ACCREDITATION PROGRAM

“The Accreditation Program promotes the highest standard of care for patients and donors in all aspects of blood banking, transfusion medicine, hematopoietic, cellular and gene therapies, and transplantation. This is accomplished by the administration of accreditation activities in a competent and reliable manner that fosters improvement in laboratory and transfusion medicine settings. The program assesses compliance to current standards and offers both educational and peer review opportunities. It is the intent that the accreditations granted and the services covered by the accreditations be recognized at a national and international level.”

Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP) regulations, CLIA ’88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality Management systems, competition within the blood banking profession, advances in the cellular therapy arena, and increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy communities conduct business. Conducting business in a quality framework is no longer an option, but a must. Ensuring that all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.

Compliance and Education
The assessment provides a review of a facility’s compliance with AABB Standards. This includes an audit of the quality and operational systems. The experience and expertise of the AABB assessors also makes the assessment process an educational experience.

How the Program Works
The facility’s quality systems and operational systems are evaluated to ensure compliance with:

• AABB Standards
• Code of Federal Regulations
• CLIA ’88

The assessment uses both quality and operational systems-based tools in performing the assessment. The assessment tools assist the assessor in determining how the facility implemented the intent of each requirement and whether that implementation was effective. Current versions of all assessment tools are available on line.

Initial Accreditation Overview (PDF)
Facilities seeking accreditation for the first time or an accredited facility adding an additional activity are required to complete an initial accreditation process prior to an on-site assessment.

Less Paperwork and a More Streamlined Process
All facilities receive a copy of the Accreditation Information Manual (AIM) that contains everything a facility needs to know to achieve accreditation, including:

• Policies, processes and procedures of the accreditation program
• Equivalencies and deemed status requirements
• Guidance documents
• Summary report forms and guidance on how to respond to the summary report
• Information on the Accreditation Program Committee and National Office Services

Customized Assessments
The Accreditation Program is designed to grant accreditation for specific activities. Each facility assessment is designed around the activities performed by that facility. Accreditation is granted for the following specific activities:

• Donor Centers – Collection, Processing, Testing and Distribution
• Transfusion Services – Testing (Pretransfusion, Compatibility), Blood Administration
• Cellular Therapy (Hematopoietic Progenitor Cells, Cord Blood, Somatic Cells)
• Immunohematology Reference Laboratories
• Relationship/Parentage Testing
• Perioperative Services
• SBB Schools

A facility’s certificate(s) of accreditation reflect the activities for which it has received accreditation.

Assessors: Trained Professionals to Conduct Your Assessment
Trained professional assessors and volunteer professionals perform the assessment. All assessors must meet qualification criteria, receive training in auditing and assessing techniques, and must demonstrate ongoing continuing competence. Training includes: auditing techniques, quality program, summary report writing, conflict resolution and other topics of interest to auditors.

A conflict of interest statement is signed for each assessment performed.

Facilities are provided with the identity of assessors in advance of the assessment for acceptance. A facility is assigned either a team or individual (sole) assessor, depending on the size and scope of activities performed by the facility.

Teams are composed of a specially trained lead assessor and general assessors with subject matter expertise. The lead assessor serves as the contact between the facility and team members.

Facilities requiring one assessor are assigned a sole assessor with subject matter expertise and who has been trained as a lead assessor.

Moving Ahead With Your Assessment
Six months prior to the expiration of the facility accreditation, the accreditation contact will be notified of the upcoming assessment and provided with a pre-assessment packet containing:

• Facility Data Verification Record to confirm your facility address; authorizing personnel; activities to be assessed; FDA license or registration; CLIA information (if combining AABB and CLIA inspections); and request for a coordinated AABB assessment/CAP inspection. This form is to be returned to the AABB National Office.
• Request for pre-assessment materials (including a brief description of your facility’s quality program and your organizational structure; a master list of documents; description of the processes for developing and changing standard operating procedures and managing events and nonconformances, training and competency assessment, and internal and external assessments; and a summary of internal and external assessment findings since the last AABB assessment). These are to be submitted to the National Office upon acceptance of the assessment team.

Providing this information will allow the assessor(s) to come to the facility well prepared and ready to provide a comprehensive and efficient assessment.

Assessment
The Lead/Sole Assessor will contact the accreditation contact within ten days of receipt of the pre-assessment materials to schedule a mutually agreeable date for the assessment.

• On the day of the assessment, the Team or Sole Assessor will meet with staff and explain the scope and objectives of the assessment, the process and the schedule for assessing the facility, and the timeline for receiving accreditation.
• Upon completion of the assessment, the Team/Sole Assessor will meet with staff to discuss the findings and leave a summary report. This report will identify nonconformances with references to requirements, and will serve as the only communication identifying the items found during the assessment. The due date for response to nonconformances will be included in the summary report.
• The facility is required to respond to all items listed as nonconformances. A follow-up letter will be provided that will confirm the timetable for submission of the corrective/preventive action plan. Upon submission of the plan for corrective or preventive action, the documents will be reviewed and a decision will be made for granting accreditation. If nonconformances have been identified that may directly impact patient care, evidence of implementation of the corrective action plan must be submitted before a certificate of accreditation is issued.

Ongoing Assistance
Assistance continues throughout the two-year accreditation period. Assessors and National Office staff are available to answer questions and offer guidance to you and your staff. Information is also available on the AABB Web site.

A Commitment From Your Professional Association
We believe that this program is one of the best vehicles to help facilities maintain conformance with federal and state regulations and ensure the safest products and services.
 
If you have any questions, please contact the Accreditation Department at accreditation@aabb.org