Benefits of the In-House Laboratory

So, you are the owner of a medical practice and the idea to perform laboratory testing in-house has crossed your mind. Maybe your office sees urgent care patients in need of a fast flu result, maybe your practice manages chronic conditions like diabetes where the A1c result is a must or maybe you are a specialist in dermatology and that pregnancy result is needed prior to prescribing medication. No matter what type of practice you have, the need for laboratory services is inevitably going to be part of that practice.  While certain tests must be sent out to your local reference laboratory because of the nature of the test, some tests are deemed easy enough to be performed within the practice. During this blog, we will discuss three major benefits of running an in-house laboratory. These benefits include topics like faster results, results you can trust and the reimbursement received when you test your own samples.

Faster Results

Let’s start with faster results. When considering an in-house laboratory, one of the first topics that comes to mind is the speed at which you will receive results. In fact, most physicians will tell you that is the best part of having an in-house laboratory. The process works as follows:

Patient checks in at the front desk

➤ Patient is taken back to an examination room

➤ Nurse takes vitals and records symptoms

➤ Once MD reviews vitals and symptoms, a determination can be made for the appropriate tests

➤ If the tests are performed in-house, results and a diagnosis are just minutes away

One example of a popular in-house test is the Complete Blood Count, also known as the CBC. A complete blood count can be resulted from draw to printed results within 15 minutes. A CBC is such a useful tool for assessing the overall health of any patient. In fact, conditions like anemia, infections and certain types of cancer may be identified using CBC results. Having results while the patient is still present in the office allows for the possibility of an immediate diagnosis.  This immediate diagnosis allows for faster treatment and therefore a better chance at a speedy recovery. Overall, as you can see, having faster results only further assists in the proper care of your patients.

Reliable Results

Our next topic is reliable results. Results you can trust mean more than anything when it comes to excellent patient care. As with any discipline, there are rules which govern laboratory testing and in-house laboratories are no exception. The rules which govern laboratory testing are compiled in a set of federal regulations called the Clinical Laboratory Improvement Amendments or CLIA for short. CLIA regulations are meant to ensure the accuracy and reliability of all laboratory testing on humans. In fact, the CLIA regulations establish rules for who can test, how those tests are to be performed and how to report those results. Even though the level of complexity in which you are testing determines the personnel qualifications, all testing personnel are required to have a few basic items within their personnel file prior to testing patients as follows:

➤ Proof of education

➤ Proof of training

➤  Signed job description

➤ Competency assessments

➤ Proof of proficiency participation

➤ Proof of Bloodborne Pathogen annual training

Now that we have covered who can test, let’s discuss how the testing is to be performed. Instructions for how testing is to be performed is explained explicitly within the package insert of waived tests and within the user manual of the instruments used to perform moderate and high complexity testing. It is of the utmost importance that all instructions be followed to the letter and that those instructions are in keeping with the CLIA regulations. Following a proper quality assessment system is imperative when considering how to produce reliable results. According to CLIA, a complete quality assessment system includes the following:

➤ Complete list of Procedures

➤ Validated Tests

➤ Properly Maintained and Calibrated Equipment

➤ Testing Personnel Training and Competencies

➤ Accurate Quality Control for your test methods

➤ Proficiency Testing

In addition to instructions, quality control is an essential aspect required to produce reliable results. Three key components to quality control include using the appropriate controls, practicing the correct method for running controls and maintaining your control records. Making sure your quality control is appropriate for your test method is vital to producing reliable results. Therefore, ordering quality control vials made by the manufacturer specific to your instrumentation is the best way to ensure your quality control is appropriate. The proper method for quality control is determined by the specialty of your testing method. In fact, whether your specialty is chemistry or hematology, CLIA has the guidelines for how many levels should be used and how often you should use them. Having all of the above mentioned components will produce results you can rely on for excellent patient care.

Reimbursement

Our final topic is reimbursement.  As you can see, a tremendous amount of preparation goes into running a successful laboratory that produces results you can trust. The final aspect of the in-house laboratory we will explore as an added benefit is reimbursement.  That’s right, instead of paying to get your laboratory results, you can create revenue for your practice by billing for the laboratory tests you perform in-house. From waived testing to moderate complexity, all laboratory tests performed in-house may be billed if appropriate to the diagnosis. While there are specific rules governing billing and the corresponding diagnosis, we will not discuss those here. The most important thing to remember is that if you test as many of your own samples as you can, the profit margin of your practice can only increase.

Conclusion

In summary, you can have faster laboratory results, results you can trust and results you can bill for if you perform in-house testing.  As we have discussed, the benefits of in-house laboratory testing are clear. Even though the thought of opening an in-house laboratory may seem daunting, having the correct resources can make this a smooth process.

DoctorsManagement has been assisting laboratories in developing CLIA compliant laboratories for over 30 years. Our team is able to assist any complexity level with all areas of compliance. For example, we offer consulting for topics such as quality control, quality assessment, proficiency testing, records retention, personnel file review, review of and assistance with instrument validation, inspection preparation, inspection response and more. Our expert team has all of the forms, manuals and experience required to create a laboratory with results you can depend on and increase your bottom line.

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