QSE 2 — Resources

Key Concepts

Key Concepts: This QSE describes the need for resources—human, financial, and otherwise—to support the work performed. It also describes personnel issues such as the qualification of staff, assessments of competence [including those performed under Clinical Laboratory Improvement Amendment (CLIA) regulations], and continuing education requirements.

Key Terms
Competence: An individual’s demonstrated ability to apply knowledge and skills needed to perform the job tasks and responsibilities at defined intervals.

Qualification (individuals): The aspects of an individual’s education, training, and experience that are necessary for the individual to successfully meet the requirements of a position.

Examples of Objective Evidence:

• Policies, processes, and procedures related to this chapter.
• Current job descriptions.
• Evaluation of staffing levels and workload, if performed.
• Process for recruiting and hiring.
• Personnel records (eg, certifications, qualifications, competence assessments, diplomas, transcripts).
• Training records.
• Evaluations of competence records.
• Evidence that job qualifications are met.
• Continuing education records.

2.0 Resources

The organization shall have adequate resources to perform, verify, and manage all the activities described in these CT Standards.

Guidance

Standard 2.0 requires that the facility have adequate resources. The staffing plan should address how to ensure adequate personnel in emergency situations and at times of increased workload. This chapter also requires that these individuals be trained, initially and at appropriate intervals, and that the organization assess their competence before independent performance of assigned activities and at least annually thereafter. (SS)

☑ Actionable Checklist

• Develop and maintain a staffing plan that includes provisions for emergency situations and increased workload.
  • Review and update the staffing plan annually or as needed.
• Ensure all personnel are trained initially and at appropriate intervals.
  • Maintain a training log for each employee.
• Conduct competency assessments before independent performance of assigned activities.
  • Schedule and document annual competency evaluations for all personnel.
• Verify that resources (staff, equipment, materials) are adequate to perform, verify, and manage all activities.
  • Conduct a resource adequacy review quarterly.
• Document and review any resource-related deviations and implement CAPAs as necessary.
  • Maintain a log of deviations and CAPAs related to resource management.

2.1 Human Resources

The organization shall employ an adequate number of individuals qualified by education, training, and/or experience.*

*21 CFR 1271.170.

Guidance

This standard requires that an appropriate number of qualified personnel be employed. Individuals may be qualified by education, experience, or both. When defining qualifications, one should consider technical knowledge, level of decision-making (technical vs medical) needed, and amount of supervision required or available.

The purpose of this standard is to ensure that only qualified individuals perform activities in the facility. Implicit in this standard is the requirement that the organization define qualifications for each job function, define and deliver appropriate training needs, and assess staff competence. Records of qualification, training, and competence assessments must be maintained. (SS)

The committee revised standard 2.1 based on updates to the AABB Quality System Essentials.  (SC)

☑ Actionable Checklist

• Define qualifications for each job function, including education and experience requirements.
  • Review and update job descriptions to reflect required qualifications.
• Develop and implement a training program tailored to each job function.
  • Ensure training records are maintained and updated regularly.
• Conduct initial and periodic competency assessments for all staff.
  • Document results and any necessary corrective actions.
• Maintain a staffing plan to ensure an adequate number of qualified personnel.
  • Review staffing levels quarterly to identify any gaps.
• Keep records of all personnel qualifications, training, and competency assessments.
  • Use a centralized system for easy access and review.
• Conduct an annual review of human resources policies and procedures.
  • Update policies as needed to comply with current standards and regulations.

2.1.1 Job Descriptions

[Cord blood applicable]

The organization shall establish and maintain job descriptions defining the roles and responsibilities for each job position related to the requirements of these CT Standards.

☑ Actionable Checklist

• Develop and maintain job descriptions for all positions related to cellular therapy.
  • Ensure each job description includes roles, responsibilities, and required qualifications.
  • Review and update job descriptions annually or as roles change.
• Cross-reference job descriptions with current SOPs to ensure alignment.
• Store all job descriptions in a centralized, accessible location for staff.
• Conduct annual audits to verify that job descriptions are current and accurate.
• Document any changes to job descriptions and communicate updates to affected staff.

2.1.2 Qualification

[Cord blood applicable]

Personnel performing critical tasks shall be qualified to perform assigned activities on the basis of appropriate education, training, and/or experience.^†

^†42 CFR 493.1403, 42 CFR 493.1409, 42 CFR 493.1415, 42 CFR 493.1421,
42 CFR 493.1441, 42 CFR 493.1447, 42 CFR 493.1453, 42 CFR 493.1459, 42 CFR 493.1461, and 42 CFR 493.1487.
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 committee added the CFRs cited above to ensure that the CT Standards remain consistent with CMS requirements. (SC)

☑ Actionable Checklist

• Develop and maintain a comprehensive SOP for personnel qualification requirements, referencing 42 CFR sections as applicable.
  • Include criteria for education, training, and experience for each critical task.
• Implement a training program that aligns with the SOP, ensuring all personnel receive necessary education and training.
  • Document completion of training in individual training records.
• Conduct competency evaluations for personnel performing critical tasks at regular intervals.
  • Maintain records of evaluations and any corrective actions taken.
• Perform a gap analysis to ensure compliance with both AABB and CMS requirements.
  • Use the AABB Assessment Tool to identify any discrepancies.
• Regularly review and update the Verification of CLIA Compliance Form prior to on-site assessments.
• Document and review any deviations from qualification requirements and implement CAPAs as needed.

2.1.3 Training

[Cord blood applicable]

The organization shall provide training for personnel performing critical tasks.^‡

^‡21 CFR 211.25.

Guidance

The committee added the CFRs cited above to ensure that the CT Standards remain consistent with CMS requirements. (SC)

☑ Actionable Checklist

• Develop and maintain a comprehensive training program for personnel performing critical tasks.
  • Reference SOP-Training-001 for detailed training procedures.
• Ensure all training materials are up-to-date and reflect current practices and regulations.
  • Review and update training materials annually.
• Document all training sessions, including date, trainer, and attendees, in the Training Log (Form-Training-Log-001).
• Conduct competency evaluations for personnel post-training to ensure understanding and proficiency.
  • Use Competency Evaluation Form (Form-Comp-Eval-001) for documentation.
• Schedule regular refresher training sessions for all personnel involved in critical tasks.
• Perform annual reviews of training records to ensure compliance with 21 CFR 211.25 and AABB standards.

2.1.3.1

[Cord blood applicable]

This training shall include:

1. Orientation.
2. Initial job-specific training to perform assigned responsibilities.
3. Quality-systems-related training.
4. Ongoing job-specific training for employee assigned responsibilities.

Standards 2.1.4, 2.1.6, and 5.1.1 apply.

Guidance

The committee edited subnumbers 2 and 4 for completeness. The additions of the clauses, “to perform assigned responsibilities” to #2, and “for employee assigned responsibilities” to #4,  ensures that the training given is focused on the work performed by the specific employees. (SC)

2.1.3.1.1

The facility shall define the qualifications and approve subject matter experts who provide training.

Guidance

The subject matter expert (SME) should have the qualification(s) required for the subject, by education, by training in/on the subject academically, theoretically, and/or practically by hands-on methods (techniques). For qualifying a member of staff/personnel as an SME, each facility needs to define:

1. Minimum qualifications required. For example, for reviewing and authorizing the clinical studies to be undertaken at the facility, the SME would be a board-certified physician in the subject, such as an oncologist for cancer-related studies or an orthopedic surgeon for studies in orthopedic cases.
2. Hours of training required. For example, to qualify the laboratory technologist/technician as an SME for flow cytometry, the facility should require a minimum of 100 hours of training.
3. Experience in years or cases/studies/samples required. For example, to qualify a laboratory technologist to train new staff, the facility might require 1 year of experience successfully completing independent processing of cord blood units.
4. Competency required for the task. For example, the staff member may have been assessed for competency in processing of cord blood units and been found competent and qualified to process cord blood independently. (SS)

☑ Actionable Checklist

• Develop and implement an orientation program for new employees.
  • Include facility tour, introduction to staff, and overview of key procedures.
• Create job-specific training plans for each role.
  • Document initial training requirements and completion in training records.
• Establish a quality-systems-related training module.
  • Ensure all employees complete this training and maintain records.
• Implement ongoing job-specific training sessions.
  • Schedule regular updates and refreshers based on role changes or updates.
• Define qualifications for subject matter experts (SMEs).
  • Document minimum qualifications, training hours, and experience required.
• Approve and document SMEs for each training area.
  • Maintain a list of approved SMEs and their qualifications in personnel files.

2.1.4 Competence

[Cord blood applicable]

Evaluations of competence shall be performed before independent performance of assigned activities and at specified intervals.

Guidance

Competency testing assesses the ability of a specific individual to perform a specific task according to procedures. A competency assessment is completed before the individual performs the task independently and at least annually thereafter.

Competency assessments for any laboratory testing are dependent on the type of testing being performed (ie, waived, moderate complexity, or high complexity), as defined by the Code of Federal Regulations (CFR) in Title 42 CFR Parts 493.5 and 493.17, and must be achieved in compliance with the CFR and the facility’s accrediting agency or organization. Accrediting bodies may include, but are not limited to, The Joint Commission, the College of American Pathologists, and the US federal government [Centers for Medicare and Medicaid Services (CMS), which enforces the Clinical Laboratory Improvement Amendments (CLIA)].

CLIA regulations list a number of other ways an individual without a degree or with a nonscience degree can qualify as testing personnel. The facility is responsible for setting the standards for its testing personnel and those performing critical tasks. Administrative personnel will also need appropriate training and experience.

This standard does not restrict competency evaluations to only “high-complexity” job functions. For example, shipping staff who send collection kits must not only be trained and determined to be competent initially, but competency evaluations must be conducted annually. In this situation, the facility’s policies should state that shipping kits for the collection of cell therapy products is a defined task for which these individuals are responsible. Written policies should define what training and competency is required for shipping out collection kits and specify instructions for how the staff should accomplish the task of shipping collection kits. The policy might stipulate (for example) that staff are shipping kits that are the correct kit, that the kits are not expired, and that they were sent to and received by the intended facility. There should also be documentation that this policy is actually followed. In sum, any responsibility of the shipping staff should be reflected in the corresponding policy and competency criteria. Any job function, no matter how simple, should require periodic competency evaluation. Errors can still occur when seemingly simple tasks are performed. (SS)

☑ Actionable Checklist

• Develop and maintain SOPs for competency evaluations specific to each job function, including laboratory testing and shipping tasks.
  • Include criteria for initial and annual competency assessments.
  • Specify procedures for different testing complexities (waived, moderate, high).
• Ensure all staff complete competency evaluations before performing tasks independently.
  • Document completion dates and results in personnel files.
• Schedule and conduct annual competency assessments for all staff, including administrative and shipping personnel.
  • Use standardized forms to record assessment outcomes.
• Review and update competency assessment criteria annually or as needed.
  • Align with current CFR and accrediting agency requirements.
• Maintain records of all competency evaluations, including corrective actions for any deficiencies identified.
• Regularly audit competency evaluation processes to ensure compliance with SOPs and standards.

2.1.4.1

[Cord blood applicable]

Action shall be taken when competence has not been demonstrated. Standard 9.1 applies.

Guidance

Personnel performing critical tasks who fail a competency assessment for any or all of the tasks should be retrained and reevaluated for performance of those tasks before they are permitted to continue in their previous capacity. If retraining fails, the person should be removed from the tasks, and a performance improvement plan should be developed. If the person is unable to be retrained and cannot demonstrate competence, the person may be subject to termination. (SS)

The committee revised standard 2.1.4.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for addressing competency failures, including retraining and reevaluation procedures.
  • Include criteria for retraining and reevaluation in the SOP.
• Maintain a log of competency assessments, including outcomes and actions taken for failures.
• Conduct retraining sessions for personnel who fail competency assessments and document completion.
• Reevaluate personnel after retraining to ensure competence is demonstrated before resuming tasks.
• Develop performance improvement plans for personnel unable to demonstrate competence after retraining.
• Review and update the SOP annually or after any changes to the AABB Quality System Essentials.

2.1.4.2

Competence shall be evaluated annually for defined tasks and activities.^*

^*21 CFR 211.25, 42 CFR 493.1413(b)(8), and 42 CFR 493.1451(b)(8).
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the Verification of CLIA Compliance Form before on-site assessment.

☑ Actionable Checklist

• Develop and maintain a Competency Assessment SOP outlining the process for annual evaluations.
  • Include criteria for evaluating competence for each defined task and activity.
• Schedule annual competency evaluations for all personnel involved in defined tasks.
  • Use a Competency Evaluation Form to document assessments.
• Train supervisors and assessors on conducting competency evaluations.
  • Maintain training records for all assessors.
• Review and update the Competency Assessment SOP annually or as needed.
• Document all completed competency evaluations in the personnel files.
• Conduct a management review of competency evaluation outcomes to identify areas for improvement.

2.1.4.3

For individuals who perform moderate- and high-complexity testing, semiannual reviews of competence shall be performed in their first year of employment. For facilities located in the United States, specified requirements apply.^†

^†42 CFR 493.1413(b)(9) and 42 CFR 493.1451(b)(9).
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the Verification of CLIA Compliance Form before on-site assessment.

☑ Actionable Checklist

• Develop and maintain an SOP for conducting semiannual competence reviews for new employees performing moderate- and high-complexity testing.
  • Include criteria for competence evaluation and documentation requirements.
• Schedule semiannual competence reviews for all applicable new employees within their first year.
  • Utilize a standardized Competence Review Form to document evaluations.
• Ensure all competence reviews are signed off by a qualified supervisor or designee.
• Maintain a log of completed competence reviews, including dates and outcomes.
• Verify compliance with 42 CFR 493.1413(b)(9) and 42 CFR 493.1451(b)(9) for facilities in the United States.
• Review and update the Verification of CLIA Compliance Form prior to AABB on-site assessments.

2.1.4.4

Competence shall be assessed when new or novel processes or procedures are introduced. Standard 5.1.4 applies.

☑ Actionable Checklist

• Develop and implement an SOP for assessing competence when new processes are introduced.
  • Include criteria for evaluating competence in the SOP.
• Maintain a log of all new or novel processes introduced.
• Schedule and document training sessions for staff on new processes.
• Conduct and record competency assessments for all relevant staff.
• Review and update competency assessment forms to reflect new processes.
• Ensure all training and competency records are current and filed appropriately.

2.1.5 Personnel Records

[Cord blood applicable]

Personnel records for each employee shall be maintained.

Guidance

Personnel records shall be maintained with a focus on those individuals who are performing critical tasks. These records should include documentation of appropriate education (ie, medical degree, graduate training, biology/medical technology degree), critical task training, and maintenance of competency. In the case where an employee leaves a job, these records must be maintained for 10 years following said departure. (SS)

☑ Actionable Checklist

• Maintain personnel records for all employees performing critical tasks.
  • Include documentation of appropriate education (e.g., medical degree, graduate training).
  • Document critical task training and competency maintenance.
• Ensure personnel records are retained for 10 years after employee departure.
• Regularly update records to reflect current training and competency evaluations.
• Conduct periodic audits of personnel records to ensure completeness and accuracy.
• Implement an SOP for the management and retention of personnel records.

2.1.5.1

For those authorized to perform or review critical tasks, records of names, signatures,
initials or identification codes, and inclusive dates of employment shall be maintained.

Guidance

The committee added new standard 2.1.5.1 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Maintain a log of all personnel authorized to perform or review critical tasks, including names, signatures, initials, or identification codes.
  • Ensure the log includes inclusive dates of employment for each individual.
• Update the personnel log promptly upon any changes in employment status or authorization.
• Cross-reference the personnel log with training records to verify authorization for critical tasks.
• Conduct regular audits to ensure the personnel log is current and complete.
• Store the personnel log in a secure, easily accessible location for reference during audits or inspections.

2.1.6 Continuing Education

[Cord blood applicable]

The organization shall ensure that continuing education requirements applicable to these CT Standards are met when applicable.

Guidance

Continuing education (CE) refers to ongoing adult learning and training after initial qualification/education has been granted. Relevant CE consists of educational activities related to the activities performed at the facility that serve to enhance professional development related to the job functions by maintaining, developing, or increasing, the knowledge and skills of an individual. CE is a critical component of maintaining competence. Proof or evidence of this education should be provided with the date and location and the actual number of contact hours spent learning or training. Relevant employees are those who have job functions related to the application of these CT Standards.

There needs to be documentation of CE for all areas in which an employee performs, has oversight for, participates in, etc. For example, a collection facility director needs to have documentation of CE on the topic of collection of the type of cell therapy product(s) that is collected at that facility. Methods for obtaining CE should be defined by facility policy and can include participation in a professional meeting (with a certificate of attendance listing the session titles, dates, and hours); presenting at a professional meeting (with a document listing the presentation title, date, and hours); participation in a professional committee (documented with a committee roster listing the employee name and dates of meetings); reading applicable journal articles (with a copy of the article); etc. Professional meetings are commonly used for CE, and it is important that facility policies define the criteria for participation and how participation is documented so as to ensure trackability. (SS)

The committee revised standard 2.1.6 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for continuing education (CE) requirements, specifying methods for obtaining CE and documentation criteria.
  • Include participation in professional meetings, presentations, committee involvement, and journal article reviews as CE methods.
• Maintain a log of all CE activities for each relevant employee, including dates, locations, and contact hours.
• Ensure each employee’s CE log is reviewed and updated annually to verify compliance with CE requirements.
• Document proof of CE activities, such as certificates of attendance, presentation titles, committee rosters, or copies of journal articles.
• Conduct an annual audit of CE records to ensure all relevant employees meet the continuing education requirements.
• Review and update the CE policy annually to align with any changes in AABB CT Standards or organizational needs.

2.1.6.1

The facility shall ensure that the medical, laboratory, procurement, and clinical program
directors, and the quality representative, annually complete a minimum of 10 hours of educational activities relevant to the role and the associated cellular therapy activity or activities performed in the facility.* Standards 1.1.3.1, 1.1.4.1, 1.1.4.2, and 1.1.5.2 apply.

*42 CFR 493.1413(b)(7) and 42 CFR 493.1451(b)(7).
For accredited facilities that are assessed by AABB for CLIA conformance, refer to the Verification of CLIA Compliance Form before on-site assessment.

Guidance

Obtaining and maintaining relevant certifications, such as the Certification for Advanced Biotherapies
Professionals (CABP), is an effective way to fulfill, track, and document educational activities. (SS)

☑ Actionable Checklist

• Develop and maintain a training log to track completion of educational activities for directors and quality representatives.
  • Include fields for date, activity description, hours completed, and relevance to role.
• Schedule annual reviews of educational activities with each director and quality representative.
  • Use a standardized form to document the review and any identified gaps.
• Identify and approve relevant educational activities that meet the 10-hour requirement.
  • Include options such as workshops, conferences, webinars, and certifications.
• Implement a process for directors and quality representatives to submit proof of completed educational activities.
  • Maintain copies of certificates, attendance records, or other documentation in personnel files.
• Conduct an annual audit of educational activity records to ensure compliance with the 10-hour requirement.
  • Document findings and any corrective actions taken in the audit report.
• Review and update the SOP for educational activity tracking and compliance annually.

2.1.6.2

Requirements for the relevant continuing education activities performed by the facility as required by these CT Standards shall be defined for employees who perform critical tasks.

☑ Actionable Checklist

• Define and document continuing education requirements for employees performing critical tasks in SOP CT-EDU-001.
• Develop a Continuing Education Plan (CEP) that outlines specific activities and timelines for critical task employees.
• Maintain a Continuing Education Log (Form CT-EDU-002) to track completed activities for each employee.
• Schedule and conduct annual reviews of the Continuing Education Plan to ensure alignment with current standards.
• Include continuing education compliance checks in regular internal audits and document findings in the audit report.
• Ensure all continuing education records are current and accessible for review during inspections.

2.2 Access to Ancillary Services and Direct Patient Care

The clinical facility shall have an agreement in place to ensure comprehensive care and relevant resources required for patient care in cellular therapies, including, but not limited to:

1. Transfusion medicine.
2. Services related to pharmacy.
3. Radiology.
4. Laboratory services.
5. Acute care or medical facilities.
6. Social and psychological support.
7. Long-term follow-up based on protocol or treatment plan.

Guidance

The intent of this standard is to make sure relevant resources are available for patient care in cellular therapies, including, but not limited to, access to medical specialty services and resources when any or some of the ancillary services on the list are based outside of the institution (eg, if the laboratory or the radiology services are outsourced to another institution). However, a written agreement is not required between the clinical facility and ancillary services, collection facilities, and processing facilities if they are within the same institution. It is implied that these ancillary services/facilities operate under the same legal entity and have a responsibility to support all services.

The term “access” indicates availability in a timely fashion, which means it will allow appropriate clinical care without delays that could jeopardize patient health or safety. For example, if a patient is bleeding and requires an urgent irradiated red cell transfusion, such a product should be available in a time frame that will minimize patient morbidity or mortality. (SS)

Excerpt of Reference Standard 6.2.9A Relevant to Resources

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
2.1.1	Job descriptions	X	X	X	C	10
2.1.2	Qualification of personnel performing critical tasks	X	X	X	C	10
2.1.3	Training records of personnel	X	X	X	C	10
2.1.3.1	Identification of qualifications required for trainers	X	X	X	C	10
2.1.4	Evaluations of competence	X	X	X	C	10
2.1.4.1	Corrective action when competence has not been demonstrated	X	X	X	C	10
2.1.5	Personnel records of each employee	X	X	X	C	10
2.1.6, 2.1.6.1	Continuing education requirements	X	X	X	C	10

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

☑ Actionable Checklist

• Establish agreements with external ancillary service providers, including transfusion medicine, pharmacy, radiology, and laboratory services.
  • Ensure agreements specify timely access to services to prevent delays in patient care.
• Develop and maintain a directory of internal and external ancillary services with contact information and service availability.
• Conduct a gap analysis to identify any missing ancillary services and develop a plan to address these gaps.
• Implement a procedure to review and update agreements with ancillary services annually.
• Maintain records of all agreements with ancillary service providers, ensuring compliance with retention requirements.
• Ensure all staff are trained on the process for accessing ancillary services, including emergency protocols.