Complete Guide on Clinical Laboratory Business Plan

If you are looking for a complete guide on a clinical laboratory business plan or how to start a clinical laboratory business? Then you came to the right place.

Health is one of the fastest-growing sectors in the world due to the high demand for quality medical services. Countries of all economic levels face problems in guaranteeing the quality and affordability of health services.

Consequently, the question arises of how to start a clinical laboratory as a business that contributes to reducing this gap and makes a positive contribution to the sector. Well, its function is highly relevant for the diagnosis and treatment of diseases.

Therefore, in this article, we will share a guide on the clinical laboratory business plan. And the requirements, permits, and elementary steps to carry it out will be taken into account, let’s get started!

What is a clinical laboratory?

Clinical laboratories are places specialized in the analysis of human biological samples for the diagnosis, study, and prevention of diseases. These analyzes are produced from the request of a doctor and usually use methodologies from different disciplines, such as:

  • Biochemistry
  • Microbiology
  • Hematology
  • Immunology
  • Hormones
  • Microbiology
  • Bacteriology

Some of the most common samples obtained in a clinical laboratory are:

  • Blood
  • Urine
  • Synovial fluid
  • Cerebrospinal fluid
  • Feces
  • Glucose
  • Thyroid
  • Cholesterol
  • Uric acid

For its part, the analysis of these samples consists of a series of phases that must be executed in order and related to each other, these are:

  • Preanalytical phase: Stage before conducting the analysis that ranges from requesting the test to its completion. That is, first the doctor requests the analysis, and a form is filled out with the patient’s data. Subsequently, the biological sample is extracted and sent for analysis.
  • Analytical phase: Here a series of techniques are used to interpret the samples. Usually, they are carried out through two processes: calibration and control. At the end of the analysis, the technician performs a validation of the main data to make sure that the work session was regular and that the controls are in the expected ranges.
  • Post-analytical phase: At this point, the results obtained are reported, recorded, and delivered.

Types of clinical laboratories

Commonly, clinical laboratories are usually public or private. Regarding private laboratories, they are those that do not depend on a hospital or a larger research center. Therefore, they usually carry out all kinds of analysis.

On the other hand, there are pharmacological analysis laboratories, which are dedicated to screening or screening drugs or their chemical compounds.

What is needed to set up a laboratory?

If you are inquiring about how to create a clinical laboratory, you must take into account some of the aspects required for it. These include permits for its start-up, infrastructure, and specialized equipment. Next, we will see each of them in detail.

Requirements and permits

First of all, within the requirements to open a clinical laboratory, it is necessary to manage all the procedures for the creation of new businesses. These can be consulted at the chamber of commerce, town hall, or institution in charge of regulating the business sector in your country. They generally include:

  • Constitution under a legal structure (natural or legal person)
  • Elaboration of statutes
  • Creation of related books
  • Land use permits
  • Operating licenses
  • Tax registration
  • Social security registration

On the other hand, all laboratory personnel must have the necessary technical documentation for the development of activities. Regarding the requirements related to health services and clinical laboratories are:

  • Registration with the national health system.
  • Execution of activities to control and reduce occupational, public, and environmental health risks.
  • Application of the corresponding regulations for the good management and handling of waste.
  • Surveillance and epidemiological control in the clinical laboratory according to the current sanitary code.
  • Definition of quality policies and standards for all clinical analysis processes.
  • Verification of analytical methods and systems, as well as basic material and equipment.

Place and structure

The next step in creating a clinical laboratory is to choose a location with enough space to delimit the different zones and service areas. Also, you will have to comply with the applicable sanitary regulations for this type of surface. Ideally, the place is located near hospitals and medical centers. To have a connection with potential customers.

Regarding the size of the place, it is recommended that it be at least 80 m2. In which the following areas will be adapted:

  • The waiting room and reception
  • Administrative office
  • Separate bathrooms for staff and clients
  • Sampling cubicles
  • Sample sorting and distribution room
  • Material washing and sterilization area

Also, different laboratory sections must be adapted for each specialty, such as:

  • Bacteriology
  • Immunology
  • Microbiology
  • Hematology,
  • parasitology
  • Urine analysis
  • Virology
  • Biochemistry.

Equipment and materials

Based on the structure and the laboratory sections, the equipment, and basic work material are determined. Next, we list the equipment and supplies needed for each of the laboratory’s service areas :

General equipment:

  • Microscopes
  • Bunsen lighter
  • Needles, syringes, cotton, alcohol, bandages, and gauze
  • Shelves, coverslips, slides, and waste bags
  • Pipettes, pears, racks, Petri dishes
  • Water stills
  • Fridge and oven
  • Chronometer
  • Autoclave
  • Kits, reagents, dyes, etc.
  • Cell counter
  • Coagulation analyzer

Biochemistry and Immunology:

  • Automatic apparatus (for example A-15) OR a semi-automatic monitor (ex: BTS-310) or a spectrophotometer.
  • Apparatus for measurements of Na, K, and Li.
  • Microcentrifuge tubes
  • Plates for ASO, PCR, and RF, and VDRL.
  • Shaker, funnel, and filter paper
  • ELISA reader device

Hematology:

  • Tubes and sheets.
  • Homogenizer for tubes
  • Reagents such as dyes, A, B, and D (Rh) antisera, Coombs serum, bovine albumin, etc.
  • Neubauer chamber.

Microbiology:

  • KOH.
  • Tubes, sheets, clips, paper.

Urinalysis and parasitology:

  • Dissolution of Lugol
  • Specific tubes for urine.
  • Test strips for chemical analysis of urine
  • Toilet paper

Results delivery room:

  • Computer with specific software for laboratories.
  • Printer, telephone, dataphone, and technological equipment as required
  • Office supplies

Steps to Start a Clinical Laboratory Business

Once the requirements and elements necessary to open a clinical laboratory are clear, it is time to talk about the steps to manage the business. Therefore, we will explain one by one the most relevant aspects to take into account during the entrepreneurship process.

1. Services

The first thing you should consider when wondering about how to create a clinical laboratory is the type of services that are offered there. As we have mentioned, in these establishments diverse biological samples are obtained and studied. Therefore, the service basically consists of attending to all patients who arrive at the laboratory with a request for sampling and analysis.

Likewise, this service also involves care for companies in the health sector such as private and public hospitals. Also, medical centers and research and science institutions. Which requires a laboratory provider to perform biological tests according to your needs.

2. Business plan

All emerging businesses must plan and analyze certain variables to start up, and a clinical laboratory is no exception. Therefore, it is crucial to develop a business plan that sets out the objectives of the venture and the actions to be followed to achieve them. Among the most important components of this document are:

  • Description of the idea: At the beginning of the process of how to create a clinical laboratory, the business idea and its characteristics should be detailed. That is, describe the activity of the company, its mission, and benefits. This to give you a clearer focus and get an overview of the company.
  • Market research: It is the basis for executing the following steps. It is an analysis of the dynamics and behavior of the market that is carried out to identify the competition, recognize the target audience and understand the operation of the sector. Based on this, establish work strategies.
  • Marketing: Refers to the strategies and techniques for marketing and promoting the business. Here, some marketing objectives are defined and the means of dissemination, execution budget, and sales projection are determined.
  • Financial plan: The initial investment budget is considered here, that is, the resources necessary to carry out the business. Also, it includes the projection of income, expenses, and expected profit margin.

3. Personnel

The work team of a clinical laboratory must be trained with technical training or higher education. Well, it generally consists of :

  • Pharmacists
  • Biochemicals
  • Biomedical
  • Clinical pathologists
  • Nurses
  • Bacteriologists
  • Nursing assistants
  • Clinical chemists
  • Doctors
  • Diagnostic Technicians

In the same way, it is very important to always provide courses, training, and training to business employees. Since the niche is constantly moving and updating.

As for the owner or manager of the place, he does not have to be a professional in the health sector. However, you must be qualified and have the skills to run a laboratory and medical services business. Also, within the laboratory, the presence of administrative personnel, human resources, and various trades is required.

4. Budget to open a laboratory

Surely you must be wondering how much it costs to make a clinical laboratory. In fact, it must be said that the investment for this business is usually a bit high due to the equipment, structure, permits and other requirements to be met. Since we are referring to specialized services related to the health sector.

Within the budget, all costs and expenses of starting the business must be considered. In other words, equipment, materials, furniture, and adaptation of the infrastructure. Also, procedures, licenses, permits, and marketing actions. Likewise, the fixed costs of the first months of operation of the laboratory should be included. These refer to the payment of rent and services, personnel expenses, maintenance, purchase of materials, etc.

Based on the above, an initial investment is estimated at around USD 50,000 and USD 80,000.

5. Promotion

Finally, setting up a clinical laboratory requires planning and executing a marketing plan for the promotion and dissemination of the business. The said plan must be carried out at the beginning of the process and included within the business plan and be based on the results of the market research.

Here all the strategies and actions, both traditional marketing and digital marketing, aimed at positioning and publicizing the laboratory will be established. These will be the vehicle to attract new customers and increase sales. Likewise, gain recognition in the market and connect with the target audience. Therefore, it is key that they are executed throughout the management and start-up of the business.

Some of the strategies that can be included in the marketing plan are:

  • Merchandising
  • Advertising in traditional media (TV and Radio)
  • Brand activation
  • Social media management
  • Email marketing
  • SEM and SEO positioning
  • Video marketing

Final words

Of course, biological sampling services have an active market that is always on the move. Also, they turn out to be indispensable in quality medical care. Therefore, a clinical laboratory is a viable business option with a high probability of success within the healthcare sector.

We hope that this basic guide of steps on how to start a clinical laboratory will be useful to you to start growing your business. Do not forget to advise, document, and investigate the specific requirements to start this venture in your country of residence.