RN Biological Implant Coordinator
Apply NowCompany: Bayhealth
Location: Dover, DE 19901
Description:
If you care about the opportunity to grow, to make a difference, to build a future and a life, then we just might have the career for you. Care to talk?
Bayhealth Medical Center is Central and Southern Delaware's healthcare leader with hospitals in Dover and Milford, as well as stand-alone Emergency Department in Smyrna and a hybrid Emergency Department and Urgent Care in Milton. We offer various practice settings throughout Kent and Sussex Counties. Bayhealth Medical Center Kent Campus is 90 minutes from Philadelphia, Washington, DC and Baltimore. Our Sussex Campus is 30 minutes to the Delaware beaches and relaxation in the sand!
Bayhealth Medical Center offers a competitive salary and comprehensive benefits package (for eligible positions) including:
Location: Kent Campus Hospital
Status: Full Time 80 Hours
Shift: Days
SALARY RANGE: 77,105.60 - 119,537.60YEARLY
General Summary:
The RN Biological Implant Coordinator is responsible for providing competent, evidenced-based care to assigned patients. The RN will spearheading the Bayhealth Medical Center Biological Implant Program, including planning, assessing, developing, implementing, and evaluating the Implant Program throughout the organization, The Implant coordinator will coordinate acquiring, receiving, storing, issuing, and tracking biological implants, and responding for product recalls. The biological implant coordinator is responsible for providers requests and ensures customer satisfaction which reflects and understanding of implants and tissue process. Coordinating all aspects for implant management by working with resource management, Prosthetic and sensory aid services as needed, sterile processing and contracting and other clinical areas using implants.
Ensures compliance with all applicable regulations regarding tissue procured for implantation. Develops and maintains a quality management plan so that all policies, procedures, and records pertaining to tissue comply with relevant regulatory standards. Design quality assurance audits, review quality control results, and ensure that deviation and adverse events are reported as required.
Responsibilities:
1. Ensures compliance with all applicable FDA regulations and JC standards related to Biological Implants. Maintains current understanding of all regulatory standards and applicable laws.
2. Develop and maintain a quality management plan. Responsible for participation in departmental and hospital programs for Quality Assessment and Improvement, identifying opportunities to improve services, making recommendations, and implementing actions as appropriate and consistent with the goals of Bayhealth. Responsible party for originating, reviewing, and updating all policies and procedures related to biological implants.
3. Coordinates meetings related to the implant program, prepares agendas and minutes, provides reports, and participates in meetings as assigned.
4. Reconciliation of implants used which may be BH owned inventory and vendor consignment stock. Coordinates with all applicable services to ensure implant availability, input of consults, replacement of used stock and payments for used stock.
5. Reviews audits from all locations, including documentation in patients' EMR, dual audits with UDI; investigates discrepancies, provides guidance and education and files variances as appropriate.
6. Serves as contact/resource person for any questions related to biological implants/policies/processes. Will act as a liaison between all departments and all sites involved in the Biological Implant program at Bayhealth. Verify and assist with training/competency of individuals involved in all process steps at all sites. Serves as liaison with internal and external regulatory agencies for the Implant and Tissue Program.
7. Ensure all implants are stored at the proper temperature; review temperature logs of all storage locations; perform quarterly alarm checks and maintenance. Regularly monitor stock that has expirations to ensure that supplies are current and up to date. Document the final disposition of expired products. Assist with any communications/follow-ups for variances/recalls/safety events. Coordinate any recalls or implant failures with Materials Management, Risk Management, and Infection Prevention. Evaluates patient EMR documentation of implants for accuracy of use, medication used for rinsing compliance and errors.
8. Coordinates with Resource Management to ensure all supply and requisitions are processed in an accurate and timely manner. Communicates about any issues with procurement, handling, condition, or delivery of products. Ensures vendor qualification is current and all required licenses are up to date.
9. Reconcile the OR Implant inventory daily to ensure all implants are accounted for.
10. Keeps current with research to provide evidence-based care and leadership on the Implant and Tissue program. Collaborates with other departments to improve processes. Develops and assists with staff education regarding tissue/implant program.
11. Ensures compliance with manufacturer's Information for Use (IFU)/guidelines for tissue preparation, ensuring availability and proper long-term documentation of IFU. Ensures that documents relating to source facility, original numeric or alphanumeric and lot identification, expiration dates, and all recipients are retained for a minimum of ten years as required by Title 21 Code of Federal Regulations 12.70.35 from the date of distribution, transplantation, disposition or expiration of tissue.
12. Initiates and completes incident report via Joint Patient Safety Reporting (JPSR) and Adverse Drug Event (ADE) relating to post-transplant infections or adverse events.
13. Collaborates with clinical staff to coordinate requests for equipment, supplies, and implants and makes recommendations when potential conflicts are identified. Contact vendors and surgeons' offices as needed. Coordinates and elevates requests for new procedures and implants to the Value Analysis Committee.
14. For assigned service(s), performs 100% daily audits on nursing documentation for all tissue and FDA-trackable implants, when used, to ensure complete and accurate entry into the tissue tracking software.
15. Meets regulatory agencies, JACHO,DHEC and FDA, requirements for the tracking of these products using unique device identifiers throughout their inventory distribution processes- from receipt to use on the patient. Reports compliance monthly and annually to the appropriate committee(s).
16. RN Implant coordinator, OR trained RN can support education, EMR intraoperative documentation and training in real time as needed.
17. Member of Value Analysis team - recommendation for cost savings and product quality metrics
18. Makes assessment and provides feedback in the event of risk to the integrity of the tissue tracking process, Creates and executes an interprofessional plan to reduce risk and / or correct process aberrancies.
19. All other duties assigned within the scope and range of job responsibilities.
Required Education, Credential(s) and Experience:
Preferred Education, Credential(s) and Experience:
To view a full list of all open position at Bayhealth, please visit:
https://apply.bayhealth.org/join/
Bayhealth Medical Center is Central and Southern Delaware's healthcare leader with hospitals in Dover and Milford, as well as stand-alone Emergency Department in Smyrna and a hybrid Emergency Department and Urgent Care in Milton. We offer various practice settings throughout Kent and Sussex Counties. Bayhealth Medical Center Kent Campus is 90 minutes from Philadelphia, Washington, DC and Baltimore. Our Sussex Campus is 30 minutes to the Delaware beaches and relaxation in the sand!
Bayhealth Medical Center offers a competitive salary and comprehensive benefits package (for eligible positions) including:
- Generous Paid Time Off and Paid Holidays
- Matching 401(k)/403(b) Plans
- Excellent Health, Dental, and Vision
- Disability and Life Insurance options
- On Site Child Care
- Educational Reimbursement
- Health Care and Dependent Care Flex Spending Accounts
- Plus, an array of Voluntary Benefits to include Critical Care Coverage and more!
Location: Kent Campus Hospital
Status: Full Time 80 Hours
Shift: Days
SALARY RANGE: 77,105.60 - 119,537.60YEARLY
General Summary:
The RN Biological Implant Coordinator is responsible for providing competent, evidenced-based care to assigned patients. The RN will spearheading the Bayhealth Medical Center Biological Implant Program, including planning, assessing, developing, implementing, and evaluating the Implant Program throughout the organization, The Implant coordinator will coordinate acquiring, receiving, storing, issuing, and tracking biological implants, and responding for product recalls. The biological implant coordinator is responsible for providers requests and ensures customer satisfaction which reflects and understanding of implants and tissue process. Coordinating all aspects for implant management by working with resource management, Prosthetic and sensory aid services as needed, sterile processing and contracting and other clinical areas using implants.
Ensures compliance with all applicable regulations regarding tissue procured for implantation. Develops and maintains a quality management plan so that all policies, procedures, and records pertaining to tissue comply with relevant regulatory standards. Design quality assurance audits, review quality control results, and ensure that deviation and adverse events are reported as required.
Responsibilities:
1. Ensures compliance with all applicable FDA regulations and JC standards related to Biological Implants. Maintains current understanding of all regulatory standards and applicable laws.
2. Develop and maintain a quality management plan. Responsible for participation in departmental and hospital programs for Quality Assessment and Improvement, identifying opportunities to improve services, making recommendations, and implementing actions as appropriate and consistent with the goals of Bayhealth. Responsible party for originating, reviewing, and updating all policies and procedures related to biological implants.
3. Coordinates meetings related to the implant program, prepares agendas and minutes, provides reports, and participates in meetings as assigned.
4. Reconciliation of implants used which may be BH owned inventory and vendor consignment stock. Coordinates with all applicable services to ensure implant availability, input of consults, replacement of used stock and payments for used stock.
5. Reviews audits from all locations, including documentation in patients' EMR, dual audits with UDI; investigates discrepancies, provides guidance and education and files variances as appropriate.
6. Serves as contact/resource person for any questions related to biological implants/policies/processes. Will act as a liaison between all departments and all sites involved in the Biological Implant program at Bayhealth. Verify and assist with training/competency of individuals involved in all process steps at all sites. Serves as liaison with internal and external regulatory agencies for the Implant and Tissue Program.
7. Ensure all implants are stored at the proper temperature; review temperature logs of all storage locations; perform quarterly alarm checks and maintenance. Regularly monitor stock that has expirations to ensure that supplies are current and up to date. Document the final disposition of expired products. Assist with any communications/follow-ups for variances/recalls/safety events. Coordinate any recalls or implant failures with Materials Management, Risk Management, and Infection Prevention. Evaluates patient EMR documentation of implants for accuracy of use, medication used for rinsing compliance and errors.
8. Coordinates with Resource Management to ensure all supply and requisitions are processed in an accurate and timely manner. Communicates about any issues with procurement, handling, condition, or delivery of products. Ensures vendor qualification is current and all required licenses are up to date.
9. Reconcile the OR Implant inventory daily to ensure all implants are accounted for.
10. Keeps current with research to provide evidence-based care and leadership on the Implant and Tissue program. Collaborates with other departments to improve processes. Develops and assists with staff education regarding tissue/implant program.
11. Ensures compliance with manufacturer's Information for Use (IFU)/guidelines for tissue preparation, ensuring availability and proper long-term documentation of IFU. Ensures that documents relating to source facility, original numeric or alphanumeric and lot identification, expiration dates, and all recipients are retained for a minimum of ten years as required by Title 21 Code of Federal Regulations 12.70.35 from the date of distribution, transplantation, disposition or expiration of tissue.
12. Initiates and completes incident report via Joint Patient Safety Reporting (JPSR) and Adverse Drug Event (ADE) relating to post-transplant infections or adverse events.
13. Collaborates with clinical staff to coordinate requests for equipment, supplies, and implants and makes recommendations when potential conflicts are identified. Contact vendors and surgeons' offices as needed. Coordinates and elevates requests for new procedures and implants to the Value Analysis Committee.
14. For assigned service(s), performs 100% daily audits on nursing documentation for all tissue and FDA-trackable implants, when used, to ensure complete and accurate entry into the tissue tracking software.
15. Meets regulatory agencies, JACHO,DHEC and FDA, requirements for the tracking of these products using unique device identifiers throughout their inventory distribution processes- from receipt to use on the patient. Reports compliance monthly and annually to the appropriate committee(s).
16. RN Implant coordinator, OR trained RN can support education, EMR intraoperative documentation and training in real time as needed.
17. Member of Value Analysis team - recommendation for cost savings and product quality metrics
18. Makes assessment and provides feedback in the event of risk to the integrity of the tissue tracking process, Creates and executes an interprofessional plan to reduce risk and / or correct process aberrancies.
19. All other duties assigned within the scope and range of job responsibilities.
Required Education, Credential(s) and Experience:
- Education: Bachelor Degree
; Health Care
; Or bachelor's degree in a related field. - Credential(s): Certified Perioperative Nurse
Registered Nurse
; Or Certified Tissue Bank Specialist (CTBS) through AATB - Experience:
Required: One year team leader experience in a healthcare environment.
Preferred: Three (3) years of leadership experience.
Preferred Education, Credential(s) and Experience:
- Education: Master Degree
Health Care
Or master's degree in a related field. - Credential(s):
- Experience:
To view a full list of all open position at Bayhealth, please visit:
https://apply.bayhealth.org/join/