If you've ever thought about expanding your primary care practice with in-office point-of-care testing (POCT), you'll want to have a clear understanding of how to run a laboratory before you start. There are many benefits to physician office lab testing, both for your patients and your practice.
Your patients benefit from:
- Faster treatment plans, based on the lab results you receive during their office visit and the treatments you tailor accordingly
- Conveniently getting routine labs drawn during their office visit so they don't have to make a separate trip to a lab for additional bloodwork
- Streamlined billing combining office visits and in-house lab services
Your practice benefits from:
- Improving patient compliance for needed treatment plans based on in-office test results
- Revenue growth and retention from in-house testing
- Greater operational efficiency by reducing the need for phone calls to relay routine outsourced lab results
- Fewer unnecessary antibiotics prescriptions for presumed bacterial infections
Read more about the pros and cons of physician office lab testing in our article, Physician office lab testing: Is it appropriate for your practice?
How to run a laboratory
Before you can launch your own POCT lab, you'll need to understand current office-based lab requirements. Relevant points include:
- Regulatory requirements, including CLIA waived laboratory procedures
- Physical requirements
- Test selection
Here's what you need to know.
The Clinical Laboratory Improvement Amendments (CLIA), a set of federal regulatory standards introduced in 1988, governs every lab that performs human testing in the United States.1
Before you can test any patient samples, you must first have a CLIA license. Your POCT lab is likely to qualify for a Certificate of Waiver. This waiver allows you to perform CLIA waived laboratory procedures in your practice.
Your waiver does not grant you the right to perform any tests that don't have CLIA waivers in your state. Additionally, you must:
- Follow all manufacturers' directions for waived tests without making any changes
- Notify your state agency of any changes to your POCT lab, including ownership, name and address
- Notify your state agency if you wish to add tests that are not CLIA waived
- Allow a representative of the Centers for Medicare & Medicaid Services (CMS) to conduct on-site inspections of your POCT lab upon request
Don't take any shortcuts with CLIA licensing. Your distributor and lab equipment supplier can help you identify cost-effective sources of information, whether you're taking the first step for CLIA-waived tests or are ready to offer more involved testing.
Learn more about CLIA waived testing in your practice in our article, How to run a laboratory: CLIA waived office-based lab requirements.
Physical requirements for POCT labs
In order to achieve reliable test results, you'll need an appropriate physical environment for your in-house POCT lab.2 In general, your staff should perform testing in a clean work area with space for patient privacy. You also need to consider their safety while collecting samples and performing testing.
Here are some points to consider as you create your in-office lab space:
- Utilities: You may need to hire contractors to add or upgrade electricity and water
- Lighting: Make sure there is bright, even lighting for sample collection and testing areas
- Workspace: Find a surface that's level, stable, easily disinfected and allows for patient confidentiality
- Ergonomics: Evaluate your lab area for possible ergonomic issues that could cause staff members undue fatigue, strains or repetitive stress injuries
- Safety labels: Label all lab equipment and testing areas for hazards and post phone numbers for equipment manufacturers
- Temperature: Make sure your lab area is not subject to temperature extremes, which can affect test results
- Housekeeping: Keep your testing area clean, organized and clutter-free and make sure that you've trained staff members to handle and dispose of biological waste properly
You'll also need to purchase various lab supplies. These may include:
- Dedicated laboratory refrigerator (no food storage allowed!)
- Phlebotomy consumables
- Urine collection cups
Bonus points if you're able to create a space that lets you expand your lab capabilities as your practice grows.
Read more about helping your staff prepare to offer physician office lab testing in our article, How to run a laboratory: Getting ready to implement physician office laboratory testing.
As the first step for CLIA waived tests, evaluate your send-out testing patterns from the previous several months and select those you send out most frequently. Focus on tests you can perform and discuss during the patient visit (15 minutes or less). Most of these are CLIA waived tests, which is important when you're implementing a new in-office laboratory.
CLIA waived tests used for general screening include:
- Comprehensive metabolic panel (CMP)
- Basic metabolic panel (BMP)
Depending on your practice profile, you may want to offer routine screens for pregnancy.
CLIA waived risk-based screening might include:
- Lead testing (children)
- Fecal occult blood (patients over 50)
- Hepatitis C virus
Also, consider CLIA waived tests used to detect acute onset disorders:
- Amylase (GI pain and appendicitis)
- Influenza (respiratory symptoms)
- Group A strep (respiratory symptoms)
- RSV (respiratory symptoms)
- COVID-19 (respiratory symptoms)
- Gastric blood (abdominal pain)
- Urinalysis (dehydration, UTI)
- Glucose (ketone breath, disorientation, loss of consciousness)
It's important to note that the complete blood count (CBC) test is not CLIA waived, despite its vast usefulness in clinical medicine in both chronic and acute cases.
Additionally, you'll want to consider adding molecular diagnostics, the testing platforms that detect specific sequences in DNA or RNA. Infectious disease diagnosis and management are likely the most relevant application of molecular testing in the primary care setting.3
New molecular diagnostic platforms now offer a wide range of tests for common respiratory and enteric pathogens that deliver fast, accurate results to guide proper antibiotic prescription. Molecular tests are becoming easier to use, with user-friendly test formats and sophisticated software and hardware. Some test methods even feature CLIA-waived testing.
Learn more about selecting tests for POCT labs, including product examples, in our article, How to run a laboratory: Determining point-of-care testing options.
Looking ahead to more complex testing
When your practice becomes comfortable offering CLIA waived testing, you may consider expanding to include moderately complex laboratory services in your practice.
You'll want to consult trusted sources such as manufacturers, distributors or consultants to help you with technical issues such as licensing, staffing and test selection based on your available lab space and equipment.
Your patient volumes and testing menu can also help you determine which analyzers, test systems and test kits you'll need.
When selecting lab test systems and analyzers, consider the equipment that:
- Fits within your available physical space
- Lets you conform to the manufacturer's specifications for electrical, plumbing, ventilation and internet capability
- Is cost-effective and easy to use
- Includes appropriate test menus and visual displays
- Requires little or no maintenance
Learn more about requirements for moderately complex lab testing in our article, Transitioning from CLIA waived tests to moderately complex lab testing at your physician office.
Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
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