Commitment to Quality & Compliance
At Clear Health Pass Woundcare, our unwavering commitment to quality and compliance is the foundation of everything we do. We ensure that every product and service we deliver meets the highest safety, ethical, and regulatory standards, from tissue acquisition to clinical application. Our goal is to provide medical professionals with the most advanced wound care solutions, backed by rigorous quality control, a fully vetted medical network, and ongoing support. Here’s how we achieve this:
Responsible Sourcing and Tissue Acquisition
We begin with ethically sourced amniotic tissue from consenting donors, exclusively from scheduled cesarean sections. Every donation is carefully screened with comprehensive medical histories, ensuring the highest levels of safety and compliance with federal regulations, including FDA guidelines and AATB® standards. This voluntary donation process is conducted under strict ethical guidelines, guaranteeing the safety and integrity of each tissue graft.
Processing and Sterilization for Safety
Once sourced, the tissues undergo a multi-step, rigorous cleaning and sterilization process to eliminate contaminants. Using FDA-approved methods, each batch is meticulously tested for sterility, integrity, and functionality to ensure patient safety. Processing takes place in highly controlled environments, adhering to ISO 6 standards or higher, to guarantee a sterile and safe product for medical application.
Manufacturing and Quality Control
Our amniotic tissue grafts are manufactured under strict compliance with FDA regulations and the American Association of Tissue Banks (AATB®) standards. We follow Good Manufacturing Practices (GMP) to deliver products of consistent quality. Every step of the manufacturing process is closely monitored to ensure that the highest standards are met, allowing us to deliver high-performance tissue grafts that healthcare professionals can rely on.
Physician Application for Skin Grafts
Our amniotic tissue graft products are designed for ease of use including physician offices, clinical and hospital settings and more. They require minimal preparation, offer up to five years of shelf life, and are simple to store and apply. Most applications can be completed in under 15 minutes, without the need for sutures, making them efficient and practical for a wide range of wound care treatments.
Ongoing Physician Support
We are dedicated to supporting physicians beyond the product. Our team provides regular training, education, and hands-on support to ensure healthcare professionals are fully equipped to use our products effectively. Additionally, our billing experts are available to assist clinicians in navigating the complexities of reimbursement and coverage, making the integration of amniotic tissue grafts into their practice seamless.
Leadership in Innovation and Thought
As a Tribal Economic Development Corporation, Clear Health Pass Woundcare is committed to advancing the field of wound care through partnerships with leading researchers, manufacturers, and governmental agencies. We continually innovate to improve wound care technologies and expand access to cutting-edge treatments for underserved communities, ensuring that our products lead the industry in quality and effectiveness.
Vetting and Care in Selecting Medical Professionals
All medical professionals that are part of our Referral or Professional Service Program undergo a thorough vetting process to ensure they meet the highest professional and ethical standards. Each physician or healthcare provider in our network is rigorously evaluated, with a comprehensive review of their credentials, licensure, board certifications, and background. This includes:
- Verification of medical licenses and board certifications.
- Review of professional history, including any disciplinary actions, malpractice claims, or sanctions.
- Ongoing monitoring to ensure continued compliance with industry standards and regulations.
We take great care to ensure that every provider we partner with adheres to our commitment to quality and patient care, ensuring that patients receive the best possible treatments from qualified and trusted professionals. This diligence reflects our belief in building a network of providers who share our vision of compassionate, high-quality care.
Regulatory Compliance and Oversight
Every product and service we offer adheres to stringent regulatory guidelines, including FDA oversight and compliance with relevant federal and state laws. We maintain a robust quality management system that ensures all our products meet or exceed regulatory requirements, ensuring safe and effective outcomes for patients. Regular audits and continuous improvement initiatives ensure that we stay at the forefront of compliance in the rapidly evolving healthcare industry.
At Clear Health Pass Woundcare, we are proud of our rigorous standards and the trust that healthcare professionals and patients place in our products and network. Through our commitment to quality, compliance, and a fully vetted network of medical professionals, we ensure that every patient receives the best possible care, supported by the highest standards in safety, reliability, and innovation.