Mycobacterium Tuberculosis: Assessing Your Laboratory

 

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

Quality laboratory testing is essential in order to reach the goal of TB elimination in the US.  Improvements in laboratory testing must be maintained and translated into expedited and improved treatment and control.  It is imperative that the laboratory community provides healthcare providers and TB controllers with accurate smear, culture, drug susceptibility and molecular results within acceptable turn-around 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 laboratory and an opportunity to thoroughly review your procedures, assign priorities, and adopt a plan to update and improve your laboratory practices if needed.

Intended Use:
Mycobacterium Tuberculosis:  Assessing Your Laboratory is intended for use in any public health, clinical, or commercial laboratory that performs TB testing in the United States.  It is designed to be a self- assessment tool, meaning that scores will not be compiled and any information given is intended for your laboratory’s own self-improvement. 

The tool consists of a series of 94 questions divided into the following 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 CLIA, CAP, JACHO, or any other accrediting agency.