Monitors, maintains, and coordinates the accreditation, compliance, and credibility of the clinical laboratories based on industry standards and all regulatory agencies. In collaboration with other management personnel in the laboratory matrix structure, manages the development and implementation of quality assurance programs with all processes in the hospital laboratories. Develops and monitors balanced scorecard metrics.
1. Working with lab directors, managers, supervisors and their designees, develops mechanisms to assure compliance with all rules, regulations, and guidelines of CLIA, CAP, JCAHO, Medicare, etc.
2. Responsible for maintaining a high level of proficiency and current knowledge of trends in methodology, technology, and ways to manage quality and metrics in the clinical laboratory.
3. Develop appropriate performance and operations reports for Executive Director, hospital administration and others and lead improvement teams to achieve set objectives.
4. Responsible for monitoring published guidelines for revisions to regulations and/or accreditation standards, and ensures laboratory compliance. Serve as a resource regarding The JC, Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulations, CAP accreditation standards, ISO15189 Standards, and various state accreditation standards, permits, or licenses for all labs, and ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
5. Direct periodic ongoing quality audits that align with quality objectives.
6. Verifies that quality policies and procedures are effectively operationalized.
7. Manage the development and monitoring of mechanisms to verify compliance with accrediting and regulatory requirements.
8. Develop and monitor processes for quality control of analytic methods and verify that all tests are monitored through an appropriate proficiency-testing program as required.
9. Oversees that appropriate method validation protocols are in place, implemented and results fully documented.
10. Oversees prompt and complete reporting of occurrences and/or serious quality issues and assures effective corrective action including issuance of revised reports as applicable. Develop and deploy quality policies and ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post-analytical issues.
11. Responsible for coordinating internal inspection process of the laboratory units and specimen collection sites to ensure compliance with applicable federal, state, and local regulations and College of American Pathologists (CAP), CLIA and ISO15189 accreditation requirements. Review and ensure that corrective action is implemented when non-conformances are found.
12. Responsible for overseeing that each Laboratory Director has a set of scorecard metrics that give a balanced view of the laboratories’ performance and that the laboratory has a comprehensive Quality Improvement Plan with metrics, and that each department communicates their metrics and implements appropriate actions.
13. Conduct Quality meetings with required participation by all areas having an impact on pre-analytical, analytical, and post-analytical phases of testing.
14. Participate in hospital and medical staff committee meetings as required and consult with medical, nursing, and administrative staff on a regular basis to coordinate and improve patient care. Incorporates integration of lab quality improvement initiatives with that of the hospital.
15. Determines staff qualifications and competency: recruits, selects, hires, trains, orients, mentors and performs annual evaluation of employees under supervision. Provides effective communication, leadership, guidance and resources. Monitors staff safety compliance and use of Personal Protective Equipment (PPE), as needed.
16. Monitors quality and quality assurance of new tests and instruments, changes to tests and instruments, and/or deletion of tests or instruments
1. Performs, as directed, safety compliance and uses Personal Protective Equipment (PPE), as needed.
2. Participates in Quality Assessment (QA) and Quality Improvement (QI) programs, as directed.
3. Ensures compliance with The Joint Commission and all other Federal, State and Regulatory Agencies.
4. Responds promptly and sincerely to customer’s needs, requests and concerns via all communication forms using easily understood language and refraining from using inappropriate language and non-verbal gestures.
5. Maintains positive working relationships as a team player through problem solving issues, speaking positively about others, listening attentively and observing the Patient Bill of Rights and Confidentiality.
6. Increases customer service knowledge, skill and ability by participating in department and institution-wide specific programs.
7. Incorporates National Jewish’s identity (Science Transforming Life®) into daily functions. Speaks positively about the institution, provides customers with prompt service, maintains a clean and safe working environment, dresses appropriately based upon National Jewish safety standards, and departmental policies and wears an ID badge visibly.
Knowledge and Skills
Incumbent must have strong oral and written communication proficiency; strong presentation skills, attention to detail and ability to multi-task; possess strong problem-solving and organizational skills. Incumbent must have extensive skills working within a matrixed resource environment, competent with project management techniques. Capacity to establish and maintain constructive business relationships with internal and external customers while maintaining integrity and confidentiality.
BS/BA in Biomedical Sciences and/or closely related field required. Masters Degree in related field or MBA preferred.
Certification and Licensure
Certification by American Society of Clinical Pathologists (ASCP) or equivalent required. Must meet the requirements for a General Laboratory Supervisor (CLIA 88). Certified in project management preferred; Certified in quality management and regulatory compliance preferred; Six Sigma Green or Black Belt preferred.
Five (5) or more years as a clinical laboratory scientist in a Medical Technologist, Clinical Technologist, or Medical Laboratory Technician role. Three (3) or more year’s experience actively leading a strong quality management program responsible for collecting data and preparing reports for quality monitors. Experience in participating in preparing for regulatory inspection and accreditation programs.
- or - Any equivalent combination of Education and/or Experience
Position is an office environment. Frequent requirements may include: sitting for extended periods, entering and manipulating data on a workstation computer and participating in team/executive meetings. Approximately 75% of daily responsibilities will be working both one-on-one and in teams with other personnel and extended one-on-one contact in a quiet environment where hearing and listening is paramount. Must possess the ability to communicate by observation, verbal, written and listening; standing; walking; climbing stairs; stooping to remove/replace files; good hand-eye coordination; lifting, pulling, pushing, and upper body twisting while handling supplies and equipment; sitting while completing paperwork; using keyboard for PC and word processing needs. Occasional requirements may include: stand, walk, use hands to manipulate, handle or feel objects, tools, or controls, reach with hands and arms, stoop, kneel, and lift/move up to 25 pounds. Incumbent may be scheduled to work an alternate schedule to accommodate essential business needs routine travel by foot or automobile to alternate work/meeting locations, possibly during inclement weather.
No environmental conditions indicated. Professional office environment with time of each day spent in interaction with management/staff, in addition to planning and working autonomously. Requires teamwork and the ability to handle multiple interruptions; frequently fast-paced; high-pressure; occasionally variable-paced; variable pressure. Personal Protective Equipment (PPE) will be provided to each employee when needed as determined by policy. Utilization of PPE is mandatory. Estimated 1600 employees in the worksite.
Manages 1-3 employees