ASRM Cellular and Gene Therapy Laboratory Accreditation Process

Accreditation Application

Accreditation Process for Cellular and Gene Therapy Labs

I. Application Requirements

1. 1. Application Form
   • Description: Labs must complete and submit an official application form.

Details:

Form Availability: The form can be obtained from ASRM at info@aabrm.org.

Information Required: Lab’s contact information, organizational structure, types of therapies offered, and a brief description of lab operations.

2. Supporting Documentation

Description: Submission of comprehensive supporting documentation is required to provide detailed information about the lab’s operations and quality systems.

• Details:
  • Standard Operating Procedures (SOPs): Copies of all relevant SOPs, including those for collection, processing, storage, and administration.
  • Quality Management System (QMS) Manual: A detailed manual outlining the lab’s QMS.
  • Organizational Chart: A chart showing the lab’s organizational structure.
  • Staff Qualifications: Documentation of staff qualifications, including resumes, certifications, and training records.
  • Facility Plans: Detailed diagrams of the lab layout and facility design.
  • Equipment Lists: A comprehensive list of all equipment used in the lab, including calibration and maintenance records.
  • Regulatory Compliance Records: Evidence of compliance with local, national, and international regulations, including licenses and certifications.

1. 3. Application Fee
   • Description: Payment of a non-refundable application fee is required.
   • Details:
     • Fee Amount: The specific amount will be determined by the accrediting body.
     • Payment Methods: Acceptable payment methods will be specified by the accrediting body.

II. Documentation Review

1. 1. Initial Assessment
   • Description: The accrediting body will conduct an initial assessment of the submitted documentation to ensure completeness and adequacy.
   • Details:
     • Review Criteria: Use of a standardized checklist to evaluate the completeness of the application and supporting documents.
     • Feedback: Provision of feedback to the lab, highlighting any missing or insufficient documentation and requesting additional information if necessary.
2. 2. Compliance Evaluation
   • Description: A thorough review of the documentation to assess the lab’s compliance with accreditation standards.
   • Details:
     • Evaluation Report: Preparation of an initial assessment report identifying any gaps or areas for improvement.
     • Corrective Actions: Recommendations for corrective actions to address any deficiencies identified during the documentation review.

III. On-Site Assessment

1. 1. Pre-Assessment Preparation
   • Description: Scheduling and preparation for the on-site assessment to ensure a smooth and comprehensive evaluation.
   • Details:
     • Notification: Advance notice to the lab of the assessment date and requirements.
     • Preparation Checklist: A checklist of items and areas to prepare for the assessment, including documents, staff availability, and facility access.
2. 2. Conducting the Assessment
   • Description: A comprehensive on-site inspection to evaluate compliance with accreditation standards.
   • Details:
     • Facility Inspection: Examination of the lab facilities and equipment to verify compliance with GMP and other standards.
     • Personnel Interviews: Interviews with key personnel to assess their knowledge and adherence to procedures.
     • Process Observation: Observation of lab processes to ensure they align with documented procedures and standards.
     • Assessment Criteria: Use of standardized assessment criteria to ensure consistency and objectivity.
3. 3. Assessment Report
   • Description: Detailed report of findings from the on-site assessment, including observations and recommendations.
   • Details:
     • Summary of Findings: Comprehensive summary of observations made during the assessment.
     • Recommendations: Specific recommendations for improvements or corrective actions, if needed.
     • Compliance Evaluation: Evaluation of the lab’s compliance with accreditation standards based on the findings.

IV. Accreditation Decision

1. 1. Committee Review
   • Description: The assessment report will be reviewed by the accreditation committee to make a final decision on accreditation status.
   • Details:
     • Committee Members: The committee will include experts in cellular and gene therapy, quality assurance, and regulatory compliance.
     • Review Process: Detailed review of the assessment report and supporting documentation.
2. 2. Accreditation Status
   • Description: Decision on whether to grant, deny, or conditionally approve accreditation, including the duration of accreditation.
   • Details:
     • Accreditation Types: Full accreditation, conditional accreditation (with specific corrective actions required), or denial.
     • Duration: Initial accreditation is granted for a period of 5 years, with regular reassessments.
     • Notification: Formal notification of accreditation status and any conditions or recommendations.
3. 3. Accreditation Certificate
   • Description: Issuance of an accreditation certificate for labs that meet the standards.
   • Details:
     • Certificate Contents: Includes the lab’s name, accreditation status, effective date, and expiration date.
     • Display Requirements: The certificate should be prominently displayed in the lab.

V. Post-Accreditation Requirements

1. 1. Continuous Monitoring
   • Description: Regular monitoring and reporting requirements to ensure ongoing compliance with accreditation standards.
   • Details:
     • Compliance Reports: Submission of periodic compliance reports detailing the lab’s adherence to accreditation standards.
     • Ongoing Audits: Regular internal and external audits to monitor compliance and identify areas for improvement.
     • Performance Metrics: Implementation of performance metrics to track quality and compliance over time.
3. 2. Renewal and Reassessment
   • Description: Process for renewal of accreditation to ensure labs continue to meet accreditation standards.
   • Details:
     • Reassessment Schedule: Defined schedule for reassessment, typically every 5 years.
     • Updated Documentation: Submission of updated documentation and compliance records as part of the reassessment process.
     • Renewal Application: Completion of a renewal application form, including any updates to the lab’s activities, processes, and quality systems.
     • Reassessment Visit: On-site reassessment visit to verify ongoing compliance with accreditation standards.
4. 3. Corrective Actions and Improvements
   • Description: Labs must implement corrective actions and improvements based on findings from audits, assessments, and reviews.
   • Details:
     • Corrective Action Plans: Development and implementation of plans to address identified deficiencies.
     • Documentation of Improvements: Records of all corrective actions and improvements made, including evidence of their effectiveness.

VI. Conclusion

A. Importance of Accreditation

• Ensures the highest standards of quality and safety in cellular and gene therapy labs.
• Enhances patient trust and improves clinical outcomes.
• Demonstrates a commitment to excellence and continuous improvement.

B. Commitment to Excellence

• Continuous improvement and adherence to best practices.
• Fostering a culture of quality and compliance.
• Engaging in ongoing education and training to stay abreast of advancements in the field.