Quality Assurance Manager - Labs

POSITION SUMMARY:

Under the direction of the Operations Directors, and in collaboration with the Chief of Pathology & Laboratory Medicine and Medical Directors, monitors, implements and supervises quality and compliance standards in the Department of Pathology & Laboratory Medicine. Manages the Laboratory Quality, Compliance and Safety Programs in the BMC Laboratory. Additionally, provides technical supervision, oversight and guidance for CLIA licenses; ensuring maintenance of standards that meet and exceed those required for The Joint Commission (JC) and College of American Pathologists (CAP) accreditation. Champions BMCs RESPECT values.

Position: Quality Assurance Manager - Labs       

Department: Laboratory Admin

Schedule: Full Time

ESSENTIAL RESPONSIBILITIES / DUTIES:

Quality & Compliance

• Champions and manages a laboratory environment that promotes quality and compliance, to ensure patient and employee safety.
• Collaborates, advises and serves as a content expert regarding all laboratory services.
• Ensures quality and compliance data is collected, analyzed, reviewed and disseminated in accordance with the requirements of accrediting agencies, particularly the College of American Pathologists (CAP),  The Joint Commission (JC), and BMCs Patient Quality and Safety department.
• Ensures all RL6 Incident Safety reports are followed up to completion. Informs Senior Administrative Director in detail regarding RL6 reports of level C or higher. Ensures Quality and Compliance coordinator prepares reports for Quality Improvement Program (QuIP) monthly reviews.
• Represents department as Safety Chair.
• Contributes to departmental goals of improving cost effectiveness, optimization of resources and revenue enhancement.
• Provides a technically sound environment to optimize the quality of laboratory services.
• Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, JC, CAP, OSHA, DPH, HCFA, FDA, AABB, NCCLS).
• Supervises and directs the QA Project Specialist, able to backup CAR-T QA as needed.
• Participates in hospital-wide Quality Assurance Program as designed by regulatory agencies, by the BMC Quality and Patient Safety Department or by the departmental/sectional Quality Assurance Policies.
• Participates in planning, data collection, monitoring evaluation and action on assigned projects within agreed upon time frames. This includes appropriate turnaround time studies and program logs as described in the departmental/sectional policy. Utilizes LIS systems for accurate data collection and monitoring.
• Exhibits innovation in planning improvements, promoting new programs and problem solving in area of responsibility.
• Values and responds to customer feedback by taking corrective action or improving suboptimal services.
• Supports Technical Supervisors throughout the department in management of Quality Control and Quality Assurance data in accordance with the Quality Control Policies of the department.
• Maintains updated Policy and Procedure Manuals using the NCCLS format in compliance with regulatory agencies ensuring documentation of manager and Medical Director review annually and at revision. Review performed according to schedule determined by manager and Medical Director.
• Manages the maintenance and operation of the Media Lab document control software.
• Monitors compliance with automated temperature monitoring system.
• Utilizing scientific experience and expertise, provides appropriate guidance and/or resolution for problems (i.e., problems involving analytic instrumentation equipment, tests systems clinical correlation, therapeutic decision making, backup systems, and system performance).
• Plans, evaluates and implements new or different methodologies and technology that enhance or expand laboratory services.
• Provides oversight for the interview process by coordinating candidate selection with input from hospital staff.  Determines selection of the appropriate candidate to maintain desired staff in accordance with departmental specifications for the position(s) being considered.
• Provides oversight for the orientation of all testing personnel to ensure that they can effectively perform procedures in accordance with laboratory standards.
• Provides oversight of the counseling and disciplinary action process by coordinating activities with input from hospital staff, such as Human Resources personnel, the Senior Administrative Director, Chief of Laboratory Medicine and Pathology, and the managers and other personnel as needed.  Executes disciplinary action consistent with hospital and departmental policies and procedures. Documents as required.
• Exercises good judgment skills to effectively articulate BMCs organizational values and to foster a cooperative spirit among the staff with regard to people within and outside the department.
• Establishes and documents a regimen for assuring the on-going proficiency of the technical staff on, at least, an annual basis.  The program should include the following:  technical procedures; Laboratory Information System; safety; and departmental policies.
• Provides continuing education opportunities to staff.  Manages and organizes education webinars and other continuing education events. Acts as Clinical Education Manager for the department.
• Supports the department’s educational mission.  Provides support and encouragement to Clinical Instructors, Technical Staff and Support Staff to actively participate in education (i.e., Medical Technology Program, Resident Training program, training of Fellows and Students as applicable). Encourages use of certification training tools such as LabCE in Media Lab.
• Works with other managers to ensure the optimal utilization of the staff for the overall benefit of the department. Facilitates cross training and other programs involved in intersectional cooperation.
• Ensures familiarity with and proper usage of all required safety equipment and monitors need for fit testing.
• Accurately documents staff attendance for payroll purposes and ensure compliance with hospital policy regarding time management.
• Demonstrates a commitment to continue self-development in management skills and scientific knowledge by attending one management and/or scientific workshop per year.
• Demonstrates reliability:  follows hospital and departmental policies and procedures; demonstrates consistent attendance and punctuality at work and departmental meetings; and completes work assignments within assigned time frames.
• Effectively cooperates and communicates with staff, members of other hospital departments, and supervisor(s).
• Communicates with staff through scheduled regular meetings. Ensures agenda precedes meeting and summarizes meeting minutes to staff members via email or other transparent method.
• Works with other supervisors, managers and Medical Directors to achieve common goals.
• Demonstrates willingness to accept instruction, guidance and/or constructive criticism from staff, peers, or supervisor(s).
• Effectively communicates with the medical and nursing staff to ensure the highest quality of service to user departments, individuals and caregivers.
• Serves and leads as a member of the Laboratory Emergency Preparedness Team.
• Demonstrates a concern for patient welfare and a commitment to the mission of the BMC.
• Utilizes hospital's values as the basis for decision making and to facilitate the division's hospital mission.
• Follows established hospital infection control and safety procedures.
• Champions a laboratory and point of care environment that promotes quality and compliance, to ensure patient and employee safety, while providing a technically sound environment to optimize the quality of laboratory services.
• Proves content expertise for accreditation, compliance and good laboratory practices.
• Contributes to departmental goals of improving cost effectiveness, optimization of resources and revenue enhancement.
• Participates in the BMC Performance Improvement Program as designed by regulatory agencies and promoted by the BMC Quality Improvement Department and by Health Center Quality / Performance Improvement Policies.
• Participates in planning, data collection, monitoring evaluation and action on assigned projects within agreed upon time frames. 
• Exhibits innovation in planning improvements/new programs and problem solving in area of responsibility.
• Prepares and implements a customer service program at BMC’s laboratories. Values and responds to customer feedback by taking corrective action to improve suboptimal services.
• Oversees Proficiency testing.
• Provides guidance to managers for implementing a program for the orientation and competency testing of all testing personnel to ensure that they can effectively perform procedures in accordance with laboratory standards.  The program should include the following:  technical procedures; Laboratory Information Systems; safety; and departmental policies.
• Provides recommendations for workstation redesign and ergonomics as needed by the CHCs.
• Reviews (monthly) documentation that all equipment and instrumentation are properly maintained and in good working order.  Ensures that appropriate maintenance and service contracts are in place.
• Must adhere to all of BMC’s RESPECT behavioral standards.
• Performs other duties as needed.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job.  The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

Requires a Bachelor’s degree from an accredited university or college in Medial Technology or related Clinical Laboratory Science which includes successful completion of a supervised course of clinical internship in an approved hospital laboratory, or a Bachelor’s degree in an life science (for example Chemistry, Biology or Biochemistry).

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:

Preferred:

Certification by American Society of Clinical Pathologists (ASCP) or National Credentialing Agency (NCA) or equivalent agency as a Medical Technologist, Clinical Laboratory Scientist, Medical Laboratory Technician, or specialty certification is preferred. Equivalent agency is defined as an agency that requires a degree in science from an accredited college or university with successful completion of an examination for certification. Such agencies include but are not limited to ASCP, NCA, American Medical Technologists (AMT), American Association of Bioanalysts (AAB), Health Education and Welfare (HEW), and American Society of Microbiologists (AMT).

EXPERIENCE:

• Minimum of 5 years full time experience in specific area of charge.
• 3 years of supervisory experience in a clinical laboratory is preferred.
• In depth familiarity with requirements of accrediting agencies, particularly The Joint Commission and College of American Pathologists.

KNOWLEDGE AND SKILLS:

• Outstanding organizational and interpersonal skills as well as strong leadership qualities to effectively manage area(s) of charge.
• In-depth scientific understanding of the area of charge and must be knowledgeable about and able to perform all tasks delineated in the job description of Medical Technologist.

Equal Opportunity Employer/Disabled/Veterans