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- [Sierra] Hello, everyone. Welcome to today's phlebotomy webinar on Standard Operating Procedures, the Five Ws, and the How. This is Sierra Tollefson, an education specialist for Mayo Clinic Laboratories. Our presenter today is Michele Legried, a quality specialist in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota. Just a couple of things to remind everyone of before we begin today, there will be a question-and-answer session at the end of the program. You can submit questions online via the Q&A icon in Zoom. Please only use the chat function for any technical issues. Today's program is being recorded, and will be posted to our website in a few weeks. And now I will turn things over to our presenter. - [Michele] Thank you, Sierra. And welcome, everyone. First off, I'd like to just, I have no relevant financial relationships, so there's no financial disclosures that I have to provide. So the learning objective for today is, it has to do with procedures, how to write them, what they are, how to define them, how to review them, and items such as those. So upon completion of this webinar, each of you should be able to describe what a standard operating procedure is, why SOPs are necessary and needed in any practice, who should write and review SOPs, as well as when should SOPs be reviewed, how to write an SOP using best practices, and then where SOPs should be maintained. So let's start with the what, what is a standard operating procedure? Well, as I did research for this webinar, I found many, many different definitions as well as taking from my own experiences writing procedures for the past many, many years. So here's how I have defined this based on everything that I've read and my experience. An SOP is a procedure that defines a step-by-step process specific to your operation or your work unit or processes within your areas that allows staff to perform routine and complex activities and/or tasks the exact same way every single time. They are also action-orientated and instructional, so what that means is is they tell you what to do as well as how to do it and the steps in which to do it, which is very important, especially when you are looking to provide best patient care practices. It also provides the people and resources needed to complete those activities. Who's responsible to do that procedure? Is it a phlebotomist? Is it a vascular access tech? Is it a supervisor? Is it... If you have multiple work units that you oversee, which work units would use this? Is it an inpatient setting? Is it an outpatient setting? Does it cross both areas of phlebotomy? It also provides links to other procedures and/or resources that they may be using or referencing within that procedure. It's the order in which the steps need to be completed, and this one really is key, Procedures should provide the ability to be used in training and orientation. When you're training new staff that are coming in, your procedure, if it's effective and written properly, can be used as the training tool, so each and every trainee receives the same information, and they can be consistent when performing collections and other tasks. Standard operating procedures provide the instructions for policies, work unit instructions, and guidelines needed for best patient care practices. What procedures are not is policies and guidelines. Policies and guidelines have their own rules associated with them and their own means in which they're to be used. A policy is really a simple document that provides details and/or business rules on how things are done in your work unit, in your organization, in your facility to achieve compliance and make decisions. It really is your facility's or organization's action plan. It tells the howtos on what you are doing and what you wish to do in the future, as well as it helps to shape the company culture and employee behaviors by listing what is allowed and what is prohibited. So as you can see, a policy is not a step-by-step instructional document. Guidelines are just basically general recommendations that are used to instruct employees through a process or a task, but here's the caveat for that, guidelines do not use a specific order, they're not set to a specific order, they're not step one, step two, step three, they really are just a guide, and they advise on what should be done in certain circumstances as well as how to troubleshoot a situation. So they may have more information other than just step-by-step instructions. So policies, if you think about it this way, policies are the guidelines under which procedures are developed. Policies are not part of the procedure because they cannot be properly structured, and they cannot be structured because it really is the action plan of the work unit. And then the procedure should or must reflect the business rules contained in the policies, so, for example, if a policy says, "Phlebotomy staff perform venipuncture collections based on a set standard to ensure best patient care practices," your procedure should be written to address that statement, and it should share, this is how we do it, step one, scan the patient wristband, step two, perform patient identification, step three, assess the vein, step four, et cetera, et cetera, et cetera. And that's where you step it out and you explain the venipuncture collection process that fits with the policy statement that this is what phlebotomists do. Also, policies and guidelines can be linked in your procedures so that they're easily accessible and easy to reference, and then you can always get back to that procedure as you continue through the process. So it's a little easier to look at it this way, policy versus procedure, the difference between these two really is, your policy has more focus on what you should not do, and your procedures have more focus on what you should do. Those can be considered guidelines, but when working together, they become a procedure based off of a policy. And procedures can be limited to a specific task or activity, whereas the scope of a policy is usually facility wide, and covers the the entire area. So the policy does in fact requires your facility to take a stand or make decisions on how to approach a specific problem that's occurring in the work unit, whereas the procedure requires the organizations to agree on how to perform a task for the best results. So, again, the policy says, "Here's what we do, and here's what we don't do." The procedure says, "Here's how we do what we say we do." So why is all of this important? Well, there's a multitude of reasons why procedures are important, but here's some of them that I feel really show just cause for procedures, and that is, procedures ensure consistent care, the same care for each patient every time, it shows quality care. If you have a procedure in place that steps out the requirements for that collection type or for performing a specific task, you can ensure that the care that you're providing also is based around quality. Procedures and activities, or activities, if there's a procedure, are also easily modified and updated. You can go in and you can make changes to those procedures based on information you've received from other individuals, from phlebotomists, from leadership, from whomever, and they're easily trainable. You have to be able to train to a procedure. It also ensures compliance with our regulatory agencies, provincial laws, and healthcare standards such as CAP, which is the College of American Pathologists, JCAHO, which is a joint commission, NYSDH is the New York State Department of Health. And I'm sure some of your areas have worked with these groups, you may not work with all of them, but these are all just some of those, also state and local laws, as well as benchmarks from other facilities and expectations that are set by your facility. So if you've got a set of expectations that you want to meet, you have to determine how you're going to meet those, so, therefore, you have to write a policy on how you're going to meet those, and then you have to write the procedures so that your staff can contribute and ensure that you're meeting your expectations. What are the benefits? All too often, I have heard techs say, "Well, I don't know if that's the right way," or, "Is that the wrong way?" Well, it depends, or the best one I hear is, "We're going to do it this way, except when this happens or when this happens or when this happens," that creates a multitude of confusion for staff, the potential for errors is significantly high. So it's always best to figure out what the benefits of procedures are, and then think about how you can write a procedure that's going to address those benefits as well as the potential errors that could occur. So the benefits of procedures are, it's a reduction of errors, it's increased efficiencies and profitability, it's a safer working environment for your staff, which is always key, established guide for resolutions of issues, it ensures the processes are completed accurately, even with interruptions. All too often, technicians can be in with a patient, and a nurse comes in or a doctor comes in, and they're asking questions, and they're talking to the patient, and the phlebotomist becomes distracted or loses their train of thought. The procedures help them get back to where they were and to continue moving forward, which reduces the error rate and also keeps them on track to complete that efficiently and effectively. Consistency and accuracy across the department, which means that all of your staff are doing the exact same things, which they should be doing, and they're following the procedures so that everything works in tandem. And then anyone can complete the task or collection correctly every single time, that's always important because it is best patient care practices. So when do you need procedures? Well, not everything needs a procedure, and that's something that we have to remember. All too often, procedures get written because there was an error made by one person or to address something that maybe was considered a severe issue, but it only happened one time, those sort of things. So when should you write a procedure? There should be a reason to create them. Isolated events and/or incidents or situations are not reason enough. So as I said, for example, let's say a phlebotomist made an error when they did a collection, and it was a reported incident, and leadership and your lab directors all got involved, and there's, and they're like, "Well, we need to write a procedure on this." Actually, no, you don't. It's one incident caused by one person over the course of multiple months or even years. This is a training issue, and this needs to be addressed with this one individual trainee. Now, if it has happened multiple times, then that's a different story, then that changes the outlook. Also, when should you write a procedure? Well, if the issue is important or there's a significant benefit. So really it's, if there's a reason to create one, make sure that reason is a good reason, and make sure that there's a significant benefit for it, and it's not just to have another procedure. Sometimes we can become inundated with procedures, and then staff don't use them, we don't know what's out there. it just, it becomes very cluttered and messy. So here are some reasons why procedures may be needed. If a process is very lengthy or complex and it has many steps, then I would say a procedure would be needed because then you would need the instructions to tell you step-by-step how to get through it. Also, if people are confused by a process, if you've got multiple staff that are saying, "I don't understand how this works," "I don't know what to do with this," "I don't know how to do this," then maybe that's the time when you should have a procedure. Also, if similar questions are being asked by many, if you've got staff that are continually asking the same questions over and over and over again, then a procedure would be needed because it'll be a significant benefit, all the staff would be on the same page, and they would know how to perform this step, and in which order within the process they should perform that. Also, if it requires consistency and needs to be done the same way every time, then you should have a procedure in place to address that. If documentation is needed or there are significant changes, so if you have like a work unit document or guideline, but there needs to be better documentation, then you would need to write a procedure. Is there serious consequences if it's done wrong, if there is a serious consequence that could occur from the process that's being completed, but there's no procedure, that increases the risk of a serious consequence, thereby, a procedure should be created to reduce that risk of serious consequence because then it would be completed right every single time. If there are too many ways in which to interpret the process, then you should have a procedure, as well as if the organization or your facility needs to meet the accreditation and regulatory compliance, then you'll need procedures. So the how, how do we do this? Well, procedures that are well-written and effective are solid, precise, and factual, they're also short and to the point. I know that sounds crazy, but realistically, a procedure is a recipe. If you were going to bake Grandma's cake, you'd get out the recipe, and it says, "Use this item, this item, this item," et cetera. And then the directions say, "Step one, mix these three items together. Step two, stir until smooth," and it walks you all the way through until it says, "Take it out of the oven and eat it." And then you've got Grandma's cake. That's what a procedure should be like. A procedure should be written like a good recipe, easy to follow, precise and factual, and short to the point. It's also important to think about your preferences versus your knacks. Now, these are two terms that we use here at Mayo in regards to processes and procedures. You may use different terms, but what they mean here for us is a preference when looking at a procedure is the actual steps within the procedure that need to be completed within that collection process. So basically, if a preference is in a procedure, then that step needs to be followed. So, for example, in our procedures for venipuncture and our line collection procedures, it says, "Scan the patient ID band, perform patient ID, and access the patient." So that's a preference. So that says we have to do it in that order, the way that it's written. A knack on the other hand is a specific way in which one individual completes the task by following the procedure. So, for example, when doing a patient collection, where to place the cap of the needle. When I was doing direct patient care, and I would go into the patient's room to perform a collection, when I would take the cap off the needle, I would put it in my pocket of my scrubs so that I didn't leave it accidentally lay on the bed when the patient rolled on, and potentially get a skin tear or get bruised or things like that. That's a knack, that's my knack, that's what I've shown to other techs I was training. But that's not stating you have to do that. So how this relates to inspections, well, if it's written in an SOP, CAP, and other regulatory agencies, expect the process to be completed as written. So, for example, as I said, that knack was placing the needle into my pockets. If I wrote that into a procedure and said, "Place the needle cap into the pocket of your scrubs," every single tech would need to do that in the order in which it was written in the procedure. If they didn't, the accreditation agencies and/or the inspectors who come on-site could say, "You are not following your procedure." So it's very important when you're writing these, to only put the actual steps into the procedure that you want staff to follow. And everything else that surrounds that collection process can be training suggestions for your trainees, and it can be shared in ways of, "This is how I do this, I'm showing you only as another option, you can adopt it or take pieces of it as you create and build your own process for doing this procedure." So what should be included and/or considered when writing an SOP? Well, first, a scope. Who is the audience? And which areas is this going to cover? So, for example, at Mayo in Laboratory Services, we have several outpatient areas as well as the inpatient area. So the outpatient collection areas are different buildings, so they have different names, so that would be the areas. So in your scope, you would define which areas specifically would be utilizing the procedure. And then the purpose, what is this procedure for? What's it meant to accomplish? Authors, you have to think about who should be involved in the writing of this procedure, and then what sort of format should you use? Are you just, do you have templates available through your organization that you use? Are you creating your own templates? Are they standard across the board for each type of document, whether it's a form or it's a guideline, or it's a training document or a procedure? Are they standard across the board? Do you know which ones you should be using? And then once you've got that procedure created, you should, you need to test and adjust it, and that's where it requires staff involvement. Get it out to the staff, get it out to the individuals that are using this procedure, and let them try it, and make sure that it works in the instructional steps that are listed. If it doesn't, get their feedback, have them become part of the build stage. And then once you've got it finalized and it's working, distribute it in training, training so that all the staff within your area know this new procedure is there, how to use it, where to locate it, as well as how to perform that new process, and then review and update it as needed. And the diagram, or the little picture you see is just kind of the steps in which we just talked about how to build the procedure. So a question just came through. Would it be considered as out of compliance, not following SOP, if QCs are being voluntarily performed more frequent than what is written in the SOP? For example, SOP for a wave test specifies QCs are done monthly, but we now decided to do it weekly. In answer to your question, no, it would not be considered outside of the SOP because you are following the SOP. You are hitting it monthly. It is your choice as an organization or a facility. If you wish to do it more frequently, you most certainly can and still remain in compliance with your procedure as it is written. However, when that procedure becomes due for review, I would make that change if that's going to be the new practice moving forward. So let's look at some examples. So as you can see by looking at the PowerPoint, I have a venipuncture collection for outpatient and a venipuncture collection for inpatient. Please note that these are just some small examples of what we were just discussing. So if you look at the venipuncture collection by outpatient, it's written in steps 1, 2, 3, 4, but as you go through it, it's very lengthy. So, for example, if you look at step number three, identify patient ing to outpatient, and HCL refers to collection/specimen retrieval process flows. Some of the information contained within here is actually training information. So where it says, "Apply tourniquet, place the gauze roll in patient's hand, and ask patient to gently hold the gauze, but please do not squeeze it." You could actually say, "Apply the tourniquet, and then, you know, assess for a vein," you know, those sort of things. All the other information that's in here truly is training. You wanna train your staff to do these other items so that you can focus solely on the collection process. So if you look at the, again, at the outpatient one, you can see there's also a scope and all the different areas that this one includes, all the different outpatient areas, 'cause it's specific to outpatient. It also has a purpose, the purpose of this procedure is to collect venous blood from a peripheral site for laboratory testing, that's what they do, that's what the outpatient area does. Now, if you look at the inpatient setting, as you can see, there's two locations listed in the scope, which are specific to the Inpatient Laboratory Services Department or the phlebotomy collection areas. Their purpose is significantly, has more information contained within it because it's specific to multiple different areas within the inpatient setting. So, for example, the purpose of this procedure is to provide instructions on collecting a peripheral venous blood sample by Inpatient Lab Services, Mayo Clinic Hospital on the Rochester and St. Marys campus and/or pediatric patients at Charlton Desk LA or Mary Bride Desk MC. Now, those two are mentioned even though they're outpatient collection areas, but inpatients collects in those areas because they have the trained staff on-site in the hospital settings where these are located. And then it goes to outlining the procedure. And in the inpatient, it's in a table format, It's got a step, it's got an action, and then it provides any SOPs or images that are relevant to that step. So the first step here would be blood scan, identify bands, and then second step, third step, fourth step. So it really does clean it up, it keeps it well contained. So if someone should become interrupted or get involved in some other conversations before they complete their process, they can easily go back and find where they were in comparison to the outpatient one. Now, you may be thinking, "Well, why are they different since it's all Laboratory Services?" Well, as I continue to move through review of the procedures, they are all slowly becoming updated to the new format of a table, because prior to me taking this role, they were written more as novels. I wanna say some of them are very, very lengthy and contain way too much information, staff don't use them, so we're working on building them better for ease of use. So here's a couple more, an order of draw and a specimen labeling. And as you can see, again, the scope is there, the purpose is there. Now, in the order of draw, instead of using numbers, it's bullets, which, that works as well, you most certainly can use bullets, provide your steps. And this really is relevant only to the order of drop, fill and dispense ing to the attachment, invert after filling, when the metal tube is collected, which method is preferred, et cetera, et cetera, et cetera. There's nothing in here that says, "Once you've inverted the tube, then place it into a block," or something like that, which would be actually placing it into a block, would be the training component. It's not required in the actual process of the order of drop. You need to do it, but not as part of the process. And then the specimen labeling, again, it's used as bullets, but it's also providing pictures within that procedure. And I will tell you that I have found over the years that staff are visual individuals, not all of them, but some of them. So you have to address those that like to read the instructions as well as those that like to read the instructions and see the visual or those that just like the visual. If you can address each one of their needs and wants, it makes for a better written procedure, a more effective procedure, and a much more used procedure by staff. So the how and the who, who should be part of the writing process? Well, think about it. Who all has a stake in this procedure? Is it your leadership team? Is it your staff, education personnel, training personnel, maybe your laboratory directors, so that you ensure that you're meeting your regulatory requirements if you're not as familiar with them, maybe your medical director? And then, of course, other subject matter experts. I mean, maybe you've got other areas than just your phlebotomy area that may reference your procedures or look at your procedures such as maybe community paramedics or nursing. And if so, you may want to get their input as well to ensure that the procedure that you're putting out developing meets the needs of all parties involved. And remember, unity is strength. When there is teamwork and collaboration, wonderful things can be achieved, and I truly believe that. I don't write the procedures myself, I can, but I don't. I do a lot of collaboration with all parties involved for the sole purpose of, I can write a procedure without any problems whatsoever, but if that procedure cannot be trained, then it's not not going to be used. Thereby, the time that I spent writing that procedure, I could have spent doing other things, because the procedure then becomes just a piece of paper. So when to review a document? Well, ing to everything that I found out on the internet from other institutions and other organizations, policies and procedures and other control documents should be reviewed between one and three years. So I can tell you Mayo's review process. So any documents that are relevant to safety or emergency procedures, PEE, and downtime are reviewed annually. So once a year they get reviewed, and they get updated as needed. And then all the other control documents that we have are reviewed every two years, unless, of course, it's brought forward that there's changes that need to be made. But as they schedule, this is how I review documents and get all the other parties involved. So the review schedule for us is based on the last publication date and then the regulatory requirements for review, because the regulatory agencies do state that there are certain procedures that must be reviewed annually, and all others must be reviewed, I believe, it's within one to three years. And then our document control system that we now use is Title21, which houses all of the documents across Mayo so that they're in one controlled environment. So why is it important to review documents? Well, you need to make sure that you are compliant with current and/or new regulatory and accreditation agency requirements. You also need to make sure that you're operating consistently and effectively. If things aren't working right with your procedures, then I would say don't wait two years to review it, I would say review it right away, and figure out where it's broken, and then fix it. Large-scale changes within the facility need, you need to make sure that those get added and changed within that procedure, as well as reported incidents or events relevant to the procedure are not caused from confusion or outdated information. If you have procedures out there that you haven't looked at in two years, but you have verbally said, "Okay, we're gonna make this change," now you have the potential of creating confusion within your staff. So it's very important, if you're going to make a change within a procedure, that you update that procedure. Now, if it's just a trial, if you're going to try something for a period of time, then I would say write an addendum to that procedure or a QRG, a quick reference guide, to state, "Here's how you're going to do this process, here's a, this is a pilot that we're trying, we want your feedback," but use this QRG to eliminate the confusion that the published procedure may cause. Give them something to follow. And then once it's been determined that this is the new way of doing things, update your procedure ingly. It's also, review also ensures that you are meeting your desired effect and the procedure is working as it is intended to. So the when and who, So who should be part of that review process? Well, again, is it your leadership team? Is it your staff? Is it your education personnel? Is it your training personnel, lab directors, medical directors, and other subject matter experts? Who needs to review this document and tell you if it's broken, if it's working, or if they have suggestions for improvement? That's really what you need to think about. Who is this going to impact? And who can provide feedback to make it better? Because after all, a good documentation trail and good content will help you down the road with unexpected liability, and that's really what we're trying to eliminate, unexpected liabilities, unexpected errors, unexpected mistakes. We wanna provide our staff with every opportunity to do the right thing each and every time they enter a patient's room. So the where, let's talk about the where, where should documents be kept and stored? Should it be file cabinets, paper versions, or an electronic environment, a digital environment? Well, again, as I did research on this, I discovered that, sort of different ways in which to do them, and I picked out what I thought was most relevant to phlebotomy and to what the phlebotomists do and what the work units do and the facilities do. So the pros about paper is paper's reliable, it's always gonna work, it's always gonna be there, it's also trustworthy to a lot of people. I mean, if you can see it, and you can feel it, it's gotta be true, right? If it's there in your hands, it's got to be true. It's also easy to read because sometimes when you scan in digital documents, they get cloudy or they get darker, and they may not be as legible. But a paper document is always easy to read. And again, some people just like paper. For me personally, I have an e-reader that I use all the time to read books, but there are times when I just wanna grab an actual paperback because I wanna feel that paper. So the electronic pros, though, are ease of access and searchability. I mean, they're right there at your fingertips. If you've got a keyword, type it in, and bam, it pops up. They're easy to share, and they're accessible. You don't have to have copies, so you're saving paper, and you don't have to distribute them to different individuals. You also don't have to make sure that once they've been shared and reviewed, that they're destroyed as they should be. Space usage, if they're electronic, you don't have to worry about storing them in file cabinets. Revisions are easier to make, as well as flexibility, you can pretty much access them from anywhere, you know, within your facility, or if you have remote access, and you've got people who work from home, they could also access them. If they're in a file cabinet, they're not quite so easy to access. So what are some of the cons when it comes to the paper? Well, storage space for one, paper files take up a whole lot of room. And depending upon the number of procedures that you have, you may need multiple filing cabinet or multiple areas in which you can store these. Also, physical damage, as you use those paper procedures, they begin to wear out, and they fade, and they get smudged, and they may tear, and they may become illegible, as well as they're easy to lose. You may have a paper document in your hand, and you may stop to talk to somebody and lay it down, and then it disappears, and it's gone, it's misplaced, or it's accidentally tossed, or it's lost. I mean, they're too easily misplaced, whereas some of the cons with electronic is there's a potential for security breaches. If you don't have a good firewall, which, because we're all in healthcare, I'm sure that's built up as it should be, but again, sometimes hackers get in, they can breach the system. If a server goes down, your electronic environment is not going to be accessible. So, again, you've got to have a backup to that. Or also customer resistance, when I say customer, I mean your staff or other individuals who may use this, they may not like the fact that they have to go into an electronic environment to get it, they may want the paper. If you think about it, in my opinion, electronic is better, and here's why I believe this, it saves time and money, so you're not hiring individuals to go through multiple files to find the procedures you want, to pull those procedures that need to be reviewed, to review those procedures, and then reprint them and put them away, it's just, it saves time and money, as well as it maximizes your facility's space, you don't need all the extra cabinetry, you don't need storage for paper piles because there aren't any. It also reduces waste, which protects the environment. So it really does reduce our carbon footprint. We don't have all the paper, so thereby, we're saving trees, and although that paper may be getting recycled, not everybody recycles as they should. So it really does help with the environment, simplifies the edits and revisions, because generally, if it's in a digital environment, multiple individuals can access and collaborate a whole lot easier than if it's paper, because then Tom has got the paper, and he's gotta make his edits, and then he gives it to Shirley, who makes her edits, and then she gives it to John, who may, and so forth and so on. So this could take days or even weeks to get the edits completed before it gets, the new revised document gets published. Access and sharing is easier, it just really is, you can send it, they can open it, you can provide a link. There's multiple ways of sharing these documents. There's also report availabilities. In most digital environments, you have the availability to print reports regarding which documents are up for review, which documents have been reviewed, how many documents were published this month, how many documents were late in their review process. So there's usually a multitude of different reports that can be pulled so that you can keep on top of the entire process of procedures. So in summary, here's what I would like to share with you. Procedures should be a simple set of instructions, step by step, for completing a process or collection the same way every time. Preferences should be in a procedure, knacks should not. Procedures should be written when there is a new process, major change, people are confused or continually asking questions, and not just because an incident was reported, again, that's a training issue, and those need to be addressed one-to-one with those individuals, unless it becomes a widespread issue across the entire work unit or department, and then that is when it would be a good time to look to see if it really did need to be in a procedure, and to get that process step added. Review of your documents needs to be made on a routine basis, and the, what I'm gonna call the benchmark, or the national standard that I found is somewhere between one to three years, that's the published range, and subject matter experts need to be involved in the writing and reviewing of all documents. It is very, very important to remember, just because you can write a document does not mean it can be trained and it will be followed. "Education is about people. There isn't a system, procedure, or process that matters if it doesn't consider the various perspectives and needs of stakeholders." So no matter what you do, when it comes to procedures, writing procedures, writing policies, writing guidelines, writing job aids, you must always consider the perspectives of your stakeholders, which are those individuals that are being asked to perform those tasks. So write your procedures so that they can easily follow them, and they can take care of our patients to the very best of our ability and their ability, and they can provide best patient care practices each and every day. - [Sierra] Thank you, Michele. - [Announcer] Thank you for participating. Please click the button below to complete the evaluation and obtain credit.