In an effort to promote transparency in healthcare, the Association of Health Care Journalists (AHCJ) has published a database of recent hospital deficiencies discovered by Medicare and Medicaid inspectors. They then highlighted 168 reports containing the phrase “immediate jeopardy.” This, of course, piqued my interest as I presumed that hospitals who were putting putting patients in “immediate jeopardy” must be some pretty bad actors.
After sifting through the hospital names, I saw no record of ones who should probably be on the list based on my personal experiences. I did find some surprises, including well respected academic centers (including Stanford, UCSD, and Intermountain Health). I did a “deep dive” on a hospital for which I have a good deal of respect and some familiarity. What I discovered was both funny and sad.
In the case of the hospital that I knew, the very grave concerns expressed by the inspectors turned out to revolve around patient signatures on HIPAA documentation, and physicians refreshing their electronic restraint orders on patients with traumatic brain injuries. These documentation mishaps had landed the hospital on the ominous list of institutions who are “putting patients lives in immediate jeopardy.”
What a waste of inspector time and hospital resources! Apparently, a hospital who passes CMS muster simply means that they are providing documentation correctness to patients. Forget the real sources of life-threatening dangers – medication errors, poor physician handoffs, unnecessary testing and treatment, and unsanitary conditions. What the safety police are focused upon is whether or not the sick and delirious signed their health information privacy paperwork.
Now don’t get me wrong, I think it’s important to let patients know their rights, etc. But I’ve yet to see more than 10% of patients even read the HIPAA-related documentation that they sign. Surely an absent signature or two shouldn’t land a hospital on a humiliating federal watch list.
True patient safety cannot be regulated. It is far too complex and nuanced, requiring collaboration between all members of a hospital’s staff. From frequent nursing surveillance, to careful medication review, to laboratory critical value alerts, to conscientious sanitation practices – hospital culture dictates whether or not a patient receives excellent care. Watch lists would be far more accurate if they were simply based on hospital employee questionnaires. As Dr. Marty Makary has discovered, complicated care quality algorithms are no more accurate at predicting hospital excellence than simply asking staff if they’d recommend the place to family members.
So next time you see your hospital flagged by the feds, don’t assume that there is a serious problem going on – better to ask someone who works there if it’s a safe place for care.
The recent peanut butter/salmonella outbreak offers another opportunity to reflect on the underlying budget crisis and staff shortage at the Food and Drug Administration. I interviewed Tommy Thompson, former Secretary of Health and Human Services, about what the peanut butter debacle tells us about the FDA inspections of our food supply.
You may listen to our conversation by clicking on the play button, or read a summary below. Enjoy!
Dr. Val: Has this recent outbreak influenced how the FDA tracks food ingredients?
Thompson: No it hasn’t. We have a serious food problem in America because the FDA is understaffed. There have been too many outbreaks of food poisoning – everything from listeria on cucumbers and onions to salmonella infections from ice cream and peanut butter. Approximately 82 million people experience an episode of food poisoning each year, 350,000 of them require treatment in a hospital and 8,000 die. People don’t seem to realize what a large problem food poisoning is until there is a new outbreak. The recent peanut butter contamination affected between 700-800 different food products.
Americans need to realize that the FDA is severely understaffed and cannot do the inspections necessary to protect all of our food. I’ve been harping about this for a long time. When I was Secretary of HHS I was able to increase the number of inspectors by 100%, but since I left the funding was decreased and the numbers of inspectors is back to the level when I started.
There are 64,000 venues that the FDA has to inspect, and there are only 700 inspectors. It is geographically and mathematically impossible to do all the inspections. The FDA is responsible for inspecting 80% of our food supply while the department of agriculture does the rest. The department of agriculture has 7000 employees and 6000 venues that they have to inspect. Just compare the resource differential between the FDA and the department of agriculture and you see the serious constraints under which the FDA operates.
The department of agriculture inspects every meat processing factory every day. But an FDA inspector may get to a food processing plant only once every 6 or 7 years.
Dr. Val: Wow, that’s enlightening and also terrifying at the same time.
Thompson: Yes, it really is. We inspect less than 1% of the food coming into America. The amount of imported food continues to increase as the number of inspectors decreases. We have some serious problems with our food supply and it’s about time that congress recognized this.
The FDA is doing the best job they can, and yet they are regularly criticized by the media. When you consider their limitations, they’re doing a heck of a good job with the resources they have.
Dr. Val: So what do we need to do to improve this situation?
Thompson: The FDA needs a larger budget, we need to get more inspectors out there, we need updated testing technology, but we also need a more modern law that would require food processing plants to file an affidavit with the FDA to ensure that their food is safe. There’s very little supervision of these companies.
Dr. Val: Is there anything the public can do to petition the government to increase funding to the FDA so they can inspect our food properly?
Thompson: There’s a coalition to improve the quality of food inspections at FDA and I’m a part of that. There are people in congress who are working on introducing legislation to provide the FDA the resources necessary to hire more inspectors, and to require affidavits of safety from food processing plants.
Dr. Val: Do you think Dr. Joshua Sharfstein will become the new FDA commissioner?
Thompson: Sharfstein is being considered for a position at FDA, whether it’s commissioner, assistant commissioner, or chief of staff I don’t know.
Dr. Val: Do you have any advice for the new FDA commissioner, whoever it is?
Thompson: Yes. In addition to lobbying for increased funding to support more inspector positions, he or she should consider appointing a special commissioner of food that would report directly to the Secretary of Health and Human Services. The new FDA commissioner should focus on getting medicines and new drugs to market. In 2008 we had fewer new drugs get to market than any year since 1981. The entire FDA is overworked, the responsibilities are great, and congress meddles too much in their affairs, though that may change now that the democrats control both houses and the presidency.
The staff at FDA are becoming demoralized because every time they make a decision someone in congress criticizes them for it. Then they become reluctant to make decisions at all.