What exactly is a “clinical laboratory?” A clinical laboratory, also commonly referred to as a medical laboratory, is a lab where tests are carried out on “clinical” specimens, such as blood or tissue samples. These tests are then used to screen the health of the patient (human or animal), allowing practitioners to correctly diagnose and prescribe treatment for any afflictions that have been discovered in the testing. The test results may also aid in the prevention of a disease or sickness.
There are more than 200,000 clinical laboratories that provide testing services in the United States. Here is a brief breakdown of these types of labs:
- Hospital-based labs: Comprise about 5% of all clinical labs yet perform the majority of tests (55% of the volume)
- Independent labs: Account for 3% of the labs and perform 32% of the test volume
- Physician office labs (POLs): Comprise over half of U.S. labs at about 53% in number but are responsible for just 8% of lab test volume
- Other laboratories include local public health laboratories and laboratories located in end-stage renal disease dialysis facilities, ambulatory surgery centers, community clinics, blood banks, and so forth. Though these various labs comprise close to 40 percent of the total number of clinical laboratories, they account for only about 5% of the total test volume.
Federal Agency Oversight for Labs
Oversight for laboratory testing falls under three main federal agencies:
- Food and Drug Administration (FDA)
- Center for Medicaid Services (CMS)
- Center for Disease Control and Prevention (CDC)
Each agency has a unique role in assuring quality laboratory testing. The protocols for the certifications and oversight of laboratory practices have been established by the Clinical Laboratory Improvement Amendments (CLIA). These CLIA regulations cover all aspects of testing, including general laboratory requirements, quality monitors, pre-analytics, analytical performance, post-analytics, and training requirements.
Common Medical Waste Streams from Diagnostic Tests
Once the diagnostic tests are performed in the laboratory, some wastes are generated that must be appropriately managed. A whole new set of federal agencies, including the EPA, DOT, OSHA, and various state and local agencies, such as state health departments, regulate the compliant disposal of these medical wastes.
These are the most common types of regulated wastes generated by clinical labs:
- Laboratory-related chemicals: Numerous chemicals used in laboratories must be managed for disposal. Most of the time, this means in a RCRA hazardous waste stream. Laboratory waste from processors, analyzers, calibrators, cleaners, reagents, stains, and test kits must be evaluated to determine whether they are hazardous.
- Regulated medical waste: Laboratories generate voluminous amounts of regulated medical waste, also referred to as infectious waste, including:
- Sharps, such as biopsy/vacutainer/butterfly needles, inoculation loops, pipettes, capillary tubes, broken glass/beakers, glass slides, scalpels, and lancets
- Soft “red bag” waste items, like specimen collection containers or processing materials contaminated with blood and other potentially infectious materials (OPIM)
The primary treatment for RMW is by autoclaving (sterilization) at a licensed disposal facility.
- Pathological and tissue waste: Most states require pathology wastes to be incinerated rather than sterilized in order to render the wastes unrecognizable. This waste is managed in red or yellow biohazard bags. Pathological waste includes fresh, formalin-fixed, and paraffin-embedded tissue samples and specimens derived from biopsies or surgical procedures.
As a leading national provider of comprehensive medical waste management solutions, Sharps Compliance can manage all these waste types generated at clinical laboratories. Contact us to learn more about our services.