Director, Regulatory Compliance / 40 Hrs / Pathology / BWH
Brigham & Women's Hospital(BWH)


Job Info


At the Brigham, we place great value on being a diverse and inclusive community. Brigham Health and the Department of Pathology are dedicated to diversity, equity and inclusion as we aim to reflect the diversity of the patients in our local community. We have a dedicated focus on equity. Thus, we believe in equal access to quality care, employment and advancement opportunities encompassing the full spectrum or human diversity: race, gender, sexual orientation, religion, ethnicity, national origin and all the other forms of human presence and expression that make us better able to provide innovative and cutting-edge healthcare and research.

GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.

Under the general direction of the Executive Director and Quality Vice Chair of the Department of Pathology, and working closely with individual Laboratory and Program Directors, as well as Hospital Quality and Safety, directs a wide variety of regulatory areas, safety and quality improvement initiatives for the Department with a focus on risk reduction for the patient populations served and in a safety culture environment. This includes regulatory compliance in all the clinical laboratories at BWH (Blood Bank/Transfusion Medicine, Clinical Laboratories and Anatomic Pathology laboratories), Point of Care testing, Provider Performed Microscopy procedures (PPMP) and oversight of regulatory compliance of all non-departmental CLIA-licensed laboratories at BWH, as well as leading and/or coordinating a number of quality improvement initiatives across the Department. There are approximately twenty-six onsite and twenty- five offsite CLIA certificates distributed across the Hospital campus for laboratory services. The Department includes approximately 600 non-physician staff FTE's; approximately 200 faculty, residents, and fellows. The Department annually produces approximately 5 million billed test results in the Clinical Laboratory and 280,000 billed tests/ reports in Anatomic Pathology, issues 45,000 whole blood and platelet products, and manages over 3,300 therapeutic patient treatments.

PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.

QUALITY MANAGEMENT AND IMPROVEMENT

  • Responsible for maintaining the Department of Pathology quality management program which provides the foundation for laboratory operations. Maintains quality policies and procedures, continuously monitors the program for effectiveness and ensures compliance with regulatory guidelines. Serves as a knowledge expert. Works closely with hospital regulatory compliance through regular meetings to ensure timely filing of safety reports and associated follow up / corrective action.
  • Directs the development and implementation of Quality and Regulatory Compliance training programs for Department of Pathology residents, faculty, staff and non-departmental CLIA licensed laboratories at BWH. This includes enrollment of Department of Pathology laboratory staff in new employee and annual mandatory trainings and tracking completion.
  • Directs the annual Department of Pathology Quality Initiative (QI) and Improvement Program. Reviews laboratory QI biannual summaries and ensure all laboratories initiatives and improvements are reported out annually at the Department of Pathology Quarterly Quality Assurance Meeting. Directs quality improvement initiatives across the Department of Pathology and collaborates with external department leadership on interdisciplinary improvements.
  • Directs the coordination of responses to Department of Pathology complaints and hospital survey action items (e.g. annual patient safety survey). Participates in complaint reviews.
  • Directs the management of quarterly metric dashboards for DFCI and BCH service level agreements (SLA), Department of Pathology safety events, TAT for critical alert value communication, failed Proficiency Testing and SLA metrics from outside reference laboratories. Monitors data for potential improvement. Participates in service level agreement review of required metrics. Working with Pathology IT, develops and monitors quality metric dashboards.
  • Directs the Department of Pathology event and error management program to include reporting, investigating, collaborative case review (approximately 8 annually), tracking and trending. Supports the reporting of errors in a just culture environment. Reviews daily events and identifies harm, near harm/near miss events that require internal investigation and a corrective action plan (approximately 175 safety reports reviewed monthly, 6-8 internal investigations completed monthly). Attends the hospital daily safety huddle and communicates events which directly impact patient care to pathology leadership. Directs the QA review of harm and near harm/near miss investigation with department QA leadership. Conducts event site visits and makes recommendations for additional corrective actions. Reports significant events to BWH Risk Management and other institutions. Trains laboratory staff on the department's safety management process. Directs the granting of department staff appropriate access to the hospital safety reporting system.
  • Directs the development and implementation of Individualized Quality Control Plans (IQCP). Directs the annual review of each IQC plan effectiveness. Directs the annual review of the BWH Laboratory Handbook clinical laboratory reference ranges and oversees the update and upload of the printable reference range list.
  • Leads Quality Assurance and Regulatory Compliance meetings held with QA leadership, QA Compliance Officers, Laboratory Compliance Officers, Operation leadership and Department Chair.
  • Directs recommendations and implementation of quality tools and software to decrease the risk associated with providing safe work environments, quality care to patients and meeting laboratory regulatory requirements. Directs quality tool training and monitoring for effectiveness.
REGULATORY COMPLIANCE
  • Establishes goals for regulatory compliance for the Department of Pathology and all non-departmental CLIA-licensed laboratories at BWH.
  • Directs the development and implementation of the department annual audit plan to include fifty-six CLIA laboratories. Schedules audits, performs audits, reviews audit findings, writes and approves audit reports. Ensures appropriate corrective actions are successfully implemented. Reports high risk findings to Department of Pathology leadership.
  • Directs the monitoring of changes to CLIA, Massachusetts DPH, JC, OSHA, FDA, AABB, FACT and ASHI regulatory standards and implements new regulations and respective interpretations of such regulations and standards. Oversees the education of department leaders on these changes.
  • Directs the laboratory Joint Commission survey readiness efforts, including survey facilitation, working with the regulatory surveyor(s) during surveys and other members of Hospital Administration as necessary. Oversees preparation of all laboratories and decentralized testing areas for successful surveys. After the survey has been completed, ensures that required leadership involvement, root cause analyses and required corrective actions are appropriately completed and documented; Directs the preparation and submission of the response to Joint Commission. Ensures responses are tracked for evidence of success and data collected to document compliance. Provides guidance and support to the Blood Bank, Donor Center and Tissue Typing compliance officers for ASHI, AABB, FACT and FDA inspection preparedness and onsite surveys.
  • Directs the management of the CLIA certificate program to include the application process, qualifying laboratory directors and monitoring certificate expirations and renewals. Oversight for the addition of new tests to CLIA certificates and assessing when CLIA/JC extension surveys are required. Oversees the provision of regulatory support to new laboratories preparing for an extension survey.
  • Serves as the department liaison with other BWH departments as related to quality, patient safety and compliance (e.g. Risk management, Compliance).
SAFETY AND ENVIROMENT OF CARE

  • Directs the Department of Pathology ongoing compliance with laboratory safety and infection control hospital, DPH and OSHA requirements. Confirms appropriate audits are performed and follow-up is completed for noncompliant issues and events. Oversight for maintaining the Department of Pathology Safety Procedure Manual. Ensures quarterly safety meetings are conducted and appropriate education provided to department staff on regulation and policy changes.
  • Directs the provision of guidance to all Department of Pathology laboratories regarding safety, infection control and hazardous material disposal. Acts as a liaison with Department of Environmental Affairs, Emergency Management and Infection Control.
  • Prepares annual safety report to the Care Improvement Council

GENERAL

  • Maintains current information & knowledge of applicable BWH policies, local, state and federal laws and
    regulations, and accreditation standards.
  • Follows all Joint Commission National Patient Safety Goals and related BWH Laboratory and Hospital policies.
  • Performs all other duties, assignments and responsibilities as requested.


Qualifications
  • Requires Bachelor's Degree in medical technology or chemical, physical, or biological science from an accredited college or university. MS, MBA/MPA or related field education/experience highly desirable.
  • MT (ASCP) or equivalent required.
  • HT, HTL, PA (ASCP), and AABB certification highly desirable.
  • QIHC, QLC, SLS, DLM (ASCP) qualification highly desirable.
  • Requires 6 -7 years of work experience in a clinical laboratory or surgical pathology setting. 4-5-years of quality assurance and regulatory compliance experience, to include Joint Commission or College of American Pathologist and other agencies (e.g. CMS, DPH, FDA). 2-4 years of leadership experience.


SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: (MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)

  • Possess in -depth knowledge of laboratory systems, and technical knowledge related to quality control, laboratory regulatory requirements.
  • Very strong organizational skills to be able to manage a wide variety of competing projects, prioritize tasks effectively, and to meet tight deadlines.
  • Strong communication skills to be able to effectively communicate with a wide audience include senior hospital administrators, physician leadership, technician staff, and other hospital personnel.
  • Solid analytical skills to be able to identify a problem or issue, synthesize the key elements for an action plan or recommendation, and to present the information in a succinct and effective manner.
  • Very strong interpersonal skills to be able to work with staff at all levels on issues of a sometimes complex, sensitive, and confidential nature.
  • Solid technical skills to be able to understand technical operational issues and to formulate an effective solution.
  • Leadership skills to be able to bring diverse groups of individuals together around a common set of goals and to create and implement an action plan.

WORKING CONDITIONS: Describe the conditions in which the work is performed.

  • Fast-paced laboratory environment where the high volume of complex testing, frequently time-sensitive, means that decision making needs to take place in a compressed time-frame. Frequently, re-prioritization of existing projects needs to take place.

SUPERVISORY RESPONSIBILITY: List the number of FTEs supervised.

  • Supervise Department of Pathology (1 FTE) Senior Compliance Officer and (1FTE) Compliance Officer. Indirect supervision of (1 FTE) Tissue Typing Compliance Officer, (1 FTE) Compliance Officer in Blood Bank/Transfusion Medicine and (1 FTE) Donor Center Compliance Officer, and other regulatory compliance staff as necessary.


  • FISCAL RESPONSIBILITY: Indicate financial "scope" information, i.e.: size of budget, volume, revenue, etc.

    No direct budgetary responsibility.

    EEO Statement
    Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.



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