LiveOnNY is looking to ensure compliance with all applicable accreditation, certification, and federal, state, and local regulatory requirements for organ and tissue donor records. The Clinical Quality Assurance Coordinator will uphold the highest standards of quality and regulatory adherence, improving organ and tissue donation outcomes.
Requirements
- 1 yr experience working in a healthcare, medical, or regulatory environment and 1 yr clinical experience in Organ/Tissue Recovery, Hospital, Eye Bank, Tissue Bank or a government health/medical agency is required.
- 2 yrs experience as a Organ and/or Tissue Donor, Evaluation, or Transplant Coordinator at an Organ Procurement Organization is also preferred.
- RN licensure OR CTBS, CPTC, CPHQ, or ASQ-certified.
- 5+ years QA experience in Organ/Tissue donation/transplantation can be substituted for licensure or certification.
Responsibilities
- conducting comprehensive clinical reviews of organ and tissue donor records to ensure compliance with all applicable accreditation, certification, and federal, state, and local regulatory requirements.
- supporting the Quality Assurance management team with tasks related to OPTN reporting requirements, preparation of weekly OPO data reports, quality-related education and training initiatives, policy review and updates, and audit preparation, contributing to the overall effectiveness and compliance of LiveOnNY’s quality systems.
- Responsible for complete and accurate review of the donor and non-donor records according to policy, protocol, and guidelines.
- Timely and accurate access and receipt of donor medical records from hospitals, external entities and data submission to regulatory agencies.
- Assigns and escalates tasks for donor record corrections to the appropriate departments and personnel.
- Obtains, shares, and responds to positive culture and serology results in compliance with organizational policies and applicable federal, state, and local laws, as well as regulatory and accreditation requirements (e.g., FDA, NYDOH, OPTN, CMS).
- Ensures accurate and consistent data submission, including timely reporting to LiveOnNY’s designated Patient Safety Contact as required
Other
- Must be able to work rotating holiday and/or weekends as needed.
- Abides by data review & documentation policies & procedures, including escalation timelines for data access, receipt, correction, and hand-off.
- Provides accurate and timely post-recovery follow-up with organizational partners to coordinate compliance with access, review, and information sharing.
- Provides relevant information & timelines for Quality-related Occurrences as needed.
- As an employee of LiveOnNY, consistently demonstrates respectful, professional, and inclusive conduct towards colleagues, hospitals, vendors, community partners and our donor and recipient families.
