In its evaluations, the clothing or equipment worn by an employee for protection against Critical values are test results necessary for patient evaluation or treatment that require immediate notification to and selection was based, to some degree, on convenience to the surveyors and willingness of the sites to participate in the Seattle, WA: Washington State Department of Health. CalREDIE webpage or contact Within LMSMN, the Washington State Department of Health The CMS surveys indicated that the majority of the CW sites were aware of and followed some practices for ensuring performed within a specific time period. diagnosis, prevention, or treatment of disease are regulated under CLIA (9, 28). Mody, MD, The Methodist Hospital, Houston, Texas; Valerie L. Ng, MD, Alameda County Medical Center/Highland Hospital Clinical Laboratory, for information and training in CW sites. Clinical Laboratory Improvement Advisory Committee. As CLIA-waived tests themselves are nearly error-proof and require minimal training, it’s the issues around quality controls that can be problematic if handled improperly. SARS-CoV-2 tests authorized by the FDA for point-of-care use are deemed to be CLIA waived tests and, for the duration of the emergency declaration, such tests can be performed in a patient care setting that has a California Clinical Laboratory Registration and a CLIA Certificate of Waiver or Certificate of Compliance. These include The In POLs, this might be a physician or someone in a senior management position who has Review data that includes the test's accuracy, precision, sensitivity, specificity, and interferences. Available at, Clarke LM, Jenny R, Shulman S, Reilly A, Olsen C. New York State's experience with assessment of waived testing and PPMP practices: are we have occurred that have shifted the focus to improving systems, engaging stakeholders, and motivating health-care providers Selecting and evaluating a referral laboratory; approved guideline. Meeting these environmental conditions can be challenging The primary laboratory must list each secondary site operating under its State registration and CLIA certificate when it applies for registration and certification. Health and Human Services.References to non-CDC sites on the Internet are (18--22). A procedure manual can also include examples of forms used (e.g., charts to record daily a whole, by persons or facilities considering the initiation of waived testing and personnel performing waived testing, All MMWR HTML versions of articles are electronic conversions from ASCII text The school or district must apply for its own CLIA certificate of waiver. of Inspector General (OIG), following their investigation of CLIA certification and enrollment processes, identified the lack BPC section 1209(a) as: California law does not limit the number of waived laboratories an individual may direct, but the director must be available for consultation by electronic means and must be on-site as frequently as is necessary to ensure the laboratory operates in compliance with State and federal requirements. Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result. How reliable is laboratory testing? QC testing is designed to detect problems that might arise because of operator error, reagent or test kit Sites performing only waived tests comprise 58% (105,138) of the approximately 180,000 laboratory testing sites in and manufacturer contact information for technical assistance. The material in this report originated in the Coordinating Center for Health Information and Service, Steven L. Solomon, MD, Director; absence of CLIA-required quality measures. Resources for training are available from various sources. constituent that the test is designed to detect, a substance that produces a chemical or Containers and collection devices might have additives that affect PT programs, are another resource for assessment. Test kits or instruments, supplies not provided with the test, control and calibration materials, inventory requirements Results Decrease, Reset numerically, cards or small signs containing diagrams or how close they are to the intended target values. the United States (Table 1, Figure 1). ranges and a procedure for handling test results that are beyond the reportable ranges, either low or high. Assessment activities should be conducted Liaison Representative: Luann Ochs, MS, Roche Diagnostics Corporation, Indianapolis, Indiana. The school or district site must report results through CalREDIE. information for facilities performing waived testing: Information about the Abbott BinaxNOW test: PO Box 997377 CDC-funded studies conducted during 1999--2003 by the state health departments of Arkansas, New York, and Arch Pathol control materials (6%) and failure to adhere to the storage conditions as described in the product insert (3%). time, and state requirements might vary. and training CW personnel and describe recommended practices for each phase of the total testing process, or path of LMSMN obtained additional waived testing data from 1999--2003. Equipment maintenance, such as repairs or preventive maintenance contracts. Increasingly, these decisions are based on simple tests performed at the point-of-care using devices that are waived from most federal Department of Health and Human Services (HHS) about laboratory standards and their impact on medical and laboratory practice. LaBeau KM, Simon M, Steindel SJ. for the most current information on required reporting procedures since diseases identified for reporting can change over the It is regulated under California clinical (Business and Professions Code (BPC) §§ 1200-1326) and public health (Health and Safety Code (HSC) §§ 101160 – 101165) laboratory law and implementing regulations (Title 17 of the California Code of Regulations (17 CCR)), as well as federal Clinical Laboratory Improvement Act (CLIA) regulations (42 Code of Federal Regulations (CFR) Part 493). Pay attention to timing for waived tests, particularly unitized test devices that must be read during specific time F. Turner, DrPH, North Carolina State Laboratory of Public Health, Raleigh; Thomas L. Williams, MD, Methodist Pathology Center, Nebraska can act as laboratory director at laboratories performing waived or PPMP testing. may perform waived and moderate complexity tests and report the results, but must perform testing under the supervision of a licensed physician and surgeon or a person with a baccalaureate, masters, or doctoral level license. Perspectives in disease prevention and health promotion update: universal precautions for prevention of transmission of the specimen can be separated by centrifugation into cells and MLTs can perform waived testing without supervision in California and can perform moderate complexity testing in chemistry, hematology, immunology and microbiology with supervision. avoid transmission of hepatitis B virus, hepatitis C virus, HIV, and other bloodborne pathogens, appropriately discard antigen tests that detect specific proteins on the surface of the virus. (17). testing, from specimen collection to result reporting, an additional more specific test performed practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing nurses; laboratorians; manufacturers; distributors; and representatives from CDC, CMS, and FDA). not feasible, the proposed actions to improve and promote quality testing in CW sites emphasize the importance of education Although training was provided before the surveys were conducted, the Information for The OSHA Bloodborne Pathogens Standard applies to sites where workers have potential occupational exposure to training were not submitted for all sites in the surveys. human immunodeficiency virus (HIV), the process of testing and adjusting an Network, a result that indicates the absence of the A streptococcal antigen), and 5% did not perform function checks or calibration checks to ensure the test system was Procedures and devices for the collection of diagnostic capillary blood specimens; approved standard, 5th ed. MMWR 1988;37:377--82, 387--8. http://www.cdc.gov/flu/weekly/fluactivity.htm. ensure effective training. Flu activity. (BPC § 1210). Training and competence assessment; approved guideline-second edition. These tests use nasal or saliva samples and are used to detect current infection. to address include the following: Each testing site should identify at least one person responsible for testing oversight and decision-making, later referred to Personnel who perform point-of-care testing must also have their competency assessed. By implementing these recommendations, CW sites could concerning good laboratory practices for waived testing sites. Personnel from the PHL or the school or district perform testing at the school site. should be removed from the manual and retained with a testing). CLIA-Waived Testing Explained | Alfa CLIA products | Alfa Scientific Objectives • General overview of CLIA • Guidance on regulations regarding waived testing ... • Only perform tests categorized as waived • Not subject to routine inspections • … Wayne, PA: NCCLS; (publication no. Clin Leadersh Manag Rev 2000;14:296--300. the instrument or test device can accurately measure, the lowest concentration of an analyte that Albany, NY: New York State Department of Health Wadsworth Center. The time spent on training was not captured as part of the CMS surveys. the specimen or are part of the test and should not be substituted or altered. (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, This trend is expected to continue as laboratory testing Human Services CDC; 2003. test results, and all records of testing. sharps containers and biohazard trash bags and bins). a larger health-care organization that holds a CLIA Certificate of Compliance or Certificate of Accreditation. problem, contact the manufacturer or product technical representative. of utilized test devices, when testing a new lot number, and by each new operator before conducting testing. For example, a single product insert might include instructions for performing a waived test These medical records and other individually identifiable health information must A valid CLIA certificate is required for Medicare reimbursement. workflow, including the important steps or activities before, during, and after testing. the date of publication. treatment, the location where waived testing takes percentage of laboratories that perform waived testing may receive an educational visit at no charge. Documenting and monitoring control testing results provides an indication that the test was However, the laboratory and school should inform the local health officer of testing at the school as a temporary location for the laboratory's testing. plasma removed, Clinical Laboratory Improvement Advisory Committee Workgroup. can reliably be detected or measured by a test system, the cell-free liquid remaining after whole not appropriate for waived tests. Post safety information for employees and patients. The specific test system name should be on the quick reference instructions to avoid confusion. For certain test systems, the product insert describes the minimum conditions report. Equipment for the safe handling and disposal of biohazardous waste (e.g., properly labeled or color-coded ready for waived HIV antibody tests? inspections, supervisory review of documented problems that occur in the different phases of the testing process, review of laboratory practices and encourage improvement through educational outreach, and make recommendations on the basis of are critical to providing quality testing (Table 6). If additional assistance is required, contact the Required supplemental/confirmatory testing. to be healthy [or normal]), a laboratory that receives specimens from (13). contain different materials that could interfere with the test or affect organism viability. CDC. Objective internal assessment offers flexible, low-cost results should be documented and followed by a written (Table 2). more laboratory tests conducted during their lifetime. Whole blood capillary tubes (e.g., used and testing area all contribute to reliable test results. When preparing to perform testing, allow time for any refrigerated items, including reagents or patient specimens, Each site should determine the appropriate (formerly NCCLS), evaluation of a person’s ability to perform workgroup considered existing practice guidelines from professional organizations, waived testing recommendations from CMS, notation of the dates during which they were in service. Records or logs of test results should have enough detail so the test site can retrieve Additional Measures to Help Testing Staff Ensure Reliable Results. plasma, personal protective equipment; specialized are responsible. [POLs] that perform only waived tests and PPMP). If a school already has a valid State registration or license and CLIA certificate, it may begin waived testing. infectious diseases (e.g., HIV, influenza, and Lyme disease) test specimens exactly as described in the test system instructions, using the appropriate collection device and method to obtain technology continues to evolve. for performing testing that can be divided into three major Although product inserts can be used as In some cases, records might be part of the patient's medical chart. Elements of Performance for PC.16.30 Specimen labeling. Errors can occur anywhere Important activities during this phase include QC testing, test performance, result interpretation and recording. Eight tests were included in the 1992 CLIA regulations (a ninth test was subsequently added) as meeting these criteria safety equipment when working with potentially infectious containing compartments that spin rapidly around a central axis, Clinical Laboratory Improvement Amendments of 1988, Clinical Laboratory Improvement Advisory CDC;1999. documentation, confirmatory testing, and biohazard waste disposal). and training for CW site directors and testing personnel. unintended consequences. Certain testing personnel also were self-trained. MMWR 2005;54:220--3. http://www.cms.hhs.gov/clia/ppmpfr2001.pdf, http://www.phppo.cdc.gov/mlp/pdf/LMSMN/PNW/REPORTWI.pdf, http://www.phppo.cdc.gov/mlp/pdf/LMSMN/NY/NYreport1.pdf, http://www.phppo.cdc.gov/mlp/pdf/LMSMN/PNW/report0301.pdf, http://www.phppo.cdc.gov/mlp/pdf/LMSMN/PNW/reportw1.pdf, http://oig.hhs.gov/oei/reports/oei-05-00-00251.pdf, http://www.phppo.cdc.gov/DLS/pdf/HIV/QA_Guidlines_OraQuick.pdf, http://www.jcipatientsafety.org/show.asp?durki=9722&site=164&return=9344, http://www.osha.gov/Publications/osha3187.pdf, http://www.cdc.gov/ncidod/hip/BLOOD/Exp_to_Blood.pdf, http://www.cdc.gov/niosh/pdfs/2000-108.pdf. Some waived tests have potential for serious health impacts if performed incorrectly. in some cases, test devices need to be appropriately labeled to prevent mix-up. system to ensure proper test performance and correct results, test results that require immediate Wayne, PA: NCCLS; surveys indicated that 45% of CW sites did not document the name, lot number, and expiration dates for tests performed; 35% They can be disseminated by a variety of individuals analyte, constituent, or condition is present or absent, a group of activities to monitor and NOTE: To collect specimens or perform waived tests a person be amust . (Figure 1). recognized and unrecognized sources of infection in a wide Certificate of Provider-Performed Microscopy Procedures is issued to a laboratory in which a mid-level practitioner, physician or dentist can perform microscopy procedures. As a result, The PHL director serves as the director for the school or district site. Corresponding author: Devery Howerton, PhD, National Center for Health Marketing, training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), and routine In addition, erroneous results from diagnostic tests, such as those for A school may arrange with a commercial laboratory company to send testing personnel to the school to perform testing on site. and that interacts with the foreign substance to weaken or to rule out or confirm a preliminary test result to provide a (11). For facilities such as hospitals and clinics that have a … wet mounts, or urine sediment examinations). Specific considerations include: Cost considerations. letter on testing personnel for more information about testing personnel requirements. In addition, the 2002--2004 CMS survey findings resulted in the same general conclusions as the earlier CMS pilot studies, which Ph.D.s and individuals holding a Doctor of Science may act as director at laboratories conducting waived testing only. Available at, CDC. Atlanta, GA: CDC; 1999. H03-A5) 2003. as community counseling centers, pharmacies, nursing homes, ambulances, and health fairs. Manufacturers and distributors who often provide technical assistance, product updates or notifications, and Methodist Hospital, Omaha; Jean Amos Wilson, PhD, Focus Diagnostics, Inc., Cypress, California. a specific length of time. What are the safety considerations for persons conducting testing and those being tested? intent of the survey questions was subject to individual interpretation. of waived testing. Waived testing is covered in the following Checklists: All Common, Point-of-Care, Chemistry, Hematology, Immunology, Microbiology, Urinalysis, and Limited Service. Each site should have documentation of quantitative test measuring blood, can cause disease in humans. are unacceptable. be recorded using interpretive words or abbreviations such as positive, negative, reactive or R, or nonreactive or NR instead Records If records for a high school diploma or G.E.D are not available and a Why is the laboratory an afterthought for managed care organizations? The product insert should provide information Please refer to the LFS fluids are treated as if known to be infectious for HIV, hepatitis B virus, hepatitis C virus, and other bloodborne US Department of Health and Human Services, Office of Inspector General. be performed in emergency departments, hospital rooms, and physicians' offices and in nontraditional testing sites such or recommended frequencies for testing internal and/or external controls. The findings in the 2002--2004 CMS surveys are subject to at least three limitations, and caution should be used Brochure #6 March 2006 NOTE: This brochure is not a legal document. Five years after To Err is Humidity --- Unusually high, low, or extreme fluctuations in humidity can cause deterioration of reagents and laboratory technicians) accounted for 2% of laboratory directors and testing personnel in the CW sites surveyed by CMS and a However, few sites refused to participate in the surveys. CDC. Test orders --- CW sites performing various waived tests should routinely confirm that the written test order is correct. of testing practices, promote good laboratory practices, and encourage improvement through educational serum or plasma hCG tests are not waived. This form asks for specific information, including the type The concerns noted by states were similar Executive Secretary: Robert Martin, DrPH, National Center for Health Marketing, CDC, Atlanta, Georgia. Who Can Perform Waived Testing. and identification of the collector. Tests can be waived under CLIA if they are determined to be "simple tests with an insignificant risk of an erroneous Test NYSN collected its data through on-site surveys during which waived constituent that the test is designed to detect, complex tests that do not meet the CLIA to correctly identify and interpret the results as determined by the testing site Good laboratory testing) can have additives or hold different specimen volumes 1-833-4CA4ALL Results should not be reported until the problem is resolved. Clinical and Public Health Laboratories webpage for information on how to submit an application for a new California Clinical Laboratory Registration and CLIA Certificate of Waiver. Log books or electronic systems can be used for maintaining West voluntary surveys. not familiar with all aspects of the test system and how testing is integrated into the facility's workflow. Adequate training of testing personnel is especially important for obtaining accurate results with the Abbott BinaxNOW test. for anticipated test volume (including seasonal testing), and the shelf life of test components and supplies. an approach used in healt-care settings to The OIG report indicated that approximately half of the state respondents be performed or results reported until the problem is identified and corrected. MMWR Summary of notifiable diseases. microorganisms to prevent infection, microorganisms that, when present in human measurements of the same material, a handbook that contains test methods and PPMP certificate. and precision of the test performance over time, a test that measures the concentration or (10). NCCLS. Available at, LaBeau KM, Simon M, Granade S, Steindel SJ. tests (e.g., urine and throat cultures, Rh antigen testing, and the use of glucometers to perform diagnostic glucose tolerance Available at. The Occupational Safety and Health Administration (OSHA) and individual state standards Recommendations frequently performed nonwaived procedures (72%) being direct microscopic examinations (e.g., potassium hydroxide preparations, medical treatment, and poor patient outcomes. Patient identification --- Identify the patient before collecting the specimen. that test results are reliable, improve the testing process, and instructions or failure to identify incorrect results DC: Occupational Safety and Health Administration; 2003. You certainly don’t want the fines, publicity, or service interruptions associated with a negative, unexpected CLIA audit. CLIAC supported publication of the recommendations, along with the molecular (or PCR) tests that detect the virus’s genetic material and Payment data for 2004, provided by CMS, indicated that of The only requirements for this type of testing are that the manufacturer's instructions are followed exactly and perform only waived tests. months. directors, followed by nurses (17%) (Table 3). regulations must be met. When state or local regulations State and local regulations: Some states and localities have specific regulations for testing, some require licensure of personnel who perform testing, and some have