Clinical Laboratory Scientist (Quality Manager)

Full Job Description

This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program.

You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appointment.

Program Approval, award amount (up to $200,000) and eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after complete review of the EDRP application.

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: United States Citizenship: Non-citizens may only 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.

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

Please see "Education" section for more details. Certification. Candidates must meet one of the certification options below.

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

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).

Exception for Non-Certified. See "Required Documents" section for details. 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. Grade Determinations: Clinical Laboratory Scientist (Quality Manager), GS-12 (1) Experience.

1 year of creditable experience equivalent to the next lower grade level is required for all GS-12 assignments. (2) Assignments.

For all GS-12 assignments above the FPL, the higher-level duties must consist of significant scope, complexity (difficulty) and range of variety and be performed by the CLS at least 25% of the time.

Candidates at this grade level are in one of the following assignments. Clinical Laboratory Scientist (Quality Manager).

The CLS 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).

The CLS ensures the laboratory maintains continuous readiness and supports the organization's performance improvement and patient safety programs.

The CLS 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.

This individual develops, implements, and performs quality management policy review.

The CLS advises lab management on quality management concerns that could impact other services and assists with the necessary follow ups.

The CLS identifies current lab functions needing improvement and develops a plan with associated individuals to implement change and monitor improvement.

The CLS uses comprehensive knowledge for statistical evaluation and analysis and understands laboratory operations and the laboratory's relationship to the organization.

The CLS follows laboratory quality control/assurance practices based on policies, procedures, and principles.

The individual 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.

The CLS provides oversight, guidance, and advice to develop required quality assurance monitors and focused reviews.

This individual 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.

The CLS 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.

The CLS implements surveillance procedures to monitor variables that affect quality of services.

The CLS is skilled in evaluating, interpreting, and teaching others to use quality control procedures and implement corrective actions. Knowledge, Skills, and Abilities.

In addition to the experience or education above, the candidate must demonstrate the following KSAs: 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.

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, which is the actual grade at which an applicant may be selected for this vacancy. Major Duties:

Total Rewards of a Allied Health Professional The incumbent serves as a Clinical Laboratory Scientist (CLS) Quality Manager within the Pathology and Laboratory Medicine Service at James J.

Peters VA Medical Center in the Bronx, NY.

They ensure compliance with clinical laboratory standards like Joint Commission (JC), The College of American Pathologists (CAP), and the Office of Inspector General (OIG), maintaining continuous readiness and supporting performance improvement and patient safety programs.

They monitor and enhance laboratory quality through policy reviews, statistical evaluations, and quality assurance practices, advising management on concerns and implementing improvements.

The incumbent will also provide oversight and consultative services for quality assurance activities, develop action plans, and ensure compliance with policies, while teaching quality control procedures and corrective actions.

Duties and tasks include but are not limited to the following: Demonstrates 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.

Demonstrates knowledge of accrediting agencies and regulatory requirements pertaining to laboratory operations. Demonstrates knowledge of laboratory operations and relationships to the organization.

Demonstrates skill in applying laboratory quality control/assurance policies, procedures, and principles and safety practices and regulations.

Demonstrates ability to apply quality management performance improvement principles, methodology, and processes to develop and manage a clinical laboratory quality management program.

Demonstrates ability to apply statistical evaluation and analysis to quality assurance data and implement corrective actions when indicated.

Compiles and analyzes the data for medical center, VISN, and national performance measures and monitors as necessary and upon request of the groups needing such data.

Compiles and analyzes data for medical technology quality monitors and distributes data to appropriate groups.

Acts as the Laboratory Safety Officer, maintaining the safety and chemical hygiene policies and procedures. Performs weekly/monthly eyewash and shower maintenance and documents as required.

Performs hazard assessments as required and ensures the semi-annual hazardous chemical inventory is completed for all laboratory sections.

Coordinates with the Industrial Hygienist and the GEMS Coordinator to ensure compliance with GEMs initiatives, reducing chemical waste and ensuring timely chemical waste removal from the laboratory.

Prepares agenda and all quality metrics for the laboratory monthly Quality and Safety Meetings. Documents minutes and provides to the laboratory administrative team for reference.

Serves as the laboratory point of contact for record retention, EILs, and equipment turn-in. Manages the laboratory electronic document control system.

Serves as the laboratory point of contact for the proficiency testing program. Ensures the laboratory activity menu remains updated and orders proficiency testing as required.

Responsible for new employee orientation for all staff new to the laboratory service. Follows all safety and infectious disease policies while conducting duties of the position.

Continuously completes medical center and laboratory training and education as required and within the established deadlines.

Takes initiative to solve problems without assistance or transferring of responsibility unless justified.

Maintains a positive attitude, willingness to work as part of a team and is supportive of coworkers. Collaborates and works well with others.

Demonstrates ability to respond and adapt to new processes, procedures, or equipment. Willing to make changes to improve service.

Assists in the preparation for regulatory inspections by reviewing and ensuring compliance with all regulatory requirements and participates in the inspection of in-house and external facilities as required.

Promptly reports all variances, incidents, and/or deviations from policy as required and in accordance with policies and procedures. Work Schedule: Monday - Friday, 8am - 4:30pm