PubMed · 14671445
Develop a firmer understanding of the role genetics plays in health and disease, and incorporate genetic questions into patient assessment.
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Dale Halsey Lea. 2003. How genetics changes daily practice.. https://doi.org/10.1097/00006247-200311000-00010
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BACKGROUND: The operational and economic impact of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was evaluated. The setting was a natural experiment which involved a single-site, clinical research study that was initiated before the enactment of HIPAA and subsequently modified to be compliant with the new policy. METHODS: A formative assessment was conducted of the recruitment process to a clinical trial evaluating the efficacy of an educational strategy to inform Veterans about the National Cancer Institute/Department of Veterans Affairs cosponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT). Personnel time and costs were determined based on weekly accrual for study periods before and after the implementation of HIPAA. Root cause analysis was used to assess the recruitment protocol and to identify areas for improvement. RESULTS: The implementation of HIPAA resulted in a 72.9% decrease in patient accrual (7.0 patients/wk vs. 1.9 patients/wk, P < 0.001), and a threefold increase in mean personnel time spent recruiting (4.1 hrs/patient vs. 14.1 hrs/patient, P < 0.001) and mean recruitment costs (49 US dollars/patient vs. 169 US dollars/patient, P < 0.001). Upon review of the modified HIPAA-compliant protocol, revisions in the recruitment procedure were adopted. The revised protocol improved weekly accrual by 73% (1.9 patients/wk vs. 7.1 patients/wk, P < 0.001) and resulted in improvements in personnel time (5.4 hrs/patient) and recruitment costs (65 US dollars/patient). CONCLUSION: Enactment of HIPAA initially placed a considerable burden on research time and costs. Establishing HIPAA-compliant recruitment policies can overcome some of these obstacles, although recruitment costs and time are likely to be greater than those observed before HIPAA.
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Audit is a term used to include case reviews, criterion-based clinical audit, enquiries into maternal mortality and perinatal deaths, and near-miss reviews. The audit cycle consists of identifying cases, collecting information, analysing the results, formulating recommendations, implementing change and re-evaluating practice, and this cycle must be repeated regularly. Implicit in the process are standards against which practice is measured. These standards are becoming increasingly explicit and may be based on hospital protocols or regional or national guidelines. When protocols or guidelines are drawn up, this must be on the basis of multidisciplinary discussion and they need to be regularly updated as new evidence emerges. Audit does not need to be expensive, but it does need the support of all staff, including managers and clinicians. Staff must understand that its purpose is not to identify errors and punish mistakes but to improve clinical care.