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Sexually
Transmitted Diseases > Program Guidelines > Medical and Laboratory Services
Appendix ML-ACLIA CLIA Background CLIA has categorized more than 150,000 test systems based on the complexity of their method. The three test categories are: 1) waived complexity; 2) moderate complexity, with a subcategory of provider performed microscopy; and 3) high complexity. Criteria for classification into these levels include (1) degree of knowledge needed to perform the test; (2) training and experience required; (3) complexity of reagent and materials preparation; (4) characteristics of operational steps; (5) characteristics and availability of calibration, quality control, and proficiency testing materials; (6) troubleshooting and maintenance required; and (7) degree of interpretation and judgment required in the testing process. The subcategory of Moderate Complexity, Provider Performed Microscopy (PPM), was created in 1993 and includes the following microscopic tests:
These are procedures limited to bright field or phase-contrast microscopy with unique characteristics that are not adequately addressed within the moderate complexity category. For example, specimens are labile and need to be examined immediately so the accuracy of the test results is not compromised. In addition, there are no recognized quality control procedures available for these tests. Initially, providers included only doctors of medicine, osteopathy, or podiatric medicine. The category was modified later to include dentists, nurse practitioners, nurse midwives, and physician assistants. Some test systems have been waived or exempted from CLIA requirements. These tests are waived because they (1) have been approved by the Food and Drug Administration (FDA) for home use, (2) use methods that are so simple and accurate that the likelihood of erroneous results by the user is negligible, or (3) DHHS has determined they pose no unreasonable risk of harm to the patient, if performed incorrectly. Waived tests that may be used in STD include dipstick/tablet urinalysis, and urine pregnancy tests. In September, 1995, the Centers for Disease Control and Prevention proposed criteria to be used to determine whether test systems could be waived from CLIA requirements. Currently, requests for waiver are reviewed using these proposed waiver criteria. Certification Implementation and enforcement of the Clinical Laboratory Improvement Amendments (CLIA) are the responsibility of the Health Care Financing Administration (HCFA). Laboratories must first register, after which HCFA surveys the laboratory, issues a certificate of compliance, and collects the appropriate fees. As waived and PPM laboratories are not subject to routine inspections, they apply to HCFA directly for the certificate. Laboratories may be issued a certificate of accreditation by a HCFA-approved organization or HCFA-approved state program in lieu of HCFA certification. Under CLIA, HCFA is also responsible for establishing proficiency testing programs, approving accreditation programs, and exempting state applications when indicated. Exemption to Certification It is generally accepted that CLIA regulations affect the staffing needed for STD clinic laboratories and who is allowed to perform certain tests, such as the Rapid Plasma Reagin Card Test for syphilis (RPR). In addition, fees collected by HCFA for certification have to be factored into the budgets of STD clinic laboratories, as well as costs for enrollment in proficiency testing programs. Laboratories that obtain a certificate for moderate or high complexity testing must enroll in a proficiency testing program and pass proficiency testing for each certified speciality and subspeciality, e.g., syphilis serology. Each laboratory must establish and follow written quality control and quality assurance procedures to ensure accurate and reliable results and to monitor their testing process. An exemption to this certification requirement is available for limited public health testing (LPHT). This exemption allows not-for-profit or federal, state, or local government laboratories at multiple sites to file a single application. This certificate provides administrative and financial relief because: (l) only one registration fee is required (rather than separate fees for each site); (2) the inspection fee is determined on the total test volume and specialities among all sites; (3) only one site must enroll in proficiency testing (although other sites must compare performance). Thus, the LPHT reduces the costs of registration fees, training, proficiency testing, and personnel requirements. A number of states currently have programs in effect to help maintain STD laboratory testing by enrolling local public health laboratories in multiple site certificates operated by the state public health laboratory. In these states, the state laboratory director often serves as the laboratory director for all of the smaller public health laboratories. Necessary training is conducted in the state laboratory or at a regional location. All programs report that they perform at least one on-site visit per year for each LPHT laboratory. Because there has been up to 150 sites per certificate, concern has been raised about effective supervision of these laboratories. CLIA '88 Test Categorization As stated earlier, Test Categorization criteria are defined as (1) degree of knowledge needed to perform the test; (2) training and experience required; (3) complexity of reagent and materials preparation; (4) characteristics of operational steps; (5) characteristics and availability of calibration, quality control, and proficiency testing materials; (6) troubleshooting and maintenance required; and (7) degree of interpretation and judgment required in the testing process. Test categorization is a continuing process. New products are categorized, and names of test system manufacturers change. The Test Categorization Database is updated monthly. A current list of all categorized test systems is found at: If you have questions regarding test systems on the test list or how to gain access to the list, please call (770) 488-8155. CLIA '88 Personnel Requirements The Clinical Laboratory Improvement Amendments (CLIA '88) have established standards for personnel, quality control, quality assurance, patient test management, and proficiency testing based on the complexity of the testing performed. The following table summarizes the personnel requirement for Moderate Complexity, including Provider Performed Microscopy (PPM), and High Complexity laboratories. Laboratories performing only waived testing do not have any personnel requirements.
Moderate Complexity level testing covers most of the stat STD tests requested routinely. Under professional training requirements for a laboratory holding a certificate for moderate complexity testing only, the director of the laboratory would need to meet the requirements listed above. The director also may serve as the technical consultant or as the clinical consultant and may perform testing. Other testing personnel would need to meet the training requirements listed above for moderate complexity testing. Appropriate training might be acquired on-the-job, through attendance at formal courses at one of the STD Prevention Training Centers, or through the National Laboratory Training Network, institutions of higher learning, state or regional laboratories (formal or informal), satellite video training sessions (distance learning), or use of computerized self-study training products.
Page last modified: August 16, 2007 Page last reviewed: August 16, 2007 Historical Document Content Source: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention |
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Program Operations Guidelines for STD Prevention
