Title 42 was last amended 2/24/2023. CLIA offers a PPM certification option for this limited set of moderate complexity tests to accommodate the unique needs of health care providers in clinical settings. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. A state licensed physician who is board certified or board eligible in anatomic or clinical pathology meets the requirements to direct a laboratory of any complexity. Regulation Y All other requirements for lab directors, supervisors, and technical consultants remain unchanged. Fill in your details below or click an icon to log in: You are commenting using your WordPress.com account. For more details, please also see the FDAs webpage on theCLIA Categorization Criteriaexternal iconand CMS webpage onCategorization of Tests.external icon. Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. Score 1. Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. WebCLIA Regulation and Guidance The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Introduction Reimbursements by Medicare may be denied if the test submitted does not match the certificate. The FDA will notify the sponsor of their CLIA categorization usually within two weeks of the marketing clearance or approval. See 42 CFR 493.17. WebA score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level. CLIA defines an authorized person as someone that has specific authorization from the state in which the test is performed. CLIA regulations state that only an authorized person may order tests. Please follow the instructions below. hb```f``: , @1V 8 0*`:`Bc6R+YmL[U6s9f-\ w 1/1.1 Please see the FDAs webpage on CLIA Waiversexternal icon. input, Clinical Laboratory (CLIA) Licensing and Certification Program, Emergency Preparedness and Response Laboratory. Since November 13, 2003, the Food and Drug Administration (FDA) has had the authority to implement the Clinical Laboratory Improvement Amendments (CLIA) test complexity categorization provisions, which includes, but is not limited to the following: The FDA CLIA database contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by Centers for Disease Control and Prevention prior to that date. Laboratories that perform CMS and CDC collaborating to determine path forward. 5 - Calibration, quality control, and proficiency testing materials, 6 - Test system troubleshooting and equipment maintenance. Certificate of Waiver These tests have been approved by the FDA for home use and require very little training to perform. Web(a) A laboratory must obtain a certificate for tests of high complexity if it performs one or more tests that meet the criteria for tests of high complexity as specified in 493.17(a). The times of testing cannot overlap and cannot be simultaneous. This qualification includes proof of a minimum education requirement (usually a college diploma). High-complexity tests should be performed in a CLIA accredited Unfortunately, Caroline Satyadi, Federal Regulation 493.1489 says that associate degree (MLT) can perform high complexity testing. WebTo perform tests classified as moderate or high complexity, a laboratory, including a physicians office laboratory, must have a CLIA certificate of compliance or certificate of accreditation and a California clinical laboratory license. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). CAP regulations: ANP.11600 Gross Examination - Qualifications All The eCFR is displayed with paragraphs split and indented to follow WebApplication Information and Resources: CLIA The Certificate of Compliance and Certificate of Accreditation authorizes a high complexity laboratory to perform all levels of testing. Score 3. Thank you. The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement. These materials are for educational purposes only and readers may not reproduce or copy any content on this website, including files downloadable from this website, without the permission of the copyright owner. Thank you for posting this, it was very informative. For further information, please see http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIA_certificate_fee_schedule.pdf. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The general supervisor must provide day-to-day supervision and must be accessible. here. CLIA covers around 320,000 laboratory entities. Only Certificate of Compliance and Certificate of Accreditation laboratories have routine inspections every two years. Analytes that do not have a Proficiency Testing program available must be evaluated at least twice a year. In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. (LogOut/ means youve safely connected to the .gov website. Accessibility
Job Responsibilities: Accept and Processes However, Medicare and Medicaid will not pay for any laboratory testing not ordered by an authorized person. The site is secure. 2. My understanding is, for example an HTL qualifies as testing personnel but a histology trainee would then qualify to be lab personnel? WebThe FDA categorizes and grades each test based on test complexity. 49 CFR 172.101 From the Code of Regulations posted Testing personnel for high-complexity can be (2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or This is an MLT so where are you finding that only MTs can work in the blood banks for high complexity as you state in your article. Point-of-care testing is a phrase used to describe the location where testing is performed, such as at the bedside or near the site of patient care. The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. Requests to change facility name, address, tax id, mailing address or laboratory director must be reported to ISDH within 30 days of the change. Only certain types of providers qualify as testing personnel for PPM tests under a PPM certificate, including physicians, dentists and midlevel practitioners. Would my associates degree and certifications qualify me to aspire to a supervisor position in Histology? Can I have more than 1 location under the same CLIA number? Full payment must be received before a compliance survey will be scheduled by ISDH. by test system name, analyst name, complexity, specialty, and date of categorization, refer to the Public Databases webpage. will also bring you to search results. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. Failure to voluntarily provide this information may result in sanctions against your CLIA certificate and may effect Medicare reimbursements. Score 3. And hired a fresh out of school MLT grad to work in micro! WebCLIA regulations apply to laboratory testing in all settings including commercial, hospital, and physician office laboratories. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing. - Centers for Medicare & Medicaid Services, Department of Health and Human Services, https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M/subject-group-ECFR2640b368593bdb0/section-493.1489, Laboratories Performing High Complexity Testing. Please do not provide confidential Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. citations and headings WebNanobiosym is hiring for a Testing Personnel ASCP, for its High-Complexity Testing CLIA LAB. WebQualifications specified in the CLIA regulations to direct a clinical laboratory offering high complexity genetic molecular biology tests Experience as a lab director with advanced genomics technologies, performing high-complexity molecular and genetic testing endstream
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<. WebA. Once approved, FDA assigns complexity to a test, grouping it into one of three categories as specified by CLIA regulations: waived, moderate and high complexity. Learn more about the eCFR, its status, and the editorial process. Score 1. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors.html, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIA_certificate_fee_schedule.pdf, http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//ptlist.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf, http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads//CLIABrochure.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6065bk.pdf, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//wgoodlab.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure9.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//brochure7.pdf, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6064bk.pdf, http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf, http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/ReadySetTestBooklet.pdf, http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf, Report
The laboratory must have a director who meets the qualification requirements of 493.1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. None of the currently available serological tests may be performed under a Certificate of Waiver. or Box 3056, Portland, OR 97208-3056. After full payment of the certificate fee is received, your next two year certificate cycle is considered renewed. When applying for a Provider Performed Microscopy Procedure (PPM) Certificate, Certificate of Compliance or Certificate of Accreditation, what additional information/documentation is required? Laboratories with in a hospital that are located in contiguous buildings on the same campus and that are under common direction may file a single application. On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. (B) Have laboratory training that includes either of the following: (1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. Job Responsibilities: Accept and Processes and tests all types of laboratory specimens; reviews and reports lab results. For commercially available FDA-cleared or approved tests, FDA scores the tests using these criteria during the pre-market approval process. Provider-performed microscopy (PPM) Procedures, Other Terms Related to Test Complexity or Waived Testing, Determining Test Complexities for Specific Tests, Centers for Disease Control and Prevention. %PDF-1.6
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hbbd``b`VWAD-P_ kL@% Subpart I of the CLIA regulations After full payment is received, your next two year certificate cycle is considered renewed. WebCLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications. WebThese CLIA regulations distinguish two basic types of laboratories those that perform high and moderate complexity testing, and those that perform waived complexity testing. full text search results For both these categories the CLIA regulations list specific requirements for proficiency testing, patient test management, quality control, quality assurance, personnel, and 2013-2022, Lablogatory, All Rights Reserved. A score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level. Score 3. Displaying title 42, up to date as of 3/02/2023. In addition, not just anyone can perform the assessments. No histocompatibility or cytogenetics testing is performed in our lab. Other sources of information are the Indiana Professional Licensing Agency (IPLA), Indiana Board of Pharmacy, and the Indiana Board of Nursing. You can review and change the way we collect information below. What kinds of facilities are subject to inspections? WebMedicare/CLIA independent lab personnel requirements Testing Personnel (include total # of personnel performing testing in front of appropriate categories) as high complexity testing director before 2/24/03 ___5. However, if this was a regulated standardemployers would be paying to send their MLTs to school. contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by Centers for Disease Control and Prevention prior to that date. The role and requirements are below. information or personal data. I feel all personnel should maintain some degree of continued education as ASCP requires for cm. ( Comments or questions about document content can not be answered by OFR staff. When there arent enough workers, overtime drives employers to come up with solutions . (A) Calibration materials are stable and readily available; (B) Quality control materials are stable and readily available; and (C) External proficiency testing materials, when available, are stable. If the laboratory is requesting payment under Medicare, the laboratory must follow the requirements in the Social Security Act regarding test ordering for Medicare reimbursement. Also, it is up to the laboratory to decide whether or not to provide Direct Access Testing. (LogOut/ Choosing an item from 644 0 obj
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As defined by CLIA, waived testsare simple tests with a low risk for an incorrect result. WebCenters for Medicare and Medicaid Services , the Food and Drug Administration , and the Centers for Disease Control and Prevention all play a role in ensuring quality lab testing in the United States. Complaints and revisit surveys are always unannounced. Before sharing sensitive information, make sure you're on a federal government site. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. WebAll LDTs are classified as high complexity tests, the most stringent category of testing under CLIA. The role and requirements are below. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. These terms do not relate directly to the test complexity categories, and it cannot be assumed that a test system is waived simply because it is performed at the point of care. WebCLIA 88 regulations for minimal educational requirements to perform high complexity testing to be inadequate and outdated (42 CFR493.1489 and 1491). Following categorization, a manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. 2. Ms Satyadi may be referring to California law in my research on this, California is the only state Ive found (as of the date of this posting) that has restrictions close to what she has mentioned here. Examples of PPM testing include: wet mounts and potassium hydroxide preparations (also known as KOH preps). They include: Sites that perform only waived testing must have a CLIA certificate and follow the manufacturers instructions; other CLIA requirements do not apply to these sites. However, as you pointed out, several commenters have pointed out and corrected the error, so we feel readers will get the information they need. To search the CLIA database . CMS 116 CLIA Application: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf, Enclosure A Disclosure of Ownership (Also, include documents requested on page 1: IRS letter of Tax ID and Secretary of State Certification), Proficiency Testing: 2011 CLIA Approved Proficiency Testing Providers: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//ptlist.pdf, Additional Information on Proficiency Testing:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf, CLIA Brochure:http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads//CLIABrochure.pdf, Calibration and Calibration Verification Procedures:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6065bk.pdf, Good Laboratory Practices for Waived Laboratories:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//wgoodlab.pdf, How to obtain a CLIA certificate:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//HowObtainCLIACertificate.pdf, Laboratory Complaints:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure9.pdf, Laboratory Director Responsibilities:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//brochure7.pdf, Certification Boards for High Complexity Laboratory Directors:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors.html, CME Credits for Moderately Complex Laboratory Directors:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CME_Courses_for_Laboratory_Directors_of_Moderate_Complexity_Laboratories.html, Verification of Performance Specifications:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6064bk.pdf, OSHA Blood Borne Pathogens standards:http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051, Individualized Quality Control Plan (IQCP):https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html, Individualized Quality Control Plan (IQCP) Developing an IQCP:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf, Ready Set Test:http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/ReadySetTestBooklet.pdf, To Test or Not to Test:http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf, What Do I Need to Do to Assess Personnel Competency?:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf. 5 and 1/2 years after being published and several commenters pointing out the major error contained in it, this article remains uncorrected. So now there is only 2 MLTs in micro! Tests are categorized as waived, moderate complexity or high complexity. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled. Certificate of Compliance or Certificate of Accreditation: Fees depend on the annual test volume and number of laboratory specialties/subspecialties. Can I have more than 1 CLIA number at the same location? I cannot say the same for some of the MTs. (i) Qualify as testing personnel under 493.1489 (b) (2); and (ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (3) (i) Except as specified in paragraph (3) (ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. Initial CLIA certificates will be mailed approximately two weeks after full payment of CLIA fees is received. Standard deficiencies must be corrected within a reasonable period not to exceed 12 months. Facilities performing moderate Under the nonwaived category are moderate- and high-complexity The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. user convenience only and is not intended to alter agency intent 0
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Navigate by entering citations or phrases 5{ "5a:jHDTUYGtdV(gpf`[g. If youd like more information about these regulations, please read the Code of Federal Regulations part 493. Please see FORMS section for required forms. I cant attest to the quality of every MLT program, but mine was excellent, although it would have been better if the amount of time in clinical rotations had been longer. Other state agencies such Indiana Department of Environmental Management (IDEM) Board of Animal Health may have state statutes and regulations that apply to your laboratory. IVD Regulatory Assistance, Recalls, Market Withdrawals and Safety Alerts, Clinical Laboratory Improvement Amendments (CLIA), Device Advice: Comprehensive Regulatory Assistance, Administrative Procedures for CLIA Categorization. the hierarchy of the document. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists (MTs) shortages across the country. Unfortunately, this blogger no longer contributes to the blog, and so cant update the post. It is true they dont have as extensive a general studies education as the MT/CLS, but they do have 2 years of education concentrated in laboratory technology. 2)The hours of operation must be specified for each laboratory. These health assessment tests examine diagnoses, prevention and treatment of the human body. The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity. I have been saying this our experienced MT are being over looked by are supervisor. (ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or, (iii) Have earned an associate degree related to pulmonary function from an accredited institution; or. See 42 CFR 493.19. WebThe regulations use a scoring system to provide a complexity level to various tests performed at these sites, based on the knowledge, experience, training, and supplies required to perform them. Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard. CLIA categorization is determined after the FDA has cleared or approved a marketing submission, or upon request for legally marketed devices, as described in the FDA guidance Administrative Procedures for CLIA Categorization. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/CLIA/03_Interpretive_Guidelines_for_Laboratories.asp#TopOfPage. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M. PPM procedures are certain moderate complexity microscopy tests commonly performed by health care providers during patient office visits. If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below. You will be subject to the destination website's privacy policy when you follow the link. These visits are announced, information gathering and are designed to help educate the laboratories on sound laboratory practices. WebThe CLIA standards require that these individuals either: (a) have a doctoral degree in a chemical, physical, biological, or clinical laboratory science and be certified by a board It cites the six minimal regulatory requirements for assessment of competency for testing personnel: Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnels qualification. WebCLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications. The final rule has been issued for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) regulations related to analytes and acceptable performance. Change request(s) may be faxed, e-mailed or mailed: Laboratory directors performing nonwaived testing (including PPM) must meet specific education, training and experience under subpart M of the CLIA requirements. Local state regulations must also be considered when using lab tests on the CLIA-waived list. The lab director is responsible for assessing employee competency. Organization and Purpose Having said that, I agree that an MLT fresh out of school definitely needs to work alongside an experienced Micro tech. Doctoral degree in lab science and doctor, physician's assistant, or nurse practitioner). A new CMS 116 CLIA Application may be completed for any changes. An official website of the United States government If you have questions for the Agency that issued the current document please contact the agency directly. These cookies may also be used for advertising purposes by these third parties. What does this mean? State of Indiana/Indiana State Department of Health (ISDH) CLIA Program Frequently Asked Questions Updated: 3/13/2019, http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//HowObtainCLIACertificate.pdf. This document is available in the following developer friendly formats: Information and documentation can be found in our http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certificate_of_-Waiver_Laboratory_Project.html. (A) Minimal scientific and technical knowledge is required to perform the test; and (B) Knowledge required to perform the test may be obtained through on-the-job instruction. It is up to STATE regulations or even facility preference to hold higher qualification standards. https://www.cms.gov/CLIA/Downloads/directaccesstesting.pdf. The contents of an appropriate job description and recommended provision to employee are outlined, along with Performance evaluation processes including recommended components. You can The State agency surveyors will ensure that personnel conduct quality testing in a manner which protects patient safety, determine each laboratory's regulatory compliance, and make certain that each laboratory is only conducting the more simple tests that are appropriate for a certificate of waiver facility. Facilities performing moderate or high complexity testing must be enrolled in an approved Proficiency Testing program for each regulated analyte. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. The CMS 116 CLIA Applications may be completed for any changes. As a The final score is used to determine whether the test system is classified as moderate or high complexity (CDC, 2021). The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Requests to terminate your CLIA certificate must be submitted in writing to ISDH. This content is from the eCFR and is authoritative but unofficial. Also, CMS list of PPMP tests (including CPT/HCPCS codes)pdf iconexternal icon. All forms (CMS 116 CLIA Application, Enclosure A Disclosure of Ownership and Enclosure I Methodology Test list) must be completed and signed and appropriate documentation attached for initial certificates and most changes of certificate type.