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Starting a Diagnostic Center? Here’s Your Guide to Setting Up a Clinical and Imaging Lab


Diagnostic clinics play a critical role in determining the wellness of a patient. Equipped with the necessary laboratory tools and imaging systems, diagnostic centers help in the early detection of illnesses and can aid doctors in the diseases they are treating.


The more diagnostic facilities there are that provide quality services, the better it is for our healthcare. As such, if you’re planning to set up your own diagnostic clinic, it’s important to take your time to do your research regarding the equipment you’ll need and the regulations you must follow. To help you out, we’ve come up with a guide on how to start a diagnostic center.


Before anything else, you first need to determine what kind of diagnostic clinic you plan to open. Are you planning on simply starting a general clinical pathology laboratory or are you leaning towards starting an imaging center? Or perhaps, do you wish to cover all bases and open a comprehensive diagnostic center that provides imaging and laboratory services?


Whatever you choose, setting up each of these requires thorough preparation. Ahead, we list down the important things you need to note when starting your own medical laboratory business in the Philippines.


How to start a clinical laboratory

This type of diagnostics clinic will allow you to conduct laboratory examinations on clinical specimens to obtain information about the health of your patient. While the instruments you’ll need for a diagnostic laboratory won’t cost as much as buying huge systems for an imaging clinic, you still need to ensure the quality of the equipment you’ll be getting.


A staff handling specimens in a clinical laboratory
A staff handling specimens in a clinical laboratory

Determine your clinical laboratory category


Depending on their service capabilities, clinical laboratories are divided into three separate categories.


Primary Category

● Routine Fecalysis

● Routine Urinalysis

● Routine Hematology or Complete Blood Count CBC - this includes the Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocytes Number Concentration (White Blood Cell or WBC Count), Leucocytes Type Number Fraction (Differential Count), and Qualitative Platelet Determination

● Blood Typing (Hospital-Based)

● Quantitative platelet determination (Hospital-Based)


Secondary Category

All those in the Primary Category and the following:

● Routine Clinical Chemistry, which includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, and Blood Total Cholesterol Concentration

● Cross-matching (Hospital-Based)


Tertiary Category

All those in the Secondary Category including:

● Immunology/Serology

● Microbiology

● Special Chemistry

● Special Hematology


Blood specimens lined up for CBC.
Blood specimens lined up for CBC.

Find quality equipment

Each clinical laboratory needs to have a sufficient number of appropriate instruments in order to operate. Again, each category of clinical laboratories are required to have the following instruments:


Primary Category

● Clinical centrifuge

● Differential blood cell counter or its equivalent

● Hemacytometer

● Hemoglobinometer or its equivalent

● Microhematocrit centrifuge

● Microscope w/ oil immersion objective


Secondary Category

All those in the Primary Category and the following:

● Photometer or its equivalent

● Refrigerator

● Timer or its equivalent

● Water bath or its equivalent


Tertiary Category

All those in the Secondary Category including the following:

● Autoclave

● Balance, trip/analytical

● Biological Safety cabinet or its equivalent

● Drying oven

● Incubator

● Rotator

● Clinical Centrifuge or its equivalent


Find a reliable vendor and score a good service contract so you can rest assured that the instruments you have are of high quality.


Apart from the laboratory equipment, keep in mind that you also have to install other required components such as ventilation systems, working counters, refrigerators, reagents, clinical supplies, and so on.

A guide on how to start a clinical laboratory in the Philippines.
A guide on how to start a clinical laboratory in the Philippines.

When you start a clinical laboratory in the Philippines, it is important that you follow local safety standards. To operate your diagnostic clinic, you need to first comply with the Department of Health (DOH)’s licensing requirements for a clinical laboratory.


Aside from having the necessary equipment for your category, the Health Facilities and Services Regulatory Bureau (BFHS) requires that you submit a floor plan reflecting the adequate area, equipment, and utility for your service capability. Primary Category clinics require at least 10 square meters of floor area, while Secondary Category Clinics would need at least 20 square meters. Finally, Tertiary Category facilities need a minimum of 60 square meters to be operational.


Your clinical laboratory should also have plans for proper maintenance of the equipment. Additionally, you need to ensure that the liquid and solid waste your clinic would produce would be discharged properly.


So you can ensure that you are compliant with regulatory requirements, check out BFHS’ licensing assessment tool and service capability checklist.


To begin your application for your license to operate, you need to file the application form for license to operate a general clinical laboratory in the BFHS office that has jurisdiction over your proposed clinic.


How to start an imaging center


A guide on how to start an imaging center
A guide on how to start an imaging center

Imaging centers on the other hand require you to use various modalities to view the inside of the body. Providing services like x-ray or ultrasound, diagnostic imaging helps give doctors the visual representation to properly analyze a patient’s organs.


Because of the equipment needed to offer these services, opening an imaging center tend to be more expensive. Thus, if you’re just starting out, it can be beneficial to invest in just a couple of modalities first before eventually growing your imaging center over time.


Choose quality equipment

To be more economical, you really need to weigh the pros and cons of each imaging system and decide which to prioritize based on the services you want to provide, your current budget, and your expected patient count. Ahead, we briefly highlight the pros of the basic systems you can choose from.


X-ray System


Octave digital x-ray system.
Octave digital x-ray system.


X-rays are versatile and can be used on different areas of the body to detect bone issues, infections, or even tumors in patients. As such, most diagnostic clinics choose to offer this alongside clinical laboratory services. This equipment comes in different modalities that each fit a field of application and setting.


When setting up your radiography center, decide whether film or digital is better for your applications. Film-based radiography systems seem to be a cheaper choice in the beginning. However, the chemicals and the long time you need for such traditional processing might be costing you more in the long run.


On the other hand, digital systems like Computed Radiography (CR) or Direct Digital Radiography (DR) might seem expensive at first glance, but their quick processing allows for a faster turnaround, allowing you to take in more patients within the day. Not to mention, the latest DR models now come with new features that make work more efficient for your staff. With technologies like wireless connectivity and automatic exposure detection, you can seamlessly process images and deliver results swiftly.


Ultrasound

VINNO 5 Portable Ultrasound System
VINNO 5 Portable Ultrasound System

Another basic piece of equipment you can include when you start your diagnostic center is the ultrasound system. Apart from monitoring the stages of pregnancy, depending on the probes used, this type of imaging equipment can also be used to capture images of other organs like the kidney, heart, blood vessels, and many more. Because of this, it’s another valuable piece of imaging technology worth investing in.


Portable ultrasound systems, of course, are the better choice if you’re looking for cheaper and space-saving equipment. It’s also a nice option to invest in if you’re planning in offering at-home diagnostic services. Console types, on the other hand, are usually more ergonomic. Equipped with advanced features, they can be used to provide more extensive ultrasound procedures and clearer images.


Another thing you need to consider is whether you’re going with black and white ultrasound systems or a color doppler. If you’re only offering basic ultrasound services, black and white is usually enough. But with specialized examinations like in vascular applications that require you to see the direction and speed of blood flow, a color ultrasound is necessary.


Electrocardiograph


Three-channel ECG machines like the EM-301 are enough for basic patient monitoring
Three-channel ECG machines like the EM-301 are enough for basic patient monitoring

While technically not an imaging exam in itself, electrocardiograms (ECG) are used by health professionals with other imaging procedures to get a clearer picture of a patient’s heart health. Using electrodes placed on the skin, electrocardiographs produce graphs to detect cardiovascular abnormalities.


You can choose from two main types of ECG machines depending on the type of test you want to provide to your patients. There is a resting electrocardiograph that will measure a patient’s cardiac electrical activity as they lie down during an appointment. You can also opt to invest in a stress test electrocardiograph, which is used when a patient is performing an intense physical activity.


The number of electrodes you decide to get is also tantamount to the precision of your diagnostics. The main channels are available in ECG machines are 1, 3, 6, and 12. Basic monitoring would usually require 4 leads, featuring 3 electrodes and 1 ground, but an electrocardiograph with 12 leads will help eliminate noise to refine the diagnosis.


Newer models of electrocardiographs also come with a wealth of features that make monitoring more convenient for your health professionals. Some come with support pacemaker detection and produce automatic ECG interpretation. You should also consider getting one with wireless connectivity that will allow you to store the digital data of your readings.


Comply with licensing requirements


Starting a diagnostic radiology center entails a longer licensing process. To ensure the safety of your health professionals and your patients, you would need to comply with the Philippine Food and Drug Administration (FDA) requirements. This includes following adequate x-ray room sizes, having licensed personnel, and securing a personnel dose monitoring service like the OSL Dosimetry service offered by TÜV Rheinland.


Thankfully, complying with these requirements is made easy as you can apply for an OSL Dosimetry service and a license to operate through online channels. Once you filed your application for FDA’s LTO, general x-ray facilities would be required to complete a self-assessment in order to gain authorization


Apply for an LTO an x-ray facility via FDA’s online portal
Apply for an LTO an x-ray facility via FDA’s online portal

Choose your location

Once you’ve had an idea of all the preparation you need to do, another thing you need to consider when starting your diagnostic clinic in the Philippines is your location. Being the only clinic in the area that provides comprehensive services will make you a go-to choice for patients in the area. However, you should also consider setting up at a site near hospitals or competitors to snatch up patients looking for quality services that may or may not be offered by those around you.


Find the right staff

Getting quality equipment is important, but at the end of the day, the precision of your service lies on the staff that man them. Getting licensed health professionals are required to obtain your LTO. To ensure your other staff can be relied on to provide a seamless service, enlist the help of your more experienced health professionals when hiring.


Set your diagnostic clinic up for success


With more than a decade in the industry, Care 4 Life can be relied on to help you with your diagnostic equipment and clinic licensing needs. Our trained staff is ready to help you find imaging and monitoring equipment fit for your needs and budget, all while ensuring that they are compliant with safety and licensing requirements. Not to mention, Care 4 Life's service also extends to properly maintaining and managing your new equipment, helping your staff get used to the new technologies offered by our products.


Make your plans a reality! If you need a thorough guide on how to start your diagnostic laboratory business in the Philippines, contact us today.

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