healthy4u

Computer woes hit Banner hospital system: Another large EHR outage ... but patient safety was not compromised

Here is yet another story in the genre of "EHRs go out, but patient care has not been compromised." (See query link at <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>; there are more than 20 posts there now): <blockquote class="tr_bq">Computer woes hit Banner hospital system Ken Alltucker, The Arizona Republic 12:30 a.m. EST February 20, 2014 <a href="http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/">http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/</a> The Phoenix-based health system used backup paper records to help provide patient care. PHOENIX -- Banner Health grappled with a widespread computer outage Wednesday as hospitals and doctors resorted to backup paper systems to provide care for patients. The Phoenix-based health system did not immediately know what triggered the computer troubles that started just before 10 a.m. PST. An official described the computer troubles as a rolling outage of computer systems at hospitals and other health care facilities in Phoenix, Colorado and Nevada.</blockquote> "Not knowing" means that you are not in control of your life-critical information systems; rather, they are in control of you. <blockquote class="tr_bq">By late Wednesday, a spokesman said, technicians had identified the problem and were fixing it. They expect to investigate the root cause of the problem Thursday.</blockquote> It took from 10 AM to "late Wednesday" to identify a problem causing a mass outage.  That should give anyone pause about dependency on fragile information systems in the hands of hospital IT departments (whose personnel undergo an ocean's less qualification-vetting than the medical personnel who depend on their work product) for one's medical care. <blockquote class="tr_bq"> Banner Health, the Phoenix area's largest health care system, activated "downtime procedures" that included using paper-based systems to track medications and other care provided to patients, officials said. Banner's emergency departments still provided care to patients and accepted new patients. Some non-emergency surgeries and appointments were delayed because of the computer troubles. "There have been some delays and inconveniences, but we are still providing care," said Bill Byron, Banner Health's senior vice president of public relations.</blockquote> In other words, what they are saying is "we really don't need these systems, that cost hundreds of millions of dollars, to provide care with the same degree of safety as with our 'downtime procedures' (a.k.a. paper)" ... and that patient safety was not compromised by this mass outage. <blockquote class="tr_bq">Banner Health, which operates 24 hospitals and several primary-care offices and outpatient centers in more than a half-dozen states, was working to "reboot" the computer systems Wednesday evening through a series of sequential fixes, Byron said. In the meantime, Banner officials were able to retrieve computer-based records that detailed patients' medical histories, including any medications, laboratory results and procedures that were previously performed.</blockquote> Officials?  What about line clinicians?  And when did this capability start if the systems needed to be "rebooted?" <blockquote class="tr_bq">Nurses and doctors shifted to writing on paper records after the computer systems experienced trouble Wednesday morning. Information from those paper charts will be keyed into the patients' computer-based health records after the problem is fixed.</blockquote> Sure, and nothing will be lost that could adversely affect patients in the future.... <blockquote class="tr_bq">Banner Health has been among the most advanced health systems in the nation in converting to computer-based health records. Banner Estrella Medical Center was among the first hospitals to open as an "all-digital" facility in the past decade. Banner's other hospitals have largely completed the final stages of installing computerized record-keeping in areas such as physician order and entry and electronic documentation.</blockquote> If they are the most advanced, what does this event say about those less advanced? <blockquote class="tr_bq">Arizona law does not require hospitals to notify state health regulators in the event of such a widespread outage.</blockquote> Health IT, as usual, enjoys widespread and extraordinary regulatory accommodation. <blockquote class="tr_bq">However, some hospitals have internal policies requiring that they notify health accrediting organizations or federal regulatory agencies, such as the Centers for Medicare and Medicaid Services, an Arizona Department of Health Services spokeswoman said.</blockquote> And how many do?  Not many, I predict. -- SS

Computer woes hit Banner hospital system: Another large EHR outage ... but patient safety was not compromised

Here is yet another story in the genre of "EHRs go out, but patient care has not been compromised." (See query link at http://hcre...

Đọc thêm »

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look <a href="http://www.nbcnews.com/health/health-care/best-health-care-system-really-john-boehner-f2D11598594">here</a>). Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News <a href="http://www.dallasnews.com/news/west-explosion/headlines/20131221-despite-crises-from-salmonella-outbreak-to-west-blast-rick-perry-s-pushed-freer-rein-for-business.ece">reviewed</a> Texas Governor Rick Perry's consistent attacks on government regulation.    <blockquote class="tr_bq">'American business in general, and American agriculture specifically, have had enough of bureaucracy at both the federal and state levels, but especially bureaucracy out of Washington,' Perry said at a congressional hearing. 'The men and women who feed and clothe this nation are suffocating under the weight of mounting federal regulations.' That was back in 1993, when Perry was Texas’ agriculture commissioner. Now Texas’ longest-serving governor, Perry has remained steadfast in his opposition to government regulations. </blockquote> Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access. However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly. As <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130713-patients-died-amid-federal-state-regulatory-inaction.ece">reported</a> in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals.  The report focused first on one hospital, Renaissance Hospital Terrell After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look <a href="http://www.bizjournals.com/houston/stories/2008/09/08/story6.html">here</a>), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood.  Almost immediately, however, there was trouble.  First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts: <blockquote class="tr_bq">from her office, she had a clear view of doctors’ foot traffic through the medical records department. When she saw [Dr Tariq] Mahmood jotting in patient charts, she knew he wasn’t seeing patients. Mahmood himself had not been credentialed to treat patients — a process in which management vets backgrounds and competencies of doctors. Part of Henry’s job was tracking such evaluations. She also knew it was a breach of privacy laws to review patients’ medical records. 'I immediately questioned some of the clerks and [insurance billing] coders,' she said. They were deeply concerned, saying he was altering the patients’ records to help boost reimbursements for insurance claims, Henry said.</blockquote> When Ms Henry complained, things did not go well, <blockquote class="tr_bq">Henry made her confidential call to the bankruptcy court in early November 2008, alleging potential fraud and threats to patient care that were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to the U.S. Justice Department, the Texas attorney general’s office and the state health department, officials confirmed. Later that month, the state health department sent an inspector to the hospital. However, the visit was brief, Henry said, and the inspector didn’t interview her or seek her help in obtaining records. Williams, the health department spokeswoman, told The News her agency’s records show the inspector was unable to substantiate violations at the time. Henry was terminated from Renaissance as part of a 'restructuring'.... </blockquote>Then the hospital was cited for turning patients away from the emergency department, <blockquote class="tr_bq">At Renaissance, two women in labor, one bleeding, were refused treatment. The inspection reports don’t reveal whether the women suffered complications because of the delays. A Renaissance employee told one of the women that if she 'could stand there and have a conversation with them then (she) wasn’t about to have a baby,' reports say.</blockquote> Then there were problems with infection control, <blockquote class="tr_bq">At Renaissance, no supervision over infection control could be found. For three months in the summer of 2010, no one was in charge of tracking infectious diseases or preventing their spread.</blockquote> The next year, the problem was blood transfusions <blockquote class="tr_bq">Inspectors returned to Renaissance in September 2011 to investigate a botched blood transfusion procedure. They found that a registered nurse had not supervised the patient’s care. In another case, an inspector witnessed an unsupervised vocational nurse administering blood to a patient, despite no evidence that she was competent to do so — another violation.</blockquote> In 2012, <blockquote class="tr_bq">During the summer, the Texas secretary of state had revoked Renaissance’s business charter for failure to pay franchise taxes. That office didn’t share the information with the health department; it isn’t required to do so. In September, state health regulators notified Renaissance that they were proposing a $35,050 fine for 13 violations, including the nursing supervision failures, dating as far back as 2010. Williams, the health department spokeswoman, could not explain why the fine process took nearly two years since the first violation. </blockquote> Finally, in 2013, patients started to die, <blockquote class="tr_bq">In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again. This time, the failures had led to three deaths: All ER patients. All with severe breathing difficulties. All receiving little to no intervention as their conditions worsened.</blockquote> In particular, <blockquote class="tr_bq">[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner. McCallum had chronic obstructive pulmonary disease. When she was admitted, nurses were ordered to monitor her vital signs and oxygen levels. Her breathing soon improved, said her niece, Lou Ann Sims. 'We were fully expecting to pick her up the next morning,' Sims said. Instead, they watched helplessly as her condition deteriorated. On Christmas Day, a physician explained to McCallum’s family that she had to be transferred to the intensive care unit. Later, Sims witnessed a scene she can’t let go of: Her aunt lay connected to a ventilator while a nurse stood smoking a cigarette just outside the door. The nurse had propped open the door with an IV pole. The family immediately sought to have McCallum transferred to another hospital. But hospital officials told them 'this would be a lateral move and was not allowed,' according to a transcript of an interview the family later conducted with state officials. McCallum died two days later. Inspectors wrote that a licensed vocational nurse had been left in charge of her treatment, without a registered nurse’s oversight. There was no evidence an RN had assessed her condition on admission or was watching over her in the ICU. They could find no doctor orders to place her on oxygen, no order for medications administered to her, 'nor evidence of communication with the M.D.' Suspecting more than just care breakdowns at Renaissance, McCallum’s family reported her death to the Texas attorney general’s fraud-control unit.</blockquote> So partially in response to this egregious case, <blockquote class="tr_bq">By February, the state health department had moved to revoke Renaissance’s operating license, and CMS had ordered its federal funding terminated — only the ninth time nationally in the last three years CMS had taken such a step.</blockquote> Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes. Other Hospitals Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, . Shelby Regional Medical Center This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look <a href="http://www.beckershospitalreview.com/hospital-management-administration/shelby-regional-medical-center-in-texas-closes-its-doors.html">here</a>).  In 2009, this hospital was also cited for providing insufficient treatment in the emergency department. In 2012, things were really falling apart, <blockquote class="tr_bq">In October 2012, inspectors were at Shelby chronicling dirty, clogged air-conditioners and failures to prevent ceiling plaster 'from falling into the patient food service line and contaminating food.' Those problems put patients’ safety in 'immediate jeopardy,' they wrote. As inspectors roamed Shelby’s halls in December, the power suddenly went out in four buildings, though not in the main hospital facility itself. The electric bill hadn’t been paid. They found other debts stacking up, too — as much as $190,442 owed to as many as 79 service providers. Signs of neglect were everywhere. Only three of 20 patient rooms inspected were 'fully functional for patient care,' they wrote. They found holes in walls, dirty and tattered curtains, and patients complaining of heat pouring from the faulty A/C system.</blockquote> Finally, in 2013, another patient died, <blockquote class="tr_bq">On Wednesday, CMS cut off federal funding to ... Shelby Regional Medical Center in Center in East Texas after regulators said a patient rushed there by ambulance never received treatment from a doctor. The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses. </blockquote>Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," <a href="http://lightandchampion.com/article/003856-mahmood-closes-shelby-regional-medical-center-staff-volunteers-time-until-doors-shut">per</a> the Shelby Light and Champion. Lake Whitney Medical Center Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.   In 2009, it was cited for inadequate care in the emergency department, <blockquote class="tr_bq">At Lake Whitney, a nurse acknowledged to inspectors that she had shredded records of a patient who was denied care following a fall, according to a report. The 'patient wasn’t going to pay anyway,' the nurse was quoted as saying in the document.</blockquote> In 2010, there was evidence of major infrastructure problems, <blockquote class="tr_bq">At Lake Whitney, patients were served food on rusty 'over-the-bed tables that were a source of possible infections for open wounds.' Bulging ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury. </blockquote>As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look <a href="http://watchdogblog.dallasnews.com/2013/08/florida-company-takes-over-lake-whitney-medical-center-effectively-dissolving-embattled-owners-troubled-chain.html/">here</a>). Cozby-Germany Hospital  I have been unable to discover when Dr Mahmood purchased this hospital.  In 2010, it became apparent that the hospital was not properly licensed, <blockquote class="tr_bq">'The administrator reported the new owner had not notified (CMS) … and has not applied for hospital licensure with the state licensing agency,' a report said. [The owner] ... also was found to have appointed his own employees to the hospital’s governing board of directors, instead of independent outsiders.</blockquote> And there were more severe problems with credentialing, <blockquote class="tr_bq">At Cozby-Germany hospital, hospital inspectors discovered that the chief of staff and another doctor had expired medical licenses. There were no 'functional' nurse and doctor credentialing processes, and clinical policies had not been updated since 2008, they said. The hospital pledged reforms.</blockquote> But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles. <blockquote class="tr_bq">At the time, Arafiles had been placed on probation by the medical board for allegations of harming nine patients, overbilling and improper coding at a Winkler, Texas, facility, according the board. He also was disciplined for intimidating the Winkler nurses who blew the whistle on his practices. In November, Arafiles would be convicted of two felonies linked to the retaliation and would surrender his license.</blockquote> In 2013, two local doctors purchased the hospital. The Vanishing Owner What made this series of cases all the more amazing is that it was really one interlinked case.  All these hospitals, plus a few more, had the same owner.  Yet no one, especially  no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit. <blockquote class="tr_bq">[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical license in 1978. Since 2008, he has practiced medicine only at his Central Texas Hospital in Cameron, south of Waco, records with the Texas Medical Board show. Older documentation is not available. Over the last two decades, he has purchased at least six hospital companies and two home-health care agencies, according to filings with the Texas secretary of state. He also has invested his money outside health care, acquiring the historic Hotel Lawrence in downtown Dallas, property records show. In addition to Renaissance, Shelby and Central Texas Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and Cozby-Germany Hospital in Grand Saline. He sold Community General Hospital in Dilley around the time of his arrest in April. The hospitals have no common corporate identity and little or no website presence, making it difficult for anyone to know they are owned by Mahmood or are part of a chain.</blockquote> However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case. <blockquote class="tr_bq">Mahmood is rarely seen in the communities where his hospitals are located, say business associates and city officials. Sometimes they catch a glimpse of him passing by in a chauffeur-driven car. 'He’s almost impossible to track down' to discuss business matters, said Tom Elliott, a director for a nonprofit company that owns the hospital building in Grand Saline. 'He lets his people do the talking.' Mahmood is a mystery to many of his own employees. He works almost entirely behind the scenes, they say, focusing largely on the business side of his operations. He often is traveling or spending time at his 10,000-square-foot gated estate in Cedar Hill, they say. 'We see him maybe once a year,' said one of his hospital physicians. 'The employees say he doesn’t like confrontation. I say he just doesn’t like to communicate. He seems to live in a different world.'</blockquote> Aftermath  At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent, <blockquote class="tr_bq">In April, federal authorities charged the 62-year-old Cedar Hill resident with defrauding Medicare and Medicaid programs through $1.1 million in false billings. Mahmood is accused of directing employees at his Central Texas Hospital in Cameron to alter underlying information in insurance claims from his other hospitals. 'In many cases,' the indictment alleges, these were 'for patients he had never seen.' Mahmood pleaded not guilty, and his attorney said he denies all charges. He has declined repeated interview requests from The Dallas Morning News. </blockquote> Note, however, that these are charges of financial fraud.  They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above. This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130719-perry-orders-investigation-into-oversight-of-troubled-rural-hospital-chain.ece">reported</a> again in the Dallas News, <blockquote class="tr_bq">The governor’s office has ordered a 'deep and comprehensive look' at health care facilities owned by Dr. Tariq Mahmood, whose chain of rural Texas hospitals avoided serious regulatory action despite years of endangering patients. The inspector general for the state Health and Human Services Commission and one of the agencies it oversees, the state health department, will conduct separate investigations, officials said Friday.</blockquote> And in February, 2014, the Dallas News <a href="http://www.dallasnews.com/investigations/20140206-texas-hospitals-chief-faces-fraud-charges-over-use-of-stimulus-grants.ece">reported</a> that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water, <blockquote class="tr_bq">The top administrator of a chain of hospitals that collapsed under the ownership of a North Texas physician faces charges that he defrauded the federal government of nearly $800,000 in stimulus funds. Joe White of Cameron rose from maintenance man to head administrator and chief financial officer over hospitals once owned by Dr. Tariq Mahmood. Now he joins Mahmood in facing the possibility of prison time. Like Mahmood, who pleaded not guilty, White is accused of identify theft and bilking the federal government of health care dollars. White has yet to enter a plea.</blockquote> Note that the CFO and apparently COO was not even a professional generic manager.  He was a former maintenance man  and operator of a Radio Shack store..  Dr Mahmood has not yet come to trial.  Many questions about the case remain unanswered:  -  Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers,  cronies, associates? -  What happened to the rigorous state investigation promised by Rick Perry? -  Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending?  Are there any other criminal investigations?\ Furthermore, despite its egregious nature, this case was amazingly <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>  The only national recognition I could find was i<a href="http://runningahospital.blogspot.com/2013/07/hospital-slumlord.html">n Paul Levy's Not Running a Hospital blog.</a>  Seven months later, I could find nothing in the national media, nothing in medical and health care literature.  Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety.  Summary Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal.  This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.   The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe. In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership, <blockquote class="tr_bq">Top health regulators weren’t even aware Mahmood owned several hospitals until The News sought information about them earlier this year. Regulatory agencies aren’t set up to track problem hospital owners or hold them accountable. Nor do they look for patterns of care breakdowns inside hospital chains. 'We just don’t have that authority,' said David Wright, deputy regional administrator for CMS. The federal agency oversees the state health department’s inspections of federally funded hospitals. 'We can only address problems in stand-alone facilities.'</blockquote> Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends, <blockquote class="tr_bq">The process allows hospitals to avoid sanctions if they cooperate. Hospitals submit “corrective action plans” to remedy failures. It can take months for state regulators to bring penalties such as fines against a facility. In the case of Renaissance, it took years. 'We want to do what’s in the best interest of the patients, and our regulatory philosophy is to get hospitals into compliance,' said Carrie Williams, spokeswoman for the Texas Department of State Health Services. 'We’re not in the business of shutting down hospitals. We will give them some leeway and work with them.'</blockquote> Of course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly all hospitals were small community not-for-profit organizations, non-profit academic institutions, or were run by local governments.  It seems quaint, and hopelessly out of date in an era when most hospitals are part of <a href="http://hcrenewal.blogspot.com/search/label/hospital%20systems">ever larger systems,</a> now often owned for-profit corporations, and when hospital system CEOs who are professional, and thus <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, not health care professionals, in an era of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a> and "maximizing shareholder value," that is, making short-term revenue the most important outcome. Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations.  Much of the content of this blog has been about bad health care leadership, i.e., leadership that is <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">ill-informed</a>, incompetent, unsympathetic or <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to health care professionals' values</a>, self-interested, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, dishonest, or even <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corrupt</a>.  In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest.  Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely for-profit in an era when management dogma puts revenue ahead of all other concerns. Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety. However, that cannot happen if this case remains anechoic.  I regret it took me so long to find it, but now I have done my part to start some echoes.  But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality? In particular, there are several prominent organizations that claim to promote health care quality and patient safety.  These organizations make these claims- <a href="http://www.jointcommission.org/topics/patient_safety.aspx">Joint Commission</a> <blockquote class="tr_bq"> For more than 60 years, The Joint Commission has been a champion of patient safety by helping health care organizations to improve the quality and safety of the care they provide. </blockquote> <a href="http://www.leapfroggroup.org/about_leapfrog">Leapfrog Group</a> <blockquote class="tr_bq"> The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded.</blockquote> <a href="http://www.qualityforum.org/who_we_are.aspx">National Quality Forum</a> <blockquote class="tr_bq"> Transforming our healthcare system to be safe, equitable, and of the highest value will take time and the work of many, but the potential rewards are great. The National Quality Forum (NQF) is a nonprofit, nonpartisan, public service organization committed to this transformation. </blockquote> <a href="http://www.rwjf.org/en/about-rwjf/our-mission.html">Robert Wood Johnson Foundation</a> <blockquote class="tr_bq">Our efforts focus on improving both the health of everyone in America and their health care—how it's delivered, how it's paid for, and how well it does for patients and their families. </blockquote> These  organizations should the ones to start the conversation about improving rather than forever shrinking regulation.   I have not heard anything from them about the deadly hospitals of Dr Mahmood.  Are they listening now?  Will we ever hear from them?  Time will tell....   Note: the entire Dallas News series on the Mahmood hospitals can be found <a href="http://res.dallasnews.com/interactives/collapseofcare/">here</a>.

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated. Some may thus conclude that the system is ba...

Đọc thêm »

InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

Radio station <a href="http://www.knpr.org/">News 88.9 KNPR</a>, the NPR affiliate in Las Vegas did a segment today on the following news story.  The station's Senior Producer had invited me to participate via phone regarding patient privacy issues. <div class="MsoNormal"> Emphases mine: </div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal"><a href="http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy">http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy</a> February 10, 2014 - Updated  February 11, 2014 Federal complaint alleges St. Rose Hospitals violated patient privacy By STEVEN SLIVKA LAS VEGAS REVIEW-JOURNAL Dignity Health, the owner of St. Rose Dominican Hospitals, is facing a federal complaint alleging it violated patient privacy by using patient records as leverage in a contract dispute. According to a Monday announcement from the Nevada Health Services Coalition, Dignity Health used patient records to contact those with coalition member plans after agreements between the two agencies fell through in January, something it contends violates the Health Insurance Portability and Accountability Act, or HIPAA. The complaint was filed with the U.S. Department of Health and Human Services Office of Civil Rights. The complaint contends St. Rose contacted former patients in an attempt to persuade them to take action with their health plans favorable to St. Rose. The complaint also said that St. Rose claimed their actions were simply to be “informative.” “It’s our position that patient data collected in the course of medical treatment should not be used to lobby or gain leverage in contract negotiations,” said Christine Carafelli, executive director of the coalition. The Nevada Health Services Coalition is a nonprofit entity that negotiates hospital contracts for discounted health care service rates for 19 member group organizations, totaling approximately 230,000 Nevada residents. A spokesperson for St. Rose said they would issue a statement on Tuesday.  </div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">The segment has now completed.  It was hosted by Dave Becker of KNPR.</div><div class="MsoNormal"> </div><div class="MsoNormal">A representative of the Health Services Coalition (<a href="http://www.lvhsc.org/">http://www.lvhsc.org/</a>), a local organization of union, casino and local government health funds who bargain together for maximum leverage, participated, as did a hospital VP.  The coalition is accusing the St. Rose hospital group (a division of Dignity Health) of using patient records to contact patients to urge them to lobby for the hospital in contract negotiations.</div><div class="MsoNormal"> </div><div class="MsoNormal">I was asked for an opinion on the acceptability of access to patient information in an organization's EHR systems (including PHI such as name, address and other contact information) for purposes of soliciting the patients to lobby the insurers on behalf of the healthcare organization for better terms.</div><div class="MsoNormal"> </div><div class="MsoNormal">My opinion was clear, which I summarize as follows:</div><div class="MsoNormal"> </div><div class="MsoNormal">1.  Hospitals do not "own" patient data to use as they please.  Is is not a simple business asset, like typewriters - or computers.  Any belief that a hospital can treat patient records as such, to be used as they pleased, would reflect arrogance; 2.  The HIPAA privacy rule and its exceptions (viewable at <a href="http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/">http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/</a>, section under "Permitted Uses and Disclosures") would preclude the use of patient's private and protected information in an EHR for selective solicitation for lobbying on behalf of the hospital;</div><div class="MsoNormal"> </div><div class="MsoNormal">3.  Who accessed the patient information, and exactly what they accessed, is not clear, and an electronic audit trail needs to be disclosed as to these issues;</div><div class="MsoNormal"> </div><div class="MsoNormal">4.  Harm could potentially come to patients if someone who accessed the information, who otherwise might not have, used it to advantage for other purposes.  This includes, for example, uses outside of the medical sphere (e.g., personal use by, say, a neighbor or competitor).  I am aware of cases of such abuse, as is HHS and so are hospitals (see my blog query links on medical record privacy and confidentiality at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality</a> and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>); and:</div><div class="MsoNormal"> </div><div class="MsoNormal">5.  The hospital could have accomplished such goals transparently, safely, and without access to private health information, by putting an ad on the radio (or newspaper etc.), or mailing a general newsletter such as I often receive from area hospitals, even hospitals where I was never a patient.</div><div class="MsoNormal"> </div><div class="MsoNormal">A hospital VP contributed soothing words that the hospital respects patient privacy, trusts its employees and doesn't wish this matter to become a stumbling block in negotiations.  However, in my opinion the hospital violated the HIPAA privacy rules and potentially put patient privacy at risk.  No amount of soothing, deflecting executive language and shifting of the discussion can change that, and a full disclosure accounting would be proper.  (I note the HIPAA privacy rules do not state "For informational purposes only.  Use patient information however you want if you trust your employees and you think the risk is low..")</div><div class="MsoNormal"> </div><div class="MsoNormal">That is, assuming an audit trail of sufficient detail is recorded in their EHRs, assuming it is turned on, and assuming it can be trusted in light of the HHS OIG report of Dec. 2013 where many hospitals admitted EHR audit trails can be deleted or edited by a person with appropriate credentials.  (See my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" at <a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a>).</div><div class="MsoNormal"> The segment audio is online here: <a href="http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939">http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939</a> -- SS  Feb. 14, 2014 Addendum: A thought experiment demonstrates just how far from propriety, in my opinion, this affair is: If a hospital can use confidential information in this manner, to enlist patients as de facto lobbyists regarding an insurer, then why could not a hospital use other data - e.g., patients' disease burden, smoking status or even sexual orientation to ask them to lobby, say, a politician to gain some advantage, such as certificate-of-need approval for expansion, or anti-competitive legislation?  Or, to ask patients to participate in political activities for/against some politician or group that might hold views or conduct activities favorable/unfavorable to the hospital's interests? -- SS </div><div class="MsoNormal"> </div>

InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

Radio station News 88.9 KNPR , the NPR affiliate in Las Vegas did a segment today on the following news story. The station's Senior Pr...

Đọc thêm »

"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be manipulated by corporate research sponsors intent on marketing their products. Background As <a href="http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html">reported</a> by the New York Times, the litigation is over allegations by thousands of patients and families that privately held Boehringer Ingelheim concealed the bleeding risks of the anticoagulant drug Pradaxa.  <blockquote class="tr_bq">Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that for decades has been the standard treatment for preventing blood clots and strokes. Many patients viewed the older warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs. <div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">The new drugs do not require such monitoring, yet claim to be as good, or better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.</div></blockquote><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">However,</div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="180" data-total-count="747" itemprop="articleBody">Since its approval in 2010, the drug, <a href="http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html" title="From the archives.">which can cause fatal bleeding</a>, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health. </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">It has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths. </div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">Internal Documents Show the Influence of Marketers on a Clinical Research Report</div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">As summarized by the NY Times, </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.</div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">In particular,</div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody">The documents show that Boehringer Ingelheim employees openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.</div><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="272" data-total-count="3045" itemprop="articleBody">In a draft version of the paper included in the court records, Dr. Reilly and his co-authors detailed specific levels of how much Pradaxa should be in a patient’s bloodstream, and said that keeping some patients within that range would help prevent strokes and bleeding.</div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody">As Dr. Reilly’s draft paper circulated within the company, some employees questioned what the marketing implications of such a conclusion would be.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody">One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.</div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody">Publishing the research results, she warned, could make it 'extremely difficult' for the company to defend its long-held position to regulators that Pradaxa did not require testing.</div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody">And, Dr. Heinrich-Nols added in the email, the research, if known, would 'undermine' the company’s efforts to compete with other new anticoagulants, such as Xarelto and Eliquis.</div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> 'I would like to ask you to check again whether this is really wanted,' she wrote about publishing the research.</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A second NY Times <a href="http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-show-concern-over-profit.html">article</a> added more details,</div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="176" data-total-count="2486" itemprop="articleBody">In one email, from June 2012, an employee wonders about the implications of internal research showing that blood levels of Pradaxa could vary significantly in a single patient.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody">'This may not be a onetime test and could result in a more complex message (regular monitoring), and a weaker value proposition … vs. competitors,' wrote the employee, whose name was redacted in accordance with privacy laws in Germany, where the company is based.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody">In another, an employee — whose name was also removed — asks about whether a newly available blood test in the United States might be useful for doctors treating patients with Pradaxa, which is also known as dabigatran. Another replies that such a test could be developed 'in-house,' but '2 years ago there was an informed decision NOT to develop this.' The employee continued, 'this would go against the ‘no monitoring’ idea/claim.'</div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody">Employees also continued to question the merits of allowing a research paper to be published showing that some patients could benefit from monitoring of their blood. The paper was <a href="https://content.onlinejacc.org/article.aspx?articleid=1748241&resultClick=24">published on Tuesday</a> but with some details removed.</div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="198" data-total-count="3637" itemprop="articleBody">'This publication will more harm than be useful for us, neither in the market but be especially harmful in the discussions with regulatory bodies,' one email read. 'Can’t this be avoided?'</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">So, in summary, Pradaxa has been marketed basically on its convenience, as a drug whose dosage need not be customized according to frequent blood tests, in contrast to cheaper generic warfarin whose dosage may need adjustment according to frequent blood tests.  Yet a clinical trail sponsored by Boehringer Ingelheim, the manufacturer of Pradaxa, seemingly showed that its risk of bleeding might be dependent on its blood level, and hence perhaps that its dosage should be varied according to blood test.  </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">However, the manuscript reporting the results of this trial was apparently subject to vetting by multiple company managers whose specific concerns were whether the results of this research "undermined" the marketing message, and hence whether these results should be changed or suppressed to avoid contradicting the company's intended marketing message.   </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">Let me try to add some context, based on my experiences in academic medicine writing research papers, commenting on colleagues' papers, and reviewing papers for journals.  Considerable discussion among the researchers and clinicians involved in research projects about how manuscripts are worded is the norm.  However, working a perhaps more innocent era, input from people with vested interests in the project producing a particular result was unheard of.  Many health care professionals thus may still act based on the idealistic assumption that clinical research reports are all about science, and not about marketing. </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">Was the Manipulation Successful?</div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A Medscape <a href="http://www.medscape.com/viewarticle/820324">article</a> noted that the published version of the research article </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">found ischemic stroke and bleeding risks were correlated with plasma concentrations of the drug in 9183 patients treated with dabigatran 110 mg or 150 mg twice daily (the available European doses). In their logistic regression analysis, the risk of ischemic stroke was inversely associated with trough concentrations of dabigatran. </div> The researchers concluded that 'the magnitude of the effect of dabigatran plasma concentrations on outcomes in atrial-fibrillation patients in <a href="http://www.medscape.com/viewarticle/708133" target="_blank">RE-LY</a> depends strongly on demographic factors, most importantly increasing age.' However, the results also confirmed a wide therapeutic range among those treated with dabigatran, with a more than fivefold variation in plasma concentrations. The researchers concluded there might be a subset of patients who could improve their risk/benefit profile by tailoring the dose of dabigatran. </blockquote> However, <blockquote class="tr_bq">In the paper, there are no references to the optimal plasma concentration of dabigatran, although such statements were in various drafts that circulated throughout the company, according to the New York Times.  When the paper was published online in October, Reilly told Reuters news  that the 'there is no single plasma concentration range that provides optimal benefit-risk for all patients" and that "no monitoring is necessary.' [see relevant Medscape article <a href="http://www.medscape.com/viewarticle/812871">here</a>.]</blockquote> So it does appear that the final version of the article included a discussion that was influenced by the marketers' wishes that the results would not appear to contradict the marketing party line.  A rigorous review of the article might have suggested that varying the dosage of the drug according to its blood level might reduce bleeding risk, and hence increase its benefits versus its harms.  However, a casual reading might not have revealed that the data in the study undermined the marketing message that Pradaxa is a better drug than warfarin because it can be given at a fixed dose without the need for inconvenient blood tests.  Thus, the efforts by the marketers to alter the dissemination of the clinical research to support marketing messages and increase sales of the drug and resulting revenues - never mind what the data showed - appeared to be successful.  Conclusions This case study, only made possible by the public release of internal corporate documents in the course of litigation, suggests that in retrospect the dissemination of the results of one particular clinical trial were manipulated in a somewhat subtle way so that the data would not contradict a marketing message that now appears rather fictional. In the absence of litigation, and of a judge willing to make public documents that one party to the litigation doubtless wanted to hide, the manipulation of this particular study might never have been apparent.  Most clinical research is now sponsored by health care corporations with vested interests in how the research turns out.  Much of this research could be manipulated by corporate marketers who wish it to support their marketing messages, the truth be damned.  We (and others) have discussed many <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">examples of apparent manipulation of clinical research</a>,  However, it is unlikely that we, physicians, health care professionals, health care researchers and policy makers, and the public, will ever know for such which studies were manipulated.  At best, very critical, skeptical, rigorous review can suggest which studies might have been manipulated. In the absence of such review, we are in danger of being swamped in a morass of manipulated research, and thus lead to make clinical decisions that are based mainly on hucksterism, not science. Thus, I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor.

"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be mani...

Đọc thêm »

H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients? It often appears that way to me. Health IT and its industry sector seem to garner extraordinary regulatory accommodations compared to other healthcare and life-critical sectors - such as freedom from meaningful safety regulation, freedom from need for human research subjects protections and informed consent on EHR risks ... and in this proposal, freedom from full legal Discovery: US Congress has a bill, H.R.2957 - Behavioral Health Information Technology Act of 2013, 113th Congress (2013-2014), at <a href="http://beta.congress.gov/bill/113th/house-bill/2957" target="_blank">http://beta.congress.gov/bill/113th/house-bill/2957</a>) with a section (SEC. 4. PROVIDING PROTECTIONS FOR CERTAIN PROVIDERS, VENDORS, AND USERS OF CERTIFIED EHR TECHNOLOGY) that provides safe harbors for reporting EHR-related errors. The text of Sec. 4 contains this: <blockquote class="tr_bq">... (c) Rules Relating to E-Discovery.--In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--         (1) information that is related to such EHR-related adverse event; and         (2) information from the period in which such EHR-related adverse event occurred. </blockquote> In other words, it seems the bill proposes, on capricious grounds, that an injured party cannot discover any information from prior to - or after - the EHR-related event they allege caused their injury, even if potentially material; for example, if the cause of the event was known about and had occurred in the past to others, or afterwards, yet went uncorrected. This seems a shield against claims of EHR vendor and/or healthcare organization corporate negligence and seems to represent anther special accommodation to health IT. This proposed Bill would also, it seems, hamper clinicians who were themselves victims of bad health IT from fully defending themselves. How this Bill's eDiscovery infringement promotes timely correction of known EHR problems, I would like to know... I also fail to see what "certification" has to do with provision of this remarkable special accommodation regarding eDiscovery. "Certification" by HHS/ONC is a features qualification/verification of features felt by committee (with no real basis in Evidence-Based Medicine principles) to foster "meaningful use", whatever that means, and make an EHR product eligible for CMS incentives. However, "certification" is not a safety testing or validation process, in the words of the certification bureaus themselves, see my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'" at <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html</a>. Finally (and with the caveat that neither I nor my colleagues are lawyers), colleagues point out that such a proposal from Congress may be at odds with the role of the government branch that does decide the Rules of Civil Procedure, including discovery rules.  Specifically, the judiciary, at both the Federal court level (e.g., per the Rules Enabling Act of 1934, an Act of Congress that gave the judicial branch the power to promulgate the Federal Rules of Civil Procedure,  <a href="http://en.wikipedia.org/wiki/Rules_Enabling_Act">http://en.wikipedia.org/wiki/Rules_Enabling_Act)</a>, and State levels. It would seem quite possible that the roster of Congressional co-sponsors of this Bill, seen at <a href="http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors">http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors</a>, have been "influenced" by the health IT industry. -- SS

H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients? It often appears that way to me. Health IT and its industry sector seem to garner extraordinary...

Đọc thêm »

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following: <blockquote class="tr_bq">Dear Dr. Silverstein, As you write, there is not a transaction of medical care that does not go through EHR systems. However, these poorly usable EHR systems stifle creative and artistic thought required to link risk, benefit, and probability of diagnosis with risks and benefits of testing and therapeutics. Assuring safety and efficacy with pre- and  aftermarket surveillance will maximize the possibility of achieving the potential of the technologies. Additionally, when I use these electronic ordering systems and  libraries of medical information, they fail to keep up with the agility and nimbleness of my mind as I seek 'random access' to pieces of data to formulate and synthesize diagnoses and therapeutic strategies. The EHRs are too slow, do not have a robust (if any) search function, randomly and whimsically store key information with ever changing formats, and generally obfuscate what should be simple. They are cumbersome and disable the ability to simultaneously and contemporaneously compare myriad data points. They get an "F" as enablers of complex diagnostics. Paper, since it can be organized as needed and set out on a desk to be seen and compared as quickly as the eye registers the data, gets an "A". The EHRs  are impediments and disrupters of communication. Example: Just today, I was witness to the fact that a stat EKG was ordered by CPOE  on a heart patient yesterday at or shortly after 4:30 pm. The intended recipient of the order (heart station) never got it because they close near 4:30 pm and there was no warning to the ordering health professional that was so. Thus, the EKG was never done, and this morning, when the requisition was seen, no one did it because it was ordered stat "yesterday", and the techs asked themselves "what good would it do for a 'stat' to be done now, a day late?" I do not know what happened to the patient.  I have many other examples of such delays facilitated by the CPOE and EHR systems that I am required to use at numerous facilities. They facilitate 'stealth' alterations in care.  Also just today, a disease-critical test ordered 3 days ago was not done because it was cancelled in 'stealth' (automatically "expired") without warning to me by the lab responsible for doing it. There is the "silent silo" syndrome as you've called it.  Also just today, a disease critical test ordered 5 days ago came back with results, but the results were posted in the information 'silo' of 5 days ago. The lab screen default on the EHR only goes back 4 days (so unless I knew to look for it, it would not be seen or acted on), further obfuscating data and delaying treatment. The EHRs lose data and orders.  Also just today, I found that blood coagulation monitoring tests that were ordered to be done with kidney dialysis (3 days per week) on a patient somehow got "lost" and were not being done for 5 days, putting my patient at risk of bleeds - or stroke if the blood was not 'thin' enough. I just walked in to examine a hospitalized patient with multi-organ failure and diabetes, on multiple meds including insulin, and recovering from respiratory failure. The nurse anxiously informed me that the blood sugar was dangerously low. I ordered treatment stat. I see patients in the morning before labs come back, and depend on nurses to review labs and notify me. Turns out that the patient was hypoglycemic on yesterday morning labs that arrived in the EHR 'silo' after I left the hospital; and was also low in potassium, but the tests just laid there comfortable in their silos; and were not communicated to anyone like in the old days when a human ward clerk or other undistracted human received them and disseminated them to the appropriate professionals. Thus, instead of getting less insulin, the patient got the usual dose with near catastrophic adversity. Misidentifications are facilitated by EHRs.  I  noticed that on several critical clinically significant changes that arose on my patient that were entered as such in an EHR silo by the RN, it was stated that they called attending physician 'Dr X', which was not me...obviously a case of EHR-facilitated misidentification. Here is a misidentification variant:  yesterday, someone (non doctor but not clear who) ordered a specialist consultation on one of my patients under my name. I did not order it nor was it needed, yet it showed up as an order for me to sign. Like you, I agree this is representative of a toxic impact of these systems on medical care and I feel like the care environment is foul, like a cesspool, compared to what has been replaced. These systems of medical devices cannot be trusted in the care of sick patients. Perhaps, they are OK for managing hang nails.</blockquote> I offer no additional comments other then if I am sick, I do not want my care interfered with in this manner by IT. Rest assured, though - there are IT hyper-enthusiasts out there (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>) who would see little problem with this, as any accidents that occur are "anecdotes", "learning experiences" or "bumps in the road." That's if they don't simply blame the user. -- SS

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following: Dear Dr. Silverstein, As you write, there i...

Đọc thêm »

Who Knew? ... Judge Finds that Hospital Takeover of Medical Practices Raised Prices

A story that caused only a few ripples in the media in late January, 2014, corroborates concerns about the increasing concentration of power in health care, and suggests new skepticism about the continuing transition of physicians from independent professionals to corporate employees. The Judge Quashes a Hospital System's Acquisition of Physicians' Practices The original story was carried, albeit briefly, in some national business news sources, e.g., the <a href="http://online.wsj.com/news/articles/SB10001424052702304856504579340733626090534">Wall Street Journal</a> and Bloomberg news.   In summary, according to the WSJ, <blockquote class="tr_bq">A federal judge ruled Friday that an Idaho hospital system must unwind its acquisition of the state's largest independent doctor group, a decision that could have significant implications as health-care providers nationwide increasingly seek to join forces.</blockquote> In particular, <blockquote class="tr_bq"> At issue was St. Luke's Health System's 2012 deal for the 40-doctor Saltzer Medical Group. The FTC argued the merger would reduce competition among primary-care physicians and give St. Luke's extra muscle to extract higher payments from health plans, which, in turn, could raise insurance prices for consumers.</blockquote> The Judge seemed to agree, <blockquote class="tr_bq">U.S. District Judge B. Lynn Winmill ruled the deal anticompetitive, but offered comments that reflected current tensions in the debate over industry consolidation. Judge Winmill said he was 'convinced' the deal would have improved the delivery of health care in the region. But he ruled that 'there are other ways to achieve the same effect that do not run afoul of the antitrust laws and do not run such a risk of increased costs.' The judge said he would order St. Luke's to fully divest Saltzer's physicians and assets. The court made only a summary of the ruling public, sealing the full decision temporarily so confidential business information can be redacted. </blockquote> Furthermore, the Bloomberg <a href="http://www.businessweek.com/news/2014-01-24/hospital-antitrust-case-won-by-u-dot-s-dot-over-doctor-group-merger-1">coverage</a> raised a related issue, <blockquote class="tr_bq">David Balto, an antitrust lawyer in Washington who has represented consumer groups, said the ruling could be read as conflicting with the Obama administration’s health care overhaul, which advocates reducing fragmentation of medical care to improve quality. ' This is going to raise really difficult questions about the kind of integration that’s envisioned by the Affordable Care Act,' he said. Winmill didn’t specify alternate means of improving patient outcomes and released only a summary of his ruling pending redaction of proprietary information in the full opinion. </blockquote> Note several aspects to this coverage.  It implied that the deal was done solely for high-minded purposes, improving "health care delivery," and in response to the need for "integration" arising from the health care reform produced by the Affordable Care Act; that health care reform might be in jeopardy from this ruling in the absence of the judge's new prescription for "improving patient outcomes"; and that details of the ruling and the justification for it were kept secret as "confidential business information."  So this initial coverage was difficult to interpret, raising more questions than it answered.  If the practice acquisition was made with such lofty goals, why couldn't it be legally saved?  How could health care reform possibly continue without Judge Winmill saying what should be done?  That last question was sarcastic, maybe the real question is why did anyone think it was the judge's job to explain how to improve health outcomes?  Finally, why was so much of the ruling and the details underlying it kept secret. In a few days, local journalists came up with a better idea of what was really going on. It Was All About the Money The same day that the Wall Street Journal and Bloomberg covered the case, the Idaho Statesman <a href="http://www.idahostatesman.com/2014/01/24/2989492/federal-judge-says-st-lukes-buyout.html">reported</a> more details about the judge's ruling that seem to suggest different interpretations, <blockquote class="tr_bq">Winmill said in his ruling that while it may not have been the goal of the acquisition, it 'appears highly likely that health care costs will rise as the combined entity obtains a dominant market position that will enable it to (1) negotiate higher reimbursement rates from health insurance plans that will be passed on to the consumer, and (2) raise rates for ancillary services (like x-rays) to the higher hospital-billing rates.'</blockquote> Then only a week later, the Statesman <a href="http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html">covered </a>the unveiling of some previously hidden portions of the ruling, first giving the background, <blockquote class="tr_bq"> As St. Luke’s Health System aggressively added hospitals and doctors over the past several years, it commanded more money from Idaho’s largest insurer, and it planned to raise prices in order to give a newly acquired group of doctors a 30 percent raise, according to <a href="http://media.idahostatesman.com/smedia/2014/01/29/09/31/1fjNtG.So.36.pdf" target="_blank">newly released court documents</a>. Unsealed Tuesday, the documents explain why U.S. District Judge B. Lynn Winmill <a href="http://www.idahostatesman.com/2014/01/25/2990546/judge-st-lukes-deal-not-legal.html" target="_blank">last week ordered St. Luke’s to nullify</a> its year-old merger with Nampa’s Saltzer Medical Group. Lawyers for St. Luke’s and Blue Cross of Idaho asked the judge not to reveal some facts in the documents, arguing that they contained trade secrets. But Winmill <a href="http://media.idahostatesman.com/smedia/2014/01/29/09/35/1dSNod.So.36.pdf" target="_blank">denied the requests</a>. 'The facts and figures sought to be redacted are crucial to the court’s analysis, and their removal would render the decision indecipherable,' Winmill said.</blockquote> Then it got to the nitty gritty,  Winmill said in his decision Tuesday to make his ruling public that when the trial started, he thought there were compelling reasons to keep parts of it veiled. But as it went on, those reasons seemed less compelling, he said. <div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div>Winmill immediately opened his entire decision.   St. Luke’s told Winmill that he should keep statements such as the following out of his public ruling: <ul><li> 'By 2012, St. Luke’s had three of the top five highest-paid hospitals, and its top hospital was receiving reimbursements 21 percent higher than the average Idaho hospital'</li><li> 'After the acquisition, if St. Luke’s were to bill for (routine services such as lab tests or X-rays) at the higher ‘hospital-based’ rates, (Blue Cross of Idaho) estimates that costs ... would increase by 30 to 35 percent.'</li><li> 'St. Luke’s own analysis projected that it could gain an extra $750,000 through hospital-based billing from Saltzer from commercial payers for lab work and $900,000 extra for diagnostic imaging.'</li><li> 'Consultant Peter LaFleur prepared an analysis at the direction of St. Luke’s showing how office/outpatient visits could be billed for higher amounts if the visit was hospital-based rather than Saltzer-based. The hospital-based billings were more than 60 percent higher.' </li></ul><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div> <div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.idahostatesman.com/2014/01/24/2989492/federal-judge-says-st-lukes-buyout.html#storylink=cpy</div> Although it certainly makes sense that the hospital system would want to know what the financial implications of buying the physicians' practices might be, the implication certainly seems to be that making a lot more money faster, in addition to any hopes for better patient outcomes, might be a goal of the merger. Trying to Keep Facts that Might Embarrass the Leaders out of Public View It is hard to understand why the hospital leadership was so fixated on keeping such information private if it were not to forestall any impression that this was all about the money.  As the Statesman reported, <blockquote class="tr_bq">Much of the four-week trial happened behind closed doors, and <a href="http://www.idahostatesman.com/2013/10/18/2821968/hundreds-of-documents-in-st-lukes.html" target="_blank">many documents were sealed or heavily redacted</a>. Lawyers for the hospitals — and for insurance companies and local employers — marked those parts of the trial private because they said they needed to protect trade secrets. St. Luke’s spokesman Ken Dey said some underlying data from Blue Cross of Idaho on which Winmill based his decision was sealed, and St. Luke’s lawyers could not access it. St. Luke’s is concerned that data might have led to some 'misleading conclusions,' he said. The <a href="http://www.idahostatesman.com/2013/11/13/2866737/statesman-other-news-groups-appeal.html" target="_blank">Statesman and several other Idaho news outlets filed a lawsuit</a> to pry open the court proceedings, and that lawsuit is now before the U.S. Ninth Circuit Court of Appeals.</blockquote> It is obviously a matter of opinion whether revealing more information might have lead to misleading, or to accurate conclusions.  Note that local journalists were driven to file their own lawsuits just to gain access to records from a trial held in a government run court, and that many of those records are still secret.   It will be interesting to see the results of these further proceedings, but it seems much more likely that the hospital system leaders tried so hard to keep everything secret to protect their own images as only caring about "patient outcomes," not money.  If these were trade secrets, given that the hospital system seems to have become dominant in the market, from what competitors were they hiding?  <div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div> Summary - Even More Reasons to be Concerned about Corporations Hiring Physicians to Take Care of Patients This case suggests some interesting conclusions which we hope are not misleading. Nationally or globally important health care issues are often still not well covered by national news media, much less the medical and health care literature.  Local journalists may doe a much better job, but local journalism is increasingly threatened. One reason important cases may be <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> is that people involved with them fear public discussion of what may prove to be embarrassing, uncomfortable or worse to them.  When those people are rich and locally influential, the likelihood of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> swallowing discussion increases. More specifically, we should be extremely skeptical of attempts at health care reform that add more bureaucracy to try to counter the effects of existing bureaucracy.  The main way current health care reform legislation seemed to address  the high costs and poor quality that we on Health Care Renewal contend may be due to concentration and abuse of power in health care is to further concentrate power without providing safeguards to prevent abuse. Finally, while this case was about whether hospitals (and other large organizations) hiring physicians to provide medical care may command higher prices, the real concern is whether physicians who now have to answer to corporate executives and organizational bureaucrats, that is who have become <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physicians</a>,  may have to put their organizations' and their leaders' needs and wants ahead of their patients' and the public's health. True health care reform would be informed by the core value that physicians are supposed to endorse: the individual patient comes first.  Health care should not be mainly about increasing corporate revenues, or pleasing corporate executives or government bureaucrats.  However, big organizations and the in-group who personally profit from their operations want to keep such concerns anechoic. Instead, we all should start by appreciating the words of Judge Winmill and the information he has provided us. Roy M. Poses MD on Health Care Renewal

Who Knew? ... Judge Finds that Hospital Takeover of Medical Practices Raised Prices

A story that caused only a few ripples in the media in late January, 2014, corroborates concerns about the increasing concentration of power...

Đọc thêm »