The rule becomes effective on Jan. 19, 2009. It provides final requirements and procedures for PSOs, new entities, with which clinicians and health care providers can work to collect, aggregate and analyze data — within a legally secure environment of privilege and confidentiality protections — to identify and reduce patient care risks and hazards.
“I expect the final rule and the creation of Patient Safety Organizations to greatly improve the quality of health care for all Americans,” HHS Secretary Mike Leavitt said. “By making it easier for clinicians and health care organizations to report and learn from adverse events without fear of new legal liability, we will be able to improve our nation’s health care systems and minimize factors that can contribute to mistakes.”
Under interim guidance issued on Oct. 8, AHRQ has already listed 15 PSOs. During the remainder of the interim period, these organizations will maintain their status as PSOs. However, these and other PSOs listed throughout the interim period are expected to comply with the final rule once it takes effect.
“The Patient Safety Organization final rule describes the clear, legally protected framework for how hospitals, clinicians, and health care organizations can work together to improve patient safety and the quality of care nationwide,” said AHRQ Director Carolyn M. Clancy, M.D.
The listing of PSOs is authorized by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The Patient Safety Act is intended to encourage voluntary, provider-driven initiatives to improve the safety of health care through the establishment of legal protections to ensure that providers who report patient safety information do not incur new legal liability; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement.
The final rule is consistent with many of the provisions of the proposed rule issued on Feb. 12. However, it also includes new requirements for PSOs, such as:
- The requirement that a PSO notify providers if the patient safety work product it submits is inappropriately disclosed or its security is breached
- Requirements for how a component PSO maintains separation between itself and its parent organization(s) have been made more flexible.
The final rule also makes several important changes from those in the proposed rule regarding the listing and delisting of PSOs and the ways in which PSOs must comply with statutory requirements, including:
- Expansion in the types of entities and organizations excluded from listing as PSOs
- Revisions to how PSOs should disclose certain relationships with health care providers
- Increased flexibility in how PSOs can store patient safety work product
- Automatic expiration of Departmental listing after 3 years unless a PSO’s listing is continued by the Secretary and
- An expedited delisting process for PSOs in a limited number of serious circumstances
AHRQ administers provisions dealing with PSO operations, and the HHS Office for Civil Rights (OCR) enforces confidentiality provisions. The final rule addresses concerns regarding how providers may efficiently collect and analyze patient safety event information with privilege and confidentiality protections while complying with existing reporting requirements that seek similar information.
“OCR is pleased to partner with AHRQ to protect and ensure the confidentiality of the information used by providers and PSOs to improve the safety and quality of patient care nationwide,” said OCR Director Winston Wilkinson.
To read the final rule and access more information about PSOs, including background on the rulemaking process, visit AHRQ’s PSO Web site atwww.pso.ahrq.gov. Additional information about the confidentiality and disclosure of patient safety work product may be found at OCR’s Web site atwww.hhs.gov/ocr/psqia/.
Byetta and Pancreatitis – An Indian View
— Dr. Shashank R Joshi, MD, DM, FACE, FRCP(Glg)
Endocrinologist, Mumbai India
Hon Editor, Journal of The Association of Physicians of India
Chair, Indian Chapter of AACE
Both your bezoar case and pancreatopathy make good reading. Incidentally, I reviewed global literature of all agents of diabetes and their impact on the pancreas. All secretagogues, as well as glinides, have case reports of pancreatitis reported. However, cause-effect relationship has never been proven, both in animal studies as well as reported anecdotes. In fact, the global reportage of pancreatitis is so small statistically that most cases had some other etiology for pancreatic injury. So currently we do not have sufficient evidence for pancreatic injury due to exenatide, but it stands to reason that in a predisposed individual it may act as a potential trigger for pancreatic injury.
The real worry will be the ongoing LAR preparation which is now under phase 3 trial program
Exenatide has some evidence to suggest that it may trigger a cholinergic response in alcoholics and that could be a beeptive pathway for pancreatic injury
So clinically, exenatide needs the following caveats prior to its use:
1) Chronic alcoholics or abuse
2) Refractory GERD
3) History of acute or chronic pancreatitis
4) Gall stones
One should avoid or exercise caution to use it in the above stated indications. Our institution avoids byetta in the above mentioned indications till further data will emerge
In India to date, one case of pancreatitis is reported.
Dear J.A. Moore,
Your question about Byetta and your nightly pain, which your doctor says is from your stomach, is a very important one, and thank you for asking it. It is not clear as to whether you are free of abdominal pain at this time. If you are pain free at this time, it may be difficult to be sure as to why you had pain in the past. If you are still having nightly pain, then my comments may be more relevant. Since I am not your doctor, I do not know enough about you to make a diagnosis or offer therapy, but I hope I can be helpful in some general suggestions. As we get older, the risk that a pain in the abdomen is a serious medical condition increases. But resistant pain in the abdomen can be from many causes: infections, such as a H.Pylori infection of the stomach, inflammation, such as pancreatitis, or a disease of the intestine called Crohn’s disease, motility problems, such as gastroparesis, and other possibilities, vascular problems such as abdominal aneurysms, and also tumors, such as cancers of the stomach and of the pancreas. But there are other, much more common and simple problems, such as irritability of the gastrointestinal tract either due to drugs, such as metformin, or conditions as irritable bowel syndrome. I certainly could not tell from what you have said whether your problem is any of the above, or whether it is or was related to byetta.
But I think your questions are right-on and you should find out why you have had pain and whether it has anything to do with either byetta or to metformin. Your doctor should be able to do some screening tests for pancreatitis, and gastroenterologists can answer other of your questions, but I would encourage you to proceed to ask your health providers to answer your excellent questions.
You should also note that in the editorial I wrote on byetta, I discussed the responsibility of doctors to answer questions of this type. Thank you again for your excellent question. I hope I have been helpful.
I have been taking Byette and have a nightly pain which the Dr says is my stomach. I am overweight and have high triglycerides. The Drs ran all kinds of tests on my gall bladder xrays plus other tests….including nuclear meds test. Gall bladder tests turned up negative. Then the Gastro Drs said it must be the valve on the stomach that’s weak on diabetics and they gave me some medicine that kept me going to the toliet. I quit the medicine after almost a week of torture. But I took 3-Omega Oils capsules 3 times a day and Liptor and Tricore. My lipids were tested two weeks ago and the pain is gone and my Lipids very low in normal range with one type being under the allowable rate but my Endo Dr said that was OK. SHOULD I WORRY THAT I may have or had pancreatitis? I am still taking the Byette plus Metformin and Lantus..