Using sterile cups in urine collection for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services. The Clinical Laboratory Improvement Amendments (CLIA), a set of federal regulatory standards introduced in 1988, governs every lab that performs human testing in the United States. The test is essential if you need a blood transfusion or are planning to donate blood. State CLIA-waiver requirements [Excel download], NASPA Pharmacist Prescribing authority: Test and Treat [Website]. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Tuberculosis purified protein derivative test, STIs (chlamydia, gonorrhea, hepatitis, HIV, herpes, syphilis, trichomoniasis, genital warts). Also learn how to find your blood, If you have type A+ blood, you have the same blood types as about one out of every three Americans. Before applying for a CLIA Certificate of Waiver, you must know which tests you want to provide. The microscope component that directs the light up through the slide is the: Theyll use a needle to draw several samples of blood from your arm or hand. pB]T{$YvhQ t^. b. Fecal occult blood test: positive CLIA Categorizations. False, The term used that indicates a laboratory test should be run immediately. Score 1. Specimen labels should include all of the following except: A centrifuge load always contains an even number of tubes. It also helps assess patient health to make clinical decisions for patient care. Study with Quizlet and memorize flashcards containing terms like Which of the following is not a CLIA-waived test? In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. Your blood type is determined by what kind of antigens your red blood cells have on the surface. Read more about helping your staff prepare to offer physician office lab testing in our article, How to run a laboratory: Getting ready to implement physician office laboratory testing. Learn about how people come to have this blood. %PDF-1.3 % Point-of-care lab testing can help with preventing the spread of infectious diseases. Please see the FDAs webpage on CLIA Waiversexternal icon. Some waived tests have potential for serious health impacts if performed incorrectly. For a quantitative test, the result is expressed numerically. A score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level. Only certain types of providers qualify as testing personnel for PPM tests under a PPM certificate, including physicians, dentists and midlevel practitioners. Staff proficient in sample collection and test device, NASPA Pharmacy-based Point-of-Care Test & Treat National Certificate Program, hosted by the NCPA Innovation Center [Website], PRS Pharmacy Point of Care Testing Resource (POCTTrack), Example Influenza Testing Policy, Duquesne University [PDF]. We take your privacy seriously. {C#78C?a$ ^!BNEn~rb(v5N774%h7*])0\okc#BF^p%;lZ*C%us!m-E+ RF7$*Py'R Score 3. In this guide, you'll learn more about how adding on-site testing to your pediatric practice can support improved patient outcomes and help reduce costs. 0000068133 00000 n a. The inspection schedule is typically every two years. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Otherwise, the FDA determines the tests complexity by reviewing the package insert test instructions, and using a criteria scorecard to categorize a test as moderate or high complexity (42 CFR 493.17). d. hematoma. Some common deficiencies that may prevent a laboratory from receiving CLIA certification include: Providing laboratory testing at the point of care can come with unique challenges, but we're here to help. A chemical added to a blood sample after collection to prevent clotting is called a(n): Additionally, you'll want to consider adding molecular diagnostics, the testing platforms that detect specific sequences in DNA or RNA. Score 1. What is the velocity of the rivet relative to the satellite just before striking it? CLIA regulations and test categorizations change frequently. The Clinical Laboratory Improvement Amendments (CLIA) is the federal program that establishes quality laboratory standards to protect patient safety and improve healthcare for laboratory testing performed on humans.1 The Centers for Medicare & Medicaid Services (CMS) oversees its regulation. Before you can test any patient samples, you must first have a CLIA license. 0000002125 00000 n 0000002951 00000 n Test! These regulations are now the gold standard for every laboratory and must be followed to the letter to avoid sanctioning or shut downs. The five types of CLIA certificates are as follows (laboratories are designated based on the highest level of testing performed they require): 1 | Certificate of Waiver: The most basic certificate allows any lab to perform any CLIA waived tests only, 2 | Certificate of Provider-Performed-Microscopy Procedures: This certificate is for laboratories performing microscopy testing (for example, KOH preps, reviewing slides under a microscope for parasites), 3 | Certificate of Registration: Some states require state inspections prior to a lab performing patient testing and prior to CLIA inspection3, 4 | Certificate of Compliance: This is a certificate granted after an inspection if a laboratory is doing moderate to complex testing, and/or any wet mounts, indicating that the laboratory is meeting the regulatory CLIA standards. Austrian Karl Landsteiner discovered blood types in 1901. , Julie S Snyder, Linda Lilley, Shelly Collins, Global Health 101 (Essential Public Health), I.A.Human Behavior and Effective Communication. Also, CMS list of PPMP tests (including CPT/HCPCS codes)pdf iconexternal icon. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site. c. magnification system. Learn more about selecting tests for POCT labs, including product examples, in our article, How to run a laboratory: Determining point-of-care testing options. All other testing conducted by a SAMHSA-certified lab requires a CLIA certificate. Blood typing is not counted as a non-waived CLIA testing as it is of utter complexity and requires meticulous medical skills and experience in order to be properly performed. A waived test is a simple point-of-care (POC) test whose process uses a one- to two-step process, requiring minimal interpretation and rarely requires special training to perform (for example, a urine pregnancy test or a blood glucose test). If your blood cells clump together in response to the anti-Rh serum, it means that you have Rh-positive blood. What is the magnification for an oil immersion microscope objective? True (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. CLIA-exempt formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program has been approved by CMS (42 CFR 493.2). These cookies may also be used for advertising purposes by these third parties. Am I able to treat patients based on a collaborative practice agreement? {Y"F'5 /*8B}\Tz3j;'jJ=sx /Q~lXlp]Rt IO,)ke#Jw=K$n#HL]*gjYJlZ7*^"6CZ{c;"@w^Ga*^`f;7VptTmT%nrY)Mj-hTyAra{LUY!, [bPMlm#zb"DA!|CYxc/+q#YQ8\!tZMKNfDeF=[$Y7 c. reagent. For commercially available FDA-cleared or approved tests, FDA scores the tests using these criteria during the pre-market approval process. Cookies used to make website functionality more relevant to you. A CoW allows laboratories to do tests categorized by the FDA as waived tests. POCT supplies can be purchased directly from a testing device manufacturer. This self-assessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. For questions, comments, or to request hardcopies of our products, please e-mail: WaivedTesting@cdc.gov, Guidance for SARS-CoV-2 Point-of-Care Testing, Clinical Laboratory Improvement Amendments (CLIA) Centers for Medicare & Medicaid Services (CMS)external icon, How to Apply for a CLIA Certificateexternal icon, Laboratory Quick Start Guide to CMS CLIA Certificationpdf iconexternal icon, How to Obtain a CLIA Certificate of Waiverpdf iconexternal icon, CLIA State Agency Contactsexternal icon, CLIA Waived Test List Food and Drug Administrationexternal icon, Health Insurance Portability and Accountability Act (HIPAA)external icon, Occupational Safety and Health Administration (OSHA) publicationsexternal icon, Occupational Safety and Health Administration (OSHA) State Plansexternal icon. 0000002691 00000 n Learn about the top blood tests and when you should have them done. The laboratory supervisor is well placed to keep abreastof these dynamic regulations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. CLIA is the governing body for all labs in the U.S. outside of military installations. All health care settingsperforming laboratory tests must have a CLIA certificate. Only research laboratory testing is exempt from CLIA. CLIA certification must be renewed every two years. CLIA 101: Answers to your most common questions about CLIA waived tests. Before sharing sensitive information, make sure you're on a federal government site. Nonwaived testing is the term used to refer collectively to moderate and high complexity testing. False. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. It regulates specific types of tests performed, as well as the training and education of personnel, quality control and the timeliness and accuracy of test results. The scores for the 7 criteria are added together and tests with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity. CLIA regulatory How can I best deploy support staff to make this service sustainable? Physician Office Laboratories and the Clinical Laboratory Improvement Act (CLIA), All health care settingsperforming laboratory tests must have a CLIA certificate. All rights reserved. In these cases, the mother needs to receive a drug called RhoGAM. b. Hyperthyroidism Score 1. In this guide, you'll learn more about how adding on-site testing to your pediatric practice can support improved patient outcomes and help reduce costs. @!&Wzr^[`- 4^jM`k:.Vh.'v^}Y[}}X3sx/Zo%~ ]1]On?c]"Nd FQ~K'GX|Z^a\\w9r^\ob:z|pp{XNq;RFf u@]Zt`)?0=/-Rc,R~ zO0 This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. a. preservatives. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled. The FDA will notify the sponsor of their CLIA categorization usually within two weeks of the marketing clearance or approval. c. Cirrhosis of the liver Point-of-care HIV and hepatitis screening in community pharmacies: a quantitative and qualitative study. The final score determines whether the test system is . Blood typing, Learn how to find out your blood type, including testing when blood is drawn and testing that requires no blood. Your skin will be cleaned before the test with an antiseptic to help prevent infection. In 2005, CDC, Division of Laboratory Science and Standards (DLSS) (previously Division of Laboratory Systems), published the MMWR Recommendations and Reports on Good Laboratory Practices for Waived Testing Sites. The recommendations in this report are intended to be a resource for physicians, nurses and others who perform waived tests in sites holding a CLIA Certificate of Waiver. redcrossblood.org/donate-blood/blood-types.html, ncbi.nlm.nih.gov/pmc/articles/PMC8873177/, ncbi.nlm.nih.gov/pmc/articles/PMC4732084/, What It Means to Have A Positive (A+) Blood Type, Why Its Safe to Receive Blood from Donors Whove Been Vaccinated for COVID-19, 6 Ways to Manage Taking Multiple Prescriptions. 0000034240 00000 n Set? 0000001128 00000 n Examples include: The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Then, complete the CLIA application form, CMS-116, and mail it to your CLIA State Agency contact based on your pharmacy location. Throughout the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) to hundreds of vendors and manufacturers of test kits, but this does not modify CLIA law. Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention(CDC). Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and . c. crystals from urine. 0000001924 00000 n In order to achieve reliable test results, you'll need an appropriate physical environment for your in-house POCT lab.2 In general, your staff should perform testing in a clean work area with space for patient privacy. They help us to know which pages are the most and least popular and see how visitors move around the site. As long as the blood they receive doesnt have any antigens that mark it as foreign, their bodies wont attack it. False. u*msGuN*] \,q6,BRV"2SZ(x. Expert Answer. The blood draw can be performed at a hospital or a clinical laboratory. What is the magnitude of your resultant displacement from mile marker 260 ? Review current literature published on providing point-of-care testing in the community pharmacy setting as well as other resources and companies who assist community pharmacies with point-of-care testing services. While some point-of-care tests are approved for a CLIA waiver, advances in technology that enhance the rapidity of testing enable more complex, nonwaived testing to be performed at or near the site of patient care. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Physician office lab testing is a great way to help improve outcomes in your primary care practice. q|>sjWsV\%iMI|^|@|xCRcm>98}Atz&L3;^=Tt!~%qa.#iGiavi@SuZBB6UVsth Ng{]=5`mZO60#{*o %E3\ %_9xrN5dAc/Ga$ UDhlhp"snv,oGv]N 9vr@`W=1m~`~^`n}O,pg 8OC:Q]#g N6.9@3q^q(]{p~ojz,>E$q9lLcvpi6T/ ]LFsxwSfk*lI3{`s*R>SG[#R/}I!Dc{~L}J See additional information. In addition to completing a CLIA-waiver, pharmacies must pay applicable certificate fees every two years and update CLIA waivers each time a new test is added to workflow. c. waived. Focus on tests you can perform and discuss during the patient visit (15 minutes or less). Point-of-Care tests are waived under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and pharmacies that conduct point-of-care testing must obtain a certificate of waiver. Thank you for taking the time to confirm your preferences. The categories of tests a laboratory offers is also a factor in determining the appropriate CLIA certificate for the laboratory. Res Social Adm Pharm. (A) Reagents and materials may be labile and may require special handling to assure reliability; or (B) Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements. Your POCT lab is likely to qualify for a Certificate of Waiver. CLIA applies to all laboratories that examine "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." This applies if even one test is to be performed. a. aliquot. Requirements for POCT in pharmacies vary by state and may include, but are not limited to, Collaborative practice agreements (CPA), additional certifications, (ie Collaborative practice pharmacist certification), or written protocols. Your patient volumes and testing menu can also help you determine which analyzers, test systems and test kits you'll need. The certificate may further authorize the lab toperform: To get CLIA certification, laboratories must: For specific guidanceon CLIA registration, categorization of tests, and ongoing compliance you may access this CMSresource. What are the requirements for reporting results? b. analyte. In some states, pharmacists can even prescribe therapy based on the results of a rapid diagnostic test. For more information, please see the How to Obtain a CLIA Certificate of Waiverpdf iconexternal iconbrochure. In cases where a premarket submission is not needed but CLIA categorization is still appropriate (e.g., devices exempt from premarket notification), manufacturers may submit a request for CLIA categorization, which includes the package insert test instructions, to CDRH. Cleaning with a chemical disinfectant Int J Clin Pharm (2022). CMS is the federal agency responsible for ensuring the accuracy and quality of an LDT. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing. Learn more . (4) A laboratory may qualify for a COW if it only conducts tests that: Pose no risk of harm if performed incorrectly. Mujahid A, et al. Score 3. It is advisable that laboratories, even those in physician offices, have a laboratory supervisorwho is responsible for oversight of the laboratory, following manufacturer guidance on operations including quality control and quality assurance, andseeing that all staff performing tests are educatedon laboratory procedures and trainedannually. Your distributor and lab equipment supplier can help you identify cost-effective sources of information, whether you're taking the first step for CLIA-waived tests or are ready to offer more involved testing. See 42 CFR 493.17. (A) Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process; and (B) Limited experience is required to perform the test. a. (JQYqdoN e~LQl/2' Score 3. LDT validations are lengthier in nature and require more rigorous proof by the individual lab. During a plasma transfusion, the liquid component of a donor's blood is put into another person's bloodstream to increase the blood's volume and, Receiving a blood transfusion from a donor who has been vaccinated for COVID-19 is safe. The military clock time of 1735 hours corresponds to 5:35 AM on the Greenwich clock. Will patients receive a prescription medication following test results? Do I need a Collaborative Practice Agreement or Protocol to be able to act on the results of the test? 3:https://mms.mckesson.com/resources/managing-my-lab/should-you-add-molecular-testing-to-your-physician-office-lab. A complete Establishing and maintaining a pediatric practice requires planning and creative management to successfully meet the needs of patients and sustain a viable work environment. The most common specimens collected for laboratory testing include: They help us to know which pages are the most and least popular and see how visitors move around the site. The target audience includes individuals who perform testing in waived testing sites (physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites) throughout the United States. 0000065178 00000 n Blood typing is especially important for pregnant people. The federal government, through the CLIA program, thoroughly regulates the evaluation and use of all lab tests including lab-developed assays. Last medically reviewed on April 5, 2022. CLIA generally requires facilities that perform a single test, including CLIA waived tests (more on those below), to obtain a CLIA certificate. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Moderate complexity lab tests, which require minimal knowledge and training. 0000001552 00000 n 0000002921 00000 n For specific guidanceon CLIA registration, categorization of tests, and ongoing compliance you may access, Preparing aPhysician OfficeLaboratoryProcedure Manual, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs. It is imperative to follow manufacturer test instructions and obey CLIA regulations. These tips may, Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. The Clinical Laboratory Improvement Amendment (CLIA) began in the late 1960s when problems arose in the cytology labs that read PAP smear samples. 0000006253 00000 n If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. 2: https://www.cdc.gov/labquality/docs/waived-tests/self-assessment-checklist-good-testing-practices.pdf c. Properly washing your hands The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This waiver allows a non-clinical facility to utilize CLIA-waived tests. CDC twenty four seven. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. We avoid using tertiary references. A waived test is a simple point-of-care (POC) test whose process uses a one- to two-step process, requiring minimal interpretation and rarely requires special training to perform (for example, a urine pregnancy test or a blood glucose test). Laboratories or sites that perform only waived tests only need to follow the manufacturers instructions for those tests to meet CLIA requirements. (A) Reagents and materials are generally stable and reliable; and (B) Reagents and materials are prepackaged, or premeasured, or require no special handling, precautions or storage conditions. For more details, please also see the FDAs webpage on theCLIA Categorization Criteriaexternal iconand CMS webpage onCategorization of Tests.external icon. An official website of the United States government, : d. Using a sterile container for sharps, A centrifuge is used to separate: Centers for Disease Control and Prevention. As defined by CLIA, waived tests are "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.". The kind of certificate depends on the category of the tests performed(see, Certain glucose and cholesterol testing methods. A list of CLIA-waived tests is available at the U.S. Food & Drug Administration website. Blood typing is a test that determines a person's blood type. State pharmacy practice laws outline whether pharmacists can: Prescribe medication based on the results of a lab test. All information these cookies collect is aggregated and therefore anonymous. Community pharmacy interventions to improve antibiotic stewardship and implications for pharmacy education: A narrative overview. In addition, the FDA requires validation of a test's clinical utility. 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. Blood group testing. Blood typing is a fast and easy way to ensure that you receive the right kind of blood during surgery or after an injury. d. Exudate. d. swab samples from wounds or mucous membranes. Personnel requirements vary based on test complexity and state requirements. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 0000001530 00000 n Score 1. %;Rn;THGwU?qBihF"HL3yy=3b^CO,JGX>O#c_N_x^3U^vLb0:wmB>GDu=/6*c"93-QdNCIZ2'BG_FnE:rM9J)29^*1 The FDA categorizes diagnostic tests by their complexityfrom the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. Results are reported as reactive or nonreactive within 20 minutes. According to the regulations, the Centers for Medicare & Medicaid Services (CMS) oversees all laboratory testing done on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. b. Aliquot Each state may have their own state regulations and governance that applies (for example, personnel licensure in addition to certification). View the full answer. Features. 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. b. blood cells from serum or plasma. Learn how transfusion reactions occur and how to minimize, Blood is a lot more complex than it looks. a. PPE Score 3. Before a laboratory test can be used for patient samples, quality control must be run to ensure that the test is considered: Commonly performed moderate complexity tests include CBCs,chemistries (BMP and CMP) and blood cultures. c. blood and urine and swab samples from wounds or mucous membranes, Laboratories that perform moderate- to high-complexity tests must undergo an unannounced inspection every 2 years. Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. d. preservative. Exceptions to this rule are New York state and Washington state, which have "exempt" status and operate their own laboratory regulatory programs. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. What is CLIA and how does it impact your lab? The goal of this course is to promote reliable, high quality testing and enhance patient safety by explaining steps of the waived testing process and to provide the learner with additional resources to assist on the job. 1: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA Costs for POCT vary depending on supplier and type of test. These may include: Bonus points if you're able to create a space that lets you expand your lab capabilities as your practice grows. manufacturer's instructions for the waived test are being followed. L0jWu&NP%_Z(.h8Wk`hURQ11M9zq:N[ZhXG%$UE?7 You will be subject to the destination website's privacy policy when you follow the link. Additionally, check with your State Agency for any other state-specific requirements. For a general overview of CLIA certificate types, see CMS Clinical Laboratory Improvement Amendments (CLIA) Brochure. Your waiver does not grant you the right to perform any tests that don't have CLIA waivers in your state. Molecular tests are becoming easier to use, with user-friendly test formats and sophisticated software and hardware. A list of all waived tests can be found at the FDA website.5. A Certificate of Waiver allows a facility to perform only tests that are classified as waived. See laboratory services & solutions >. Shop clinical lab products > CLIA inspectors in the 50 states report their findings to CMS, which is how CMS determines a laboratory's level of quality. Posterpdf icon [HTML Poster][Spanish], This poster can readily be displayed in a testing area to remind testers of 10 important practices to follow for accurate and reliable testing. [OnDemand CE], 2023 National Community Pharmacists Association, State Dept. For many Americans, the accuracy of clinical laboratory test results can be a life or death matter. The standards for moderate and high complexity testing differ only in the personnel requirements. a. Aspirate (A) Troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems; or (B) Maintenance requires special knowledge, skills, and abilities. 5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm d. All are correct, Kinn's Chapter 45 Introduction to the clinica, Chapter 44 - Assisting in Clinical Laboratory, . Set? 7. https://www.fda.gov/media/102367/download. Immersion oil prevents refraction of the light and improves the resolution of the magnified image. Point-of-Care Testing Playbook. Clinical laboratory test systems are assigned a moderate or high complexity category on the basis of seven criteria given in the CLIA regulations. If you dont know the answers to the above questions, reach out to your state authority for answers State Pharmacy Association, State Board of Pharmacy, State Health Department. Thank you for taking the time to confirm your preferences. Laboratory department that studies bacteria, fungi, yeasts, parasites, and viruses is: The clinical chemistry department performs which of the following tests? Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information.

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