This case is going to set some new standards and it is too early to know which way the standards will settle. Two law professors are arguing for healthcare organizations to be spared from having to "prepare endlessly for every contingency." While I can agree with part of this, I do feel that healthcare organizations should not be exempt from negligence and carelessness.
There are a lot of unanswered questions about what actually happened to patients at Memorial Medical Center in New Orleans and we will probably never know the full truth. Some potential charges were dropped and will be buried in the archives of the legal system.
The other question on my mind is if healthcare organizations are even interested in being prepared for emergencies. Most have the emergency preparedness papers in a file for satisfaction of various inspection agencies, but do all the employees even know the basic steps and even the backup plans? Highly doubtful! How often do they have a drill for preparedness? Most will do this during the daytime maybe once a year to minimize the cost, but those on the evening and night shifts may have been told that there is one, but don't know anything about the procedures and plan of action.
Most healthcare organizations have only one or two types of emergencies to be concerned about from the weather. Most are build out of the flood plains so what happened during hurricane Katrina is a rare occurrence except in the hurricane prone areas. The rest need to worry about tornadoes and winter storms from the weather. They all must be concerned about fires and terrorism.
So the question becomes, should they be allowed a blanket exemption from lawsuits, or will lawsuits still be allowed for negligence? I would not be happy with a blanket exemption. If this even comes close to reality, I would urge everyone to require that healthcare organizations be required to undergo state monitored, unannounced emergency preparedness drills at least twice a year and preferably on a quarterly basis. This would insure new employees are prepared and that they happen.
This would also require that state agencies be prepared to conduct the drills at varying times and not just for one shift. Most state inspections that exist now happen between the hours of 8:00 AM and 5:00 PM. This often leaves the night shift exempt and without training for any type of emergency.
Read the article here and then decide what you think, be prepared to take a stand or bury your head in the sand. Emergencies happen and if you happen to be in a healthcare facility during an emergency, what would you want?
05 August 2011
04 August 2011
New Rules Proposed for Studies and Researchers
This is somewhat like rules to protect the rule breakers. Yes, a little extreme, but when it comes to the government writing rules, this includes everyone but those in the government. The largest abuser of human subjects is the Veterans Administration which seemingly gets to do what it wants to abuse veterans in trails and studies. But this is just my view of existing rules and the new rules being proposed.
The article in the New England Journal of Medicine (NEJM) lays out the history of the current rules first. Then it discusses the process of revising the current rules and the place to view the proposed new rules. While the responsibility of enforcing the rules rests with about 14 different federal departments and the Food and Drug Administration has similar but not identical regulations.
Most of the identification and investigation still rests with institutional review boards (IRBs), but as directed by the different federal departments for oversight. These IRBs need to be freed of some burdens to be able to their duties more effectively.
Two important items for discussion and potential revision of the rules (very much needed) is the exempt category and enhancing protections for research participants. Many studies continue to have the risk of having private information and inappropriate information released to the public. The proposal of having these studies in the exempt category fall under the rules of the Health Insurance Portability and Accountability Act (HIPAA) is one of the better proposed rule changes.
The enhancing protections for research participants topic has many good suggestions and all need consideration. Briefly they are closing the gap that some studies use to bypass federal oversight, consolidation of reporting requirements of adverse events, revising informed consent documents to eliminate lengthy legal boilerplating, and making them more readable for knowledgeable informed consent, and finally rules about biospecimens – their control and use.
The one area I have not found any concern about are for regarding human participants is the Veterans Administration. Since they are a government entity, they do not seem the have an IRB to review their activities or any agency to discipline them for their rule violations. Therefore this is an area that needs attention and the Secretary of Defense needs to be able to empower a board of review for the Veterans Administration's abuse of our veterans. Yes, the Department of Defense (DOD) and the Department of Veterans Affairs (DVA) have some reporting requirements for adverse events, but there seems to be no oversight or requirements for failure to report.
The authors do state that some reforms are needed now with the growing body of human participants and new types of research. They appropriately warn that these reforms should not be delayed for another 20 years.
The article in the New England Journal of Medicine (NEJM) lays out the history of the current rules first. Then it discusses the process of revising the current rules and the place to view the proposed new rules. While the responsibility of enforcing the rules rests with about 14 different federal departments and the Food and Drug Administration has similar but not identical regulations.
Most of the identification and investigation still rests with institutional review boards (IRBs), but as directed by the different federal departments for oversight. These IRBs need to be freed of some burdens to be able to their duties more effectively.
Two important items for discussion and potential revision of the rules (very much needed) is the exempt category and enhancing protections for research participants. Many studies continue to have the risk of having private information and inappropriate information released to the public. The proposal of having these studies in the exempt category fall under the rules of the Health Insurance Portability and Accountability Act (HIPAA) is one of the better proposed rule changes.
The enhancing protections for research participants topic has many good suggestions and all need consideration. Briefly they are closing the gap that some studies use to bypass federal oversight, consolidation of reporting requirements of adverse events, revising informed consent documents to eliminate lengthy legal boilerplating, and making them more readable for knowledgeable informed consent, and finally rules about biospecimens – their control and use.
The one area I have not found any concern about are for regarding human participants is the Veterans Administration. Since they are a government entity, they do not seem the have an IRB to review their activities or any agency to discipline them for their rule violations. Therefore this is an area that needs attention and the Secretary of Defense needs to be able to empower a board of review for the Veterans Administration's abuse of our veterans. Yes, the Department of Defense (DOD) and the Department of Veterans Affairs (DVA) have some reporting requirements for adverse events, but there seems to be no oversight or requirements for failure to report.
The authors do state that some reforms are needed now with the growing body of human participants and new types of research. They appropriately warn that these reforms should not be delayed for another 20 years.
03 August 2011
Intensive Versus Conventional BG Debate Rages On
Although this study is little different from the other European studies published recently it does add a few insights and hypothesize on some other ideas and for that I will give them credit. However, they leave a few things unstated that need definition. When they use the term conventional, they do nothing to enlighten readers about how the term is being used or meant to indicate.
From some other statements, we are left wondering what they consider normal blood glucose levels. We can all guess when they say normal levels of people without diabetes. So normal levels for people with diabetes is considered ??? (guessing about 7.0 on the US A1c scale).
One thing everyone seems very concerned about in all the articles published recently is hypoglycemia. I do agree that it is something to be concerned about, but unless you are hypoglycemically unaware or afraid to test, I find this argument less than appealing in proper management of diabetes. It is always a factor that needs careful attention and concern, but if a person is careful and understands their body, a blood glucose level of 5.5 to 6.4 A1c is attainable without intensive lowering therapy.
Then when you add exercise and nutritional restraint it is even more attainable and the blood glucose level of 5.0 is reasonable. I will admit that I would be concerned about getting to the level of 4.5 for an A1c and the possibility of hypoglycemia.
The authors state that while there was little difference between intensive and conventional blood glucose therapy, there is a definite advantage for lower blood glucose levels in reducing the small blood vessel damage leading to damage to the eyes and kidneys. They forget to mention the additional advantages of lower blood glucose levels in preventing blood vessel damage to the inner ear to prevent hearing loss and the prevention of diabetic neuropathy.
This study basically covers the same ground as the German and French studies, but it was done in Denmark. I have written about these studies also. The press release for this study can be read here.
From some other statements, we are left wondering what they consider normal blood glucose levels. We can all guess when they say normal levels of people without diabetes. So normal levels for people with diabetes is considered ??? (guessing about 7.0 on the US A1c scale).
One thing everyone seems very concerned about in all the articles published recently is hypoglycemia. I do agree that it is something to be concerned about, but unless you are hypoglycemically unaware or afraid to test, I find this argument less than appealing in proper management of diabetes. It is always a factor that needs careful attention and concern, but if a person is careful and understands their body, a blood glucose level of 5.5 to 6.4 A1c is attainable without intensive lowering therapy.
Then when you add exercise and nutritional restraint it is even more attainable and the blood glucose level of 5.0 is reasonable. I will admit that I would be concerned about getting to the level of 4.5 for an A1c and the possibility of hypoglycemia.
The authors state that while there was little difference between intensive and conventional blood glucose therapy, there is a definite advantage for lower blood glucose levels in reducing the small blood vessel damage leading to damage to the eyes and kidneys. They forget to mention the additional advantages of lower blood glucose levels in preventing blood vessel damage to the inner ear to prevent hearing loss and the prevention of diabetic neuropathy.
This study basically covers the same ground as the German and French studies, but it was done in Denmark. I have written about these studies also. The press release for this study can be read here.
02 August 2011
US Guidelines for Sugar May Be Too High
You Think!!!. Hopefully results from a new study will end the plate method of nutrition. The study shows that adults who consume 25 percent of their daily calories from fructose or high-fructose corn syrup beverages for two weeks experience increases in serum levels of cholesterol and triglycerides. Yet, this percentage is within the current government guidelines. Another reason why we don't need government involvement in nutritional guidelines.
The authors of the latest study are hoping the results will spur the government to reevaluate the guidelines. Fat chance, I say for this to happen as this would have to affect government subsidies and turn certain agricultural interests against government.
While the official print is not set for publication until October 2011, the press release is interesting and thought provoking to say it mildly.
Senior author Kimber Stanhope, PhD, from the departments of nutrition and molecular biosciences, University of California, Davis, and colleagues say “the study was conducted to help sort out a discrepancy in 2 prominent sets of recommendations - the Dietary Guidelines for Americans, jointly published by the US Department of Health and Human Services and the US Department of Agriculture, recommend that people consume a maximum of 25% of their daily calories as added sugars. In contrast, the American Heart Association recommends an upper limit of 5%.”
"While there is evidence that people who consume sugar are more likely to have heart disease or diabetes, it is controversial as to whether high sugar diets may actually promote these diseases, and dietary guidelines are conflicting," remarked Dr. Stanhope in a press release.
The study was done to highlight the effects of the higher government-recommended limits of sugar consumption. The study is too small (48 individuals) to be taken seriously and involved consuming beverages that contained fructose, high-fructose corn syrup, or glucose at the 25 percent upper limit for calorie intake for two weeks. The study did not include sucrose.
The researchers claim that survey (but no data from any survey is included) suggests that thirteen percent of the US population consumes 25 percent or more of their calories from added sugar. The researchers conclude, their findings indicate the need for the government to reconsider its recommendations that the maximum upper limit of 25 percent of total energy be received from added sugar.
For this study to be sufficient to make such bold recommendations seems a stretch and more like a plea (although not part of the release) for funding of a larger study.
The authors of the latest study are hoping the results will spur the government to reevaluate the guidelines. Fat chance, I say for this to happen as this would have to affect government subsidies and turn certain agricultural interests against government.
While the official print is not set for publication until October 2011, the press release is interesting and thought provoking to say it mildly.
Senior author Kimber Stanhope, PhD, from the departments of nutrition and molecular biosciences, University of California, Davis, and colleagues say “the study was conducted to help sort out a discrepancy in 2 prominent sets of recommendations - the Dietary Guidelines for Americans, jointly published by the US Department of Health and Human Services and the US Department of Agriculture, recommend that people consume a maximum of 25% of their daily calories as added sugars. In contrast, the American Heart Association recommends an upper limit of 5%.”
"While there is evidence that people who consume sugar are more likely to have heart disease or diabetes, it is controversial as to whether high sugar diets may actually promote these diseases, and dietary guidelines are conflicting," remarked Dr. Stanhope in a press release.
The study was done to highlight the effects of the higher government-recommended limits of sugar consumption. The study is too small (48 individuals) to be taken seriously and involved consuming beverages that contained fructose, high-fructose corn syrup, or glucose at the 25 percent upper limit for calorie intake for two weeks. The study did not include sucrose.
The researchers claim that survey (but no data from any survey is included) suggests that thirteen percent of the US population consumes 25 percent or more of their calories from added sugar. The researchers conclude, their findings indicate the need for the government to reconsider its recommendations that the maximum upper limit of 25 percent of total energy be received from added sugar.
For this study to be sufficient to make such bold recommendations seems a stretch and more like a plea (although not part of the release) for funding of a larger study.
01 August 2011
New Horizons for New Doctors
This sounds exciting and for once the medical students are the guinea pigs. Will this mean more compassionate doctors? This will remain to be seen, but I like the analogies used in the article. What is discouraging is the length of time required to make this a national program and not just at two medical schools working together.
Stephen Klasko, MD, MBA, dean of the University of South Florida (USF) College of Medicine in Tampa, where the SELECT (Scholarly Excellence. Leadership Experiences. Collaborative Training) program is based stated, “we intend to change the DNA of healthcare, one future physician leader at a time. This medical school admissions program is set up to consider the individual's emotional intelligence in addition to the individual's ability to memorize organic chemistry formulas and score high on MCAT.
Dr Klasko said that he has observed medical care shifting from the model of the kindly Dr. Welby to the narcissistic, brusk, but brilliant Dr. House. The SELECT program is meant to produce physicians who will be as bright as Dr. House, but as compassionate as Dr. Welby.
SELECT was jointly created and operated by USF College of Medicine, where students will spend their first 2 years, and Lehigh Valley Health Network (LVHN) in Allentown, Pennsylvania, where they will complete their clinical training within a healthcare network that shares this philosophy.
The four-year program will have new methods to teach the science and technical expertise that are needed for the practice of medicine while putting patients and their needs and expectations at the forefront.
I will let you read about the details in the article here. I find this promising for the future of medicine where doctors will not use fear and myths to frighten patients, but use their intelligence to enlighten patients and teach patients what needs to be accomplished for their better health. This will put the patient first and the medical problem as part of the patients desires and goals.
Stephen Klasko, MD, MBA, dean of the University of South Florida (USF) College of Medicine in Tampa, where the SELECT (Scholarly Excellence. Leadership Experiences. Collaborative Training) program is based stated, “we intend to change the DNA of healthcare, one future physician leader at a time. This medical school admissions program is set up to consider the individual's emotional intelligence in addition to the individual's ability to memorize organic chemistry formulas and score high on MCAT.
Dr Klasko said that he has observed medical care shifting from the model of the kindly Dr. Welby to the narcissistic, brusk, but brilliant Dr. House. The SELECT program is meant to produce physicians who will be as bright as Dr. House, but as compassionate as Dr. Welby.
SELECT was jointly created and operated by USF College of Medicine, where students will spend their first 2 years, and Lehigh Valley Health Network (LVHN) in Allentown, Pennsylvania, where they will complete their clinical training within a healthcare network that shares this philosophy.
The four-year program will have new methods to teach the science and technical expertise that are needed for the practice of medicine while putting patients and their needs and expectations at the forefront.
I will let you read about the details in the article here. I find this promising for the future of medicine where doctors will not use fear and myths to frighten patients, but use their intelligence to enlighten patients and teach patients what needs to be accomplished for their better health. This will put the patient first and the medical problem as part of the patients desires and goals.
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