Clinical Laboratory Improvement Amendments of 1988

(Measure passed House, amended)

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 materials from the human body for laboratory procedures without a certificate issued by the Secretary of Health and Human Services. Makes certificates valid for a maximum of two years.

Requires certain criteria to be met for issuance or renewal of a certificate, including that the laboratory makes agreements regarding: (1) inspections by the Secretary; and (2) treating proficiency testing samples in the same manner as other materials.

Authorizes a laboratory to be accredited for certification if it meets the standards of an approved accreditation body and if the laboratory authorizes that body to submit information to the Secretary as the Secretary requires. Allows the Secretary to approve an accreditation body if certain criteria are met, including: (1) that the body's standards are at least as stringent as the Secretary's; and (2) that the body agrees to collect from the laboratories it accredits and forward to the Secretary certain fees. Sets forth procedures relating to withdrawal of an accreditation body's approval. Directs the Secretary to evaluate annually the performance of each accreditation body by conducting inspections.

Directs the Secretary 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 personnel; and (4) qualification under a proficiency testing program. Directs the Secretary to reduce the burden of compliance with such standards on laboratories which only perform simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.

Directs the Secretary to establish standards for the proficiency testing programs for certified laboratories to be conducted by the Secretary, an approved private nonprofit organization, or an approved accrediting body. Mandates that proficiency be tested for each examination and procedure quarterly, subject to exception. Directs the Secretary to establish a system to make proficiency testing program results available, on a reasonable basis, upon request of any person, with explanatory information.

Directs the Secretary to establish national standards for quality assurance in cytology services.

Authorizes the Secretary, on an announced or unannounced basis, during regular hours of operation, to enter and inspect certified laboratories. Grants the Secretary access to all facilities, equipment, materials, records, and information.

Provides for intermediate sanctions, including civil monetary penalties. Allows the Secretary, after notice and opportunity for hearing, to suspend, revoke, or limit a certificate for specified causes. Allows suspension or limitation before a hearing in certain circumstances. Prohibits any person who has owned or operated a laboratory which has had its certificate revoked from owning or operating a certified laboratory within two years of revocation. Requires suspension of the certificate 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: (1) judicial review of certificate suspensions, revocations, and limitations; and (2) sanctions, including criminal fines and imprisonment.

Directs the Secretary to require payment of fees for issuance and renewal of certificates, with the amounts set by the Secretary based on the volume and scope of the testing being performed. Directs the Secretary to establish the fees at lower rates for labortories which are accredited.

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) certificate revocations; (3) sanctions or intermediate sanctions; (4) withdrawal or revocation of accreditation; (5) injunctions; and (6) exclusions from participation under title XVIII (Medicare) or XIX (Medicaid) of the Social Security Act.

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 with these provisions where State laws are at least as stringent.

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.