FMEA Forms

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    FAILURE MODE EFEECTS ANALYSIS

    PROCESS STEPS: Describe the process graphically, according to your policy and procedure for the activity, and number eachone. If the process is complex you may want to select one process step or sub-process to work on.

    DIRECT ADMITS

    1 2 3 4 5

    MD Decision to Obtain Orders Bed Assignment Registration

    Admit

    List the sub-processes for each process step and letter

    Sub process steps Sub process steps Sub process steps Sub process steps Sub process steps

    A. MD/Office staff call A. Phone A. Determine bed type A. Enter Data A. Call transport or

    hospital - why? direct patient to area

    B. Verification of bed B. Fax B. Check Bed Availability B. Verify Accuracy B. Call unit to come

    availability with? of data in system and get patient

    C. C. Send with patient C. Notify unit of bed C. Complete Advance C. Transport pt to

    assignment Directives/Rights/HIPPA appropriate care area

    D. D. D. D. D.

    E. E. E. E. E.

    F. F. F. F. F.

    Transport or Direction

    To Unit

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    FAILURE MODE EFFECTS ANALYSIS

    SUB-PROCESS STEPS: Graphically describe the sub-processes for each process step and then list the possible failure modes for each one

    If the process is complex you may want to select sub-process to work on.

    PROCESS: MD DECISION TO ADMIT

    A B C D E

    MD/Office Staff Verification of Bedcalls Hospital Availability

    Failure Modes Failure Modes Failure Modes Failure Modes Failure Modes

    1. Wrong person 1. No bed available 1 1 1contacted with info2. Patient arrives 2 2 2 2

    without prior notice3 3 3 3 3

    4 4 4 4 4

    5 5 5 5 5

    6 6 6 6 6

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    FAILURE MODE EFFECTS ANALYSIS

    SUB-PROCESS STEPS: Graphically describe the sub-processes for each process step and then list the possible failure modes for each one

    If the process is complex you may want to select sub-process to work on.

    PROCESS: OBTAIN ORDERS

    A B C D E

    MD/Office Staffphones/faxes/

    gives orders topatient

    Failure Modes Failure Modes Failure Modes Failure Modes Failure Modes

    1 No orders received 1 1 1 1

    2 Orders incomplete 2 2 2 2

    or illegible3 3 3 3 3

    4 4 4 4 4

    5 5 5 5 5

    6 6 6 6 6

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    FAILURE MODE EFFECTS ANALYSIS

    SUB-PROCESS STEPS: Graphically describe the sub-processes for each proces step and then list the possible failure modes for each one

    If the process is complex you may want to select sub-process to work on.

    PROCESS: BED ASSIGNMENT

    A B C D E

    Determine Bed Check Bed Assign BedType Availability

    Failure Modes Failure Modes Failure Modes Failure Modes Failure Modes

    1 Incorrect assignment 1 No bed available 1 Bed assignment person 1 1made (gender, age, dx) (high census, type, etc.) not available2 2 Overlapping bed 2 No bed assignment 2 2

    assignment made3 3 Bed not clean/bed broken 3 Patient arrives to floor 3 3

    without bed assigned

    4 4 Late discharges 4 4 4

    5 5 5 5 5

    6 6 6 6 6

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    FAILURE MODE EFFECTS ANALYSIS

    SUB-PROCESS STEPS: Graphically describe the sub-processes for each proces step and then list the possible failure modes for each one

    If the process is complex you may want to select sub-process to work on.

    PROCESS: REGISTRATION

    A B C D E

    Register Patient Enter Data Advance Directives Patient ID Documents toVerify Accuracy of Consents/HIPAA Care Area

    Data already insystem

    Failure Modes Failure Modes Failure Modes Failure Modes Failure Modes

    1 Clerk not available 1 System down 1 1 Patient incorrectly 1 Documents notidentified (banded) available to caregivers

    2 Patient reports to wrong 2 Incorrect info entered 2 2 Patient not "banded" 2

    area3 3 Patient unable to give or 3 3 3

    verify accuracy

    4 4 4 4 4

    5 5 5 5 5

    6 6 6 6 6

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    FAILURE MODE EFFECTS ANALYSIS

    SUB-PROCESS STEPS: Graphically describe the sub-processes for each proces step and then list the possible failure modes for each one

    If the process is complex you may want to select sub-process to work on.

    PROCESS: TRANSPORT

    A B C D E

    Call Transport Direct Patient to Call unit to come & Transport to UnitCare Area get patient

    Failure Modes Failure Modes Failure Modes Failure Modes Failure Modes

    1 Transport not available 1 Patient gets lost 1 Staff not available 1 Patient arrives without 1to get patient being registered

    2 Transport equipment not 2 No one available to 2 2 Patient arrives without 2

    available receive patient unit notification3 3 3 3 Patient arrives and bed not 3

    ready

    4 4 4 4 4

    5 5 5 5 5

    6 6 6 6 6

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET

    Process Step: MD Decision to Admit

    Potential Failure Mode 1. Wrong person 2. Patient arrives 3. No bed available

    (what could go wrong) contacted with without prior notice

    informationEffect (what could happen) Delay in care Delay in treatment Delay in treatment

    Customer dissatisfaction Treatment errors Customer dissatisfaction

    Increased risk of bad Increased risk of bad outcomes Loss of revenue

    outcomes Customer dissatisfaction Patient Safety/Risk Issue

    Staff overburdened Increased risk of noso.

    infections (rush to clean)

    Patient in inappropriate

    level of care

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s) 1. Unclear hospital 1. MD/Office staff too busy 1. High census

    (why the failure could occur - list all possibilities process to call or forgets 2. Delay in cleaning

    for each failure mode and conduct analysis for all failure modes within the 2. Noncompliant MD's 2. Unclear hospital process 3. Discharge delays

    scope of this FMEA) 3. Lack of Education 3. Noncompliant MD/Office 4. Inapproriate utilization

    regarding process staff 5. Communication

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 2

    Process Step: Obtain Orders

    Potential Failure Mode 1. No orders 2. Orders incomplete

    (what could go wrong) received or illegible

    Effect (what could happen) Delay in treatment Delay in treatmentIncorrect treatment Incorrect treatment

    Increased risk of bad out-

    comes

    Customer Dissatisfaction

    Increased LOS

    Increased work load for

    staff

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s) MD too busy Admit status not documented

    (why the failure could occur - list all possibilities MD noncompliance or documented incorrectly

    for each failure mode and conduct analysis for all failure modes within the Patient loses them Fax copies unreadable

    scope of this FMEA) Fax busy/malfunction Handwriting illegible

    Lack of education (what's

    required by Reg. Agencies)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 3

    Process Step: Bed Assignment

    Potential Failure Mode 1. Incorrect assign- 2. No bed available 3. Overlapping bed

    (what could go wrong) ment made (gender, (high census, type, etc) assignment

    age, diagnosis, etc.) (See MD Decision toAdmit Process)

    Effect (what could happen) Customer dissatisfaction Customer dissatisfaction

    Spread of infection Delay in treatment

    Delay in treatment

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s) Manual/decentralized Manual/decentralized

    (why the failure could occur - list all possibilities process process

    for each failure mode and conduct analysis for all failure modes within the Inaccurate info Multiple contacts

    scope of this FMEA) Communication failure Inaccurate recordkeeping

    by units

    Communication failure

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 4

    Process Step: Bed Assignment

    Potential Failure Mode 4. Bed not clean/bed 5. Late Discharges 6. Bed assignment

    (what could go wrong) broken person not available

    Effect (what could happen) Increased risk of infection Hospital on diversion due to Customer dissatisfaction

    Incresed risk of injury no beds Delay in treatment

    Customer dissatisfaction Loss of revenue

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s) Unit not communicated Late rounding by MD's No back-up system in

    (why the failure could occur - list all possibilities with Env. Services that Awaiting diagnostic reports place

    for each failure mode and conduct analysis for all failure modes within the patient discharged

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 5

    Process Step: Bed Assignment

    Potential Failure Mode 7. No bed assign- 8. Patient arrives to

    (what could go wrong) ment made floor without bed

    assigned

    Effect (what could happen) Delay in treatment Delay in treatment

    Customer dissatisfaction Customer dissatisfaction

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s) Bed unavailable Communication Failure

    (why the failure could occur - list all possibilities Not staff priority

    for each failure mode and conduct analysis for all failure modes within the Lack of staff accountabil-

    scope of this FMEA) ity/responsibility

    No request received

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 6

    Process Step: Registration

    Potential Failure Mode 1. Registration Clerk 2. Patient reports to 3. System down

    (what could go wrong) not available wrong area

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilities

    for each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 7

    Process Step: Registration

    Potential Failure Mode 4. Incorrect info 5. Patient unable to give 6. Patient

    (what could go wrong) entered or verify accuracy of incorrectly identified

    info "banded"

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilities

    for each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 8

    Process Step: Registration

    Potential Failure Mode 7. Patient not 8. Documents not avail-

    (what could go wrong) "banded" - able to staff (i.e., consent

    identified to treat, etc.)

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilities

    for each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 9

    Process Step: Transport

    Potential Failure Mode 1. Transport not 2. Appropriate transport 3. Patient gets lost

    (what could go wrong) available equipment not available

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilities

    for each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 10

    Process Step: Transport

    Potential Failure Mode 4. No one available 5. Staff not available 6. Patient arrives

    (what could go wrong) to receive patient to come and get patient without being

    registered

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilitiesfor each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due

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    HEALTHCARE FAILURE MODE EFFECTS ANALYSIS WORKSHEET page 11

    Process Step: Transport

    Potential Failure Mode 7. Patient arrives 8. Patient arrives and

    (what could go wrong) without unit being bed not ready

    notified

    Effect (what could happen)

    Severity: 1 = no harm; 2 = temporary harm; 3 = permanent harm;

    4 = Death/Major loss of function

    Potential Cause(s)

    (why the failure could occur - list all possibilitiesfor each failure mode and conduct analysis for all failure modes within the

    scope of this FMEA)

    Probability: 1 = remote; 2 = uncommon; 3 = occasional; 4 = frequent

    Current Control Measure

    Detectability: 1 = Very Likely; 2 = Likely; 3 = UnLikely; 4 = Very Unlikely

    Hazard Score (RPN = Severity x Probability x Detectablility)

    Decision: Proceed or Rationale for Stopping based on score or

    explanation

    Action (Eliminate, Control or Accept)

    Description of Intervention

    Outcome Measure

    Person Responsible

    Management Concurrence (Yes or No)

    Implementation Time Frame/Date Due