CAPHLD
Whitepaper

POSITION PAPER: Legislative Step

From the early 1900's, the State of California has recognized the important role that the laboratory plays in supporting local public health programs. In 1905, the State Board of Health ruled that cities with populations of 25,000 or more should provide their own public health laboratories, and subsequently the first California Public Health Laboratory was established in San Francisco. This clearly established State policy to develop local public health laboratories. Some years later the board amended this ruling to require any health department serving a population of 50,000 or more to provide its own local public health laboratory service. Over the years, the public health laboratory system has grown to include the State laboratory at Berkeley and to forty local public health laboratories. Some of these laboratories are operated by counties and others are city establishments. In 1927, the legislature enacted a law requiring that the State board of Health approve all such public health laboratories.

Today, the State of California regulates two distinct categories of laboratories where medical testing (1) is a primary activity: the clinical laboratory (including hospital laboratories) and the public health laboratory. These laboratories perform many of the same procedures and rely upon many of the principles from the same bodies of science; however, there is major difference in their primary function. The clinical laboratory helps the clinician whose patient is the individual; the public health laboratory helps the health officer whose patient is the community.

A medical laboratory test is any examination of material derived from the human body for the purpose of providing information for the diagnosis prevention or treatment of any disease or impairment of or the assessment of the health of human beings. The missions of the two types of laboratories (public health and clinical) are distinct and unmistakable; hence attempts to merge them may well dilute the effectiveness of each, presenting problems of budget priorities, personnel and cost of testing.

While the clinical laboratory emphasizes services to support primary patient care, the public health laboratory emphasizes services to support epidemiologic investigations and programs to prevent and control infectious diseases and pollution of air, water, and food. It supports disease prevention, which tends to keep hospital beds and clinic visits to a minimum.

One example of the combination of patient care and prevention provided to the TB patient presenting at a public health clinic. The patient is worked up, treated and followed based on laboratory data. Contacts are sought and treated as necessary again based on laboratory data. The index case may also be located and treated.

In most cases, early intervention is successful; and in such cases hospitalization will not be required. Patients can remain at home with obvious savings in the cost of care. In the case of recalcitrant patients who refuse to take the prescribed medication,

laboratory data can be used to support court-enforced isolates and medication. In other words the health department exercises its police powers based on data generated in the public health laboratory. More importantly, when release from forced detention is effected, that too is based on public health laboratory test results.

Many of the medical tests conducted in the public health laboratory are conceived to fill health needs that are not being met by private medical services. Data generated by medical and environmental tests performed in public health laboratories help the local health department determine when to exercise its police powers to protect the public's health and safety.

The different roles of public health and clinical laboratories have resulted in their being governed to a great extent by different codes and standards. In California, clinical laboratories are governed by the California Business and Professions Code (B&PC); public health laboratories are governed primarily by the California Health and Safety Code (H&SC). Implementing regulations for both types of laboratories are contained in different sections of California Code of Regulations (CCR). The statutes and regulations establishing and defining public health laboratories are described below:

1. Power to establish and required access to public health laboratory: Section 1075 (CCR), requires that local health departments have available the services of an official public health laboratory. The statutory authority for this regulation is contained in Section 1000 (H&SC). Many public health laboratory services support health department program needs that cannot be met by private medical services. Examples of public health laboratory services that are not readily available in private medical laboratories include food borne illness examinations, water testing and rabies testing. Another reason for establishment of public health laboratories is to support the health department's enforcement role in protecting the public from microbial and chemical pollutants. Often times the public health laboratory provides data needed by the health department to exercise its police powers; results of analyses performed in the public health laboratory may be used by the health officer to confine individuals who are infected with a communicable disease (e.g. tuberculosis), restrict the activities of a business such as a restaurant or water distributor associated with a disease outbreak, or restrict public access to a recreational area (e.g. posting a beaches following a sewage spill). Laboratory data used to support the health officer's police power often have significant financial impact and command public attention. Control of these services within the health department laboratory is necessary to maintain credibility and accountability.