Quality Improvement & Patient Safety Section Newsletter - January 2006, Vol 7, #1
Patient Safety and Quality Improvement Act of 2005
David L. Meyers, MD, FACEP
On July 29, 2005, President Bush signed into law the Patient Safety and Quality Improvement Act (PSQIA) of 2005. The overarching purpose of this law is to establish an environment and framework which will foster activities to improve patient care and safety. The impetus for this legislation came from revelations in the Institute of Medicine’s (IOM) 1999 report, To Err Is Human: Building a Safer Health System, about the many deaths (cited as up to 98,000) and injuries resulting from health care in the US. The second IOM report, Crossing the Quality Chasm, in 2001, further elaborated the state of quality in health care and offered proposals for addressing the gap between the ideal of the highest quality care and the reality of care as it is currently provided in America.
PSQIA directs the Secretary of Health and Human Services to facilitate the creation, maintenance and certification of patient safety organizations (PSOs) which would develop and maintain databases to provide an "interactive evidence-based management resource" for clinicians and organizations. These organizations will have several functions. First, they will accept and aggregate data, reports, records, memoranda and written or oral statements prepared or compiled for patient safety reasons and/or reported to a patient safety organization. Second, they will provide for the performance of analyses (including root cause analyses) of the collected information with the goal of improving patient safety and quality in health care. Third, the results of the analyses will be provided as "feedback" to the reporting entities and clinicians for use in improving care.
In the law, many terms are defined including "patient safety activities," "patient safety organization," and "provider," which includes practitioners and health care organizations. "Patient safety work product" very broadly means any information in written or oral form that may result in improved patient safety, health care quality, or health care outcomes, provided it is gathered by a qualified entity for the purpose of being reported or is developed by a PSO for patient safety activities. It is thought that the entities most likely to qualify to perform these activities are the existing quality improvement organizations which contract with Centers for Medicare and Medicaid Services (CMS) to review and enhance care to Medicare beneficiaries, although other organizations could be established for these purposes.
A key intent of the PSQIA is that the activities of the PSO, including information and data voluntarily submitted to it by clinicians and health care institutions in the prescribed ways, would be protected from further disclosure. The privilege is rather broad, such that a patient safety work product would not be subject to:
- subpoena or order related to a federal, state, or local civil or administrative disciplinary proceeding against a provider;
- discovery in connection with a federal, state, or local civil or administrative disciplinary proceeding against a provider;
- disclosure under the Freedom of Information Act;
- use as evidence in any federal, state, or local civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider;
- use in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under state law.
These protections have the potential to eliminate what is widely viewed as a very significant barrier to the voluntary reporting of errors and near misses to existing state patient safety organizations – the fear that the reports will be used to pursue professional liability or judicial actions against providers.
Like many federal laws with grand scope, the initial enthusiasm felt by many in the patient safety advocacy community may be tempered by some practical considerations around implementation of the law through the rule-making and regulatory process. Much is uncertain at this point, three months into its life. For example, no PSO can be certified and no reporting can take place until the Department of Health and Human Services (HHS) issues final regulations. Also, while it is generally recognized that Congress intended this law to apply to medical errors, as written, many health care activities could qualify as patient safety activities.
Reporting under the act is voluntary, and it is uncertain whether the defined voluntary reporting entities and individuals will actually report errors, near misses, and other relevant matters, even with the protections of the law. How the PSOs will be determined is also uncertain at present. The relationship between "patient safety work product" and existing quality improvement, risk management, and peer review functions will need to be clarified, as will the nature of the protections afforded these existing activities.
All of us in emergency medicine, as well as throughout health care, have an important stake in the issues addressed by this law. Its ultimate impact on the safety and quality of our patients’ care remains to be seen. Many organizations representing providers affected by the PSQIA, including the American and many state hospital associations, the AMA and many other physician groups, as well as patient advocacy representatives, are currently analyzing its provisions and developing positions and recommendations for the benefit of their constituents, while awaiting the results of the rule-making process. That, of course, will be key to the implementation and enforcement of the law. We may be at the beginning of a new era in addressing patient safety and quality. This will become clearer over the next 12 months.
Beer’s List: Medications to Avoid in the Elderly
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Dickson S. Cheung, MD
The elderly are particularly susceptible to polypharmacy, but are certain medications more dangerous than others? A list developed by gerontologist Mark H. Beers, MD, discourages the use of certain medications that are known to have significant adverse effects in the elderly.
Below are examples of medications on Beer’s list:
Strong anticholinergic and sedating properties
Not effective orally and has disadvantages compared with other narcotic analgesics
Few advantages over acetaminophen
Avoid daily use > two weeks
Most CNS side effects of any NSAID
View the full listing online.
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Physician Consortium for Performance Improvement
Convened and staffed by the American Medical Association
The American Medical Association (AMA) convenes the Physician Consortium for Performance Improvement (Consortium) in recognition of physicians’ professional responsibility to provide quality health care. The Consortium is a physician-led initiative that includes:
- Experts in methodology,
- Clinical experts representing more than 65 national medical specialty and state medical societies,
- Agency for Healthcare Research and Quality (AHRQ),
- Centers for Medicare and Medicaid Services (CMS),
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO) – liaison member,
- National Committee for Quality Assurance (NCQA) – liaison member.
Products to date
To date, the Consortium has developed performance measures for the following conditions. Several of these measurement sets were developed with specialty societies taking the lead with the Consortium.
||Measures in Development
Chronic Obstructive Pulmonary Disease
Community-Acquired Bacterial Pneumonia
Coronary Artery Disease2
Major Depressive Disorder
Osteoarthritis of the Knee3
Preventive Care and Screening Measures:
Colorectal Cancer Screening
Influenza Immunization, Adult
Tobacco Use Cessation
Child and Adolescent Major Depressive Disorder
1 Developed by the National Diabetes Quality Improvement Alliance
2 Developed in collaboration with the American College of Cardiology and the American Heart Association
3 Developed in collaboration with the American Academy of Orthopaedic Surgeons
4 To be developed in collaboration with the American Academy of Pediatrics, American Academy of Family Physicians
5 To be developed in collaboration with the American College of Surgeons, the National Surgical Quality
Improvement Program (NSQIP), and the Veterans Administration
National Recognition and Alignment
The AMA/Consortium measures are gaining national recognition
- CMS Initiatives: CMS is pilot testing the AMA/Consortium measures in the Doctors’ Office Quality (DOQ) and DOQ-Information Technology (DOQ-IT) Projects. In addition, the AMA/Consortium measures are among those being pilot tested in other CMS demonstration projects such as the Medicare Physician Group Practice (PGP) Demonstration and the CMS Medicare Care Management Performance Demonstration Project.
- National Quality Forum (NQF): The NQF has agreed to conduct an expedited review process for a clinical measurement set for NQF’s Ambulatory Care Project. The measurement set is a collection of process measures developed by three leading organizations: the AMA/Consortium, CMS, and the NCQA. All of the Consortium’s measures are included in this review.
- Bureau of Primary Healthcare (BPHC): The AMA is working with BPHC to align AMA/Consortium measures with performance measures being used in BPHC’s Health Disparities Collaboratives
- Electronic Performance Measurement Specifications Project: The AMA and CMS co-sponsored an effort to develop technical specifications which will enable any electronic health record system vendor to integrate Consortium measures into their product
AHRQ – Partnership for Quality
This project is a 4-year partnership between AMA and organizations positioned to implement performance measures developed by the Consortium. The project, entitled "Effecting Change in Chronic Care: The Tipping Point," seeks to accelerate improvement in outpatient care for chronically ill patients. Partners include the Iowa Foundation for Medical Care (IFMC), Midwest Heart Specialists, Northwestern University, and national partners, including CMS, the Blue Cross Blue Shield Association, and United Healthcare.
- Specifically, two of the AMA’s partners, Midwest Heart Specialists and Northwestern University, are conducting validity and reliability testing for the Consortium’s cardiovascular measures that have been integrated into each partner’s respective EHRS. Additionally, Midwest Heart, IFMC, and United Healthcare are testing the feasibility of exporting de-identified clinical performance data in a standardized format directly from a practice site to multiple payers.
AHRQ – Transforming healthcare quality through IT/implementation
The AMA is collaborating with the Alliance of Chicago Community Health Services (Alliance), a network of 23 clinic sites providing care for more than 70,000 clients in 300,000 encounters annually. This collaboration, titled "Enhancing Quality in Patient Care (EQUIP)," shares a mutual vision for quality improvement and reduction of disparities in health care across minority populations through use of Consortium-developed measures that are integrated into an electronic health record system to be installed at the Chicago Alliance’s clinical sites.
For more information on the Consortium or its products please contact:
Karen Kmetik, PhD
Director, Clinical Performance Evaluation
American Medical Association
Erin O’Brien, MPH
American Medical Association
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Age and Quality of Care
Helmut W. Meisl, MD, FACEP
As my years of emergency medicine progress, I always wonder whether I am practicing better than I have in the past. The usual thought is that experience is beneficial, and that my quality of medical care is improving or at least not becoming worse. However is this my own delusion? Two articles caught my interest. The first one is:
Shaughnessy AF, Slawson DC. Easy ways to resist change in medicine. Brit Med J. 2004;329(7480):1473-1474.
This is a humorous article, but has some astute observations and a great deal of wisdom about our intrinsic resistance to change. The introduction states "Under the guise of "quality improvement," managed care organizations, accrediting bodies, and the government are meddling in medicine. Even continuing medical education, previously a form of intellectual entertainment or a forum for much needed sleep, has refocused its efforts towards improving the care of patients."
They then go on to describe techniques to resist change:
- "Don't pay attention" where one is so busy with one’s practice that there is no time for reading and medical education.
- "Attack the data" where one finds some fault with the literature, so that the new information can be dismissed.
- "Maintain absolute confidence" with the best medicine being taught while one was in medical school, and no need to consider later evidence-based medicine, simply adhere to one’s " belief based medicine."
- "Follow the pack," and be the last one to change one’s practice.
- "Defer to experts" with one not making any new or independent decisions.
- "Bring in the lawyers" where one might be sued for attempting anything new.
- "Blame patients," as they all expect antibiotics for their colds.
- "Show how much you've changed" where one makes some minor change, as using a new antibiotic, based on information from a pharmaceutical representative. "It’s more important to feel up to date than to actually be up to date."
- "Pull rank" when receiving information from a source that may not be one’s peer level, and say "Where did you get your medical degree?"
- "Simply refuse" to believe or accept the information.
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Grading the Graders: Leapfrog
Dickson S. Cheung, MD
Companies are a large stakeholder in health care because they are usually the ultimate payer of health care through insuring their patients. In 1998, a large group of Fortune 500 companies banded together to change the way they purchased health care to influence its quality and affordability. They got funding from the Business Roundtable, Robert Wood Johnson Foundation, and finally launched the Leapfrog Group in November 2000.
How they work and what they have done
Their initial focus was to reduce preventable mistakes. They have done this by supporting hospitals that have computer physician order entry, evidence-based hospital referral programs, and board-certified ICU physician staffing. They work in three main ways: building transparency, providing incentives and rewards for institutions that follow higher standards, and creating consistency and leverage for change.
How Leapfrog differs
Leapfrog participation by hospitals is strictly voluntary via an online survey. It costs on average $25,000-50,000 for hospitals to report their findings to Leapfrog. They have high customer visibility similar to the Centers for Medicaid and Medicare Services, JCAHO, and Healthgrades. They focus heavily on the structure of health institutions, eg, staffing, systems, moderately on the process, and not at all on outcomes.
More information can be found at www.leapfroggroup.org.
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This publication is designed to promote communication among emergency physicians of a basic informational nature only. While ACEP provides the support necessary for these newsletters to be produced, the content is provided by volunteers and is in no way an official ACEP communication. ACEP makes no representations as to the content of this newsletter and does not necessarily endorse the specific content or positions contained therein. ACEP does not purport to provide medical, legal, business, or any other professional guidance in this publication. If expert assistance is needed, the services of a competent professional should be sought. ACEP expressly disclaims all liability in respect to the content, positions, or actions taken or not taken based on any or all the contents of this newsletter.