Where do you start when trying to minimize the risks from healthcare technology? ECRI Institute (https://www.ecri.org), an independent nonprofit that researches the best approaches to improving patient care, helps hospitals answer this question with the release of its 4th annual list of Top 10 Health Technology Hazards for 2011. Available now as a free download with registration, the list features the top 10 health technology hazards that warrant critical attention by hospitals and other healthcare organizations in the coming year.
The Top 10 Health Technology Hazards list is updated each year based upon the prevalence and severity of incidents reported to ECRI Institute by healthcare facilities nationwide; information found in the Institute’s medical device problem reporting databases; and the judgment, analysis, and expertise of the organization’s multidisciplinary staff. Many of the items on this year’s list are well-recognized hazards with numerous reported incidents over the years.
The 2011 list, originally published in ECRI Institute’s Health Devices journal (Nov. 2010), offers information about how these hazards occur, with recommendations for prevention and a comprehensive resource list for more in-depth information. The top five hazards on ECRI Institute’s 2011 list are:
1. Radiation overdose and other dose errors during radiation therapy
2. Patient Alarm hazards
3. Cross-contamination from flexible endoscopes
4. The high radiation dose of CT scans
5. Data loss, system incompatibilities, and other health IT complications
“If a hospital or health system needs help prioritizing its technology-related patient safety efforts, our top 10 list is a good place to start,” says James P. Keller, Jr., Vice President, Health Technology and Safety, ECRI Institute.“From dose errors during radiation therapy, to critical patient alarms that are set incorrectly, inappropriately silenced, or ignored, each of the problems on our list can be prevented or made less likely to occur if recommendations for effective risk-mitigation strategies are employed,” says Keller in a one-minute overview video about the report.
Healthcare professionals can obtain the complete 2011 list and its recommendations at no cost by using the following link: https://www.ecri.org/Forms/Pages
Patient Safety & Quality Healthcare covers news, trends and case studies in the Patient Care, Patient Safety and Quality Healthcare industries.
Showing posts with label Patient Safety. Show all posts
Showing posts with label Patient Safety. Show all posts
Thursday, December 16, 2010
Thursday, December 9, 2010
Safety Huddles in a Culture of Patient Safety
Originally published in Patient Safety & Quality Healthcare magazine
By Mary Lu Gerke, PhD, RN; Cheryl Uffelman, RN, MSN;
Kim Weber Chandler, RN, BSN
When the Institute of Medicine (IOM) published To Err Is Human: Building a Safer Health System in 2000, the executives and health quality and patient safety staff at Gundersen Lutheran immediately started discussions around issues emphasized in the report. One of the initiatives started at that time included increasing the engagement of our frontline staff in improving patient safety. This foundational work supported the development and evolution of what we now call Safety Huddles.
Gundersen Lutheran provides high-quality emergency, specialty, and primary healthcare services to patients throughout western Wisconsin, southeastern Minnesota, and northeastern Iowa. As one of the largest multispecialty group medical practices and a major teaching hospital, the organization comprises nearly 700 medical, dental, and associate staff, supported by a staff of more than 6,000.
Safety Huddles at the hospital officially began in July 2006. One of our first formal Safety Huddles was prompted by a tragic event that occurred in a major healthcare facility in Wisconsin. A 15-year-old first-time mom received an epidural medication intravenously, which led to a seizure and, subsequently, her death. When we heard this story in the news, many of us wondered if something similar could happen at our hospital. The quality and patient safety staff took the lead in pulling together a group of professionals and frontline staff to explore that possibility.
Members of the group included the patient safety coordinator, medication safety manager, OB and pediatric pharmacists, director of pharmacy, managers of labor and delivery, registered nurses from labor and delivery, anesthesiologists, and risk management staff. This meeting was called a Safety Huddle because the group “huddled” to find out what issues led to the patient’s death, what could be done to fix them, and assure itself that a similar incident would not happen here.
Prior to the Safety Huddle, the patient safety coordinator read the details of the incident and put together a list of system failures at that hospital that might have led to the event. The coordinator also interviewed bedside RNs from Gundersen Lutheran’s labor and delivery to determine and list potential failures. That list was provided to the group at the beginning of the Safety Huddle.
To read the rest of the article please visit Patient Safety & Quality Healthcare
By Mary Lu Gerke, PhD, RN; Cheryl Uffelman, RN, MSN;
Kim Weber Chandler, RN, BSN
When the Institute of Medicine (IOM) published To Err Is Human: Building a Safer Health System in 2000, the executives and health quality and patient safety staff at Gundersen Lutheran immediately started discussions around issues emphasized in the report. One of the initiatives started at that time included increasing the engagement of our frontline staff in improving patient safety. This foundational work supported the development and evolution of what we now call Safety Huddles.
Gundersen Lutheran provides high-quality emergency, specialty, and primary healthcare services to patients throughout western Wisconsin, southeastern Minnesota, and northeastern Iowa. As one of the largest multispecialty group medical practices and a major teaching hospital, the organization comprises nearly 700 medical, dental, and associate staff, supported by a staff of more than 6,000.
Safety Huddles at the hospital officially began in July 2006. One of our first formal Safety Huddles was prompted by a tragic event that occurred in a major healthcare facility in Wisconsin. A 15-year-old first-time mom received an epidural medication intravenously, which led to a seizure and, subsequently, her death. When we heard this story in the news, many of us wondered if something similar could happen at our hospital. The quality and patient safety staff took the lead in pulling together a group of professionals and frontline staff to explore that possibility.
Members of the group included the patient safety coordinator, medication safety manager, OB and pediatric pharmacists, director of pharmacy, managers of labor and delivery, registered nurses from labor and delivery, anesthesiologists, and risk management staff. This meeting was called a Safety Huddle because the group “huddled” to find out what issues led to the patient’s death, what could be done to fix them, and assure itself that a similar incident would not happen here.
Prior to the Safety Huddle, the patient safety coordinator read the details of the incident and put together a list of system failures at that hospital that might have led to the event. The coordinator also interviewed bedside RNs from Gundersen Lutheran’s labor and delivery to determine and list potential failures. That list was provided to the group at the beginning of the Safety Huddle.
To read the rest of the article please visit Patient Safety & Quality Healthcare
Family and Patients Contribute to Patient Safety
Originally published in July/August issue of Patient Safety & Quality Healthcare
By Inga Adams-Pizarro, MHS; Tennille D. Daniels, MPH; and Patty Montone Charvat
Engaging patients and families as integral members of the healthcare team is an essential step in delivering high-quality, safe patient care. One approach for empowering patients and families being implemented in hospitals nationwide is to invite them to activate rapid response teams (RRTs) if patients show signs of physical deterioration or something doesn’t appear “quite right” with the patient.
The growth in RRTs came as a result of the Institute for Healthcare Improvement (IHI) 100,000 and 5 Million Lives Campaigns, which include RRTs as one strategy for enhancing health quality and patient safety. Generally, the RRT consists of intensive care unit (ICU) personnel who can be summoned to assess and treat any patient outside the ICU who shows signs of deterioration and who may be at risk for cardiac arrest or death. Team make-up varies by hospital, but often includes one or more ICU nurses, a respiratory therapist, and a physician who can be called upon when needed.
Initially, only healthcare professionals could activate RRTs. But, with the inspiration of Sorrel King, whose 18-month-old daughter Josie died as a result of a series of medical errors, patients and families are being empowered to activate teams. Experience has shown that families are often the first ones to recognize that there is an issue or a patient is in distress and requires assistance. In fact, tragic stories like that of the death of Josie King may have been prevented if families were, or felt, free to call on a healthcare team for fresh eyes to assess a change in condition or circumstance.
Hearing Sorrel King say, “If I would have been able to call a rapid response team, I believe Josie would be here today,” led a number of hospitals to consider and implement Condition Help (Condition H). Among the most notable is the University of Pittsburgh Medical Center (UPMC), one of the first hospitals in the nation to initiate Condition H. Since implementation, UPMC has been sharing its success and lessons learned with other facilities across the country. Now, Maryland hospitals are moving to adopt this important and innovative approach.
To read the rest of the article please visit Patient Safety & Quality Healthcare
Friday, December 3, 2010
Cardinal Health Foundation Announces Funding For Patient Safety and Quality Healthcare
The Cardinal Health Foundation announced that, for the third consecutive year, it has awarded more than $1 million in grant funding to help U.S. hospitals, health systems and community health clinics improve the efficiency and quality of healthcare.
Forty organizations in 25 states have been awarded grants ranging from $7,500 up to $37,500 as part of the 2010 Cardinal Health Foundation E3 Grant Program, which was launched in 2008 to improve the effectiveness, efficiency and excellence of health care, nationwide.
Since the grant program’s inception, the Cardinal Health Foundation has awarded 108 grants totaling more than $3 million to help hospitals, health systems and clinics implement evidence-based best practices that improve patient safety and the cost effectiveness of health care.
The 2010 E3 Grant Program encouraged applicants to submit funding requests for projects that will either improve medication management or improve efficiency and patient safety within the operating room. A full list of winners in each category is provided below.
The Cardinal Health Foundation also this year invited E3 Grant Program applicants to apply for scholarships to attend professional development programs hosted by the Institute for Healthcare Improvement (IHI). As a result, the Cardinal Health Foundation awarded scholarships to help individuals from 37 heath care facilities attend IHI professional development programs that will teach them how to create a culture of patient safety within their organizations.
“By improving medication and operating room safety and efficiency, health care providers can dramatically reduce health care costs and even more importantly, they can save lives,” said Shelley Bird, executive vice president of public affairs for Cardinal Health and chairperson of the Cardinal Health Foundation. “The Cardinal Health Foundation is proud to support the innovative work of our 2010 E3 Grant Program winners, and we believe their efforts will lead to direct and long-lasting improvements in health care efficiency, cost-effectiveness and quality.”
Organizations that received 2010 E3 Grant Program funding for medication management projects:
* Antelope Memorial Hospital; Neleigh, Neb.; Computerized Physician Order Entry and Barcode-Enabled Point-of-Care Systems
* Baptist Health’s Institute for Patient Safety and Medical Simulation; Montgomery, Ala.; The Impact of Error Prevention Technique Testing in a Simulation Laboratory
* St. Joseph’s Hospital & Medical Center; Phoenix, Ariz.; Simulation for Safe Medication Processes
* CentraState Healthcare Foundation; Freehold, N.J.; “The White Vest Study” (preventing nurse interruptions while administering medication)
* Community Health Network Foundation; Indianapolis, Ind.; Improving Medication Reconciliation Practices at Discharge
* Clovis Medical Center; Fresno, Calif.; Utilization of Pharmacy Technicians in the Medication Reconciliation Process
* Eastern Maine Healthcare Systems; Brewer, Maine; Reaching Out for Your Safety—FDA Alerts in Primary Care
* El Rio Community Health Center; Tucson, Ariz.; Improving Medication Safety by Providing Pharmacists with Patient Diagnosis on Electronic Prescription Orders
* FirstHealth Moore Regional Hospital; Pinehurst, N.C.; The Effectiveness of Hourly Rounding on Patient Safety, Satisfaction and Nursing Workload
* Forsyth Medical Center Foundation; Winston-Salem, N.C.; Safe Med Plus: An Innovative Medication Reconciliation / Patient Safety Program to Reduce Hospital Readmissions
* Ingham Regional Medical Center; Lansing, Mich.; Care Transitions Initiative
* Kansas University Endowment Association; Kansas City, Kan.; A Dedicated Pharmacist to Improve Medication Safety and the Quality of the Discharge Process and Decrease Readmissions
* Lahey Clinic; Burlington, Mass.; Lahey Clinic Medication Reconciliation Partnership Project
* Bassett Medical Center; Cooperstown, N.Y.; Anticoagulation Management Service Systems Expansion
* Natchaug Hospital; Mansfield, Conn.; NetSmart Infoscriber Initiative for Community-based Program EMR
* National Coalition for Cancer Survivorship; Silver Spring, Md.; Oral Medicine Adherence Education Program
* Nationwide Children’s Hospital Foundation; Columbus, Ohio; Reduction of Adverse Drug Events via a Critical Care Collaborative (Phase II)
* Niagara Falls Memorial Medical Center; Niagara Falls, N.Y.; Bedside Medication Administration
* Paynesville Area Health Care System; Paynesville, Minn.; Bridging Medication Reconciliation Gaps in Our Community
* Rush University Medical Center; Chicago, Ill.; Care Trans-IT: An Informatics Tool to Facilitate Medication Reconciliation During Care Transitions
* Mercy Willard Hospital; Willard, Ohio; Pharmacist-Lead Diabetes Management Outpatient/Inpatient Service
* St. Aloisius Medical Center; Harvey, N.D.; Medication Safety Grant
* Suburban Hospital; Bethesda, Md.; Dedicated Pharmacist for the Hospitalist Program
* Cleveland Clinic Foundation; Cleveland, Ohio; Evaluation of Two Patient Education Methods for Patient Knowledge, Clinical Outcomes and Associated Costs in Patients Recently Started on Warfarin
* Health Care Improvement Foundation; Philadelphia, Pa.; A Regional Demonstration Project to Improve Safe Use of HYDROmorphone
* The Institute for Family Health; New York, N.Y.; Preventing Medication-Related Birth Defects Using Electronic Health Records
* Wayne State University; Detroit, Mich.; Comparison of Outpatient Medication Prescription Error Rates in a Pediatric Emergency Department Pre and Post Electronic Medication Error Alert System
* Wellmont Health System; Kingsport, Tenn.; Pharmacy Technician-Based Medication Reconciliation Program Pilot Study
Organizations that received 2010 E3 Grant Program funding for projects that will improve operating room safety and efficiency:
* CAMC Institute; Charleston, W.Va.; Vascular Surgical Antibiotic Prophylaxis Study (VSAPS)
* Cincinnati Children’s Hospital Medical Center; Cincinnati, Ohio; Developing Procedural Competency through Video-Assisted Assessment of Pediatric Airway Management
* Grady Health System Foundation; Atlanta, Ga.; Operating Room Safety
* Health Alliance of the Hudson Valley; Kingston, N.Y.; Operating Room ‘Culture of Safety’ at Health Alliance of the Hudson Valley
* Holy Spirit Health System; Camp Hill, Pa.; Lean Healthcare: Improving efficiency and patient flow in the Operating Room
* Johns Hopkins Heath System; Baltimore, Md.; Prevention of Surgical Site Infections Utilizing Intra-Operative Cameras to Improve Operative Practices
* Memorial Hermann Healthcare System; Houston, Texas; Impact of SSCL Use on Surgical Complications
* Memorial Sloan-Kettering Cancer Center; New York, N.Y.; Multiphase Targeted Intervention to Increase Staff Communication of Patient and Safety Concerns in the Operating Room
* Rhode Island Hospital; Providence, R.I.; Marking in the Universal Protocol: Enhancing Time-Outs (MUP-ET)
* Saint Alphonsus Family Maternity Center; Boise, Idaho; Labor & Delivery Universal Surgical Team
* Saint Peter’s University Hospital; New Brunswick, N.J.; Streamlining the Patient Preoperative Process
* University of Alabama at Birmingham; Birmingham, Ala.; Perioperative Patient Throughput
About the Cardinal Health Foundation
The Cardinal Health Foundation supports local, national and international programs that improve health care quality and build healthy communities. The Cardinal Health Foundation also offers grants to encourage employee service to the community and works through international agencies to donate much-needed medical supplies and funding to those who need them in times of disaster. To learn more, visit cardinalhealth.com/community.
About Cardinal Health
www.psqh.com
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $99 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #17 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com.
Forty organizations in 25 states have been awarded grants ranging from $7,500 up to $37,500 as part of the 2010 Cardinal Health Foundation E3 Grant Program, which was launched in 2008 to improve the effectiveness, efficiency and excellence of health care, nationwide.
Since the grant program’s inception, the Cardinal Health Foundation has awarded 108 grants totaling more than $3 million to help hospitals, health systems and clinics implement evidence-based best practices that improve patient safety and the cost effectiveness of health care.
The 2010 E3 Grant Program encouraged applicants to submit funding requests for projects that will either improve medication management or improve efficiency and patient safety within the operating room. A full list of winners in each category is provided below.
The Cardinal Health Foundation also this year invited E3 Grant Program applicants to apply for scholarships to attend professional development programs hosted by the Institute for Healthcare Improvement (IHI). As a result, the Cardinal Health Foundation awarded scholarships to help individuals from 37 heath care facilities attend IHI professional development programs that will teach them how to create a culture of patient safety within their organizations.
“By improving medication and operating room safety and efficiency, health care providers can dramatically reduce health care costs and even more importantly, they can save lives,” said Shelley Bird, executive vice president of public affairs for Cardinal Health and chairperson of the Cardinal Health Foundation. “The Cardinal Health Foundation is proud to support the innovative work of our 2010 E3 Grant Program winners, and we believe their efforts will lead to direct and long-lasting improvements in health care efficiency, cost-effectiveness and quality.”
Organizations that received 2010 E3 Grant Program funding for medication management projects:
* Antelope Memorial Hospital; Neleigh, Neb.; Computerized Physician Order Entry and Barcode-Enabled Point-of-Care Systems
* Baptist Health’s Institute for Patient Safety and Medical Simulation; Montgomery, Ala.; The Impact of Error Prevention Technique Testing in a Simulation Laboratory
* St. Joseph’s Hospital & Medical Center; Phoenix, Ariz.; Simulation for Safe Medication Processes
* CentraState Healthcare Foundation; Freehold, N.J.; “The White Vest Study” (preventing nurse interruptions while administering medication)
* Community Health Network Foundation; Indianapolis, Ind.; Improving Medication Reconciliation Practices at Discharge
* Clovis Medical Center; Fresno, Calif.; Utilization of Pharmacy Technicians in the Medication Reconciliation Process
* Eastern Maine Healthcare Systems; Brewer, Maine; Reaching Out for Your Safety—FDA Alerts in Primary Care
* El Rio Community Health Center; Tucson, Ariz.; Improving Medication Safety by Providing Pharmacists with Patient Diagnosis on Electronic Prescription Orders
* FirstHealth Moore Regional Hospital; Pinehurst, N.C.; The Effectiveness of Hourly Rounding on Patient Safety, Satisfaction and Nursing Workload
* Forsyth Medical Center Foundation; Winston-Salem, N.C.; Safe Med Plus: An Innovative Medication Reconciliation / Patient Safety Program to Reduce Hospital Readmissions
* Ingham Regional Medical Center; Lansing, Mich.; Care Transitions Initiative
* Kansas University Endowment Association; Kansas City, Kan.; A Dedicated Pharmacist to Improve Medication Safety and the Quality of the Discharge Process and Decrease Readmissions
* Lahey Clinic; Burlington, Mass.; Lahey Clinic Medication Reconciliation Partnership Project
* Bassett Medical Center; Cooperstown, N.Y.; Anticoagulation Management Service Systems Expansion
* Natchaug Hospital; Mansfield, Conn.; NetSmart Infoscriber Initiative for Community-based Program EMR
* National Coalition for Cancer Survivorship; Silver Spring, Md.; Oral Medicine Adherence Education Program
* Nationwide Children’s Hospital Foundation; Columbus, Ohio; Reduction of Adverse Drug Events via a Critical Care Collaborative (Phase II)
* Niagara Falls Memorial Medical Center; Niagara Falls, N.Y.; Bedside Medication Administration
* Paynesville Area Health Care System; Paynesville, Minn.; Bridging Medication Reconciliation Gaps in Our Community
* Rush University Medical Center; Chicago, Ill.; Care Trans-IT: An Informatics Tool to Facilitate Medication Reconciliation During Care Transitions
* Mercy Willard Hospital; Willard, Ohio; Pharmacist-Lead Diabetes Management Outpatient/Inpatient Service
* St. Aloisius Medical Center; Harvey, N.D.; Medication Safety Grant
* Suburban Hospital; Bethesda, Md.; Dedicated Pharmacist for the Hospitalist Program
* Cleveland Clinic Foundation; Cleveland, Ohio; Evaluation of Two Patient Education Methods for Patient Knowledge, Clinical Outcomes and Associated Costs in Patients Recently Started on Warfarin
* Health Care Improvement Foundation; Philadelphia, Pa.; A Regional Demonstration Project to Improve Safe Use of HYDROmorphone
* The Institute for Family Health; New York, N.Y.; Preventing Medication-Related Birth Defects Using Electronic Health Records
* Wayne State University; Detroit, Mich.; Comparison of Outpatient Medication Prescription Error Rates in a Pediatric Emergency Department Pre and Post Electronic Medication Error Alert System
* Wellmont Health System; Kingsport, Tenn.; Pharmacy Technician-Based Medication Reconciliation Program Pilot Study
Organizations that received 2010 E3 Grant Program funding for projects that will improve operating room safety and efficiency:
* CAMC Institute; Charleston, W.Va.; Vascular Surgical Antibiotic Prophylaxis Study (VSAPS)
* Cincinnati Children’s Hospital Medical Center; Cincinnati, Ohio; Developing Procedural Competency through Video-Assisted Assessment of Pediatric Airway Management
* Grady Health System Foundation; Atlanta, Ga.; Operating Room Safety
* Health Alliance of the Hudson Valley; Kingston, N.Y.; Operating Room ‘Culture of Safety’ at Health Alliance of the Hudson Valley
* Holy Spirit Health System; Camp Hill, Pa.; Lean Healthcare: Improving efficiency and patient flow in the Operating Room
* Johns Hopkins Heath System; Baltimore, Md.; Prevention of Surgical Site Infections Utilizing Intra-Operative Cameras to Improve Operative Practices
* Memorial Hermann Healthcare System; Houston, Texas; Impact of SSCL Use on Surgical Complications
* Memorial Sloan-Kettering Cancer Center; New York, N.Y.; Multiphase Targeted Intervention to Increase Staff Communication of Patient and Safety Concerns in the Operating Room
* Rhode Island Hospital; Providence, R.I.; Marking in the Universal Protocol: Enhancing Time-Outs (MUP-ET)
* Saint Alphonsus Family Maternity Center; Boise, Idaho; Labor & Delivery Universal Surgical Team
* Saint Peter’s University Hospital; New Brunswick, N.J.; Streamlining the Patient Preoperative Process
* University of Alabama at Birmingham; Birmingham, Ala.; Perioperative Patient Throughput
About the Cardinal Health Foundation
The Cardinal Health Foundation supports local, national and international programs that improve health care quality and build healthy communities. The Cardinal Health Foundation also offers grants to encourage employee service to the community and works through international agencies to donate much-needed medical supplies and funding to those who need them in times of disaster. To learn more, visit cardinalhealth.com/community.
About Cardinal Health
www.psqh.com
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $99 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #17 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com.
Consumers Advancing Patient Safety Endorses White Paper on Reducing Medication Errors
Medication errors are one of the most widespread and preventable causes of harm in modern healthcare. Now Consumers Advancing Patient Safety (CAPS) and more than a dozen other leaders in the patient safety field are teaming up to promote best practices to prevent them.
Together with Joint Commission, the Society of Hospital Medicine and other leaders in hospital healthcare, CAPS has endorsed a new white paper that gives hospitals practical recommendations for implementing system-wide medication reconciliation programs.
The white paper, Making Inpatient Medication Reconciliation Patient Centered, Clinically Relevant, and Implementable: A Consensus Statement on Key Principles and Necessary First Steps.
It will also be published in the Journal of Hospital Medicine.
“Medication reconciliation can be a complex challenge to tackle,” says Mitchell Dvorak, CAPS executive director. “The new white paper gives clinicians, quality and patient safety personnel, and regulatory agencies practical steps for reducing medication-related preventable harm.”
The white paper identifies ten key areas for improvement in medication reconciliation and provides actionable “first steps” for addressing each.
It closes with “Patient safety and patient/family-centered care must be the principal drivers in the development of medication reconciliation implementation systems,” a sentiment echoed by Dvorak, and emphasizes that medication reconciliation must be seen as a patient safety issue, not simply about accreditation. “Ultimately, this is about using a team-based approach to provide the best possible care to every hospitalized patient.”
to learn more about Patient Safety please visit www.psqh.com
Together with Joint Commission, the Society of Hospital Medicine and other leaders in hospital healthcare, CAPS has endorsed a new white paper that gives hospitals practical recommendations for implementing system-wide medication reconciliation programs.
The white paper, Making Inpatient Medication Reconciliation Patient Centered, Clinically Relevant, and Implementable: A Consensus Statement on Key Principles and Necessary First Steps.
It will also be published in the Journal of Hospital Medicine.
“Medication reconciliation can be a complex challenge to tackle,” says Mitchell Dvorak, CAPS executive director. “The new white paper gives clinicians, quality and patient safety personnel, and regulatory agencies practical steps for reducing medication-related preventable harm.”
The white paper identifies ten key areas for improvement in medication reconciliation and provides actionable “first steps” for addressing each.
It closes with “Patient safety and patient/family-centered care must be the principal drivers in the development of medication reconciliation implementation systems,” a sentiment echoed by Dvorak, and emphasizes that medication reconciliation must be seen as a patient safety issue, not simply about accreditation. “Ultimately, this is about using a team-based approach to provide the best possible care to every hospitalized patient.”
to learn more about Patient Safety please visit www.psqh.com
Thursday, December 2, 2010
How Patient-Provider Engagement Can Transform Patient Safety
By Dave deBronkart
How would the world change if, suddenly, clinicians had a highly motivated partner in carrying out each care plan? I propose that a new level of patient safety will be possible if we shift to a shared care plan model, with patients and families aware of the plan and engaged in its execution.
I look at healthcare through the lens of a former patient: in 2007 great medicine saved me from Stage IV renal cell carcinoma. But I view it through another lens, too: as a high-tech business person who's watched industries evolve for years, it grips me that this miraculous industry has made so little progress on cost or safety—despite immense efforts by really smart people.
To me, that's a sign we've overlooked something. I assert we're making a fundamental error when we expect clinicians to know and do everything, and we pay a heavy price (literally and figuratively) for this mistake. We should share the load: enlist patients and families in making healthcare better.
The Plausible Promise of Participatory Medicine*
The Society for Participatory Medicine defines this new model as "a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners" (www.ParticipatoryMedicine.org). The Society arose in 2009 out of the "e-patient" concept developed by Tom Ferguson, MD (1944-2006). I joined the movement in 2008 after hearing about it from my physician, Dr. Danny Sands. In this column I write on my own, not on behalf of the Society.
A cornerstone of Ferguson's view is that in today's Internet-enabled world, what's possible in healthcare is radically different from 1990:
* Patients today have access to information that used to be accessible only to clinicians and researchers. That doesn't make them clinicians, but it does show why it's possible for ordinary patients to bring value to the table.
* Today patients can band together in smart communities, sharing experiences and research findings in ways that are inherently patient-centered. (Hospitals work at understanding what patients want; patients know what they want.) This doesn't mean every gathering of patients is inherently smart; it does show how it's possible for patients to aggregate knowledge.
* While patients have access to increased power, clinicians are gripped in a pincer: inexorable pressure to see more patients, while enduring an information explosion. Increasingly, it's impossible for clinicians to keep up. I vetted this point with my oncologist, and he said, "Right—unless you're a sub-sub-specialist like me."
Ferguson saw this as an opportunity for empowered, engaged, equipped, enabled "e-patients" to help. At his death, he was compiling his observations into a white paper, which his team completed: "e-Patients: How they can help us heal healthcare." The paper is available for download at the Society's blog, http://e-patients.net.
Ferguson talked about patients being engaged in their care. He didn't talk about patient safety per se (though he did cite To Err Is Human [IOM, 2000]), but I'd like to extend his thinking to quality and safety, using five principles of participatory medicine. Visit www.psqh.com for the rest of the article.www.psqh.com
To read more Patient Safety news, articles and equipment please visit www.psqh.com
How would the world change if, suddenly, clinicians had a highly motivated partner in carrying out each care plan? I propose that a new level of patient safety will be possible if we shift to a shared care plan model, with patients and families aware of the plan and engaged in its execution.
I look at healthcare through the lens of a former patient: in 2007 great medicine saved me from Stage IV renal cell carcinoma. But I view it through another lens, too: as a high-tech business person who's watched industries evolve for years, it grips me that this miraculous industry has made so little progress on cost or safety—despite immense efforts by really smart people.
To me, that's a sign we've overlooked something. I assert we're making a fundamental error when we expect clinicians to know and do everything, and we pay a heavy price (literally and figuratively) for this mistake. We should share the load: enlist patients and families in making healthcare better.
The Plausible Promise of Participatory Medicine*
The Society for Participatory Medicine defines this new model as "a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners" (www.ParticipatoryMedicine.org). The Society arose in 2009 out of the "e-patient" concept developed by Tom Ferguson, MD (1944-2006). I joined the movement in 2008 after hearing about it from my physician, Dr. Danny Sands. In this column I write on my own, not on behalf of the Society.
A cornerstone of Ferguson's view is that in today's Internet-enabled world, what's possible in healthcare is radically different from 1990:
* Patients today have access to information that used to be accessible only to clinicians and researchers. That doesn't make them clinicians, but it does show why it's possible for ordinary patients to bring value to the table.
* Today patients can band together in smart communities, sharing experiences and research findings in ways that are inherently patient-centered. (Hospitals work at understanding what patients want; patients know what they want.) This doesn't mean every gathering of patients is inherently smart; it does show how it's possible for patients to aggregate knowledge.
* While patients have access to increased power, clinicians are gripped in a pincer: inexorable pressure to see more patients, while enduring an information explosion. Increasingly, it's impossible for clinicians to keep up. I vetted this point with my oncologist, and he said, "Right—unless you're a sub-sub-specialist like me."
Ferguson saw this as an opportunity for empowered, engaged, equipped, enabled "e-patients" to help. At his death, he was compiling his observations into a white paper, which his team completed: "e-Patients: How they can help us heal healthcare." The paper is available for download at the Society's blog, http://e-patients.net.
Ferguson talked about patients being engaged in their care. He didn't talk about patient safety per se (though he did cite To Err Is Human [IOM, 2000]), but I'd like to extend his thinking to quality and safety, using five principles of participatory medicine. Visit www.psqh.com for the rest of the article.www.psqh.com
To read more Patient Safety news, articles and equipment please visit www.psqh.com
Fortify HIT Contracts with Education and Ethics to Protect Patient Safety, Say Informatics Experts
An original and progressive report on health information technology (HIT) vendors, their customers and patients, published online, makes ground-breaking recommendations for new practices that target the reduction or elimination of tensions that currently mar relationships between many HIT vendors and their customers, specifically with regard to indemnity and error management of HIT systems. In light of the Obama Administration's $19 billion investment in HIT, paid out in ARRA stimulus funds, these recommendations are particularly significant in helping to foster greater use of electronic health records and other tools in the transition from paper records, largely understood to be a hindrance to quality patient care.
The recommendations, adopted by AMIA -- the association of informatics professionals and a trusted authority in the HIT community -- strive to imbue the HIT vendor-customer relationship with transparency, veracity, and accountability through collaborative education focused on the installation, configuration and use of HIT systems, in combination with enterprise-wide ethics education to support patient safety. The recommendations are the result of deliberations by an AMIA Board-appointed Task Force. The position statement will appear in the January/February 2011 print edition of JAMIA, the scholarly peer-reviewed journal of informatics in health and biomedicine, co-published by AMIA and the BMJ Group.
"There was a need to consider, study and analyze questions of appropriate oversight," said AMIA Board Chairwoman Nancy M. Lorenzi, PhD, Assistant Vice Chancellor for Health Affairs and Professor of Biomedical Informatics, Vanderbilt University. "With as much interest and investment in HIT as there is today, AMIA -- an unbiased third party -- wanted to take a fresh look at gray areas that currently exist between vendors and their customers to see where new practices could be implemented to better support patient outcomes and protect patients, who these systems ultimately serve. We think these recommendations do an excellent job of addressing fairness and balancing accountability in the HIT marketplace and in the health sector."
The report, titled "HIT Vendors, their customers and patients: New challenges in ethics, safety, best practices and oversight," makes specific recommendations on Contract Language, Education and Ethics, Ethical Standards, User Groups, Best Practices, and Marketing. An additional section addresses Regulation and Oversight of the HIT Industry and next steps.
The report's first author is Kenneth W. Goodman, PhD, FACMI, director of the University of Miami Bioethics Program. Dr. Goodman chaired the Task Force responsible for the report, a group of AMIA members comprising nationwide representatives of academia, industry, and leading healthcare institutions.
"AMIA provided an important forum in which complex and sometimes conflicting positions were candidly discussed, analyzed and balanced," said Dr. Goodman. "HIT systems are ubiquitous these days and need better oversight. These recommendations demonstrate a high-value commitment to patient safety, quality care, and innovation -- healthcare goals sometimes difficult to reconcile. These recommendations," he added, "can help individual institutions do more to support successful HIT implementation."
Among the recommendations is contract language specified to protect patient safety and to spell out the shared responsibility that vendors and their customers have for successful implementation. "Hold harmless" clauses in contracts between vendors and purchasers or clinical users, that absolve vendors for errors or defects in their software, are declared unethical by AMIA.
The AMIA position states that "safe and successful HIT systems further require ethics education, which has become a standard part of professional development in the corporate world." HIT vendors and their clients are urged to adopt enterprise-wide ethics education to parallel what accrediting healthcare organizations require. Standards for corporate conduct and subsequent education about such standards are also recommended. A variety of informational tools, many aimed for post-market use, are cited among best practices to assist institutions and clinical practices in achieving optimal HIT implementation.
AMIA President and CEO Edward H. Shortliffe, MD, PhD, praised the Task Force and its accomplishment. "This group of informatics and industry leaders recognized the need to meld business ethics into successful adoption of HIT. Their recommendations balance the forces that drive the competitive HIT marketplace with the practical needs of clinicians, patients, researchers, public health workers and officials. AMIA stands by their work and hopes these recommendations will be embraced by the HIT community."
Full text of the AMIA position on HIT vendors, their customers and patients is available online at www.jamia.org as an open-access document. Its co-authors are Eta Berner, EdD, FACMI, professor of health informatics at University of Alabama at Birmingham; Mark A. Dente, MD, GE Healthcare IT; Bonnie Kaplan, PhD, FACMI, lecturer at Yale University School of Medicine, and Bioethics Center Scholar at the Interdisciplinary Center for Bioethics at Yale's Institution for Social and Policy Studies; Ross Koppel, PhD, professor in the Sociology Department and in School of Medicine at University of Pennsylvania; Donald Rucker, MD, vice president and chief medical officer at Siemens Healthcare U.S.A.; Daniel Z. Sands, MD, MPH, FACMI, director of medical informatics at Cisco Internet Business Solutions Group, and clinical assistant professor of medicine at Harvard Medical School; and Peter Winkelstein, MD, MBA, chief of the Division of General Pediatrics at Women & Children's Hospital of Buffalo, and chief medical informatics officer at UB/MD, the University of Buffalo Physicians Group.
AMIA, the leading professional association for informatics professionals, serves as the voice of the nation's top biomedical and health informatics professionals and plays an important role in medicine, health care, and science, encouraging the use of data, information and knowledge to improve both human health and delivery of healthcare services.
To read more about Patient Safety please visit www.psqh.com
The recommendations, adopted by AMIA -- the association of informatics professionals and a trusted authority in the HIT community -- strive to imbue the HIT vendor-customer relationship with transparency, veracity, and accountability through collaborative education focused on the installation, configuration and use of HIT systems, in combination with enterprise-wide ethics education to support patient safety. The recommendations are the result of deliberations by an AMIA Board-appointed Task Force. The position statement will appear in the January/February 2011 print edition of JAMIA, the scholarly peer-reviewed journal of informatics in health and biomedicine, co-published by AMIA and the BMJ Group.
"There was a need to consider, study and analyze questions of appropriate oversight," said AMIA Board Chairwoman Nancy M. Lorenzi, PhD, Assistant Vice Chancellor for Health Affairs and Professor of Biomedical Informatics, Vanderbilt University. "With as much interest and investment in HIT as there is today, AMIA -- an unbiased third party -- wanted to take a fresh look at gray areas that currently exist between vendors and their customers to see where new practices could be implemented to better support patient outcomes and protect patients, who these systems ultimately serve. We think these recommendations do an excellent job of addressing fairness and balancing accountability in the HIT marketplace and in the health sector."
The report, titled "HIT Vendors, their customers and patients: New challenges in ethics, safety, best practices and oversight," makes specific recommendations on Contract Language, Education and Ethics, Ethical Standards, User Groups, Best Practices, and Marketing. An additional section addresses Regulation and Oversight of the HIT Industry and next steps.
The report's first author is Kenneth W. Goodman, PhD, FACMI, director of the University of Miami Bioethics Program. Dr. Goodman chaired the Task Force responsible for the report, a group of AMIA members comprising nationwide representatives of academia, industry, and leading healthcare institutions.
"AMIA provided an important forum in which complex and sometimes conflicting positions were candidly discussed, analyzed and balanced," said Dr. Goodman. "HIT systems are ubiquitous these days and need better oversight. These recommendations demonstrate a high-value commitment to patient safety, quality care, and innovation -- healthcare goals sometimes difficult to reconcile. These recommendations," he added, "can help individual institutions do more to support successful HIT implementation."
Among the recommendations is contract language specified to protect patient safety and to spell out the shared responsibility that vendors and their customers have for successful implementation. "Hold harmless" clauses in contracts between vendors and purchasers or clinical users, that absolve vendors for errors or defects in their software, are declared unethical by AMIA.
The AMIA position states that "safe and successful HIT systems further require ethics education, which has become a standard part of professional development in the corporate world." HIT vendors and their clients are urged to adopt enterprise-wide ethics education to parallel what accrediting healthcare organizations require. Standards for corporate conduct and subsequent education about such standards are also recommended. A variety of informational tools, many aimed for post-market use, are cited among best practices to assist institutions and clinical practices in achieving optimal HIT implementation.
AMIA President and CEO Edward H. Shortliffe, MD, PhD, praised the Task Force and its accomplishment. "This group of informatics and industry leaders recognized the need to meld business ethics into successful adoption of HIT. Their recommendations balance the forces that drive the competitive HIT marketplace with the practical needs of clinicians, patients, researchers, public health workers and officials. AMIA stands by their work and hopes these recommendations will be embraced by the HIT community."
Full text of the AMIA position on HIT vendors, their customers and patients is available online at www.jamia.org as an open-access document. Its co-authors are Eta Berner, EdD, FACMI, professor of health informatics at University of Alabama at Birmingham; Mark A. Dente, MD, GE Healthcare IT; Bonnie Kaplan, PhD, FACMI, lecturer at Yale University School of Medicine, and Bioethics Center Scholar at the Interdisciplinary Center for Bioethics at Yale's Institution for Social and Policy Studies; Ross Koppel, PhD, professor in the Sociology Department and in School of Medicine at University of Pennsylvania; Donald Rucker, MD, vice president and chief medical officer at Siemens Healthcare U.S.A.; Daniel Z. Sands, MD, MPH, FACMI, director of medical informatics at Cisco Internet Business Solutions Group, and clinical assistant professor of medicine at Harvard Medical School; and Peter Winkelstein, MD, MBA, chief of the Division of General Pediatrics at Women & Children's Hospital of Buffalo, and chief medical informatics officer at UB/MD, the University of Buffalo Physicians Group.
AMIA, the leading professional association for informatics professionals, serves as the voice of the nation's top biomedical and health informatics professionals and plays an important role in medicine, health care, and science, encouraging the use of data, information and knowledge to improve both human health and delivery of healthcare services.
To read more about Patient Safety please visit www.psqh.com
Saturday, November 27, 2010
Patient Safety and Savings in Las Vegas
By Mitch Work, MPA, FHIMSS; and Chuck Appleby
UMC implemented this unique software in December 2009 on its cardiac care unit (CCU) and cardiovascular care unit (CVCU), where 24 beds support patients with some of the highest needs in the hospital. The innovative system assists clinical pharmacists in identifying patients for adverse clinical events and tracks laboratory results for any changes requiring potential intervention.
As one of the country's fastest-growing cities in the early 21st century, Las Vegas, Nevada, has had to shoulder all the demographic challenges that distinction entails. Through it all, University Medical Center (UMC) has steadfastly maintained its role as the safety net for the sickest and neediest patients in this metro area of nearly two million people. UMC, a 565-bed facility affiliated with the University of Nevada School of Medicine, combines the role of county hospital with that of Nevada's only Level 1 Trauma Center, only burn-care unit, and a world-class children's hospital.
Founded in 1931 to serve workers building nearby Hoover Dam and operated by Clark County, non-profit UMC has never been deterred from its mission despite red-hot competition from several new for-profit hospitals built during the burgeoning growth of the early 2000s. While 10 large hospitals now compete for the local market, the recession has dramatically curtailed that growth‚Ät least one new hospital stands empty today‚Änd further accentuates UMC's charitable role. Each year it admits about 30,000 inpatients and treats nearly 70,000 adult patients in its emergency department and more than half-a-million ambulatory patients.
In keeping with its mission, UMC has focused its 4,000 employees, including 1,550 nurses and 1,400 physicians, on patient-centered care emphasizing quality and patient safety, including core measures, a "patient safety net" system to report medical errors in a non-punitive manner, as well as aggressive infection-control and medication-safety programs.
A key piece of UMC's patient-care strategy is a closed-loop medication management system that uses automated dispensing cabinets and barcode scanning at nursing stations to ensure accurate medication dispensing. Now UMC is advancing that strategy by becoming the first hospital in the nation to adopt software that integrates clinical data from multiple sources and delivers alerts to nurses at their automated medication dispensing cabinets when potential adverse drug reactions are detected.
UMC implemented this unique software in December 2009 on its cardiac care unit (CCU) and cardiovascular care unit (CVCU), where 24 beds support patients with some of the highest needs in the hospital. The innovative system assists clinical pharmacists in identifying patients for adverse clinical events and tracks laboratory results for any changes requiring potential intervention.
Previously, the pharmacy or laboratory identified an adverse event (example: potassium levels being too high), and would place a call to the nurses caring for the patient for corrective action. Now with the Pyxis® Advisor technology, this same information is sent automatically to the automated medication dispensing cabinet on the patient's floor triggering an alert that reports on out-of-range laboratory values. Nurses must respond to each alert before proceeding with medication dispensing for the patient. Through this connectivity, nurses are now getting the same kind of clinical decision support reported through their automated medication dispensing cabinet and nearer to the point of care where it can help nurses most in caring for their patients.
For the rest of the article please visit Patient Safety & Quality Healthcarewww.psqh.com
Addressing Institutional Conflict of Interest to Promote Patient Safety
By Bryan A. Liang, MD, PhD, JD; and Tim Mackey, MAS
Studies show that 67% of academic departments have financial relationships with industry (Campbell, 2007b). The Institute of Medicine has warned that academic institutions lack independent review, with resulting tolerance of conflicts due to financial gains, which may pose serious barriers to addressing the issue (IOM, 2009). These financial inducements may result in an emphasis of profits over patient safety (U.S. GAO, 2001).
Such warnings are not theoretical. Institutional forms of conflicts of interest have resulted in institutions and their representatives basing their decisions on financial rewards instead of on an overarching concern for patient safety. The death of teenager Jesse Gelsinger—a clinical study participant at the University of Pennsylvania—highlights these risks.
Addressing institutional conflicts of interest is therefore key to mitigating the risks associated with patient safety. Scrutiny of relationships between industry and academic institutions, as well as establishing internal, independent bodies and policies to improve oversight and intercept conflicts that represent a threat to patient safety must be integrated into systems to avoid tragedies such as the Gelsinger case.
The Jesse Gelsinger Case
Perhaps the most dramatic example of failing to manage institutional conflicts is the death of an 18-year-old study participant, Jesse Gelsinger, in a gene therapy trial at the University of Pennsylvania in 1999 (Rothman 2008). Gelsinger suffered from ornithine transcarbamylase deficiency, which affects the body's ability to eliminate ammonia (Wolf & Lo, 2000). Although potentially life threatening, Geslinger had managed the condition with a strategy of a low-protein diet and medication, and otherwise enjoyed a normal life (Stolberg, 1999). Gelsinger understood that he would not benefit directly from his participation in the Phase I gene therapy study; his decision to participate was motivated by hope that results from the study would avail him of his restrictive diet routine in the future (Wolf & Lo, 2000).
Gelsinger began the study, but almost immediately clinical problems emerged. The evening of his injection with the gene therapy, he experienced a high fever and abdominal pain, and by the next morning, severe hepatic failure and blood clotting. He then lapsed into a coma. His clinical condition rapidly deteriorated, and over the next several days, Geslinger suffered multi-organ failure and, subsequently, brain death. Only 4 days after receiving the gene therapy treatment, he was removed from life support, and died. Jesse Gelsinger's death was then reported to government officials (Stolberg, 1999).
Investigations
Initial investigations by government entities into Gelsinger's death postulated that the genetic therapy vector that was administered to him caused a systemic inflammatory response syndrome. That led to acute respiratory distress syndrome, and eventually his death due to anoxia (Hollon, 2000). These investigations focused on the safety of the adenovirus gene therapy vector, which was used in the gene therapy, and on potential medical error (Stolberg, 1999).
But beyond these components, systems assessments also reviewed broader issues. In this extended analysis, highly troubling revelations of both individual and institutional conflicts of interests existing between investigators and the university and industry began to emerge, leading to more detailed scrutiny of the motivations and judgment exercised by those involved in the trial (Wolf & Lo, 2000).
Several months later, officials from the FDA announced that Gelsinger should never have been a participant in the study due to his clinical condition. Further, the institution's investigators violated FDA requirements by failing to immediately report earlier patients who had experienced serious side effects prior to the Gelsinger study. In addition, informed consent documents provided to participants were altered from that approved by the FDA by omitting important information regarding the death of animal subjects that had undergone similar treatment (Stolberg, 1999).
Yet these FDA discoveries were just the beginning. Upon further review, analyses showed Gelsinger's case was rife with substantive institutional wrongdoing spurred by unmanaged financial conflicts. First, reports submitted by the institution to the FDA, NIH, and IRBs misrepresented the actual clinical findings, and proper disclosures did not occur in the informed consent process (U.S. Department of Justice, 2005). It was also discovered that both the director of the institute leading the research and the University of Pennsylvania itself had significant financial interests in the biotech company that would bring the therapy to market (Rothman, 2008). In fact, both the former dean of the institution's medical school and the lead investigator of the study stood to benefit financially from the commercialization of the therapy through their patent ownership. As well, the academic medical center also had an equity stake in the biotechnology company collaborator, and would have profited from commercialization that would then inure to all of these individuals and institutions (Fox, 2000).
To read the rest of the article please visit Patient Safety & Quality Healthcarewww.psqh.com website
Studies show that 67% of academic departments have financial relationships with industry (Campbell, 2007b). The Institute of Medicine has warned that academic institutions lack independent review, with resulting tolerance of conflicts due to financial gains, which may pose serious barriers to addressing the issue (IOM, 2009). These financial inducements may result in an emphasis of profits over patient safety (U.S. GAO, 2001).
Such warnings are not theoretical. Institutional forms of conflicts of interest have resulted in institutions and their representatives basing their decisions on financial rewards instead of on an overarching concern for patient safety. The death of teenager Jesse Gelsinger—a clinical study participant at the University of Pennsylvania—highlights these risks.
Addressing institutional conflicts of interest is therefore key to mitigating the risks associated with patient safety. Scrutiny of relationships between industry and academic institutions, as well as establishing internal, independent bodies and policies to improve oversight and intercept conflicts that represent a threat to patient safety must be integrated into systems to avoid tragedies such as the Gelsinger case.
The Jesse Gelsinger Case
Perhaps the most dramatic example of failing to manage institutional conflicts is the death of an 18-year-old study participant, Jesse Gelsinger, in a gene therapy trial at the University of Pennsylvania in 1999 (Rothman 2008). Gelsinger suffered from ornithine transcarbamylase deficiency, which affects the body's ability to eliminate ammonia (Wolf & Lo, 2000). Although potentially life threatening, Geslinger had managed the condition with a strategy of a low-protein diet and medication, and otherwise enjoyed a normal life (Stolberg, 1999). Gelsinger understood that he would not benefit directly from his participation in the Phase I gene therapy study; his decision to participate was motivated by hope that results from the study would avail him of his restrictive diet routine in the future (Wolf & Lo, 2000).
Gelsinger began the study, but almost immediately clinical problems emerged. The evening of his injection with the gene therapy, he experienced a high fever and abdominal pain, and by the next morning, severe hepatic failure and blood clotting. He then lapsed into a coma. His clinical condition rapidly deteriorated, and over the next several days, Geslinger suffered multi-organ failure and, subsequently, brain death. Only 4 days after receiving the gene therapy treatment, he was removed from life support, and died. Jesse Gelsinger's death was then reported to government officials (Stolberg, 1999).
Investigations
Initial investigations by government entities into Gelsinger's death postulated that the genetic therapy vector that was administered to him caused a systemic inflammatory response syndrome. That led to acute respiratory distress syndrome, and eventually his death due to anoxia (Hollon, 2000). These investigations focused on the safety of the adenovirus gene therapy vector, which was used in the gene therapy, and on potential medical error (Stolberg, 1999).
But beyond these components, systems assessments also reviewed broader issues. In this extended analysis, highly troubling revelations of both individual and institutional conflicts of interests existing between investigators and the university and industry began to emerge, leading to more detailed scrutiny of the motivations and judgment exercised by those involved in the trial (Wolf & Lo, 2000).
Several months later, officials from the FDA announced that Gelsinger should never have been a participant in the study due to his clinical condition. Further, the institution's investigators violated FDA requirements by failing to immediately report earlier patients who had experienced serious side effects prior to the Gelsinger study. In addition, informed consent documents provided to participants were altered from that approved by the FDA by omitting important information regarding the death of animal subjects that had undergone similar treatment (Stolberg, 1999).
Yet these FDA discoveries were just the beginning. Upon further review, analyses showed Gelsinger's case was rife with substantive institutional wrongdoing spurred by unmanaged financial conflicts. First, reports submitted by the institution to the FDA, NIH, and IRBs misrepresented the actual clinical findings, and proper disclosures did not occur in the informed consent process (U.S. Department of Justice, 2005). It was also discovered that both the director of the institute leading the research and the University of Pennsylvania itself had significant financial interests in the biotech company that would bring the therapy to market (Rothman, 2008). In fact, both the former dean of the institution's medical school and the lead investigator of the study stood to benefit financially from the commercialization of the therapy through their patent ownership. As well, the academic medical center also had an equity stake in the biotechnology company collaborator, and would have profited from commercialization that would then inure to all of these individuals and institutions (Fox, 2000).
To read the rest of the article please visit Patient Safety & Quality Healthcarewww.psqh.com website
How Patient-Provider Engagement Can Transform Patient Safety
By Dave deBronkart
How would the world change if, suddenly, clinicians had a highly motivated partner in carrying out each care plan? I propose that a new level of patient safety will be possible if we shift to a shared care plan model, with patients and families aware of the plan and engaged in its execution.
I look at healthcare through the lens of a former patient: in 2007 great medicine saved me from Stage IV renal cell carcinoma. But I view it through another lens, too: as a high-tech business person who's watched industries evolve for years, it grips me that this miraculous industry has made so little progress on cost or safety—despite immense efforts by really smart people.
To me, that's a sign we've overlooked something. I assert we're making a fundamental error when we expect clinicians to know and do everything, and we pay a heavy price (literally and figuratively) for this mistake. We should share the load: enlist patients and families in making healthcare better.
The Plausible Promise of Participatory Medicine*
The Society for Participatory Medicine defines this new model as "a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners" (www.ParticipatoryMedicine.org). The Society arose in 2009 out of the "e-patient" concept developed by Tom Ferguson, MD (1944-2006). I joined the movement in 2008 after hearing about it from my physician, Dr. Danny Sands. In this column I write on my own, not on behalf of the Society.
A cornerstone of Ferguson's view is that in today's Internet-enabled world, what's possible in healthcare is radically different from 1990:
* Patients today have access to information that used to be accessible only to clinicians and researchers. That doesn't make them clinicians, but it does show why it's possible for ordinary patients to bring value to the table.
* Today patients can band together in smart communities, sharing experiences and research findings in ways that are inherently patient-centered. (Hospitals work at understanding what patients want; patients know what they want.) This doesn't mean every gathering of patients is inherently smart; it does show how it's possible for patients to aggregate knowledge.
* While patients have access to increased power, clinicians are gripped in a pincer: inexorable pressure to see more patients, while enduring an information explosion. Increasingly, it's impossible for clinicians to keep up. I vetted this point with my oncologist, and he said, "Right—unless you're a sub-sub-specialist like me."
for the rest of column please visit Patient Safety & Quality Healthcare magazine
How would the world change if, suddenly, clinicians had a highly motivated partner in carrying out each care plan? I propose that a new level of patient safety will be possible if we shift to a shared care plan model, with patients and families aware of the plan and engaged in its execution.
I look at healthcare through the lens of a former patient: in 2007 great medicine saved me from Stage IV renal cell carcinoma. But I view it through another lens, too: as a high-tech business person who's watched industries evolve for years, it grips me that this miraculous industry has made so little progress on cost or safety—despite immense efforts by really smart people.
To me, that's a sign we've overlooked something. I assert we're making a fundamental error when we expect clinicians to know and do everything, and we pay a heavy price (literally and figuratively) for this mistake. We should share the load: enlist patients and families in making healthcare better.
The Plausible Promise of Participatory Medicine*
The Society for Participatory Medicine defines this new model as "a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners" (www.ParticipatoryMedicine.org). The Society arose in 2009 out of the "e-patient" concept developed by Tom Ferguson, MD (1944-2006). I joined the movement in 2008 after hearing about it from my physician, Dr. Danny Sands. In this column I write on my own, not on behalf of the Society.
A cornerstone of Ferguson's view is that in today's Internet-enabled world, what's possible in healthcare is radically different from 1990:
* Patients today have access to information that used to be accessible only to clinicians and researchers. That doesn't make them clinicians, but it does show why it's possible for ordinary patients to bring value to the table.
* Today patients can band together in smart communities, sharing experiences and research findings in ways that are inherently patient-centered. (Hospitals work at understanding what patients want; patients know what they want.) This doesn't mean every gathering of patients is inherently smart; it does show how it's possible for patients to aggregate knowledge.
* While patients have access to increased power, clinicians are gripped in a pincer: inexorable pressure to see more patients, while enduring an information explosion. Increasingly, it's impossible for clinicians to keep up. I vetted this point with my oncologist, and he said, "Right—unless you're a sub-sub-specialist like me."
for the rest of column please visit Patient Safety & Quality Healthcare magazine
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