Craft the Perfect Letter for Outstanding Payment for Product Quality

Letter for outstanding payment for Product quality

hello everyone and welcome to today's live broadcast iqcp is a four-letter word presented by dr. Steven cotton we're excited to bring you this educational web seminar presented by lakor's the leading scientific social networking website and provider of virtual events and webinars advancing scientific collaboration and learning for more information please go to .hsn the Jo love lab words and I'll be your moderator for today's event before we thinking I would like to remind everyone that this event is interactive we encourage you to participate by submitting as many questions as you want at any time you want during the presentation just click the green Q&A button located at the lower left of the presentation window and type your question into the box that appears on the screen we'll answer as many questions as we have time for at the end of the presentation also please notice that you will be viewing the presentation in the slide window to enlarge the window just click on the screen icon located at the lower right if you have trouble seeing or hearing the presentation please click on the support button at the top right of the presentation window for use the Q&A button to let us know you're having a problem this is an educational webinar and thus offers free continuing education credits after the webinar is over please sleep on the CTE button located in the bottom left-hand corner of your webpage and follow the process of obtaining your credits now I'd like to introduce dr. Steven cotton dr. cotton is director for chemistry in your knowledge a toxicology and point-of-care testing at the Ohio State University Wexner Medical Center an assistant professor in pathology at The Ohio State University he received his PhD in pharmaceutical sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill where he also completed his training in clinical chemistry in the Department of Pathology dr. cotton is board-certified in clinical chemistry by the American Board of clinical clinical chemistry he's also served as the chair of the ATCC Ohio Valley local section and is currently the newsletter editor and online community moderator for the new mass spectometry and separation sciences and this three division of the American Association for clinical chemistry his primary research interests include drug testing in alternative matrices and operational efficiency metrics for clinical laboratories please join me in welcoming dr. Stephen cotton I will now turn the presentation over to him thank you for that wonderful introduction so today we're gonna talk about iqcp and its impact on laboratories so what does iqcp mean to you this has been a topic that is provided a lot of stress for laboratories and there's been some creative acronyms associated with this one of them is idiots questioning competent professionals I question confusing policies indiscriminate quagmire creating panic I quit clinical pathology or imposed quality control plan but most of you probably know that it stands for individualized quality control plans so just an outline of what we're going to cover we're first going to begin conventional approaches to quality control in the lab and then we're going to discuss CMS changes to quality control what that means for the affected tests and then how to perform an IQ CP and then finally end with what does the College of American Pathologists a about iqcp what is in their checklist so a little bit of background guidance for quality control for clinical laboratories has conventionally stated two things it is said that two levels of external quality control must be performed every 24 hours or you must follow the manufacturer's instructions for quality control however this can create some conflicts if the manufacturers do not recommend external controls at the same frequency of every 24 hours and so this discrepancy has largely gone unenforced as there are many tests and many instrument platforms which are moderately are highly complex that actually don't meet these clear requirements an effective January 1st 2016 if labs wished to remain compliance the practice of running QC less frequently they must perform in iqcp and so the iqcp involves three things it involves a risk assessment a quality control plan and a quality assessment now labs have shared a lot of frustrations regarding about this because this concept of iqcp is relatively abstract and it's relatively new and so a lot of laughs have simply said we'll just I wish I could understand this better just tell me what I need to do don't make me think about something how can a small hospital with limited resources perform the appropriate studies needed to implement an IQ see there was been very few very little training and the instructions have been very confusing the amount of work required is often very daunting and the guidance is vague and abstract so it's very frustrating for something so important with such poorly defined expectations and probably most importantly labs have said we haven't had enough time to do this so let's go into some of the things that CMS has changed about quality control the initial notification that there was going to be a change to quality control starts in 2011 this is where the initial notification that EQC or equivalent quality control would be phased out and then replaced with a lab specific risk-based QC approach flash-forward two years CMS releases a bulletin better describing these QC changes they discuss iqcp training and the transition process that will be effective January 1st 2016 and will be phased in during a two-year period at that point there will be no more EQC equivalent QC or electronic you see that will be valid so what is iqcp mean for you it may be impractical to run two levels of external QC every day for your test this can be due to just cost restraints too many instruments the methodology the assay doesn't really limit itself to running to external levels you might batch per cartridge or per kit or per specimen or there could be just a lack of control material and so iqcp gives labs the flexibility to meet these regulatory QC requirements that are appropriate for your test system your patient population and your test environment it's important to note that iqcp is technically voluntary but the implementation is needed if you run less than two levels of external control every day of patient testing some of these sub specialties that have been excluded from iqcp include anatomic pathology histopathology oral pathology and cytology there are also some interesting nuances with tests with multiple sub specialties so under CLIA certain tests may be assigned one of several sub specialties the test is eligible for an iqcp based on any of the subspecialties then the laboratory may elect to use an IQ CP approach the bat test regardless of the subspecialty they have assigned to it in their laboratory for example fish testing may be classified as either histopathology or cytogenetics and so the lab may have it under histopathology on their CLIA certificate if so the lab can still use an IQ CP for their fish testing so what are some of the responsibilities of the CLIA lab director first and foremost the director is responsible for accurate and reliable test results that are appropriate for patient care no matter what QC method or approach is is used they are also responsible for ensuring that the iqcp meets the requirements set forth in the iqcp interpretive guidelines they are also responsible for signing and dating the iqcp this cannot be delegated so now that we've reviewed the CMS changes to QC let's talk about the affected some of the affected tests what tests might be included in this iqcp program a lot of these are actually point-of-care tests some tests that currently use electronic quality control methods like eye stats microbiology testing blood gases moderately complex kid testing a CT or clotting and anywhere where manufacturer QC is less stringent than clear requirements so I've broken that down into a little more detail here for blood gas instruments internal or electronic QC is most often used and these instruments can be deployed throughout the hospital they can be a part of respiratory therapy which has multiple sites throughout the hospital but they can also be found in operating rooms and the ed4 microbiology testing ability testing on the Microscan gene expert testing proceedeth and commercially prepared media may not actually have two levels of external control run daily in addition you can have rapid molecular tests for flu serum specimens on point of care HCG kits and pointer fear on testing or TV what test is iqcp not include this is not a comprehensive list it is the responsibility of the laboratory to audit all of their tests to see if they currently meet the criteria of two levels of external QC every day of patient testing and we'll talk more about this later so we're gonna go into the meat of the presentation how do we actually perform an IQ CP well CMS has provided an iqcp workbook it is available for download online at WWDC and it outlines the steps involved to develop an IQ CP that meets the requirements set forth by CMS the iqcp or individualized quality control plan has three major components it is composed of a risk assessment that looks at what can go wrong with this particular test system that is the starting point of the iqcp once you've performed the risk assessment and identified the risks involved with that testing you can develop a quality control plan so how do we prevent or detect errors from happening for the risks that we've identified and then the third step is a quality assessment is the quality control plan that we've put in place effective we're actually identifying and preventing errors in our test system our labs are probably already addressing some if not most of these things in our qi and QM programs so the iqcp is really just a formal process of collating all of your efforts together in a single cohesive plan let's begin with the risk assessment so the first part of the risk assessment is to really look at the total testing process there are three stages and five areas that are required for laboratories to evaluate the three stages are the pre analytical phase the analytical phase and the post analytical phase for the five areas they can be divided into those three stages these these include looking at the specimen the test system the reagents the environment and the testing personnel by looking at the three stages and the five areas together you evaluate the total testing process to look at the risks associated with that test or test system so some of the five required areas if we look at some areas related to the specimen are there specifics related to patient preparation are there issues with specimen collection and labeling are there issues with specimen storage and stability and transport are there specifics related to processing that can affect the outcome for the test system are there adequate systems in place to identify spotted specimens to look at calibration issues mechanical failure optical failure or built in procedural or electronic controls that give you information about the performance of the test system additionally what about the reagents do you look do you need to look at shipping and receiving storage conditions preparation or expiration of the reagents and then the environment are there temperature humidity requirements altitude or dust requirements that may impact the accuracy of your test system and finally lab should evaluate their testing personnel do they need specific training do they need regular competency are there unique educational requirements and experience needed and staffing do you have a high turnover of staff in certain areas that may impact their training and competency over other areas CMS has provided a worksheet to evaluate this risk assessment in these five areas and so what's shown here are the pre analytical analytical and post analytical phases going across the top followed by the five stages specimen test system reagent environment and testing personnel a good way to evaluate the consequence of your risk is a risk hazard matrix this is actually not specific to iqcp but it can be used to classify the degree of risk that you may have identified and the two areas that you want to look at are the likelihood then that an event will happen versus the potential consequence that an event will happen so if the likelihood is high that you will have a very severe event that would be considered a high risk error but if you have a very low likelihood that an event will occur and if it does the potential consequences low that would be categorized as a low risk event so let's walk through a blood gas example here so let's say we've identified for the specimen we can cut we can have issues of mislabeled specimens and we can have issues of clots can we put a system in place that can detect and identify this yes well we could implement barcode scanning and we have a standard operating procedure for the collection that clearly identifies labeling of the specimen for this test system if calibration is expired does that impact there is the results yes well can we have a system in place that identifies that yes the instrument has automatic lockout and autumn calibration for the reagent what is the impact of a degraded reagent to impact your results can we identify this yes we can use QC whether its internal or external QC to evaluate the stability of the reagent and let's say your test system is impacted by excess humidity do we have an ability to detect excess humidity and prevent it yes we can keep a daily log of the humidity levels in the lab and then recognize when the humidity requirements are not met for that test system and for the testing personnel if you have inexperienced technologists would that impact the results yes can you do something to mitigate that risk we can implement training and competency and even have them review the iqcp risk assessment that we've done for that test system and then we can go back and classify the likelihood or the risk hazard for each individual risk that we've identified and I've given some just examples here that maybe we think that the specimens are medium the expired calibration is very low due to the lockout the reagent is medium the environment might be high maybe we have a high issue a big issue with humidity in our lab and then inexperienced technologist would be low because we're confident in our training and competency the historical data can actually be used to classify the risk and justify their classification so it's important for labs to go back and review their own historical data so using historical data the eye and iqcp your own laboratory data is the support for your risk assessment and your QC plan you can look at the number of instruments the number of instruments that have sent back for repairs over the last two years the number of failed PT specimens with discrepant reports the number of event reports or service occurrences that have included that particular instrument or platform the number of personnel in the turnover of personnel each year the number of rejected specimens and their reason for rejection over the last year the number of corrected reports or your own internal QC data so now that we've identified the risk and we've classified them based on importance we can now design a quality control plan that meets the risks let's say the medium and high risk and creates a system to mitigate or identify those particular errors as I said before once you complete the risk assessment you need to determine which risks need to be monitored or controlled or have they already been addressed by the manufacturer the quality control plan must is designed must incorporate all the possible QC procedures not just traditional to see the number of the QC plan must include the following items the number of QC the type of QC the frequency and the acceptable criteria your QC plan can incorporate many different types of QC this can be electronic controls equipment maintenance logs internal controls personnel training and competency assessment calibration data proficiency testing or other data specific to the test platform there is no minimum frequency however no QC is unacceptable and QC cannot be less than the manufacturers recommendation and the QC frequency that you propose must be must be supported by your risk assessment so let's go back to the risk that we buy dead identified in our example from our risk assessment we thought we had an issue with mislabeled specimens plots the type of quality control we want to implement as verification of the specimen label and verification of the specimen quality we want to do this with each specimen and then how are we going to track this and what have we accepted criteria we're gonna refer to our specimen collection policy and we're gonna track all of our rejected specimens in the instance of a degraded reagent the type of quality control that we're going to use is an internal quality control and this is going to be two levels every eight hours ing to the manufacturer and the results must be within the manufacturers range and these results must be documented so for our other risk of excess humidity that we've identified we're gonna perform temperature and humidity checks in the lab and this is going to be gun this is going to be performed daily and are acceptable criteria ing to the manufacturer it's going to be 30 to 80 percent so we've taken the risk we've developed a quality control plan and now we're going to use the quality assessment to take all of the QC measures that we've established and we're gonna create a system to review and detect and improve the quality control plan let's take a moment and contrast quality control versus quality assessment if quality control means recording temperatures quality assessment means the review of the temperature logs if quality control means documenting your QC results then the quality assessment means reviewing QC results monthly or even daily if your quality control is documenting personnel training then your quality assessment would be reviewing and auditing your your employee training records furthermore document maintenance would be reviewing maintenance and documenting competency would be reviewing and auditing your personnel files so some of the documents that you may want to consider and this is from CMS regarding their iqcp workbook may include QC data sheets Delta check logs proficiency testing results complaints or event reports from specimen collection logs specimen rejection logs critical values or panic values turnaround time reports temperature logs maintenance logs training logs and FDA alerts and so the quality assessment takes all of your QC measures that you've established and you want to create a system to systematically on a regular basis review and detect and improve the quality plan that you've put in place so here's an example of a quality assessment so the QA activity would be supervisor review and instrument pronounced that are reviewed and QC logs that's done on a monthly basis and the assessment was their variation if there was yes then you propose a corrective action so in this case for the corrective action they listed remedial training of testing personnel and then reassess the testing personnel performance their second QA monitor would be accompany assessment this is done on an annual basis after the first year if there was no variation then you don't need to rewrite or review the assessment if the QA monitor is the laboratory director reviews and signs the QC logs if this is done quarterly and there's no variation from the established policy then you don't need to provide a corrective action so what are some of the iqcp resources and templates that you can use you can use the templates provided by CMS which are available on online however many manufacturers have actually created templates and platforms for assays that are affected by iqcp this primarily evaluates the risk assessment portion of the iqcp and labs will still need to individualize the plan based on their specific needs I would encourage you to reach out to your vendor for your support I've listed two examples of companies blood-gas that are affected by iqcp both of which have created iqcp templates which can be used by laboratories additionally the American Society of microbiology has created PowerPoint templates and PDF templates for iqcp plans for commercial m.i.c antimicrobial susceptibility testing because this is a test system that is affected by iqcp so now we're going to look at what CA P says in their new checklist regarding CMS proposed changes to iqcp so what does cap say about iqcp there are currently two important documents on CAPS website there is a flowchart for determination of eligibility to use an iqcp and there is also a new iqcp cap checklist item and forms the flow chart the flow chart determines whether an iqcp can be used based on the testing weights or non wave status the pathology subspecialty the manufacturers recommendation for QC frequency and some information regarding microbiology testing let's look individually now at the cap checklist items there are five checklist items that were reviewed and approved by CMS in August of 2015 the five checklist items specifically deal with iqcp and there are two iqcp related forms the first one is that laboratories must now have and maintain an iqcp list so the laboratory has identified all the tests that they have implemented in iqcp plan and completed the cap forms the laboratories using individualized quality control plans this is very similar to the laboratory developed tests list that all laboratories must now have and maintain as well checklist item sir form one is the list of iqcp this is the list of individualized quality control plans and so you can see that they the cap is asking for three specific things they're asking for the laboratory section or department that the iqcp a lives the test instrument and device this includes the name of the instrument the manufacturer and the model and then the tests are specific analytes that are included in this iqcp so for instance for a blood gas analyzer one instrument may actually have multiple analytes that are impacted by iqcp and these can be found on caps website on a lab solution suite accreditation forms and instructions the second thing is an iqcp summary form and so this is very similar to the form provided by CMS but cap has customized it a little bit for the two for the inspection process and so you can see it has the instrument device including the name and manufacturer and model the test effected the number of devices in use at that CLIA site and the number of test sites if there are more than one sites at a particular CLIA number and then you may recognize the five areas that were required in the risk assessment and so the bottom has you list all of the processes that you've identified as being risks during your risk assessment and these deal with reagents environment specimen test system testing personnel and they've included an other category as well so checklist item number two actually details a little bit more about the risk assessment so it first says that the iqcp for a test device an instrument includes a risk assessment to evaluate the potential sources of error to include all of the following and I've highlighted three things that are actually additional items relative to what is listed in the CMS document the first thing is the intended medical use of the test system and impact if inaccurate results are reported or clinical risk and so if you remember when we talked about classifying risks as low medium or high this is where cap wants you to actually evaluate the clinical risk and this is not detailed in the CMS regulations for iqcp the other thing that is unique to cap is the data from the laboratories own environment instrument equipment performance and testing personnel must be used in the risk assessment so they are really stressing that laboratories use their own data to go back and look at historical data to evaluate these risks and then the final thing is that the manufacturer's instructions and recommendations are actually included in the risk assessment so if the manufacturer lists a specific item that can greatly impact the analytical performance of a test system you need to really look at that in your risk assessment and make sure that that is addressed in your quality control plan so the third new cap checklist item for i4ii QC B is the quality control plan approval so in addition to writing a quality control plan the iqcp has to be approved by the laboratory director prior to implementation and it's important to note that this is not it cannot be delegated to a designate it has to be approved by the laboratory director so checklist item number four the elements of the quality control plan so many of these mimic what is outlined in the CMS guidelines for the quality control plan so you must monitor aspects based on the risk assessment that detailed the number and the type of QC and the frequency of the quality control that you're going to use the criteria for it's acceptable performance how are you're going to monitor the test and environment and the reagents the specimen quality instrument calibration training a competency but the one thing that is actually unique to the cap checklist item is that they want a provision for dealing with multiple identical devices or variations used under one iqcp so you can't just monitor a single blood gas analyzer if you have 11 in your respiratory therapy department so you have to have a system that actually evaluates these multiple identical devices the other item that is of note is that external material control material must be analyzed at least every 31 days and with new Lots and shipments of reagents or more frequently if indicated in the manufacturer's instructions so even if the manufacturer does not suggest that you need to run QC every 31 days cap is outlined that external control material must be analyzed every 31 days and so it's important again to make sure that you've addressed multiple identical devices so we'll talk about that a little bit more and the nuances there so there's a couple of different scenarios let's say you have the same instrument at the same CLIA site under the under the same CLIA site at multiple locations you can have one iqcp per test system or CLIA site but the quality control plan must monitor all in at your Clea site you can have the same instrument at multiple Clea sites within a health care system in this case multiple IQ CPS are needed for each Clea site portions of the risk assessment may be shared but each laboratories individual data must be used and each CLIA director must sign their respective I can see a plan let's say you have multiple analytes on a single instrument one iqcp per test system the risk assessment must address the test system and each individually and they let's say you have the same analyte on multiple instruments in this case you would need a separate iqcp for each test system or instrument that is a unique manufacturer model so the new checklist item number five relates to the quality assessment the majority of the things outlined in the cap checklist are actually mirrors of what CMS says the one thing that I want to point out here is that cap has added that reappraisal of the quality control plan by the laboratory director or designate is done at least annually so this is not included in the CMS guidelines for iqcp but it is included in the CA P guidelines so just to compare and contrast what CMS has mandated about iqcp versus what cap is added for the risk assessment CMS and CLIA said you must look at the specimen the test system the reagent environment and personnel cap has added that you need to evaluate the clinical risk you need to include your laboratory data and you need to also make sure you've looked at the manufacturer's instructions for the quality control plan CMS and CLIA has said you must explicitly define the number the type the Freak see an acceptable criteria for you for your QC and cap is at it that you need to make sure you have provisions from multiple devices on one iqcp plan for the quality assessment CMS has simply said that you need to review the QC data that you have set forth in your Houston plan and Kappas added that you need to reappear QC plan annually by the laboratory director or designee and you need a list of all i q CP tests at a specific CLIA site and so the things listed on the right-hand column again are just additional cap components that are not included in the CMS regulations so how do we put it all together just to recap we begin with a risk assessment and we want to look at our three analytical analytical and post analytical phases we do that by looking at five different areas including the specimen type the operator the reagents the environment and the test system your gonna identify some risks from that risk assessment and you're gonna draw from your historical data and analyte and location specific risks for your CLIA or laboratory site and then you're gonna take the risk that you've identified and you're gonna find a way to control those particular risks so let's say we've identified fifteen risks we might be able to control or identify those risks with five types of quality control and those are going to be put together into a quality control plan so what's and now moving from the quality control plan to the quality assessment we have our five controls and for the quality assessment for cap they want to make sure that you review the quality control and instrument equipment and maintenance and function data they want you to evaluate pre analytic analytic and post analytic errors and they also want to make sure that you evaluate complaints from clinicians and other health care providers related to the testing you want to make sure that this data is reviewed monthly that you have some corrective action if you find deviation and that the quality control plan is reappeared annually by the director so what are the benefits of iqcp well is there a financial incentive you could make an argument that there's actually a large cost avoidance by doing an IQ CP if you were to predict your annual QC cost of running two levels of external control every day of patient testing versus the predicted annual cost of just running controls per month on your number of instruments you could actually calculate a cost avoidance number and that really is something you can take to your administration and say by performing an IQ CP I've actually saved money or avoided cost for the laboratory the second thing is it provides evidence-based quality assurance by looking at your historical data you're actually taking a step back and looking at what are the risks specific to your lab and your test system and do you have a quality plan in place that effectively identifies those risks so in conclusion we've talked about how we take the risk assessment to identify what can go wrong design a quality control plan as a way to prevent or detect errors use that quality control plan to then do a quality assessment to see is the quality control plan working so iqcp it gives labs flexibility to design their QC programs and iqcp is voluntary the goal is really to monitor the total testing process and it should provide a continuous cycle of risk assessment measurement and review and with that I believe we will take some questions Thank You dr. Stephen cotton for that informative presentation it's time for Q&A they do have a question you'd like to ask dr. cotton please do so now just click on the green Q&A button at the lower left of the presentation window type the question into the box that appears on your screen and click send will answer as many questions that we have time for now let's get started dr. cotton our first question is what documentation needs to be signed at the night qcp changes that's great so I think ing to great question so ing to cap if you make a change to the iqcp plan itself the plan does need to be resized but you don't have to go back and resize the risk assessment next question has anything changed since I see iqcp was implemented well 18 ever be subject to iqcp so I just very recently cap has released an updated checklist and I did see a couple of changes the first one was related to commercial media through microbiology I believe now is exempt I'm having to do an IQ CP the second one relates to fish as I mentioned about subspecialty classification and I believe that cap is actually revised their stance on whether or not fish testing actually needs an IQ CP and so I would encourage you to look at your if you are cap accredited laboratory so look at your revised checklist and I believe that both fish and microbiology media have been removed from or now exempt from having to do dr. cotton and how do you address multiple instruments multiple locations in an efficient IQ seeking creo yeah that's that's great question as well so at our institution we certainly have labs that are spread out over multiple sites we have a very large respiratory therapy department and we also have testing that's performed at different CLIA sites and so what we have found most efficient is actually having one site do the majority of the risk assessment and then share that with the other sites and then the other sites will then take the risk assessment and then insert their own historical data as well as location specific risk to really create an individualized risk assessment and we really feel like that by having each site look at their own historical data it is actually a really good way to to catch to develop a very smart quality control plan that really does a good job at catching errors it is certainly a little more work but it is you do avoid reinventing the wheel completely because if one site kind of takes the lead to design the risk assessment to sort of take a deep dive into that particular test system and then the other sites can then go back and say okay well I didn't really think about that but let me add on my specific location risks or mine specific issues related to testing at my site it does actually save save you some some time certainly and we found that for IQ CPS that we have very similar testing across the healthcare system the majority of the time the quality control plans are actually very similar so we are able to sort of take this a single design individualize its some for the risk assessment but then the quality control plan tends to be the same they have great questions coming in but we're almost out of time this will have to be our last doctor cotton what is required as part of the annual evaluation or iqcp sure sure so as I mentioned before that the laboratory director does have to resign the quality control plan annually it's also really important if you do make a change as the first question hinted at that you do reevaluate your your quality control plan and obviously if you do change test systems within that particular year whether you're swapping out kits from a different vendor then you would actually need to do redo the risk assessment if you're actually changing vendor platform or a manufacturer I would like to once again thank dr. Stephen cotton where's presentation dr. cotton do you have any final comments for our audience I would just say that iqcp once you've got one under your belts it's really not that scary as long as you sit down with everyone and maybe work through a template that that that can be adopted by your lab iqcp should be a friend thank you once again dr. cotton before we go and let's let everyone know that today's webcast will be available for on-demand viewing in February 2017 you will receive an email from lab roots letting you know when they're split cows will be available for replay please share that announcement with your colleagues who may have missed today's live event that's all for now we thank you for joining us and hope to see you again soon goodbye