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Laboratory testing facilities have many regulatory bodies with which they must contend. It can become confusing, time consuming and expensive for small, independent clinics and physician office laboratory testing sites to follow and meet CLIA requirements to achieve compliance.

The solution comes from Laboratory Advisory Bureau. Our field-proven staff knows the standards and regulations that must be met depending on what types of testing are performed at the site. No one knows federal agencies and standards like Laboratory Advising Bureau. We’re here to help you cut through all that red tape.

  • CLIA Overview and Requirements

    Clinical Laboratory Improvement Amendments, or CLIA, are federal regulatory standards that apply to all clinical laboratory testing performed on humans, except clinical trials and basic research. Centers for Medicare and Medicaid Services has primary responsibility for the operation of the CLIA Program, which is funded by user fees from regulated facilites.

    All types of laboratory testing are rated by FDA according to complexity and their potential risk to public health, with 1 being the most simple test, like waived tests, and 3 being the most complex. FDA looks at how complex it is for the analyst to run the test, level of personnel training, knowledge and amount of interpretation needed to evaluate test results using good laboratory practices.

    1. Waived tests

      • Simple laboratory examinations and procedures cleared by the FDA for home use

      • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible

      • Pose no reasonable risk of harm to the patient if the test is performed incorrectly

      • Waived laboratories must enroll in CLIA, pay the applicable fee and follow manufacturers' instructions.

    2. Tests of moderate complexity

      • Somewhere between waived and high complexity category

      • CLIA certification is necessary to perform these tests

      • Qualified individual(s) need to be identified for 4 positions

        • Director

        • Technical Consultant

        • Clinical Consultant

        • Testing Personnel.

      • Requires enrollment and successful participation in an approved Proficiency Testing Program.

    3. Tests of high complexity

      • Highest complexity rating

      • Require labs and clinics to acquire a CLIA certification

      • Qualified individuals need to be identified for 5 positions

        • Director

        • Technical Supervisor

        • Clinical Consultant

        • General Supervisor

        • Testing Personnel.

      • Extensive quality control measures must be in place

      • All personnel should be trained in latest laboratory practices.

      • Requires enrollment and successful participation in an approved Proficiency Testing Program

  • OSHA Overview and Requirements

    Occupational Safety and Health Administration, or OSHA, has a mission to prevent work-related injuries, illnesses and death by issuing and enforcing rules for workplace safety and health. OSHA is an agency of the U.S. Department of Labor.

    OSHA guidelines require:

    • Availability and maintenance of safety equipment

    • Measures to control the risk of exposure to chemical hazards or biological specimens by employees of the lab testing facility

    • Sanitary condition of testing lab

    • Annual inspections

    • Waste management program

    • Procedures for infectious material response, ventilation failure, first aid, fires, emergencies

    • Documentation of all spills and exposure incidents

  • HIPAA Overview and Requirements

    Health Insurance Portability and Accountability Act of 1996, or HIPAA, required the Department of Health and Human Services (HHS) to establish national standards for the security of electronic health care information. This law specifies a series of administrative, technical and physical security procedures to be enacted nationwide to assure the confidentiality of electronic protected health information. The HIPAA national standards and training are meant to improve efficiency of the health care system.

    HIPAA requires:

    • All workforce members be trained on procedures to ensure confidentiality of patient information

    • Training sessions must be documented to verify compliance

    • Disclosure of protected health information, or PHI, when required by law, within 30 days of patient request or to facilitate treatment, payment or health care operations, or when consent has been granted by patient

    • Correction of incorrect PHI

    • Record of disclosures of PHI

    • Notification of patient rights


Clinical Laboratory Improvement Amendments (CLIA)

Occupational Safety & Health Administration (OSHA)

Health Insurance Portability and Accountability Act (HIPAA)