Clinical Laboratory Scientist (Quality Manager)

This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months of appointment. Program Approval, award amount (up to $200,000) & eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after review of the EDRP application. Former EDRP participants ineligible to apply.

The Clinical Laboratory Scientist (CLS) (Quality Manager) serves as a consultant, facilitator, trainer, and technical advisor to staff at all levels to ensure facility compliance with clinical laboratory accreditation and regulatory standards that include, but are not limited to: Joint Commission (JC), College of American Pathologists (CAP), and the Office of the Inspector General (OIG).

Duties may include, but are not limited to:

• Ensures the laboratory maintains continuous readiness and supports the organization's performance improvement and patient safety programs.
• Maintains a laboratory performance improvement program.
• Ensures monitoring of components and customer feedback, and interacts with management officials and organizations involved in inter-laboratory quality assurance and proficiency testing.
• Develops, implements, and performs quality management policy review.
• Advises lab management on quality management concerns that could impact other services and assists with the necessary follow ups.
• Identifies current lab functions needing improvement and develops a plan with associated individuals to implement change and monitor improvement.
• Uses comprehensive knowledge for statistical evaluation and analysis and understands laboratory operations and the laboratory's relationship to the organization.
• Follows laboratory quality control/assurance practices based on policies, procedures, and principles. evaluates and implements new techniques and procedures to address laboratory quality including development of validation plans in terms of equipment, method comparison, and establishment of reference intervals using statistical methods and theoretical knowledge.
• Provides oversight, guidance, and advice to develop required quality assurance monitors and focused reviews.
• Provides consultative services for laboratory-related root cause analysis, health care failure mode effect analysis, and sentinel events and develops action plans and outcome measures.
• Establishes processes to monitor compliance with policies, identify patterns and/or trends, and ensure findings from quality management activities and performance improvement initiatives are used to redesign systems to improve quality.
• Implements surveillance procedures to monitor variables that affect quality of services.
• Evaluates, interprets, and teaches others to use quality control procedures and implement corrective actions.

Work Schedule: Monday - Friday, 6:30 a.m. - 3:00 p.m. PST (Hours may vary depending on agency's need.)
Telework: Not Available.
Virtual: This is not a virtual position.
Functional Statement #: 000000
Relocation/Recruitment Incentives: Not Authorized.
EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact VHA.ELRSProgramSupport@va.gov, the EDRP Coordinator for questions/assistance. Learn more
Permanent Change of Station (PCS): Not Authorized.

Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met.

Basic Requirements:

• Citizenship. Be a citizen of the United States (U.S.). Non-citizens may be appointed when it is not possible to recruit qualified citizens in accordance with 38 U.S.C. § 7407(a)
• English Language Proficiency. Candidates must be proficient in spoken and written English in accordance with 38 U.S.C. § 7403 (f).
• Education. A bachelor's degree or higher from an accredited college or university.
• Certification.
  • Candidates must meet one of the certification options below.
    • Generalist certification as an MLS given by ASCP BOC or AMT.
    • Generalist certification as an MT given by ASCP BOR or AMT.
    • Categorical certification or Specialist certification by ASCP or AMT.

NOTE: Categorical and specialist certifications are not acceptable for CLS Generalist positions or lab sections unrelated to the categorical or specialist certification held. Categorical or specialist certifications are acceptable for higher-graded positions within the relevant lab section or one of the non-section specific assignments (including, Ancillary Testing Coordinator, Education Coordinator, Laboratory Information Manager, Quality Manager, Laboratory Manager, Regional Technical Specialist, National Quality and Compliance Agent, Regional Program Manager, Regional Director, Laboratory Director, or National Quality and Compliance Officer).

• Certification cont.
  • Exception for Non-Certified.
    • Applicants who do not currently hold valid certification may be hired by VA and actively work toward their certification if they meet one of the routes identified in Appendix A that makes them eligible to take the MLS certification exam through the ASCP BOC or the MLS certification exam through AMT Certification Agency.
    • Non-Certified applicants who otherwise meet the eligibility requirements for licensure may be given a temporary appointment CLS under the authority of 38 U.S.C. § 7405(c)(2).
    • Non-Certified individuals may only provide care under the supervision of a certified CLS at or above the FPL.
    • Non-certified individuals may only be appointed at the entry level and may not be promoted/converted until certification is obtained.
    • Temporary appointments of non-certified CLS may not be extended beyond 2 years or be converted to a new temporary appointment.

Failure to Obtain Certification. In all cases, CLSs must actively work to meet requirements for certification starting from the date of their placement into the occupation. At the time of appointment, the Human Resources (HR) Office staff, in collaboration with the supervisor, will provide the employee with the written requirements for certification, including the time by which the certification must be obtained and the consequences for not becoming certified by the deadline. Failure to obtain certification during this time period may result in separation from employment.

Loss of Credential. If an employee fails to maintain the required certification, management officials, in collaboration with HR Office staff, must immediately remove the employee from duties and responsibilities associated with this occupation. This may also result in separation from employment.

• If a CLS currently has, or ever had, their CLS certification revoked, suspended, denied, restricted, limited, or issued/placed in a probationary status, HR Office staff must appoint them according to the provisions in VA Handbook 5005, Part II, Chapter 3, Section B, paragraph 16.

Grandfathering Provision. Employees in VHA in this occupation under a permanent, appropriate, and legal placement on the effective date of this qualification standard, are considered to have met all qualification requirements for the grade and/or assignment held, including positive education and certification where applicable. For employees who do not meet all the basic requirements of this standard but met the qualifications applicable to the position at the time they were appointed, the following provisions apply:

• Employees may be reassigned, promoted up to and including the full performance (journey) level, or be changed to a lower grade within the occupation but may not be promoted beyond the journeyman level or newly placed in supervisory or managerial positions.
• If an assignment above the FPL requires an additional certification over and above the basic requirements, employees must meet the assignment-specific requirement before they can be promoted.
• Employees who are appointed on a temporary basis prior to the effective date of the qualification standard may not have their temporary appointment extended or be reappointed on a temporary or permanent basis until they fully meet the basic requirements of the standard.
• Employees retained in this occupation under this provision who subsequently leave the occupation lose protected status and must meet the full VA qualification standard requirements in effect at the time of re-entry to the occupation.
• Employees initially grandfathered into this occupation who subsequently obtain certification that meets all the basic requirements of this qualification standard must maintain the required credentials as a condition of employment in the occupation.

NOTE: This provision is not intended to regularize appointments/ placements.

GS-12 Grade Determinations: In addition to the basic requirements for employment, candidates must have one year of creditable experience in the federal government or equivalent to the next lower grade level (GS-11). Examples of Specialized Experience include, but not limited to: Develops, performs, evaluates, interprets, correlates, and validates the accuracy of laboratory procedures and results in line with current laboratory regulatory requirements; Performs variety of laboratory specialties such as chemistry, microbiology, immunology, hematology, and immunohematology samples using manual or automated methods; Conducts quality control and routine maintenance of instrumentation and troubleshooting; Correlates abnormal lab data with pathological states; Determines the validity of test results, and the need for additional tests; Monitoring quality control systems and measures, collaborating in the diagnosis and treatment of patients.

Knowledge, Skills and Abilities. In addition to the specialized experience, candidates must demonstrate the following Knowledge, Skills, and Abilities (KSA's):

• Knowledge of the concepts, principles, and practices of medical technology sufficient to perform the full range of duties involved in planning, or coordinating, and evaluation.
• Knowledge of the concepts, principles, and practices of medical technology sufficient to perform the full range of duties involved in planning, coordinating, and evaluating laboratory services.
• Knowledge of accrediting agencies and regulatory requirements pertaining to laboratory operations.
• Knowledge of laboratory operations and relationships to the organization.
• Skill in applying laboratory quality control/assurance policies, procedures, and principles and safety practices and regulations.
• Ability to apply quality management performance improvement principles, methodology, and processes to develop and manage a clinical laboratory quality management program.
• Ability to apply statistical evaluation and analysis to quality assurance data and implement corrective actions when indicated.

Preferred Experience:

• Possess skill, knowledge and experience working in a Clinical Laboratory in the Department of Corelab.

Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/.

The full performance level of this vacancy is GS-12.

Physical Requirements: See VA Directive and Handbook 5019, Employee Occupational Health Service for requirements.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.

Foreign Education. To be creditable, education completed outside the U.S. must be deemed at least equivalent to that gained in a conventional U.S. program by a private organization specializing in the interpretation of foreign educational credentials. Graduates of foreign baccalaureate degree programs meet the educational requirements if they meet either of the following:

• Foreign transcripts are evaluated by an acceptable evaluation agency, and the degree is found to be equivalent to a NAACLS-approved U.S. clinical laboratory science degree program. OR
• The applicant submits a letter from ASCP BOC or AMT stating the individual is eligible to take the certification examination.

NOTE: Possession of a certification identified above automatically determines the foreign education as creditable and no further documentation or proof of equivalency is needed.

• You must be a U.S. Citizen to apply for this job.
• To be considered for this position, you must complete all required steps in the process. In addition to the application and questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job.
• All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA.
• Selective Service Registration is required for males born after 12/31/1959.
• Must be proficient in written and spoken English.
• Subject to background/security investigation.
• Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP).
• Complete all application requirements detailed in the "Required Documents" section of this announcement.

As a condition of employment for accepting this position, you will be required to serve a 1 or 2-year trial period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider:

• your performance and conduct;
• the needs and interests of the agency;
• whether your continued employment would advance organizational goals of the agency or the Government; and
• whether your continued employment would advance the efficiency of the Federal service.

Upon completion of your trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.