Non Diagnostic Health Screening
You will find below application forms for registration of a nondiagnostic health screening program. These regulations apply to programs involving blood analyses carried out separately from regular clinical settings.
The objectives of the program are to ensure:
• Quality control of the laboratory tests, especially when portable equipment is used.
• The utilization of protocols that address staff training measures for patient handling, safety, and infection control.
• That full disclosure is made to the patient of the risks and limitations of the procedure.
• That the patient receives appropriate written advice as to the meaning of the results, including the possible need for referral to licensed sources of health care for follow-up.
The information required from you is to help us assess that these objectives are met. Site visits may be made to programs.
Please note that you must also provide a current valid CLIA registration number in order to register your screening program. The purpose of this registration program is to ensure compliance with California regulations, however, your program is also required to comply with CLIA 88 regulations and may be subject to federal inspection.
If you have any questions about the program, please contact Debra Palacio at 681-5255.
Non Diagnostic Health Assessment Application
Part I: Registration
Part II: Additonal Site
Part III: Compliance
All three are required for new and renewing applicants. Once registered, only Part II is required for additional events per year.
1st time registration (one event is included in this fee): $100
Events: $63 for NGHA programs which operates for no longer than seven consecutive days.
$100 for NGHA programs whose operation extends over a period of time longer than seven days.
If over 30 days, please contact us at 805-681-5255.