Human Factors and Operating Room Design Challenges

 

System A (e.g. airline)

System B (e.g. hospital)

Feasibility of changing practice, procedures, and context of hospital to match airline

The innovation

Salient features currently used in System A?

Salient features of innovation proposed for use in System B?

Could and should System B adopt the same innovation as is used by System A?

The resources

What resources were used in producing the outcomes (e.g. staff time, money, equipment, space)?

What resources in System B?

Does System B have the resources to emulate the practice of System A?

The people

What are the salient characteristics of the key actors in terms of expertise, experience, commitment?

What are the characteristics of the key actors in System B?

Insofar as there is a mismatch, would it be desirable or feasible to recruit different staff, invest in training, etc.?

Institutional factors

How much were the outcomes dependent on organizational/departmental structure, organizational cultures?

To what extent does the organizational structure and culture of System B determine practice?

Differences? Feasible or desirable to change the institutional structures and cultures in B?

Environmental factors

How much were the outcomes dependent on particular environmental factors (e.g. political, legislative, etc.)?

To what extent is the external environment of System B comparable to System A?

Differences? Change the external environment of System B?

Measures

What baseline, process, outcome, and other measures were used to evaluate success?

Does (or could) System B use the same measures?

Desirable or feasible for System B to change the way it measures and records practice?

Procedures

What was exactly done in System A that led to the outcomes reported?

Does (or could) System B do exactly the same?

Differences? Should System B change what it does?

Outcomes

What were the key outcomes, for whom, at what cost, and what are they attributable to?

What were the key outcomes in System B? Achieve for same actors as A?

To what are the differences attributable? Desirable outcomes that System B is not achieving?


Source: de Korne DF, van Wijngaarden J, Hiddema F, Bleeker FG, Pronovost PJ, Klazinga NS. 2010. Diffusing aviation innovations in a hospital in the Netherlands. Jt Comm J Qual Patient Saf 36(8):339–347





Risks in the Operating Room


Operating rooms (ORs) are high-risk areas for preventable patient harm [1618]. Besides wrong-site surgery and medication or instrument-related incidents, surgical site infection (SSI) has been reported to be one of its major categories [16, 17, 1921]. For example, bacterial air and fomite contamination are generally accepted as the main causal risk factor of SSIs [19, 20, 22, 23]. Proper ventilation in and near the OR coupled with rigorous hand hygiene is key in establishing an environment that stops the spread of infection [24, 25]. Since Lidwell et al. in 1982 demonstrated a correlation between airborne bacteria contamination levels and the incidence of postoperative wound infections, the use of ultraclean ORs with laminar air flow (LAF) ventilation has been recommended for many types of surgery [19, 20, 22]. With LAF, cold, clean air is blown into the OR from a ceiling system and contaminated air is sucked out through ventilation grids in the walls. Different studies have shown the effects of LAF ventilation on the number of contaminations of samples in different OR areas [19, 20, 22].

In the past 30 years, much attention has been given to the proper installation of LAF systems as well as details about its size, position, concentration, efficiency, degree of filter, temperature, and other technicalities [26]. The actual effect of the clean air, however, is largely dependent on the correct positioning of the surgical table and instruments in its flow as well as staff traffic behaviour and patterns (e.g. number of people standing within the flow or against wall vents) [22, 23, 2528]. Energy from movement of devices and staff decreases the volume of clean air and both hinder air flow [25, 28].

In most literature on hygiene and infection studies, the focus is on teaching, training, and changing staff behaviour , e.g. appropriate OR dress or hand hygiene discipline [16, 17, 19, 22, 25, 27]). Adhering to infection prevention recommendations like correct positioning of devices within the clean air flow is rarely emphasized, despite infection prevalence being dependent on design characteristics of the OR.

Most safety improvements in high-risk industries first focus on work area design—here defined as ‘creating and developing concepts and specifications that optimize the function value and appearance of products and systems for the mutual benefit of both user and manufacturer’ [29]—before attempting to change behaviour. Many studies performed in industry have concluded that it is hard to change behaviour; changing design is probably easier [3034]. On offshore oil vessels, for example, the position of all materials on decks is marked to support safe behaviour [35], as are the positions of airplanes and all surrounding equipment on the airport tarmac [36].

Human factor engineering, concerned with the understanding of interactions among humans and other elements of a system, can help in ‘mistake proofing’ by changing designs to make processes more reliable and effective [21, 37]. Influencing users’ behaviour is challenging and smart design can potentially shape behaviour towards sustainable practices and improve teamwork dynamics and situational awareness [38, 39]. Teamwork has been defined as ‘skills for working in a group context, in any role, to ensure effective joint task completion and team member satisfaction’ [40]. Situational awareness has been defined for this context as ‘developing and maintaining a dynamic awareness of the situation in theatre based on assembling data from the environment, understanding what they mean and thinking ahead what might happen next’ [41]. Behaviour steering could be used as a strategy that could be integrated into product design [33, 42], encouraging users to behave in ways prescribed by the designer through embedded affordances and constraints. In operating rooms, human factor engineering and design thinking therefore plays an important role in safety and efficiency improvement. An unacceptable number of avoidable patient safety incidents result from the widening disparity between surgical innovation and the environment in which it is applied [43, 44]. Design that aims to minimize the increasing problem of patient safety must consider the behaviour of staff and patients as well as the complex interrelationships between culture; technology; and achieving reliable, high-quality surgical outcomes [44]. While OR floor marking is increasingly applied in the design of ORs, little is known about its effects on clean air compliance .



Case Study I: Effects of Operating Floor Marking on the Position of Surgical Devices1


The application of OR floor marking at the Rotterdam Eye Hospital, The Netherlands (REH) was part of a safety learning programme between surgical staff at the hospital and terminal operators at Amsterdam’s Schiphol Airport. While the direct purposes of floor marking are obviously different for airside and OR (prevention of collisions and logistic support in a dynamic environment versus infection prevention and proximity for ease of use in a relatively static environment), the main goal of doing the right things on the right spot is similar. The hospital used a laminar flow system with an inflow of 0.27 m/s, from a ceiling rectangle area of 160 × 220 cm, and with a total content of 124.5 m3 per OR (See also Fig. 24.1a). The relative humidity was 55 % and the temperature was 19.5 °C. The ventilation rate was calculated at 20.5 per hour. An OR workspace analysis was performed, indicating 42 different items on various positions. The following equipment was routinely used during ophthalmic operations: surgical table, one (mostly) or two (e.g. for more extensive retina surgery) instrument tables, Mayo instrument stand (e.g. for retina surgery and cataracts with general anaesthesia), surgical lamp (for oculoplastic and strabismus surgery), chair for surgeon, chair for assistant (resident or surgical nurse), medicine and disposable material trolley, anaesthesia instrument, chair for anaesthesiologist, phacoemulsification and vitrectomy machinery for cataract, respectively, vitreoretinal surgery (See Fig. 24.1b).

A332506_1_En_24_Fig1a_HTML.jpgA332506_1_En_24_Fig1b_HTML.gifA332506_1_En_24_Fig1c_HTML.jpg


Fig. 24.1
(a) Position of surgical devices at the operating room (photo: REH). Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects of operating floor marking on the position of surgical devices to promote clean air flow compliance and minimize infection risks. BMJ Qual Saf 2012; 21(9):746–52. (b) Overview of the OR floor and space analysis (photo: REH). (c) Airside marking at Amsterdam Airport Schiphol (Schiphol 2010). Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects of operating floor marking on the position of surgical devices to promote clean air flow compliance and minimize infection risks. BMJ Qual Saf 2012; 21(9):746–52. (d) Provisional surgery floor marking for T1 and T2 (photo: REH). (e) Permanent surgery floor marking for T3 (photo: REH)

The REH is a major referral centre, handling approximately 140,000 outpatient visits and 14,000 surgical cases annually. According to Dutch infection prevention guidelines, the ORs of virtually all ophthalmic surgeries are required to have an LAF [46]. We studied the potential relationships between equipment position and endophthalmitis (an internal inflammation of the eye), the most common infection in intraocular surgery, particularly cataract surgery, which can result in loss of vision or the eye itself [47]. A mixed methods study was done including interviewing providers and doing a detailed time series analysis to measure compliance (the position of devices within the clean air flow) 5 months before marking (T0, n = 180 surgeries), and at 1 month (T1, n = 194 marked, n = 86 not marked), 6 months (T2, n = 166 marked), and 20 months (T3, n = 199 marked). The positions of devices, mobile OR table, instrument table, Mayo stand, and surgical lamp were determined by four circulating nurses (Fig. 24.1a).


Floor Marking Effects


The marking project was a co-creation of a multidisciplinary team with hospital surgical staff and tarmac operators from Schiphol airport.2 Five mutual site visits were included. During three airport sessions, experience in airside marking, position of materials, traffic flows, safety rules and regulations, and incident management were discussed. Different colours and patterns indicate the exact position of approaching and departing planes, fuel and luggage devices, and vehicle and foot traffic (Fig. 24.1c).

During two hospital sessions , OR traffic flows, position of surgical tables and materials, safety management, and incident reporting were discussed. Marking was applied to two of the four ORs. Red tape (width 2.5 cm) was pasted on the contours of the laminar flow area (162 cm × 224 cm) of the OR floor (Fig. 24.1d). The stop positions of the surgical tables were indicated by white tape dots. In a second phase a permanent mark was applied (Fig. 24.1e).

Surgeons, nurses, and other staff were not specifically instructed to change the positioning of the devices. After T0 documentation of positioning, compliance with laminar flow was determined based on device positioning at T1–T3. The results are presented in Table 24.2.


Table 24.2
Percentages of surgeries with the instrument table, Mayo instrument stand, and surgical lamp in the laminar





































































































   
T0

T1

T2

T3

p Value

n = 182

n = 86

n = 195

n = 167

n = 199

Not marked (%)

Not marked (%)

Marked (%)

Marked (%)

Marked (%)

Instrument table

Completely in

 6.1

10.7

36.1

52.1

53.8

0.000a

Partly out

26.7

72.6

37.6

27.0

27.6

Largely out

67.2

16.7

26.3

20.9

18.6

Mayo instrument standb

Completely in

74.2

82.4

82.8

84.6

84.7

0.080c

Partly out

18.2

 8.8

 8.7

 9.0

15.3

Largely out

 7.6

 8.8

 8.5

 6.4

 0.0

Surgical lampd

Completely in

41.8

35.8

38.7

28.7

48.6

0.000a

Partly out

15.7

22.4

 6.5

 4.7

 0.7

Completely out

42.5

41.8

54.8

66.7

50.7


Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects of operating floor marking on the position of surgical devices to promote clean air flow compliance and minimize infection risks. BMJ Qual Saf 2012; 21(9):746–52

a χ 2 test T0not marked − T1marked

bIncludes only cases where the Mayo instrument stand was used (34 %)

c χ 2 test T0not marked − T3marked

dExcludes oculoplastic and strabismus cases because the surgical lamp is in use

Instrument table . Before marking, the instrument table was positioned completely within the laminar flow in only 6.1 % of the cases. With floor marking, this significantly increased to 36.1 % (T1, p = 0.000), 52.1 % (T2, p = 0.000), and finally 53.8 % (T3, p = 0.000). At T1, only 10.7 % of the instrument tables in the ORs without floor marking was positioned completely within the laminar flow. At T2 and T3, in almost half of the cases, the instrument tables were still positioned (partly) outside of the clean air flow. In interviews, staff indicated that in their view an ergonomically correct position is more important than positioning the instrument table in the clean air flow. For some operations a diagonal position is necessary, requiring more space. The size was also criticized: “For retinal surgery, you can’t position a resident and a scrub tech and all your instruments in the flow area. The field is too small” (ophthalmic surgeon).

Mayo stand. Mayo stands (above the patient) were increasingly positioned within the laminar flow after marking: from 74.2 % (T0) to 82.8 % (T1), 84.6 % (T2), and 84.7 % (T3). These changes were not statistically significant. The number was expected to approach 100 % because the stand is normally positioned close to the patient. In certain surgeries, however, it was placed at a distance because as one surgeon noted: Having sufficient space to move and position your arms is more important for a successful surgery than the position in the flow”.

Surgical lamp . In many ophthalmic surgeries (with the exceptions of strabismus and oculoplastic surgeries) the microscope light is used instead of the surgical lamp. To maximize clean air flow, the surgical lamp should then be positioned outside the area since its volume and energy disturb clean air flow. In such cases, the surgical lamp was decreasingly positioned in the flow: from 41.8 % (T0) to 38.7 % (T1, p = 0.000) and 28.7 % (T2, p = 0.000). However, at T3 (20 months after the marking) in 48.6 % of the cases the lamp was again positioned in the air flow. In interviews, staff indicated that they often forgot to reposition it because, according to them, there is no clear marking.

There’s an indication of the clear air flow on the floor now, but not in 3D. If we were doing surgery in a real clean air box, all disturbing devices could be eliminated” (nurse).

In the 2 years after the marking, the incidence of ophthalmic infections (endophthalmitis) was lower than in the 4 years before (Table 24.3). Due to very low incidence (0.078 % in 128,130 cases over previous 11 years), no significant differences could be found. Notably, changes in corneal versus corneoscleral incisions and the use of prophylactic antibiotics probably acted as confounders and it is not sure whether besides this associative relation there is also a causal relation.


Table 24.3
Endophthalmitis infection statistics at the case hospital, 2000–2010

















































































 
2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Total surgeries

9701

9955

10,328

10,428

11,199

11,864

12,692

12,610

13,338

13,242

12,773

Postoperative endophthalmitis infections in all surgeries

7 (0.072 %)

9 (0.090 %)

8 (0.077 %)

6 (0.058 %)

12 (0.105 %)

10 (0.084 %)

10 (0.078 %)

14 (0.102 %)

9 (0.067 %)

7 (0.053 %)

8 (0.063 %)

Cataract surgeries

4986

5018

5126

5274

6011

6015

7040

6893

7366

7442

7164

Postoperative endophthalmitis infections in cataract surgery

4 (0.080 %)

5 (0.099 %)

7 (0.136 %)

4 (0.076 %)

11 (0.083 %)

7 (0.116 %)

3 (0.043 %)

8 (0.116 %)

5 (0.068 %)

5 (0.067 %)

3 (0.042 %)


Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects of operating floor marking on the position of surgical devices to promote clean air flow compliance and minimize infection risks. BMJ Qual Saf 2012; 21(9):746–52

According to interviewed staff, discussions and site visits between airside operators and surgical staff resulted in an increased awareness of the specific risk areas in the OR. Due to the exchange sessions, professionals not only focused on the position of the surgical table, but were more aware of the complete air flow area, including the instrument table positions. Therefore, the surgical table’s stop position was permanently marked (T3). The surgical team usually focused on the position of the patient in the clean air flow. During discussions about risks, however, the focus was on the total risk surfaces. Since the wound surface in ophthalmic surgery is very small, the materials used appear to play a larger role. For example, surgical staff indicated that they became aware that donor tissue for a corneal transplant was placed outside of the flow:

“The donor cornea is prepared in the laminar flow. When the patient arrives at the OR, we reposition the instrument table with the donor tissue. Through the marking, we became aware that the donor cornea is not in the clean air flow during heavy traffic flows (patient arrival, staff entry) at the first part of the surgery” (surgeon).

Some ophthalmic surgeons were sceptical about the marking initiative at the start. Clean air flows were seen as important to prevent infections, but due to low infection rates in ophthalmology it was in their view not worthwhile to use marking and measure compliance. Confronted with the compliance results after the marking, they indicated that marking seemed to increase awareness and good positioning.

“Marking not only encourages staff to position the patient and instruments correctly, it also makes clear that non-sterile visitors have to stay outside the marked area” (surgeon).

The circulating and scrub nurses found that they positioned the instruments increasingly in the laminar flow since the marking project without being aware of any differences. Only when they saw the results were they convinced that positioning had changed. The new design nudges for a compliance improvement without a need for specific instructions or even explicit awareness of the staff involved.


Marking Floors as Improvement Design Intervention


Marking the clean air area on the floor of ORs resulted in significantly increased compliance with the positioning of surgical devices. While the focus was previously on the position of the patient, the marking resulted in a focus on positioning instrument tables within the clean airflow. The change was sustained over time. Drawing a simple line created awareness and resulted in discussions about the required surface and the correct position of devices and staff. At first, the surgical light was more often put in the right position (out of the clean airflow when not needed) but this was not sustained. The marking seemed to have created an initial awareness, but perhaps because the marking on the floor and the lamp hangs on the ceiling, the marking did not help to sustain the behaviour to position the lamp outside the clean air area .


Case Study II: Video Feedback to Improve Sensomotor and Non-technical Skills3



Sensomotor and Non-technical Factors in the Operating Room


Over the last decade, ORs have consistently been indicated as high-risk areas for preventable harm, yet the factors contributing to complications and surgical confusion within this context are usually multifactorial and remain poorly understood [43]. Poor surgical outcomes may result from a combination of surgical complications resulting from poor surgical technique, or suboptimal OR support resulting from inadequate communication among the surgical team, or an interplay and combination of the earlier two major aspects of OR safety [50].

Traditional training of surgeons is focused exclusively on developing and training technical (surgical) skills [51]. However, an analysis of the reasons for surgical adverse events revealed that these events stem from behavioural or non-technical aspects of performance (e.g. poor communication among members of the surgical team) [50, 52]. Surgical training of new surgeons within this complex environment is highly dependent on a supervisor–trainee trust and mentorship in a one-to-one training model. Objective assessment and monitoring of surgical skills with the goals of enhancing learning and improving resident outcomes are crucial [53]. However, current training schemes have shown to be subjective with significant intersupervisor variability and significant variation in style and consistency of feedback [54, 55].

There is therefore a need to explore more objective assessment methodologies to assess surgical expertise [56]. Operating room safety has admittedly improved with measures instituted such as ‘Time Out’ (to ensure operating on correct side, site, procedure, etc.), education with regard to needle stick injuries/lost or flying needles/missing swabs, ensuring the safety and availability of surgical instruments, and sterile procedure to name a few. Despite numerous costly measures already in place, reportable incidents still occur, some of which are serious [21]. We have therefore explored the application of video recordings.


Video Feedback as Means for Improvement


The hospital initiated a Team Resource Management (TRM) Programme with top management participation. Video feedback was to be used and is recognized as a very useful approach in reviewing and understanding work processes as well as a means for quality improvement [57, 58]. Inspired by aviation, a ‘black box’ approach was introduced in one of our hospitals. Aviation safety experts videotaped ophthalmic surgeries monthly to give the surgical team feedback on the application of the safety procedures taught during the classroom TRM sessions. Standard operating procedures for the production, use, and distribution of the images were documented. The aviation black box is automated, but for financial constraints the hospital used a handheld video recorder.

Videotaping team activities was not easily accepted and the medical staff was initially hesitant, fearing that recorded unexpected outcomes could be used against them. Only ophthalmologists who participated in the larger TRM Programme consented to having their surgeries videotaped, but with the stipulation that the images be taken with a handycam and used solely for their own training. The chief ophthalmologist, who had declared his willingness in an earlier stage of the programme, consented to make the recordings available to all the hospital’s staff, residents, and nurses, stimulating others to get involved in the programme. In the end, 70 % of the ophthalmologists participated in the training.


Awareness of Risks


Awareness of risks was observed via the video analysis. From the staff interviews and observations, it was clear that anticipation of approaching safety threats was a recurrent session topic. Participants talked about a lack of standards and interoperability and requested this be addressed:

“There are no strict protocols for what I do and what the surgeon does. Continuous evaluation and risk assessment depends on the surgeon [alone]” (resident).

As a result of the discussions, multidisciplinary, standard operating procedures were agreed upon, including a pre-operative briefing (with task division) and time out. The importance of situational awareness and the influence of human factors were a recurrent topic in the video feedback items (Table 24.4). The videotapes revealed team-specific differences in performing the time-out procedure and the variation in using the safety communication rules agreed on during the TRM training. The videos also showed that the absence of team members at the pre-operative briefing resulted in less structure and more communication gaps during surgery. As one aviation safety expert said,
Oct 1, 2017 | Posted by in NURSING | Comments Off on Human Factors and Operating Room Design Challenges

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