The ongoing significance of the United States CLIA regulation of laboratories

US federal oversight of laboratory test facilities was introduced in 1988 following a Pulitzer Prize-winning series of articles that exposed a Pap-smear scandal

The Clinical Laboratory Improvement Amendments (CLIA) legislation ─ which was enacted in 1988 ─ marked a watershed moment in the regulation of laboratories in the United States. It was passed to address growing concerns about the quality and reliability of laboratory testing and their results that had direct implications for public health and patient safety.

Prior to implementation, oversight of laboratory operations has been fragmented, inconsistent and all too often unable to guarantee the reliability of diagnostic tests and procedures that had been offered to patients. An urgent need for comprehensive regulation arose with these decisive factors:

• The central role of laboratory results in clinical decision-making.
• Advances in the complexity of medical tests and technology.
• Documented harms that had arisen as a consequence of healthcare decisions made on the basis of poor-quality tests.

The US Congress revised its CLIA framework to address the fact that laboratory testing services had become the backbone of modern medicine. Healthcare professionals very heavily relied on lab results to make diagnostic decisions, consider treatment options and otherwise manage complex medical conditions. From routine blood work to bleeding-edge genetic tests, the data provided from the laboratory played an increasingly vital role in guiding clinical investigation, medical interventions or planning for surgery.

The original Clinical Laboratory Improvement Act had been enacted by the US Congress in 1967 and had sought to regulate hospital-based laboratories and other laboratories that engaged in commerce at an interstate level. However, labs that were operated by doctors themselves – often referred to as Physician Office Labs (POLs) – and other smaller establishments had been excluded from the federal-level standards imposed by the 1967 legislation. Indeed, who paid for the test, a private entity or a federal health programme was one of the key determinations over whether CLIA 1967 applied. Accordingly, fewer than 10% of all clinical laboratories were required in law to meet the federally defined quality standards.

Life-altering consequences could follow on from test results and so it was prima facie significant that those tests should be both accurate and reliable. But prior to CLIA 1988, the regulatory framework for laboratories was found to be insufficient to ensure the high quality and standardisation that was needed for accurate tests. This had brought about an environment of potential serious risk to patients, and in some areas, it was a wild west environment.

Advances in molecular biology, microbiology, immunology and biochemistry had expanded the potential capabilities of diagnostic laboratories but this also introduced the potential for more errors.

Unfortunately, at that time some laboratories were not adhering to best practice in quality and accuracy. They were not providing sufficient training for staff and also failing to maintain equipment. Consequently, procedures were too often inconsistent to ensure reproducible and reliable results. These discrepancies created significant variations in the quality of testing services offered across different laboratories, which undermined trust by both patients and healthcare practitioners in diagnostic results.

Furthermore, CLIA was responding to incidents that had underscored the pressing need for oversight of inadequate laboratories. A series of high-profile cases had revealed how laboratories that were poorly run could severely compromise patient care and risk seriously negative health outcomes.

An article published in The Wall Street Journal (WSJ) on 2 February 1987 exposed a scandal which involved several commercial laboratories that had inaccurately analysed Pap screening smears to test for cervical cancer. If detected at an early-stage cervical cancer was most often a treatable condition. The WSJ story had detailed the case of a woman, Janice Johnson, who died in 1981 after two routine Pap smear tests had incorrectly been determined to both be negative for cervical cancer.

Doubts over accuracy of other tests grew and extended to those for HIV and even cholesterol. In the series of articles that the WSJ published following the initial scandal, the newspaper cited a 1985 study that found half of 5,000 labs that had surveyed in the research could not produce acceptable results for a standard sample in a cholesterol test.

Another related problem was the growth of so-called ‘Pap-mills’ which offered bulk discounts to doctors sending large numbers of smear test slides. The discounting practice meant doctors were then able to benefit from the marginal cost difference in the price the labs charged them compared with the standard, off-the-shelf, single-test price which was being charged back to their patients.

Studies were conducted by the US Centers for Disease Control and Prevention, and other organisations, which revealed alarming rates of errors in proficiency testing among laboratories. These errors included misidentifications, false positives and false negatives in critical tests for diseases such as cancer, diabetes and some infectious disease including HIV. Public outrage over these revelations served as part of the catalyst for the CLIA 1988 legislative reform.

The data highlighted a glaring need for standardised criteria to evaluate and ensure the competency of laboratories, particularly as testing methods became more sophisticated and patients’ reliance on laboratory results continued to increase.

Prior to CLIA 1988, US lab regulations varied widely depending on laboratory type and even its funding sources. Indeed, laboratories that conducted tests paid for by the US federal health programmes of Medicare or Medicaid were subject to federal regulations through the Clinical Laboratory Improvement Act of 1967, but these rules did not apply where tests were paid for privately or in smaller facilities that performed limited testing.

The lack of consistent oversight meant that large numbers of labs operated without meaningful regulatory scrutiny, at either state or federal level, resulting in a patchy landscape in terms of quality and accountability.

Recognising the growing urgency to address the problem, Congress passed CLIA 1988 in order to create a unified regulatory framework that would ensure the quality and reliability of all laboratory testing performed on humans in the United States, regardless of payment source.

The legislation established minimum standards to meet in areas such as personnel qualifications, equipment calibration, testing methodologies, recordkeeping and proficiency testing. One of its defining features was its comprehensive scope: CLIA 1988 applied to virtually all facilities conducting laboratory testing, from large hospital laboratories to small physician office laboratories, closing the regulatory gaps in which substandard practices to exist.

Updating the 1967 legislation, a central tenet of CLIA 1988 was establishing quality assurance (QA) measures that were tailored to the complexity and purpose of the tests that were being performed. The legislation classified laboratory tests into three categories based on their level of complexity:

• waived
• moderate
• high complexity

…and imposed different requirements for labs depending on the category.

This classification system ensured that the most rigorous standards were applied to tests with the highest potential for errors or the greatest impact on patient outcomes. For those laboratories that were conducting high-complexity tests requirements to meet stricter personnel qualifications, implementation of more robust QA programmes, and participate in regular proficiency testing to demonstrate their competence. Equally, CLIA 1988 more broadly sought to create a culture of accountability and continuous improvement within the laboratory industry.

The CLIA 1988 legislative updates put particular emphasis on proficiency testing as a key mechanism to ensuring QA and so identify any underperforming laboratories. Proficiency testing involved the periodic assessment of a laboratory’s ability to perform tests accurately by having the facility analyse samples with known results and compare its performance to predetermined benchmarks.

CLIA 1988 required in law that laboratories participate in proficiency testing in order to be licenced where the labs were performing moderate- and high-complexity testing. This enabled regulators to identify deficiencies quickly and regularly and then require corrective action to limit – as far as was practicable – any compromises in patient safety. This systematic approach to monitoring laboratory performance helped establish a baseline standard of quality across the industry and provided patients with greater confidence in the reliability of their test results.

The implementation of CLIA 1988 also had broader implications for the healthcare system as a whole. By improving the accuracy and reliability of laboratory testing, the legislation contributed to better disease surveillance, earlier detection of outbreaks, and the opportunity for more effective public health interventions.

The standardisation of laboratory practices also facilitated data sharing and collaboration among healthcare providers and public health agencies, enhancing the overall quality of care and the United States’ capacity to respond to emerging health threats.

The passing of CLIA 1988 has proved an essential step that has addressed the deficiencies and inconsistencies that had undermined laboratory testing in the United States. The legislation recognised the vital role that lab results play in medical decision-making and the need to better protect patients from the unacceptable risks to health that the previously lax regulatory framework had exposed. The principles established by CLIA 1988 remain critical to ensure that laboratories operate with integrity, precision and an ongoing commitment to patient well-being.

—By Alan Booth