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Study Protocol

Assess The Workload Management Model and Enhanced Quality Control in The Central Sterile Supply Department:  A Study Protocol.

[version 1; peer review: 2 approved with reservations]
PUBLISHED 03 May 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Introduction

The Central Sterile Supply Department (CSSD) plays a crucial role in ensuring the safety and efficacy of medical instruments and equipment used in healthcare settings. Effective workload management and quality control are essential for maintaining high standards of patient care and minimizing the risk of healthcare-associated infections. This study protocol aims to assess the implementation and impact of a new workload management model and enhanced quality control measures in a CSSD setting.

Methods

The study will employ a mixed-methods approach, including quantitative analysis of workload data, qualitative interviews with CSSD staff, and observational assessments of workflow and quality control procedures. The workload management model under investigation involves the allocation of resources based on demand patterns and the implementation of scheduling algorithms to optimize staff efficiency. Enhanced quality control measures include the implementation of advanced sterilization technologies, rigorous inspection protocols, and continuous staff training initiatives.

Results

The study expects to provide insights into the effectiveness of the workload management model in optimizing resource allocation and improving staff productivity. Additionally, it aims to evaluate the impact of enhanced quality control measures on the reliability and safety of instrument sterilization processes. Findings from this study will inform recommendations for further improvements in CSSD operations and contribute to the advancement of best practices in sterile supply management.

Conclusion

The successful implementation of an effective workload management model and enhanced quality control measures in the CSSD is crucial for maintaining patient safety and ensuring the efficient functioning of healthcare facilities. By systematically evaluating the implementation and impact of these interventions, this study protocol seeks to contribute to the ongoing improvement of CSSD operations and the enhancement of healthcare quality.

Keywords

Central Sterile Supply Department, workload management, quality control, healthcare-associated infections, sterilization, mixed-methods study.

Introduction

The central sterile supply department (CSSD) is maintaining a sterile and safe environment for patient care. CSSD ensuring that all the medical equipment is properly cleaned, sterilized, and ready for use in medical procedure and help to control the infection. Inadequate management of CSSD to show the hospital acquired infection and economic harm. Numerous operating devices are complicated to clean because of different type structure in devices. Mismanagement and technology may affect the improper cleaning and reduce the hospital acquired infections. It adopts a continual improvement process to accomplish the target. By the way of cycle are plan do, check, action (PDCA).1

The traditional concept of Central Sterile Supply Department (CSSD) often involves a decentralized approach to managing the disinfection and cleaning of medical devices. This decentralized model may not provide comprehensive and systematic coverage, leading to potential gaps or oversights in the process, which can compromise patient safety. Moreover, decentralized management can be prone to inefficiencies and inconsistencies across different departments or units within a healthcare facility. In recent years, there has been a shift towards adopting a centralized management model for medical devices within CSSD. This shift represents an advancement in the approach to device management, aiming to address the limitations of the traditional decentralized method. Centralized management allows for greater standardization, control, and efficiency in the sterilization and cleaning processes.2

Ensuring the quality control of the sterilization process within the Central Sterile Supply Department (CSSD) is indeed crucial for maintaining the reliability of sterile supplies and, ultimately, ensuring patient safety. As medical technology advances and devices become more complex and specialized, the challenges faced by CSSDs in handling and sterilizing these devices increase significantly. Mishandling or inadequate sterilization of advanced medical devices can lead to compromised patient care and safety. One of the key challenges in CSSD management is adapting to the diverse needs of sub-specialty clinics within the healthcare facility. As the practice of medicine becomes increasingly specialized, each specialty clinic may have unique requirements and preferences regarding medical device sterilization and handling. A one-size-fits-all approach may not be sufficient to meet the specific needs and standards of each specialty. Establishing a management model for the CSSD that considers the needs of sub-specialty clinics can help address these challenges more effectively. Supply Department (CSSD) is indeed crucial for maintaining the reliability of supplies and, ultimately, ensuring patient safety. As medical technology advances and devices become more complex and specialized, the challenges faced by CSSDs in handling and sterilizing these devices increase significantly. Mishandling or inadequate sterilization of advanced medical devices can lead to compromised patient care and safety.3

The quality of work life for nursing staff in the Central Sterile Processing Department (CSPD) is influenced by various factors, and managing human resources and materials effectively is paramount to optimizing results and meeting institutional demands. Here are some key challenges faced by nursing staff in CSPD: Human Resource Management: Ensuring adequate staffing levels, managing schedules, and addressing staffing shortages or turnover are common challenges. Material Management: Proper inventory management, procurement of supplies, and equipment maintenance are critical for ensuring the smooth functioning of CSPD. Workload and Time Management: Balancing workload demands with available resources is essential for preventing burnout and maintaining staff morale. Compliance and Quality Assurance, Compliance and Quality Assurance, Professional Development and Recognition, Psychological and Physical Well-being, addressing these challenges requires a holistic approach to human resource management, material logistics, and organizational culture within CSPD. By prioritizing staff engagement, professional development, and well-being, healthcare institutions can create a conducive work environment that promotes employee satisfaction, productivity, and ultimately, the delivery of high-quality patient care.4

Recordkeeping is indeed a critical aspect of operations within a Central Sterile Supply Department (CSSD). The meticulous documentation of sterilization processes and related activities serves several essential purposes, including: patient safety, Regulatory compliance and Audits, legal documentation, traceability and accountability, quality improvement resources managements. Effectiveness, safety, and regulatory compliance of sterilization processes within CSSDs. By maintaining accurate and comprehensive documentation, CSSDs can uphold high standards of patient care, minimize risks, and demonstrate accountability in their operations. Overall, robust recordkeeping practices are indispensable for ensuring the effectiveness, safety, and regulatory compliance of sterilization processes within CSSDs. By maintaining accurate and comprehensive documentation, CSSDs can uphold high standards of patient care, minimize risks, and demonstrate accountability in their operations.5

The Central Sterile Supply Department (CSSD) plays a crucial role in ensuring patient safety and the success of surgical procedures by providing properly processed and sterilized instruments and equipment. Despite its importance, CSSD has historically been undervalued and stigmatized within the hospital setting. This lack of recognition can be attributed to various factors, including historical precedents, organizational structures, and perceptions of its role within the healthcare system. Initially, the tasks of instrument preparation and sterilization were often relegated to personnel working in the operating room, with little autonomy or recognition as a distinct department. As a result, CSSD was not viewed as a vital component of patient care, and its significance was often overlooked. However, as healthcare standards evolved and the importance of infection control became increasingly recognized, the role of CSSD in ensuring patient safety became more apparent. Despite this recognition, CSSD still faces challenges in gaining full recognition and appreciation for its essential role within the hospital. Stigmatization may persist due to misconceptions about the nature of CSSD work or a lack of understanding of its critical contributions to patient care. By promoting a culture of appreciation and respect for CSSD and its contributions to patient safety, hospitals can enhance the quality of surgical care and uphold their commitment to patient-centred excellence.6

With the increasing use of sophisticated medical equipment in healthcare settings, ensuring comprehensive cleaning and disinfection of instruments has become increasingly challenging. Recent outbreaks or incidents associated with inadequate reprocessing of endoscopes have highlighted the urgent need to maintain stringent standards in sterilization or reprocessing departments.7

Aim: Assess The Workload Management Model and Enhanced Quality Control in The Central Sterile Supply Department.

Objective

  • 1). To observe the workload management structure in the central sterile supply department

  • 2). To study the enhanced quality control in the central sterile supply department

Protocol

At Acharya Vinoba Bhave Rural Hospital, the central sterile supply department shall carry out the study and the department will be used to directly gather the data. This study aimed to understand the challenges faced by end users of processed CSSD content as well as their understanding of CSSD workflow.

Methods

Management structure

Control approach

The CSSD had three working zones for control treatment (routine management): unsterile, clean, and sterile. Each zone was assigned a team leader who assisted the CSSD in completing all of the zone’s work. The CSSD’s working professionals were assigned to different work zones at random.

Observation approach

observation approach (i.e., workload management structure) To enhance quality control, the staff in the Central Sterile Supply Department (CSSD) were categorized into various groups according to their professional title, years of experience in the CSSD, skill level, highest level of education attained, and individual areas of interest.

Study design: this study is an observational study comparing management structure in our hospital daily work (quality control) will be applied in our hospitals and this will be set as a control approach.

The observational management structure will be applied based on the workload management structure that will be enhanced.

Study setting: The study will be conducted in a tertiary care hospital, sawangi meghe, Wardha.

Participants: Healthcare personnel will be randomly selected from the following department: Gynaecology, orthopaedics, surgery, and paediatric.

Data sources/measurement: google scholar, Scopus, PubMed.

Bias: The overall workload damage in medical instrument during the observation and control periods. After implementing the workload management model, the CSSD staff’s theoretical and practical knowledge improved.

Study size: In this study, we shall use random sampling of more than 88 participants.

Statistical methods

α=0.05,β=0.2,μ1=32.8,μ2=30.2,б1=4.5,б2=4.2

Group 1=44, Group2=44

Sample size:88

Z=1.96б

n1=n2=(Zα+Zβ)2σ2(δ)2
Zα=1.96at5%errorr&CIat95%
Zβ=0.84=Powerat80%

Primary data:14 staff in the central sterile supply department, by observation and question base survey.

Secondary data: a survey on a question base for other departments that include (Gynaecology, orthopaedics, surgery, and paediatric).

Inclusion criteria: Technicians and In-charge, ANM, GNM Inclusion criteria: This study will encompass ANMs (Auxiliary Nurse Midwives), GNMs (General Nursing Midwives), Technicians, and In-charges who are currently on duty at their Central Sterile Supply Department. Additionally, the survey will be conducted among randomly selected personnel from other departments, including Gynaecology, Orthopaedics, Surgery, and Paediatrics, based on a set of predefined questions.

Exclusion criteria: Doctor and attendant from the department will be excluded.

Dissemination: This protocol is intended for publication in an indexed journal.

Study status: Not yet started

Discussion

Observational study to observe the workload and quality indicators in the central sterile supply department. The study compared the concentration of bioaerosols in two different Central Sterile Supply Departments (CSSDs) – one without negative pressure and the other with negative pressure. In the Central Sterile Supply Department (CSSD), bioaerosol concentrations were measured at 273.15 and 206.71 CFU/m3 in areas without negative pressure, while those with negative pressure exhibited lower concentrations at 116.96 CFU/m3 and 131.10 CFU/m3. The number of isolated colonies was significantly lower in the CSSD with negative pressure (P = .01541). These results indicate that the implementation of a negative pressure system in the CSSD cleaning area led to a notable reduction in bioaerosol levels. However, it is important to note that the concentrations of bioaerosols in both CSSDs remained below the established guidelines for indoor air quality in many countries. Therefore, it cannot be definitively concluded that CSSDs lacking a negative pressure system in their cleaning area pose an occupational risk.8

The satisfaction level of respondents with CSSD services saw a substantial rise from 54% in 2012 to 89% in 2019, a statistically significant improvement (95% CI: 0.56 to 0.25) with a p-value of 0.001. This indicates a notable enhancement in service quality over the years. this endeavor contributed to the formation of a cohesive team and fostered an environment of transparency within the CSSD. Improvement strategies were informed by data analysis, encouraging other departments such as Radiology and Laundry to adopt similar approaches to understand and meet user expectations. The study underscores the efficacy of internal user satisfaction surveys as a valuable mechanism for continual quality enhancement. It unequivocally demonstrates that consistent monitoring leads to an improvement in service quality.9,10

A total of 101 adverse incidents were documented, with the primary reason identified as insufficient cleaning quality (34, 33.66%), followed by mistakes in instrument assembly (25, 24.75%), and issues related to marking (7, 6.93%). Variables such as the role of the accountable individual, educational attainment, years of experience, structural aspects of the device, quantity of instruments in the set, and set dimensions were discovered to potentially impact the occurrence of adverse incidents (P < 0.05). Additionally, integrating a standardized grading system in accordance with the Central Sterile Supply Department's protocols can ensure effective handling of adverse incidents and uphold consistency in service quality.10

Workload management plays a vital role in maintaining optimal performance levels and preventing burnout among CSSD staff. By implementing a structured workload management model, the CSSD can better allocate resources, streamline processes, and prioritize tasks based on their importance and urgency. This can lead to improved workflow efficiency, reduced turnaround times, and enhanced overall productivity.11

Furthermore, effective quality control measures are essential for ensuring the safety and sterility of medical equipment and supplies processed within the CSSD. By integrating enhanced quality control protocols, such as regular audits, standardized operating procedures, and staff training programs, the CSSD can minimize the risk of contamination, infection, and equipment failure. This ultimately contributes to the delivery of high-quality patient care and promotes patient safety.12

Ethical considerations

The ethical approvalwas obtained from the Institutional Ethics Committee (IEC), Datta Meghe Institute of Higher Education and Research (DHIIMER) Wardha.

Approval number: DMIHER (DU)/IEC/2023/1176, dated 01/07/2023

Consent to participate written informed consent will be taken from study participants for participation in study and publication for data.

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Supare PP and Kanyal D. Assess The Workload Management Model and Enhanced Quality Control in The Central Sterile Supply Department:  A Study Protocol. [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:444 (https://doi.org/10.12688/f1000research.148937.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 14 Jun 2024
Dr. Munaza Bibi, Bahria University, Karachi, Sindh, Pakistan 
Approved with Reservations
VIEWS 0
Dear Author,
I appreciate your efforts but a few changes are required for improvement.
Abstract
Mention the study's purpose by emphasizing its importance in the healthcare context. Moreover, the method needs to be mentioned clearly along with ... Continue reading
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Bibi DM. Reviewer Report For: Assess The Workload Management Model and Enhanced Quality Control in The Central Sterile Supply Department:  A Study Protocol. [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:444 (https://doi.org/10.5256/f1000research.163325.r280612)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 11 Jun 2024
Withaya Chanchai, Siam University, Bangkok, Bangkok, Thailand 
Approved with Reservations
VIEWS 7
Dear author,
I found your article to have several inconsistencies and incoherence divided into
Abstract:
  1. Clarify the Objective: State the main objective of the study clearly and succinctly.
  2. Highlight the Importance: Emphasize
... Continue reading
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HOW TO CITE THIS REPORT
Chanchai W. Reviewer Report For: Assess The Workload Management Model and Enhanced Quality Control in The Central Sterile Supply Department:  A Study Protocol. [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:444 (https://doi.org/10.5256/f1000research.163325.r276048)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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VERSION 1 PUBLISHED 03 May 2024
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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