Coalition Infusion Therapy Safety: Why Are We Here?

Transcription

1 Coalition Infusion Therapy Safety: Why Are We Here? 1. Celebrate Success & How Far We ve Come 2. Frameworks for Universal Adoption of Safety Technology 3. Conference Outcomes that can Move the Needle Nat Sims, MD Massachusetts General Hospital Annapolis MD March 12, 2015

2 Disclosure Roles at MGH and Partners Healthcare Sims Lab activities Smart Pump Evolution Solutions to Shared Infusion Volume Low Cost Infusion Devices Auto Titration Anesthesia w/ Brain State Sensing MGH owned Patents (distributions) No Conflicts of Interest!! Energy from 4/15/15 excellence in care

3 Goals of Talk Welcome old and new on our shared journey Recapitulate context, history, issues, beliefs, energy Keep moving forward Exciting agenda Focus on tasks at hand Invoke an operational tempo of positive change and inevitability of improvement Zoom in Details Low hanging fruit Zoom out Strategic impact action Provoke controversy Questions for CEO s Been there done that (2008) It worked Alternative Options: Ad Hoc Audit (specific metrics) Formal Data Platforms (NQF 2012)

4 Topics Dramatic Improvements in Quality and Safety Vignettes from the Sharp End Infusion Device Invention, Innovation, Local Success ( ) Crisis, Conferences, and Successes ( ) How Meaningful Use is driving IV/IT Integration The Future is Not Evenly Distributed > Adoption!! Questions for CEO s or more assertive

5 DRAMATIC IMPROVEMENTS IN QUALITY AND SAFETY

6 Airlines: Technology PLUS Policy

7 Business Process Re Engineering, Deregulation, Consolidation SABRE ALFRED E. KAHN, KENNEDY Airline Deregulation Act of 1978

8 Analogy: Airlines to Healthcare SABRE = EPIC Expensive, complex technology to massively scale an activity while increasing quality and safety Airline Deregulation Act of 1978 = Patient Protection and Affordable Care Act of 2010 Increased competition focused on value and outcomes Intense Consolidation Cost of quality (infrastructure) is very high Amortize those costs by acquisitions

9 Some Other Safety Improvement Trajectories psanes.org/home/tabid/37/anid/43/default.aspx container/new ntsb data show general aviation has become less risky over past 20 years/ Decline. Reality or Myth? // dryoho.com/dr yoho/clinical/surgeryrisks2.cfm

10 VIGNETTES FROM THE SHARP END

11 Patient Care System = IT + Humans

12 Patient Care System = IT + Humans

13 Bates Study :Hunting for Errors at the Sharp End

14 Increase in Complexity..

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16 As Complexity Increases..Training

17 DEVICE INVENTION; INNOVATION; SUCCESSFUL LOCAL INITIATIVES

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19 Tech Push and Clinical Pull In a letter requesting one [xxxx] Infusion Pump, Model No. xxx, for $750, for each of the two cardiac operating rooms. The vasoactive roller coaster became far less common. Edward Lowenstein: A Journey of the Heart This is No Humbug 2003 Kitz et al.

20 Critical Care These first generation IVAC devices were effective but bulky. when we arrived at the SICU, the entire system of infusions was changed to conform to SICU protocols, often leading to another period of instability. This effect was particularly vexing since the monitoring was being changed to the ICU system at the same time. Nursing protocols insisted drug infusion solutions be prepared by ICU nurses in the Unit. Furthermore, the drug concentrations employed in the Unit were often greater than in the OR in order to avoid post operative positive water balance. [Lowenstein]

21 Cardiac Surgical ICU MGH 1985

22 Industry: Tech Push 1987 Tech Push vs Clincal Pull

23 Clinical Pull : Multiple Lines for O.R. and ICU syr; 3 modes; Std Drugs; Color Labels Tech Push vs Clincal Pull

24 Avoiding the Vasoactive Roller Coaster Tech Push vs Clincal Pull

25 ANESTHESIOLOGY NEWS MAY Can be programmed for any of three infusion modes. In Standard Mode, concentration is programmed in mg/ml and dose in mcg/min... Once a dose has been entered, the pump automatically calculates the effective rate in ml/h and displays it as well... Tech Push vs Clincal Pull

26 Drug Specific Configured Pump

27 Smart But No Customization >24 DRUG LIBRARY Alfentanil Lidocaine Amrinone Nitroglycerine Atracurium Nitroprusside Dobutamine Phenylephrine Dopamine Propfol Epinephrine Succinylcholine Esmolol Sufentanil Fentanyl Thiopental Isoproterenol Vecuronium Midazolam Atracurium P Mivacurium Sufentanil_p Norepinephrine Vecuronium P Sept 1992 Sept 1988

28 Smart but no editor

29 An Error in the First Drug Library Feb 1993

30 Managing Off Label Best Practices with a PC based Drug Library Editor 1997

31 Filed Feb 1995

32 Healthy Competitive Marketplace by 2004 Protecting patients from harm May 2001 / Dec 2001 January 2004 Toolbox customer release Feb 2005 Beta trials Janary 2005

33 LEADERSHIP INITIATIVES: FROM LOCAL TO NATIONAL

34 Enterprise Leadership 2004

35 Enterprise Leadership Mongan& Meyer

36 Partners Website: HPM 2 Patient Safety Reducing Medication Errors Source:

37 PHS Website: HPM 2 Patient Safety Reducing Medication Errors (cont.)

38 Conferences!!

39 2008 ASHP Conference Action Plan

40 2008 ASHP Conference Action Plan. Achieved not by advocacy, but by Meaningful Use and CIS Vendors

41 2008 ASHP Conference Action Plan

42 Smart Pump Acceptance as More than DERS

43 GAPS AND CRISIS: FEATURES, PHASING, AND ALIGNMENT

44 FDA Infusion Pump Workshop, May 25 26, 2010 Valerie A. Flournoy "Medical Device Recalls" Al Taylor "Infusion Pump Design Deficiencies" Michael Fraai, M.S., CCE Infusion Pump Workshop Mats Ohlson, MPA "Infusion Devices" Maria Cvach, MS, RN, CCRN "Infusion Pump Issues" Jim Lefever "Infusion Device Incidents" LCDR Mary E. Brooks, RN, BSN, MS "Collected Voices" "Postmarket Surveillance of External Infusion Pumps" Bisi Lawuyi "Therapeutic Products Directorate" Richard Chapman "Assurance Cases For External Infusion Pumps" Ron Kaye, MA "Human Factors / Usability for Infusion Pumps: Additional Test Data Requested In New Draft Guidance" LCDR Alan Stevens "Total Product Life Cycle Infusion Pump Guidance" "Risk Management" Nat Sims, MD "Conceptual Framework for an Improved Drug Infusion Pump Standard" Mary Logan, JD, CAE AAMI Alan Ravitz and Peter Doyle "JHAPL JHSOM P5S Project: Public Private Partnership to Promote Patient Safety"

45 2010 Crisis Response CLARION THEMES 1 Incidents: R&A 2 Integrate Drug Libraries with Info Systems 3 Mitigate Use Errors 4 Multiple Infusions 5 Alarms and Environments (Home)

46 Missing Feature: Automatic Identification to Pick Correct Drug Library Entry. Achieved (?) not by advocacy, but by Meaningful Use, emar and CIS Vendors June 2003 ASHP Dec 2004 HIMSS Feb 2005

47 2011 Integration Phasing and Alignment re do the Marla Husch study we can t all be like Lancaster IT priorities and Meaningful Use

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52 2014!! MU Stage 2 > Pump Integration 2014 EHR Certification Criteria (45CFR ) 314(a)(1) CPOE provider order entry 314(a)(10) DRUG FORMULARY CHECKS Access to at least one internal or external formulary 314(a)(16) EMAR electr med admin record Track medications from order to administration using assistive technologies in conjunction with emar If 1,10,16 in place then inherently drug libraries MUST be harmonized with the standard formulary (Sims) Happening at Partners Healthcare today: one formulary, one order set, one drug library, one standard concentration, common limits (etc)

53 DO WE NEED QUESTIONS FOR CEO S, OR CLINICAL QUALITY INDICATOR METRICS DRIVEN BY DATA PLATFORMS FROM PUMPS

54 Questions for CEO s Have you had an IV drug harm patient harm incident with death, patient injury, or ICU transfer requiring reporting or deliberations of a senior committee? Have you been cited by Joint Commission for syringe or drug labeling non compliance or any other IV medication issue? With what frequency are Drug Library Updates performed wirelessly using enterprise security and authentication standards? Are you tracking % utilization of Drug Libraries?

55 Questions for CEO s Are you compliant with Meaningful Use Stage 2 for Standard Formularies, CPOE, and emar with assistive technologies? Is Drug Library Management done by a multidisciplinary team? Are Drug Library entries harmonized with POE, emar, and the Standard Formulary (audit item!!!)

56 Data from Pumps >> Clinical Quality Indicators Percent of smart infusion pumps linked to a wireless network; Proportion of smart infusion pumps in the institution; Timeliness of drug administration; Compliance with use of pump data gathering and/or safety features; Percent of scanned nurse IDs at the point of care; and Rates of averted adverse events.

57 /// /// THANK YOU!!