Summit Health is the only provider that meets the regulatory requirements for on-site CLIA-waived health screenings and immunizations in all 50 states. Our clinical department tracks all of Summit Health’s screening licenses and certifications to ensure currency and compliance with state and federal regulations.

Maintaining compliance with CLIA (Clinical Laboratory Improvement Amendments) and other regulatory requirements is detailed, time-consuming work that can be overwhelming without a significant investment and staff dedicated to that purpose. Summit Health has a director of regulatory affairs whose job it is to monitor changes in local, state, and federal regulations and ensure that we meet all requirements. In addition, Summit Health has a Medical Advisory Board and a licensed medical director, with standing orders in all 50 states and Puerto Rico.

As part of our competitive analysis, Summit Health has contacted every state to determine which of our competitors holds the necessary licenses to conduct health screenings. Much to our surprise, we learned that none of our competitors is licensed to conduct health screenings in all 50 states. Employers that utilize health screening vendors that are not licensed for a state in which they provide screening risk adverse legal and regulatory outcomes, embarrassment, and significant setbacks for their wellness programs.

Summit Health’s director of regulatory compliance and our national laboratory consulting firm monitor federal and state regulations, and boards of pharmacy. In addition, our Medical Advisory Board reviews and approves all our guidelines and protocols, and our legal counsel annually reviews changes to health care industry and government regulations.

National Guidelines

To establish our healthy heart screening guidelines, Summit Health monitors national guidelines from the following reference sources:

• For lipid testing, the National Institutes of Health (NIH) and primarily the National Cholesterol Education Panel (NCEP) – Adult panel III. (www.nhlbi.nih.gov)
• For fasting and non-fasting glucose, the American Diabetes Association (ADA),
• For Blood Pressure and BMI screening, the National Heart, Lung and Blood Institute (NHBLI).
  
  

State Regulations

Summit Health must follow not only federally mandated reference guidelines, but also comply with state-specific testing/counseling/referral guidelines. For example:

• Maryland has state-specific regulations on counseling and referral regulations which are more stringent and give specific indications of the education a patient must receive based on the screening results. Maryland also allows limited testing (cholesterol and HDL). These guidelines dictated by Maryland CLIA.
  
  
• Maine CLIA requires the use of a state-specific educational pamphlet for healthy heart counseling and only allows limited testing (cholesterol and HDL).
  
  
  
• Massachusetts CLIA requires that Summit Health provide a list of instrument limitations to each participant so they may be taken into consideration during the interpretation of test results.
  
  
• Oregon does not allow Triglyceride testing on any participant who has not fasted at least 12-16 hours prior to the event.

Click here to see the Summit Health Federal CLIA certificate.

Summit Health has a medical director in every state, authorized to prescribe biometric screenings, venipunctures, and immunizations. While members of the Medical Advisory Board can also provide standing orders for immunizations and screenings, the primary roles of the Medical Advisory Board are to:

1. Review and approve Summit Health medical protocols and procedures on a yearly basis; making appropriate changes as necessary.
2. Update referral and panic values per NIH clinical practice guidelines.
3. Review educational presentations and participant handouts.
4. Develop physician interpretation letters and review lab results.
5. Develop protocols for new Summit Health screenings and immunization programs.
6. Authorize Summit Health to bill insurance companies, including Medicare.
7. Comply with requests for information in the application for and renewal of state licensures.
8. Serve as the credentialing committee for the Summit Health physician network.
9. Provide guidance on new services, including our Mobile Executive Physical.