Clinical Laboratory Scientist (Quality Manager)

01Basic Requirements

United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy.

02Education

A bachelor's degree or higher from an accredited college or university.

03Certification

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. 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:(1) 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. (2) 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. (3) 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. (4) 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. (5) 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.

04Grade Determinations

Clinical Laboratory Scientist (Quality Manager), GS-12.

05Experience

1 year of creditable experience equivalent to the next lower grade level is required for all GS-12 assignments. Knowledge, Skills, and Abilities: In addition to the experience or education above, the candidate must demonstrate the following KSAs: (A) 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. (B) Knowledge of accrediting agencies and regulatory requirements pertaining to laboratory operations. (C) Knowledge of laboratory operations and relationships to the organization. (D) Skill in applying laboratory quality control/assurance policies, procedures, and principles and safety practices and regulations. (E) Ability to apply quality management performance improvement principles, methodology, and processes to develop and manage a clinical laboratory quality management program. (F) Ability to apply statistical evaluation and analysis to quality assurance data and implement corrective actions when indicated.

06Preferred Experience

A bachelor's degree in Medical Technology, Clinical Laboratory Science, or Medical Laboratory Science. MT(ASCP) or MLS(ASCP). Demonstrated experience leading or managing clinical laboratory quality assurance and quality improvement programs, including the development, implementation, and monitoring of policies to ensure ongoing compliance with national regulatory and accreditation standards (e.g., CAP, The Joint Commission, CLIA).

Extensive knowledge of advanced laboratory principles and practices across multiple disciplines, with a proven record of developing and overseeing corrective action plans, conducting root cause analyses, and implementing process changes to enhance laboratory performance and patient safety.

Strong leadership, communication, and interpersonal skills, with experience collaborating with multidisciplinary teams, mentoring laboratory staff, and providing education and training in quality management principles and best practices. Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. The full performance level of this vacancy is 12. The actual grade at which an applicant may be selected for this vacancy is GS-12.

07Physical Requirements

Physical aspects associated with work required of this assignment are typical for the occupation, see Duties section for essential job duties of the position. May require standing, lifting, carrying, sitting, stooping, bending, puling, and pushing. May be required to wear personal protective equipment and undergo annual TB screening or testing as conditions of employment.

Work Environment: Work is performed in an office/clinic setting with minimal risks that requires normal safety precautions; the area is adequately lighted, heated, and ventilated. However, the work environment requires someone with the ability to handle several tasks at once in sometimes stressful situations.

In addition to the duties and functions of a Full Performance Level Clinical Laboratory Scientist (CLS), the incumbent serves as the Quality Manager for the Service. The Quality Manager is responsible for developing, implementing, and monitoring quality management programs to ensure laboratory services meet all regulatory and accreditation standards.

They lead quality assurance and performance improvement initiatives, analyze data to identify trends and drive corrective actions, and oversee document control and proficiency testing programs. Duties include, but not limited to: Develops, implements, reviews, and facilitates the planning of quality management policies and procedures for the laboratory. Measures physician, nursing, and patient satisfaction with laboratory services.

Evaluates and implements new techniques/procedures, including development of validation plans using statistical methods. Identifies areas requiring improvement or deficiencies, proposes solutions, develops implementation plans, monitors progress, and evaluates outcomes. Formulates measures for data collection and analysis to assist or correct problem areas. Advises laboratory management on quality management concerns impacting other services and assists with follow-up.

Applies statistical evaluation and analysis to QA data; performs trend analysis, standard deviation, and corrective actions as indicated. Responds to national accreditation agencies {including VHA Clinical Laboratory Scientist Quality and Compliance Agent), VISN inquiries, surveys, and questionnaires. Acts as Laboratory Safety Officer; maintains safety, chemical hygiene, and infection control policies.

• Provides education and training to all laboratory staff in technical competencies, including data collection, analysis, and relevant statistical methods.
• Maintains competency in at least one laboratory section (Blood Bank, Chemistry, Hematology, Microbiology/Molecular, Point of Care Testing) and performs testing as assigned.
• Ensures compliance and documentation of accreditation requirements (CAP, TJC, FDA, etc.).
• Manages proficiency testing programs and coordinates analysis of survey data.

Provides quarterly and/or annual quality reports to the Chief, Pathology and Laboratory Medicine and the Pathology Laboratory Manager. Work Schedule: Monday-Friday 07:30am-4:00pm with occasional weekends and holidays; Subject to change based on the needs of the facility. Telework: Not Available Virtual: This is not a virtual position. Functional Statement #: 01596-F Relocation/Recruitment Incentives: Not Authorized EDRP Authorized: Former EDRP participants ineligible to apply for incentive.

Contact [email protected], the EDRP Coordinator for questions/assistance. Learn more Permanent Change of Station (PCS): Not Authorized