.svg?sfvrsn=be606e78_3)
When you send a specimen out to the lab, how can you be sure the result will be accurate and returned on time? The truth is, you can't. People are imperfect and instruments can malfunction, and no one can guarantee 100 percent accuracy. Nevertheless, there are some simple steps you can take to minimize errors and maximize the chances that you will receive the service you need when you need it. In this article, I'll outline seven practical tips for evaluating your laboratory services.
Ask for Credentials
The regulations governing laboratories-the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which took effect in 1992-require laboratory directors to have at least a bachelor of science degree. However, the director of your lab should have a PhD, MD, or DO degree because circumstances are likely to arise that require physician-to-physician communication. For example, one of your surgeons may need information about how test results relate to a disease process. On more than one occasion, I have reviewed blood smears when there has been an abnormal white blood cell count or explained a biopsy result that a physician had taken from a patient. The director also should be on-site and involved in the daily operations of the lab. No matter how qualified, the director cannot manage the lab from a distance and be available to respond to your immediate needs.
The technicians' credentials can also vary from lab to lab, so I recommend asking for a list of all testing personnel's qualifications. Although CLIA requires specialized academic training for technicians who perform complex tests (that is, tests that involve extensive calculations, special specimen preparation, labile reagents, or other tasks that require substantial expertise), the regulation requires only a high-school diploma and on-the-job training for personnel who perform most routine tests-like CBCs, urinalyses, sodium, potassium, and hemoglobin. The trouble is, no matter how ?routine' the test, an inaccurate result can cause scheduling setbacks or, in rarer situations, serious clinical issues for the outpatient facility. In my opinion, the more degreed medical technicians the lab employs to perform your routine tests, the better.
Ensure Accreditation
Just as most patients do not have the expertise to judge the quality of your outpatient services up-front, most facility managers cannot know everything there is to know about laboratory testing and operations. For this reason, rely on the accrediting agencies to do some of the work for you. There are currently at least five agencies that inspect and/or accredit labs, including The Centers for Medicare and Medicaid Services, JCAHO, your state department of health, the College of American Pathologists, COLA, and the American Association for Laboratory Accreditation. Although accreditation programs and agencies vary, the simple fact that the lab has passed the accreditation process helps ensure some level of quality. COLA and the College of American Pathologists' accreditation, for example, ensures that the lab has met CLIA standards for Medicare and Medicaid reimbursement, JCAHO standards, and your state's requirements.
I also recommend verifying that any subcontracted laboratories are also accredited, especially if your lab routinely outsources your specimens. Keep in mind that Medicare and Medicaid will not reimburse for any lab work performed in an unaccredited facility.
Review QA Records
Accredited labs are required to run quality control samples every day, and you can get a good picture of your lab's accuracy record by reviewing these reports for some of your most common tests. When performing a single run of 15 serum sodium samples, for example, a technologist/technician will also test control samples of known sodium concentrations as part of this run. The technologist/technician then compares these results with the lab's predetermined criteria, which is typically within two standard deviations above or below the actual concentration. These reports should demonstrate a 95 percent probability; that is, no more than one in 20 samples should be two standard deviations or more above or below the actual quantity. If four or five of 20 control samples fall outside of the criteria and the lab fails to offer an obvious cause or solution, it is time to consider looking elsewhere for laboratory services. Given the somewhat complex statistics involved, however, I recommend having a pathology expert review the QA records before making any decisions. In addition, the lab should always release their QA reports to you willingly. Hesitation is a sign that the lab may have something to hide.
Take a Tour
Even though you may not know much about the science of pathology, a brief tour can reveal a lot about a laboratory's operations. Take a look for yourself, and assess the facility as you would a new apartment, child care provider, or potential new employer. Is it organized? Is it clean? Do the employees behave professionally? Are the telephones being answered promptly? If not, you may be better off cutting your losses now.
Assess Turnaround Time Factors
Laboratory tests typically take just minutes or, as in the case of blood gases, even seconds to perform. The real time drain lies in the pre- and post-analytical work; that is, specimen pick-up and delivery, logging in of samples, pre-processing (e.g., centrifuge), and paperwork. For this reason, it makes sense to carefully evaluate all of these factors that can lengthen your turnaround time-including the location, outsourcing policy, and delivery of results. For example, how far away is the lab from your facility? The further the lab, the longer it takes to get the specimen there. How often does the lab need to outsource your samples? This adds yet another potentially time-consuming step to the process. Finally, what are your options for receiving results? Will they come right away via the computer, or will you need to wait for overnight delivery, US mail, or a courier?
Negotiate
Remember that nearly everything is negotiable. For example, do you want your own employees to be responsible for collecting tissue, blood, and other samples? If so, will the lab personnel help train your staff in venipuncture and proper specimen collection techniques? Will the lab provide you with a manual that clearly spells out the requirements for each type of test; e.g., type of sample, quantity needed, proper preservation methods, etc.? Who will furnish the supplies, you or the lab? Is the lab willing to repeat all or a certain number of tests free of charge when the results are questionable? For example, your surgeon may want to re-run a test if the result does not readily correlate with the patient's clinical condition. Perhaps the lab is willing to install a computer terminal in your facility? Finally, who is your lab liaison, exactly when is this person available to you, and what is his or her level of expertise?
Take Control
When assessing and negotiating with a lab, always put yourself in the driver's seat. You are the client, and as such, you should establish the partnership's expectations based on your needs, not the lab's stated capabilities. I recommend creating a list of your own criteria even before you approach a lab, and then evaluating the services of more than one lab against your list. For example, determine up front what types of tests you will need on a "STAT" basis, and outline your expectations for routine tests in terms of turnaround time, delivery method, and accuracy. Doing so will help you prioritize your needs, itemize the specific services available, evaluate the value of the services, and ultimately end up with the lab that is most qualified to serve you and your patients well.
Ask for CredentialsThe regulations governing laboratories-the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which took effect in 1992-require laboratory directors to have at least a bachelor of science degree. However, the director of your lab should have a PhD, MD, or DO degree because circumstances are likely to arise that require physician-to-physician communication. For example, one of your surgeons may need information about how test results relate to a disease process. On more than one occasion, I have reviewed blood smears when there has been an abnormal white blood cell count or explained a biopsy result that a physician had taken from a patient. The director also should be on-site and involved in the daily operations of the lab. No matter how qualified, the director cannot manage the lab from a distance and be available to respond to your immediate needs.
The technicians' credentials can also vary from lab to lab, so I recommend asking for a list of all testing personnel's qualifications. Although CLIA requires specialized academic training for technicians who perform complex tests (that is, tests that involve extensive calculations, special specimen preparation, labile reagents, or other tasks that require substantial expertise), the regulation requires only a high-school diploma and on-the-job training for personnel who perform most routine tests-like CBCs, urinalyses, sodium, potassium, and hemoglobin. The trouble is, no matter how ?routine' the test, an inaccurate result can cause scheduling setbacks or, in rarer situations, serious clinical issues for the outpatient facility. In my opinion, the more degreed medical technicians the lab employs to perform your routine tests, the better.
|
Ensure Accreditation Just as most patients do not have the expertise to judge the quality of your outpatient services up-front, most facility managers cannot know everything there is to know about laboratory testing and operations. For this reason, rely on the accrediting agencies to do some of the work for you. There are currently at least five agencies that inspect and/or accredit labs, including The Centers for Medicare and Medicaid Services, JCAHO, your state department of health, the College of American Pathologists, COLA, and the American Association for Laboratory Accreditation. Although accreditation programs and agencies vary, the simple fact that the lab has passed the accreditation process helps ensure some level of quality. COLA and the College of American Pathologists' accreditation, for example, ensures that the lab has met CLIA standards for Medicare and Medicaid reimbursement, JCAHO standards, and your state's requirements.
I also recommend verifying that any subcontracted laboratories are also accredited, especially if your lab routinely outsources your specimens. Keep in mind that Medicare and Medicaid will not reimburse for any lab work performed in an unaccredited facility.
Review QA RecordsAccredited labs are required to run quality control samples every day, and you can get a good picture of your lab's accuracy record by reviewing these reports for some of your most common tests. When performing a single run of 15 serum sodium samples, for example, a technologist/technician will also test control samples of known sodium concentrations as part of this run. The technologist/technician then compares these results with the lab's predetermined criteria, which is typically within two standard deviations above or below the actual concentration. These reports should demonstrate a 95 percent probability; that is, no more than one in 20 samples should be two standard deviations or more above or below the actual quantity. If four or five of 20 control samples fall outside of the criteria and the lab fails to offer an obvious cause or solution, it is time to consider looking elsewhere for laboratory services. Given the somewhat complex statistics involved, however, I recommend having a pathology expert review the QA records before making any decisions. In addition, the lab should always release their QA reports to you willingly. Hesitation is a sign that the lab may have something to hide.
Take a TourEven though you may not know much about the science of pathology, a brief tour can reveal a lot about a laboratory's operations. Take a look for yourself, and assess the facility as you would a new apartment, child care provider, or potential new employer. Is it organized? Is it clean? Do the employees behave professionally? Are the telephones being answered promptly? If not, you may be better off cutting your losses now.
Assess Turnaround Time FactorsLaboratory tests typically take just minutes or, as in the case of blood gases, even seconds to perform. The real time drain lies in the pre- and post-analytical work; that is, specimen pick-up and delivery, logging in of samples, pre-processing (e.g., centrifuge), and paperwork. For this reason, it makes sense to carefully evaluate all of these factors that can lengthen your turnaround time-including the location, outsourcing policy, and delivery of results. For example, how far away is the lab from your facility? The further the lab, the longer it takes to get the specimen there. How often does the lab need to outsource your samples? This adds yet another potentially time-consuming step to the process. Finally, what are your options for receiving results? Will they come right away via the computer, or will you need to wait for overnight delivery, US mail, or a courier?
NegotiateRemember that nearly everything is negotiable. For example, do you want your own employees to be responsible for collecting tissue, blood, and other samples? If so, will the lab personnel help train your staff in venipuncture and proper specimen collection techniques? Will the lab provide you with a manual that clearly spells out the requirements for each type of test; e.g., type of sample, quantity needed, proper preservation methods, etc.? Who will furnish the supplies, you or the lab? Is the lab willing to repeat all or a certain number of tests free of charge when the results are questionable? For example, your surgeon may want to re-run a test if the result does not readily correlate with the patient's clinical condition. Perhaps the lab is willing to install a computer terminal in your facility? Finally, who is your lab liaison, exactly when is this person available to you, and what is his or her level of expertise?
Take ControlWhen assessing and negotiating with a lab, always put yourself in the driver's seat. You are the client, and as such, you should establish the partnership's expectations based on your needs, not the lab's stated capabilities. I recommend creating a list of your own criteria even before you approach a lab, and then evaluating the services of more than one lab against your list. For example, determine up front what types of tests you will need on a "STAT" basis, and outline your expectations for routine tests in terms of turnaround time, delivery method, and accuracy. Doing so will help you prioritize your needs, itemize the specific services available, evaluate the value of the services, and ultimately end up with the lab that is most qualified to serve you and your patients well.
.svg?sfvrsn=56b2f850_5)