The goals of the federal and state antitrust laws and of the federal and state health planning laws often appear to be in conflict. The health planning laws encourage cooperation among providers of health care services and the sharing of facilities and services, based upon the premise that competition in the health care field has not succeeded in containing costs or adequately distributing resources. Generally, it can be said that the health planning laws, by establishing controls to prevent the unnecessary duplication of services, protect service monopolies. In contrast, antitrust laws are designed to prevent the establishment of monopolies which are able to control the supply of services. The antitrust laws are intended to promote a vigorous and competitive economy, in which businesses have a full opportunity to compete on the basis of price, quality and service. As a result of this conflict, those involved in health planning have become concerned about the legal environment in which they act.

Within the past decade, in vitro diagnostic kits have become increasingly important to the clinical laboratory. Smaller hospital laboratories, in particular, lack the resources to develop and evaluate the large number of laboratory tests considered standard today. For these laboratories, the commercially available reagents, packaged with directions for use, provide a simple method of adding an otherwise unavailable test to the laboratory “menu.” These laboratories, however, are precisely the ones which lack the time, resources, and personnel to evaluate each kit. Furthermore, many manufacturers provide little or no information to back up their labeling claims for in vitro diagnostic kits, and there is little independently published information on the subject. The laboratory director is left to rely upon the integrity of the manufacturer, and typically chooses between competing products on the basis of unit cost and ease of performance.

Congress addressed these problems with the Medical Device Amendments of 1976, which extended the application of the Food, Drug and Cosmetic Act.

In the health care field, the concept of protected employee activity under the National Labor Relations Act (NLRA) must be balanced against the need to avoid the disruption of patient care. Congress acknowledged the need to balance these competing concerns when it included Section 8(g) within the 1974 Health Care Institution Amendments to the NLRA.

Section 8(g) establishes a notification procedure with which a labor organization must comply before commencing a strike or other concerted work-stoppage. In an effort to ameliorate the threat which an unannounced and unanticipated stoppage of work poses to the delivery of health care, Section 8(g) requires that a labor organization provide the health care institution and the Federal Mediation and Conciliation Service with written notice specifying the date and time of any strike, picketing, or other work-stoppage at least ten days in advance of the planned activity.