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Failure Mode and Effects Analysis in Health Care

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Failure Mode and Effects Analysis in Health Care Powered By Docstoc
					                                April 27,2010




By Allyson Doan, Verica Saveski, Jere’
     Sims, and Dallisa Williams
   Understand what Healthcare Failure Mode and
    Effect Analysis Method is.
   Know the history of the Failure Mode and
    Effect Analysis Method.
   Know FMEA terms.
   Know how to use the FMEA method.
   Know when this method is used and by whom.
   Know the steps to use the method.
The process of
evaluation to identify
where and how a design
inadequacy might fail by
assessing the impact of
difference failures, and
identifying the parts of
the process that are in
most need of change.
            Developed in the U.S. Military 11/9/1949.

            Titled Procedures for Performing a Failure
             Mode, Effects, and Critical Analysis
                   Failures were classified according to their impact on
                     mission success and personnel/equipment safety




Cayman Business Systems, 2004
     Failure Mode
                  The way in which a process can fail
     Effect
                  The impact on the process or customer requirements as a
                   result of the failure
     Severity
                  The impact of the effect on the customer or process
     Root Cause
                  The initiating source of the failure mode
     Occurrence (or frequency)
                  How often the failure is likely to occur
     Detection
                  The likelihood that the failure will be discovered in a
                   timely manner, or before it can reach the customer

iSix Sigma, 2010
           Steps in the process
           Failure Modes
               What could go wrong?
           Failure causes
               Why would failure happen?
           Failure effects
               What would be the consequences of each failure?




Institute for Healthcare Improvement, 2010
         Analyze and evaluate processes for potential
          impact of considered changes
             Discuss and analyze steps of a process
             Consider changes
             Calculate Risk Priority Number (RPN)
                Obtained by multiplying values assigned to severity,
                  occurrence, and detection.
         Track improvement over time
             calculate the total RPN for a process
             track the RPN over time to see if changes have lead
              to improvement

Institute for Healthcare Improvement, 2010
              All health facilities that are accredited by
               JCAHO use the FMEA method. A FMEA is
               performed at least once a year for all accredited
               health facilities.
              The JCAHO standards are used by hospitals,
               physicians, nurses, pharmacists and other health
               care organizations, as a means to improve
               quality of care in the organization. The JCAHO
               is used to accredit and certify medical
               organizations.

http://medicalhealthcarefmea.com/
   Standard MM.2.20 Medications are
    properly and safely stored.
   Standard MM.2.30 Emergency
    medications and/or supplies are
    consistently available, controlled, and
    secured.
   Under the Code Documentation and
    Quality Review of Codes, there are
    standards like:
    Standard PI.1.10 The hospital collects data to
    monitor the performance of potentially high-
    risk processes, e.g. resuscitation and its
    outcomes.
   Standard PI.2.10 Data are systematically
    aggregated and analyzed.
   Data are analyzed and compared internally
    over time and externally with other sources of
    information when available.
   Comparative data are used to determine if
    there is excessive variability or unacceptable
    levels of performance when available.
   Standard PI.2.20 Undesirable patterns or
    trends in performance are analyzed.
   Standard PI.3.10 Information from data
    analysis is used to make changes that improve
    performance and patient safety and reduce the
    risk of sentinel events”.
   JCAHO standards are also used for medical
    restraints, administering medication and
    conscious sedation.
   Leads to improved patient care
   Demonstrates the organization's commitment to
    safety and quality
   Offers a consultative and educational experience
   Supports and enhances safety and quality
    improvement efforts
   May substitute for federal certification surveys for
    Medicare and Medicaid
   Provides a competitive advantage
   Fulfills licensure requirements in many states
   Recognized by insurers and other third parties
   Strengthens community confidence
Step 1. Define the Scope of the HFMEA along with a
   clear definition of the process to be studied:
FMEA is focused on ICU Monitors and response time.

Step 2. Assemble the team and define goals:

Team Members: Management, Physicians, Nursing
  Staff, Respiratory Therapists, Biomedical Engineer
Goal: To reduce response time to ICU Monitor
  Alarms
                      Healthcare FMEA Process
                                     Teaching Example 1

          Step 3a. Graphically describe process:

        Patient transferred    Patient connected         Provide care
                                                                                Respond as
                 to                to monitor            and monitor
                                                                                appropriate
                ICU             and equipment               alarms


       Sub-Process Steps 1    Sub-Process Steps 2     Sub-Process Steps 3   Sub-Process Steps 4
       a. Determine type      a. Connect to           a. Periodically       a. Verify validity of
          of isolation &         ventilator if           check monitor         alarms
          post                   required                status
                                                                            b. Reconnect
       b. Determine           b. Connect              b. Respond to            equipment as
          parameters to be       monitoring              alarms                needed
          monitored              devices to patient
                                                                            c. Medically
       c. Gather and          c. Set alarm                                     intervene as
          calibrate monitor      parameters                                    needed
          and accessories
                              d. Test alarm                                 d. Silence alarm
                                 broadcast
                                                                            e. Readjust alarm
                                                                               parameters as
(Dunn, n.d)
                                                                               needed
                        Healthcare FMEA Process
                                     Teaching Example 1

        Step 3b. List failure modes:

       Patient transferred    Patient connected        Provide care
                                                                             Respond as
                to                to monitor           and monitor
                                                                             appropriate
               ICU             and equipment              alarms


      Failure Mode 1         Failure Mode 2         Failure Mode 3       Failure Mode 4
      a. Determined          a. Incorrectly         a. Failed to check   a. Did not verify
         wrong                  connected              status               alarm
         parameters to be       monitoring
                                                    b. Misread or        b. Did not adjust
         monitored              devices
                                                       misinterpret         parameters
                             b. Did not set alarm
                                                    c. Partially check
                                parameters
                                                    d. Did not respond
                             c. Did not test
                                alarm broadcast     e. Respond slowly          Identified
                                                       or late                   area of
                                                                                failure

(Dunn, n.d)
Step 4. Analyze each identified failure mode:
Determine probability, severity and detectability
   using rating scale.

Step 5. List causes, interventions and outcome:
Redesign process by assigning action to eliminate
   or control failure mode.
                                  Healthcare FMEA Process
                                                                                                                                               Teaching Example 1
                                       HFMEA Subprocess Step: 3B1 - Respond to Alarms
                           HFMEA Step 4 - Hazard Analysis                                                                                                                                            HFMEA Step 5 - Identify Actions and Outcomes
  Failure                                                                     Scoring                                                          Decision Tree Analysis




                                                                                                                                                                                (Control, Accept,
                                                                                                                                                                                  Action Type
 Mode: First




                                                                                                                                                                                   Eliminate)




                                                                                                                                                                                                                                                                                     Management
                                                                                                                                                                                                                                                                                     Concurrence
                                                                                                                                                                                                                                                                  Responsible
                                                                                                                                               Single Point




                                                                                                                                               Detectability
Evaluate failure          Potential




                                                                                                                                               Weakness?
                                                                                                                                                                                                     Actions or Rationale for                 Outcome




                                                                                                            Frequent Probability

                                                                                                                                   Haz Score




                                                                                                                                               Measure ?



                                                                                                                                                                     Proceed?
 mode before                                                                                                                                                                                                Stopping                          Measure
                          Causes




                                                                                                                                               Existing
                                                             Severity




                                                                                                                                                                                                                                                                  Person
                                                                                                                                               Control
  determining
   potential
    causes                                       Catastrophi
3B1 Don't
    respond to
                                                                                                                                   16                  N    N    Y
                                                     c
    alarm


                   3B1a      Ignored alarm                                                                                                                                                          Reduce unw anted alarms by:          Unw anted alarms on                         Yes




                                                                                                                                                                                                                                                                     Nurse Manager
                                                      Catastrophic




                            (desensitized)                                                                                                                                                          changing alarm parameter to fit      floor are reduced by
                                                                                                            Frequent




                                                                                                                                                                                                    patient physiological condition      75% w ithin 30 days of
                                                                                                                                   16                  N    N    Y                    C
                                                                                                                                                                                                    and replace electrodes w ith         implementation.
                                                                                                                                                                                                    better quality that do not become
                                                                                                                                                                                                    detached
                   3B1b    Didn't hear; care                                                                                                                                                        Alarms w ill be broadcast to      Alarms w ill be                                Yes
                                                      Catastrophic Catastrophic Catastrophic Catastrophic

                                                                                                            Occasional




                                                                                                                                                                                                                                                                  Biomedical
                          giver left immediate                                                                                                                                                      Central Station w ith             broadcast to the




                                                                                                                                                                                                                                                                  Engineer
                                  area                                                                                             12                  N    N    Y                    C             retransmission to pagers          central station w ithin 4
                                                                                                                                                                                                    provided to care staff.           months; complete by
                                                                                                                                                                                                                                      mm/dd/yyyy
                   3B1c    Didn't hear; alarm                                                                                                                                                       Set alarm volume on isolation     Immediate; w ithin 2                           Yes
                                                                                                            Occasional




                                                                                                                                                                                                                                                                  Biomedical
                            volume too low                                                                                                                                                          room equipment such that the      w orking days;




                                                                                                                                                                                                                                                                  Engineer
                                                                                                                                   12                  N    N    Y                    E             low est volume threshold that can complete by
                                                                                                                                                                                                    be adjusted by staff is alw ays   mm/dd/yyyy
                                                                                                                                                                                                    audible outside the room.
                   3B1d    Didn't hear alarm;                                                                                                                                                                   See 3B1b                     See 3B1b
                                                                                                            Frequent




                            remote location
                           (doors closed to                                                                                        16                  N    N    Y                    C
                            isolation room)
                                                                                                            Occasional




                   3B1e    Caregiver busy;                                                                                                                                                          Enable equipment feature that        Immediate; w ithin 2                        Yes




                                                                                                                                                                                                                                                                  Biomedical
                           alarm does not                                                                                                                                                           w ill alarm in adjacent room(s) to   w orking days;




                                                                                                                                                                                                                                                                  Engineer
                            broadcast to                                                                                           12                  N    N    Y                    C             notify caregiver or partner(s).      complete by
                               backup                                                                                                                                                                                                    mm/dd/yyyy



 (Dunn, n.d)
Step 1.
FMEA is focused on Bar Code Medication
   Administration and accurate documentation of
   medications.

   Step 2.
   Team Members: Management, Nursing Staff,
    Pharmacy staff, Information Resource
    Management

   Goal: To accurately record dispensation of
    medication.
                              Healthcare FMEA Process
                                                     Teaching Example 2

            Step 3a. Graphically describe process:

                                                Auto electronic         Pharmacy fills
          Medication ordered                      Transfer to           script & sends       Nurse administers
                                               Pharmacy package             to unit


         Sub-Process Steps 1                   Sub-Process Steps 2   Sub-Process Steps 3    Sub-Process Steps 4
         a. Order sent to                      a. Check drug         a. Fills verified      a. Logs on to laptop
            pharmacy                              allergies &           orders
                                                                                            b. Retrieves meds
                                                  interations
                                                                     b. Loads med-cart         from med-cart
                                               b. Check proper          and sends to unit
                                                                                            c. Scans meds and
                                                  dosages
                                                                                               patiends ID band
                                               c. Send order to
                                                                                            d. Administers
                                                  auto dispensing
                                                                                               medication to
                                                                                               patient
                                                                                            e. Patient medical
                                                                                               records updated
(VA National Center for Patient Safety, n.d)
                                   Healthcare FMEA Process
                                                         Teaching Example 2

            Step 3b. List failure modes:
                                                                            Pharmacy fills
                                                 Auto electronic
                                                                            script & sends
        Medication ordered                         Transfer to                                    Nurse administers
                                                                                to unit
                                                Pharmacy package


         Failure Mode 1                        Failure Mode 2            Failure Mode 3          Failure Mode 4
         a. Order is not sent to               a. Allergies and          a. Verification not     a. Laptop not working
             pharmacy                             interactions are not       complete               or unavailable
                                                  verified
                                                                                                 b. Med-cart stocked
                                               b. Incorrect dosages                                 incorrectly
                                                                                                 c. Scanner missing
                                                                                                 d. Barcode unreadable
                                                                                                    or missing
                                                                                                 e. ID Band missing or
                                                                                    Identified      unreadable
                                                                                      area of
                                                                                      failure

(VA National Center for Patient Safety, n.d)
                                         Healthcare FMEA Process
                                                                                                            Teaching Example 2


                                      HFMEA Step 4 - Hazard Analysis                                                                                                                  HFMEA Step 5 - Identify Actions and Outcomes
                                                                      Scoring                                      Decision Tree Analysis




                                                                                                                                                                                                                                             Responsible


                                                                                                                                                                                                                                                           Concurrence
                                                                                                                                                                                                                                                           Management
                                                                                                                                                                    Action
Failure Mode:      First




                                                                                                                                                                                                                                               Person
                                                                                                                                                                     Type




                                                                                                                                       Detectability
                                                                                                            Single Point
                                                                                                            Weakness?
                                                                                                                                                                               Actions or Rationale for



                                                                        Probability
 Evaluate failure mode




                                                                                                Haz Score




                                                                                                                           Measure ?
                               Potential Causes                                                                                                                   (Control,                                     Outcome Measure




                                                                                                                                                       Proceed?
  before determining                                                                                                                                                                  Stopping




                                                                                                                           Existing
                                                           Severity




                                                                                                                           Control
                                                                                                                                                                   Accept,
   potential causes
                                                                                                                                                                  Eliminate)

4A(2)   No Power
                                                                        Occasional
                                                           Moderate




                                                                                                6               Y             N         N              Y


                           4A(2)a      Battery failure                                                                                                             Control         Backup battery          Total down time is less than or   Chief            Y
                                                                                                                                                                                                                 equal to 15 minutes         IRM
                                                                        Occasional Occasional
                                                           Moderate




                                                                                                6               Y             N         N              Y



                           4A(2)b Battery not charged up                                                                                                           Control      Add 120v reseptacles              Power available            Chief            Y
                                                           Moderate




                                                                                                                                                                                                                                             ENG
                                                                                                6               Y             N         N              Y




   (VA National Center for Patient Safety, n.d)
   The Failure Mode and Effect Analysis method is a effective way to
    prevent medical error. The method focuses on observing an error,
    how it occurs, acknowledging the failure effect, followed by
    creating a solution to the failure. This method should be
    performed before techniques are put to use to prevent negative
    safety outcomes and negative performance outcomes. By defining
    the topic, assembling a team, understanding the process, and
    conducting a hazard analysis, medical errors can be prevented.
    This method insures patients and employees that health providers
    are highly qualified to deliver quality care and safety. The
    commitment that health care providers deliver is highlighted by
    the pre assessments taken in order to prevent any negative
    outcomes.
Cayman Business Systems.
         (2004,January 28). Potential Failure Mode and Effects Analysis. Retrieved April 23, 2010.
    http://elsmar.com/FMEA/sld011.htm

Dunn, Edward J.. (n.d) Healthcare Failure Mode and Effect Analysis. Retrieved April 24, 2010 from
    VA National Center for Patient Safety website
    http://www.fmeainfocentre.com/presentations/HFMEA_FacDev.ppt#3

Institute for Healthcare Improvement. (2010) Failure Modes and Analysis Tool. Retrieved April 24,
      2010. http://www.ihi.org/ihi/workspace/tools/fmea/.

iSix Sigma. (2010). FMEA Can Add Value in Various Project Stages. Retrieved April 23,
      2010.http://www.isixsigma.com/index.php?option=com_k2&view=item&id=1520:fmea-can-
      add-value-in-arious-project-stages&Itemid=203.

JCAHO AND RESUSCITATION. (2010). Retrieved April 21, 2010, from Resuscitation Central :
    http://www.resuscitationcentral.com/documentation/jcaho-health-care-hospital-
    accreditation/

VA National Center for Patient Safety. (n.d). The Basics of Healthcare Failure Mode and Effect
    Analysis. Retrieved April 24, 2010 from
    http://www.patientsafety.gov/SafetyTopics/HFMEA/FMEA2.pdf

http://medicalhealthcarefmea.com/

				
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