Improving the safety patient and quality of care of the totally implantable venous access device process in oncology: An experience in a developing country tertiary university hospital





Abstract


Background


The totally implantable venous access device, named also the implantable chamber, is one of the most medical devices used in the oncological therapies. However, the process of implementing such devices provide several failure modes which decrease the quality of care and the enhance the risk of patient complications. For this reason, it is essential to develop an effective risk management plan enable to detect and reduce different associated risks in order to improve the quality and the safety processes in the totally implantable venous access device implementation activity.


Methods


The process of identification and assessment of risks is ensured using an adapted Failure Modes and Effects Analysis (FMEA) to the context of developing countries (application field is a Moroccan oncology university centre). Finally, the prioritization of corrective actions is calculated based on a proposed parameter (named the Priority Level) which takes into consideration developing countries constraints.


Results


The study of the totally implantable venous access device process leads to identify a large number of potential failures (n=72) which are divided in 3 classes (19 % intolerable, 51 % to be monitored; and 29 % of intolerable). Moreover, the adapted approach of FMEA proves high optimization of the project in terms of time and resources. An action program mapping is developed in order based on the Rik Priority Number and the Priority Level.


Conclusion


The implantable chamber poses a major challenge to any practitioner in oncology. This study constitutes the first experience in risk management of implantable chambers under developing countries constraints while highlighting all the failures to be prevented during their handling.


1


Introduction


1.1


Background


Every healthcare department, regardless of its discipline, is required to address a large number of challenges at well-distinguished levels. In fact, failures and risks affect both medicines and medical devices alike. The totally implantable venous access device (TIVAD), also known as an implantable chamber, is one of the most critical processes facing several failure modes and unwanted events in chemotherapy treatment.


The TIVAD, is a medical device that is implanted under the skin and remains in place for a prolonged period. The crucial important role that plays the TIVAD in the chemotherapy treatment against the potential risks that may occur throughout ensuring steps of the TIVAD from instauration and education processes to the ablation for patients destined to receive a chemotherapy treatment requires to plan a quality and safety improvement system especially in the context of a healthcare organization which belongs to a developing country. However, according to a recent study the healthcare systems in developing countries are facing several challenges in term of human resources, financial issues, and leadership. For this reason, circumstances and constraints related to a cancer hospital in a developing country such as Morocco necessitates to develop an innovative approach of risk management enable to be adaptable to the studied context.


The World Health Organization (WHO) defines the risk management in the healthcare sector as the process of identifying, prioritizing and responding to risks across an organization, with the aim of identification and prioritization of risks toward a department or a hospital with enhancing opportunities and mitigating threats. Otherwise, risk management is a system that ensures a continuous improvement of the quality of care and performance of the processes through the proactive approach. One of the most commonly used tools for managing risks in healthcare departments and improving the quality of the system is Failure Modes and Effects Analysis (FMEA). The widespread adoption of the FMEA method is due to its effectiveness and its suitability for the healthcare context.


1.2


Literature review and research question


The related literature shows that the FMEA method is well known in the field of oncological treatment. In fact, many studies have been published which aiming to manage risks using the FMEA method in oncological departments and processes such as the radiation oncology (radiotherapy) department, the chemotherapy department, , the medication process in oncology, cancer surgery, oral oncology, etc.


According to the reviewed literature, researchers usually adopt the classical FMEA, which does not take into consideration the limitations, constraints and specific circumstances of the specificities of the context, especially when these studies are performed in developing countries. For this reason, several attempts to apply FMEA have failed or have not demonstrated significant effectiveness. Moreover, the literature review shows that no published study has focused on applying FMEA in the process of the TIVAD manipulation for the chemotherapy treatment.


1.3


The selected application field of the study


The day hospital is selected as the application department. It represents an oncological medical service that is concerned with the administration of different chemotherapy molecules, according to the number of sessions required for each patient. For this reason, the present study chooses the day hospital as the study location knowing that most patients undergo their treatment through this central route (TIVAD).


1.4


The aim of the study and the structure of the article


The aim of the present study is to develop an adapted FMEA model that can be effectively implemented to manage risks and improve the quality of care for the process of the TIVAD in patients treated with chemotherapy in the day hospital department. To achieve this objective, this article is organized as follows: next Section presents the materials adopted to develop this model by presenting the context (setting and participants) of the study, the principle method used of this study which the FMEA. Then, this study presents the new proposed model of FMEA which was modified to be suitable for the context of the study. after that, a presentation of results in the TIVAD process for chemotherapy in a Moroccan cancer public hospital. and finally, the study highlights discussion of results and provides some conclusions.


2


Materials


This study adheres to the Standards for Quality Improvement Reporting Excellence (SQUIRE) 2.0 guidelines in the Methods section for reporting quality improvement interventions. According to these guidelines, the Methods section highlights six key elements: the context (setting), the intervention (participants and FMEA procedure), the study of the intervention, the measures, and the analysis (adapted model designed). The ethical aspect is not applicable to our study as it does not involve human subjects or sensitive data.


2.1


Setting


The National Institute of Oncology (NIO), Rabat, Morocco, is mainly specialized in the treatment of oncological diseases. It contains six clinical departments, including three oncological units: the day hospital, a surgery department, a radiotherapy department and intensive care department. The NIO is a national and international centre of the cancer diseases treatment.


The Day Hospital (DH) department, located within the NIO is situated near the main doors just after the initial reception of patients. It specializes in pre-chemotherapy consultations, the programming of chemotherapy sessions, consultations for pain management and adaptation of treatment with analgesics.


The DH most often receives patients with a TIVAD and requiring the administration of anti-cancer treatments, blood product transfusions, treatments for inflammatory cancerous pathologies or requiring adequate pain management. the handling of the implantable chamber is organized by a protocol established in 2019 in consultation with the surgical team detailing all the instructions to follow when inserting the needle or removing it in complete safety for the patient ( Fig. 1 ).




Fig. 1


Process of handling and maintenance of TIVAD in the DH.


2.2


Participants


The FMEA team is with expertise, punctuality and total commitment in order to provide good quality services to patients. It consists of five expert members in the identification within the framework of the FMEA model: the quality and safety specialist, the head nurse (DH), the coordinator of nursing service, the responsible for pharmacovigilance and the nurse responsible for TIVAD management (surgical department).


After having discussed the concept of the FMEA tool for all the members of the team. The latter established a work plan organized by periodic meetings and which is based on the model of FMEA process identification, failure mode identification, towards the calculation of the RPN (multiplication of risk factors O, S, D). Experts are based in the assignment of the O, D and S values on criteria defined in the Table 1 .



Table 1

Significations of O, D and S point-scales.




































Point scales Significations
Occurrence Non-Detection Severity
1 Rare Very easily detectable Insignificant Consequences
2 <Once/6months Easily detectable Perturbation of Activity
3 <Once/3months Moderately detectable Decrease of Customer Satisfaction
4 <Once/1months Hardly detectable Dangerous Harm
5 <Once/week=frequent Not detectable Patient/Professional Safety


2.3


FMEA procedure


FMEA is named also Failure Mode, Effect and Criticality Analysis (FMECA) is one of the formal design methodologies that has been developed by the US army. The adoption of the FMEA method in the healthcare sector was in the 1990s.


The FMEA is a proactive method used to manage risks in organizations by ensuring the identification, the analysis (roots and consequences determination), the assessment and the mitigation of risks and potential failure modes. , In the risk assessment step, the FMEA uses the Risk Priority Number (RPN) value to evaluate and classify each failure mode. The RPN value is calculated by multiplying three risk factors, namely severity(S), occurrence(O) and non-detection(D) for each of the failure modes. Thus, the FMEA is generally implemented by performing the following phases , , :




  • Phase 1: determination of the studied process.



  • Phase 2: grouping the work team and definition of criteria.



  • Phase 3: identification of failure modes (risks).



  • Phase 4: analysis of risks by determining causes and consequences.



  • Phase 5: calculation of the RPN values based on the equation <SPAN role=presentation tabIndex=0 id=MathJax-Element-1-Frame class=MathJax style="POSITION: relative" data-mathml='RPN=O×D×S’>RPN=š‘‚Ć—š·Ć—š‘†RPN=OƗDƗS
    RPN = O Ɨ D Ɨ S
    .



  • Phase 6: categorization of the risks with using the tolerance classes about each risk.



  • Phase 7: establishment of the corrective actions plan associated to the intolerable risks.



The Fig. 2 illustrates details of steps related to the flowchart of conventional approach of the FMEA method.


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May 22, 2025 | Posted by in ANESTHESIA | Comments Off on Improving the safety patient and quality of care of the totally implantable venous access device process in oncology: An experience in a developing country tertiary university hospital

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