QSE 1 — Organization

Key Concepts

Key Concepts: This quality system essential (QSE) describes the responsibilities of executive management, the nature of the quality system, and the need for ongoing attention to operational and quality issues through demonstrated management commitment.

Key Terms
Customer: The recipient of a product or service. A customer may be internal (eg, another organizational unit within the same organization) or external (eg, a patient, client, donor, or another organization).

Emergency Management: Strategies and specific activities designed to manage situations in which there is a significant disruption to organization operations or a significantly increased demand for the organization’s products or services.

Executive Management: The highest-level personnel within an organization, including employees, clinical leaders, and independent contractors, who have responsibility for the operations of the organization and who have the authority to establish or change the organization’s quality policy. Executive management may be an individual or a group of individuals.

Organization: An institution, or a location or operational area within that organization; the entity assessed by the AABB and receiving AABB accreditation for specific activities.

Policy: A set of basic principles or guidelines that direct or restrict the organization’s plans, actions, and decisions.

Procedure: A defined series of tasks and instructions that specify how an activity is to be performed.

Process: A set of related activities that transform inputs into outputs.

Quality Management System: The organizational structure, responsibilities, policies, processes, procedures, and resources established by executive management to achieve quality.

Examples of Objective Evidence:

• Policies, processes, and procedures related to this chapter.
• Organizational charts or documents describing roles, responsibilities, and decision-making authority.
• Evidence of executive management review of a quality system.
• Applicable federal, national, state, and local laws and regulations, as well as copies of any required certificates.
• Defined quality system.
• Process for approving exceptions to policies, processes, and procedures, as well as documented examples, if applicable.
• Risk assessments and mitigation strategies.
• Emergency operation and disaster continuity plan(s).
• Executive management review of customer feedback.

1.0 Organization

The organization shall define the parties responsible for the provision of products or services.

Guidance

The primary purpose of this chapter is to ensure that a facility has statements of quality goals or objectives and that all parties involved in activities that affect quality understand these goals and objectives of the organization and their responsibility in fulfilling them. Another purpose is to ensure that management at the highest level of the program is ultimately responsible and accountable for quality in the activities covered by these CT Standards.

Standard 1.0 requires that there be a structure that clearly identifies the parties who are responsible for providing cellular therapy products covered by the CT Standards. It also requires that the relationship of individuals who are responsible for key quality functions be defined. Each program must evaluate and identify key quality functions within its own organization. An organizational chart would be one example of meeting this standard. (SS)

☑ Actionable Checklist

• Develop and maintain an up-to-date organizational chart that clearly defines roles and responsibilities for all parties involved in cellular therapy services.
  • Ensure the organizational chart is reviewed and approved by senior management annually.
• Define and document quality goals and objectives in a Quality Manual or equivalent document.
  • Communicate these goals and objectives to all staff members through regular training sessions.
• Establish a process for assigning and documenting responsibility for key quality functions.
  • Include these responsibilities in job descriptions and performance evaluations.
• Conduct regular management reviews to ensure accountability for quality at the highest level.
  • Document the outcomes and action items from each management review meeting.
• Implement a system for tracking and updating any changes in organizational structure or responsibilities.
  • Use a change control log to document updates and ensure all relevant documents are revised accordingly.

1.1 Executive Management

The organization shall have a defined executive management.
Executive management shall have:

1. Responsibility and authority for the quality system and operations.
2. Responsibility for compliance with these CT Standards and applicable laws and regulations, including all applicable current good manufacturing practice (cGMP) requirements.
3. Authority to establish or make changes to the quality system.

Guidance

Although others in the facility may be more involved in implementing the quality system, executive management is ultimately responsible and accountable for the quality of the activities covered by these CT Standards. Executive management of the facility should have an understanding of the scope of activities performed and what laws and regulations are applicable to those activities. Executive management must then have a visible role in supporting and implementing the quality system throughout the facility that ensures adherence to those requirements. Executive management is defined as the highest-level personnel within an organization, including employees who have responsibility for the organization’s operations
and who have the authority to establish or change the organization’s quality policy. Depending on the size and complexity of the facility, executive management may consist of only the laboratory director or may involve an operations executive, customer service representatives, risk assessment managers, and representatives from other areas deemed appropriate by the facility. The facility must define the structure of executive management in its policies.

Executive management also holds ultimate responsibility for implementation of a plan or policy for management of information technology (IT) systems at the organization, pertaining to IT systems and equipment owned by the organization or on its network, including servers and equipment systems connected through wired or wireless connection, or a virtual private network (VPN) connection. The plan should address policies for network monitoring, malware protection, password and network management, remote access, server and workstation security, access authorization and termination, and secured disposal of retired IT equipment or devices. (SS)

#3 - The committee revised standard 1.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Define and document the structure of executive management in the facility’s policies.
  • Include roles such as laboratory director, operations executive, and other relevant positions.
• Establish and document the authority of executive management over the quality system.
  • Reference SOPs that outline the authority to establish or change the quality policy.
• Ensure executive management is trained on applicable laws, regulations, and cGMP requirements.
  • Maintain up-to-date training records and competency evaluations.
• Develop and implement a plan for IT systems management, including network monitoring and security.
  • Include policies for malware protection, password management, and secured disposal of IT equipment.
• Conduct regular management reviews to assess compliance with CT Standards and applicable regulations.
  • Document findings and actions taken in management review meeting minutes.

1.1.1

The facility shall demonstrate institutional support for the cellular therapy program.

Guidance

Good quality practices come from the top levels of executive management all the way down to personnel who perform, verify, and manage daily operations. Institutional support is necessary for a successful cellular therapy (CT) program; all of the human and financial resources needed to operate in compliance with the CT Standards should be provided. Safety of products and quality care for donors and recipients is essential to improved patient outcomes.

Standard 10.0 is also relevant, which indicates the facility should establish and maintain policies, processes, systems, and procedures designed to minimize risks to the health and safety of employees, donors, patients, volunteers, and other persons affected within the work environment. This includes having the institutional support needed to provide suitable quarters, environment, and equipment in order to maintain safe operations, and periodic evaluation to ensure ongoing functionality and adequacy. Objective evidence that the facility is meeting this standard could include the results of all recent audits by accreditors or regulatory agencies such as the US Food and Drug Administration (FDA) or Occupational Safety and Health Administration (OSHA). Additional subjective evidence could include executive management’s participation in CT program meetings and data review of results of internal audits. (SS)

☑ Actionable Checklist

• Obtain a written statement of support from executive management for the cellular therapy program.
  • Ensure the statement includes commitment to provide necessary resources and support.
• Schedule regular meetings with executive management to review program performance and resource needs.
  • Document meeting minutes and action items.
• Conduct a gap analysis to identify resource needs for compliance with CT Standards.
  • Develop a plan to address identified gaps and present it to management.
• Maintain records of audits by accreditors or regulatory agencies, such as FDA or OSHA.
  • Review audit findings with executive management and document corrective actions.
• Implement a process for periodic evaluation of facilities, equipment, and environment.
  • Document evaluations and any necessary improvements or upgrades.
• Ensure executive management participates in data reviews of internal audits.
  • Document management’s input and any resulting action plans.

1.1.2

The facility shall register for all applicable products and activities with the Food and Drug Administration (FDA) or relevant Competent Authority. When applicable, the facility shall obtain regulatory approval for all products and activities.

Guidance

This standard acknowledges that regulation of cell therapy products may differ by country or region. The facility is responsible for identifying the relevant regulatory agency or Competent Authority and for understanding applicable regulations and mechanisms for obtaining approval. For example, this involves evaluation of how unmanipulated, minimally manipulated, or more-than-minimally manipulated products, and products intended for autologous or allogeneic use may be regulated differently. Generally, facilities that house activities related to any aspect of cell therapy activity (eg, procurement, processing, storage, and distribution) will be expected to be registered with relevant authorities. AABB accreditation does not replace the requirement to obtain regulatory approval where warranted. (SS)

☑ Actionable Checklist

• Identify all applicable products and activities that require FDA or Competent Authority registration.
  • Review current product and activity inventory against regulatory requirements.
• Register the facility with the FDA or relevant Competent Authority for all applicable products and activities.
  • Maintain copies of registration documents and confirmations.
• Obtain regulatory approval for all products and activities as required.
  • Document all approvals and maintain records in a centralized location.
• Develop and maintain an SOP for the process of identifying regulatory requirements and obtaining necessary approvals.
• Conduct regular reviews to ensure ongoing compliance with regulatory requirements.
  • Schedule and document periodic audits of registration and approval status.
• Train relevant staff on regulatory requirements and the process for maintaining compliance.
  • Keep training records and competency evaluations up to date.

1.1.3 Procurement Facilities

The procurement facility shall have a medical director who is ultimately responsible for ensuring that the determination of donor eligibility and medical suitability was performed, when applicable.

Guidance

The medical director is required to participate in the development of policies, processes, and procedures related to the procurement facility. These policies and procedures should include medical director involvement with reports of adverse events, reporting to required authorities, and donor eligibility. (SS)

The committee updated standard 1.1.3 for clarity. The committee removed the clauses “shall be a member of executive management” and “(if performed by another facility) and procurement of the product” as they were viewed more in the vein of guidance and less what constitutes a standard. The element of “medical suitability” was included for completeness. (SC)

☑ Actionable Checklist

• Ensure the medical director is appointed and documented as responsible for donor eligibility and medical suitability determinations.
  • Update the organizational chart to reflect the medical director’s role and responsibilities.
• Develop and maintain SOPs for donor eligibility and medical suitability determinations with medical director input.
  • Include procedures for medical director review of adverse event reports and reporting to authorities.
• Schedule regular reviews and updates of donor eligibility SOPs with the medical director.
• Document all instances of medical director involvement in donor eligibility and adverse event reviews.
• Conduct internal audits to verify compliance with SOPs and the medical director’s responsibilities.
• Maintain training records for the medical director on current standards and procedures related to donor eligibility.

1.1.3.1 Procurement Medical Director

The procurement medical director shall be a member of executive management and shall
be a licensed physician with relevant experience, and qualified by training. The procurement
medical director shall participate in continuing education relevant to the activities performed by the facility as required by these CT Standards. The procurement medical
director shall have responsibility and authority for the scope of accredited medical
activities related to the procurement of cellular therapy products and services under these CT Standards. When the medical director delegates these responsibilities to another qualified medical professional (designee), the medical director shall retain ultimate responsibility.

Guidance

Continuing education (CE) refers to adult learning and training after a degree of higher education has been granted. CE consists of educational activities that serve to enhance professional development by maintaining, developing, or increasing the knowledge and skills of an individual relevant to the responsibilities of the position. CE is a critical component of maintaining competence. Proof or evidence of this education should be provided along with a certificate of attendance and the actual number of contact hours spent learning or training. (SS)

The committee updated standard 1.1.3.1 by including the clause “shall be a part of executive management” as the committee felt it fit better in the standard focused on the actual procurement medical director, and not the facility itself. The committee also added the clause “…the scope of accredited…” and “…under these CT Standards.” to ensure that the individual in this role has responsibilities focused around the content of the CT Standards. (SC)

1.1.3.1.1

The procurement medical director shall have at least 1 year of experience in the scope of procurement activities performed by that facility.

Guidance

The facility should define how the medical director will gain this experience to ensure the individual will be able to take on the responsibility of the position and maintain ongoing competency, whether it is by a combination of direct observation, record review, and participation in after-action reviews or by some other means. Proof or evidence of this experience should be provided. Examples of how this can be accomplished include real-world experiences such as shadowing of experienced personnel performing critical procedures, simulation training for hands-on experience, and participating in after-action reviews and regular review of records so that a medical director can anticipate common issues and how those issues may be resolved as part of risk management and corrective and preventive action. These types of activities to gain experience coupled with maintaining competency reinforce accountability of the director. (SS)

The committee created new standard 1.1.3.1.1, however the content previously appeared as a part of standard 1.1.3.1.2 and the intent has not changed. (SC)

1.1.3.1.2

[Cord blood applicable]

The procurement medical director shall have had active oversight of a minimum of 10 cell product procurement procedures related to their scope of responsibilities throughout the preceding 2-year accreditation cycle. Standard 2.1.2 applies.

Guidance

The minimum of 10 product procurement procedures to be overseen includes at least one for each activity performed by the facility over the accreditation cycle. If a procedure occurs relatively rarely, the medical director may oversee the procedure(s) performed by the staff to maintain competency. Such procedures should be identified in a standard operating procedure (SOP) and should be documented. The objective is to ensure the medical director is engaged in the management and review process of activities for which the facility is covered. Examples of active management for a procurement medical director may include direct involvement in donor eligibility determination to ensure criteria are met, overseeing the procurement of material from a donor to ensure procedures are followed, and review and management of a process deviation and implementation of corrective actions. (SS)

The committee edited this standard for clarity. The committee added the clause “active oversight” to the standard as well as “related to the scope of responsibilities” to ensure that the individual in this role is an active participant in the role.  The addition concerning scope was added to ensure that the oversight performed relates to their job functions. (SC)

☑ Actionable Checklist

• Verify that the procurement medical director is a licensed physician with relevant experience.
  • Maintain documentation of the medical director’s license and qualifications.
• Ensure the procurement medical director is part of executive management.
  • Include the medical director in executive management meeting minutes.
• Document the medical director’s continuing education relevant to facility activities.
  • Keep records of CE certificates and contact hours.
• Define and document the medical director’s responsibilities and authority in SOPs.
  • Review and update SOPs to reflect the medical director’s role in procurement activities.
• If responsibilities are delegated, ensure the medical director retains ultimate responsibility.
  • Document delegation agreements and review them annually.
• Confirm the medical director has at least 1 year of experience in procurement activities.
  • Maintain records of experience through shadowing logs, training records, and after-action reviews.

1.1.4 Processing Facilities

The processing facility shall have a laboratory medical director and a laboratory director who will be responsible for the processing, storage, and/or provision of the product under their responsibilities.

Guidance

The committee elected to update standard 1.1.4 for clarity. The committee added the clause “processing facility shall have a laboratory” to ensure that the focus of the standard was clear in terms of the medical director. (SC)

☑ Actionable Checklist

• Appoint a qualified laboratory medical director and laboratory director for the processing facility.
  • Verify and document the qualifications and credentials of the appointed directors.
• Define and document the responsibilities of the laboratory medical director and laboratory director in an SOP.
• Ensure the laboratory medical director and laboratory director are involved in the oversight of processing, storage, and provision of products.
• Maintain a current organizational chart reflecting the roles of the laboratory medical director and laboratory director.
• Conduct and document regular meetings between the laboratory medical director, laboratory director, and relevant staff to review responsibilities and performance.
• Include the roles and responsibilities of the laboratory medical director and laboratory director in the facility’s training program.

1.1.4.1 Laboratory Medical Director

The laboratory medical director(s) shall be a member of executive management and shall be a licensed physician with relevant experience, and qualified by training. The processing laboratory medical director shall participate in continuing education in activities performed by the facility as required by these CT Standards. The laboratory medical director(s) shall have responsibility and authority for the scope of accredited medical activities related to the processing and provision of cellular therapy products and services under these CT Standards. When the medical director delegates these responsibilities to another qualified medical professional (designee), the medical director shall retain ultimate responsibility.*

*42 CFR 493.1405, 42 CFR 493.1407, 42 CFR 493.1443, and 42 CFR 49.1445.
For accredited facilities that are assessed by AABB for conformance with the Clinical Laboratory Improvement Amendments (CLIA), refer to the Verification of CLIA Compliance Form before on-site assessment.

Guidance

The purpose of these standards is to ensure that the laboratory medical director can delegate their responsibilities to a designee even though the laboratory medical director retains ultimate responsibility. The standards do not explicitly stipulate whether the designee must have either a doctoral degree or a physician’s license; however, relevant standards in Chapter 2, Resources, would apply. For example, Standards 2.1.1 and 2.1.2 require the facility to identify job qualifications based on education, training, and/or experience. Standard 2.1.3 requires the facility to establish policies for training all personnel.

Also, initial and annual competency evaluations must be performed for defined tasks and activities (Standard 2.1.4), as well as relevant continuing education (CE) for all relevant employees (Standard 2.1.6). Therefore, the facility should define in written policies what training, competency, and CE the designee needs to have documented and how the facility determines that the designee has the appropriate qualifications. Also, there must be written documentation of the actual training, competence, and CE on file for the designee in addition to the laboratory medical director. One example of a situation in which the designee may not need a doctoral degree or physician’s license is when the laboratory medical director has already approved policies that define the acceptable criteria for the release of cell therapy products. Then, when the release criteria are met for a product before distribution, a nonphysician individual with
documentation of qualifications, training, competency, and CE may be delegated as designee for that review step, as long as the release criteria are met.

Alternatively, some situations require the same type of physician’s license for a designee, such as when the procuring facility must obtain a physician’s order before the procurement procedure. In order to meet this standard, any designee should be a physician with documentation of relevant and appropriate qualifications, training, competency, and CE that makes them qualified to write a physician’s order for procurement. CE refers to adult learning and training after a degree of higher education has been granted. CE consists of educational activities that serve to enhance professional development by maintaining, developing, or increasing the knowledge and skills of an individual relevant to the responsibilities of the position. CE is a critical component of maintaining competence. Proof or evidence of this education should be provided along with a certificate of attendance and the actual number of contact hours spent learning or training. (SS)

The committee updated standard 1.1.4.1 by including the clause “shall be a part of executive management” as the committee felt it fit better in the standard focused on the actual procurement medical director, and not the facility itself. The committee also added the clause “…the scope of accredited…” and “…under these CT Standards.” to ensure that the individual in this role has responsibilities focused around the content of the CT Standards. (SC)

1.1.4.1.1

The laboratory medical director shall have at least 1 year of experience in the scope of processing activities performed by the facility.^†

^†42 CFR 493.1443.
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the
Verification of CLIA Compliance Form before on-site assessment.

 

Guidance

The facility should define how the laboratory medical director will gain this experience to ensure the individual will be able to take on the responsibility of the position and maintain ongoing competency, whether it is by a combination of direct observation, record review, and participation in after-action reviews or by some other means. Proof or evidence of this experience should be provided. See guidance to Standard 1.1.3.1.1. (SS)

The committee created new standard 1.1.4.1.1, however the content previously appeared as a part of standard 1.1.4.1.2 and the intent has not changed. (SC)

1.1.4.1.2

[Cord blood applicable]

The laboratory medical director shall have had active oversight of a minimum of 10 cell product processing procedures related to their scope of responsibilities throughout the preceding 2-year accreditation cycle. Standard 2.1.2 applies.

Guidance

The laboratory medical director has to have overseen a minimum of 10 product processing procedures, including at least one for each activity performed by the facility over the term of its accreditation cycle. If a procedure occurs relatively rarely, the medical director may oversee the procedure(s) performed by the staff to maintain competency. Such procedures should be identified in SOPs and should be documented. See guidance to Standard 1.1.4.2. (SS)

The committee edited this standard for clarity. The committee added the clause “active oversight” to the standard as well as “related to the scope of responsibilities” to ensure that the individual in this role is an active participant in the role.  The addition concerning scope was added to ensure that the oversight performed relates to their job functions.  (SC)

☑ Actionable Checklist

• Ensure the laboratory medical director is a licensed physician with relevant experience and qualifications.
  • Verify and document the director’s license and qualifications in personnel records.
• Confirm the laboratory medical director is a member of executive management.
  • Maintain documentation of the director’s role in executive management meeting minutes.
• Implement a continuing education program for the laboratory medical director.
  • Track participation in relevant continuing education activities in training records.
• Develop a policy for delegation of responsibilities by the laboratory medical director.
  • Document any delegation of responsibilities to a qualified designee.
  • Ensure the medical director retains ultimate responsibility, as documented in SOPs.
• Conduct initial and annual competency evaluations for the laboratory medical director and any designees.
  • Maintain records of competency evaluations in personnel files.
• Verify compliance with CLIA requirements using the Verification of CLIA Compliance Form.
  • Keep the completed form on file for AABB assessments.

1.1.4.2 Laboratory Director

The laboratory director shall be a member of executive management and have a relevant
doctoral degree, with relevant experience, and who is qualified by training. The laboratory
director shall participate in continuing education for the specific cellular therapy products being produced. The laboratory director shall be responsible for technical aspects of the facility for the scope of accredited services that are related to the processing and provision of cellular therapy products and services under these CT Standards. When the laboratory director delegates these responsibilities to a designee, the laboratory director shall retain ultimate responsibility.*

*42 CFR 493.1405, 42 CFR 493.1407, 42 CFR 493.1443, and 42 CFR 493.1445.
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the Verification of CLIA Compliance Form before on-site assessment.

Guidance

This standard says that the laboratory director can delegate certain specified responsibilities to an appropriately trained and qualified designee, but with the specific understanding that the laboratory director retains ultimate responsibility. The standards do not explicitly stipulate whether the designee must have either a doctoral degree or a physician license; however, relevant standards in Chapter 2, Resources, would apply.

For example, Standards 2.1.1 and 2.1.2 require the facility to identify job qualifications based on education, training, and experience. Standard 2.1.3 requires the facility to establish policies for training all personnel. Also, initial and annual competency evaluations must be performed for defined tasks and activities (Standard 2.1.4), as well as relevant continuing education (CE) for all relevant employees (Standard 2.1.6). Therefore, the facility should define in written policies what training, competency, and CE the designee needs to have documented and how the facility determines that the designee has the appropriate qualifications for completion of certain specified tasks. Also, there must be written documentation of the actual training, competence, and CE on file for the designee in addition to the laboratory medical director.

One example of a situation in which the designee may not need a doctoral degree or physician’s license is when the laboratory medical director has already approved policies that define what the acceptable criteria are for the release of cell therapy products. Then, when the release criteria are met for a product before distribution, a nonphysician individual with documentation of their qualifications, training, competency, and CE may be delegated as designee for that particular review step, as long as the release criteria are met.

Conversely, other situations require the same type of physician’s license for a designee, such as when the procuring facility must obtain a physician’s order before the procurement procedure. In order to meet this standard, any designee should be a physician with documentation of relevant and appropriate qualifications, training, competency, and CE that makes them qualified to write a physician’s order for procurement.

CE refers to adult learning and training after a degree of higher education has been granted. CE consists of educational activities that serve to enhance professional development by maintaining, developing, or increasing the knowledge and skills of an individual relevant to the responsibilities of the position. CE is a critical component of maintaining competence and staying informed and experienced with technological and medical advances over time. Proof or evidence of this education should be provided along with a certificate of attendance and the actual number of contact hours spent learning or training. (SS)

The committee updated standard 1.1.4.2 by including the clause “shall be a part of executive management” as the committee felt it fit better in the standard focused on the actual procurement medical director, and not the facility itself. The committee also added the clause “…the scope of accredited…” and “…under these CT Standards.” to ensure that the individual in this role has responsibilities focused around the content of the CT Standards. (SC)

1.1.4.2.1

The laboratory director shall have at least 1 year of experience in the scope of processing activities performed by the facility.^†

^†42 CFR 493.1443.
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the Verification of CLIA Compliance Form before on-site assessment.

Guidance

The facility will define in an SOP how the laboratory director will gain this experience to ensure the individual will be able to take on the responsibility of the position, whether it is by direct observation, record review, combination of both, or some other means. Proof or evidence of this experience should be provided. See guidance to Standard 1.1.3.1.1. (SS)

The committee created new standard 1.1.4.2.1, however the content previously appeared as a part of standard 1.1.4.2.2. (SC)

1.1.4.2.2

[Cord blood applicable]

The laboratory director shall have had active oversight of a minimum of 10 cell product processing procedures related to their scope of responsibilities throughout the preceding 2-year accreditation cycle. Standard 2.1.2 applies.

Guidance

The minimum of 10 product processing procedures to be overseen includes at least one for each activity performed by the facility over the accreditation cycle. If a procedure occurs relatively rarely, the medical director may oversee the procedure(s) performed by the staff to maintain competency.  Such proceduresshould be identified in an SOP and should be documented. (SS)

The committee edited this standard for clarity. The committee added the clause “active oversight” to the standard as well as “related to the scope of responsibilities” to ensure that the individual in this role is an active participant in the role.  The addition concerning scope was added to ensure that the oversight performed relates to their job functions.  (SC)

☑ Actionable Checklist

• Verify that the laboratory director holds a relevant doctoral degree and has documented relevant experience.
• Ensure the laboratory director participates in continuing education specific to cellular therapy products.
• Document the laboratory director’s ultimate responsibility for technical aspects, even when delegating tasks.
  • Maintain a list of delegated responsibilities and qualified designees.
  • Ensure designees have documented training and competency evaluations.
• Keep a current SOP outlining the qualifications and training required for designees.
• Conduct and document annual competency evaluations for the laboratory director and designees.
• Review and update the Verification of CLIA Compliance Form prior to on-site assessments.

1.1.4.3

In order for the laboratory director to also serve as laboratory medical director, the individual shall meet the requirements stated in Standards 1.1.4.1 and 1.1.4.2.

Guidance

If this person oversees both the medical and technical aspects of product processing, 5 of the 10 procedures can be the same and count toward the experience requirements of both positions. (SS)

☑ Actionable Checklist

• Verify that the laboratory director meets the qualifications outlined in Standards 1.1.4.1 and 1.1.4.2.
  • Review the director’s CV and credentials to ensure compliance.
  • Document verification in the personnel qualification log.
• Ensure that the laboratory director has completed the required number of procedures.
  • Maintain a log of procedures performed by the director, highlighting overlap where applicable.
  • Review and update the log annually to ensure ongoing compliance.
• Develop SOPs that outline the dual role responsibilities of the laboratory director.
  • Cross-reference SOPs with Standards 1.1.4.1 and 1.1.4.2.
  • Review SOPs annually and update as necessary.
• Conduct an internal audit to assess compliance with the dual role requirements.
  • Document findings and implement corrective actions if needed.
  • Schedule follow-up audits to ensure continuous compliance.

1.1.5 Clinical Program

☑ Actionable Checklist

• Develop and maintain a documented organizational chart for the clinical program.
• Ensure job descriptions are current and reflect responsibilities related to cellular therapy.
• Conduct and document regular management reviews of the clinical program structure.
• Establish SOPs for communication between clinical program and other departments.
• Maintain records of all clinical program meetings and decisions.
• Implement a process for regular review and update of clinical program policies.

1.1.5.1 Clinical Facility

The clinical facility shall have a program director responsible for patient care and product administration.

Guidance

The committee edited standard 1.1.5.1 for clarity. The committee added the clause “have a program director” and removed the clause, “shall be a member of executive management.” This change mirrors similar edits to this chapter. (SC)

☑ Actionable Checklist

• Designate a qualified individual as the program director responsible for patient care and product administration.
  • Ensure the program director’s qualifications and responsibilities are documented in their job description.
• Maintain an up-to-date organizational chart that includes the program director’s role and reporting structure.
• Develop and implement an SOP detailing the program director’s responsibilities and authority.
• Conduct regular reviews of the program director’s performance and responsibilities in management meetings.
• Document any changes in the program director’s role or responsibilities and update relevant SOPs accordingly.

1.1.5.2 Clinical Program Director

The clinical program director shall be a member of the executive management and shall be a board-certified physician licensed to practice medicine in at least one specialty or subspecialty, who is qualified by training with relevant experience. The clinical program
director shall participate in continuing education for the clinical activities performed by the facility. This individual shall be responsible for all aspects of the clinical program,
including quality management and the selection and care of patients and donors.

Guidance

Continuing education (CE) refers to adult learning and training after a degree of higher education has been granted. CE consists of educational activities that serve to enhance professional development by maintaining, developing, or increasing the knowledge and skills of an individual relevant to the responsibilities of the position. CE is a critical component of maintaining competence. Proof or evidence of this education should be provided along with a certificate of attendance and the actual number of contact hours spent learning or training. (SS)

The committee edited standard 1.1.5.2 for clarity. The committee added the clause “shall be a member of executive management” which previously appeared in standard 1.1.5.1. (SC)

1.1.5.2.1

The clinical program director shall have at least 1 year of experience in the scope of clinical services.

Guidance

The facility should define how the clinical program director will gain this experience to ensure the individual will be able to take on the responsibility of the position and maintain ongoing competency, whether it is by a combination of direct observation, record review, and participation in after-action reviews, or by some other means. Proof or evidence of this experience should be provided. See guidance to 1.1.3.1.1. (SS)

1.1.5.2.2

[Cord blood applicable]

Relevant continuing education shall be obtained throughout the accreditation cycle in the scope of clinical activities performed in the facility.

Guidance

See guidance to Standard 1.1.5.2. (SS)

1.1.5.2.2 is new to this edition, however the content previously appeared as a part of standard 1.1.5.2.1. The intent of the standard has not changed. (SC)

1.1.5.3 Clinical Team

The clinical facility shall define who is a member of the clinical team. The team shall consist of at least one physician who is board certified in the appropriate subspecialty. The team shall have access to, and consult with, the appropriate medical and surgical specialties as well as other healthcare disciplines.

Guidance

Standard 1.1.5.3 requires the clinical team to have at least one physician who is board certified in the appropriate subspecialty. “Appropriate subspecialty” refers to the subspecialty directly related to the organ system and/or disease targeted by the cellular therapy. For example, a clinical program treating heart failure with mesenchymal stem cells should have a team member who is board certified in cardiology. Additionally, this standard requires the clinical team to have access to other specialties and healthcare disciplines as appropriate. Examples of specialties that need to be “accessible” include:

1. Those directly related to administration of the cellular therapy. For example, if line placement is required by interventional radiology, there should be access to a physician in that specialty. If anesthesia is required, there should be access to a physician in that specialty.
    
2. Those related to care of the recipient before or after administration of the cellular therapy. For example, if there is the need for therapy before conditioning with radiation, the clinical program should have access to individuals with radiation oncology expertise. If there is the potential for intensive care unit admission, the clinical team should have access to individuals with critical care expertise. (SS)

☑ Actionable Checklist

• Verify that the Clinical Program Director is a member of executive management and holds board certification in a relevant specialty.
• Ensure the Clinical Program Director is licensed to practice medicine and has at least 1 year of experience in the scope of clinical services.
• Maintain documentation of the Clinical Program Director’s continuing education activities, including certificates and contact hours.
• Define and document the process for the Clinical Program Director to gain and maintain relevant experience and competency.
• Establish a system to track and review the Clinical Program Director’s ongoing participation in continuing education throughout the accreditation cycle.
• Review and update SOPs to reflect the responsibilities and qualifications of the Clinical Program Director in line with the standard.

1.2 Quality System

The organization shall have a quality system. The organization’s executive management shall ensure that this quality system is implemented and followed at all levels of the organization.

Guidance

Standard 1.2 requires that each facility have a quality system. Implicit in this requirement are the development, documentation, and ongoing maintenance of the quality system. The quality system must, at a minimum, address the elements identified in Chapters 1 through 10 of the CT Standards. A quality system encompasses the policies, processes, and procedures that affect the quality of products or services.

All requirements contained in these CT Standards can be assumed to affect quality. Facilities currently implementing a quality system that satisfies AABB requirements can be assured that the requirements of this section are met.

The role and responsibilities of the quality system should be defined appropriately based on the regulatory environment of the program activities. Quality oversight in a clinical setting is focused on medical and clinical approval, with appropriate controls in place to ensure the health of the patient. This responsibility largely rests with the medical director and the clinical team. In the production environment, quality oversight is focused on ensuring the purity, potency, and safety of the product that is manufactured. The quality role must be independent of any influence that would interfere with this goal. The organizational chart must reflect this independence. The final approval of all procedures, processes, validation and qualification plans, product release, and corrective and preventive actions is the responsibility of the quality unit. (SS)

The committee revised standard 1.2 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and document a comprehensive quality system that addresses all elements in Chapters 1 through 10 of the CT Standards.
  • Ensure the quality system includes policies, processes, and procedures affecting product and service quality.
• Ensure executive management oversight and commitment to implementing and maintaining the quality system at all organizational levels.
• Define and document the roles and responsibilities of the quality system, ensuring independence from influences that could compromise product quality.
• Maintain an organizational chart that reflects the independence of the quality unit from production and clinical operations.
• Establish a process for the quality unit to approve all procedures, processes, validation plans, product releases, and CAPAs.
• Conduct regular management reviews to assess the effectiveness and compliance of the quality system.

1.2.1 Quality Representative

The quality system shall be under the supervision of a designated person who reports to executive management.

Guidance

Standard 1.2.1 requires that there be a designated individual within the organization who oversees the implementation of the quality system. The designated individual may have other responsibilities, and ideally, they will not assess activities for which they are responsible. The individual designated to oversee the quality function must report to executive management, exercise control in all matters relating to compliance with these CT Standards and federal, state, and local regulations, and have authority to recommend corrective action when it is appropriate. (SS)

The committee revised standard 1.2.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Designate a Quality Representative responsible for overseeing the quality system.
  • Ensure the Quality Representative reports directly to executive management.
  • Confirm the Quality Representative has authority to recommend corrective actions.
• Document the Quality Representative’s role and responsibilities in an SOP.
• Maintain records of the Quality Representative’s qualifications and training.
• Conduct regular reviews of the Quality Representative’s performance and responsibilities.
• Ensure the Quality Representative does not assess activities for which they are responsible.

1.2.1.1

The quality representative shall have defined independent authority for ensuring that the facility establishes, implements, and maintains a quality system that meets the requirements of these CT Standards. When the quality representative delegates these responsibilities to a designee, the quality representative shall retain ultimate responsibility.

1.2.1.1.1

[Cord blood applicable]

This individual shall report to executive management at least quarterly on quality system activities and to other staff as appropriate.

1.2.1.1.2

[Cord blood applicable]

These reports shall be used for management review and improvement of the quality system.

☑ Actionable Checklist

• Define the authority and responsibilities of the quality representative in an SOP.
  • Include delegation procedures and documentation requirements.
• Schedule quarterly meetings for the quality representative to report to executive management.
  • Document meeting minutes and action items.
• Develop a template for the quality system activity report.
  • Ensure it includes data for management review and quality improvement.
• Implement a process for distributing quality system reports to relevant staff.
  • Maintain a distribution log for accountability.
• Conduct management reviews based on quarterly reports.
  • Document outcomes and improvement actions in a management review log.

1.2.2 Management Reviews

[Cord blood applicable]

Management shall assess the effectiveness of the quality system at defined intervals.

Guidance

The committee revised standard 1.2.2 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Schedule regular management review meetings at defined intervals (e.g., quarterly).
  • Document meeting agendas and minutes.
  • Include a review of quality objectives, audit results, and CAPAs.
• Develop an SOP for conducting management reviews.
  • Ensure the SOP includes criteria for assessing quality system effectiveness.
• Maintain a log of management review outcomes and action items.
• Assign responsibility for follow-up on action items from management reviews.
• Review and update the management review SOP annually or as needed.
• Ensure training records reflect management’s understanding of the review process.

1.2.2.1

[Cord blood applicable]

The review of the quality system shall occur at a minimum on an annual scheduled basis to ensure that the system meets the requirements of these CT Standards.

Guidance

The committee revised standard 1.2.2.1 by including the clause “shall occur at a minimum” to ensure that management reviews of the quality system occurs on an annual basis. (SC)

☑ Actionable Checklist

• Schedule an annual management review of the quality system.
  • Include a review of compliance with AABB CT Standards.
  • Ensure participation from key management and quality personnel.
• Document the outcomes and action items from the management review.
  • Use a standardized form or template for consistency.
• Review and update SOPs related to quality system management.
  • Cross-reference updates with current AABB CT Standards.
• Maintain records of management review meetings and decisions.
  • Store records in a centralized, accessible location.
• Implement corrective actions identified during the review.
  • Track progress and completion of action items in a CAPA log.

1.2.3

The facility shall establish and maintain a quality system to ensure that activities related to donor and patient care, as well as the procurement, processing, storage, testing, distribution, administration, and postadministration monitoring of cellular therapies, conform to specified requirements.

☑ Actionable Checklist

• Develop and document a comprehensive Quality Management System (QMS) SOP.
  • Include procedures for donor and patient care activities.
  • Detail processes for procurement, processing, storage, and testing.
  • Outline distribution, administration, and postadministration monitoring protocols.
• Conduct a gap analysis against AABB and FACT-JACIE standards to identify areas for improvement.
• Implement a schedule for regular internal audits to assess compliance with the QMS.
• Maintain a crosswalk document mapping all SOPs to relevant standards and regulations.
• Ensure all personnel are trained on the QMS and maintain up-to-date training records.
• Document and review all deviations, corrective and preventive actions (CAPAs), and management reviews regularly.

1.3 Policies, Processes, and Procedures

[Cord blood applicable]

Policies, processes, and procedures shall be implemented and maintained to satisfy the applicable requirements of these CT Standards. All such policies, processes, and procedures shall be in writing or captured electronically and shall be followed.

Guidance

Standard 1.3 requires that the facility develop and implement written quality and operational policies, processes, and procedures. A policy is a documented general principle that guides present and future decisions. Policies are often generated as a result of standards, regulations, or a company’s “rules.” A mission statement is generally understood to be at the level of a policy. A policy might also be a generally articulated “rule,” such as a no-smoking policy.

A process is a description of a specific work goal and defines what is done and who does it. Processes are larger and more complicated activities than procedures. Processes usually involve more than one person, and often more than one department or work area within a program. The responsibility of a particular person within a process may or may not involve performing a specific procedure. Although most facilities have documented their procedures, documentation of processes is less prevalent. A common way to describe a process in writing is by using a flow diagram with interconnected steps and branch points. Processes may also be described in tables or a narrative format. Documentation of all processes is required by Standard 1.3.

A procedure is a series of simple tasks that complete one piece of work. When written down, the procedure serves as a set of work instructions. Procedures are usually performed by one person, from beginning to end. Instructions for entry of infectious disease test results into the laboratory information system, performing an ABO/Rh test of a cord blood unit, and running a quality control sample on a hematology analyzer are examples of procedures. There may be policies that relate to some of the steps in a procedure, for example, storage parameters and labeling policies.

A way to think about the distinctions among a policy, a process, and a procedure is that:

• Policies are rules.
• Processes are what we do.
• Procedures are how we do things.

Standard 1.3, Policies, Processes, and Procedures, is a commonly cited standard for nonconformances. Examples of the reasoning behind the nonconformances include the following:

1. Policies, processes, and procedures are not updated to reflect standards that are new in the most recent edition of CT Standards.
2. There is no written direction for staff on how to communicate concerns to AABB (Standard 1.7).
3. There is no SOP for how to respond to alarms (Standard 3.9.2).
4. There is no process validation for BacT Alert for hematopoietic progenitor cell (HPC) products (Standard 5.1.4). (SS)

The ​committee revised standard 1.3 based on updates to the AABB Quality System Essentials. (SC) 

☑ Actionable Checklist

• Develop and maintain a comprehensive list of all policies, processes, and procedures relevant to cellular therapy services.
  • Ensure each document is clearly categorized as a policy, process, or procedure.
• Implement a review schedule to update all policies, processes, and procedures to align with the latest CT Standards.
  • Document review dates and responsible personnel in a log.
• Create a flow diagram or narrative description for each process to ensure clarity and completeness.
  • Include all involved departments and roles in the process documentation.
• Establish a system for electronic or written documentation of all policies, processes, and procedures.
  • Ensure accessibility to all relevant staff and maintain version control.
• Conduct regular internal audits to verify adherence to documented policies, processes, and procedures.
  • Document audit findings and corrective actions in a quality management system.
• Train staff on the distinctions and applications of policies, processes, and procedures.
  • Maintain training records and competency evaluations for all staff.

1.3.1

The medical director and/or laboratory director (as applicable) shall approve all medical and technical policies, processes, and procedures.

Guidance

The committee revised standard 1.3.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Ensure the medical director and/or laboratory director reviews and approves all medical and technical policies.
  • Document approvals in the policy approval log.
• Implement a process for regular review and re-approval of policies, processes, and procedures.
  • Schedule reviews annually or as needed based on changes.
• Maintain a record of all approved policies, processes, and procedures in a centralized document control system.
• Conduct training for staff on any new or revised policies, ensuring training records are updated.
• Include policy approval status in internal audit checklists to verify compliance.
• Review and update the SOP for policy approval to reflect current practices and responsibilities.

1.3.1.1

[Cord blood applicable]

The procurement medical director shall review and approve all procurement policies, processes, and procedures.

☑ Actionable Checklist

• Ensure the procurement medical director reviews all procurement policies annually.
  • Document the review and approval in the policy review log.
• Update SOPs to require procurement medical director’s approval for new or revised procedures.
• Maintain a record of all approved procurement processes with signatures.
• Conduct an internal audit to verify compliance with the review and approval process.
• Include procurement policy review in the management review agenda.
• Train staff on the requirement for procurement medical director approval and document training completion.

1.3.1.2

[Cord blood applicable]

The laboratory medical director shall review and approve all medical laboratory policies, processes, and procedures.

☑ Actionable Checklist

• Ensure the laboratory medical director reviews all medical laboratory policies annually.
  • Document the review using a standardized form (e.g., Policy Review Form).
• Obtain written approval from the laboratory medical director for each new or revised policy.
  • File approvals in the policy management system.
• Maintain a log of all policies, processes, and procedures reviewed and approved by the medical director.
• Schedule regular review meetings with the laboratory medical director to discuss policy updates.
• Conduct internal audits to verify compliance with the policy review and approval process.
• Update SOPs to reflect the requirement for medical director review and approval.

1.3.1.3

[Cord blood applicable]

The laboratory director shall review and approve all technical laboratory policies, processes, and procedures.

☑ Actionable Checklist

• Ensure the laboratory director reviews all technical laboratory policies annually.
  • Document the review and approval using the “Policy Review Form.”
• Maintain a log of all technical laboratory procedures requiring director approval.
• Schedule a quarterly meeting for the laboratory director to review new or revised procedures.
• Update the SOPs to reflect the laboratory director’s approval date and signature.
• Conduct an internal audit to verify compliance with the policy review process.
• Store all signed and approved documents in the designated quality management system.

1.3.1.4

[Cord blood applicable]

The clinical program director shall review and approve all clinical policies, processes, and procedures related to administration and patient care.

☑ Actionable Checklist

• Ensure the clinical program director reviews all clinical policies, processes, and procedures annually.
  • Document the review and approval in the policy management system.
• Maintain a log of all clinical policies, processes, and procedures reviewed by the clinical program director.
• Implement a tracking system to ensure timely updates and reviews of clinical documents.
• Conduct regular audits to verify compliance with the review and approval process.
• Update SOPs to reflect the requirement for clinical program director approval.
• Retain records of all approvals for a minimum of 5 years.

1.3.1.5

Signatures of the individual approving all policies, processes, and procedures shall comply with the requirements of the FDA or relevant Competent Authority.

Guidance

The form of the signature should be linked directly to the responsible person. In the United States, for example, confirming the identity of the signatory can be achieved by a pen-and-ink signature, by an electronic signature with two points of authentication (21 CFR Part 11), or by a digital image that represents a true and exact copy of the signature such as the signature or signed documents in portable document file (PDF) format. (SS)

☑ Actionable Checklist

• Verify that all policy, process, and procedure documents have an approval signature.
  • Ensure signatures comply with FDA or relevant Competent Authority requirements.
• Implement a system for electronic signatures that meets 21 CFR Part 11 standards.
  • Include two points of authentication for electronic signatures.
• Maintain a log of all approved documents with corresponding signatures.
• Conduct regular audits to ensure compliance with signature requirements.
• Update SOPs to reflect current signature approval processes.
• Train staff on the correct procedure for obtaining and verifying signatures.

1.3.2

[Cord blood applicable]

Any exceptions to medical and technical policies, processes, and procedures shall require justification and preapproval by the medical director and/or laboratory director, as applicable.

Guidance

All exceptions to policies, processes, and procedures require preapproval (ie, before the event occurs) by the appropriate individual. Depending on the situation, preapproval may be required by only one or by several individuals, as defined in an SOP. For example, due to a delay in delivery from an outside procurement center, a product infusion may occur 1 hour past the expiration date. The recipient’s physician and the laboratory medical director may believe the benefits of infusing the product outweigh the risks. Both of these individuals would preapprove the infusion. Such incidents should be handled in conformance with Chapter 7, Deviations, Nonconformances, and Adverse Events. (SS)

☑ Actionable Checklist

• Develop an SOP detailing the process for obtaining preapproval for exceptions to policies, processes, and procedures.
  • Include criteria for when preapproval is required and by whom.
  • Define documentation requirements for justification and approval.
• Create a form or log to document all exceptions, including justification and preapproval signatures.
• Train relevant staff on the SOP for handling exceptions and ensure understanding of the preapproval process.
• Implement a review process to ensure all exceptions are documented and preapproved as per the SOP.
• Conduct regular audits to verify compliance with the exception preapproval process.
• Review and update the SOP and training materials annually or as needed based on audit findings or changes in regulations.

1.4 Risk Assessment

[Cord blood applicable]

The facility shall have a process to perform risk assessments for activities at defined intervals. Standards 5.1.1 and 6.1.5 apply.

Guidance

The purpose of this standard is to ensure that any new or changed product, process, or procedure is evaluated prospectively for associated risks to the purity, potency, efficacy, or safety of the product. Risk assessment evaluates the probability of occurrence and the severity or impact. Identified risks with a higher probability of harm or unexpected outcome can be mitigated by the implementation of an administrative control (policy or procedure) or an engineering control (clean room or biological safety cabinet for open-product manipulations).

Documentation of the risk assessment and mitigation strategies could be included in the validation program or a more formalized risk assessment tool. The outcome should be shared with executive management for acceptance. This standard is closely aligned with other standards designed to ensure that risk assessment and risk mitigation are integral elements of process or change control planning and that mitigation strategies are validated or verified for effectiveness before implementation. (SS)

The committee revised standard 1.4 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement a risk assessment SOP that outlines the process for evaluating risks associated with new or changed products, processes, or procedures.
  • Include criteria for assessing the probability and severity of risks.
  • Define intervals for regular risk assessment reviews.
• Utilize a formalized risk assessment tool to document identified risks and mitigation strategies.
  • Ensure documentation is included in the Validation Master Plan (VMP).
• Conduct risk assessments for all new or modified processes and document outcomes.
  • Include risk mitigation strategies and their validation or verification.
• Share risk assessment outcomes and mitigation strategies with executive management for review and acceptance.
• Perform regular internal audits to ensure compliance with risk assessment procedures and documentation.
• Maintain records of all risk assessments, including any deviations and corrective actions taken.

1.4.1

Mitigation strategies shall identify, assess, and address the level of risk associated with quality and safety.

Guidance

The committee revised standard 1.4.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and document a risk assessment SOP to identify potential risks to quality and safety.
  • Include criteria for risk identification, assessment, and prioritization.
• Conduct a comprehensive risk assessment for all critical processes.
  • Use a standardized risk assessment form to document findings.
• Implement mitigation strategies for identified risks.
  • Assign responsibility for each mitigation action to specific personnel.
• Review and update the risk assessment and mitigation strategies annually.
  • Document the review process and any changes made.
• Train all relevant staff on risk assessment procedures and mitigation strategies.
  • Maintain training records and competency evaluations for all personnel involved.

1.5 Operational Continuity

The organization shall address continuity in the event that operations are at risk.

Guidance

Operational continuity refers to the means of ensuring critical functions continue in settings that may hamper the ability to carry out those functions. This element of review is a key aspect of resolution and planning for individual firms. The situations that would be covered by each facility would be different based on size, location, and scope of work. It should be noted that operational continuity would be needed not only in the setting of a “disaster.” For example, if a key employee left a facility without notice and there was no immediate backup to perform their functions, if a critical piece of equipment were to fail or if a facility were to be sold to another entity, there would be policies, processes, and procedures in place to ensure critical operations are designed to function at a level needed to maintain key quality metrics.

These policies and procedures could include agreements to share resources or critical supplies between similar organizations in times of exceptional need. For example, a listing of additional and qualified suppliers of equivalent resources or supplies that could be accessed during unusual circumstances may be a valuable resource. It is not expected that a facility can anticipate every possible risk; however, SOPs can be developed to address known common risks as well as procedures for unspecified, more unusual situations. (SS)

The committee added revised standard 1.5 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and document an Operational Continuity Plan (OCP) addressing potential risks to critical functions.
  • Include procedures for handling unexpected staff departures and equipment failures.
• Identify and establish agreements with alternative suppliers for critical supplies and resources.
• Conduct risk assessments to identify potential operational disruptions specific to the facility.
• Implement and maintain SOPs for managing identified risks and unusual situations.
• Schedule regular reviews and updates of the OCP to ensure its effectiveness and relevance.
• Train staff on the OCP and conduct drills to test response to operational disruptions.

1.5.1

The facility shall have a policy to address critical supply shortages.

Guidance

The policy should include strategies for addressing acute or short-term product shortages as well as those that may be protracted and affecting a large portion of the industry (eg, limited availability of supplies as a result of disasters or recalls, changes in donor eligibility criteria, or implementation of new testing). The policy should include the identification and communication methods to include all potentially implicated services. Developing and establishing a facility interdisciplinary task force team that involves facility leadership, cellular therapy experts, clinician stakeholders, and quality/risk management representatives that can be quickly convened in these circumstances is one way to meet the intent of this standard. This team can perform an impact analysis for patient care and identify at-risk patient populations. This task force may determine the priorities for the facility as well as assess the impact on administration
and financial issues. This team may also obtain corroboration from the clinical areas to comply with existing facility policies for the appropriateness of product use. (SS)

☑ Actionable Checklist

• Develop and document a policy addressing critical supply shortages, including both short-term and long-term scenarios.
  • Include strategies for addressing shortages due to disasters, recalls, or changes in regulations.
• Establish an interdisciplinary task force team with facility leadership, cellular therapy experts, and quality/risk management representatives.
  • Define roles and responsibilities for each team member.
• Implement a communication plan for notifying all potentially affected services of supply shortages.
  • Include methods for internal and external communication.
• Conduct an impact analysis to assess the effect of supply shortages on patient care and identify at-risk populations.
  • Document findings and proposed actions in a report.
• Review and update the policy annually or as needed based on changes in supply chain dynamics or regulatory requirements.
• Maintain records of all task force meetings, decisions, and actions taken in response to supply shortages.

1.6 Emergency Preparedness

The organization shall have an emergency operation plan(s) to respond to the effects of internal and external disasters.

Guidance

The facility should determine its plan for responding to disasters, both internal and external. Such a plan may be part of a larger institutional plan or be specifically for the laboratory. The plan should include communication and notification procedures, assessment of service needs and capabilities, assessment of systems (phone, internet, computer programs, etc) and critical functions (processing, storage, testing, etc), identification of backup facilities, decision-making, authority, escalation to executive management, required documentation, and service expectations.

Ideally, there is redundancy in the communication systems. An example of this is cell phones, which may be an obvious first choice, but in the event of a disaster, cell towers are not always a reliable form of communication. Therefore, secondary and tertiary systems such as UHF/VHF and HAM radios are important and valuable. Because these types of systems are not used on a daily basis, testing on a predetermined schedule becomes very important.

Other backup systems could also be used. Paper communication systems should be periodically tested to ensure that all current forms are available and that instructions for completion of and delivery of the forms are clear. Regardless of the system used, there should be scheduled testing. Records of testing of the emergency communications system should be available for review.

The immediate goals of an emergency plan are to:

1. Protect the safety of all personnel in the facility, as well as staff and visitors.
2. Safeguard vital materials, records, and cell therapy products.
3. Coordinate emergency response and recovery procedures.

The objective of the emergency plan and related documents is to provide guidelines for emergency situations, to assist the staff in identifying key roles and responsibilities, to achieve safe building evacuations, maintain effective communications, protect inventory, and develop strategies for resuming normal function once the emergency condition has resolved.

The first step toward preparedness is to establish an emergency response team. Team leaders are trained to disseminate emergency instructions, institute notification via the phone tree and email list, assess the need for evacuation, and provide first aid if required. This team will be headed by the laboratory director. The team leaders will have responsibility for updating the contingency plan and contacts list, training the staff in emergency and recovery procedures (including new staff when they join the organization), and performing mock drills on an annual basis. Also, the safety officer will maintain supplies and equipment that might be needed to respond to an emergency.

Examples of internal disasters include fire, loss of utilities, worker strikes, workplace violence, smoke, fumes, release of chemicals or radiation, hostage situations, and bomb threats.

Examples of external disasters include earthquakes, hurricanes, tornadoes, storms, floods, fire, riots, train derailments, plane crashes, power outages, cyber-attacks, and terrorist attacks. (SS)

The committee revised standard 1.6 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and document an emergency operation plan specific to the facility.
  • Include communication and notification procedures.
  • Assess service needs, capabilities, and critical functions.
  • Identify backup facilities and systems.
• Establish an emergency response team led by the laboratory director.
  • Train team leaders in emergency instructions and procedures.
  • Update the contingency plan and contacts list regularly.
• Implement redundancy in communication systems, including secondary and tertiary options.
  • Schedule regular testing of all communication systems.
  • Maintain records of communication system tests for review.
• Conduct annual mock drills to test emergency response and recovery procedures.
  • Document outcomes and improvements from each drill.
• Maintain supplies and equipment necessary for emergency situations.
  • Ensure all staff are trained in the use of emergency supplies and equipment.

1.6.1

[Cord blood applicable]

The emergency management plan, including emergency communication systems, shall be tested at defined intervals.

Guidance

For example, the facility may consider using a mock disaster scenario to mimic a real-life event. The disaster planning teams would be tasked with documentation of disaster planning, immediate action, communications, and successful and timely resolution. The team would document all steps taken, including a review of the disaster mock exercise for effectiveness and continuous improvement. This is a common nonconformance because facilities often do not test at defined intervals. The facility may also document after-action review on real scenarios to meet this standard.

Reviews should include changes to key personnel, systems, locations, customers, backup facilities, or products/services since the previous test. Any potential gaps in communication, unanticipated issues arising during the test, or lack of clarity on decision-making should be reviewed for opportunities to improve the emergency management plan. (SS)

☑ Actionable Checklist

• Develop and document an emergency management plan, including communication systems, in an SOP.
• Schedule and conduct mock disaster scenarios at defined intervals, at least annually.
  • Use the mock disaster scenario to test all aspects of the emergency management plan.
  • Document all actions taken during the mock disaster scenario.
• Perform an after-action review following each test or real scenario.
  • Identify and document any gaps or issues encountered.
  • Update the emergency management plan based on findings from the review.
• Ensure all relevant personnel are trained on the emergency management plan and maintain training records.
• Review and update the emergency management plan whenever there are changes in key personnel, systems, or locations.

1.6.1.1

This evaluation shall occur, at a minimum, on an annual scheduled basis.

Guidance

See guidance to Standard 1.6.1. (SS)

The committee created new standard 1.6.1.1 for consistency and to mirror the requirements of standard 1.2.2.1. (SC)

☑ Actionable Checklist

• Schedule an annual evaluation of the organization’s quality management system.
  • Document the evaluation schedule in the Quality Management System (QMS) calendar.
• Develop an evaluation checklist based on the organization’s quality objectives and standards.
  • Reference SOP QMS-001 for evaluation criteria and process.
• Conduct the evaluation using the developed checklist.
  • Record findings in the Evaluation Report Form (ERF-001).
• Review evaluation findings in a management review meeting.
  • Document meeting minutes and action items in the Management Review Log (MRL-001).
• Implement corrective actions for identified gaps or deficiencies.
  • Track corrective actions in the Corrective Action Log (CAL-001).

1.7 Communication of Concerns

The organization shall have a process for personnel to anonymously communicate concerns about quality or safety. Personnel shall be given the option to communicate such concerns either to their organization’s executive management, AABB, or both. AABB’s contact information shall be readily available to all personnel.

Guidance

The facility shall develop a process whereby personnel can communicate their concerns directly or anonymously to the facility’s executive management or to AABB. This process should allow employees to voice their concerns without fear of reprisal. Corrective action plans should be developed to address communicated problems. All communications to AABB can be sent to the Accreditation Department at the AABB National Office by phone (301-215-6492), or email (with attached files). (SS)

☑ Actionable Checklist

• Develop and implement an SOP for anonymous communication of quality or safety concerns.
  • Include procedures for submitting concerns to executive management and AABB.
• Ensure AABB contact information is visibly posted in common areas and accessible online.
• Train all personnel on the communication process and their rights to anonymity.
  • Document training sessions and maintain records.
• Establish a log to track submitted concerns and their resolutions.
  • Review log regularly in management meetings.
• Develop corrective action plans for addressing communicated concerns.
  • Document and review CAPAs in management reviews.
• Conduct regular audits to ensure the communication process is effective and accessible.

1.8 Customer Focus

Executive management shall identify the organization’s customers and their needs and expectations for products or services.

Guidance

Executive management must have an understanding of the customer expectations for products and services, including contractual obligations, as well as knowledge of which laws and regulations apply to these activities. (SS)

☑ Actionable Checklist

• Identify and document all customer groups and their specific needs and expectations.
  • Review and update the customer identification document annually.
• Conduct regular meetings with executive management to discuss customer feedback and expectations.
  • Maintain minutes of these meetings and track action items.
• Develop and maintain a Customer Needs and Expectations SOP.
  • Ensure SOP includes processes for gathering and analyzing customer feedback.
• Establish a process for reviewing and updating contractual obligations with customers.
  • Document all changes and ensure they are communicated to relevant staff.
• Conduct a gap analysis to ensure compliance with applicable laws and regulations related to customer interactions.
  • Document findings and implement corrective actions as needed.
• Include customer focus objectives in the organization’s quality management review.
  • Document discussions and decisions related to customer focus in management review minutes.

1.9 Facility Status Changes

The facility shall communicate to AABB within 30 days a change that directly or indirectly impacts a facility’s accreditation status.

Guidance

The committee created new standard 1.9 for completeness. This standard exists in other sets of AABB Standards and mirrors that language. (SC)

☑ Actionable Checklist

• Develop a procedure for identifying changes that impact accreditation status.
  • Include criteria for determining significant changes.
  • Assign responsibility for monitoring potential changes.
• Create a notification template for communicating changes to AABB.
• Establish a timeline to ensure notification to AABB within 30 days of change.
• Train staff on the procedure for reporting facility status changes.
• Maintain a log of all communications with AABB regarding facility status changes.
• Conduct an annual review of the procedure to ensure compliance and update as necessary.

1.9.1

If the organization is the subject of regulatory enforcement action by a relevant Competent Authority, they shall notify AABB within 7 days of receipt of notification.

Guidance

Standards 1.9.1 and 1.10 were added to clarify that significant events such as changes in standing with regulatory authorities or harm caused to individuals are considered changes that may directly or indirectly impact the facility’s accreditation status. Timely notification of these changes is required. (SS)

The committee created new standard 1.9.1 based on feedback received during the comment period. This standard now requires accredited programs contact AABB if they are under investigation by their relevant Competent Authority. This ensures AABB accreditation’s department is aware of all issues that could potentially impact the program or AABB as an accreditation organization.
The committee also added a new definition to the Glossary for “Regulatory Enforcement Action” for clarity.

Regulatory Enforcement Action: Measures taken by a Competent Authority that include, but are not limited to, progressive measures (eg, suspension or termination of operations, information notices requiring specific documentation or data, fines incurred) or action based on critical triggers (eg, pattern of recurrent, unresolved issues, deficiencies in risk management systems). (SC)

☑ Actionable Checklist

• Develop an SOP for identifying and reporting regulatory enforcement actions to AABB.
  • Include procedures for notifying AABB within 7 days of receiving notification.
• Train relevant staff on the new SOP and document completion in training records.
• Establish a log to track all regulatory enforcement actions and notifications sent to AABB.
• Conduct a quarterly review of regulatory compliance status and document findings.
• Perform an internal audit to ensure adherence to the SOP and update as necessary.
• Maintain a crosswalk document linking SOPs to AABB Standard 1.9.1 for easy reference.

1.10 Unanticipated Event Notification

Within 30 days, the organization shall notify AABB of the discovery of an event that has caused, is causing, or is likely to cause serious injury or harm, or death, to an individual resulting from deviation(s) related to the scope of these CT Standards.

Guidance

Standards 1.9.1 and 1.10 were added to clarify that significant events such as changes in standing with regulatory authorities or harm caused to individuals are considered changes that may directly or indirectly impact the facility’s accreditation status. Timely notification of these changes is required. Facilities should report nonconforming events that could cause serious injury, harm, or death to individuals, requiring immediate corrective and preventive action, to AABB. (SS)

Standard 1.10 is new to the edition and has been included for completeness. This requirement mirrors requirements set forth by AABB’s Accreditation Department.
The committee also added a new definition to the Glossary for “Unanticipated Event” for clarity.

Unanticipated Event: Unplanned occurrences that can cause serious injury or harm, or death, to an individual, resulting from a deviation(s). (SC)

☑ Actionable Checklist

• Develop and implement an SOP for identifying and reporting unanticipated events within 30 days.
  • Include criteria for what constitutes an unanticipated event.
  • Define roles and responsibilities for reporting.
• Establish a notification protocol to inform AABB of unanticipated events.
  • Use a standardized form or template for reporting.
  • Maintain a log of all notifications sent to AABB.
• Train all relevant staff on the SOP for unanticipated event notification.
  • Document training sessions and maintain records.
• Conduct regular internal audits to ensure compliance with the notification requirement.
  • Review logs and reports for timeliness and completeness.
• Include unanticipated event notification in the management review agenda.
  • Discuss trends and potential improvements in the process.

1.11 Human Subject Research

Executive management shall ensure that the applicable laws and regulations concerning research on human subjects, as well as any requirements stipulated by the facility’s independent ethics committee, are followed.

Guidance

The role of executive management is to have responsibility and oversight of the facility, including
research activities. Although executive management may not have specific knowledge or expertise to comment on study design, they will retain the ultimate responsibility for ensuring that research activities meet applicable laws and regulations and other requirements such as those specified by the institutional review board (IRB). (SS)

☑ Actionable Checklist

• Develop and maintain an SOP for ensuring compliance with laws and regulations on human subject research.
  • Include a process for regular review and updates of the SOP.
• Establish a system for executive management to review and approve all research activities involving human subjects.
• Ensure all research proposals are submitted to and approved by the facility’s independent ethics committee or IRB.
  • Maintain records of all IRB approvals and correspondence.
• Conduct regular training sessions for executive management on applicable laws and regulations concerning human subject research.
  • Document attendance and completion of training sessions.
• Implement a process for ongoing monitoring and auditing of research activities to ensure compliance.
  • Document findings and corrective actions from audits.
• Schedule regular management reviews to discuss compliance status and any issues related to human subject research.

1.11.1

Executive management shall ensure that the design of research protocols prevents conflicts of interest that interfere with recipient care.

☑ Actionable Checklist

• Review and update SOPs related to research protocol design to include conflict of interest checks.
  • Ensure SOPs reference AABB CT Standard 1.11.1.
• Develop a conflict of interest disclosure form for all personnel involved in research protocols.
• Implement a process for executive management to review and approve research protocols for potential conflicts of interest.
• Conduct training sessions for staff on identifying and managing conflicts of interest in research.
• Maintain records of all conflict of interest disclosures and management decisions.
• Schedule regular audits to ensure compliance with conflict of interest policies in research protocols.

1.11.2

Executive management shall ensure that reviews or audits of the research design are performed at defined intervals.

Excerpt of Reference Standard 6.2.9A Relevant to Organization

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
1.1.3.1.2	Procurement medical director management or review of 10 cell procurement procedures	X	X	X	C	10
1.1.4.1.2	Laboratory medical director management or review of 10 cell product processing procedures	X	X	X	C	10
1.1.4.2.2	Laboratory director management or review of 10 cell product processing procedures	X	X	X	C	10
1.1.5.2.2	Relevant continuing education of the clinical program director	X	X	X	C	10
1.2.1.1.1, 1.2.1.1.2	Quarterly reports by quality representative to executive management	X	X	X	C	10
1.2.2	Management review of effectiveness of the quality system	X	X	X	C	10
1.2.2.1	Yearly review of the quality system	X	X	X	C	10
1.3	Policies, processes, and procedures	X	X	X	C	10
1.3.1.1	Procurement medical director review and approval of all medical policies, processes, and procedures	X	X	X	C	10
1.3.1.2	Laboratory medical director review and approval of all medical policies, processes, and procedures	X	X	X	C	10
1.3.1.3	Laboratory director review and approval of all technical policies, processes, and procedures	X	X	X	C	10
1.3.1.4	Clinical program director review and approval of all clinical policies, processes, and procedures	X	X	X	C	10
1.3.2	Exceptions to policies, processes, and procedures	X	X	X	C	10
1.4	Risk assessment	X	X	X	C	10
1.6.1	Emergency operation plan tested at defined intervals	X	X	X	C	2 years, or two organizational testing intervals (whichever is longer)

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

☑ Actionable Checklist

• Schedule regular reviews or audits of research design at defined intervals.
  • Document the schedule in a research audit calendar.
• Assign responsibility for conducting research design reviews to qualified personnel.
  • Ensure personnel are trained and records of training are maintained.
• Develop a standard operating procedure (SOP) for conducting research design reviews.
  • Include criteria for review and approval processes in the SOP.
• Maintain records of all research design reviews, including findings and actions taken.
  • Store records in a secure and accessible location for a minimum of 10 years.
• Conduct management reviews of the effectiveness of research design audits.
  • Document outcomes and any corrective actions in management review minutes.
• Integrate research design review findings into the quality management system for continuous improvement.