Specialist, Quality and Regulatory Affairs

University Hospitals•Cleveland, OH

3d•Onsite

About The Position

This position is responsible for providing support to the quality and regulatory activities within Pathology - this position will support our anatomic pathology and cytopathology departments. Areas of focuses for the Quality Department are driving overall process improvement, workflow mapping and development, conduct safety reviews, coordinate response efforts to nonconformances, development of educational content and tools to improve quality outcomes, and ensure compliance with regulatory and accreditation entities. This role manages ad hoc projects that fall into these categories for the system, as well as long-term initiatives, with the overarching goal of creating standardization to ensure the same, high quality experience for all patients interacting with UH Pathology.

Requirements

Bachelor's Degree In chemical, physical or biological science or medical laboratory (Preferred)
Associate's Degree In chemical, physical or biological science or medical laboratory (Required)
High School Equivalent / GED with documented training prior to 9/1/1997 and performance of high complexity training on or before 4/24/1995 (Required)
5+ years’ Experience working in the medical laboratory (Required)
Proficiency with Microsoft Office, including advanced knowledge of Excel (Required proficiency)
Proficiency with Laboratory Information Management Systems (LIMS) (Required proficiency)
Detail oriented (Required proficiency)
Self-motivated (Required proficiency)
Effective communication skills (Required proficiency)
Critical thinker with an innovative mindset (Required proficiency)

Nice To Haves

Anatomic Pathology (AP) experience preferred
Hands-on experience in anatomic pathology and/or cytopathology operations strongly preferred
1–3 years of AP quality and/or regulatory experience preferred
Experience tracking and analyzing quality metrics (e.g., TAT, adequacy rates, discrepancies, amended reports), preferred
Experience supporting or participating in lab inspections and audits, preferred
Working knowledge of Media Lab (Preferred proficiency)
Working knowledge of Midas (Preferred proficiency)
Familiarity with PowerBI and/or other visualization software (Preferred proficiency)
Strong knowledge of AP workflows, including specimen handling and slide preparation, preferred
Understanding of common risk areas in AP/cytology, preferred
Ability to trend data and drive process improvement, preferred
Medical Technologist (MT-ASCP) (Preferred)
Medical Laboratory Scientist (MLS-ASCP) or equivalent certification (Preferred)
Pathology/Cytologist (CT-ASCP) (Preferred)
Medical Lab Technician (MLT-ASCP) (Preferred)
Pathology/Histotechnician (HT-ASCP) or equivalent certification (Preferred)
Histotechnologist, HTL(ASCP) (Preferred)

Responsibilities

Lead internal and external regulatory surveys and inspections, and standardize response process across the system.
Responsible for achieving and maintaining compliance with regulatory and accrediting agencies (e.g. CAP, CLIA, ODH, DNV, FDA, ASHI, etc.) for all laboratory sections and locations across all patient settings.
Orders, monitors and coordinates proficiency testing survey program and ensures compliance with Clinical Laboratory Improvement Amendments (CLIA).
Develop Media Lab content in Compass and Document Control modules to align with strategic goals and regulatory standards, with the goal of achieving standardization policy and procedure organization across the system.
Serve as representative on a variety of Quality related committees to create system alignment in Quality and Regulatory affairs for the system, as well as disseminate recall and safety notices throughout the system.
Manage and develop system-wide database containing quality metrics for various laboratory sections.
Pull data for quality indicator review for the various sections within pathology for review at Quality Management meetings, and facilitate Quality Management meetings.
Coordinate development and implementation of action plans when metrics fall below acceptable threshold.
Participate in Learning From Defects reviews and project manage action items coming out of the meeting to close the loop on patient safety issues, as well as disseminate solutions and best practices to the system.
Manage partnerships with educational institutions, coordinate clinical rotations for students, and create pathways for existing employees to further their educated and become eligible for additional credentials/certification.
Provides analytical support related to operations and finance.
Access and analysis of information to support key strategic initiatives.
Monitors various reports and data.
Work on assigned projects aimed at improving processes, enhancing revenue, and reducing costs.
Lead training sessions for external stakeholders regarding regulatory compliance.
Lead internal training sessions regarding use of policy/competency assessment software (Media Lab) as well as training of new hires.
Performs other duties as assigned.
Complies with all policies and standards.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.