Tools commonly used in the Laboratories-Clinical industry for day-to-day tasks and operations.

• Automated Hematology Analyzers
• Coagulation Analyzers
• Chemistry Analyzers
• Immunoassay Analyzers
• Microscopes
• Flow Cytometers
• Polymerase Chain Reaction (PCR) Machines
• Mass Spectrometers
• Liquid Chromatography-Mass Spectrometry (LC-MS) Systems
• Electrolyte Analyzers
• Blood Gas Analyzers
• Urine Analyzers
• Microbiology Culture Systems
• Histology Equipment
• Cytology Equipment
• Immunohistochemistry (IHC) Stainers
• Digital Imaging Systems
• Laboratory Information Management Systems (LIMS)
• Quality Control Materials

Common products and services typical of NAICS Code 621511-05, illustrating the main business activities and contributions to the market.

• Clinical Chemistry Testing
• Hematology Testing
• Microbiology Testing
• Immunology Testing
• Serology Testing
• Histology Testing
• Cytology Testing
• Molecular Diagnostics
• Toxicology Testing
• Endocrinology Testing

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

• Clinical Laboratory Improvement Amendments (CLIA): CLIA regulates laboratory testing and requires clinical laboratories to be certified by the Centers for Medicare & Medicaid Services (CMS) before they can accept human samples for diagnostic testing. The certification is based on the complexity of the tests performed and the level of risk to patients. [CMS CLIA]
• Medical Technologist Certification: Medical technologists are required to be certified by the American Society for Clinical Pathology (ASCP) or other certifying organizations. Certification is based on education, experience, and passing an exam. [ASCP Certification]
• Clinical Laboratory Scientist License: Clinical laboratory scientists are required to be licensed by the state in which they practice. Licensing requirements vary by state but typically include education, experience, and passing an exam. [American Medical Technologists State Licensure]
• Laboratory Director Certification: Laboratory directors are required to be certified by the American Board of Bioanalysis (ABB) or other certifying organizations. Certification is based on education, experience, and passing an exam. [ABB Certification]
• Clinical Chemistry Specialist Certification: Clinical chemists are required to be certified by the National Registry of Certified Chemists (NRCC) or other certifying organizations. Certification is based on education, experience, and passing an exam. [NRCC Certification]

A concise historical narrative of NAICS Code 621511-05 covering global milestones and recent developments within the United States.

• The clinical laboratory industry has a long and rich history dating back to the 19th century. In 1891, the first clinical laboratory was established in the United States at the Johns Hopkins Hospital in Baltimore, Maryland. This laboratory was responsible for the development of many of the diagnostic tests that are still used today. In the early 20th century, the clinical laboratory industry began to expand rapidly, with the establishment of many new laboratories across the country. During World War II, clinical laboratories played a critical role in the war effort, providing diagnostic testing for soldiers and civilians alike. In recent years, the clinical laboratory industry has continued to evolve, with the development of new technologies and the expansion of testing capabilities. In the United States, the clinical laboratory industry has undergone significant changes in recent years. One of the most notable changes has been the shift towards automation and computerization. This has allowed laboratories to process tests more quickly and efficiently, while also reducing the risk of errors. Another important development has been the increasing use of molecular diagnostics, which allow for more accurate and targeted testing. In addition, there has been a growing emphasis on quality control and accreditation, with many laboratories seeking certification from organizations such as the College of American Pathologists. Overall, the clinical laboratory industry in the United States is a dynamic and rapidly evolving field that plays a critical role in healthcare.

The anticipated future trajectory of the NAICS 621511-05 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

• Growth Prediction: Stable

  The clinical laboratory industry is expected to grow in the coming years due to the increasing demand for diagnostic testing services. The aging population and the rise in chronic diseases such as diabetes and cancer are driving the demand for clinical laboratory services. Additionally, the COVID-19 pandemic has increased the demand for testing services, which is expected to continue in the near future. The industry is also expected to benefit from technological advancements such as automation and artificial intelligence, which can improve the accuracy and efficiency of testing services. However, the industry may face challenges such as reimbursement cuts and regulatory changes, which could impact the profitability of clinical laboratories.

Recent groundbreaking advancements and milestones in the Laboratories-Clinical industry, reflecting notable innovations that have reshaped its landscape.

• Development Of Liquid Biopsy Tests: Liquid biopsy tests are non-invasive diagnostic tests that can detect cancer by analyzing blood samples. These tests are less invasive and more convenient than traditional biopsy tests, which require tissue samples. Liquid biopsy tests are expected to become more widely used in the future due to their accuracy and convenience.
• Use Of Artificial Intelligence In Diagnostic Testing: Artificial intelligence can be used to analyze large amounts of data and improve the accuracy of diagnostic testing. For example, AI algorithms can analyze medical images and detect abnormalities that may be missed by human radiologists. AI can also be used to analyze genetic data and identify disease risk factors.
• Expansion Of Point-Of-Care Testing: Point-of-care testing refers to diagnostic tests that can be performed at the patient's bedside or in a doctor's office. These tests are faster and more convenient than traditional laboratory tests, which require samples to be sent to a central laboratory for analysis. Point-of-care testing is expected to become more widely used in the future due to its convenience and cost-effectiveness.
• Development Of New Diagnostic Tests: The clinical laboratory industry is constantly developing new diagnostic tests to detect diseases and monitor treatment effectiveness. For example, new tests have been developed to detect genetic mutations that increase the risk of cancer. Other tests have been developed to monitor the effectiveness of cancer treatments.
• Use Of Blockchain Technology In Laboratory Testing: Blockchain technology can be used to securely store and share medical data, which can improve the accuracy and efficiency of laboratory testing. For example, blockchain can be used to securely store patient data and test results, which can be accessed by healthcare providers as needed.