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Quality Management Software Needs Greater Accountability

By Hon. David Carlucci

We’ve come a long way in healthcare in recent decades and the data clearly show that following established, best-practice procedures is critical to saving lives. Even so, more than 250,000 Americans die each year from medical malpractice, according to a 2016 Johns Hopkins University study — pre-Covid-19 — so we have an enormous way to go.

Quality management software in hospitals and pathology labs is supposed to protect the integrity of healthcare data and to ensure that best practices are used when treating patients, but legal software currently on the market allows users to cover up mistakes without any trace that they occurred. That’s dangerous to patients and to patient justice, and something must be done about it.

When malpractice is alleged, the first thing patient attorneys subpoena are these records. They’re supposed to show exactly what was done to treat each patient. Time stamps are expected to indelibly capture where, when and by whom medical decisions were approved and performed. Authorizing entities are supposed to be identified and permanently recorded.

In at least one software product widely used in the U.S., though, there are blatant workarounds to each of these patient safeguards. Users can backdate medical procedures to before they were approved without any bells going off. Login names and passwords are visible to administrative users, and user profiles can be merged. Documents requiring medical director approval can be signed off on without the express approval of a medical director, and answers on tests are conveniently highlighted for test takers, among other things.

Legislation I introduced in the New York State Senate (New York S.9060) would have prohibited things so obviously wrong in the medical quality management software industry — so obviously dangerous to patients — that they should render even the most casual reader slack-jawed:

  • Falsifying a medical record or live file;

  • Backdating records or the altering of real-time, computer-generated time stamps;

  • Merging user profiles that could obscure user identities, and

  • Displaying user passwords in plain text to other people.

How is it possible that any of these functions isn’t already banished? It defies common sense.

Medical quality management software has revolutionized American medicine and saved countless lives. But it’s an industry with remarkably little oversight, considering its importance. We need to do better.

David Carlucci was a New York State Senator, and a member of the Senate Health Committee, from 2011-2021.

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