Director Lab Quality and Reg Affairs

Summary:

Provides leadership in the areas of quality assurance, quality control, proficiency testing, quality related training and standardization compliance within the laboratory. This position is also responsible for project management activities as they relate to identified areas within the laboratory requiring standardization to improve quality and efficiency of laboratory operations. Provides support related to the RI and MA Pathology faculty professional practice activities, reporting with a dotted line relationship to the Chief of Pathology. On behalf of the Chief, works with the department's MDs and PhDs to enhance their quality of services, productivity, revenue generation, and efficiency.  Works to ensure collaboration and alignment between Pathology operations and faculty.

Responsibilities:

• Defines, establishes and coordinates the overall quality strategy and approach to determine, investigate and resolve quality issues in collaboration with the Laboratory Director.
• Develops, implements, and coordinates the Total Quality Plan, including Quality Control, for all depts in collaboration with the Laboratory Director.
• Utilizes incident reports, quality tools and various other data sources in order to determine causes of quality issues and concerns, trends this data and develops action plans with mgmt.
• Conducts root cause analyses for adverse events or quality issues/concerns and conducts prospective analyses (such as failure modes and effect analysis) for new processes and systems or changes to workflow.
• Oversees the Lab compliance to all regulatory standards, including but not limited to CLIA, CAP, The Joint Commission, and the RI Dept of Health.
• Develops training, competencies and other in-service programs and materials as needed to educate dept directors, managers and staff on quality control, proficiency testing and other regulatory issues.
• Orders, receives, reviews, monitors, proctors, and coordinates all phases of proficiency testing and alternative testing.

• Coordinates and reviews instrument verifications, validations, linearity, calibration verifications and analytical measurement ranges.
• Ensure compliance with laboratory accreditation, regulatory standards and information management policies by providing leadership and guidance to staff to ensure that quality policies, processes and procedures are established, current and adhered to by all laboratory staff.
• Oversee internal audit processes, external assessments, proficiency testing programs; document control systems; competency assessment; training and other quality processes.
• Identify training needs, as well as design and implement training programs specific to the quality system.
• Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitate laboratory improvement activities.
• Analyze data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and laboratory experience.
• Monitor customer satisfaction and performance metrics.
• Identify and report quality issues and problems to management with recommendations for resolution.
• Establish processes and policies for effective and professional communication between laboratory staff and among other interested parties.
• May supervise others and provide input into financial, safety and procurement decisions.
• Work with the safety officer and security/biosecurity officer to align quality practices, including data analysis, monitoring of trends, prevention, corrections, and continuous quality improvement.
• Ensure that the laboratory's organizational structure is committed to achieving and maintaining quality, advocating for a culture of quality, safety and ethics, and analyzing quality measures to evaluate the costs of maintaining quality.
• Ensure that laboratory personnel and instrumentation meet performance standards (QMS
• Ensure that operational processes meet organizational requirements through the application of workflow processes or the development of method validation and performance verification processes and procedures.
• Ensure that there is an effective system to control and manage documents and records.
• Develop and ensure that processes and procedures are in place for detecting and managing nonconforming events and performing internal audits and external assessments.
• Develop and ensure mechanisms for continuous quality improvement.
• Works with the Chief and assists division/section chiefs to establish faculty-related productivity goals for clinical, research and academic activities, revenue, operational and service quality efforts; supports the development and implementation of action steps to achieve faculty-related goals.
• Ensures that all professional billing opportunities are being identified and maximized. Ensures the effectiveness and accuracy of the professional fee-related billing processes (including consult billing).
• Performs other duties as assigned.

Other information:

EDUCATION:

Bachelors Degree in Biology, Life Sciences, Medical Technology, or Degree with 24 credits of sciences is required

Masters Degree in Chemistry, Biology, or Other Medical Science is preferred

Certified in ASCP, BSBB, CPHQ and PMP is preferred

EXPERIENCE:

3 Years experience with clinical laboratory quality programs is required

3 Years of progressive leadership. Preferably on an enterprise level

5 Years experience in a clinical laboratory preferably in an academic medical center setting is required.

Previous experience and extensive knowledge of regulations, including CLIA, CAP, TJC and DOH is required.

Previous experience with process improvement techniques is preferred.

SUPERVISORY RESPONSIBILITY:

• Supervisory responsibility for over 9 FTEs

Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital, USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union