Road Map to a Mediation Safety Program Mediation Safety 2012 Minnesota Hospital Assoiation
The Road Map to a Mediation Safety Program provides evidene-based reommendations/standards for Minnesota hospitals in the development of a omprehensive mediation safety program. The road map and aompanying tool kit were developed by the MHA Adverse Drug Event Advisory Group with funding through CMS Partnership for Patients (P4P) Initiative. The road map reflets published literature and guidelines by relevant professional organizations and regulatory agenies as well as best praties identified by the MHA Adverse Drug Event Advisory Group. The road map and tool kit will be reviewed regularly and updated as indiated through published literature. We would like to thank the following individuals for sharing their time, expertise and stories whih made the road map and tool kit possible. ADE Advisory Group Kristi Gullikson, PharmD, FASHP, Allina Health/ Abbott Northwestern Hospital, Jill Strykowski, MS, RPh, Allina Health, Mery/Unity Hospitals, Coon Rapids/Fridley William Dikey, MD, Allina Health/Abbott Northwestern Hospital, Jennifer Watson, PharmD, CentraCare St. Cloud Hospital Ryan Lee, PharmD, BCPS, Sanford Health Bemidji Dik Spehar, RPh, Essentia Health, Duluth Tim Cernohous, PharmD, Essentia Health, Duluth Angie Bolgrean, PharmD, Essentia Health, Duluth Steve Meisel, PharmD, CPPS, Fairview Health Servies, Jean Kohs, RPh, Hennepin County Medial Center, Jakie Kern, New River Medial Center, Montiello Ron Kitzmann, RPh, MBA, Park Niollet Methodist Hospital, Kathy Cummings, BSN, Institute for Clinial Systems Improvement, Bloomington Kim MCoy, MPH, MS, Stratis Health, Bloomington Brian Isetts, PharmD., BCPS, Centers for Mediare and Mediaid Servies, Washington, D.C. Tania Daniels, PT, MBA, Minnesota Hospital Assoiation Nora Vernon, RN, MS, Minnesota Hospital Assoiation Mikey Reid, RN, MS, Minnesota Hospital Assoiation Hypoglyemi Agent Subgroup Kristi Gullikson, PharmD, FASHP, Lead, Allina Health/Abbott Northwestern Hospital, William Dikey, MD, Allina Health/Abbott Northwestern Hospital, Ryan Lee, PharmD, BCPS, Sanford Health, Bemidji Dik Spehar, RPh, Essentia Health, Duluth Ron Kitzmann, RPh, MBA, Park Niollet Methodist Hospital, Janie Puttbrese, PharmD, Sanford Health Bemidji Carol Manhester, RN, Fairview Health Servies, Faith Pollok, RN, ACNS-BC, CDE, Allina Health, Mihelle Borhart, PharmD, Fairview Health Servies, Opioid Subgroup Steve Meisel, PharmD, CPPS, Lead, Fairview Health Servies, Virginia Gahfoor, PharmD, Fairview Health Servies, Joel Carter, MD, Park Niollet Health Servies, Rosie Bloom, MS, RN, ACNS-BC, AOCNS, Park Niollet Methodist Hospital, Maria Zarambo, PharmD, BCOP, Allina Health, Abbott Northwestern Hospital, Antioagulant Subgroup Jill Strykowski, MS, RPh, Lead, Allina Health, Mery/ Unity Hospitals, Coon Rapids/Fridley Jean Kohs, RPh, Hennepin County Medial Center, Angie Bolgrean, PharmD, Essentia Health, Duluth Haley Holtan, Pharm D, Hennepin County Medial Center, Linda Dikey, RN, Allina Health, Jennifer Watson, PharmD, CentraCare St. Cloud Hospital 2012 Minnesota Hospital Assoiation
Road Map to a Mediation Safety Program Mediation Safety S Safety Safe from ADE Speifi Ations(s) Audit Questions Yes No Teams and Organizational Struture 1) Seure endorsements and resoures for Mediation Safety. 1a) The faility s leadership endorses implementation and sustainment of the Mediation Safety road map praties. 1b) Senior leadership has learly ommuniated overall goals for Mediation Safety. 1) Senior leadership regularly reviews progress toward goals and supports adding resoures as appropriate. 1d) The faility has a designated senior leadership sponsor for Mediation Safety. 2) Promote Mediation Safety representation and hampions throughout the faility. 2a) The faility has an interdisiplinary team involved in addressing Mediation Safety with representation from aross the faility. Mediation Safety hampions/team members/liaisons with lear roles and expetations have been designated from: 2b) Physiian/liensed independent provider knowledgeable in mediation safety. 2) Nursing 2d) Safety/Quality 2e) Pharmay 2f) The faility has a proess in plae to engage other team members as regular or ad-ho members as appropriate (e.g., dietary, laboratory, surgery, purhasing, eduation, risk management, human resoures). 2g) The faility has a designated oordinator(s) for Mediation Safety. 2h) The oordinator(s) has designated time to serve in this oordination funtion. 3) Identify gaps and develop ation plans The interdisiplinary team: 3a) Reviews the Mediation Safety plan throughout the year, and updates the plan as needed, to prioritize and address newly identified improvement opportunities. 3b) Reviews data results at least quarterly and identifies strengths and opportunities. 3) Commissions subgroups as needed to address priority issues requiring subjet matter experts (e.g., IV team, respiratory, pain team). A Aess to Information 1) Trak progress on proess and outome measures. Data Colletion A proess is in plae to ollet Mediation Safety bundle/proess data for the following as appliable: 1a) Hypoglyemi agent gap analysis 1b) Antioagulant gap analysis 1) Opioid agent gap analysis A proess is in plae to trak the following ADE measures, at a minimum: 1d) Number of patients with INR >5 (or outside of established therapeuti range.) 1e) Number of patients with blood gluose < 40 (or outside of established therapeuti range.) 1f) Number of naloxone administrations (or established opioid ADE measure) Page 1 Road Map to a Mediation Safety Program 2012 Minnesota Hospital Assoiation
1h) A proess is in plae to affirm the reliability of both the proess and outome data obtained through audits. 1i) Standard riteria exist for onduting audits. (e.g. hart audits) when needed. 1j) The faility s doumentation system (eletroni or paper) is designed to apture suffiient detail about adverse drug events that our to allow for adequate event analysis. 2) Review and analyze the data for improvement opportunities. Data Analysis A proess is in plae to: 2a) Routinely review and analyze data for proess improvement opportunities/defets. 2b) Analyze data related to possible mediation-related readmissions to identify gaps and opportunities for improvement. 2) Trak progress against established targets (e.g., run harts, ontrol harts, dashboards, soreards.) 2d) Prioritize and at upon identified issues. 3) Mediation Safety Program data is shared within and aross units on a regular basis to identify improvement strategies. Data and Information Sharing Mediation Safety Program Event and Adverse Drug Event data and learnings are shared on a regular basis: 3a) Within units 3b) Aross units 3) With leadership 3d) With medial staff 3e) With the board (s) 3f) Mediation Safety Program/Adverse Drug Event learnings are routinely shared through stories as well as through data (e.g., inlude in daily briefings, unit staff meetings, safety ommittees, newsletters.) 4) Reporting test results in timely manner 4a) A proess is in plae to provide stat laboratory test results 24 hours a day and 7 days per week to ensure safe and timely monitoring of high risk mediations. 5) Condut patient sreening and identify potential risks 5a) The faility s eletroni health reord diretly interfaes with the laboratory system to automatially alert pratitioners to abnormal values, indiating a potential need to modify high-alert mediation therapy. {add n/a option} The faility s eletroni health reord and/or pharmay omputer system: 5b) Sreens mediation therapy against the patient s N/A: linial profile for ontraindiations, interations and dose appropriateness before drugs are administered. 5) Alerts health are pratitioners to dupliate lass orders N/A: for mediations. 5d) Performs dose range heks. N/A: 5e) A proess is in plae for pratitioners to sreen for and doument existing diseases or onditions that ould affet the dosing of mediation therapy prior to initiating antithromboti, hypoglyemi or opioid therapy. 6) Use prospetive analysis methods to identify risks and/or potential failures in are 6a) Prospetive risk analysis methods (e.g., drug monograph, failure modes and effets analysis - FMEA) are used to proatively identify potential risks assoiated with introdution of new mediations and mediation modalities (e.g., fentanyl PCA or liposomal bupiviaine) and new devies (e.g., smart pumps). 6b) A proess is in plae to prioritize and at upon issues identified through the analysis. Page 2 Road Map to a Mediation Safety Program 2012 Minnesota Hospital Assoiation
F Faility Expetations 1) Follow standardized praties 1a) The faility follows standardized linial pratie guidelines when developing order sets, poliies and proedures. 1b) There is standard proess in plae to promptly retrieve outdated protools, pathways, guidelines, nomograms, order sets, flow sheets and/or heklists throughout the faility and to replae with updated versions. 1) There is a standard proess in plae to ommuniate hanges to staff. In failities with key or multiple teams addressing mediation safety (e.g., antioagulation therapy group, pain ommittee or diabetes management team): 1d) Key teams lead and develop institutional poliies and proedures related to speifi high-alert mediations (e.g., the antioagulation therapy teamleads antioagulation praties; pain team leads opioid praties; diabetes management team leads hypoglyemi agent praties). 1e) There is a proess in plae to ensure ommuniation and information sharing within teams and aross teams. 2) Leadership establishes and ommuniates lear expetations 2a) Diret patient are staff (e.g., nurses, physiians, pharmaists, pharmay tehniians) is informed of expetations and performane standards regarding their role in the Mediation Safety Program. 2b) Support staff (e.g., laboratory, supply hain, operations) is informed of expetations and performane standards regarding their role in mediation safety. 2) The faility has a well defined proess to support a ulture that enourages staff to speak up and stop the line regarding any onern related to mediation safety. 2d) The stop the line proess learly outlines: When to stop the line; How to stop the line, e.g., I need larity ; The hain of ommand to follow if not supported in stopping the line; Clear ommuniation to staff from managers and leadership that staff will be supported if they speak up. 3) Provide eduation for diret are and support staff Expetations and supporting Mediation Safety Program eduation have been inorporated into new employee orientation for: 3a) Diret patient are staff 3b) Support staff 3) Expetations and supporting Mediation Safety Program eduation have been inorporated into employee orientation for personnel employed by outside agenies and ontrated personnel. 3d) Mediation Safety Program eduation is provided to diret are staff at least annually. 3e) Mediation Safety Program eduation is provided to support staff when new relevant information is available. 3f) Expetations and supporting Mediation Safety Program eduation have been inorporated in new physiian orientation. The faility has a proess in plae whih evaluates staff ompetenies related to high-risk mediations inluding: 3g) Eduation on high risk mediations in provider, presriber, pharmay, and nursing staff orientation and ongoing ompeteny assessment. 3h) Development of poliies whih learly delineate the roles and responsibilities of physiians, presribers, pharmaists, and nurses for high-risk mediation use. 3i) Eduation on how to ondut effetive independent double heks for high risk mediations. Page 3 Road Map to a Mediation Safety Program 2012 Minnesota Hospital Assoiation
4) Establish a strutured ommuniation proess 4a) The faility has strutured ommuniation tools (e.g., Situation, Bakground, Assessment, Reommendation (SBAR) for ommuniation related to high-risk mediations at all levels of the organization. A strutured hand-off proess is in plae throughout the organization with speifi elements outlined that must be inluded for hand-offs: 4b) During shift-hange 4) Between departments/units 4d) To other failities 5) Establish an effetive mediation reoniliation proess. The faility s admission mediation reoniliation proess inludes, at a minimum: 5a) A good faith effort at verifiation of patient home mediation list. 5b) Identifiation and resolution of potential drug interations. 5) Identifiation and resolution of onomitant therapies. The faility s disharge mediation reoniliation proess inludes, at a minimum: 5e) Verifiation of patient mediations and dosages. 5f) Flag potential for mediation-related readmissions (e.g., polypharmay, high-alert mediations, multiple disease states, et.). 6) Dislose unantiipated outomes. A proess is in plae to promptly inform families when an Adverse Drug Event ours and inludes, at a minimum: 6a) Diretion on who should disuss the unantiipated outome with the patient/ family and how that disussion should our. 6b) Individuals designated to provide dislosure to patients reeive training on effetive dislosure strategies. 6) A proess for dislosing to, and updating, patient/family as the event is reviewed and analyzed. 6d) A designated person is available to provide support and just-in-time training to staff members who are about to dislose an unantiipated outome to a patient/family. E Engagement of Patient, Client, Resident and Family 1) Eduate and empower patients and families. 1a) A proess is in plae to assess and address any barriers to patient/ family ability to understand their role in Adverse Drug Event prevention (e.g., ultural, language, hearing impairment and health literay). 1b) Patients/families are eduated on their role in preventing Adverse Drug Events and prevention measures they an expet to see from staff and providers aring for them in the hospital (e.g., bedside baroding, explaining purpose of mediations, identifying potential side effets of mediations, asking name and birthdate before mediation administration). 1) A proess is in plae to assess patient /families level of understanding of the eduation provided (e.g., teah bak.) 1d) The faility has a proess in plae to enourage patients and families to speak up if they have onerns about diret are/support staff/ provider praties or other issues that may inrease the risk of a mediation error. 1e) A proess is in plae to report bak to patients/families that have shared a onern. Page 4 Road Map to a Mediation Safety Program 2012 Minnesota Hospital Assoiation