Supervisor, Donor Records

Position Summary 

This position is primarily responsible for managing the collection, assignment, review, and completion of incoming birth tissue donor charts and records necessary to manufacture BioTissue products, or to allocate donor gifts. The Manager is responsible for receipt, tracking, and monitoring all TAP, ESP, and Sharing Miracles donor charts for completion through the lifecycle of the donation process in the electronic donor management system. The position has a significant effect on manufacturing operations, quality functions, and relationships with acquisition partners and donor allocation partners.

Oversees the day-to-day oversight of the donor eligibility review and chart assignment process and has direct oversight of Contractor Donor Assessment Coordinators performing review of donor charts. Monitors individual performance of those Contractor Donor Assessment Coordinators, including their first pass yield, provides support when needed, and maintains department goals, metrics, and scorecards. Hires and onboards new Contractor Donor Assessment Coordinators. Works closely with the Manager of Donor Eligibility and Logistics and Medical Directors for donor and tissue suitability guidance based on BioTissue’s exclusionary criteria, AATB and FDA standards, and other regulatory bodies.

Reviews Contractor Donor Assessment Coordinator’s AI requests and communicates those needed to complete donor charts and determine suitability. Updates case statuses and tracks completion of records to ensure efficient turnaround time for records to quality.  Communicates clearly and effectively with Tissue Partners for understanding of requirements. Maintains and tracks new and pending requests.

Facilitates verification of training in conjunction with Quality related to Tissue Procurement, Donor Eligibility.

Works closely with Sharing Miracles Donation Coordinator to monitor and assess completion of required documentation of donor charts for completeness and accuracy. Assigns tasks as necessary and provides feedback to Manager of Acquisition Operations for performance and metrics, including first pass yield.

Essential Duties & Responsibilities 

• Strong skillset in quality chart review, good documentation practices, AATB, and FDA standards are required, as well as excellent interpersonal and communication skills.
• Manages the electronic donor management system for completeness of each individual record with tracking and visibility for competition or routing with task assignment for outstanding items or necessary corrections. Collaborates with Tissue Procurement Management for system enhancements, customizations and serves as a SME for the electronic donor management system and backup administrator as needed.
• Primary liaison for hospital and physician offices medical records. Builds and maintains relationships with HIM and facilitates necessary credentialing. Serves as the lead for EMR access and records management for hospitals and birth centers directly contracted with Sharing Miracles. Troubleshoot, problem solve and escalate as needed in order to ensure chart receipt for the determination of donor eligibility.
• Monitors quality trends between Sharing Miracles, TAPs, and ESPs for requests for additional information (AI), chart correction turnaround time, and chart submission turnaround time. 
• Identifies non-conformances and communicates errors or issues to Tissue Procurement Management. Provides feedback to Supplier Quality to support investigations.
• Pulls, upload, and tracks charts for donor allocation partners (DAP) for review and acceptance.  Provides remote and onsite support and communicates to the Lead, Logistics and Inventory Control position to support donor optimization. 
• Interacts with Medical Directors as needed to support operations. Provides MD assignments for DE review and monitors monthly review quotas and turnaround time for completion.
• Manages the chart review process to maintain timely completion of all required fields and accuracy and completion of all required chart components, and adherence to BioTissue, AATB and FDA exclusionary criteria.
• Collaborates with the Manager of Donor Eligibility and Logistics for any changes and updates to the BioTissue exclusionary criteria under the Medical Advisory Committee, or changes of standards set forth by applicable regulatory bodies. Meets deadlines to update procedures in the company QMS and support staff training to maintain compliance.
• Collaborates with the Manager of Donor Eligibility and Logistics and Lead, Logistics and Inventory Control to communicate quarterly performance metrics to acquisition partners. Compiles performance data for internal procurement through Sharing Miracles for chart submission turnaround time and corrections to ensure efficiencies in operations and identify areas of needed improvement.
• Monitors laboratory results and requests corrections when needed from the laboratory.  Responds to laboratory SSR’s to ensure sample suitability and timely processing of samples. Supports and communicates to Tissue Procurement Management regarding non-conformances and errors resulting in non-payment for lab services.
• Collaborates with the Lead, Logistics and Inventory Control position to provide details surrounding donor rejections for reimbursement.
• Provides the review and approval of Independent Contractor, MD, and Laboratory Invoices. Serves as back up to the Lead, Logistics and Inventory Control for the review and approval of other departmental invoices.
• Operates with the highest level of integrity and ethical performance. 
• The incumbent is expected to be present at BioTissue locations, where needed.

May require domestic travel up to 15% of the time. 

Skills & Abilities

• Time Management
• Knowledge of good documentation practices (GDP)
• Interpersonal Communication
• Teamwork
• Strong Training Capabilities
• Adaptability
• Communication Skills
• Conflict Resolution
• Problem Solving
• Active Listening
• Detail oriented
• Organization
• Analytical Skills
• Emotional Intelligence
• Strong Work Ethic

Position Expertise/Qualifications 

• Requires 5-8 years of related Tissue Banking experience
• Bachelor’s Degree Preferred
• Current CTBS Certification

Physical Requirements

• Sedentary work that generally requires sitting and/or standing
• The incumbent is expected to be present at BioTissue locations, where needed.