A new regulation from the US Department of Health and Human Services permits patients or their designees to receive laboratory reports directly from labs, rather than through their physicians. The federal regulation preempts a number of state laws that previously permitted patients to receive laboratory results only through their doctors, or with their doctors' permission. The regulations also amend rules under the Health Insurance Portability and Accountability Act (HIPAA) to require labs to provide copies of individual health information to any patient who requests it, within 30 days of the request. Labs were previously exempt from that HIPAA requirement. Under the new rule, labs will be able to charge a reasonable copying fee for the information they provide.
The goal of the new regulations is to increase patients' control over their own medical information. It will permit patients to build, either on their own or with the help of firms, their own comprehensive medical records. The regulations may improve patient safety, given findings that over 7% of physicians fail to report abnormal test results to their patients. The American Medical Association and the American Academy of Family Physicians are reported as having raised concerns that patients would not be able to understand laboratory results without their physicians' help, but neither group opposed the regulation.
Showing posts with label Health and Human Services. Show all posts
Showing posts with label Health and Human Services. Show all posts
Wednesday, February 5, 2014
Saturday, January 7, 2012
86% of Medical Error Goes Unreported
Hospital incident reporting systems were informed of only 14% of errors that harmed Medicare patients, according to this report on a recent survey undertaken by the Department of Health and Human Services Office of Inspector General. Hospital staff didn't perceive 61% of adverse events as reportable. Another 25% were classified as of a type commonly reported, but somehow not reported this time.
Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.
Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.
The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.
Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.
Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.
The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.
Friday, January 6, 2012
Regulation, War, and Face Transplants
These proposed regulations from the US Department of Health and Human Services would subject vascularized composite allographs (VCA) to the rules currently governing solid organ procurement and transplantation. VCA involves transplanting multiple tissue-types as a single functional unit. The highest-profile VCA procedures are face and hand transplants, but VCA procedures around the world have included limb transplants, abdominal wall transplants, finger transplants, and transplants of penises and uteruses. What the procedures have in common is the need for re-vascularization via surgical connection of blood vessels to the transplanted tissue. Bringing these procedures under the existing organ procurement and transplantation rules will rationalize the supply and distribution of transplantable tissue, and permit medical teams to find better matches for their patients.
Recent successes in face-transplantation have captured a great deal of media attention. But another reason for this move is the medical aftermath of the US military presence in Iraq and Afghanistan. More than 1,000 military personnel have lost an arm or a leg in these conflicts; one fifth of those have lost two or more limbs. In the summer of 2010 there were an estimated 200 soldiers who might be eligible for partial or full face transplant, and an additional 50 who could use hand or forearm transplants. The US Departments of Defense and of Veterans Affairs have been leading funders of research on limb and face transplantation. The proposed regulation of VCA is in part aimed at permitting more veterans to get the procedures they need, with the best available material.
Recent successes in face-transplantation have captured a great deal of media attention. But another reason for this move is the medical aftermath of the US military presence in Iraq and Afghanistan. More than 1,000 military personnel have lost an arm or a leg in these conflicts; one fifth of those have lost two or more limbs. In the summer of 2010 there were an estimated 200 soldiers who might be eligible for partial or full face transplant, and an additional 50 who could use hand or forearm transplants. The US Departments of Defense and of Veterans Affairs have been leading funders of research on limb and face transplantation. The proposed regulation of VCA is in part aimed at permitting more veterans to get the procedures they need, with the best available material.
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