A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Accreditation & Good Tissue, Manufacturing, and Laboratory Practices (GTMLP) Coordinator is a highly skilled staff specialist who assists in the development, coordination, and implementation of activities to assure compliance with accreditation and regulatory requirements. The Accreditation & GTMLP Coordinator is critical for supporting the complex regulatory needs and cutting-edge innovative care and therapies provided at U-M Health by compiling information about the regulations, policies, and standards related to tissue; applying this information to actual U.S. Food and Drug Administration (FDA) Current Good Tissue Practice (CGTP) compliance situations and The Joint Commission (TJC) accreditation-related situations; providing consultation to enable recommendations and decisions regarding actions plans; and developing educational resources for faculty and staff. The coordinator implements and assists in the evaluation of quality assurance and quality improvement programs designed to ensure compliance with regulatory agencies, accrediting agencies and organizational policies regarding GTMLP. Areas of responsibility include U-M Health's adherence to TJC accreditation standards related to tissue and compliance with applicable CGTP requirements. Participates in accreditation and regulatory survey visits. Locations receiving oversight by this role include ORs located at UH, CVC, Mott, KEC, EAA, BCSC; Trauma Burn Unit, Center for Reproductive Medicine, Blood Bank and Transfusion Service and Cellular Therapy Laboratory, Oral Maxillofacial Surgery Center, Wound Care Clinic at Domino's Farms, and MEND at Domino's Farms. This position reports to the Accreditation and Regulatory Readiness Director.
This position is eligible for remote and/or flexible work opportunities at the discretion of the hiring department, but does have an expectation to be onsite periodically.
Standard Operating Policies and Procedures, Training, etc. (50%) Provides in-depth understanding of current practices in U-M Health including laboratory (e.g. Blood Bank, Cellular Therapy Lab) and clinical (e.g. Kellogg Eye Center, Trauma/Burn, Center for Reproductive Medicine, etc.) areas. Reviews the quality control program to identify system issues, gap analysis and quality control trends; design and monitors the implementation of corrective action(s), as necessary. Maintains quality assurance standard operating policies and procedures and educational programs for faculty and staff. Provides direction and support to regulatory and accreditation compliance including TJC, State and Federal regulations (e.g. CMS, Food and Drug Administration (FDA) Current Good Tissue Practice (CGTP), and TJC). Provides information and education to faculty and staff regarding the technical skills and requirements for GTMLP. Stays current with FDA regulatory progression and policy movement and monitors for any relevant new regulatory guidance or updated guidance that may impact the Center for Reproductive Medicine (CRM). Supports and assists in as appropriate, the process for collecting quality assurance data, adverse events, findings of investigations and procedural deviations, revisions, reports both internally and to external groups, including annual work and improvement plans. Serves on appropriate committees to ensure development, implementation, and execution of the quality assurance program. Acts as a resource to multidisciplinary quality assurance development teams. Obtains FDA annual establishment registrations for tissue suppliers. Participates in accreditation & regulatory survey visits. Audit Program (45%)
Conducts daily and monthly electronic reviews of all areas that use and store tissue to determine U-M Health's adherence to accreditation standards related to tissue. Facilitates and performs biannual scoring of TJC Transplant Safety standards pertaining to tissue. Addresses daily temperature monitoring alerts, coordinates with tissue storage units any temperature excursions, and reports monthly temperature monitoring data for tissue storage units. In collaboration with manager, designs and operates an audit program to assure the control of critical processes. Monitors the timeliness and efficacy of corrective actions in the quality assurance program and deficiencies identified in quality assurance management. Audits and provides feedback regarding the competency assessment program to ensure a properly functioning process that meets regulatory requirements. Other duties as assigned (5%)
Bachelor's degree in nursing, basic science, or other health care field with 2 - 5 years of relevant experience in laboratory medicine/TJC accreditation standards or an equivalent combination of experience is required. Demonstrates knowledge of process improvement and outcome measurement experience. Ability to analyze data and identify trends. Ability to act in a consultative capacity to assist clinicians, allied health personnel, and other clinical staff with regulatory questions and scenarios, matters requiring sensitivity, and circumstances with complex variables. Demonstrates ability to work in a team environment utilizing facilitation skills, excellent communication, interpersonal, and problem-solving skills. Demonstrates ability to work independently, to meet deadlines efficiently, to perform multiple tasks simultaneously and to be highly self-motivated. Proficient in the use of Microsoft Office Suite (primarily Excel, Word, PowerPoint, and Outlook) and Adobe Acrobat. Ability to reliably attend remote meetings. Demonstrates experience working with and knowledge of the AABB, FDA, CAP, CMS and TJC regulations. Experience in teaching, training, and policy and procedure development. Working knowledge of systems used internally such as MiChart, RL Datix, VERGE Health, RL Datix patient safety event reporting system, PolicyStat, Mobile Aspects, Centricity Perioperative Manager Resource Catalog, TempTrak, Dropbox at U-M, MLearning, etc. Strong working knowledge of CGTP and expertise in applying these requirements in a clinical setting or regulated industry. Experience in applying TJC hospital accreditation standards and FDA requirements to clinical contexts. Experience in the tissue banking industry and demonstrates ability to succeed in this type of highly regulated environment. Experience reading, interpreting, revising, and explaining complex policies, regulations, and guidance. Experience creating educational content and resources, as well as coaching faculty and staff on how to prepare for and handle FDA site inspections and TJC surveys. Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
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