Clinical Laboratory Regulatory Specialist

Summary This position is located in the Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), Center for Clinical Standards and Quality (CCSQ/QSOG),Division of Clinical Improvement and Quality. As a Clinical Laboratory Regulatory Specialist, GS-0644-13, you will coordinate actions regarding certification, recertification, decertification, Medicare terminations, and CLIA application denials, revocations/suspensions of CLIA intermediate sanctions. Learn more about this agency Duties Provide expert interpretation of law and regulations, guidelines, and procedures on laboratory testing to state CLIA Identify and recommend areas for special study regarding laboratory services, such as recommendations for new or revised regulations and guidelines; comparison between onsite review of documentation versus actual test performance. Analyze, develop, and clearly express complex findings, issues, and technical data in oral form. Coordinate and recommend action regarding certification, recertification, terminations, CLIA application denials, revocations/suspensions of CLIA certificates, and alternative sanctions and hearings for laboratories. Requirements Conditions of employment You must be a U.S. Citizen or National to apply for this position. You will be subject to a background and suitability investigation. Selective Service: Males born after December 31, 1959, must be registered or exempt from Selective Service-http//www.sss.gov One-year probationary period may be required. If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) form I-9 will be verified through the DHS "E-Verify" System. All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choice. Incumbents must have a current and valid driver's license from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Qualifications ALL QUALIFICATION REQUIREMENTS MUST BE MET BY THE CLOSING DATE OF THIS ANNOUNCEMENT. Your resume (limited to no more than 2 pages) must include detailed information as it relates to the responsibilities and specialized experience for this position. Evidence of copying and pasting directly from the vacancy announcement without clearly documenting supplemental information to describe your experience will result in an ineligible rating. This will prevent you from receiving further consideration. In order to qualify for the GS-13, you must meet the following: You must demonstrate in your resume at least one year (52 weeks) of qualifying specialized experience equivalent to the GS-12 grade level in the Federal government, obtained in either the private or public sector, to include: (1) Developing, evaluating, or implementing activities of health quality and safety standards for laboratories under Clinical Laboratory Improvement Amendments (CLIA) and (2) Coordinating CLIA inspections of laboratories to review their compliance with requirements of the CLIA by state agency CLIA surveyors or Federal CLIA surveyors. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills, and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education Education Requirement: In addition to meeting the qualification requirements, all candidates must have the following educational requirements: Basic Requirements Education A. A Bachelor's or graduate/higher level degree from a regionally accredited college/university including courses in biological science, chemistry and mathematics, AND successful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. OR B. A full 4-year course of study that included 12 months in a college or hospital-based medical technology program or medical technology school approved by a recognized accrediting organization. The professional medical technology curriculum may have consisted of a 1-year post- bachelor's certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor's in medical technology. OR C. A Bachelor's or graduate/higher level degree from an accredited college/university, including 16 semester hours (24 quarter hours) of biological science (with one semester in microbiology), 16 semester hours (24 quarter hours) of chemistry (with one semester in organic or biochemistry), one semester (one quarter) of mathematics, AND five years of full time acceptable clinical laboratory experience in Blood Banking, Chemistry, Hematology, microbiology, Immunology and Urinalysis/Body Fluids. This combination of education and experience must have provided knowledge of the theories, principles, and practices of medical technology equivalent to that provided by the full 4-year course of study described in A or B above. All science and mathematics courses must have been acceptable for credit toward meeting the requirements for a science major at an accredited college or university. Acceptable experience is responsible professional or technician experience in a hospital laboratory, health agency, industrial medical laboratory, or pharmaceutical house; or teaching, test development, or medical research program experience that provided an understanding of the methods and techniques applied in performing professional clinical laboratory work. Certification/licensure as a medical technologist (generalist) obtained through written examination by a nationally recognized credentialing agency or State licensing body is a good indication that the quality of experience is acceptable... TRANSCRIPTS are required to verify satisfactory completion of the educational requirement listed above. Please see "Required Documents" section below for what documentation is required at the time of application. Click the following link to view the occupational questionnaire: https://apply.usastaffing.gov/ViewQuestionnaire/12954016 Additional information Bargaining Unit Position: Yes- American Federation of Government Employees, Local 1923 Tour of Duty: Flexible Recruitment Incentive: Not Authorized Relocation Incentive: Not Authorized Financial Disclosure: Not Required OPM GS Pay Table: Atlanta GA. $112-556-$146,325 Denver CO. $118,675-$154,280 Kansas City MO. $108,173-$140,627 Philadelphia PA. $117,284-$$152,471 Seattle WA. $119,630-$155,521 Workplace Flexibility at CMS: This position has a regular and recurring reporting requirement to the CMS office listed in this announcement. CMS offers flexible working arrangements and allows employees the opportunity to participate in alternative work schedules at the manager's discretion. The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced federal employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit the required documentation and be rated well-qualified for this vacancy. Click here for a detailed description of the required supporting documents. A well-qualified applicant is one whose knowledge, skills and abilities clearly exceed the minimum qualification requirements of the position. Additional information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at www.opm.gov/rif/employee_guides/career_transition.asp. RPL Eligibility Required Documents: The following documents are required to verify your RPL eligibility: 1) Your most recent SF-50 (Notification of Personnel Action), or equivalent, as stated in the job announcement that shows position occupied (block #34 of your SF-50), tenure, grade and step, salary, and full performance level; 2) Your SF-50 showing Separation - RIF. If that is not available yet, then official documentation of your Reduction in Force (RIF) separation notice or a proposed removal/separation notice; AND3) Your latest performance rating and rating of record (if separate documents) showing your rating score as at least fully successful or equivalent. Expand Hide  additional information Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. Benefits A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.