Improving safety for children with cardiac disease

2007 ◽  
Vol 17 (S4) ◽  
pp. 127-132 ◽  
Author(s):  
Ravi R. Thiagarajan ◽  
Geoffrey L. Bird ◽  
Karen Harrington ◽  
John R. Charpie ◽  
Richard C. Ohye ◽  
...  

AbstractThe complexity of the modern systems providing health care presents a unique challenge in delivering care of the required quality in a safe environment. Issues of safety have been thrust into the limelight because of adverse events highly publicized in the general media.In the United States of America, improving the safety and quality in health care has been set forth as a priority for improvements in the 21st century in the report from the Institute of Medicine. Many measures have now been initiated for improving the safety of patients at hospital, regional, and national level, and through initiatives sponsored by governments and private organizations. In this review, we summarize known concepts and current issues on the safety of patients, and their applicability to children with congenital cardiac disease. Prior to examining the issues of medical error and safety, it is important to define the terminology.An error is defined as the failure of a planned action to be completed as intended, also known as an execution error, or the use of a wrong plan to achieve an aim, this representing a planning error. An active error is an error that occurs at the level of the frontline operator, and the effects of which are felt immediately. A latent error is an error in the design, organization, training and maintenance, that leads to operator errors, and the effects of which are typically dormant in the system for lengthy periods of time. Latent errors may cause harm given the right circumstances and environment.An adverse event is defined as an injury resulting from medical intervention. A preventable adverse event is an adverse event that occurs due to medical error. Negligent adverse events are a subset of preventable adverse events where the care provided did not meet the standard of care expected of that practitioner.The study of improving the delivery of safe care for our patients is a rapidly growing field. Important components for development of programmes to improve the safety of patients include the leadership for the programme, the implementation of process design based on human limitations, the promotion of teamwork and function, the anticipation of unexpected events, and the creation of a learning environment.Much is yet to be learned about the risk and incidence of adverse events during hospitalization of children with congenital cardiac disease. Errors due to human factors, such as poor communication, poor coordination, and suboptimal team work, have shown to be important causes of adverse outcomes in children undergoing cardiac surgery, and should be a focus for improvement. Future research on evaluating causes and prevention of medical errors and adverse events in this population at high risk, and consuming high resources, is essential.Issues of inadequate safeguards for patients have been prominent in the media, and have been highlighted in reports from the Institute of Medicine. Our review discusses research on the causes of medical error, and proposes concepts to design successful programmes to improve safety for the patients on a local level.

2008 ◽  
Vol 18 (S2) ◽  
pp. 1-37 ◽  
Author(s):  
Jeffrey P. Jacobs

AbstractThe Multi-Societal Database Committee for Pediatric and Congenital Heart Disease was established in 2005 with the goal of providing the infrastructure, spanning geographical and subspecialty boundaries, for collaboration between health care professionals interested in the analysis of outcomes of treatments provided to patients with congenital cardiac disease, with the ultimate aim of improvement in the quality of care provided to these patients. The purpose of these collaborative efforts is to promote the highest quality comprehensive cardiac care to all patients with congenital heart disease, from the fetus to the adult, regardless of the patient’s economic means, with an emphasis on excellence in teaching, research and community service. This manuscript provides the Introduction to the 2008 Supplement to Cardiology in the Young titled: “Databases and The Assessment of Complications associated with the Treatment of Patients with Congenital Cardiac Disease”. This Supplement was prepared by The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Complication”: “A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval.”The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Adverse Event”: “An adverse event is a complication that is associated with a healthcare intervention and is associated with suboptimal outcome. Adverse events represent a subset of complications. Not all medical errors result in an adverse event; the administration of an incorrect dose of a medication is a medical error, but it does not always result in an adverse event. Similarly, not all adverse events are the result of medical error. A child may develop pneumonia after an atrial septal defect repair despite intra- and peri-operative management that is free of error. Complications of the underlying disease state, which are not related to a medical intervention, are not adverse events. For example, a patient who presents for medical care with metastatic lung cancer has already developed a complication (Metastatic spread) of the primary lung cancer without any healthcare intervention. Furthermore, complications not associated with suboptimal outcome or harm are not adverse events and are known as no harm events. The patient who receives an incorrect dose of a medication without harm has experienced a no harm event, but not an adverse event.”Based on the above definitions, it is apparent that The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease has taken an inclusive approach to defining the universe of complications. Complications may or may not be associated with healthcare intervention and may or may not be associated with suboptimal outcome. Meanwhile, adverse events must be associated with healthcare intervention and must be associated with suboptimal outcome.


2001 ◽  
Vol 29 (3-4) ◽  
pp. 346-368 ◽  
Author(s):  
Bryan A. Liang

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes.


2020 ◽  
Author(s):  
Maulidya Nabila

Hampir setiap tindakan medis menyimpan potensi resiko. Banyaknya jenis obat, jenis pemeriksaan dan prosedur, serta jumlah pasien dan staf Rumah Sakit yang cukup besar, merupakan hal yang potensial bagi terjadinya kesalahan medis (medical errors).Menurut Institute of Medicine (1999), medical error didefinisikan sebagai: The failure of a planned action to be completed as intended (i.e., error of execusion) or the use of awrong plan to achieve an aim (i.e., error of planning). Artinya kesalahan medis didefinisikan sebagai: suatu Kegagalan tindakan medis yang telah direncanakan untuk diselesaikan tidak seperti yang diharapkan (yaitu., kesalahan tindakan) atau perencanaanyang salah untuk mencapai suatu tujuan (yaitu., kesalahan perencanaan). Kesalahan yangterjadi dalam proses asuhan medis ini akan mengakibatkan atau berpotensimengakibatkan cedera pada pasien, bisa berupa Near Miss atau Adverse Event (KejadianTidak Diharapkan/KTD).Near Miss atau Nyaris Cedera (NC) merupakan suatu kejadian akibat melaksanakan suatu tindakan (commission) atau tidak mengambil tindakan yang seharusnya diambil (omission), yang dapat mencederai pasien, tetapi cedera serius tidak terjadi, karenakeberuntungan (misalnya, pasien terima suatu obat kontra indikasi tetapi tidak timbul reaksi obat), pencegahan (suatu obat dengan overdosis lethal akan diberikan, tetapi staflain mengetahui dan membatalkannya sebelum obat diberikan), dan peringanan (suatu obat dengan overdosis lethal diberikan, diketahui secara dini lalu diberikan antidotenya). Adverse Event atau Kejadian Tidak Diharapkan (KTD) merupakan suatu kejadianyang mengakibatkan cedera yang tidak diharapkan pada pasien karena suatu tindakan (commission) atau tidak mengambil tindakan yang seharusnya diambil (omission), dan bukan karena “underlying disease” atau kondisi pasien.Kesalahan tersebut bisa terjadi dalam tahap diagnostik seperti kesalahan atauketerlambatan diagnosa, tidak menerapkan pemeriksaan yang sesuai, menggunakan cara pemeriksaan yang sudah tidak dipakai atau tidak bertindak atas hasil pemeriksaan atauobservasi; tahap pengobatan seperti kesalahan pada prosedur pengobatan, pelaksanaanterapi, metode penggunaan obat, dan keterlambatan merespon hasil pemeriksaan asuhanyang tidak layak; tahap preventive seperti tidak memberikan terapi provilaktik serta monitor dan follow up yang tidak adekuat; atau pada hal teknis yang lain seperti kegagalan berkomunikasi, kegagalan alat atau system yang lain. Oleh karena itu, diperlukannya peran dari anggota keluarga pasien, sehingga dapat meningkatkan keselamatan pasien di Rumah Sakit .


2019 ◽  
Author(s):  
Jessica Shank Coviello

In 2016, the Institute of Medicine (IOM) reported medical error as the 3rd leading cause of death in healthcare systems in the United States. Effective communication of patient care needs across healthcare disciplines is critical to ensure patient safety, quality of care, and to improve operational efficiencies in healthcare systems. Ineffective collaboration and communication among healthcare professionals within the procedural areas increases the potential of harm as a patient moves from one healthcare professional to another. Health care systems are thus encouraged to train employees with a focus on interprofessional education (IPE) and collaborative practice. IOM and World Health Organization (WHO) recommend the use of IPE to help improve communication and collaboration. However the current educational structure in many institutions does not include IPE. As such, healthcare professionals work in silos, with little or no collaboration with one another, which may result in service duplication, increased service cost, and poor health outcomes for patients.


2019 ◽  
Vol 16 (1) ◽  
pp. 65-70
Author(s):  
Lasse Pakanen ◽  
Noora Keinänen ◽  
Paula Kuvaja

AbstractThe medico-legal autopsy is an essential tool in investigating deaths caused by an adverse event in health care, for both clinical risk management and for professional liability issues. However, there are no statistics available regarding the frequency of autopsies performed due to suspected adverse events. This study aimed to determine the number of medico-legal autopsies done because of presumed adverse events, whether these events were unintentional, medical errors or cases in which malpractice was suspected. Furthermore, differences in treatment types, causes and manner of death were analyzed. The data was obtained from all medico-legal autopsies performed in Northern Finland and Lapland during 2014–2015 (n = 2027). Adverse events were suspected in 181 (8.9%) cases. The suspicions of an adverse event occurring were most often related to medication, gastrointestinal surgery and orthopedic surgery. The manner of death was classified as medical (or surgical) treatment or investigative procedure in 22 (12.2%) cases. The causes of death were completely unrelated to the suspected adverse event in 41 (22.7%) cases. In conclusion, the frequency of presumed adverse events was quite high in this data set, but in the majority of the cases, the suspicion of an adverse event causing death was disproved by an autopsy. Nonetheless, proper investigation of these cases is essential to ensure legal protection of the deceased, next of kin and health care personnel, as well as to support clinical risk management.


2011 ◽  
Vol 22 (2) ◽  
pp. 121-127 ◽  
Author(s):  
Lisa W. Howley ◽  
Jon Kaufman ◽  
Erica Wymore ◽  
Patti Thureen ◽  
Jeff K. Magouirk ◽  
...  

AbstractBackgroundThe benefits of early enteral feeding in neonates are well known and yet the optimal pre-operative nutrition of prostaglandin-dependent infants with congenital cardiac disease remains ill-defined. This survey delineates international nutritional practices and trends with this population.Materials and methodsPaediatric practitioners responded to an Internet-based survey that explored assessment of feeding practices, criteria for feeding readiness, medication dosing, concurrent feeding with umbilical catheters, and the observed incidence of feeding intolerance. Documented nutritional strategies were not correlated with patient outcomes.ResultsA total of 200 caregivers responded to the survey. Fewer United States caregivers (56%) reported routine pre-operative enteral feeding in prostaglandin-dependent infants when compared with caregivers outside the United States of America (93%). Of those respondents willing to feed, approximately two-thirds did not base their decision on the ductal flow direction. Numerous and heterogeneous parameters were reported to assess feeding readiness. Many caregivers report scepticism with regard to enteral feeding safety in neonates with an umbilical artery catheter, and to a lesser extent in the presence of an umbilical venous catheter. In summary, there is a prevailing lack of consensus regarding pre-operative enteral nutrition to prostaglandin-dependent neonates.ConclusionsThis survey demonstrates noticeable variations in pre-operative nutritional practices between providers from around the world. Arguments that support or refute this practice have little support in the medical literature. Future studies should aim to demonstrate the safety of such practice and compare the outcomes of prostaglandin-dependent neonates who were pre-operatively enterally fed with those who were not.


Cardiology ◽  
2017 ◽  
Vol 138 (4) ◽  
pp. 249-253 ◽  
Author(s):  
Victor L. Serebruany ◽  
Vasily Cherepanov ◽  
Moo Hyun Kim ◽  
Oleg Litvinov ◽  
Hector A. Cabrera-Fuentes ◽  
...  

Background: The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers. However, the initial filers and comparative patterns for oral P2Y12 platelet inhibitor reporting are unknown. We assessed who generated original FAERS reports for clopidogrel, prasugrel, and ticagrelor in 2015. Methods: From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors. All adverse event filing originating sources were dichotomized into consumers, lawyers, pharmacists, physicians, other health care professionals, and unknown. Results: Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96.9%) than with prasugrel (2,896; 98.9% out of 2,927 cases) or ticagrelor (2,163, or 82.3%, out of 2,627 cases, respectively). Overall, most adverse events were filed by consumers (8,336, or 44.4%), followed by physicians (5,290, or 28.2%), other health care professionals (2,997, or 16.0%), pharmacists (1,125, or 6.0%), and finally by lawyers (129, or 0.7%). The origin of 811 (4.7%) initial reports remains unknown. The adverse event filing sources differ among drugs. While adverse events coreported with clopidogrel and prasugrel were commonly originated by patients (40.4 and 84.3%, respectively), most frequently ticagrelor reports (42.5%) were filed by physicians. Conclusion: The reporting quality and initial sources differ among oral P2Y12 platelet inhibitors in FAERS. The ticagrelor surveillance in 2015 was inadequate when compared to clopidogrel and prasugrel. Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints. These differences justify stricter compliance control for ticagrelor manufacturers and may be attributed to the confusion of treating physicians with unexpected fatal, cardiac, and thrombotic adverse events linked to ticagrelor.


Author(s):  
Neelam Dhingra-Kumar ◽  
Silvio Brusaferro ◽  
Luca Arnoldo

AbstractPatient safety is a fundamental principle of health care. However, many medical practices and risks associated with health care are emerging as major challenges for patient safety globally and contribute significantly to the burden of harm due to unsafe care. Available evidence suggests hospitalizations in low- and middle-income countries lead annually to 134 million adverse events, contributing to 2.6 million deaths. About 134 million adverse events worldwide give rise to 2.6 million deaths every year. Estimates indicate that in high-income countries, about 1 in 10 patients is harmed while receiving hospital care. This problem affects both high-income countries and low- and middle countries even if priorities and issues may differ. The most important adverse events concern medication procedures, healthcare-associated infections, surgical procedures, injection safety, blood transfusions, venous thromboembolism, sepsis, and diagnostic and radiation errors. Since 1999 when the Institute of Medicine (IOM) published its report “To err is human,” some progress has been made but patient harm is still a daily problem in healthcare. As a matter of fact, new threats are emerging due to population aging, along with new treatments and technologies which must be dealt with in addition to still-unresolved, long-standing problems. In this context, it is very important to adopt an international common strategy that creates networks, shares knowledge, programs, tools, good practices and develop and track indicators focusing on the specific priorities of each country and region.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3557-3557 ◽  
Author(s):  
Shaum Kabadi ◽  
Ravi K Goyal ◽  
Saurabh P Nagar ◽  
James A Kaye ◽  
Keith L Davis ◽  
...  

Abstract Introduction: Contemporary data describing treatment patterns, adverse events (AEs) and outcomes in CLL patients in clinical practice is lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health care resource use (HCRU), and costs in patients with newly diagnosed CLL. Methods: Using a nationally representative population of privately insured patients in the US, adult patients with CLL were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL-directed treatment. Treatment patterns up to 4 lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per-patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results: Of all patients meeting the selection criteria (n=7,639; median age, 66 years), 18% (n=1,379) received a systemic therapy during study follow-up. The most common systemic therapy regimens, regardless of therapy line, were bendamustine/rituximab (BR) (32%), rituximab monotherapy (24% [including maintenance]), ibrutinib monotherapy (15%), and fludarabine/cyclophosphamide/ rituximab (FCR) (14%). Of these, BR was the most common LOT-1 regimen (28.1%), while ibrutinib was the most common regimen in LOT-2 (20.8%) and in LOT-3 (25.5%). Use of idelalisib was limited to 1.6% of all patients receiving systemic therapy; however, an increasing trend was observed as patients moved from first to fourth LOT (<1% in LOT-1, 3.1% in LOT-2, 4.7% in LOT-3, and 8.6% in LOT-4). AEs identified during the most common treatments for CLL are presented by treatment regimen in Table 1. The mean monthly all-cause and CLL-related costs, among patients treated with a systemic therapy, were $7,943 (SD=$15,757) and $5,185 (SD=$9,935), respectively. Figure 1 depicts mean monthly costs by care setting and number of AEs, among all patients. Mean (SD) monthly all-cause costs during the post-index date follow-up were $905 ($1,865) among those with no AEs, $1,655 ($5,364) among those with 1-2 AEs, $2,883 ($8,483) among those with 3-5 AEs, and $6,032 ($13,290) among those with ≥6 AEs. Conclusions: This population-based study yielded recent real-world evidence on treatment patterns, AEs, HCRU, and costs in patients enrolled in health plans in the US. Immunochemotherapy, particularly BR, remained the preferred frontline therapy for CLL, whereas ibrutinib was the preferred therapy in LOT-2 and LOT-3, during the study period. This study demonstrates that the AE burden associated with current treatment alternatives for CLL is substantial, and the management of AEs occurring during treatments may have a significant impact on the overall health care costs. Disclosures Kabadi: AstraZeneca: Employment. Goyal:RTI Health Solutions: Employment, Research Funding. Nagar:RTI Health Solutions: Employment, Research Funding. Kaye:RTI Health Solutions: Employment, Research Funding. Davis:RTI Health Solutions: Employment, Research Funding. Mato:Celgene: Consultancy; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy; Sunesis: Honoraria, Research Funding; TG Therapeutics: Research Funding; Janssen: Consultancy, Honoraria; Acerta: Research Funding; Prime Oncology: Speakers Bureau; Regeneron: Research Funding.


2017 ◽  
Vol 13 (12) ◽  
pp. 288 ◽  
Author(s):  
Vinsas Janusonis

The aim of study: to evaluate inpatients, experienced adverse events (AE) in Klaipeda university hospital (KUH) contingent, healthcare profiles, location and causal factors, the degree of risk, possibility to avoide its, and to compare assessment of doctors and experts, and estimate their changes in different analyzed periods. Material and methods. The study carried out by analyzing the AE reporting forms in KUH at 2000-2014time period. Exploring and comparing 1690 patients, experienced AE data by age, gender, health care profile, the reasons. Results. The survey showed that AE was 0.3 % of hospitalized patients, most of them (54.9 %) ‒ associated with surgery. The largest group of AE ‒ repeated operations (44.8 %), related to childbirth AE (26.2 %) and related to infection ‒ (13.1 %). Almost half (43.2 %) AE were medium risk, one-third (33.8 %) ‒ minimal and one-fifth (21.6 %) ‒ high risk. Doctors (nurses) and experts opinions on the major causative factors of AE ‒ the individual characteristics of the patients (88.5 % and 90.3 %) basically was similar. However, due to the individual characteristics of doctors (nurses) ‒ experts often (14.2 %) could see them as causal factor than doctors or nurses (9.8 %). Due possibility of AE avoidance ‒ doctors (nurses) and experts opinion that almost half of them (44.7 % and 48.8 %) were avoidable was the same, but stood for full possibility of avoidance (11.2 % doctors (nurses) and 16.9 % experts) and complete inevitability (44.1 % doctor (nurses) and 34.3 % experts) of AE. Conclusions: Long-term operating adverse events reporting and registration system and analysis showed that adverse events in KUH is much less than in comparable large multiprofile hospitals of other countries. The structure of AE have advantages with structure in other countries ‒ the most adverse events related to surgery, infections, nursing, but there are significant differences ‒ reported little adverse events related to drugs, diagnostics, and a small number of falls compared with many births related AE. The majority ‒ almost four fifths of the AE was minimal or medium risk, one-fifths ‒ high-risk. The AE related with deaths were few. The main causal factors of AE ‒ individual characteristics of the patients and the doctors, and team work failure. A twothirds of AE could be fully or partially prevented.


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