| Literature DB >> 35243066 |
Ehsan Ullah1,2, Mirza Mansoor Baig3, Hamid GholamHosseini3, Jun Lu1,4,5,6,7.
Abstract
We performed FMEA on the existing RRS with the help of routine users of the RRS who acted as subject matter experts and evaluated the failures for their criticality using the Risk Priority Number approach based on their experience of the RRS. The FMEA found 35 potential failure modes and 101 failure mode effects across 13 process steps of the RRS. The afferent limb of RRS was found to be more prone to these failures (62, 61.4%) than the efferent limb of the RRS (39, 38.6%). Modification of calling criteria (12, 11.9%) and calculation of New Zealand Early Warning Scores (NZEWS) calculation (11, 10.9%) steps were found to potentially give rise to the highest number of these failures. Causes of these failures include human error and related factors (35, 34.7%), staff workload/staffing levels (30, 29.7%) and limitations due to paper-based charts and organisational factors (n = 30, 29.7%). The demonstrated electronic system was found to potentially eliminate or reduce the likelihood of 71 (70.2%) failures. The failures not eliminated by the electronic RRS require targeted corrective measures including scenario-based training and education, and revised calling criteria to include triggers for hypothermia and high systolic blood pressure.Entities:
Keywords: Clinical deterioration; Early warning score; Failure modes and effects analysis; Rapid response system; Vital signs
Year: 2022 PMID: 35243066 PMCID: PMC8857483 DOI: 10.1016/j.heliyon.2022.e08944
Source DB: PubMed Journal: Heliyon ISSN: 2405-8440
Figure 1Schematic representation of a RRS.
Figure 2Stages of the failure mode and effect analysis.
Figure 3Flow diagram of steps involved in a rapid response system.
Rating scale for severity, occurrence and detection of failure modes in a RRS.
| No harm to patient/no effect on detection of patient deterioration | 1 |
| Non-documented vital signs or NZEWS or incorrect calculated NZEWS | 2 |
| Actual or potential delay to or lack of detection of patient deterioration | 3 |
| Once in more than a year | 1 |
| Once in a year | 2 |
| Once in six months | 3 |
| Once in three months | 4 |
| Once a month | 5 |
| Once a week | 6 |
| Once every 3 days | 7 |
| Once per day | 8 |
| One per 8-hour shift | 9 |
| More than once per 8-hour shift | 10 |
| 100% detection | 1 |
| >50% detection | 2 |
| 11–50% detection | 3 |
| <10 % detection | 4 |
| 0% detection | 5 |
Failure modes, their effects and causes across the process steps of a RRS∗.
| Serial No | Process Step | Failure Mode | Failure Mode Effects | Causes | RPN | Will electronic RRS reduce the risk? |
|---|---|---|---|---|---|---|
| 1 | 1.Timeliness of vital signs observations | Delay in undertaking vital signs | Delay in detecting possible derangements in vital signs and/or NZEWS which may lead to delayed review and/or rapid response hence increased chances of adverse events | Lack of reinforcing function/mechanism to remind staff when vital sign observations become due based on patient's previous NZEWS value and/or minimum 4-hourly vital signs monitoring | 108 | No |
| 2 | Non-compliance with protocols such as minimum 4-hourly vital signs monitoring on general wards | 108 | No | |||
| 3 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 108 | No | |||
| 4 | 2. Pulse Rate (PR) | Non-measurement of the PR | Delay in detecting possible derangements in vital signs and/or NZEWS | Too busy staff or inadequate staff allocation, memory lapse | 120 | Yes |
| 5 | Non-compliance with protocols such as minimum 4-hourly vital signs monitoring, and due to inability to calculate NZEWS score | 120 | Yes | |||
| 6 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 120 | Yes | |||
| 7 | Non-documentation of the PR | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 18 | Yes | |
| 8 | Non-compliance with protocols | 18 | Yes | |||
| 9 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 18 | Yes | |||
| 10 | No trigger for rhythm abnormalities | Heart rhythm abnormalities that do not cause haemodynamic instability are not recognised and managed | Not included in the monitoring protocols | 25 | ||
| 11 | 3. Systolic blood pressure (SBP) | Non-measurement of the SBP | Delay in detecting possible derangements in vital signs and/or NZEWS | Incorrect or less frequent measurements due to previous set of vital signs or NZEWS being miscalculated or staff not able to take measurement due to being busy, distracted or memory lapse or non-cooperation of patient | 120 | Yes |
| 12 | Non-compliance with protocols | 120 | Yes | |||
| 13 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission unless non-cooperation of patient is documented in clinical notes, if relevant | 120 | Yes | |||
| 14 | Non-documentation of the SBP | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 18 | Yes | |
| 15 | Non-compliance with protocols | 18 | Yes | |||
| 16 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission unless non-cooperation of patient is documented in clinical notes, if relevant | 18 | Yes | |||
| 17 | No trigger until too high SBP | Significant high Systolic BP (<220 mmHg) alone may continue for hours to days and could be indication of significant illness without any change in NZEWS | Protocol definition issue | 90 | No | |
| 18 | 4.Temperature | Non-measurement of the temperature | Delay in detecting possible derangements in vital signs and/or NZEWS | Too busy staff or inadequate staff allocation, memory lapse | 70 | No |
| 19 | Non-compliance with protocols | 70 | No | |||
| 20 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 70 | No | |||
| 21 | Non-documentation of the temperature | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 12 | No | |
| 22 | Non-compliance with protocols | 12 | No | |||
| 23 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 12 | No | |||
| 24 | No trigger for hypothermia | Significant illness such as sepsis may not be recognised | Protocol definition issue | 75 | No | |
| 25 | 5. Respiratory rate (RR) | Non-measurement of the RR | Delay in detecting possible derangements in vital signs and/or NZEWS | Too busy staff or inadequate staff allocation, memory lapse | 120 | No |
| 26 | Non-compliance with protocols | 120 | No | |||
| 27 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 120 | No | |||
| 28 | Errors in measurement the RR | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 36 | No | |
| 29 | Non-compliance with protocols | 36 | No | |||
| 30 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 36 | No | |||
| 31 | Non-documentation of the RR | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 18 | No | |
| 32 | Non-compliance with protocols | 18 | No | |||
| 33 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 18 | No | |||
| 34 | 6. Oxygen saturation | Non-measurement of oxygen saturation | Delay in detecting possible derangements in vital signs and/or NZEWS | Incorrect or less frequent measurements due to previous set of vital signs or NZEWS being miscalculated or staff not able to take measurement due to being busy, inadequate staffing levels or memory lapse | 105 | Yes |
| 35 | Non-compliance with protocols | 105 | Yes | |||
| 36 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 105 | Yes | |||
| 37 | Non-documentation of oxygen saturation | Delay in detecting possible derangements in vital signs and/or NZEWS | Interruptions due to other more urgent tasks | 18 | Yes | |
| 38 | Non-compliance with protocols | 18 | Yes | |||
| 39 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 18 | Yes | |||
| 40 | 7. Oxygen requirement | Non-measurement of oxygen requirement | Delay in detecting possible derangements in vital signs and/or NZEWS | Incorrect or less frequent measurements due to previous set of vital signs or NZEWS being miscalculated or staff not able to take measurement due to being busy, distracted or memory lapse | 90 | Yes |
| 41 | Non-compliance with protocols | 90 | Yes | |||
| 42 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 90 | Yes | |||
| 43 | Non-documentation of oxygen requirement | Delay in detecting possible derangements in vital signs and/or NZEWS | Too busy, interrupted by other more urgent task, memory lapse | 18 | Yes | |
| 44 | Non-compliance with protocols | 18 | Yes | |||
| 45 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 18 | Yes | |||
| 46 | 8. Level of consciousness | Errors in interpretation of the level of consciousness | Delay in detecting possible derangements in vital signs and/or NZEWS | Human error, complacency, lack of awareness of patient's sleeping pattern | 75 | No |
| 47 | Non-compliance with protocols | 75 | No | |||
| 48 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 75 | No | |||
| 49 | Non-documentation of the level of consciousness | Delay in detecting possible derangements in vital signs and/or NZEWS | Too busy staff or inadequate staff allocation, memory lapse | 72 | No | |
| 50 | Non-compliance with protocols | 72 | No | |||
| 51 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 72 | No | |||
| 52 | 9. NZEWS calculation | Non-calculation of NZEWS | Delay in detecting possible derangements in vital signs and/or NZEWS | Time-consuming, difficult to calculate when staff working with huge cognitive load, interruptions | 135 | Yes |
| 53 | Non-compliance with protocols | 135 | Yes | |||
| 54 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 135 | Yes | |||
| 55 | Incorrect calculation of NZEWS | Delay in detecting possible derangements in vital signs and/or NZEWS | Time-consuming, difficult to calculate when staff working with huge cognitive load, interruptions | 135 | Yes | |
| 56 | Non-compliance with protocols | 135 | Yes | |||
| 57 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 135 | Yes | |||
| 58 | Incorrect NZEWS calculated for type and age of patient such as adult NZEWS calculated when patient required a paediatric or maternal early warning score | 72 | ||||
| 59 | Non-compliance with protocols | 72 | Yes | |||
| 60 | Non-documentation of NZEWS | Delay in detecting possible derangements in vital signs and/or NZEWS | Time-consuming, difficult to calculate when staff working with huge cognitive load, interruptions | 150 | Yes | |
| 61 | Non-compliance with protocols | 150 | Yes | |||
| 62 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 150 | Yes | |||
| 63 | 10. Escalation of care | Revised frequency of observations does not match the NZEWS protocol | Delay in detecting possible derangements in vital signs and/or NZEWS | Incorrect or less frequent measurements due to previous set of vital signs or NZEWS being miscalculated or staff not able to take measurement due to being busy, distracted or memory lapse | 120 | Yes |
| 64 | Non-compliance with protocols | 120 | Yes | |||
| 65 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 120 | Yes | |||
| 66 | Secondary responders are not informed about deterioration in a timely manner | Delay in detecting possible derangements in vital signs and/or NZEWS | Need to use phone or pager or task manager application, multiple devices and technology which creates inconsistency, causes delays in decision making | 90 | Yes | |
| 67 | Non-compliance with protocols | 90 | Yes | |||
| 68 | Staff allocated to the patient is traceable through clinical records data and can be held responsible for this omission | 90 | Yes | |||
| 69 | Secondary responders are not able to review patient in a timely manner | Delay in detecting possible derangements in vital signs and/or NZEWS | Limited secondary responder resource, busy responding to other patients elsewhere, not involved in a timely manner | 105 | Yes | |
| 70 | Non-compliance with protocols | 105 | Yes | |||
| 71 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 105 | Yes | |||
| 72 | 11. Modification of triggers | Non documentation of modifications | Delay in detecting or respond to possible derangements in vital signs or NZEWS because of the masking effect of modifications | Complacency, lack of safety net/defensive barriers and culture | 105 | Yes |
| 73 | Non-compliance with protocols | 105 | Yes | |||
| 74 | Staff making inappropriate modifications, leaving incomplete documentation of the modifications, or not authorising the modifications at appropriate level of seniority may be held accountable | 105 | Yes | |||
| 75 | Lack of sufficient space on NZEWS chart to document modifications every 24 hours | Delay in detecting or respond to possible derangements in vital signs or NZEWS because of the masking effect of modifications | Paper-based charts giving way documentation of modifications elsewhere in clinical records | 75 | Yes | |
| 76 | Non-compliance with protocols | 75 | Yes | |||
| 77 | Staff making inappropriate modifications, leaving incomplete documentation of the modifications, or not authorising the modifications at an appropriate level of seniority may be held accountable | 75 | Yes | |||
| 78 | Workarounds are common (modifications are validated for entire admission) | Delay in detecting or respond to possible derangements in vital signs or NZEWS because of the masking effect of modifications | Culture, lack of interdisciplinary dialogue, lack of space on paper-based charts to accommodate frequent modifications, lack of reinforcing functions | 60 | No | |
| 79 | Non-compliance with protocols | 60 | No | |||
| 80 | Staff making inappropriate modifications, leaving incomplete documentation of the modifications, or not authorising the modifications at an appropriate level of seniority may be held accountable | 60 | No | |||
| 81 | Handwritten modification may be illegible | Delay in detecting or respond to possible derangements in vital signs or NZEWS because of the masking effect of modifications | Paper-based charts | 60 | Yes | |
| 82 | Non-compliance with protocols | 60 | Yes | |||
| 83 | Staff making inappropriate modifications, leaving incomplete documentation of the modifications, or not authorising the modifications at an appropriate level of seniority may be held accountable | 60 | Yes | |||
| 84 | 12. Call to response time | Limited information shared by pager/phone | Delay in detecting possible derangements in vital signs and/or NZEWS | Technological limitation | 30 | Yes |
| 85 | Non-compliance with protocols | 30 | Yes | |||
| 86 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 30 | Yes | |||
| 87 | Responder cannot access vital signs and NZEWS chart remotely | Delay in detecting possible derangements in vital signs and/or NZEWS | Paper-based charts and technological limitation of the mode of communication used | 30 | Yes | |
| 88 | Non-compliance with protocols | 30 | Yes | |||
| 89 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 30 | Yes | |||
| 90 | Non-documentation of call to response time | Delay in detecting possible derangements in vital signs and/or NZEWS | Paper-based charts, documentation also paper based and is separated physically from NZEWS charts and likely to be missed in busy environment | 90 | Yes | |
| 91 | Non-compliance with protocols | 90 | Yes | |||
| 92 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 90 | Yes | |||
| 93 | 13. Secondary response | Limited information shared by pager/phone and rarely a phone advice only is appropriate | Delay in detecting possible derangements in vital signs and/or NZEWS | Paper-based charts and technological limitation of the mode of communication used | 30 | Yes |
| 94 | Non-compliance with protocols | 30 | Yes | |||
| 95 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 30 | Yes | |||
| 96 | Secondary responders do not communicate or initiate actions remotely | Delay in detecting possible derangements in vital signs and/or NZEWS | Paper-based charts, complex information, not suitable to be effectively communicated by phone call and pager system not capable of passing long messages | 60 | Yes | |
| 97 | Non-compliance with protocols | 60 | Yes | |||
| 98 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 60 | Yes | |||
| 99 | Non-documentation of the actions taken by secondary responder | Non-availability of the actions undertaken by one staff member to another, leading to delays in response and/or duplication of work | Paper-based charts, documentation also paper based and is separated physically from NZEWS charts and likely to be missed in busy environment | 45 | Yes | |
| 100 | Non-compliance with protocols | 45 | Yes | |||
| 101 | Staff who are paged, tasked, or sent a RRS activation call (777 call) are traceable and could be held accountable for delayed review or response | 45 | Yes |
Authors plan to calculate RPN for each failure mode post implementation of electronic RRS for comparison when/if this is possible.
Elimination or reduction of failures by demonstrated electronic system across process steps.
| Process steps | All failures | ||
|---|---|---|---|
| Eliminated | Not eliminate | Sub-total | |
| 1. Timing of vital signs | 0 | 3 | 3 |
| 2. Heart Rate | 6 | 1 | 7 |
| 3. Blood pressure | 6 | 1 | 7 |
| 4.Temperature | 0 | 7 | 7 |
| 5. Respiratory rate | 0 | 9 | 9 |
| 6. Oxygen saturation | 6 | 0 | 6 |
| 7. Oxygen requirement | 6 | 0 | 6 |
| 8. Level of consciousness | 0 | 6 | 6 |
| 9. NZEWS calculation | 11 | 0 | 11 |
| 10. Escalation of care | 9 | 0 | 9 |
| 11. Modification of calling criteria | 9 | 3 | 12 |
| 12. Accessing afferent inputs (by responders) | 9 | 0 | 9 |
| 13. Timeliness and documentation of rapid response | 9 | 0 | 9 |
| Total | 71 | 30 | 101 |