Published Jun 29, 2001
Hospital mistakes must be disclosed Accreditation at risk if patients aren't
By Robert Davis
USA TODAYHospitals must now tell patients and their families when they have
been hurt by a medical error, according to nationwide standards that take
effect Sunday.The standards by the nation's leading health care accrediting
agency are the first to hold hospitals accountable for a higher level of
patient safety. As many as 98,000 people die each year from medical errors,
according to the Institute of Medicine. The medical community is scrambling
to try to make health care safer, but the effort has been hampered partly
because of the way that errors are handled.When a mistake is made today,
there is no legal requirement that a patient be told. The result is that
those close to the error know of the mistake, but the event is kept secret.
Left hidden, common medical mistakes -- such as administering a drug
incorrectly -- are rarely identified quickly and studied for ways to make the
health care system safer, researchers say.''These standards are meant to
create a culture of safety,'' says Dennis O'Leary, president of the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO), a non-profit
group that accredits 80% of the nation's hospitals. He announces the
standards today. ''Errors are not reported inside organizations because
caregivers are fearful they will be punished.''The new standards are designed
to promote open discussion and review of errors so that fixes can be found
and applied, O'Leary says. A hospital could get in more trouble for not
looking for errors than by committing them. ''If we can save a lot of lives
by making some basic changes in patient care processes, it will be a
wonderful benefit,'' he says.The new standards, available at http://www.jcaho.org,
do not require new hospital bureaucracies. JCAHO simply demands that hospital
leaders tackle medical errors and patient safety -- or risk losing
accreditation.During regular hospital inspections, the commission now will
look for patient safety compliance from hospital CEOs to patients. Each
hospital in the USA must: Actively work to prevent errors; design patient
safety systems, such as systems that double-check a drug order before a
prescription is filled; and encourage and act on internal reports of
errors.The JCAHO calls a medical error ''an unintended act, either of
omission or commission, or an act that does not achieve its intended
outcome.''The American Medical Association, which has an ethical standard
that says doctors should always tell patients about medical errors, applauds
the commission's new standards.''Safety has to start with the leadership of
an organization,'' says the AMA's Donald Palmisano, a surgeon in New Orleans.
''That is what JCAHO is doing here.''The American Hospital Association
agrees. ''We are very supportive,'' the association's Don Nielsen says.The
new standards should not cost hospitals anything to implement, he
says.O'Leary says that ''to create a culture of safety, caregivers must feel
safe that they are not going to be punished and that the system is designed
to protect them when they do make a human error.''
I posted on this one also, under expectations of perfectionism vs. high quality standards.
I worry about creating such a punitive environment for mistakes that people just get hopeless. The fact is when nurses give 35 to 50 med doses a day (my estimate) I think over time, mistakes will happen. With that statement, I am NOT trying to excuse mistakes and I have always felt that the goal was to work toward perfection. Likely anyone here who has done clinical nursing has committed a med error and you feel horrible. You would give anything to snatch the moment back and do it again. And we all know that UNDERSTAFFING can only worsen error rates. But I can see these rules being enacted in a very personal and punitive way. I have concerns about this ruling. Does anyone have more information that might enlighten me?
NRSKarenRN, BSN, RN
Info on this can be found @ http://www.jcaho.org.
New JCAHO Standards are underlined.Patient Rights and Organization Ethics Chapter
Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes.
Intent of RI.1.2.2
The responsible licensed independent practitioner or his or her designee clearly explains the outcome of any treatments or procedures to the patient and, when appropriate, the family, whenever those outcomes differ significantly from the anticipated outcomes.
Education includes information about patient responsibilities in the patient's care.
Intent of PF.3.7
The safety of health care delivery is enhanced by the involvement of the patient, as appropriate to his/her condition, as a partner in the health care process1. In addition, hospitals are entitled to reasonable and responsible behavior on the part of the patients and their families. The hospital identifies patient and family responsibilities and educates the patient and family about these responsibilities. Specific attention is directed at educating patients and families about their role in helping to facilitate the safe delivery of care2.
Responsibilities include at least the following:
Providing information. The patient is responsible for providing, to the best of his or her knowledge, accurate and complete information about present complaints, past illnesses, hospitalizations, medications, and other matters relating to his or her health. The patient and family are responsible for reporting perceived risks in their care3[/u] and unexpected changes in the patient's condition. The patient and family help the hospital improve its understanding of the patient's environment by providing feedback about service needs and expectations.
Asking questions. Patients are responsible for asking questions when they do not understand what they have been told about their care or what they are expected to do.
Following instructions. The patient and family are responsible for following the care, service, or treatment plan developed. They should express any concerns they have about their ability to follow and comply with the proposed care plan or course of treatment. Every effort is made to adapt the plan to the patient's specific needs and limitations. When such adaptations to the treatment plan are not recommended, the patient and family are responsible for understanding the consequences of the treatment alternatives and not following the proposed course.
Accepting consequences. The patient and family are responsible for the outcomes if they do not follow the care, service, or treatment plan.
Following rules and regulations. The patient and family are responsible for following the hospital's rules and regulations concerning patient care and conduct.
Showing respect and consideration. Patients and families are responsible for being considerate of the hospital's personnel and property.
Meeting financial commitments. The patient and family are responsible for promptly meeting any financial obligation agreed to with the hospital.
Patients are educated about their responsibilities during the admission, registration, or intake process and as needed thereafter.
The leaders ensure implementation of an integrated patient safety program throughout the organization.
Intent of LD.5
The patient safety program includes at least the following:
Designation of one or more qualified individuals or an interdisciplinary group to manage the organization-wide patient safety program. Typically these individuals may include directors of performance improvement, safety officers, risk managers, and clinical leaders.
Definition of the scope of the program activities, that is the types of occurrences to be addressed--typically ranging from "no harm" frequently occurring "slips" to sentinel events with serious adverse outcomes.
Description of mechanisms to ensure that all components of the health care organization are integrated into and participate in the organization-wide program.
Procedures for immediate response to medical/health care errors, including care of the affected patient(s), containment of risk to others, and preservation of factual information for subsequent analysis.
Clear systems for internal and external reporting of information relating to medical/health care errors.
Defined mechanisms for responding to the various types of occurrences, e.g., root cause analysis in response to a sentinel event, or for conducting proactive risk reduction activities.
Defined mechanisms for support of staff who have been involved in a sentinel event.
At least annually, a report to the governing body on the occurrence of medical/health care errors and actions taken to improve patient safety, both in response to actual occurrences and proactively.
Leaders ensure that the processes for identifying and managing sentinel events (2), are defined and implemented.
Intent of LD.5.1
When a sentinel event occurs in a health care organization, it is necessary that appropriate individuals within the organization be aware of the event; investigate and understand the causes that underlie the event; and make changes in the organization's systems and processes to reduce the probability of such an event in the future. The leaders are responsible for establishing processes for the identification, reporting, analysis, and prevention of sentinel events and for ensuring the consistent and effective implementation of a mechanism to accomplish these activities including:
Determination of a definition of sentinel event and near misses(3), which are approved by the leaders and communicated throughout the organization; at a minimum, the organization's definition must include those events that are subject to review under the Joint Commission's Sentinel Event Policy as published in this manual;
Creation of process for reporting of sentinel events through established channels within the organization and, as appropriate, to external agencies in accordance with law and regulation;
Creation of a process for conducting thorough and credible root cause analyses which focuses on process and system factors, and;
Documentation of a risk-reduction strategy and action plan that includes measurement of the effectiveness of process and system improvements to reduce risk.
Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.
Intent of LD.5.2
The organization seeks to reduce the risk of sentinel events and medical/health care system error-related occurrences by conducting its own proactive risk assessment activities and by using available information about sentinel events known to occur in health care organizations that provide similar care and services. This effort is undertaken so that processes, functions and services can be designed or redesigned to prevent such occurrences in the organization.
Proactive identification and management of potential risks to patient safety have the obvious advantage of preventing adverse occurrences, rather than simply reacting when they occur. This approach also avoids the barriers to understanding created by hindsight bias and the fear of disclosure, embarrassment, blame, and punishment that can arise in the wake of an actual event.
Leaders provide direction and resources to conduct the following proactive activities to reduce risk to patients:
At least annually, select at least one high-risk process for proactive risk assessment; such selection is to be based, in part, on information published periodically by the Joint Commission that identifies the most frequently occurring types of sentinel events and patient safety risk factors;
Assess the intended and actual implementation of the process to identify the steps in the process where there is, or may be, undesirable variation (i.e., what engineers call potential "failure modes");
For each identified "failure mode" identify the possible effects on patients (what engineers call the "effect"), and how serious the possible effect on the patient could be (what engineers call the "criticality" of the effect);
For the most critical effects, conduct a root cause analysis to determine why the variation (the failure mode) leading to that effect may occur;
Redesign the process and/or underlying systems to minimize the risk of that failure mode or to protect patients from the effects of that failure mode;
Test and implement the redesigned process;
Identify and implement measures of the effectiveness of the redesigned process; and
Implement a strategy for maintaining the effectiveness of the redesigned process over time.
Leaders ensure that patient safety issues are given a high priority and addressed when processes, functions, or services are designed or redesigned.
Intent of LD.5.3
When processes, functions, or services are redesigned, information from within the organization and from other organizations about potential risks to patient safety, including the occurrence of sentinel events, is considered and, where appropriate, used to minimize the risk to patients affected by the new or redesigned process, function, or service.
Continuing re the above post:
So from all of this, I determine it will be the Dr who will need to tell the patient of an error or any situation resulting in an unanticipatted outcome. Organization will be responsible for identify reported problems, unexpected outcomes and doing root cause analysis to determine ways to prevent future incidents.
Per JCAHO "Proactive identification and management of potential risks to patient safety have the obvious advantage of preventing adverse occurrences, rather than simply reacting when they occur. This approach also avoids the barriers to understanding created by hindsight bias and the fear of disclosure, embarrassment, blame, and punishment that can arise in the wake of an actual event."
I would push for adequate staffing under the safety issue and send info re inadequate staffing to risk mgmt and who ever is in charge of these new standards as understaffing IS a patient safety issue.
Would NOT admit med mistake to client without another nurse as witness to conversation; best to let charge nurse/administration handle this with you.
I feel this will have agood side and a very bad side to it. One the consumer the patient has a right to know when there has been a error without a question.they are paying for the care they have the right to know when there has been a mistake.but I feel you will see a large increase of nurses being sued and the hospitals being less accountable.In that case very few people are going to stay in the nursing field for the fear of losing everything.Lawyers are going to jump on this one without a dought and set up shop trying to get patients to file suits.As posted before if you are taking care of several patients there is going to be a mistake it is to bad congress does not spend as much time and force making mandatory in ALL states to enforce patient ratio and mandatory overtime bills for patients rights. :o :o
Hi. NRSKaren, I agree with your assessment of the JCAHO ethics standards. JCAHO talks about proactive identification and risks, but isn't their response to the medical error problem a reaction? When were the standards published?
How do you keep the media out of this? I can just see a regular column in my local newspaper of errors reported by families, patients, or their advocates. Should we be concerned about this possibility? How enforceable is the patient responsibility part of the standards when there is no adequate staff to provide and oversee care? Looks like another can of worms being opened by an organization who works on a different planet from us. Just my opinion.
A good article covering this.
June 25,2001 Issue
Week in Healthcare
Enforcing a new openness: JCAHO to hospitals: Let patients know when their care hasn't met standards
By: Jeff Tieman
Before your hospital's next accreditation survey, add this to your ``to do'' list: Develop a policy for informing patients when they've received substandard care.
Starting July 1, hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations will be required to tell patients when their treatment outcomes vary from anticipated results.
That requirement is one of several new JCAHO patient-safety standards that take effect next week and have met with mixed reaction in the industry. Some hospital executives have hailed the new standards as an important part of limiting medical errors and keeping patients in the loop about their own care. Others in the industry believe the disclosure requirement could be difficult to codify and may lead to more litigation.
About 800 of the 4,939 hospitals accredited by the JCAHO will be surveyed for compliance with the new standards before year-end. Hospitals contacted by Modern Healthcare said they have at least started to address patient safety and don't anticipate major expenses or operational headaches associated with implementing the standards.
JCAHO President Dennis O'Leary, M.D., acknowledged concerns about a spike in litigation, but he argued that it's more likely patients will steer clear of lawyers if they're told the truth.
``Be honest and share the facts,'' said O'Leary, who has headed the Oakbrook Terrace, Ill.-based commission since 1986. ``Don't ask to be sued.''
Disclosure won't be easy
Requiring hospitals and doctors to disclose their mistakes may be fairly complicated, some said, because it will demand a specific policy on when and how to release such information.
``Are people going to have trouble with it? Absolutely,'' said James Conway, chief operations officer of the Dana Farber Cancer Institute in Boston and a board member of the National Patient Safety Foundation. ``The first time (doctors or clinicians) disclose and get beat up for doing it, they're not going to do it again.''
Dana Farber has been telling patients about treatment errors and outcomes deviations for five years, Conway said, and it has been involved in ``no significant litigation expressly as a result of that.''
Suits a concern
Nevertheless, new lawsuits arising out of the JCAHO requirements are ``a concern to anybody,'' said Lisa Cortes, director of risk management and in-house counsel for Scott and White, a healthcare system in Temple, Texas, that operates a 440-bed hospital and 520-physician medical group. Balancing the new disclosure requirement with privacy laws mandated by the Health Insurance Portability and Accountability Act of 1996 will be a significant challenge, Cortes said.
Some patients will appreciate being informed, she said, and others ``will try to use it as a hammer.'' To prevent such a reaction, Scott and White physicians must reach a consensus that a medical error occurred before divulging the information to patients. ``Bad outcomes do not necessarily mean a medical error,'' Cortes said.
The Association of Trial Lawyers of America said the JCAHO's disclosure requirement could reduce litigation by promoting an atmosphere of trust. ``People appreciate honesty and being told what's happening to them or what might happen to them,'' said Carlton Carl, an association spokesman. ``The more people know about their condition, the more favorably they view their doctor.''
That position is in stark contrast to the fiery debate in Washington over a patients' bill of rights. That debate has centered on the crowded courtrooms and costly litigation that could result from allowing patients to sue their health plans over treatment decisions.
On July 1, six new JCAHO standards become effective, five of which are directed at top executives. Perhaps the most far-reaching standard requires hospitals to implement an organization-wide patient-safety program with executive-level sponsorship and participation.
IOM reports spurred action
Patient safety has become an increasingly contentious issue since the release of two Institute of Medicine reports indicating that as many as 98,000 Americans are killed by hospital medical errors annually and that the nation's healthcare delivery system is ``plagued by a serious quality gap.''
In the wake of those reports, the JCAHO determined that fewer than half of its quality standards related to patient safety. ``It became clear that the timing was right to raise the bar for patient-safety expectations,'' O'Leary said.
The JCAHO first proposed the standards last April and fielded comments last summer and early fall. The organization had ``lots of response,'' O'Leary said, ``because this is not a boring set of standards.''
The Centers for Medicare and Medicaid Services, the American Hospital Association and patient-safety groups were also among those that reviewed the standards.
Of particular concern to hospitals, O'Leary said, was a proposed standard that would have required hospitals to prioritize processes with respect to patient safety. Because hospitals perceived that as a ``make-work'' provision, it was removed from the final set of standards last December.
That move runs counter to some of the latest thinking on error reduction, which is to focus on error-prone or high-risk treatments. Part of the mission of the Leapfrog Group, a coalition of Fortune 500 companies and leading purchaser organizations, is to minimize the errors providers commit during high-risk procedures (May 28, p. 30).
Plan builds on providers' efforts
Nashville-based HCA-The Healthcare Co., which owns or leases 196 U.S. hospitals, is ``very supportive'' of the new JCAHO standards and their underlying goals, a company spokesman said. ``Engaging patients in their care has been a big push for a long time in healthcare,'' the spokesman said.
The chief challenge for HCA, he said, will not be complying with the new standards but documenting that hospitals are in fact following the rules. HCA anticipates ``minimal new costs'' associated with that effort.
``I personally don't see a lot of stuff in the (JCAHO) policy that adds significant cost,'' agreed Dana Farber's Conway.
He participated in a JCAHO panel that debated the standards and said most of the new requirements expand on existing ones, such as hospitals' need to effectively share clinical data.
The JCAHO said one of its main goals in promulgating the standards is to create a ``blame-free'' culture of safety in hospitals so that caregivers feel free to report errors and educate patients.
``I think it would be nice to look at our culture and make sure we are not afraid to report errors,'' said Ingrid Flemming, director of risk management and patient information management services at Northern Michigan Hospital in Petoskey.
To prepare for the JCAHO's new standards, the 202-bed hospital is educating physicians, executives and even patients, which represents the bulk of the work that will be necessary, Flemming said.
``Anyone with a solid risk-management program will not have a problem with the patient-safety standards,'' she said.
The JCAHO's new patient-safety standards won't be reviewed as part of the standards review program that it announced in May.
[Modern Healthcare Magazine]
I can understand the rights of patients, but what about the nurses and doctors and other medical personnal! Kick us when we are down. I work in a very busy ER, when we don't save a life and don't follow ACLS protocal to a T does that mean we put a patients life in jepordy? What about the nurse that pushes demeral too fast and the patient, vomits is that considered an error? What about the patients that come in and don't even know what their medications they are taking or what medication they are allergic too, when are the patient going to take resposibility for their actions! The patient that can't breath that has COPD, but tells you oh ya I smoke 2 packs of cigs a day. Am I out in left field, do I see the picture correct? Sometimes I just don't understand, I can educate my patients with going home instructions written and verbal and I still get the feeling they will do whatever they darn will please and if it doesn't go well for them they come back green with hate to make you look like a bad nurse, doctor, etc. I respect JACHO, but I think we need to start having the patients take some responsibility for their ACTIONS!!!!!!
MJourney and nurses:
These safety standards were developed in December 2000 as part of JCAHO's new proactive approach to healthcare. They are to be implimented as of July 1, 2001.
Review of the Education Chapter standards: Standard PF3.7
Providing information The patient is responsible for providing, to the best of his or her knowledge, accurate and complete information about present complaints, past illnesses, hospitalizations, medications, and other matters relating to his or her health. The patient and family are responsible for reporting perceived risks in their care and unexpected changes in the patient's condition
I see these standards as putting the emphasis on the client/patient to inform health care providers of any and all health caare problems including use of recreational drugs and unusual health practices. Also, if the patient deviates from the plan of treatment recomendations, then they are resonsible for the outcome. It us up to us as nurses to documernt teaching, care plan and patients deviation from plan of care in non-biased way, also documeting patient informed of possbile harm from not following the plan. Main point is to DOCUMENT all teaching /conversations and patients understanding. Most facilites are getting patient to sign DC form as teaching completed then.
I think my question is when a facility works nurses short or long hours is it going to be the nurse taking responsibility or the facilityIs the facilities also since this will be public use this against the nurses?
NRSKarenRN, Thanks for your reply. We already have the patient sign after giving D/C instructions. Alot of them still do not get Rx filled and I know that because they will bring their child back the next day and say they are not any better? We also give out care notes at my ER for Rx and the patients Dx, this too meets JCAHO reqirements. My point was being it gets old when pts. really don't care about themselves, but they will try to hold it against the nurse if she messes up. I know we don't have a perfect society, but this is frusturating.
Because of the Nurse Practice Act & the Nurse Code of Ethics & the obligations nurses have under them, you will be held responsible if you accept an assignment that you know to be unsafe or continue to work when you know you are exhausted & are not working at your optimal level, because a "reasonable & prudent" nurse would have used better judgement & not placed her pts in a hazardous situation, no matter how far up the chain of command she to go to do it. The public may be a little more sympathetic to your position of being between a rock & a hard place but your state board may not & you could have charges placed on your license, or even lose it.
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