JOB SUMMARY:

Provides strategic leadership and direction for the Southern California Region clinical laboratory system. Serves as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership on quality and regulatory compliance. Serves as the Southern California Region clinical laboratory system liaison to the regulatory and accreditation agencies in matters that are important to the regions clinical laboratory compliance efforts and operations. Supports Southern California Region Clinical Laboratory Directors and Hospital leaders in supporting continuous quality and regulatory compliance improvement.

BASIC QUALIFICATIONS:

Experience

• Minimum ten (10) years of experience in a high-volume clinical laboratory required with minimum five (5) years directly related quality and regulatory compliance experience.

Education

• Masters degree in clinical laboratory science; OR
• Masters degree in health care administration, business administration, public administration or related field with additional studies in quality management related courses, OR
• Six (6) years of experience in a directly related field.
• High School Diploma or General Education Development (GED) required.

License, Certification, Registration

• Clinical Cytogeneticist Scientist License (California) OR Clinical Microbiologist Scientist License (California) OR Clinical Laboratory Scientist License (California) OR Clinical Hematologist Scientist License (California) OR Clinical Genetic Molecular Biologist Scientist License (California) OR Clinical Chemist Scientist License (California) OR Clinical Histocompatibility Scientist License (California) OR Clinical Toxicologist Scientist License (California) OR Clinical Immunohematologist License (California)

ADDITIONAL REQUIREMENTS:

• Demonstrated ability and track record to apply cutting edge quality system theories, techniques, principles, practices, processes, or methods to initiate change in the clinical laboratory quality, service, and compliance performance to meet SCPMG strategic goals.
• Excellent skills in complex analytic problem solving, strategic planning, program development, project management, change management and group process.
• Demonstrated knowledge and effective use of statistical tools and techniques for problem solving and process improvement.
• Demonstrated effectiveness in staff development, team building, conflict resolution and group interaction.
• Able to manage several projects simultaneously, complete projects efficiently and on deadline, sometimes with necessarily little lead-time. Influential and effective in both written and verbal communication skills (negotiation, listening and collaboration).
• Experienced at presentingProficiency with Microsoft Office (i.e., Excel, Word, Power Point).
• Must be able to work in a Labor/Management Partnership environment.
• Other tasks as assigned

PREFERRED QUALIFICATIONS:

• N/A.

ESSENTIAL RESPONSIBILITIES:

• Under the broad guidelines and mission provided by the Southern California Region clinical laboratory system stakeholders (includes but not limited to: Regional Laboratory Physician Leaders, Regional Laboratory Managers, and SCPMG Executive Office):
• Provides strategic leadership and direction for the Southern California Region clinical laboratory-wide integrated quality and regulatory compliance system that will differentiate SCPMG laboratories positively from their competitors in the area of quality, service, regulatory compliance, and cost effectiveness.
• Ensures the integration of clinical laboratory continuous quality improvement, and regulatory compliance standards and best practices.
• Provides leadership in building a region-wide clinical laboratory quality and regulatory compliance team, which will serve as one of the main conduits for the Southern California Region clinical laboratory quality and regulatory compliance standardization processes.
• Serves as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership on quality and regulatory compliance.
• Aggressively mitigates regulatory risk areas.
• Leads in the evaluation of compliance with regulatory and accreditation agencies requirements through an infrastructure for compliance readiness assessment.
• Ensures regulatory inspection readiness.
• Serves as the Southern California Region clinical laboratory system liaison to the regulatory and accreditation agencies in matters that are importance to the regions clinical laboratory compliance efforts and operations strategically.
• Establishes contacts and working relationships with the regulatory and accreditation agencies.
• Assesses, interprets, and coordinates stakeholders opinions as to the impacts of various proposed laboratory laws and regulations to the Kaiser Permanente organization and services with our government liaisons.
• Supports Southern California Region Clinical Laboratory Directors in quality and regulatory compliance improvement.
• Supports laboratories in meeting regulatory requirements such as preparing for laboratory licensing application, routine, or complaint inspection and remedial actions as needed.
• Provides leadership in promoting a culture of continuous quality and service improvement and consistent regulatory compliance in the Southern California Region clinical laboratory system.
• Identifies improvement opportunities and coordinates processes and procedures to reduce laboratory risks.
• Collaborates with SCPMG and Hospital/Health Plan Compliance Office, Accreditation, Regulation, & Licensing, Southern California Region Risk Management and Patient Safety Committee, Southern California Region Quality Oversight Committee, SCPMG Medical/Legal, Program Legal, SCPMG Government Affairs, and other departments as appropriate to ensure continuous regulatory compliance and quality improvement.
• Develops clinical laboratory quality practice and regulatory compliance training and mentoring programs for clinical laboratorians who are assigned in quality and regulatory compliance areas.
• Supports Labor/Management Partnership initiatives.
• Supports the Principles of Responsibilities by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and licensing requirements as applicable, and Kaiser Permanentes policies and procedures.

For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment:

• Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente’s Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state, and local laws and regulations, accreditation, and licensure requirements (where applicable), and Kaiser Permanente’s policies and procedures.
• Models and reinforces ethical behavior in self and others in accordance with the Principles of Responsibility, adheres to organizational policies and guidelines; supports compliance initiatives; maintains confidences; admits mistakes; conducts business with honesty, shows consistency in words and actions; follows through on commitments.
• Job duties with at least occasional or possible access to: (1) patients, the general public, or other employees; (2) confidential protected health information and other confidential KP information (including employee, proprietary, financial or trade secret information); (3) KP property and assets, for example, electronic assets, medical instruments, or devices; (4) controlled substances regulated by federal law or potentially subject to diversion