Education and Training
Clinical laboratory science can be both challenging and rewarding. Clinical laboratories provide vital information and services that enable physicians in diagnosing, treating, and managing their patients more effectively. As such, this workforce is essential to our healthcare systems – aiding prevention of disease outbreaks while responding swiftly to public health emergencies – with emerging diseases, pandemics, bioterrorism agents highlighting an ever-increasing demand for trained laboratory professionals.
Medical laboratories are healthcare facilities staffed by clinical laboratory scientists who perform tests on biological specimens from their patients. Most are located within hospital facilities, and can either be classified as clinical or research depending on what specimens are tested and what services are provided (1).
Many laboratory skills can be taught, and clinical laboratory science programs have evolved over time to meet changing clinical demands. Traditionally, apprenticeship training was provided through hospital laboratories under the supervision of experienced pathologists. Beginning in the late 1800s and early 1900s, more formalized educational programs emerged within universities and colleges, designed to impart broad laboratory skillsets to aspiring laboratory scientists. Most undergraduate and graduate level laboratory sciences programs in the US are accredited by the Accrediting Council for Clinical Laboratory Sciences (NAACLS) (2).
At most programs, aside from clinical microbiology and genetics, students learn fundamental principles rather than specific technical disciplines. This allows students to gain experience working in various laboratory environments while working across all aspects of a clinical lab – providing invaluable training for future careers as clinicians in hospitals or point-of-care testing sites (3).
The COVID-19 pandemic had a profound impact on laboratory workforce members across different career stages and Pathology disciplines, from undergraduates adjusting to emergency remote teaching arrangements for classroom instruction; post graduate laboratory professionals adjusted to new ways of working as they responded to service demand demands. Therefore, collaboration between higher education institutions (HEIs) and industry must be strengthened so clinical laboratory workforce are equipped to respond swiftly and effectively when requirements change quickly and effectively in health service provision.
Accreditation
Accreditation of laboratories is an internationally accepted means of assessing and validating their management system and technical operations, providing increased confidence in measurements and results produced by them that adhere to established standards.
Accredited laboratories must demonstrate technically competent staff, valid test methods and traceable measurements, as well as well-documented quality systems with policies, procedures and work instructions that meet accreditation standards. LIMS tools can help laboratories document and enforce standard operating procedures (SOPs), helping maintain consistent processes to fulfill accreditation requirements while meeting accreditation criteria. A central repository allows for better compliance with standard data formats and structures essential to maintaining quality information produced by laboratories.
The College of American Pathologists (CAP) offers a voluntary laboratory accreditation program that recognizes laboratories for meeting international patient safety and quality standards. Their inspection process involves reviewing laboratory facilities and equipment before having them inspected by a trained inspector who uses an on-site checklist to assess lab practices, procedures, facilities, as well as for any deficiencies identified during inspection; any deficiencies must then be rectified before becoming accredited by CAP.
Laboratories seeking CAP accreditation must abide by Clinical Laboratory Improvement Amendments (CLIA) regulations in order to be reimbursed from Medicare and Medicaid, while receiving accreditation can exempt clinical laboratories from federal inspection for interstate licensure purposes.
JCI also has an in-depth laboratory accreditation program that encompasses all areas of lab operations and medical care facilities, with strict compliance standards regarding patient safety and quality performance being required to become accredited with them.
Central Laboratory services accreditation is an ongoing process and requires laboratories to actively engage in ongoing monitoring and quality improvement. Accrediting bodies perform periodic surveillance audits and may request additional documentation or reassessment to determine whether laboratories continue meeting accreditation criteria. If noncompliance occurs, decisions will be made either to deny or revoke accreditation – any decision to revoke would have the right of appeal available to it.
Equipment and Instrumentation
Laboratories require an array of equipment to conduct various tests on patient samples and achieve reliable results for patient testing. Daily tasks and anticipated workload all play an integral role in selecting suitable equipment.
Consider cost-effectiveness when selecting equipment options; take into account both initial and long-term costs of adopting any new technologies. Investigate whether new instruments offer additional automation that reduces human errors or contamination risk, such as additional automation for sample handling.
Equipment that uses electricity should include an overload protection circuit to quickly disconnect an overloaded apparatus or wiring issue, including vacuum pumps, drying ovens and stirring motors left unattended for extended periods. Furthermore, make sure all electrical devices use three-conductor line cords that comply with national standards and codes; any use of two-prong cheaters to connect equipment using three-conductor plugs to older non-grounded receptacles should be avoided as this can be hazardous to public safety.
Medical technologists working in clinical laboratories conduct tests on patient samples to assist physicians in diagnosing and treating illness and injury. These laboratories are typically located within hospital facilities.
Laboratory professionals increasingly rely on technology to uncover answers that would otherwise remain inaccessible through traditional means, including spectrophotometry, atomic absorption spectroscopy, cytometry, flame emission photometry, nephelometry and electrochemical sensors. Many laboratories also rely on electronic systems known as laboratory information systems or LISs to manage the vast quantities of data generated during lab operations – commonly referred to as laboratory information systems or LIs.
While assessing each instrument for technical capability, consider its role as both backup or primary testing methodology in your lab and potential clinical improvements that cannot be found elsewhere in your organization. Ask each vendor about service plan options and pricing as well as minimum response time requirements so as to minimize downtime during patient testing.
Staffing
Clinical laboratories require qualified laboratory staff with proper training and certifications to perform the various tasks that are essential in producing quality results. Unfortunately, staff shortages have long been an issue within clinical labs resulting in them failing to produce accurate and timely patient care results and impacting ambulatory site testing capabilities.
Laboratories are faced with numerous factors that exacerbate their challenges, including reduced training programs and changes to how tests are performed – such as using point-of-care (POCT) tests at ambulatory sites – which has resulted in an increasing demand for laboratory technicians and technologist support in this setting.
As demand has skyrocketed, so has vacancy rates seen by American Society for Clinical Pathology surveys conducted between 2018 and 2019; 7-11% for Phlebotomy positions alone were vacant according to this research study conducted in 2018. Such low vacancy rates can have serious repercussions for the quality of work produced in laboratories as well as how many tests they offer to providers in-house.
As COVID-19 began spreading in early 2020, Gotham Health’s clinical laboratory operations team faced several hurdles that contributed to a staffing crisis – such as restrictions of non-essential businesses and social distancing requirements during pandemic, which hindered recruitment efforts of lab personnel. Further complicating matters was their need to move staff from ambulatory sites into acute care hospital clinical laboratories that had become overwhelmed with new SARS-CoV-2 patients admitted for care.
Healthcare organizations must devise strategies centered on recruiting and retention to address current and ongoing staffing challenges, which may prove costly, yet necessary investments in clinical laboratory staffing. Furthermore, organizations should remain aware of trends within their laboratory environment by monitoring new technologies and methodologies; this will prepare them for any unexpected events which might arise down the line.