SUMMARY: Responsible for the overall operation of the lab and the competency of all laboratory personnel. Maintain compliance with State, Federal and accrediting regulatory requirements, conduct Performance Improvement, Quality Control and supervision of the Laboratory Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Must be accessible to the laboratory to provide on-site, telephone, or electronic consultation as needed.
• May direct no more than five labs.
• Ensure that the physical plant and environmental conditions are appropriate for the testing performed and provide a safe environment from physical, chemical and biological hazards.
• Ensure testing systems provide quality laboratory services for pre-analytic, analytic, and post-analytic phases of testing.
• Ensure test methods selected have the capability of providing quality results.
• Ensure verification procedures used are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method.
• Ensure that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
• Ensure that an approved procedure manual is available to all personnel.
• Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.
• Interview, hire, evaluate, and counsel laboratory staff.
• Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results.
• Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, and receive the appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all testing operations reliable to provide and report accurate results.
• Ensure that policies and procedure are established for monitoring individuals who conduct per-analytical, analytical, and post-analytical phases of testing to verify that they maintain competency to:
• Process specimens
• Perform test procedures
• Report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.
• Provide a written list of responsibilities of each individual in the laboratory that specifies the level of activity each is authorized to perform; whether supervision is required for specimen processing, test performance, or results reporting; and whether consultant or director review is required prior to reporting patient test results.
• Ensure that the laboratory is enrolled in an approved proficiency testing (PT) program.
• Ensure that PT samples are tested in the same manner as patient samples.
• Ensure that PT results are returned on time to the PT Program.
• Ensure that PT results are reviewed by the appropriate staff and the corrective action plan is followed when PT results are found to be unsatisfactory.
• Ensure that PT samples are performed according to COLA and CLIA regulations prohibiting referral of specimens and communication of results.
• Ensure that quality control and quality assessment programs are established and maintained to identify failures in quality as they occur.
• Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
• Ensure that remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance characteristics are identified. Patient test results are reported only when they system is functioning properly.
• Operate and maintain the clinical analyzers.
• Resolves technical problems and ensures remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
• Identifies training needs and ensures testing personnel received regular in-service training.
• Evaluates the competency of all testing personnel on an ongoing basis.
• Evaluates and documents performance of individuals responsible for testing at six months and twelve months in the first year of employment and yearly thereafter, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual’s performance must be reevaluated for the new test methodology or instrumentation.
• Monitor Quality Control of patient testing, and to generate and distribute patient test result forms.
• Adhere to laboratory’s quality control requirements on all patients testing to ensure accuracy.
• Identify problems and factors that adversely affect test performance and follow the laboratory’s established corrective action policies and procedures whenever test systems are not within the laboratory’s established acceptance levels of performance.
• Assess and verify the validity of patient test results through the evaluation of quality sample values prior to reporting patient results.
• Participate in various committees, meetings, in-service training as required.
• Participate actively in quality improvement programs.
• Reviews all results of tests done for completeness and accuracy.
• Reviews and transmits patient charges for department in compliance with policies and procedures.
• Participates as an active member of the hospital and departmental team to support special projects and activities.
• Maintain acceptable standards of patient treatment.
• Accurately and promptly implements provider’s orders.
• Maintains a professional approach with confidential hospital and patient information and ensures safe patient environment.
• Responsible for the implementation of and compliance with all safety policies and procedures within the department.
• Maintain certifications and continuing education requirements needed to perform job. 
• Miscellaneous duties as assigned requested or required.

QUALIFICATIONS:

• Support the Administrator as part of the leadership team.
• Participates in strategy formulation, strategic plans execution, strategic process improvements, and communication of strategies to all stakeholders.
• Analyzes department performance, trends, existing or new regulatory requirements and their impact on department operations.
• Develop, review, revise and enforce policies, procedures, quality assurance or any other hospital and/or state requirements.
• Plan, direct, coordinate the technical functions and ensure quality work performed.
• Knowledgeable of laboratory policy and procedures for specimen handling and processing, test analysis, reporting and maintaining records of patient test results.
• Knowledgeable of laboratory’s quality control policies.
• Knowledgeable about state and federal regulations of laboratory.
• Supports and enforces infection control policies and procedures.
• Liaison between Lab, patients, all Departments, Administration, Providers and the community.
• Maintain discretion and confidentiality in communications.
• Knowledgeable about policies and procedures regarding reporting and release of protected health information (PHI).

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in Lab Science, minimum. Must be registered by a national registry (AMT, ASCP).
• 2 years lab training or experience in non-waived specialty/subspecialty of service.
• 2 years supervisory experience (required).
• Basic Life Support certificate.

LANGUAGE/READING SKILLS:

• Communicate verbally and technically in writing in English. Legible hand writing is required.

MATHEMATICAL SKILLS:

• Advanced statistical concepts in laboratory medicine.

REASONING ABILITY: Responds to unusual or varied situations that are not covered by existing standards, procedures and precedents. 

WORK ENVIRONMENT: Regularly required to stand, walk, sit, ascend and descend stairs, possess ability to handle, finger or feel objects, tools or controls; reach with hands and arms.  

Must be able to lift 25 pounds from the floor to waist. Specific vision abilities include close vision and the ability to clearly focus vision.