Public Health Laboratory

General Information

• What is the Public Health Lab?

  Answer:  Public Health Laboratory is a specially licensed laboratory responsible for supporting all disease control and environmental health activities within PHP&S. The PHL supports epidemiologic investigations and programs to prevent and control infectious disease and pollution of air, water, and food. The PHL provides laboratory services for county public health and personal health centers, 5 county hospitals, county environmental management and veterinary units, and private providers. Organizationally, PHL is divided into the following divisions: General Bacteriology, TB and Mycology, Parasitology, Serology, Virology, Molecular Diagnostics, Molecular Epidemiology, Environmental Microbiology, Support Services, and Nondiagnostic General Health Assessment (NGHA) Office.

• How are test results reported?

  Answer:  

  Specimens are processed upon receipt and results are returned to submitter when testing is completed. Turnaround times vary with the amount of time required to make the various test determinations. Urgent reports are telephoned when the results are available. Other reports are faxed or mailed as submitter requests.

  The laboratory will notify submitter by telephone of the following:

  Test results on specimens from patients in sensitive occupations.

  Positive results for cerebrospinal fluids, V. cholerae, B. pertussis, malaria, E. histolytica, and other selected tests of public health significance. All results from rabies specimens.

  In addition, positive rabies results are reported to the Public Health Investigation Division immediately.

NGHA Program

• What is the definition of a NGHA Program?

  Answer:  A NGHA program is a program in which bioanalytical screening is provided to an asymptomatic individual to screen for a non-infectious chronic health condition. Individuals who appear likely to have a marker or risk factor are then referred to licensed sources of care for appropriate follow-up. NGHA programs must provide significant public health benefit as determined by accepted public health protocols and practice.

• Which laws govern regulation of NGHA programs in California?

  Answer:  Sections 1244, 1244.1, 1244.3, and 1244.4 in Chapter 195 or the California Business and Professions Code regulate NGHA programs.

• What are some examples of NGHA programs?

  Answer:  All of the following would fall into the category of NGHA programs:

  • A cholesterol screening program held at a shopping mall and sponsored by a hospital, in which blood is collected by fingerstick and tested onsite using a portable machine.
  • Glucose testing performed at a pharmacy in which blood is collected by fingerstick and test onsite using a portable analyzer.
  • Examination of stool for occult blood at a senior citizens' community center.

  
  
  The following are NOT NGHA programs:

  • Collection of blood by venipuncture at a shopping mall which is subsequently tested for glucose (or other components) at a licensed medical laboratory. (Note: this may be illegal in California unless the shopping mall location is approved as a blood drawing station).
  • Blood pressure screening.
  • Estimation of body fat content.

• Are testing programs conducted at hospitals exempt from regulations relating to NGHA Programs?

  Answer:  Programs that meet the definition of NGHA conducted by hospitals are NGHA's except: (a) those where testing is performed within the hospitals licensed Clinical Laboratory, (b) those exempted by 1241g of the Business and Professions Code.

• Are testing programs conducted at clinics NGHA's?

  Answer:  Testing programs conducted at licensed community clinics and free clinics (as defined in subdivision (a) of Section 1204 of the California Health and Safety Code) are NOT NGHA Programs.

• Why do fees for operation of NGHA programs differ among various counties?

  Answer:  Fees are calculated separately by each county or city health department using their own individual methods. Salaries of employees hired by local governments to regulate NGHA programs my vary considerably due to differences in prevailing wages in different locales. Costs of operating programs may be high in some areas depending on the number and complexity of the programs being regulated, number of personnel required, and size of geographic area covered.

• What must be done before a NGHA program can be operated?

  Answer:  Necessary documentation must be filed with the local health officer (or his/her designee) at least 30 days prior to the date the NGHA will be operated. In the County of Los Angeles (LACo), contact the NGHA office at (213) 250-8677 for specific requirements.

• Is a separate permit for transport and disposal of biomedical waste required?

  Answer:  Regulations differ among different local health departments. Contact the local environmental health enforcement agency for specific requirements. In the County of Los Angeles (LACo), the State Department of Health Services is the designated agency responsible for regulating this activity. The State Medical Waste telephone number is (916) 327-6904 (Sacramento).

• Must NGHA programs comply with CLIA?

  Answer:  Yes, More information about CLIA requirements may be obtained by calling the State of California Lab Field Services Office at (510) 873-6328.