Clinical Lab Manager: Education, Responsibilities & Certification

When thinking of a laboratory, people may imagine a room filled floor to ceiling with black countertops lined with pipettes, beakers filled with measured chemicals, and people walking around wearing lab coats and protective eyewear.

While some of the world’s biggest scientific breakthroughs have taken place in scientific research labs, more commonly daily diagnostic tasks take place in clinical laboratories. The daily tasks of clinical laboratory scientists involve running tests on biological specimens collected from patients as directed by a physician.

The National Center for Biotechnology Information (NCBI) states the purpose of lab environments is to help physicians and patients to address medical and public health needs (NCBI 2019). To safely support the needs of physicians, patients, and clinical lab scientists, clinical lab managers ensure that laboratory facilities run efficiently in order to produce reliable and timely medical test results.

Clinical lab managers are responsible for keeping a clinical laboratory safe, efficient, and ensuring that procedures and equipment meet state, national, and often international standards. Most clinical lab managers have a minimum of five years of clinical laboratory science experience and a degree in biology, chemistry, or a related field of science. Some clinical lab managers have advanced degrees or experience in healthcare administration as well.

Without the skilled leadership of a clinical lab manager, medical laboratories cannot run smoothly, nor provide physicians and patients with high international standards of responsive medical care.

Clinical lab managers are chiefly responsible for supervising the work of clinical laboratory scientists and technicians, developing lab safety policies that align with international accreditation standards, and overseeing budgetary and administrative responsibilities. Safety is of paramount importance in a laboratory and clinical lab managers must also oversee the functionality of laboratory equipment, train clinical laboratory scientists and technicians on how to use the equipment properly, and report the conditions of a clinical laboratory regularly to a supervisor or accreditation board.

Daily responsibilities of a clinical lab manager include:

• Overseeing the day-to-day operations of a clinical laboratory
• Communicating with supervisory medical directors
• Coordinating test procedures between difference scientists
• Verifying test procedures were performed with precision and accuracy
• Ensuring all equipment in the laboratory setting meets safety standards
• Training and supervising clinical laboratory scientists and technicians
• Resolving technical problems with solutions that follow accreditation standards
• Performing regular needs analysis for laboratory settings
• Ensuring that patient data is accurate and secure
• Implementing new programs, testing procedures, methodologies, and laboratory equipment
• Managing clinical laboratory staff
• Maintaining professional knowledge through attendance at professional workshops
• Running clinical laboratory tests when clinical scientists are short-staffed

This is a general list of daily responsibilities for clinical lab managers; professional duties may vary depending on the specific type of clinical laboratory environment.

For those who want to know what a typical day in the life of a clinical lab manager looks like, Rita Pitts, a clinical lab manager at a genomics lab, breaks down a day in her life of what it’s like to manage a clinical lab (YouTube “Illumina Career Profile” Dec. 2018).

A typical day begins by determining if there were any issues from the previous shift’s testing procedures. Clinical laboratory scientists process real patient samples by handling whole blood samples and assessing it for laboratory test results.

The next step is to look at the quality of the tests currently in process. Testing procedures often involve running samples and evaluating patient samples for specific diseases or genetic conditions.

The next step is to receive new daily samples via courier. To do this, regular collaboration with the inventory management team is a necessary step in getting the samples processed. Once samples are received and inventoried, they are then sent to the clinical laboratory scientists and undergo tests as directed by physicians for specific medical conditions.

Additionally, project meetings with clinical laboratory scientist teams are scheduled while laboratory samples are being processed. The details of current projects being coordinated by clinical laboratory science teams are discussed as well as project deadlines. The role of the clinical lab manager in project meetings is to ensure that the project stays within the safety regulations of the laboratory.

For the most part, Rita Pitts says clinical laboratory science work is mostly spent processing clinical samples such as blood, tissue, skin, and other bodily fluids to test for specific diseases or genetic conditions.

According to assistant professor emeritus Rodney Forsman at the Mayo Clinic College of Medicine in Rochester, Minnesota, “Laboratory managers are often promoted from the ranks of the technical staff. If an individual has the capacity to learn the science of laboratory medicine, they can learn the management skills given, the desire and aptitude to do so.” Management skills are essential for clinical laboratory science professionals whether they choose to advance their careers into leadership or organize a project.

The U.S. Bureau of Labor Statistics (BLS) does not have career-specific data for clinical laboratory managers, but it reports that entry-level clinical laboratory technologist positions require a minimum of a bachelor’s degree (BLS 2019).

Due to the varied nature of clinical laboratory manager responsibilities, employers may require clinical lab managers to have advanced degrees in healthcare administration or a science-related field to prepare them for management responsibilities and grant writing required of some positions. Many clinical lab management positions require a minimum of five years of clinical laboratory science experience in order to meet minimum job qualifications.

Because they are responsible for interacting with a wide range of professionals—including laboratory scientists, support staff, external logistics partners, accreditation auditors, and healthcare leaders—clinical lab managers must be well-versed in scientific and management communication skills. The in-depth knowledge gained from years of clinical work experience prepares clinical lab managers to pay close attention to detail since the nature of clinical laboratory work includes handling sensitive patient information and biological samples.

It’s clear that the responsibilities of a clinical lab manager require a thorough scientific educational background, previous laboratory science experience, and communicative management knowledge relevant to scientific and healthcare settings.

Clinical laboratory scientist licensure requirements vary by state and information for state-specific licensure requirements can be found at the American Society for Clinical Laboratory Science (ASCLS). For national certifications, the American Society for Clinical Pathology (ASCP) and American Medical Technologists (AMT) offer the gold standard of credentialing in this field.

Accredited laboratories are externally reviewed and verified to meet the highest industry standards for safety and quality. Laboratories can seek accreditation through the College of American Pathologists (CAP). To bolster their professional qualifications and make their laboratories more professional, clinical laboratory directors can become members of the American Association of Bioanalysts (AAB); an organization dedicated to serving clinical laboratory professionals and operations.

To prepare clinical laboratory scientists for career opportunities as clinical lab managers, the American Association for Clinical Chemistry (AACC) offers certificate programs in laboratory management. Courses include statistical methods, practical approaches to quality control, and laboratory leadership and operational management.

Clinical lab managers are employed in a wide variety of healthcare environments that require regular clinical laboratory testing services. The BLS reports the employers of clinical laboratory technologists and technicians and their corresponding occupational percentages as follows (BLS 2019):

• General medical and surgical hospitals (state, local, and private): 48 percent
• Medical and diagnostic laboratories: 19 percent
• Offices of physicians: nine percent
• Junior colleges, colleges, universities, and professional schools (state, local, and private): six percent
• Outpatient care centers: three percent

While this data is not representative of the clinical lab manager occupation, it is likely that these professional environments hire clinical lab managers to be in charge of laboratory operations at these facilities.

Three common management models in use by clinical lab managers to organize workflow, ensure laboratory process control, and streamline clinical laboratory efficiency are: Laboratory Quality Management System, International Standards Organization, and Lean Six Sigma.

Laboratory Quality Management System (LQMS): a handbook released by the World Health Organization (WHO) provides a comprehensive reference guide to all clinical laboratory professionals and outlines 12 essentials for quality management of a public health or clinical laboratory:

• Organization
• Personnel
• Equipment
• Purchasing and inventory
• Process control
• Information management
• Documents and records
• Occurrence management
• Assessment
• Process improvement
• Customer service
• Facilities and safety

International Standards Organization (ISO): An international standard for laboratory policies and procedures has been established by the ISO for medical laboratories to use in developing their quality management systems and assessing their own competencies. Accrediting bodies, regulatory authorities, and customers can know that a clinical laboratory is of the highest quality if it meets the ISO 15189:2012 standards which are reviewed every five years.

Lean Six Sigma: A known management training protocol to improve efficiency in corporate, healthcare, engineering, and industrial work environments, Lean Six Sigma focuses on eliminating waste in processes through analysis and streamlining. Its applications for clinical laboratory management operations allow clinical laboratory teams to eliminate unnecessary steps, shorten wait times and travel distances, and allow clinical laboratory managers to help clinical lab scientists and technicians focus on their jobs and be more productive.

Case studies published by Six Sigma and NCBI show numerous examples of daily processes in clinical laboratory settings that were eliminated or streamlined in order to improve productivity. Six Sigma management training opportunities are available online and in-person in several locations throughout the United States.