Quality Systems FAQs
How long has AlloSource been in the tissue banking industry?
AlloSource is a nonprofit organization founded in 1994 to honor and respect the gift of human tissue donation by responsibly developing, processing and distributing life-saving and life-enhancing allografts for our communities.
Are there multiple manufacturing sites?
AlloSource has only one manufacturing site located in Centennial, Colorado.
What is the approximate square footage of the facility (excluding warehouse)?
The Centennial, CO Campus Headquarters is approximately 102,611 square feet.
How many employees does AlloSource have?
Currently, there are approximately 400 employees engaged in fulfilling the AlloSource mission through multi-shift, 365-day processing to the highest quality and service standards.
What is the evidence attesting to the quality of AlloSource?
AlloSource has an unparalleled safety record and there has never been a confirmed adverse event tied back to the use of AlloSource tissue.
- AlloSource is registered with the United States Food and Drug Administration (FDA) and is compliant with all applicable quality requirements, including:
— 21 CFR Part 1270, Human Tissue Intended for Transplantation
— 21 CFR Part 1271, Human Cells, Tissues & Cellular and Tissue Based Products
— 21 CFR Part 820, Quality System Regulation
- AlloSource is accredited by the American Association of Tissue Banks (AATB) and is compliant with AATB Standards for tissue banking and with all applicable state regulations and voluntary guidelines as required.
- Tissue received by AlloSource is recovered by AATB accredited OPOs and follows all testing requirements of the AATB and FDA.
- AlloSource is licensed by and compliant with current Clinical Laboratory Improvement Amendments (CLIA) standards.
- AlloSource is registered by an accredited body and compliant with Quality Management Systems requirements of:
— ISO 9001:2008
— ISO 13485:2003
- Our staff holds a variety of certifications including: Certified Tissue Banking Specialist (CTBS), CBSPD (for sterile processing), RAC (Regulatory Affairs), CPIM (supply chain certification through APICS), OSHA certifications, EMT, Paramedic, and RN.
Is AlloSource registered with the FDA? ISO?
Yes, all registrations, certifications, and licenses including FDA registration are available on our Certificates and Licenses page.
Is AlloSource accredited by the American Association of Tissue Banks (AATB)? If so, in what areas is AlloSource accredited?
AlloSource maintains compliance with AATB Standards for Processing, Storage, and Distribution of Skin Cardiac, and Musculoskeletal Tissue for Transplantation and/or Education/Research.
Specifically, AlloSource is accredited by AATB for Processing, Storage and Distribution of Amniotic Membrane, Cardiac, Skin and Musculoskeletal Tissue, and Processing of Adipose Tissue for Transplantation and/or Education/Research.
Does AlloSource perform tissue recovery? From how many donors does AlloSource recover tissue annually?
AlloSource does not perform recovery activities. While other tissue processors simply contract with recovery Organ Procurement Organizations (OPOs), AlloSource’s OPOs are true partners, working collaboratively with each other and AlloSource to maximize tissue donation and its benefits to their local communities.
How is the donor tissue recovered? Are consistent medical and social screening and selection criteria applied to all donors? Under what types of controlled conditions does recovery occur?
AlloSource does not perform any recovery activities.
- Tissue received by AlloSource is recovered by partner OPOs and follows all testing requirements of the AATB and FDA.
- The donor selection criteria used by AlloSource OPO’s are audited periodically by AlloSource as required by AATB.
- All recovery is performed using aseptic processes and AATB accepted practices.
Where is the donor tissue recovered, domestically or outside the US?
AlloSource OPOs are all located within the United States.
What is the donor selection criterion with respect to criteria that may negatively affect tissue safety and quality? Does AlloSource ever accept a deferred donor or donors previously rejected by one or more other tissue banks?
Donor Selection criteria can differ between recovery agencies and can vary by product and customer as allowed by the regulations. All AlloSource donors must meet AlloSource Acceptance Criteria.
AlloSource makes the commitment to never compromise integrity for gain and expediency. Doing things The AlloSource Way means driving our decisions from a philosophy of respecting our donors, understanding the needs of our doctors, and providing the best tissue for our recipients. Our filter of integrity means our commitment is working with our customers to do it right, not just get it done, so we can Do More With Life.
Who performs the laboratory tests on which donor eligibility is based?
Before tissue is processed, serological and microbial testing samples are taken. Tissue must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from processing or transplantation. Communicable disease testing for each donor is performed by a laboratory registered with FDA and certified to perform such testing on human tissue in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493. AlloSource maintains all testing records, which include, but are not limited to:
- Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
- Human Immunodeficiency Virus Type 1 (HIV-1 NAT)
- Antibody to Hepatitis C (HCV)
- Hepatitis C Virus (HCV NAT)
- Hepatitis B Core IgG/IgM Antibody (HBcAb)
- Hepatitis B Surface Antigen (HBsAg)
- Rapid Plasma Reagin or Serologic Test For Syphilis (RPR or STS)
A list of additional communicable disease tests performed is provided upon request.
What processes/activities does AlloSource subcontract out?
Recovery, sterilization, and document storage are provided by AlloSource approved suppliers. In addition, some laboratory services, preventative maintenance, and calibration services may be subcontracted. Subcontracted processes are audited as part of the AlloSource Supplier Quality program.
Who makes the final decision on donor tissue acceptance and release? What is this person’s background?
Donor eligibility determination is ultimately made by the AlloSource Medical Director in accordance with applicable requirements.
Dr. Ross Wilkins currently serves as the Senior Medical Director for AlloSource, Chairman of AlloSource’s Medical Advisory Board and recently had the new campus headquarters named after him. Recognized internationally as an expert on limb preservation, bone and soft tissue tumors and bone transplantation, Dr. Wilkins serves as an Orthopedic Surgeon for Colorado Limb Consultants, Medical Director for The Denver Clinic for Extremities at Risk, Chairman and Founder of The Limb Preservation Foundation and Faculty Member at the Colorado State University Animal Cancer Center.
Dr. Wilkins has been honored with a number of distinguished awards including Denver Business Journal’s Lifetime Champion in Healthcare (2007), Top Doctors in Denver, Orthopedic Surgery (2007), America’s Best Doctors (2006-2013), Orthopedic Oncology (2006-2013), George W. Hyatt Memorial Award (1999), Edward C. Stafne Humanities in Medicine Award (1996), Best Doctors in America – Orthopedic Oncology (1994-2013), Member of Honor, Romanian Academy of Medical Sciences (1994) and U.S. News and World Reports Top 1% Orthopedic Surgeons.
What types of tissue does AlloSource process?
Using the gift of cardiac tissues, musculoskeletal tissues, osteoarticuar, and skin, AlloSource responsibly processes more than 200 types of precise bone, skin, soft-tissue and custom-machined allografts for use in an array of life-saving and life-enhancing medical procedures. Also, in order to ensure AlloSource staff stay current on surgical procedures and special surgical needs, our committed technicians interact often with the surgeons who transplant the tissue.
Can AlloSource allograft tissue be traced to the specific donor?
AlloSource employs the use of identifying numbers by which the allograft can be traced to a specific donor. Each donor is assigned a unique AlloSource Donor ID, along with a three or four digit lot number to differentiate each graft.
How is tissue processing performed?
All donor tissue that arrives at AlloSource has unique characteristics. Tissue processing is therefore individualized by design and starts with intense, dedicated visual and physical inspection of each tissue.
Our specialized, highly trained technicians closely inspect traditional tissue in preparation for our proprietary cleansing process, AlloTrue™, and ensure the tissue is treated with the highest quality processes from start to finish.
Prior to processing, all potential tissue donors undergo a comprehensive screening that includes a physical assessment, medical history and social risk review. Tissue is then recovered and tests are performed on blood and tissue samples to screen for disease and bacterial infection. Testing required by the FDA and AATB includes screens for HIV, Hepatitis B and C, and syphilis.
Is processing performed strictly aseptically, or are terminal sterilization methods used? If terminal sterilization methods are used, what type is used, and what is the level of irradiation?
Tissue processing is performed aseptically. Depending on the final product it may be:
- Disinfected and aseptically packaged, or
- Terminally sterilized where the type and level of sterilant were determined via a validation. Products in a sterile configuration conform to ANSI/AMI/ISO 11137-2:2006.
Does AlloSource have a validation process for package sterility?
HCT/P’s labeled as sterile have been sterilized using a validated method with a sterility assurance level (SAL) of 10-6.
If water is used in the manufacturing process, what quality standard applies?
USP Sterile water is used where it is called for in manufacturing. Otherwise aseptic processing uses a validated High Purity Water System which meets the requirements of Standard Methods for Drinking Water, and U.S. Pharmacopeia 36.
What solutions are used in the processing of soft tissue grafts?
Most current information for processing reagent(s), preservation and storage details can be found on the specific product Package Insert and/or final product label.
Are there MSDS sheets for AlloSource products?
No, please reference specific product package inserts for product details.
Do AlloSource demineralized bone allografts possess any osteoinductive potential?
Orthobiologic products offered by AlloSource such as AlloFuse and AlloFlex do have osteoconductive and osetoinductive properties. For a full list of products, please visit our Orthobiologics page.
What is the percentage of residual calcium levels in AlloSource demineralized bone products?
Residual calcium levels meet AATB Standards requirements of < 8% by a standard method or customer expectations.
Are shipping container validations available for review?
Each of the containers used for transporting AlloSource allografts have been validated for temperature control and durability. The validations include calculation of sublimation rates, which are used to determine the expiration time of the transport container based on the amount of dry ice or wet ice placed in the container. These transport expiration times are posted on the shipping label on the outside of the container.
What is the shelf life of the package?
Please refer to the final product package label and product package insert/directions for use, storage conditions, and expiration date. Do not use if the expiration date has been exceeded or if there is evidence of defects in package or label integrity. Graft packaging should be checked at the time of receipt to ensure all seals are intact and that no damage to the packaging materials has occurred.
Does AlloSource have a documented procedure for handling issues or complaints passed on from the customer? Does the organization/facility have a formal training program for all employees, and are training records maintained? Does the organization/facility have documented procedures for conducting internal audits?
AlloSource takes great pride in being an industry leader in regulatory compliance. As one of the nation’s largest non-profit providers of bone, skin and soft tissue allografts, AlloSource maintains a Quality Assurance program which includes complaint handling, training, audits, and record retention all in compliance with applicable federal and state regulations, as well as voluntary standards. We not only support regulation, but we also work closely with the FDA to continuously improve industry guidelines.
Does AlloSource provide copies of all current standard operating procedures?
It is AlloSource policy not to distribute internal procedures; however, policies and procedures will be provided and may be reviewed and evaluated during on-site audits.
What is the AlloSource’s document retention policy?
Record retention may vary depending on the type of record; however, all retention requirements meet 21 CFR Part 1271 and 21 CFR Part 820 as well as ISO 13485 regulatory requirements.