{"id":9123,"date":"2023-05-02T10:25:39","date_gmt":"2023-05-02T10:25:39","guid":{"rendered":"https:\/\/www.mybiosource.com\/learn\/?page_id=9123"},"modified":"2023-05-02T10:32:34","modified_gmt":"2023-05-02T10:32:34","slug":"best-practices-for-maintaining-clia-certification-and-compliance","status":"publish","type":"page","link":"https:\/\/www.mybiosource.com\/learn\/best-practices-for-maintaining-clia-certification-and-compliance\/","title":{"rendered":"Best Practices for Maintaining CLIA Certification and Compliance"},"content":{"rendered":"

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CLIA regulations dictate that the level of certification a laboratory acquires is contingent upon the level of complexity of the tests it conducts. There are three levels of test complexity outlined by CLIA: waived<\/span> tests, moderate-complexity tests, and high-complexity tests Waived<\/span> tests are simple and low-risk tests that are exempt from CLIA regulations, but must be performed according to the manufacturer’s instructions. They can be granted a certificate of waiver if the testing methodology is simple and accurate, or if incorrect usage poses no harm to the patient. Training for waived<\/span> tests is typically obtained through on-the-job instruction. Examples of waived<\/span> tests include non-automated urinalysis, urine pregnancy tests, fecal occult blood tests, and blood glucose tests using FDA-cleared home monitoring devices.<\/p>\n

Portable point-of-care<\/span> testing systems, which are performed outside of the laboratory setting at the bedside or site of patient care, are also considered waived<\/span> under CLIA. These systems, manufactured by companies such as i-STAT, Abaxis, and HemoCue, may detect complex molecules and proteins. Examples of waived<\/span> point-of-care tests include tests for hemoglobin<\/span> A1c, MMP-9 protein in human tears, TSH<\/span> assay for hypothyroidism<\/span> screening, urinary nuclear matrix protein<\/span> NMP22 for the monitoring of bladder<\/span> cancer patients, and multiplexed nucleic acid<\/span> tests for respiratory pathogens.<\/p>\n

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Criteria\u2019s for Categorizing Non-Waived<\/span> Clinical Laboratory<\/u><\/strong><\/h4>\n

CLIA regulations provide seven criteria for categorizing non-waived<\/span> clinical laboratory test systems. The criteria are as follows:<\/p>\n

Knowledge<\/strong> required to perform the test can be obtained through on-the-job training (score 1) or specialized scientific and technical knowledge is essential (score 3).<\/p>\n

Minimal training and experience<\/strong> are required for preferably analytic and post-analytic phases (score 1), or specialized training and substantial experience may be necessary (score 3).<\/p>\n

Reagents and materials<\/strong> are generally stable and reliable (score 1), or may require special handling to assure reliability (score 3).<\/p>\n

Operational steps<\/strong> are either automatically executed or easily controlled (score 1), or require close monitoring and extensive calculations (score 3).<\/p>\n

Calibration, quality control, and proficiency testing materials<\/strong> are stable and readily available (score 1), or maybe labile or not available (score 3).<\/p>\n

Troubleshooting is automatic or requires minimal judgment<\/strong> (score 1), or may require special knowledge, skills, and abilities (score 3).<\/p>\n

Minimal interpretation and judgment<\/strong> are required for preferably analytic and post-analytic processes (score 1), or extensive independent interpretation and judgment are required (score 3).<\/p>\n

A score of 1 through 3 indicates the level of complexity, with 1 being the lowest and 3 being the highest. The sum of scores for the seven categories determines the classification of the test as either “moderate complexity” (a score of 12 or less) or “high complexity” (a score greater than 12).<\/p>\n

Clinical laboratories<\/span> seeking to perform moderate or high-complexity testing must apply for a certificate of compliance (COC) or a certificate of accreditation<\/span> (COA). Initially, they are issued a certificate of registration<\/span> (COR) which is valid for a maximum of 2 years until a compliance inspection can be performed. Once all CLIA requirements are met, a COC or COA is issued by one of the six CMS-approved accrediting organizations.<\/p>\n

    \n
  1. American Association of Blood Banks (AABB)<\/li>\n
  2. American Osteopathic Association<\/span> (AOA)<\/li>\n
  3. American Society for Histocompatibility and Immunogenetics (ASHI)<\/li>\n
  4. College of American Pathologists<\/span> (CAP)<\/li>\n
  5. Commission on Office Laboratory Accreditation<\/span> (COLA)<\/li>\n
  6. The Joint Commission<\/span> (JC)<\/li>\n<\/ol>\n

    These organizations may differ in their inspection format, but their accreditation<\/span> standards must adhere to CLIA regulations. Laboratories<\/span> are free to choose the accrediting organization of their preference.<\/p>\n

     <\/p>\n

    Best Practices for Maintaining CLIA Certification and Compliance<\/u><\/strong><\/h4>\n

    Maintaining CLIA certification and compliance is essential for laboratories<\/span> to operate legally and provide high-quality patient care. Here are some best practices for maintaining CLIA certification and compliance:<\/p>\n

    Know the CLIA regulations<\/strong>: Familiarize yourself with the CLIA regulations that apply to your laboratory. You should be aware of the CLIA requirements for personnel qualifications, quality control, proficiency testing, and laboratory management.<\/p>\n

    Develop and implement policies and procedures<\/strong> that meet the CLIA regulations. Your policies and procedures should address all aspects of laboratory testing, including pre-analytical, analytical, and post-analytical phases.<\/p>\n

    Train your personnel<\/strong>: Ensure that all laboratory personnel receive appropriate training to perform their job duties according to CLIA regulations. Training should be documented, and training records should be maintained.<\/p>\n

    Perform quality control<\/strong>: Establish and implement a comprehensive quality control program that meets the CLIA requirements. This includes monitoring and documenting the performance of all testing systems, instruments, and reagents used in the laboratory.<\/p>\n

    Participate in proficiency testing programs<\/strong> that meet the CLIA requirements. Proficiency testing is an external evaluation of a laboratory’s testing performance compared to other laboratories<\/span>.<\/p>\n

    Document everything<\/strong>: Document all laboratory activities, including testing procedures, quality control measures, proficiency testing results, personnel training, and instrument maintenance.<\/p>\n

    Conduct regular inspections and audits<\/strong> to ensure that your laboratory is complying with CLIA regulations. You can use CLIA checklists to help identify areas of non-compliance.<\/p>\n

    Stay up-to-date with changes<\/strong> to the CLIA regulations by regularly reviewing updates from the Centers for Medicare and Medicaid Services (CMS) and attending CLIA training seminars and conferences.<\/p>\n

    By following these best practices, laboratories<\/span> can maintain CLIA certification and compliance, ensuring that they provide high-quality patient care and operate legally.<\/p>\n

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    Design, Validation, and Implementation of Assays with Quality Control Procedures under CLIA Regulations<\/strong><\/span><\/h4>\n

    In the United States, all medical laboratory practices performed on humans for diagnostic<\/span> purposes, except for research, are regulated by the Centers for Medicare and Medicaid Services. The Clinical Laboratory Improvement Act (CLIA) program, which is administered by the Division of Laboratory Services, aims to ensure quality laboratory testing and has established regulations for laboratory quality control, including method validation. The regulatory requirements for personnel, quality control, quality assurance<\/span>, method validation, and proficiency testing vary depending on the complexity category of the individual test. Molecular diagnostic<\/span> tests, including those for human papillomavirus<\/span> (HPV), are classified as high-complexity tests under CLIA, and laboratories<\/span> performing these tests must have a valid certification of accreditation<\/span> that covers high-complexity testing. The CLIA ’88 legislation governs these regulations.<\/p>\n

    There are three main steps involved in the process control for designing an assay, which is:<\/p>\n

    Design and verification<\/strong>: This step involves designing the assay and verifying that it works as intended. During this stage, the assay is developed and tested to ensure that it is sensitive, specific, and reproducible.<\/p>\n

    \"\"<\/p>\n

    Validation of the assay<\/strong>: In this step, the assay is evaluated to determine its performance characteristics and its ability to produce accurate and reliable results. This typically involves testing the assay on a large number of samples and comparing the results with a gold standard or reference method.<\/p>\n

    Implementation of the assay with QC procedures<\/strong>: Once the assay has been designed, verified, and validated, it can be implemented in a clinical or research setting. Quality control (QC) procedures are put in place to ensure that the assay continues to produce accurate and reliable results over time. This involves monitoring the performance of the assay and taking corrective action if any issues are identified.<\/p>\n

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    \u00a0<\/strong><\/p>\n

    References<\/strong><\/span><\/p>\n

      \n
    1. Medicare, Medicaid and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 57 Federal Register 7002 (1992).<\/li>\n
    2. US Department of Health and Human Services. Clinical Laboratories Improvement Amendments of 1988, 63 Federal Register 55031 (1988) (codified at 42 CFR \u00a7 493).<\/li>\n
    3. US Food and drug administration (FDA). CLIA Categorizations. Categorization Criteria. Available online at: https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/ CLIA-categorizations.<\/li>\n
    4. Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots. Approved guideline GP10-A. Wayne, Pa: NCCLS, 1995; reaffirmed May 2001.<\/li>\n
    5. Clinical Laboratory Improvement Advisory Committee (01 October 2019). \u201cClinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table\u201d (PDF).Centers for Disease Control and Prevention.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

        CLIA regulations dictate that the level of certification a laboratory acquires is contingent upon the level of complexity of the tests it conducts. There are three levels of test complexity outlined by CLIA: waived tests, moderate-complexity tests, and high-complexity tests Waived tests are simple and low-risk tests that are exempt from CLIA regulations, but […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-9123","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/pages\/9123","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/comments?post=9123"}],"version-history":[{"count":0,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/pages\/9123\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/media?parent=9123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}