Mobile Health Screenings

There are two different types of mobile health screenings allowed under state law, each having specific requirements. Regardless of type, consumers should be aware of the risks and limitations involved, and should exercise due diligence and caution.

1.  NON-DIAGNOSTIC assessment of general health:

Program Information

a.    The purpose of this type of program is to screen asymptomatic individuals for chronic health disorders and to refer individuals to licensed sources of care as indicated.

b.    Testing is performed on site and reported directly to the person requesting the test.

Test Restrictions

c.    The program only performs tests classified as waived under the federal Clinical Laboratory Improvement Amendments (CLIA) according to the manufacturer's instructions, and does not test for human immunodeficiency virus (HIV) or any reportable disease or condition.

d.    The tests performed must be approved by the U.S. Food and Drug Administration (FDA) for sale to the public without a prescription in the form of an over-the-counter test kit.

e.    Blood collection is performed by skin puncture only.

f.     Testing of a urine specimen is performed by the dipstick method only.

g.    Personnel must be licensed or certified to perform skin punctures.

Operation Requirements

h.    The entity providing the program must be registered with the California Department of Public Health (CDPH).

i.      The program maintains a supervisory committee consisting of, at a minimum, a licensed physician and surgeon and a licensed clinical laboratory scientist.

j.      The entity operating that program must notify the local health officer in the county of operation 30 days prior to the event of the: location, type and kind of non-diagnostic general health assessments being conducted, dates and times of operation of programs, and evidence that the program will be operated in compliance with CDPH guidelines.

k.    The local health officer must be notified of any changes to location, dates, or times at least 24 hours prior to the event.

2.    DIAGNOSTIC screening health fair:

Testing Restrictions

a.    This program can perform any clinical laboratory test.

b.    Personnel collecting and performing the tests must be licensed, certified, and qualified to do so.

Operation Requirements

c.    The entity providing the program must be licensed or registered with CDPH, and must have the appropriate CLIA certificate for the type of testing performed.

d.    If testing is performed in a van, the van should have a CLIA certificate with the address of the main location. The CLIA certificate can cover multiple vehicles, but each van should be able to provide a copy of the CLIA certificate.

Consumer Safety Tips

Prior to going to a mobile health screening we recommend that consumers:

Contact the provider to:

• Find out what type of testing is being offered.
• Find out the purpose of the program and how the results will be used.
• Ask if blood collection will be performed by skin puncture or venipuncture.
• Ask for the qualifications of the personnel that will collect blood specimens or perform tests.
• Ask to see their license or registration with CDPH.
• Check to see if they notified the local health department.
• Find out if there is a charge for services or if it is covered by medical or insurance.

Consumers can:

• Check to see if the local health department was notified.

Consumers should:

• NOT give personal information such as SSN or medical record number.
• Always be vigilant regarding identity theft.
• Be aware of the risk of infection from blood borne pathogens.
• Follow up with their own physicians. Screening tests and general health assessments are limited. They may not always provide a complete or accurate assessment of health. These test result may set off false alarms or give a false sense of security, due to false positive or false negative results.