Summary The Clinical Laboratory Scientist (CLS) Quality Manager 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. Responsibilities Major duties include, but are not limited to: Collaborates with Laboratory Supervisors/Team Leaders to create and apply reengineering and continuous performance improvement initiatives, both within the laboratory and/or the organization. Serves as a recognized expert and provides authoritative advice and consultative services to management at all levels of the organization. Partners with laboratory supervisory/management officials to maintain a laboratory performance improvement program and ensure monitoring of components and customer feedback to: Implement effective processes and system controls to ensure the highest possible product quality, service quality, and patient safety. Detect and prevent errors in laboratory practice. Reduce process variations that can cause errors. Improve efficiency of processes without sacrificing quality or safety. Comply with all applicable laws, regulations, policies, precedents, and accreditation requirements. Chairs a monthly laboratory quality meeting. Assists in identifying, defining, and resolving issues associated with complex aspects of collected data. Prepares Quarterly and Yearly QA reports and submits to the appropriate management officials within the organization. Ensures facility inspection readiness by conducting mock inspections and audits, completing regulatory checklist items, and providing feedback to the supervisory team about potential areas of failure. Interacts with supervisory/management officials, test reagent and instrumentation manufacturers, and with organizations involved in inter-laboratory quality assurance and proficiency testing. Serves as Laboratory Safety Manager Ensures all sections meet safety procedures and protocols of various regulatory agencies Maintains and updates safety manuals, chemical hygiene plan, and safety in-service training programs. Documents accidents and recommends improvements. Ensures laboratory adheres to all practices and regulations related to workplace safety. Performs periodic inspections. Maintains current safety, disaster, and chemical hygiene standard operating procedures. Ensures employees have received safety training and maintains documentation. Documents accidents and recommends improvements. Represents laboratory on appropriate medical center committees (Safety committee and Gems); and interacts with other medical center staff, such as the industrial hygienist, infection control officer, and biomedical engineers. Serves as Accreditation Agency Administrator Orders appropriate CAP surveys, maintains statistical data on accreditation agencies performance, maintains CAP survey books and serves as the primary CAP proctor. Utilizes the accreditation agencies websites for transactions such as updating test menus, submitting application for inspections, and printing reports and information. Maintains all accreditation agencies certificates. Works with supervisor and staff to ensure continuous readiness for inspections by performing regulatory review and internal assessments Serves as the point of contact for the National PLM Quality and Compliance Agent. Work Schedule: Full Time, 8:00am- 4:30pm, Monday- Friday Recruitment Incentive (Sign-on Bonus): Not Authorized Permanent Change of Station (Relocation Assistance): Not Authorized Paid Time Off: 37-50 days of annual paid time offer per year (13-26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year) Parental Leave: After 12 months of employment, up to 12 weeks of paid parental leave in connection with the birth, adoption, or foster care placement of a child. Child Care Subsidy: After 60 days of employment, full time employees with a total family income below $144,000 may be eligible for a childcare subsidy up to 25% of total eligible childcare costs for eligible children up to the monthly maximum of $416.66. Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement) Telework: Not Available Virtual: This is not a virtual position. Functional Statement #: 000000 Permanent Change of Station (PCS): Not Authorized Requirements Conditions of Employment You must be a U.S. Citizen to apply for this 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. You may be required to serve a trial period. 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 dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Must pass pre-employment physical examination. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications 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 VA Policy. 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. (a) Generalist certification as an MLS given by ASCP BOC or AMT. (b) Generalist certification as an MT given by ASCP BOR or AMT. (c) Categorical certification or Specialist certification by ASCP or AMT. Exception for Non-Certified.(a)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.(b)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).(c)Non-Certified individuals may only provide care under the supervision of a certified CLS at or above the FPL.(d)Non-certified individuals may only be appointed at the entry level and may not be promoted/converted until certification is obtained.(e)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. May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria). Grade Determinations: In addition to the basic requirements for employment, candidates must meet the following grade-determining criteria for placement at grade levels specified. Clinical Laboratory Scientist (Quality Manager), GS-12 Experience. 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: 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: Current working knowledge of laboratory regulatory requirements, with direct experience regulatory inspections. 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: The incumbent must be able to perform moderate lifting up to 20 lbs., straight pulling, pushing, reaching above the shoulder, use of fingers and both hands, walking, standing for up to 4 hours, kneeling, repeated bending, use of both arms and legs. Specific visual requirements include use of both eyes, depth perception, ability to distinguish colors and shades of colors, hearing (aids permitted), clear, high cognitive function and emotional stability; ability to read ordinary @type without strain. Education 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/. Additional Information This occupation is listed on the OIG Determination of Veterans Health Administration's Occupational Staffing Shortages fiscal year (FY) 2025 dated October 1, 2024. Therefore, vacancy announcement is exempt from Veterans Preference. Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. During the application process you may have an option to opt-in to make your resume available to hiring managers in the agency who have similar positions. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions. This job opportunity announcement may be used to fill additional vacancies. This position is in the Excepted Service and does not confer competitive status. VA encourages persons with disabilities to apply. The health-related positions in VA are covered by Title 38, and are not covered by the Schedule A excepted appointment authority. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act.
