Lab Quality and Compliance Program Manager

POSITION SUMMARY

Position Summary

Provides expertise in laboratory quality and performance improvement, and coordinates regulatory activities to support safe, cost-effective, efficient, timely, and equitable patient care. Collaborates with the Laboratory Director, faculty, and Quality Management to develop and implement annual departmental quality plan. Provides subject matter expertise to support organizational quality priorities and departmental goals by monitoring, assessing, analyzing, reporting on, and facilitating improvement activities related to laboratory processes and outcomes.  Contributes to a positive work environment that promotes HMC values.

 

ESSENTIAL FUNCTIONS

Job Duties & Responsibilities

 

Quality Assessment & Improvement (QA/QI) Program Administration. Representative duties and responsibilities include, but are not limited to:

• Maintains Quality Assessment & Improvement (QA/QI) program for laboratory, including developing and preparing annual Departmental Quality Plan.
• Coordinates cadence of QA/QI Committee meetings and all associated activities.
• In conjunction with appropriate lab leadership, reviews and determines relevant key performance indicators to track on the laboratory indicator dashboard.
• Maintains departmental list of performance improvement (PI) initiatives.
• Facilitates quality improvement initiatives; works with and supports section leads.

 

Oversees Quality Control & Testing. Representative duties and responsibilities include, but are not limited to:

• Ensures adherence to departmental policies and procedures. Monitors quality control results and identifies trends or discrepancies requiring corrective action.
• Manages the competency testing program, including proficiency surveys (e.g., CAP) and peer observations, for all point-of-care testing personnel. Reviews and analyzes PT/QC monthly reports to ensure compliance and identify opportunities for improvement.
• Develops and maintains point-of-care testing policies and procedures, incorporating current best practices and regulatory requirements. Collaborates with the laboratory director and Medical Director to review and approve new or revised procedures.  Communicates policy and procedure updates to point-of-care testing staff.
• Directs the preparation and coordination for on-site inspections of point-of-care testing, including developing and implementing a readiness plan.
• Establishes and implements systems and processes to ensure ongoing compliance with accreditation standards for all point-of-care testing functions. Leads efforts to maintain accreditation.
• Establishes and maintains a system for monitoring point-of-care testing instrumentation, QC, and proficiencies. Analyzes data to identify trends and implement corrective actions as needed.

 

Data Analysis and Reporting. Representative duties and responsibilities include, but are not limited to:

• Performs data analysis for indicators and initiates root cause analysis when indicated.
• Presents monitoring and performance data as needed.
• Performs and oversees departmental audits on various systems and topics, including but not limited to competency testing, Point of Care Testing, proficiency testing, QC performance and review, compliance with regulatory requirements (ie; CAP, CLIA. DNV), and annual Lab and Hospital Quality audits.
• Maintains Project Tracker dashboard for the Quality department and others as needed.

 

Regulatory Compliance and Accreditation. Representative duties and responsibilities include, but are not limited to:

• Subject matter expert on regulations for accreditation, compliance, and quality requirements.
• Prepares & submits bi-annual accreditation application to The College of American Pathologists (CAP).
• Manages communications and responses to regulatory agencies (DNV, CAP, FDA, CLIA).
• Manages CLIA certificate renewals for HMC. Completes CMS forms when required.

 

 

JOB SPECIFICATIONS

Minimum Qualifications

Education & Experience

REQUIRED: 

• Bachelor’s degree in medical technology, chemistry, physical or biological science and four or more years’ experience in a clinical laboratory with increasing responsibility for quality and regulatory assurance.

PREFERRED: 

• Master’s degree or advance degree in medical technology, business or healthcare related field.

Licenses & Certifications

REQUIRED:          

• MT (ASCP) or MLS (ASCP) or equivalent certification.

PREFERRED: 

• Certification in healthcare quality.

 

Required Knowledge, Skills, and Abilities

Knowledge of:

• Principles of data organization, storage, retrieval, and security. Is proficient in using information management systems and databases.
• Comprehensive understanding of quality improvement methodologies (e.g., Lean, Six Sigma, PDSA cycles, Root Cause Analysis).
• Quality management systems (e.g., CLIA), and various quality tools (e.g., fishbone diagrams, Pareto charts, control charts, flowcharts).
• Selection and application of the appropriate tools and methodologies for different situations. Keeps abreast of current trends and best practices in quality improvement.

 

Skill in:

• Creation of clear and concise technical quality reports that effectively communicate complex information.
• Strong writing and presentations including communicating complex information to diverse audiences (management, staff, regulatory bodies).
• Statistical analysis and use of software used in application of quality analysis.

 

Ability to:

• Effectively communicate with team members, stakeholders, and other parties, including active listening, clear articulation of ideas, and the ability to facilitate discussions and resolve conflicts.
• Producing clear, concise, and professional written communication, such as reports, emails, presentations, and documentation.

 

Additional Posting Information

Hillsboro Medical Center believes in providing equal employment opportunities for all qualified individuals. Recruitment, hiring, promotions, transfers, working conditions, training, and compensation will be based on qualifications without regard to race, color, sex, sexual orientation, gender identity, religion, age, creed, national origin, marital status, family relationship, veteran status, genetic information, physical or mental disability, or any other status or characteristic protected by applicable law. We further commit ourselves to continuing the practical application of this policy in our daily business conduct.