The impact of the amendment to the Infectious Diseases Control Law on the management of clinical laboratories

: In December 2006, the Japanese parliament promulgated an amendment of the Law Concerning the Prevention of Infectious Diseases and Medical Care for Patients of Infections (the Infectious Diseases Control Law). The main elements of the amendment provide a pathogen control system that will prevent biological terrorism, global and accidental spread of infectious diseases and allow for comprehensive control of infectious diseases, including tuberculosis. State intervention was substantially curtailed in the original Infectious Diseases Control Law because of the demand at the time for decentralization. However, the rising danger of bio-terrorism has established an urgent need for direct control by the state. Developing the necessary regulations for laboratory safety and pathogen collection to prevent bioterrorism is an onerous task. The rules must take account of real conditions on the ground and to be seen to work. However, whereas the new rules may be efficient in the prevention of terrorism, there is a real suspicion that they will impede and obstruct the day-to-day routine of the clinical laboratories. We report a questionnaire concerning the influence of this law on the clinical laboratory management in 84 university hospital laboratories. The imposition of well-intentioned but implausible regulations that impair or disrupt routine laboratory work encourages employees to selectively ignore regulations that they feel are impractical or irrelevant.