MAUDE was my first source. She led me to a largely hidden world of death and injury inside America's hospitals. She provided scant details. Sometimes she was simply wrong. But she was unerringly on target where it counted most. That information became the foundation of a Chicago Tribune series (Sept. 10-12) which detailed how overwhelmed and under-trained nurses kill and injure thousands of patients every year as hospitals sacrifice safety for an improved bottom line.
MAUDE is available as your source, too. Officially, MAUDE is the Manufacturer and User Facility Device Experience database offered freely by the U.S. Food and Drug Administration (www.fda.gov/cdrh/databases.html). It is also available from NICAR. With more than one million records, the database tracks adverse events involving medical devices. With a twist in thinking, it can also be used to track cases involving human error.
Amidst the dozens of fields are two 1,000-character text fields, which provide mini-narratives of each incident. In thousands of cases plucked out through Access queries nurses were believed responsible for fundamental errors. How many patients have been accidentally overdosed through the use of infusion pumps? How many patients were fatally trapped in their bed rails? How many patients connected to life-saving machinery died unnoticed in their hospital beds?
MAUDE was just one of a dozen major sources for this project. Despite the narratives, MAUDE typically offers vague, inconclusive information. There are no patient or hospital identifiers. Fortunately, there are companion paper records that can yield more details and I pulled many thousands of reports - but MAUDE is more of a pointer than a destination. I exported Access query files to Excel and began building a custom database beginning with the sketchiest of clues gleaned from MAUDE.
'Blanks' were filled through the use of a dozen state and federal public record sources, from federal healthcare investigative reports to court records. My custom database became a giant jigsaw puzzle. MAUDE helped define a border, but other databases and paper records filled in the picture. I launched into this subject with little more than a realization that the nursing profession was a largely unexamined, essential component of the U.S.
healthcare system. There were no signature lawsuits or events. The Tribune encourages reporters to scout out general themes. I initially looked at workplace safety issues surrounding the way medications are labeled, but I quickly settled into the challenge of quantifying nursing-related errors. Exploiting a back-door FOIA strategy, I obtained five years of nurse disciplinary records spanning every state and U.S.
territory. The National Council of State Boards of Nursing (www.ncsbn.org) compiles this non-public database. However, paper copies of the database are regularly sent to state licensing agencies, which turns the privately compiled data into a public record. Illinois reluctantly turned over the massive files, which were scanned into Access. Violations receive numerical tags as well as descriptions, such as drug offense, medical error or felony conviction.
After identifying key cases, I filed additional FOIAs for full investigative files from each state. These records can provide a startling picture into how patients are killed and injured. Records revealed that some states withhold information about death or injury from public files as part of a plea bargaining process with nurses who agree not to contest administrative sanctions. For an airtight picture of Illinois, I computerized 10 years worth of disciplinary records after spending two weeks combing through musty file cabinets located in the bowels of a state licensing agency.
Many states offer limited records online through boards of nursing agencies (www.ncsbn.org/files/boards/boardswebsites.asp). MAUDE coupled with disciplinary records began to provide a clearer, provable picture of medical errors linked to nursing. But a Lexis-Nexis search of lawsuits provided more cases and filled more blanks. Another gold mine of solid information is found in federal investigative reports by the Health Care Financing Administration, part of the U.S.
Department of Health and Human Services. HCFA provided computer searches from their extensive database. For example, I wanted lists of every hospital that had received a routine annual survey or had been the focus of a complaint investigation. In most states, HCFA investigations are conducted by state public health officials who contract with the federal government. Reports are kept by HCFA and the state.
FOIA reports from the state; it's much quicker. Federal law designates these files as public records. Even if there is a state law banning disclosure of hospital records (as in Illinois), federal public record laws supersede state law. A handful of states post information on the Web. The best is Colorado's Department of Public Health and Environment (www.cdphe.state.co.us/hflhfd.asp), which provides searchable access and mini-narratives involving hospital investigations.
Most hospitals maintain private databases. Some facilities turned over their data for inclusion in my custom database. For example, one hospital acknowledged dozens of medical errors monthly. The Tribune also created custom databases to track staffing levels and other criteria, such as how many nonprofit hospitals had been purchased by for-profit companies. The Volunteer Trustees (www.volunteertrustees.org/index.html), a national organization of not-for-profit hospital and health system governing boards, maintains a database of conversions.
Likewise, dozens of healthcare organizations have accumulated databases of information. Many will share portions of their records, which can provide pointers to court cases or state and federal documents.