Adverse Health Care Events Reporting System: What have we learned?

Transcription

1 Adverse Health Care Evets Reportig System: What have we leared? 5-year REVIEW Jauary 2009

2 For More Iformatio: Miesota Departmet of Health Divisio of Health Policy P.O. Box East Seveth Place, Suite 220 St. Paul, MN Upo request, this material will be made available i a alterative format such as large prit, Braille or cassette tape. Prited o recycled paper.

3 Table of Cotets Executive Summary... 2 Evaluatio Process Overview Patiet Safety Officer Survey... 5 Patiet Safety Officer Focus Groups CEO Iterviews... 6 Results: Impact of the Reportig Law Safety as a Priority Biggest Chages i Facilities as a Result of the Law Leadership Ivolvemet Physicia Ivolvemet Implemetatio of Best Practices Sharig of Iformatio Process Improvemets ad Stadardizatio Chages i Cliical Practice Results: Measurig Progress Are We Safer? Results: Reportig ad Review Process Prevetability Defiig Reportable Evets Results: Resource Use& Future Needs Recommedatios ad Next Steps Appedix A

4 Executive Summary I 2003, the Miesota Legislature passed the Adverse Health Care Evets Law, requirig hospitals ad ambulatory surgical ceters to report to the Miesota Departmet of Health wheever oe of 27 ow 28 - serious adverse health evets occurred. This law is ow i its fifth year of implemetatio. Durig that time, MDH has collected iformatio o early 800 adverse evets, icludig iformatio about their causes ad the steps beig take to prevet them from happeig agai. The reportig law was evisioed as a system for ehacig both accoutability ad trasparecy i Miesota. While coutig evets is importat, the true stregth of the adverse evets reportig system has always bee its focus o learig, sharig of iformatio about root causes ad best practices for prevetio, ad icreased awareess of ad trasparecy about adverse evets. A importat goal of the reportig law was to serve as a mechaism for drivig quality improvemet i facilities across Miesota, as part of a broader statewide visio of creatig the safest healthcare system possible. I light of those goals, the Miesota Departmet of Health udertook a evaluatio of the adverse evets system i 2008, to determie the extet to which it has bee successful as a catalyst for improvemet ad learig. The evaluatio, coducted through focus groups, iterviews, ad surveys with reportig facilities from aroud the state, foud that: 72 percet of respodig facilities feel that the reportig law has made us safer tha we were i A strog majority of reportig facilities say that patiet safety is a higher priority ow tha it was i Adoptio of best practices has improved dramatically sice 2003, particularly i the areas of sharig of adverse evets data with boards of directors, staff ad other facilities, disclosig adverse evets to patiets ad family members, leadership egagemet, ad assessmet of each orgaizatio s safety culture. Facilities have made umerous chages i policies, processes, ad approaches to prevetio of the most commo types of adverse evets. Usig a team approach to prevetio of falls, 2 Miesota Departmet of Health

5 pressure ulcers, wrog site surgery, ad retaied objects is ow much more widespread, as is the idetificatio of champios to help promote ad implemet ew strategies. Despite feelig that the law has bee a catalyst for chage, facilities still struggle at times to uderstad which evets are reportable, ad to determie whether or ot evets were prevetable. The reportig ad review process, while useful for the majority of facilities, may eed to be streamlied to esure that it is easy to use, timely, ad costructive. The majority of facilities have implemeted sigificat chages as a result of the law, with greater levels of egagemet at all levels of their orgaizatio, ad agree that the law has led to dramatic chages i each orgaizatio s processes ad culture. But to esure that we sustai ad build upo these achievemets, MDH ad its parters should explore the followig aveues i the comig year: Developig ew methods for regularly sharig key learigs from idividual adverse evets, as well as iformatio about overall treds, with reportig facilities. Implemetig chages to esure that the reportig system is as easy to use as possible, provides meaigful ad costructive feedback o idividual evets ad broader categories of evets, ad is timely. Ecouragig regular admiistratio of safety culture surveys by all healthcare orgaizatios aroud the state, ad providig assistace to facilities i how to act effectively o their fidigs, how to bechmark their results agaist similar facilities, ad how to commuicate fidigs to staff ad to leadership. Workig with admiistratio/boards of directors to ecourage adoptio of active leadership strategies. Workig with educators, cliical traiig sites, ad healthcare providers to ecourage itegratio of teamwork ad iterdiscipliary traiig, traiig about patiet safety priciples, ad educatio about the role of orgaizatioal culture as a part of the educatio of all Miesota physicias ad other providers Workig with professioal orgaizatios ad practicig physicias to esure that physicias ad surgeos are fully egaged i patiet safety iitiatives. Patiet safety is a complex ad multifaceted cocept, oe that ca be ad is measured i may differet ways by idividual facilities ad state/atioal orgaizatios. I the last five years, Miesota has take great strides towards creatig a statewide culture of safety, trasparecy, ad learig, ad the reportig law has bee a crucial part of that process. Goig forward, MDH ad its parters will eed to lear from the successes of the first five years, while also cotiually workig to egage all stakeholders aroud this importat issue, ad makig sure that patiet safety remais a priority for all healthcare providers ad cosumers. Miesota Departmet of Health 3

6 Evaluatio Process Overview I 2003, the Miesota Legislature passed the Adverse Health Care Evets Law, requirig hospitals ad, later, ambulatory surgical ceters to report to the Miesota Departmet of Health wheever oe of 27 serious adverse health evets occurred. The law was modified durig the 2007 legislative sessio to add a 28th reportable evet, ad to expad or refie defiitios of several other evets. Reportable evets uder the Adverse Health Care Evets Law iclude: Surgery or a ivasive procedure o the wrog part of the body or the wrog patiet, or performig the wrog surgery or ivasive procedure o a patiet; Foreig objects left i the body after surgery or a ivasive procedure; Falls associated with death or serious disability; Serious pressure ulcers (bedsores); Medicatio errors associated with serious disability or death; Patiet suicide or attempted suicide resultig i serious disability; ad Crimial evets such as sexual or physical assault. Sice 2003, early 800 adverse health evets have bee reported to MDH uder the reportig law. Moitorig how ofte these adverse evets occur is importat, as chages over time i the frequecy of serious adverse evets ca costitute oe measure of patiet safety. The goal of the reportig system, though, from its iceptio, has bee ot just to cout how ofte serious adverse evets occur, but to facilitate quality improvemet through evaluatio of potetial areas of risk or system failure, ad to share learigs from adverse evets with facilities aroud the state as a way of fosterig system chage. While coutig the frequecy with which adverse evets occur, ad reportig the results publicly, is very importat, it is the focus o systems chage ad learig that is key to sustaiable improvemets i patiet safety. Reported Adverse Evets Stage 3/4 Pressure Ulcers Foreig Objects Wrog Site Surgery Ustageable Pressure Ulcers Falls - Serious Disability Wrog Procedure Other Falls - Death Medicatio Errors Crimial Suicide Wrog Patiet Miesota Departmet of Health

7 I Jauary 2009, MDH released its fifth aual adverse health evets report, providig iformatio about 312 evets that had happeed durig the previous reportig period ad highlightig steps take by facilities to prevet their recurrece. To coicide with the fifth aual report, MDH embarked o a five-year evaluatio of the reportig system, seekig to aswer six key questios (right). To aswer these questios, MDH coveed a series of focus groups with patiet safety officers from aroud the state, coducted a survey of patiet safety leaders from reportig facilities aroud the state, ad worked with the Miesota Hospital Associatio to iterview a sample of hospital CEO s. Patiet Safety Officer Survey I November 2008, MDH coducted a survey of 178 patiet safety officers, urse maagers, risk maagers, ad others ivolved i developig ad implemetig patiet safety campaigs, reportig or aalyzig adverse health evets, ad moitorig safety ad quality measures withi their facilities. A total of 60 idividuals (34%) respoded to the survey, which icluded the followig questios: To what extet has your facility implemeted broad chages related to data sharig, trasparecy, ad surveys of patiet safety culture sice the passage of the AE law? Evaluatio Questios What are the most sigificat patiet safety challeges facig reportig facilities today related to evet reportig ad process improvemet? What have the biggest successes bee? What chages have bee implemeted withi reportig facilities as a result of the adverse evets reportig law? How are we safer, or ot safer, tha we were five years ago? Does the AHE process help or hider the patiet safety jourey? How could/should the process be modified to be more reflective or useful? What do reportig facilities eed from MDH ad other stakeholders i order to move forward o patiet safety? To what extet has your facility implemeted staffig, educatio, policy/procedure, or other chages i respose to specific categories of adverse evets? To what extet has the priority level of patiet safety withi your orgaizatio chaged sice the passage of the law? Are we safer ow tha we were five years ago? To what extet has your facility made use of adverse evets-related resources available through MDH, MHA, or Stratis Health? What resources will be helpful for your facility goig forward? Miesota Departmet of Health 5

8 Survey Resposes by Facility Type beds beds beds 10% 28% Survey respodets came from a wide variety of facilities; 18% represeted ambulatory surgical ceters, 22% came from hospitals with fewer tha 25 beds, ad 10% came from hospitals with more tha 500 beds. Respodets were most likely to be Directors of Nursig or Quality Improvemet Maagers, patiet safety maagers/ officers, or risk maagers. Patiet Safety Officer Focus Groups MDH also coducted a series of patiet safety officer/maager focus groups i October, A total of 18 hospitals ad six ambulatory surgical ceters participated i the focus groups, with represetatio from large ad small facilities located throughout the state. Each focus group was asked the followig questios: 1. What has bee your biggest challege i implemetig the adverse evets law? 2. How has your facility chaged as a result of the adverse evets law? 3. What would you cosider your orgaizatio s biggest success as a result of the reportig law? 4. How would you rate your facility s overall success aroud patiet safety? 5. How do we kow if we re makig a differece i patiet safety, idividually ad at the state level? What are the idicators of progress? 6. Has the role of leadership withi your orgaizatio chaged sice the law was passed? 7. What does leadership commuicate about the role/priority level of patiet safety? 8. How has the reportig system chaged patiet safety i MN? Are we safer ow because of it, or less safe? What has its impact bee? 9. What do you thik has to happe ext at your facility, ad at the state level, to make care safer? 12% 10% 500+ beds 22% 18% ASC <25 beds 10. What s the most importat thig MDH or MHA (MN Hospital Associatio) could do to make it easier for you to implemet the law? To improve safety? 182 CEO Iterviews Five hospital CEO s represetig hospitals of differet sizes from differet regios of the state were iterviewed i November, Each CEO was asked a series of questios about their perceptios of the law at the time of its passage ad curretly, chages that have occurred as a result of the law, challeges related to implemetatio, ad measurig the success of the law: 6 Miesota Departmet of Health

9 1. What did you thik of the ew law whe it was siged? a. What did you thik success would look like if the law were properly implemeted? b. How did you thik your orgaizatio would chage as a result of the law? 2. Today, what do you thik of the law? a. How has the law succeeded? b. How has your orgaizatio chaged as a result of the law? 3. Has your orgaizatio used iformatio from other hospitals icidets to make chages? 4. Ca you cite ay specific chages i your orgaizatio that grew out of reported evets or other iformatio you leared through the law? 5. How has leadership ad board work chaged regardig patiet safety? a. Has the structure of the board chaged? 6. Sice 2003, how has the ivestigatio of icidet reports/safety reports chaged? 7. Before 2003, did you report out or have ay improvemet projects aroud ay of the 28 adverse evets? 8. How does your orgaizatio measure whether patiet safety has improved? 9. Has the way you measure orgaizatioal culture chaged i the last five years? 10. What has bee the biggest challege related to implemetig the law? 11. What s the sigle most importat actio MHA/MDH could take i order to make the law more successful i reducig safety evets? To make it easier for hospitals to implemet the law? The resposes from focus group participats, survey respodets, ad CEO iterviews are summarized i this report. Commets ad survey resposes are orgaized ito four categories: 1. The impact of the adverse health evets reportig law 2. Measurig progress 3. The adverse evets reportig system ad review process 4. Resource use ad future resource/traiig eeds This report cocludes with a summary of recommedatios ad ext steps for the Miesota Departmet of Health, the Miesota Hospital Associatio, the Miesota Alliace for Patiet Safety (MAPS), ad other key stakeholders as we cotiue forward i our jourey towards esurig that the healthcare provided i Miesota is the safest i the atio. Miesota Departmet of Health 7

10 Results: Impact of the reportig law The AHE law has succeeded i haressig the attetio of seior leaders ad the Board o the key AHE topics. EVERY- ONE uderstads retaied foreig objects, pressure ulcers, ad wrog site/procedure evets. Evaluatio participats shared a strog belief that the reportig system has bee a catalyst for a great deal of chage withi their facilities ad across the state. The most dramatic chages have bee i the areas of board awareess, participatio ad leadership, i implemetatio of best practices, ad i trasparecy ad sharig of learig. Safety as a Priority A strog majority of survey respodets idicated that patiet safety has always bee a high priority withi their orgaizatios, eve prior to the implemetatio of the adverse evets law. But respodig facilities idicated that its importace as a priority has grow substatially sice the passage of the law. Ratig the priority level of patiet safety sice the passage of the law, 69 percet of respodets idicated that they felt patiet Safety as a Priority % 69% % 43% 33% Neutral High Priority Very High Priority safety was a very high priority, compared with 33 percet who idicated that it was a very high priority prior to the passage of the law. These results varied based o the type of facility; ambulatory surgical ceter ad very small (< 25 beds) hospitals were more likely to classify patiet safety as a very high priority tha medium-sized ad larger hospitals, who teded to idicate that it was a high priority both before ad after the passage of the law. I every group, though, facilities reported that the priority level of safety has icreased sice 2003, a strog sigal that the law has bee effective i drawig attetio to evets that may have previously bee see as uavoidable complicatios of care. The law opeed people s cosciousess up to lookig at thigs we would t have looked at i a systematic way before. This higher priority maifests itself i several ways, icludig the establishmet of high-level patiet safety/quality improvemet committees, leadership ivolvemet i root cause aalyses, the additio of patiet safety as a stadig ageda item for goverig board, leadership ad staff meetigs, ad icreased resources devoted to patiet safety activities. Biggest Chages i Facilities as a Result of the Law Some chages that have come about as a result of the adverse evets law are difficult to quatify, but provide strog evidece of a shift i the focus of orgaizatios towards prevetio, sharig of 8 Miesota Departmet of Health

11 iformatio ad learig. Chages i culture, frequecy of staff assertiveess i risky or hierarchical situatios, level of buy-i or support from leadership ad from physicias, ad icreased trasparecy aroud adverse evets ad ear misses are all chages that oe would hope to see as a result of a statewide or facility-level safety campaig; all are chages that were cited by evaluatio participats to varyig degrees. I some cases, these efforts may have bee i place prior to the law, or would have bee implemeted eve i the absece of the law. However, a clear theme that emerged from the resposes is the idea that the law helped to focus attetio o safety beyod what it might otherwise have bee, ad that it raised the sese of urgecy about correctig the root causes of these evets. Facilities oted that the law was a catalyst for: Icreased awareess ad ivolvemet at the highest levels withi the facility, particularly by the CEO ad Board of Directors. Improved commuicatio to ot oly discuss whether a evet falls ito the AE categories, but to report icidets that would ot have bee reported before. Icreased focus o these evets as usually prevetable, ad o aalysis of their root causes. As oe evaluatio participat said, the law has helped to shift the focus from respodig to adverse evets to prevetio of them: There was a time that if o oe was adversely affected the issue did ot get the attetio that it was due. There is a chage i staff uderstadig so ow potetial ad actual adverse evets receive the same attetio. The goal is to prevet. But while the public reportig aspect of the system has The biggest chage for bee a catalyst for may chages, ad has icreased the us was that our circulatig pace at which best practices are adopted, it also creates urses ow feel that they uique pressures o reportig facilities. Cocers about have the authority to stop whether all facilities were usig the same defiitios to progress i the O.R. util the determie whether or ot evets were reportable were Pause for the Cause (presurgical time-out) has bee raised by several participats, as were cocers about the media focus solely o umbers rather tha o the may successfully completed. positive chages that are happeig. As oe participat commeted: The biggest chage is greater acceptace of trasparecy aroud adverse evets, especially broadcastig our evets ad evet patters to the frot-lie. There is probably also a greater pull to lear from other facilities with the same challeges. (Our) focus was always o patiet safety, however ow safety efforts are better uderstood by more of our staff ad we prioritize this work ahead of other work. The resources beig provided assist us to further this work quicker. Data is helpig us to create more sese of urgecy for this work. As soo as leadership seds the message that we re havig too much of somethig [reported adverse evets], the we will have fewer reported that s a tough balace. Miesota Departmet of Health 9

12 Leadership Ivolvemet Oe of the keys to a creatig a safe culture is for executives ad boards of directors to show through resource allocatio, seekig out ad respodig to data, ad maitaiig a physical presece i the facility through patiet safety rouds or discussios with staff - that patiet safety is a high priority. Evaluatio participats strogly agreed that the reportig law has bee a importat driver for high-level chage, which takes a umber of forms: (The report) certaily is a required coversatio every CEO must have with the board every year. If there was t a good coversatio about patiet safety ad quality with the board every year before, this required it. I do t have ay problem gettig fuds for evets, safer techology, for example. I thik the law has added support for gettig resources. The board speds as much time o safety as o fiace. I would ever have broached that subject [patiet safety] myself if the law had t bee passed; I would t have brought it to the board level. At a board committee level, every moth the first thig o the ageda is ay adverse evets. Our board members do safety rouds. Beyod the board level, the law has helped executives focus o adverse evets as well; ad whe safety is a high priority at the top, that sese of urgecy teds to spread throughout the orgaizatio. As oe CEO put it, Startig with myself, I ve chaged. Before this time, I thought we were doig a great job, we had a quality perso i place. But I really sat up ad paid attetio to what a differece this makes i the quality of care people receive. We re ow talkig about it at every level i the orgaizatio, everyoe from housekeepers ad dietary to leadership ad board members. The fact that executives ad board members are becomig more egaged i patiet safety efforts, ad more hads o i their approach to learig about potetial safety hazards ad successful solutios, is a very dramatic chage compared with where Miesota, as a state, was five years ago. While ideas, solutios, ad eergy for prevetig adverse evets ca ad do come from frot lie staff, those same staff will quickly lose that eergy if they do t feel that patiet safety is a priority for the etire orgaizatio, ad that the issues they idetify will be addressed. Developig more leaders who ca serve as patiet safety champios, ad who ca model the importace of high-reliability priciples ad a fair ad just culture, will move us closer to the poit where that approach will become the orm for all healthcare providers. Physicia Ivolvemet While attetio to patiet safety has icreased at all levels i reportig facilities, makig sure that physicias are egaged i ad supportive of ewly-implemeted policies ad practices, ad that they are full parters i creatig a culture i which all team members feel comfortable speakig up about safety risks remais a challege i may facilities. Most participats who brought up 10 Miesota Departmet of Health

13 this topic agreed that the vast majority of physicias ad surgeos are compliat with ew stadardized processes ad safety measures, but that buy-i is ot uiversal. Ad, as several oted, a lack of uiversal ad ethusiastic buy-i from physicias ad surgeos ca have a dramatic effect o culture ad attitudes, particularly withi the operatig room. Respodets oted that the captai of the ship metality still exists to a extet, with surgeos ot always beig ope to beig questioed about their decisios or choices. As a result, some OR team members are reluctat to speak up about issues of cocer, or if they feel that a surgeo or other provider is about to make a error. Oe CEO oted that some physicias ca be a difficult sell whe a facility is tryig to implemet stadardized processes such as site markig or time-outs for ivasive procedures, ad that the ew emphasis o trasparecy is, for may, a dramatic chage from the past. Certaily (a challege) has bee educatig the providers. They grew up i the school of peer review, secrecy ad protectio, to ow where they re beig asked to disclose everythig. That s bee a leap for them. Physicias are usually ot employees of hospitals, but rather are idepedet practitioers who have privileges i oe or more facilities. This meas that makig sure that they are icluded i all plaig for adoptio of ew policies, ad requirig participatio i certai activities or processes, ca be challegig. A additioal complicatig factor for certai facilities is that they may have physicias from eighborig states who also have privileges i their facility. If those states have differet disclosure ad reportig laws, differet practices for pre-operative verificatio, or differet approaches to addressig other issues, makig that cogitive switch ca be difficult for physicias. This ca also be a issue whe physicias practice i multiple facilities withi Miesota, highlightig the eed for a cosistet approach to prevetio across facilities wheever possible, as i the area of time-outs. Implemetatio of Best Practices While progress o the jourey towards the safest possible healthcare system ca be measured i may ways, oe very importat factor is the extet to which facilities have created a culture that values trasparecy, sharig of learig about risks ad solutios, settig goals, ad supportig staff who speak up about risks. Survey respodets were asked about a umber of best practices related to data sharig ad trasparecy, to see whether or ot the rate of adoptio of these practices has icreased over the last five years. Implemetatio of Best Practices Curretly Prior to Law Sharig of adverse evet data with Board Sharig of adverse evet data with staff Sharig of adverse evet data with other facilities Policy of disclosig adverse evets to patiet/families Leadership Walk Arouds Admiistratio sets measureable patiet safety goals Regular assessmet of patiet safety culture 0 20% 40% 60% 80% 100% Miesota Departmet of Health 11

14 Now I always ask the questio, Have you talked to your colleagues aroud tow about ways they ve bee successful i this area? The ability to dialogue was made easier; it s o loger a taboo topic. (The reportig system) was able to idetify issues before they happeed so whe somethig had happeed at five facilities but it had t happeed at yours yet, it gave us a opportuity to address issues before they eve occurred. The results showed a very dramatic movemet o all measures sice 2003, to the poit where adoptio of the full set of best practices has become the orm across the vast majority of facilities rather tha the exceptio. May of these practices have a strog basis i patiet safety research ad literature, ad form the foudatio of a comprehesive patiet safety program. I 2003, whe the adverse evets reportig system was just begiig, it was uusual for facilities to share ay iformatio about their adverse evets with staff or eve boards of directors, ad almost uheard of for a facility to share adverse evets data with other facilities. This has bee oe of the areas that has see the most dramatic growth, with more tha 80 percet of facilities ow sharig adverse evets data with other facilities ad all or early all sharig data ad learigs with staff ad boards of directors. This sharig of iformatio is at the heart of the adverse evets reportig system, ad it has bee a catalyst for may facilities to try ew approaches or solutios that have bee tested by others before them. Ofte, facilities are able to implemet ew strategies proactively, havig leared about a evet i aother facility that could affect them i the future. The resposes also provide more evidece of growig leadership ivolvemet i patiet safety. Executives ad boards of directors are ow twice as likely to set measurable goals for staff aroud patiet safety as they were i 2003, ad the percetage of facilities that have adopted Leadership walk-arouds, or regular visits by executives or board members to cliical areas to lear about patiet safety issues, has icreased from just over 30 percet i 2003 to 60 percet i While strategies to prevet adverse evets ofte focus o educatio, ew policies, ad revised processes, these chages are less likely to be sustaiable ad effective i the log ru if the orgaizatio s culture is ot oe i which patiet safety is a high priority ad staff feel safe talkig about potetial risks or behaviors that might compromise safety. Orgaizatios should regularly assess their ow culture, to see whether those fudametal priciples are i place ad that they are beig as supportive as possible of staff who do speak up about risks or adverse evets. Compared with 2003, may more facilities are ow coductig regular culture assessmets; adoptio of this best practice has grow from less tha 30 percet i 2003 to more tha 80 percet i 2008 amog respodig facilities. Fially, more ad more facilities are puttig disclosure policies ito place, esurig that patiets ad family members who experiece a adverse evet or other serious outcome are provided with iformatio about the evet, ad about what the facility is doig to prevet it from happeig agai. Prior to the passage of the law, early sixty percet of facilities had disclosure policies; that figure has ow grow to 90 percet. Not all of these chages ca be attributed solely to the adverse evets law. May of these practices have become much more widely supported atiowide, have bee part of atioal iitiatives such as the Istitute for Healthcare Improvemet s 100,000 Lives campaig, ad have a growig basis of support i literature. Give that cotext, some may have bee adopted eve i 12 Miesota Departmet of Health

15 the absece of the adverse health evets law. However, focus group ad survey respodets idicated that the law has pushed chages such as these to happe more quickly or more thoroughly tha they might have otherwise. Adoptio of these best practices has accelerated greatly i the last five years, but there is still room for improvemet. While the percetage of respodig facilities that use leadership walkarouds has icreased to 60 percet, a umber of facilities idicated that they still eed ideas or assistace i egagig leaders i patiet safety iitiatives. Implemetatio of walk-aroud policies might be oe strategy that could be explored by those facilities, alog with providig additioal traiig to boards of directors or usig existig hospital leaders to serve as champios amog their peers. Regular assessmet of safety culture ad the settig of measurable patiet safety goals by facility admiistratio also still hover aroud 80 percet, idicatig that more support may be eeded i those areas. Sharig of iformatio Oe of the goals of the adverse health evets reportig law, whe it was first implemeted, was to create a first of its kid system that ecouraged sharig of adverse evets iformatio across facilities as a strategy for fosterig learig. The theory was that if facilities could lear from the experieces of others, they would be more effective i prevetig similar evets from occurrig i their ow facilities, thus acceleratig the adoptio of chage across the state. As oted above, evaluatio participats agreed that this has bee oe of the key successes of the reportig system. there s a exorbitat amout of iformatio. Part of the problem there is tryig to filter that dow to a useable tool that ca be circulated to everyoe. It s bee difficult. I particular, may participats highlighted the Miesota Hospital Associatio s work i implemetig statewide calls to actio aroud the four most commo adverse evets as oe of the most successful examples of data sharig ad collaboratio. I these campaigs, developed i respose to data submitted through the adverse evets system, CEO s agree to implemet a series of evidece-based best practices ad to report quarterly o their progress. As oe participat oted: I feel the workgroups put together by MHA to address the most frequet adverse evets have bee a importat step forward i improvig care ad patiet safety. It has bee very good to work with other hospitals i the state to improve patiet safety, ad ivet oe ew wheel, for example for the prevetio of pressure ulcers, rather tha everyoe tryig to reivet their ow idividual wheel. However, evaluatio participats also oted that there is room for improvemet i the compilatio, aalysis, ad sharig of data by MDH. Sometimes, the sheer volume of iformatio available ca be overwhelmig, ad participats expressed a eed for MDH to fid ways to break key learigs dow ito maageable blocks, focusig o root causes, successful corrective actios, ad more guidace o where they should focus their attetio. Others expressed a desire for more iformatio about the big picture, ad a better sese of what we re learig o a large scale from the reportig system. (We) look at what s goig o i other hospitals ad if they see somethig uusual they ll make sure we re followig it, like (prevetig the) use of dagerous abbreviatios, labelig, dagerous medicatio uses we try to lear from what other hospitals are doig. Miesota Departmet of Health 13

16 Process Improvemets ad Stadardizatio Before we had some kid of processes, but ow we have improved processes; we re closer to the stadard ow. Oe of the keys to successful implemetatio of procedures or policies that are meat to prevet adverse evets is cosistecy ot oly withi but also, whe feasible, across facilities. While complete stadardizatio is t usually possible i every situatio due to differig patiet eeds, it s importat to make sure that there are basic steps that are doe the same way every time, wheever possible. Evaluatio participats oted that the overall level of stadardizatio of processes has icreased, a key elemet i developig a highly reliable orgaizatio with clear expectatios. This stadardizatio is particularly crucial i the operatig room ad i procedural areas. As recet evets have highlighted, a lack of cosistecy i how facilities carry out pre-operative time-outs ad site markig ca icrease the risk that a error will reach the patiet. Ofte, a lack of stadardizatio meas that some team members do t uderstad how to implemet a process correctly, ad that it s more difficult for team members to spot situatios i which other are driftig from the correct approach. It s ot a optio to ot mark somethig dow (i the surgery room). Chages i cliical practice Nurses kow that the clipboard goes ito the room with a markig pe; they explai that this is the site documetatio process that we implemet here. Over the life of the adverse evets reportig system, the most commoly reported evets have bee serious pressure ulcers (bedsores), wrog-site surgery, retaied foreig objects, ad falls. These four categories of evets have accouted for more tha 80 percet of all reported evets across the five years that the system has bee i effect. A particular focus of MDH s work, ad that of the Miesota Hospital Associatio, has bee o defiig best practices for prevetio of these evets, ad helpig facilities to implemet those practices successfully. Facilities lear about best practices through a variety of aveues. The four statewide Calls to Actio are a importat resource for may participats, providig them with a roadmap or budle of steps that should be put i place i order to prevet evets from recurrig. But our growig uderstadig about how to prevet evets also comes from aalysis of idividual evets, feedback give through the review process, ad cosultatio with cliical experts. Evaluatio participats oted that they have made a umber of chages i their policies, processes ad resource allocatio i the four areas that are most commoly reported (falls, pressure ulcers, wrog site surgery, ad retaied foreig objects). Overall, the most commo steps that facilities took i respose to these evets were implemetig process chages, providig additioal educatio to staff, sharig data across the facility, ad creatig topic-specific teams, such as orgaizatio-wide ski safety or falls teams. 14 Miesota Departmet of Health

17 100 Chages i Respose to Adverse Evets 80 X 60 X X 40 X X X 20 X Pressure Ulcers Wrog Site Surgery Falls X X Retaied Objects 0 More Staff More Resources New Policy Chaged Policy Champio Process Chage Teams Educatio Sharig Data The idea of idetifyig a champio for a particular type of evet, who ca ecourage peers to be egaged i the topic, help to educate about best practices, ad serve as a very visible supporter of process chages, has begu to be more widely adopted across facilities, i part because of the Calls to Actio. More tha half of respodets had idetified oe or more champios for falls ad pressure ulcers, ad early half had doe so for pressure ulcers ad retaied objects. Ofte, this type of peer-reiforcemet ad role-modelig positio ca help to miimize oppositio to plaed chages, particularly if the champio is someoe who is widely see as ifluetial ad kowledgeable. The adoptio of team approaches to aalyzig ad prevetig adverse evets has also caught o with may facilities. More tha 60 percet of facilities had established falls teams, ad roughly half had established teams to address pressure ulcers, wrog-site surgery, ad retaied objects. These teams ca iclude a very broad group of caregivers, icludig physicias, urses, therapists, dietary staff, aides, trasport staff, techicias i procedural areas, ad eve maiteace staff, depedig o the issue. This reflects a growig awareess that may of these issues ca cross shifts, uits, ad disciplies, ad that ay corrective actios that do ot ivolve all caregivers are less likely to be successful. Miesota Departmet of Health 15

18 Results: Measurig Progress While there has bee a lot of activity, coversatio, ad policy chages, there is o proof that we have positively iflueced the risk of these evets. To some extet this is because the AHE law was ever set up as a measuremet system, there is o risk-stratificatio, there are o deomiators, ad we are cotiually modifyig the defiitios. So it is possible that there has bee improvemet but it has ot bee detected. Patiet safety is a complex ad multifaceted cocept, oe that ca be ad is measured i may differet ways by idividual facilities ad state/atioal orgaizatios. Safety ca be measured i terms of the absece of serious reportable evets, the presece of a safe ad trasparet culture, the implemetatio of best practices, the perceptios of patiets that they are receivig safe ad high-quality care, or performace relative to state or atioal goals. As a result, may facilities struggle with the questio of how best to measure the extet to which they are makig progress, particularly i the area of adverse evets. Prior to the implemetatio of the law, there was o statewide system for assessig how frequetly these evets happeed. While idividual facilities tracked their ow adverse or serious evets, ress) is to moitor how may Certaily oe gauge (of prog- there was o policy i place requirig reportig people are talkig about it. I of a cosistet set of evets to a cetral locatio, differet meetigs someoe ad o compilatio or reportig of results across will always make a commet facilities. At the time the law was implemeted, that before may ot have bee there was also o reliable way of predictig how i the equatio--it s so foremost o people s mids, you may evets were likely to be reported each year, how Miesota might compare with other states, hear commets all the time. or how log it might take to lear from ad ultimately reduce the frequecy of these evets. The questio of how progress should be measured was also discussed by stakeholders, with most agreeig that the best way to assess progress is to use multiple measures of success. Whe CEO s were asked what they thought success would look like at the time of the law s implemetatio i 2003, most oted that a reductio i adverse evets should be a key goal of the law. But they also oted that icreased collaboratio amog facilities aroud prevetio of adverse evets, trasparecy, ad sharig of learig were also a importat part of the defiitio of success for the reportig system. There is o way to really kow how may icidets were happeig before. The first few years of the law have icluded chages ad clarificatios i defiitios of reportable evets, ogoig educatio about facilities requiremets uder the law, ad the developmet of strog systems for otifyig facilities about chages i defiitios. This start-up process has muddied the waters somewhat, makig it difficult to kow whether ay year to year shifts i the umber of evets are due to defiitioal chages, improvemets i compliace, a better uderstadig of the law, or statistical oise. A few facilities oted that while they kew that umbers would probably go up before they wet dow, as a result of improved uderstadig of the law ad icreased compliace, they were experiecig some frustratios related to the fact that evets cotiue to happe. Some 16 Miesota Departmet of Health

19 oted that while they had experieced multiple evets i the same category, the evets themselves were so differet that sharig learigs or corrective actios betwee the evets was t really possible: For some topics, such as medicatio errors, sexual assault, or ifat abductio, they are so rare ad the causative factors are so diverse that learig ad applicatio beyod the origial evet ad site is almost impossible. This quote highlights aother crucial aspect of the reportig system; its ability to allow facilities to lear how to more effectively prevet rare evets that they may ot have ever experieced. With evets that happe so rarely, some facilities may have put processes ito place that have ot yet bee tested by a real case. I that eviromet, spottig potetial risks i a process or system ca be more difficult. But by learig from facilities that have experieced these evets, others are able to idetify where their ow systems have the potetial to fail, ad implemet process improvemets to prevet those failures. We have had a large reductio of patiet falls i our facility. Our pressure ulcers are miimal ad our processes are take seriously ad have bee istituted hospital wide from ursig through physicias. Others commeted that the huma elemet is always upredictable, eve with the best-desiged system. As oe CEO put it: After the first year we put a buch of procedures i place to prevet it, ad the exact same thig happeed agai. Ad it all comes back to humas. You thik you fix all the systems but it just takes oe perso, oe time, oe thig ad that s a problem with healthcare. It s so people depedet; it s very difficult to get our arms aroud. Success would mea that people would actually work together to try to prevet these evets across hospitals, ad I thik that s come to pass. I may ways, this commet gets to the heart of the challege that may facilities face whe workig to prevet adverse evets. As the ladmark Istitute of Medicie report To Err is Huma so clearly stated, the healthcare system is depedet o humas to deliver care, ad those humas are fallible. We have a tedecy to expect perfectio, ad to assume that every perso is capable of complete vigilace i all situatios at all times, eve i a eviromet where patiets eeds ad coditios may be chagig rapidly. We expect this eve whe we kow that perfectio is impossible. Ad yet, healthcare providers have a obligatio to esure that the care they deliver is as safe as possible every time, ad that they are puttig redudacies ad barriers i place to prevet the ievitable huma errors from reachig ad harmig patiets. They also have a obligatio to maage their staff s behavioral choices ad to make it easier for them to choose the safest optio every time rather tha takig shortcuts that may compromise care. That tesio betwee expectatios of perfect performace, the reality of huma fallibility, ad the huma tedecy to make thigs simpler sometimes results i frustratio, both for leaders ad for frot-lie staff. Our practices are more itetioally directed at patiet safety - this is obvious by chart reviews, etc. However, we are ot seeig sigificat chages i our umbers. Miesota Departmet of Health 17

20 The adverse evets law was a catalyst for broader, orgaizatio-wide appreciatio of istaces previously viewed as a complicatio or the atural course of healthcare delivery to istaces that could ad should be prevetable/avoidablea catalyst for a paradigm shift. The law has also improved the sese of urgecy aroud becomig safer. Are we safer? Over the five years that the adverse evets reportig system has bee i effect, a umber of state ad atioal campaigs have brought icreased attetio to specific patiet safety issues. At the same time, chages such as the decisio of certai payers to o loger pay for prevetable evets ad icreasig regulatory oversight of care providers have bee catalysts for a umber of safety-related iitiatives. Give that chagig eviromet, separatig out the impact of the adverse evets reportig law itself ca be difficult. However, a strog majority of facilities respodig to the survey felt that the reportig law has made us safer tha we were five years ago. Respodets stated agai that it ca be difficult to kow whe a evet has bee preveted, ad that we had o baselie prior to the law with which to compare curret performace; they also oted that the adverse evets law aloe is ot resposible for all safety improvemets that have happeed. As oe focus group participat stated, the law is oe driver for chage but ot the oly driver. Are We Safer? Neutral 28% More Safe 62% 10% Sigificatly more safe 182 I agree that the attetio to safety is startig to move the culture. People are talkig differetly about safety ad about teamwork. However, evaluatio participats agreed that i may facilities, the reportig law has helped to drive a greater degree of trasparecy, improved iterdiscipliary teamwork, icreased awareess of patiet safety issues ad risks, ad chages to iteral evet review processes. Several participats also oted that the law has give added back-up or authority to their efforts. As oe participat oted, the law has give us the power to eforce. Respodets also remarked that awareess ad trasparecy aloe will ot make care safer, ad that we still have a great deal of work ahead of us before we ca defiitively say that we ve improved care i a measurable ad 18 Miesota Departmet of Health

21 sustaiable way. Several oted that the reportig system may lead to a diversio of attetio or resources from other areas that are equally importat, that trasferable learig from rare evets may be limited, or that a focus o implemetatio of best practices may mask cotiuig icidece of evets. It s really raised the bar. I m proud to say that. Give the lack of a baselie, issues related to defiitioal clarificatios or expasios, ad the may dimesios alog which progress ca be measured, assessig whether or ot the law has bee successful i reducig the frequecy of adverse evets is difficult. Nearly all evaluatio participats agreed that we are safer ow as a result of the law, but may also agreed that coutig the umber of evets that happe i ay give year is ot the oly, or perhaps eve the best, way to measure safety. As oe CEO oted, there are may idicators of patiet safety, icludig measures required or recommeded by Medicare, Leapfrog, the Joit Commissio, ad other orgaizatios. To truly measure progress, it s ecessary to look at the icidece of adverse evets, but also at progress o these other measures of success. the focus o these evets by ecessity diverts attetio from other evets that may be occurrig more frequetly i a give istitutio. Therefore, we may be simply steppig o a balloo i terms of overall safety. Still, the focus is helpful as it disciplies the orgaizatio to focus o its core processes. Miesota Departmet of Health 19

22 Results: Reportig ad Review Process It s iroic that we re i the busiess of makig systems work better for huma beigs yet, as part of the reportig process (we) have to work with such a difficult system. The techical part of the process is t really ituitive. It does t flow right. Tryig to pick a classificatio (for a root cause) you pick oe because you have to, but it may ot be what you would choose if there were other choices. I the five years that the adverse evets reportig system has bee i place, it has evolved from a relatively simple web-based reportig system ad review process to a much more comprehesive system that ecompasses multiple reviews of every evet, a larger amout of data that is required for each evet, ad alerts ad campaigs based o best practices ad other issues idetified through the reportig ad review process. But the backboe of the system remais the reportig ad aalysis of idividual adverse evets. This process is desiged to provide focused feedback to reportig facilities about each evet, as well as a mechaism for movig them towards more robust aalysis of the root causes of the evet ad the developmet of strog ad effective corrective actios. O a larger scale, the review process is also a mechaism for aalysis of treds ad learigs across facilities, some of which have formed the basis for statewide campaigs to prevet the most commo types of adverse evets. I practice, though, the system itself ca sometimes pose challeges for reportig facilities. To facilitate aalysis of treds across evets, the webbased reportig system sometimes pushes facilities to fit the fidigs of their ofte far-ragig aalyses ito pre-determied boxes rather tha submittig free-form resposes. This ca mea that more follow-up is ecessary i order to get the whole story about a evet, leadig to delays i movig evets through the review process to completio. (We have a) much more diliget process i aalyzig evets ad actios for follow-up ow. As the umber of reported ad reportable evets has grow, ad as the umber of potetial reviews of ay particular evet has grow from two to three, the review process has experieced times of slower pass-through. Several participats said that it has take several moths before they received a review o their evets. I some istaces, those participats said their teams had already moved o by the time they received feedback o their evet aalysis (implemetig corrective actio plas, etc), ad that it ca be difficult to brig participats back to those evets to further hoe the aalysis or to develop ew fixes. We were JCAHO previously so root cause aalysis was i place, ad reportig o paper has t chaged a lot. But what has chaged is people do t see it as a paperwork compliace issue aymore, they take it to heart. Both the relatively rigid framework of the reportig system ad the sometimes slow-movig review process ca lead to frustratio for reportig facilities, as expressed by focus group participats. Focus group participats also expressed frustratios with the cotet of the review process, which attempts to balace costructive feedback o a evet with the requiremet 20 Miesota Departmet of Health

23 that each evet pass o all review criteria. This balace of quality improvemet ad costructive criticism sometimes causes frictio; participats idicated that the process sometimes feels more like regulatio tha quality improvemet, ad commeted that it ca feel discouragig to hear that they eed to go back ad make chages to a pla that they had cosidered complete. Overall, participats suggested that the process could be modified so that it has a icreased focus o learig ad coachig, rather tha o poitig out isufficiecies. Prevetability Aother very commo theme that emerged i focus groups ad iterviews was the issue of prevetability. While the Natioal Quality Forum s list of Serious Reportable Evets i HealthCare, o which Miesota s Adverse Health Care Evet reportig law is based, is sometimes referred to as the ever evets list, there are situatios i which evets may ot be prevetable. Particularly i the case of pressure ulcers, cliically complex patiets with multiple co-morbidities ca quickly develop pressure ulcers eve with the best of care, as ca patiets who are udergoig log surgical procedures. I the area of falls, facilities occasioally ecouter situatios where eve the best risk assessmet ad patiet educatio programs ca t prevet a patiet from decidig ot to use their call light to ask for assistace i a particular situatio. Facilities also sometimes have to balace cocers of safety ad patiet privacy, as whe a patiet would like to use the bathroom by themselves but the care pla might idicate a eed for closer observatio. While the sharig of iformatio throughout the healthcare facility populatio might spark ad reew iterest i the topics, the actual reportig of iformatio is a data process oly ad has ot seemed to ifluece the umber of adverse evets that are reported. There are too may variables (that) make these evets ot prevetable a lot is out of our cotrol. While these situatios are rare, they ca lead to frustratio, give that evets must be reported regardless of whether the facility cosiders them prevetable or ot, ad the public report does ot distiguish betwee prevetable ad o-prevetable evets. Without the ability to share more iformatio with the public about the circumstaces surroudig each evet, some facilities worry that o-prevetable evets will be viewed as withi their cotrol, makig them appear less safe whe they may ot have had total cotrol over the situatio. These situatios also raise the cocer that, without stadards for determiig what makes a particular evet prevetable, the level of certaity required to make that determiatio may differ across facilities. Dealig with staff perceptios that certai evets are ot prevetable ca add a additioal layer of challege. If frot-lie staff or leadership believe that, for example, pressure ulcers caot be preveted, they may be less likely to look for potetial areas of process improvemet i more complex cases, or to view fixes desiged to address these issues as ulikely to succeed. The questio of prevetability will always be evolvig. What we may cosider to be oprevetable today may well be prevetable i the future, as we cotiue to lear more about Miesota Departmet of Health 21

24 (Falls ad pressure ulcers) are ot ecessarily all avoidable because of patiet choice. It s sort of a overridig cosesus that pressure ulcers are ot prevetable. where the risks lie ad develop ew strategies to reduce those risks. The challege, with the issue of prevetability, is to make sure that we are lookig at all possible aveues for improvemet, rather tha viewig prevetability as static, ad workig to reduce risk as much as possible. Defiig Reportable Evets Defiitioal issues ad chages also pose a ogoig challege for reportig facilities. While the Adverse Health Evets Reportig Law defies 28 categories of reportable evets, there has bee a ogoig eed to provide guidace to facilities o how to iterpret reportability of idividual evets that may ot fit eatly ito oe category, or where the statute may ot have captured the full variety of possible scearios. Over the five years that the reportig system has bee i operatio, clarificatios or decisio tools have bee developed related to the defiitio of serious disabilities, whe a surgery is cosidered complete for the purposes of idetifyig retaied foreig objects, what is cosidered a ivasive procedure, the differece betwee deep tissue ijuries ad pressure ulcers, ad the defiitio of sexual assault, amog other topics. The ogoig refiig of evet defiitios has led to cofusio for some reportig facilities, as well as a eed to verify that the defiitios are iterpreted, ad evets reported, i the same way across facilities. It also makes it difficult to compare results from the early years of the reportig system to those from more recet years, after defiitioal guidace has bee issued. As oe CEO oted, if reportability is t viewed the same way across facilities, the report itself is less accurate, ad it becomes less useful i paitig a true picture of how ofte, ad why, these evets occur. If there are icosistet defiitios of evets, facilities that are broader i their iterpretatio of what is reportable may also face the possibility of more egative media coverage or scrutiy whe the aual report is released tha those who use a arrower defiitio of reportability; i effect, this puishes those that are makig a greater effort to fid ad report all evets, eve those for which reportability is uclear. 22 Miesota Departmet of Health

25 Results: Resource Use & Future Needs Through the reportig system ad the collaborative efforts of the Miesota Hospital Associatio, the Miesota Departmet of Health, ad Stratis Health, reportig facilities have access to a umber of traiig opportuities, resources, ad forums for sharig ad learig from each other. Evaluatio participats were asked about their use of available resources, ad the degree to which they foud them to be useful. I geeral, respodets idicated that all of the available resources are useful to them; more tha 60 percet of respodets idicated that every type of resource was useful, ad the average across all categories was 82% idicatig that the resource was very useful or useful. Matchig what evaluatio participats said i respose to earlier questios, they idicated that the MHA-led Calls to Actio o wrog site surgery, retaied spoges i labor ad delivery, falls, ad pressure ulcers were the most useful tools/resources for their work. Participatio i the campaigs themselves was very highly rated, as was the quality of the tools ad templates that were made available to campaig participats. Additioally, survey respodets oted that the safety alerts that are periodically issued by MDH ad MHA are very useful. Use of Adverse Evets Resources Safety Alerts Newsletters/Publicatios MDH Traiig MHA Traiig MHA Calls to Actio Calls to Actio Tools/Templates Participatio i Listserves Days of Sharig MHA Data-sharig Database Feedback Durig Review Process 59% 36% 31% 53% 14% % 49% 14% 41% 48% 10% 57% 29% 14% 67% 24% 27% 50% 20% 37% 40% 21% 26% 44% 23% 20% 43% 25% 12% Very Useful Useful Neutral Not Very Useful Agai mirrorig earlier resposes, a smaller percetage of facilities idicated they foud the feedback ad commets that they received durig the evet review process to be useful, although this umber was still over 60 percet. Miesota Departmet of Health 23

26 Goig forward, participats expressed a desire for a variety of resources, traiig, ad data sharig tools from MDH ad MHA, to help them work more effectively with leadership, egage patiets ad families, ad draw out key poits from the data collected by the adverse evets system: Iformatio about treds/patters i submitted root cause aalysis ad corrective actio plas Stories ad case studies about successful practices implemeted i other Miesota facilities or i other states Summaries of relevat atioal research or publicatios Iformatio about successful strategies for egagig leadership i patiet safety Opportuities to share experieces or challeges related to specific types of adverse evets or other topics Successful strategies for egagig leadership Iformatio ad resources related to patiet/family egagemet ad disclosure Improved fuctioality i the web-based registry for ruig reports 24 Miesota Departmet of Health

27 Recommedatios ad Next Steps The evaluatio of the adverse health evets reportig system revealed a umber of clear messages about the success of the system. The reportig law has bee a catalyst for dramatic improvemets i adoptio of best practices aroud trasparecy ad disclosure, ad i sharig of data ad learig both withi ad across facilities. It has also bee a driver for icreased ivolvemet/egagemet i patiet safety by board members ad executives, as well as by staff at all levels. I the last five years, Miesota has take great strides towards creatig a statewide culture of safety, trasparecy, ad learig, ad the reportig law has bee a crucial part of that process. But the resposes of evaluatio participats also poit out that there is still room for improvemet. As the reportig system moves ito its ext phase, there are a umber of steps that the Miesota Departmet of Health, its parters, ad other stakeholders should take to esure that the progress of the first five years is maitaied, ad that we are doig everythig possible to support ad assist facilities as they implemet additioal strategies for improvemet. Recommedatios for ext steps iclude: Developig ew methods for regularly sharig key learigs from idividual adverse evets, as well as iformatio about overall treds, with reportig facilities. With a sometimes overwhelmig amout of iformatio available, facilities eed help to filter through large amouts of data ad decide what will be most useful for them to accelerate learig/adoptio of best practices. Moitorig the process for reportig ad reviewig adverse evets, ad implemetig chages to esure that the reportig system is as easy to use as possible, provides meaigful ad costructive feedback o idividual evets ad broader categories of evets, ad is timely. Ecouragig regular admiistratio of safety culture surveys by all healthcare orgaizatios aroud the state, ad providig assistace to facilities i how to act effectively o their fidigs, how to bechmark their results agaist similar facilities, ad how to commuicate fidigs to staff ad to leadership. Workig with admiistratio/boards of directors to ecourage adoptio of active leadership strategies such as executive/board walk arouds ad the establishmet of measurable safety goals for every facility, ad cultivatig executive or board-level champios who ca educate peers about effective practices for creatig ad maitaiig a safe culture. Workig with educators, cliical traiig sites, ad healthcare providers to ecourage itegratio of teamwork ad iterdiscipliary traiig, traiig about patiet safety priciples, ad educatio about the role of orgaizatioal culture as a part of the educatio of all Miesota physicias ad other providers Workig with professioal orgaizatios ad practicig physicias to esure that physicias ad surgeos are fully egaged i patiet safety iitiatives, ad cultivatig additioal physicia champios or leaders o specific cliical issues such as wrog-site surgery, retaied foreig objects, ad pressure ulcers. Miesota Departmet of Health 25

28 Appedix A Defiitios. Subdivisio 1. Scope. Uless the cotext clearly idicates otherwise, for the purposes of sectios to , the terms defied i this sectio have the meaigs give them. Subd. 2. Commissioer. Commissioer meas the commissioer of health. Subd. 3. Facility. Facility meas a hospital or outpatiet surgical ceter licesed uder sectios to Subd. 4. Serious disability. Serious disability meas (1) a physical or metal impairmet that substatially limits oe or more of the major life activities of a idividual or a loss of bodily fuctio, if the impairmet or loss lasts more tha seve days or is still preset at the time of discharge from a ipatiet health care facility, or (2) loss of a body part. Subd. 5. Surgery. Surgery meas the treatmet of disease, ijury, or deformity by maual or operative methods. Surgery icludes edoscopies ad other ivasive procedures. 26 Miesota Departmet of Health FACILITY REQUIREMENTS TO REPORT, ANALYZE, AND CORRECT. Subdivisio 1. Reports of adverse health care evets required. Each facility shall report to the commissioer the occurrece of ay of the adverse health care evets described i subdivisios 2 to 7 as soo as is reasoably ad practically possible, but o later tha 15 workig days after discovery of the evet. The report shall be filed i a format specified by the commissioer ad shall idetify the facility but shall ot iclude ay idetifyig iformatio for ay of the health care professioals, facility employees, or patiets ivolved. The commissioer may cosult with experts ad orgaizatios familiar with patiet safety whe developig the format for reportig ad i further defiig evets i order to be cosistet with idustry stadards. Subd. 2. Surgical evets. Evets reportable uder this subdivisio are: (1) surgery performed o a wrog body part that is ot cosistet with the documeted iformed coset for that patiet. Reportable evets uder this clause do ot iclude situatios requirig prompt actio that occur i the course of surgery or situatios whose urgecy precludes obtaiig iformed coset; (2) surgery performed o the wrog patiet; (3) the wrog surgical procedure performed o a patiet that is ot cosistet with the documeted iformed coset for that patiet. Reportable evets uder this clause do ot iclude situatios requirig prompt actio that occur i the course of surgery or situatios whose urgecy precludes obtaiig iformed coset; (4) retetio of a foreig object i a patiet after surgery or other procedure, excludig objects itetioally implated as part of a plaed itervetio ad objects preset prior to surgery that are itetioally retaied; ad (5) death durig or immediately after surgery of a ormal, healthy patiet who has o orgaic, physiologic, biochemical, or psychiatric disturbace ad for whom the pathologic processes for which the operatio is to be performed are localized ad do ot etail a systemic disturbace. Subd. 3. Product or device evets. Evets reportable uder this subdivisio are: (1) patiet death or serious disability associated with the use of cotamiated drugs, devices, or biologics provided by the facility whe the cotamiatio is the result of geerally detectable cotamiats i drugs, devices, or biologics regardless of the source of the cotamiatio or the product;

29 (2) patiet death or serious disability associated with the use or fuctio of a device i patiet care i which the device is used or fuctios other tha as iteded. Device icludes, but is ot limited to, catheters, drais, ad other specialized tubes, ifusio pumps, ad vetilators; ad (3) patiet death or serious disability associated with itravascular air embolism that occurs while beig cared for i a facility, excludig deaths associated with eurosurgical procedures kow to preset a high risk of itravascular air embolism. Subd. 4. Patiet protectio evets. Evets reportable uder this subdivisio are: (1) a ifat discharged to the wrog perso; (2) patiet death or serious disability associated with patiet disappearace, excludig evets ivolvig adults who have decisio-makig capacity; ad (3) patiet suicide or attempted suicide resultig i serious disability while beig cared for i a facility due to patiet actios after admissio to the facility, excludig deaths resultig from selfiflicted ijuries that were the reaso for admissio to the facility. Subd. 5. Care maagemet evets. Evets reportable uder this subdivisio are: (1) patiet death or serious disability associated with a medicatio error, icludig, but ot limited to, errors ivolvig the wrog drug, the wrog dose, the wrog patiet, the wrog time, the wrog rate, the wrog preparatio, or the wrog route of admiistratio, excludig reasoable differeces i cliical judgmet o drug selectio ad dose; (2) patiet death or serious disability associated with a hemolytic reactio due to the admiistratio of ABO/HLA-icompatible blood or blood products; (3) materal death or serious disability associated with labor or delivery i a low-risk pregacy while beig cared for i a facility, icludig evets that occur withi 42 days postdelivery ad excludig deaths from pulmoary or amiotic fluid embolism, acute fatty liver of pregacy, or cardiomyopathy; (4) patiet death or serious disability directly related to hypoglycemia, the oset of which occurs while the patiet is beig cared for i a facility; (5) death or serious disability, icludig kericterus, associated with failure to idetify ad treat hyperbilirubiemia i eoates durig the first 28 days of life. Hyperbilirubiemia meas bilirubi levels greater tha 30 milligrams per deciliter; (6) stage 3 or 4 ulcers acquired after admissio to a facility, excludig progressio from stage 2 to stage 3 if stage 2 was recogized upo admissio; (7) patiet death or serious disability due to spial maipulative therapy; ad (8) artificial isemiatio with the wrog door sperm or wrog egg. Subd. 6. Evirometal evets. Evets reportable uder this subdivisio are: (1) patiet death or serious disability associated with a electric shock while beig cared for i a facility, excludig evets ivolvig plaed treatmets such as electric coutershock; (2) ay icidet i which a lie desigated for oxyge or other gas to be delivered to a patiet cotais the wrog gas or is cotamiated by toxic substaces; (3) patiet death or serious disability associated with a bur icurred from ay source while beig cared for i a facility; (4) patiet death or serious disability associated with a fall while beig cared for i a facility; ad (5) patiet death or serious disability associated with the use or lack of restraits or bedrails while beig cared for i a facility. Subd. 7. Crimial evets. Evets reportable uder this subdivisio are: (1) ay istace of care ordered by or provided by someoe impersoatig a physicia, urse, pharmacist, or other licesed health care provider; (2) abductio of a patiet of ay age; (3) sexual assault o a patiet withi or o the grouds of a facility; ad (4) death or sigificat ijury of a patiet or staff member resultig from a physical assault that occurs withi or o the grouds of a facility. Miesota Departmet of Health 27

30 Subd. 8. Root cause aalysis; corrective actio pla. Followig the occurrece of a adverse health care evet, the facility must coduct a root cause aalysis of the evet. Followig the aalysis, the facility must: (1) implemet a corrective actio pla to implemet the fidigs of the aalysis or (2) report to the commissioer ay reasos for ot takig corrective actio. If the root cause aalysis ad the implemetatio of a corrective actio pla are complete at the time a evet must be reported, the fidigs of the aalysis ad the corrective actio pla must be icluded i the report of the evet. The fidigs of the root cause aalysis ad a copy of the corrective actio pla must otherwise be filed with the commissioer withi 60 days of the evet. Subd. 9. Electroic reportig. The commissioer must desig the reportig system so that a facility may file by electroic meas the reports required uder this sectio. The commissioer shall ecourage a facility to use the electroic filig optio whe that optio is feasible for the facility. Subd. 10. Relatio to other law; data classificatio. (a) Adverse health evets described i subdivisios 2 to 6 do ot costitute maltreatmet, eglect, or a physical ijury that is ot reasoably explaied uder sectio or ad are excluded from the reportig requiremets of sectios ad , provided the facility makes a determiatio withi 24 hours of the discovery of the evet that this sectio is applicable ad the facility files the reports required uder this sectio i a timely fashio. (b) A facility that has determied that a evet described i subdivisios 2 to 6 has occurred must iform persos who are madated reporters uder sectio , subdivisio 3, or , subdivisio 16, of that determiatio. A madated reporter otherwise required to report uder sectio , subdivisio 3, or , subdivisio 3, paragraph (e), is relieved of the duty to report a evet that the facility determies uder paragraph (a) to be reportable uder subdivisios 2 to 6. (c) The protectios ad immuities applicable to volutary reports uder sectios ad are ot affected by this sectio. (d) Notwithstadig sectio , , or ay other provisio of Miesota statute or rule to the cotrary, either a lead agecy uder sectio , subdivisio 3c, or , subdivisio 13, the commissioer of health, or the director of the Office of Health Facility Complaits is required to coduct a ivestigatio of or obtai or create ivestigative data or reports regardig a evet described i subdivisios 2 to 6. If the facility satisfies the requiremets described i paragraph (a), the review or ivestigatio shall be coducted ad data or reports shall be obtaied or created oly uder sectios to , except as permitted or required uder sectios to , or as ecessary to carry out the state s certificatio resposibility uder the provisios of sectios 1864 ad 1867 of the Social Security Act. (e) Data cotaied i the followig records are opublic ad, to the extet they cotai data o idividuals, cofidetial data o idividuals, as defied i sectio 13.02: (1) reports provided to the commissioer uder sectios , 147A.155, , , ad ; (2) evet reports, fidigs of root cause aalyses, ad corrective actio plas filed by a facility uder this sectio; ad (3) records created or obtaied by the commissioer i reviewig or ivestigatig the reports, fidigs, ad plas described i clause (2). For purposes of the opublic data classificatio cotaied i this paragraph, the reportig facility shall be deemed the subject of the data Commissioer duties ad resposibilities. Subdivisio 1. Establishmet of reportig system. (a) The commissioer shall establish a adverse health evet reportig system desiged to facilitate quality improvemet i the health care system. The reportig system shall ot be desiged to puish errors by health care practitio- 28 Miesota Departmet of Health

31 ers or health care facility employees. (b) The reportig system shall cosist of: (1) madatory reportig by facilities of 27 adverse health care evets; (2) madatory completio of a root cause aalysis ad a corrective actio pla by the facility ad reportig of the fidigs of the aalysis ad the pla to the commissioer or reportig of reasos for ot takig corrective actio; (3) aalysis of reported iformatio by the commissioer to determie patters of systemic failure i the health care system ad successful methods to correct these failures; (4) sactios agaist facilities for failure to comply with reportig system requiremets; ad (5) commuicatio from the commissioer to facilities, health care purchasers, ad the public to maximize the use of the reportig system to improve health care quality. (c) The commissioer is ot authorized to select from or betwee competig alterate acceptable medical practices. Subd. 2. Duty to aalyze reports; commuicate fidigs. The commissioer shall: (1) aalyze adverse evet reports, corrective actio plas, ad fidigs of the root cause aalyses to determie patters of systemic failure i the health care system ad successful methods to correct these failures; (2) commuicate to idividual facilities the commissioer s coclusios, if ay, regardig a adverse evet reported by the facility; (3) commuicate with relevat health care facilities ay recommedatios for corrective actio resultig from the commissioer s aalysis of submissios from facilities; ad (4) publish a aual report: (i) describig, by istitutio, adverse evets reported; (ii) outliig, i aggregate, corrective actio plas ad the fidigs of root cause aalyses; ad (iii) makig recommedatios for modificatios of state health care operatios. Subd. 3. Sactios. (a) The commissioer shall take steps ecessary to determie if adverse evet reports, the fidigs of the root cause aalyses, ad corrective actio plas are filed i a timely maer. The commissioer may sactio a facility for: (1) failure to file a timely adverse evet report uder sectio , subdivisio 1; or (2) failure to coduct a root cause aalysis, to implemet a corrective actio pla, or to provide the fidigs of a root cause aalysis or corrective actio pla i a timely fashio uder sectio , subdivisio 8. (b) If a facility fails to develop ad implemet a corrective actio pla or report to the commissioer why corrective actio is ot eeded, the commissioer may susped, revoke, fail to reew, or place coditios o the licese uder which the facility operates Iterstate coordiatio; reports. The commissioer shall report the defiitios ad the list of reportable evets adopted i this act to the Natioal Quality Forum ad, workig i coordiatio with the Natioal Quality Forum, to the other states. The commissioer shall moitor discussios by the Natioal Quality Forum of amedmets to the forum s list of reportable evets ad shall report to the legislature wheever the list is modified. The commissioer shall also moitor implemetatio efforts i other states to establish a list of reportable evets ad shall make recommedatios to the legislature as ecessary for modificatios i the Miesota list or i the other compoets of the Miesota reportig system to keep the system as early uiform as possible with similar systems i other states. Miesota Departmet of Health 29

32 For More Iformatio: Miesota Departmet of Health Divisio of Health Policy P.O. Box East Seveth Place, Suite 220 St. Paul, MN