Failure Modes and Effects Analysis (FMEA) Tool
Breast Cancer Specimen Collection & Handling Study
UCSF RN to MSN Clinical Nurse Leader
Walnut Creek, California, United States
Hospital-Community
Aim:
Analyze breast cancer definitive surgery specimen collection and handling process and determine if each step is in compliance with ASCO/CAP Guidelines. Each step and/or criteria will be 90% in compliance with ASCO/CAP Guidelines within six month of FMEA date.
Process Data
Date: 04/06/2015
Step
Description
1
Document time breast cancer specimen is removed from the body
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Time the breast cancer specimen was removed from the body is not documented.
Distraction; Oversight; Confusion as to who is responsible for documentation
Inability to calculate the exact cold ischemic time of specimen
2
2
5
20
Checklist for Specimen Collection & Handling
Update Policy & Procedure
Define who will document time specimen was removed from the body
OR staff inservice
Step
Description
2
Document time breast cancer specimen is placed in formalin. (Not to exceed 1 hour from excision)
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Time breast cancer specimen is placed in formalin is not documented.
Competing duties & other responsibilities, no designated responsible person, lack of knowledge of importance of cold ischemic time of specimens
Specimen is at risk for degradation, which has the potential to effect the quality of test results. Missing documentation of time specimen is placed in formalin causes inability to calculate accurate cold ischemic time.
2
2
6
24
Create specimen collection & handling checklist; update Policy & Procedure; designate responsible person for documentation; surgical staff inservice
Step
Description
3
Cold ischemic time is 60 minutes or under
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Cold ischemic time is over 60 minutes
distraction, oversight, other duties & responsibilities, not assigned to one person, lack of education on effects of degradation on specimen and potential to affect quality of test results
Degradation of specimen can effect the quality of the test results; would not be consistent with CAP Guidelines.
2
2
6
24
Checklist for breast cancer specimens; update policy & procedure, assign responsibility, inservice for OR staff.
Step
Description
4
Document time breast cancer specimen is sent to Pathology
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Time that breast cancer specimen is sent to pathology is not documented
Oversight, distraction, not assigned
Potential for delay in specimen getting to Pathology. Chain of custody of specimen is not accurate.
8
8
1
64
Determine if this is a necessary step for documentation. Responsible person for placing specimen in formalin to also record when specimen sent to Pathology
Step
Description
5
Document time breast cancer specimen arrives in Pathology
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Time that breast cancer specimen arrives at Pathology is not documented
Universal time of 00:00 on date of surgery is used for specimen arrival. Gaps in system to record all arrival times of surgical specimens.
Chain of custody of specimen is not adequately documented. Determine if this is a necessary step in process
6
8
2
96
Determine if this is a necessary step or whether it can be eliminated.
Step
Description
6
Date & Time of Pathology Diagnosis
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Date & Time of Pathology Diagnosis is not recorded. Would not be consistent with CAP Guidelines
Extremely unlikely to happen
Inability to calculate warm ischemic time, or total time specimen remained in formalin
1
9
6
54
Step
Description
7
Date & times necessary to calculate warm ischemic time have been documented.
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Date & times necessary to calculate warm ischemic time have not been documented.
Distraction, oversight, not assigned, lack of knowledge regarding importance of warm ischemic time effect on specimens & test results.
Inability to accurately calculate the warm ischemic time; possible inaccurate ER/PR/Her-2/neu results if under or over time in formalin. Would not be in compliance with CAP Guidelines,
4
6
6
144
Checklist to accompany specimen, update in policy & procedure, inservice
Step
Description
8
Warm ischemic time is within range of 6-72 hours
Failure Mode
Causes
Effects
Occ
Det
Sev
RPN
Actions
Warm ischemic time is under 6 hours or over 72 hours
Friday/weekend surgeries at risk, backlog of specimens in pathology.
Under or over exposure has the capability to effect the accuracy of ER/PR & Her-2/neu test results
1
2
6
12
If the warm ischemic time is less than 6 hours or over 72 hours, case studies will occur to determine cause
Calculated Totals
Total Risk Priority Number for the process
438
Occ:
Likelihood of Occurrence (1-10)
Det:
Likelihood of Detection (1-10)
NOTE:
1
= Very likely it WILL be detected
10
= Very likely it WILL NOT be detected
Sev:
Severity (1-10)
RPN:
Risk Priority Number (Occ × Det × Sev)
Annotation
None
