Achieve full compliance for your tissue & implant management program
The best way to achieve comprehensive regulatory compliance, reduce risk to your organization and most important, provide the utmost in patient safety, is to combine Champion Medical Technologies Regulatory Compliance Consulting Services with GraftTracker® and UDITracker®.
We are highly experienced and knowledgeable in working with clients to provide tissue and implant consulting services. We work with private, military, state and federal government hospitals, tissue banks, blood banks and surgery centers to help them establish and implement process efficiencies and proficient workflows that meet and exceed the requirements for regulatory compliance.
Do you meet the requirements for Joint Commission, DNV, HFAP & FDA?
It’s not an easy task keeping up with current changes and new requirements. If your facility doesn’t meet regulatory standards, it can cost you time and money and most important it can compromise your greatest goal, patient safety. We will perform a comprehensive review of your current tissue/implant program(s) to determine if you are meeting the requirements and give you the tools and information you need to fulfill the expectation of the regulatory agencies and establish best practices.
Human tissue and implant best practices may include:
- Meeting the Joint Commission Tissue Safety Standards
- Tracking and tracing biologic products
- Understanding what products fall under scrutiny, and which should be tracked as a best practice.
- Understanding the recommendations and establishing better relationship with your product suppliers
- Examining what products are most used and which are wasted; this is a loss of the Gift of donation.
Do you have comprehensive SOPs to support your workflow?
Your tissue and implant tracking success is only as strong as your process. We’ll work with your organization to review your current policies and procedures. Don’t have any procedures in place? Don’t worry, we’ll work with you to write them and establish a cohesive workflow based on those SOPs. Once implemented, we are confident that will provide you with a thorough tissue/implant process that guarantees success.
Policy, procedure and SOP services include:
- Review of current policies
- Recommendations for changes, additions or improvement
- Recommendations for process improvements
- Assistance with vendor qualifications
Are you prepared for your next Joint Commission review?
A Joint Commission survey can be daunting. We can help you prepare for your next assessment by going through a mock audit of your existing tissue/implant management program.
Mock survey includes:
- Onsite review by a Certified Tissue Banking Specialist
- Assessment of your compliance with Joint Commission standards and elements of performance
- The mock survey activities can be designed to mirror your anticipated Joint Commission agenda and survey.
- Identification in a written report of non-compliant elements or processes in need of improvement;
- Instruction and recommendations on how to make necessary changes to come into compliance;
- Review off-site or on-site policies for compliance with Joint Commission standards.