II. Goals of the Sentinel Event Policy

Transcription

1 Setiel Evets (SE) I. Setiel Evets I support of its missio to cotiuously improve the safety ad quality of health care provided to the public, The Joit Commissio i its accreditatio process reviews hospitals activities i respose to setiel evets. The accreditatio process icludes all full accreditatio surveys ad, as appropriate, for-cause surveys, ad radom validatio surveys specific to Evidece of Stadards Compliace (ESC). A setiel evet is a uexpected occurrece ivolvig death or serious physical or psychological ijury, or the risk thereof. Serious ijury specifically icludes loss of limb or fuctio. The phrase or the risk thereof icludes ay process variatio for which a recurrece would carry a sigificat chace of a serious adverse outcome. Such evets are called setiel because they sigal the eed for immediate ivestigatio ad respose. The terms setiel evet ad error are ot syoymous; ot all setiel evets occur because of a error, ad ot all errors result i setiel evets. II. Goals of the Setiel Evet Policy The policy has four goals: 1. To have a positive impact i improvig patiet care, treatmet, ad services ad prevetig setiel evets 2. To focus the attetio of a hospital that has experieced a setiel evet o uderstadig the factors that cotributed to the evet (such as uderlyig causes, latet coditios ad active failures i defese systems, or orgaizatioal culture), ad o chagig the hospital s culture, systems, ad processes to reduce the probability of such a evet i the future 3. To icrease the geeral kowledge about setiel evets, their cotributig factors, ad strategies for prevetio 4. To maitai the cofidece of the public ad accredited hospitals i the accreditatio process CAMH, Jauary 2013 SE 1

2 Comprehesive Accreditatio Maual for Hospitals III. Stadards Relatig to Setiel Evets Stadards Each Joit Commissio accreditatio maual cotais stadards i the Leadership (LD) chapter that relate specifically to the maagemet of setiel evets. Hospital-Specific Defiitio of Setiel Evet LD , EP 7, requires each accredited hospital to defie setiel evet for its ow purposes ad to commuicate this defiitio throughout the orgaizatio. While this defiitio must be cosistet with the geeral defiitio of setiel evet as published by The Joit Commissio, accredited hospitals have some latitude i settig more specific parameters to defie uexpected, serious, ad the risk thereof. At a miimum, a hospital s defiitio must iclude those applicable evets that are subject to review uder the Setiel Evet Policy as defied i Sectio IV of this chapter. Expectatios Uder the Stadards for a Hospital s Respose to a Setiel Evet Accredited hospitals are expected to idetify ad respod appropriately to all setiel evets (as defied by the hospital i accordace with the precedig paragraph) occurrig i the hospital or associated with services that the hospital provides, or provides for. Appropriate respose icludes coductig a timely, thorough, ad credible root cause aalysis; developig a actio pla desiged to implemet improvemets to reduce risk; implemetig the improvemets; ad moitorig the effectiveess of those improvemets. Root Cause Aalysis Root cause aalysis is a process for idetifyig the factors that uderlie variatio i performace, icludig the occurrece or possible occurrece of a setiel evet. A root cause aalysis focuses primarily o systems ad processes, ot o idividual performace. The aalysis progresses from special causes * i cliical processes to commo * Special cause is a factor that itermittetly ad upredictably iduces variatio over ad above what is iheret i the system. It ofte appears as a extreme poit (such as a poit beyod the cotrol limits o a cotrol chart) or some specific, idetifiable patter i data. SE 2 CAMH, Jauary 2013

3 Setiel Evets causes i orgaizatioal processes ad systems ad idetifies potetial improvemets i these processes or systems that would ted to decrease the likelihood of such evets i the future or determies, after aalysis, that o such improvemet opportuities exist. Actio Pla The product of the root cause aalysis is a actio pla that idetifies the strategies that the hospital iteds to implemet i order to reduce the risk of similar evets occurrig i the future. The pla should address resposibility for implemetatio, oversight, pilot testig as appropriate, time lies, ad strategies for measurig the effectiveess of the actios. Survey Process Whe coductig a accreditatio survey, The Joit Commissio seeks to evaluate the hospital s compliace with the applicable stadards, Natioal Patiet Safety Goals, ad Accreditatio Participatio Requiremets, ad to score those requiremets based o performace throughout the hospital over time. Surveyors are istructed ot to search for setiel evets durig a usual survey or to iquire about setiel evets that have bee reported to The Joit Commissio. Surveyors may coduct a assessmet of a hospital s performace improvemet practices ad procedures, such as root cause aalyses ad proactive risk assessmet. If, i the course of coductig the usual survey activities, a setiel evet is (ewly) idetified, the surveyor will take the followig steps: Iform the CEO that the evet has bee idetified Iform the CEO the evet will be reported to The Joit Commissio for further review ad follow-up uder the provisios of the Setiel Evet Policy. The surveyor makes o determiatio of whether or ot the evet is a reviewable setiel evet, but rather will had off further discussio to Joit Commissio Cetral Office staff i the Setiel Evet Uit of the Office of Quality Moitorig. Staff i the Setiel Evet Uit will cotact the hospital after all survey activity is etirely completed to explore the evet ad determie whether or ot submissio of Commo cause is a factor that results from variatio iheret i the process or system. The risk of a commo cause ca be reduced by redesigig the process or system. CAMH, Jauary 2013 SE 3

4 Comprehesive Accreditatio Maual for Hospitals a root cause aalysis is required. If so, the hospital will proceed with the steps described after a evet is determied to be reviewable. (See the Required Respose to a Reviewable Setiel Evet sectio i this chapter.) Durig the o-site survey, the surveyor(s) will assess the hospital s compliace with setiel evet related stadards i the followig ways: Review the hospital s process for respodig to a setiel evet Iterview the hospital s leaders ad staff about their expectatios ad resposibilities for idetifyig, reportig o, ad respodig to setiel evets Ask for a example of a root cause aalysis that has bee coducted outside the most recet 12-moth period to assess the adequacy of the hospital s process for respodig to a setiel evet. Additioal examples may be reviewed if eeded to more fully assess the hospital s uderstadig of ad ability to coduct root cause aalyses. I selectig a example, the hospital may choose a closed case or a ear miss to demostrate its process for respodig to a setiel evet. IV. Reviewable Setiel Evets Defiitio of Occurreces That Are Subject to Review by The Joit Commissio Uder the Setiel Evet Policy The defiitio of a reviewable setiel evet takes ito accout a wide array of occurreces applicable to a wide variety of health care orgaizatios. Ay or all occurreces may apply to a particular type of hospital. Thus, ot all of the followig occurreces may apply to your particular hospital. The subset of setiel evets that is subject to review by The Joit Commissio icludes ay occurrece that meets ay of the followig criteria: Near miss or close call Used to describe ay process variatio that did ot affect a outcome but for which a recurrece carries a sigificat chace of a serious adverse outcome. Such evets fall withi the scope of the defiitio of a setiel evet but outside the scope of those setiel evets that are subject to review by The Joit Commissio uder its Setiel Evet Policy. SE 4 CAMH, Jauary 2013

5 Setiel Evets The evet has resulted i a uaticipated death or major permaet loss of fuctio ot related to the atural course of the patiet s illess or uderlyig coditio or The evet is oe of the followig (eve if the outcome was ot death or major permaet loss of fuctio ot related to the atural course of the patiet s illess or uderlyig coditio): o Suicide of ay patiet receivig care, treatmet ad services i a staffed aroudthe-clock care settig or withi 72 hours of discharge o Uaticipated death of a full-term ifat o Abductio of ay patiet receivig care, treatmet, ad services o Discharge of a ifat to the wrog family o Rape, assault (leadig to death or permaet loss of fuctio), or homicide of ay patiet receivig care, treatmet, ad services # o Rape, assault (leadig to death or permaet loss of fuctio), or homicide of a staff member, licesed idepedet practitioer, visitor, or vedor while o site at the health care orgaizatio A distictio is made betwee a adverse outcome that is primarily related to the atural course of the patiet s illess or uderlyig coditio (ot reviewed uder the Setiel Evet Policy) ad a death or major permaet loss of fuctio that is associated with the treatmet (icludig recogized complicatios ) or lack of treatmet of that coditio, or otherwise ot clearly ad primarily related to the atural course of the patiet s illess or uderlyig coditio (reviewable uder the Setiel Evet Policy). I idetermiate cases, the evet will be presumed reviewable ad the hospital s respose will be reviewed uder the Setiel Evet Policy accordig to the prescribed procedures ad time frames without delay for additioal iformatio such as autopsy results. Major permaet loss of fuctio meas sesory, motor, physiologic, or itellectual impairmet ot preset o admissio requirig cotiued treatmet or lifestyle chage. Whe major permaet loss of fuctio caot be immediately determied, applicability of the policy is ot established util either the patiet is discharged with cotiued major loss of fuctio or two weeks have elapsed with persistet major loss of fuctio, whichever is the loger period. # Sexual abuse/assault (icludig rape), as a reviewable setiel evet, is defied as ucoseted sexual cotact ivolvig a patiet ad aother patiet, staff member, or other perpetrator while beig treated or o the premises of the hospital, icludig oral, vagial or aal peetratio or fodlig of the patiet s sex orga(s) by aother idividual s had, sex orga, or object. Oe or more of the followig must be preset to determie reviewability: Ay staff-witessed sexual cotact as described above Admissio by the perpetrator that sexual cotact, as described above, occurred o the premises Sufficiet cliical evidece obtaied by the hospital to support allegatios of ucoseted sexual cotact Shadig idicates a chage effective July 1, 2013, uless otherwise oted i the Table of Chages. CAMH Update 1, March 2013 SE 5

6 Comprehesive Accreditatio Maual for Hospitals o o o o o Hemolytic trasfusio reactio ivolvig admiistratio of blood or blood products havig major blood group icompatibilities (ABO, Rh, other blood groups) Ivasive procedure, icludig surgery, o the wrog patiet, wrog site, or wrog procedure ** Uiteded retetio of a foreig object i a patiet after surgery or other ivasive procedures Severe eoatal hyperbilirubiemia (bilirubi >30 milligrams/deciliter) Prologed fluoroscopy with cumulative dose >1,500 rads to a sigle field or ay delivery of radiotherapy to the wrog body regio or >25% above the plaed radiotherapy dose Examples of reviewable setiel evets are provided i Table 1 (page SE-7). Examples of setiel evets that are outside the scope of those setiel evets that are subject to review by The Joit Commissio uder the Setiel Evet Policy are provided i Table 2 (page SE-8). ** All evets of ivasive procedure, icludig surgery, o the wrog patiet, wrog site, or wrog procedure are reviewable uder the policy, regardless of the magitude of the procedure or the outcome. Shadig idicates a chage effective July 1, 2013, uless otherwise oted i the Table of Chages. SE 6 CAMH Update 1, March 2013

7 Table 1. Examples of Setiel Evets That Are Reviewable Uder The Joit Commissio s Setiel Evet Policy Note: This list may ot apply to all settigs. Examples iclude the followig: Ay patiet death, paralysis, coma, or other major permaet loss of fuctio associated with a medicatio error A patiet commits suicide withi 72 hours of beig discharged from a hospital settig that provides staffed aroud-the-clock care Ay elopemet, that is, uauthorized departure, of a patiet from a aroudthe-clock care settig resultig i a temporally related death (suicide, accidetal death, or homicide) or major permaet loss of fuctio A hospital performig the wrog ivasive procedure or operatig o the wrog side of the patiet s body, o the wrog site o the patiet s body, or o the wrog patiet Ay itrapartum (related to the birth process) materal death Ay periatal death urelated to a cogeital coditio i a ifat havig a birth weight greater tha 2,500 grams A patiet is abducted from the hospital where he or she receives care, treatmet, or services Assault, homicide, or other crime resultig i patiet death or major permaet loss of fuctio Assault, homicide, or other crime resultig i death or major permaet loss of fuctio of a staff member, licesed idepedet practitioer, visitor, or vedor A patiet fall that results i death or major permaet loss of fuctio as a direct result of the ijuries sustaied i the fall Hemolytic trasfusio reactio ivolvig major blood group icompatibilities A foreig body, such as a spoge or forceps, that was left i a patiet after surgery Note: A adverse outcome that is directly related to the atural course of the patiet s illess or uderlyig coditio, for example, termial illess preset at the time of presetatio, is ot reportable except for suicide i, or followig elopemet from, a 24-hour care settig (see above). Setiel Evets Shadig idicates a chage effective July 1, 2013, uless otherwise oted i the Table of Chages. CAMH Update 1, March 2013 SE 7

8 Comprehesive Accreditatio Maual for Hospitals Table 2. Examples of Setiel Evets That Are Not Reviewable Uder The Joit Commissio s Setiel Evet Policy Note: This list may ot apply to all settigs. Examples iclude the followig: Ay close call ( ear miss ) Full or expected retur of limb or bodily fuctio to the same level as prior to the adverse evet by discharge or withi two weeks of the iitial loss of said fuctio, whichever is the loger period Ay setiel evet that has ot affected a recipiet of care (patiet, idividual, residet) Medicatio errors that do ot result i death or major permaet loss of fuctio Suicide other tha i a aroud-the-clock care settig or followig elopemet from such a settig A death or loss of fuctio followig a discharge agaist medical advice (AMA) Usuccessful suicide attempts uless resultig i major permaet loss of fuctio Mior degrees of hemolysis ot caused by a major blood group icompatibility ad with o cliical sequelae Note: I the cotext of its performace improvemet activities, a hospital may choose to coduct itesive assessmet, for example, root cause aalysis, for some ot reviewable evets. Please refer to the Performace Improvemet (PI) chapter of this accreditatio maual. How The Joit Commissio Becomes Aware of a Setiel Evet Each hospital is ecouraged, but ot required, to report to The Joit Commissio ay setiel evet meetig the criteria for reviewable setiel evets. Alteratively, The Joit Commissio may become aware of a setiel evet by some other meas such as commuicatio from a patiet, a family member, a employee of the hospital, or a surveyor, or through the media. Shadig idicates a chage effective July 1, 2013, uless otherwise oted i the Table of Chages. SE 8 CAMH Update 1, March 2013

9 Setiel Evets Reasos for Reportig a Setiel Evet to The Joit Commissio Although self-reportig a setiel evet is ot required ad there is o differece i the expected respose, time frames, or review procedures, whether the hospital volutarily reports the evet or The Joit Commissio becomes aware of the evet by some other meas, there are several advatages to the hospital that self-reports a setiel evet: Reportig the evet eables the additio of the lessos leared from the evet to be added to The Joit Commissio s Setiel Evet Database, thereby cotributig to the geeral kowledge about setiel evets ad to the reductio of risk for such evets i may other hospitals. Early reportig provides a opportuity for cosultatio with Joit Commissio staff durig the developmet of the root cause aalysis ad actio pla. The hospital s message to the public that it is doig everythig possible to esure that such a evet will ot happe agai is stregtheed by its ackowledged collaboratio with The Joit Commissio to uderstad how the evet happeed ad what ca be doe to reduce the risk of such a evet i the future. Required Respose to a Reviewable Setiel Evet If The Joit Commissio becomes aware (either through volutary self-reportig or otherwise) of a setiel evet that meets the criteria of this policy ad the evet has occurred i a accredited hospital, the hospital is expected to do the followig: Prepare a thorough ad credible root cause aalysis ad actio pla withi 45 caledar days of the evet or of becomig aware of the evet Submit to The Joit Commissio its root cause aalysis ad actio pla, or otherwise provide for Joit Commissio evaluatio of its respose to the setiel evet uder a approved protocol (see Sectio VI), withi 45 caledar days of the kow occurrece of the evet The Joit Commissio will the determie whether the root cause aalysis ad actio pla are acceptable. If the determiatio that a evet is reviewable uder the Setiel Evet Policy occurs more tha 45 caledar days followig the kow occurrece of the evet, the hospital s respose will be due i 15 caledar days. If the hospital has failed to submit a root cause aalysis withi a additioal 45 days followig its due date, its accreditatio decisio may be impacted. CAMH, Jauary 2013 SE 9

10 Comprehesive Accreditatio Maual for Hospitals Please ote that a hospital that experieces a setiel evet as defied by the hospital, but that does ot meet the criteria for review uder the Setiel Evet Policy, is still expected to complete a root cause aalysis (as required by Stadard LD ) but does ot eed to submit it to The Joit Commissio. Review of Root Cause Aalyses ad Actio Plas A root cause aalysis will be cosidered acceptable if it has the followig characteristics: The aalysis focuses primarily o systems ad processes, ot o idividual performace The aalysis progresses from special causes i cliical processes to commo causes i orgaizatioal processes The aalysis repeatedly digs deeper by askig Why? ; the, whe aswered, Why? agai, ad so o The aalysis idetifies chages that could be made i systems ad processes (either through redesig or developmet of ew systems or processes) that would reduce the risk of such evets occurrig i the future The aalysis is thorough ad credible To be thorough, the root cause aalysis must iclude the followig: A determiatio of the huma ad other factors most directly associated with the setiel evet ad the process(es) ad systems related to its occurrece A aalysis of the uderlyig systems ad processes through a series of Why? questios to determie where redesig might reduce risk A iquiry ito all areas appropriate to the specific type of evet as described i Table 3 (page SE-11) A idetificatio of risk poits ad their potetial cotributios to this type of evet A determiatio of potetial improvemet i processes or systems that would ted to decrease the likelihood of such evets i the future, or a determiatio, after aalysis, that o such improvemet opportuities exist To be credible, the root cause aalysis must do the followig: Iclude participatio by the leadership of the hospital ad by idividuals most closely ivolved i the processes ad systems uder review Be iterally cosistet (that is, ot cotradict itself or leave obvious questios uaswered) SE 10 CAMH, Jauary 2013

11 Setiel Evets Provide a explaatio for all fidigs of ot applicable or o problem Iclude cosideratio of ay relevat literature A actio pla will be cosidered acceptable if it does the followig: Idetifies chages that ca be implemeted to reduce risk or formulates a ratioale for ot udertakig such chages Idetifies, i situatios where improvemet actios are plaed, who is resposible for implemetatio, whe the actio will be implemeted (icludig ay pilot testig), ad how the effectiveess of the actios will be evaluated All root cause aalyses ad actio plas will be cosidered ad treated as cofidetial by The Joit Commissio. A detailed listig of the miimum scope of root cause aalysis for specific types of setiel evets is icluded i Table 3 (below). Table 3. Miimum Scope of Root Cause Aalysis for Specific Types of Setiel Evets Detailed iquiry ito these areas is expected whe coductig a root cause aalysis for the specified type of setiel evet. Iquiry ito areas ot checked (or listed) should be coducted as appropriate to the specific evet uder review. Areas of Potetial Root Causes Suicide (24-Hour Care) Medicatio Error Procedural Complicatio TYPES OF SENTINEL EVENTS Wrog-Site Surgery Treatmet Delay Restrait Death Elopemet Death Assault/Rape/Homicide Trasfusio Reactio Patiet Abductio Uaticipated Death of Full-Term Ifat Uiteded Retetio of Foreig Body X X X X Behavioral assessmet process X X X X X X X X X Physical assessmet process Idividual idetificatio process X X X Idividual observatio procedures X X X X X X X X Care plaig process X X X X X X Cotiuum of care X X X X X Staffig levels X X X X X X X X X X X X Orietatio ad traiig of staff X X X X X X X X X X X X X cotiued o ext page Fall Related Icludes the process for assessig idividual s risk to self (ad to others, i cases of assault, rape, or homicide where a idividual is the assailat). Icludes search for cotrabad. CAMH, Jauary 2013 SE 11

12 Comprehesive Accreditatio Maual for Hospitals Table 3. (cotiued) Areas of Potetial Root Causes Suicide (24-Hour Care) Medicatio Error Procedural Complicatio TYPES OF SENTINEL EVENTS Wrog-Site Surgery Treatmet Delay Restrait Death Elopemet Death Assault/Rape/Homicide Trasfusio Reactio Patiet Abductio Uaticipated Death of Full-Term Ifat Uiteded Retetio of Foreig Body Competecy assessmet/credetialig X X X X X X X X X X X X X Supervisio of staff X X X X X X X Commuicatio with idividual/family X X X X X X X X Commuicatio amog staff members X X X X X X X X X X X X X Availability of iformatio X X X X X X X X X Adequacy of techological support X X Equipmet maiteace/maagemet X X X X X X Physical eviromet X X X X X X X X X X Security systems ad processes X X X X X X X X X X X Medicatio maagemet ## Fall Related Follow-up Activities After the Joit Commissio has determied that a hospital has coducted a acceptable root cause aalysis ad developed a acceptable actio pla, The Joit Commissio will otify it that the root cause aalysis ad actio pla are acceptable ad will assig a appropriate follow-up activity, typically oe or more Setiel Evet Measures of Success (SE MOS) due i four moths. (See the Setiel Evet Measures of Success sectio for more details.) Icludes supervisio of physicias-i-traiig. Icludes furishigs; hardware (for example, bars, hooks, rods); lightig; distractios. ## Icludes selectio ad procuremet; storage; orderig ad trascribig; preparig ad dispesig; admiistratio; ad moitorig. SE 12 CAMH, Jauary 2013

13 Setiel Evets V. The Setiel Evet Database To achieve the third goal of the Setiel Evet Policy, to icrease the geeral kowledge about setiel evets, their cotributig factors, ad strategies for prevetio, The Joit Commissio collects ad aalyzes data from the review of setiel evets, root cause aalyses, actio plas, ad follow-up activities. These data ad iformatio form the cotet of the Joit Commissio s Setiel Evet Database. The Joit Commissio is committed to developig ad maitaiig this Setiel Evet Database i a fashio that will protect the cofidetiality of the hospital, the caregiver, ad the patiet. Icluded i this database are three major categories of data elemets: 1. Setiel evet data 2. Root cause data 3. Risk reductio data De-idetified aggregate data relatig to root causes ad risk-reductio strategies for setiel evets that occur with sigificat frequecy will form the basis for future errorprevetio advice to hospitals through Setiel Evet Alert ad other media. The Setiel Evet Database is also a major compoet of the evidece base for developig ad maitaiig the Natioal Patiet Safety Goals. VI. Procedures for Implemetig the Setiel Evet Policy Volutary Self Reportig of Reviewable Setiel Evets to the Joit Commissio If a hospital wishes to report a occurrece i the subset of setiel evets that are subject to review by The Joit Commissio, the hospital will be asked to complete a form accessible through its Joit Commissio Coect extraet site. From this site, select Self Report Setiel Evet from the Cotiuous Compliace Tools sectio. Reviewable Setiel Evets That Are Not Reported by the Hospital If The Joit Commissio becomes aware of a setiel evet subject to review uder the Setiel Evet Policy which was ot reported to The Joit Commissio by the hospital, the CEO or desigee of the hospital is cotacted, ad a prelimiary assessmet of the CAMH, Jauary 2013 SE 13

14 Comprehesive Accreditatio Maual for Hospitals setiel evet is made. A evet that occurred more tha oe year before the date The Joit Commissio became aware of the evet will ot, i most cases, be reviewed uder the Setiel Evet Policy. I such a case, a writte respose will be requested from the hospital, icludig a summary of processes i place to prevet similar occurreces. Determiatio That a Setiel Evet Is Reviewable Uder the Setiel Evet Policy Based o available factual iformatio received about the evet, Joit Commissio staff will determie whether the evet is reviewable uder the Setiel Evet Policy. (See the Reviewable Setiel Evets sectio for more details.) Challeges to a determiatio that a evet is reviewable will be resolved through cosultatio with seior Joit Commissio staff. Iitial O-Site Review of a Setiel Evet A iitial o-site review of a setiel evet will usually ot be coducted uless it is determied that there is a potetial ogoig immediate threat to patiet health or safety or potetially sigificat ocompliace with Joit Commissio stadards. Immediate Threat to Health or Safety icidets iclude situatios i which the hospital s ocompliace with oe or more stadards has caused, or is likely to cause, serious ijury, harm, impairmet, or death to a patiet ad is likely to cotiue. Complaits are assiged this priority if the iformatio idicates immediate corrective actio is ecessary. All are immediately referred to Joit Commissio Executive Leadership for authorizatio to coduct a uaouced for-cause survey. If a o-site ( for-cause ) review is coducted, the hospital will be billed a sufficiet charge, based o the established fee schedule, to cover the costs of coductig such a survey. Disclosable Iformatio If The Joit Commissio receives a iquiry about the accreditatio decisio of a hospital that has experieced a reviewable setiel evet, the hospital s accreditatio decisio will be reported i the usual maer without makig referece to the setiel evet. If the iquirer specifically refereces the specific setiel evet, The Joit Commissio will ackowledge that it is aware of the evet ad curretly is workig or has worked with the hospital through the setiel evet review process. SE 14 CAMH, Jauary 2013

15 Setiel Evets Submissio of Root Cause Aalysis ad Actio Pla The hospital that experieces a setiel evet subject to the Setiel Evet Policy is asked to submit two documets: (1) the complete root cause aalysis, icludig its fidigs, ad (2) the resultig actio pla that describes the hospital s risk reductio strategies ad measures for evaluatig their effectiveess. This iformatio will be submitted to The Joit Commissio Cetral Office usig a olie root cause aalysis collectio tool, *** also accessible from the Cotiuous Compliace Tools sectio of the Joit Commissio Coect extraet site, uder the Setiel Evet Activities lik. The root cause aalysis ad actio pla are ot to iclude the ame(s) of caregivers ad patiets ivolved i the setiel evet. Alteratively, if the hospital has cocers about waivers of cofidetiality protectios as a result of sedig the root cause aalysis documets to The Joit Commissio, the followig alterative approaches to a review of the hospital s respose to the setiel evet are acceptable: 1. A review of the root cause aalysis ad actio pla documets brought to Joit Commissio headquarters by hospital staff, the take back to the hospital o the same day 2. A o-site meetig with a specially traied Joit Commissio staff member to review the root cause aalysis ad actio pla 3. A o-site visit by a specially traied Joit Commissio staff member to review the root cause aalysis ad fidigs without directly viewig the root cause aalysis documets through a series of iterviews ad a review of relevat documetatio. For purposes of this review activity, relevat documetatio icludes, at a miimum, ay documetatio relevat to the hospital s process for respodig to setiel evets, the patiet s medical record, ad the actio pla resultig from the aalysis of the subject setiel evet. The latter serves as the basis for appropriate follow-up activity. 4. Whe the hospital affirms that it meets specified criteria respectig the risk of waivig cofidetiality protectios for root cause aalysis iformatio shared with The Joit Commissio, a o-site visit by a specially traied surveyor is arraged to coduct the followig: a. Iterviews ad reviews relevat documetatio, icludig the patiet s medical record, to obtai iformatio about the followig: *** Also referred to as Alterative 0. CAMH, Jauary 2013 SE 15

16 Comprehesive Accreditatio Maual for Hospitals The process the hospital uses i respodig to setiel evets The relevat policies ad procedures precedig ad followig the hospital s review of the specific evet, ad the implemetatio thereof, sufficiet to permit ifereces about the adequacy of the hospital s respose to the setiel evet b. A stadards-based survey that traces a patiet s care, treatmet, ad services ad the hospital maagemet fuctios relevat to the setiel evet uder review Alteratives 1, 2, 3, or 4 will result i a sufficiet charge to the hospital to cover the average direct costs of the alterative. Iquiries about the fee should be directed to The Joit Commissio s Pricig Uit at The Joit Commissio must receive a request for review of a hospital s respose to a setiel evet usig ay of these alterative approaches withi at least five busiess days of the self-report of a reviewable evet or of the iitial commuicatio by The Joit Commissio to the hospital that it has become aware of a reviewable setiel evet. The Joit Commissio s Respose Joit Commissio staff assess the acceptability of the hospital s respose to the reviewable setiel evet, icludig the thoroughess ad credibility of ay root cause aalysis iformatio reviewed ad the hospital s actio pla. If the root cause aalysis ad actio pla are foud to be thorough ad credible, The Joit Commissio will otify the orgaizatio ad assig oe or more SE MOS. (See the Setiel Evet Measures of Success sectio for more details.) If the respose is uacceptable, Joit Commissio staff will provide cosultatio to the hospital o the criteria that have ot yet bee met ad will allow a additioal 15 caledar days beyod the origial submissio period for the hospital to resubmit its respose. If the respose does ot meet established criteria, the hospital s accreditatio decisio may be impacted if The Joit Commissio determies the hospital has ot udertake serious improvemet efforts. Whe the hospital s respose (iitial or revised) is foud to be acceptable, The Joit Commissio issues a letter that does the followig: For more iformatio about the tracer methodology, see The Accreditatio Process (ACC) chapter. SE 16 CAMH, Jauary 2013

17 Setiel Evets Reflects the Joit Commissio s determiatio to cotiue or modify the hospital s curret accreditatio decisio Assigs a appropriate follow-up activity, typically oe or more SE MOS due i four moths Setiel Evet Measures of Success The hospital s follow-up activity will be coducted through the MOS process. A MOS is a umerical or quatifiable measure usually related to a audit that determies if a plaed actio was effective ad sustaied. The SE MOS are due four moths after the root cause aalysis ad actio pla are determied to be acceptable by The Joit Commissio. If the plaed actio ca be associated with a stadard or Natioal Patiet Safety Goal requiremet, it will have a level of compliace expectatio based o the type of elemet of performace (EP) for the associated stadard or Natioal Patiet Safety Goal requiremet. That is, if the actio is equivalet to a EP that is idetified as a Category A EP, the level of compliace expectatio for the SE MOS for that actio will be 100%. If the actio is equivalet to a EP that is idetified as a Category C EP, the miimum required level of compliace for the SE MOS for that actio will be 90%. If the actio caot be associated with a existig stadard or Natioal Patiet Safety Goal requiremet, the hospital will idetify the level of compliace expectatio, which must be at least 85%, subject to approval by The Joit Commissio. The followig iformatio further outlies the SE MOS requiremet: If a SE MOS is submitted o time but does ot meet established levels of compliace, the Joit Commissio staff will request a additioal four moths of data. If the secod set of data does ot meet established levels of compliace, the hospital s accreditatio decisio may be impacted. If a SE MOS is 90 or more days late, the hospital s accreditatio status may be impacted if The Joit Commissio determies the hospital has ot udertake serious improvemet efforts. A decisio to maitai or chage the hospital s accreditatio decisio as a result of the follow-up activity or to assig additioal follow-up requiremets will be based o existig decisio rules ad the determiatio of staff i the Setiel Evet Uit, uless otherwise determied by the Accreditatio Committee. CAMH, Jauary 2013 SE 17

18 Comprehesive Accreditatio Maual for Hospitals Hadlig Setiel Evet Related Documets Hadlig of ay submitted root cause aalysis ad actio pla is restricted to specially traied staff i accordace with procedures desiged to protect the cofidetiality of the documets. Upo completio of The Joit Commissio review of ay submitted root cause aalysis ad actio pla ad the abstractio of the required data elemets for The Joit Commissio s Setiel Evet Database, the origial root cause aalysis documets ad ay copies will be destroyed. Upo request, the origial documets will be retured to the hospital. The iformatio cotaied i ay electroically submitted RCA tool will be de-idetified oce the review is completed. The actio pla resultig from the aalysis of the setiel evet will iitially be retaied to serve as the basis for the SE MOS. Oce the actio pla has bee implemeted ad meets the established levels of compliace as determied through the SE MOS, The Joit Commissio will destroy ad delete the actio pla. If the SE MOS was submitted electroically, the iformatio will likewise be de-idetified upo completio of the review. Oversight of the Setiel Evet Policy The Accreditatio Committee of The Joit Commissio s Board of Commissioers is resposible for overseeig the implemetatio of this policy ad procedure. I additio to reviewig ad decidig idividual cases ivolvig chages i a hospital s accreditatio decisio, The Joit Commissio staff will periodically audit the root cause aalyses ad SE MOS ad report these fidigs to the Accreditatio Committee. For the purposes of these audits, The Joit Commissio temporarily retais radom (de-idetified) samples of these documets. Upo completio of the audit, these documets are also destroyed. For more iformatio about The Joit Commissio s Setiel Evet Policy ad Procedures, visit The Joit Commissio s website at or call the Setiel Evet Hotlie at SE 18 CAMH, Jauary 2013