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welcome this is lighthouse lab services.my name is John Harrell I'm the.president of lighthouse cloud services.and I have Tara Llewellyn our manager of.our laboratory director program here.with me and today we're going to go.through how to fill out a CLIA.application a CMS 1/16 form we're going.to focus today on filling this out as a.new application so if you're starting a.new medical laboratory that's going to.be doing diagnostic testing you will.need a CLIA certificate and we're going.to walk through how to fill that out.this form is also used beyond being an.initial application for changes to your.tests menu or certificate type or change.to your lab director would also be using.this form so on section 1 we are going.to focus on what is required when you.submit your application you're going to.need to put in your facility name you're.going to need to put in an email address.and a tax ID number your federal tax ID.number it's going to need to match the.facility name that you use so try to.stay away from using DBAs and use the.actual name of the company as it's.listed with the federal tax ID number.email address and phone number are also.required and the location that's listed.here needs to be the location that the.laboratory will be present at they could.and sometimes do especially if you're.applying for Medicare do a brick and.mortar check to make sure that this is a.legitimate brick and mortar location and.they'll often look for a sign so the.sign should match the facility name that.you list ideally so you that's the.information you're going to fill out in.section 1 you will also need to supply.the name of your laboratory director at.this point and terror can tell you a.little bit about the credentials.required for that so on section 1 of.this form you will need to list your lab.directors first and last legal names as.well as their middle initial as well as.their credentials and depending on the.level of complexity of the testing that.you are applying to do in half your lab.director will need a different level of.education.or experience for moderate complexity.labs your lab director is going to need.at least a bachelor's degree and a few.years of experience and the testing that.you do as well some training for high.complexity labs you need a.board-certified doctoral level director.and you will need to supply all of these.credentials attached to your CMS 1/16.form when you submit that to CLIA to.verify that the lab director is properly.credentialed and of course if you have.questions about your lab director if.they're qualified and/or if you need.that worker services you can certainly.contact us that lighthouse to assist.with it.yes thanks Sarah one other thing to note.is it is going to ask for your CLIA.number here you will not have one as.this is your initial application that's.going to be issued to you based on.approval of this form but if you are.making a change you would include your.CLE application number identification.number there section two is where you're.going to select the type of application.that you're requesting a certificate of.waiver is used for FDA approved CLIA.waived testing so you're going to need.to know what your test menu is that's.for a very simple test typically.point-of-care test a pregnancy rapid.traffic leaf all it to that certificate.of waiver category the certificate of.provider perform microscopy is for a.physician or an MD that is looking to.use a microscope in their office.certificate of compliance is if you're.applying directly to your local CLIA.office for oversight and a certificate.of accreditation is if you would like to.apply and be inspected by a deemed.agency of CMS and agencies that are.allowed are listed here which would be.the Joint Commission cap a Oh a cola a a.BB a Shi and a to LA we have the most.experienced used in cap in Cola cap we.would recommend not for an initial.application but maybe for a laboratory.that's been around for a little while.the requirements for that.are pretty intense and usually do not.make sense for a new lab I'm just.starting up and it's going to be hard to.satisfy the requirements so you might.want to upgrade to cap at some point.down the road Cola is a great idea we.often put many of our labs through Cola.and Cola is a little bit more.consultative in their approach to.helping a lab get started and make sure.that they're doing their testing.appropriately and they're a little bit.more likely to answer a question that.you might have there's going to be.things that are up to your.interpretation on regulations from the.CMS guidelines and Cola will give you.some guidance on that whereas if you're.dealing with your local CMS office we.found that they will typically just read.you a regulation but not interpret it.and I think that they haven't given.authority to the local branch.representatives to interpret for.intentional reasons and so we recommend.going with Cola will cost you a little.bit more but not a not a big number a.few hundred dollars a year on average.section three is the type of laboratory.pretty self-explanatory so you're going.to find the type of organization that.you are in check the appropriate box.most common for us is dealing with.either hospital CLIA.which is number fourteen independent.labs would be the most common and that.would be a typical for-profit laboratory.and that's section number 15 and then.physician office lab and practitioner.other are both often used if you're.looking to do an in-house lab inside of.a clinic or behavioral health center you.would select options 21 or 22 when.you're trying to determine as a.physician if you're looking to own a.laboratory your choices are typically.between numbers 15 and 21 and there are.some ramifications to what you choose.here and some losses and so as a.physician if you choose to own an.independent laboratory you cannot send.your own patient samples to that.laboratory or else that would be.considered an inducement and as pretty.serious consequences so you want to be.aware of that if you are a physician.office laboratory that is to serve your.patience and you would not say hire a.Salesforce or take samples from other.groups there are times when you all.allowed to accept samples from other.physicians but you cannot provide them.any renewal in' and you know disclaimer.that we're not lawyers but we're just.given kind of our guidance on what we.know from doing this for the last 16.years and filling out this form quite a.bit but we'd be happy to answer any.questions you might have about that and.are available to fill out this form for.you we do this for free for any of our.laboratory director clients we provide.the medical laboratory director of.record to over 150 labs around the.country and I would be happy to help you.with that and fill this form out at no.cost if we're providing that lab.director and we can typically do that in.one to two business days but that's the.section 3 let us know if you have any.questions you'll see our name and number.at the bottom of the of this screen.there.Tara can you tell us a little bit more.about section 4 yes for section 4 you.want to list the hours of laboratory.testing that is happening in the lab.these are the times that your lab is.going to be running testing in-house you.want to be sure to be very specific.about the days and times that you are.planning to be open to run specimens.there is a box there to check if you.will be running specimens 24 hours a day.7 days a week otherwise you're going to.fill out each day Sundays Saturday and.each time the time that you'll start.testing and time you're in testing each.day it could be different each day.depending on when your staff is there to.run specimens but you do want to be very.specific here because any time that you.listed as being open and operational in.this section you could receive a.surprise visit by the CLIA office CLIA.inspector in our representative and so.you want to make sure that there is.someone on site during those times just.in case there would be any unexpected.drop in or for scheduling your.inspections moving forward additionally.if you offer I'm sorry additionally if.you are.a shared office lab or you are sharing.your laboratory testing space with.another lab that has a separate CLIA.license typically those operate on.separate days and you just want to make.sure that again you're not overlapping.on the times there if you do happen to.be in a shared laboratory space if you.have questions about this we'd be happy.to answer those as well yeah that's a.great point thanks Tara section 5 it's.pretty much going to always be a no we.filled out this form you know greater.than 50 times and I think there's only.been one time that we were not an O on.section 5 and that was for a long-term.care lab that was going to be providing.multiple CLIA waived locations in the.long term care center so they could put.a centrifuge to spin blood before they.took the samples home and do some.point-of-care testing out in the field.and so for the most part you're going to.be an O here if you do fall into that.both the instructions are pretty simple.and there's a list of exemptions that.you can need one two or three and then.you need to list the addresses of every.location where that testing is performed.if you have more than will fit on this.page you can attach an addendum there.section six is for waive testing waive.testing like we said is very simple.typically point-of-care testing and.you're going to list the type of testing.and the device that you're going to use.for that box there section 7 is 4 ppm.that provided for for microscopy and.that's for physicians that are going to.use microscope in their clinic to do.some testing you will need to indicate.your estimated test volume at this time.on that that is an estimate section 8 is.for an on wave testing so this is where.most people will fall if you're not a.wave lab you're going to be either.moderate or high complexity lab you can.determine whether you're moderate or.high based on the testing type that.you're doing as well as the platform of.the instrumentation and equipment that.you're using so if you're using a.fda-approved instrument and you're.is considered an IV D in vitro.diagnostic they're going to be moderate.complexity in the qualifications of your.laboratory director as well as your.testing personnel will reflect that we.do have a map of all 50 states at.Lighthouse lab services comm that you.can click on that will show you the.staffing requirements for both moderate.and high complexity for each state note.that there are some states that do not.recognize moderate complexity testing so.even if you're testing type is an IV D.is FDA approved and would be considered.moderate if your state doesn't recognize.it you probably fall into the high.complexity category which means you're.going to trigger the requirements for.staffing for high complexity and need a.high complexity lab director testing.personnel etc I'm happy to help with.questions about that because it does get.tricky but assuming that nothing is.outside the ordinary this is where you.would fill in your testing type as well.as the instruments that you're going to.use to do that testing would be done.here again you can attach a separate.page if it gets wrong and you need to.you also going to need to check your.subspecialty type.fairly self-explanatory but not really.for some areas Mike Rosario alekhya ler.is the fastest-growing area that we.experienced for lab testing and it.doesn't have a category it'll normally.fall underneath microbiology however it.could also fall under clinical genetics.at times so you're going to select.whatever is appropriate but besides that.you should be able to figure out your.testing type based on taste on the boxes.that are provided here for you to check.you will also need to provide an.estimate of total test volume at this.time my guidance on this is to estimate.low the way that it works for your CLIA.fee is going to be based on your total.test volume you're probably going to see.a fee somewhere in the 1,500 to 2,500.dollar range if you're using certificate.or accreditation.you'll be paying a fee to the.accrediting body as well like I said on.total will be a little bit higher but.you do get some benefits as a result of.that but this is where you put that.estimated test volume.they're going to verify that when they.do their inspection they're going to do.an initial inspection at six months six.to nine months on average and then.you're going to be inspected every two.years after that and based on your.actual test volume is what you'll pay to.a point if you estimate a number here.and you end up doing less tests than.that you're not going to get any kind of.refund however if you do estimate on the.low side and you end up doing more.testing you'll just pay for the.difference that's why we would counsel.you to shoot a little bit low this is.not the time to be real optimistic.section nine type of control.I think it's self-explanatory most.groups who work with fall into the.for-profit category but if you're a.non-profit hospital or other non-profit.you'd fall into that voluntary nonprofit.section government agency they're also.listed here as well and then Tara why.don't you tell us a little bit about our.section ten yes section ten you're going.to need to list your directors other.affiliations with labs so if the.director that you have hired is also.serving as a CLIA laboratory director.for any other CLIA licensed facilities.whether that be moderate or high.complexity you're going to need to list.those affiliations in this section you.will need to include the CLIA number in.the name of each laboratory and there.are several boxes there for you to do so.if you work with us here at Lighthouse.to receive lab director services that's.something that we'll provide and can.work with you to get that from the.laboratory director if not you know you.just talk to your laboratory director.make sure you understand all of his or.her other affiliations and you include.those on this page CLIA here is trying.to determine and ensure that your.laboratory director is not overseeing.more than five laboratories as that is.the federal maximum allowed for lab.directors to oversee some states have.allowed fewer lab directorships per.director than that but that's the.general guideline here and then finally.at the bottom you are going to print the.name of the owner and the director of.the lab and then it.one signature either of the owner or the.lab director I would encourage you here.to have your lab director sign this form.it will be acceptable for any of the.ownership group to sign here instead.however we are seeing local CLIA offices.request that if the owner of the lab in.lieu of the lab director signing the CMS.at 1:16 form here they will ask that the.lab director sign wedding signature a.letter or statement stating that they.are indeed agreeing to work with the.laboratory in this capacity and and this.is to ensure that the lab director is on.board is signing up and is willing to.work with the lab in this capacity we've.seen in the past where some labs have.put forth a lab director and actually.blood director has no knowledge of that.so sometimes it's easy to obtain those.credentials and go ahead and apply and.previously with the owners being able to.simply sign by themselves you know we.were seeing that happen and so now the.CLIA offices are are insuring and.double-checking that laboratory.directors are on board before approving.the application so the best thing to do.here to avoid that additional.corroboration needed by the CLIA office.is just to have your laboratory director.sign in wedding before you submit to.application great point thanks Tara so.that's that's the basics of it when you.do send this in you're going to need to.send it along with your laboratory.directors resume as well as a copy of.their board certification but do not.send in any payment with it at this time.they're going to let you know what you.owe.once they process your application.they're also not allowed to start.testing until you receive approval from.the CLIA office so you can send off this.application you're probably going to.wait 30 to 45 days on average depending.on the local office that you submit to.some of them take longer some are.quicker you also are allowed to in most.states so there are California is one.that you're not but in most states.you're allowed to go ahead and start.with.the validation ahead you could send this.application and prior to your validation.right so you can go ahead and send this.in get your equipment get the supplies.you need and start validating so you are.running tests but those are not.diagnostic tests on human samples right.so you cannot run anything diagnostic.and report it out until you have been.approved of your your application has.been approved that rule for California.and New Jersey is a little bit different.where they want you to go ahead and do.your validation and include your.validation study along with your.application and so that's the basics of.it hopefully you guys found that helpful.we do have more information on our.website lighthouse lab services com.we do have blogs and articles there we.have an article that's going to be.posted about the how-to on filling this.out which will have pictures and more of.a written description so if you want to.reference that I hope that's helpful and.thank you let us know if we can help our.phone number 1-800 eight three eight oh.six oh two and our email address is on.the bottom of the screen there if you.have a question and give us a call we.can help with this as well as we're.validating and setting up your.laboratory supplying you as scientists.applying you as a lab director and.anything else that you might need thanks.and have a great day.

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Form Cms 20027 FAQs

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Do military members have to pay any fee for leave or fiancee forms?

First off there are no fees for leaves or requests for leave in any branch of the United States military. Second there is no such thing as a fiancée form in the U.S. military. There is however a form for applying for a fiancée visa (K-1 Visa)that is available from the Immigration and Customs Service (Fiancé(e) Visas ) which would be processed by the U.S. State Department at a U.S. Consulate or Embassy overseas. However these fiancée visas are for foreigners wishing to enter the United States for the purpose of marriage and are valid for 90 days. They have nothing to do with the military and are Continue Reading

How can I fill out Google's intern host matching form to optimize my chances of receiving a match?

I was selected for a summer internship 2016. I tried to be very open while filling the preference form: I choose many products as my favorite products and I said I'm open about the team I want to join. I even was very open in the location and start date to get host matching interviews (I negotiated the start date in the interview until both me and my host were happy.) You could ask your recruiter to review your form (there are very cool and could help you a lot since they have a bigger experience). Do a search on the potential team. Before the interviews, try to find smart question that you are Continue Reading

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Just register on the admission portal and during registration you will get an option for the entrance based course. Just register there. There is no separate form for DU CIC.

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It can also be that he used the wrong form and will still be deducting taxes as he should be. Using the wrong form and doing the right thing isnt exactly a federal offense

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