AmeriPath is one of the leading anatomic pathology practices in the United States offering a broad range of testing and information services used by physicians in the detection, diagnosis, evaluation and treatment of cancer and other diseases and medical conditions. At AmeriPath, we believe there is a patient behind every diagnosis. AmeriPath's extensive diagnostics infrastructure includes over 400 pathologists and doctorate-level scientists providing services in over 40 independent pathology laboratories and in more than 200 hospitals across the US.

Does working for the leader in the Health Services industry sound like the professional challenge you are seeking? AmeriPath invests in your personal and professional growth by providing you with education and training opportunities to keep current in your field. The culture is truly collaborative. Everyone's input is valued. You will get the chance to work with bright, highly motivated people.

JOB SUMMARY
Lead, support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with company values and mission.

 
JOB RESPONSIBILITIES

Direct, advocate for and enable visibility of quality processes. 

Ensure accountability within allareas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality. 

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 AmeriPath 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.

Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. 

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.

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 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.

JOB REQUIREMENTS

Bachelor's degree or equivalent (chemical, physical, biological or clinical laboratory science or medical technology) and or combination of Education and three years Quality Assurance experience is required

Experience with Quality Assurance and statistical Quality Control required

At least three years employment in a laboratory setting preferred
Qualification as General Laboratory Supervisor as defined by CLIA ’88 desired

Certification by American Society of Clinical Pathologists (ASCP)(or equivalent) desired

Certification by American Society for Quality (ASQ) desired

Six Sigma Green Belt Training desired

Along with competitive salaries and career growth opportunities, regular full time employees who work at least 32 hours per week are eligible for Health and Dental plans, a vision plan and a 401(k) retirement plan - all of which include company contributions. There are also disability plans available, flexible savings and college savings plans, and tuition reimbursement.

AmeriPath is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.