What’s the Difference Between LIMS and LIS?

The terms laboratory information systems (LIS) and laboratory information management systems (LIMS) are often used interchangeably; however, they have some major differences. As noted above, the biggest difference is that a LIMS isn’t exclusive to medical settings. Unlike an LIS, which is solely used for the purpose of collecting and storing patient data at a healthcare facility, a LIMS is used at water treatment plants along with other non-medical settings such as pharmaceutical labs, in drug trials, and at environmental testing labs.

Since laboratory information systems are primarily used to collect and process patient information in a clinical setting, they must meet the reporting requirements outlined under HIPAA (the Health Insurance Portability and Accountability Act) and other hospital accreditation agencies. This is in contrast to a LIMS, which has to meet the reporting requirements of various scientists in the field, as well as the Food and Drug Administration (FDA).

Benefits of Testing Lab Software

Laboratory testing is a vital component of disease diagnosis and treatment.
As such, there are many benefits of testing lab software. Here are just a few:

Great Results: With an LIS system, patients’ lab results…

To start testing for the novel coronavirus, laboratories must obtain a CLIA certification. Once a laboratory completes that step, it may use CDC-approved test kits for the COVID-19 test procedure. Both private and government-run laboratories may provide COVID-19 diagnostic tests as long as they have the right tools and COVID-19 testing software.

Reduced Costs: One of the biggest benefits of…

https://www.cdc.gov/coronavirus/2019-ncov/lab/virus-requests.html

A clinical testing laboratory can request testing supplies from the CDC. The CDC also provides a comprehensive guide to materials that laboratories need to provide the COVID-19 testing process.

Security: All healthcare facilities need to prioritize…

In addition to using the right laboratory supplies, those who provide the COVID-19 testing process will also need the right COVID-19 testing software. The CDC’s COVID-19 test kits are designed for use “with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software,” according to the CDC’S diagnostic testing guidelines for clinical laboratories.

Early Detection: Testing lab software allows laboratories

Once a laboratory begins COVID-19 diagnostic and/or antibody testing, that laboratory must report its findings appropriately. Laboratories must report their findings within 24 hours of completing a test.

Laboratories should send their test results to either their state public health department or their local public health department, depending on the laws in that laboratory’s area. The CDC provides a list of items to report for each test, as well as a guide on how to report the results.

Usability and Reusability: Since many of the same tests…

Once a laboratory begins COVID-19 diagnostic and/or antibody testing, that laboratory must report its findings appropriately. Laboratories must report their findings within 24 hours of completing a test.

Laboratories should send their test results to either their state public health department or their local public health department, depending on the laws in that laboratory’s area. The CDC provides a list of items to report for each test, as well as a guide on how to report the results.

Starting a Laboratory Business: Tips You Need
to Get Started

If you’re looking to start your own laboratory business, there are a few entrepreneurial requirements you must meet first. As with any company, you will need to have a company description and an executive summary. The executive summary is the most important part of this proposal, as it will outline your experience in this area and what makes you an ideal fit to start a laboratory. This executive summary will also come in handy if you are seeking any type of financial backing.

Your business plan should also include the following:

  • Targeted demographic/market analysis
  • Types of services/products you will provide
  • Request for funding
  • Management information
  • Impact of governmental requirements
  • Staff/board of directors qualifications
  • Strategies for continued business growth

When opening up your own laboratory business, you need to highlight your strengths and why your business will be successful. Once you’ve created your business plan, you will need to set up your business structure to determine whether it’s going to be a sole proprietorship, corporation, or Limited Liability Company (LLC).

Next, you will need to secure startup money. This is often referred to as “seed money” and can help pay for the laboratory space, equipment, insurance, and any other fees acquired throughout the setup process. After this, you’ll need to find a space to open up your laboratory. In order to open up your own lab, you’ll have to purchase lab equipment, either from a manufacturer or through a pharmaceutical auction. Next, you’ll need to hire personnel with the necessary skills and experience to carry out the functions of the laboratory.

In order to fully function as a medical laboratory, you will need:

  • Updated medical licenses for all personnel
  • To be in compliance with local zoning ordinances
  • To be in compliance with how bodily fluids are handled
  • Malpractice insurance
  • Approval from the Centers for Medicare & Medicare Services
  • Permits from statute-issued blood banks

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Establishing a New Lab Test

Regardless of whether you’re a new lab getting set up or already established, there may come a time when you want to introduce a new test due to popular demand or increased need – such as the COVID-19 vaccine. In order to establish a new lab test, there is a specific template you need to use. We outline these steps below:

Step 1: Select Your Test. Your first stop will be to decide which test you want to move forward with. This isn’t done by preference, but rather due to evidential demand. Once it’s determined that demand exists for a particular lab test, you will then have to analyze the cost of such testing, how complex it will be, the manual work involved, and where the testing will be conducted. You will also have to determine whether or not your lab currently has the capabilities to conduct such testing. Even though there may be a demand for certain tests, it may not always be fiscally possible.

Step 2: Research. As with anything medicine-related, you need to research the type of testing you want to bring in-house. Research teams are usually comprised of lab managers, medical billing specialists, and IT specialists. The goal of the research team is to determine whether or not there is enough service, support, and space available to conduct such testing, as well as to go over billing codes, reimbursement, necessary training, physical requirements, test reliability, and how much waste will be produced.

Step 3: Talk With Vendors. After the research phase is completed, it’s time to talk to vendors. Vendors can provide you with details on other labs that currently use the testing you’re looking to bring on. This gives you the chance to visit the other labs to see how they conduct their testing and ask any questions about how successful the testing has been at their facility so you have some preliminary information. Vendors will provide you with equipment, training, and free testing kits.

Step 4: Final Decision. Once all the steps above have been completed, you should have all the information you need to make a final decision about moving forward. Once a decision has been made to move forward, you will need to get approval from the management team. When seeking approval, you should include all relevant factors including but not limited to the cost of the testing, the benefits, impact it will have on the patients, and pertinent literature to support the need.

Step 5: Go Through the Process. First, you will need to make sure that the test is either FDA-approved or cleared. Furthermore, each new lab testing must have a Certificate of Compliance, Certificate of Waiver, Certification of Registration, Certificate of Provider-Performed Microscopy Procedures, or Certificate of Accreditation.

Step 6: Documentation. The next step will be to develop documentation between the lab and the vendor. This document includes important information such as who is responsible for administering the lab testing, how results will be verified, and what the written procedures are. This documentation may also include a patient log and training log.

Step 7: Training. Once it’s determined who will be administering the new lab testing, those individuals will be required to undergo specific training. Once they are trained on how to perform the new test, they will be evaluated for competency. Staff will be continuously evaluated six months and a year after the new test is implemented. Evaluations will continue annually once the one-year mark has been passed.

FAQ

Frequently Asked Questions

What is a Laboratory Information System?

A laboratory information system, commonly referred to as an LIS, is a type of medical software that laboratory facilities use to store important patient data that medical offices and treating physicians need in order to properly diagnose and treat a patient. This data primarily includes both incoming and outgoing laboratory testing orders and test results. Furthermore, an LIS system is able to track lab orders and transmit data to a patient’s electronic health record (EHR). As with all electronic health records, a patient’s personal information, including their name, birth date, gender, address, and medical history, is stored in this laboratory information system.

  • A laboratory information system can also store and process the following information:
  • The physician who ordered or read the lab results
  • The date the patient was admitted to a facility or had lab work done
  • The department that ordered the lab work
  • Workflow management
  • Comparison of a patient’s lab results
  • The type of specimen that was taken and subsequent tracking of where it is in the analysis process
  • Quality assurance
  • ICD-9 codes for billing purposes
  • Communication among staff, including documentation of phone calls or emails

These electronic systems make it possible for patients to arrive at a laboratory for testing and not have to divulge their medical history at each visit or keep a record of all their previous lab tests.

How Did the LIS System Get Started?

A laboratory information system, commonly referred to as an LIS, is a type of medical software that laboratory facilities use to store important patient data that medical offices and treating physicians need in order to properly diagnose and treat a patient. This data primarily includes both incoming and outgoing laboratory testing orders and test results. Furthermore, an LIS system is able to track lab orders and transmit data to a patient’s electronic health record (EHR). As with all electronic health records, a patient’s personal information, including their name, birth date, gender, address, and medical history, is stored in this laboratory information system.

  • A laboratory information system can also store and process the following information:
  • The physician who ordered or read the lab results
  • The date the patient was admitted to a facility or had lab work done
  • The department that ordered the lab work
  • Workflow management
  • Comparison of a patient’s lab results
  • The type of specimen that was taken and subsequent tracking of where it is in the analysis process
  • Quality assurance
  • ICD-9 codes for billing purposes
  • Communication among staff, including documentation of phone calls or emails

These electronic systems make it possible for patients to arrive at a laboratory for testing and not have to divulge their medical history at each visit or keep a record of all their previous lab tests.

How Does a Laboratory Information System Work?

A laboratory information system, commonly referred to as an LIS, is a type of medical software that laboratory facilities use to store important patient data that medical offices and treating physicians need in order to properly diagnose and treat a patient. This data primarily includes both incoming and outgoing laboratory testing orders and test results. Furthermore, an LIS system is able to track lab orders and transmit data to a patient’s electronic health record (EHR). As with all electronic health records, a patient’s personal information, including their name, birth date, gender, address, and medical history, is stored in this laboratory information system.

  • A laboratory information system can also store and process the following information:
  • The physician who ordered or read the lab results
  • The date the patient was admitted to a facility or had lab work done
  • The department that ordered the lab work
  • Workflow management
  • Comparison of a patient’s lab results
  • The type of specimen that was taken and subsequent tracking of where it is in the analysis process
  • Quality assurance
  • ICD-9 codes for billing purposes
  • Communication among staff, including documentation of phone calls or emails

These electronic systems make it possible for patients to arrive at a laboratory for testing and not have to divulge their medical history at each visit or keep a record of all their previous lab tests.

Types of Laboratory Information Systems

A laboratory information system, commonly referred to as an LIS, is a type of medical software that laboratory facilities use to store important patient data that medical offices and treating physicians need in order to properly diagnose and treat a patient. This data primarily includes both incoming and outgoing laboratory testing orders and test results. Furthermore, an LIS system is able to track lab orders and transmit data to a patient’s electronic health record (EHR). As with all electronic health records, a patient’s personal information, including their name, birth date, gender, address, and medical history, is stored in this laboratory information system.

  • A laboratory information system can also store and process the following information:
  • The physician who ordered or read the lab results
  • The date the patient was admitted to a facility or had lab work done
  • The department that ordered the lab work
  • Workflow management
  • Comparison of a patient’s lab results
  • The type of specimen that was taken and subsequent tracking of where it is in the analysis process
  • Quality assurance
  • ICD-9 codes for billing purposes
  • Communication among staff, including documentation of phone calls or emails

These electronic systems make it possible for patients to arrive at a laboratory for testing and not have to divulge their medical history at each visit or keep a record of all their previous lab tests.

Lab Startup Costs

The initial startup costs for a lab can be quite costly. Here’s a breakdown of how much equipment may cost:

  • Computer: $1,000-$2,000
  • Waiting area furniture: $5,000
  • Microscopes: $900-$3,000
  • Refrigerators/freezers: $5,000-$15,000
  • Hematology analyzer: $9,000-$20,000
  • Lab supplies (needles, gloves, cotton, gauze pads, etc): $2,000
  • Laboratory software: anywhere from $500-$1,500 a month

This doesn’t include the costs of salaried employees, insurance, and other day-to-day expenses like renting or purchasing property or paying for utilities. Proper funding is required in order to get a lab off the ground. There are a number of funding options out there for you to explore:

Funding

Due to the expenses that come with starting up a lab, there are ways to gain funding for the operation. One way is to receive funding from a venture capital firm. These firms invest in startup companies with the potential for a stake in the business.

Another way to receive funding is through government grants. Under certain conditions, small businesses engaged under R&D can get research grants under the Small Business Technology Transfer (STTR) or Small Business Innovation Research (SBIR) programs. These programs allow small businesses to take on federal R&D objectives that could eventually lead to commercialization.

A few other options through the SBA to consider are guaranteed loan programs, surety bonds, and equity financing. With a guaranteed loan, the SBA guarantees the repayment of loans. These kinds of loans usually aren’t available to small businesses if the company that is borrowing has access to other kinds of funding.

A surety bond works in a similar fashion where the SBA guarantees a surety that the SBA will take on a percentage of the loss if the contract is breached for some reason.

The SBA offers equity financing through the SBA’s Small Business Investment Company (SBIC). The SBA goes to private investment funds to provide the capital to these businesses, and the SBA gives these investors access to low-cost, government-guaranteed debt.

Why Do Labs Need Medical Lab Software?

Even though a laboratory plays a vital role in the diagnosis and treatment of many serious conditions, it is still a business and needs to efficiently operate as one. As such, medical lab software is necessary for the following reasons:

  • It reduces intake errors and minimizes the risk of medical negligence.
  • It helps to automate billing to ensure that the patient is being billed correctly, claims are accurately being sent to the insurance company, the office is getting paid, and that payments are being made
    on time.
  • It allows staff to easily locate errors or ways the system can be improved to create a better workflow.
  • It increases employee productivity.
  • It ensures that certain procedures are being done correctly.
  • It allows for record management.

While this isn’t an exhaustive list, a laboratory information system is part of making sure the lab runs smoothly. A smooth-running lab means better patient care. As with anything, you need to make sure that your LIS system will fit the needs of your patients and support the overall efficiency and services
of the lab itself.

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Why Choose Psychē Systems for Your LIS?

If you run a lab and you’re looking for a new laboratory information system, look no further than Psychē Systems. For over four decades, we’ve innovated and helped medical laboratories of every type create specialty LIS systems that allow them to optimize efficiently and cost-effectively. We have a modern laboratory information system that’s designed to fit every need your lab may have.

Our LIS systems can be customized to fit your budget and your client’s preferences. We make sure that our LIS systems operate off of our best-in-class applications. This includes nucleoLIS, which is geared towards supporting cytogenetic, toxicology, molecular, and clinical laboratory testing. We also use WindoPath, which is a fully CAP- and CLIA-compliant application that supports anatomic pathology, as well as areas of urology, gastroenterology, and dermatopathology that are more niche. And finally, we use MicroPath, which is a unique, flexible application that supports microbiology testing.

We have a full suite of robust connectivity solutions, including Outreach, a comprehensive medical record (EMR) integration and interfacing to laboratory instruments, and other third-party systems. All of our solutions can be securely hosted on-premise or within our hosted services environment.

Contact Us Today!

Contact us today to learn more about our options for LIS systems and how we can tailor your system to your needs.
We have an unwavering commitment and focus to innovation. Psychē Systems meets the high standards of the healthcare industry for patient safety, laboratory integrity, and customer efficiency.

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