Clinical Laboratory Improvement Amendments
[4] 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.
Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.
[6][7] 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.
[10] 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.
[14] However, when CLIA '88 was published on February 28, 1992, it did not explicitly mention andrology and embryology laboratories creating uncertainty in regulatory oversight.
[14] 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.
[14] 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.
[29][33] 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.
[29] 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.
[31] 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."
[29] Ideally, researchers should obtain informed consent from individuals, and aim for transparency in their intended use for the human tissue while protecting the privacy of the donor.
[37] After the initial testing is complete, the residual dried blood spots (DBS) on newborn screening cards may be used for secondary purposes including shared with law enforcement and sold for research.
[42][43] The absence of parental awareness and consent for these activities, and a lack of transparency and federal regulations, has led to significant public concern and apprehension.
[46] The American Civil Liberties Union (ACLU), Council for Responsible Genetics(CRG), and the International Association of Privacy Professionals(IAPP) oppose the long term storage of identifiable NBS blood spots.
'"[52] In New Jersey, the Institute for Justice filed a class-action lawsuit in 2022 under the 4th amendment seeking to limit the retention period of NBS cards after they were found to be used in warrantless law enforcement investigations without consent.
[48][53][54] The origins of CLIA can be traced back to the late 1960s, when cytology laboratories faced issues due to overworked personnel and a high incidence of errors in reading PAP smears.
[55] The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
[59][60] With the COVID-driven inspection backlog and a lack of inspectors, the move was criticized as being purely a financially driven attempt to capture additional market share.
