scholarly journals An Analysis of Patient Safety Events Submitted by Abortion Facilities in Pennsylvania 2017–2019

2020 ◽  
pp. 62-71
Author(s):  
Elizabeth Kukielka
Keyword(s):  
Patient Safety ◽  
Healthcare Facility ◽  
Induced Abortion ◽  
Uterine Perforation ◽  
Safe Procedure ◽  
Intrauterine Pregnancy ◽  
Safety Reporting ◽  
Elective Abortion ◽  
Incomplete Abortion ◽  
Medication Related Events

Induced abortion, also called elective abortion, therapeutic abortion, and termination of pregnancy, is widely considered a safe procedure, but complications are known to occur. In Pennsylvania, an induced abortion may be performed at an abortion facility as an outpatient procedure, and these facilities are required to report patient safety events to the Pennsylvania Patient Safety Reporting System (PA-PSRS). We extracted 736 events submitted to PAPSRS by abortion facilities from 2017 through 2019 and analyzed these events in order to better understand patient safety concerns at abortion facilities in particular. All patients were female, and they ranged in age from 14 to 47 years, with a median patient age of 27 years (interquartile range = 23 to 31 years). Complications related to an induced abortion comprised the majority of events (71.6%; n=527), followed by unplanned transfers to the emergency department or acute visits to a healthcare facility following an induced abortion (13.9%; n=102). The most common complication associated with induced abortion was an incomplete abortion (i.e., retained pregnancy tissue; n=343); other complications included failed abortions (i.e., a continuing intrauterine pregnancy following an abortion; n=101), infections (e.g., endometritis and pelvic inflammatory disease [PID]; n=45), and surgical complications (e.g., hematometra, uterine perforation, and cervical lacerations; n=66). The remainder of events (14.5%; n=107) described other patient safety events that occurred at abortion facilities, such as documentation failures and medication-related events.

A Public Health Approach to Patient Safety Reporting Systems Is Urgently Needed

2011 ◽  
Vol 7 (2) ◽  
pp. 109-112 ◽  
Author(s):  
Douglas J. Noble ◽  
Sukhmeet S. Panesar ◽  
Peter J. Pronovost
Keyword(s):  
Public Health ◽  
Patient Safety ◽  
Public Health Approach ◽  
Safety Reporting ◽  
Reporting Systems

scholarly journals A Brief Analysis of Telemetry-Related Events

2019 ◽  
pp. 42-50
Author(s):  
Elizabeth Kukielka ◽  
Kelly Gipson ◽  
Rebecca Jones
Keyword(s):  
Patient Safety ◽  
Cardiac Rhythm ◽  
Reporting System ◽  
Healthcare Providers ◽  
Steady Increase ◽  
Monitoring Equipment ◽  
Safety Reporting ◽  
Common Event ◽  
Life Threatening ◽  
Compromise Patient Safety

Successful telemetry monitoring relies on timely clinician response to potentially life-threatening cardiac rhythm abnormalities. Breakdowns in the processes and procedures associated with telemetry monitoring, as well as improperly functioning telemetry monitoring equipment, may lead to events that compromise patient safety. An analysis of reports submitted to the Pennsylvania Patient Safety Reporting System (PA-PSRS) from January 2014 through December 2018 identified 558 events specifically involving interruptions or failures associated with telemetry monitoring equipment or with the healthcare providers responsible for setting up and maintaining proper functioning of that equipment. The analysis highlighted a steady increase in the quantity of event reports associated with telemetry monitoring submitted to PA-PSRS. User errors accounted for nearly half (47.1%, 263 of 558) of events in the analysis. The most common event subtypes included: errors involving batteries in telemetry monitoring equipment (14.0%); errors in which patients were not connected to telemetry monitoring equipment as ordered (12.9%); errors involving broken, damaged, or malfunctioning telemetry monitoring equipment (10.9%); and errors in which patients were connected to the wrong telemetry monitoring equipment (9.0%).

scholarly journals Improving patient safety reporting with the common formats: Common data representation for Patient Safety Organizations

2016 ◽  
Vol 64 ◽  
pp. 116-121 ◽  
Author(s):  
Peter L. Elkin ◽  
Henry C. Johnson ◽  
Michael R. Callahan ◽  
David C. Classen
Keyword(s):  
Patient Safety ◽  
Data Representation ◽  
Safety Reporting ◽  
The Common

scholarly journals Value of Ultrasonographic Guidance For Operative Hysteroscopy on the Safety and Outcome of the Procedure: Randomized Control Trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M I Amer ◽  
W Elbasuony ◽  
M A Ali
Keyword(s):  
Success Rate ◽  
Ultrasound Guidance ◽  
Rare Complication ◽  
Abnormal Uterine Bleeding ◽  
University Hospital ◽  
Uterine Perforation ◽  
Safe Procedure ◽  
Simultaneous Treatment ◽  
Operative Hysteroscopy ◽  
Significant Difference

Abstract Background Hysteroscopy is a minimally invasive intervention that can be used to diagnose and treat many intrauterine and endocervical problems. Hysteroscopic polypectomy, myomectomy are just a few of the commonly performed procedures. Hysteroscopy has nearly replaced standard D&C for the management of abnormal uterine bleeding (AUB), as it allows for direct visualization and diagnosis of intrauterine abnormalities, and it often offers an opportunity for simultaneous treatment. Operative hysteroscopy is a safe procedure resulting in complication in 0.95-3% of cases. The most frequently observed complications include hemorrhage (2.4%), uterine perforation (1.5%), and cervical laceration (1-11%). Another rare complication is excessive fluid absorption with or without resultant hyponatremia. Can use of ultrasound guidance during operative hysteroscopy decrease the rate of the operative complication? Objective To assess the value of ultrasound guidance for operative hysteroscopy on decreasing the complication and improving the success rate of the procedure. Patients and Methods It is estimated that a sample size of 88 patients that were divided to 44 patients in the Ultrasound guidance group and 44 patients in the group that didn’t perform ultrasound. The patients were encountered from those presented at the gynecology clinic of the Ain Shams university hospital or those presented at ECDU with the inclusion criteria in the period between December 2017 to November 2018. The patients were approached to participate on study and a written informed consent was taken from all the patients. Results Comparative study between the 2 groups revealed; highly significant increase in success rate in ultrasound guided hysteroscopy (USH) group; compared to conventional hysteroscopy (CH) group; with highly significant statistical difference (p < 0.01) and non-significant difference as regards failure and complications rates (p > 0.05). Conclusion Our study found that ultrasound assistance for difficult hysteroscopy reported that ultrasound appears to be a safe and reliable method of assistance.

scholarly journals A Study of Complications following Self-administration with Medical Abortion Pills

2015 ◽  
Vol 10 (1) ◽  
pp. 20-24 ◽  
Author(s):  
A Giri ◽  
VR Srivastav ◽  
A Suwal ◽  
B Sharma
Keyword(s):  
Medical Abortion ◽  
Safe Procedure ◽  
Self Administration ◽  
Self Medication ◽  
Missed Abortion ◽  
Over The Counter ◽  
Medical College ◽  
Incomplete Abortion ◽  
Abortion Complications ◽  
History Of

Aims: The objective of this study was to find out the complications following self-administration with medical abortion pills.Methods: A prospective descriptive study was conducted in Department of Obstetrics and Gynecology,Nepal Medical College over a period of two years from January 2013 to December 2014 among 48 women who were admitted with abortion complications and also gave history of self-administration of abortion pills.Results: During the study period, 48 women with history of self-medication with abortion pills were admitted with various abortion complications. There were 60% of women who had consumed abortion pills within approved nine weeks gestation while 19% had consumed after nine weeks and 21% after twelve weeks. Majority (60%) were admitted with incomplete abortion, 4% with missed abortion, 13% with continued live pregnancy, 6.5% with septic abortion and 6.5% with ectopic pregnancy. Anemia was present in 79% of patient. More than one third of the patient had severe anemia and blood transfusion was needed in 52%. Surgical evacuation was required in 71% of patient; medical abortion with repeat doses of mifepristone and misoprostol was done in was done 13% and 6.5% needed laparotomy for ectopic pregnancy.Conclusions: Though medical abortion is considered to be highly effective and safe procedure, unsupervised selfadministration of medical abortion pills was associated with serious maternal morbidities. There should be some policy torestrict over the counter sale of this medicine.

scholarly journals Striving for excellence in abortion services

2006 ◽  
Vol 30 (4) ◽  
pp. 468 ◽  
Author(s):  
Ea C Mulligan
Keyword(s):  
Quality Improvement ◽  
Surgical Outcomes ◽  
Surgical Outcome ◽  
Potential Effect ◽  
Outcome Data ◽  
Uterine Perforation ◽  
Complication Rates ◽  
Incomplete Abortion ◽  
Positive Results

The legalisation of abortion allowed the publication of surgical outcome data demonstrating low complication rates. South Australian data from the outcomes of surgery conducted at the Pregnancy Advisory Centre illustrate the monitoring of complication rates such as uterine perforation, continuing pregnancy and incomplete abortion to improve surgical outcomes. While quality improvement systems produce positive results, there are many barriers to their uptake in Australia. Hostility towards abortion has the potential effect of retarding the adoption of improved techniques.

How a System for Reporting Medical Errors Can and Cannot Improve Patient Safety

2006 ◽  
Vol 72 (11) ◽  
pp. 1088-1091 ◽  
Author(s):  
John R. Clarke
Keyword(s):  
Patient Safety ◽  
Medical Errors ◽  
Systems Of Care ◽  
Improve Patient Safety ◽  
Integrated System ◽  
Ease Of Use ◽  
Near Misses ◽  
Safety Reporting ◽  
Ideal System ◽  
Reporting Systems

The Institute of Medicine has recommended systems for reporting medical errors. This article discusses the necessary components of patient safety databases, steps for implementing patient safety reporting systems, what systems can do, what they cannot do, and motivations for physician participation. An ideal system captures adverse events, when care harms patients, and near misses, when errors occur without any harm. Near misses signal system weaknesses and, because harm did not occur, may provide insight into solutions. With an integrated system, medical errors can be linked to patient and team characteristics. Confidentiality and ease of use are important incentives in reporting. Confidentiality is preferred to anonymity to allow follow-up. Analysis and feedback are critical. Reporting systems need to be linked to organizational leaders who can act on the conclusions of reports. The use of statistics is limited by the absence of reliable numerators and denominators. Solutions should focus on changing the cultural environment. Patient safety reporting systems can help bring to light, monitor, and correct systems of care that produces medical errors. They are useful components of the patient safety and quality improvement initiatives of healthcare systems and they warrant involvement by physicians.

scholarly journals Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

2017 ◽  
Vol 14 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Raymond Perez ◽  
Patrick Archdeacon ◽  
Nancy Roach ◽  
Robert Goodwin ◽  
Jonathan Jarow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Educational Materials ◽  
Research Staff ◽  
Safety Reporting ◽  
New Drug ◽  
Final Rule

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

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