The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA's Clinical Laboratory Improvement Amendments (CLIA). Accessed Nov. 14, 2015.
CLIA Program In accordance with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: diagnosis, prevention, or treatment of disease or impairment health assessments An objective of the CLIA is to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. Most laboratory-developed tests have been regulated under this program. In 2014, the FDA started a public discussion about regulating some LDTs.
Test complexity
Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score of 1 is the lowest level of complexity, and a score of 3 is the highest. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.CLIA Categorization Criteria (December 2012)
Criteria for categorization: Knowledge Training and experience Reagents and materials preparation Characteristics of operational steps Calibration, quality control, and proficiency testing materials Test system troubleshooting and equipment maintenance Interpretation and judgment The Centers for Medicare & Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.
List of CLIA test complexity categorizations: Waived Moderate Provider-performed microscopy (PPM) High Laboratory-developed test (LDTs)
Complementary and alternative medicine laboratories Complementary and alternative medicine tests, such as live blood analysis (LBA), biological terrain assessment (BTA), dental sensitivity testing, and cytotoxic testing have not been categorized by the CDC, and are thus treated as high complexity laboratory developed tests. CAM tests are often ordered by chiropractors, naturopaths, and nutritionists and accompanied by non-validated clinical interpretations which are used to recommend or justify costly, unnecessary, and potentially damaging treatments. A 2001 OIG report found that the majority of laboratories performing CAM tests were not enrolled in CLIA and that CAM laboratory personnel did not meet the high complexity qualifications. For laboratories enrolled in CLIA, they had their certificates revoked or were sent deficiency notices for failing to adhere to CLIA regulations. No CLIA laboratory has been able to validate its LBA CAM tests per standards. CAM tests are not covered by health insurance. The number of CAM laboratories is unknown; the sales of supplemental remedies based on the results of these tests is unknown. Since CLIA does not regulate the clinical validity/usefulness of a test, it is possible for a CLIA laboratory to offer tests that have no clinical utility.
Getting laboratories that conduct CAM testing to enroll in CLIA is itself a challenge. Medical laboratories enroll in CLIA to qualify for Medicare/Medicaid reimbursement; nearly all providers bill patients directly for CAM laboratory tests. Additionally, CAM providers are concerned by the closure of other CAM laboratories under CLIA, and have sought to avoid detection. Some CAM providers and laboratory personnel have not had exposure to laboratory curriculum and are unaware of CLIA requirements. CLIA is largely reliant on laboratories to self-identify themselves for enrollment.
Providers of CAM laboratories have opposed CLIA oversight and suggested they be regulated by their peers or by a CAM-specific division. CAM providers have stated that they should be exempt from CLIA since CAM laboratories do not participate in health insurance. Others claim that they are exempt from CLIA because the tests are performed solely for research purposes and not used in patient care and treatment decisions. Several pathologists have stated that CAM testing falls within the scope of their medical license and should not be regulated under CLIA.
CLIA provisions are geared towards CLIA-certified laboratories, but not for those that have not enrolled. When a CAM laboratory is found to be operating without a CLIA certificate, they are sent a cease and desist letter to stop testing until the laboratory is CLIA certified. There are no administrative remedies available to CMS when a laboratory refuses to enroll in CLIA and refuses to cease testing. CMS cannot impose monetary or other administrative penalties on laboratories that defy the law, but can only refer cases to other Federal or State agencies. CMS plays the primary role in federal oversight of laboratories under CLIA, and there are limited regulations at the state level that restrict CAM laboratories.
Andrology and embryology laboratories and reproductive tissue banks CLIA applies to sperm analysis and the postcoital test, but does not apply to andrology or embryology laboratories, to testing performed as part of an assisted reproductive technology (ART), or to reproductive tissue banks. There are no federal personnel requirements.
The lack of CLIA applicability has been criticized noting how semen analysis is categorized as a high complexity test whereas the analysis of oocytes and embryos is unregulated, despite similar equipment and techniques in use. There are accreditation programs such as the CAP/ASRM Reproductive Laboratory Accreditation Program (RLAP), and TJC and CAP offer specialty accreditations, but these are voluntary in nature.
In the summer of 1991, HHS notified the American Society of Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) that in vitro fertilisation (IVF) and gamete intrafallopian transfer (GIFT) laboratories were to be covered under CLIA '88. However, when CLIA '88 was published on February 28, 1992, it did not explicitly mention andrology and embryology laboratories creating uncertainty in regulatory oversight. In 1992, Senator Ron Wyden (D-OR) introduced the Fertility Clinic Success Rate and Certification Act (FCRCA), colloquially called the "Wyden bill", requiring the Disease Control and Prevention (CDC) to develop a model program for the certification of embryo laboratories, to be carried out voluntarily by interested states. This created initial confusion as to whether CLIA was applicable. In 1994, HCFA stated that in vitro fertilization was categorized as a therapeutic procedure, not a diagnostic procedure, and therefore not covered under CLIA. As such, AAB/ABB took the position that IVF laboratory tests are covered under CLIA, while ASRM and SART took the opposing position. On September 16, 1998, the Clinical Laboratory Improvement Advisory Committee (CLIAC) made a non-binding recommendation that CLIA coverage apply to embryology laboratories and suggested the College of American Pathologists (CAP) and ASRM accreditation checklist. However, the United States Secretary of Health and Human Services Donna Shalala did not implement the recommendation prompting the AAB to sue HHS to force a decision on March 16, 1999. In response, ASRM filed an amicus brief opposing AAB's lawsuit. On March 8, 2000, the lawsuit was dismissed by Thomas F. Hogan due to lack of standing.
In 1994, the American Board of Bioanalysis (ABB) created the first CLIA-approved HCLD board exam for andrologists and embryologists.
Fees/Funding The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.
CLIA-waived tests Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver. In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver, although many waived tests are not done according to designed protocols – more than 50% of such tests are done incorrectly – and result in medical errors, some with fatal consequences.
Record and specimen retention CLIA [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003] and the College of American Pathologists (CAP) Adopted August 1995. Revised September 2020 have written policies for the minimum period that laboratories should keep laboratory records and materials, with some examples as follows: Microscopy slides Histology and non-forensic autopsy 10 years Forensic autopsy Indefinitely Cytology, fine needle aspiration 10 years Cytology, apart from fine needle aspiration 5 years Paraffin-embedded blocks Non-forensic 2 or 10 years Forensic Indefinitely Requisition form and test report Pathology reports 10 years Other 2 years Blood bank records Quality control records 5 years Donor and recipient records 10 years Records of indefinitely deferred donors Indefinitely Wet tissues Until report is completed or 2 weeks thereafter Proficiency testing records and quality management/quality control records 2 years Discontinued procedures 2 years Blood smears and other body fluid smears, microbiology slides (including Gram stains) 7 days Flow cytometry plots 10 years
During the retention period, specimens are considered part of the medical record and must be kept in a CLIA-accredited laboratory to ensure compliant handling and storage conditions. If a specimen is sent out to a non-CLIA biorepository and recalled, the additional testing would not be in compliance. There is an effort to make more biobanks CLIA equivalent as specimen recalls become more common due to expanded testing.
Specimen ownership and utilization
Although CLIA specifies minimum retention periods, it does not explicitly state which entity retains ownership of the specimen during retention and after the retention period. The US currently lacks well-defined federal regulations governing the ownership and use of physical human tissue specimens, their derivatives, and the biological information they contain. The current standing by bioethicists is that patients who have consented to have their diagnostic specimens collected have also abandoned them, and thus have no ownership rights. The Common Rule permits the use of biospecimens that would otherwise be discarded, provided that the donor can not be identified, though utilization of the materials for research may require Institutional review board (IRB) approval. The Association of American Medical Colleges (AAMC) has taken the stance that it "unambiguously rejects the concept that individuals retain any property interest in their excised tissues."
Proponents of patient ownership rights advocate that patients must own their samples so that they can make informed decisions about how the tissues will be used, such as in bioweapons development, stem cell research, and for-profit ventures. The 21st Century Cures Act enacted in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."