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 Table of Contents  
Year : 2018  |  Volume : 6  |  Issue : 2  |  Page : 38-44

Patient safety and infection control in operation theatre: A prospective observational study in a tertiary care hospital of India

1 Medical Officer (Hospital Services) and Project Officer, Army Hospital (Research and Referral), New Delhi, India
2 Department of Hospital Administration, All India Institute of Medical Sciences, New Delhi, India

Date of Web Publication10-Jan-2019

Correspondence Address:
Dr. Vijaydeep Siddharth
Department of Hospital Administration, Old Private Ward Ground Floor, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110 029
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jpsic.jpsic_14_18

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Introduction: This study aimed to observe the various patient care processes pertaining to patient safety including infection control.
Materials and Methods: A descriptive, prospective, observational, qualitative study was conducted in operation theatre (OT) complex of a tertiary care teaching hospital of North India from January to December 2016. Eleven operating rooms utilised for performing routine surgeries were included in the study. Non-participant observations were made by the single trained observer, and in-depth unstructured discussions were also held with the key stakeholders. One OT each for a full day per week was observed. Simple random sampling without replacement using chit system was used for selecting the OT and day of the week for data collection.
Results: There are documented infection control guidelines which are being utilised for infection control. There is no patient safety committee, no guidelines on patient safety and no mechanism has been established for reporting of the patient safety incidents. Implementation of surgical safety checklist was inadequate and only nursing personnel filled it. There is a comprehensive training programme available for infection control among nursing staff only but not on patient safety. Only one adverse event was observed during the study period, in addition to four near misses.
Conclusion: Culture of patient safety needs to be established, especially in critical areas such as OT. Mechanism needs to be developed for capturing data pertaining to patient safety and patient safety practices, especially implementation of surgical safety checklist need intense and sustained efforts.

Keywords: Infection control, operation theatre, patient safety, surgical safety

How to cite this article:
Sahran D, Siddharth V, Satpathy S. Patient safety and infection control in operation theatre: A prospective observational study in a tertiary care hospital of India. J Patient Saf Infect Control 2018;6:38-44

How to cite this URL:
Sahran D, Siddharth V, Satpathy S. Patient safety and infection control in operation theatre: A prospective observational study in a tertiary care hospital of India. J Patient Saf Infect Control [serial online] 2018 [cited 2023 Jun 7];6:38-44. Available from: https://www.jpsiconline.com/text.asp?2018/6/2/38/249843

  Introduction Top

Patient safety is the avoidance of unintended or unexpected harm to the patients during the delivery of healthcare.[1] It is a significant issue within healthcare delivery systems worldwide.[2] Infection control is a problem for patient safety. Hence, it occupies a unique position in the field of patient safety since it is universally relevant to health workers and patients at every single healthcare encounter.[3] Healthcare-associated infection rates are higher in low- and middle-income countries when compared with high-income countries.[4] Infection control interventions are important for containing surgery-related infections. For this reason, the modern operating room (OR) should have well-developed infection control policies.[5]

An operation theatre (OT) complex is the 'heart' of any hospital providing surgical services[6] and is a facility within a hospital where surgical operations are carried out in a sterile aseptic environment.[7],[8] Surgical care is complex and is prone to errors and subsequent adverse events.[9] The reduction of perioperative harm is a major priority of healthcare and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety.[10]

Surgical safety checklists represent a relatively simple and promising strategy for addressing surgical patient safety.[11] Implementation of the surgical safety checklist is associated with concomitant reductions in the rates of death, complications among patients, with improvements in OR personnel perceptions of mutual respect, effective leadership, ability to be assertive when necessary to improve safety, coordination among surgeons and anaesthesia providers and effective communication.[12],[13] Safety redundant systems must be in place to decrease errors in surgery.[14] The existing literature is limited when it comes to patient safety in OT/surgical services in developing countries, and hence, this study was aimed to observe patient safety with greater emphasis on infection control.

  Materials and Methods Top

A descriptive, prospective, observational, qualitative study was carried out in the OT complex of a teaching tertiary care hospital of New Delhi in India for a period of 1 year that is, January–December 2016. The study commenced after obtaining approval from the Institute Ethics Committee. Hospital OT complex consisted of 12 OTs equipped for conducting surgeries under general anaesthesia including renal transplant, liver transplant and robotic surgeries, out of which 11 OTs were earmarked for elective cases of different specialities (general surgery, gastrointestinal surgery, paediatric surgery, obstetrics and gynaecology, urology and ear, nose and throat), and one OT was being utilised for emergency cases. Only OT being utilised for emergency cases was excluded from the study due to logistic constraints.

Data collection was done using direct observations, in-depth discussions with key stakeholders and analysis of OT records. In person, non-participant observations were made by single observer, who had requisite knowledge and training in infection control as well as patient safety. One OT each for a full day (working hours) per week was observed not only for patient safety incidents that is, adverse events, near misses and sentinel event but also the structural as well as environmental aspects having an impact on patient safety and different processes with bearing on patient safety with special reference to infection control practices. Simple random sampling without replacement using chit system was done for the selection of OT and day of the week for observation. When all the 11 OTs were studied, only then the second cycle of observation was started. The observations were not made on Sundays and gazetted holidays (since OT is non-functional for routine surgeries). If the observation day selected through simple random sampling fell on a gazetted holiday, then the next working day was utilised for observation for the selected OT. The observations were not carried out when OT s were being renovated. In-depth discussions were conducted with the key stakeholders that is, doctors, nursing staff, hospital infection control personnel, engineering staff, and housekeeping staff to understand the different processes related to patient safety, namely infection control processes including sterilisation practices, use of surgical safety checklist and mechanism for reporting of adverse events.

  Results Top

The hospital under study is an 1100-bedded hospital having an OT complex consisting of 12 operating suites. It is situated on 8th floor (penultimate floor) along with intensive care unit, which is accessible through lifts and stairs. OT complex is of double corridor design and the main entrance leads into the inner 'clean corridor'. Operating suites have been designed as twin ORs with common ancillary areas such as anaesthesia room, scrub area, lay up room, flash sterilisation and instrument washing area. Patients are wheeled inside the OT complex through the main entrance into the trolley bay area (situated next to entrance), from where they are then shifted onto the patient trolley of OT. Thereafter, they are wheeled into the anaesthesia preparation room and then into the OT or sometimes directly into the OT. From past annual reports of surgeries, an increase in average major and minor operation/day/OT in the last 5 years (2011–2015) was observed [Figure 1].
Figure 1: Average number of surgeries (major and minor) conducted per day per operation theatre from 2011 to 2015

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During the 28 observation days spread over 9 months, a total of 129 (69.34%) surgeries out of 186 scheduled/posted surgeries were conducted and observed with an average of 4.61 surgeries per day. Out of 129 surgeries performed, 78 (60.47%) were major surgeries with an average of 3.12 major surgeries per day and 51 (39.53%) were minor surgeries with an average of 3.92 minor surgeries per day [Table 1]. The average workforce present inside OT during a major surgery was 14.71 and during a minor surgery was 6.49.
Table 1: Speciality wise details of the observations made during the study period

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Patient safety programme/plan

In the OT complex, there is no written documented surgical safety programme/plan. It was also observed that the institute is not having a comprehensive documented patient safety programme. However, multiple fragmented patient safety activities/initiatives are being carried out by different departments/units. There is no system in place for collecting data related to patient safety incidents that is, sentinel event and adverse event. Even though the surgical safety checklist has been implemented within OT complex, it is not being properly implemented and only partially filled.

Structural/environmental components of patient safety

The flooring of the OT complex is of polyvinyl chloride with electroconductive copper wire beneath it. The medical gases, compressed medical air, vacuum and waste anaesthesia gas disposal system/anaesthesia gas scavenging system are provided for each OT by central manifold facility. There is also a provision of CO2 gas supply through the manifold as one CO2 point (for laparoscopic surgery). The OTs are centrally air conditioned with 100% fresh air with laminar flow and high-efficiency particulate air (HEPA) filters have been installed in all air handling units (AHU's). There is one AHU for three OTs. Pre-filters are cleaned every week and Microvee filters are cleaned fortnightly using water and detergent. There are two extra sets of all filters available so that they can be replaced in AHU within half an hour on Sunday by closing the AHU. HEPA filters are replaced 6 monthly without conducting any efficiency evaluation.

Infection control (including biomedical waste management) and sterilisation practices

Infection control activities in main OT complex are carried out as per the Hospital Infection Control Manual. Infection control nurses are responsible for the surveillance, investigation and data collection. Microbial samples of OT environment are cultured every month using settle plate method and surface samples are taken from the sterilised instruments. The corridor samples are taken only after the major renovation work has been executed.

Nursing staff supervises the hospital support staff while disinfecting the OT. Hospital attendant does the surface disinfection of the OT table, walls, fixtures, equipment surfaces and sanitary attendant (SA) does the job of disinfecting OT floor. Surface disinfection of the OT floor is routinely done before the start of surgical procedure, in between cases and at the end of the day using 20% Baccishield® solution (stabilised hydrogen peroxide 11%w/v with 0.01% diluted silver nitrate solution). Bacillol 25 (100 g) which contains ethanol (10 g) and 2 propanol (9 g) and 1 propanol (6 g) is used for disinfecting (in 25 s) all the monitors, surfaces, OT table, cables, etc., in the morning before the surgical procedure starts and also for disinfecting OT table in between the cases. In terminal cleaning of the OT, in addition to the surface disinfectant of OT floor, cleaning of trolleys, walls, fixtures with Baccishield® and water is carried out. After surface disinfection of the OT, fogging is done with 20% Baccishield® solution (200 ml Baccishield + 800 ml water) for 30–45 min, and it remains closed for a minimum of at least 30 min after fogging.

Instruments, such as laryngoscope blades, scopes, microinstruments, needles, plastic tubing, cautery wire and lens of laparoscopic set, are kept in the 2% glutaraldehyde solution for high-level disinfection. In certain surgeries, laparoscopic instruments, such as metallic ports, specimen vials, etc., which are needed in quick successions, are sterilised through flash sterilisation using flash autoclaves within the OTs. Two plasma sterilisers having cycle of 52 min and 30 min have been installed in the MOT complex for sterilisation purpose for heat-sensitive instruments/devices/equipment's, namely, laparoscopic instruments such as disposable and metallic ports and laryngeal mask airways tubing. Sterilisation of the instruments/equipment/devices is carried out in the OT complex by plasma sterilisation and through steam sterilisation at Central Sterile Supply Department (CSSD). Sterilised sets are kept inside OT and if not used in 72 h are again sent for sterilisation to CSSD.

Clean linen is supplied to linen room in the main OT complex by the laundry in the morning every day, and then different types of packets are made from clean linen by the staff posted in linen room. Then, these prepared packets are sent to CSSD for sterilisation, and the sterilised linen sets are brought in the night from the CSSD as pre-packed sets, which are laid outside each OT and checked by the morning nursing staff and then laid out as per the list or operations. Dirty OT laundry is picked up from all the OTs by the SA mostly after completion of each surgical case and then terminally after the last patient is wheeled out of the OT. The dirty laundry is lifted twice in a day and transported through dedicated lift to the laundry for washing.

Biomedical waste (BMW) is picked up from all the OTs four times in a day and all BMW collection containers are washed and then colour-coded polythene bags as per BMW handling rules are placed over the containers by the SA mostly after completion of each surgical case and then terminally after the last patient is wheeled out of the OT. It is temporarily stored in two separate rooms and transported through the dedicated lift to intermediate BMW storage facility.

Patient safety events

Various patient safety-related observations pertaining to infection control, surgical safety checklist, medical device, medication management, OT environment, etc., are summarised in [Table 2]. Only one adverse event and four near misses were observed during the study period [Table 3].
Table 2: Observations pertaining to patient safety made in the operation theatre

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Table 3: Near misses and adverse event observed in the operation theatre complex

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  Discussion Top

Patient safety and infection control have been very challenging issues and get further intricate when it comes to OT, given the critical nature of the healthcare services being rendered. Awareness of this problem prompted the World Health Organisation to promote the creation of the World Alliance for Patient Safety. Prevention of healthcare-associated infection is the target of the Alliance, First Global Patient Safety Challenge, 'Clean Care is Safer Care', launched in October 2005.[15]

Lack of adherence to infection control practices by all categories of staff that is, doctors (faculty and residents), nursing staff and housekeeping staff was observed. There could be various reasons for the same that is, lack of knowledge, discipline issues and training. Similarly, lower adherence was observed to infection control protocols despite the proven efficacy of infection control practices for preventing and controlling healthcare-associated infections.[5],[16] Several unique cultural, financial and environmental factors that influence adherence differ from conditions in developed countries, and new approaches to the problem of non-adherence to infection control guidelines are needed.[5] There is a need for improvement in the perception and practice of infection control measures among healthcare workers for both self and patient's protection.[17] A need for improved information systems, standardised protocols and procedures adapted to local situations and for training and research.[18]

Patient safety initiatives, aimed at creating a safe OR culture, are increasingly being adopted. Safety climate in surgical departments can be validly measured and varies widely among hospitals, providing the opportunity to benchmark performance.[19] The reduction of perioperative harm is a major priority of in-hospital healthcare and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety.[10]

In this study, implementation of patient safety processes was found to be inadequate and in nascent stage. It was also observed that the implementation of surgical safety checklist was inadequate and partially filled. Similarly, in another study, it was observed that none of the checklists in the patient files were filled in, however, components of the Surgical safety checklist (SSC) were completed.[20] It has been proven that the implementation of SSC is associated with improvements in the perception of teamwork and perceived perioperative safety among OR personnel.[13] However, it needs constant supervision and instruction until it becomes self-evident and accepted. Further efforts, consisting mainly of hands-on leadership and training, are necessary.[21]

Patient safety climate can be effectively assessed.[22] Establishing a quality improvement process in resource-limited settings is an enormous task, considering the host of challenges that these facilities face. The steps toward changing the status quo for improved quality care require critical self-assessment, the willingness to be change as well as determined commitment and contributions from all concerned stakeholders.[23] Although inadequate resources are likely a substantial challenge to the improvement of patient safety in India, other patient safety barriers, such as health systems changes, training and education, could be addressed with fewer resources. While initial approaches to improving patient safety have focused on implementing processes that represent best practices, multifaceted interventions to also address more structural problems (such as resource constraints, systems issues and medical culture) may be important.[24]

This study qualitatively and comprehensively tried to observe the infection control and patient safety processes. In addition, given the fact that all observations were made using non-participant methodology took care of the Hawthorne effect and provided a realistic snapshot of the existing situation. This study has come out with the issues pertaining to infection control practices and patient safety; however, it has not looked into the causal factors. It opens up an area for investigation into the factors responsible for the observed outcomes of this study and preventive measures to address the issue.

  Conclusion Top

Comprehensive, structured and organised patient safety Standard operating procedures (SOPs)/initiatives are lacking in the OT complex except for the infection control practices. Infection control practices need further improvement, especially with regard to donning/usage of personal protective equipment by healthcare staff. Surgical safety checklist has been introduced in the OT but is not being implemented properly and in the right spirit. Observed near misses, adverse event and infection control practices observation clearly reflect upon the urgent necessary patient safety measures to be implemented for preventing such events happening in future.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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