Manager, Quality Assurance

Overview

The Manager of QA and POCT is a highly trained professional who provides quality patient care using technical knowledge and judgement to process specimens: perform clinical laboratory testing; evaluate and report test results. The QA and POCT Manager is also responsible for performing quality assurance, training and other duties to support the laboratory operations. The QA and POCT Manager performs supervisory duties in the absence of the Lab Manager, as assigned.

Responsibilities

• Keeps Lab Administration (administrator and director) advised of all pertinent information. Informs staff of policy and procedural changes in hospital and laboratory. Works with Quest Quality Assurance leaders. Works with Nurse Managers.  Works with Pathologists and Section Heads for CAP and Quest inspections.  Keeps CAP records updated.
• Administers the POC program. Writes policies and procedures related to POC testing. Administers P.T. for POC. Develops training and competency assessments for staff performing POC testing. Orders reagents and ensures adequate supplies are available for all testing areas. Conducts annual review of POC procedures. Works with Quest POC team. Attends Quest POC meetings.  Works with the Satellite ED for POC testing. 
• Administers P.T. program for the laboratory. Writes policies and procedures for laboratory. Maintains the document control system for the laboratory procedures. Prepares reports as required by Quality Management and accrediting agencies (Quarterly and annual PI reports, annual review of effectiveness of CHP and Safe Work Practices, BBP plan, QI plan) Responsible for Safety Committee and maintaining records. Attends meetings for Quest Quality Assurance.  Attends administrative hospital huddle meeting when lab director is unavailable.  Reviews and answer OneLink reports for Risk Management. 
• Direct, advocate for and enable visibility of quality processes. Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality. Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department supervisors and members of the Quality Assurance (QA) Committee.
• Direct internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards. Review and ensure that corrective action is implemented when non-conformances are found.
• Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites.
• Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations. Collaborate with business unit management even if primary responsibility has not been assigned to QA.
• Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.
• Ensure that a Validity Check program is in place, as well as a Blind Samples resubmission program, if applicable.
• Ensure that a defined instrument to instrument, method to method, and laboratory to laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually. Quality Assurance/Quality Improvement
• Conduct monthly QA meetings with required participation by all areas having an impact on pre-analytical, analytical and post-analytical phases of testing (exception Billing). Create effective materials (e. g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.
• Ensure that each department has a comprehensive Quality Improvement plan with monitors and that each department communicates their metrics and implements appropriate actions.
• Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.
• Prepare, revise and distribute a QA Manual that includes local QA policies. Ensure all applicable employees are trained and comply with policies. Ensure all QA policies have annual review.
• Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.
• Ensure performance of required Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance (NQA). Quality Control
• Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate. Quality Assurance Initiatives
• Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations.
• Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results. Ensure the process is in place, up to date, distributed and that all personnel are in compliance.
• Ensure prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable.
• Ensure complete tracking of revised reports in compliance with the SOP and ensure effective corrective action.
• Ensure compliance with all NQA standards as required.

Qualifications

Required Work experience:

Minimum 6 years Clinical laboratory experience.

Education

B.S. Degree in Medical Technology or B.S. in related field, plus one-year internship in an approved school of medical technology

Knowledge: 

• Writes responses to PT and inspection deficiencies.
• Works with hospital and Quest Safety officers in maintaining Safety Data Sheets.
• Knowledge of CAP, CLIA and ISO standards and regulations.
• Basic theoretical and operational job knowledge in quality assurance and laboratory operations.
• Knowledge of organizational/departmental policies and procedures.
• Demonstrates knowledge of current company policies and procedures.
• Assists with completion of licensure and inspection forms.
• Works with Pathologists and section heads in updating procedures and staff in Media Lab (Document Control for Laboratory Procedures). Works with section heads in completing requirements for new testing.
• Knowledge of CAP, CLIA and ISO standards and regulations.
• Demonstrates knowledge of current local, state, and federal requirements.
• Demonstrates initiative and strong problem-solving skills, teamwork, and interdepartmental collaboration. 

Skills:

• Demonstrate leadership skills through accountability, integrity, and collaboration in daily tasks.
• Excellent interpersonal and communication skills (oral and written) necessary to effectively interact with all levels of staff.
• Project a positive, professional demeanor.
• Communicate with employees in a manner that creates an informed, positive environment.
• Facilitate efforts to work with others in a way that promotes teamwork and change.
• Must be detail-oriented, have the ability to work independently, establish work priorities and to handle several tasks simultaneously.
• Strong organizational and prioritization skills.
• Proven problem-solving skills with the ability to develop appropriate resolutions.
• Proficiency in Microsoft Office (Word, Excel and Outlook, Google) and Laboratory Information Systems. 

LICENSECERTIFICATIONS:

ASCP Preferred

EEO

Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.