This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. <br /><br />I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase <b>"but patient care/patient safety was not compromised"</b>), is really a term for life-threatening health IT bugs and malfunctions.  See query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for examples of health IT "glitches" (retrieves multiple posts).<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpyDXrISVqufhC1OX4Qiik6pFNxIueFaUkAZrjyxcKT2cpNF9zcS9pQkHYWyZMp8RxM6gPn8BG3vZAXtqUOUpVbf5Fv4AHrXgzHfB_JoT6Ou4Kup25VRYDSx5S_okwyCWmdy3K5LekH52x/s1600/Main-Samuel-Starr-3204412.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpyDXrISVqufhC1OX4Qiik6pFNxIueFaUkAZrjyxcKT2cpNF9zcS9pQkHYWyZMp8RxM6gPn8BG3vZAXtqUOUpVbf5Fv4AHrXgzHfB_JoT6Ou4Kup25VRYDSx5S_okwyCWmdy3K5LekH52x/s1600/Main-Samuel-Starr-3204412.jpg" width="150" /></a></div><br /><br />Here's a "glitch" that tragically killed this boy: <br /><br /><blockquote class="tr_bq"><b>Three-year-old boy dies after new NHS computer system delays heart treatment</b><br /><br />Mar 05, 2014<br />By James Tute<br /><br /><a href="http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365">http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365 </a><br /><br />Coroner Maria Voisin rules that new booking system meant he did not receive life-saving treatment<br /><br />A three-year-old boy died in his parents' arms <b>after a new NHS computer system failed to schedule him for a vital heart scan</b>, a coroner has ruled.<br /><br />Samuel Starr was born with a congenital cardiac defect and needed surgery not long after he was born in 2010.<br /><br />Although he made a good recovery doctors said he would need regular tests to check on his progress.<br /><br />But he did not have a scan until 20 months after his first major operation <b>because of a delay following the introduction of a new computer system</b>, Cerner Millennium.<br /><br />When he finally had the appointment doctors found Samuel needed open heart surgery. During the procedure, Samuel had a stroke.<br /><br />A month later, after further complications, he died in the arms of his devastated parents, Catherine Holley and Paul Starr, at Bristol Royal Hospital for Children.</blockquote><br />There are some in my field who would (and have) called incidents like this "anecdotes" or "bumps in the road."<br /><br />Yet, as I've recently posted, an internationally-renowned healthcare safety tester, ECRI Institute (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>), and the medical malpractice insurer of the Harvard medical community, CRICO (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>), have confirmed cases like this are no mere anecdotes.  I estimate from their numbers, and from cases known to me personally and from descriptions of others, that on the order of ten thousand (that's likely low) patients annually are being injured and/or die as a result of bad health IT in the U.S. alone.  Lack of transparency about such incidents impairs knowing the true numbers.<br /><br /><blockquote class="tr_bq">Ms Holley wept as she told the hearing of the moment she kissed her son goodbye, saying: "He was a kind and gentle boy with a great understanding of the world.<br /><br />"As we read Samuel his favourite stories, he died in our arms."<br /><br />Avon Coroner Maria Voisin, recording a narrative conclusion, <b>ruled the booking system meant Samuel was not seen and did not receive treatment.</b></blockquote><br />This case somewhat reminds me of the case of a newborn whose x-ray test was done, but never looked at due to a bug in the software that scheduled films to be read, see <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>, case #2<br /><br /><blockquote class="tr_bq">Concluding a three-day inquest at Flax Bourton Coroner's Court in North Somerset, Ms Voisin said: "Samuel Starr was born with a complex cardiac disease. "He required surgery and regular check-ups at outpatients to manage his conditions.  "Due to the failure of the hospital outpatients booking system there was a five month delay in Samuel being seen and receiving treatment. "Samuel's heart was disadvantaged and he died following urgent surgery."</blockquote><br />Just a "glitch."<br /><br /><blockquote class="tr_bq">Doctors diagnosed that Samuel had a restricted pulmonary artery - causing blood to easily flow away from his heart to his lungs - during a 20-week scan in pregnancy ... On March 3, 2010, Samuel underwent open heart surgery at Bristol Royal Hospital for Children. He was discharged six days later and referred to the Paediatric Cardiac Clinic at the Royal United Hospital (RUH) in Bath for check-ups.<br /><br />In October 2010, Samuel had his first check-up, in which an echocardiogram, also known as an "echo", was carried out. Ms Holley said she was told the procedure would be next carried out early in the new year.<br /><br />But it did not happen until April 2011 and an echo was not performed.  Paediatric cardiologist Dr Andrew Tometzki told the inquest he did not "deem it necessary" on that day to carry out the echo scan. Dr Tometzki then ordered a further review - where an echo scan would be carried out - in nine months' time.<br /><br /><b>Samuel's parents did not receive information about the check-up and raised their concerns with community children's nurse Clare Mees.</b><br /><br />Ms Mees, who works for Sirona Lifetime Services, <b>said she would chase up the matter</b> with Dr Tometzki's secretary.<br /><br />Medical secretary Annabelle Attridge insisted she had taken details and forwarded them on to a dedicated appointments team.<br /><br /><b>However, the inquest heard <span style="color: red;">"glitch problems"</span> with a new booking system meant the appointment was not logged.  <span style="color: red;"></span></b></blockquote><br />Apparently not due to human fault: <br /><br /><blockquote class="tr_bq">Paediatric clinic co-ordinator Donna McMahon said while Samuel's medical records had been created on the new Millennium computer programme, <b>no appointments had been transferred across.</b></blockquote><br />Just a "glitch."  Just a "bump in the road."<br /><br /><blockquote class="tr_bq">Ms McMahon said she was first aware of the appointment delay when she received an email from nurse Ms Mees in May 2012.<br /><br />Samuel did not have the vital check-up until June 21.<br /><br />Coroner Ms Voisin added: "This overall failure led to a five month delay in Samuel being seen by his cardiologist.<br /><br />"This meant Samuel had not been seen for five months and had not had an echo for 20 months."<br /><br />His parents were horrified when Dr Tometzki informed them Samuel required heart surgery that spring.</blockquote><br />Just a "glitch."  Just a "bump in the road."<br /><br /><blockquote class="tr_bq">... "Just hours before his operation Samuel was dancing around the ward and telling the nurses all about Spiderman - we had to remind him to quieten down," Ms Holley said.<br /><br />Samuel's chest was closed on August 8. As he was brought out of sedation on August 9, he suffered a stroke and cardiac arrests.<br /><br />"It is clear that if the surgery had been performed earlier, the procedure would have been the same," Ms Voisin said.<br /><br /><b>But she said expert evidence found that as time went on "the more complicated the surgery is, as the more disadvantaged the heart is and the more difficult it is to get over the operation".</b></blockquote><br />Delays in care of fragile patients - in this case a young child, but in many other cases, ED and ICU patients of all ages - is very unwise.<br /><br /><blockquote class="tr_bq">Samuel's condition continued to deteriorate and on September 6 his parents were recommended for treatment to be withdrawn after he had a second cardiac arrest.<br /><br />The coroner said she would not write a report making recommendations to the hospital, as changes had already been implemented.</blockquote><br />Likely, workarounds to bad health IT, inviting future catastrophe.<br /><br />In my view, many cases such as this never make headlines, as the findings ignore the role of the IT and blame people, cases are settled with gag clauses, patients (who survive) or family are never told of the role of the IT, or lawsuits prove too expensive or too unpleasant to pursue.<br /><br />But patient safety is never compromised by "glitches", and regulation will just stifle innovation.<br /><br />My condolences to the parents.  I've suffered a death in my own family as a result of health IT, and I'm a specialist in the field.  Laypeople have no chance. <br /><br />One should pray the next child affected in this way is not one's own.<br /><br />-- SS<br /><br /><b>Mar. 25, 2014 addendum:  </b><br /><br />Also see these related posts, the first mentioning <b>"teething problems"</b>, another euphemism for potentially-deadly EHR malfunctions:<br /><br /><blockquote class="tr_bq"><b>Cerner's Blitzkrieg on London: Where's the RAF?</b><br /><b> </b><a href="http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html">http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html</a><b> </b><br /><br /><b>North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story</b><br /><a href="http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html">http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html</a></blockquote><br />-- SS

This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase "but patient care/patient safety was not compromised"),…

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UK: Another Example of IT Malpractice With Bad Health IT (BHIT) Affecting Thousands of Patients, But, As Always, Patient Care Was "Not Compromised"

<div class="post-title entry-title" itemprop="name">At my Dec. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised</a>" and others, I noted:</div><div class="post-title entry-title" itemprop="name"><br /></div><blockquote class="tr_bq">... claims [in stories regarding health IT failure] that "no patients were harmed" ... are both misleading and irrelevant:<br /><br />Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages <span style="font-weight: bold;">might not appear for days or weeks after the outage</span> ... Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was <span style="font-weight: bold;">greatly elevated risk</span>. Sooner or later, such outages will maim and kill.</blockquote><br />Here is a prime example of why I've opined at my Sept. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/09/good-health-it-v-bad-health-it-paper-is.html" target="_blank">Good Health IT (GHIT) v. Bad Health IT (BHIT): Paper is Better Than The Latter</a>" that a good or even average paper-based medical record keeping system can facilitate safer and better provision of care than a system based on bad health IT (BHIT).<br /><br />Try this with paper:<br /><br /><blockquote class="tr_bq"><b><span style="font-size: small;"><a href="http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-coverup-over-lost-cancer-patient-records-8191066.html" target="_blank">NHS 'cover-up' over lost cancer patient records</a></span></b><br /><br />Thousands awaiting treatment were kept in the dark for five months when data disappeared<br /><br />Sanchez Manning<br />The Independent<br />Sunday 30 September 2012<br /><br />Britain's largest NHS trust took five months to tell patients it had mislaid medical records for thousands of people <b>waiting for cancer tests and other urgent treatments</b>. Imperial College Healthcare NHS Trust discovered in January <b>that a serious computer problem and staff mistakes had played havoc with patient waiting lists.</b></blockquote><br />It's quite likely the "serious computer problem" far outweighed the impact of "staff mistakes", as disappearing computer data does so in a "silent" manner.  One does not realize it's missing as there's not generally a trail of evidence that it's gone.<br /><blockquote class="tr_bq"><br />About 2,500 patients were forced to wait longer on the waiting lists than the NHS's targets, and the trust had no idea <b>whether another 3,000 suspected cancer patients on the waiting list had been given potentially life-saving tests</b>. Despite the fact that the trust discovered discrepancies in January and was forced to launch an internal review into the mess, including 74 cases where patients died, it did not tell GPs about the lost records until May.</blockquote><br />That is, quite frankly, outrageous if true and (at least in the U.S.) might be considered <a href="http://legal-dictionary.thefreedictionary.com/Criminal+Negligence" target="_blank">criminally negligent</a> (<i>failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner)</i>.<br /><br /><blockquote class="tr_bq">Revelations about the delay prompted a furious response yesterday from GPs, local authorities and patients' groups. Dr Tony Grewal, one of the GPs who had made referrals to Imperial, said doctors should have been told sooner to allow them to trace patients whose records were missing. "The trust should have contacted us as soon as it was recognised that patients with potentially serious illnesses had been failed by a system," he said. "GPs hold the ultimate responsibility for their patient care."</blockquote><br />That is axiomatic.<br /><br /><blockquote class="tr_bq">The chief executive of the Patients Association, Katherine Murphy, added: "This is unacceptable for any patient who has had any investigation, but especially patients awaiting cancer results, where every day counts. The trust has a duty to contact GPs who referred the patients. It's unfair on the patients to have this stress and worry, and the trust should not have tried to hide the fact that they had lost these records. They should have let the GPs know at the outset."</blockquote><br />Unfair to the patients is an understatement,  However, if one's attitude is that <i><b>computers have more rights than patients</b></i>, as many on the health IT sector seem to with their ignoring of patient rights such as informed consent, lack of safety regulation, and lack of accountability, then it's quite acceptable.<br /><br /><blockquote class="tr_bq">The trust defended the delay in alerting GPs, arguing that it needed to check accurately how much data it had lost before making the matter public. It said a clinical review had now concluded that no one died as a result of patients waiting longer for tests or care.</blockquote><br />That would be perhaps OK if the subjects whose "data had been lost" through IT malpractice were lab rats.<br /><br /><blockquote class="tr_bq">Despite this, three London councils – Westminster, Kensington and Chelsea, and Hammersmith and Fulham – are deeply critical of the way the trust handled the data loss. Sarah Richardson, a Westminster councillor who heads the council's health scrutiny committee, <b>said that trust bosses had attempted to "cover up" the extent of the debacle. "Yes, they've done what they can but, in doing so, [they] put the reputation of the trust first,"</b> she said. "Rather than share it with the GPs, patients and us, they thought how can we manage this information internally. They chose to consider their reputation over patient care."</blockquote><br />As at my Oct. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles: Computers Have More Rights Than Patients?</a>", to be more specific, they may have put the reputation of the Trust's <i>computers</i> first.  <br /><br /><blockquote class="tr_bq">Last week, it was revealed that Imperial has been fined £1m by NHS North West London for the failures that led to patient data going missing. On Wednesday, an external review into the lost records said a "serious management failure" was to blame for the blunder.</blockquote><br />Management of what, one might ask? <br /><br /><blockquote class="tr_bq">Imperial's chief financial officer, Bill Shields, admitted at a meeting with the councils that the letter could have been produced more quickly. He said that, at the time, the trust had operated with "antiquated computer systems" and had a "light-touch regime" on elective waiting times.</blockquote><br />Version 2.0A will, as again is a typical refrain, fix all the problems.<br /><br /><blockquote class="tr_bq">Terry Hanafin, the leading management consultant who wrote the report, said the data problems went back to 2008 and had built up over almost four years until mid-2011. Mr Hanafin said the <b>priorities of senior managers at that time were the casualty department and finance.</b></blockquote><br />Clinical computing is not business computing, I state for the thousandth time.  When medical data is discovered "lost", the <b>only</b> response should be ... find it, or inform patients and clinicians - <b>immediately.</b><br /><br /><blockquote class="tr_bq">He further concluded that while the delays in care turned out to be non-life threatening, they had the potential to cause pain, distress and, in the case of cancer patients, "more serious consequences" ... The trust <b>said it had found no evidence of clinical harm </b>and stressed that new systems have now been implemented to record patient data. It denied trying to cover up its mistakes or put its reputation before concerns for patients. "Patient safety is always our top priority," said a spokesman.</blockquote><br />"More serious consequences" is a euphemism for horrible <b>metastatic cancer and death</b>, I might add.  The leaders simply cannot claim they "<i>found no evidence of clinical harm</i>" regarding delays in cancer diagnosis and treatment until time has passed, and followup studies performed on this group of patients.<br /><br />This refrain is evidence these folks are either lying, CYA-style, or have no understanding of clinical medicine whatsoever - in which case their responsibilities over the clinic need to be ended in my opinion.<br /><br />I, for one, would like to know the exact nature of the "computer problem", who was responsible, and if it was a software bug, how such software was validated and how it got into production. <br /><br />-- SS<br /><br />Oct. 1, 2012 Addendum:<br /><br />What was behind the problems, according to another source?  <b> </b><br /><br /><b>Bad Health IT (BHIT):</b><br /><br /><blockquote class="tr_bq"><b><a href="http://www.ehi.co.uk/news/EHI/8094/poor-it-behind-imperial-cancer-problems" target="_blank">Poor IT behind Imperial cancer problems</a></b><br />e-Health Insider<br />28 September 2012<br />Rebecca Todd<br /><br />An independent review of data quality issues affecting cancer patient referrals to Imperial College Healthcare NHS Trust has identified “poor computer systems” as a key cause of the problem.<br /><br />The review’s report highlights the trust’s use of up to 17 different IT systems as causing problems for patient tracking.<br /><br />However, it says the trust should be aware of the risks of [replacing the BHIT and] moving to a single system, Cerner Millennium, <b>because of reported problems in providing performance data after similar moves at other London trusts.</b><br /><br />In January 2012, the report says the NHS Intensive Support Team was reviewing the way reports on cancer waiting times were created from Imperial’s cancer IT system, Excelicare.<br /><br />The team discovered that almost 3,000 patients were still on open pathways who should have been seen within two weeks. In May, letters were sent to GPs to try and ascertain the clinical status of around 1,000 patients.</blockquote><br />BHIT must be forbidden from real-world deployments, and fixed rapidly or dismantled (as Imperial College Healthcare NHS Trust appears to be doing), although the "solution" might be just as bad, or worse, than the disease.<br /><br />-- SS

UK: Another Example of IT Malpractice With Bad Health IT (BHIT) Affecting Thousands of Patients, But, As Always, Patient Care Was "Not Compromised"

At my Dec. 2011 post "IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised" and others, I noted:... claims [in stories regardi…

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Key lesson from the NPfIT - The Tony Collins Blog

<span style="font-weight: bold;">ComputerWorldUK</span><span style="font-weight: bold;">.com</span><br /><br /><a href="http://blogs.computerworlduk.com/the-tony-collins-blog/2011/05/the-national-programme-of-failed-it-in-the-nhs/"></a><blockquote><span style="font-weight: bold;font-size:130%;" ><a href="http://blogs.computerworlduk.com/the-tony-collins-blog/2011/05/the-national-programme-of-failed-it-in-the-nhs/">Key lesson from the NPfIT - The Tony Collins Blog</a></span><span style="font-weight: bold;"><br /><br />Listening to critics is critical to the success of big projects. But has this lesson been learnt?</span><br /><br />Published 07:56, 20 May 11<br /><br />A US doctor Scot Silverstein, who has an expertise in clinical IT design, says of the NAO report on the NPfIT that the initials should stand for: "National Programme of Failed IT.”<p class="MsoNormal"></p><p class="MsoNormal"></p><p class="MsoNormal">He says on the blog <a href="http://hcrenewal.blogspot.com/2011/05/national-programme-of-failed-it-in-uk.html">Health Care Renewal</a>:</p><p class="MsoNormal">"Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the "National Programme of Failed IT in the NHS." No new acronym will be needed.</p></blockquote><p class="MsoNormal"></p><p class="MsoNormal">Read the entire ComputerWorldUK piece by Tony Collins. Some of the excuses and rationalizations described during this programme are simply stunning.</p><p class="MsoNormal">This idea, though, I find fascinating:</p><p class="MsoNormal"></p><blockquote>One of the lessons that emerges from disastrous business decisions, as recorded on the excellent BBC2 series "<a href="http://www3.open.ac.uk/media/fullstory.aspx?id=21194">Business Nightmares"</a> with Evan Davis, is that<span style="font-weight: bold;"> expensive new ideas should be tested, and repeatedly tested, by the harshest </span><span style="font-weight: bold;">critics of those ideas. </span><br /></blockquote><p class="MsoNormal">-- SS<br /></p>

Key lesson from the NPfIT - The Tony Collins Blog

ComputerWorldUK.comKey lesson from the NPfIT - The Tony Collins BlogListening to critics is critical to the success of big projects. But has this lesson been learnt?Published 07:56, 20 May 11A US doct…

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UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a> and <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a>, for example.<br /><br />However, they have appeared to have learned from their mistakes and in fact are on the way to being far ahead of the U.S. in terms of understanding what it truly takes for HIT to be efficacious - and perhaps even more importantly, <span style="font-weight: bold;">as safe as possible.</span><br /><br />From an informatics colleague who informed me of these developments:<br /><br /><span></span><blockquote><span>The UK has recently adopted the ISO draft standards for the development and deployment of HIT. They don't go as far as premarket approval, but do require vendors to develop and deliver to healthcare organizations a formal hazard assessment for their products, require both to continually update their risk assessments, and require care delivery organizations to have an explicit process for identifying & mitigating risks, and formally accepting (or not) the residual risks that remain. The thinking is these standards will be adopted across the EU once the ISO approval process is completed.</span></blockquote><br /><br />These two remarkable documents are available from the UK's NHS:<br /><span style="font-size:100%;"><br /></span><div class="PlainText"><blockquote><a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009">http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009</a><br /><span style="font-weight: bold;font-size:130%;" ><br />"Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software"</span><br />Formerly ISO/TR 29322:2008(E)<br />DSCN18/2009<br /><br />and<br /><br /><a href="http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009">http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009</a><br /><br /><span style="font-weight: bold;font-size:130%;" >"Health Informatics — Application of clinical risk management to the manufacture of health software"</span><br />Formerly ISO/TS 29321:2008(E)<br />DSCN14/2009<br /></blockquote><br />From the first of these, the overall intro:<br /><br /><blockquote>ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.</blockquote><br />Then on to matters at hand:<br /><br /><blockquote><span style="font-weight: bold;">Introduction</span><br /><br /><span style="font-weight: bold;">The threat to patient safety</span><br /><br />There is mounting concern around the world about the substantial number of avoidable clinical incidents which have an adverse effect on patients, of which a significant proportion result in avoidable death or serious disability, see references [1], [2], [3], [4], [5] and [6]. A number of such avoidable incidents involved poor or "wrong" diagnoses or other decisions. A contributing factor is often missing or incomplete information, or simply ignorance, e.g. of clinical options in difficult circumstances or of the cross-reaction of treatments (a substantial percentage of clinical incidents are related to missing or incomplete information).<br /><br />It is increasingly claimed that information systems such as decision support, protocols, guidelines and pathways <span style="font-weight: bold;">could markedly reduce such adverse effects.</span> <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);"><br /><br />[As I have written in many places such as</span> <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> <span style="color: rgb(255, 0, 0);">and</span> <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">here</a>, <span style="color: rgb(255, 0, 0);">this may or may not be true regarding today's commercial healthcare IT as it is currently designed and deployed. Evidence supporting the assertion, especially robust studies such as randomized controlled clinical trials, is scarce, and evidence contradicting it is growing. The technology remains experimental - ed.]</span></span><br /><br />If for no other reason – and there are others – this is leading to increasing deployment and use of increasingly complex health software systems, such as for decision support and disease management. It can also be anticipated that, due to pressures on time and to medico-legal aspects, clinicians will increasingly rely on such systems, with less questioning of their "output", as a "foreground" part of care delivery rather than as a "background" adjunct to it. Indeed, as such systems become integrated with medical care, any failure by clinicians to use standard support facilities may be criticised on legal grounds.<br /><br />Increased use of such systems is not only in clinical treatment but also in areas just as important to patient safety, such as referral decision-making. Failure to make a "correct" referral, or to make one "in time", can have serious consequences.<br /><br />Economic pressures are also leading to more decision support systems. The area of generic and/or economic prescribing is the most obvious, but achieving economy in the number and costs of clinical investigative tests is another.<br /><br />Thus the use of health software and medical devices in increasingly integrated systems, e.g. networks, can bring substantial benefit to patients. <span style="font-weight: bold;">However unless they are proven to be safe and fit for purpose they may also present potential for harm or at least deter clinical and other health delivery staff from making use of them, to the ultimate detriment of patients.</span> <span style="font-weight: bold; color: rgb(255, 0, 0);">Annex A provides some examples of the potential for harm.</span><br /><br />Harm can of course result from unquestioning and/or non-professional use, although the manufacturers of health software products, and those in health organizations deploying and using such products within systems, can mitigate such circumstances through, for example, instructions for use, training and on-screen presentation techniques, guidance, warnings or instructions.<br /><br />Some of these system deficiencies are <span style="font-weight: bold;">insidious, may be invisible to the end user</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[an obviously perilous situation - ed.]</span> and are typically out of the sole control of either the manufacturer or the deploying health organization.</blockquote><br />The reports note the obvious, something that the health IT vendors' <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">contractual gag clauses</a> and secrecy in the health IT industry make difficult to rigorously evaluate:<br /><br /><blockquote>A necessary pre-cursor for determining and implementing controls to minimize risks to patients, from a health software systems that is manufactured and then deployed and used within a health organization, <span style="font-weight: bold;">is a clear understanding of the risks which the deployed system might present to patients if malfunction or an unintended event were to occur</span>, and the likelihood of such a malfunction or event causing harm to the patient.</blockquote><br />These risks cannot be properly evaluated in an industry where the flows of information are dominated by the vendors.<br /><br />Some examples of potential for harm, from annex (appendix) A, will likely sound quite familiar to readers of Healthcare Renewal:<br /><br /><ul><li>Patient (mis)identification</li><li>Inadvertent accidental prescribing of dangerous drugs (such as methotrexate)</li><li>Incorrect patient details retrieved from radiology information system</li><li>CT and MRI images could not be seen after being moved to PACS</li><li>Drug mapping error</li><li>Pre-natal screening risk computation errors</li><li>Radiotherapy errors</li><li>Slack security</li></ul><br />I especially note the following in the first document (on deployment):<br /><br /><blockquote>5.3 Competencies of personnel<br /><br />Persons performing risk management tasks will need to have the knowledge, experience and competencies appropriate to the tasks assigned to them. This will need to include, where appropriate, knowledge and experience of the particular health software systems (or similar health software products) and applications, the technologies involved and risk management techniques. <span style="font-weight: bold;">This should include appropriate registered clinical input throughout the process. Appropriate competency and experience records will need to be maintained.</span><br /><br />Clinical risk management tasks can, and should, be performed by a project team that contains representatives of each of the functions that are involved in deploying and subsequently using the health software systems or system, with each contributing their specialist knowledge to build both awareness and consensus. <span style="font-weight: bold;">Of particular importance will be clinical input from clinicians who are familiar with the practical realities of the environments within which the software system will be used and the clinical processes to which the software system is directed.</span><br /></blockquote><br />Emphasis on the last sentence is mine. At a time when U.S. CIOs and health IT "talking heads" still find the need to write touchy-feely "Master of the Obvious" articles extolling the virtues of permitting clinicians 'input' into health IT projects, usually under the aegis of unempowered "Directors of Informatics" or "Chief Medical Information Officers" (a.k.a. Directors of Nothing and Chiefs of Nothing, with no true executive presence or authority), the latter direct, definitive sentence is refreshing.<br /><br />Miracle of miracles, even postmarketing surveillance is covered (the pharma and medical device industries have been mandated by regulators to conduct such studies on their products for decades):<br /><br /><blockquote><span style="font-weight: bold;">11 Post-deployment monitoring</span><br /><br />Both manufacturers and organizations deploying and using health software and other products within systems, have a <span style="font-weight: bold;">business need to establish, document and maintain a process to collect and review information about the clinical safety performance of the products and system in the post-deployment phase,</span> at least to help manage their liabilities but also to enable them to optimize their products and systems.</blockquote><br />There is much more in these documents.<br /><br />Download and read the PDF's. I will have more to say in future posts, but thank god someone is considering the risks to patients of this technology, touted as universally beneficent by <span style="font-style: italic;">health IT exceptionalists</span>, in a serious manner.<br /><br />Now if only we can import this thinking into the United States.<br /><br />-- SS<br /><br /></div>

UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports here and here, for example.However, they have appeared to have learned from their mistakes…

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