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For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions" /> <meta name="DC.AccessRights" content="restricted" /> <meta name="DC.Relation" content="10.1136/bmj.q2272" /> <meta name="DC.Relation" content="10.1136/bmj-2020-063064" /> <meta name="DC.Description" content="Regulation of healthcare and other services typically involves on-site assessments by teams of inspectors. The scrutinised organisations invest large amounts of time and energy in preparation, which is diverted away from other priorities. The verdicts issued by national inspectors have strong consequences for service providers, users, and wider society. Given the high stakes involved, it is remarkable that the quality of the assessment measurement has never been evaluated. Assessing the reliability of inspection systems in healthcare and other sectors should be an urgent priority for policy makers. Policy regarding healthcare regulation is in flux. In England, the health secretary Wes Streeting has promised “comprehensive reform” after an unfavourable review of the Care Quality Commission (CQC).1 In Denmark, the Institute for Quality and Accreditation in Health Care has phased out national hospital inspections in favour of a less punitive local scheme.2 In the US, the Joint Commission on Accreditation of Healthcare Organizations has been criticised for using standards that have only a low level of evidence supporting them.3 Beyond healthcare, the suicide of a head …" /> <meta name="DC.Contributor" content="Richard J Lilford" /> <meta name="DC.Contributor" content="Timothy P Hofer" /> <meta name="article:published_time" content="2024-10-29" /> <meta name="article:section" content="Opinion" /> <meta name="citation_title" content="Regulation of health facilities: often criticised but seldom evaluated" /> <meta name="citation_journal_title" content="BMJ" /> <meta name="citation_publisher" content="British Medical Journal Publishing Group" /> <meta name="citation_publication_date" content="2024/10/29" /> <meta name="citation_mjid" content="bmj;387/oct29_8/q2388" /> <meta name="citation_id" content="387/oct29_8/q2388" /> <meta name="citation_public_url" content="https://www.bmj.com/content/387/bmj.q2388" /> <meta name="citation_abstract_html_url" content="https://www.bmj.com/content/387/bmj.q2388.abstract" /> <meta name="citation_full_html_url" content="https://www.bmj.com/content/387/bmj.q2388.full" /> <meta name="citation_pdf_url" content="https://www.bmj.com/content/bmj/387/bmj.q2388.full.pdf" /> <meta name="citation_issn" content="1756-1833" /> <meta name="citation_journal_abbrev" content="BMJ" /> <meta name="citation_doi" content="10.1136/bmj.q2388" /> <meta name="citation_pmid" content="39471996" /> <meta name="citation_volume" content="387" /> <meta name="citation_article_type" content="Editorial" /> <meta name="citation_section" content="Opinion" /> <meta name="citation_author" content="Richard J Lilford" /> <meta name="citation_author_institution" content="Institute of Applied Health Research, University of Birmingham, UK" /> <meta name="citation_author" content="Timothy P Hofer" /> <meta name="citation_author_institution" content="Division of General Internal Medicine, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA" /> <meta name="citation_author_institution" content="Center for Clinical Management Research, Veterans Affairs Ann Arbor Health System, Ann Arbor, MI, USA" /> <meta name="citation_reference" content="Department of Health and Social Care. 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Policy regarding healthcare regulation is in flux. In England, the health secretary Wes Streeting has promised “comprehensive reform” after an unfavourable review of the Care Quality Commission (CQC).1 In Denmark, the Institute for Quality and Accreditation in Health Care has phased out national hospital inspections in favour of a less punitive local scheme.2 In the US, the Joint Commission on Accreditation of Healthcare Organizations has been criticised for using standards that have only a low level of evidence supporting them.3 Beyond healthcare, the suicide of a head …" /> <meta name="og-title" property="og:title" content="Regulation of health facilities: often criticised but seldom evaluated" /> <meta name="og-url" property="og:url" content="https://www.bmj.com/content/387/bmj.q2388" /> <meta name="og-site-name" property="og:site_name" content="The BMJ" /> <meta name="og-description" property="og:description" content="Regulation of healthcare and other services typically involves on-site assessments by teams of inspectors. The scrutinised organisations invest large amounts of time and energy in preparation, which is diverted away from other priorities. The verdicts issued by national inspectors have strong consequences for service providers, users, and wider society. Given the high stakes involved, it is remarkable that the quality of the assessment measurement has never been evaluated. Assessing the reliability of inspection systems in healthcare and other sectors should be an urgent priority for policy makers. Policy regarding healthcare regulation is in flux. In England, the health secretary Wes Streeting has promised “comprehensive reform” after an unfavourable review of the Care Quality Commission (CQC).1 In Denmark, the Institute for Quality and Accreditation in Health Care has phased out national hospital inspections in favour of a less punitive local scheme.2 In the US, the Joint Commission on Accreditation of Healthcare Organizations has been criticised for using standards that have only a low level of evidence supporting them.3 Beyond healthcare, the suicide of a head …" /> <meta name="og-type" property="og:type" content="article" /> <meta name="og:image" property="og:image" content="https://www.bmj.com/sites/default/files/highwire/bmj/387/8449.cover-source.jpg"/> <meta name="twitter:card" content="summary_large_image"><meta name="twitter:image" property="twitter:image" content="https://www.bmj.com/sites/default/files/sites/defautl/files/attachments/bmj-article/2024/10/person_outside_hospital_istock-2170018550.jpg"><meta 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& Views</a></li> <li>Regulation of health...</li> <li class="active last">Regulation of health facilities: often criticised but seldom evaluated</li> </ol> <a id="main-content"></a> <div class="region region-content"> <section id="block-system-main" class="block block-system clearfix"> <div class="panel-display" > <div class="hero"> <div class="hero-wrapper"> <div class="hero-content" style="position: relative; left: 0px; top: 35.5px;"> </div>  </div>  </div>  <div class="row"> <div class="left-content col-xs-12 col-sm-8 col-md-8 col-lg-8"> <article> <div class="panel-pane pane-highwire-article-citation" > <div class="pane-content"> <div class="highwire-article-citation highwire-citation-type-highwire-article node1102668" data-node-nid="1102668" id="node-1102668--2541729966" data-pisa="bmj;387/oct29_8/q2388" data-pisa-master="bmj;bmj.q2388" data-apath="/bmj/387/bmj.q2388.atom"><cite class='highwire-cite highwire-citation-bmj-article-top'> <span class='highwire-cite-article-type'>Opinion</span> <h1 class="highwire-cite-title" id="page-title">Regulation of health facilities: often criticised but seldom evaluated</h1> <span class='highwire-cite-journal'>BMJ</span> <span class='highwire-cite-published-year'>2024</span>; <span class='highwire-cite-volume-issue'>387</span> <span class='highwire-cite-doi'> doi: <a href="https://doi.org/10.1136/bmj.q2388">https://doi.org/10.1136/bmj.q2388</a></span> <span class='highwire-cite-date'>(Published 29 October 2024)</span> <span class='highwire-cite-article-as'> Cite this as: <span class="italic">BMJ</span> 2024;387:q2388 </span> </cite> </div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-panel-tabs pane-panels-ajax-tab-tabs" > <div class="pane-content"> <ul class="tabs inline panels-ajax-tab"><li class="first"><a title="Article Tab - Article" href="/content/387/bmj.q2388" class="panels-ajax-tab-tab" data-panel-name="jnl_bmj_tab_art" 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class="panels-ajax-tab-container"><div class="panels-ajax-tab-loading" style ="display:none"><img class="loading" src="https://www.bmj.com/sites/all/modules/contrib/panels_ajax_tab/images/loading.gif" alt="Loading" title="Loading" /></div><div class="panels-ajax-tab-wrap-jnl_bmj_tab_art"><div class="panel-display panel-1col clearfix" > <div class="panel-panel panel-col"> <div><div class="panel-pane pane-highwire-markup" > <div class="pane-content"> <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" data-highwire-cite-ref-tooltip-instance="highwire_reflinks_tooltip" class="content-block-markup" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div class="article fulltext-view "><span class="highwire-journal-article-marker-start"></span><div class="contributors"><ol class="contributor-list" id="contrib-group-1"><li class="contributor" id="contrib-1"><span class="name">Richard J Lilford</span><span class="contrib-role">, professor of public health</span><a id="xref-aff-1-1" class="xref-aff" href="#aff-1">1</a>, </li><li class="last" id="contrib-2"><span class="name">Timothy P Hofer</span><span class="contrib-role">, professor of medicine</span><a id="xref-aff-2-1" class="xref-aff" href="#aff-2">2</a><a id="xref-aff-3-1" class="xref-aff" href="#aff-3">3</a></li></ol><ol class="affiliation-list"><li class="aff"><a id="aff-1" name="aff-1"></a><address><sup>1</sup>Institute of Applied Health Research, University of Birmingham, UK</address></li><li class="aff"><a id="aff-2" name="aff-2"></a><address><sup>2</sup>Division of General Internal Medicine, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA</address></li><li class="aff"><a id="aff-3" name="aff-3"></a><address><sup>3</sup>Center for Clinical Management Research, Veterans Affairs Ann Arbor Health System, Ann Arbor, MI, USA</address></li></ol></div><p id="p-1">Regulation of healthcare and other services typically involves on-site assessments by teams of inspectors. The scrutinised organisations invest large amounts of time and energy in preparation, which is diverted away from other priorities. The verdicts issued by national inspectors have strong consequences for service providers, users, and wider society. Given the high stakes involved, it is remarkable that the quality of the assessment measurement has never been evaluated. Assessing the reliability of inspection systems in healthcare and other sectors should be an urgent priority for policy makers.</p><p id="p-2">Policy regarding healthcare regulation is in flux. In England, the health secretary Wes Streeting has promised “comprehensive reform” after an unfavourable review of the Care Quality Commission (CQC).<a id="xref-ref-1-1" class="xref-bibr" href="#ref-1">1</a> In Denmark, the Institute for Quality and Accreditation in Health Care has phased out national hospital inspections in favour of a less punitive local scheme.<a id="xref-ref-2-1" class="xref-bibr" href="#ref-2">2</a> In the US, the Joint Commission on Accreditation of Healthcare Organizations has been criticised for using standards that have only a low level of evidence supporting them.<a id="xref-ref-3-1" class="xref-bibr" href="#ref-3">3</a> Beyond healthcare, the suicide of a head teacher in England prompted calls to remove the “inadequate” classification used by the Office for Standards in Education, Children’s Services and Skills.<a id="xref-ref-4-1" class="xref-bibr" href="#ref-4">4</a> The problem is that regulation policy is based more on expert consensus than evidence. There is a lack of evidence to inform decisions concerning the frequency of inspections, the methods used in the inspection process, and the sanctions (if any) that might be levied.</p><p id="p-3">In addition to questions about the unintended consequences of inspections and the validity of assessment processes, another key element is ignorance about the reliability of facility inspections. A reliable system of measurement provides consistent results over repeated observations. Without an assessment of reliability, policy makers and public commentators are flying blind.</p><p id="p-4">Facility inspections under organisations such as the CQC in England, the Joint Commission International in the US, and SafeCare in sub-Saharan Africa are carried out by teams of inspectors who must use their judgment in addition to data that organisations are required to collect as a matter of routine. Evaluations that rely on judgment typically have very low interobserver agreement beyond what would be expected by chance.<a id="xref-ref-5-1" class="xref-bibr" href="#ref-5">5</a><a id="xref-ref-6-1" class="xref-bibr" href="#ref-6">6</a><a id="xref-ref-7-1" class="xref-bibr" href="#ref-7">7</a> It is therefore quite likely that decisions based on the quality inspections of organisations are similarly unreliable. Decisions that are unreliable will produce substantial amounts of misclassification as to whether organisations are adequate or not.</p><p id="p-5">The reliability of inspections would not be hard to assess. Pairs of teams could be randomly allocated to visit different providers in different orders, for example. A study using this design evaluated the reliability of assessment of grant applications by the US National Institutes for Health and found alarmingly low levels of reliability.<a id="xref-ref-8-1" class="xref-bibr" href="#ref-8">8</a> Once we know how reliable the assessments are, a meaningful debate could follow. If reliability was high, then strong actions such as changing management teams, merging organisations, or even revoking licences could be justified in the public interest. But if it was low and agreement was little more than would be expected by chance, then a more facilitative approach would be warranted, including provision of management support.</p><p id="p-6">Only two randomised controlled trials of health facility regulation (outside of pharmacy practice) have been published that coupled the inspection with provision of managerial support—one in Kenya<a id="xref-ref-9-1" class="xref-bibr" href="#ref-9">9</a> and the other in South Africa.<a id="xref-ref-10-1" class="xref-bibr" href="#ref-10">10</a> Both suggest that regulation can improve service quality. Before conducting further trials, the reliability of different types of inspection should first be established.</p><p id="p-7">It is hard to imagine that policy makers would agree to withdrawing all types of scrutiny even if reliability was found to be low. The act of inspecting does provide internal incentives for an organisation to get its house in order and provides a method to reassure the public that service providers are held to account. It is also possible that some types of inspection are more reliable than others; reliability might be negatively correlated with the size of the organisation inspected, for example. Likewise, it might be possible to train inspectors to improve reliability, although there is a known paradox where too much training (standardisation of measurement) can reduce the validity of those measurements.<a id="xref-ref-11-1" class="xref-bibr" href="#ref-11">11</a></p><p id="p-8">These are downstream considerations, and the most urgent priority is to assess the reliability of inspection systems in healthcare and other sectors. Streeting has recently ordered a formal review of the oversight organisations based on critiques that recommend several changes to the process of inspections, but none of these mention formal evaluation of the quality of assessment.<a id="xref-ref-12-1" class="xref-bibr" href="#ref-12">12</a> Using an unevaluated method to make highly consequential judgements—such as those that may mislead the public or jeopardise institutions—is a policy of low rectitude. The time has come to inspect the inspector.</p><div class="section fn-group" id="fn-group-1"><h2>Footnotes</h2><ul><li class="fn-other" id="fn-1"><p id="p-9">Provenance: not commissioned, not externally peer reviewed.</p></li><li class="fn-conflict" id="fn-2"><p id="p-10">Competing interests: RJL acknowledges funding from the National Institute for Health and Care Research (Applied Research Collaboration West Midlands, EP/V028936 and the Midlands Patients Safety Research Collaboration, NIHR204294). TPH is supported by funding from the VA Health Services Research and Development Service, and the National Institutes of Health. Views expressed are of the authors, and not those of the NHS, the National Institute for Health and Care Research, the Department of Health and Social Care, the Agency for Healthcare Research and Quality, or the University of Michigan or Department of Veterans Affairs.</p></li></ul></div><div class="section ref-list" id="ref-list-1"><h2>References</h2><ol class="cit-list"><li><a class="rev-xref-ref" href="#xref-ref-1-1" title="View reference 1 in text" id="ref-1">↵</a><div class="cit ref-cit ref-web" id="cit-387.oct29_8.q2388.1"><div class="cit-metadata unstructured">Department of Health and Social Care. 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class="nlm-given-names">Richard J</span> <span class="nlm-surname">Lilford</span> <span class="nlm-role">professor of public health</span></span>, <span data-delta="1"><span class="nlm-given-names">Timothy P</span> <span class="nlm-surname">Hofer</span> <span class="nlm-role">professor of medicine</span></span></div> <div class="highwire-cite highwire-cite-highwire-article highwire-citation-bmj-article-citation-export clearfix" > <span class="highwire-cite-authors" ><!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"> <html><body><span data-delta="0"><span class="nlm-surname">Lilford</span> <span class="nlm-given-names">R J</span></span>, <span data-delta="1"><span class="nlm-surname">Hofer</span> <span class="nlm-given-names">T P</span></span>. </body></html> </span> <span class="highwire-cite-title article-title">Regulation of health facilities: often criticised but seldom evaluated</span> <span class="highwire-cite-metadata" 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