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Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: the case of internal audits.

ABSTRACT: BACKGROUND:Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study aims to contribute to the knowledge on how to increase compliance with obligatory rules and regulations. METHODS:The internal audit system (the 'tracer system') of a large Dutch academic hospital is used as a case to investigate different implementation approaches and their effect on compliance. This case allowed us to use a multi-actor and multi-method approach for data collection. Internal audits (N?=?16) were observed, audit reports were analyzed, and semi-structured interviews were conducted with both the internal auditors (N?=?23) and the ward leaders (N?=?14) responsible for compliance. Framework analysis was used to analyze the data. RESULTS:Although all auditors use catalytic enforcement actions, these do not lead to (intended) compliance of all ward leaders. Rather, the catalytic actions contribute to (intended) compliance of ward leaders that are motivated, whereas they do not for the ward leaders that are not motivated. For the motivated ward leaders, catalytic enforcement actions contribute to (intended) compliance by increasing ward leaders' knowledge of the rules and how to comply with them. CONCLUSIONS:Our findings suggest that the effectiveness of implementation actions depends not only on the actions themselves, but also on the pre-existing motivation to comply. These findings imply that there is not one 'best' approach to the implementation of obligatory rules. Rather, the most effective approach depends on the willingness to comply with rules and regulations.

SUBMITTER: Weske U

PROVIDER: S-EPMC5791382 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: the case of internal audits.

Weske Ulrike U Boselie Paul P van Rensen Elizabeth L J ELJ Schneider Margriet M E MME

BMC health services research 20180130 1

<h4>Background</h4>Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study a ...[more]

PMID: 29382331

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Project description:ObjectivesHospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety.Design and settingA mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals.ResultsResponse rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan-do-check-act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports.ConclusionThis study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety.

Project description:IntroductionIn recent years, tobacco control policy initiatives have emerged at the subnational level in China. In 2013, for example, Qingdao enacted a 100% smoke-free policy that gave regulatory authority to multiple enforcement agencies. Given that little is known about the extent of smoke-free policy compliance in smaller Chinese cities, this study assessed compliance with Qingdao's Tobacco Control Regulation and whether compliance differed by enforcement agency.MethodsA cross-sectional observational study was undertaken between October and November 2018. Venues were selected based on enforcement agency and included restaurants, retail stores, schools, government buildings, hospitals, business offices, and other hospitality venues. Comprehensive lists of venues were identified where they existed, and a random sample of venues were subsequently selected. For venue categories for which there were no comprehensive lists, a walking protocol was used. Observational data included evidence of smoking, the presence of no-smoking signage, and designated smoking areas (DSAs). Descriptive statistics were obtained. Subsequently, logistic regression models were used to determine the association between enforcement agency and policy compliance.ResultsA total of 694 venues were observed. For all venue types, 64.7% were compliant with the composite indicator 'evidence of smoking'. Findings also showed that smoke-free compliance varied by enforcement agency (p<0.001). Venues with evidence of smoking and not posting of no-smoking signs at the main entrance were lowest among venues that fall under Public Security Bureau. Compliance with posting no-smoking signs inside was lowest in venues that fall under the Industry and Commercial Administration (I&C). While Qingdao's smoke-free policy prohibits DSAs, our findings showed that 2% of venues that fall under the jurisdiction of I&C had DSAs.ConclusionsAn effective coordination mechanism that can ensure a consistent and standardized approach is urgently needed in Qingdao. With such a concerted effort, it will be possible to achieve the target of 100% smoke-free indoor places in Qingdao.

Project description:ImportanceAlthough federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process.ObjectiveTo evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access.Design, setting, and participantsA cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings.ExposuresScripted interview with medical records departments in a single-blind, simulated patient experience.Main outcomes and measuresRequestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments.ResultsAmong the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times.Conclusions and relevanceThe study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

Dataset Information

Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: the case of internal audits.

Publications

Using regulatory enforcement theory to explain compliance with quality and patient safety regulations: the case of internal audits.

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