The Clinical Laboratory Improvement Amendments (CLIA) were established in 1988 to create standards and monitor quality for all laboratory testing regardless of where the test was performed. CLIA defined a "clinical laboratory" as a facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for diagnosis, prevention, or treatment of disease or impairment, or for health assessments. This is a sweeping definition that encompasses all physician-operated laboratories that had been operated as a convenience for patients and a revenue stream for the practice. The only exception to the certification and regulation procedures is for an office that merely draws blood, as long as there is no charge for the service.

When establishing a medical office that will do laboratory procedures, a physician must first determine what category of test he or she will be performing and obtain the proper applications to become certified to perform those tests. There are three types of certifications: waived tests (simple tests); tests of moderate complexity, including provider-performed microscopy; and tests of high complexity.

Waived tests are simple tests with a low risk for an incorrect result. Sites performing only waived tests must have a CLIA certificate and follow the manufacturer's instructions.

The term "nonwaived testing" refers to moderate- and high-complexity testing. Offices performing these tests need to be inspected and must meet the CLIA quality standards. A high-complexity laboratory is required to have skilled personnel who are trained and licensed to perform the laboratory tests and must have a laboratory director to oversee lab operations.

More information can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCLIACertificate.pdf.

Occupational Safety and Health Act

This act requires employers to comply with safety and health standards created by the act, as well as with other regulations issued by the agency it created. The regulations cover bloodborne pathogens, hazard communication, and several other very specific requirements. The regulations that most commonly apply to medical practices are found here.

Americans With Disabilities Act Regulations

Congress passed the Americans With Disabilities Act of 1990 (ADA) to prohibit discrimination against individuals with disabilities in employment, public accommodations, state and local government services, public transportation, and telecommunications. Physician offices are covered under the definition of "public accommodation," regardless of office size or the number of employees. Owners of public accommodations are prohibited from discriminating against disabled people with regard to the provision of goods, services, facilities, privileges, advantages, or accommodations.

Compliance with ADA requires a physician's office to be aware of three issues:

• Hiring—discriminatory employment/hiring practices are prohibited;

• Layout of the office and equipment—architectural barriers must be removed; and

• Interaction with patients—healthcare providers have a duty to effectively communicate with patients who have vision or hearing impairments.