Quality Commitment

As a founding principle of our business, Insception Lifebank continues to embrace Quality in everything that we do. In line with our company’s vision statement; we are committed to the highest level of quality to deliver the highest value to our customers.

Our continued focus on quality innovation, new services and newer technologies allows us to offer our clients a premier cord blood and cord tissue banking service. Our commitment to our quality culture is the cornerstone of our success.

Our Laboratory and storage facilities continue to meet rigorous health care and safety requirements set by Canadian and International Regulatory Agencies and Accreditation programs. We are committed to providing a quality of service to our clients to assure that their cord blood and cord tissue is safely stored for future use.

Our Quality Management System is regularly assessed by regulatory agencies and accreditation programs. For more information, please see copies of our current Registrations and Accreditations available below.

Insception Lifebank Accreditations:

1. AABB accreditation
2. FACT accreditation

Insception Lifebank Registrations:

1. Health Canada CTO 100042

Quality Management System

Insception Lifebank interacts with a diverse customer base including Parents, Family Physicians, Obstetricians, Gynecologists, Nurses, Midwives as well as clinical trial sponsors and Cord Blood transplant facilities. As Canada’s #1 Cord Blood Program, we have a dynamic Quality Management System designed to ensure all key relationships are protected and served under the highest quality of care.

Integral to Insception Lifebank’s operation is our Quality Management System. The Quality Management System is based on 10 quality System Essentials developed by ISO (International Organization for Standardization) and comprises of the following elements:

• Executive Management strategic review and planning
• Staff Qualification, Training and Competency Assessment Program
• Equipment Management Program for Control, Calibration and Validation of Critical Equipment
• Quality Agreements with all our Suppliers and Service Providers
• Quality Assurance and Quality Control to ensure accuracy, precision and traceability of our processes
• Document and Records Management Program
• Incident and Error Reporting Systems
• External and Internal Audit Program
• Customer Focus and Continuous Quality Improvement Initiatives
• Workplace Health & Safety Commitment

In addition to the above standards requirements, we incorporate recommended practices set by Clinical Laboratory Standards Institute (CLSI) and Society for Obstetricians and Gynecologists Ontario (SOGC) into our Quality Management System.

Accreditation and Regulation

As an internationally recognized Cord Blood Program we meet the following Standards and Regulatory requirements:

AABB

Our Cord Blood Program is AABB Accredited and has maintained Accreditation status since August 2006. We are assessed every 2 years against the current edition of the AABB Standards for Cellular Therapy Products and Services
https://www.aabb.org

Netcord FACT (Foundation for the Accreditation of Cellular Therapy)

Our Cord Blood Program has been accredited with FACT since April 2012. We are inspected every three years for compliance to the current edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking and release for Administration
http://www.factwebsite.org/

Health Canada

We are regulated by Health Canada and our facilities are inspected every three years for compliance to the “Safety Requirements for Cells, Tissues and Organs for Transplantation’ (CTO) Regulations. Our most recent inspection was in March 2017 and we have a compliant rating.
https://www.hc-sc.gc.ca/index-eng.php

FDA

We maintain Tissue Establishment Registration with FDA and meet applicable FDA current Good Tissue Practice regulations (21 CFR 1271). Tissue establishment registration facilitates an FDA inspection program of US and International Cord Blood banks.
https://www.fda.gov/ucm2006018.htm

Conferences and Exhibits

Each year Insception Lifebank is represented at international cord blood and cell therapy conferences. We are a strong advocate for Cord blood stem cell banking globally and we continue to invest resources to be involved at various levels and contribute to these scientific conferences. Attendance provides valuable opportunities to gain knowledge and share best practices with industry. These advancements in quality practices and new technologies can be incorporated, and ultimately provide a premium service for our clients.

• AABB Annual Meeting
• ISCT Annual Meeting
• International Cord Blood Symposium
• World Cord Blood Congress

Staff Inspectors and Assessors

Insception is proud to have 3 certified AABB Assessors as part of our Laboratory and Quality team. Harnessing this unique level of expertise in the development of our Laboratory, Quality, and Technical policies and methods further demonstrates our commitment to quality.

Recent Quality Accomplishments

March 2022 – Successful Accreditation renewal with AABB
July 2020 – Health Canada Inspection – Compliant
July 2020 – Successful Accreditation renewal with AABB
Aug 2019 – Successful Accreditation renewal with Netcord FACT
July 2018 – ISBT 128 Labeling Compliance
June 2018 – Launch of Cord Blood Collection Tutorial/Video
May 2018 – Successful Accreditation renewal with AABB
Jan 2017 – Health Canada Inspection – Compliant
Jan 2016 – Successful Accreditation renewal with AABB
Oct 2015 – Successful Accreditation renewal with Netcord FACT
March 2015 – Netcord FACT Accreditation Renewal Inspection
July 2014 – Integrated New Cord Blood Tissue Processing Laboratory to Quality Management System
March 2014 –Health Canada CTO Inspection – Compliant rating
Jan 2014 – Successful Accreditation renewal with AABB
Sep 2012 – Quality Acquisition Lifebank Cord Blood Bank, Burnaby BC
May 2012 – Awarded Initial Netcord FACT Accreditation