOP for Deviation Evaluation and Approval.
• Obtain documented approval from the qualified individual before product release.
  • Maintain records of approvals in the Deviation Log.
• Review and update the list of qualified individuals annually.
  • Document training and competency evaluations for these individuals.
• Conduct regular audits to ensure compliance with deviation evaluation procedures.
  • Use the Internal Audit Checklist for Deviations.

7.1.3.1

The release approval shall be made by the procurement medical director, the laboratory medical director, the laboratory director, clinical program director, and/or the patient’s physician, depending upon the circumstances.

☑ Actionable Checklist

• Identify and document the roles responsible for release approval in SOPs.
  • Include procurement medical director, laboratory medical director, laboratory director, clinical program director, and patient’s physician.
• Develop a release approval form that requires signatures from the designated roles.
• Implement a training program for all personnel involved in the release process.
  • Include training on the specific responsibilities of each role in the release approval.
• Conduct regular audits to ensure compliance with the release approval process.
• Maintain a log of all release approvals, including the names and roles of approvers and the date of approval.
• Review and update the release approval SOP annually or as needed based on changes in personnel or regulations.

7.2 Nonconformances

[F]

Upon discovery, nonconforming products or services shall be evaluated and their disposition determined.

Guidance

The committee revised standard 7.2 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and maintain an SOP for the identification and evaluation of nonconforming products or services.
  • Include criteria for determining nonconformance and steps for evaluation.
• Train staff on the SOP for handling nonconformances and document all training sessions.
• Implement a log or database to record all nonconformances, including details of the discovery, evaluation, and disposition.
• Conduct regular reviews of nonconformance records to identify trends and areas for improvement.
• Establish a process for determining the disposition of nonconforming products or services, including potential rework, rejection, or acceptance under concession.
• Document all decisions related to the disposition of nonconforming products or services, including rationale and responsible personnel.

7.2.1

Nonconforming products or services shall be quarantined and/or destroyed.

Guidance

The committee added standard 7.2.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for identifying and handling nonconforming products or services.
  • Include procedures for quarantine and destruction.
• Train staff on the SOP for nonconforming product management.
  • Document all training sessions and maintain records.
• Maintain a log of all nonconforming products or services.
  • Include details of quarantine and destruction actions.
• Conduct regular audits to ensure compliance with the SOP.
  • Document findings and corrective actions.
• Review and update the SOP annually or as needed based on audit findings.
• Ensure all deviations related to nonconforming products are documented and reviewed.

7.2.2

The unintended distribution or use of products or services that do not conform to specified requirements shall be prevented.

Guidance

The committee revised standard 7.2.2 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for identifying and managing nonconforming products or services.
  • Include procedures for immediate segregation and labeling of nonconforming products.
  • Define roles and responsibilities for handling nonconformances.
• Maintain a nonconformance log to document all instances of nonconforming products or services.
• Conduct regular training sessions on the SOP for all relevant staff and maintain training records.
• Establish a review process for nonconformance incidents to identify root causes and implement corrective actions.
• Perform regular audits to ensure compliance with the nonconformance management SOP.
• Review and update the SOP and related documents annually or as needed based on audit findings and regulatory updates.

7.2.3

The organization shall:

1. Identify, quarantine, retrieve, recall, and determine the disposition of nonconforming products or services.
2. Identify and manage nonconforming products or services.

Guidance

The committee added standard 7.2.3 to the edition mirroring a standard in the 34^th edition of Standards for Blood Banks and Transfusion Services. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for identifying nonconforming products or services.
  • Include criteria for identification and notification procedures.
• Establish a quarantine process for nonconforming products.
  • Maintain a quarantine log to track all items and their status.
• Create a retrieval and recall procedure for nonconforming products.
  • Document all retrieval and recall actions in a recall log.
• Define and document the disposition process for nonconforming products.
  • Use a disposition form to record decisions and actions taken.
• Conduct regular training sessions on nonconformance management for relevant staff.
  • Keep training records and competency evaluations up-to-date.
• Review and update the nonconformance management SOP annually or as needed.

7.2.4 Released Nonconforming Products or Services

[F]

Products or services that are determined after release not to conform to specified requirements shall be evaluated to determine the effect of the nonconformance on the quality and/or safety of the product or service.

Guidance

The committee added standard 7.2.4 to the edition mirroring a standard in the 34^th edition of Standards for Blood Banks and Transfusion Services. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for evaluating nonconforming products or services post-release.
  • Include criteria for determining the impact on quality and safety.
• Train staff on the SOP for handling released nonconforming products.
  • Document training sessions and maintain records.
• Establish a log for tracking all instances of released nonconforming products.
  • Include details of the nonconformance, evaluation, and outcome.
• Conduct a risk assessment for each nonconforming product or service identified post-release.
  • Document findings and actions taken.
• Implement corrective and preventive actions (CAPAs) based on evaluation outcomes.
  • Review CAPA effectiveness periodically and update records.
• Include nonconforming product evaluations in regular management reviews.
  • Document discussions and decisions made during reviews.

7.2.4.1

[F]

Records shall include the disposition of the nonconforming product or service, the rationale, and the name(s) of the individual(s) responsible for the decision.

Guidance

The committee added standard 7.2.4.1 to the edition mirroring a standard in the 34^th edition of Standards for Blood Banks and Transfusion Services. (SC)

7.2.4.1.1

The records shall include a description of nonconformances and any subsequent actions taken.

Guidance

The committee has added new standard 7.2.4.1.1 for completeness, though concepts appeared in 7.2. This mirrors requirements set forth by national requirements and accreditation requirements. (SC)

☑ Actionable Checklist

• Ensure all records of nonconforming products or services include the disposition, rationale, and responsible individual’s name(s).
  • Review and update SOP on documentation of nonconformances to include required elements.
  • Train staff on documenting disposition, rationale, and responsible personnel for nonconforming products.
• Implement a form or electronic system to capture detailed descriptions of nonconformances.
  • Include fields for actions taken in response to nonconformances.
• Conduct regular audits of nonconformance records to ensure completeness and accuracy.
• Maintain a log of all nonconformances and dispositions, ensuring it is up-to-date and accessible.
• Review and update the CAPA process to ensure it addresses actions taken for nonconformances.
• Schedule periodic management reviews to discuss trends and improvements related to nonconformances.

7.2.5 Product Review, Investigation, and Look-Back

The facility shall identify and manage nonconforming products and the initiation of an investigation, including look-back as applicable, as soon as possible.

☑ Actionable Checklist

• Develop and implement an SOP for identifying and managing nonconforming products.
  • Include criteria for product nonconformance and steps for immediate action.
• Train staff on the SOP for managing nonconforming products and document training records.
• Establish a log for documenting nonconforming products and associated investigations.
• Initiate investigations for nonconforming products within 24 hours of identification.
• Conduct a look-back investigation if applicable, and document findings and actions taken.
• Review and update the SOP annually or as needed based on investigation outcomes.

7.2.5.1 Customer Notification

The facility shall report to the customer:

1. Any cellular therapy products lost, damaged, or otherwise unsuitable for use.
2. Released products or delivered services that are determined to be nonconforming, as soon as possible.

☑ Actionable Checklist

• Develop and implement an SOP for customer notification of lost, damaged, or unsuitable cellular therapy products.
  • Include criteria for identifying products as lost, damaged, or unsuitable.
  • Define timelines for notification to ensure prompt communication.
• Create a standardized form or template for documenting customer notifications.
• Train staff on the SOP and use of the notification form.
• Maintain a log of all customer notifications, including date, time, and details of the communication.
• Conduct regular audits of the notification process to ensure compliance with the SOP.
• Review and update the SOP annually or as needed based on audit findings or process changes.

7.2.5.2

Products identified as nonconforming following distribution shall be reported to the FDA or relevant Competent Authority in accordance with written policies, processes, and procedures.*

*21 CFR 1271.350.

☑ Actionable Checklist

• Develop and maintain an SOP for reporting nonconforming products to the FDA or relevant Competent Authority.
  • Include criteria for identifying nonconforming products post-distribution.
  • Define roles and responsibilities for reporting.
• Train staff on the SOP for reporting nonconforming products.
  • Document training completion and competency evaluations.
• Create a log for tracking all reported nonconforming products.
  • Ensure log includes product details, date of report, and authority notified.
• Conduct regular audits to ensure compliance with the SOP for reporting nonconforming products.
  • Review a sample of reported cases for adherence to procedures.
• Implement a CAPA process for addressing any deficiencies identified in the reporting process.
  • Document all CAPAs and follow up on their effectiveness.
• Review and update the SOP annually or as needed based on regulatory changes or audit findings.

7.2.5.3

[F]

Customers shall be notified when the nonconforming products can impact the purity, potency, safety, or efficacy of the product.

Guidance

When a product is identified that does not conform to the manufacturing specifications for distribution or issue, one possible way that the facility could consider to meet the intent of the standard is to open an investigation (also referred to as “look-back”) into the cause of the nonconformance. There are several ways of managing a look-back. As soon as possible, there should be an evaluation of other products that also might be associated with the cause of the nonconformance. All affected products should be quarantined until they can be determined to be acceptable for release, or destroyed if they cannot be safely released. In this standard, the customer refers to the facility or individual receiving the product from the facility. The customer may be another facility or the recipient’s care team. If the product(s) have been released from the distributor, then notification to the receiving facility or the recipient may be warranted.
Evaluation of the need to report should be conducted as soon as possible for those products that might have compromised purity, potency, safety, or efficacy. Reporting of these distributed products to regulatory authorities such as the FDA may be indicated. (SS)

☑ Actionable Checklist

• Develop an SOP for notifying customers about nonconforming products affecting purity, potency, safety, or efficacy.
  • Include criteria for assessing impact on product quality.
  • Define roles and responsibilities for notification.
• Implement a log to document all customer notifications regarding nonconforming products.
• Conduct training sessions for staff on the notification process and document attendance.
• Establish a procedure for evaluating the need to report nonconforming products to regulatory authorities.
  • Include a decision tree or flowchart for reporting requirements.
• Perform regular audits to ensure compliance with the notification SOP.
• Review and update the notification SOP annually or as needed based on audit findings or regulatory changes.

7.2.6 Review and Disposition of Nonconforming Products and Services

Authority for determining disposition of nonconforming products and review of nonconforming services shall be defined.

☑ Actionable Checklist

• Define and document the authority responsible for disposition decisions in the SOP for Nonconforming Products.
  • Include criteria for disposition decisions in the SOP.
• Establish a review process for nonconforming services in the Quality Management Plan.
• Maintain a log of all nonconforming products and services, including disposition outcomes.
• Conduct regular training for staff on identifying and reporting nonconformances.
• Review and update the SOP for Nonconforming Products annually or as needed.
• Document all disposition decisions and include them in the management review process.

7.2.6.1

A nonconforming material or product shall be managed in one of the following ways:

1. Modified to meet the specified requirements.
2. Accepted by the customer, after disclosure of the nonconformance.
3. Relabeled, in conformance with applicable requirements.
4. Destroyed.

Guidance

#1 - The committee edited the language in the introduction sentence and subnumber 1 for clarity but the intent of the standard has not changed. (SC)

☑ Actionable Checklist

• Develop and maintain an SOP for managing nonconforming materials or products, including modification, acceptance, relabeling, or destruction.
  • Include criteria for modification to meet specified requirements.
  • Outline the process for obtaining customer acceptance after disclosure of nonconformance.
  • Detail procedures for relabeling in compliance with applicable requirements.
  • Specify protocols for the destruction of nonconforming materials.
• Train staff on the SOP for managing nonconforming materials and document training records.
• Implement a tracking log for all nonconforming materials or products, including actions taken.
• Conduct regular audits to ensure compliance with the SOP for nonconforming materials management.
• Review and update the SOP annually or as needed based on audit findings or regulatory changes.

7.2.6.2 Authorized Release of Nonconforming Products

[F]

A nonconforming product shall be released by exception only when there is a documented
clinical need for the product and when approved by the relevant medical director and other relevant facility-defined personnel, including a quality representative. Standard 5.20.1 applies.

Guidance

The committee added the clause, “…and other relevant facility defined personnel, including quality representative” to the standard for completeness. The committee noted that there are more individuals that can release a nonconforming product, however the medical director would retain ultimate responsibility for all actions and decisions. (SC)

7.2.6.2.1

The following are required:

1. Notification to the recipient’s physician of the out-of-specification or nonconforming values or results.
2. Documentation of the recipient’s physician’s approval for use of the product. Standard 5.23.1 applies.

☑ Actionable Checklist

• Develop and maintain an SOP for the authorized release of nonconforming products, including criteria for clinical need and approval process.
  • Include steps for obtaining approval from the medical director and relevant facility-defined personnel, including a quality representative.
• Create a form or log to document the clinical need and approvals for the release of nonconforming products.
• Ensure notification procedures are in place for informing the recipient’s physician of nonconforming values or results.
• Document the recipient’s physician’s approval for the use of nonconforming products in accordance with Standard 5.23.1.
• Conduct regular training sessions for staff on the SOP for releasing nonconforming products and document attendance.
• Perform internal audits to verify compliance with the SOP and documentation requirements for nonconforming product release.

7.2.7 Microbially Contaminated Products

The facility shall address the management of cellular therapy products with positive microbial culture results, including:

1. Product labeling.
2. Investigation of cause.
3. Notification of other facilities and/or departments involved in procurement, processing, and distribution of the product.
4. Notification of the donor’s physician, if it affects the donor’s health.
5. Notification of the recipient’s physician.
6. Recipient follow-up and outcome analysis.
7. Reporting to regulatory agencies, if appropriate.

Standard 7.2.6.2 applies.

☑ Actionable Checklist

• Develop and implement an SOP for managing microbially contaminated products, including steps for each required action.
  • Include detailed procedures for product labeling with contamination status.
  • Outline investigation procedures to determine the cause of contamination.
• Establish a notification protocol for informing all relevant facilities and departments involved in procurement, processing, and distribution.
• Create a notification process for the donor’s physician if the contamination affects the donor’s health.
• Implement a notification system for the recipient’s physician regarding contaminated products.
• Develop a recipient follow-up and outcome analysis procedure to assess the impact of contamination.
• Ensure a reporting mechanism is in place for notifying regulatory agencies when required.
• Maintain a log of all contamination events, investigations, notifications, and outcomes for audit purposes.

7.3 Adverse Events

The organization shall detect, monitor, evaluate, manage, and report adverse events related to safety and quality.

☑ Actionable Checklist

• Develop and implement an SOP for detecting and reporting adverse events.
  • Include criteria for identifying adverse events and timelines for reporting.
• Maintain a log of all reported adverse events, including details and outcomes.
• Conduct regular training sessions on adverse event identification and reporting for all staff.
• Perform root cause analysis for each adverse event to determine contributing factors.
• Implement corrective and preventive actions (CAPAs) based on root cause analysis findings.
• Include adverse event data in management review meetings for ongoing evaluation and improvement.

7.3.1

Records of adverse events and the related investigations, evaluations, and notifications shall be maintained.

☑ Actionable Checklist

• Establish and maintain a log for recording all adverse events.
  • Include fields for date, description, and personnel involved.
• Develop an SOP for investigating adverse events.
  • Ensure it includes steps for root cause analysis and corrective actions.
• Implement a notification process for relevant stakeholders.
  • Maintain a list of contacts and notification timelines.
• Conduct regular reviews of adverse event records.
  • Schedule quarterly management reviews to discuss findings.
• Ensure all staff are trained on the adverse event SOP.
  • Keep training records and competency evaluations up to date.

7.3.2

Investigation results and analysis shall be communicated among all facilities involved, if applicable.

Guidance

The facility must identify an approach to evaluate complications or adverse events. The goal of such a process is to identify the underlying cause of the adverse event and to potentially prevent it from occurring in other cases. The response should consider limiting clinical implications of the event/complication, the potential need to remove equipment from use, preventing use of implicated equipment, ruling out clerical errors, etc. Subsequently, the program should outline the steps for additional investigation.

Agreements that include requirements for communication should be in place per Standard 4.2.3.2, including sub-Standard 4.2.3.2.3. For collections that are performed by contracted procurement facilities for further manufacture, this may entail that a contracted collector communicate investigation results per contractual requirements with, for example, the contracting partner. It is then the responsibility of the manufacturing partner to fulfill its obligations for communication of such information to other entities as appropriate. For processing facilities, this may entail that the processing facility communicate investigation results per contractual requirements with the manufacturer, such as when events during collection may have impacted the quality or safety of the product. It is then the responsibility of the manufacturing
partner to fulfill their obligations for communication to other entities, such as an administering facility, as appropriate. A contracted manufacturer or party holding licensure may not be under contractual obligation to communicate to a procurement and/or processing facility investigation results unless an element of the procurement or processing phase was identified as a contributing factor through the investigation and analysis process. Facilities may want to develop policies or plans (eg, a safety outcome monitoring and analysis plan) describing the mechanisms for obtaining, and frequency of attempts made to obtain, relevant clinical outcome data for safety outcome analysis. The plan should include audit criteria by which to assess reported outcome data, such as septic transfusion reactions. Documents and records should be retained according to facility requirements per Standard 6.0. (SS)

☑ Actionable Checklist

• Develop and implement an SOP for communication of investigation results and analysis among all involved facilities.
  • Include steps for identifying and evaluating complications or adverse events.
  • Outline procedures for limiting clinical implications and removing implicated equipment from use.
• Establish agreements with all contracted facilities to ensure communication requirements are met per Standard 4.2.3.2.
  • Ensure agreements specify responsibilities for communicating investigation results.
• Create a safety outcome monitoring and analysis plan.
  • Define mechanisms for obtaining clinical outcome data and frequency of data collection attempts.
  • Include audit criteria for assessing reported outcome data.
• Maintain documentation and records of all communications and investigations as per Standard 6.0.
• Conduct regular audits to ensure compliance with communication and investigation procedures.
• Train relevant staff on SOPs and agreements related to communication of investigation results.

7.3.3

[F]

The procurement facility shall have a process to detect, monitor, evaluate, manage, and report donor adverse events.

☑ Actionable Checklist

• Develop and implement an SOP for detecting and monitoring donor adverse events.
  • Include criteria for identifying adverse events and immediate actions to take.
• Train staff on the SOP for donor adverse event detection and management.
  • Maintain training records and conduct competency evaluations.
• Establish a log for recording all donor adverse events.
  • Ensure the log includes event details, evaluation, and management actions.
• Implement a process for evaluating the severity and impact of each adverse event.
  • Use a standardized form for documenting evaluations.
• Report donor adverse events to relevant regulatory bodies as required.
  • Maintain records of all reports submitted.
• Conduct regular reviews of adverse event data to identify trends and implement improvements.
  • Document findings and actions taken in management review minutes.

7.3.4

[F]

The clinical facility shall have a process to detect, monitor, evaluate, manage, and report recipient adverse events related to the cellular therapy. Standard 5.28 applies.

☑ Actionable Checklist

• Develop and implement an SOP for detecting and reporting recipient adverse events related to cellular therapy.
  • Include criteria for identifying adverse events and timelines for reporting.
• Train clinical staff on the SOP for adverse event detection and reporting.
  • Maintain training records and competency evaluations.
• Establish a log for documenting all reported adverse events.
  • Ensure entries include event details, evaluation, and actions taken.
• Conduct regular reviews of adverse event logs to identify trends and areas for improvement.
  • Document findings and any corrective actions taken.
• Implement a process for management review of adverse events and associated CAPAs.
  • Record outcomes and decisions from management reviews.

7.3.5

[F]

The processing facility shall have a process to evaluate reported adverse events.

Guidance

In the previous edition of CT Standards, it was not specifically stated that the processing facility should have a process to evaluate reported adverse events. Standard 7.0 requires that the facility shall have policies, processes, and procedures to capture, investigate, assess, and report adverse events. Standard 7.3.5, as previously stated for clinical and procurement facilities, now explicitly states that processing facilities shall have a standardized approach to evaluate adverse events. (SS)

☑ Actionable Checklist

• Develop and implement an SOP for evaluating reported adverse events in the processing facility.
  • Include criteria for identifying and categorizing adverse events.
  • Outline steps for investigation and assessment of each adverse event.
• Train all relevant staff on the adverse event evaluation SOP and document training records.
• Maintain a log of all reported adverse events, including details of the evaluation process and outcomes.
• Conduct regular internal audits to ensure compliance with the adverse event evaluation process.
• Review and update the adverse event evaluation SOP annually or as needed based on audit findings or regulatory updates.
• Document all deviations and CAPAs related to adverse event evaluations and review them in management meetings.

7.3.6 Communicable Diseases

Guidance

The committee added new standards 7.3.6 – 7.3.6.1.2 for completeness. These standards were based on existing standards in the Standards for Blood Banks and Transfusion Services, 34^th edition.  (SC)

☑ Actionable Checklist

• Develop and implement an SOP for the identification and reporting of communicable diseases.
  • Include criteria for identifying potential communicable diseases.
  • Outline the process for reporting to relevant authorities.
• Maintain a log of all reported communicable disease cases.
  • Ensure entries include date, disease type, and reporting details.
• Conduct regular training sessions on communicable disease identification and reporting.
  • Document attendance and competency evaluations.
• Perform quarterly audits of communicable disease reporting processes.
  • Review logs and SOP adherence during audits.
• Implement a CAPA plan for any deviations identified in communicable disease management.
  • Track CAPA progress and effectiveness in a dedicated log.

7.3.6.1 Reporting of Communicable Diseases

[F]

The administering facility shall have a defined process to evaluate and report communicable
disease transmission by cellular therapy products. The process shall include the following (Standard 5.10.2.8 applies):

7.3.6.1.1

Prompt investigation of each event by the appropriate medical director or designee.

7.3.6.1.2

If transmission is confirmed or not ruled out, the identity of the implicated cellular therapy product(s) shall be reported to the collecting facility, supplier, or manufacturer.

Guidance

Infectious disease testing is performed on donors to minimize the transmission of communicable diseases. However, testing may fail to detect the presence of an infectious agent when the infection is in the window period, at the time the product is received from the facility. The customer may be another facility or the recipient’s care team. Administering facilities must monitor cellular therapy product recipients for the presence of postinfusion communicable diseases and have a defined process to receive, evaluate, and report the communicable disease transmission to the collecting facility, supplier, manufacturer, and/ or Competent Authority, as appropriate. (SS)

☑ Actionable Checklist

• Develop and document an SOP for evaluating and reporting communicable disease transmission by cellular therapy products.
  • Include procedures for prompt investigation by the medical director or designee.
  • Define timelines for each step of the investigation process.
• Train relevant staff on the SOP and document training records.
• Establish a log for recording all communicable disease transmission events and investigations.
• Create a communication protocol for reporting confirmed or suspected transmissions to the collecting facility, supplier, or manufacturer.
  • Include contact information and reporting templates.
• Conduct regular audits of the communicable disease reporting process to ensure compliance and effectiveness.
• Review and update the SOP annually or as needed based on audit findings or regulatory changes.

7.4 Reporting

Reporting of deviations, nonconforming products, and adverse events shall be in accordance with the facility’s policies, these CT Standards, and applicable laws and regulations.*

*21 CFR 1271.350.

☑ Actionable Checklist

• Develop and maintain an SOP for reporting deviations, nonconforming products, and adverse events.
  • Ensure the SOP aligns with 21 CFR 1271.350 and AABB CT Standards.
• Train all relevant staff on the reporting SOP and document training completion.
• Implement a reporting form or electronic system to capture all necessary details of deviations, nonconformances, and adverse events.
• Establish a log to track all reported incidents, including dates, descriptions, and actions taken.
• Conduct regular audits to ensure compliance with reporting procedures and identify any gaps.
• Review and update the reporting SOP annually or as needed based on regulatory changes or internal findings.

7.4.1

When more than one facility is responsible for the reporting of deviations, nonconforming products, and adverse events, the responsibility to share results of any subsequent investigation(s) shall be defined by agreement.

Guidance

When multiple facilities are responsible for reporting deviations, nonconformances, and/or adverse
events, the results of subsequent investigation must be shared among these facilities. This responsibility must be defined in a written agreement. (SS)

The committee added new standard 7.4.1 to the edition to ensure that facilities that share reporting responsibilities of deviations, nonconformances and adverse events define responsibility through agreement. This would include the roles of both parties in reporting. (SC)

Excerpt of Reference Standard 6.2.9A Relevant to Deviations, Nonconformances, and Adverse Events

Standard	Record to Be Maintained	Quality System Records	Donor Eligibility/Management Issues	Unit/Recipient	Retention after Creation (C) or Final Disposition (F) of Related Product	Minimum Retention Time (in years)1
7.1	Deviations	X	X	X	F	10
7.2	Nonconforming products or services	X	X	X	F	10
7.2.4	Nature of nonconformances discovered after release and subsequent actions taken, including acceptance for use	X	X	X	F	10
7.2.4.1	Disposition of the nonconforming product or service	X	X	X	F	10
7.2.5.3	Impact of nonconforming products on purity, potency, safety, or efficacy of the product	X	X	X	F	10
7.2.6.2	Authorized release of nonconforming products	X	X	X	F	10
7.3.3	Detection, reporting, and evaluation of procurement-related donor adverse events	X	X	X	F	10
7.3.4	Detection, reporting, evaluation, and treatment of administration- related recipient adverse events	X	X	X	F	10
7.3.5	Evaluation of reported adverse events	X	X	X	F	10
7.3.6.1	Evaluation and reporting of communicable diseases	X	X	X	F	10

¹Applicable federal, state, or local law may exceed this period.

☑ Actionable Checklist

• Establish a written agreement with all facilities involved in reporting deviations, nonconformances, and adverse events.
  • Define the roles and responsibilities of each facility in the agreement.
  • Include procedures for sharing investigation results among facilities.
• Review and update SOPs related to deviations, nonconformances, and adverse events to reflect shared responsibilities.
• Maintain records of all agreements and ensure they are accessible for audits.
• Conduct training sessions for staff on the updated procedures and agreements.
  • Document attendance and competency evaluations in training records.
• Implement a tracking system for deviations, nonconformances, and adverse events that involves all responsible facilities.
  • Ensure the system allows for documentation of investigation results and sharing with relevant parties.
• Schedule regular management reviews to assess the effectiveness of the agreements and shared reporting processes.