Setiel Evets (SE) I. Setiel Evets The Joit Commissio adopted a formal Setiel Evet Policy i 1996 to help critical access hospitals that experiece serious adverse evets improve safety ad lear from those setiel evets. Careful ivestigatio ad aalysis of patiet safety evets, as well as strog corrective actios that provide effective ad sustaied system improvemet, is essetial to reduce risk ad prevet patiet harm. The Setiel Evet Policy explais how The Joit Commissio parters with critical access hospitals that have experieced a serious patiet safety evet to protect the patiet, improve systems, ad prevet further harm. Defiitio of Setiel Evet A setiel evet is a patiet safety evet (ot primarily related to the atural course of the patiet s illess or uderlyig coditio) that reaches a patiet ad results i ay of the followig: Death Permaet harm Severe temporary harm * A evet is also cosidered setiel if it is oe of the followig: Suicide of ay patiet receivig care, treatmet, or services i a staffed aroud-theclock care settig or withi 72 hours of discharge, icludig from the critical access hospital s emergecy departmet (ED) Uaticipated death of a full-term ifat Discharge of a ifat to the wrog family Abductio of ay patiet receivig care, treatmet, or services * Severe temporary harm is critical, potetially life-threateig harm lastig for a limited time with o permaet residual, but requires trasfer to a higher level of care/moitorig for a prologed period of time, trasfer to a higher level of care for a life-threateig coditio, or additioal major surgery, procedure, or treatmet to resolve the coditio. Adapted from: Throop C, Stockmeier C. The HPI SEC & SSER Patiet Safety Measuremet System for Healthcare. 2011 May. Accessed Aug 12, 2014. http://hpiresults.com/publicatios/hpi%20white%20paper%20-%20sec%20sser %20Measuremet%20System%20REV%202%20MAY%202010.pdf. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 1 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals Ay elopemet (that is, uauthorized departure) of a patiet from a staffed aroudthe-clock care settig (icludig the ED) leadig to the death, permaet harm, or severe temporary harm of the patiet Hemolytic trasfusio reactio ivolvig admiistratio of blood or blood products havig major blood group icompatibilities (ABO, Rh, other blood groups) Rape, assault (leadig to death, permaet harm, or severe temporary harm, or homicide of ay patiet receivig care, treatmet, or services while o site at the critical access hospital Rape, assault (leadig to death, permaet harm, or severe temporary harm, or homicide of a staff member, licesed idepedet practitioer, visitor, or vedor while o site at the critical access hospital Ivasive procedure, icludig surgery, o the wrog patiet, at the wrog site, or that is the wrog (uiteded) procedure Uiteded retetio of a foreig object i a patiet after a ivasive procedure, icludig surgery Severe eoatal hyperbilirubiemia (bilirubi >30 milligrams/deciliter) Sexual abuse/assault (icludig rape) as a setiel evet, is defied as ocosesual sexual cotact ivolvig a patiet ad aother patiet, staff member, or other perpetrator while beig treated or o the premises of the critical access 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 that it is a setiel evet: 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 critical access hospital to support allegatios of ucoseted sexual cotact Ivasive procedures, icludig surgery, o the wrog patiet, or at the wrog site, or that is the wrog procedure are reviewable uder the policy, regardless of the type of the procedure or the magitude of the outcome. After surgery is defied as ay time after the completio of fial ski closure, eve if the patiet is still i the procedural area or i the operatig room uder aesthesia. This defiitio is based o the premise that a failure to idetify ad correct a uiteded retetio of a foreig object prior to that poit i the procedure represets a system failure, which requires aalysis ad redesig. It also places the patiet at additioal risk by extedig the surgical procedure ad time uder aesthesia. If a foreig object (for example, a eedle tip or screw) is left i the patiet because of a cliical determiatio that the relative risk to the patiet of searchig for ad removig the object exceeds the beefit of removal, this would ot be cosidered a setiel evet to be reviewed. However, i such cases, the orgaizatio shall (1) disclose to the patiet the uiteded retetio, ad (2) keep a record of the retetios to idetify treds ad patters (for example, by type of procedure, by type of retaied item, by maufacturer, by practitioer) that may idetify opportuities for improvemet. SE 2 Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets 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 Fire, flame, or uaticipated smoke, heat, or flashes occurrig durig a episode of patiet care Ay itrapartum (related to the birth process) materal death Severe materal morbidity (ot primarily related to the atural course of the patiet s illess or uderlyig coditio) whe it reaches a patiet ad results i permaet harm or severe temporary harm # The above list is cosistet across all Joit Commissio accreditatio programs, though some of these evets may be ulikely to occur i certai settigs. I cases i which the critical access hospital is ucertai that a patiet safety evet is a setiel evet as defied by The Joit Commissio, the evet will be presumed to be a patiet safety evet ad ot a setiel evet uless determied otherwise through further ivestigatio or the presetatio of relevat iformatio. Patiet safety evets require aalysis ad should be shared with the Office of Quality ad Patiet Safety through a orgaizatio respose (see the Patiet Safety Systems [PS] chapter). All setiel evets must be reviewed by the critical access hospital ad are subject to review by The Joit Commissio. Accredited critical access hospitals are expected to idetify ad respod appropriately to all setiel evets (as defied by The Joit Commissio) occurrig i the critical access hospital or associated with services that the critical access hospital provides. A appropriate respose icludes all of the followig: Fire is defied as a rapid oxidatio process, which is a chemical reactio resultig i the evolutio of light ad heat i varyig itesities. A combustio process that results i smolderig coditio (o flame) is still classified as fire. Source: Natioal Fire Protectio Associatio. NFPA 901: Stadard Classificatios for Icidet Reportig ad Fire Protectio Data. Quicy, MA: NFPA, 2011. # Severe materal morbidity is defied, by the America College of Obstetrics ad Gyecology, the US Ceters for Disease Cotrol ad Prevetio, ad the Society of Materal-Fetal Medicie, as a patiet safety evet that occurs from the itrapartum through the immediate postpartum period (24 hours), requirig the trasfusio of 4 or more uits of packed red blood cells (PRBC) ad/or admissio to the itesive care uit (ICU). Admissio to the ICU is defied as admissio to a uit that provides 24-hour medical supervisio ad is able to provide mechaical vetilatio or cotiuous vasoactive drug support. Ogoig vigilace to better idetify patiets at risk ad timely implemetatio of cliical itervetios cosistet with evidece-based guidelies are importat steps i the ogoig provisio of safe ad reliable care. Appropriate systems improvemets ca be iformed by idetifyig occurreces of materal morbidity, reviewig the cases, ad aalyzig the fidigs. For additioal details, see Update: Revised Defiitio of Severe Materal Morbidity i Setiel Evet Policy, Jue 2015 Perspectives. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 3 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals A formalized team respose that stabilizes the patiet, discloses the evet to the patiet ad family, ad provides support for the family as well as staff ivolved i the evet Notificatio of critical access hospital leadership Immediate ivestigatio Completio of a comprehesive systematic aalysis for idetifyig the causal ad cotributory factors Strog corrective actios derived from the idetified causal ad cotributig factors that elimiate or cotrol system hazards or vulerabilities ad result i sustaiable improvemet over time Time lie for implemetatio of corrective actios Systemic improvemet Setiel evets are oe category of patiet safety evets. A patiet safety evet is a evet, icidet, or coditio that could have resulted or did result i harm to a patiet. A patiet safety evet ca be, but is ot ecessarily, the result of a defective system or process desig, a system breakdow, equipmet failure, or huma error. Patiet safety evets also iclude adverse evets, o-harm evets, close calls, ad hazardous coditios, which are defied as follows: A adverse evet is a patiet safety evet that resulted i harm to a patiet A o-harm evet is a patiet safety evet that reaches the patiet but does ot cause harm. A close call (or good catch ) is a patiet safety evet that did ot reach the patiet. A hazardous (or usafe ) coditio(s) is a circumstace (other tha a patiet s ow disease process, or coditio) that icreases the probability of a adverse evet. The critical access hospital determies how it will respod to patiet safety evets that do ot meet the Joit Commissio s defiitio of setiel evet. Adverse evets shall prompt otificatio of critical access hospital leaders, ivestigatio, ad corrective actios, i accordace with the critical access hospital s process for respodig to patiet safety evets that do ot meet the defiitio of setiel evet. A adverse evet may or may ot result from a error. No-harm evets, close calls, ad hazardous coditios are tracked ad used as opportuities to prevet harm, i accordace with the critical access hospital s process for respodig to patiet safety evets that do ot meet the defiitio of setiel evet. (See also Leadership [LD] Stadard LD.04.04.05, elemet of performace [EP] 3, which SE 4 Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets states: The scope of the safety program icludes the full rage of safety issues, from potetial or o-harm errors [sometimes referred to as ear misses, close calls, or good catches] to hazardous coditios ad setiel evets.) II. Goals of the Setiel Evet Policy The policy has the followig four goals: 1. To have a positive impact i improvig patiet care, treatmet, ad services ad i prevetig uiteded harm 2. To focus the attetio of a critical access 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 critical access hospital culture), ad o chagig the critical access hospital s culture, systems, ad processes to reduce the probability of such a evet i the future 3. To icrease the geeral kowledge about patiet safety evets, their cotributig factors, ad strategies for prevetio 4. To maitai the cofidece of the public, cliicias, ad critical access hospitals that patiet safety is a priority i accredited critical access hospitals III. Respodig to Setiel Evets Stadards Each Joit Commissio accreditatio maual cotais stadards that relate specifically to the maagemet of setiel evets. (See the Appedix to this chapter for related stadards.) Stadard LD.04.04.05, elemet of performace (EP) 7, requires each accredited critical access hospital to defie patiet safety evet for its ow purposes ad to commuicate this defiitio throughout the critical access hospital. This defiitio must ecompass setiel evets as defied by The Joit Commissio. A accredited critical access hospital is ecouraged to iclude i its defiitio evets, icidets, ad coditios i which o or oly mior harm occurred to a patiet. The critical access hospital determies how it will respod to patiet safety evets that do ot meet the defiitio of setiel evet. I additio, Rights ad Resposibilities of the Idividual (RI) Stadard RI.01.02.01, EP 21, requires a accredited critical access hospital to iform the patiet or surrogate decisio-maker about uaticipated outcomes of the care, treatmet, ad services that Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 5 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals relate to setiel evets as defied by The Joit Commissio. EP 22 of that stadard specifies that the licesed idepedet practitioer who is resposible for maagig the patiet s care, treatmet, ad services (or his or her desigee) must iform the patiet about uaticipated outcomes of care, treatmet, ad services that relate to setiel evets whe the patiet is ot already aware of the occurrece or whe further discussio is eeded. Comprehesive Systematic Aalysis As idicated above, appropriate respose to a setiel evet icludes the completio of a comprehesive systematic aalysis for idetifyig the causal ad cotributory factors. Root cause aalysis, which focuses o systems ad processes, is the most commo form of comprehesive systematic aalysis used to idetify the factors that uderlie a setiel evet. A critical access hospital may use other tools ad methodologies to coduct its comprehesive systematic aalysis. The Joit Commissio ecourages a critical access hospital to cotact the patiet safety specialist assiged to the critical access hospital s evet or to call the Office of Quality ad Patiet Safety at 630-792-3700 if it has questios regardig usig the tools discussed above or other tools it is cosiderig. (See the Review of Comprehesive Aalyses ad Corrective Actio Plas sectio for further discussio of acceptability.) Corrective Actio Pla The product of the comprehesive systematic aalysis is a corrective actio pla. The corrective actio pla idetifies the strategies that the critical access hospital iteds to implemet i order to reduce the risk of similar evets occurrig i the future. The idetified actios should elimiate or cotrol system hazards or vulerabilities that have bee idetified by the comprehesive systematic aalysis. Aalysis teams should idetify at least oe stroger or itermediate stregth actio whe possible (see Figure 3 o page 17 of the Natioal Patiet Safety Foudatio [NPSF] RCA2: Improvig Root Cause Aalyses ad Actios to Prevet Harm report at http://c.ymcd.com/sites/www.psf.org/resource/resmgr/pdf/rca2_v2-olie-pub_010816.pdf for more iformatio o stregth of actio). The pla must address the followig: Idetificatio of corrective actios to elimiate or cotrol system hazards or vulerabilities directly related to causal ad cotributory factors Resposibility for implemetatio SE 6 Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets Time lies for completio Strategies for evaluatig the effectiveess of the actios Strategies for sustaiig the chage Reportig a Setiel Evet to The Joit Commissio Each critical access hospital is strogly ecouraged, but ot required, to report to The Joit Commissio ay patiet safety evet that meets the Joit Commissio defiitio of setiel evet. A critical access hospital beefits from self-reportig i the followig ways: The Joit Commissio ca provide support ad expertise to the critical access hospital durig the review of a setiel evet. A review with the Office of Quality ad Patiet Safety provides the opportuity for the critical access hospital to collaborate with a patiet safety specialist who is likely to have reviewed similar evets. Reportig raises the level of trasparecy i the critical access hospital ad helps promote a culture of safety. Reportig coveys the critical access hospital s message to the public that it is doig everythig possible, proactively, to prevet similar patiet safety evets i the future. Further, 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 critical access hospitals. The value of this review is reflected by the fact that more tha 75% of setiel evets reported to The Joit Commissio are self-reported by the critical access hospitals that experieced the 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 critical access hospital, a surveyor, or through the media. Self-reportig a setiel evet is ot required ad there is o differece i the expected respose, time frames, or review procedures, whether the critical access hospital volutarily reports the evet or The Joit Commissio becomes aware of the evet by some other meas. If a critical access hospital wishes to report a setiel evet to The Joit Commissio, it will be asked to complete a form accessible through its Joit Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 7 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals Commissio Coect extraet site. From this site, place the cursor over Cotiuous Compliace Tools. A dropdow list will appear. From this list, select Self Report Setiel Evet. If The Joit Commissio becomes aware of a setiel evet that was ot reported by the critical access hospital to The Joit Commissio, the critical access hospital s CEO (or desigee) is cotacted, ad a prelimiary assessmet of the 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 critical access hospital, icludig a summary of the processes that were desiged to prevet similar occurreces. Required Respose to a Setiel Evet All setiel evets must be reviewed by the critical access hospital, whether or ot they are reported to The Joit Commissio. I additio, 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 critical access hospital, the critical access hospital is expected to do the followig: Prepare a thorough ad credible comprehesive systematic aalysis ad corrective actio pla withi 45 busiess days of the evet or of becomig aware of the evet. Submit to The Joit Commissio its comprehesive systematic aalysis ad corrective actio pla, or otherwise provide for Joit Commissio evaluatio its respose to the setiel evet usig a approved methodology withi 45 busiess days of the kow occurrece of the evet. The Joit Commissio will determie whether the comprehesive systematic aalysis ad corrective actio pla are acceptable. The fact that a critical access hospital has experieced a setiel evet will ot impact its accreditatio decisio. However, willful failure to respod appropriately to the setiel evet could have such a impact. For istace, if the critical access hospital fails to submit a comprehesive systematic aalysis withi a additioal 45 days followig its due date, its accreditatio decisio may be impacted. I these istaces, patiet safety specialists i the Office of Quality ad Patiet Safety, alog with the medical director ad patiet safety officer, would recommed the chief medical officer ad the executive leadership of The Joit Commissio chage the critical access hospital s accreditatio status. SE 8 Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets Submissio of Comprehesive Systematic Aalyses ad Corrective Actio Plas A critical access hospital that reports a setiel evet must submit the comprehesive systematic aalysis, icludig the resultig corrective actio pla that describes the critical access hospital s risk reductio strategies as well as how the effectiveess of those strategies will be evaluated. This iformatio is submitted electroically ad will be reviewed i a coferece call ivolvig Joit Commissio staff ad critical access hospital staff (Alterative 0). Documets shall ot iclude the ames of caregivers ad patiets ivolved i the setiel evet. If the critical access hospital has cocers about waivig cofidetiality protectios as a result of sedig the comprehesive systematic aalysis documets to The Joit Commissio, the followig four optioal alterative approaches to a review of the critical access hospital s respose to the setiel evet are acceptable: 1. A review of the comprehesive systematic aalysis ad corrective actio pla documets brought to Joit Commissio headquarters by critical access hospital staff, the take back to the critical access hospital o the same day (Alterative 1). This ca also be performed via web-based video coferecig with a patiet safety specialist who is located at The Joit Commissio (Web-Alterative). Whe the web-based video coferece is used, the critical access hospital s participats remai at the critical access hospital. 2. A o-site meetig at the critical access hospital with a Joit Commissio patiet safety specialist to review the comprehesive systematic aalysis ad corrective actio pla (Alterative 2). This ca also be performed via web-based video coferecig with a patiet safety specialist who is located at The Joit Commissio (Web- Alterative). 3. A o-site review with a Joit Commissio patiet safety specialist to review the corrective actio pla ad relevat documetatio (Alterative 3). The patiet safety specialist may ask questios regardig the comprehesive systematic aalysis, but will ot review that documet itself. For purposes of this review activity, relevat documetatio icludes, at a miimum, ay documetatio relevat to the critical access hospital s process for respodig to setiel evets ad the corrective actio pla resultig from the aalysis of the setiel evet. The corrective actio pla serves as the basis for determiig appropriate follow-up activity. This ca also be performed via web-based video coferecig with a patiet safety specialist who is located at The Joit Commissio (Web-Alterative). Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 9 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals 4. A o-site visit by a specially traied surveyor arraged to coduct the followig (Alterative 4): a. Iterview ad review of relevat documetatio, icludig, if applicable, the patiet s medical record, to evaluate the followig: The process the critical access hospital uses i respodig to setiel evets The relevat policies ad procedures precedig ad followig the critical access hospital s review of the specific evet, ad the implemetatio thereof, sufficiet to permit ifereces about the adequacy of the critical access hospital s respose to the setiel evet b. A stadards-based survey that traces a patiet s care, treatmet, ad services ad the critical access hospital maagemet fuctios relevat to the setiel evet uder review Each of these optios will result i a fee to the critical access hospital to cover the average direct costs of the optio. Iquiries about the fee should be directed to the Joit Commissio s Pricig Uit at 630-792-5115. The Joit Commissio must receive a request for review of a critical access hospital s respose to a setiel evet usig ay of these optios withi five busiess days of the self-report of a setiel evet or of the iitial commuicatio by The Joit Commissio to the critical access hospital that it has become aware of a setiel evet. Review of Comprehesive Systematic Aalyses ad Corrective Actio Plas A comprehesive systematic aalysis will be reviewed for thoroughess, credibility, ad acceptability. A critical access hospital s comprehesive systematic aalysis should idetify system vulerabilities so that they ca be elimiated or mitigated. The aalysis should ot focus o idividual health care worker performace, but should seek out uderlyig systems-level causatios that were maifest i persoel-related performace issues. ** To help adhere to these characteristics it is recommeded but ot required that the followig guidelies be cosidered whe developig causative factor statemets: Clearly show the cause-ad-effect relatioship. ** Natioal Patiet Safety Foudatio. RCA2: Improvig Root Cause Aalyses ad Actios to Prevet Harm. Bosto: Natioal Patiet Safety Foudatio, 2015. Departmet of Veteras Affairs. Veteras Health Admiistratio Patiet Safety Hadbook 1050.01. Mar 4, 2011. Accessed Feb 11, 2015. http://www.va.gov/vhapublicatios/viewpublicatio.asp?pub_id=2389. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 10 CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets Use specific ad accurate descriptors for what occurred, rather tha egative ad vague words. Huma errors must have a precedig cause. Violatios of procedure are ot root causes, but must have a precedig cause. Failure to act is oly causal whe there is a preexistig duty to act. To be thorough, the comprehesive systematic aalysis must iclude the followig: The aalysis repeatedly asks a series of Why questios, util it idetifies the systemic causal factors associated with each step i the sequece that led to the setiel evet The aalysis focuses o systems ad processes, ot solely o idividual performace 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 The aalysis of the uderlyig systems ad processes through the series of Why questios determies where redesig might reduce risk A iquiry ito all areas appropriate to the specific type of evet 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 comprehesive systematic aalysis must do the followig: Iclude participatio by a process ower, who is ot a member of the respose team; typically this is a seior leader of the critical access hospital or a desigee Each actio recommeded by a review team should be approved or disapproved, preferably by the CEO or alteratively by aother relevat member of top maagemet. If a actio is disapproved, the reaso for its disapproval should be shared with the comprehesive systematic aalysis ad actio team so that the costrait ca be uderstood ad aother developed by the team to replace it if the system vulerability is ot otherwise effectively addressed i the corrective actio pla. A seior leader is ot ecessarily required to be actively ivolved i the day-to-day work of the comprehesive systematic aalysis team. However, the team should report to the seior leader or desigee, ad he or she should be ivolved i decidig or approvig the actios the critical access hospital will take as a result of the comprehesive systematic aalysis ad actio pla. Natioal Patiet Safety Foudatio. RCA2: Improvig Root Cause Aalyses ad Actios to Prevet Harm. Bosto: Natioal Patiet Safety Foudatio, 2015. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 11 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals Iclude patiets, family, or patiet represetatives whe appropriate to esure a thorough uderstadig of the facts Iclude idividuals most closely ivolved i the processes ad systems uder review Be iterally cosistet (that is, ot cotradict itself or leave obvious questios uaswered) Provide a explaatio for all fidigs of ot applicable or o problem Iclude a bibliography of ay relevat literature A corrective actio pla will be cosidered acceptable if it does the followig: Idetifies ad implemets actios to elimiate or cotrol systems hazards or vulerabilities It is recommeded but ot required that review teams should attempt to idetify actios that are likely to reduce the risk or prevet the evet from recurrig ad if that is ot possible, reduce the severity or cosequeces if it should recur. It is recommeded that the review team use a tool that will assist i idetifyig stroger actios that provide effective ad sustaied system improvemet. A tool such as the Actio Hierarchy ca help orgaizatios evaluate the stregth of the corrective actios idetified i their comprehesive systematic aalysis. The US Departmet of Veteras Affairs Natioal Ceter for Patiet Safety developed this tool i 2001. Idetifies, i situatios i which improvemet actios are plaed, who is resposible for implemetatio, whe the actio will be implemeted, how the effectiveess of the actios will be evaluated, ad how the actios will be sustaied Idetifies at least oe stroger or itermediate stregth actio for each comprehesive systematic aalysis All comprehesive systematic aalyses ad corrective actio plas will be cosidered ad treated as cofidetial by The Joit Commissio. Follow-up Activities After The Joit Commissio has determied that a critical access hospital has coducted a acceptable comprehesive systematic aalysis (for example, root cause aalysis) ad developed a acceptable corrective actio pla, The Joit Commissio will otify the critical access hospital that the comprehesive systematic aalysis ad corrective actio A example of the Actio Hierarchy tool is available at http://www.patietsafety.va.gov/docs/joe /rca_tools_2_15.pdf, page 28. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 12 CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets pla are acceptable ad will assig a appropriate follow-up activity. This will be a mutually agreed-upo documetatio of sustaied improvemet ad reductio of risk, which may iclude oe or more Setiel Evet Measure(s) of Success (SE MOS). IV. The Setiel Evet Database The third goal of the Setiel Evet Policy is to icrease the geeral kowledge about patiet safety evets, their cotributig factors, ad strategies for prevetio. To achieve this, The Joit Commissio collects ad aalyzes data from the review of setiel evets, ad their comprehesive systematic aalyses, corrective actio plas, ad follow-up activities. These data ad iformatio comprise the cotet of the Joit Commissio s Setiel Evet Database. The Setiel Evet Database is also a major compoet of the evidece base for developig ad maitaiig the Joit Commissio s Natioal Patiet Safety Goals. The database also iforms the developmet prevetio advice to critical access hospitals through Setiel Evet Alert or other media. For these purposes, The Joit Commissio uses de-idetified aggregate data relatig to root causes, cotributig factors, ad riskreductio strategies. The Joit Commissio is committed to developig ad maitaiig this Setiel Evet Database i a fashio that will protect the cofidetiality of the critical access hospital, the caregiver, ad the patiet. V. Determiatio That a Setiel Evet Is Subject to Review Based o available iformatio received about the evet, a patiet safety specialist from the Office of Quality ad Patiet Safety (OQPS) will determie whether a evet meets the defiitio i Sectio I, ad is therefore a setiel evet. Challeges to a determiatio that a evet is a setiel evet will be resolved through discussios betwee seior Joit Commissio staff ad seior critical access hospital leaders. VI. Optioal 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 a potetial ogoig Immediate Threat to Health or Safety exists. A Immediate Threat to Health or Safety is a threat that represets the most immediate risk ad has or may potetially have serious adverse effects o the health or safety of patiets. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 13 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals All potetial Immediate Threats to Health or Safety are referred to Joit Commissio executive leadership for authorizatio to coduct a uaouced o-site for-cause survey. If a o-site survey is coducted, the critical access hospital will be billed a sufficiet charge, based o a established fee schedule, to cover the costs of coductig such a survey. VII. Disclosable Iformatio If The Joit Commissio receives a iquiry about the accreditatio decisio of a critical access hospital that has experieced a setiel evet, the critical access hospital s curret accreditatio status will be reported i the usual maer without makig referece to the setiel evet. If the iquirer specifically refereces the particular setiel evet, The Joit Commissio will ackowledge that it is aware of the evet ad curretly is workig or has worked with the critical access hospital through the setiel evet review process. VIII. The Joit Commissio s Respose Patiet safety specialists from The Joit Commissio assess the acceptability of the critical access hospital s respose to the setiel evet, icludig the thoroughess ad credibility of ay comprehesive systematic aalysis iformatio reviewed ad the critical access hospital s corrective actio pla. (Root cause aalysis is the most commoly used method of comprehesive systematic aalysis.) If the comprehesive systematic aalysis ad corrective actio pla are foud to be thorough ad credible, patiet safety specialists from The Joit Commissio will otify the critical access hospital ad assig oe or more or other mutually agreed-upo documetatio of sustaied improvemet ad reductio of risk, such as SE MOS. (See the Setiel Evet Measures of Success [SE MOS] sectio below for more details.) A patiet safety specialist from The Joit Commissio will provide cosultatio to the critical access hospital if the respose is uacceptable, ad will allow a additioal 15 busiess days beyod the origial submissio period for the critical access hospital to resubmit its respose. If the respose is still uacceptable, the critical access hospital s accreditatio decisio may be impacted. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 14 CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets IX. Setiel Evet Measures of Success (SE MOS) The critical access hospital s follow-up activity may be coducted through the SE MOS process. A SE MOS is a umerical or quatifiable measure, ideally with a umerator ad deomiator, that idicates whether a plaed actio was effective ad sustaied. The SE MOS is due o a mutually agreed-upo date. IF a SE MOS is used, the followig iformatio would apply: If a SE MOS is submitted o time but does ot meet pre-established levels of compliace, the patiet safety specialist from The Joit Commissio will request a additioal four moths of data. If the secod set of data does ot meet preestablished levels of compliace, the critical access hospital s accreditatio decisio may be impacted. If submissio of a SE MOS is 90 or more days late, the critical access hospital s accreditatio status may be impacted. X. Hadlig Setiel Evet Related Documets Hadlig of ay submitted comprehesive systematic aalysis ad corrective actio pla is restricted to specially traied staff i accordace with procedures desiged to protect the cofidetiality of the documets. At the time the review of the de-idetified comprehesive systematic aalysis is etered ito the Setiel Evets Database, the origial documets will be destroyed, as well as ay copies. However, upo request the origial documets may be retured to the critical access hospital. The iformatio cotaied i ay electroically submitted comprehesive systematic aalysis tool will be de-idetified after the review is completed. The corrective actio pla resultig from the aalysis of the setiel evet will iitially be retaied log eough to serve as the basis for appropriate follow-up activities, such as the SE MOS or other mutually agreed-upo documetatio of sustaied improvemet. After the corrective actio pla has bee implemeted ad meets the established levels of compliace, The Joit Commissio will destroy ad delete the corrective actio pla. If the SE MOS was submitted electroically, the iformatio will likewise be de-idetified upo completio of the review. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 15 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals XI. Oversight of the Setiel Evet Policy The executive leadership of The Joit Commissio is resposible for approval of this policy ad overseeig its implemetatio. I additio to reviewig ad decidig idividual cases ivolvig chages i a critical access hospital s accreditatio decisio, Joit Commissio staff will periodically audit the comprehesive systematic aalysis ad documetatio of follow-up activities. 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, visit the Joit Commissio s website at http://www.joitcommissio.org or call the Office of Quality ad Patiet Safety at 630-792-3700. XII. Survey Process Whe coductig a accreditatio survey, The Joit Commissio seeks to evaluate the critical access hospital s compliace with the applicable stadards, Natioal Patiet Safety Goals, ad Accreditatio Participatio Requiremets, ad to assess the critical access hospital s performace based o those requiremets. Surveyors are istructed ot to search for or ivestigate setiel evets durig a accreditatio survey or to iquire about setiel evets that have bee reported to The Joit Commissio. However, surveyors may assess a critical access hospital s performace improvemet practices, such as its processes for respodig to a setiel evet. If durig the course of coductig survey activities, a potetial serious patiet safety evet is ewly idetified, the surveyor will take the followig steps: Iform the critical access hospital 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 Surveyors are ot authorized to review the comprehesive systematic aalysis documets ad determie credibility, thoroughess, or acceptability. Surveyors ca oly apply the related stadards ad elemets of performace to assess performace improvemet practices, such as processes for respodig to safety evets, adverse evets, hazardous usafe coditios, close calls, ad setiel evets. The surveyor makes o determiatio of whether or ot the evet is a setiel evet ad does ot focus o or explore the evet further, but rather will had off further discussio to a patiet safety specialist i the Office of Quality ad Patiet Safety. Surveyors are Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 16 CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets ot authorized to ivestigate setiel evets. The patiet safety specialist will cotact the critical access hospital after all survey activity is etirely completed to explore the evet ad determie whether or ot submissio of a comprehesive systematic aalysis is required. If so, the critical access hospital will proceed with the steps described after a evet is determied to be a setiel evet. (See the Required Respose to a Setiel Evet sectio i this chapter.) Durig the o-site survey, the surveyor(s) will assess the critical access hospital s compliace with setiel evet related stadards i the followig ways (see Stadards LD.04.04.05 ad RI.01.02.01 i the Appedix): Review the critical access hospital s process for respodig to a setiel evet Iterview the critical access hospital s leaders ad staff about their expectatios ad resposibilities for idetifyig, reportig o, ad respodig to setiel evets Appedix. Accreditatio Requiremets Related to Setiel Evets The followig stadards ad associated elemets of performace (EPs) are related to setiel evets: Leadership (LD) Stadard LD.04.04.05 The critical access hospital has a orgaizatiowide, itegrated patiet safety program withi its performace improvemet activities. Elemets of Performace for LD.04.04.05 1. The leaders implemet a critical access hospitalwide patiet safety program. 2. Oe or more qualified idividuals or a iterdiscipliary group maages the safety program. 3. The scope of the safety program icludes the full rage of safety issues, from potetial or o-harm errors (sometimes referred to as close calls ["ear misses"] or good catches) to hazardous coditios ad setiel evets. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 17 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals 4. All departmets, programs, ad services withi the critical access hospital participate i the safety program. 5. As part of the safety program, the leaders create procedures for respodig to system or process failures. Note: Resposes might iclude cotiuig to provide care, treatmet, ad services to those affected, cotaiig the risk to others, ad preservig factual iformatio for subsequet aalysis. 6. The leaders provide ad ecourage the use of systems for blame-free iteral reportig of a system or process failure, or the results of a proactive risk assessmet. (See also LD.03.04.01, EP 5; LD.04.04.03, EP 3; PI.01.01.01, EP 8) Note: This EP is iteded to miimize staff reluctace to report errors i order to help a orgaizatio uderstad the source ad results of system ad process failures. The EP does ot coflict with holdig idividuals accoutable for their blameworthy errors. 7. The leaders defie patiet safety evet ad commuicate this defiitio throughout the orgaizatio. Note: At a miimum, the orgaizatio s defiitio icludes those evets subject to review i the Setiel Evets (SE) chapter of this maual. The defiitio may iclude ay process variatio that does ot affect the outcome or result i a adverse evet, but for which a recurrece carries sigificat chace of a serious adverse outcome or result i a adverse evet, ofte referred to as a close call or ear miss. 8. The critical access hospital coducts thorough ad credible comprehesive systematic aalyses (for example, root cause aalyses) i respose to setiel evets as described i the Setiel Evets (SE) chapter of this maual. 9. The leaders make support systems available for staff who have bee ivolved i a adverse or setiel evet. Note: Support systems recogize that coscietious health care workers who are ivolved i setiel evets are themselves victims of the evet ad require support. Support systems provide staff with additioal help ad support as well as additioal resources through the huma resources fuctio or a employee assistace program. Support systems also focus o the process rather tha blamig the ivolved idividuals. 10. At least every 18 moths, the critical access hospital selects oe high-risk process ad coducts a proactive risk assessmet. (See also LD.04.04.03, EP 3) Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 18 CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets Note: For suggested compoets, refer to the Proactive Risk Assessmet sectio at the begiig of this chapter. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. CAMCAH Update 1, July 2017 SE 18a E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals This page is blak due to revisios through the CAMCAH update. Shadig idicates a chage effective July 1, 2017, uless otherwise oted i the What's New. SE 18b CAMCAH Update 1, July 2017 E-ditio July 1, 2017, Release
Setiel Evets 11. To improve safety ad to reduce the risk of medical errors, the critical access hospital aalyzes ad uses iformatio about system or process failures ad the results of proactive risk assessmets. (See also LD.04.04.03, EP 3) 12. The leaders dissemiate lessos leared from comprehesive systematic aalyses (for example, root cause aalyses), system or process failures, ad the results of proactive risk assessmets to all staff who provide services for the specific situatio. (See also LD.03.04.01, EP 5) 13. At least oce a year, the critical access hospital provides goverace with writte reports o the followig: All system or process failures The umber ad type of setiel evets Whether the patiets ad the families were iformed of the evet All actios take to improve safety, both proactively ad i respose to actual occurreces For rehabilitatio ad psychiatric distict part uits i critical access hospitals: The determied umber of distict improvemet projects to be coducted aually 14. The leaders ecourage exteral reportig of sigificat adverse evets, icludig volutary reportig programs i additio to madatory programs. Note: Examples of volutary programs iclude The Joit Commissio Setiel Evet Database ad the US Food ad Drug Admiistratio (FDA) MedWatch. Madatory programs are ofte state iitiated. Rights ad Resposibilities of the Idividual (RI) Stadard RI.01.02.01 The critical access hospital respects the patiet s right to participate i decisios about his or her care, treatmet, ad services. Note: For rehabilitatio ad psychiatric distict part uits i critical access hospitals: This right is ot to be costrued as a mechaism to demad the provisio of treatmet or services deemed medically uecessary or iappropriate. CAMCAH, Jauary 2017 SE 19 E-ditio July 1, 2017, Release
Comprehesive Accreditatio Maual for Critical Access Hospitals Elemets of Performace for RI.01.02.01 21. The critical access hospital iforms the patiet or surrogate decisio-maker about uaticipated outcomes of care, treatmet, ad services that relate to setiel evets as defied by The Joit Commissio. (Refer to the Glossary for a defiitio of setiel evet.) 22. The licesed idepedet practitioer resposible for maagig the patiet s care, treatmet, ad services, or his or her desigee, iforms the patiet about uaticipated outcomes of care, treatmet, ad services related to setiel evets whe the patiet is ot already aware of the occurrece or whe further discussio is eeded. Note: I settigs where there is o licesed idepedet practitioer, the staff member resposible for maagig the care of the patiet is resposible for sharig iformatio about such outcomes. SE 20 E-ditio July 1, 2017, Release CAMCAH, Jauary 2017