Laboratory Director

The Laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.

A: Job Specific The laboratory director must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. The laboratory director must ensure that testing systems are developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.

The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. The laboratory director must ensure verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

The laboratory director must ensure laboratory personnel are performing the test methods as required for accurate and reliable results. The laboratory director must ensure the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that the proficiency testing samples are tested as required by CLIA 1988 requirements for proficiency testing. Additionally, the laboratory director must ensure that proficiency testing results are returned within the timeframes established by the proficiency testing program, all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action and that an approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory.

The laboratory director must ensure that all quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. Text BoxThe laboratory director must ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that patient test results are reported only when the system is functioning properly\The laboratory director shall ensure that reports of test results include pertinent information required for interpretation and 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.

The laboratory director must 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 in accordance with the personnel requirements of CUA 1988, Subpart-M-Personnel. The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.

The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.

The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of pre-analytic, analytic and post-analytic phases of testing, that identifies ·which examinations and procedures each individual 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.

B: Company Specific Adheres to dress code, appearance is neat and clean and wears appropriate identification while on duty. Completes annual health, safety, and education requirements. Maintains professional growth and development.

Maintains confidentiality of all patient and/or employee information to assure patient and/or employee rights are protected. Demonstrates knowledge of the principles of growth and development over the life span and the skills necessary to provide age-appropriate care to the patient population served. Reports to work on time as scheduled; adheres to policies regarding notification of absence.

Attends all mandatory in-services and staff meetings. Represents the organization in a positive and professional manner. Complies with all organizational policies regarding ethical business practices.

Communicates the mission, ethics, and goals of the hospital, as well as the focus statement of the department. Maintains current licensure/certification for position, if applicable. Consistently demonstrates Guest Relation’s skills to patients, physicians, visitors, employees, and any other individuals with whom they may come in contact.

Consistently follows departmental and hospital Health, Safety, Security, Hazardous Materials policies and procedures. HIPAA: Conduct job responsibilities in accordance with HIPAA privacy laws, follow hospital policy in provision of patient confidentiality. Able to identify patient confidentiality issues and reports to proper hospital personnel immediately.

Compliance: Conducts job responsibilities in accordance with standards set forth in FHMC Code of Conduct, FHMC policy and procedures, applicable federal and state laws, and applicable standards. Employee must maintain a courteous and respectful attitude toward fellow employees, staff, contractors, vendors and the public at all times. Employee must avoid loud, profane, or unprofessional language at all times during the performance of duties.

It is immediate grounds for termination if Employee engages in misconduct or is incompetent or negligent in the proper performance of duties or is disorderly, dishonest, intoxicated, or discourteous. Knowledge/Skills/Abilities: Excellent oral and written communication and interpersonal skills.