around-the-clock care setting or within 72 hours of discharge, including from the organization s emergency department (ED)

Transcription

1 Setiel Evets (SE) I. Setiel Evets The Joit Commissio adopted a formal Setiel Evet Policy i 1996 to help behavioral health care orgaizatios that experiece serious adverse evets improve safety ad lear from those setiel evets. Careful ivestigatio ad aalysis of patiet safety evets *, as well as evaluatio of corrective actios, is essetial to reduce risk ad prevet patiet harm. The Setiel Evet Policy explais how The Joit Commissio parters with orgaizatios that have experieced a serious patiet safety evet to protect the idividual served, 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 idividual served 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 idividual served receivig care, treatmet, or services i a staffed aroud-the-clock care settig or withi 72 hours of discharge, icludig from the orgaizatio s emergecy departmet (ED) Uaticipated death of a full-term ifat Discharge of a ifat to the wrog family * I the term patiet safety evet, the word patiet correspods to idividuals served i the Behavioral Health Care settig. 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 May. Accessed Aug 12, HPI%20White%20Paper%20-%20SEC%20SSER%20Measuremet%20System% 20REV%202%20MAY% pdf. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 1

2 Comprehesive Accreditatio Maual for Behavioral Health Care Abductio of ay idividual served receivig care, treatmet, or services 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 idividual served 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 idividual served receivig care, treatmet, or services while o site at the orgaizatio 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 orgaizatio 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) 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 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 orgaizatio, 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 orgaizatio 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. 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. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 2 CAMBHC Update 2, Jauary 2015

3 Setiel Evets Flame or uaticipated smoke, heat, or flashes occurrig durig a episode of patiet care # Ay itrapartum (related to the birth process) materal death or severe materal morbidity ** 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 orgaizatio 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 setiel evet ad the orgaizatio s respose will be reviewed uder the Setiel Evet Policy accordig to the prescribed procedures ad time frames. Such evets are cosidered setiel because they sigal a eed for immediate ivestigatio ad respose. All setiel evets must be reviewed by the orgaizatio ad are subject to review by The Joit Commissio. Accredited orgaizatios are expected to idetify ad respod appropriately to all setiel evets (as defied by The Joit Commissio) occurrig i the orgaizatio or associated with services that the orgaizatio provides. A appropriate respose icludes all of the followig: A formalized team respose that stabilizes the idividual served, discloses the evet to the idividual served ad family, ad provides support for the family as well as staff ivolved i the evet Notificatio of orgaizatio leadership Immediate ivestigatio Completio of a comprehesive systematic aalysis for idetifyig the causal ad cotributory factors Corrective actios Time lie for implemetatio of corrective actios Systemic improvemet # 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, ** 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 ad Fetal Medicie, as a patiet safety evet that occurs itrapartum through the immediate postpartum period (24 hrs), that requires the trasfusio of 4 or more uits of blood products (fresh froze plasma, packed red blood cells, whole blood, platelets) 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. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 3

4 Comprehesive Accreditatio Maual for Behavioral Health Care 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 idividual served. 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 idividual served. A o-harm evet is a patiet safety evet that reaches the idividual served but does ot cause harm. A close call (or ear miss or good catch ) is a patiet safety evet that did ot reach the idividual served. A hazardous (or usafe ) coditio(s) is a circumstace (other tha a idividual s ow disease, process, or coditio) that icreases the probability of a adverse evet. The orgaizatio determies how it will respod to patiet safety evets that do ot meet the defiitio of setiel evet. Adverse evets shall prompt otificatio of orgaizatio leaders, ivestigatio, ad corrective actios, i accordace with the orgaizatio 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 orgaizatio s process for respodig to patiet safety evets that do ot meet the defiitio of setiel evet. (See also Leadership [LD] Stadard LD , elemet of performace [EP] 3, which 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 care, treatmet, or services ad i prevetig uiteded harm Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 4 CAMBHC Update 2, Jauary 2015

5 Setiel Evets 2. To focus the attetio of a orgaizatio 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 orgaizatio culture), ad o chagig the orgaizatio 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 orgaizatios that the safety of idividuals served is a priority i accredited orgaizatios 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, begiig o page SE-15, for a list of related stadards.) Leadership Stadard LD , EP 7, requires each accredited orgaizatio to defie patiet safety evet for its ow purposes ad to commuicate this defiitio throughout the orgaizatio. This defiitio must ecompass setiel evets as defied by The Joit Commissio. A accredited orgaizatio is ecouraged to iclude i its defiitio evets, icidets, ad coditios i which o or oly mior harm occurred to a idividual served. The orgaizatio 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 , EP 21, requires accredited orgaizatios to iform the idividual served or surrogate decisio-maker about uaticipated outcomes of the care, treatmet, or services that relate to setiel evets as defied by The Joit Commissio. 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 orgaizatio may use other tools ad methodologies to coduct its Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 5

6 Comprehesive Accreditatio Maual for Behavioral Health Care comprehesive systematic aalysis. The Joit Commissio ecourages the orgaizatio to cotact the Patiet Safety Specialist assiged to the evet or to call its Setiel Evet Uit at if it has questios regardig usig the tools discussed above or other tools it is cosiderig. (See the sectio Review of Comprehesive Systematic Aalyses ad Actio Plas o page SE-10 for further discussio of acceptability.) Actio Pla The product of the comprehesive systematic aalysis is a actio pla. The actio pla idetifies the strategies that the orgaizatio iteds to implemet i order to reduce the risk of similar evets occurrig i the future. The pla must address the followig: Actio to be take Resposibility for implemetatio Time lies Strategies for measurig the effectiveess of the actios Strategies for sustaiig the chage Reportig a Setiel Evet to The Joit Commissio Each orgaizatio 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, listed i Sectio I o page SE-1. a orgaizatio beefits from selfreportig i the followig ways: The Joit Commissio ca provide support ad expertise to the orgaizatio durig the review of a setiel evet. A review with the Joit Commissio s Setiel Evet Uit of the Office of Quality ad Patiet Safety provides the opportuity for the orgaizatio to collaborate with a Patiet Safety Specialist who is likely to have reviewed similar evets. Reportig raises the level of trasparecy i the orgaizatio ad helps promote a culture of safety. Reportig coveys the orgaizatio s message to the public that it is doig everythig possible, proactively, to prevet similar patiet safety evets i the future. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 6 CAMBHC Update 2, Jauary 2015

7 Setiel Evets 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 orgaizatios. 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 orgaizatios 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 orgaizatio, a surveyor, or through the media. Selfreportig a setiel evet is ot required ad there is o differece i the expected respose, time frames, or review procedures, whether the orgaizatio volutarily reports the evet or The Joit Commissio becomes aware of the evet by some other meas. If a orgaizatio wishes to report to The Joit Commissio a occurrece of a setiel evet, the orgaizatio will be asked to complete a form accessible through its Joit 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 orgaizatio to The Joit Commissio, the orgaizatio 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 orgaizatio, 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 orgaizatio, 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 orgaizatio, the orgaizatio is expected to do the followig: Prepare a thorough ad credible comprehesive systematic aalysis ad actio pla withi 45 busiess days of the evet or of becomig aware of the evet. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 7

8 Comprehesive Accreditatio Maual for Behavioral Health Care Submit to The Joit Commissio its comprehesive systematic aalysis ad 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 actio pla are acceptable. The fact that a orgaizatio 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 orgaizatio 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, staff i the Setiel Evet Uit would recommed that the Accreditatio Committee of the Joit Commissio s Board of Commissioers chage the orgaizatio s accreditatio status Submissio of Comprehesive Systematic Aalysis ad Actio Pla A orgaizatio that is reportig a setiel evet must submit the comprehesive systematic aalysis, icludig the resultig actio pla that describes the orgaizatio 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 orgaizatio staff. Documets shall ot iclude the ames of caregivers ad idividuals served ivolved i the setiel evet. If the orgaizatio 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 orgaizatio s respose to the setiel evet are acceptable: 1. A review of the comprehesive systematic aalysis ad actio pla documets brought to Joit Commissio headquarters by orgaizatio staff, the take back to the orgaizatio o the same day. This ca also be performed via web-based video coferecig with a Patiet Safety Specialist who is located at The Joit Commissio. Whe the web-based video coferece is used, the orgaizatio s participats remai at the orgaizatio. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 8 CAMBHC Update 2, Jauary 2015

9 Setiel Evets 2. A o-site meetig at the orgaizatio with a Joit Commissio Patiet Safety Specialist to review the comprehesive systematic aalysis ad actio pla. This ca also be performed via web-based video coferecig with a Patiet Safety Specialist who is located at The Joit Commissio. 3. A o-site review with a Joit Commissio Patiet Safety Specialist to review the actio pla ad relevat documetatio. 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 orgaizatio s process for respodig to setiel evets, ad the actio pla resultig from the aalysis of the subject setiel evet. The 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. 4. A o-site visit by a specially traied surveyor arraged to coduct the followig: a. Iterview ad review of relevat documetatio, icludig, if applicable, the medical record of the idividual served, to evaluate the followig: l The process the orgaizatio uses i respodig to setiel evets l The relevat policies ad procedures precedig ad followig the orgaizatio s review of the specific evet, ad the implemetatio thereof, sufficiet to permit ifereces about the adequacy of the orgaizatio s respose to the setiel evet b. A stadards-based survey that traces care, treatmet, or services received by a idividual served ad the orgaizatio maagemet fuctios relevat to the setiel evet uder review. Each of these optios will result i a fee to the orgaizatio to cover the average direct costs of the optio. 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 orgaizatio 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 orgaizatio that it has become aware of a setiel evet. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 9

10 Comprehesive Accreditatio Maual for Behavioral Health Care Review of Comprehesive Systematic Aalyses ad Actio Plas A comprehesive systematic aalysis will be reviewed for thoroughess, credibility, ad acceptability. 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 orgaizatio or a desigee 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 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 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 orgaizatio will take as a result of the comprehesive systematic aalysis. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 10 CAMBHC Update 2, Jauary 2015

11 Setiel Evets Idetifies, i situatios where 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 All comprehesive systematic aalyses ad actio plas will be cosidered ad treated as cofidetial by The Joit Commissio. Follow-up Activities After The Joit Commissio has determied that a orgaizatio has coducted a acceptable comprehesive systematic aalysis (for example, root cause aalysis) ad developed a acceptable actio pla, The Joit Commissio will otify the orgaizatio that the comprehesive systematic aalysis ad actio pla are acceptable ad will assig a appropriate follow-up activity. There 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, actio plas, ad follow-up activities. These data ad iformatio form 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 orgaizatios through Setiel Evet Alert or other media. For these purposes, The Joit Commissio uses deidetified aggregate data relatig to root causes, cotributig factors, ad risk-reductio strategies. The Joit Commissio is committed to developig ad maitaiig this Setiel Evet Database i a fashio that will protect the cofidetiality of the orgaizatio, the caregiver, ad the idividual served. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 11

12 Comprehesive Accreditatio Maual for Behavioral Health Care V. Determiatio That a Setiel Evet Is Subject to Review Based o available iformatio received about the evet, Joit Commissio staff 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 orgaizatio 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 there is a potetial ogoig Immediate Threat to Health or Safety. 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. 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 review is coducted, the orgaizatio 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 orgaizatio that has experieced a setiel evet, the orgaizatio 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 orgaizatio through the setiel evet review process. VIII. The Joit Commissio s Respose Joit Commissio staff assess the acceptability of the orgaizatio s respose to the setiel evet, icludig the thoroughess ad credibility of ay comprehesive systematic aalysis iformatio reviewed ad the orgaizatio s actio pla. (Root cause aalysis is the most commoly used method of comprehesive systematic aalysis.) If the comprehesive systematic aalysis ad actio pla are foud to be thorough ad Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 12 CAMBHC Update 2, Jauary 2015

13 Setiel Evets credible, The Joit Commissio will otify the orgaizatio 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 sectio below for more details.) Joit Commissio staff will provide cosultatio to the orgaizatio if the respose is uacceptable, ad will allow a additioal 15 busiess days beyod the origial submissio period for the orgaizatio to resubmit its respose. If the respose is still uacceptable, the orgaizatio s accreditatio decisio may be impacted. IX. Setiel Evet Measures of Success (SE MOS) The orgaizatio s follow-up activity may be coducted through the MOS process. A SE MOS is a umerical or quatifiable measure 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, Joit Commissio staff will request a additioal four moths of data. If the secod set of data does ot meet pre-established levels of compliace, the orgaizatio s accreditatio decisio may be impacted. If submissio of a SE MOS is 90 or more days late, the orgaizatio s accreditatio status may be impacted. X. Hadlig Setiel Evet Related Documets Hadlig of ay submitted comprehesive systematic aalysis ad 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 orgaizatio. The iformatio cotaied i ay electroically submitted comprehesive systematic aalysis tool will be de-idetified after the review is completed. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 13

14 Comprehesive Accreditatio Maual for Behavioral Health Care The 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 actio pla has bee implemeted ad meets the established levels of compliace, 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. XI. Oversight of the Setiel Evet Policy The Accreditatio Committee of the Joit Commissio s Board of Commissioers is resposible for approval of this policy ad overseeig its implemetatio. I additio to reviewig ad decidig idividual cases ivolvig chages i a orgaizatio s accreditatio decisio, Joit Commissio staff will periodically audit the comprehesive systematic aalysis ad documetatio of follow-up activities ad preset aggregate deidetified data to the Accreditatio Committee ad the Board of Commissioers. For the purposes of these audits, The Joit Commissio temporarily retais radom deidetified 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 or call the Setiel Evet Hotlie at XII. Survey Process Whe coductig a accreditatio survey, The Joit Commissio seeks to evaluate the orgaizatio s compliace with the applicable stadards, Natioal Patiet Safety Goals, ad Accreditatio Participatio Requiremets, ad to assess the orgaizatio 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 coduct a assessmet of a orgaizatio s performace improvemet practices, such as its processes for respodig to a setiel evet. If, durig the course of coductig ay survey activities, a potetial serious patiet safety evet is ewly idetified, the surveyor will take the followig steps: Iform the orgaizatio CEO that the evet has bee idetified Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 14 CAMBHC Update 2, Jauary 2015

15 Setiel Evets 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 setiel evet ad does ot focus o or explore the evet further, but rather will had off further discussio to Joit Commissio Cetral Office staff i the Setiel Evet Uit of the Office of Quality ad Patiet Safety. Surveyors are ot authorized to ivestigate setiel evets. Staff i the Setiel Evet Uit will cotact the orgaizatio 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 orgaizatio 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 o page SE-7.) Durig the o-site survey, the surveyor(s) will assess the orgaizatio s compliace with setiel evet related stadards i the followig ways: Review the orgaizatio s process for respodig to a setiel evet Iterview the orgaizatio 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 are stadards related to setiel evets ad associated elemets of performace (EPs): Stadard LD The orgaizatio has a orgaizatiowide, itegrated safety program for idividuals served. Elemets of Performace for LD The leaders implemet a orgaizatiowide safety program for idividuals served. 2. Oe or more qualified persos maage 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 ear misses, close calls, or good catches) to hazardous coditios ad setiel evets. 4. All programs ad services withi the orgaizatio participate i the safety program. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 15

16 Comprehesive Accreditatio Maual for Behavioral Health Care 5. As part of the safety program, the leaders create procedures for respodig to system or process failures. Note 1: Resposes might iclude cotiuig to provide care, treatmet, or services to those affected, cotaiig the risk to others, ad preservig factual iformatio for subsequet aalysis. Note 2: For opioid treatmet programs: Examples of reportable patiet deaths iclude the followig: Drug-related deaths Methadoe or bupreorphie deaths Uexpected or suspicious deaths Treatmet-cotext deaths that raise idividual, family, commuity, or public cocer 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 , EP 8; LD , EP 5; LD , EP 3) 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 resultig i a serious adverse outcome or a adverse evet, ofte referred to as a close call or ear miss. 8. The orgaizatio 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 persos. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 16 CAMBHC Update 2, Jauary 2015

17 Setiel Evets 11. To improve safety, the orgaizatio aalyzes ad uses iformatio about system or process failures ad, whe coducted, the results of proactive risk assessmets. (See also LD , 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 , EP 5) 13. At least oce a year, the leaders provide goverace with writte reports o the followig: All system or process failures The umbers ad types of setiel evets Whether the idividuals served ad the families were iformed of the evet All actios take to improve safety, both proactively ad i respose to actual occurreces 14. The leaders ecourage exteral reportig of sigificat adverse evets, icludig to 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. Stadard RI The orgaizatio respects the right of the idividual served to collaborate i decisios about his or her care, treatmet, or services. Elemets of Performace for RI The orgaizatio iforms the idividual served or surrogate decisio-maker about uaticipated evets that relate to setiel evets cosidered reviewable by The Joit Commissio. Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. CAMBHC Update 2, Jauary 2015 SE 17

18 Comprehesive Accreditatio Maual for Behavioral Health Care Shadig idicates a chage effective Jauary 1, 2015, uless otherwise oted i the What's New. SE 18 CAMBHC Update 2, Jauary 2015