Discussion: Distractons in Our Environment

Discussion: Distractons in Our Environment ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS ON Discussion: Distractons in Our Environment Please see reading assignment, required articles and writing assignment. The assignment due date will be will be due on October 13th, 2018 by 11:59 est. Discussion: Distractons in Our Environment reading_assignment.png week_6_assignment.png required_article.pdf required_article.pdf week_6_required_article.docx required_article.pdf Colum ns and D e p a rtm e n ts HTM NEWS & VIEWS Patient Safety and Healthcare Technology Management Salim Kai and Alan Lipschultz patient safety efforts within their healthcare The 1999 Institute of Medicine (IOM) report, organization. The authors seek to enable these To Err is Human: Building a Safer Health A la n Lipschultz, HTM departments that are not actively System concluded that between 44,000 and CCE, PE.CSP, involved in patient safety efforts to gain the 98,000 people die each year in U.S. hospitals is p resident knowledge and tools to use as leverage in order from preventable medical errors.1 More o f H ealthcare Technology to increase their patient safety involvement. recent evidence-based estimates2 state that C onsulting LLC in Historically many HTM departments have over 400,000 people die each year from N orth Bethesda, been limited to the types of healthcare preventable medical errors— more than four M D. E-mail: [email protected] hctc.pro times the original IOM estimates. Preventing technology that they maintain. The universe Salim Kai, MS-PSL, of healthcare technology is much greater harm to patients while providing their care CBET, is a clinical and includes technology such as patient continues to be a complex and costly under­ engineer w ith implants and disposable medical devices. taking for any hospital or healthcare system. the University o f HTM departments should The need to reduce M ichigan Health “think big” and consider medical errors has gained System in A n n Patient safety is a all types of healthcare national, as well as Arbor, M l. E-mail: healthcare discipline [email protected] med. umich. edu technology in relation to international, attention, aimed at researching, this article. Even if not and has affected many thoroughly knowledgeable studying, and preventing stakeholders in the field of about these technologies, medicine such as health­ medical errors using HTM professionals are care organizations, evidence based methods. usually analytical and healthcare professionals, “gadget oriented.” Discussion: Distractons in Our Environment There­ manufacturers, and the fore, in many instances, federal government, as they should be able to help tackle a myriad well as nongovernmental organizations such of safety issues from a technical standpoint. as The Joint Commission and the Leapfrog Group. The IOM outlined specific strategies W hat is Patient Safety? and recommendations to promote safer delivery of care, with a clear call for change Patient safety is a healthcare discipline aimed throughout the whole healthcare system.3 at researching, studying, and preventing Healthcare Technology Management (HTM) medical errors using evidence based meth­ professionals are a crucial part of that system ods. It is intended to promote safer care and because many patient safety issues involve minimize medical errors. Many can be technology. Unfortunately many HTM prevented. Activities by patient safety profes­ professionals are not actively involved in sionals, including those with patient A b ou t the Authors ? 60 B io m e d ic a l I n s t r u m e n t a t io n & T e c h n o lo g y January/February 2015 Columns and Departments backgrounds, can help reduce medical errors and prevent accidental injury. What is a Culture of Safety? A culture affects the outcome and the quality of care of patients. Culture in healthcare is defined as a set of “beliefs, shared values, norms, assumptions, attitudes, roles, and practices”4’5 shared by professionals with a “similarity of approach, outlook and priori­ ties .” 5 A culture also is how an organization responds when things go bad or when opportunities are encountered .Discussion: Distractons in Our Environment 6 In a culture of safety, “values [are] shared among organization members about what is important, their beliefs about how things operate in the organization ,” 7 and their interaction “with work unit and organiza­ tional structures and systems, which together produce behavioral norms in the organiza­ tion that promote safety.” 7 HTM professionals would do well to learn about their organization’s patient safety efforts, included in the mission, vision and values. Most healthcare organizations have statements issued by top leadership about patient safety initiatives. The HTM department should not only be aware of these statements, but also which teams have an active responsibility to set and accomplish patient safety goals. If none of the organization’s patient safety goals include healthcare technology as an important element, perhaps HTM can help develop such goals. In doing so, the HTM depart­ ment or team should seek to align its vision with that of the institution. Risk Management The risk management group at your facility should have a good working relationship with HTM. Risk management is normally the primary recipient for close calls or adverse event reports and, therefore, it is the group that can make sure HTM is notified in a timely manner of pertinent adverse events. Alternatively, there can be direct reporting to the HTM or clinical engineering department. This helps ensure that devices are sequestered and disposables are retained for evaluation. There are times when HTM is the first department to suspect that there is a problem with a medical device that may affect patient safety. There are other times when clinicians send devices to HTM for “repair” and HTM realizes that there was a device-related or near-miss event (DRE or NME). In either situation, risk management and HTM should have an agreement as to when and how HTM should notify risk management. There will be instances when HTM should not attempt a repair or even test the medical device in question without authorization from risk management. The risk management group at your facility should have a good working relationship with HTM. Discussion: Distractons in Our Environment GLOSSARY A d v e rs e P a tie n t E v e n t (APE): A n u n a n tic ip a te d e v e n t t h a t causes h a rm t o a p a tie n t a ris in g fr o m a n y a spect o f h e a lth c a re m a n a g e m e n t. Device R elated E ve nt (DRE): A n APE t h a t involves a m edical device o r devices. M e d ic a l D evice: As d e fin e d by th e FDA, “a n in s tru m e n t, a p p a ra tu s, im p le m e n t, m ach in e , c o n triv a n c e , im p la n t, in v itr o re a g e n t, o r o th e r s im ila r o r re la te d a rtic le , in c lu d in g a c o m p o n e n t p a rt, o r accessory w h ic h is re c o g n iz e d in th e o ffic ia l N a tio n a l F orm ulary, o r th e U n ite d States P h arm a ­ co p o e ia , o r a n y s u p p le m e n t t o th e m ; in te n d e d f o r use in th e d ia g n o sis o f disease o r o th e r c o n d itio n s , o r in th e cure, m itig a tio n , tre a tm e n t, o r p re v e n tio n o f disease, in m an o r o th e r anim a ls; o r in te n d e d t o a ffe c t th e s tru c tu re o r any fu n c tio n o f th e b o d y o f m an o r o th e r a nim a ls, a nd w h ic h does n o t achieve a n y o f its p rim a ry in te n d e d purposes th ro u g h chem ical a c tio n w ith in o r on th e b o d y o f m an o r o th e r a n im a ls and w h ic h is n o t d e p e n d e n t u p o n b e in g m e ta b o liz e d f o r th e a c h ie v e m e n t o f a n y o f its p rim a ry in te n d e d p u rp o se s.” (Author’s note: The defin itio n o f medical device is much broader than w hat HTM groups typically deal with. I have deliberately used this broad d efinition because HTM groups should be aware of, and possibly involved in, a ll APEs th a t involve medical devices, even i f the HTM group is n o t norm ally responsible fo r those devices.) N e a r-M iss E v e n t (N M E ): As d e fin e d b y C hang e ta l, e ve n ts t h a t are ” s u ffic ie n tly c le a r p re cursors o f adverse e ve n ts t o p o in t th e w a y to id e n tific a tio n o f sp e cific in d iv id u a l a n d systems fa ilu re s .” N ear-m iss e ven ts a re m u ch m o re c o m m o n th a n APE a n d th u s re p re s e n t a m u ch g re a te r o p p o r tu n ity f o r o rg a n iz a tio n s t o im p ro v e s a fe ty b y p re v e n tin g fu tu r e events. (A uthor’s n o te : TJC defines a sim ilar term, “close call,” as “any process variation th a t d id n o t a ffe ct an outcome b u t fo r which a recur­ rence carries a significant chance o f a serious adverse outcom e.”) S e rio u s In ju ry : As d e fin e d b y th e FDA, “a n in ju ry o r illness t h a t is life th re a te n in g , resu lts in p e rm a n e n t im p a irm e n t o f a b o d ily fu n c tio n , o r p e rm a n e n t d a m a g e t o a b o d y s tru c tu re , o r n ecessitates m e d ica l o r s u rg ic a l in te r v e n tio n t o p re c lu d e p e rm a n e n t d a m a g e o r im p a ir m e n t.” Biomedical Instrumentation & Technology January/February 2015 61 Colum ns and D e p a rtm e n ts HTM and Risk Management also should have a clear process for making sure that DRE and NME are reported to the manufac­ turer and/or the U.S. Food and Drug Administration (FDA) in accordance with the Safe Medical Devices Act. Discussion: Distractons in Our Environment In many organizations, the role of risk management (and often HTM) is reactive; there is one or more adverse events and there is a reaction to prevent future events. Instead of being reactive, it is better to proactively address patient safety to prevent adverse events before they happen. Indeed, TJC requires performing a number of failure modes and effects analyses (FMEA) every year or two. Patient Safety Officer In many organizations, the patient safety officer is the leader of the patient safety committee. HTM should strive to maintain a good relationship with the patient safety officer. HTM should have a seat on the Patient Safety Committee. The outreach to the patient safety officer must be thought out carefully. The executive manager over HTM should be involved. It is very helpful to have an example from the past when HTM “discovered” a serious problem with a medical device with significant implications for patient safety. The HTM representative to the Patient Safety Commit­ tee must be qualified and an active contributor to the committee. The effective tag and sequester process coupled with an effective electronic reporting system gives an organization the ability to provide a safer environment for patients, staff, and visitors. Define active involvement Active involvement refers to the HTM department being part of the hospital’s continuous quality improvement team to solve problems involving clinical technology used in patient care.8 HTM professionals should continue to seek ways to increase their patient safety involvement within the organization. A need for a technology content expert who can share insights about specific medical device use often exists. This involvement extends 62 beyond the traditional duties of performing preventive maintenance, corrective mainte­ nance, and incoming equipment inspections. This is an opportunity for HTM profes­ sionals to become leaders in patient safety within their healthcare organizations by partnering with other disciplines. Active involvement involves reviewing safety reports submitted by staff involving clinical and information technologies, medical equip­ ment, and disposable products • Adverse event reviews: Participate in adverse event reviews using established tools such as root cause analysis (RCA), which is typically used after an adverse event or near miss to drill down to the most important cause of the event, and FMEA, which is a proactive tool to discover risks and means to control them. It may also be used after an event or near miss to look at strategies to prevent future events. • Safe Medical Devices Act Committee: Participate in interdisciplinary committee specifically aimed at solving patient safety issues with medical equipment and products where some are reported to MedSun/FDA. This engages the manufac­ turer of the device to take a closer look at the clinical user device experience and whether some improvements are required. Tag and sequester A tag and sequester program is a coordi­ nated system to capture devices involved in safety events to be sequestered, analyzed, and to provide recommendations to staff on best practices.Discussion: Distractons in Our Environment The effective tag and sequester process, coupled with an effective electronic reporting system, gives an organization the ability to provide a safer environment for patients, staff, and visitors. Medical devices, single use, and reusable products involved in a patient safety event are tagged and sequestered to prevent further use of the medical device on any patient. The tagging and sequestering of the devices ensures the institution has the opportunity to: • Investigate the medical device and perform a root cause analysis • Notify appropriate agencies, as applicable • Provide corrective action as appropriate to avoid future incidents B io m e d ic a l I n s t r u m e n t a t io n & T e c h n o lo g y January/February 2015 Colum ns and D e p a rtm e n ts • Determine if the equipment is safe, and if safe, to release the equipment for patient use In an organization where safety is valued as a system priority, the use of a patient safety reporting system is one method to Gathering Data In an organization where safety is valued as a system priority, the use of a patient safety reporting system is one method to analyze events and errors, thereby improving safety. From a system perspective, reporting is important because it offers the organization an opportunity to learn about its vulnerabili­ ties. When data are collected, analyzed, and used as learning tools to improve existing processes, future problems can be mini­ mized and prevented. A well-designed, web-based electronic reporting system is the ideal method to capture a snapshot or brief summary of a safety event that took place. The report structure should be simple enough to be completed in a few minutes, and the reporter should have the option to report anony­ mously if she or he so chooses. The reporting system should include incentives to promote voluntary reporting in the quest to collect data about the organization and its culture. The reporting system should actively encour­ age staff to capture close calls, as well as adverse events. 9,10 If your organization does not have an electronic reporting system for capturing these events, you might want to find out about efforts to acquire such a system. Without such a system, it can be very difficult to gather significant data about patient safety mishaps. analyze events and errors, thereby improving safety. Does H TM get automatic notification? If HTM is not currently getting copies of electronic reports involving medical devices at the time they are generated, it is important to seek out the system administrator and get added to the distribution list. Timely notifica­ tion of an event is important so that follow-up can also be timely. Discussion: Distractons in Our Environment There will be times when a device involved in a patient event has been simply sent to HTM for a routine “repair,” when what is needed is a more in-depth probe into the failure before the device is fixed. Other times, HTM will want to speak directly to the person filling out the report, because of a significant patient safety impact, or sometimes HTM will want to chase down the disposables associated with the event, not just the elec­ tronic medical equipment. All of the situations mentioned are significantly hampered if HTM only finds out about these electronic reports days after the event was filed. Do reports contain a question about technology? Another benefit of a reporting system is the ability to provide information to manufactur­ ers and/or the FDA and effect changes in policies and procedures throughout the organization. The reporting system should have a medical device section where device information is logged in so that it can be retrieved later. The device section should include fields to first identify the type of device, capture electronic medical equipment serial and model number, or determine a product’s catalog or lot number. Another important consideration is for the technology event to be categorized for risk and probability of occurrence. Preventing harm to patients while providing their care continues to be a complex and costly undertaking for any hospital or healthcare system. B io m ed ical In s tr u m e n ta tio n & T e c h n o lo g y January/February 2015 63 Columns and Departments Does H T M follow up on event reports? In an organization where patient safety is prioritized and HTM professionals are valued for their technical expertise, they are included as content expert reviewers of safety notices so that they can weigh in on best strategies to solve technology-related problems. An automated notification is generated and sent to the HTM depart­ m ent’s inbox for timely review. Clinical engineers team up with biomed technicians to analyze the event and provide recommen­ dations for process improvements. Discussion: Distractons in Our Environment Does H T M have the knowledge/resources to make an im pact? HTM groups that desire a more active role in patient safety within their organization must do an honest self-assessment of their capa­ bilities and resources. Without the proper staff qualifications or adequate resources, the HTM department will not be able to take on more responsibility and add value to the institution’s overall patient safety initiatives. The HTM department must employ an articulate (verbally HTM groups that desire a more and written) member with a good working knowledge of active role in patient safety within patient safety issues, physiol­ their organization must do an ogy, and common medical honest self-assessment of their terminology. These skills and capabilities and resources. knowledge are essential to communicate effectively with both clinicians and administration about patient safety matters. Few clinicians really understand the physical principles behind the medical devices they use. This is due, in part, to a lack of including it in the training curriculum for clinicians. Many HTM professionals have historically been oriented toward repairing medical technology without necessarily understanding the physical principles behind the device theory and design. It may be an oversimplification, but this is typically a “technician” mindset. Even if they do under­ There is an unmet need, and an opportunity for HTM professionals to make a much larger impact on patient safety. 64 stand, HTM professionals may not be able to explain those principles to someone who is not technically inclined (i.e. a clinician or administrator). There are also times when a medical device operates exactly as designed, but the design is faulty or did not anticipate the manner in which the device is used in the real world. An HTM professional with an engineering training typically has received additional training on physical and design principles. Of course, there are technicians who think like an engineer and have picked up engineering principles without formal coursework. This sort of engineering expertise is extremely valuable to being an active member of the patient safety team. Discussion: Distractons in Our Environment Those who have been trained as clinical engineers have the added advantage of receiving formal training in patient safety issues, physiology and common medical terminology. To achieve meaningful impact on patient safety, the HTM department must also have the resources to devote to patient safety. Without these resources, the most qualified HTM professional will drown in the basic day-to-day HTM world of managing inven­ tory and scheduled maintenance and corrective maintenance activities. If the HTM department, along with senior management above HTM, believes that there is an unmet need for HTM participation in patient safety activities, it would do well to assess the skills and added resources needed. 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