What was passed by congress in 1988 and established quality standards for all laboratory testing?

Editor’s note: This is the first of a two-part series on billing for lab tests in physician offices.

The Clinical Laboratory Improvement Amendments (CLIA) program establishes quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with The Centers for Medicare & Medicaid Services and obtain CLIA certification.

CLIA was passed by Congress in 1988 to improve the quality of testing in all laboratories nationwide. These health assessment tests examine diagnoses, prevention and treatment of the human body. The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.

Waived tests: Waived tests include any test listed in the regulation process of categorizing and re-categorizing of tests; any test in which the manufacturer’s instructions allow inspections and random compliance checks; and tests cleared by the FDA for home usage. When billing for waived tests approved on or after Jan. 23, 1996, laboratories must use the QW modifier. It is not mandatory for tests approved before Jan. 23, 1996.

The specified tests that are listed in the FDA regulation as waived are:

1. Dipstick or tablet reagent urinalysis, nonautomated, for the following:
   • Bilirubin
   • Glucose
   • Hemoglobin
   • Ketone
   • Leukocytes
   • Nitritew
   • pH
   • Protein
   • Specific gravity
   • Urobilinogen
2. Fecal occult blood
3. Erythrocyte sedimentation rate—nonautomated
4. Hemoglobin-copper sulfate—nonautomated
5. Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
6. Spun microhematocrit
7. Added 1/19/93. Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout
8. Moderate & high-complexity tests: Moderate- and high-complexity tests must meet requirements for proficiency testing, patient test management, quality assurance/control and personnel. Waived tests are exempted from these requirements.

Proficiency testing evaluates the laboratory’s performance mandated by CLIA. Moderate and high complexity tests are required to enroll in an approved PT program for specialties in which certification is sought. Regulations create rules for PT providers that include sample problem solving, distribution, preparation, result reporting and records.

Patient test management must maintain and establish a system to ensure identification and reliability of specimens during the testing process and correct handing of the results. Requirements for the submission and handling, specimen referral, test applications, test records and reports are stipulated by the regulations.

Quality assurance/control ensures that every laboratory create quality control procedures that oversee and assess every test technique to guarantee precise and dependable results. Each laboratory must ascertain written policies and procedures for a QA program intended to oversee and assess the complete testing process.

Clinical Laboratory Improvement Amendments of 1988

Clinical Laboratory Improvement Amendments of 1988

A bill to amend the Public Health Service Act to revise the authority for the regulation of clinical laboratories.

10/31/1988 Became Public Law No: 100-578.10/31/1988 Signed by President.10/31/1988 Became Public Law No. 100-57810/21/1988 Presented to President.10/11/1988 Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.10/06/1988 Passed/agreed to in House: Passed House by Voice Vote.10/06/1988 Introduced in House

10/31/1988 Became Public Law No: 100-578.10/31/1988 Signed by President.10/31/1988 Became Public Law No. 100-57810/21/1988 Presented to President.10/19/1988 Measure Signed in Senate.10/12/1988 Message on Senate action sent to the House.10/11/1988 Passed Senate without amendment by Voice Vote.10/11/1988 Measure laid before Senate by unanimous consent.10/07/1988 Received in the Senate, read twice.10/06/1988 Passed House by Voice Vote.10/06/1988 Called up by House Under Suspension of Rules.10/06/1988 Referred to House Committee on Energy and Commerce.10/06/1988 Introduced in House

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures. Read more About Related Bills.

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.

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.