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Prepared by
Devery Howerton, PhD, Nancy Anderson, MMSc, Diane Bosse, MS, Sharon Granade, Glennis Westbrook
Division of Public Health Partnerships, National Center for Health Marketing, Coordinating Center for Health Information and Service
The material in this report originated in the Coordinating Center for Health Information and Service, Steven L. Solomon, MD, Director; National Center for Health Marketing, Jay M. Bernhardt, PhD, Director; and the Division of Public Health Partnerships, Robert Martin, DrPH, Director.
Corresponding author: Devery Howerton, PhD, National Center for Health Marketing, Coordinating Center for Health Information and Service; 4770 Buford Hwy NE, MS G-23, Atlanta, GA, 30341. Telephone: 770-488-8126; Fax: 770-488-8275; Email: [email protected].
Summary
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999--2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999--2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase.
Introduction
Laboratory testing plays a critical role in health assessment, health care, and ultimately, the public's health. Test results contribute to diagnosis and prognosis of disease, monitoring of treatment and health status, and population screening for disease. Laboratory testing affects persons in every life stage, and almost everyone will experience having one or more laboratory tests conducted during their lifetime. An estimated 7--10 billion laboratory tests are performed each year in the United States (1,2), and laboratory test results influence approximately 70% of medical decisions (2--4). Increasingly, these decisions are based on simple tests performed at the point-of-care using devices that are waived from most federal oversight requirements (and are thus designated as waived tests), including requirements for personnel qualifications and training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), and routine quality assessment.
Advances in technology have made tests simpler, contributing to this shift in testing. In the past, tests such as prothrombin time, cholesterol, and glucose either used complex manual methodologies or were performed using sizable instrumentation suitable for use by highly trained personnel in traditional clinical laboratory settings. Many tests can now be performed using compact or hand held devices by personnel with limited experience and training. These advances have enabled more testing to be performed in emergency departments, hospital rooms, and physicians' offices and in nontraditional testing sites such as community counseling centers, pharmacies, nursing homes, ambulances, and health fairs. Since the 1992 inception of the program implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the numbers of waived tests and the sites that perform them have increased dramatically. This trend is expected to continue as laboratory testing technology continues to evolve.
The purpose of this report is to highlight quality issues identified in waived testing sites on the basis of surveys conducted on-site by the Centers for Medicare & Medicaid Services (CMS) during 1999--2004 and studies of waived testing practices funded through CDC during 1999--2003. In addition, this report presents recommendations developed by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for improving the quality of waived testing. By following these recommendations, errors that could potentially lead to patient harm and the associated morbidity and mortality can be prevented.
Background
CLIA Requirements for Waived Testing
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 CLIA (5). The CLIA program is administered by CMS and is implemented through three federal agencies---CDC, CMS, and the Food and Drug Administration (FDA). When CLIA was implemented in 1992, CLIAC was chartered to provide scientific and technical advice and guidance to the U.S. Department of Health and Human Services (HHS) about laboratory standards and their impact on medical and laboratory practice. The committee consists of 20 members selected by the HHS secretary from authorities knowledgeable in the fields of laboratory medicine, pathology, public health, and clinical practice and includes consumer representatives and an industry liaison. CLIAC also includes three ex officio members from CDC, CMS, and FDA.
By law, CLIA regulations are based on a complexity model, with more complicated testing subject to more stringent requirements (6). The three categories of testing for CLIA purposes are waived, moderate complexity (including the provider-performed microscopy procedures [PPMP] subcategory), and high complexity. Facilities performing only waived tests have no routine oversight and no personnel requirements and are only required to obtain a Certificate of Waiver (CW), pay biennial certificate fees, and follow manufacturers' test instructions.
Tests can be waived under CLIA if they are determined to be 'simple tests with an insignificant risk of an erroneous result' (5). Eight tests were included in the 1992 CLIA regulations (a ninth test was subsequently added) as meeting these criteria and later, the FDA Modernization Act of 1997 clarified that tests cleared by FDA for home use are automatically waived. An additional route to waiver exists through a process in which FDA evaluates studies and other information submitted by manufacturers to demonstrate that a test meets the waiver criteria of being simple and having a low risk for error. https://weedever933.weebly.com/spore-galactic-adventures-were-to-insert-my-serial-key.html. Approximately 1,600 test systems representing at least 76 analytes are waived under CLIA (Table 1).
Scope of Waived Testing
Sites performing only waived tests comprise 58% (105,138) of the approximately 180,000 laboratory testing sites in the United States (Table 1, Figure 1). Waived testing performed in these sites is often wellness testing, screening tests, or other critical testing that introduces a large population of persons into the health-care setting. Although the testing performed in CW sites accounts for <10% of the total U.S. testing volume, this percentage has been increasing each year since the CLIA program began (Table 1). Most testing is not waived and is typically performed in hospital or reference laboratories (Certificate of Compliance and Certificate of Accreditation), which comprise 20% of the total number of testing sites (Figure 1). The remaining testing sites (22%) have PPMP certificates, meaning that in addition to waived tests, direct microscopic examinations of certain specimens can be performed as part of the patient's examination by that patient's physician or midlevel health-care practitioner. An increasing shift toward waived testing has resulted in a corresponding increase in health-care expenditures for this testing. Medicare Part B, the federal medical insurance program for persons aged >65 years and certain disabled persons, covers diagnostic laboratory testing. Payment data for 2004, provided by CMS, indicated that of the $3,494,840,086 spent on reimbursed laboratory testing for that year, $128,169,398 (3.7%) was for waived tests. The volume of Medicare Part B reimbursed waived laboratory testing in 2004 represented 8% of the total reimbursed testing volume for that year, a 57% increase over the volume in 2000 (Table 1).
Patient Safety Concerns Related to Waived Testing
Efforts to reduce medical errors, improve health-care quality, and increase patient safety have been gaining national attention. A report issued in 1999 by the Institute of Medicine (IOM) presented a national agenda to address these issues and recommended strategies for change that included the implementation of safe practices at the health-care delivery level (7). As described in the IOM report, errors most often occur when multiple contributing factors converge, and preventing errors and improving patient safety require a systems approach. Five years after this seminal report, small but consequential changes have occurred that have shifted the focus to improving systems, engaging stakeholders, and motivating health-care providers to adopt new safe practices (8).
Although by law waived tests should have insignificant risk for erroneous results, these tests are not completely error-proof and are not always used in settings that employ a systems approach to quality and patient safety. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system and how testing is integrated into the facility's workflow. Although data have not been systematically collected on patient outcomes with waived testing, adverse events can occur (9). Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences.
The lack of oversight and requirements for personnel qualifications and training for an increasingly large number of CW sites is a concern and could contribute to errors and patient harm. During 1999--2001, CMS conducted on-site surveys of a representative sample of CW sites in 10 states to assess the quality of testing in these sites. These pilot surveys identified quality issues that could result in medical errors (10). Contributing factors included inadequate training in good laboratory practices and high turnover rates of testing personnel. As a result, during 2002--2004, CMS conducted nationwide on-site surveys of CW facilities to collect additional data that would provide an assessment of testing, promote good laboratory practices and encourage improvement through educational outreach, and make recommendations on the basis of cumulative survey findings. The data collected from these surveys, along with data on waived testing practices gathered through CDC-funded studies conducted during 1999--2003 by the state health departments of Arkansas, New York, and Washington (collectively referred to as the Laboratory Medicine Sentinel Monitoring Network [LMSMN]), support the initial CMS findings of gaps in good laboratory practices in these sites (11--16). In addition, a 2001 report issued by the HHS Office of Inspector General (OIG), following their investigation of CLIA certification and enrollment processes, identified the lack of routine on-site visits to CW sites by surveyors representing state agencies and private sector accreditation organizations as presenting vulnerabilities in these sites. The OIG report indicated that approximately half of the state respondents reported problems related to quality issues with the waived laboratories in their states (e.g., failure to follow manufacturers' instructions or failure to identify incorrect results and performing unauthorized testing) (17). The concerns noted by states were similar to those identified in the CMS pilot studies.
CLIAC Response
An initial CMS report of its 2002--2003 survey findings, presented to CLIAC in 2004, supported earlier concerns about the quality of testing practices and the need for education and training of testing personnel in CW sites. In response, the committee recommended publication of the 2002--2004 CMS data in conjunction with other data pertinent to waived testing performance along with recommendations for good laboratory practices for waived testing sites. This information would then be available to provide guidance to physicians, nurses, and other health-care providers in CW facilities. As a result, a workgroup was appointed to consider practices associated with the waived testing process and their impact on the quality of waived testing. This workgroup was comprised of key stakeholders in waived testing (i.e., CLIAC members; physicians; nurses; laboratorians; manufacturers; distributors; and representatives from CDC, CMS, and FDA). In its evaluations, the workgroup considered existing practice guidelines from professional organizations, waived testing recommendations from CMS, personal and professional experience, and publications related to waived testing. The workgroup's findings were presented to CLIAC for its deliberations at the February 2005 meeting, at which time CLIAC provided recommendations to HHS concerning good laboratory practices for waived testing sites. CLIAC supported publication of the recommendations, along with the data from the studies of CW sites, and suggested the publication could serve as a comprehensive source document that could be used to develop additional educational tools appropriate for specific target audiences.
Surveys of Waived Testing Sites
Methods
During 2002--2004, approximately 150 CMS and state agency surveyors conducted on-site surveys nationwide using a questionnaire at 4,214 sites performing testing under a CLIA CW. Surveyors self-selected CW sites on the basis of test volume, location, and facility types. Different facilities were surveyed each year so that no repetition exists among CW sites represented in the CMS data in this report. LMSMN obtained additional waived testing data from 1999--2003. Within LMSMN, the Washington State Department of Health established the Pacific Northwest Sentinel Network (PNWSN), which included approximately 650 waived and nonwaived laboratories in Alaska, Idaho, Oregon, and Washington. The Arkansas Sentinel Network (ASN) consisted of 94 local health units integrated into the state health agency (mostly waived testing sites) and approximately 600 waived and nonwaived laboratories in Arkansas and surrounding states. PNWSN and ASN gathered data about waived testing practices through questionnaires mailed to network members (11). The New York Sentinel Network (NYSN) consisted of approximately 600 limited service laboratories (facilities other than physician office laboratories [POLs] that perform only waived tests and PPMP). NYSN collected its data through on-site surveys during which waived testing practices were assessed by surveyor observation and record reviews (11).
Survey Findings
Demographics
CMS surveyed 4,214 CW sites during April 15, 2002--November 12, 2004. This included 897 sites in 2002, 1,575 sites in 2003, and 1,742 sites in 2004. Of the CW facility types surveyed, POLs compose the largest percentage (47%), followed by skilled nursing facilities (14%) (Table 2). The CW sites surveyed estimated performing a broad range of annual test volumes (Figure 2). Of the facilities surveyed by CMS during 2003--2004 (2002 data not available), 90% reported that they performed no more than five different waived tests, and 99% performed no more than 10 different waived tests. Although the exact volume of each test performed per site is not known, on the basis of the number of sites testing for each analyte, the five most commonly performed waived tests were identified as glucose, dipstick urinalysis, fecal occult blood, urine human chorionic gonadotropin (hCG) (visual color comparison), and group A streptococcal antigen (direct test from throat swabs) (Figure 3). This correlates with data for the top five waived tests identified through the LMSMN, especially for POLs (11). Although not among the most commonly performed, waived tests are available for certain infectious diseases of public health significance and were reportedly performed by CW sites in the CMS surveys (influenza, 46 sites; HIV, four; and Lyme disease, one).
Personnel and Training
Under CLIA, no education or training is required for the director or testing personnel in CW sites. The educational background and qualifications for directors and testing personnel at CW sites were collected as part of the CMS surveys and by LMSMN (PNWSN and NYSN). The CMS surveys indicated that in 69% of CW sites, physicians served as directors, followed by nurses (17%) (Table 3). Similarly, 59% of the PNWSN CW site directors were physicians, with the remaining 41% having other backgrounds or degrees (12). For CW testing personnel, according to the CMS data, the top four categories were nurses (46%), medical assistants (25%), physicians (9%), and high school graduates (7%) (Table 3). NYSN reported that registered nurses (RNs) and licensed practical nurses (LPNs) served as testing personnel in 84% of the limited service laboratories they surveyed (13). Trained laboratorians (i.e., medical technologists and medical laboratory technicians) accounted for 2% of laboratory directors and testing personnel in the CW sites surveyed by CMS and a smaller percentage in the limited service laboratories surveyed by the NYSN (13).
CMS surveys indicated that 43% of CW sites experienced a change in testing personnel during the preceding 12 months. Among the top categories of testing personnel in the PNWSN, turnover rates were highest for medical assistants (17%), followed by LPNs (13%), RNs (9%), and physicians (2%) (14). Although the majority of CW sites in the CMS surveys (90%) reported that new personnel were trained, fewer sites (85%) evaluated staff to ensure competency. Data identifying who provided training were not submitted for all sites in the surveys. However, according to the CW sites that provided this information for 2003--2004 (Table 4), nurses most frequently provided waived test training (33%), followed by the manufacturer or sales representatives (15%). Findings from a PNWSN study indicated that the highest percentage of personnel were initially trained by another employee (25%) or trained themselves by using instructions provided with the waived test system (17%) (15). Another PNWSN study indicated that most training (77%) took place in a day or less (14). Comments from this study reflected the thinking that training is not always necessary or that minimal time should be spent on training because persons have been trained in school or on other jobs. Ispy treasure hunt download mac. The time spent on training was not captured as part of the CMS surveys.
Testing Practices
The CMS surveys indicated that the majority of the CW sites were aware of and followed some practices for ensuring the accuracy and reliability of their testing. However, lapses in quality were identified at certain sites, some of which could result in patient harm. In some instances, CW sites were determined to be performing testing that was an imminent and serious threat to the public's health because they were performing nonwaived testing in the absence of CLIA-required quality measures. The CMS surveys indicated that 5% of CW sites were conducting tests that were not waived, the most frequently performed nonwaived procedures (72%) being direct microscopic examinations (e.g., potassium hydroxide preparations, wet mounts, or urine sediment examinations). Surveyed CW testing sites also reported performing various other nonwaived tests (e.g., urine and throat cultures, Rh antigen testing, and the use of glucometers to perform diagnostic glucose tolerance testing [an intended use not specified in manufacturers' instructions]). When performing nonwaived tests, surveyors noted that, in some instances, the sites were not meeting CLIA requirements for qualified personnel, QC, PT, or test system maintenance. In addition, these sites did not have adequate records of their testing activities, including test system procedures, training records, or other documentation.
Of the CW facilities CMS surveyed, 12% did not have the most recent instructions for the waived test systems they were using, and 21% of the sites reported they did not routinely check the product insert or instructions for changes to the information (Table 5). On the basis of manufacturer's instructions, 21% of the CW sites did not perform QC testing as specified, and 18% of the sites did not use correct terminology or units of measure when reporting results. Among other quality deficiencies identified were failure to adhere to proper expiration dates for the test system, reagents, or control materials (6%) and failure to adhere to the storage conditions as described in the product insert (3%). Six percent of CW sites did not perform follow-up confirmatory tests as specified in the instructions for certain waived tests (e.g., group A streptococcal antigen), and 5% did not perform function checks or calibration checks to ensure the test system was operating correctly. Findings from the LMSMN studies were similar to the CMS findings for these quality deficiencies (11).
Although not usually specified in the product insert (and therefore not a CLIA requirement), proper documentation and recordkeeping of patient and testing information are also important elements of good laboratory practices. CMS surveys indicated that 45% of CW sites did not document the name, lot number, and expiration dates for tests performed; 35% did not maintain logs with records of their QC testing; 31% did not maintain a log or record of tests performed; and 9% did not require a requisition or test orders documented in a patient chart before performing a test (Table 5). NYSN observed similar findings but noted increased compliance with state requirements for documentation/recordkeeping when laboratories had formal affiliations with New York State-licensed laboratories (11).
Discussion
The findings from the CMS surveys and LMSMN studies indicated that the majority of CW testing sites performed testing correctly and provided reliable service. However, in CW sites, most directors and testing personnel did not have formal laboratory training or testing experience, there was a high turnover of personnel, and lapses in following manufacturers' instructions and instituting practices to ensure the quality of the testing were noted. The survey findings indicated that 485 (12%) of the 4,214 CW sites surveyed did not have the current manufacturers' instructions available, and 701 (21%) of the 3,317 sites surveyed during 2003--2004 did not check to be sure there had been no changes to the instructions. Test system instructions can change over time and CW sites sometimes switch test systems that could have different instructions. CMS survey results also indicated that, in varying proportions, when CW sites had the current instructions, they did not follow critical steps in the testing process (e.g., performing QC testing, reporting results correctly, adhering to expiration dates and appropriate storage requirements, and performing test system function checks or calibration checks). This is a concern because the only CLIA requirement for performing waived testing is to follow the manufacturer's instructions. Neglecting to follow instructions could cause inaccurate test results that could lead to incorrect diagnoses, inappropriate or unnecessary medical treatment, and poor patient outcomes.
CMS surveys indicated that certain CW sites (5%) were performing testing more complex than waived testing without taking required measures to ensure quality. In certain CW sites, nonwaived microscopic examinations were being performed by personnel who lacked the education and training needed to develop the interpretive and judgment skills necessary to accurately perform these procedures. In addition, measures such as QC, PT, adequate documentation, and monitoring are required to ensure the accuracy and reliability of nonwaived test results. Although direct microscopic examinations can be conducted by a physician or midlevel health-care practitioner as part of a patient examination, testing must be conducted under a CLIA PPMP certificate.
The quality issues identified through these surveys might have been caused, in part, by high turnover rates of testing personnel in CW sites, inadequate training with respect to waived testing, and lack of understanding of good laboratory practices, including the importance of following all aspects of the manufacturers' instructions. Although the study results indicated that most testing personnel were trained, they were often trained for minimum periods by persons who did not have formal education or training in clinical laboratory testing and who might not have understood the importance of measures to ensure quality testing. Certain testing personnel also were self-trained. In addition, when testing personnel were not evaluated to determine their competency level following training or on an ongoing basis, no assessment was conducted to determine whether the training was effective. The data demonstrate a need for educational information among CW site directors and testing personnel about the importance of following manufacturers' instructions, adhering to expiration dates, performing QC testing, and proper documentation and recordkeeping. One of the recommendations in the 2001 OIG report was that CMS should provide educational outreach to directors of waived and PPMP laboratories about the CLIA requirements (17).
The findings in the 2002--2004 CMS surveys are subject to at least three limitations, and caution should be used in extrapolating the survey data to make generalizations about waived testing. First, the CMS surveys were not intended to be a scientific study of a random sample of CW sites. Waived testing data were collected by CMS to provide an assessment of testing practices, promote good laboratory practices, and encourage improvement through educational outreach. Although surveyors attempted to include a wide variety of CW sites in the sample, the sites were self-selected by surveyors and selection was based, to some degree, on convenience to the surveyors and willingness of the sites to participate in the voluntary surveys. However, few sites refused to participate in the surveys. Overall, the sites represent a nationwide sample and the distribution of CW facility types is similar to the distribution of CW facility types in the United States (Table 2). In addition, the 2002--2004 CMS survey findings resulted in the same general conclusions as the earlier CMS pilot studies, which were conducted on a random sample of laboratories (10). Second, the CMS data were collected and entered into the database by a large number of persons, introducing variability. Although training was provided before the surveys were conducted, the intent of the survey questions was subject to individual interpretation. Because the phrasing of some questions differed slightly from 2002 to 2003--2004, in certain cases, the meanings of the questions also changed. Finally, the CMS surveys did not assess the frequency of erroneous test results in CW sites or whether lapses in following manufacturers' instructions directly affected test results or patient outcomes. Similar limitations to these were identified in the LMSMN studies (11).
The findings of the CMS and LMSMN studies are strikingly similar. Xml converter microsoft. Even though the majority of CW sites meet the CLIA requirement to follow manufacturers' instructions for test performance, and many sites follow additional good laboratory practices, over the years these studies have demonstrated that a persistent percentage of CW sites do not meet minimal requirements and are not aware of recommended practices to help ensure quality testing. Because surveying all CW sites is not feasible, the proposed actions to improve and promote quality testing in CW sites emphasize the importance of education and training for CW site directors and testing personnel. To provide a guide that can be adapted for use, either in part or as a whole, by persons or facilities considering the initiation of waived testing and personnel performing waived testing, CLIAC provided recommendations for good laboratory practices. By implementing these recommendations, CW sites could improve quality, reduce testing errors, and enhance patient safety.
Recommended Good Laboratory Practices
Overview
These recommendations are intended to promote the use of good laboratory practices by physicians, nurses, and other providers of waived testing in a variety of CW sites. They were developed on the basis of recommendations and other resources that provided additional information for promoting patient safety and the quality of CLIAC waived testing in laboratories or nontraditional testing sites (18--22). These recommendations address decisions that need to be made and steps to be taken as a facility begins offering waived testing or adds a new waived test. They also address developing procedures and training CW personnel and describe recommended practices for each phase of the total testing process, or path of workflow, including the important steps or activities before, during, and after testing. The activities that occur in each of these phases are critical to providing quality testing (Table 6).
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Considerations Before Introducing Waived Testing or Offering a New Waived Test
Forethought, planning, and preparation are critical to initiating high-quality waived testing in any type of setting. This section describes factors to consider before opening a waived testing site or offering an additional waived test. Questions to address include the following:
- Management responsibility for testing. Who will be responsible and accountable for testing oversight at the CW site, and does this person have the appropriate training for making decisions on testing?
- Regulatory requirements. What federal, state, and local regulations apply to testing, and is the site adequately prepared to comply with all regulations?
- Safety. What are the safety considerations for persons conducting testing and those being tested?
- Testing space and facilities. What are the physical and environmental requirements for testing?
- Benefits and costs. How will the care offered in the site benefit by introduction of testing or the addition of a new test, and what will it cost?
- Staffing. How will introduction of testing affect the current work flow, are there sufficient personnel to conduct testing, and how will they be trained and maintain testing competency?
- Documents and records. What written documentation will be needed, and how will test records be maintained?
Management Responsibility
Each testing site should identify at least one person responsible for testing oversight and decision-making, later referred to as the CW site director. In POLs, this might be a physician or someone in a senior management position who has the appropriate background and knowledge to make decisions about laboratory testing. Ideally, the person signing the CW application (CMS Form 116) is responsible for management of the testing operations. The management staff should demonstrate a commitment to the quality of testing service by complying with applicable regulatory requirements and promoting good laboratory practices.
Regulatory Requirements
CLIA certification. Each site offering only waived testing that is not included under any other type of CLIA certificate must obtain a CLIA CW before testing patient specimens. Certain sites offering waived testing can be certified as part of a larger health-care organization that holds a CLIA Certificate of Compliance or Certificate of Accreditation. In addition, certain public health testing sites offering only waived testing can be included under a limited public health or mobile testing exception. A valid CLIA certificate is required for Medicare reimbursement.
To apply for a CLIA certificate, CMS Form 116 (http://www.cms.hhs.gov/clia/cliaapp.asp) must be completed and sent to the state agency for the state in which the testing site is located. This form asks for specific information, including the type of testing site (laboratory type), hours of operation, estimated total annual volume of waived testing, and the total number of persons involved in performing waived testing. The form must be signed by the facility owner or the facility director. Specific state agencies and contacts are available at http://www.cms.hhs.gov/clia/ssa-map.asp. The state agency will process the application and send an invoice for the registration fee. If additional assistance is required, contact the appropriate CMS regional office (http://www.cms.hhs.gov/clia/ro-map.asp).
CLIA requirements that apply to testing sites operating under a CW include the following:
- Renew the CW every 2 years.
- Perform only waived tests. Waived tests include test systems cleared by FDA for home use, and simple, low-risk tests categorized as waived under CLIA. Sometimes a test that can be performed using different specimens or procedures might be waived only for certain specimen types or procedures. Because the list of waived tests is constantly being revised as new test systems are added, the most current information about waived tests and appropriate specimens is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.
- Follow the instructions in the most current manufacturer' s="" product="" insert,="" without="" modification,="" when="" performing="" the="" test.="" changes="" to="" the="" timing="" of="" the="" test="" or="" physical="" alteration="" of="" the="" test="" components="" (e.g.,="" cutting="" test="" cards="" or="" strips="" to="" increase="" the="" number="" of="" specimens="" tested="" per="" kit)="" are="" examples="" of="" modifications.="" if="" modified,="" tests="" are="" no="" longer="" waived="" tests="" and="" become="" subject="" to="" the="" more="" stringent="" clia="" requirements="" for="" nonwaived="" testing.="">
- Permit announced or unannounced on-site inspections by CMS representatives.
- A written plan for exposure control, including postexposure evaluation and follow-up for the employee in the event of an 'exposure incident;'
- Use of Universal Precautions, an approach to infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, hepatitis B virus, hepatitis C virus, and other bloodborne pathogens. Universal Precautions is one component of Standard Precautions, a broader approach designed to reduce the risk for transmission of microorganisms from both recognized and unrecognized sources of infection in hospitals;
- Use of safer, engineered needles and sharps;
- Use of personal protective equipment (PPE) such as gloves and protective eyewear;
- Provision of hepatitis B vaccination at no cost for those with possible occupational exposure who want to be vaccinated;
- Safety training for handling blood, exposure to bloodborne pathogens, and other infectious materials; and
- Equipment for the safe handling and disposal of biohazardous waste (e.g., properly labeled or color-coded sharps containers and biohazard trash bags and bins).
- Prohibit eating, drinking, or applying makeup in areas where specimens are collected and where testing is being performed (i.e., where hand-to-mouth transmission of pathogens can occur);
- Prohibit storage of food in refrigerators where testing supplies or specimens are stored;
- Provide hand-washing facilities or antiseptic hand-washing solutions; and
- Post safety information for employees and patients.
- Humidity --- Unusually high, low, or extreme fluctuations in humidity can cause deterioration of reagents and test components, affect the rate of chemical reactions and specimen interaction, or make test endpoints blurred and difficult to read.
- Temperature --- Temperature ranges for storage of test components and controls and for test performance are defined by the manufacturer to maintain test integrity. Extreme temperatures can degrade reagents and test components, impact reaction times, cause premature expiration of test kits, and affect the test results.
- Lighting --- Inadequate lighting can negatively affect specimen collection, test performance, and interpretation of test results.
- Work space --- Work surfaces should be stable and level and be able to be adequately disinfected; work space should be adequate in size for patient confidentiality, ease of specimen collection, test performance, and storage of supplies and records.
- Intended use -- Be aware of the intended medical use for which FDA approved the test system as explained in the product insert. This section describes what is being measured by the test, the type of specimen for which it is approved, and whether it is a quantitative or qualitative measurement.
- Performance characteristics --- Assess the information on performance provided by the test manufacturer or published data. Review data that includes the test's accuracy, precision, sensitivity, specificity, and interferences.
- Patient population --- Consider the population that will be tested before offering a test. Some tests have not been evaluated for use in specific age groups (e.g., pediatric populations). The predictive value for certain types of test results in a specific patient population depends on the test's sensitivity, specificity, and the prevalence of the condition in the population. For example, when testing for a certain condition or disease in a low-prevalence population, the predictive value of a positive result will be low compared with the predictive value of a negative result. Refer to the product insert for limitations for use in particular patient populations.
- Need for supplemental testing or patient follow up --- Some waived tests provide preliminary results as part of a multitest series (e.g., rapid HIV testing) or results that must be considered in conjunction with other medical information. These test results might require additional testing before a definitive test result is obtained, and patients might need posttest counseling about the meaning of the test result. Assess the potential need for additional time, documentation, and staffing and a mechanism to refer additional testing to another laboratory when offering such tests.
- Test system considerations --- Consider the simplicity of operating the test system, length of time to obtain a result, and the level of technical support provided by the manufacturer or distributor. Sales restrictions, such as special training requirements, development of a quality assurance program, or provision of information to patients, might apply to some waived tests and require additional planning and resources.
- Test kits or instruments, supplies not provided with the test, control and calibration materials, inventory requirements for anticipated test volume (including seasonal testing), and the shelf life of test components and supplies.
- Equipment maintenance, such as repairs or preventive maintenance contracts.
- Additional safety and biohazard equipment.
- Personnel training, competency assessment, and the potential need for additional personnel.
- Recordkeeping and information systems.
- Required supplemental/confirmatory testing.
- Regulatory compliance.
- Resource needs to manage public health reporting, if required nationally or by the state.
- Is staffing adequate?
--- Determine whether employees have sufficient time and skills to reliably perform all activities needed for testing in addition to their other duties.
--- Be aware that temporary or parttime personnel might be less proficient in performing testing.
--- Evaluate staff for color-blindness because this can limit their ability to interpret test results based on color endpoints. - How much training will be needed?
--- Take into account the staff turnover rate and the ongoing need to provide training for new personnel.
--- Factor in the time and resources for adequate training and competency evaluation of staff before they perform testing.
--- Consider how testing personnel will maintain competency, especially when testing volume is low. - Use a template with standard component headings to facilitate writing a new procedure and promote ease of use when performing testing;
- List all materials needed and how to prepare them before testing;
- Include instructions for patient preparation and specimen collection;
- Highlight key steps in the procedure (e.g., test incubation time);
- List test limitations;
- Describe actions to take when the test does not perform as expected;
- Integrate control procedures with the steps for performing patient testing to assure control testing is performed;
- Include established reference intervals and critical values for the test; and
- Describe how to record and report results and how to handle critical values.
State and local regulations. States and local jurisdictions vary as to the extent to which they regulate laboratory testing. Some states and localities have specific regulations for testing, some require licensure of personnel who perform testing, and some have phlebotomy requirements. State and local jurisdictions often regulate biohazard safety, including handling and disposal of medical waste. The person responsible for testing oversight should ensure that all state and local requirements are met. These requirements might be more or less stringent than federal requirements. When state or local regulations governing laboratory testing are more stringent than the federal CLIA requirements, they supersede what is required under CLIA.
Safety requirements. The Occupational Safety and Health Administration (OSHA) and individual state standards require employers to provide a safe and healthy work environment for employees. Each CW site must comply with OSHA standards pertinent to workplace hazards (23). Regulatory requirements for all OSHA standards, including specific information for medical and dental offices (24), are available at http://www.osha.gov and by telephone, 800-321-6742.
The OSHA Bloodborne Pathogens Standard applies to sites where workers have potential occupational exposure to blood and infectious materials (25). The requirements for compliance with this standard include, but are not limited to:
Specific information on the Bloodborne Pathogens Standard and needlestick prevention is available at http://www.osha.gov/SLTC/bloodbornepathogens/index.html.
CDC and the Clinical and Laboratory Standards Institute (CLSI) (formerly NCCLS) have also published information about biosafety and precautions for preventing transmission of bloodborne pathogens in the workplace (26--30).
Privacy and confidentiality requirements. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established federal privacy standards to protect patients' medical="" records="" and="" other="" health="" information="" provided="" to="" health="" plans,="" doctors,="" hospitals,="" and="" other="" health-care="" providers.="" under="" hipaa,="" cw="" sites="" are="" required="" to="" establish="" policies="" and="" procedures="" to="" protect="" the="" confidentiality="" of="" health="" information="" about="" their="" patients,="" including="" patient="" identification,="" test="" results,="" and="" all="" records="" of="" testing.="" these="" medical="" records="" and="" other="" individually="" identifiable="" health="" information="" must="" be="" protected,="" whether="" on="" paper,="" in="" computers,="" or="" communicated="" orally.="" in="" addition,="" cw="" sites="" should="" be="" aware="" that="" applicable="" state="" laws="" that="" provide="" more="" stringent="" privacy="" protections="" for="" patients="" supersede="" hipaa.="" additional="" information="" on="" hipaa="" is="" available="" at="" http://www.hhs.gov/ocr/hipaa.="">Developing Procedures and Training Personnel
Physical Requirements for Testing
Testing should be performed in a separate designated area where adequate space to safely conduct testing and maintain patient privacy is available. In addition, some tests have specific environmental requirements described in the manufacturer's product insert that need to be met to ensure reliable test results. Meeting these environmental conditions can be challenging in nontraditional settings (e.g., health fairs) or community outreach venues (e.g., shopping malls, meeting rooms, parks, parking lots, mobile vans, and buses). Factors to consider include:
Benefit and Cost Considerations
Evaluating the benefits of a particular test. Evaluate the test system, its intended use, performance characteristics, and the population to be tested when assessing whether to introduce waived testing or a new waived test. Information for this evaluation can be obtained from the test manufacturer' s="" product="" insert="" (table="" 7)="" or="" by="" speaking="" with="" the="" manufacturer's="" technical="" representatives.="" specific="" considerations="" include:="">
Cost considerations. A fiscal assessment of testing is part of a good management program. Before offering a new test, consider the level of reimbursement and factors that contribute to total test cost. These factors include:
Personnel Considerations
Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. No CLIA requirements exist for waived testing personnel qualifications; however, applicable state or local personnel regulations must be met. Personnel issues to consider include:
After the decision is made to offer waived testing, it is good practice to develop written policies and procedures so that responsibilities and testing instructions are clearly described for the testing personnel and facility director. The testing procedures form the basis of training for testing personnel. These procedures should be derived from the manufacturer' s="" instructions="" and="" should="" be="" in="" a="" language="" understandable="" to="" testing="" personnel.="">
Written Test Procedures
To comply with CLIA requirements and provide accurate testing, CW sites must adhere to the manufacturer's current testing instructions. These instructions, as outlined in the product insert, include directions for specimen collection and handling, control procedures, test and reagent preparation, and instructions for test performance, interpretation, and reporting (Table 7). In addition, certain manufacturers provide quick reference instructions formatted as cards or small signs containing essential steps in conducting a test. Quick reference instructions should be clearly posted where testing is performed. The specific test system name should be on the quick reference instructions to avoid confusion.
A comprehensive procedure manual is a valuable resource for CW sites. Although product inserts can be used as test procedures, these instructions will typically need to be supplemented with testing information that is unique to the CW site's operations and workflow (31). A procedure manual can also include examples of forms used (e.g., charts to record daily test kit storage temperatures, infectious disease reporting forms, or logs for recording control testing and test results) and check lists for personnel training. New testing procedures should be reviewed and signed by the CW site director before incorporating them into the procedure manual. The manual should be updated as tests or other aspects of the testing service change and should be reviewed by the director whenever changes are made. When procedures are no longer used, they should be removed from the manual and retained with a notation of the dates during which they were in service.
When writing procedures for each CW site, it might be helpful to:
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