Clinical Laboratory Scientist (Quality Manager)

Created at: April 15, 2025 00:31

Company: Veterans Health Administration

Location: Castle Point, NY, 12511

Job Description:

The incumbent serves as a qualified and experienced Clinical Laboratory Scientist, functioning as the Quality Manager for all areas in the laboratory including Blood Bank, Chemistry, Urinalysis, Special Chemistry, Coagulation, Hematology, and Microbiology for both Castle Point and Montrose Campuses in the Pathology and Laboratory Medicine Section (PLMS) of the VA Hudson Valley Healthcare Systems (VAHVHCS).
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. ยง 7403 (f) Education: A bachelor's degree or higher from an accredited college or university. 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: (1) 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 (2) 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 below automatically determines the foreign education as creditable and no further documentation or proof of equivalency is needed. 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. 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). Physical Requirements: See VA Directive and Handbook 5019, Employee Occupational Health Service for requirements. 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 above, applicants must meet the following grade requirements. GS-12 Clinical Laboratory Scientist (Quality Manager) Experience. 1 year of creditable experience equivalent to the next lower grade level is required for all GS-12 assignments. In addition to the experience above, the candidate must demonstrate the following Knowledge, Skills, and Abilities: : (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. Assignment. The CLS serves as a Technical Specialist CLS, providing expert authoritative advice and consultation for more markedly difficult, complex, unique and/or emerging tests that require special knowledge. Examples include, but are not limited to, molecular pathology, gas chromatography/mass spectroscopy, and flow cytometry. The CLS advises all organizational levels on various aspects of specialized testing, including appropriateness that takes into consideration clinical context. The CLS advises on alternate testing to overcome ambiguities in the clinical diagnoses and analyzes emerging trends and technology to adopt appropriate methods and testing. The CLS develops policies, precedents, regulatory, licensing, and accrediting requirements to establish, monitor, and maintain the specialized testing. The CLS assumes responsibility for training and competency assessment of staff and students within the area assigned. The technical specialist often works independently and is given freedom of action under the general guidance of a pathologist or other laboratory practitioner 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. The actual grade at which an applicant may be selected for this vacancy is GS-12. Physical Requirements: See VA Directive and Handbook 5019, Employee Occupational Health Service for requirements.
Principal Duties and Responsibilities Responsible for designing, establishing, maintaining, evaluating, and reporting of a comprehensive Quality Assurance and Continuous Quality Improvement program for the VAHVHCS Pathology and Laboratory Medicine Service Line (PLMS), which meets the requirements of the Joint Commission, AABB, FDA, VHA and the VISN 2 Quality Program. This includes integration of any individual laboratory section plans into an interrelated and integrated QCQI plan for VAHVHCS. Represents PLMS Management on all Clinical Laboratory issues pertaining to education and quality improvement during accrediting agency, federal, state, and VHA inspections. Coordinates and assists staff members with all responses to deficiencies cited by accreditation organizations (Joint Commission, AABB, FDA), state, federal and VHA. Responds to all quality management deficiencies cited by accreditation organizations and VHA. The purpose of the position is to design, maintain and evaluate quality management and improvement systems that assure the medical reliability and timeliness of laboratory data in accordance with clinical, accrediting, and regulatory agency requirements. Provides oversight, guidance, and advice in the development of required Quality Assurance monitors and focused reviews. The QC Coordinator uses judgment in selecting, interpreting and adapting guidelines to establish systems that meet all requirements for quality, reliability, and compliance with accreditation requirements for quality in planning, developing, and implementing a quality control/quality improvement program. The incumbent serves as an authority to PLMS to assure compliance with inspection and accreditation requirements and regulations. Provides guidance and serves as an authority on accreditation regulations. The QC Coordinator must consider many factors or variables that may affect both the complex multi-divisional facility. These factors include the clinical and economic relevance of the issue, the feasibility of monitoring in terms of statistical considerations and the labor required, and the likelihood of detecting significant quality problems. He/she must also consider the possibility of effecting corrective action in response to identified problems. The work has a significant impact on the adequacy of patient care delivery systems, data management, accuracy and timeliness of testing, and quality of services to patients and providers. The work also impacts accreditation of the laboratory by many regulatory agencies, including VHA, Joint Commission, AABB, and FDA. The work also has an economic impact as it promotes efficient utilization of laboratory resources and services. Performs duties as a Clinical Laboratory Scientist Conducts desk audits or site visits, when appropriate, to assess compliance with VHA regulations, accreditation agency regulations, and PLMS policy/procedures. Maintains membership on hospital and Network committees as appropriate, Patient Safety, Quality Management. Serves as PLMS liaison on these committees. Utilize knowledge of mathematics Performs statistical analysis (Variations, Standard Deviation, trend analysis) on Quality Control assurance data collected to identify, document, and take corrective action on out-of-control test results as appropriate. Conducts regular Quality Assurance/Performance Improvement meetings and collates monthly data, looking for trends. Maintains the CAP Proficiency Testing program for PLM&S. Ensures that all Proficiency Exams are logged and tracked in the system. Monitors proficiency testing results for all Laboratory Sections as required by accrediting agencies. Provides guidance and advice to PLMS Section Supervisors on the development of required Quality Assurance monitors and focused reviews. Provides consultative services for laboratory related root cause analysis, healthcare failure mode effect analysis and sentinel events. Coordinates PLMS response to FDA product recalls. Serves as VAHVHCS Laboratory representative for lab related FDA recalls. Provides guidance and advice to PLMS Staff on the development of staff competencies. Initiates annual review of staff competency documents by the Supervisors, Technical Directors and Quality Manager. Benchwork The incumbent is expected to work as a clinical laboratory scientist on the bench for about 70% of the time. However, this may change based on the facility needs. The incumbent may be asked to cover weekend and holidays encompassing two campuses and 7 CBOC's in the Hudson Valley Healthcare System. Performs laboratory testing as assigned. Performs phlebotomy and specimen processing as assigned. Work Schedule: Days 7:30am-4:00pm Telework: Not Available Virtual: This is not a virtual position. Functional Statement #: 12426-F Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized


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