2015 Patient Safety Top10
Content
Top 10 Top Patient Safety Concerns for Healthcare Organizations
Publisher: ECRI Institute EXECUTIVE STAFF Jeffrey C. Lerner, Ph.D. Presiden and Chief Execuive Officer Anthony J. Montagnolo, M.S. Execuive Vice Presiden and Chief Operaing Officer Ronni P. Solomon, J.D. Execuive Vice Presiden and General Counsel Vivian H. Coates, Coates, M.B.A. Vice Presiden, Informaion Services and Technology Assessmen Michael Argentieri, M.S., BME Vice Presiden, Marke Developmen Mark E. Bruley, CCE Vice Presiden, Acciden and Forensic Invesigaion G. Daniel Downing, M.B.A. Vice Presiden, Finance James P. Keller, Jr., M.S. Vice Presiden, Healh Technology Evaluaion and Safey Jennifer L. Myers Vice Presiden, SELECT Healh Technology Services Thomas E. Skorup, M.B.A., FACHE Vice Presiden, Applied Soluions David W. Watson, Ph.D. Vice Presiden, Operaions, ECRI Insiue Europe Jin Lor, MIE (Aus) Regional Direcor, Souheas Asia
MISSION STATEMENT ECRI Insiue is an independen nonprofi organizaion whose mission is o benefi paien care by promoing he highes sandards of safey, qualiy, and cos-effeciveness in healhcare. We accomplish his hrough our research, publishing, educaion, and consulaion. Our goal is o be he world’s mos rused, independen, organizaion providing healhcare informaion, research, publishing, educaion and consulaion o organizaions and individuals in healhcare.
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www.ecri.org/PatientSafetyTop10.
Top 10 Patient Safety Concerns for Healthcare Organizations
Introduction
NOT JUST A TOP 10 LIST Wih his repor, ECRI Insiue is releasing is op 10 lis of paien safey concerns for 2015. This is he second year we have compiled he lis, which is parly based on our review of paien safey even repors, research requess, and roocause analyses submited o ECRI Insiue PSO, one of he firs paien safey organizaions (PSOs) o be federally cerified under he provisions of he Paien Safey and Qualiy Improvemen Ac (PSQIA). PSQIA gives healhcare organizaions a unique opporuniy o volunarily share heir safey surveillance daa in a proeced environmen so PSOs can aggregae and analyze he daa. The law also charges PSOs wih he responsibiliy o share he findings and lessons learned. The release of our op 10 lis of paien safey concerns is in keeping wih ha responsibiliy. ECRI Insiue’s Top 10 Paien Safey Concerns for Healhcare Organizaions is Organizaions is more han jus a lis; i’s a reminder ha, despie he atenion given o paien safey over he las 15 years or so, we can do beter. Since we began collecing paien safey evens in 2009 as a PSO, we have received nearly 500,000 even repors. Each even ofen describes a sysems-relaed breakdown, or a near failure, in he care process process of he paiens paiens our members are commited o serving. Some of of he evens evens describe serious, prevenable paien injuries or deahs. Behind each even here’s a sory abou paiens and heir loved ones who pu hemselves in he hands of heir providers expecing qualiy care and services. And here’s a separae sory abou he providers whose lives and careers are orn apar when paiens are harmed because fauly sysems and processes make problems more likely o occur. Our paien safey analys Sheila Rossi, who shares her own encouner wih a medicaion error in his year’s repor, reminds us of he sories behind hese evens and he moivaion for our op 10 lis. “When we say ‘he paien’ in healhcare, i someimes becomes impersonal,” Rossi says, urging everyone o pu hemselves in paiens’ shoes and o ask, “How do I preven his from happening o me ?” me?” Healhcare providers, regardless of wha seting hey pracice in, can sar wih our op 10 lis of paien safey concerns and use i o guide heir own discussions abou paien safey and improvemen iniiaives. We will coninue o publish our op 10 lis annually because we are commited o paien safey and o helping you o deliver he safes care for all of us, your paiens. Sincerely,
William M. Marella, MBA Execuive Direcor, Operaions and Analyics ECRI Insiue’s Paien Safey, Risk, and Qualiy Group
Top 10 Patient Safety Concerns for Healthcare Organizations
Top 10 Patient Safety Concerns for Healthcare Organizations: 20 2015 15 ECRI Insiue has released is newes lis of he op 10 paien safey concerns confroning healhcare organizaions. The lis serves as a “caalys for discussion” among healhcare leaders abou he op paien safey issues faced by heir organizaions, says Caherine Pusey, RN, MBA, manager, clinical analyss a ECRI Insiue PSO. ECRI Insiue’s Top 10 Paien Safey Concerns for Healhcare Organizaions Organizaions for for 2015 is compiled by ECR ECRII Ins Insi iue ue PS PSO, O, one of he fir firs s pa paie ien n saf safey ey org organi aniza zaion ionss (PSO (PSOs) s) o be fed federa erally lly cer cerifi ified. ed. “The lis is based on wha we see hroughou he year among he paien safey even repors, researc rese arch h requess, and roo-cause analyses submited submited o ECRI Insiue PSO,” PSO,” says Pusey. Under he Paien Safey and Qualiy Improvemen Ac, healhcare organizaions can volunarily submi paien safey repors o PSOs in a proeced environmen for PSOs o aggregae, analyze, and share findings and lessons learned. ECRI Insiue PSO has been collecing paien safey daa since 2009 and, by he end of 2014, had received nearly 500,000 even repors. The lis also draws upon ECRI Insiue saff experise, including he knowledge gained invesigaing incidens, observing and assessing hospial pracices, and reviewing healh-echnology-relaed problem repors submited o ECRI Insiue’s volunary medical device problem reporing program. In fac, four of he paien safey concerns idenified for he op 10 lis also rank among ECRI Insiue’s op healh echnology hazards for 2015. Refer o “ECRI Insiue’s Top 10 Liss” for more informaion on he healh echnology hazard lis, which is compiled by ECRI Insiue’s Healh Devices Group. “Mos organizaions have heir own op 10 lis. They should review our lis of paien safey concerns o idenify issues ha should be on heirs,” says Pusey. “We’re no saying ha every organizaion mus address all 10 opics, bu hey should should deermine where where here are similariies similariies and variaions.” Using ECRI Insiue’s op 10 lis proacively o improve qualiy of care and paien safey is also in keeping wih he provisions of he Join Commission’s recenly released paien safey sysems chaper for is 2015 accrediaion manual. The chaper describes he imporance and srucure of an inegraed approach o paien safey for healhcare organizaions.
ECRI Institute’s Top 10 Patient Safety Concerns for 2015
1
Alarm hazards: inadequate alarm configuration policies and practices*
2
Data integrity: incorrect or missing data in EHRs and other health IT systems
3
Managing patient violence
4
Mix-up of IV lines leading to misadministration of drugs and solutions*
5
Care coordination events related to medication reconciliation
6
Failure to conduct independent double checks independently*
7
Opioid-related events
8
Inadequate reprocessing of endoscopes and surgical instruments
9
Inadequate patient handoffs related to patient transport*
Medication errors related to pounds and 10 kilograms* *New to the 2015 list.
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Top 10 Patient Safety Concerns for Healthcare Organizations
Half of he iems on he op 10 lis are new for 2015; he oher half are recurring or variaions of concerns from 2014 when ECRI Insiue firs released is op 10 lis of paien safey concerns. Refer o “ECRI Insiue’s Top 10 Paien Safey Concerns for 2015” for he full lis. Iems from he 2014 lis ha do no appear on his year’s lis, such as mislabeled laboraory specimens and paien falls while oileing, sill remain a concern, says Pusey. “Bu oher opics have risen o a higher level of atenion.”
APPLICABILITY TO MULTIPLE SETTINGS
Many of he opics on ECRI Insiue’s lis of op 10 paien safey concerns exend o muliple healhcare setings and highligh he relevance of hese issues o he coninuum of care spanning physician pracices and oher oupaien medical setings, acue care hospials, and aging services providers in posacue care environmens, nursing homes, and hospice care.
Many of the Top 10 Safety Events Span Multiple Healthcare Settings
“While some of hese hazards are mos applicable o acue care, several are also relevan in ambulaory setings, and some—especially hose relaed o medicaions and care coordinaion—span he coninuum of care,” says William M. Marella, MBA, execuive direcor, operaions and analyics for ECRI Insiue’s Paien Safey, Risk, and Qualiy group. Because he opics on ECRI Insiue’s lis of paien safey concerns are largely based on repors submited by hospials, hese hese issues, while while imporan o muliple healhcare setings, may no always rank among he op 10 concerns for nonhospial setings, such as physician pracices and aging services providers. For example, appropriae managemen of alarms is imporan in long-erm care setings such as nursing homes where alarms are used o deec residen wandering and elopemen, falls, and oher risks, says Vicor Lane Rose, NHA, MBA, CPASRM, operaions manager of ECRI Insiue’s Aging Services Risk Managemen program wihin is Paien Safey, Risk, and Qualiy group. The opic, however, may no rank as aging services providers’ number one concern, he adds, because oher issues, such as skin managemen, appropriae saffing and scheduling, and falls managemen, are ypically among he highes prioriies for he aging services secor.
Hospital
Ambulatory Care
Aging Services
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Top 10 Patient Safety Concerns for Healthcare Organizations
ECRI Institute’s Top 10 Lists ECRI Insiue’s op 10 liss of paien safey concerns and healh echnology hazards highligh four overlapping issues ha deserve he atenion of healhcare organizaions. Togeher, hey reflec a unied effor by ECRI Insiue o promoe paien safey in healhcare organizaions. ECRI Insiue’s Top 10 Health Technology Hazards , released released every every fall, focuses on on echnology, echnology, whereas whereas ECRI ECRI Insiue’s Insiue’s Top 10 Patient Safety Concerns for Healthcare Organizations addresses Organizations addresses broader paien safey issues. Like he lis of paien safey concerns, he op 10 lis of healh echnology hazards reflecs ECRI Insiue’s healhcare safey experise. The lis is compiled based on he saff’s experience invesigaing device-relaed incidens, evaluaing medical devices in ECRI Insiue’s esing laboraory, and reviewing repors from ECRI Insiue’s and oher organizaions’ daabases for medical device problems and paien safey evens. ECRI Insiue has published is lis of healh echnology hazards for eigh years and is lis of paien safey concerns for wo years. Boh liss are published annually. Despie he differen focuses of he wo liss, Caherine Pusey, RN, MBA, manager, clinical analyss a ECRI Insiue PSO, is sruck ha wo differen eams idenified four overlapping areas as prioriies for healhcare organizaions in 2015. “Separaely, we are idenifying some of he same issues.” The four overlapping concerns are as follows: 1. Alarm hazards from inadequae alarm configuraion policies and pracices 2. Daa inegriy failures from incorrec or missing daa in EHRs and oher healh IT sysems 3. IV line mix-ups leading o misadminisraion of drugs and soluions 4. Inadequae reprocessing of endoscopes and surgical insrumens In fac, hese four echnology-relaed opics are he op four iems idenified in ECRI Insiue’s Top 10 Health Technology Hazards for 2015. The 2015. The overlap of hese four prioriy opics “shows he significance of healhcare echnology as i impacs paien safey overall,” says James P. Keller, MS, vice presiden, healh echnology evaluaion and safey, ECRI I nsiue. “A “A big reason why echnology shows prominenly on he op 10 lis of paien safey concerns is he growing complexiy of echnology and he increased reliance on echnology in delivering healhcare,” he says, lising areas such as healh IT and alarm hazards. The 2015 repor of healh echnology hazards also has some broader opics ha span muliple echnologies. One was insufficien cybersecuriy proecions for medical devices and sysems. “Despie litle evidence o dae of direc harm o paiens, cybersecuriy is neverheless a poenial hrea ha healhcare faciliies mus begin addressing,” says Rob Schluh, senior projec officer a ECRI Insiue and he lead projec manager for ECRI Insiue’s Top 10 Health Technology Technology Hazards for 2015 projec. 2015 projec. “The vulnerabiliy of medical devices o malware ha could affec device funcionaliy or he inegriy of paien daa is of paricular concern.” ECRI Insiue predics ha cybersecuriy is a paien safey consideraion ha will require increased atenion in he coming years. Anoher broad opic on he 2015 op echnology hazards lis was deficien medical device recall and safey-aler managemen programs. “We see healhcare organizaions wih aniquaed reca ll managemen programs,” says Schluh. “One key concern we have is ha he capabiliies of some hospials’ programs may no be keeping pace wih he growh over he pas decade in he number of recalls and oher alers ha are issued.” ECRI Insiue also publishes an annual wach lis of he op 10 echnology and infrasrucure issues ha a hospial C-suie should carefully examine. The lis draws upon ECRI Insiue’s decades of experience evaluaing he safey, effeciveness, effeciveness, and coseffeciveness of healh echnologies. “C-suie leaders need a concise way of seeing where new and emerging healh echnologies fi, if a all, in heir healh sysems,” says Diane Roberson, direcor, healh echnology assessmen, ECRI Insiue. Topics on he 2015 C-suie lis include he following: Z Disinfecion robos Z Three-dimensional priners Z Google Glass Z Posdischarge clinics
All hree repors are publicly available from ECRI Insiue’s websie. Top 10 Health Techno Technology logy Hazards for 2015 is 2015 is publicly available a htps://www.ecri.org/Pages/2015-Hazards.aspx htps://www.ecri.org/Pages/2015-Hazards.aspx.. The 2015 Top 2015 Top 10 Hospital C-Suite Watch List is List is freely available a htps://www.ecri.org/Pages/ECRI-Insiue-2015-Top-10-Hospial-C-Suie-Wach-Lis.aspx.. htps://www.ecri.org/Pages/ECRI-Insiue-2015-Top-10-Hospial-C-Suie-Wach-Lis.aspx
Top 10 Patient Safety Concerns for Healthcare Organizations
How the List Was Compiled
How to Use the List
To compile is lis of paien safey concerns, ECRI Insiue PSO reviewed is daabase of paien safey evens, roocause analyses, and cusom research requess submited hroughou he year by healhcare organizaions and is parner PSOs, as well as sough guidance from is eam of expers.
ECRI Insiue recommends ha healhcare organizaions use is op 10 lis of paien safey concerns as a saring poin for heir paien safey discussions and for seing heir paien safey prioriies. Use he lis o idenify wheher he organizaion has experienced paien safey breakdowns in similar areas and wheher wheher he concerns concerns should be argeed for improvemen. For areas seleced for improvemen, organizaions can creae risk miigaion sraegies based on he recommendaions provided wih he op 10 lis for each area of concern. Addiional Addiional ECRI Insiue resources, some freely available on ECRI Insiue’s websie, are highlighed hroughou he repor.
“Our op 10 lis isn’ generaed from a complicaed algorihm or formula. I’s very much a consensus process ha atemps o disill he judgmen of ECRI Insiue’s paien safey expers, our advisors, and our members,” says Marella. “Topics are nominaed based on our analysis of safey evens repored o ECRI Insiue and our parner PSOs as well as wha’s happening in he broader paien safey communiy.” The final lis reflecs he inpu of ECRI Insiue PSO’s eam of analyss and oher ECRI Insiue saff, as well as members of ECRI Insiue PSO’s advisory council.
“Our hope is ha healhcare providers use his lis o reflec on which of hese hazards exis in heir care setings and on wheher hey have sysems in place o preven or minimize harm from hose ha are relevan in heir seings,” says Marella. Rose recommends ha faciliies across he healhcare specrum use he lis o “undersand he risks ha do exis a your organizaion, o quanify hem, and o find ou where hey’re hey’re happening so he organizaion can idenify pracices o miigae he risks.” Given ha paien safey improvemens can ofen require an invesmen in saff ime and he organizaion’s resources, Pusey recommends ha organizaions presen he lis o heir senior leaders and members of heir governing boards o gain heir atenion and suppor.
Top 10 Patient Safety Concerns for Healthcare Organizations
1. Alarm Hazards: Inadequate Alarm Confguration Policies and Practices
Topping he lis of paien safey concerns is alarm hazards from inadequae alarm configuraion policies and pracices, a opic which also ranks as ECRI Insiue’s op healh echnology hazard for 2015. Since ECRI Insiue began publishing is lis of op healh echnology hazards in 2007, “alarm hazards have been a or near he op of he lis,” says Rob Schluh, senior projec officer a ECRI Insiue and he lead projec manager for he Top 10 Healh Technology Hazards for 2015 projec. 2015 projec. The need o address alarm hazards is paricularly imporan wih he Join Commission’s ongoing Naional Paien Safey Goal for healhcare organizaions o improve he safey of clinical alarm sysems.
ECRI INSTITUTE RESOURCES HRC
Z Clinical Alarms Other Memberships and Sources*
Z The Alarm Safety
In recen years, much of he lieraure relaed o alarm hazards has focused on alarm faigue—a condiion ha can lead o alarms missed by providers who are overwhelmed by, disraced by, or desensiized o he muliple alarms ha acivae. In is 2015 lis, ECRI Insiue encourages healhcare insiuions o look beyond alarm faigue. “In addiion o missed alarms ha can resul from excessive alarm acivaions, hospials also have o be concerned abou alarms ha don’ acivae when a paien is in disress,” says Schluh. “In our experience, alarm-relaed adverse evens—wheher hey resul from missed alarms or from unrecognized alarm condiions—ofen can be raced o alarm sysems ha were no configured appropriaely.” To mee he Join Commission’s Naional Paien Safey Goal on clinical alarm safey, organizaions accredied by he group mus, as of 2016, esablish policies and procedures o manage alarm signals idenified by he organizaion as essenial for paien safey. ECRI Insiue recommends ha organizaions examine heir alarm configuraion policies and procedures o address he full range of facors ha can lead o alarm hazards. “Our acciden invesigaions have found ha hospials have eiher no had consisen or no had any pracices o deermine how alarms are se by care area or by paien ype,” says James P. Keller, MS, vice presiden, healh echnology evaluaion and safey, ECRI Insiue. For example, “i doesn’ make sense o use he same defaul alarm setings in pediaric inensive care as in adul inensive care,” he explains, ye ECRI Insiue has found ha many hospials do no have a policy o adjus he alarm defaul setings by care area. Similarly, hospial policies ofen fail o specify when and who can make adjusmens o he defaul alarm setings, says Keller. In addiion o he recommendaions for addressing alarm hazards conained in he Top 10 Healh Technology Hazards for 2015 , ECRI Insiu Insiue e has compiled compiled is is Alarm Alarm Safey Safey Handbook Handbook and and Alarm Safey Workbook Workbook o o help organizaions undersand he breadh of alarm hazards, idenify alarm safey vulnerabiliies, and develop an effecive program for managing clinical alarms o improve paien safey. The maerials are provided as a membership benefi for cerain ECRI Insiue programs and are available o ohers for purchase. See “ECRI Insiue Resources” for more informaion.
Z Z
Z
Z
Handbook: Strategies, Tools, and Guidance and accompanying workbook. Alarm Safey Resource Cener Inerfacing Monioring Sysems wih Venilaors: Ven ilaors: How Ho w Well Do They Communicae Alarms? ( Alarms? (Health Health Devices)) Devices Physiologic Monioring Sysems: Our Judgmens on Eigh Sysems ( Sysems (Health Health Devices)) Devices Top 10 Health Technology Hazards for 2015
* Some ECRI Insiue resources are publicly available. To obain oher ECRI Insiue repors, conac us by elephone a (610) 825-6000, ex. 5891, or by e-mail a clien[email protected] clien[email protected]..
Top 10 Patient Safety Concerns for Healthcare Organizations
2. Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems Healh informaion echnology (IT)–relaed issues have been a recurring heme on ECRI Insiue’s op 10 liss, appearing on he op 10 healh echnology hazards lis for he las six years and on he op 10 lis of paien safey concerns since is sar in 2014. For he wo mos recen years, boh liss have idenified daa inegriy errors as a resul of incorrec or missing daa in elecronic healh records (EHRs) and oher healh IT sysems. ECRI Insiue recognizes ha healh IT offers numerous poenial benefis, such as supporing clinical decision making, enhancing provider communicaion, providing access o paien daa in a secure environmen, engaging paiens, and reducing medical errors. Bu he echnology can creae new safey risks if i is no designed appropriaely, implemened carefully, carefully, and used houghfully. In fac, in 2014, ECRI Insiue convened he Parners Parnership hip for Healh IT Paien Safey , Safey , a mulisakeholder collaboraive collaboraive esablished o proacively idenify and address healh IT paien safey risks in a nonpuniiv nonpuniivee environmen. “Wih he inroducion of any new echnology, we need o idenify and respond o novel problems i presens as well as old problems ha he new echnology doesn’ eliminae,” says Marella. Daa inegriy issues “exised wih paper medical records as well, bu now as EHRs become more ineroperable, incorrec informaion is more readily available, more easily shared, and harder o eliminae,” he says. “In order o ge a reurn on he invesmen we’ve made in EHRs and clinical decision suppor, we now need o ackle he more mundane problem of making sure he daa in he EHR is accurae.” “We’ve seen he rapid growh of healh IT sysems, paricularly in he hospial seting,” says “We’ve Keller. “Organizaions need o have beter esing of he sysems and checks and balances [afer implemenaion] o make sure failure poins for missing daa or incorrec daa enries are idenified and addressed.” As an example, consider he following even repored o ECRI Insiue PSO and is parner PSOs involving wo separae healh IT sysems—an EHR sysem and a dieary managemen program: The paien’s peanu allergy was lised in he EHR bu he informaion did no cross over o he dieary deparmen’s sysem. sysem. The paien quesioned wheher he food allergy informaion had been received by he dieary deparmen afer receiving receiving a food ray ha was no idenified as free of peanu producs. The near miss highlighed he need for a sofware fix o ensure ha imporan paien daa from he EHR is ransferred o he organizaion’s dieary IT sysem for paien menu managemen.
Top 10 Patient Safety Concerns for Healthcare Organizations
Examples of daa inegriy failures, as lised in he Top 10 Healh Technology Hazards for 2015 repor, 2015 repor, include he following: X
Appearance of one paien’s daa in anoher paien’s record
X
Missing daa or delayed daa delivery
X
Clock synchronizaion errors beween medical devices and sysems
X
Defaul values being used by misake, or fields being prepopulaed wih erroneous daa
X X
Inconsisencies in paien informaion when boh paper and elecronic records are used
ECRI INSTITUTE RESOURCES HRC
Z Elecronic Healh
Records Other Memberships and Sources
Z ECRI Institute PSO
Oudaed informaion being copied and pased ino a new repor
To correc hese problems, organizaions mus idenify daa inegriy failures as hey occur in order o apply fixes o preven similar problems from recurring. To do so, hey mus empower fronline fronline workers and healh IT sysem users o repor all ypes of healh IT-relaed incidens, including hose ha do no cause any harm as well as near-miss incidens, and circumsances ha precede an acual even and are caugh before anyhing can happen. Through is problem and even reporing programs, ECRI Insiue has found ha healhcare saff do no always recognize healh IT’s IT’s conribuion o an even. For example, only afer analysis of an inciden in which a pharmacis placed a medicaion order in he wrong paien’s record was i recognized ha he error was faciliaed by a medicaion managemen sysem ha allowed users o have muliple paien records open a he same ime. Reporing he even as jus a medicaion error overlooks overlooks oher conribuing facors, such as he healh IT sysem’s configuraion o permi muliple paien records o be open on a user’s screen.
Z
Z
Z
Z
“When reporing an adverse even or near miss, saff should consider wheher some funcion or feaure of a healh IT sysem could have conribued o he problem,” says Schluh. Some even reporing programs give reporers he abiliy o idenify he repor as a healh IT-relaed issue. For example, he Agency for Healhcare Research and Qualiy’s mos recen version of he Common Formas (version 1.2) includes an even repor for healh IT evens and unsafe condiions. The Common Formas are used by PSOs and heir paricipaing providers for even reporing and allow daa aggregaion in a sysemaic manner.
Z
Deep Dive: Health Information Technology Healh IT Parnership Proceedings:: ParnerProceedings ing for Success How o Connec wih he Righ EMR Inegraion Ven Vendor dor (Health Devices) Devices) Making Connecions: Inegraing Medical Devices wih Elecronic Medical Records (Health Devices)) Devices Paien Safey a Inersecion of Medical and Informaion Technology (PSO Navigator)) Navigator Top 10 Health Technology Hazards for 2015
Top 10 Patient Safety Concerns for Healthcare Organizations
3. Managing Patient Violence
Every day, U.S. hospials deal wih violen paien incidens and hreaening behaviors ha affec he safey and well-bei well-being ng of saff, paiens, and visiors. According According o curren lieraure on he opic, violence is occurring in all care setings, even in oncology and maerniy unis, and no jus in he emergency deparmen (ED). Clinical saff in acue care unis ypically lack raining in behavioral healh and may dismiss or poorly handle behavioral cues ha signal imminen violence, says Ruh Ison, MDiv, STM, paien safey analys/consulan a ECRI Insiue PSO. Ison noes ha repors submied o ECRI Insiue PSO and is parner PSOs show ha docors, nurses, ancillary saff, and even securiy officers working in emergency and acue care setings are grealy challenged in managing paiens who become violen or hreaen violence. In 2014, failure o adequaely manage hreaening or violen behavior of paiens in acue care setings was among ECRI Insiue’s op 10 paien safey concerns. The range and impac of paien violence across he hospial is no limied o incidens ha make he headlines. Clinical saff may feel abandoned and lef wihou he resources o do heir jobs safely, given he frequency wih which hey mus manage violen behavior in paiens—a leas 15 incidens a day, according o one PSO member hospial. The firs hing ha hospial leadership mus do is acknowledge ha violence is occurring wihin he faciliy’s walls, says Judy Gushue, RN, BS, MJ, CEN, CPHQ, paien safey analys, ECRI Insiue PSO. When healhcare workers perceive assauls and hreas as a workplace hazard ha mus be oleraed, hey underrepor—resuling underrepor—resuling in lack of awareness and inacion by hospial leadership. “Lack of psychiaric services and inervenion inervenionss pus pressure on nurses and oher fronline saff o be rained in violence de-escalaion echniques,” echniques,” she poins ou. Ison believes ha raining saff in de-escalaion sraegies is a smar invesmen ha can improve paien and worker safey on many levels, reducing coercion and empowering saff o engage, raher han avoid, paiens wih agiaion or hreaening behavior while promoing safe condiions. The effor may prove o be more cos-effecive han use of unrained “siters,” who have been menioned in PSO even repors as he arges of atacks by paiens, Ison says. The siter’s presence or behavior may be perceived by he paien as provocaive, as he siter is placed in he posiion of prevening he paien from engaging in cerain unsafe behaviors, she noes. Unrained siters may no be sensiive o he paien’s clinical siuaion, may no fully undersand he recommended safey precauions, or may argue wih he paien. Oher siter behaviors (e.g., exing, chating, playing games on a smarphone) migh resul in siter inatenion or even provoke a violen response from he paien.
Top 10 Patient Safety Concerns for Healthcare Organizations
Gushue adds ha in addiion o requiring reporing and providing saff raining in deescalaion sraegies and skills, he hospial should have a faciliy-wide safey plan ha considers all levels of risk, from he single acue episode of hreaening behavior o an acive shooer siuaion anywhere in he faciliy or on campus. “Know he risks posed by your paien populaion—local populaion—local police saisics may help idenify areas of risk or peak periods when risk may be greaer.” The program should address physical securiy and response (e.g., use of hidden alarms, cameras, elecronic saff locaor services, increased sraegic securiy presence, limiing sies of enrance and egress a nigh), implemening and monioring compliance wih policies and procedures for inspecing belongings of visiors and paiens for weapons, reconfiguring ED waiing areas, invoking emergency legal processes for commimen or reamen (when appropriae), and esablishing a rained rapid response eam o assess poenial violen behavior and inervene when summoned. Ison agrees: he acue sympoms ha demonsrae a paien’s behavioral or medical o cooperae wih care inervenion inervenionss should no be misinerpreed by healhcare inabiliy o inabiliy workers as unwillingness unwillingness;; however, “aggressive or agiaed behavior signals a high-risk, high-acuiy siuaion ha needs immediae clinical atenion comparable o a sroke, cardiac, or respiraory even.” Ison has idenified he following paien facors from ECRI Insiue PSO even repors involving violen paien behavior: acue subsance abuse or addicion, acue wihdrawal, drug-seeking behavior, psychosis, possurgical saus, and various medical and menal healh comorbidiies (e.g., neurologic disorders, infecions, delirium, adverse prescripion drug reacions, developmenal disabiliies) combined wih behavioral healh sympoms (e.g., paranoia, moor agiaion, emoional volailiy) and social dislocaion. Clinical managemen sraegies can include sanding orders and medicaion order ses ha can be acivaed immediaely by he saff on duy, as well as securiy measures. And while acuely agiaed or hreaening, violen paiens should never be handed off, as hese are emergency siuaions. Subsequen handoff communicaion of he paien’s medical saus should include idenificaion of acue socioemoional or behavioral healh issues ha are adversely affecing he paien, Ison says. These migh be addressed by social workers or behavioral healh healh saff. Diminishing he risks involved wih paien violence sars wih acceping is realiy across healhcare setings, Gushue says. The experise of leadership, managemen, and clinical saff a all levels is needed o develop a comprehensive response ha mees hese vulnerable paiens’ medical needs and keeps all healhcare saff safe in he process.
ECRI INSTITUTE RESOURCES HRC
Z Paien Violence Z Workplace Violence
Prevenion Plan Z Violence Risk Assessmen Tool for Home Care Other Memberships and Sources
Z Residen Aggres-
sion and Violence (Continuing Care Risk Management)) Management Z Residen Aggression/ Violence Assessmen Tool ( Tool (Continuing Continuing Care Risk Management) Management)
Top 10 Patient Safety Concerns for Healthcare Organizations
4. Mix-Up of IV Lines Leading Lead ing to Misadministration of Drugs and Solutions Inravenous (IV) line mix-ups can lead o medicaion errors, resuling in wrong-drug, wrong-rae, wrong-dose, or wrong-sie infusions, some wih serious consequences. Paiens, paricularly hose in criical care setings, can have muliple IV infusions, increasing he risk of connecing he line o he wrong infusion pump, wrong fluid conainer, or wrong adminisraion roue. Paiens may have oher inerfering facors, such as leads and cables for physiologic moniors, increasing he risk of misakes wih IV line mix-ups, says Keller. Someimes described as “spagheti syndrome” or he angle of ubes, caheers, and cables ha engulf paiens, he muliple lines “make i harder o rack he source of an IV line as i leads from he paien’s inserion sie o he original source,” he says. In he following even repored o ECRI Insiue PSO and is parner PSOs, an older paien received oo much heparin because he IV lines for heparin and saline were misconneced: The ED paien was suspeced of having a hear atack and was sared on a high-risk proocol for IV heparin. Afer he paien was ransferred ransferred o he uni, he nurse noiced ha he heparin bag was almos empy. The nurse checked he pump and saw ha i was running a he faser rae inended for he saline soluion. The ubing lines were mixed up, and he heparin ran for four hours a he faser rae, resuling in he paien receiving seven imes as many unis of heparin as inended. The paien was reaed for a heparin overdose and ransferred o he criical care uni. Alhough he risk of IV line mix-ups is pronounced in he criical care seting, he risk also exiss in oher acue care setings, as he above even illusraes, and in nonhospial setings, such as a nursing home, where residens may require, for example, boh an IV anibioic and pain medicaion. Alhough paiens in hese setings may have fewer lines, misakes can sill occur, paricularly if he provider does no have he same advanced raining as a criical care nurse o ensure safey, says Keller.
Top 10 Patient Safety Concerns for Healthcare Organizations
Among ECRI Insiue’s recommendaions o preven IV infusion-li infusion-line ne confusion are he following: X
Trace all lines back o heir origin before making connecions. Doing so verifies ha he correc lines will be joined. Lines should be rechecked upon he paien’s arrival in a new seting or service and a shif changes as par of he handoff process.
X
Develop a policy of posiioning differen lines on differen sides of he paien. Consisenly puting lines in he same place migh make i easier for clinicians o correcly idenify hem and connec hem appropriaely.
X
Label each infusion line wih he name of he drug or soluion being infused.
X
Do no force connecions. If a connecion is difficul o make—ha is, if i requires a lo of effor—chances are i should s hould no be made.
ECRI INSTITUTE RESOURCES HRC
Z Prevening Miscon-
necions of Lines and Cables Z Invasive Lines Other Memberships and Sources
Z Be a T.R.A.C.E.R. no
Separaely, misconnecions can also occur when ubing from one delivery sysem is misconneced o a sysem inended for a differen purpose (e.g., an eneral feeding pump being conneced o o an IV line). line). New connecor connecor sandards are being being developed o reduce his risk; however, he sandards will no preven all line misconnecions. Once he new design sandards for connecors are fully in place, IV lines will coninue o use he same ype of connecor, making i possible o sill have IV infusion mix-ups.
Z
ECRI Insiue recommends using posers o remind saff abou sraegies o preven ubing misconnecions. For example, ips for clinical saff are summarized in a poser developed by ECRI Insiue Insiue summarizing is is TRACER program o preven ubing misconnecions. Informaion for obaining he poser from ECRI Insiue, as well as oher resources, is provided in “ECRI Insiue Resources.”
Z
Z
™
Z
Z Z
a RACER! (poser) RACER! (poser) Choosing a Syringe Infusion Pump (Health Devices) Devices) Fixing Bad Links o Preven Tubing Misconnecions (PSO Navigator)) Navigator Infusion Pump Inegraion: Why Is I Needed and Wha Are he Challenges? (Health Devices) Devices) Paien-Conrolled Analgesic Infusion Pumps: Making a Painless Purchase (Health Devices) Devices) Top 10 Health Technology Hazards for 2015 Which Smar Pumps Are Smares? Raings for Six Large-Volume Infusion Pumps (Health Devices) Devices)
Top 10 Patient Safety Concerns for Healthcare Organizations
5. Care Coordination Events Related Relat ed to Medication Reconciliation A every care ransiion, such as admissions, ransfers, and discharges, “he paien’s medicaions should be reconciled o ensure he paien is on he correc medicaions for he nex phase of care,” says Mary Beh Michell, MSN, RN, CPHQ, CCM, SSBB, paien safey analys and consulan a ECRI Insiue PSO. Inadequae medicaion reconciliaion pus paiens a risk for medicaion errors, inadequae follow-up care, and hospial readmissions. On admission, medicaion reconciliaion is challenging o conduc effecively unless he paien or family members have kep accurae records of he paien’s medicaions, says Michell. To ensure he lis’s accuracy, she recommends verifying he paien’s medicaion lis wih anoher source, such as he paien’s primary care physician and/or pharmacy. The backup approach approach is no no fail-safe, fail-safe, howev however, er, if he paien paien goes o muliple muliple pharmacies pharmacies or is seen by muliple specialiss, “all of whom may order prescripions for he paien,” she says. Providers should also ask abou any over-he-couner and herbal medicaions ha he paien may be aking, as well as any ransdermal paches ha are in place. A faciliy migh also refer o he paien’s las medical record from a previous say o idenify he paien’s lis of medicaions a discharge. “Bu ha may no be a good source for informaion if i’s been a long ime since he paien’s las hospializaion or if he paien has had medicaion changes by heir primary care physician and/or specialiss,” says Michell. The paien’s medicaions may have changed if he previous hospializaion was no recen, as in he following even repored o ECRI Insiue PSO and is parner PSOs: The paien was admited hrough he ED. The paien brough a lis of curren medicaions. The lis was compared o he paien’s medicaion lis from a previous say. Two oher medicaions, an anipsychoic drug and a diabees medicine, from he previous say were no on he paien’s medicaion lis and were ordered. No one wen over he paien’s curren medicaion lis wih he paien. During he paien’ss say, he paien’s paien’ paien’s wife wife repored repored he he paien paien was having hallucinaions hallucinaions and seemed seemed coninually coninually drowsy when ha wasn’ he paien’s norm. I was deermined ha he paien had no aken he wo addiional medicaions for a year, so hey were disconinued. When a paien is admited for care, providers may decide o disconinue some or all of he paien’s medicaions aken before he admission in order o address he paien’s acue needs. They may also inroduce new medicaions o rea he acue condiion. As he paien’s condiion improves or changes and when he paien is ransferred o anoher level of care, clinicians mus coninue o evaluae he paien’s medicaion needs, deciding wheher o disconinue he medicaions for he acue condiion, inroduce any new drugs, or resume any of he medicaions ha he paien ook before admission. “By he ime he paien is ready for discharge, hey should no be receiving new medicaions ha hey did no receive while in he hospial,” says Michell. “The poin of conducing medicaion reconciliaion every sep along he way of he hospializaion is ha by he ime he paien is ready for discharge, hey should be on he righ medicaions and he healhcare providers should know ha he paien can olerae he medicaions when aken ogeher.”
Top 10 Patient Safety Concerns for Healthcare Organizations
While EHRs can improve communicaion among providers abou paiens’ medicaions, Michell warns o use he echnology cauiously. For example, a discharge, don’ simply prin he paien’s lis of medicaions wihou assigning someone o go hrough he lis o look for errors, such as dosing errors and duplicae orders for similar drugs wih differen names, she recommends. In addiion, some EHRs allow only one person o reconcile he medicaions, which means ha ha physician mus be sure of all of he medicaions and recommended doses from he specialis physicians. If he paien is being discharged o anoher healhcare seting, medicaion reconciliaion can only be achieved by effecively managing he paien’s discharge from he hospial and he admission o he oher faciliy, such as a nursing home or subacue care faciliy, says Rose. “Boh pieces need o be managed . . . for medicaion reconciliaion o work well,” he says. If he discharge and admission process from one faciliy o anoher is poorly managed, paien care can suffer. “Medicaions ha were disconinued a he hospial may no be resared when he person comes back o an aging services provider or reurns home,” says Rose. The aging services provider mus hen coordinae wih he hospial and physician who was overseeing he paien’s care or he paien’s primary care physician o idenify he paien’s medicaions. “I’s no an easy process and can lead o delays in resuming he paien’s care,” Rose says. Typically, aging services providers conduc char checks wihin 24 hours of a residen’s reurn o he faciliy afer a hospial discharge o review he residen’s medicaions, o see if anyhing was sopped or added, and o deermine if here’s a reason for he change, says Rose. If he residen is new o he faciliy, he organizaion will verify ha informaion wih he individual’s primary care physician. There are many ways o manage medicaion reconciliaion. Some publicly available resources for medicaion reconciliaion recommend pharmacis-led inervenions, bu here are oher approaches as well. A good mechanism o ensure ha he medicaion reconciliaion process works well is o proacively evaluae he process using a failure mode and effecs analysis (FMEA) o idenify gaps in ha process. Consider involving he pharmaciss, case managers, nursing, and oher FMEA eam members in idenifying soluions o close he gaps, says Michell. “Pharmaciss don’ necessarily need o lead he inervenions, bu hey need o be involved involved wih wih he mulidi mulidisciplinar sciplinary y eam in closing he gap,” she says. Rose, who also recommends ha aging services providers conduc a similar proacive analysis of heir medicaion reconciliaion processes, encourages hospials and aging services providers o engage each oher in he medicaion reconciliaion assessmen. “Find ou where he risks exis and have inelligen conversaions wih your care parners in he communiy o pu pracices in place o miigae hem,” he says. Refer o “ECRI Insiue Resources” for addiional informaion.
ECRI INSTITUTE RESOURCES HRC
Z Discharge Planning Z Medicaion Safey Z Subacue Care in
Long-Term Care Setings
Top 10 Patient Safety Concerns for Healthcare Organizations
6. Failure to Conduct Independent Double Checks Independently
In blood banking, having wo praciioners perform an independen double check of he blood group before ransfusion ransfusion is a long-sanding long-sanding requiremen. requiremen. “Nobody “Nobody in he universe universe would hink of doing a blood ransfusion wihou doing an independen double check firs because you could could kill he paien prety quickly,” quickly,” saes Elizabeh Elizabeh Drozd, MS, MT(ASCP) SBB, CPPS, paien safey analys, ECRI Insiue PSO. “Bu for high-aler medicaions, we’ve seen a lo of conroversy abou doing independen double checks and have seen a lo of failures in ha process.” The following wo evens repored o ECRI Insiue PSO and is parner PSOs illusrae how failures in independen double checks can affec paiens: Paien was receiving receiving a heparin drip, which required a double check per policy. The dosing nomo gram and rae were were double-checked double-checked appropriaely, appropriaely, bu here was no double check when he nurse changed he rae on he infusion pump. The drip rae was changed o 18 mL/hr insead of 15 mL/hr, resuling in an elevaed parial hromboplasin ime wih bleeding from he IV sie. An independen double double check was was no compleed compleed when a paien-conrolled paien-conrolled analgesia analgesia (PCA) (PCA) pump was se, resuling in a 10-fold opioid overdose. Naloxone was adminisered, and he paien was rans ferred o he he inensive inensive care uni (ICU). When double checks are used, one major issue is he failure o conduc hem in a way ha is ruly independen. As he second provider, “I wan o check your work oally independenly of wha you’re elling me,” says Drozd. “I wan o look a everyhing,” such as paien ideniy, indicaion and appropriaeness, drug or blood ype, dose, programmed infusion rae, and roue. To achieve ruly independen double checks, he organizaion needs saff buy-in. “They have o undersand why independen double checks are done independenly,” Drozd emphasizes. Imporanly, he process mus be free of he poenial for confirmaion bias. For example, if he firs provider asks he second provider, “I go 5,000 unis of heparin. Wha do you ge?” he second provider is already biased oward a specific dose and drug. A provider may overly rely on he second provider’s check, possibly skipping seps, if he or she expecs ha simply doing a double check will cach any errors or believes ha he second provider “doesn’ make misakes.”
Top 10 Patient Safety Concerns for Healthcare Organizations
In addiion, he organizaion mus be judicious when deciding which processes require an independen double check. A common misake is o “add a double check as a soluion o everyhing,” says Drozd, poenially leading o double check faigue. Insead, “use independen double checks wih a lo of cauion and only for processes ha could harm he paien very, very quickly.” Sysems issues should also be invesigaed. For example, if policies and procedures require an independen double check in a paricular siuaion bu a second provider is ofen unavailable,, saff may use workarounds or even skip he double check. unavailable How can organizaions invesigae wheher hey are performing independen double checks in a way ha is ruly independen? “The only way, really, is o begin o audi and observe he acual process,” says Drozd. “You have o be ou here in he paien care areas and observe,” using a checklis of wha o look for. This approach is labor-inensi labor-inensive, ve, bu “i’s also your opporuniy o link wih he individuals o explain he imporance of doing i properly.” Alhough here are many poenial barriers o ruly independen double checks, he Insiue for Safe Medicaion Pracices (ISMP) calculaes ha hey can deec up o 95% of errors. “When done properly, hey do deec a significan amoun of errors,” says Drozd.
ECRI INSTITUTE RESOURCES HRC
Z Ask HRC: Conduc-
ing and Documening Double-Checks for Medicaion Safey Z High-Aler Medicaions Z Blood Transfusions
Top 10 Patient Safety Concerns for Healthcare Organizations
7. Opioid-Rela Op ioid-Related ted Events Event s
“The use and he prescribing of opioids has significanly increased in recen years,” says Sephanie Uses, PharmD, MJ, JD, paien safey analys, ECRI Insiue PSO, and “ha’s one of he reasons opioid safey has become more of an issue.” According o he U.S. Deparmen of Healh and Human Services’ Naional Acion Plan for Adverse Drug Even Prevenion , he number of prescripion opioids dispensed doubled beween beween 1999 and 2010, and by he end of ha period, he number of relaed deahs exceeded he number of overdose deahs involving heroin and cocaine combined. The number of ED visis relaed o opioid misuse and abuse oaled more han 420,000 in 2011—double he number of visis in 2004. Problems relaed o opioid overdose, such as over-seda over-sedaion ion and respiraory depression, are a major paien safey concern, bu hey are no he only ones. Oher issues include gasroinesinal adverse evens (e.g., nausea, vomiing, consipaion), hyperalgesia, prurius, and immunologic or hormonal dysfuncion. Among evens in ECRI Insiue’s PSO daabase, he problem is “no specific o any one opioid,” says Uses. However, hose commonly involved in evens are hydromorphone, oxycodone, opioids used in PCA, and fenanyl paches. Two issues issues are especially concerning. Firs, “some of he more common errors wih hydromorphone are due o is poency,” says Uses. Hydromorphone is abou seven imes as poen as morphine, bu physicians someimes prescribe he same amoun of hydromorphone as hey would morphine, leading o overdose, as in he following even repored o ECRI Insiue PSO and is parner PSOs: Paien presens presens o ED wih abdominal pain. The paien’s pain is poorly relieved wih morphine 4 mg; atending physician changes pain orders o hydromorphone 4 mg inravenousl inravenouslyy every 4 hours as needed. The paien’s nurse adminisers a dose of hydromorphone. Shorly afer he dose is given, he nurse noices decreased responsiveness, he paien becomes apneic, and code blue is called. Two doses of naloxone are given. Paien becomes responsive and is ransferred o he inensive care uni for monioring. Second, prescribers someimes fail o disinguish paiens who are opioid-oleran (hose who have been aking an opioid of a leas a cerain hreshold dosage for a leas a week) from hose who are opioid-naïve (hose who have no). For example, opioid-naïve paiens should no be prescribed fenanyl paches, and hese paiens should receive only very low doses of susained-release oxycodone, if he drug is used a all. They should no receive coninuous infusion when PCA herapy is iniiaed; raher, bolus-only herapy should be used.
Top 10 Patient Safety Concerns for Healthcare Organizations
Opioid-relaed evens are no resriced o he hospial. For example, oxycodone and Opioid-relaed fenanyl paches may be used in long-erm and ambulaory care setings and a home. In addiion, family members or friends may inappropriaely ake he paien’s medicaions o self-rea heir pain, or he drugs may be oherwise misused or abused by he paien or ohers. ISMP has also repored on incidens, including deahs, in children and older aduls wih cogniive impairmen who have suck fenanyl paches on heir bodies or ingesed hem. “Fenanyl is so poen,” says Uses, “a young child will sop breahing righ away” afer ingesing or applying a fenanyl pach. Alhough many sraegies should be employed o promoe safey hroughou he medicaion-use process, Uses highlighs a few key inervenions o preven and miigae he kinds of evens ECRI Insiue PSO is seeing. Prescribers should be educaed abou opioid safey and he evens ha c an resul. One cenral issue is appropriae prescribing. “Does he paien really require an opioid?” says Uses. “Someimes ha’s no he firs choice ha we need o go o.” Order ses—wih differen drug forms and dosages for opioid-naïv opioid-naïvee and opioid-oler opioid-oleran an paiens, for example—may help guide clinicians as well. In hospials, saff should be rained o monior for sedaion. “A lo of imes, people don’ monior for sedaion and don’ recognize sedaion as a problem unil he paien is already experiencing respiraory depression,” Uses cauions. The Pasero Opioid Sedaion Scale is one ool ha saff can use o monior for opioid-induced sedaion. A home and in oher nonhospial setings, paiens and caregivers mus know how o appropriaely sore and dispose of opioids. These drugs should no be kep in easy view and reach of ohers, and disposal opions include ake-back days, locked drop boxes, and appropriae disposal a home. To invesigae opioid-relaed evens hey are experiencing, healhcare organizaions can no only look a heir adverse even daabase bu also use rigger ools—for example, by running daily repors o idenify when naloxone, a reversal agen, is dispensed. Faser noificaion allows for easier invesigaion invesigaion of evens, and “you can rack and rend and see wha your problems are,” Uses noes.
ECRI INSTITUTE RESOURCES HRC
Z High-Aler
Medicaions Z Pain Medicaion and PRN Orders Z Paien-Conrolled Analgesia Z Infusion Pumps Other Memberships and Sources
Z ECRI Institute PSO
Deep Dive: Medication Safety Z Pain Relief: How o Keep Opioid Adminisraion Safe ( Safe (PSO PSO Navigator)) Navigator Z Pasero Opioid Sedaion Scale (POSS) wih Inervenions Z Prevening OpioidInduced Respiraory Depression (webinar Depression (webinar for ECRI Insiue PSO)
Top 10 Patient Safety Concerns for Healthcare Organizations
8. Inadequate In adequate Reprocessing of Endoscopes and Surgical Instruments Reprocessing of endoscopes and surgical insrumens, a op 10 paien safey concern and healh echnology hazard for 2014, reurns o boh op 10 liss for 2015. In fac, reprocessing has been raised as a op 10 healh echnology hazard for six years in a row. “We coninue coninue o see reprocessing issues in our acciden invesigaio invesigaions” ns” and in media repors, says Schluh. Addiionally, as ECRI Insiue was preparing Top 10 Healh Technology Technology Hazards for 2015 , he he Ebola Ebola viru viruss had beco become me fron fron-page -page news news,, furhe furherr “highlig “highlighing hing he crii criical cal impor imporance ance of he reprocessing funcion,” says Schluh. The poenial harm o paiens from he ransmission of infecious agens remaining on reusable devices can be severe. More han half of he “immediae hrea o life” findings from Join Commission Commission surveys surveys conduced in 2013 were direcly direcly relaed o improper improper equipmen reprocessing, Schluh noes. Healhcare faciliies reprocess housands of reusable surgical insrumens and devices every day for subsequen use. No only are he devices difficul o clean, bu “muliple seps are required o ge i righ,” says Keller. Each sep mus be properly performed from sar o finish. For example, if he devices are no horoughly cleaned, organisms may remain on he devices, unaffeced by disinfecion or serilizaion. Similarly, if he devices are no horoughly dried in he final reprocessing sep, “hey are a breeding ground for organisms o grow posprocessing,” says Keller.
Top 10 Patient Safety Concerns for Healthcare Organizations
Furher complicaing he reprocessing funcion are he muliple ypes of devices, each wih heir own cleaning and disinfecion or serilizaion insrucions, says Keller. If auomaed reprocessing sysems are used for endoscope disinfecion, each device model will likely require unique model-specific model-specific channel adapers o properly flush each channel of he device, he adds. Any ime a change is inroduced o reprocessing, such as a new disinfecan, cleaning agen, or channel cleaning brushes, he impac of he change needs o be evaluaed for any ripple effec on he qualiy of he process. For example, afer being asked o invesigae an infecion oubreak in an endoscopy clinic, ECRI Insiue discovered ha he clinic had swiched o a new cleaning soluion ha required a longer soak ime for insrumens han required wih he previously used cleaning soluion. The clinic’s reprocessing procedures were no longer effecive, because he clinic had no adjused he insrumen soak ime required wih he new soluion. In addiion o he recommendaions for ensuring adequae device reprocessing lised in Top 10 Healh Technology Hazards for 2015 , oher guidance guidance from ECRI Insiue Insiue is lised lised in “ECRI Insiue Resources.”
ECRI INSTITUTE RESOURCES HRC
Z Reprocessing of
Flexible Endoscopes Z Reprocessing in Cenral Service Z Endoscope Reprocessing: The Imporance of Being Proacive Other Memberships and Sources
Z CRE and Duodeno-
Z
Z
Z
Z
scope Resource Cener Clear Channels: Ensuring Effecive Endoscope ReproHealth cessing ( cessing (Health Devices)) Devices Inadequaely Reprocessed Insrumens: If I’s Diry, How Can PSO I Be Clean? ( Clean? (PSO Monthly Brief ) Serile Processing Deparmen’s Role in Paien Safey (PSO Navigator)) Navigator Top 10 Health Technology Hazards for 2015
Top 10 Patient Safety Concerns for Healthcare Organizations
9. Inadequate Patient Handoffs Related to Patient Transport
“Transporing a paien wihin he hospial o anoher clinical seting or beween unis wihin he faciliy presens risk of harm o he paien and, depending on he needs of he paien, can be an unsetling experience for nurses charged wih caring for he paien, and for he ransporer,” says Kelly Graham, BS, RN, paien safey analys a ECRI Insiue PSO. Safe ranspor involves idenifying and providing appropriae resources and requiremens for each paien during ranspor and includes proper handoff communicaion o and from appropriaely rained ransporers. Paiens may be ranspored o he wrong deparmen, he wrong paien may be ranspored, or paiens may be lef unmoniored a he receiving sie. A sandardized process for paien ranspor and handoff communicaion can reduce risk during ranspor and a he sending and receiving ends of he process, Graham says. Risks of ranspor vary wih paien acuiy. “Ideally, he level of care provided during ranspor pairs wih he care he paien receives in he uni,” Graham adds. Criically ill paiens, for example, are exposed o periods of poenial insabiliy during ranspor. Mainaining oxygenaion during ranspor and acivaing a code when a p aien’s condiion rapidly deerioraes during ranspor are bu a few examples of poenial risk. To enhance safey, criically ill paiens are ypically ranspored by eams of qualified criical care providers wih defined roles for monioring and ensuring venilaor suppor. The ranspor process and relaed communicaion is guided by formal policy reflecing guidelines from he Sociey of Criical Care Medicine and he American College of Criical Care Medicine for ransporing criically ill paiens. Bu because danger is inheren in he ranspor process of all paiens, faciliy ranspor policy and procedures should guide handoff communicaion for he safe ranspor of he non-ICU paien. The Join Commission requires ha each paien handoff communicaion include a sandardized sandard ized and a nd ineracive approach for he safe ransfer of a paien from one care area o anoher. Handoffs are an inegral par of safe ranspor, and wihou careful atenion o handoff communicaion and ranspor safey a each poin in he ranspor process, errors can occur, Graham says. Noably, of 2,390 paien-ranspor-re paien-ranspor-relaed laed repors submited o he Pennsy Pennsylvania lvania Paien Safey Auhoriy Auhoriy from May 2004 hrough Sepember 2008, 41% involved communicaion communicaion issues, according o an aricle in he March 2009 Pennsylvania Paien Safey Advisory. Advisory . ECRI Insiue PSO and is parner PSOs have received repors involving ineffecive handoffs in he paien ranspor process ha have conribued o paien harm in a variey of care seings. The following repor provides an example of inadequae handoff communicaion during ranspor of an infan wihin a hospial: Immediaely afer undergoing a surgical procedure, he infan was ranspored o he neonaal inensive care uni (NICU) in an open crib. Saff in he uni had no been informed ha he infan’s
Top 10 Patient Safety Concerns for Healthcare Organizations
body emperaure dropped in he operaing room (OR), or ha he infan was ranspored direcly from he OR o he uni, and ha he infan had no been moniored moniored in a recovery recovery uni. A nurse prepre paring he infan for he NICU NICU say expressed expressed concern abou he infan’s pale coloring and slowed slowed respiraion. The baby was given vigorous spinal simulaion in an effor o resore breahing and reurn body emperaure o normal, and required inubaion when breahing did no fully respond o he spinal simulaion. Graham recommends ha faciliies’ even and near-miss reporing sysems capure ranspor-relaed incidens incidens and near misses ha occur “off uni” and during ranspor. Such repors can idenify gaps in policies, procedures, or raining; he need for improved communicaion processes and oversigh for follow-up and monioring of handoff proocols; and oher problems ha may require reassessmen of ranspor policies and procedures. Graham suggess ha ranspor policies and procedures be based on consideraion of numerous issues, he following among hem: X
Idenifying unis are mos ofen involved in ranspor and safey hazards paricular o he unis
X
Developing crieria for deermining he level of ranspor eam needed (depending on Developing paien assessmen and he level of care required)
X
Ensuring availabiliy of equipmen, assigning responsibiliy for mainenance of herapies during ranspor, and roubleshooing equipmen during ranspor
X
Deermining raining, experience, and compeency required of ranspor personnel in ligh of expeced levels of inervenion ha may be required during ranspor
X
Developing and implemening ools and checkliss o suppor handoff communicaion among he care eam, ranspor personnel, and saff a he receiving sie
Policies and procedures migh incorporae use of a ranspor form, ofen referred o as a “Ticke o Ride” form, ha helps convey essenial informaion from he sending uni, provides a checklis o be addressed by ranspor saff and by he receiving uni, and incorporaes a siuaion-backgro siuaion-background-assessmenund-assessmen-recommendaion recommendaion (SBAR) forma o enhance communicaion a each end of he process. ECRI Insiue has also developed handoff communicaion sraegies ha address ranspor. For addiional informaion, see “ECRI Insiue Resources.”
ECRI INSTITUTE RESOURCES HRC
Z Communicaion Z Safe Paien Mobiliy
Policy and Procedure Other Memberships and Sources
Z Handoffs: Oppor-
uniy for Safe Care (PSO Navigator) Navigator)
Top 10 Patient Safety Concerns for Healthcare Organizations
10. Medication Errors Related to Pounds and Kilograms
The paien safey evens presened in his repor are no jus saisics, as he issue of poundkilogram mix-ups illusraes. “We definiely definiely see hese evens in he PSO daa,” says Sheila Rossi, MHA, paien safey analys/consulan, ECRI Insiue PSO. Bu she gained a firshand undersanding of he issue hrough her own personal experience. On a visi o a local ED, Rossi’s wo-year-old son was weighed in he riage room. Laer, he physician deermined ha he needed wo oral medicaions, o be given by Rossi and her husband. “Having previously given him wo similar medicaions a home, we had some idea of he dosing based on his age and weigh,” Rossi says. When he nurse brough in wo big syringes, Rossi Rossi and her husband husband said, “Wow, “Wow, ha looks like like a lo of medicaion,” and quesioned he amoun. “Almos in unison, he nurse and he docor said, ‘I’s weigh-based dosing.’”” Sill rusing heir insinc ha somehing wasn’ righ, Rossi and her husband gave dosing.’ heir son a porion of each dose, disposing of he excess in a napkin, afer he providers lef he room. The nex morning, he physician called and apologized, informing Rossi ha here had been a mix-up in in he weigh-based weigh-based calculaion. calculaion. Their son had been weighed in pounds, bu bu his 30-pound weigh had been enered ino he EHR as 30 kilograms (equivalen o abou 66 pounds). The oral syringes had each conained roughly wice he amoun of medicaion he should have received; forunaely, neiher was a high-aler medicaion. Bu, says Rossi, “My concern wasn’ so much for my child; my concern was for he nex child ha comes along and wha sysem fixes hey were going o make so ha his would no occur again.” Mix-ups beween pounds and kilograms are no limied o EDs and hospials; hey can happen “anyplace ha has a scale,” says Rossi. And alhough he problem poses “a huge poenial for error wih aduls,” children and older aduls may be even more sensiive o medicaion dosing errors. Similarly, overdoses involving high-aler medicaions pose a paricular paien safey concern. Consider he following even repored o ECRI Insiue PSO and is parner PSOs, which involved an older adul: Weigh was enered in he EHR incorrecly. The employee used pounds for kilograms. A low-molecWeigh ular-weigh heparin was dosed for more han double he paien’s weigh. The pharmacy discovered he error, and he order was disconinued. The anicoagulaion saus of he paien was moniored.
Top 10 Patient Safety Concerns for Healthcare Organizations
One of he mos effecive sraegies o reduce he risk of such errors is o “ge rid of scales ha measure in pounds,” says Rossi. There are many barriers o employing his sraegy. For example, i requires subsanial capial, and parens ofen wan o know heir child’s weigh in pounds. Alernaives may include adjusing elecronic scales so ha hey display only in kilograms and giving parens weigh conversion chars. “If you can ge rid of ha mix-up a he very firs sep in he process, pounds are never inroduced ino he equaion,” says Rossi. Oher high-impac sraegies include he following:
ECRI INSTITUTE RESOURCES HRC
Z Medicaion Safey:
Inaccurae Paien Weigh Can Cause Dosing Errors Z Medicaion Safey
X
Ensuring ready availabiliy of pediaric scales (e.g., o reduce reliance on parenal esimaes, which are likely o be in pounds)
X
Recording and displaying weigh only in kilograms in he EHR
Other Memberships and Sources
X
Inegraing digial scales wih he EHR o eliminae or reduce he need for daa enry
Z Medicaion Safey:
X
Using clinical decision suppor funcions ha compare enered weigh wih expeced weigh (e.g., based on growh chars)
X
Purchasing infusion pumps wih dose error reducion feaures
X
No soring in clinical areas any high-aler drugs or oher medicaions ha have he poenial o cause paien harm if weigh-based doses are miscalculaed
To invesigae his issue, organizaions may sar by reviewing heir even-repori even-reporing ng sysems. Bu ha may yield limied informaion because “i assumes ha people are acually reporing hese evens as weigh-based errors,” Rossi noes. Char audis and observaio observaion n can help he organizaion explore furher. “How are paiens being weighed, wha scales are used, how is he weigh enered ino he EHR, where are he chances for error?” says Rossi. Rossi’s encouner offers some moivaion and perspecive for all paien safey evens. “When we say ‘he paien’ in healhcare, i someimes becomes impersonal, and we see he paien as someone else, a body or objec o which care is delivered and in some cases bad evens or oucomes occur. We have all been or will become ‘paiens’ a some poin in our lives,” says Rossi. “How are we going o improve paien safey for ourselves? How do we pu ourselves in he paien’s shoes and say, ‘How do I preven his from happening o me me?’ ?’””
Inaccurae Paien Weigh Can Cause PSO Dosing Errors ( Errors (PSO Navigator)) Navigator
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Publisher: ECRI Institute EXECUTIVE STAFF Jeffrey C. Lerner, Ph.D. Presiden and Chief Execuive Officer Anthony J. Montagnolo, M.S. Execuive Vice Presiden and Chief Operaing Officer Ronni P. Solomon, J.D. Execuive Vice Presiden and General Counsel Vivian H. Coates, Coates, M.B.A. Vice Presiden, Informaion Services and Technology Assessmen Michael Argentieri, M.S., BME Vice Presiden, Marke Developmen Mark E. Bruley, CCE Vice Presiden, Acciden and Forensic Invesigaion G. Daniel Downing, M.B.A. Vice Presiden, Finance James P. Keller, Jr., M.S. Vice Presiden, Healh Technology Evaluaion and Safey Jennifer L. Myers Vice Presiden, SELECT Healh Technology Services Thomas E. Skorup, M.B.A., FACHE Vice Presiden, Applied Soluions David W. Watson, Ph.D. Vice Presiden, Operaions, ECRI Insiue Europe Jin Lor, MIE (Aus) Regional Direcor, Souheas Asia
MISSION STATEMENT ECRI Insiue is an independen nonprofi organizaion whose mission is o benefi paien care by promoing he highes sandards of safey, qualiy, and cos-effeciveness in healhcare. We accomplish his hrough our research, publishing, educaion, and consulaion. Our goal is o be he world’s mos rused, independen, organizaion providing healhcare informaion, research, publishing, educaion and consulaion o organizaions and individuals in healhcare.
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Top 10 Patient Safety Concerns for Healthcare Organizations
Introduction
NOT JUST A TOP 10 LIST Wih his repor, ECRI Insiue is releasing is op 10 lis of paien safey concerns for 2015. This is he second year we have compiled he lis, which is parly based on our review of paien safey even repors, research requess, and roocause analyses submited o ECRI Insiue PSO, one of he firs paien safey organizaions (PSOs) o be federally cerified under he provisions of he Paien Safey and Qualiy Improvemen Ac (PSQIA). PSQIA gives healhcare organizaions a unique opporuniy o volunarily share heir safey surveillance daa in a proeced environmen so PSOs can aggregae and analyze he daa. The law also charges PSOs wih he responsibiliy o share he findings and lessons learned. The release of our op 10 lis of paien safey concerns is in keeping wih ha responsibiliy. ECRI Insiue’s Top 10 Paien Safey Concerns for Healhcare Organizaions is Organizaions is more han jus a lis; i’s a reminder ha, despie he atenion given o paien safey over he las 15 years or so, we can do beter. Since we began collecing paien safey evens in 2009 as a PSO, we have received nearly 500,000 even repors. Each even ofen describes a sysems-relaed breakdown, or a near failure, in he care process process of he paiens paiens our members are commited o serving. Some of of he evens evens describe serious, prevenable paien injuries or deahs. Behind each even here’s a sory abou paiens and heir loved ones who pu hemselves in he hands of heir providers expecing qualiy care and services. And here’s a separae sory abou he providers whose lives and careers are orn apar when paiens are harmed because fauly sysems and processes make problems more likely o occur. Our paien safey analys Sheila Rossi, who shares her own encouner wih a medicaion error in his year’s repor, reminds us of he sories behind hese evens and he moivaion for our op 10 lis. “When we say ‘he paien’ in healhcare, i someimes becomes impersonal,” Rossi says, urging everyone o pu hemselves in paiens’ shoes and o ask, “How do I preven his from happening o me ?” me?” Healhcare providers, regardless of wha seting hey pracice in, can sar wih our op 10 lis of paien safey concerns and use i o guide heir own discussions abou paien safey and improvemen iniiaives. We will coninue o publish our op 10 lis annually because we are commited o paien safey and o helping you o deliver he safes care for all of us, your paiens. Sincerely,
William M. Marella, MBA Execuive Direcor, Operaions and Analyics ECRI Insiue’s Paien Safey, Risk, and Qualiy Group
Top 10 Patient Safety Concerns for Healthcare Organizations
Top 10 Patient Safety Concerns for Healthcare Organizations: 20 2015 15 ECRI Insiue has released is newes lis of he op 10 paien safey concerns confroning healhcare organizaions. The lis serves as a “caalys for discussion” among healhcare leaders abou he op paien safey issues faced by heir organizaions, says Caherine Pusey, RN, MBA, manager, clinical analyss a ECRI Insiue PSO. ECRI Insiue’s Top 10 Paien Safey Concerns for Healhcare Organizaions Organizaions for for 2015 is compiled by ECR ECRII Ins Insi iue ue PS PSO, O, one of he fir firs s pa paie ien n saf safey ey org organi aniza zaion ionss (PSO (PSOs) s) o be fed federa erally lly cer cerifi ified. ed. “The lis is based on wha we see hroughou he year among he paien safey even repors, researc rese arch h requess, and roo-cause analyses submited submited o ECRI Insiue PSO,” PSO,” says Pusey. Under he Paien Safey and Qualiy Improvemen Ac, healhcare organizaions can volunarily submi paien safey repors o PSOs in a proeced environmen for PSOs o aggregae, analyze, and share findings and lessons learned. ECRI Insiue PSO has been collecing paien safey daa since 2009 and, by he end of 2014, had received nearly 500,000 even repors. The lis also draws upon ECRI Insiue saff experise, including he knowledge gained invesigaing incidens, observing and assessing hospial pracices, and reviewing healh-echnology-relaed problem repors submited o ECRI Insiue’s volunary medical device problem reporing program. In fac, four of he paien safey concerns idenified for he op 10 lis also rank among ECRI Insiue’s op healh echnology hazards for 2015. Refer o “ECRI Insiue’s Top 10 Liss” for more informaion on he healh echnology hazard lis, which is compiled by ECRI Insiue’s Healh Devices Group. “Mos organizaions have heir own op 10 lis. They should review our lis of paien safey concerns o idenify issues ha should be on heirs,” says Pusey. “We’re no saying ha every organizaion mus address all 10 opics, bu hey should should deermine where where here are similariies similariies and variaions.” Using ECRI Insiue’s op 10 lis proacively o improve qualiy of care and paien safey is also in keeping wih he provisions of he Join Commission’s recenly released paien safey sysems chaper for is 2015 accrediaion manual. The chaper describes he imporance and srucure of an inegraed approach o paien safey for healhcare organizaions.
ECRI Institute’s Top 10 Patient Safety Concerns for 2015
1
Alarm hazards: inadequate alarm configuration policies and practices*
2
Data integrity: incorrect or missing data in EHRs and other health IT systems
3
Managing patient violence
4
Mix-up of IV lines leading to misadministration of drugs and solutions*
5
Care coordination events related to medication reconciliation
6
Failure to conduct independent double checks independently*
7
Opioid-related events
8
Inadequate reprocessing of endoscopes and surgical instruments
9
Inadequate patient handoffs related to patient transport*
Medication errors related to pounds and 10 kilograms* *New to the 2015 list.
8 3 1 5 1 S M
Top 10 Patient Safety Concerns for Healthcare Organizations
Half of he iems on he op 10 lis are new for 2015; he oher half are recurring or variaions of concerns from 2014 when ECRI Insiue firs released is op 10 lis of paien safey concerns. Refer o “ECRI Insiue’s Top 10 Paien Safey Concerns for 2015” for he full lis. Iems from he 2014 lis ha do no appear on his year’s lis, such as mislabeled laboraory specimens and paien falls while oileing, sill remain a concern, says Pusey. “Bu oher opics have risen o a higher level of atenion.”
APPLICABILITY TO MULTIPLE SETTINGS
Many of he opics on ECRI Insiue’s lis of op 10 paien safey concerns exend o muliple healhcare setings and highligh he relevance of hese issues o he coninuum of care spanning physician pracices and oher oupaien medical setings, acue care hospials, and aging services providers in posacue care environmens, nursing homes, and hospice care.
Many of the Top 10 Safety Events Span Multiple Healthcare Settings
“While some of hese hazards are mos applicable o acue care, several are also relevan in ambulaory setings, and some—especially hose relaed o medicaions and care coordinaion—span he coninuum of care,” says William M. Marella, MBA, execuive direcor, operaions and analyics for ECRI Insiue’s Paien Safey, Risk, and Qualiy group. Because he opics on ECRI Insiue’s lis of paien safey concerns are largely based on repors submited by hospials, hese hese issues, while while imporan o muliple healhcare setings, may no always rank among he op 10 concerns for nonhospial setings, such as physician pracices and aging services providers. For example, appropriae managemen of alarms is imporan in long-erm care setings such as nursing homes where alarms are used o deec residen wandering and elopemen, falls, and oher risks, says Vicor Lane Rose, NHA, MBA, CPASRM, operaions manager of ECRI Insiue’s Aging Services Risk Managemen program wihin is Paien Safey, Risk, and Qualiy group. The opic, however, may no rank as aging services providers’ number one concern, he adds, because oher issues, such as skin managemen, appropriae saffing and scheduling, and falls managemen, are ypically among he highes prioriies for he aging services secor.
Hospital
Ambulatory Care
Aging Services
9 3 1 5 1 S M
Top 10 Patient Safety Concerns for Healthcare Organizations
ECRI Institute’s Top 10 Lists ECRI Insiue’s op 10 liss of paien safey concerns and healh echnology hazards highligh four overlapping issues ha deserve he atenion of healhcare organizaions. Togeher, hey reflec a unied effor by ECRI Insiue o promoe paien safey in healhcare organizaions. ECRI Insiue’s Top 10 Health Technology Hazards , released released every every fall, focuses on on echnology, echnology, whereas whereas ECRI ECRI Insiue’s Insiue’s Top 10 Patient Safety Concerns for Healthcare Organizations addresses Organizations addresses broader paien safey issues. Like he lis of paien safey concerns, he op 10 lis of healh echnology hazards reflecs ECRI Insiue’s healhcare safey experise. The lis is compiled based on he saff’s experience invesigaing device-relaed incidens, evaluaing medical devices in ECRI Insiue’s esing laboraory, and reviewing repors from ECRI Insiue’s and oher organizaions’ daabases for medical device problems and paien safey evens. ECRI Insiue has published is lis of healh echnology hazards for eigh years and is lis of paien safey concerns for wo years. Boh liss are published annually. Despie he differen focuses of he wo liss, Caherine Pusey, RN, MBA, manager, clinical analyss a ECRI Insiue PSO, is sruck ha wo differen eams idenified four overlapping areas as prioriies for healhcare organizaions in 2015. “Separaely, we are idenifying some of he same issues.” The four overlapping concerns are as follows: 1. Alarm hazards from inadequae alarm configuraion policies and pracices 2. Daa inegriy failures from incorrec or missing daa in EHRs and oher healh IT sysems 3. IV line mix-ups leading o misadminisraion of drugs and soluions 4. Inadequae reprocessing of endoscopes and surgical insrumens In fac, hese four echnology-relaed opics are he op four iems idenified in ECRI Insiue’s Top 10 Health Technology Hazards for 2015. The 2015. The overlap of hese four prioriy opics “shows he significance of healhcare echnology as i impacs paien safey overall,” says James P. Keller, MS, vice presiden, healh echnology evaluaion and safey, ECRI I nsiue. “A “A big reason why echnology shows prominenly on he op 10 lis of paien safey concerns is he growing complexiy of echnology and he increased reliance on echnology in delivering healhcare,” he says, lising areas such as healh IT and alarm hazards. The 2015 repor of healh echnology hazards also has some broader opics ha span muliple echnologies. One was insufficien cybersecuriy proecions for medical devices and sysems. “Despie litle evidence o dae of direc harm o paiens, cybersecuriy is neverheless a poenial hrea ha healhcare faciliies mus begin addressing,” says Rob Schluh, senior projec officer a ECRI Insiue and he lead projec manager for ECRI Insiue’s Top 10 Health Technology Technology Hazards for 2015 projec. 2015 projec. “The vulnerabiliy of medical devices o malware ha could affec device funcionaliy or he inegriy of paien daa is of paricular concern.” ECRI Insiue predics ha cybersecuriy is a paien safey consideraion ha will require increased atenion in he coming years. Anoher broad opic on he 2015 op echnology hazards lis was deficien medical device recall and safey-aler managemen programs. “We see healhcare organizaions wih aniquaed reca ll managemen programs,” says Schluh. “One key concern we have is ha he capabiliies of some hospials’ programs may no be keeping pace wih he growh over he pas decade in he number of recalls and oher alers ha are issued.” ECRI Insiue also publishes an annual wach lis of he op 10 echnology and infrasrucure issues ha a hospial C-suie should carefully examine. The lis draws upon ECRI Insiue’s decades of experience evaluaing he safey, effeciveness, effeciveness, and coseffeciveness of healh echnologies. “C-suie leaders need a concise way of seeing where new and emerging healh echnologies fi, if a all, in heir healh sysems,” says Diane Roberson, direcor, healh echnology assessmen, ECRI Insiue. Topics on he 2015 C-suie lis include he following: Z Disinfecion robos Z Three-dimensional priners Z Google Glass Z Posdischarge clinics
All hree repors are publicly available from ECRI Insiue’s websie. Top 10 Health Techno Technology logy Hazards for 2015 is 2015 is publicly available a htps://www.ecri.org/Pages/2015-Hazards.aspx htps://www.ecri.org/Pages/2015-Hazards.aspx.. The 2015 Top 2015 Top 10 Hospital C-Suite Watch List is List is freely available a htps://www.ecri.org/Pages/ECRI-Insiue-2015-Top-10-Hospial-C-Suie-Wach-Lis.aspx.. htps://www.ecri.org/Pages/ECRI-Insiue-2015-Top-10-Hospial-C-Suie-Wach-Lis.aspx
Top 10 Patient Safety Concerns for Healthcare Organizations
How the List Was Compiled
How to Use the List
To compile is lis of paien safey concerns, ECRI Insiue PSO reviewed is daabase of paien safey evens, roocause analyses, and cusom research requess submited hroughou he year by healhcare organizaions and is parner PSOs, as well as sough guidance from is eam of expers.
ECRI Insiue recommends ha healhcare organizaions use is op 10 lis of paien safey concerns as a saring poin for heir paien safey discussions and for seing heir paien safey prioriies. Use he lis o idenify wheher he organizaion has experienced paien safey breakdowns in similar areas and wheher wheher he concerns concerns should be argeed for improvemen. For areas seleced for improvemen, organizaions can creae risk miigaion sraegies based on he recommendaions provided wih he op 10 lis for each area of concern. Addiional Addiional ECRI Insiue resources, some freely available on ECRI Insiue’s websie, are highlighed hroughou he repor.
“Our op 10 lis isn’ generaed from a complicaed algorihm or formula. I’s very much a consensus process ha atemps o disill he judgmen of ECRI Insiue’s paien safey expers, our advisors, and our members,” says Marella. “Topics are nominaed based on our analysis of safey evens repored o ECRI Insiue and our parner PSOs as well as wha’s happening in he broader paien safey communiy.” The final lis reflecs he inpu of ECRI Insiue PSO’s eam of analyss and oher ECRI Insiue saff, as well as members of ECRI Insiue PSO’s advisory council.
“Our hope is ha healhcare providers use his lis o reflec on which of hese hazards exis in heir care setings and on wheher hey have sysems in place o preven or minimize harm from hose ha are relevan in heir seings,” says Marella. Rose recommends ha faciliies across he healhcare specrum use he lis o “undersand he risks ha do exis a your organizaion, o quanify hem, and o find ou where hey’re hey’re happening so he organizaion can idenify pracices o miigae he risks.” Given ha paien safey improvemens can ofen require an invesmen in saff ime and he organizaion’s resources, Pusey recommends ha organizaions presen he lis o heir senior leaders and members of heir governing boards o gain heir atenion and suppor.
Top 10 Patient Safety Concerns for Healthcare Organizations
1. Alarm Hazards: Inadequate Alarm Confguration Policies and Practices
Topping he lis of paien safey concerns is alarm hazards from inadequae alarm configuraion policies and pracices, a opic which also ranks as ECRI Insiue’s op healh echnology hazard for 2015. Since ECRI Insiue began publishing is lis of op healh echnology hazards in 2007, “alarm hazards have been a or near he op of he lis,” says Rob Schluh, senior projec officer a ECRI Insiue and he lead projec manager for he Top 10 Healh Technology Hazards for 2015 projec. 2015 projec. The need o address alarm hazards is paricularly imporan wih he Join Commission’s ongoing Naional Paien Safey Goal for healhcare organizaions o improve he safey of clinical alarm sysems.
ECRI INSTITUTE RESOURCES HRC
Z Clinical Alarms Other Memberships and Sources*
Z The Alarm Safety
In recen years, much of he lieraure relaed o alarm hazards has focused on alarm faigue—a condiion ha can lead o alarms missed by providers who are overwhelmed by, disraced by, or desensiized o he muliple alarms ha acivae. In is 2015 lis, ECRI Insiue encourages healhcare insiuions o look beyond alarm faigue. “In addiion o missed alarms ha can resul from excessive alarm acivaions, hospials also have o be concerned abou alarms ha don’ acivae when a paien is in disress,” says Schluh. “In our experience, alarm-relaed adverse evens—wheher hey resul from missed alarms or from unrecognized alarm condiions—ofen can be raced o alarm sysems ha were no configured appropriaely.” To mee he Join Commission’s Naional Paien Safey Goal on clinical alarm safey, organizaions accredied by he group mus, as of 2016, esablish policies and procedures o manage alarm signals idenified by he organizaion as essenial for paien safey. ECRI Insiue recommends ha organizaions examine heir alarm configuraion policies and procedures o address he full range of facors ha can lead o alarm hazards. “Our acciden invesigaions have found ha hospials have eiher no had consisen or no had any pracices o deermine how alarms are se by care area or by paien ype,” says James P. Keller, MS, vice presiden, healh echnology evaluaion and safey, ECRI Insiue. For example, “i doesn’ make sense o use he same defaul alarm setings in pediaric inensive care as in adul inensive care,” he explains, ye ECRI Insiue has found ha many hospials do no have a policy o adjus he alarm defaul setings by care area. Similarly, hospial policies ofen fail o specify when and who can make adjusmens o he defaul alarm setings, says Keller. In addiion o he recommendaions for addressing alarm hazards conained in he Top 10 Healh Technology Hazards for 2015 , ECRI Insiu Insiue e has compiled compiled is is Alarm Alarm Safey Safey Handbook Handbook and and Alarm Safey Workbook Workbook o o help organizaions undersand he breadh of alarm hazards, idenify alarm safey vulnerabiliies, and develop an effecive program for managing clinical alarms o improve paien safey. The maerials are provided as a membership benefi for cerain ECRI Insiue programs and are available o ohers for purchase. See “ECRI Insiue Resources” for more informaion.
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Handbook: Strategies, Tools, and Guidance and accompanying workbook. Alarm Safey Resource Cener Inerfacing Monioring Sysems wih Venilaors: Ven ilaors: How Ho w Well Do They Communicae Alarms? ( Alarms? (Health Health Devices)) Devices Physiologic Monioring Sysems: Our Judgmens on Eigh Sysems ( Sysems (Health Health Devices)) Devices Top 10 Health Technology Hazards for 2015
* Some ECRI Insiue resources are publicly available. To obain oher ECRI Insiue repors, conac us by elephone a (610) 825-6000, ex. 5891, or by e-mail a clien[email protected] clien[email protected]..
Top 10 Patient Safety Concerns for Healthcare Organizations
2. Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems Healh informaion echnology (IT)–relaed issues have been a recurring heme on ECRI Insiue’s op 10 liss, appearing on he op 10 healh echnology hazards lis for he las six years and on he op 10 lis of paien safey concerns since is sar in 2014. For he wo mos recen years, boh liss have idenified daa inegriy errors as a resul of incorrec or missing daa in elecronic healh records (EHRs) and oher healh IT sysems. ECRI Insiue recognizes ha healh IT offers numerous poenial benefis, such as supporing clinical decision making, enhancing provider communicaion, providing access o paien daa in a secure environmen, engaging paiens, and reducing medical errors. Bu he echnology can creae new safey risks if i is no designed appropriaely, implemened carefully, carefully, and used houghfully. In fac, in 2014, ECRI Insiue convened he Parners Parnership hip for Healh IT Paien Safey , Safey , a mulisakeholder collaboraive collaboraive esablished o proacively idenify and address healh IT paien safey risks in a nonpuniiv nonpuniivee environmen. “Wih he inroducion of any new echnology, we need o idenify and respond o novel problems i presens as well as old problems ha he new echnology doesn’ eliminae,” says Marella. Daa inegriy issues “exised wih paper medical records as well, bu now as EHRs become more ineroperable, incorrec informaion is more readily available, more easily shared, and harder o eliminae,” he says. “In order o ge a reurn on he invesmen we’ve made in EHRs and clinical decision suppor, we now need o ackle he more mundane problem of making sure he daa in he EHR is accurae.” “We’ve seen he rapid growh of healh IT sysems, paricularly in he hospial seting,” says “We’ve Keller. “Organizaions need o have beter esing of he sysems and checks and balances [afer implemenaion] o make sure failure poins for missing daa or incorrec daa enries are idenified and addressed.” As an example, consider he following even repored o ECRI Insiue PSO and is parner PSOs involving wo separae healh IT sysems—an EHR sysem and a dieary managemen program: The paien’s peanu allergy was lised in he EHR bu he informaion did no cross over o he dieary deparmen’s sysem. sysem. The paien quesioned wheher he food allergy informaion had been received by he dieary deparmen afer receiving receiving a food ray ha was no idenified as free of peanu producs. The near miss highlighed he need for a sofware fix o ensure ha imporan paien daa from he EHR is ransferred o he organizaion’s dieary IT sysem for paien menu managemen.
Top 10 Patient Safety Concerns for Healthcare Organizations
Examples of daa inegriy failures, as lised in he Top 10 Healh Technology Hazards for 2015 repor, 2015 repor, include he following: X
Appearance of one paien’s daa in anoher paien’s record
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Missing daa or delayed daa delivery
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Clock synchronizaion errors beween medical devices and sysems
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Defaul values being used by misake, or fields being prepopulaed wih erroneous daa
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Inconsisencies in paien informaion when boh paper and elecronic records are used
ECRI INSTITUTE RESOURCES HRC
Z Elecronic Healh
Records Other Memberships and Sources
Z ECRI Institute PSO
Oudaed informaion being copied and pased ino a new repor
To correc hese problems, organizaions mus idenify daa inegriy failures as hey occur in order o apply fixes o preven similar problems from recurring. To do so, hey mus empower fronline fronline workers and healh IT sysem users o repor all ypes of healh IT-relaed incidens, including hose ha do no cause any harm as well as near-miss incidens, and circumsances ha precede an acual even and are caugh before anyhing can happen. Through is problem and even reporing programs, ECRI Insiue has found ha healhcare saff do no always recognize healh IT’s IT’s conribuion o an even. For example, only afer analysis of an inciden in which a pharmacis placed a medicaion order in he wrong paien’s record was i recognized ha he error was faciliaed by a medicaion managemen sysem ha allowed users o have muliple paien records open a he same ime. Reporing he even as jus a medicaion error overlooks overlooks oher conribuing facors, such as he healh IT sysem’s configuraion o permi muliple paien records o be open on a user’s screen.
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“When reporing an adverse even or near miss, saff should consider wheher some funcion or feaure of a healh IT sysem could have conribued o he problem,” says Schluh. Some even reporing programs give reporers he abiliy o idenify he repor as a healh IT-relaed issue. For example, he Agency for Healhcare Research and Qualiy’s mos recen version of he Common Formas (version 1.2) includes an even repor for healh IT evens and unsafe condiions. The Common Formas are used by PSOs and heir paricipaing providers for even reporing and allow daa aggregaion in a sysemaic manner.
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Deep Dive: Health Information Technology Healh IT Parnership Proceedings:: ParnerProceedings ing for Success How o Connec wih he Righ EMR Inegraion Ven Vendor dor (Health Devices) Devices) Making Connecions: Inegraing Medical Devices wih Elecronic Medical Records (Health Devices)) Devices Paien Safey a Inersecion of Medical and Informaion Technology (PSO Navigator)) Navigator Top 10 Health Technology Hazards for 2015
Top 10 Patient Safety Concerns for Healthcare Organizations
3. Managing Patient Violence
Every day, U.S. hospials deal wih violen paien incidens and hreaening behaviors ha affec he safey and well-bei well-being ng of saff, paiens, and visiors. According According o curren lieraure on he opic, violence is occurring in all care setings, even in oncology and maerniy unis, and no jus in he emergency deparmen (ED). Clinical saff in acue care unis ypically lack raining in behavioral healh and may dismiss or poorly handle behavioral cues ha signal imminen violence, says Ruh Ison, MDiv, STM, paien safey analys/consulan a ECRI Insiue PSO. Ison noes ha repors submied o ECRI Insiue PSO and is parner PSOs show ha docors, nurses, ancillary saff, and even securiy officers working in emergency and acue care setings are grealy challenged in managing paiens who become violen or hreaen violence. In 2014, failure o adequaely manage hreaening or violen behavior of paiens in acue care setings was among ECRI Insiue’s op 10 paien safey concerns. The range and impac of paien violence across he hospial is no limied o incidens ha make he headlines. Clinical saff may feel abandoned and lef wihou he resources o do heir jobs safely, given he frequency wih which hey mus manage violen behavior in paiens—a leas 15 incidens a day, according o one PSO member hospial. The firs hing ha hospial leadership mus do is acknowledge ha violence is occurring wihin he faciliy’s walls, says Judy Gushue, RN, BS, MJ, CEN, CPHQ, paien safey analys, ECRI Insiue PSO. When healhcare workers perceive assauls and hreas as a workplace hazard ha mus be oleraed, hey underrepor—resuling underrepor—resuling in lack of awareness and inacion by hospial leadership. “Lack of psychiaric services and inervenion inervenionss pus pressure on nurses and oher fronline saff o be rained in violence de-escalaion echniques,” echniques,” she poins ou. Ison believes ha raining saff in de-escalaion sraegies is a smar invesmen ha can improve paien and worker safey on many levels, reducing coercion and empowering saff o engage, raher han avoid, paiens wih agiaion or hreaening behavior while promoing safe condiions. The effor may prove o be more cos-effecive han use of unrained “siters,” who have been menioned in PSO even repors as he arges of atacks by paiens, Ison says. The siter’s presence or behavior may be perceived by he paien as provocaive, as he siter is placed in he posiion of prevening he paien from engaging in cerain unsafe behaviors, she noes. Unrained siters may no be sensiive o he paien’s clinical siuaion, may no fully undersand he recommended safey precauions, or may argue wih he paien. Oher siter behaviors (e.g., exing, chating, playing games on a smarphone) migh resul in siter inatenion or even provoke a violen response from he paien.
Top 10 Patient Safety Concerns for Healthcare Organizations
Gushue adds ha in addiion o requiring reporing and providing saff raining in deescalaion sraegies and skills, he hospial should have a faciliy-wide safey plan ha considers all levels of risk, from he single acue episode of hreaening behavior o an acive shooer siuaion anywhere in he faciliy or on campus. “Know he risks posed by your paien populaion—local populaion—local police saisics may help idenify areas of risk or peak periods when risk may be greaer.” The program should address physical securiy and response (e.g., use of hidden alarms, cameras, elecronic saff locaor services, increased sraegic securiy presence, limiing sies of enrance and egress a nigh), implemening and monioring compliance wih policies and procedures for inspecing belongings of visiors and paiens for weapons, reconfiguring ED waiing areas, invoking emergency legal processes for commimen or reamen (when appropriae), and esablishing a rained rapid response eam o assess poenial violen behavior and inervene when summoned. Ison agrees: he acue sympoms ha demonsrae a paien’s behavioral or medical o cooperae wih care inervenion inervenionss should no be misinerpreed by healhcare inabiliy o inabiliy workers as unwillingness unwillingness;; however, “aggressive or agiaed behavior signals a high-risk, high-acuiy siuaion ha needs immediae clinical atenion comparable o a sroke, cardiac, or respiraory even.” Ison has idenified he following paien facors from ECRI Insiue PSO even repors involving violen paien behavior: acue subsance abuse or addicion, acue wihdrawal, drug-seeking behavior, psychosis, possurgical saus, and various medical and menal healh comorbidiies (e.g., neurologic disorders, infecions, delirium, adverse prescripion drug reacions, developmenal disabiliies) combined wih behavioral healh sympoms (e.g., paranoia, moor agiaion, emoional volailiy) and social dislocaion. Clinical managemen sraegies can include sanding orders and medicaion order ses ha can be acivaed immediaely by he saff on duy, as well as securiy measures. And while acuely agiaed or hreaening, violen paiens should never be handed off, as hese are emergency siuaions. Subsequen handoff communicaion of he paien’s medical saus should include idenificaion of acue socioemoional or behavioral healh issues ha are adversely affecing he paien, Ison says. These migh be addressed by social workers or behavioral healh healh saff. Diminishing he risks involved wih paien violence sars wih acceping is realiy across healhcare setings, Gushue says. The experise of leadership, managemen, and clinical saff a all levels is needed o develop a comprehensive response ha mees hese vulnerable paiens’ medical needs and keeps all healhcare saff safe in he process.
ECRI INSTITUTE RESOURCES HRC
Z Paien Violence Z Workplace Violence
Prevenion Plan Z Violence Risk Assessmen Tool for Home Care Other Memberships and Sources
Z Residen Aggres-
sion and Violence (Continuing Care Risk Management)) Management Z Residen Aggression/ Violence Assessmen Tool ( Tool (Continuing Continuing Care Risk Management) Management)
Top 10 Patient Safety Concerns for Healthcare Organizations
4. Mix-Up of IV Lines Leading Lead ing to Misadministration of Drugs and Solutions Inravenous (IV) line mix-ups can lead o medicaion errors, resuling in wrong-drug, wrong-rae, wrong-dose, or wrong-sie infusions, some wih serious consequences. Paiens, paricularly hose in criical care setings, can have muliple IV infusions, increasing he risk of connecing he line o he wrong infusion pump, wrong fluid conainer, or wrong adminisraion roue. Paiens may have oher inerfering facors, such as leads and cables for physiologic moniors, increasing he risk of misakes wih IV line mix-ups, says Keller. Someimes described as “spagheti syndrome” or he angle of ubes, caheers, and cables ha engulf paiens, he muliple lines “make i harder o rack he source of an IV line as i leads from he paien’s inserion sie o he original source,” he says. In he following even repored o ECRI Insiue PSO and is parner PSOs, an older paien received oo much heparin because he IV lines for heparin and saline were misconneced: The ED paien was suspeced of having a hear atack and was sared on a high-risk proocol for IV heparin. Afer he paien was ransferred ransferred o he uni, he nurse noiced ha he heparin bag was almos empy. The nurse checked he pump and saw ha i was running a he faser rae inended for he saline soluion. The ubing lines were mixed up, and he heparin ran for four hours a he faser rae, resuling in he paien receiving seven imes as many unis of heparin as inended. The paien was reaed for a heparin overdose and ransferred o he criical care uni. Alhough he risk of IV line mix-ups is pronounced in he criical care seting, he risk also exiss in oher acue care setings, as he above even illusraes, and in nonhospial setings, such as a nursing home, where residens may require, for example, boh an IV anibioic and pain medicaion. Alhough paiens in hese setings may have fewer lines, misakes can sill occur, paricularly if he provider does no have he same advanced raining as a criical care nurse o ensure safey, says Keller.
Top 10 Patient Safety Concerns for Healthcare Organizations
Among ECRI Insiue’s recommendaions o preven IV infusion-li infusion-line ne confusion are he following: X
Trace all lines back o heir origin before making connecions. Doing so verifies ha he correc lines will be joined. Lines should be rechecked upon he paien’s arrival in a new seting or service and a shif changes as par of he handoff process.
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Develop a policy of posiioning differen lines on differen sides of he paien. Consisenly puting lines in he same place migh make i easier for clinicians o correcly idenify hem and connec hem appropriaely.
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Label each infusion line wih he name of he drug or soluion being infused.
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Do no force connecions. If a connecion is difficul o make—ha is, if i requires a lo of effor—chances are i should s hould no be made.
ECRI INSTITUTE RESOURCES HRC
Z Prevening Miscon-
necions of Lines and Cables Z Invasive Lines Other Memberships and Sources
Z Be a T.R.A.C.E.R. no
Separaely, misconnecions can also occur when ubing from one delivery sysem is misconneced o a sysem inended for a differen purpose (e.g., an eneral feeding pump being conneced o o an IV line). line). New connecor connecor sandards are being being developed o reduce his risk; however, he sandards will no preven all line misconnecions. Once he new design sandards for connecors are fully in place, IV lines will coninue o use he same ype of connecor, making i possible o sill have IV infusion mix-ups.
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ECRI Insiue recommends using posers o remind saff abou sraegies o preven ubing misconnecions. For example, ips for clinical saff are summarized in a poser developed by ECRI Insiue Insiue summarizing is is TRACER program o preven ubing misconnecions. Informaion for obaining he poser from ECRI Insiue, as well as oher resources, is provided in “ECRI Insiue Resources.”
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a RACER! (poser) RACER! (poser) Choosing a Syringe Infusion Pump (Health Devices) Devices) Fixing Bad Links o Preven Tubing Misconnecions (PSO Navigator)) Navigator Infusion Pump Inegraion: Why Is I Needed and Wha Are he Challenges? (Health Devices) Devices) Paien-Conrolled Analgesic Infusion Pumps: Making a Painless Purchase (Health Devices) Devices) Top 10 Health Technology Hazards for 2015 Which Smar Pumps Are Smares? Raings for Six Large-Volume Infusion Pumps (Health Devices) Devices)
Top 10 Patient Safety Concerns for Healthcare Organizations
5. Care Coordination Events Related Relat ed to Medication Reconciliation A every care ransiion, such as admissions, ransfers, and discharges, “he paien’s medicaions should be reconciled o ensure he paien is on he correc medicaions for he nex phase of care,” says Mary Beh Michell, MSN, RN, CPHQ, CCM, SSBB, paien safey analys and consulan a ECRI Insiue PSO. Inadequae medicaion reconciliaion pus paiens a risk for medicaion errors, inadequae follow-up care, and hospial readmissions. On admission, medicaion reconciliaion is challenging o conduc effecively unless he paien or family members have kep accurae records of he paien’s medicaions, says Michell. To ensure he lis’s accuracy, she recommends verifying he paien’s medicaion lis wih anoher source, such as he paien’s primary care physician and/or pharmacy. The backup approach approach is no no fail-safe, fail-safe, howev however, er, if he paien paien goes o muliple muliple pharmacies pharmacies or is seen by muliple specialiss, “all of whom may order prescripions for he paien,” she says. Providers should also ask abou any over-he-couner and herbal medicaions ha he paien may be aking, as well as any ransdermal paches ha are in place. A faciliy migh also refer o he paien’s las medical record from a previous say o idenify he paien’s lis of medicaions a discharge. “Bu ha may no be a good source for informaion if i’s been a long ime since he paien’s las hospializaion or if he paien has had medicaion changes by heir primary care physician and/or specialiss,” says Michell. The paien’s medicaions may have changed if he previous hospializaion was no recen, as in he following even repored o ECRI Insiue PSO and is parner PSOs: The paien was admited hrough he ED. The paien brough a lis of curren medicaions. The lis was compared o he paien’s medicaion lis from a previous say. Two oher medicaions, an anipsychoic drug and a diabees medicine, from he previous say were no on he paien’s medicaion lis and were ordered. No one wen over he paien’s curren medicaion lis wih he paien. During he paien’ss say, he paien’s paien’ paien’s wife wife repored repored he he paien paien was having hallucinaions hallucinaions and seemed seemed coninually coninually drowsy when ha wasn’ he paien’s norm. I was deermined ha he paien had no aken he wo addiional medicaions for a year, so hey were disconinued. When a paien is admited for care, providers may decide o disconinue some or all of he paien’s medicaions aken before he admission in order o address he paien’s acue needs. They may also inroduce new medicaions o rea he acue condiion. As he paien’s condiion improves or changes and when he paien is ransferred o anoher level of care, clinicians mus coninue o evaluae he paien’s medicaion needs, deciding wheher o disconinue he medicaions for he acue condiion, inroduce any new drugs, or resume any of he medicaions ha he paien ook before admission. “By he ime he paien is ready for discharge, hey should no be receiving new medicaions ha hey did no receive while in he hospial,” says Michell. “The poin of conducing medicaion reconciliaion every sep along he way of he hospializaion is ha by he ime he paien is ready for discharge, hey should be on he righ medicaions and he healhcare providers should know ha he paien can olerae he medicaions when aken ogeher.”
Top 10 Patient Safety Concerns for Healthcare Organizations
While EHRs can improve communicaion among providers abou paiens’ medicaions, Michell warns o use he echnology cauiously. For example, a discharge, don’ simply prin he paien’s lis of medicaions wihou assigning someone o go hrough he lis o look for errors, such as dosing errors and duplicae orders for similar drugs wih differen names, she recommends. In addiion, some EHRs allow only one person o reconcile he medicaions, which means ha ha physician mus be sure of all of he medicaions and recommended doses from he specialis physicians. If he paien is being discharged o anoher healhcare seting, medicaion reconciliaion can only be achieved by effecively managing he paien’s discharge from he hospial and he admission o he oher faciliy, such as a nursing home or subacue care faciliy, says Rose. “Boh pieces need o be managed . . . for medicaion reconciliaion o work well,” he says. If he discharge and admission process from one faciliy o anoher is poorly managed, paien care can suffer. “Medicaions ha were disconinued a he hospial may no be resared when he person comes back o an aging services provider or reurns home,” says Rose. The aging services provider mus hen coordinae wih he hospial and physician who was overseeing he paien’s care or he paien’s primary care physician o idenify he paien’s medicaions. “I’s no an easy process and can lead o delays in resuming he paien’s care,” Rose says. Typically, aging services providers conduc char checks wihin 24 hours of a residen’s reurn o he faciliy afer a hospial discharge o review he residen’s medicaions, o see if anyhing was sopped or added, and o deermine if here’s a reason for he change, says Rose. If he residen is new o he faciliy, he organizaion will verify ha informaion wih he individual’s primary care physician. There are many ways o manage medicaion reconciliaion. Some publicly available resources for medicaion reconciliaion recommend pharmacis-led inervenions, bu here are oher approaches as well. A good mechanism o ensure ha he medicaion reconciliaion process works well is o proacively evaluae he process using a failure mode and effecs analysis (FMEA) o idenify gaps in ha process. Consider involving he pharmaciss, case managers, nursing, and oher FMEA eam members in idenifying soluions o close he gaps, says Michell. “Pharmaciss don’ necessarily need o lead he inervenions, bu hey need o be involved involved wih wih he mulidi mulidisciplinar sciplinary y eam in closing he gap,” she says. Rose, who also recommends ha aging services providers conduc a similar proacive analysis of heir medicaion reconciliaion processes, encourages hospials and aging services providers o engage each oher in he medicaion reconciliaion assessmen. “Find ou where he risks exis and have inelligen conversaions wih your care parners in he communiy o pu pracices in place o miigae hem,” he says. Refer o “ECRI Insiue Resources” for addiional informaion.
ECRI INSTITUTE RESOURCES HRC
Z Discharge Planning Z Medicaion Safey Z Subacue Care in
Long-Term Care Setings
Top 10 Patient Safety Concerns for Healthcare Organizations
6. Failure to Conduct Independent Double Checks Independently
In blood banking, having wo praciioners perform an independen double check of he blood group before ransfusion ransfusion is a long-sanding long-sanding requiremen. requiremen. “Nobody “Nobody in he universe universe would hink of doing a blood ransfusion wihou doing an independen double check firs because you could could kill he paien prety quickly,” quickly,” saes Elizabeh Elizabeh Drozd, MS, MT(ASCP) SBB, CPPS, paien safey analys, ECRI Insiue PSO. “Bu for high-aler medicaions, we’ve seen a lo of conroversy abou doing independen double checks and have seen a lo of failures in ha process.” The following wo evens repored o ECRI Insiue PSO and is parner PSOs illusrae how failures in independen double checks can affec paiens: Paien was receiving receiving a heparin drip, which required a double check per policy. The dosing nomo gram and rae were were double-checked double-checked appropriaely, appropriaely, bu here was no double check when he nurse changed he rae on he infusion pump. The drip rae was changed o 18 mL/hr insead of 15 mL/hr, resuling in an elevaed parial hromboplasin ime wih bleeding from he IV sie. An independen double double check was was no compleed compleed when a paien-conrolled paien-conrolled analgesia analgesia (PCA) (PCA) pump was se, resuling in a 10-fold opioid overdose. Naloxone was adminisered, and he paien was rans ferred o he he inensive inensive care uni (ICU). When double checks are used, one major issue is he failure o conduc hem in a way ha is ruly independen. As he second provider, “I wan o check your work oally independenly of wha you’re elling me,” says Drozd. “I wan o look a everyhing,” such as paien ideniy, indicaion and appropriaeness, drug or blood ype, dose, programmed infusion rae, and roue. To achieve ruly independen double checks, he organizaion needs saff buy-in. “They have o undersand why independen double checks are done independenly,” Drozd emphasizes. Imporanly, he process mus be free of he poenial for confirmaion bias. For example, if he firs provider asks he second provider, “I go 5,000 unis of heparin. Wha do you ge?” he second provider is already biased oward a specific dose and drug. A provider may overly rely on he second provider’s check, possibly skipping seps, if he or she expecs ha simply doing a double check will cach any errors or believes ha he second provider “doesn’ make misakes.”
Top 10 Patient Safety Concerns for Healthcare Organizations
In addiion, he organizaion mus be judicious when deciding which processes require an independen double check. A common misake is o “add a double check as a soluion o everyhing,” says Drozd, poenially leading o double check faigue. Insead, “use independen double checks wih a lo of cauion and only for processes ha could harm he paien very, very quickly.” Sysems issues should also be invesigaed. For example, if policies and procedures require an independen double check in a paricular siuaion bu a second provider is ofen unavailable,, saff may use workarounds or even skip he double check. unavailable How can organizaions invesigae wheher hey are performing independen double checks in a way ha is ruly independen? “The only way, really, is o begin o audi and observe he acual process,” says Drozd. “You have o be ou here in he paien care areas and observe,” using a checklis of wha o look for. This approach is labor-inensi labor-inensive, ve, bu “i’s also your opporuniy o link wih he individuals o explain he imporance of doing i properly.” Alhough here are many poenial barriers o ruly independen double checks, he Insiue for Safe Medicaion Pracices (ISMP) calculaes ha hey can deec up o 95% of errors. “When done properly, hey do deec a significan amoun of errors,” says Drozd.
ECRI INSTITUTE RESOURCES HRC
Z Ask HRC: Conduc-
ing and Documening Double-Checks for Medicaion Safey Z High-Aler Medicaions Z Blood Transfusions
Top 10 Patient Safety Concerns for Healthcare Organizations
7. Opioid-Rela Op ioid-Related ted Events Event s
“The use and he prescribing of opioids has significanly increased in recen years,” says Sephanie Uses, PharmD, MJ, JD, paien safey analys, ECRI Insiue PSO, and “ha’s one of he reasons opioid safey has become more of an issue.” According o he U.S. Deparmen of Healh and Human Services’ Naional Acion Plan for Adverse Drug Even Prevenion , he number of prescripion opioids dispensed doubled beween beween 1999 and 2010, and by he end of ha period, he number of relaed deahs exceeded he number of overdose deahs involving heroin and cocaine combined. The number of ED visis relaed o opioid misuse and abuse oaled more han 420,000 in 2011—double he number of visis in 2004. Problems relaed o opioid overdose, such as over-seda over-sedaion ion and respiraory depression, are a major paien safey concern, bu hey are no he only ones. Oher issues include gasroinesinal adverse evens (e.g., nausea, vomiing, consipaion), hyperalgesia, prurius, and immunologic or hormonal dysfuncion. Among evens in ECRI Insiue’s PSO daabase, he problem is “no specific o any one opioid,” says Uses. However, hose commonly involved in evens are hydromorphone, oxycodone, opioids used in PCA, and fenanyl paches. Two issues issues are especially concerning. Firs, “some of he more common errors wih hydromorphone are due o is poency,” says Uses. Hydromorphone is abou seven imes as poen as morphine, bu physicians someimes prescribe he same amoun of hydromorphone as hey would morphine, leading o overdose, as in he following even repored o ECRI Insiue PSO and is parner PSOs: Paien presens presens o ED wih abdominal pain. The paien’s pain is poorly relieved wih morphine 4 mg; atending physician changes pain orders o hydromorphone 4 mg inravenousl inravenouslyy every 4 hours as needed. The paien’s nurse adminisers a dose of hydromorphone. Shorly afer he dose is given, he nurse noices decreased responsiveness, he paien becomes apneic, and code blue is called. Two doses of naloxone are given. Paien becomes responsive and is ransferred o he inensive care uni for monioring. Second, prescribers someimes fail o disinguish paiens who are opioid-oleran (hose who have been aking an opioid of a leas a cerain hreshold dosage for a leas a week) from hose who are opioid-naïve (hose who have no). For example, opioid-naïve paiens should no be prescribed fenanyl paches, and hese paiens should receive only very low doses of susained-release oxycodone, if he drug is used a all. They should no receive coninuous infusion when PCA herapy is iniiaed; raher, bolus-only herapy should be used.
Top 10 Patient Safety Concerns for Healthcare Organizations
Opioid-relaed evens are no resriced o he hospial. For example, oxycodone and Opioid-relaed fenanyl paches may be used in long-erm and ambulaory care setings and a home. In addiion, family members or friends may inappropriaely ake he paien’s medicaions o self-rea heir pain, or he drugs may be oherwise misused or abused by he paien or ohers. ISMP has also repored on incidens, including deahs, in children and older aduls wih cogniive impairmen who have suck fenanyl paches on heir bodies or ingesed hem. “Fenanyl is so poen,” says Uses, “a young child will sop breahing righ away” afer ingesing or applying a fenanyl pach. Alhough many sraegies should be employed o promoe safey hroughou he medicaion-use process, Uses highlighs a few key inervenions o preven and miigae he kinds of evens ECRI Insiue PSO is seeing. Prescribers should be educaed abou opioid safey and he evens ha c an resul. One cenral issue is appropriae prescribing. “Does he paien really require an opioid?” says Uses. “Someimes ha’s no he firs choice ha we need o go o.” Order ses—wih differen drug forms and dosages for opioid-naïv opioid-naïvee and opioid-oler opioid-oleran an paiens, for example—may help guide clinicians as well. In hospials, saff should be rained o monior for sedaion. “A lo of imes, people don’ monior for sedaion and don’ recognize sedaion as a problem unil he paien is already experiencing respiraory depression,” Uses cauions. The Pasero Opioid Sedaion Scale is one ool ha saff can use o monior for opioid-induced sedaion. A home and in oher nonhospial setings, paiens and caregivers mus know how o appropriaely sore and dispose of opioids. These drugs should no be kep in easy view and reach of ohers, and disposal opions include ake-back days, locked drop boxes, and appropriae disposal a home. To invesigae opioid-relaed evens hey are experiencing, healhcare organizaions can no only look a heir adverse even daabase bu also use rigger ools—for example, by running daily repors o idenify when naloxone, a reversal agen, is dispensed. Faser noificaion allows for easier invesigaion invesigaion of evens, and “you can rack and rend and see wha your problems are,” Uses noes.
ECRI INSTITUTE RESOURCES HRC
Z High-Aler
Medicaions Z Pain Medicaion and PRN Orders Z Paien-Conrolled Analgesia Z Infusion Pumps Other Memberships and Sources
Z ECRI Institute PSO
Deep Dive: Medication Safety Z Pain Relief: How o Keep Opioid Adminisraion Safe ( Safe (PSO PSO Navigator)) Navigator Z Pasero Opioid Sedaion Scale (POSS) wih Inervenions Z Prevening OpioidInduced Respiraory Depression (webinar Depression (webinar for ECRI Insiue PSO)
Top 10 Patient Safety Concerns for Healthcare Organizations
8. Inadequate In adequate Reprocessing of Endoscopes and Surgical Instruments Reprocessing of endoscopes and surgical insrumens, a op 10 paien safey concern and healh echnology hazard for 2014, reurns o boh op 10 liss for 2015. In fac, reprocessing has been raised as a op 10 healh echnology hazard for six years in a row. “We coninue coninue o see reprocessing issues in our acciden invesigaio invesigaions” ns” and in media repors, says Schluh. Addiionally, as ECRI Insiue was preparing Top 10 Healh Technology Technology Hazards for 2015 , he he Ebola Ebola viru viruss had beco become me fron fron-page -page news news,, furhe furherr “highlig “highlighing hing he crii criical cal impor imporance ance of he reprocessing funcion,” says Schluh. The poenial harm o paiens from he ransmission of infecious agens remaining on reusable devices can be severe. More han half of he “immediae hrea o life” findings from Join Commission Commission surveys surveys conduced in 2013 were direcly direcly relaed o improper improper equipmen reprocessing, Schluh noes. Healhcare faciliies reprocess housands of reusable surgical insrumens and devices every day for subsequen use. No only are he devices difficul o clean, bu “muliple seps are required o ge i righ,” says Keller. Each sep mus be properly performed from sar o finish. For example, if he devices are no horoughly cleaned, organisms may remain on he devices, unaffeced by disinfecion or serilizaion. Similarly, if he devices are no horoughly dried in he final reprocessing sep, “hey are a breeding ground for organisms o grow posprocessing,” says Keller.
Top 10 Patient Safety Concerns for Healthcare Organizations
Furher complicaing he reprocessing funcion are he muliple ypes of devices, each wih heir own cleaning and disinfecion or serilizaion insrucions, says Keller. If auomaed reprocessing sysems are used for endoscope disinfecion, each device model will likely require unique model-specific model-specific channel adapers o properly flush each channel of he device, he adds. Any ime a change is inroduced o reprocessing, such as a new disinfecan, cleaning agen, or channel cleaning brushes, he impac of he change needs o be evaluaed for any ripple effec on he qualiy of he process. For example, afer being asked o invesigae an infecion oubreak in an endoscopy clinic, ECRI Insiue discovered ha he clinic had swiched o a new cleaning soluion ha required a longer soak ime for insrumens han required wih he previously used cleaning soluion. The clinic’s reprocessing procedures were no longer effecive, because he clinic had no adjused he insrumen soak ime required wih he new soluion. In addiion o he recommendaions for ensuring adequae device reprocessing lised in Top 10 Healh Technology Hazards for 2015 , oher guidance guidance from ECRI Insiue Insiue is lised lised in “ECRI Insiue Resources.”
ECRI INSTITUTE RESOURCES HRC
Z Reprocessing of
Flexible Endoscopes Z Reprocessing in Cenral Service Z Endoscope Reprocessing: The Imporance of Being Proacive Other Memberships and Sources
Z CRE and Duodeno-
Z
Z
Z
Z
scope Resource Cener Clear Channels: Ensuring Effecive Endoscope ReproHealth cessing ( cessing (Health Devices)) Devices Inadequaely Reprocessed Insrumens: If I’s Diry, How Can PSO I Be Clean? ( Clean? (PSO Monthly Brief ) Serile Processing Deparmen’s Role in Paien Safey (PSO Navigator)) Navigator Top 10 Health Technology Hazards for 2015
Top 10 Patient Safety Concerns for Healthcare Organizations
9. Inadequate Patient Handoffs Related to Patient Transport
“Transporing a paien wihin he hospial o anoher clinical seting or beween unis wihin he faciliy presens risk of harm o he paien and, depending on he needs of he paien, can be an unsetling experience for nurses charged wih caring for he paien, and for he ransporer,” says Kelly Graham, BS, RN, paien safey analys a ECRI Insiue PSO. Safe ranspor involves idenifying and providing appropriae resources and requiremens for each paien during ranspor and includes proper handoff communicaion o and from appropriaely rained ransporers. Paiens may be ranspored o he wrong deparmen, he wrong paien may be ranspored, or paiens may be lef unmoniored a he receiving sie. A sandardized process for paien ranspor and handoff communicaion can reduce risk during ranspor and a he sending and receiving ends of he process, Graham says. Risks of ranspor vary wih paien acuiy. “Ideally, he level of care provided during ranspor pairs wih he care he paien receives in he uni,” Graham adds. Criically ill paiens, for example, are exposed o periods of poenial insabiliy during ranspor. Mainaining oxygenaion during ranspor and acivaing a code when a p aien’s condiion rapidly deerioraes during ranspor are bu a few examples of poenial risk. To enhance safey, criically ill paiens are ypically ranspored by eams of qualified criical care providers wih defined roles for monioring and ensuring venilaor suppor. The ranspor process and relaed communicaion is guided by formal policy reflecing guidelines from he Sociey of Criical Care Medicine and he American College of Criical Care Medicine for ransporing criically ill paiens. Bu because danger is inheren in he ranspor process of all paiens, faciliy ranspor policy and procedures should guide handoff communicaion for he safe ranspor of he non-ICU paien. The Join Commission requires ha each paien handoff communicaion include a sandardized sandard ized and a nd ineracive approach for he safe ransfer of a paien from one care area o anoher. Handoffs are an inegral par of safe ranspor, and wihou careful atenion o handoff communicaion and ranspor safey a each poin in he ranspor process, errors can occur, Graham says. Noably, of 2,390 paien-ranspor-re paien-ranspor-relaed laed repors submited o he Pennsy Pennsylvania lvania Paien Safey Auhoriy Auhoriy from May 2004 hrough Sepember 2008, 41% involved communicaion communicaion issues, according o an aricle in he March 2009 Pennsylvania Paien Safey Advisory. Advisory . ECRI Insiue PSO and is parner PSOs have received repors involving ineffecive handoffs in he paien ranspor process ha have conribued o paien harm in a variey of care seings. The following repor provides an example of inadequae handoff communicaion during ranspor of an infan wihin a hospial: Immediaely afer undergoing a surgical procedure, he infan was ranspored o he neonaal inensive care uni (NICU) in an open crib. Saff in he uni had no been informed ha he infan’s
Top 10 Patient Safety Concerns for Healthcare Organizations
body emperaure dropped in he operaing room (OR), or ha he infan was ranspored direcly from he OR o he uni, and ha he infan had no been moniored moniored in a recovery recovery uni. A nurse prepre paring he infan for he NICU NICU say expressed expressed concern abou he infan’s pale coloring and slowed slowed respiraion. The baby was given vigorous spinal simulaion in an effor o resore breahing and reurn body emperaure o normal, and required inubaion when breahing did no fully respond o he spinal simulaion. Graham recommends ha faciliies’ even and near-miss reporing sysems capure ranspor-relaed incidens incidens and near misses ha occur “off uni” and during ranspor. Such repors can idenify gaps in policies, procedures, or raining; he need for improved communicaion processes and oversigh for follow-up and monioring of handoff proocols; and oher problems ha may require reassessmen of ranspor policies and procedures. Graham suggess ha ranspor policies and procedures be based on consideraion of numerous issues, he following among hem: X
Idenifying unis are mos ofen involved in ranspor and safey hazards paricular o he unis
X
Developing crieria for deermining he level of ranspor eam needed (depending on Developing paien assessmen and he level of care required)
X
Ensuring availabiliy of equipmen, assigning responsibiliy for mainenance of herapies during ranspor, and roubleshooing equipmen during ranspor
X
Deermining raining, experience, and compeency required of ranspor personnel in ligh of expeced levels of inervenion ha may be required during ranspor
X
Developing and implemening ools and checkliss o suppor handoff communicaion among he care eam, ranspor personnel, and saff a he receiving sie
Policies and procedures migh incorporae use of a ranspor form, ofen referred o as a “Ticke o Ride” form, ha helps convey essenial informaion from he sending uni, provides a checklis o be addressed by ranspor saff and by he receiving uni, and incorporaes a siuaion-backgro siuaion-background-assessmenund-assessmen-recommendaion recommendaion (SBAR) forma o enhance communicaion a each end of he process. ECRI Insiue has also developed handoff communicaion sraegies ha address ranspor. For addiional informaion, see “ECRI Insiue Resources.”
ECRI INSTITUTE RESOURCES HRC
Z Communicaion Z Safe Paien Mobiliy
Policy and Procedure Other Memberships and Sources
Z Handoffs: Oppor-
uniy for Safe Care (PSO Navigator) Navigator)
Top 10 Patient Safety Concerns for Healthcare Organizations
10. Medication Errors Related to Pounds and Kilograms
The paien safey evens presened in his repor are no jus saisics, as he issue of poundkilogram mix-ups illusraes. “We definiely definiely see hese evens in he PSO daa,” says Sheila Rossi, MHA, paien safey analys/consulan, ECRI Insiue PSO. Bu she gained a firshand undersanding of he issue hrough her own personal experience. On a visi o a local ED, Rossi’s wo-year-old son was weighed in he riage room. Laer, he physician deermined ha he needed wo oral medicaions, o be given by Rossi and her husband. “Having previously given him wo similar medicaions a home, we had some idea of he dosing based on his age and weigh,” Rossi says. When he nurse brough in wo big syringes, Rossi Rossi and her husband husband said, “Wow, “Wow, ha looks like like a lo of medicaion,” and quesioned he amoun. “Almos in unison, he nurse and he docor said, ‘I’s weigh-based dosing.’”” Sill rusing heir insinc ha somehing wasn’ righ, Rossi and her husband gave dosing.’ heir son a porion of each dose, disposing of he excess in a napkin, afer he providers lef he room. The nex morning, he physician called and apologized, informing Rossi ha here had been a mix-up in in he weigh-based weigh-based calculaion. calculaion. Their son had been weighed in pounds, bu bu his 30-pound weigh had been enered ino he EHR as 30 kilograms (equivalen o abou 66 pounds). The oral syringes had each conained roughly wice he amoun of medicaion he should have received; forunaely, neiher was a high-aler medicaion. Bu, says Rossi, “My concern wasn’ so much for my child; my concern was for he nex child ha comes along and wha sysem fixes hey were going o make so ha his would no occur again.” Mix-ups beween pounds and kilograms are no limied o EDs and hospials; hey can happen “anyplace ha has a scale,” says Rossi. And alhough he problem poses “a huge poenial for error wih aduls,” children and older aduls may be even more sensiive o medicaion dosing errors. Similarly, overdoses involving high-aler medicaions pose a paricular paien safey concern. Consider he following even repored o ECRI Insiue PSO and is parner PSOs, which involved an older adul: Weigh was enered in he EHR incorrecly. The employee used pounds for kilograms. A low-molecWeigh ular-weigh heparin was dosed for more han double he paien’s weigh. The pharmacy discovered he error, and he order was disconinued. The anicoagulaion saus of he paien was moniored.
Top 10 Patient Safety Concerns for Healthcare Organizations
One of he mos effecive sraegies o reduce he risk of such errors is o “ge rid of scales ha measure in pounds,” says Rossi. There are many barriers o employing his sraegy. For example, i requires subsanial capial, and parens ofen wan o know heir child’s weigh in pounds. Alernaives may include adjusing elecronic scales so ha hey display only in kilograms and giving parens weigh conversion chars. “If you can ge rid of ha mix-up a he very firs sep in he process, pounds are never inroduced ino he equaion,” says Rossi. Oher high-impac sraegies include he following:
ECRI INSTITUTE RESOURCES HRC
Z Medicaion Safey:
Inaccurae Paien Weigh Can Cause Dosing Errors Z Medicaion Safey
X
Ensuring ready availabiliy of pediaric scales (e.g., o reduce reliance on parenal esimaes, which are likely o be in pounds)
X
Recording and displaying weigh only in kilograms in he EHR
Other Memberships and Sources
X
Inegraing digial scales wih he EHR o eliminae or reduce he need for daa enry
Z Medicaion Safey:
X
Using clinical decision suppor funcions ha compare enered weigh wih expeced weigh (e.g., based on growh chars)
X
Purchasing infusion pumps wih dose error reducion feaures
X
No soring in clinical areas any high-aler drugs or oher medicaions ha have he poenial o cause paien harm if weigh-based doses are miscalculaed
To invesigae his issue, organizaions may sar by reviewing heir even-repori even-reporing ng sysems. Bu ha may yield limied informaion because “i assumes ha people are acually reporing hese evens as weigh-based errors,” Rossi noes. Char audis and observaio observaion n can help he organizaion explore furher. “How are paiens being weighed, wha scales are used, how is he weigh enered ino he EHR, where are he chances for error?” says Rossi. Rossi’s encouner offers some moivaion and perspecive for all paien safey evens. “When we say ‘he paien’ in healhcare, i someimes becomes impersonal, and we see he paien as someone else, a body or objec o which care is delivered and in some cases bad evens or oucomes occur. We have all been or will become ‘paiens’ a some poin in our lives,” says Rossi. “How are we going o improve paien safey for ourselves? How do we pu ourselves in he paien’s shoes and say, ‘How do I preven his from happening o me me?’ ?’””
Inaccurae Paien Weigh Can Cause PSO Dosing Errors ( Errors (PSO Navigator)) Navigator
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