File note - summary of confidential meetings with HQSC, HDC, ACE. NBSP Incident: Sep - Nov 201?. Withdrawal of potential participants from pilot programme Incident summary In mid?September 201?, as part of a quality review of pilot records, the NSU identified that the pilot had permanently withdrawn people from the Waitemata Bowel Screening Pilot if their postal invitation was returned because they did not live at the address used, or the person had moved out of Waitemata DHB. Issue recognised through data quality review of pilot soon after NBSP started correct process in place {or will soon be} for National Bowel Screening Programme and ago now in Waitemata DHB. ul: on? the opportunity to participate in the bowel screening progra - - . is group? invitations were originally sent to an old/?incorrect addres - . - the permanently withdrawal from the programme. register It had been anticipated that if the original addr -- .I 2 al would this information would feed through to immediately be re?invited to partici i rs the pilot register did not support this function via this mechanism had not occurred. cl they had accepted the screening offer [around 60% of people . - -- -: invitation). potentially been detected earlier ifthe individual had been proved outcome. NSU approach is to Apologise to the cases [where screeningm_ay potentially have meant an earlier detection of their cancer AND where this delay made a difference to their outcome/treatment path. A senior clinician involved in their care will meet these people and families. 0 This step will likely not involve all eight cases with cancer as for example the address update on the NHI only happened when they had contact with the health system because of cancer ptomsidiagnosis/treatment ASAP re-invite the remaining 2,500 people with an updated address. They will first receive a letter of apology re the delay in their re-invitation. A small number in this grouse will be expected to have a CRC detected and will require personal clinical follow as above. 0 Proactive media release planned 0 Advice to Minister (new and old Governments} ACC: 6 Nov 2017: ACC Of?ce, Aitken St, Wellington 0 ACC: Peter Robinson, Chief Clinical Advisor - NSU: Jane D?Hallahan and Anne McNicholas Jane provided overview of incident [as above) Discussion - Main discussion was around how I if ACC legislation would apply for a case with CRC where adverse outcome could be attributed to the delay in the screening eg treatment error - 5 99mm) Asked what likely wording in letter wo?d ?W?sh include advic-S gtziiglli) HQSC: try of?? @?muth? St. Wellin ngton \VOsb (Gen anger); )Sarah Upston Specialist Adverse Events Learning mmeiv 5U: ith CRC eg would it and Anne McNicholas Jane 0? iew of incident 3 9(2ltgilil - CRC cases have occurred in those not offered screening including CRC related death . 9(2itgltii 0 Root cause analysis and clinical audit requirediunderway to identify what happened and how and the strength of link between delay and CRC diagnosis {unlikely to be completely sure of this link} - Some CRC diagnoses occurred very close to date of address update on NHI so likely address was updated during CRC diagnostic pathway ie could not have been detected by screening as no address update on NHI occurred over period between initial invitation to invalid address and subsequent CRC presentation to health system 0 Ethics underpinning open disclosure are key to Ministry approach . HQSC described historical cardiac surgery incident where preventable deaths occurred because of length of wait times associated with shortfall in system capacity ie did not receive care in a timely manner [16 cases in total) 3 9(21iglli) - HQCS prefers terms open ?communication? instead of ?disclosure? HQCS prefers term a ?just? culture instead of ?no blame? I HQSC reinforcing messages learning from what went wrong . Qtzilglli} HDC: Ell'llov 201?: HDC effica?ggellin?t 0 .1 erandJane King . scoped by group {some} I It was a pilot 0 one purpose of these is to identify? process or svstem issues that addressed prior to a national rollout various learnings are made all the way through pilots as well as established programmes . 1's at one level it is debatable that the incident requires individual letters of apology to all 2,500 andfor those CRC Pilot activelv advised people to see their GP if they had People who had not received an invitation/kit could phone and . The issue was identified during the pi NSU approach is to apply dut oi . ultimateiv protects publ' 9i2liglli} - An audif ic:. .nalvsi 's ight thing to do and - screening programmes av to establish what happened how it happened ?lei i . will ta ip of the delay in re-invitation. unclusion Same duty.r of ca re applies for pilot participants as for other health services Operating under the requirements of dutv of candour and open disclosure the Ministry plans to send a letterto all 2500? it will apologise for the delay in the rte?sending oftheir invitation following their change in address. Ministry will carefully consider wording; 9(2liglil} NSAC: 15 Nov 2017 meeting: Ministrv of Health, Molesworth 5t. Wellington - NSAC: 15 Nov 2011? meeting attendees - NSU: Jane O?Hallahan and Anne McNicholas Jane provided overview of incident (advised as a totally in-confidence briefing) - NSAC agreed with l?v?linistri,r approach of open disclosure and a letter of apology to the affected 2500 people; and personal contact for those with a cancer diagnosis that could potentially have been delayed . NSAC noted there was a long bow between the failure to invite and a delayed or missed cancer diagnosis given the nature of screening programmes; and therefore commented that all systems need to talk to each other' . talk about the nature of screening with the public; and .- 5 please call the programme. cg? t9? important for letters to potential participants be careful with language ar use "opportunitv to benefit? was missed or ?not given the opportu Fw: favourite topic Stephanie Chapman to: Clare Davey a.m. Sentby: Emily Campbell x-I . Emily Campbell Group Administrator National Bowel Screening Programme National Screening UNIT Ministry of Health healtl1.govt.nz Forwarded by Emily CampbelltMOH on 27i02r2018 10:51 am. From: Andrew SimpsonlMUH . To: Jane 0? HallehaniMOH@MOl?l Cc: Stephanie ChapmaniMOHtngOH Astrid KoornrreeffMOH@MOH Date: 29? #201? 03: 31 a Subject: favourite topic Hi Jane some summary points as I understand them. and. some question?s We believe that open disclosure appropriate for the 3 cases (although the clinicians have noted their disagreement with this position}- rationale being that inviting these people was the intent of the pilot and a lot of effort put into securing correct address and. raising issue for resolution however not resolved. My take that reason cases not Invited wasII due to systems issue that was within our ability to resolve . . .- .- -. . - I The 2500? was meant to be a meeting to resolve this. I had Impression (maybe erroneously) that sending letter to the 2500 has already been. agreed 'with the DHB and issue is about the content of the letter in discussion With the last night -l not sure that the invite list has been agreed. If I follow thinking above re intent of the pilot-,3. there' Is a case that only 500 need the letteI re disclosure as they could I1avepeen invited to the previous round of screening but weren due to the systems issue The other 2001}- 'address?s only earns available within this screening round and it they were invited within this round they will have met the aims and parameters of the pilot as it was structured This to me is the debatable point and has this been resolved with the DHB as I have the Impression that it hasn't I i . Happy to be corraetegf.? . we need it) by end of weak cheers . - I Andrew Simpson elite-i Office of the {:Ilitii?i lvlL-Ilioral Guilder Fl I I: 'If? It I.) I Debbie Holdevvorth (WDHB) From: Dabble Holdsworth (WDHB) Sent: Wednesday. 29 November 201? 13:43 To: Subiect: Duty of Candour Guidance?onjp." Hi Andy As we discussed last night? the difference of clinical opinion is whether what has happened falls into scope of open disclosure. As you know the clinicians involved in direct patient care did not behave it [did {including John]- and that thore was real risk of more harm that needed to be talten into consideration.- our public health physicians also agree with this view. There is currentlv no Streening Unit Portico,f on Open disclosure to gu?de this decision: i understand from Jane this? Is being developed and this will be aligned with the attached document. The section' on dIfferentIalIng audit results from limitations of screening and things going Wrong is my perspective lane 5 interpretation is that something has gone Wrong ie there has been an error and it lies with the Mihistrv. Odrview has been that It was well understood there were limitations of the register [external reviews) and the. MDH did their own audits which concluded that not everyone was being invited but" most weie and was~wrthih the 95% qualltv standard. On this basis I would interpret what has happened' Is as a result ofan audit rather than an event. Given the balance of clinical view doesn'tsuopoi -t the screening. Unit-s view and the concern re more harm than good, you might want to get an external Independent viehi on his HQSC might be the appropriate bodv I know the NSU did consult with a number oi?hodies before even letti us know that included HDC ACC and HQSC I think before this advice could be considered guiding, you would want to make sure it wash given in the context of this being framed as an arm refer-ring- to Jill Lanes letter to [idle stating this was incorrect withdrawal of eligible patients - - Regarding the 2 500-. I am still oithe view the vast majoritv are still current provided they are invited prior to December 31 however happv to concede _a different process is followed I want to flag that these individuals could have been invited weeks ago and ongoing delavs' Is increasing the risk. To send a different letter requires a manual process for each individual whith will'add further to the delay. I did say i would forward whari had been sent as I wasn?t sure if it had been-tipd'atedhdwever assume vou will have this directly by now. happv with the intent of the letter as it is cutrendy-constructed otherthan it needs to reflect the message that will he conveved in the Open disclosure process. Regards Debbie Dr Debbie th I Director Funding Waitemata and Auckland DH 85 Level 2, Shea Terrace, Tali apLIrIa PI ivete Bag n: (IE-5 Edz?ent?aa El lln: 3?1 (1) )g govt. adhb. eovtmz Public Health England Nils Sereenlng x. K: Guidance en Candeur and disc-?eeing arid-ll reeullze Incorporating diisdoeure 0f audit guidance ?Dieclosure of screening: advrceon beet lb-rr?ctiee 2006Version 1:0! September'g-UHB leads the NHS Screening Programmes ?i'r Guidance on applying Duty of Candour and disclosing audit results About Public Health England Public Health England (PHE) exists to protect and improve the nation's health and wellbeing. and reduce health inequalities. it does this through World?class science, knowledge and intelligence. advocacy. partnerships and the delivery of specialist public health services. PHE Is an operationally autonomous executive agency ot the Department of Health. Public Health England. Wellington Hoose.133 155 Waterloo Road tendon Tel: 020 i654 8000 gov. ultiphe I Twitler: uk Facebook: iacebook. corniPubliclI-lealthEn'gland ?r About PHE Screening Screening identifies apparently healthy people who may be at increased risk of a disease or condition. enabling earlierlreatment or better informed decisions. National population screening programmes are implemented in the on the advice of the UK National Screening Committee NSC). which makes Independem evidence- based recommendations to ministers in the UK countries. The Screening Quality Assurance Service ensures programmes ale safe and effectlve Iljy checking that national standards are met. PI-IE leads the NIHS Screening Programmes and hosts the UK NSC secretariat. PHE Screening. FloorEI. Zone E. Skipton House. 80 London Road. London BLl-l gov. ukitopIcI?populatIon screening programmes Twitter: @PHE?Soreening Blng-ghescreening clog gov.ul< For queries rotating to this document. please contact: Crown copyriglI-t'IZ'Oi'GI You may re?LIse this-information (excluding logos) free of charge in any format or medium. under the terms of the Open Government Licence v3.0. To view this licence. visit OGL Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Published September 2016 PHE publications gateway number: 2D18343 I ?Jill English Cammlan 1D alt-mgr communication 333 Guidance on applying Duty of Candour and disclosing audit results Contents About Public Health England About PHE Screening Purpose NHS screenin rc rammes 9 . Duty of candour r; \33 l: Supporting a culture of openness and transparency in NHS sensem/rfg programmes . Using audit to distinguish limitations of screening from something going wrong When to apply duty of candour In screening programmes How to disclose audit results Appendix A: Inedico? legal aspects fr?- . Appendix B: example of process for disclosing audit results In NHS Breast screening programme - Appendix C: Interval cancers esplalned in the NHS Blteast screening programme: notes for professionals and patients . Appendix D: safety incidents in HHS-screening programmes Appendix E: references. {Daemon?53mm 10 15 1? 18 21 22 Guidance on applying Duty of Candour and disclosing aLIdil results Purpose The aim ofthis publication is to advise providers and commissioners of NHS screening programmes on best practice in providing information to individuals when they receive a diagnosis for a screened condition (positive diagnosisJ?i after a screening result that was reported as normal (negative). It advises organisations how to: a ensure they are open and transparent with users of screening programmes a ensure compliance with duty of candour regulations in these cIIcumstances a disclose results ofaudits undertaken following a diagnosis for a screened condition (positive) after a screening result that was reported as. normal (negative) PHE the organisation responsible for the NHS- screening programmes has produced this guidance working with clinical colleagues the Care Quality Commission (CQC) and the Independent Cancer Patients? Voice Many of the examples in this publication are from the NHS Breast screening programme This is. because i'nost queries about the application of duty of candour regulations' In screening programmes have Idome from clinicians working In the We will do further worlr following pubhcation to collect examples from other NHS screening programmes and develop tools, and training materials. These will be shared through other routes such as the PHE Screening biog. 1 In this document. screened or diagnosed? positive means the screening resuitwas abnormal or the target condition was detected. Scresned or diagnosed 'nega live means the resultwas normal or the target condition was not detected Guidance on applying Duty of Candourend disclosing audit results NHS screening programmes The screening programmes covered by this guidance are: 0 NHS Abdominal aortic aneurysm screening programme a NHS Bowel cancer screening programme a NHS Breast screening programme a NHS Cervical screening programme 9 NHS Diabetic screening programme t' I NHS Fetal anomaly screening programme NHS Infectious diseases In pregnancy screening programnt; an NHS Sickle cell and Thaiassaemia screening programme 0 NHS Newborn and infant physical examination screening programme} a NHS Newborn biood spot screening programme .- 0 NHS Newborn hearing screening programme-g Screening is the process of identifying healthy peopie who may be at increased Iisk of a disease oI condition - - Screening tests: a cannot offer 100% sensitivity (ability of the test? to coIrectiy identity all true positives those with the condition or disease) a cannot offer ?it'Jt't?itI specificity (ability of the test to corIeotty identity all true negatives - those withgut the condition or Elise-ass). in every screening programme ttheare false positives {wrongly reported by the test as having the conditlon} and false negatives {wrongly Ieporteti by the test as not having the condition), ti. in addition the. ttlseese screened for for example cancer can occur between scIeening epIsodes\ Both false posiliIIe anti false negative results can result in harm to an individuei. i?loneyer, these are not unexpected findings and are a feature of all screening programmes. Screening programmes should operate within agreed parameters so they offer more benefit than harm to the screened population, at a reasonable cost to the HS. Guidance on applying Duty of Candour and disclosing audit results Duty of candour The intention ofthe duty of candour legislation is to ensure that providers are open and transparent with people who use services. It sets out some specific requirements providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong. The approach of being open and transparent should be no different in 'NHS'screenihg programmes. However because of the nature of screening programmes sometimes it can be hard for screening services to know how to distinguish bet-yeah a fatse negativeffalse positive that has occurred because of the titnitations of screening and a false negativerfalse positive that has occurred because senate-thing has gone wrong' . Duty of candour regulations 1 Duty of candour regulations apply as soon as reasonably practicable a. ter the screening service has become aware that a ndtifiahle safety incident has occurred. The following extract 15 taken and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. . In relation to a health senric'e-hod'y. 'notifiabje' safety incidentI means any unintended or unexpected incidentithat-ocpurred in-tespect of a service user during the provision of a regulated in the reasonahleapinion of a health care professional, could result in, or appears-to have {resulted in: the death. of the service near where the death relates diIeotly to the incident rather than to the natural Course oflhe service users illness or underlying condition or a severe harm or prolonged harm to the service user In relation to a registered person who Is not a health service body (clinician) 'notifiable safety incident?. means any unintended orunexpecled incident that In the reasonable opinion of a health care professional appears to have resulted In: a the death of the service user. where the death relates directly to the incident rather than to the natural course of the service user?s illness or underlying condition a an impairment of the sensory. motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days a changes to the structure of the service user?s body a the service user experiencing prolonged pain or prolonged harm. or a the shortening of the life expectancy of the service user 6 iiI . Guidance on applying Duty of Candour and disciosing audit results Or. requires treatment by a health care professional in order to prevent: a the death of the service user. or any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned above if the answer is yes to any of the indicators outlined above then duty of candour applies. How does duty of candour apply to NHS screening programmes? I 5" There are circumstances when a person who has been screened may expertence severe or moderate harm. This may be because: I a the condition screened for has not been detected and it is not treated early enough to improve the outcome for the patient examples can include breast cancer. fetal anomaly and abdominal aortic aneurysm the person with orwithout the talget condition is harmed by the procedure for detecting the condition exalt-?roles include Ides of a fetus due to amniocentesis and death from bowel rupture foilovving coionoscopy a they experience Ii harm from being told they are screen positive (or screen negative) and then findiI?Iglout thettheir true result 1s different These are recognised a screening programme and are therefore not ?unexpected' ifIItlIiie ptg'gramme is opetating within agreed standards. Therefore, .yvhen these events occur they should not be automatically treated as notifiable safety Incidents However when a patient has come to either moderate or serioua harm in a screening programme a review {_a-LIdit) should be carried out to understand why this has occurred. If the audit reveals. something has gone wrong' in the screening process, then this should be ire-\ted as a notifiable safety incident and duty of canriotn regulations will so; few, I Noti?able incidents should be managed in accordance with 'Managing safety incidents in NHS screening programmes' (PHE 2015)?i and ?The serious incident framework? (nus England 2015)?. Guidance on apptving Duty of Candour and disclosing audit results Supporting a culture of openness and transparency in NHS screening programmes People who are invited for screening should be aware of the potential harms as well as. . the potential benefits of being screened. Screening services should provide people with the information they need in formats they understand in order to make informed decisions aboutwhetherto take up the otter of screening This information should include the fact that the screening programme may sometimes tail to pick up the condition orthe rIsit factor When a person is diagnosed with a condition or disease after anegative screening result. the screening service should let it wiilgreview (audit) why this has happened It the person wants to know the findings of this review then the scIeening service should provide that information. This approach will help ensure the organisation is open and transparent. - The value ofaudits The screening pathway in-votves a nurnher?of'steps: invitation. sample taking. examination (carryin'e?jolut the screening-test) and reporting, results. intervention and diagnosis. At any one or more of these steps there may he suhoptirnat provision or an existing abnotinalitvmay not have been identified despite an effective programme. Audit helpsto- identity poten'tiat'problems at any one or more of these steps it also helps improve the whole process for patients in the future Without audit the opportunity to leaIn vital lossons from individual cases would he lost in many ca?s?es'?atjid its witl not find that something has gone wrong Disclosing the results of a'uditsl'to patients, regardless of their ?ndings. shows that an organisation is being open and transparent. Guidance on applying Duty of Candour and disclosing audit results Using audit to distinguish limitations of screening from something going wrong Audits should review the specific part ofthe pathway where an error may have occurred that could have contributed to a patient being seriously or moderately harmed. This is most often the screening test (for example. ultrasound grading of images mammography cytology) or the diagnostic element of the pathway (RI/example. II amniocentesis breast screening assessment. colposcopy colonoscopy or?hIstology) Where an error may have occurred in the screening test or dIagnostIc part of the screening pathway, the review shout id explicitly consider and document. ?Eli-i a was the process for undertaking the screen or dIsgnosIs correctly carried out according to NHS screening guidance? 0 is the programme operating to national standards Elnd the national speci?cation? if the answer to either of these questions is earthen theaudit review should: I: document thatthere has been a failure in screening process (handle in accordance with ?Managing safety incidents in NHS screening programmes (PHE 2015) and ?The serious incident framework? {Ni-i8 England 20 id) is specifically consider. Iwhelher the failure to follow pIocess has (or could have in the reasonable opinion Idt aI health ca re IIpreiessicnaI) contributed to the person being seriously or moderately haI med The audit should then consideI Whether or not staff ca rryIng out the screening or diagnostic- test did so to .a standard that most staff could be expected to achieve. It the conclusion is that most staff would not have made a similar error of interpretation and that this error led Ito serious': or moderate harm than this should be documented as an error due to Interpretatlon performance below an eXpected standard. therefore If the audit ?nds that there was either a process failure andior if iIIteIpreta-tion pierionnance fell below an expected standard and this contributed to sedous or moderate harm to the screened person, then something has gone Wrongj. This should then be recorded as a notifiable safety incident and duty of candour regulations should be followed, including the otter of an apology. Guidance on applying Duty of Candour and disclosing audit results When to apply duty of candour in screening programmes Female meanness -2 I . .3. ,2 - ?ex/L . nil Emmi reneleElE-whas genre end :nmennelree - menu been ?remen Sign . Harden?? ascer?mg in patent-:1- - 1? - egg? - Elli? l3"? M?u?ur' I 533% NEW r13 31:: 1O lzli Guidance on applying Dutv of Candour and disclosing audit results How to disclose audit results This section advises how to disclose information after an audit of screened cases where there has been an unexpected affected result or diagnosis. it is in addition to any local policies, protocols or guidelines. it is not intended to replace or supersede them. The process ofdisclosure of audit should he built around an individual?s needs Health liteIaoy should be taken into account when explaining what has happened and when-- using written material to support discussions. Some individuals with certs, dIsahIiItIes oI those with mental health Issues may lack capacity and be so Jest/toxtlfi?dentai Capacity Actz. Provision should he made for advocates key orkers or ceramic to be included In relevant discussions. Clinicians should read and ensure they understand the audit results and InformatIcn relating to the individual patient before the IntervIewI it is impoItant to follow the process heicw Which takes into account the needs of patients and outlines the basic modicor'iegat requirements in such circumstances. A disclosure process is sepalate from and. does not preclude or replace the complaints process or medicoslegal processes. Appendix 1 provides further. information on nae-dice -legal aspects of disclosure. The masses for disclosing audit results in the breast smeening proglamme is illustrated in Appendix 2. - Informing the ipat_ient or their farnil-ji3 that an audit has been undertaken It Is recommended that a patient or family attends the first appointment to receive a positive diagnosis fpllowmg a negative screening result they are informed (written Iaiher than verbal InformatIon may be most appropriate at this stage): that the screemng pIcgramme Ioutinely reviews all previous screening if thep weuidi _iilte to discuss these findings at any time they should infolm their clinician responsible for the treatment or intervention It is good practice to repeat this information at later appointments and include this in all written information given to patients. 3 in some circumstances this may include other individuals such as the legal guardian of an affected hahv 11 Guidance on applying Duty of Cendour and disclosing audit results The clinician responsible for the treatment or intervention should always respect a patient?s wish to decline information at any time. The patient may change their mind at any point during or after treatment. Letting patients and family know that this decision will be routinely reviewed a year after diagnosis can allow patients time to consider how they wish to deal with information from an audit. ?Where an audit has been undertaken and the results show that a diagnosis or treatment intervention could possibly have been made at an earlier stage in the screening pathway, the patient should be made aware of the audit endliottered the opportunity to discuss their screening history and the result oftheaudit. Who should disclose the information? ldeally.t the clinician responsible for the treatment or Intervention should be the one to undertake the discussion with the patient?s key worken'spectailst nurse where applicable. . . There will be instances where the clinician respondible for theft'reatment or intervention is employed by a different organisation to- the one where the screening episode tool-t place. In these circumstances it to important that clear agreement is reached betWeen the organisations about how the Information is given and by whom. Both organisations should document this agreement and share the outcome of any discussions with the patient about the tIndIngs oi the audit and action taken When should the beg?iuen? it is important that.clinicians?arefietitibie and any information disclosure occurs at a time suited to thejzttatient's needs. The provider of thaiderice where the diagnosis is made is responsible for ensuring: a the screeningser'vice is aware of the diagnosis 0 the result otthe subsequent audit is locally documented, once known The optimum time for the audit Iesult to be offered can then be identified dunng patient' a treatment journey. The best time for information disclosure is liitely to become clear during or after treatment, by which time a rapport may have built up between the patient and the clinician responsible for the treatment or intervention. 12 Guidance on applying Duty of Candour and disclosing audit results it may be appropriate that such discussions happen after treatment has finished unless the patient requests information about their screening history during conversations about their care. The offer of audit disclosure will also be included in the patient information and by the key worker (where applicable) during the patientjourney. In screening programmes. the time and method for communicating with individuals may be affected by local circumstances and the context of the individual case. if a decIsIon is taken to delay communication because of individual andror populat?op needs the clinician should clearly document the reasons How should the information be given? The patient should be given the opportunity for a friend relative caper or advocate to be present at the discussion. ill I At the disclosure interview the clinician should a checkthe patient's Understanding of why he or she has asked for the information a find out how much the patient wants to know I: discuss the relevant reports and their implications allow the patient time it: voice his or her comments and concerns . 3/ -. The results of the audit should form the. basis of the discussion and the clinician should allow themselves enough time .to prepare. A scripted interview Is not recommended but clinicians may tind- it helpful to prepafe in advance a list of points to cover in the course of the meeting. tithe is? not undertaken by the radioiogistiscreen interpreting lead it may [Ia helpfulitp discuss the audit findings with them in advance of the meeting wilh the patient. fore offering explanauons it is important to check the patients understanding and ?lid out what the; needfwant to itnow about their screening history The results should he used to guide the discussion and the amount or information given at this stage. Clinicians should give patienls time to voice any comments or concerns about their care. There should also be time for the clinician to respond, checking the patients understanding and whether further is wanted or required. 13 Guidance on applying Duty of Candour and disclosing audit results If patients decline information It is important to respect the patients wishes if they decline the offer, The clinician should make it clear that the individual can request the information at a future date should they change their mind. if the patient changes their mind following discharge from treatment they should be informed that they can either contact their screening service or their GP. who can make the necessary arrangements. ifthe patient ortheir family has indicated previously that they do notwish to know the. results ofthe audit and this has been documented including cases where the result of- the audit has led to a noti?able safety incident. then the organisation Is not required to . write to the patient with an apology. - - Record Keeping The results of the discussion should be cieari documented by the shaman in the patients hospital record A record cfthe diI recession should also he sent to the GP and the patient. - - Access to to We infor mahoniresources . .. . A number of proyIdercrganIsatIons offer traInIhg in breaking bad news which clinicians may wish to access. if . . . . Local guidelines and?pictccois enculd'ihfeadl?ered to. Explaining to agp'a'tie'nt or their family why their condition Was not detected can be complex Use Ito-t ijsual aids such as a pictogram (Appendix 3) to explain the occurrence of intervai cancers in breast screening can support these conversations The Nursing and MidWifer Councii in conjunction with the General Medical Council hays produced the toilowing helptui guidamnce Openness and honesty when things go wrong. the pIcfesSIonal duty of candcurv ?14 Guidance on applying Duty of Candour and disclosing audit results Appendix A: medico-legal aspects The advice in this section focuses on the communication of the results of audit undertaken for education and improvement of the service rather than the prevention of claims for damages. What does the law expect of clinicians? Under normal conditions the law expects no more of those caring for patients than that they perform as may be reasonably expected of members their profession ?x I \r Clinicians may be concerned that by being open and communicating news of a reporting discrepancy, patients may regard, the disclosure a?ahedmission of error. From a medics legal perspective such conclusions may not deiusli i Patients or relatives who indicate they wish. to complain or Iseelt lagal 'redress should be given information about how they may proceed - What do clinicians need to know? Patient information is confidential. In most instances it may be shared between li?ust staff only in relation to the management of a patieht's treatment. Points to consider .whe'ifiiconducting a disclosure interview Steps can be taken to reduce the Iikcl lihood of complaints and claims. It is impoitant to understand the likely issues and to deal with them sensitively. When talking to patients about disclosure of audit ?ndings the quality of the explanation is crucial and must be detailed. . Complaints or claims are less likely if patients perceive that the process which led to the interview' is tiansoarent and they receive an apology or expression of sympathy foi their pi esent position. Apologies and airplanations, as opposed to admissions of liability. are encouraged. The NHS Litigation Authority Circular 02102 Apologies and Esplanations provides guidance on this issue Issues of consent to audit and confidentiality in respect of patient data should be addressed during the disclosure interview. 15 Guidance on applying Duty of Candour and disclosing audit results It is important to note that the law judges standards according to the year in which the sample was taken. Therefore. improvements in screening technique will not result in a retrospective finding of liability. Denials of liability can be as unhelpful as admissions of liability, while a lack of definite advice may lead to allegations of stalling for time orfudging the issue. A consistent approach is required which sets out the issues objectively its legal question is raised or access to records Is requested the clinician should refer to local trust policy and check with the trust's legal team. Providers should be chief; demonstrate they have undertaken due diligence in assessing how the dot applies to each serious incident and seelt legal advice where necessary .. (C 0 - his?" I Patients should be advised that: i) no matter how closely the review panel clue: Fi?: conditions the conditions of a review different: records etc patient knowpt has $93? vigilance and lncrea r?pert?g?dbma 0 finding discrepa pl @113? -Ee do been made I the ooh I I a binds?ipl asak?ficant' Imp ?gure inteIpretatton of images a imgiA/w wor WES paiameters of sensitivity and specificity and no set pie 2 arc-titties at the time of screening in\a numb i log pr'oglammes, suoh as fetal anomaly ultrasound, cervical and the result is based on interpretation of appearances on a wg??r mammoglam in ciIcumstances where the boundary between ?nish and ahno: mality Is not firmly drawn this may result In debate between imparts as to the appr'oleate classification of the sample or the interpletation of the dhnage the patient should be given the option to see another clinician fora second opinion should they wish a? Advising patients cree ning a review includes ous co ditto as cancer. will heighten lat the same findings should have 0 Further sources of information Where requested, patients should be given the contact details for the trust?s Patient Advisoiy Liaison Service (PALS) and be informed about the trust's complaint procedure. The following associations may also be of use to the patient: Citizens Advice and AVMA (Action Against Medical Accidents). 'io? fillGuidance on asmiying 371.3733:- Append? (31:5. 8:9 2 '19: eggs ?for disclosing audii results in NHS Bieagis ?this othenvise' narm could be caused. ?731 . meaning YW only give feedback when in]; results of the audit review proeesis??re availabL. Feadback should be given in accordance with .. ?Gwen :nrbm'uajoi?a scraenmg I??wew and ?a??rml .. 4.54.5524" b'naas't-canca . -. . ?va?p?mq 11' ?3111135 - 5.1.- 2.5.1? . - Jant?a?m "ima?reau?entdiscussmn -. .uu. .un. - Pa?n?ent declines resuiisl Paiient Including pussihle misserj receives resu?t can cer result Discusston 3.511%} cf?mlan {amp . ?3:33- si?ol?d ensurg may preparaa for majmerv '11 .. . Oalerg?xum?uer ?screenrrig ?se'mcea: angles 1119mm": 1T Wice? n?ingsu 5 .. Gurdance on appleng Butt.I of Ceno'our and disclosing audit results Appendix C: interval cancers explained in the NHS Breast Screening Programme: notes for professionals and patients Of 1 .000 women screened for breast cancer: I. eight are diagnosed with cancer x9 . eggs If? 992 have a normal result, ofwhom around three develop an Inte \V'j An interval cancer is a breast cancerfound during the three rmalr isuhf and before the next screening appointment. In England\\, oxim women wiil develop an interval cancer The diagram on page 20 shows why interal canc\;r\c \an coo: how professionals and organisations can armrest an transparen if a woman develops an intet?g ant/agathe SCICEEHX \ptogpamme should: a review the pr ?-Qf?b ceasing mm? a comps? pr a mantra cse taken atth'e time ofdiagncsis the Won "nan re Swishes? to explain the findings giugi stint . \s?eitx ai?d improve Of the ?g 0 aging. interval cancers each year in England: Io: condek??t] will have :leveloped cancel between screening appointr cents t? tint eansthere was no sign of cancer at the pIevioIIs screen ?arcund 1,200 had a cancer which was not piclted up at their previous screen {false negatives) When a cancer was not picked up at the previous screen (faise negative) this is usually because the cancer changes were hard to see and would only be seen with hindsight. in a small number of cases, other screeners think the changes should have been picked up. These are notifiable safety incidents. Services should follow the statutory requirements of duty of candoun Any such incident should be investigated so lessons can be learnt and a formal apology offered to the woman 18 Guidance on applying Duty of (land our and disclosing audit results Notes for professionals Review teams in breast screening units currently classify interval cancers into categories one. two or three to support learning and development. However, a national survey showed screening units vary in the way they do this. In some Units this classification may have significant overlap with the decision about which interval cancers should felt within the remits ofa noti?able safety incident, but this is not the case for all units. Local review teams should therefore reach a clearly documented decision as ch??ich cases should be considered noti?able safety incidents. For instance wherK aw: there has been a general service failure or inadequate assessment pv (I Further work' Is being done to ensure a clearer and more celgis(approach classification of interval cancers 5-5 55/ . 5555\5"if? 3.. . .- (3-: EAR-?sz ?11'3? .v.uer \anx - .Guidance on Duty ofCendour and dis'closrng results HHS Breast Soreening Programme: interval oanoers explained An Interval cancer Is an cancer dragn0%d the 3-year period e?er a normal result. Interval cancers occur In around 3 of event 1 I000 women waned. Out of every 1 F000 women screened for breast Cancer: 5539 East) IE 14 er diagnosed with cancer m: 3.5.1 I Iran-en heme Sir}?! Canning 11-131 Er?; L53 scleeners have Ear: age detects-10m eub?e changes can be seen E-FI {he screening marrmc-g?am {Tale-3 ugs?'ae} These 'I'I'cman ehcdd ham-1h? ?ndings cemnuniosded to {hem usee seer arse are uidsnze'. Tshin rail ?1 a 3: I Ir-I?s a In men and ,1 can ensure ?'re'f are cp?zret'ng in -- his one t: 1:33" span and tmuperenr 3 - qua-d. Iii?:3; manner. Momma" e-z?cn l3 L5 required. I?ll-33539111?; I2. Ilium: a egg-1mg Eugenie 11'ch rucu'rs 13-2: human hearse-insets thei mist screens-rs L14 'I'IeruH have detezred tn the screening msmn?rsgrem isle-:1 fries negate-ea}. These are 7? no?Ii-?e?efo and a Formal $531; in ecwrderce Raul}; e-t' Gen darn: negrlati-ms ehculd [ze- fch?Iv-ezl. All InIen cancers should be resle?raedreudlte:l 20 si Gurdance on appivrng Duty of Gendour and dlsciosmg aLIdIt results Appendix D: safety incidents in NHS screening programmes The guidance on screening safeivincidents applies to all organisations that provide NHS screening programmes in England whether an NHS trust, NHS foundation trust, general practitioner or private provider. ?t The guidance details the accountabilities for reporting. investigating and ma gt insidents' In NHS screening programmes. it covers the management 0 rn ris, gag safety incidents and serious incidents It Is written for staff working in< nude screening services organisations that host screening service @Issroners screening, Public Health England (PHE) screening and Im a?gohilteams-l it screening quality assurance service (SQASJ )natio a vgbrogrart PHE regions and cen?ues and local authority duect% ISL: hands HT?ies Bu a no?) 2'1 I Guidance on appIyIng {Shut}.I of Caodoor and disolosmg eudIt resulls Appendix E: references Regulation 201 Duty of candour 2015 Information forall providers: NHS bodies. adult social care. primary medical and dental care, and independent healthcare 'i Health and Social Care Act 2008 (Regulated Activities} Regulations 2014: Regulation 20. 1? PHE. Managing safety incidents in NHS Screening Programme. 2015 if: s?e Qg?w gramme?C FE- . l? NHS England Serious Incident framework 2015 england nhs. uldpatientsafetyiserious- incident! fif?g <10 NHSLA Letter to Trusts 02/03 Explanations and 33% Openness and honesty when things gowrodg ofessi KNEW of?candow. General Medical Council It Nursing?o?i ?dwifery ouuotl\.m ~29 5 (Coir Sent by: Toby ReganiMOH To: Stephanie Susan susan.parry@adhb.goyt.nz, Maree Astrid D1i12i2017 05:04 pm. KoornneefIMOH@MOH. Jane D'HallaheniMOH@MOH. Erina CC: bcc: Subject: Brief update on incident Hi All. Just to keep you all in the loop. 1. We have begun booking meeting time with GP of the three impacted 2. We expect the meetings with the cases will begin on Tuesday next we 3 Subject to having the letters, phone scripts and FAQs signed off we?ilQa to sending lett \[he 2500 people next Wednesday (there will be two groups those aged out anths? eh i le} 4. The ICC (Waitemata) will begin moving people from withdraw; to _inVitii?Yx bKau us eady for kits to be sent) next Thursday and will aim to do 250 per daylit \1 There are probably other things going on but the ball Is -. Mm - Have a good weekend Toby R, Toby Regan x. Manager .F Information. Quality and Equity .5 National Screening Unit Ministry of Health (5 . j/ 04 816 2161 ?ll/E/A? . . A .-. (Egg/:1 Fax: 04 816 4434 ?3?53; http: health. gov nz?, mailto. Toby_ Regan@q1ob?goyt r?cz" 3) HEALTH swoon or Database number: 20171748 Security classification: ln-Con?dence i VE i3. 30 Nov 2917 ,lFiIe number: now-142017 i Action required by: urgent Ulilce of Hon David Clark; Briefing: Withdrawal of eligible people in the Bovv'el Screening Pilot To: Hon Dr David Clark. Minister of Health 1 Background The Bowel Screening Pilot screening pilot (the pilot} (Health Report 201N489 refers). The withdrawal of eligible participants affects three eligible a bowel cancer and may have been harmed as participv - Introduction . This briefing provides you with an update on the withdrawal of BHW in tl? .. a; resulted in an earlier diagnosis of bowel cancer. On A bowel screening pi - ii .- emata DHB since 2011 and is due to complete the third scree-' . . uii'. Waitemata DHB will move to National Bowel Screening - . .tus on 1 January 2018. The pilot invited people aged 50- yea - - . tected bowel cancer in 375 people. Data collected during the rticipation levels. cancer detection rates and the impact on health 3* Programme which commenced on 1? July 201?. Suf?cient colonoscopy workforce capacity is critical to a successful roll-out The pilot was supported by the Bowel Screening Pilot Information Technology System (ESP) which provides a centralised invitation and recall system and tracks the person?s journey through the screening pathway. Bowel Screening is an opt?off programme in which eligible people are automatically invited. invitation lists of new people are created through an extract from the National Health Index (NHI) based on the eligible age range and geographic location. This is loaded into the BSP which generates an invitation letter at the appropriate time. Re-invitation for existing people. who are within the eligible age range and geography occurs every two years from the time their previous test was received back by the Laboratory or from the date of their previous invitation if the test was not returned. The NHI is linked to ESP and regularly Updates a person?s address if there has been an address change on the NHI (for example a person visited their General Practitioner (GP) and updated their address). Contacts: Jill Lane. Director. Service Commissioning to protect the privacy Astrid Koornneet . Group Manager. National Screening Unit "0f individuals Page 1 of 4 or 9 HEALTH mum-J. Database number: 20171748 10. This process enabled the programme to re-invite eligible people following an address update. Withdrawal from the pilot 1 1. A person either directly or via their GP can opt not to take part in the pilot for either clinical or personal reasons (for example they had a colonoscopy in the last five years). They contact the Waitemata DHB Coordination Centre (the Coordination Centre) and ask to be withdrawn. 12. As part of any invitation based process there are people who no longer live at the address active in the NHI which can result in returned ?gone no address" mail to the Coordination Centre. 13. The Coordination Centre makes the best effort to find a current address. if no he found. it was the standard operating protocol agreed with the Ministry for the withdrawn status. 14. Once a person is assigned to withdrawn status BSP no longer 5 excludes the person from any future invitations. A manual 8% ir din withdrawn status. Withdrawal from the National Bowel Screening Pr 15. In the Programme a person is only withdr . they either directly or via their GP can opt not to take part in t- - .ilo nal reasons {for example they had a colonoscopy in the last fiv Issue mh 201?, a of a quality review of pilot records, the National Screening .19 Musil'l 6% Ministry of Health, became concerned about the process of wt lay pla . he permanent withdrawalof people asaresultofmailbeing returned Dre ted a I sing sent to a person even if their address was subsequently updated in the NHI - .. ay the NSU requested the pilot to only assign a withdrawn status when asked directly (tr; era-n or their GP. The NSU also asked that people for whom invitations were returned to the - ?nation centre as "gone no address". be assigned a two year recall. This ensures the person is ~invited and not permanently withdrawn. 18. The NSU undertook a and in-depth analysis of the pilot data to ascertain whether people missed out on the opportunity to be part of the pilot programme. This data was matched against the NHI and the New Zealand Cancer Registry. 19. During the week of 16th October 2017 the NSU confirmed 12,834 people were withdrawn from the programme due to mail being returned. in analysing these withdrawals the NSU found: . 10,349 are not currently affected by this inappropriate withdrawal as their address in the NHI had not been updated since they were withdrawn. . 2.441 people had their address updated in the NHI but were not invited to participate in bowel screening because they were classed as withdrawn. . 30 people have died of unrelated causes. . Fourteen people have been diagnosed with bowel cancer. six of whom had their address updated appropriately and at the time of their diagnosis- . Eight people hays been diagnosed with bowel cancer after their address was updated in the NHI. this includes three peopte who have died from bowel cancer. Page 2 of 4 "Mmunwor HEALTH ?smut: kuou Database number: 201?1?48 20. The Director General of Health was advised of the potential issue. by the Director of Service Commissioning on 16 October, and the need for further analysis before further actions and decisions could be taken. 21. The former Minister of Health Dr Jonathan Coleman was informed by phone of the potential issue on 18 October 201? following a meeting with his office. 22. The further analysis indicated that the delay between an address update and the bowel cancer diagnosis for the eight people with bowel cancer is between one and 41 months. Waitemata DHB also validated the numbers identified through the NSU process to ensure the data was as robust as possible. 23. On 1 November the NSU informed Waitemata DHB that this issue had been id- of the eight people with bowel cancer. The clinicians for the War '6 - reviewed this data against the clinical notes of the patients. - urticul he'Egh! people HI ata DHB and le diagnosed with bowel ta DHB and the independent could have had an impact on the 24. Work has been ongoing to clarify and understand the impac a $34 . diagnosed with bowel cancer after their address was u. a within the Ministry. 9 25. Waiternata commissioned an independen . cancer. A clinical group with represen tiv reviewer met on 2? November - outcome of the eight people. 26. It was agreed that an - - screening would have had no impact on ?ve of the eight casesresult of the delayed invitation to screening rinciple across our health system and internationally under these ure means being open and transparent with people andlor their family ersety affected by a clinical event. 28. a ornmissioned a full event review through an independent expert to further reduce the Ili of this occurring again. The report from this event review is expected in the new year. tops 29. On 1 December the NSU will contact the general practitioner of the three people to arrange a time to discuss their patient. 30. It is expected this conversation will happen on Monday 4 December. The NSU will be guided by the general practitioner as to the most appropriate approach to the person, including if the person or family should be contacted. 31. Based on the discussion with the general practitioner In the week of 4 December 2017 the Clinical Director of NSU and the Clinical Director of the Bowel Screening Programme will contact and offer to meet the three people tandicr their families where appropriate) who were withdrawn from the pilot and subsequently diagnosed with bowel cancer. 32. The NSU will explain what has happened and will take the opportunity to apologise. A letter will be provided to these three people after the conversation has occurred. The conversations and letter will be tailored to the circumstances of each case. Page 3 of 4 33. 34. 35. 36. 38. 39. 4t]. Recommendat' @g The Minist that yo% $35 re Wasps planned. @an 3) MINISTRY or EALTH muons Database number: 20171748 Following the principles of open communication, the NSU will also write to the 2441 people withdrawn from the screening programme to apologise for the technical issue which prevented them being re- invited earlier and to invite them to participate in screening. The NSU plans to write to the 2,441 people. on 8 December 2017', to re?invite them to bowel screening. it is anticipated the invitation and screening will be sent out to the 2.441 before Christmas. For the 10.349 people who are not currently affected by this withdrawal from the programme. their status will be changed to recall in order that should their address in the NHI be updated in the future they will be re-invited to participate in the Programme. Contacting these people andior their families may attract media attention. A reactive communications plan is attached, including draft letters to the eing and a draft media holding statement for reactive use. The letters to the three people are yet to be confirmed. The - . red ba th.? iscussion with the general practitioner and the individual or famil v. ails letter will be shared with your of?ce. Dr Jane O'Hallahan. Clinical Director of th vailal? any media questions. You will receive a briefing taken resulting from the full event review. Mi ister nature: Director Service Commissioning Date! a {2/1 Page 4 of 4 i. .00 .ulmarm'car f" A Database number: 20171489 Security classification: ln?Confidence 3 NOV 2017 File number: - Action required by: routine Briefing: Bowel Screening Pilot?s incorrect withdrawal of eligible pepple To: Hon Dr David Clark. Minister of Health Introduction This briefing provides you with information on a serious clinical incide Waitemata District Health Board (DHB) bowel screening pilot (the pilot . nuarya -- he pilot invited people in the 50?74 year age range. By March ct be ancer in 3T5 people. Data collected during the pilot provided vital .- i els. cancer detection rates and the impact on health services, and ir - -owel Screening Programme which commenced on 1? July 201?. 5. at: screening provides health benefits and is cost saving 2 Equal participation is essential - Sufficient colonoscopy workforce capacity is critical to a successful roll-out 5. The pilot was supported by the Bowel Screening Pilot information Technology System (BSP). BSP provides a centralised invitation and recall system and tracks the person's journey through the screening pathway. 7. Bowel Screening is an opt?off programme in which eligible people are automatically invited. Invitation lists of new people are created through an extract from the National Health Index (Ni-ll) based on the eligible age range and geographic location. This is loaded into the BSP which generates an invitation letter at the appropriate time. 8. Re?invitation for existing people, who are within the eligible age range and geography occurs every two years from the time their previous test was received back by the Laboratory. 9. The is linked to ESP and regularly updates a person?s address if there has been a change to theiraddress details on the NHI (for example a person visited their General Practitioner (GP) and updated their address). Contacts: 1 Jill Lane, Director. Service Commissioning I 59(2)(a} to protect the privacy Astrid Koornneei Group Manager, National Screening Unit 0f lndiVidU3 3 Page 1 of 4 10. Ml NI OF HEALTH ennui! muons Database number: 201 "1'1 489 This process enabled the programme to re-invite eligible people following an address update. Withdrawal from the pilot programme 11. A person either directly or via their GP can opt not to take part in the pilot for either clinical or personal reasons (for example they had a colonoscopy in the last five years). These are the only official reasons for withdrawal. They contact the Waitemata DHB Coordination Centre (the Coordination Centre) and ask to be withdrawn. 12. As part of any invitation based process there are people who no longer live at the address active in the which results in returned ?gone no address? mail to the Coordination Centr 13. The Coordination Centre makes the best effort to find a current address1 see found. the person is assigned a withdrawn status. 14. a as? land - I ange a withdrawn status. issue 20. ton the opportunity to be part of the pilot programme. This data was matched against the the New Zealand Cancer Registry. yearre a ertook a and in-depth analysis of the pilot data to ascertain whether people @l . 18. During the week of 16th October 201? the NSU confirmed 12,834 people were incorrectly withdrawn from the programme. in analysing these withdrawals the NSU found: a 10.349 are not currently affected by this inappropriate withdrawal as their address in the had not been updated since they were withdrawn. . 21441 people had their address updated in the NHI but were not invited to participate in bowel screening because they were classed as withdrawn . 30 people have died of unrelated causes Six people have bowel cancer but their address was updated appropriately and at the time of their diagnosis . Eight people have been diagnosed with bowel cancer after their address was updated in the NHI, this includes three people who have died from bowel cancer. . The Director General of Health was advised of this issue. by the Director of Service Commissioning on 16 October, and the need for further analysis before further actions and decisions could be taken. The former Minister of Health Dr Jonathan Coleman was informed by phone of the issue on 18 October 2017 following a meeting with his office. Page 2 of 4 OF EA LTH menu Huron. Database number: 201 T1489 21. Work has been ongoing to clarify and understand the impact on people particularly for the eight people diagnosed with bowel cancer after their address was Updated in the 22. This work indicated that the delay between an address update and the bowel cancer diagnosis for the eight people with bowel cancer is between one and 41 months. The impact on these eight people as a result of this delay is unknown and cannot be retrospectively quantified. 23. On 1 November the NSU informed Waitemata DHB that this issue had been identified and shared the of the eight people with bowel cancer. The clinicians for the Waitemata Bow are reviewing this data against the clinical notes of the patients. The Clinical Dir Jane O'Hallahan will discuss with clinicians the findings from the clinical November 201?. 24. Waitemata DHB is also validating the numbers identified ace 0 sugdata is as robust as possible. This process will be completed a - ove Next steps 25. Considering the impact of this incident .- aka a process of open disclosure. which is an accepted pri $4 - internationally under these circumstances. Open disclosur 5- nt with people andfor their family 26. In the week of 13 of NSU and the Clinical Director of the Bowel meet the eight people (andior their families where the pilot and subsequently diagnosed with bowel .Wappened and will take the opportunity to apologise. The conversations a: .?ria from toes of each case. tee of open disclosure, the NSU will also write to the 2,441 people incorrectly the screening programme to explain what happened and to re-invite them to NSU plans to write to the 2,441 people. by the end of November 2017. as some may have a bowel cancer that has not yet been detected. 30. For the 10,349 people who are not currently affected by this inappropriate withdrawal, their status will be changed to recall in order that should their address in the be updated in the future they will be re-invited to participate in the national screening programme. 31. The NSU will commission a full serious event review through an independent expert to further reduce the possibility of this occurring again. 32. Contacting theSe people andfor their families may attract media attention. 33. To mitigate the risk of a negative media response the NSU is proposing to take a proactive approach to inform the public of this incident, once the eight people and/or their families have been contacted. 34. A communications plan is being prepared, including draft letters to the eight affected people and will be shared with your office priorto release. This will be provided to your office the week of? November. Page 3 of 4 I OF HEALTH MANNE- HAUORA Database number: 20171489 35. Dr Jane O'Hallahan, Clinicai Director of the NSU will be avaiiable to answer any media questions. Recommendations The Ministry recommends that you: a} Note this report b} Agree to meet with o?iciais to discuss this incident and planned actions. Page 4 of 4 vlleview ofClinical Records of Patients Who Did Not Receive an Invitation to Participate in the Bowel Screening Programme and Who Subsequently Received a Cancer Diagnosis Commissioned by the Director of Funding. Waitemata and Auckland Rs 20?" November 2017 Dear Dr Iloldsworth. My name is Maree Weston, Consultant Colorectal and General Surge Counties Manukau I share the role lead for Bowel Cancer Screenin 5 art at in July 2018. have been asked to provide an independent . notsenL These patien Summer},I have had the opportunity to review the records of the 8 cases mentioned above, have thought about these and i have discussed these with my Colorectal Surgical colleagues at It is my opinion that in 5 of the 8 cases there is no possibility that offering a screening test at the time oftheh' address being updated would have altered the outcome for those patients. With regards to the three remaining patients [Case 2, Case 4 and Case 7} a signi?cant amount of time had elapsed between the date oftheir address update and the date oidiagnosis of cancer (33, 41 and 25 months respectively}. While earlier diagnosis for these patients would have been ideal. it is impossible to conclude that an earlier diagnosis would have been made or that a premalignant polyp would have existed at the time intewal mentioned. The screening uptake ofSII?E-ii and the unknown false negative rate 1&1 mean that there is no guarantee these patients would have ace-1% screening offer and then had a true positive test result. The .p . all but real miss rate for polyps at coionoscopjr. did not receive repeat screening invitatlo and it is impossible to prove any im act was kind egg Mi in my opinion there has been definitely no im