Clinical Laboratory Improvement Amendments of 1988

Clinical Laboratory Improvement Amendments of 1988 - Title I: Clinical Laboratories Under the Public Health Service Act - Amends the Public Health Service Act to prohibit soliciting or accepting specimens for laboratory procedures without a license or an accreditation.

Requires certain criteria to be met for issuance or renewal of a license, including that the laboratory agrees: (1) not to provide services under referrals from physicians or any entity which has a financial interest in or receives compensation from the laboratory; and (2) to bill patients directly. Makes licenses valid for a maximum of two years.

Directs the Secretary of Health and Human Services to issue standards to assure consistent performance, including standards regarding: (1) quality assurance and quality control; (2) maintenance of records, equipment, and facilities; (3) qualifications of certain personnel; and (4) participation in a proficiency testing program.

Directs the Secretary to establish: (1) national standards for quality assurance in cytology services; and (2) an external proficiency evaluation system for cytological services.

Amends provisions authorizing the Secretary to require payment of fees for the issuance and renewal of licenses to remove the limit on the amount of the fees.

Directs the Secretary to annually compile information which is useful in evaluating the performance of a laboratory, including information relating to: (1) convictions for fraud and abuse, false billings, or kickbacks; (2) license revocations; (3) intermediate sanctions; (4) injunctions; (5) performance characteristics; (6) the results of the proficiency testing; (7) inspection deficiencies; and (8) exclusions from participation under title XVIII (Medicare) or XIX (Medicaid) of the Social Security Act.

Declares that a laboratory which is accredited by an accreditation body approved by the Secretary is not required to be licensed. Allows the Secretary to approve an accreditation body if certain criteria are met, including that the body's standards must be at least as stringent as those for licensing. Sets forth procedures relating to: (1) withdrawal of an accreditation body's approval; and (2) accreditation of a laboratory. Authorizes the Secretary, on an announced or unannounced basis, to inspect a laboratory and all equipment, containers, records, and other materials.

Allows the Secretary, after notice and opportunity for hearing, to revoke, suspend, or limit a license or accreditation for specified causes. Allows suspension before a hearing in certain circumstances. Requires a revocation to stay in effect for at least three years. Requires the suspension of the license of a laboratory which has been excluded from participation under title XVIII (Medicare) of the Social Security Act because of actions relating to quality.

Allows temporary and permanent injunctions under suit by the Secretary. Provides for judicial review of license or accreditation revocation, suspension, or limitation.

Provides for intermediate sanctions, including civil monetary penalties, and sanctions, including criminal fines and imprisonment.

Permits the Secretary, by agreement, to use and pay for the services or facilities of any Federal, State, or local public agency or nonprofit private organization.

Allows the Secretary to exempt laboratories from compliance where State laws are at least as stringent.

Repeals provisions exempting from licensing requirements laboratories operated: (1) by certain health professionals solely as an adjunct to the treatment of their own patients; and (2) for any person engaged in the business of insurance solely for the purpose of making insurance decisions.

Title II: Studies - Directs the Secretary, through the Public Health Service, to conduct studies on various aspects of validity, reliability, and accuracy of tests performed by clinical laboratories and to report the results to the Congress.