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, accurate, and proficiently and for assuring compliance with the applicable regulations. Registered as the center Laboratory Director with CLIA.
1 Reviews, understands, and complies with all CSL Plasma Services policies and procedures. Maintains
confidentiality with respect to employee, donor, and center records during the course of all duties. Maintains high
medical standards and ensures that current good manufacturing practices (cGMPs) are adhered to through
collaboration with center management, center quality unit, and involvement in overall center activities.
2 Serves as or delegates to another appropriate employee the duties of “Laboratory Director”, “Technical
Consultant”, and “Clinical Consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988
regulations (CLIA). May be required to provide direct oversight of total protein testing.
3 Must be accessible to the center to provide onsite, telephone or electronic consultation
as needed.
4 Directs no more than 5 laboratories or number per state requirements.
5 Functions as the Technical Consultant, Clinical Consultant and Testing Personnel if qualified or delegates these responsibilities to qualified individuals.
6 Ensures testing performed in the laboratory provides quality test performance. Ensures an appropriate and safe environment for testing.
7 Ensure procedures and changes in procedures are approved before use.
8 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.
9 Specify in writing the responsibilities and duties of CLIA personnel
10 Ensures test methodology have the capability of providing quality results.
11 Review test and control data to ensure verification procedures are adequate to determine accuracy, precision and performance including the establishment and review of the center’s normal reference interval.
12 Observe laboratory personnel to ensure test methods are performed as required for accurate and reliable results.
13 Monitor the completion and results of Proficiency Testing.
14 Ensures quality programs are established, maintained and identify failures as they occur.
15 Ensures adequate analytical performance for the test system by reviewing the Quarterly Control Procedures Report.
16 Ensures all necessary corrective actions are taken and documented when significant deviations occur.
17 Ensures prior to testing all personnel have the appropriate education, experience and training and have demonstrated they can perform testing operations reliably.
18 Ensures approved procedure manual is available for any aspects of the testing process.
19 Ensures reports of test results include pertinent information required for interpretation.
20 Ensures counselling is available for test results reported.
MD, DO, or DPM with a license to practice medicine, osteopathy, or podiatry
in the state in which the laboratory is located and must have one of the
additional qualifications listed below:
laboratory testing.
education (CME) credit hours in laboratory practice or laboratory
training equivalent to 20 CMEs.
a Laboratory Director if he had laboratory experience during medical
residency. Time spent in research or teaching can be counted as
experience and need not occur subsequent to graduation.
Pathology or the American Osteopathic Board of Pathology.
PhD in a chemical, physical, biological, or clinical laboratory science AND
meet one of the additional qualifications listed below:
American Board of Clinical Chemistry, the American Board of
Bioanalysis, or the American Board of Medical Laboratory
Immunology.
laboratory testing.
Education:
Master’s degree in a chemical, physical, biological, clinical laboratory science
or medical technology AND meet both of the additional qualifications listed
below:
non-waived testing.
testing.
Bachelor’s degree in a chemical, physical, or biological science or medical
technology AND meet both of the additional qualifications listed below:
non-waived testing
testing
MD, DO, or DPM with a license to practice medicine, osteopathy, or podiatry
in the state in which the laboratory is located and must have one of the
additional qualifications listed below:
laboratory testing.
education (CME) credit hours in laboratory practice or laboratory
training equivalent to 20 CMEs.
a Laboratory Director if he had laboratory experience during medical
residency. Time spent in research or teaching can be counted as
experience and need not occur subsequent to graduation.
Pathology or the American Osteopathic Board of Pathology.
PhD in a chemical, physical, biological, or clinical laboratory science AND
meet one of the additional qualifications listed below:
American Board of Clinical Chemistry, the American Board of
Bioanalysis, or the American Board of Medical Laboratory
Immunology.
laboratory testing.
Master’s degree in a chemical, physical, biological, clinical laboratory science
or medical technology AND meet both of the additional qualifications listed
below:
non-waived testing.
testing.
Bachelor’s degree in a chemical, physical, or biological science or medical
technology AND meet both of the additional qualifications listed below:
non-waived testing
testing
SPECIFIC TO PUERTO RICO
Any of the healthcare professionals specified below shall be able to serve as Director of a Clinical Analysis Laboratory, Blood Bank and Transfusion Services:
o Licensed Physician with a valid Professional Certificate of Registration;
o Certified or eligible to be certified by the American Board of Pathology or qualifications equivalent to this requirement; and
o Certified by the Board of Medical Examiners of Puerto Rico as clinical pathologist.
o Specialist physician certified or eligible to be certified by the National Board of his or her specialty and authorized by the Board of Medical Examiners of Puerto Rico to practice that specialty in Puerto Rico, who shall only be able to lead a laboratory within his or her specialty; and
o Have at least one year of training in the laboratory during the medical residence or have at least two (2) years of experience leading or supervising a laboratory.
o Possess a valid license and Professional Certificate of Registration and that on or before February 28, 1992, served as director of a laboratory or met the requirements to be a director in accordance with the current regulation and Law; or
o Possess a doctorate’s degree in clinical laboratory sciences or in one of the clinical analysis specialties from a duly accredited institution and be certified by the Board approved by HHS; or that before February 24, 2003, served or was serving as director of a laboratory and had at least two (2) years of training or experience, or both, and two (2) years of experience leading or supervising a laboratory; or
o Possess a master’s degree in medical technology with at least two (2) years of experience in the laboratory, one (1) of which must be in supervision, or possess a certificate or bachelor’s degree in medical technology with at least four (4) years of experience in the laboratory, two (2) of which must be in supervision, [sic] shall be able to lead a laboratory that carries out analyses using methodologies or testing systems that require the following:
a minimum of scientific and technical knowledge to carry out the test; a minimum training to carry out the test in the preanalytical, analytical, and postanalytical phases; use of reagents and materials already prepared and packed that do not need a special handling for preparation, use, and storage conditions; that the steps in the test process are executed automatically and are controlled (i.e., temperature control, processing time, etc.); calibration material, external proficiency and controls that are highly stable, reliable, and easily found; that the problems in the testing system are dealt with and are autocorrected automatically; that the guides to solve the problems are clearly described, are easily followed, and require minimal judgement from the operator; equipment maintenance provided by the manufacturer when it is necessary or easily performed; minimal independent judgement and interpretation while performing the activities of the preanalytical, analytical, and postanalytical phases of the test and solution of the problems.
o Certified in Clinical or Anatomical Pathology by the American Board of Pathology or possess qualifications equivalent to the ones required for that certification.
o Medical Doctor and possess at least one (1) year of training or experience in a blood bank and transfusion services.
Any of the healthcare professionals specified below shall be able to serve as Director of a Cytology and/or Anatomical Pathology Laboratory:
Anatomical Pathologist with the following credentials:
o Physician with a valid license and Professional Certificate of Registration.
Any of the healthcare professionals specified below shall be able to serve as Director of a Blood Gas Laboratory:
Anatomical or Clinical Pathologist with the following credentials:
o Physician with a valid license and Professional Certificate of Registration.
One year of residency training as an MD or DO
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