QI programs intrinsic part of care: article

In general, quality improvement programs should be considered “an intrinsic part of good clinical care” and carried out under separate, less stringent rules and consent guidelines than those governing human subject research projects that require patient consent and institutional review board, or IRB, oversight, according to a nine-page article, “The Ethics of Using Quality Improvement Methods in Health Care” published online today on the Web site of the Annals of Internal Medicine.

The article is a summary of work that began in 2003 when the not-for-profit Hastings Center, Garrison, N.Y., convened a group of healthcare experts to discuss the ethical issues involved in quality-improvement efforts. The sessions led to the publication last summer of a 40-page report on the topic.

Research for the report and today’s article was performed under a grant from the federal Agency for Healthcare Research and Quality at HHS. The Hastings Center publishes two journals on healthcare policy and oversees research in bioethics involving care and decisionmaking at the end of life, emerging technologies and public health.

The quality improvement ethics project addressed three questions:

  • What is quality improvement and what is its role in healthcare?
  • What ethical requirements should quality improvement activities meet?
  • What arrangements are needed to ensure ethical conduct of quality improvement?

The definition of quality improvement stated in the article is fairly straightforward: “The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in healthcare deliver in particular groups.”

{The assertion that all Americans should be forced to have their medical records searched and used for “Quality Improvement” without consent is both unethical and illegal. The nation’s electronic medical records are a massive treasure trove of identifiable and highly sensitive data, inspiring a never-ending parade of users who want access to our records without consent because they believe can provide some benefit to us. Maybe so. The problem is that we should each be able to decide what our records can be used for, not anyone else. Every new access to and use of electronic health records subjects us to new risks that our privacy will be violated. That is why our informed consent should be obtained first beforeany use, no matter how helpful or benign. ~ Dr. Deborah Peel, Patient Privacy Rights}

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