<rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:dc="http://purl.org/dc/elements/1.1/"><channel><title>patientsafetyaction</title><description>patientsafetyaction</description><link>https://www.patientsafetyaction.org/psan-blog</link><item><title>This is How I Would Stop HAIs</title><description><![CDATA[People ask me what I would do to help stop Hospital acquired infections. It’s been 10 years today since my father died of HAI. Right after he was infected with MRSA, I started researching the causes, the prognosis, the incubation period, prevention, spread and prevalence of these infections. The subject is complex and broad, but these are a few of my ideas about how we can actually make a huge dent in this problem.1. Get a more accurate count of infections and the deaths caused by them and make]]></description><dc:creator>Kathy Day, RN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2019/01/09/This-is-How-I-Would-Stop-HAIs</link><guid>https://www.patientsafetyaction.org/single-post/2019/01/09/This-is-How-I-Would-Stop-HAIs</guid><pubDate>Thu, 10 Jan 2019 05:52:25 +0000</pubDate><content:encoded><![CDATA[<div><div>People ask me what I would do to help stop Hospital acquired infections. It’s been 10 years today since my father died of HAI. Right after he was infected with MRSA, I started researching the causes, the prognosis, the incubation period, prevention, spread and prevalence of these infections. The subject is complex and broad, but these are a few of my ideas about how we can actually make a huge dent in this problem.</div><div>1. Get a more accurate count of infections and the deaths caused by them and make it public. Transparency and accountability will lead to better funding and actions to stop this scourge.</div><div>a. Develop a way for patients or their family members to report their own infections, because we know hospitals and other healthcare facilities are not reporting all of their infectionsb. Require that all infections that contribute to a death, be listed as a cause of death (COD) on death certificates in every State.</div><div>2. Require Hospitals/LTCs/Dialysis centers/Surgical Centers to post any current outbreaks on their websites and in plain view for incoming patients.</div><div>a. “Outbreak” must be defined first. Currently ‘outbreak’ means something different according to what infection is being discussed.</div><div>3. Rapid screen patients for MRSA and other common infections on emergency admission, or a week in advance of planned admissions. Practice Universal precautions without exception. Postpone elective surgery until the patient has been decolonized. Contact precautions must be followed without exception for all MRSA colonized and infected patients. All other precautions according to the offending infection must be followed to a tee, by all staff and visitors and this must be enforced.</div><div>4. Put everyone in their own room, preventing spread of infection from one patient to another in the same room.</div><div>5. Clean up Hospitals and the equipment in them. Assign each patient their own frequently used equipment, ie. Blood pressure cuffs, wheelchairs, walkers, etc.</div><div>6. Handwashing all around every time, before and after touching, nurses, doctors, xray and lab techs, visitors, and anyone else who touches patients.</div><div>7. Help patients to understand their own role in prevention of infections, examples are handwashing, general hygiene, covering wounds, good nutrition/hydration, covering coughs, not wearing slippers that have been on dirty floors into their bed.</div><div>8. Give the Federal and State CDCs regulatory powers. This way, instead of writing recommendations, they can write requirements. Every hospital that is held accountable for infections that they caused, will say “we met the CDC recommendations” and/or “We met the standards of care”. And they may have met some of them, but certainly not all of them because they don’t’ have to…none of the recommendations are mandated.</div><div>Also, the CDC would not have to wait until crisis to go into places with known problems. An invitation would not be needed. Places with known infection outbreaks and/or ongoing infection issues could be visited and problems remedied without waiting for permission to enter. Not a single patient should become infected because the CDC is waiting for an invitation to help the facility.</div><div>9. Stop paying Hospitals and other Healthcare facilities for the costs of these infections. Nobody should have to pay ONE PENNY for an infection they caught while in a facility. Penalties are not enough. Stop payment from any source patients, insurances or the Federal Government.</div><div>This is my short list of ideas. They were gleaned from all sorts of experts and meetings on the subject of infections. If these things had been in play when my father was hospitalized for rehab for a simple ankle fracture, I sincerely believe his infection would have been prevented. Two other community members had already died of hospital acquired MRSA infection the same month he was admitted. No outbreak was declared and nothing was ever reported on a State level about that. No extra precautions or steps were taken to stop the hospital MRSA outbreak. There was no consistency with handwashing, gloving or precautions even after his infection was diagnosed. With some hard work and dedication to patients, we can stop this from happening to others.</div><div>See more great insight from Kathy Day, RN at her blog site, http://mcclearymrsaprevention.com</div></div>]]></content:encoded></item><item><title>Strength Through Advocacy and Perseverance</title><description><![CDATA[The Bleeding Edge, a Netflix Original documentary due to be released on July 27th, highlights four medical devices: Essure, metal-on-metal hip implants, pelvic mesh, and the da Vinci surgical robot. One of these devices, Essure, has changed the course of our lives. Essure has taken us on a path we could have never imagined. From the moment we were “sold” on this medical device, it impacted our families, our finances, and our health. After we each felt our families were complete, we decided to]]></description><dc:creator>Amanda Dykeman and Amanda Rusmisell</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/07/26/Strength-Through-Advocacy-and-Perseverance</link><guid>https://www.patientsafetyaction.org/single-post/2018/07/26/Strength-Through-Advocacy-and-Perseverance</guid><pubDate>Fri, 27 Jul 2018 05:33:58 +0000</pubDate><content:encoded><![CDATA[<div><div><div><a href="http://bleedingedgedoc.com/">The Bleeding Edge</a>, a Netflix Original documentary due to be released on July 27th, highlights four medical devices: <a href="http://www.essure.com/">Essure</a>, metal-on-metal hi<a href="https://www.facebook.com/groups/Essureproblems/?ref=bookmarks">p impla</a>n</div>ts, pelvic mesh, and the da Vinci surgical robot. One of these devices, Essure, has changed the course of our lives. Essure has taken us on a path we could have never imagined. From the moment we were “sold” on this medical device, it impacted our families, our finances, and our health.</div><div>After we each felt our families were complete, we decided to consult with our physicians about ending our own fertility. What was supposed to be a simple in-and-out office procedure turned into what seems like a lifetime sentence of pain, suffering, and emotional turmoil. Desperate for answers and a remedy, we searched online and stumbled upon the <a href="https://www.facebook.com/groups/Essureproblems/">Essure Problems Group on Facebook</a>. It didn’t take long for us to realize we weren’t alone. The group was a haven of support, education and collaboration.</div><div>We both decided to become more active in the Facebook group, helping find research and resources to share across the online community. Day in and day out we watched as thousands of women joined and explained eerily similar situations. We listened to women who described everything from immense pain to allergic and autoimmune-type reactions, unexpected pregnancies and pregnancy loss, device perforations, migrations, and hysterectomies, and we even witnessed death among our members. Over the course of a short period of time, we quickly realized we couldn’t just sit idly by and watch the devastation Essure was causing. It became all too clear that manufacturing companies did not have consumers’ health as their first priority. We knew we had to organize to make a change.</div><div>We banded together and worked as a team to advocate because the quality of thousands of women’s lives depended on it. We felt compelled to become their voices and eventually we started hitting milestones: our first discovery of corruption and wrongdoing through research; the first doctor who believed us and wanted to help; our first story on the evening news; our first meeting with the FDA; our first conversation with an attorney; and first trips to Washington, D.C. to seek help from our Congressional leaders.</div><div>Through our contacts with Congressional leaders we were able to introduce several versions of a bill to help correct the broken system. The current bill in front of Congress is the <a href="https://www.congress.gov/bill/115th-congress/house-bill/2164">Medical Device Safety Act of 2017</a>. This bill will restore the litigation rights of all consumers on medical devices that fall under FDA’s premarket approval process.</div><div>All of this work was done while we held jobs, cared for our own health, and ran our households. Through these experiences, we received affirmation that it wasn’t just the Essure device risking lives daily. We learned there is a serious problem in this country with how all medical devices are marketed and regulated under the FDA.</div><div>Over the course of a short time, it became apparent that the organizations and companies that were in place to help us actually put profits before the health and well-being of patients. This has compelled us and our group to take a stand against a very broken system. We have persisted on our path. While our movement evolved, we beat on every door and wouldn’t stop until Essure was pulled off the market. We know that our most recent milestones, the inclusion of Essure as one of four devices featured in The Bleeding Edge documentary, will serve as a teaching tool so that others can join us and learn to advocate for themselves as well.</div><div>Our efforts caused Bayer to announce on July 20th, 2018, just one week before the release of <a href="http://bleedingedgedoc.com/">The Bleeding Edge</a>, that it will be halting all sales and distribution of Essure. This announcement was celebrated by thousands of E-Sisters worldwide. All the efforts of the members of the Essure Problems Group paid off! Even though this was a victory, there is still much work to be done. The Medical Device Safety Act of 2017 must be pushed through Congress. Suffering women who have been implanted with Essure still need support to have the coils removed and women still being sold Essure need to be warned about the dangers of this medical device. Bayer needs to be held accountable for harming thousands of women worldwide. Lastly, the FDA needs to understand their current system of approving and monitoring medical devices is not working.</div><div>Essure irreparably changed our lives and took us down paths we could have never imagined, from helping form an online support community to becoming patient safety advocates and activists. At some point in our own lives or the lives of our loved ones, we will all likely face the decision of whether or not to use a medical device. We should all be able to trust that they have been tested, approved, and sold to us in good faith. While technology has undoubtedly led to some wonderful life-saving advancements, the profit-driven medical device industry still requires much more regulation, including FDA action when implanted devices cause harm. We can’t always trust that the term “FDA Approved” automatically means a medical device has been proven safe and effective. It is imperative that we all learn to do our own due diligence and research, to be our own advocates, and to make the best informed possible decisions for our healthcare.</div><div>To learn more about medical device safety and the E-Sisters’ stories, watch <a href="https://www.netflix.com/title/80170862">The Bleeding Edge documentary</a> on Netflix on July 27.</div><div>The Bleeding Edge trailer - <a href="https://www.youtube.com/watch?v=slmilObZl28">https://www.youtube.com/watch?v=slmilObZl28</a></div><div>Amanda Dykeman is Head Research Coordinator and Administrator of<a href="https://www.facebook.com/groups/Essureproblems/?ref=bookmarks">Essure Problems</a>/Vice President of <a href="http://www.ashesnonprofit.com/">ASHES Nonprofit</a>. Amanda Rusmisell is Legislative Liaison and Administrator of <a href="https://www.facebook.com/groups/Essureproblems/?ref=bookmarks">Essure Problems</a>/Secretary of<a href="http://www.ashesnonprofit.com/">ASHES Nonprofit.</a></div></div>]]></content:encoded></item><item><title>How Much Do You Know About Your Implants?</title><description><![CDATA[It’s Patient Safety Day 2018! The Patient Safety Action Network wants to talk to you about medical device safety. Here is the list we collectively created last March within our “top patient safety opportunities”: Poor vetting of new medical devices Continued use of known unsafe devices, e.g., surgical mesh, breast implants, Essure Inadequate warnings, information for patients on risks for use of certain devices Inability to sanitize/sterilize reusable devices Promoting use of devices that are]]></description><dc:creator>PSAN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/07/23/How-Much-Do-You-Know-About-Your-Implants</link><guid>https://www.patientsafetyaction.org/single-post/2018/07/23/How-Much-Do-You-Know-About-Your-Implants</guid><pubDate>Mon, 23 Jul 2018 07:01:00 +0000</pubDate><content:encoded><![CDATA[<div><div>It’s Patient Safety Day 2018! The Patient Safety Action Network wants to talk to you about medical device safety. Here is the list we collectively created last March within our “<a href="https://www.patientsafetyaction.org/psan-projects">top patient safety opportunities”:</a></div><div>Poor vetting of new medical devicesContinued use of known unsafe devices, e.g., surgical mesh, breast implants, EssureInadequate warnings, information for patients on risks for use of certain devicesInability to sanitize/sterilize reusable devicesPromoting use of devices that are very expensive and show no improvement over older devices, e.g., robotic vs laparoscopic surgeries</div><div>Think about this: When problems are revealed about your medical implant or you begin having adverse reactions, you are stuck with it; you cannot remove it without a surgical procedure. Many have discovered that getting an implant removed can be a very difficult endeavor – <a href="https://www.meshmedicaldevicenewsdesk.com/">surgical mesh</a>can break apart and become so embedded in bodily tissues that it has been compared with getting gum out of one’s hair. Many women who opted for the non-surgical Essure to prevent future pregnancies had<a href="http://essureproblems.webs.com/home">painful and debilitating reactions</a>to the device and ended up having hysterectomies because removing these coils in their fallopian tubes is extremely difficult and poses new serious risks to patients. </div><div>Medical devices can provide life-saving and life-changing help to many patients, but most people have no idea that when their surgeon recommends use of a device or medical implant, they are often participating as subjects in a grand scientific experiment.</div><div>For most medical devices, the process for bringing them to the market does not even require an “approval” by the FDA. By law, these devices are “cleared” by the agency to be used on patients as long as they are substantially similar to some prior device. Take an example of hip and knee implants – if the design is basically a ball and socket then it is similar, regardless of whether it is made of material never tested in the human body. The unfortunate results of an estimated one million<a href="https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241604.htm">metal on metal hip devices</a>being implanted in patients is a good example of how flawed this process can be. </div><div>Linda Radach was one of them. Now, 12 years and 4 corrective surgeries later she still suffers from the effects of that initial device: “In 2006 when I was told my hips needed to be replaced, my surgeon recommended a new metal on metal technology. At the time I had no reason to question him. When the first hip implant failed within three years, it became apparent that something was seriously wrong, and yet there were no reasonable explanations provided. The tissues in my hip joints were damaged and toxic levels of cobalt and chromium from the implants also entered my blood stream, creating havoc with my health. I have learned the hard way that the most important action a patient can take is to do their own research upon an implant recommendation and to be informed. It is essential to ask questions to your doctor, and to persist until you have all of the answers you need to make a fully informed decision.”</div><div>Linda’s experience points to other critical information that patients need to know about new devices.<a href="https://safepatientproject.org/press_release/dangerous-medical-device-loophole-puts-patients-at-risk">They can even be cleared based on similarity to another device that was removed from the market due to safety concerns</a>. In 2011, the Institute of Medicine studied this process extensively and found that it was “flawed based on its legislative foundation.” The<a href="http://www.nationalacademies.org/hmd/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx">IOM called for a new framework</a>, stating “resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” In 2012, many of us went to Congress to try to change this process. The FDA and Congress ignored these experts (and us). </div><div>The few devices that are categorized as high risk or innovative are required by law to show the FDA evidence of their safety and effectiveness. (Not many are truly innovative.) Typically, even these are not adequately tested enough to ensure safety. Part of the problem is the difficulty in conducting comparative studies with these devices in enough patients who are tracked for long enough to see what happens when left in the human body for years. For medical device studies, it may be unethical or even impossible to conduct blind, randomized control trials using a placebo or to implant the device into healthy subjects. </div><div>Since the “pre-market” system for vetting medical devices is often absent any serious scientific evidence, it is critical to have a “post-market” oversight structure that alerts the FDA, physicians and the public/patients when patterns of problems arise. While Congress has recognized this need for more than a decade, the U.S. <a href="https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm">still doesn’t have a nationally coordinated, publicly accessible system</a>that adequately tracks and responds to adverse events in a timely manner. The FDA does have <a href="https://www.fda.gov/Safety/MedWatch/default.htm">a website where patients and doctors can report</a>these events, which is a very good way to bring issues to their attention.<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">One can look up problems reported about your implant</a>on the FDA site but it is not very consumer friendly or thorough. Unfortunately, it is clear that the agency is not using this information in a timely and proactive manner. While women have been reporting problems with vaginal surgical mesh and Essure devices, the agency has taken years to respond with<a href="https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345201.htm">warnings</a>to the public and medical community and to impose<a href="https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm604098.htm">requirements on device companies.</a></div><div>However, sometimes Margaret Meade’s quote,“Never doubt that a small group of thoughtful, committed, citizens can change the world. Indeed, it is the only thing that ever has,” is proven true. Just last week, after years of activists turning their pain into organizing, raising public awareness, and pressuring FDA and the maker of Essure to remove it from the US market, Bayer announced that effective the end of this year, it will no longer sell Essure in this country. </div><div>In recent years, the FDA finally implemented a system requiring that each device have a <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm">unique device identifier</a>, but the law doesn’t require health care providers to document these in patients’ records<a href="http://www.startribune.com/effort-to-improve-tracking-of-medical-devices-divides-industry-consumer-groups/451942493/">or billing records</a>(which are publicly accessible and can be used by researchers). Nearly every consumer product on the market – from aspirin to toasters - can be and is traceable when things go wrong. The FDA should to do the same with medical implants.</div><div>So, that brings us back to our top opportunities for improvement in the safety of medical devices listed above. Except for changing the approval process, which requires action by Congress, these are very concrete problems that FDA could solve now. </div><div>Please educate those you know, and talk to your doctor about this if they are interested in using a device as part of your care. You can raise these issues to your elected officials in Congress and urge them to address these problems. Lastly, you can also forward them this blog. </div><div>Please leave comments below for a continued dialogue. We would like to hear your ideas for solutions to these “opportunities for improvement&quot;.</div></div>]]></content:encoded></item><item><title>The Power of Our Patient Safety Action Network (PSAN)</title><description><![CDATA[The most gratifying and inspiring part of my Patient Safety work is when I can help someone who has been harmed by their healthcare. Although I am a retired RN, I certainly do not have all the answers to people’s questions. That is where my expert patient safety colleagues come in. https://www.patientsafetyaction.org/Last week a friend asked if I would talk with Jane (fictitious name), who is a friend of her sisters. Jane lives in New York State and had a robotic radical hysterectomy for]]></description><dc:creator>Kathy Day, RN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/05/11/The-Power-of-Our-Patient-Safety-Action-Network-PSAN</link><guid>https://www.patientsafetyaction.org/single-post/2018/05/11/The-Power-of-Our-Patient-Safety-Action-Network-PSAN</guid><pubDate>Fri, 11 May 2018 16:14:08 +0000</pubDate><content:encoded><![CDATA[<div><div>The most gratifying and inspiring part of my Patient Safety work is when I can help someone who has been harmed by their healthcare. Although I am a retired RN, I certainly do not have all the answers to people’s questions. That is where my expert patient safety colleagues come in. https://www.patientsafetyaction.org/</div><div>Last week a friend asked if I would talk with Jane (fictitious name), who is a friend of her sisters. Jane lives in New York State and had a robotic radical hysterectomy for endometrial cancer. She is 70 years old. Her surgery was nearly 2 years ago, and she is still working on her recovery, with Pilates and trying to improve her abdominal muscle tone. She has come a long way in her recovery, but she isn’t done and 2 years is a long time for recovery from Robotic assisted hysterectomy.</div><div>I had the same surgery and it went very smoothly. I recovered in a very short time, and I had no complications or lingering disability. I was operated on one day and I went home the next. I only took Tylenol occasionally for very mild pain. In just a few weeks I was back to my old self.</div><div>Jane had a completely different experience, although she planned on one like mine. During her surgery the robot failed. Her doctors exact words were “The f*#*ing machine just stopped working”. As a result, her vena cava (assuming it was her inferior VC) was nicked, and she had a serious hemorrhage. In order for the surgeon to find the bleed, her belly was opened from the bottom of her sternum to just above her pubis. She woke up in the ICU after a 6 hour surgery. She has suffered with brain fog and a number of physical issues that required a lot of rehab and physical therapy. She has a long zipper like scar from the top to bottom of her abdomen, unlike my own 5 barely visible scars. After hearing about her experience, friends advised Jane to seek legal recourse. Three attorneys have looked at her case but have not taken it anywhere. So, Jane did not know where to turn next and she felt very alone.</div><div>Obviously, I can’t fix Jane’s problem, but because of my network of patient safety experts in PSAN, I knew who to ask for help.</div><div>1. I messaged a PSAN member who is an expert on patient harm data from the volumes of reports to the FDA. She gave me info for Jane on where and how to report her experience. Jane was astounded to learn that there are over 20,000 FDA reports on the Davinci Robot. Jane felt totally isolated with her problems, until she learned about this. Her doctor told her she was the only one he was aware of. That may be true, but she is certainly not the only one in NY or the US! </div><div><a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home</a></div><div>2. I wrote a brief email to the Consumers Union Safe Patient Project Email listserve with a brief description of what had happened to Jane and asked for suggestions. This email listserve will soon transition to the PSAN. I got responses from 3 esteemed colleagues.</div><div>The first response came from a man who has also been harmed under the Davinci Robot. and he also recommended that Jane report on the FDA website, and to check if her hospital has reported this robot failure to the manufacturer. If not then they are in violation of reporting requirements.</div><div>Angie recommended that Jane join the Unplug the Robot group, <a href="http://unplugtherobot.blogspot.com/">http://unplugtherobot.blogspot.com/</a> and sent along the email address of the leader of that group. This puts Jane in touch with other women who have had very similar experiences as her. The group also has information on expert attorneys who handle the same kind of harm that she has suffered.</div><div>Then a PSAN member who is an attorney emailed me. He offered to talk with Jane. He told me that there is no class action lawsuit against Intuitive (makers of the Davinci Robot) which was a surprise. He said the robots are used for too many different kinds of surgery to do a class action.</div><div>Four amazing colleagues in our network responded to me about Jane’s dilemma over 2 days and I have passed on all of this information to her. I guarantee that she no longer feels alone. There is nothing any more isolating than being sick or in pain, and knowing it is because of a failed device, or a preventable human error. People who have not experienced anything similar are uncomfortable with this kind of conversation and there are no local community support groups. Efforts are made by doctors, hospitals and device makers to keep these things under wraps, and that is even further isolating.</div><div>In this quest to help Jane, I have learned so much. This is what our PSAN network does. We learn, we share and we help. We are a family of expert patient safety advocates. The value of that in our Patient Safety work, our own lives and the lives of those we help is immeasurable.</div><div>See more insightful blog posts by Kathy Day, RN at <a href="http://mcclearymrsaprevention.com">http://mcclearymrsaprevention.com</a></div></div>]]></content:encoded></item><item><title>Informed Consent</title><description><![CDATA[Informed consent is the process in which a patient is given information to make an informed decision about whether he or she will pursue a particular treatment or procedure. Informed consent is essential for the patient to understand how a particular treatment, surgery, pharmaceutical drug, or implanted device will affect his or her body. Because the standards of informed consent vary from state to state, physicians are governed only by their ethical code, state regulatory authorities, and the]]></description><dc:creator>Informed Consent Team for PSAN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/19/Informed-Consent-1</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/19/Informed-Consent-1</guid><pubDate>Mon, 19 Mar 2018 15:34:37 +0000</pubDate><content:encoded><![CDATA[<div><div>Informed consent is the process in which a patient is given information to make an informed decision about whether he or she will pursue a particular treatment or procedure. Informed consent is essential for the patient to understand how a particular treatment, surgery, pharmaceutical drug, or implanted device will affect his or her body. Because the standards of informed consent vary from state to state, physicians are governed only by their ethical code, state regulatory authorities, and the nebulous “standard of care” applicable to all medical professionals. However, doctors seldom provide sufficient information for a patient to make a genuinely informed decision about invasive procedures. Furthermore, the concept of informed consent must be expanded to the prescribing of drugs and implants. Drugs and implanted devices can be viewed as an invasion to one’s body and are no less significant and dangerous than surgical procedures.</div><div>Types of Informed Consent</div><div>There are two basic types of informed consent. These are provider-centered informed consent and patient-centered informed consent. Provider-centered informed consent is generally for the protection of the medical provider from liability for failure to “inform” the patient before invading his or her body. Patient-centered informed consent is intended to deliver sufficient information to the patient that he or she can make an intelligent decision, in cooperation with the doctor, about the best way to proceed.</div><div>State Laws Governing Informed Consent</div><div>There are two ways laws are applied to informed decision. One is a standard built around what a “responsible body of physicians deems important.” The other is built around what a “reasonable patient” would want to know. In the U.S., states are almost evenly split on which standard has legal standing. These are directly parallel to the types of informed consent described above. The “reasonable patient” standard seems to be defined only after the fact when a patient alleges that he or she was not informed of the consequences of an invasive procedure. The jury in such a case then decides whether a “reasonable patient” would have wanted to know the missing information.</div><div>Decision Aids</div><div>The old complaint from doctors that they do not have enough time to give genuine informed consent has fallen away as high-quality decision aids have become available. Reputable decision-aid sources are shown in the box below.</div><div>Decision Aid Sources</div><div><a href="https://shareddecisions.mayoclinic.org">Mayo Clinic</a><a href="https://healthy.kaiserpermanente.org/health/care/!ut/p/a0/FchLDsIgEADQs_QAkxlCG4m7YtsrKOwmE1JJ-DQU9frq8j30-EBf-B137rEWTj87CaWHdhVO8krcazvxjh790XjPjK5UEJZn-B-3HiUFdBtNm9U0w2gnBUqtBPZGIyxklNZmXZS-4JGz-czD8AV7bv5A/">Kaiser Permanente</a><div><a href="https://decisionaid.ohri.ca">The Ottawa Hospital Research Institute</a> (AHRQ makes reference to this source)</div><div><a href="http://www.med-decs.org/en/reliability">http://www.med-decs.org/en/reliability</a>(huge database of decision aids, read reliability first)</div></div><div>Expanding Informed Consent to Medications and Implanted Devices</div><div>It is common for patients to be surprised by the side effects of drugs or devices used in their treatment Serious side effects are more common if a drug is prescribed off-label, but even on-label prescribing can cause serious harm or death. A drug is off-label if the FDA did not approve it for the patient’s specific condition or age group. For example, some drugs approved for adults are off-label for children, adolescents and the elderly. There is a major push by the pharmaceutical industry to promote off label use of drugs or devices if there is evidence of effectiveness.</div><div>An additional risk comes from use of drugs that have a “black-box” warning. These are drugs that just missed being removed from marketing by the FDA based on data accumulated after FDA approval. Black box warnings are the strictest labeling requirements that the FDA can mandate. First implemented in 1979, black box warnings highlight serious and sometimes life-threatening side effects. The general supposition is that the patient will read the drug label and insert, and thereby determine if it is a black-box drug. This is insufficient. There must be a discussion about side effects, initiated by the prescriber well before the patient is handed the drug and its insert at a pharmacy. Michelle Llamas, senior writer at Drugwatch reports that &quot;We get many patients writing to us about tendon problems with a class of antibiotics called fluoroquinolones (Cipro, Levaquin). The FDA placed a black box on these drugs in 2008. But, many patients still tell us they were not made aware of these issues by their physicians or were told they were so rare it would not happen to them.&quot;</div><div>Report drug side effects at: <a href="https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm">https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm</a>. All of the above issues surrounding prescription drugs apply to devices that are implanted in the body.</div><div>The Empowered Patient and Informed Consent</div><div>A patient that knows about the informed consent process is better able to make informed choices. A checklist to use during the informed consent process can be very helpful. Presenting the checklist to the clinician before discussion of whether to accept the recommended medication or procedure enables patients to make a more informed decision. The box below contains such a checklist. You may need to adapt the checklist to your specific situation.</div><div>Reasonable Patient’s Informed Consent Checklist</div><div>What are all my options for treatment of my condition or illness, and what are the risks and benefits of each? Please be specific concerning risks and benefits of each choice I may have.If an invasive diagnostic procedure is recommended, how will the results of the procedure change my treatment plan?Will the recommended invasive procedure be according to evidence-based guidelines? If not, then please explain in detail why not.What harm might I experience if I choose watchful waiting? Please be specific about known risks of doing this.May I view objective decision aids for my disease or illness.Who will perform the recommended invasive procedure and how will trainees be involved?If I choose an invasive procedure, what will my recovery be like? Will I have restrictions on my lifestyle during or after recovery? What are the chances I’ll have lasting pain?Will any drugs prescribed to me be off-label or have a black-box warning? If so, please characterize the risks of those drugs and explain why a less-risky drug cannot be prescribed.</div></div>]]></content:encoded></item><item><title>The Patients’ List of
Top Patient Safety Opportunities</title><description><![CDATA[Early this week, the Patient Safety Action Network shared and discussed the ECRI Institute’s Top 10 list of Patient Safety Concerns. After review of ECRI’s list and report, and much debate, our group decided to create our own list. Our members have rich knowledge and firsthand experience with patient harm. We know what patients’ priorities are and we’ve infiltrated the work of others on local, state and federal levels towards solutions to end medical harm. This list comes from the collective]]></description><dc:creator>PSAN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/16/The-Patients%E2%80%99-List-Top-Patient-Safety-Opportunities</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/16/The-Patients%E2%80%99-List-Top-Patient-Safety-Opportunities</guid><pubDate>Fri, 16 Mar 2018 16:47:06 +0000</pubDate><content:encoded><![CDATA[<div><div>Early this week, the Patient Safety Action Network shared and discussed the ECRI Institute’s Top 10 list of Patient Safety Concerns. After review of ECRI’s list and report, and much debate, our group decided to create our own list. Our members have rich knowledge and firsthand experience with patient harm. We know what patients’ priorities are and we’ve infiltrated the work of others on local, state and federal levels towards solutions to end medical harm. This list comes from the collective voices of PSAN.</div><div>We recognized that no list is ever complete and we will continue to work on our list.</div><div>Do you have ideas on how to fix these problems? </div><div>1. Healthcare Acquired Infections, Sepsis</div><div>a. Prevention</div><div>b. Early detection/treatment of infections and sepsis</div><div>c. Screening patients for colonization of multidrug resistant organisms</div><div>d. Multidrug resistance</div><div>e. Lack of new antibiotics available</div><div>f. Prescribing inappropriate antibiotics for existing diagnosis/microorganism</div><div>g. Overuse of antibiotics</div><div>2. Pharmaceuticals</div><div>a. Use of unsafe drugs/adverse effects of medicines</div><div>b. Ignoring black box warnings</div><div>c. Poor FDA process for approval of drugs</div><div>d. Failure to coordinate medications to determine patient sensitivity and need</div><div>e. Overuse of pharmaceuticals</div><div>f. Inappropriate/irresponsible prescribing of opioids, benzodiazepines, psychotropic drugs</div><div>3. Unsafe Medical Devices</div><div>a. Poor vetting of new devices</div><div>b. Continued use of known unsafe devices, e.g., surgical mesh, breast implants, Essure</div><div>c. Inadequate warnings, information for patients on risks for use of certain devices</div><div>d. Inability to sanitize/sterilize reusable devices</div><div>e. Promoting use of devices that are very expensive and are no improvement over older devices, e.g., robotic vs laparoscopic surgeries</div><div>4. Patient Engagement, Communications</div><div>a. No shared decision making</div><div>b. Poor informed consent</div><div>c. Poor communications between healthcare team and patient</div><div>d. Dismissing patient and family concerns</div><div>e. Failure to communicate errors to patients and families</div><div>f. Exclusion of patients and families in Root Cause Analysis</div><div>g. No list of robust and well known enforceable PATIENT RIGHTS</div><div>5. Failure to Rescue</div><div>a. Healthcare worker alarm fatigue</div><div>b. Lack of continuous monitoring in hospital setting (e.g., “Dead in Bed”)</div><div>c. Need for rapid response teams in every hospital</div><div>6. Medical and Surgical errors</div><div>a. Concurrent surgeries</div><div>b. Wrong patient </div><div>c. Wrong site</div><div>d. Wrong procedure</div><div>e. Failure to use surgical check lists</div><div>f. Need for audio/video recording in surgical suites</div><div>g. Anesthesia errors</div><div>h. Diagnostic errors, including imaging and diagnostic test interpretation errors, leading to misdiagnosis</div><div>i. Medication errors: dose, route, patient, medication, time, mixture</div><div>j. Maternal deaths and harm</div><div>7. Professionalism, Oversight and Availability</div><div>a. Failure to practice evidence based medicine</div><div>b. Allowing dangerous doctors to continue practicing</div><div>c. Inaccessibility to appropriate healthcare (financial, geographic, shortage of professional healthcare providers)</div><div>d. Poor professional nurse staffing in hospitals, long term care/rehab, dialysis centers</div><div>e. Nurse and doctor shortage; nurse/doctor work overload</div><div>8. Pricing, Costs and Insurance</div><div>a. Complete and total disregard for cost of care</div><div>b. Insurance company interference with physician prescribing and ordering</div><div>c. Healthcare insurance literacy</div><div>d. Out of network, observation status and other insurance tricks</div><div>e. Financial ruin because of healthcare costs, leads to inability to access needed care</div><div>9. Transparency, Accountability, Integrity</div><div>a. Medical errors and harm not listed on death certificates, no accurate medical error death data</div><div>b. Falsifying medical records after harm</div><div>c. Underreporting of harm and lack of public information on harm</div><div>d. Protection of Profession at any cost</div><div>e. Erosion of rules barring companies from trying to convince doctors to use drugs and devices in untested ways</div><div>f. Selling of sickness; more disclosure and oversight of drug and medical device marketing to healthcare providers</div><div>g. Dissecting the hearts out of medical students</div></div>]]></content:encoded></item><item><title>National Patient Safety Awareness Week, March 11-17</title><description><![CDATA[This week is National Patient Safety Awareness week. It is a good time to reflect on patient safety in the United States. We can all work together to improve awarenss of the need for improved patient safety.There are many estimates about how many people are harmed through preventable medical error each year. Estimates suggest that about 100,000 to 440,000 people die per year from preventable medical error each year. Many more sustain harm that was significant but not fatal.One life destroyed by]]></description><dc:creator>Evelyn McKnight</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/14/National-Patient-Safety-Awareness-Week-March-11-17</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/14/National-Patient-Safety-Awareness-Week-March-11-17</guid><pubDate>Wed, 14 Mar 2018 18:49:22 +0000</pubDate><content:encoded><![CDATA[<div><div>This week is National Patient Safety Awareness week. It is a good time to reflect on patient safetyin the United States. We can all work together to improve awarenss of the need for improved patient safety.</div><div>There are many estimates about how many people are harmed through preventable medical error each year. Estimates suggest that about 100,000 to 440,000 people die per year from preventable medical error each year. Many more sustain harm that was significant but not fatal.</div><div>One life destroyed by medical error is one too many. But these numbers suggest that annually hundreds of thousands of people have their lives destroyed by preventable medical error. These numbers represent real lives of real people. We are all patients. We are all at risk for suffering caused by healthcare. We must take action to save ourselves and those we love from harm sustained through healthcare.</div><div>In my home state, we have the means to examine adverse events and educate for prevention through the Nebraska Coalition fo Patient Safety (NCPS). NCPS collects voluntary reports of suspected medical error from medical facilities. It aggregates the data to develop feedback, training and education about causes of medical error and shares the learning with member facilities. Members receive feedback on events, root cause analysis support, information and evidence-based best practices, and patient safety culture development.</div><div>However, when the NCPS was established in 2005, a consistent vehicle for funding was not established. The Coalition depends upon voluntary membership dues; this limited and uncertain budget hampers NCPS reach and effectiveness.</div><div>Last month, I jumped at an opportunity to increase patient safety in Nebraska by working on legislation to create consistent funding for NCPS. A bill to provide additional fees to some licensed healthcare providers to create the Patient Safety Cash Fund was introduced as LB1127. If passed, $10 will be collected per year from licensed physicians, nurses, pharmacists, occupational and physical therapists to create the Patient Safety Cash Fund. This fund would go directly to the Nebraska Coalition for Patient Safety.</div><div>If LB 1127 is enacted, the Coalition will:</div><div>expand their work from hospitals only to the continuum of care;engage all healthcare stakeholders, regardless of their position on the current bill, to conduct a patient safety needs assessment, develop a strategy to address cross-cutting priority needs, and then evaluate the effectiveness of our efforts;hire additional staff with knowledge and skills in clinical care, informatics, human factors, and organizational culture to receive the increased volume of reports and aggregate and analyze them (while reserving funds for office space, computers, software, and web support);implement a communication plan to provide feedback to healthcare professionals and the public using aggregate data to describe the patient safety hazards we identify and the resources needed to address them; andexpand efforts to ensure all healthcare professionals have the language and tools needed to advocate for patients.</div><div>In summary, LB 1127 has the power to engage all healthcare professionals in Nebraska in our most important priority…keeping patients safe while receiving care that is intended to help them.</div><div>I’m pleased to report that the Health and Human Services Committee held an executive session and voted to advance patient safety bill LB 1127 to General File! We will continue to work with other committed organizations like the Nebraska Medical Association and the Nebraska Hospital Association to pass the bill and increase patient safety!</div><div>For more from Evelyn McKnight, visit <a href="http://honoreform.org">HonoReform</a></div></div>]]></content:encoded></item><item><title>Patient Safety Awareness Week – Embracing the Right ‘Culture of Safety’</title><description><![CDATA[Patient Safety Awareness Week began on Sunday. Therefore, it is only appropriate to commemorate this week (and all following weeks) with awareness about safe patient care among healthcare professionals and the public. Much too often, patient safety is overshadowed by other healthcare-related issues (and agendas), such as expanding insurance coverage in state and local markets, medical and insurance mergers and acquisitions, and the opioid crisis – to name just a few. Some issues can’t be]]></description><dc:creator>David Lind</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/13/Patient-Safety-Awareness-Week-%E2%80%93-Embracing-the-Right-%E2%80%98Culture-of-Safety%E2%80%99</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/13/Patient-Safety-Awareness-Week-%E2%80%93-Embracing-the-Right-%E2%80%98Culture-of-Safety%E2%80%99</guid><pubDate>Tue, 13 Mar 2018 20:16:00 +0000</pubDate><content:encoded><![CDATA[<div><div><a href="http://www.unitedforpatientsafety.org/2018_patient_safety_awareness_week_focuses_on_patient_engagement_and_safety_culture">Patient Safety Awareness Week</a> began on Sunday. Therefore, it is only appropriate to commemorate this week (and all following weeks) with awareness about safe patient care among healthcare professionals and the public. </div><div>Much too often, patient safety is overshadowed by other healthcare-related issues (and agendas), such as expanding insurance coverage in state and local markets, medical and insurance mergers and acquisitions, and the opioid crisis – to name just a few. Some issues can’t be appropriately addressed soon enough (e.g. opioid epidemic), while other agendas are more about obtaining growth through acquisitions, often in the guise that more ‘value’ will be created to benefit the patient and the public. In healthcare, it appears optics is an extremely important and powerful tool. </div><div>So why is it so hard to make healthcare safer? There are many reasons, but four primary culprits stand out above all others: </div><div>Complexity of healthcare delivery system Flawed systems are not designed to optimize patient safety Ineffective communication contributes to patient harmWeak incentives to push improvement processes </div><div>We all know that healthcare is complex. Much of it is due to flawed systems that are laden with unclear and distorted regulations often resulting in unintentional consequences which adversely impact patient care. Additionally, poor organizational safety cultures and communication practices compound the previous two reasons for unsafe care. </div><div>Much of the patient safety problem stems from not having a ‘business case’ to do the right thing at the right time. Business models are dependent on incentives – strong incentives – that will steer behaviors to the desired goal(s). When it gets down to it, inadequate financial incentives stunt the necessary initiatives required to spark safer patient care. Come to think of it, this is also part of human nature. </div><div>Unfortunately, in healthcare, it appears to be less about ‘doing the right thing’ and more about having appropriate incentives that will create the ‘business case’ of providing safe care to patients. This mentality must change. </div><div><div>After publishing ‘Iowans’ Views on Medical Errors,’ I created a number of Fact Sheets that address some takeaway thoughts for patients, <a href="https://dplindbenchmark.com/the-medical-error-problem-do-employers-have-solutions/">employers</a> and <a href="https://hhri.net/iowans-views-on-medical-errors-iowa-patient-safety-study/">healthcare providers</a>. These printable documents are found in the right sidebar on this HHRI webpage. Given the importance of this week, I would like to briefly address one particular Fact Sheet, </div><a href="https://hhri.net/wp-content/uploads/2017/11/Fact-Sheet-8-Strategies-for-Hospitals-and-Clinics-Final.pdf">‘8 Strategies for Hospitals and Clinics to Prevent Medical Errors.’</a></div><div>I clearly realize that healthcare administrators will likely scoff at my ‘attempt’ to help them reform themselves, after all, they have been doing this reformation work for years, if not decades. But it seems to me – and many national medical experts included – patient safety begins with having a legitimate culture of safety at each medical establishment. And, it begins in the boardroom on down to each department in the organization. From this embedded culture, all other safety strategies can successfully follow. </div><div>My strategies, in no particular order – follow ‘culture of safety:’ </div><div>Embrace a culture of safetyTreat staff burnout as an organizational priorityAdopt a structure to improve patient handoffsDevelop and nurture a patient and family-led advisory council Be vigilant about reducing infectionsWork to avoid diagnostic errorsTo avoid medication errors, find opportunities to include pharmacistsElectronic health records systems must be interoperable</div><div>In 2017, the American College of Healthcare Executives and the <a href="http://www.npsf.org">Institute for Healthcare Improvement/National Patient Safety Foundation</a> published an excellent resource to address this critical strategy for delivering safe care: <a href="https://www.osha.gov/shpguidelines/docs/Leading_a_Culture_of_Safety-A_Blueprint_for_Success.pdf">“Leading a Culture of Safety: A Blueprint for Success.”</a></div><div>Patients experience medical errors not because doctors and hospitals wish to do them harm. Rather, unsafe care occurs because the systems and cultures of medicine influence medical providers to make decisions that don’t produce the best clinical results. It’s really quite simple. What patients want and need – coordinated and compassionate care that is affordable and safe – must align with the ‘business case’ of those who are paid to deliver it.</div><div>A ‘culture of safety’ should not just be a slogan in advertisements, but rather, THE reason healthcare organizations exist.</div><div>To stay abreast of healthcare-related issues, we invite you to subscribe to <a href="https://hhri.us5.list-manage.com/subscribe?u=a663997fba4045bf245645c5a&amp;id=191b461ddf">David's blog.</a></div></div>]]></content:encoded></item><item><title>Insulin Pricing</title><description><![CDATA[A Patient Safety DilemmaPatient safety awareness week is March 11-17, which this year occurs at the same time as the Right Care Alliance campaign targeting insulin prices. At first glance you might not think these two events are related, but as an active patient safety advocate and member of the Right Care Alliance, I believe that insulin prices are a patient safety issue. Here’s why.When I graduated from nursing school in 1970, the price of a vial of insulin was just a couple dollars. Insulin]]></description><dc:creator>Kathy Day, RN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/12/Insulin-Pricing</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/12/Insulin-Pricing</guid><pubDate>Mon, 12 Mar 2018 22:07:19 +0000</pubDate><content:encoded><![CDATA[<div><div>A Patient Safety Dilemma</div><div>Patient safety awareness week is March 11-17, which this year occurs at the same time as the Right Care Alliance campaign targeting insulin prices. At first glance you might not think these two events are related, but as an active patient safety advocate and member of the Right Care Alliance, I believe that insulin prices are a patient safety issue. Here’s why.</div><div>When I graduated from nursing school in 1970, the price of a vial of insulin was just a couple dollars. Insulin is a life, limb, eyesight, heart, skin, foot saving medicine for diabetics who are dependent on it. Without it, the heart and circulation are harmed and many patients lose limbs. Patients can go blind and kidneys can fail. Skin integrity can be compromised in the form of skin ulcers. Healing is sluggish or impossible. Infections are common and harder to treat. Diabetes is a pervasive disease, but it can be treated and well controlled with medication (insulin), diet and exercise. Type I, insulin dependent diabetes can affect people of all ages including children, and is the most severe form of the disease. About 7 million Americans rely on insulin.</div><div>We have had insulin for almost a century. It was developed in 1921. The patent rights were sold just a few years later for $3. The PATIENTS rights to affordable insulin were sucked up by big Pharma in the past few decades.</div><div>During a talk with healthcare professionals and patient advocates Dr Kasia Lipska, a Yale School of Medicine Endocrinologist, shared “a patient’s recollection that a vial of insulin cost $1.49 in 1972, which would be $8.86 now when adjusted for inflation. In 2004, that same vial would cost $60, and today it would go for roughly $300, she said. Improvements in performance are no longer justifying those spikes in prices, she said.” http://insulinnation.com/treatment/how-insulin-became-so-expensive-a-history/</div><div>So, we have gone from a couple dollars for a vial of insulin to $200 or $300 for that same vial.</div><div>This is such an egregious abuse of patients and their pocketbooks. Like dialysis, patients cannot live without it. They will suffer the effects of uncontrolled diabetes and probably death if they are Type I diabetic and they cannot afford Insulin.</div><div>This is a huge Patient Safety issue. The industry that produces this medicine deserves to make money. They are making life saving medicine after all. But, do they have the right to price it so high that many patients are forced to go without or to ration it? Should patients suffer or die because they can’t afford necessary medicine? Certainly not. Even with prescription insurance, benefits cap out way before the end of a year and then patients are forced to pay most of the costs themselves.</div><div>There have been baby steps to cover more patients for this kind of life saving care and medicine. The ACA allowed kids up to 26 years of age to stay on parents insurance coverage, and they eliminated the preexisting conditions exemption or up pricing. But, even with that, most average citizens 26 and over, cannot afford an additional $300 to $600 a month for insulin and diabetes supplies. Even copays cap out and they may end up paying out of pocket before the end of the year if they have prescription coverage.</div><div>No Insulin dependent diabetic should be forced stop taking or rationing their insulin. This guarantees a bad outcome or death. This is the worst and most preventable Patient Safety breach of all, and just to feed the greed of big pharmaceutical companies.</div><div>Perhaps it is time for Federal regulators and CMS to look at Type I diabetes the same way they look at Chronic kidney failure. Insulin for diabetics is the same as dialysis for CKF patients. It is a means for survival. Everybody should be covered for that lifesaving care through Medicare, regardless of age, and the price of treatment should also be regulated. We must find a way to control corporate greed and to stop manufacturers from pricing medicine so high that patients in need cannot afford it.</div><div>We in the Patient Safety movement have worked toward transparency and accountability in healthcare. We have pushed for increased reporting of healthcare harm and we can do this with the pharmaceutical companies. We can go after State or Federal legislation that requires reporting of any patient who has died because they could not afford their insulin. We have networked so that we can always find a voice for any relevant newspaper, TV or radio news interview or investigative report on a patient safety issue.</div><div>We have infiltrated all pertinent government committees, private and public conferences and events, by submitting abstracts, and becoming part of the program when possible. Sometimes we simply attend and we aim to bring the patients voice to the conversation. We have picketed outside of hospitals and events where we were not particularly welcomed. We have worked with Federal and State agencies who write the rules and recommendations and who fund them. We volunteer on patient advisory boards for government agencies, Hospitals, and medical organizations. We work independently and with each other to help the work toward elimination of healthcare harm. It’s time to pull together and target the Pharmaceutical Industry, because their greed is harming patients.</div><div>See more of Kathy Day's blog posts at her blog site, <a href="http://mcclearymrsaprevention.com">McCleary MRSA Prevention.</a></div></div>]]></content:encoded></item><item><title>Institutional Betrayal</title><description><![CDATA[Do victims of medical errors go through psychological changes in addition to their physical ailments? Many report a sense of “betrayal” that goes beyond event itself. And are these effects limited to the direct victim, or do close friends and family also suffer? John James lost his son tragically to a medical error. The medical error resulting in his son's death affected every living member of his family. In fact, after the passing of his mother last year, he found a diary documenting just how]]></description><dc:creator>PSAN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/03/01/Institutional-Betrayal</link><guid>https://www.patientsafetyaction.org/single-post/2018/03/01/Institutional-Betrayal</guid><pubDate>Thu, 01 Mar 2018 18:02:04 +0000</pubDate><content:encoded><![CDATA[<div><div>Do victims of medical errors go through psychological changes in addition to their physical ailments? Many report a sense of “betrayal” that goes beyond event itself. And are these effects limited to the direct victim, or do close friends and family also suffer? John James lost his son tragically to a medical error. The medical error resulting in his son's death affected every living member of his family. In fact, after the passing of his mother last year, he found a diary documenting just how deeply the loss of her grandson affected her. Janet Holt's betrayal came in the form of complete denial from the medical community that her horrific pain was coming from the implant she received. She spent years begging for a physician to help her. The mental scars will last a lifetime for her. And attorney Peter Mullenix has observed that his medical malpractice victim clients seem to suffer emotionally in ways that are distinct from other kinds of injured clients. According to <a href="https://www.ctvnews.ca/health/first-of-its-kind-study-examines-institutional-betrayal-1.3748514">this article</a>, some researchers have also seen this and coined the phrase &quot;Institutional Betrayal&quot; to describe it.</div></div>]]></content:encoded></item><item><title>Comity in Patient Safety Advocacy</title><description><![CDATA[As a patient safety advocate, I have dealt with a lot of discomfort. My early encounters/discussions with organizations and others about healthcare harm were frustrating and enraging at times. Others in the room didn’t know how to take me or even what the heck I was doing in their special inner sanctum. I was often dissed and interrupted rudely, but I refused to walk away. The reason for my work and the source of my passion was my father’s preventable death from an infection he caught in the]]></description><dc:creator>Kathy Day, RN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/02/05/Comity-in-Patient-Safety-Advocacy</link><guid>https://www.patientsafetyaction.org/single-post/2018/02/05/Comity-in-Patient-Safety-Advocacy</guid><pubDate>Tue, 06 Feb 2018 02:53:53 +0000</pubDate><content:encoded><![CDATA[<div><div>As a patient safety advocate, I have dealt with a lot of discomfort. My early encounters/discussions with organizations and others about healthcare harm were frustrating and enraging at times. Others in the room didn’t know how to take me or even what the heck I was doing in their special inner sanctum. I was often dissed and interrupted rudely, but I refused to walk away. The reason for my work and the source of my passion was my father’s preventable death from an infection he caught in the Hospital. I had heard enough of Dad’s doctors’ lame excuses and I knew that half of what they said was either to cover up their hospitals carelessness or outright lies. The biggest lie of all was when they said “These things happen and there isn’t much they can do about it”</div><div>When I set out, my attitude wasn’t great. I told others that my father’s hospital would regret what they did. I was hell bent and I was going after my perceived enemy.</div><div>My first important foray was helping my local Maine representative write a legislative proposal for the prevention of MRSA. It was time consuming extremely detailed work. I was driven and I loved it. My State legislator recommended asking my old union, Maine State Nurses Association, to lobby my bill. I did that. I attended a meeting of their leadership and shared Dad’s story. I asked for their support. They granted it. The media was there and we all answered questions about why I was doing this.</div><div>Without the help of those nurses, I’m not sure where that legislation would have gone. With their help, we got a law passed to screen hospital patients for MRSA. My representative and the nurses taught me the law making process, which I was clueless about. Some of the nurses in that leadership group were nurses from my father’s hospital. That was extremely confusing and uncomfortable for me and for them too. It muddied my attitude toward the offending hospital. A few of them would not walk with me at the State House and lobby beside me because they weren’t sure if they wanted to support my proposal or not. It was hard to deal with at that time, but it also made me begin to dissect my thinking and anger.</div><div>I have become friends with many of the nurses from my father’s hospital. They now support my work and my goals. I have helped them, the same as they have helped me. I attend the annual MSNA conference and bring the “patient’s voice”. My voice is different, because this patient is also a nurse. But, the difference is that I am a liberated retired nurse and I can use my voice in ways and in places that an employed nurse cannot. It could jeopardize their livelihood if they spilled their guts publicly. When the nurses expressed their concern about a corporate dialysis company coming in to take over my local clinics, I created a campaign to try and stop the purchase. I was convinced that it was not good for our community, the nurses or the dialysis patients it would affect. That corporation was known for hiring cheaper staff, having poor RN to patient ratios, and being a blatantly PROFITS over PATIENTS organization. The corporate business attitude spills out in a lot of destructive and dangerous ways. That purchase went through regardless of our campaign, and it affected a number of my nurse colleagues. It’s my understanding that all of those MSNA dialysis nurses who worked in my local dialysis clinics, left their specialty work and their new corporate employer within the first year under the new ownership.</div><div>At last year’s annual MSNA meeting, I gave a passionate comment about how important it is for them to DEMAND safe staffing levels, and NOW is the time. I told them I am getting old and I want safe staffing levels when I am a patient in the future. I encouraged them to go after mandated nurse to patient ratios at the State and National levels. I worked for decades as an RN in places that understaffed and endangered patients. I don’t see the point of continuing to endure those kinds of working conditions and patient safety threats.</div><div>I am still angry about my Dad’s death, and that he died because of a hospital acquired infection. But, I no longer let the anger consume me and control my work. I don’t let it influence who I partner with to get the work done. The work is about making healthcare safer and that means we have to work with people who are inside the healthcare system and people who regulate it. Exactly how far would I get if I was angry all the time, raging, yelling and interrupting conversations. How many conferences meetings, councils, committees and summits would welcome me at if I didn’t LISTEN as well as SPEAK? How much would anyone pay attention to me at all if I didn’t use my sense of humor and come across as a caring human being? How can I get respect if I don’t give it? If I alienate the very people who can make necessary changes and put them into practice, how far would I get?</div><div>I have learned to never prejudge entire groups of people or entire facilities because they are associated with the harm that my father and so many others have suffered.</div><div>When I started out I had two goals. They were to stop MRSA infections in Hospitals, and to make sure no one else would ever suffer and die because of preventable harm, like my father did.</div><div>Today, 9 years later, I wouldn’t be one step closer to my goals if I had allowed my anger to control my work.</div><div>See more of Kathy Day's blog posts at her blog site, <a href="http://mcclearymrsaprevention.com/?p=2088">McCleary MRSA Prevention.</a></div></div>]]></content:encoded></item><item><title>Why Do We Advocate?</title><description><![CDATA[Why do we advocate?I have asked myself this question many, many times.As patients and consumers, we all know that advocating for patient safety is not easy. Most of us are never paid for our volunteer work. Yet, we spend countless hours educating ourselves and the public on patient safety issues; we do this regardless of the day of the week, despite the fact that we come from all walks of life and have jobs and personal obligations in our lives; we go to Congress, state legislatures, and other]]></description><dc:creator>Yanling Yu, PhD</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/01/24/Why-Do-We-Advocate</link><guid>https://www.patientsafetyaction.org/single-post/2018/01/24/Why-Do-We-Advocate</guid><pubDate>Wed, 24 Jan 2018 16:47:00 +0000</pubDate><content:encoded><![CDATA[<div><div>Why do we advocate?</div><div>I have asked myself this question many, many times.</div><div>As patients and consumers, we all know that advocating for patient safety is not easy. Most of us are never paid for our volunteer work. Yet, we spend countless hours educating ourselves and the public on patient safety issues; we do this regardless of the day of the week, despite the fact that we come from all walks of life and have jobs and personal obligations in our lives; we go to Congress, state legislatures, and other government agencies to testify on behalf of patients; and we serve on various health care committees to bring patients’ perspectives to the policy-makers’ table.</div><div>We sometimes get recognition and compliments for our volunteer efforts; but more often than not, we are viewed as “complainers” who are unable to accept the harm or our love one’s deaths due to preventable medical errors. It is hard work, and, sometimes, it is frustrating and exhausting.</div><div>Then, why do so many of us still keep advocating for patient safety?</div><div>One of our patient safety colleagues and a retired NASA research scientist, Dr. John James published an article, “A new, evidence-based estimate of patient harms associated with hospital care” (Journal of Patient Safety, 2013). In his analysis, John shows that the number of patient deaths due to preventable harm is more than 400,000 per year. This is more than 1000 people dying a day, equivalent to two jumbo jets crashing and killing everyone onboard. It is hard to accept even one jumbo jet crashing. Why do we accept more than 400,000 patients dying every year due to medical errors? So, we rise from our personal grief and tragedies and embrace the impossible. Despite of the difficulties, we nevertheless persist.</div><div>We join our hands and come together under the Patient Safety Action Network (PSAN) with a common goal to make a difference, individually and collectively, so that what happened to us and our loved ones will not happen to other.</div><div>This is our movement to save more lives.</div><div>“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has.” By Margaret Mead</div></div>]]></content:encoded></item><item><title>Numerators</title><description><![CDATA[Five years ago this summer while under deep anesthesia for arm surgery number 3, I drifted above the line and joined the group called numerators. I awoke with a Hospital Acquired Infection. Numerators are the most diverse minority group on Earth, our members include, every race, every creed, every color. Some are very old, sadly some are only days old. Numerators have lost a lot to join this group, many have lost organs, and some have lost all their limbs, all have many kinds of scars from their]]></description><dc:creator>Kerry O&amp;#39;Connell</dc:creator><link>https://www.patientsafetyaction.org/single-post/2018/01/23/Numerators</link><guid>https://www.patientsafetyaction.org/single-post/2018/01/23/Numerators</guid><pubDate>Tue, 23 Jan 2018 21:41:05 +0000</pubDate><content:encoded><![CDATA[<div><div>Five years ago this summer while under deep anesthesia for arm surgery number 3, I drifted above the line and joined the group called numerators. I awoke with a Hospital Acquired Infection. Numerators are the most diverse minority group on Earth, our members include, every race, every creed, every color. Some are very old, sadly some are only days old. Numerators have lost a lot to join this group, many have lost organs, and some have lost all their limbs, all have many kinds of scars from their journey. It was not their choice to leave the world of denominators and many will struggle the rest of their lives to understand why.</div><div>Denominator Docs argue with denominator bureaucrats on how many of us made the suffered needlessly. All too often they blame us for being to dirty, to unhealthy, too wounded. We Numerators are a great embarrassment to both groups thus they passionately count the successful denominators but struggle daily to count us. There are lots of silly rules for not counting some infected souls as if by not counting us we might not exist. The Denominator world created a huge computer network called NHSN requiring thousands of man-hours to run yet they still can’t find most of our numerator members. Our outnumbered group is then divided by the denominators to create a nameless, faceless, mysteriously small number called rates. “Rates” like their cousin “odds” claim to portray hope while predicting doom for some. Denominators are in love with rates, for no matter how many numerators they have sired someone else has sired more. Rates sooth the denominator conscious and allow them to sleep peacefully at night. Recently, rates have even evolved into sadistic SIR’s which ruthlessly sanction how many unlucky souls it is acceptable to infect each year.</div><div>As large as our numerator group is, we are still plagued with great loneliness as denominators do their best to make sure we don’t talk to each other. The denominators created an act called HIPPA to protect the numerators but it became a means to steal our names and faces preventing the world from knowing that we exist. Numerators have no organization, no colored ribbons, no walks, and no marathons, our knights are few and far away. Our nightmare is devalued from disease to a mere “complication”. Yet as I travel the state speaking, one third of all denominators I meet have a family member or close friend who has become a numerator.</div><div>Upon our initiation into the group numerators have only two real choices; either a slow painful death, or hand over your life’s savings for treatment. Sadly, some hand over their money and still endure a slow painful death. Numerators endure the full physical, emotional, and financial burden of infections on their own. As tough as it is to be a numerator, it is far worse to be a denominator whose loved one has joined our ranks and endured the slow painful death.</div><div>Numerators don’t ask for much from the world. We ask that denominators look behind the numbers to see the people, to love us, count us, respect our suffering, and help keep us out of bankruptcy for once we were denominators just like you. Our greatest dream is that you find the daily strength to truly care. To care enough to follow the checklists, to care enough to wash your hands, to care enough to only use virgin needles, for the saddest day of all for Numerators is when another unsuspecting denominator rises above the line to join our group.</div><div>Kerry's blog first appeared at <a href="https://patientsafetymovement.org/advocacy/patients-and-families/patient-stories/kerry-oconnell/">https://patientsafetymovement.org/advocacy/patients-and-families/patient-stories/kerry-oconnell/</a></div></div>]]></content:encoded></item><item><title>California Doctors Are Getting Away With Sexual Misconduct</title><description><![CDATA[With the news full of stories about sexual misconduct, it’s worth mentioning cases where the perpetrators have hidden in plain sight – with the blessing of the Medical Board of California (MBC) and the state legislature. These are doctors who are allowed to continue practicing even after being found responsible for sexual misconduct. The Medical Board has disciplined more than 450 doctors in recent years for crossing the line with patients. Surprisingly, MBC investigators are not required to]]></description><dc:creator>Marian Hollingsworth</dc:creator><link>https://www.patientsafetyaction.org/single-post/2017/11/30/California-Doctors-Are-Getting-Away-With-Sexual-Misconduct</link><guid>https://www.patientsafetyaction.org/single-post/2017/11/30/California-Doctors-Are-Getting-Away-With-Sexual-Misconduct</guid><pubDate>Thu, 30 Nov 2017 22:43:00 +0000</pubDate><content:encoded><![CDATA[<div><div>With the news full of stories about sexual misconduct, it’s worth mentioning cases where the perpetrators have hidden in plain sight – with the blessing of the Medical Board of California (MBC) and the state legislature. These are doctors who are allowed to continue practicing even after being found responsible for sexual misconduct. </div><div>The Medical Board has disciplined more than 450 doctors in recent years for crossing the line with patients. Surprisingly, MBC investigators are not required to notify law enforcement of a sexual assault complaint. They can quietly investigate a doctor without any warning to the public. Doctors usually remain in practice unfettered throughout the course of the MBC investigation, which usually takes about three years. Some physicians do have their licenses revoked if the accusations are found to be true, but others are discreetly put on probation, ordered to take behavior classes, and have a chaperone in the examination room. AND their patients are never told. The MBC feels that if patients are interested, they will take the time to look up doctors themselves.</div><div>What is also surprising is that a license revocation is rarely permanent. Doctors can petition for reinstatement within a few years. At least three doctors found responsible for sexual misconduct have had their licenses reinstated; two of the cases involved underage girls. In one notable case, Dr. Dev Gnanadev, the current MBC president, sat on the panel that reinstated the license of a physician he knew who had assaulted four women, including a minor. Records show that doctor, Hari Narayana Ma Reddy, had also pleaded guilty to battery, a misdemeanor, after being charged with felony sexual battery of the minor. There was never an investigation of Gnanadev sitting on the panel by either the Department of Consumer Affairs (DCA), which oversees the MBC or the Business and Professions Committee. An investigation is not likely now, due to the fact that the new director of the DCA, Dean Grafilo, used to work for the California Medical Association (CMA), the doctors lobbying association. Gnanadev has donated thousands of dollars to the CMA, and is a former president of the group. </div><div>The Medical Board doesn’t bother to follow its own discipline guidelines for sexual misconduct case, which states physicians should get a minimum of 7 years probation, even when the relationship is consensual. Last year, a physician was given just 35 months probation, less than half the recommended time. for unwanted sexual contact with five female patients.</div><div>California legislators have been complicit in the protection of these doctors, due in part to strong-arming by the CMA. In 2016, lawmakers failed to pass SB 1033, which would have required doctors on probation for egregious cases to notify their patients. Just last summer, an effort to insert a similar requirement into the SB 798 Sunset Bill failed when lawmakers watered down the reporting requirements so much that only a handful of doctors would qualify. The amendment’s author, Senator Jerry Hill, angrily yanked it out of SB 798 rather than have a weak reporting requirement. The Sunset Bill then passed, allowing the MBC to continue without any changes addressing public safe.</div><div>Will there ever be a bill to protect California consumers from doctors who assault their patients? Not if the current mindset persists. Until then, consumers are told to look up their doctors on the Medical Board’s convoluted website before every single appointment. And if there is an issue where the doctor has been improper, the consumer should go directly to the police – not to the Medical Board. </div><div>See more of Marian's blog at <a href="https://mariansmusings.tumblr.com">Marian's Musings</a>.</div><div>Marian has co-created a very informative site,<a href="http://4patientsafety.org">4PatientSafety.org</a><a href="http://4patientsafety.org">. It contains a National Bad Doctor database and a blog about risky California</a>hospitals.</div></div>]]></content:encoded></item><item><title>DO YOU KNOW WHAT AN SIR IS?</title><description><![CDATA[A few days ago there was a member of the public in our meeting I tried to listen to the conversation through her ears. This is what happened. Right off the bat, acronyms were used that she, and possibly others in the group do not understand. Beyond that, some of those acronyms are used in public reports. It isn’t intentional when professional infection prevention professionals speak in complicated lingo, it is their everyday language. But, when consumers are part of the conversation, the very]]></description><dc:creator>Kathy Day, RN</dc:creator><link>https://www.patientsafetyaction.org/single-post/2017/11/06/DO-YOU-KNOW-WHAT-AN-SIR-IS</link><guid>https://www.patientsafetyaction.org/single-post/2017/11/06/DO-YOU-KNOW-WHAT-AN-SIR-IS</guid><pubDate>Wed, 15 Nov 2017 21:43:30 +0000</pubDate><content:encoded><![CDATA[<div><div>A few days ago there was a member of the public in our meeting I tried to listen to the conversation through her ears. This is what happened. </div><div>Right off the bat, acronyms were used that she, and possibly others in the group do not understand. Beyond that, some of those acronyms are used in public reports. It isn’t intentional when professional infection prevention professionals speak in complicated lingo, it is their everyday language. But, when consumers are part of the conversation, the very least that could be offered is a printed glossary of terms for newcomers, and for some of the people around the table who do not do this work every day, like me and a few others. I know for a fact that other regular members of our collaborative don’t understand all of those acronyms or terms that are tossed about during our meetings.</div><div>So, what exactly is an SIR? It is an acronym for “Standard Infection Ratio“. It is a way that the CDC, both State and national, reports infection rates. The SIR is a risk adjusted number that is reported that includes the number of expected infections, by facility or by State, or Nationally. For example, if a big trauma center that accepts the most complicated patients has a higher number of “expected” infections, that is somehow formulated into their SIR. There is also a risk adjustment for teaching hospitals. WHAT???!!!! The actual number of infections is not reported when using an SIR. The mean is the number 1, and anything under 1 like .48 is on the better side of 1 and anything above 1 , like 1.4, is on the worse side. Under 1 means fewer infections, and over 1 means more infections. Contrary to most reports, a higher score does not mean a better score. So, is that now as clear as mud? After all my years of these meetings, I’m still not 100% sure this explanation is totally accurate, but it is close enough.</div><div>So, what does having an SIR in an infection report mean?. Well, one thing that it means is that Hospitals (or entire States) can actually HAVE an expected number of infections and that is figured into their SIR report. That is how the final reported SIR numbers are risk adjusted. REALLY?? It seems to me that expected number of infections should always be ZERO….always. Zero expected infections is exactly what I and I assume all patients expect from any Hospital, so why can they have anything above that as an expectation, no matter what or who their patient population is. I know this will stir up some discussion and anger from the larger hospitals that claim they care for all the most complex patients, but they also have the resources, the staff (we hope!), and the experts that smaller facilities do not. And, it is their job although challenging, to keep all of their patients infection free. Nobody ever said elimination of infections would be easy.</div><div>This incomprehensible methodology is routinely used to create public reports on infections. Then the experts who create these muddy reports have the nerve to say that patients do not understand infection reports. Of course they don’t. A lot of doctors and nurses don’t understand them either. They don’t know what an SIR is. Creating a report that even some professionals don’t understand is a disservice to patients and consumers. How about this approach for a change? Report actual numbers, not SIRs. For example, report the number of hysterectomies the hospital performs every year, and the number of those patients who get a surgical site infection (SSI) as a result. Hospital A does 1500 hysterectomies (all varieties) every year, and 3 patients get an SSI. Or, Hospital B performs 50 such surgeries and 3 patients get an SSI. Even with my limited mathematical skills, I can figure out which hospital generally gets the best results regarding infections. This type of report is useful in two ways. It gives the volume of procedures done, and it also gives the number of infections that occur, both very important pieces of information for patients. As a patient, I don’t particularly appreciate or understand “risk adjustments” that help hospitals have a better infection report, I just want to know exactly what my personal risk is with a particular facility, doctor or surgeon.</div><div>If Hospitals and entire States are going to publicly report infections, as they absolutely should, make the report useful to everyone, not just to infection prevention professionals and other savvy experts, who actually understand these wonky reports. Consumers will use that public information to make choices that could very well affect their lives and pocketbooks. Preventable infections cause horrible suffering and sometimes death, and they can tack on a huge amount to an already high hospital bill. We want clear, accurate and easy to understand information about infections. Creating a public report that only infection professionals can decipher is not really a public service. It only serves the experts who can understand it.</div><div>This has been my brief but spectacular explanation of and opinion about the SIR!</div><div>SEE MORE OF KATHY DAY'S BLOG POSTS AT HER BLOG SITE, McCLEARY MRSA PREVENTION <a href="http://mcclearymrsaprevention.com/?p=2045">http://mcclearymrsaprevention.com/?p=2045</a></div><div>http://www.maine.gov/dhhs/mecdc/infectious-disease/hai/documents/2016-hai-annual-report-maine.pdf.pdf</div><div>http://www.comparemaine.org/</div><div>http://www.leapfroggroup.org/hospitals/search/list/states/Maine</div><div>https://www.cdc.gov/hai/surveillance/progress-report/faq.html</div><div>https://www.cdc.gov/nhsn/pdfs/ps-analysis-resources/nhsn-sir-guide.pdf</div></div>]]></content:encoded></item></channel></rss>