MAIN FUNCTION:
The Quality Systems Manager ensures system-wide communication, training, competency assessment, and compliance monitoring with the Laboratory’s Quality Management System (QMS) requirements.
The Quality Systems Manager must have the education, experience, and authority to discharge the position's responsibilities and access personnel at all levels of the laboratory organization as required. The designated individual is expected to be a resource when regulatory agencies need document review and compliance assessment. Assists the System Director of Laboratory Services in planning, organizing, and directing the department. Oversees all laboratory services in the absence of the System Director. Reports to the System Director of Laboratory Services.
DUTIES AND RESPONSIBILITIES
** 1. Operates area of responsibility by standards established by external licensing, accreditation, regulatory, and auditing entities such that:
Any standard deficiency is corrected within 30 days of identification by the inspecting agency. Recommendations from such agencies are addressed in writing to the Systems Director of Laboratory Services within seven days of receipt. No deficiencies occur for areas of responsibility, which would result in any license or permit being suspended, reducing ArnotHealth's ability to accomplish its mission.
** 2. Understands and enforces compliance with all Laboratory Policies and Procedures. Arnot
Health Policies and Procedures, Federal Regulations, and New York State Department of Health
Regulations. Ensures all department areas are informed of regulatory changes and identifies potential non-compliance issues.
** 3. Acts as the department’s primary contact with all regulatory agencies and on-site inspections.
** 4. Maintains laboratory regulatory oversight with the Quality Management System at Arnot Ogden Medical Center and Ira Davenport Memorial Hospital.
** 5. In conjunction with the Systems Director of Laboratory Services, Manager(s), and Medical Director(s), define quality goals and performance expectations that ensure the quality and timeliness of laboratory services.
** 6. Maintains statistical records as required or requested in alignment with the Laboratory Quality Management System; completes reports and surveys related to the section within applicable timeframes.
** 7. Maintains the laboratory data analytics system. Creates and updates the data reports for laboratory and clinical services.
** 8. Organizes and manages the laboratory Quality Improvement Management meetings and collaboratively works with the manager(s) to ensure quality goals are reviewed on a scheduled basis and performance expectations are met.
** 9. Maintains and presents monthly and quarterly quality reports and audits to the ArnotHealth Performance Management Committee, Patient Safety Council, Annual System Quality Management Report, and other ad hoc committees.
** 10. Develops new procedures for areas of responsibility, including writing standard operating procedures (SOPs) per CLSI guidelines. Maintains and reviews all processes in areas of responsibility. Reviews all systems on a designated basis and documents this review. Ensures the Medical Director(s) approve(s) all major changes before implementation.
** 11. In conjunction with other managerial staff and medical directors, investigates incident reports and complaints, documents findings, and any follow-up action when required. Assists in the review of PFALTS. Recommends disciplinary actions when warranted.
** 12. Performs system and process audits at a level consistent with regulatory requirements, provides written documentation of findings, and, in conjunction with appropriate managers(s), develops plans of correction—monitors implementation for improvement.
** 13. Serves as the Laboratory program education coordinator and primary contact for educational outreach programs, including clinical affiliation partnerships, laboratory internships, and job shadowing programs. Collaborates with the laboratory leadership team to schedule clinical laboratory technology students.
** 14. Oversees all activities related to the Laboratory Customer Service department and directs the Customer Service representative (s).
Provide departmental education related to the orientation of new employees to the Laboratory and employment expectations. Educate new employees, students, and current employees on the department's Quality Management system, including ongoing studies.
Assists with the annual continuing education plan developed by the Medical Director and the Systems Director of Laboratory Services for technical staff members.
Has working knowledge and understanding of all computer systems as they apply to the area of responsibility.
Maintains close communications with the Medical Director(s) and Systems Director of Laboratory Services. Informs management of issues and actions taken to resolve problems.
Assists the System Director of Laboratory Services in project detail and coordination. May perform related research activities, special studies, and assignments under the direction of the Systems Director of Laboratory Services, Medical Director, or Pathologists.
Acts as a resource to health care personnel by providing pertinent and accurate information promptly and courteously. Represents the Laboratory on standing and ad hoc committees as requested. Interacts effectively, willingly, and professionally with patients, guests, and other healthcare professionals (including other ArnotHealth staff members) according to Laboratory and ArnotHealth policies.
If required, participate in and document at least 12 hours of continuing education per year and all mandatory educational programs.
Is familiar with and demonstrates customer service principles both as an individual and as
a role model in the department and ArnotHealth.
May be required to work occasional evenings, nights, weekends, and off-campus duty to complete audits and training programs.
Investigate and track problems related to outreach services; recommend action to improve the quality of service.
Review laboratory-related occurrence reports with appropriate staff members on a timely basis. Monitor trends and recommend appropriate action.
Understands and demonstrates the importance of satisfying the needs of the customers/patients by interacting with them in a friendly and caring way, being attentive to the customers' needs, both psychologically and physically, and taking the initiative to maintain communication with customers to provide a secure and pleasant experience with ArnotHealth.
It is understood that this job description lists typical duties for the classification and is not considered inclusive of all duties that may be assigned.
EDUCATION:
Required: Bachelor’s degree in Clinical Laboratory Technology (or Medical Technology), or a bachelor’s degree or in biology, chemistry, other physical sciences, or the substantial equivalent. An advanced degree may be substituted for experience.
EXPERIENCE:
Required:3-5 years of recent Clinical laboratory experience in a certified laboratory
Preferred: Organizational and communication skills.. Two years of previous work experience or education in quality assurance is preferred; however, equivalent combinations of directly related education and experience in quality assurance, quality management systems, and quality improvement may be considered case-by-case. Quality certification in Six Sigma or Lean, ASQ, or CPHQ is preferred.
PHYSICAL DEMANDS:
Light to moderate physical effort. This position requires frequent standing and walking. Frequently lift 25lbs, occasionally lift 40 lbs. Typical clinical laboratory environment.
EXPOSURE CATEGORY:
Category I. Tasks involve exposure to blood, body fluids, or tissues.
** A.D.A. Essential Functions