Top eight factors to consider when setting up a histology laboratory
Although there are numerous factors to consider when setting up a histology laboratory, with our 20 years of experience we’ve identified the ones we hear our clients mention most frequently. We summarized them into one place in hopes that this will help others feel more educated.
Benefits for patient and practice
If you’re thinking about adding a lab to your practice, you already know that in-house testing can offer benefits for both your patients and your business.
But it’s what you don’t know that can cost you.
Installing a lab and getting the proper certification can mean following a complex bureaucratic process that requires extensive planning. Any misstep can end up wasting time, money, and even having patients go elsewhere. That’s why it’s important to know everything that you need in place to set up an in-house lab and keep it running successfully.
This guide offers a look at the reasons thousands of physicians across the country — and many more throughout the world — have decided to set up their own office labs. Perhaps what you find here can help you launch a lab at your practice.
Planning Your Lab
When setting up a medical laboratory, the first step is planning. You need to decide what types of services your lab will provide. Based on that, the type and size of space and equipment needed, number and qualifications of staff and their salaries, legal requirements and safety protocols all have to be considered.
Once you decide on your services, you’ll need to acquire your lab space and establish which areas will be designated for which services. You’ll also need to consider whether you should buy or rent your space.
Next comes all of the legal requirements involved, from picking a business entity to ensuring that all federal and state certifications and licensing requirements are met.
Lab Equipment Options
One of your biggest expenditures will be for equipment. There are many pieces of lab equipment required depending on your lab services. Also keep in mind that all equipment will need maintenance and calibration schedules and standard operating procedures so your staff can refer to them.
Remanufactured cost-effective lab equipment
Due to tight budgets and cost restrictions, labs are challenged to find ways to get the equipment they need to optimize and run their laboratories as efficiently as possible. Remanufactured equipment is a great way to make your lab state-of-the-art while saving money.
Medical Equipment Source’s remanufacturing standard operating procedures are comprised of a mechanical, electrical and aesthetic process to provide the highest-quality histopathology laboratory equipment. We fully test and conduct a quality control process on each unit to ensure that all equipment meets and/or exceeds manufacturer’s specifications and all equipment comes with a warranty.
New Equipment for your Laboratory
Medical Equipment Source has forged partnerships with several manufacturers and can provide new laboratory instrumentation to support your laboratory equipment needs. All equipment comes with a warranty. We are also the exclusive distributors of the MES1000 cryostat, MES800 microtome, HP300 Tissue processor, DP360 Automated Slide Stainer, CS500 Glass Coverslipper, and the SC2000 Staining/Coverslipper System.
Staffing Your Lab
Your second large expenditure will be for staff. You will need to hire qualified technicians who are certified for the appropriate lab positions, pay your staff a competitive salary and provide your staff with ongoing training.
Standard Operating Procedure (SOP)
An SOP is a document with written step-by-step instructions of a procedure conducted in the laboratory that your staff will follow. A lab should have an SOP for each procedure and should include the name of the test, the purpose, instructions for the entire testing process and the name of the person preparing the SOP.
Lab Inspections: Are You Ready?
To ensure that a lab performs safe and accurate tests, different federal and state regulators will conduct investigations to check for compliance.
Though most inspections are scheduled in advance, they can still provoke stress. (Some inspections can also take place without notice.) The best advice? Always be prepared for a surveyor’s visit.
Refer to the checklist on the next page for some of the items a lab should have available at inspection time.
Regulatory Standards
One of the biggest hurdles in the opening and running an in-house lab is ensuring it meets regulatory requirements.
To stay operating, histology labs must regularly prove they meet requirements that cover all aspects of their work including the requirements of Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP) and the Occupational Safety and Health Administration (OSHA).
Several different regulatory bodies will inspect labs to check that all requirements are met. Which can all be handled by MES through our preventative maintenance (PM) contracts which we can get you help now on.
About MES
Since 2002, Medical Equipment Source has been providing laboratory equipment services to private practices and independent laboratories across the country and the world.
From lab set-ups to equipment maintenance to consulting contracts, Medical Equipment Source provides a complete range of solutions to physicians and practice managers looking to grow their business by offering their own in-house lab services. Medical Equipment Source provides help with lab and exam room furnishings; lab equipment and layout; consumables; repair services and more.
Today, Medical Equipment Source is an authority in the physician-owned lab market, with clients in 49 states and 30 countries. Those clients range from physicians who have launched their own labs to lab technicians who have built their own space.
Hear from our clients
“They didn’t judge my incredibly small budget but instead helped me get my start,”
says Heather, who started working with MES when she first opened her California lab.
“I’ve been in business for 10 years thanks to that.”
Lab Setup Guide
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