Cincinnati Children's Hospital Medical Center - Regulatory & Compliance Careers

Regulatory & Compliance Jobs
at Cincinnati Children's Hospital Medical Center

Full Job Title: Clinical Lab Sr QA Specialist

Job Number: 94001

Location: Cincinnati, OH

Date Posted: 8-9-2017



DEPARTMENT: Lab Administration

SUPERVISOR'S TITLE: Varies

TITLES SUPERVISED: N/A TOTAL NUMBER OF FTE'S DIRECTLY OR INDIRECTLY SUPERVISED: 0

PURPOSE OF POSITION: Under general direction, coordinates quality assessment and improvement activities, safety and regulatory compliance, and staff education and competency. Assist in Quality Assurance and Compliance activities in the Laboratory. Monitor customer and employee satisfaction data. Design, implement, evaluate and monitor patient safety programs and quality improvement projects. Provide staff guidance, education and training related to aforementioned areas. Monitor/audit and evaluate data related to aforementioned areas. Participate in research projects related to aforementioned areas. Lead activities and maintain documentation necessary for CAP and CLIA certification. Manage deviations and corrective actions.

Responsibilities
·Data Management III
Develop/design/create, evaluate, restructure, and/or manage specific database(s). Input and ensure the integrity of data and/or records. Standardize and document processes. May coordinate data collection. May conduct data analysis, create reports, and disseminate to the appropriate individuals.
·Process Improvement II
Identify, lead, and direct process/quality improvement/assurance activities. Measure and present results of improvement efforts and ongoing performance measures of processes. In collaboration with appropriate individuals, develop strategic plans for improvement. May manage activities such as training and audits which support process improvement initiatives/activities. May participate on process improvement team(s).
·Training - Content Development II
Participate in or collaborate in the design, objectives, and/or implementation of training/educational programs for a designated audience. May lead and/or assist with the preparation of related reports and/or presentations. May provide input on training needs and/or evaluate training outcomes. May investigate or recommend new training tools/approaches.
·Training - Delivery III
Collaborate in the formal or informal training, education, and/or development of staff, new employees, patients, visitors, students, fellows, residents, and/or the community. May collaborate to identify ongoing educational/training needs. May be responsible for documentation and compliance. Promote/market educational/training opportunities as requested. May provide related reports/data.
·QUALITY ASSURANCE LEADERSHIP
Under general direction, coordinates laboratory quality assessment and improvement activities, safety and regulatory compliance, and staff education and competency relating to quality. Audit/monitor pre and post testing variables which impact the safety of laboratory, blood bank and transfusion practice. Develop new systems to improve system performance within allotted resources. Coordinate an effective communication plan for system improvement notices or reminders. Coordinate audits of laboratory practices for appropriate process, procedure and documentation. Serves as a liaison within the division or organization including affiliations with Hoxworth and other partner organizations. May maintain and control SOPs, forms and documents, maintenance records and laboratory logs. May arrange laboratory compliance support provided by the CCHMC Office of Research Compliance and Regulatory Affairs.
·ACCREDITATION
Coordinate CCHMC accreditation activities to ensure adherence to accreditation and regulatory standards. Maintain compliance with applicable federal, state, and local regulatory requirements, including HIPAA and/or other accreditation standards. Coordinate CAP accreditation activities including ongoing compliance with CAP standards and preparations for CAP interim and on-site inspections for laboratory services. Ensure ongoing compliance with Clinical Laboratory Improvement Act (CLIA) - 88 laboratory regulations and the State of Ohio. Coordinates State of Ohio/Centers for Medicare Medicaid Services (CMS) regulatory activities and preparation for on-site inspections. Coordinate Joint Commission accreditation's activities including ongoing compliance with Joint Commission regarding transfusion practice standards and preparation for Joint Commission surveys. Serves as liaison to hospital Accreditation Services and/or Blood Utilization Review Team as required. Design and/or implement programs, policies, and/or procedures to ensure compliance. Track laws and regulations that might affect policies and procedures. May prepare compliance reports and communicate results as necessary.
·PERSONAL DEVELOPMENT
Demonstrates commitment to professional growth and competence. Demonstrates a commitment to keep current in CCHMC policies and procedures as evidenced by attending all mandatory in-services and meetings. Reviews current literature in field as demonstrated by contributing this knowledge in appropriate staff meetings. Attends CCHMC or community-based in-services in area of clinical need or interest. Coordinates training (both technical and safety) and competency of laboratory staff. Continually monitors compliance. Maintains currency in field through continuing education, literature and seminars. Implements this knowledge into the clinical and/or research labs. May provide education to personnel, patients or family through structured presentations and unstructured interactions while performing tests or resolving technical questions.
·SAFETY
Attends required Cincinnati Children's training sessions, including radiation safety, laboratory safety, bloodborne pathogens and OSHA. Enforce compliance with Infection Control policies and procedures. Understands, adheres to and models Core Standards as defined organizationally and specifically within the department/unit. Respect patient rights for informed consent and the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. May ensures the exchange of appropriate patient care and clinical information when patients are admitted, referred, transferred or discharged. Be a patient and staff safety advocate and work within Safety Coaching system to create a safety minded environment in the laboratories.
·Collaboration
Work collaboratively/cooperatively with others to achieve goals. Proactively adjust one's style and/or efforts to complement those of others. Develop positive working relationships with peers/colleagues. Share knowledge and/or provide support for team members. Contribute to and promote a positive and professional work environment/atmosphere. May serve as a liaison within the division or organization.

Skills & Competencies
·Prioritization
Using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.
·Diversity Appreciation
Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself
·Decisive Leadership
Taking responsibility for guiding others' actions and providing direction to a group; stepping forward to take the lead in addressing difficult issues and making tough judgment calls
·Strategic/Systems Thinking
Formulating credible, effective, long-range strategies to attain overarching organizational objectives; anticipating future trends, as well as potential threats or opportunities; accurately predicting how strategies will play out
·Supervision
Ability to supervise others
·Ambiguity Tolerance
Effectively handling uncertainty; creating structure and focus in the face of ambiguity; taking effective action without having complete understanding and knowledge of the total picture or all the facts
·Energy
Being highly energetic; possessing great reserves of energy; having a bias for action; preferring a fast-paced work style
·Initiative
Challenging the status quo and seizing opportunities to enhance work processes and outcomes; voluntarily seeking new or extra responsibilities and challenges; going beyond what is expected; proactively delving into work without hesitation
·Independence and Teamwork
Ability to work autonomously, with independent judgment, as well as in a collaborative team environment.
·Organization
Strong organizational and project management skills to handle projects independently.
·Planning
Taking an organized approach to work and planning ahead; identifying objectives aligned with business strategies, structuring work, and estimating necessary time and resources; anticipating and adjusting for potential obstacles and problems; monitoring work progress
·Professional Demeanor
Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
·Emotional Resilience
Remaining composed and calm when faced with setbacks, disappointments, rejection, crises, stress or pressure; readily putting aside concerns to get the job done; taking a problem solving rather than an emotional approach when faced with a difficult situation; being even-tempered and non-defensive
·Analysis - Basic
Analytical ability sufficient to evaluate data, make judgments and recommendations
·Problem Solving
Ability to independently work through details of a problem to reach a positive solution
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.

Required:
·Bachelor of Science Degree in Clinical Laboratory Science OR a related science discipline
·4 years technical experience in a related laboratory including specific responsibilities for quality assurance or educational activities
·Knowledge of accreditation, safety, and regulatory requirements

Preferred:
·Cert Medical Tech (ASCP) OR Equivalent
·Master's Degree in a related field
·Supervisory experience

Cincinnati Children’s is an Equal Opportunity Employer. Qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, age, genetic information, physical or mental disability, military or veteran status, sexual orientation, gender identity/expression, or other protected status in accordance with applicable federal, state, and local laws and regulations. If you would like more information about equal employment opportunity (EEO) rights as an applicant under the law, please click here

Cincinnati Children’s will not discriminate against applicants and employee for inquiring about, discussing or disclosing their pay or, in certain circumstances, the pay of their co-workers. If you would like more information about the Pay Transparency Nondiscrimination Provision, please click here