To Test Or Not To Test

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To TestorNot toTest?Considerations forWaived sts/Center for Surveillance, Epidemiology, and Laboratory ServicesDivision of Laboratory SystemsCS255581-B

IntroductionBackgroundHealth care providers use laboratory test results todiagnose disease, determine prognosis, and monitora patient’s treatment or health status. Current practiceshows an increased trend for medical decisions based onsimple tests performed at the point of care. Many of thesetest systems are waived under the Clinical LaboratoryImprovement Amendments of 1988 (CLIA) and can beperformed without routine regulatory oversight undera Certificate of Waiver from the Centers for Medicare &Medicaid Services (CMS).PurposeThis booklet describes considerations and preparations needed prior to performing waivedtesting and may assist those who want to implement and oversee waived testing or offer a newtest under a CLIA Certificate of Waiver.Additional materials that may be useful: The Ready? Set? Test! booklet describesrecommended practices for physicians,nurses, medical assistants, pharmacists,and others who perform patient testingunder a CLIA Certificate of Waiver. The Ready? Set? Test! poster lists ten goodpractices for testing. The Ready? Set? Test! online training providesscenario based training on recommendedpractices for waived testing and offerscontinuing education credit.These materials can be found here: hough some of the recommendations in this booklet exceed CLIA requirements forwaived testing, following these good testing practices will likely lead to reliable, highquality test results and will enhance patient safety.Introduction — 3

ContentsIntroduction . . . . . . . . . . . . . . . . 3 Testing personnel . . . . . . . . . . . . 16Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Choose the Right Employee . . . . . . . . . . . . . . . 16Overall considerations . . . . . . . . . . 7Employee Training . . . . . . . . . . . . . . . . . . . . . . . . 16Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Employee Performance. . . . . . . . . . . . . . . . . . . . 17Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Starting to test . . . . . . . . . . . . . 18Issues to Consider. . . . . . . . . . . . . . . . . . . . . . . . . . 7Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Oversight of testing. . . . . . . . . . . . 8Manufacturer’s Instructions. . . . . . . . . . . . . . . . 18Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Responsibility for Management. . . . . . . . . . . . . 8Quality assessment . . . . . . . . . . . 20Personnel Support. . . . . . . . . . . . . . . . . . . . . . . . . 8Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Regulatory requirements . . . . . . . . . 9Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Tips . . . . . . . . . . . . . . . . . . . . 21Waived Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Resources . . . . . . . . . . . . . . . . 22CLIA Certificate of Waiver. . . . . . . . . . . . . . . . . . . 9“Off-Label Use” of Waived Tests. . . . . . . . . . . . 10Appendix A. . . . . . . . . . . . . . . . 23State and Local Requirements . . . . . . . . . . . . . 10Appendix A1 . . . . . . . . . . . . . . . 28Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Requirements for Confidentialityand Patient Privacy. . . . . . . . . . . . . . . . . . . . . . 12Location for testing. . . . . . . . . . . 13Appendix A2. . . . . . . . . . . . . . . 31Appendix B. . . . . . . . . . . . . . . . 35Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Appendix C. . . . . . . . . . . . . . . . 39Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Appendix D. . . . . . . . . . . . . . . . 43Waste Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Selecting tests . . . . . . . . . . . . . 14Appendix E. . . . . . . . . . . . . . . . 47Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Appendix F. . . . . . . . . . . . . . . . 51Test Characteristics. . . . . . . . . . . . . . . . . . . . . . . . 14Appendix G. . . . . . . . . . . . . . . . 53Types of Samples. . . . . . . . . . . . . . . . . . . . . . . . . . 14Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Table of Contents — 5

Overall considerationsOverviewBefore deciding to begin testing at your facility or adding a new test to your test menu, it isimportant to carefully weigh the potential benefits in light of the various issues to be considered.BenefitsSome of the benefits of performing waived testing include: rapid availability of results while the patient is available for immediate follow-up, simple tests have minimal need for training, and portability of many waived tests allows for easier testing in nontraditional settings.IssuestoConsiderAlthough waived testing can be beneficial, infrequent testing may result in concerns about theability of the testing personnel to perform the test correctly. Infrequent testing may also resultin increased cost due to reagents and controls becoming outdated before being used. Considerthe following when deciding when to perform testing versus sending samples to a referencelaboratory for testing. Oversight of testing— Someone will need to be responsible for managing testing andmaking decisions to assure quality testing. Regulatory requirements— Every site will need to follow applicable federal, state, and/orlocal requirements for testing, safety, confidentiality, and privacy. Location for testing— Testing will need to be performed in a location with adequatespace, an appropriate physical environment, and accommodations for proper disposal ofbiohazardous waste. Selecting tests— Consider the test characteristics, sample requirements, and costs whenchoosing a test. Testing personnel— Personnel who perform testing will need to be trained andperiodically assessed on their ability to perform quality testing. Starting to test— Make sure that you have, understand, and follow the currentmanufacturer’s instructions. Quality assessment— Continually monitor, evaluate, and look for ways to improve thequality of testing.Overall considerations — 7

Oversight of testingOverviewMaintaining a consistent high level of quality and service should be part of the daily routine foreach employee involved in patient care. Designating someone to oversee testing and providesupport to the personnel who perform testing will help your testing site(s) achieve the goal ofquality patient testing.ResponsibilityforManagementEach testing site should identify at least one person responsible for overseeing testing anddecision-making. The person overseeing testing might be a physician or someone in a seniormanagement position who has the appropriate background and knowledge to make decisionsabout laboratory testing. The person overseeing testing should:have appropriate background and knowledge for making decisions and solving problems99with testing,demonstrate a commitment to the quality of testing,99understand how to comply with applicable regulatory requirements, and99promote good laboratory practices.99Personnel SupportPersonnel who perform testing should be encouraged touse quality practices, ask questions and seek help whenthey have concerns. Some recommendations are to: Post or have telephone numbers for emergencysituations readily available. Identify a resource person or expert (for example,a consultant and/or test manufacturer’s technicalrepresentative), who is available either off-site oron-site, to answer questions and be of assistance. Post telephone numbers for manufacturer’s technical assistance. Make sure all equipment is maintained and service contracts purchased for equipment thatrequire additional maintenance beyond the abilities of the staff. Designate one person to discuss new tests and other testing materials with salesrepresentatives or test distributors. This person should understand the responsibilities andimpact of changing from one test system to another and introducing a new test. Provide employees a way to voice their concerns regarding the quality of patient testingwithout fear of disciplinary action or other adverse consequences. Promote and offer opportunities for employee training and continuing education.8 — Oversight of testing

Regulatory requirementsOverviewEvery site that performs laboratory testing must follow applicable regulatory requirements. Theseinclude federal, state and local requirements for testing as well as requirements for safety andconfidentiality of personal information.Waived TestsWaived tests include test systems cleared by the Food and Drug Administration (FDA) for homeuse and those tests approved for waiver under the Clinical Laboratory Improvement Amendmentsof 1988 (CLIA) criteria. The FDA list of waived tests is continuously being updated. The mostcurrent information on FDA-cleared waived tests for verification that the test(s) performed by yourlaboratory is categorized as waived can be found at the following website: cfClia/testswaived.cfmCLIA CertificateofWaiverBefore testing patient samples, federal regulations require testing sites to have a CLIA certificateissued by CMS. Sites performing only one or more waived tests must file a Certificate of Waiverapplication and obtain a separate certificate for each location.To obtain a CLIA Certificate of Waiver, complete CMS form 116 found s/downloads/cms116.pdfYour completed CMS form 116 should be sent to the address of the local State Agency for thestate in which your laboratory resides. You should contact this State Agency for additional formsthat may be necessary to complete the registration process. Additionally, the CLIA contact inthe Regional Office may provide assistance. The list of CMS State Agency & Regional Office CLIAContacts can be found at: ation/CLIA/State Agency and Regional Office CLIA Contacts.htmlIf you do not have online access and do not have information about your State Agency,you may contact the CLIA program at 410-786-3531 for the address and phone number ofyour State Agency.For additional information on how to obtain a Certificate of Waiver, refer to the CMS brochurelocated online at: pdfOnce your site has obtained a CLIA Certificate of Waiver, requirements for testing include:Perform only waived tests.99Follow the current manufacturer’s instructions for the waived tests you perform, without99any changes.Pay the certificate renewal fee every two years.99Notify your State Agency of any changes in ownership, name, address, or director within 3099days, or if you wish to add tests that are not waived.Allow announced or unannounced on-site inspections by a CMS representative.99Regulatory requirements — 9

Although not routinely done, CMS will inspect waived testing sites under certain circumstancessuch as: if a complaint has been filed, to determine if the testing site is only performing waived tests, if there is a risk of harm to a patient due to inaccurate testing, and to collect information about practices being used at waived testing sites.“Off-L abel Use”ofWaived TestsBased on the testing site’s need and the unique population it serves, there may be instanceswhen the site chooses to modify an FDA-cleared or approved test system. Modification meansusing a test system in a way other than that described in the intended use, precautions,limitations, or other sections of the manufacturer’s instructions. The modified use of a test systemis considered “off-label use” because it is not supported by the manufacturer’s clinical data andit is not part of the FDA-cleared or approved instructions. “Off-label use”, or modified use of atest system, defaults the test to the high-complexity testing category under CLIA regulations,and will require sites using the modified test system to meet all applicable CLIA requirementsfor high-complexity testing. These include requirements for proficiency testing (PT), establishingperformance characteristics, quality control (QC), quality assessment, and adherence to personnelqualifications. Laboratories with a CLIA Certificate of Waiver that are using modified test systemswill need to upgrade to a CLIA Certificate of Compliance or a CLIA Certificate of Accreditation ifthey continue to use modified test systems.Example of “Off-Label Use” of Waived TestsUsing a waived blood glucose monitoring system to test a patient whose hematocrit oroxygenation level is above or below the range indicated in the manufacturer’s instructions wouldbe an “off-label use” of this system. Results of blood glucose testing in this situation may lead toclinical interventions that could cause patient harm. If the patient’s hematocrit and oxygenationlevel are within the manufacturer’s stated limits, then performing a glucose test using the waivedglucose monitoring system would not be considered off-label testing and the test system wouldstill be considered waived.S tateandL ocal RequirementsState and local jurisdictions vary in how they regulate laboratory testing. Some haverequirements governing testing, personnel licensure or phlebotomy. Often there are specificregulations for biohazard safety or the handling and disposal of medical waste. The personoverseeing testing should ensure that all state and local requirements are met. When state,local, and federal requirements are not the same, follow the strictest requirement that appliesto your site.10 — Regulatory requirements

SafetyFederal Regulations for SafetyThe Occupational Safety and Health Administration (OSHA) requiresemployers to provide a safe and healthy workplace for employees.Each site must comply with OSHA standards including:Comply with OSHA standards to assure the safety and health99of employees. OSHA provides a list of regulations that normallyapply to medical and dental offices in a brochure, Medical &Dental Offices— A Guide to Compliance with OSHA 7.pdfTreat all human blood and certain human body fluids as if they are infectious. Strictly enforce99the use of universal precautions and compliance with the bloodborne pathogens ens/index.htmlEnsure use of safer, engineered needles, sharps containers and personal protective equipment99(PPE) such as gloves and protective eyewear. See OSHA’s PPE Fact Sheet:http://www.osha.gov/OshDoc/data General Facts/ppe-factsheet.pdfImplement a sharps injury prevention program. CDC provides a Workbook for Designing,99Implementing, and Evaluating a Sharps Injury Prevention workbook 2008.pdfOffer hepatitis B vaccination at no cost for employees with possible occupational exposure.99Provide safety training to employees on handling blood and other infectious materials.99Provide equipment for safely handling and disposing of biohazardous waste.99Have a written plan for exposure control. See an /hazards/tb/sampleexposurecontrolplan.htmlMaintain records of occupational injuries and illnesses. OSHA provides a record keeping99handbook: HA 3245 REVISED.pdfAdditional safety practices when performing testing are:No eating, drinking, or applying makeup in areas where samples are collected and where99testing is performed.Do not store food in refrigerators where testing supplies or samples are stored.99Have sinks for hand-washing or antiseptic hand washing solutions available.99Post safety information for employees and patients.99Development of a site-specific safety plan that describes policies, procedures, and work practicesfor employee safety provide testing personnel and staff protection from the health hazards thatmay be involved in testing.See Appendix A for an example Safety Plan including an example Safety Training Checklist andIncident Report.State Regulations for SafetyMany states have Occupational Safety and Health (OSH) Plans that are monitored by OSHA.If you live in a state that provides a State Plan, you must comply with the State OSH standards.OSHA provides information on State OSH programs: http://www.osha.gov/dcsp/osp/index.htmlRegulatory requirements — 11

RequirementsforConfidentialityandPatient PrivacyThe Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses the protectionand privacy of personal health information. Testing sites are required to establish policies andprocedures to protect the confidentiality of health and personal information about their patients,including patient identification, test results, and all records of testing. All personnel should receivetraining on maintaining the confidentiality of patient information. Several states have medicalprivacy laws that apply to testing sites. Refer to the following link for more information on HIPAA:http://www.hhs.gov/ocr/privacy/See Appendix B for an example Security and Confidentiality Agreement form.12 — Regulatory requirements

Location for testingOverviewAssuring the appropriate physical environment for performing testing is important for achievingreliable test results. In general, testing should be performed in a clean work area with space forpatient privacy while safely collecting samples and performing testing. Each testing site shouldarrange for proper disposal of hazardous waste.EnvironmentAssuring the appropriate physical environment for performingtesting is important for achieving reliable test results. Ingeneral, testing should be performed in a clean work area withspace for patient privacy while safely collecting samples andperforming testing. Each testing site should arrange for properdisposal of hazardous waste. Workspace— should be stable, level, and allow patientconfidentiality, disinfection, sample collection, propertesting, and storage of supplies and records. Lighting— sample collection and testing area(s) shouldbe well lit. Ergonomics— should be considered and evaluated for the tasks employees perform. Safety labels— equipment and testing areas should be clearly labeled for hazards. Temperature— can affect reagents and test components, reaction times, the expiration oftest kits, and test results. Follow the manufacturer’s instructions for storage and testing andavoid temperature extremes. Humidity levels— can affect reagents and test components, the rate of chemical reactionsand sample interaction, and test endpoints. Utilities— such as electricity and water may be necessary for some testing devices andequipment. Housekeeping— testing areas should be clean, organized, and free of clutter. If applicable,make sure housekeeping staff are trained on the potential hazards involved in handlingbiological waste and have proper safety training to work with such material.Waste DisposalHazardous

Before testing patient samples, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only one or more waived tests must file a Certificate of Waiver application and obtain a separate certificate for each location. To obtain a CLIA Certificate of Waiver, complete CMS form 116 found at:

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