From the Operating Theater to the Pathology Laboratory: Failure Mode, Effects, and Criticality Analysis of the Biological Samples Transfer
<p>FMECA model: from identifying a high-risk process to redesigning it to reduce risk and ensure greater patient protection.</p> "> Figure 2
<p>FMECA model: qualitative and quantitative analysis.</p> "> Figure 3
<p>Pre-analytical phase.</p> "> Figure 4
<p>Identified risk priorities.</p> ">
Abstract
:1. Introduction
2. Materials and Methods
- A.
- Computer compilation and registration;
- B.
- Collection;
- C.
- Biological sample packaging;
- D.
- Biological sample sent to the PL;
- E.
- Biological sample transport;
- F.
- Biological sample delivery to the PL.
3. Results
3.1. Quantitative Process Analysis
3.2. Patient Safety Improvement Actions
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Phase | Activity | Responsibility | |
---|---|---|---|
A. Computer compilation and registration | A1 | Diagnostic examination request via HIS | CN |
A2 | Printing of labels with patient data | CN | |
A3 | Container labeling | CN | |
B. Collection | B1 | The biological sample is delivered from the surgeon to the IN | Surgeon; IN |
B2 | The biological sample is delivered from the IN to the CN | IN; CN | |
C. Biological sample packaging | C1 | The biological sample is collected in the primary pathology specimen jar | CN |
C2 | The biological sample is collected in the secondary pathology specimen jar | CN | |
D. Biological sample sent to the laboratory | D1 | The CN contacts the Hospital Internal Transporter Service notifying the collection of a biological sample for frozen section intra-operative consultation | CN |
D2 | The label identifying biological samples for frozen section intra-operative consultation is attached by the CN | CN | |
D3 | The biological sample is taken by the CN outside the operating room and stored in a room designated for this purpose | CN | |
E. Biological sample transport | E1 | The HIT picks up and transports the sample to the PL | HIT |
F. Biological sample delivery to the PL | F1 | The HIT hands over the biological sample to the FSHT | HIT |
Severity (S) | Occurrence (O) | Detection (D) | Score |
---|---|---|---|
No harm Mild harm Moderate harm | Very low (1:10,000) | Very high (9:10) | 1–2 |
Low (1:5000) | High (7:10) | 3–4 | |
Moderate (1:200) | Moderate (5:10) | 5–6 | |
Severe harm | High (1:100) | Low (2:10) | 7–8 |
Death | Very high (1:20) | Very low (<1:10) | 9–10 |
Activity | Failure Mode | Implications for Patient Safety | S | O | D | RPN |
---|---|---|---|---|---|---|
A1 | Incorrect diagnostic examination request via HIS | Request and report assigned to the wrong patient | 5 | 2 | 2 | 20 |
A2 | Printing of labels with wrong patient data | Request and report assigned to the wrong patient | 5 | 2 | 2 | 20 |
A3 | Label placed on the lid and not on the container jar | Failure to match biological sample to patient | 10 | 1 | 2 | 20 |
B1 | No risk of failure | Not applicable | 0 | 0 | 0 | 0 |
B2 | No risk of failure | Not applicable | 0 | 0 | 0 | 0 |
C1 | Primary pathology specimen jar broken and/or damaged and/or not adequate | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 1 | 1 | 10 |
C2 | Secondary pathology specimen jar broken and/or damaged and/or not adequate | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 1 | 1 | 10 |
D1 | Failure to provide patient identification data. HIT withdraws a different sample from the one requested | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 3 | 1 | 30 |
D2 | The label is not applied | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 3 | 2 | 60 |
D3 | The biological sample is taken to the secondary access. HIT does not take the sample | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 3 | 2 | 60 |
E1 | HIT takes the biological sample to the medical laboratory instead of PL due to lack of label | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 3 | 2 | 60 |
F1 | FSHT temporally abs | Delay in transport and response, resulting in longer time for anesthesia and surgery | 10 | 4 | 2 | 80 |
Actions | Improvement Actions | Monitoring Actions |
---|---|---|
F1 | At the PL entrance, a dedicated frozen section information sign was placed with the name and telephone number of the FSHT on duty for each day of the month. All HITs were informed of the other rooms in the laboratory where they could find the FSHT if they were not present in the laboratory dedicated to the frozen sections. | Periodic check of the correct filling-in of the adopted forms and involvement of the FSHTs and HITs. |
D2 | Periodic re-training for operating room nurses and HITs (1–2 times/year) regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the correct filling-in of the adopted forms. |
D3 | Periodic re-training for operating room nurses and HITs (1–2 times/year) regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the proper application of the procedure. Periodic check of the secondary access for pathology specimen jars. |
E1 | Periodic re-training for FSHTs and HITs (1–2 times/year) regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the correct filling-in of the adopted forms. |
D1 | Introduction of a register on which for each patient it is mandated: (a) to affix the patient identification label; (b) to write down the number of samples, the time the sample(s) was deposited, and to affix the signature of the CN who deposited the sample(s) at the designated place; (c) to write down the number of samples, the time the sample(s) was collected, and to affix the signature of the HIT who collected the sample(s) at the designated place. | Periodic check of the correct filling-in of the adopted forms. |
A1 | Periodic re-training regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the correct filling-in of the adopted forms. |
A2 | Periodic re-training regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the correct filling-in of the adopted forms. |
A3 | Periodic re-training regarding the procedure for the traceability, collection, transport, and storage of histopathological samples. | Periodic check of the correct filling-in of the adopted forms. |
C1 | Double nursing check before sending samples to the PL. | Periodically checking the ratio of the primary or secondary pathology specimen jar not adequate/broken/damaged to the number of primary or secondary pathology specimen jars used. |
C2 | Double nursing check before sending samples to the PL. | Periodically checking the ratio of the primary or secondary pathology specimen jar not adequate/broken/damaged to the number of primary or secondary pathology specimen jars used. |
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De Micco, F.; De Benedictis, A.; Scendoni, R.; Tambone, V.; Di Palma, G.; Alloni, R. From the Operating Theater to the Pathology Laboratory: Failure Mode, Effects, and Criticality Analysis of the Biological Samples Transfer. Healthcare 2024, 12, 2279. https://doi.org/10.3390/healthcare12222279
De Micco F, De Benedictis A, Scendoni R, Tambone V, Di Palma G, Alloni R. From the Operating Theater to the Pathology Laboratory: Failure Mode, Effects, and Criticality Analysis of the Biological Samples Transfer. Healthcare. 2024; 12(22):2279. https://doi.org/10.3390/healthcare12222279
Chicago/Turabian StyleDe Micco, Francesco, Anna De Benedictis, Roberto Scendoni, Vittoradolfo Tambone, Gianmarco Di Palma, and Rossana Alloni. 2024. "From the Operating Theater to the Pathology Laboratory: Failure Mode, Effects, and Criticality Analysis of the Biological Samples Transfer" Healthcare 12, no. 22: 2279. https://doi.org/10.3390/healthcare12222279