CLSI Blog Articles

Read the latest articles about CLSI and laboratory standards in the official CLSI Blog. Browse our most recent blog articles below.

Looking Back at CLSI–Ghana PEPFAR Activities (2010-2015)

CLSI received President's Emergency Plan for AIDS Relief (PEPFAR) funding for work in Ghana beginning in 2010. CLSI’s programming targeted building capacity of the laboratory leadership in Ghana, focusing on a systems approach to quality in laboratory medicine, supporting the development and implementation of appropriate policies for laboratory operations at all levels throughout the health care system.

Overcoming Phlebotomy Challenges in Pediatric Patients

Children are some of the most difficult patients from whom to collect blood sample specimens. Ensuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance.

Nucleic Acid Testing Validation and Verification

Nucleic acid testing is one of the fastest growing fields in laboratory medicine. First-generation nucleic acid tests concentrated on measuring the presence or quantity of a single target, often using a single internal control. Recently, the multiplex nucleic acid testing field has expanded greatly for both laboratory-developed and marketed tests.

Laboratory Disaster Planning During COVID-19

Now, more than ever, it’s important to implement a disaster plan for your lab or update your lab’s current plan. Emergencies can impede your lab’s efficiency and sometimes even bring operations to a standstill. Preparation can help ensure that your lab continues to deliver high quality results and keep patients and laboratory workers healthy during the COVID-19 pandemic.

Standards for Emergency and Accreditation Preparedness: Interview With Jane Oates

We spoke with Jane Oates, Administrative Laboratory Director of Salem Medical Center, about how implementing CLSI standards in the lab can help with emergency preparedness.

Standardization in Molecular Diagnostics: More Critical Now Than Ever

We spoke with Ted Schutzbank, PhD D(ABMM), Scientific Affairs Manager of Diagnostics at Meridian Bioscience about the importance of standardization in molecular diagnostics and the new testing methods available for COVID-19.

Antimicrobial Resistance and the COVID-19 Pandemic

Antimicrobial resistance is one of the most serious global health threats in the world. In the United States, there are 2.8 million antibiotic-resistant infections each year that cause more than 35,000 deaths. Some experts fear that the real number is much higher. The superbugs that cause these infections thrive in hospitals and medical facilities, putting all patients at risk. The patients at greatest risk from superbugs are the ones who are already more vulnerable to illness from viral lung infections like influenza, severe acute respiratory syndrome (SARS), and COVID-19.

COVID-19 Testing Information and Resources for Laboratories

As of April 8, 2020, the global health threat now known as coronavirus disease-2019 (COVID-19) had infected more than 1.3 million people in over 200 countries and caused more than 79,000 deaths [1]. According to the “Operational Planning Guidelines to Support Country Preparedness and Response” developed by the World Health Organization (WHO), a coordinated global response plan that primarily involves prevention of human-to-human transmission of the virus, caring and monitoring of infected patients, and rapid diagnosis of the disease followed by effective infection control measures is required to control the COVID-19 pandemic [2].

Performing a Biological Risk Assessment in the Laboratory

While laboratory workers are always vigilant against laboratory-acquired infections, uncertainty has arisen in the medical laboratory community about the most effective way to protect against COVID-19. The United States Department of Labor Occupational Safety and Health Administration (OSHA) provides guidelines for safe COVID-19 specimen processing, as well as information about proper personal protective equipment (PPE) for laboratory workers.

Regulation of Laboratory Tests Is About to Change

The bipartisan bill, Verifying Accurate Leading-edge IVCT Development Act (VALID), was introduced to Congress on March 5, 2020. This legislative effort, if enacted, will overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of LDTs and manufacturers’ IVCTs.