Process Evaluation of Decontamination, Cleaning and Sterilization of medical instruments at public health centers of Mekelle zone, Tigray, Ethiopia, 2018

Background: Today Health Care Associated Infections are the major public health problems in majority of developing world including Ethiopia. The use of disposable equipment is the best way to ensure patient comfort and security, however, low income country health system could not acquire disposable format for certain devices due to the cost. Then some instruments need to be sterilized for re-use. In this study we have evaluated the sterilization status of medical instruments. Method: Descriptive study design was employed in this evaluation study. The evaluation was conducted in 147 health care workers and nine public health centers of Mekelle zone from January to June, 2017. Systematic random sampling method was conducted to select study participants. In the quantitative part, observation of health care workers’ practice and availability of materials were conducted using checklists. As a complement, key informant interviews were also conducted. Collected quantitative data were checked, coded and entered into SPSS version 20 for analysis. Frequencies Mean, percentage, tables were used for results presentation. Result: Availability, compliance and safety of health care workers ’ dimensions were used to evaluate the implementation of the intervention. Accordingly, availability of resources in the studied health centers has been rated as good (74.2%) . And compliance level of health care workers has found to be fair (66.1%). However, practice of safety by the health care workers has found to be poor (48%). Conclusion: According the judgment criteria, the overall implementation status of decontamination, cleaning and sterilization service has been rated as fair (63.4%).


Introduction
Health care associated infections (HCAI) are a major public health concern throughout the world, contributing to increased morbidity, mortality, and cost (1). It is a major safety issue affecting the quality of care of hundreds of millions of patients every year in both developed and developing countries (2). According to the World Health Organization (WHO) review, health facility-wide prevalence of health care-associated infections varies from 5.7% to 19.1%, with a pooled prevalence of 10.1% in low-income countries (3). Recent studies suggest that the burden of HCAIs may be disproportionally high in resource-limited settings with rates of HCAIs estimated to be 2-20 times that of developed countries (4), (5).
In developing countries, the problem is three times higher when compared to the incidence observed in patient care units in the United States America (6). Today infection in healthcare facilities is a major public health problem in majority of developing world including Ethiopia.
In Ethiopia HCAIs are major problems that need attention and action to improve the health institution infection prevention practices. Hence, in Ethiopia in general the problem of HCAIs related to poor infection prevention including improper decontamination, cleaning and sterilization of medical equipment are common in health care facilities (7).
Preventing HCAI is then a major objective for health facilities that aimed at providing safe health care to patients. The use of disposable equipment is the best way to ensure patient comfort and security. However, low income country health system could not acquire disposable format for certain devices due to the cost. Then some instruments need to be sterilized for re-use (8). Proper decontamination, cleaning and sterilization of medical equipment and other items that have contact with patient's body or their body fluid is the main and critical method in preventing and reducing the transmission of HCAIs and their impacts in health facilities during medical procedures and patient care (9).
The purpose of this evaluation was to provide clear and scientific information about the implementation status of the one and main part of infection prevention called decontamination, cleaning and sterilization of medical equipment in Mekelle zone health centers to stakeholders and then the findings will be used as a base line data for further studies. The objective of this evaluation research was to assess the implementation status of decontaminating, cleaning and sterilizing process of medical instruments in Mekelle zone health centers, Tigray-Ethiopia, 2017.

Methods and Materials
This evaluation study was conducted in nine health centers and 147 health care workers using descriptive study design with mixed method approach in Mekelle zone from January to May, 2017.Proportional allocation was done to each health center and profession according to the number of health care workers they have. Then using simple random sampling HCWs were selected from each health center and profession. English version observational check lists was used to check the practices' of HCWs following the standard. In the quantitative part, observation of health care workers' practice and availability of materials were conducted using checklists. Data was entered and cleaned using EPI Info and analysis was done using SPSS version 20.As a complement, key informant interviews were also conducted.
Frequencies, Mean, percentage and tables were used for quantitative results presentation and qualitative data were coded, categorized and finally conceptualized.
Evaluation proposal was first approved by Mekelle University College of health science, School of Public health Ethical review committee. Following this written permission was given to Tigray regional health bureau and the bureau also given written permission for each health centers. In addition to this informed consent was obtained from the health centers and HCWs prior to observing the practices and availability of materials. Their participation was voluntarily and they can be free to decline or withdraw at any time in the course of the study, so only those willing to participate were included in the study. Confidentiality was kept by making the checklists anonymous and no personal identifiers were used.

Socio-demographic characteristics of participants
This evaluation research was conducted in 9 public health centers of Mekelle zone. All those health centers were financed by Tigray health bureau proportionally. A total of 147 HCWs were observed their practices during decontamination, cleaning and sterilization of medical instruments and their safety during the process. From the total participants, majority (72.8%) were females. The age of participants ranged from 23-57 years with mean of 39 (+7).Regarding their profession, 76.9% participants were nurses and the rest 23.1% were midwives and laboratory personnel. Regarding their service year, 71.3% HCWs had served for more than 10 years in their respective profession.

3.1.1Availability of resources
All health centers were assessed for the availability of basic supplies and equipment needed for decontamination, cleaning and sterilization process and safety of HCWs during the process. Based on this, all (9) health centers had functional autoclaves, bleach, detergent, brush, face masks, protective garment (apron), sterilization unit and gloves. Only 3 health centers had both national IP guideline and trained man power. Seven HCs had both eye wear/goggle and protective shoes. However, all (9) HCs had no indicators and procedure flow charts posted on the wall of the working area during the data collection period.
Generally, the overall availability of resources was 74.2 %.

Compliance of the health care workers with the national guideline
Observation was conducted for147 HCWs for their practices in decontamination, cleaning and sterilization process of medical instruments in comparison with the national guideline. Among the total participants, 79 (53.7%) HCWs processed soiled and clean instruments in the same work area and 68 (46.3%) HCWs processed in the same room, but separate areas.
All (100%) HCWs decontaminated soiled instruments before cleaning using chlorine solution. Almost all 137 (93.2%) HCWs prepared chlorine solution for by diluting 1 part of chlorine 5% with 9 parts of water. Only 23 (15.6%) HCWs immersed soiled instruments in chlorine solution for 10 minutes, the rest 124 (84.4%) had immersed either for less than 10 minutes or more than 10 minutes.
None of the health workers had used indicator to monitor the success of sterilization process during the data collection time. Regarding labeling with sterilization date, 107 (72.8%) HCWs had used labeling for sterilized medical instruments. And, only 48 (32.7%) HCWs had withdrawn oldest sterile packs from the storage to use according to their date of sterilization (first sterilized first used). From the total participants, 97 (66%) HCWs had monitored time during sterilization and 100% HCWs had monitored pressure and temperature of the autoclave, though these were adjusted permanently. Thus, the overall compliance level of HCWs was 66.1%.

Safety of health care workers
In this evaluation study, 147 HCWs were observed for their proper selection and use of personal protective equipment during processing medical instruments. Thus, all 100% HCWs had worn gloves. Similarly, 60 (40%) HCWs had worn protective garment and 14 (9.2%) HCWs had worn face mask. In general, the overall safety practices of HCWs during decontamination, cleaning and sterilization of medical instruments was 48%.

Key informant interview
Majority of the key informants described decontamination, cleaning and sterilization of medical instruments including safety of HCWs, as it is the immersion of contaminated medical instruments (contamination is either during procedures or long time shelf life) in 0.5% chlorine solution for 10 minutes then washing using detergents and brushes, drying by using air then sterilize and ready them for the next procedure. They said also when they do this process it is important that using of PPE materials to prevent them from exposure to different potentially infectious substances. Following the description they listed the following resources as inputs for decontamination, cleaning and sterilization. These were; Autoclave, detergents, bleach, trained man power, guidelines, indicators, brushes, goggle, boots, apron, disposable gloves, water and face masks. "I think this arises from our weakness not availability and other institutional problems, because we don't care ourselves to care others. Let's tell you the truth please look the cabinet and the shelves they are full of PPE materials, but we are not committed to use them.
Based on this the solution is already simple we should have use them for the future".
All the interviewers recommend that TRHB and other responsible bodies should be given focus for the service, give training for the HCWs and should support resources like updated guidelines, indicators, procedure flow charts and others.

Discussion
In general, the implementation status of decontamination, cleaning and sterilization process in public health centers of Mekelle zone has found to be fair (63.4%). When disaggregated by dimension, the overall availability of resources has been rated good (74.2%). Regarding the compliance level of HCWs, it was judged as fair (66.1%). However, the overall safety of HCWs during decontamination, cleaning and sterilization was judged as poor (48%).

Availability of resources
The overall finding of availability dimension has found to be good (74.2%) when computed against the preset judgment standards. In this evaluation study, our findings showed that all (9) HCs had Autoclaves, Chlorine solution, Detergents, Sterilization unit, Gloves, Face mask, Protective garment/Apron, water access and brushes. On the other hand 7 health centers had both eye shields and protective shoes. According to the judgment criteria, this result was rated as good. The reason majority of interviewers mentioned for why not 100% was due to loss of focus for the service and no communications between the HCWs and other responsible bodies. This low availability of eye goggle and protective shoes contributes in increasing the risk of exposure to potentially infectious agents during decontamination, cleaning and sterilization process.
Health centers which had both written IP guideline and trained man power were only 3.
According the judgment criteria and the national guideline it was rated poor. This poor availability of trained man power was lower than a study finding in Benin (54.9%) (8). As evidenced by one key informant interviewer, these differences were due to no continuous training is given, trained staff turnover and assigning of trained staffs in other duties. In addition to this the reasons for the shortage of written IP guidelines is due to simply stored in the environmental health offices and other units out of the decontamination, cleaning and sterilization areas. This shortage of written guidelines and trained manpower makes decontamination, cleaning and sterilization practice not conform to the standards and this leads HCWs to practice by guess. One key informant quoted out the reasons for the above shortages of resources as follows. cleaning and sterilization unit. Similarly, there was no health center which had indicators to see the success of sterilization process. This finding was lower than study finding in Bahirdar city which was 11.1% (7). This difference might be due to loss of focus for the service.

Compliance with the national guideline
This evaluation study found that the overall result for compliance was rated fair (66.1%).
There were excellent practices of HCWs observed in decontaminating soiled instruments prior to cleaning and sterilization and monitoring of pressure as well as temperature during sterilization. Similarly, 93% HCWs were prepared chlorine solution according to the national guideline which is 1 part of chlorine solution with 9 parts of water. This finding is slightly lower than the study finding in Bahir-dar city (100%) (7). This 7% declining in compliance level of HCWs during preparing chlorine solution was comes from laboratory personnel.
Regarding, the drying status of instruments after removal from the autoclave, it was very good 88%. When we see number of layers used to wrap clean instruments going to be sterilized, 76% (29/38) HCWs used two layers of cotton wrap. Ideally, two layers of wrapping material are recommended, as there are frequently small tears in individual layers.
A second layer will prevent instruments from contamination before use, and two layers are thin enough to allow steam to penetrate and sterilize the item (10). Based on this idea it was a good practice of wrapping during sterilization.
Regarding labeling of medical instruments with sterile date after sterilization, 72% HCWs were did it which was good. This finding is better than a study conducted in Bahir-dar city (25%) (7). Time monitoring during sterilization is very important, but this study found that only 71% HCWs were monitored the correct time. As a result this may cause ineffective sterilization process of medical instruments.
Clean and contaminated instruments must be separated, ideally into different rooms, because it reduces the risks of contaminating or confusing clean instruments with soiled ones (10), so this study found that 46% HCWs were used separate rooms for soiled and clean instruments during processing. According the judgment criteria this was judged as poor practice. This may increase the risk of cross-contamination of each other and confusing HCWs in differentiating clean from contaminated instruments. In this study the other poor practice of HCWs was, using oldest packs first which was only 32%. On the other hand only 15.3% HCWs were immersed contaminated instruments in 0.5% chlorine solution for 10 minutes.
The rest 84.7% HCWs immersed either for less than 10 minutes or more than 10 minutes. This showed that there was big difference with the national guideline, because contaminated items should be immersed for 10 minutes prior to cleaning (9). If the duration of immersion is less than 10 minutes, it causes ineffective sterilization of instruments and if it is greater than 60 minutes, it causes rest of the instruments.
In this study there was no HCW used indicator during sterilization of medical instruments. This is completely wrong according to the national guideline. This might be due to no availability of indicators in the health centers. The reasons and possible solutions were quoted by one interviewer as follows.

Safety of health care workers
Personal Protective Equipment (PPE) protects HCWs by creating a barrier between the person and any potentially infectious substance (11). This study tried to assess the proper selection and use of PPE by HCWs during decontamination, cleaning and sterilization process. Thus, the overall finding of safety in HCWs in Mekelle zone public health centers was poor (48%). When we see each practice, 100% HCWs were worn disposable gloves during decontamination, cleaning and sterilization of medical instruments. This finding is higher than studies done in Bahir-dar city 73.4% (7). Possible justification could be due to time gap, increasing the awareness and attitude of HCWs on infection prevention.
Regarding protective garment/apron 41% HCWs were worn it during decontamination, cleaning and sterilization of medical instruments. According the judgment criteria and national guideline it was poor practice, but when we compare with the study finding conducted in Bahir-dar city (10%), it was increased. This might be due to professional differences of study participants and increased awareness of the HCWs with the time gap.
Other poor practices of HCWs in using PPE during decontamination, cleaning and sterilization of medical instruments were face mask, eye shields and protective shoes which were 9.6%, 8% and 4% respectively. Those results were much lower than the national guideline. On the other hand this finding is lower than a research findings conducted in Bahir-dar city which was 12% for face mask, 10.6% for protective shoes and 9.4% for eye goggle. These poor practices of HCWs in using PPE may increase the risk of exposure to different health hazards. One key informant gave his witness for this issue as the following quotation.
"I think this is arises from our weakness not availability and other organizational problems, because we don't care ourselves to care others. Let's tell you the truth please look the cabinet and the shelves they are full of PPE materials, but we are not committed to use them.
Based on this the solution is already simple we should have use them for the future".

Conclusion
Based on the judgment parameters developed after discussion has been conducted with the key stakeholders, the overall implementation status of the service was rated fair (63.4%).Regarding each dimension, the result for availability dimension found to be good (74.2%) and compliance dimension was rated fair (66.1%). However, the overall Safety of HCWs was rated poor (48%).

Acknowledgement
My appreciation and heartiest gratitude goes to my advisor Mr. Alem Desta and my co-

Authors' Contribution
BT: Was Contributing in title selection, doing the Evaluability Assessment, Developing the proposal and indicators, Collecting and analyzing data; AD: was supporting me in detail, especially during the indicator development; MM: Was help me in the general structure of the research.

Competing Interests
No Competing interest

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