CLIA Waived Testing and its Impact on Patient’s Safety and Clinical Laboratories

Introduction

CLIA waived tests are simple tests that don’t need complicated processing and can be done by uncertified operators or even at home by the public such as pregnancy tests, dipsticks for urinalysis, blood glucose by glucose monitoring devices cleared by the FDA for home use and more.

For the test to be waived certain requirements should be met as follow: first, the test should be simple and of low complexity where the probability of error is negligible. Second, there should be no need for specimen processing, means using whole blood or direct use of body fluids for testing. Third, the test should be of low risk of harm to the patient in case the test performed incorrectly. Finally, the test should be approved by food and drug administration (FDA) for home use. (“CLIA waived testing”, 2018).

CLIA stands for Clinical Laboratory Improvement Amendments. It is an organization established in 1988 in a purpose of updating existing regulations such as “licensing of clinical laboratories, regulations of test complexity, proficiency testing, quality assurance, and other clinical laboratory processes”. (“CLIA waived testing”, 2018).

Some waived tests have a potential harmful health consequence when performed inaccurately. For instance, results from waived tests that used to alter medication dosage, as seen in prothrombin time and glucose testing in the purpose of monitoring patients with anticoagulation abnormalities and diabetes, should be of high quality so the right dosage administered. Furthermore, erroneous tests outcomes, such as human immunodeficiency infection (HIV) antibody tests, can have an incidental consequence. To diminish the danger of incorrect outcomes, the test should be performed effectively, via trained workforce and in a situation where good lab practices are followed. (Waived Tests CDC, 2018).

CLIA Historical Data

In 1992, CLIA published 8 types of tests that met waiver criteria including, urinalysis dipstick for bilirubin, glucose tests by glucose monitoring devices approved by the FDA for home use, hemoglobin measurements using non-automated methods, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. In addition to fecal occult blood, ovulation tests, urine pregnancy tests, manual erythrocyte sedimentation rate tests. (“CLIA of 1988 waiver history”, 2014).

In 1993, the last guideline published adding to the list of waived tests: hemoglobin measurement using a single analyte analyzer with a component features to perform a specimen and reagent interactions, giving direct estimation and readout. In the same year, 1100 questions received concerned waived test criteria and failure of a certain test to achieve waiver. The Centers for Disease Control and Prevention (CDC) contacted CLIA and CLIA advised that CDC should specify criteria and process for waiver and establish a temporary prohibition on considering tests for waiver approval until the criteria were better defined. CDC set up the temporary prohibition, as suggested, while creating rules and a proposed standard to reassess the CLIA prerequisites for waiver approval. CDC defined a certain test as waived if it is “simple” and “not prone to error” as criteria to meet the statutory prerequisite that waived tests ” have an insignificant risk of an erroneous result” and required that waived test give an accurate result regardless testing conditions and setting. (“CLIA of 1988 waiver history”, 2014).

In 1994, the waiver temporary prohibition revoked, and CDC established a tentative waiver review process. also, the manufacturers of moderate complexity test were notified by CDC that it would consider any moderate complexity tests that met the statutory waiver criteria and for which the producer applied for a waiver as per the draft rules containing waiver criteria a process for reviewing waiver requests. (“CLIA of 1988 waiver history”, 2014).

The suggested rule was issued in 1995, clear statutory criteria for deciding which tests could be waived and to grant an automatic waiver of home use tests approved by FDA.  In addition, the rule suggested that all previously waived tests be evaluated again using clear waiver criteria in the regulation. (“CLIA of 1988 waiver history”, 2014).

Food and Drug Administration Modernization Act of 1997 (FDAMA), revised CLIA law and assured that any test approved by FDA for home use is qualified for CLIA waiver. The waiver section of CLIA now states that  waived tests “are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” (“CLIA of 1988 waiver history”, 2014).

The Partners for Public Health and Government files a citizen appeal in 1998, asking for CDC and the Health Care Financing Administration (HCFA) – now the Centers for Medicare and Medicaid Services (CMS) – to join the deliberated rulemaking to develop waiver regulations. (“CLIA of 1988 waiver history”, 2014).

In 1999, CDC, HCFA, and FDA signed an agreement to transfer the responsibility for categorizing the commercially marketed laboratory tests based on complexity and evaluate requests for a waiver from CDC to FDA. (“CLIA of 1988 waiver history”, 2014).

In 2000 FDA hosted a public workshop, to gather feedback on the criteria and process used to decide if a test eligible for a waiver. 29 individuals representing government, industry, professional laboratory organizations, and academic institutions participate in the workshop and some provided written notes. (“CLIA of 1988 waiver history”, 2014).

FDA posted draft rules for waiver requirements in 2001, “Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA,” on its website and forwarded a copy to CDC to distribute in the next CLIAC meeting. (“CLIA of 1988 waiver history”, 2014).

In 2005, FDA announced the availability of the revised draft rules entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications” to recommend a clear process for a manufacturer to submit waiver applications. This draft guidance supplanted the previous draft guidance entitled “Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver.” (“CLIA of 1988 waiver history”, 2014).

Finally, FDA issued a notification in 2008 declaring the availability of the final guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The guidance contained information and suggestions for device manufacturers considering FDA for waiver approval. (“CLIA of 1988 waiver history”, 2014).

Initially few tests considered waived such as: non automated urinalysis dipstick for limited numbers of analytes, ovulation tests that use color comparison to detect LH surge, fecal occult blood, urine pregnancy tests that use color comparison to detect the presence of beta HCG in urine, manual ESR tests, blood glucose level detection using glucose-monitoring devices approved by the FDA for home use, single analyte instrument used to detect microhematocrit and Hemoglobin by direct measurement and readout (added 19 January 1993). (Campbell and Klein 2006).

Waived tests approved were rapidly increasing, currently, a wide range of testing in different lab areas were waived. For example, in the infectious disease area, tests were waived including: “Helicobacter pylori antibody, HIV-1 and -2 antibodies, Influenza A and B, Lyme antibody screen, monospot, Respiratory syncytial virus, Respiratory syncytial virus antibody, Streptococcus group A”. In the urinalysis area, more tests approved waived such as qualitative semen analysis and fern test. In addition, detecting antigen linked with bladder tumor is now waived test and can be done simply by qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. (Campbell and Klein 2006).

Also, a wide range of chemistry tests are now waived and don’t need special training or proficiency testing included during laboratory inspection. “Alanine aminotransferase, aspartate aminotransferase, Microalbumin, Drugs of abuse, urine ethanol, nicotine, Cholesterol, high-density lipoprotein, triglycerides, Creatinine, N-Telopeptide, Follicle-stimulating hormone, luteinizing hormone, Glucose, fructosamine, hemoglobin A1c, Human chorionic gonadotropin, Ketones, and Lactate” are examples of current chemistry waived testing. Finally, ESR, fecal and gastric occult blood, hematocrit and hemoglobin and PTINR are examples of  current hematology waived testing. (Campbell and Klein 2006).

Despite the convenience of the waived tests in saving time and provide prompt diagnosis and treatment when performed at the doctor’s office, there are some concerns regarding the quality of waived testing results. The exemption of waived from personal qualifications and training, quality control, proficiency testing and routine inspection is the progenitor of many of these concerns. (Rothenberg, 2015).

CMS and the CDC carried out a study between 2001 and 2004, where random waived laboratories were surveyed. The study results showed a higher level of quality problems associated with waived testing performed by these laboratories. These included absences of accessibly written procedure, workforce training, competency appraisals, performing of required quality control, proper attention to the reagents expiry date and storage requirements; and failure to enter the test results into electronic medical records. Errors can happen in any phase of the testing process and have genuine ramifications for patient care. (“Waived Testing and Patient Safety” COLA, 2015).

Quality in waived testing is reliant upon a focused accentuation on preparing and competency of the testing workforce. There have been some very exposed instances of patient harm and even death identified because of inaccurate waived testing, such as glucose erroneous results that use to decide insulin dose. This by itself ought to be a call to the lab community to demand that waived testing be “put under the microscope”. But it is similarly important to earn community trust in public health screening initiative by asserting the importance of waived testing personnel training and competency adherence. (“Waived Testing and Patient Safety” COLA, 2015).

Seven out of ten of therapeutic decisions made based on laboratory tests results. That is a key component of decision-making that occurs in daily healthcare settings. The issue is that there should be more emphasis on quality, ensuring that the test is done accurately because this leads to diagnosis and treatment determinations. (Kearney-Strouse, 2014)

The other viewpoint is that what occurring in patient-centered medical homes around laboratory medicine has occurred in several healthcare delivery models. What they are doing is “Do the test once; use it many times.” On the off-chance that the real supposition made that is laboratory tests are done well, and they deliver quality outcomes, at that point it makes sense to send the information used by primary care clinician to make an initial diagnosis to a specialist if there’s a referral, or to the hospital if hospitalization needed. That information used to then either approve the initial diagnosis or to expand upon the initial diagnosis. (Kearney-Strouse, 2014).

For instance, under a patient-focused medical home, testing data from a retail clinic will flow into a medical record eventually be the responsibilities of a practicing physician to arrange care. Except if there is some emphasis on quality in laboratory medicine, this will lead to unintended results of either redundant testing that may not be reimbursed or perhaps information in the medical record that would lead to misinterpretation, misdiagnosis and potentially unsuitable treatment. (“Waived Testing and Patient Safety” COLA, 2015).

The concept will be to do the test first on a high-quality instrument and afterward decrease repetitive testing with the goal that high-quality test results used as the patient move through the healthcare system. However, most physician practices used waived testing only. In the waived test settings, if the procedure or the instrument utilized is good, human errors happen in the preanalytical and post-analytical phases. for instance, errors that happen while the test sample collected, or after running the test. Regardless of the test complexity, quality issues are involved. Most medical laboratory in the United States currently are using waived testing devices that have pre-analytical, analytical and post-analytical issues that could be easily avoided and resolved, however, without oversight, this can’t be avoided. These sites are creating problem data that are being utilized in the diagnosis and treatment of patients. (Kearney-Strouse, 2014).

Initiatives need to follow to cut down waived testing poor quality results such as: introducing quality initiatives into waived medical laboratories, with the goal that physicians could be qualified for up to a 30% reimbursement in the event that they participate in one of the quality initiative programs available. Moreover, working with primary physicians to create a training program that easily followed and has a great impact on ensuring that testing personnel are skilled and remain on top of preanalytical and post-analytical problems and they’re aware of how to tackle such problems. Also, testing personnel should demonstrate knowledge on how to read the package insert and follow the manufacturer’s instructions. Finally, a basic knowledge of medical laboratory principles is required to maintain high-quality results. (Kearney-Strouse, 2014).

Conclusion

The idea of the waived test created by Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). Simple tests, easy to perform, deliver an accurate result with a neglected percentage of error and cause no harm in case the test was not performed correctly are some of the characteristics of waived tests defined by CLIA. Subsequently, these tests are exempt (“waived”) from government prerequisites for testing personnel training, quality control (with the exception as determined by the manufactures), proficiency testing, quality assurance, and the requirement for routine inspections. Waived testing includes FDA cleared tests for home use.

Development of written procedures is a good laboratory practice used to define the staff responsibilities and provide clear instructions on how to correctly perform testing and avoid errors throughout all phases of the testing process. These procedures may obtain from the manufacturer’s guidelines and should be written in a simple and understandable language.

Although waived testing doesn’t require special training, it is essential that testing personnel should be trained to maintain quality testing and patient care. Personnel should be able to follow the manufacturer’s instructions in each test they perform before reporting patient results. The site director or other individuals in charge of supervising testing should guarantee that testing personnel get sufficient training and are able to follow procedure. Maintain a training checklist is useful to guarantee the staff competency.

Although procedure manual is not a federal requirement for waived testing, it is   required to follow up the manufacturer’s instructions when performing waived testing. When suitable, the package insert might be utilized to create a test procedure. If a lab is performing many different tests, it is useful to create a procedure manual to arrange and keep different procedures. The procedure manual is used for all procedure, including those for pre-analytical activities, post- analytical reporting, safety precautions, and more.

References:

• CLIA waived testing. (2018) retrieved from American Collage of physician https://www.apastyle.org/learn/faqs/web-page-no-author
• Clinical Laboratory Improvement Amendments of 1988. Waiver History October 1988 – October (2014) https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac1114/5a_CLIAC_Waived_Testing_History.pdf
• Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA. Released March 1, (2001).
• SheldonCampbellM.D., Ph.D.aRoger D.KleinM.D. J.D.b, (2006).Accessed at http://www.fda.gov/cdrh/ode/guidance/1147.pdf (2005 in historical data).  https://wwwn.cdc.gov/CLIA/Resources/WaivedTests/default.aspx.
• Irwin Rothenberg MBA, MS, MLS(ASCP), June 9, (2015), WAIVED TESTING: SPECIFIC QUALITY AND PATIENT CARE CONCERNS
• Jennifer Kearney-Strouse, (2014), Physicians should take steps to improve the testing done in their hospitals and offices.
• Waived Testing and Patient Safety, COLA (2015)
• https://www.cola.org/insights-newsletters/2015/Jan/insightsjanfeb15.pdf.