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Clinical Laboratory Regulatory Specialist

Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards & Quality (CCSQ)

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.

Overview

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Accepting applications
Open & closing dates
05/06/2026 to 05/12/2026
Salary
$90,925 - $118,204 per year

This is the BASE salary for the position. Please see "Additional Information" for locality pay rates.

Pay scale & grade
GS 13
Locations
6 vacancies in the following locations:
Denver, CO
Atlanta, GA
Kansas City, MO
Philadelphia, PA
Remote job
No
Telework eligible
Yes—as determined by the agency policy.
Travel Required
25% or less - You may be expected to travel up to 5% for this position.
Relocation expenses reimbursed
No
Appointment type
Permanent
Work schedule
Full-time
Service
Competitive
Promotion potential
13
Supervisory status
No
Security clearance
Not Required
Drug test
No
Position sensitivity and risk
Moderate Risk (MR)
Trust determination process
Financial disclosure
No
Bargaining unit status
Yes
Announcement number
CMS-CCSQ-26-12954016-DE
Control number
867999000

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Duties

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  • 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

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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.

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.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), the responses you provide on the application questionnaire, and the results of the online assessments required for this position. Please follow all instructions carefully. Errors or omissions may affect your rating.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

  • Attention to Detail
  • Customer Service
  • Decision Making
  • Flexibility
  • Integrity/Honesty
  • Interpersonal Skills
  • Learning
  • Reasoning
  • Self-Management
  • Stress Tolerance
  • Teamwork


In order to be considered for this position, you must complete all required steps in the process. In addition to the application and application questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job.

Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on the online assessment may also result in your removal from consideration.

You will be placed in one of the following categories based on category rating and selection procedures if you meet all of the requirements outlined in this job opportunity announcement:
  • Best Qualified - for those who are superior in the evaluation criteria
  • Well Qualified - for those who excel in the evaluation criteria
  • Qualified - for those who only meet the minimum qualification requirements
If you are found to be among the top-qualified candidates, you will be referred to the selecting official for employment consideration.

This is a competitive vacancy announcement advertised under Delegated Examining Authority. Selections made under this vacancy announcement will be processed as new appointments to the civil service. Current civil service employees would therefore be given new appointments to the civil service; however, benefits, time served, and all other Federal entitlements would remain the same.

The category rating process does not add veterans' preference points or apply the "rule of three," but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Veterans' preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent will be listed in the highest quality category (except in the case of professional or scientific positions at the GS-09 level or higher).

Centers for Medicare & Medicaid Services

The Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) works in partnership with the entire health care community to improve quality and efficiency in an evolving health care system and provides leadership in the broader health care marketplace.

CMS' effectiveness depends on the capabilities of a dedicated, professional staff that is committed to supporting these objectives. A career with CMS offers the opportunity to get involved in important national health care issues and be part of a dynamic, fast-paced, and highly visible organization. For more information on CMS, please visit: http://www.cms.gov/.

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

Agency contact information

CMS HR Inquiries
Email
hrinquiries@cms.hhs.gov
Address
Center for Clinical Standards and Quality
7500 Security Blvd
Woodlawn, MD 21244
US

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