The QA Review Specialist will be responsible for assuring that standards for division specific activities related to tissue/organ recovery have been met thereby ensuring the safety and quality of organs and tissues recovered. Specific areas of responsibility include but are not limited to review of donor charts, facilitate the collection and completion of relevant medical records needed to assist in the determination of suitability, participate in audits to ensure compliance with SOP's and regulatory standards, maintenance of environmental monitoring records, assist in training of recovery staff and assist in the collection of data.RESPONSIBILITIES
- Assist as directed in regard to all aspects of division specific tissue/organ activity and quality review projects.
- Perform audits of division specific activities as they relate to tissue screening, authorization, recovery and documentation to ensure compliance with all governing organizations and SOP's: including but not limited to: donor charts, cleaning and disinfection logs, donor logs, supply receipts and inspection and training records.
- Facilitate obtaining relevant medical records needed to determine donor eligibility as requested by the QA department.
- Maintain frequent communication with the Administration, Family Services Program and Recovery Services Departments to coordinate follow up communication with donor families as requested by the Tissue Bank.
- Establish and maintain frequent and effective communication with the QA Recovery Review Department at LifeLink Tissue Bank.
- Develop and maintain relationships with donor Hospitals, Medical Examiners/Coroners, Eyebanks, Police Departments and Emergency Medical Services to ensure timely acquisition of donor information.
- Assists with the maintenance and development of the Standard Operating Procedures for specific division related operations.
- In conjunction with the Tissue Bank, assist with education and the communication of policies and protocols to the staff - ensuring and maintaining up-to-date training records.
- Assists with inspections from governing organizations to include the FDA, AATB, State agencies and other processing organizations.
- Provides an ongoing resource to Recovery Supervisors in the development, review, and implementation of training and educational programs.
- Remains informed of developments in quality and regulatory issues as they relate to tissue banking through literature, attending seminars and/or conferences and disseminating such information to staff.
- Schedules and maintains the proper documentation for all repair, maintenance, validation and calibration of equipment utilized for tissue recovery at each division.
- Participate in meetings and prepare data for review as requested.
- Works in conjunction with the Organ QC Coordinator and Tissue QA Coordinator to ensure cross- coverage for each department in the area of medical records, charting and QA as needed.
- Assists with entry of data into iTransplant.
- Participates in ongoing performance improvement initiatives.
- Track outstanding information required to close charts for final sign-off within deadlines and in conjunction with the Manager, establish standard practices for obtaining required information.
- Follow up tissue procurement activities to identify and report variances according applicable protocols.
- Perform purchases inspection in order to release supplies for use.
REQUIREMENTS
- Bachelor's degree preferred, degree in an Allied Science (RN, LPN, ORT, EMT, CST) and/or experience in a health related background highly desired.
- Ability to review and identify relevant medical records needed for the determination of donor suitability.
- Strong communication and writing skills.
- Mental ability to prepare and audit records as they relate to all procedures.
- Knowledge of the regulatory and quality standards established by the FDA and the American Association of Tissue Banks desirable.
- Mental ability and visual acuity necessary to identify breaches of policy as they relate to all procedures.
- Knowledge of all tissue banking procedures to include: sterile technique, procurement, processing, storage and distribution desirable.