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. Infectious disease diagnosis and management are likely the most relevant application of molecular testing in the primary care setting.3. b. STAT a. Aspirate 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. b. feces or gastric content. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. c. waived. 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). A point-of-care test is also available. This waiver allows a non-clinical facility to utilize CLIA-waived tests. As long as the blood they receive doesnt have any antigens that mark it as foreign, their bodies wont attack it. Tests developed by the laboratory or that have been modified from the approved manufacturers instructions default to high complexity according to the CLIA regulations. The only individuals and places that can perform blood typing are those that are CLIA-certified. 0000065178 00000 n Score 3. (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. [OnDemand CE], 2023 National Community Pharmacists Association, State Dept. Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and . Before you can test any patient samples, you must first have a CLIA license. Self Assessment Checklist pdf icon[PDF 16 KB]. What makes these polymers different from one another? Learn how McKesson's laboratory products and services can help you build your point-of-care testing program. c. accurate. 172 0 obj << /Linearized 1 /O 175 /H [ 1266 286 ] /L 92371 /E 68532 /N 3 /T 88812 >> endobj xref 172 22 0000000016 00000 n The inspection schedule is typically every two years. Knowing how to market your in-office lab testing can help attract new patients and differentiate your practice. 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. Saving Lives, Protecting People, How to Obtain a CLIA Certificate of Waiver, Clinical Laboratory Improvement Amendments (CLIA) Centers for Medicare & Medicaid Services (CMS), Laboratory Quick Start Guide to CMS CLIA Certification, CLIA Waived Test List Food and Drug Administration, Health Insurance Portability and Accountability Act (HIPAA), Occupational Safety and Health Administration (OSHA) publications, Occupational Safety and Health Administration (OSHA) State Plans, The Next Generation Sequencing Quality Initiative, Meet NGS Quality Initiative Project Partners, Laboratory Resources for Diagnostic Excellence ECHO, Provider Performed Microscopy Procedures (PPMP), Individualized Quality Control Plan (IQCP), Laboratory Medicine Best Practices (LMBP), U.S. Department of Health & Human Services. CLIA waived tests used for general screening include: Depending on your practice profile, you may want to offer routine screens for pregnancy. Craig Medical Distribution ELDON-RH - McKesson Medical-Surgical CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. a. reliable. The microscope component that directs the light up through the slide is the: The purpose of the CLIA regulations is to establish quality standards, strengthen federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test resultsno matter how simple the testno matter how small the laboratory. In 1967, the CLIA was passed, and the first lab regulations were born. CLIA Categorizations. What additional resources will I need for counseling patients? Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. (A) Calibration materials, if available, may be labile; (B) Quality control materials may be labile, or not available; or (C) External proficiency testing materials, if available, may be labile. 0000001924 00000 n Figueira, I., et al. CLIA 101: Answers to your most common questions about CLIA waived tests Some laboratories may also be exempt if only certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) for toxicology. 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. a Laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results. State CLIA-waiver requirements [Excel download], NASPA Pharmacist Prescribing authority: Test and Treat [Website]. All information these cookies collect is aggregated and therefore anonymous. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. 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. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for . c. Cirrhosis of the liver This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. If glucose tests are not performed correctly, a patient . 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.
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