I'm your presenter Bridget Smedrick. I'm currently the Director of CLIA Compliance for Doctors Management. I have a Bachelor's of Science pre-med concentration in Biology and Chemistry from the University of Tennessee. I'm a certified medical technologist since 2000, belonging to the American Society of Clinical Pathology. I have over two decades of laboratory experience from physician office laboratories to high complexity laboratories. I am a licensed laboratory supervisor. Doctors Management is a full-service medical practice management and consulting firm. We simplify the business of medicine so that you can focus on caring for your patients and the future of your business. We advise both large and small medical practices and healthcare organizations on topics such as increasing practice profits, reducing compliance risk, improving patient satisfaction, reducing stress for physicians and staff. Our team consists of nationally recognized industry experts in compliance, coding, auditing, financial services, patient retention, human resources, and more. The learning objectives for this session will be as follows. To discuss how CLIA requires laboratories to implement new non-waved testing using precision, accuracy, reportable range, reference range, calibration, and calibration verification while comparing CLIA and COLA requirements. Performance Specification Regulations, also known as Specification Verification, are required for all moderate complexity tests since April of 2005 for CLIA laboratories and since June of 2007 for all COLA laboratories. This was previously only required for high complexity testing. Specification Verification only applies to non-waved test systems. The laboratory personnel is responsible for verifying each non-waved test system. Your manufacturer may guide the text and do calculations. However, ultimately, laboratory personnel are responsible for performing the actual verification. Verification of performance should occur in the following instances for all new non-waved instruments or methods, including multiples of the same instruments and replacements of identical systems, for all new analytes added to an established method, when changing methods or reagent manufacturers, for all loner instruments, and also after moving an analyzer to a new location. The studies included in performance specification are as follows. Accuracy, Precision, Reportable Range, and Reference Range. Accuracy. Accuracy is a measure of your correctness of your result. You should test multiple specimens with known values and compare your results to the original ones. Acceptable materials include old proficiency testing samples, specimens tested at another lab with known results, parameters, or controls of different levels. You need at least three, a low, mid, and high. You should define your criteria for acceptability before starting your accuracy study. You should determine if you have met your criteria following your study. The accuracy must be performed by the laboratory staff and then approved by your laboratory director, and accuracy must be completed before you begin any patient testing. Precision. Precision studies reflect the repeatability or reproducibility of your results. They are accomplished by running the same sample multiple times and calculating the coefficient of variation percentage. It must be performed by your laboratory personnel. It must be comparable to the manufacturer's stated precision, and your results must be completed prior to testing patient samples. Reportable Range. Your reportable range establishes the lowest to highest result that your test system can reliably measure. You can perform a reportable range study using linearity kits or controls. You need preferably three levels, but most kits include four to five. You should perform your study using all bottles included in your kit. Your laboratory can report patient results only within the verified range. This study must be completed prior to testing any patient samples. Reference Range, also known as Normal or Expected Range, is a range of results expected for a group of healthy patients with no indication of abnormalities for the particular test in question. You should start with the manufacturer's suggested range. After sufficient data is gathered, you should verify that the manufacturer's range is appropriate for your laboratory's patients. If not, the range may be adjusted to meet your needs. You should have the approval of the director or the clinical consultant for this study. Your study may be included as a quality assessment monitor. It's important to note that both COLA and CLIA will accept as few as 10 patient samples for this study. The process for introducing a new instrument into your test system include the following. Run any appropriate background counts, reagent checks, or system checks. Perform a precision study. Calibrate the instrument. Verify your calibration. Perform accuracy or correlation studies. Run specimens to verify the reportable range. Begin patient testing using published reference ranges. Have all aspects approved by the director, and then verify the applicability of reference ranges based on patient test results. Let's examine some of the differences between CLIA and COLA as pertaining to accuracy. CLIA requires the following. Run 20 specimens of known value across the reportable range. Establish criteria for acceptability. Determine if you meet that criteria, and follow the manufacturer recommendations, which usually includes performing accuracy studies every 6 months. COLA, on the other hand, is as follows. Run 5 specimens of known value across the reportable range. Establish criteria for acceptability. Determine if you meet that criteria, and you're required to perform accuracy every 6 months. Now let's examine the differences between CLIA and COLA concerning precision studies. For CLIA, run 11 samples, eliminate the first result, and calculate the percent coefficient of variation. Only one level is required, and you perform the study in duplicate and over time. COLA requires the following. Run 2 levels 5 times each, running on different days, in different batches, and by different operators. You then calculate your percent coefficient of variation for each level. When performing reportable range studies in your laboratory, it is important to remember the following tips from CLIA. After initial installation, CLIA does not require another reportable range study unless you have altered the instrument, moved it, or received a loaner. Please don't confuse this study with an accuracy check or linearity that is required every 6 months. For COLA laboratories, you should remember the following. If you used samples for precision that were very low or very high, then you have verified your reportable range by adding a middle point. When you add a sample with a value in the middle of normal patient range, you have also performed an initial calibration verification. Important points to remember concerning reference range studies for CLIA laboratories are as follows. Your reference range can be performed periodically for quality assessment monitoring. Your reference range study does not need to be performed again after initial installation, and you can spread this process over the first 6 months of testing. For COLA laboratories, collect between 5 and 10 normal verified patient results. Test only once and spread the testing over at least 3 days. You should then calculate your mean and two standard deviations and compare your results to the established or documented normal range. The reference range process can occur over a 6 month period, and you should continue to perform this check periodically as a quality assessment monitor. The number of samples used in any study is not arbitrary. Both CLIA and COLA encourage their laboratories to follow the rule of 20 data points whenever possible. However, both organizations recognize that 20 may be prohibitive for some small testing facilities. You should ask your surveyor ahead of time what he or she would accept for your size laboratory. A good rule of thumb to use is that you should test at least 10 samples. What is calibration verification? Calibration verification is additional testing after the calibration of your instrument that confirms the test system will accurately recover the concentration of the analyte over your verified reportable range. Calibration verification verifies that your calibration is correct in all areas of the reportable range. Calibration or calibration verification should be performed under the following circumstances. On installation of new instrumentation, at least every 6 months, more often if it's required by your manufacturer, with each complete change of reagents, anytime parts are replaced or significant part problems occur or if you move your instrument, when you're having problems with quality control, proficiency testing, or patient results. Your calibration or calibration verification must be reviewed by the technical consultant or your laboratory director. You should also remember to maintain complete documentation for your calibration or calibration verification for 2 years. The simplest way to perform a calibration or calibration verification is to use a commercial linearity kit from a company such as Main Standards or Audit Micro. You may also use materials with known values across your reportable range which have at least 3 levels. Examples include your quality control, known patient samples, or proficiency testing samples. Please remember you are required to have your director review the results and determine if your laboratory's criteria has been met. Should your calibration or calibration verification fail, you should do the following. First, repeat your calibration. Next, repeat the calibration verification. Then, you should run controls. If it still doesn't pass, then you should call the manufacturer for advice. Please remember you can only run patients after you are successful with both calibration and controls. When evaluating your test system for the appropriate performance specifications, it is important to remember the following. For qualitative tests, you must verify the accuracy for presence or absence. Use at least 2 negatives and 2 positives, testing each 2 times on different days by different operators. For non-FDA approved tests, your laboratory must establish performance specifications, verify them, and then prove their reliability. Any altered FDA approved tests become high complexity and their reliability must then be proven.

Bridget Smedrick

CLIA Compliance

non-waved testing

calibration verification

performance specifications