PURPOSE: To standardize hospital management of patients with simple congenital heart disease (CHD), we developed a protocol called the 'clinical pathway (CP)'and evaluated quality improvement in patient outcomes. METHODS: The study included a group of 60 patients with simple CHD who had surgery between June 1 and October 31, 1998. The control group included 48 patients who had surgery for the same disease during the corresponding time in 1997. Two CPs were developed according to state and place of residence of patients. Information on patients was reviewed including: education, physical examination, hospital stay, type of care and date of discharge from the hospital. The effect of each protocol on standard procedures was reviewed. After patient discharge additional performance information was assessed including: procedures used, duration of hospital stay, medical cost, treatment outcome, complications and parent satisfaction. RESULTS: The duration of hospital stay prior to surgery (1.8 days vs. 3.0 days), the ICU stay (1.3 days vs. 3.6 days), number of ward days after surgery (5.3 days vs. 7.9 days) and total number of hospital days (8.5 days vs. 14.7 days) were significantly shortened in the study group compared to the control group. The intubation time (P=0.000) and the frequency of laboratory studies (P=0.000) during the hospitalization decreased in the study group compared to the control group. The average medical costs of cases was also significantly lower in the study group (P=0.001). There were no deaths, readmissions or serious complications in the study group. A questionnaire survey of patient family members showed that they were satisfied with care; with more than 85 percent response rate to questionnaire items. CONCLUSION: Application of our new CP protocol shortens hospital stay and reduces medical costs while improving the quality of care for patients and their families. This CP protocol should now be considered for more complex CHD.