Amy Zale Email & Phone Number

White Oak, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Oversees 75 employees and a $100 million budget in implementing the CLIA program at the Federal, state and local levels, including overseeing administration, budgeting, policy development and field operation.• Leads national COVID response, both policy and operations, for the CLIA program.• Leads internal and external stakeholder engagement calls, meetings, conferences in high pressure settings to convey the position of the CLIA program and the Agency during COVID public health emergency.• Works closely with organizational leadership, including CMS Administrator and CCSQ Senior Leadership Team, to strategically affect direction of operations.• Collaborates on annual budget and developed comprehensive plan to accomplish company objectives while staying within budget.• Plans and executes meetings to connect organizational representatives, community members and stakeholders.• Strengthens external relationships and interacted with customers and clients to identify business needs and requirements.

Baltimore, Maryland Area

Serves as policy manager and senior advisor to Clinical Laboratory Improvement Amendments (CLIA) Director • Leads quality programs and projects for the CLIA Program.• Supervises and leads work performed by 13 subordinate administrative and professional staff.• Works closely with the Office of Legislation (OL) and the Office of General Counsel (OGC) on any and all clinical laboratory issues.• Provides expert technical advice and assistance to senior managers and staff to assure the accomplishment of the goals and objectives of the strategic plans for CMS, the Centers for Clinical Standards and Quality (CCSQ), the Quality, Safety, and Oversight Group (QSOG), and DCLIQ.• Establishes and maintains relationships and ongoing communication and provides timely oral and written expert guidance, technical assistance and consultation pertaining to CLIA and related data systems to staff, State Agency surveyors, senior leadership, and internal and external stakeholders, including the Department of HHS, The FDA, and the Centers for Disease Control and Prevention.• Performs highly specialized reviews of legislative and administrative proposals relevant to CLIA and survey and certification operations and makes recommendations to senior management to assure CLIA program integrity and intent is maintained.• Leads national COVID response, both policy and operations, for the CLIA program.• Represents DCLIQ and senior CMS officials (QSOG or CCSQ) in conferences, task forces, technical discussions, and consultations with other CMS and departmental components, congressional staffs, and outside professional organizations in resolving issues regarding the agency's position, policy and standards development, enforcement, and data systems design for the CLIA program.• Leads internal and external stakeholder engagement calls, meetings, conferences in high pressure settings to convey the position of the CLIA program and the Agency during COVID public health emergency.

Baltimore, Maryland Area

Responsible for assuring accountability to health care consumers for the necessity, appropriateness and quality of laboratory services.• Oversaw the complete development, evaluation, implementation, and monitoring activities of health quality and safety standards and other healthcare procedures for laboratories under CLIA.• Represented DCLIQ and CMS officials in conferences, task forces, and technical discussions, with other CMS and departmental components.• Communicated effectively, both orally and in writing, in order to develop and deliver presentations, briefing materials, reports designed to convey complex, technical information to diverse stakeholders.• Developed and implemented new policies, regulatory guidance, procedures, and regulations related to the CLIA program.• Developed New Employee Mentoring Program as part of a continuous improvement focus.• Co-lead QSOG employee engagement focus group.

Baltimore, Maryland, United States

Project Management Professional who administered the CLIA Program, wrote policy and regulation to ensure quality laboratory results. Ensured comprehensive compliance with a complex system of laboratory regulatory and accreditation requirements.• Researched and addressed the most complex and exacting regulatory and accreditation compliance issues, including any and all issues related to cutting edge policy and practice of laboratory administration and science.• Researched, analyzed, evaluated, developed, implemented, and monitored program policies related to the CLIA program.• Analyzed policy to determine the impact on program initiatives in conjunction with the Office of Legislation (OL) and the Office of General Counsel (OGC).• Coordinated projects across the Department of Health and Human Services (HHS) in support of the Clinical Laboratory Improvement Amendments (CLIA) program.• Evaluated the effectiveness of existing policies and reviews new policy and legislative initiatives for potential impact on the CLIA program.• Directed, monitored and reported on major projects assigned to DCLIQ workgroups by the Director/Deputy Director.• Researched and defended policy and program issues and prepares and analyzes issue papers for use by, Project Manager for multiple projects across HHS, to include the Tri-Agency Systemic Harmonization and Interoperability Enhancement for Laboratory Data initiative (SHIELD), the Analytic Instruments: Trusted Communications workgroup, and the Tri-Agency Task Force for Emergency Diagnostics (TTFED), with the U.S Food and Drug Administration (FDA) and The Centers for Disease Control (CDC).• Represented the DCLIQ before the Congressional Energy and Commerce Subcommittee.• Researched and prepared documentation for the CMS administrator to reference while testifying before Congress.

Walter Reed Army Institute Of Research

Coordinated projects across organizational lines in support of program Bacterial Diseases Branch and Department Of Defense (DoD) initiatives.• Program Manager who developed the Multi-drug Resistant Organism Repository and Surveillance Network (MRSN) that operated in multiple states and two countries.• Program manager for and provided oversight of program projects to ensure Department of Wound Infections and Department of Defense (DOD) objectives were met.• Maintained an active $25K Government Purchase Card (GPC) and served as an approving official for Department of Defense Government Purchase Card program for four federal government credit card holders.• Authored scientific papers for publication and oral presentations including posters for national and international meetings, and papers in peer-reviewed journals.• Taught the Rapid Diagnostic Testing section of the WRAIR Tropical Medicine Course.• Assisted in the development of didactic material for the Rapid Diagnostic Testing section of the WRAIR Tropical Medicine Course.• Allocated, received approval for and spent $1+ million for reagents, supplies, supporting equipment, software, instrumentation, shipping costs.• Reviewed and evaluated data to determine the safety and efficacy of medical device products and other scientific systems or designs; recommended new policies and guidelines used to evaluate medical device products and scientific systems or designs.• Served as a subject matter expert in Clinical Microbiology and Molecular Epidemiology, evaluated and analyzed the quality and efficiency of microbiological methods and recommending new approaches.• Provided oversight and integrity to meet program initiative by assisting in the inspection process in compliance with the CAP regulations to gain accreditation.

Washington, District Of Columbia, United States

• Coordinated projects across organizational lines in support of program initiatives to include the research, data analysis, and publication of the annual Walter Reed Army Medical Center (WRAMC) antibiogram, worked with the pharmacist, infection control and infectious disease service to create the hospital antibiotic formulary for entire Military Treatment Facility (MTF).• Coordinating research projects and epidemiological studies across organizational lines in support of program integrity initiatives to include collaboration with the Infection Control service and the Infectious Disease Service.• Functioned as a Molecular Epidemiologist and Microbiologist in the Infectious Disease Laboratory (IDL), applying molecular methods to bacterial isolates.• Researched bacterial outbreaks, analyzed data, and coordinated communication across organizational lines.• Providing oversight of research studies by independently performing Pulsed Field Gel Electrophoresis for epidemiological purposes.• Analyzed and evaluated data to determine the safety and efficacy of medical device products and other scientific systems or designs.• Planned, implemented and performed numerous research project in collaboration with multiple services and the Global Emerging Infections Surveillance (GEIS).• Communicated directly with physicians and upper management within the DOD.• Coauthored manuscripts for peer reviewed journals.• Presented results at national meetings.• Performed the full range of clinical laboratory testing procedures and reported results.

American/U.S. Law/Legal Studies/Jurisprudence

Master'S Degree, Project Management

Bachelor Of Science (Bs), Clinical Laboratory Science/Medical Technology/Technologist