Getting Ready to Implement In-Office Laboratory Testing

When determining whether to add laboratory testing to your medical practice, the one question you should ask yourself is, “Will a treatment plan be initiated or modified based upon what I learn from having test results available during the patient visit?” Findings show that in more than 90% of patient conditions in primary care settings, the answer is yes.

Yet, even with such a high percentage, many medical practices don’t offer in-house laboratory testing for a variety of concerns:

• My patients do not want/need test results during the visit
• We don’t have time to do the tests in house
• My staff is comprised of dedicated care givers; we are not lab professionals
• We don’t have the room
• We don’t have the right lab license
• We don’t have the financing to set up a lab
• We are concerned that our results may not be satisfactory
• We are already subject to a large and increasing volume of regulatory oversight and do not have the time or resources to keep lab records and manage lab inspections

In response to these concerns, we offer three key criteria that can help tell you how to prepare for developing and implementing a physician office laboratory.

1 | Readiness to implement a laboratory
2 | Willingness to implement a laboratory
3 | Ability to implement a laboratory

But, first and foremost, each practice must decide its defining reason for implementing a laboratory, and make sure it is clearly communicated to both the staff and the patients of the practice confidently. This is your “lab mission”. One recommended lab mission is: “to provide routinely needed lab screening and monitoring tests important to guide development and/or modifications to the treatment programs for our patients”. The mission statement establishes the credible reason for performing these services and serves as a reminder of the importance of lab testing in the patient care mission overall. It also creates the general boundaries of which tests will be performed and which will be sent out to a hospital or reference laboratory.

Once you are confident of your lab mission, it’s time to address being “ready”. Careful planning smooths the path to efficient implementation and adds confidence with the staff and patients alike.

Are you ready to implement a laboratory?

Test Ready

Being lab ready has many dimensions, including determining which tests to perform. This is a critical decision. Here are some considerations and best practices to think about:

• Many practices focus on tests that can be performed and discussed during the patient visit (15 minutes or less)
  • This would include lipids, urinalysis, rapid pregnancy, respiratory and some cardiac markers as well as hemoglobin A1C
    • Most but not all of these tests will be CLIA waived and most will not require a capital investment
  • Starting with core tests and adding more tests as your experience grows is a sound way to begin testing
• A simple way to determine your core testing needs will be to evaluate the last few months of tests sent out and select those you send out most frequently
• Your distribution partner can provide you with literature and even product demonstrations to help you select the right tests and technology
• A more exhaustive discussion of commonly performed tests, key technologies and their CLIA status will be provided in the third article in this series
• Discussion and consultation with your staff and colleagues about patient testing needs should help you solidify your choices

Staff Ready

• Does the staff buy in to the lab services to be provided?
  • Their commitment to success is critical; you need to remind them that lab is a routine element of patient care
• Roles and responsibilities for testing need to be established
  • Who will draw blood if needed?
  • Who may WANT to perform testing
  • Who is the backup person if your routine testing person is ill, on vacation or leaves the practice
    • A lab without back up can lead to issues once the practice and patients become accustomed to having lab tests performed during the visit
  • Assure a training plan for the testing devices is in place
    • Your distributor and lab equipment supplier can help
    • Training leads to confidence and competency

Insurance & Billing Office Ready

• Is your staff prepared to bill for the tests you will perform?
  • Make sure the ICD-10 and CPT codes are well known and readily available
• Discussion and consultation with your key private insurance providers before testing is important to assure they know your plans and will cover the testing you plan to perform
• It is not uncommon for the first claim for a new CPT code to be challenged even though it is appropriate
  • Be ready to re-submit a few of your first claims and have dialog with the payers

License Ready*

• Know which CLIA license you need to have to perform the tests you plan to perform
  • Personnel, quality control and training requirements vary based on that decision
  • Your distributor and lab equipment supplier can help you understand these requirements
  • No matter what scope of testing you plan to perform, you will need to complete a CMS 116 form and send back to the Centers for Medicare and Medicaid services
• For moderate complexity labs, the requirements include a qualified medical director
• There are a number of online courses available (typically 20 hours) to permit a physician to qualify
  • How to apply for a CLIA certificate (CMS)
  • CLIA application for certification (CMS)
  • Personnel for non-waived testing (COLA)

Are you willing to implement a laboratory?

Willingness to implement lab testing involves both confidence in the testing mission and commitment to implement the lab tests and overcome obstacles along the way.

• You and your staff need to be committed to the decision to test in house
• You need to portray confidence to the patients of the practice
  • Most practices find patients prefer this level of service during the visit
• Be prepared for speed bumps: product back orders, training plan modifications, facility modifications and the like
  • They are all part of establishing a new level of service and will become routine over time
• Willingness will help assure that the practice continually challenges which tests it performs and how efficiently it manages this element of the practice.

Are you able to implement a laboratory?

Ability tests every element of “readiness” and is your final assurance that your laboratory will run smoothly and provide the service level you and your patients expect.

• Licensing and personnel considerations are paramount and need thorough understanding and evaluation
  • Colleagues and third party resources including online tutorials provide essential knowledge
  • Your distributor and lab equipment supplier can help you identify cost effective sources of information
• Be prepared to upgrade your facility to be “lab ready”
  • Expect surprises along the way and be prepared to meet them head on
    • E.g. you may need a modest upgrade to electrical service or a neatly organized filing system to manage this new lab service
• Ongoing training for all staff involved in lab testing is both required and important
  • Continuing education is an essential element of an efficient, modern lab
• Have a backup staff plan in place before you initiate testing
  • Assure at least two personnel are ready, willing and able to perform tests to avoid service interruptions
• Be prepared for patient questions about why the practice performs some tests and not others

Continue your learning. Read more about in-office laboratory testing.

*This content is intended to provide only a general overview and it is recommend an expert be consulted regarding specific licensing requirements.