Background:
Tuberculosis (TB) is a serious infectious disease. An estimated 10-15 million United States citizens have latent tuberculosis infections and without detection and treatment, approximately 10% of these individuals will develop tuberculosis at some point in their lives. In 2017, 9,093 new TB cases were reported in the US, a decrease of 1.6% from 2016.¹ The growing threat of multidrug resistant (MDR) and extensively-drug resistant (XDR) TB not only leads to increased cases of tuberculosis but also increased costs. TB-related healthcare costs approach $1 billion each year in the US and costly outbreaks still occur.

Quality laboratory testing is essential in order to reach the goal of TB elimination in the US. Continued improvements in laboratory testing programs are key and directly translate into expedited and improved treatment and control. The laboratory community must provide healthcare providers and TB controllers with accurate results within acceptable turnaround times while providing a safe work environment for laboratorians. Mycobacterium tuberculosis: Assessing Your Laboratory is intended to be used as a self-assessment tool to provide information on best practices in the mycobacteriology laboratory and an opportunity to thoroughly review your procedures, assign priorities and adopt a plan to update and improve your laboratory practices.

Intended Use:
Mycobacterium Tuberculosis:  Assessing Your Laboratory is intended for use in any public health, clinical, or commercial laboratory that performs TB/mycobacteriology testing in the US.  It is designed to be a self- assessment tool and information submitted to the tool from different laboratories is not complied and data is not shared in any way. 

The tool consists of a series of 96 questions divided into sections:

• General Specimen Collection and Handling
• Safety
• General Laboratory Practice
• Smears from Clinical Specimens
• Public Health and Epidemiology
• Specimen Processing and Decontamination
• Inoculation and Growth Detection
• Susceptibility Testing
• Direct Detection

It is advised that laboratories only answer the questions in the sections that correspond with services that their mycobacteriology laboratory provides. Each question has an accompanying guidance section that contains information that may be helpful in improving the quality of your laboratory operations in that particular area. For best results, it is suggested that several individuals within your laboratory participate in the self-assessment process.

The regulations included in this tool are not exhaustive and following the recommendations in the Guidance Sections will not necessarily make your laboratory compliant with Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologist (CAP), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), state-specific health codes or public health reporting requirements or any other accrediting agency or regulatory body.