Summary: H.R.5471 — 100th Congress (1987-1988)All Information (Except Text)

There is one summary for H.R.5471. Bill summaries are authored by CRS.

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Introduced in House (10/06/1988)

Clinical laboratory Improvement Amendments of 1988 - 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.

Requires a laboratory which only performs simple examinations and procedures which have an insignificant risk of an erroneous result, and which complies with other requirements, to be issued a certificate of waiver which exempts it from complying with provisions of this Act relating to standards (including proficiency testing) and inspections.

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 the body agrees to: (1) inspect the laboratories it accredits; (2) apply standards which are at least as stringent as the Secretary's (3) assure that the laboratory continues to meet standards; (4) notify the Secretary of any denial, suspension, withdrawal, or revocation of accreditation, or of changes in the body's standards, and (5) notify each laboratory if the body's approval is withdrawn by the Secretary. Provides for temporary continuation of a laboratory's license if the accreditation body's approval is withdrawn. Directs the Secretary to evaluate annually the performance of each accreditation body.

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 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 quaterly, 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, to enter and inspect, during regular hours of operation, certified laboratories. Grants the Secretary access to all facilities, equipment, materials, records, and information. Directs the Secretary to conduct inspections of laboratories to determine their compliance with requirements and standards.

Provides for intermediate sanctions, including directed plans for correction, civil money penalties, and payment for the costs of onsite monitoring.

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 and, in certain circumstances, for inspections and proficiency testing. Requires fees to vary by group or classification of laboratory. Allows fees to be based on the dollar volume and scope of the testing being performed.

Directs the Secretary, on April 1, 1990, and annually thereafter, to compile and make available to physicians and the public 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, suspensions, or limitations; (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.

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 not later than May 1, 1990.