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RLE Journal Article PDF
RLE Journal Article PDF
RLE Journal Article PDF
BACKGROUND: The Association of Perioperative Registered Nurses (AORN) released new guidelines for
operating room attire in 2015 in an attempt to reduce surgical site infections (SSIs). These
guidelines have been adopted by the Centers for Medicare and Medicaid Services. We aimed
to assess the relationships among operating room attire, SSIs, and healthcare costs.
STUDY DESIGN: In March 2016, our center introduced the AORN attire policy. National Health Safety Network
data from our hospital were collected on general surgery, cardiac, neurosurgery, orthopaedic, and
gynecology procedures from January 2014 to November 2017. The SSI rates and microbiolog-
ical culture data for 30,493 procedures before and after policy implementation were compared
using propensity score matching. The associated costs of the AORN policy were analyzed.
RESULTS: After 1:1 propensity score matching, 12,585 matched pairs spanning the policy change were
included (25,170 patients total); before policy change (BC group) and after policy change
(AC group). The rate of SSIs did not differ between groups (1.0% AC group vs 1.1% BC
group; p ¼ 0.7). There was no difference in the incidence of Staphylococcal species cultured
from wounds (19.3% AC group vs 16.8% BC group; p ¼ 0.6). Multivariable analyses
demonstrated that wound classification and emergent procedures were the strongest indepen-
dent predictors of SSIs. The cost of attire for 1 person entering the operating room increased
from $0.07 to $0.12 before policy change to $1.11 to $1.38 after policy change. Use of the
mandated operating room long-sleeved jackets alone in our institution was associated with an
added cost of $1,128,078 annually, which translates to an estimated $540 million per year for
all US hospitals combined.
CONCLUSIONS: Implementation of the AORN guidelines has not decreased SSIs and has increased healthcare
costs. (J Am Coll Surg 2019;228:98e106. 2018 by the American College of Surgeons.
Published by Elsevier Inc. All rights reserved.)
Table 1. Partial List of Association of Perioperative Registered Nurses Recommendations for Operating Room Attire
Recommendation
Head, hair, ears, facial hair, and the nape of the neck should be covered when entering the semi-restricted and restricted areas
Arms should be covered with long-sleeved jackets in semi-restricted areas
Scrub attire should be worn that covers the arms when prepping the patients or when preparing packaging and sterile items in the clean
assembly area of sterile processing
Non-disposable head coverings should be covered with a disposable head cover
100 Elmously et al Operating Room Attire and Healthcare Cost J Am Coll Surg
NHSN categories (colorectal, cardiac, craniotomy, spine, algorithm was used and the success of matching was exam-
hip replacement, and hysterectomy) from January 2014 to ined by comparing standardized differences in the distribu-
November 2017 at the 2 main campuses were included. tion of the covariates between the 2 treatment strategies; a
Age, sex, BMI, diabetes history, ASA class, wound classi- difference of <10% between the 2 groups for confounding
fication, type of procedure, and procedure characteristics variables was considered acceptable (Fig. 1). All of the ana-
were collected for all patients. Patients with SSIs were lyses were considered significant at a 2-tailed p value of
identified by hospital epidemiologists and infection pre- <0.05. With 30,493 patients included for analysis, our
ventionists, according to CDC definitions. The SSIs study has a >97% power to detect an absolute difference
were further sub-categorized into superficial and deep of 0.5% in SSI between groups (ie 1% to 0.5%).
SSI, intra-abdominal abscess, osteomyelitis, endocarditis,
mediastinitis, intracranial and spinal abscess, and pros-
thetic joint infections. RESULTS
Study population
Outcomes Of the 30,493 procedures in this study, 17,908 (58.7%)
The primary end point of interest was the incidence of SSI were performed before the policy change (BC group)
within 30 days of operation compared between patients and 12,585 (41.3%) were performed after the policy
undergoing operations before and after the mandatory change (AC group). Unmatched patient demographics
operating room attire policy change. Other outcomes of and procedural characteristics according to operating
interest included the contribution of individual bacterial room attire appear in (Table 2). Compared with patients
species to the SSI microbiome. This was done by undergoing operations before the policy change, patients
comparing the rate of wound cultures positive for poten- after the policy change had higher BMI, higher prevalence
tial skin contaminates (Staphylococcal species) in patients of diabetes mellitus, and lower ASA scores. Further, pro-
with SSIs to determine whether covering all exposed skin cedures before the policy change were shorter in duration,
of operating room personnel reduced infections from less frequently emergent, and had a significantly different
these bacterial species. Data pertaining to the added hos- makeup of procedure types (eg colorectal procedures, cra-
pital costs of purchasing, as well as disposing of the niotomies, and spine procedures), as well as different pro-
disposable full-sleeved jackets, were also analyzed. portions of wound classifications (Table 2).
These differences and others were negated after propen-
Statistical analysis sity score matching (Fig. 1). The propensity score-
Statistical analyses were performed using STATA, version matched model did have a higher proportion of emergent
15 (Stata Corp). Continuous variables are described as procedures in the BC group when compared with the AC
mean SD. Categorical variables are described as per- group (Table 3).
centages and were analyzed using the chi-square test.
Continuous variables were assessed for normality using
the Shapiro-Wilk test; Student’s t-test was used to
compare the means of parametric variables and the Wil-
coxon rank sum was calculated to compare nonparametric
continuous variables. A multivariable logistic regression
was used to demonstrate independent patient and proce-
dural predictors of SSIs.
To account for the nonrandom selection of patients for
operations before and after the policy change, as well as
differences in patient baseline characteristics between
groups, we used propensity score matching. The propensity
score was defined as the probability of undergoing opera-
tions under the new AORN operating room attire policy.
To estimate these scores we used multivariable logistic
regression conditioned on variables confounding SSI:
patient BMI, diabetes, wound classification (clean, clean-
Figure 1. Standardized difference plot. Differences before and after
contaminated, dirty, contaminated), and procedure type propensity score matching comparing covariates confounding sur-
(colorectal, cardiac, craniotomy, spine, hip replacement, gical site infection for patients undergoing operations before and
and hysterectomy). A 1:1 nearest-neighbor matching after the policy change.
Vol. 228, No. 1, January 2019 Elmously et al Operating Room Attire and Healthcare Cost 101
not differ between groups (28.2% BC group vs 28.4% single person to enter the operating room wearing the
AC group; p ¼ 0.9) (Fig. 4). appropriate attire before and after the policy change was
calculated according to the following prices provided:
Added cost of the Association of Perioperative bouffant $0.07, skull cap $0.12, cap with beard cover
Registered Nurses’ operating room attire policy $0.34, disposable operating room jacket $1.04. Before
Cost data pertaining to operating room attire were calcu- the policy change, wearing a bouffant or surgical cap to
lated using annual forecasted projections by our Strategic enter the operating room created a cost that ranged
Sourcing Department. These data are available in aggre- from $0.07 to $0.12 per person. After the policy change,
gate for the 2 hospital campuses included in this study taking into account the mandatory long-sleeved jackets
(1,869 beds in total). The necessary recurring cost for a and beard covers when appropriate, the cost ranged
DISCUSSION
The current large-scale propensity-score matched study
comprising diverse surgical procedures demonstrates
that the implementation of a new non-evidence-based
operating room attire policy did not decrease the inci-
dence of SSIs. Further, based on our microbiological
Figure 2. Multivariable model for predictors of surgical site infec- analyses, efforts such as banning skullcaps in favor of
tion. Forest plot of multivariable logistic regression model for the bouffants and requiring long-sleeved jackets for all non-
association of patient and procedural factors with postoperative scrubbed personnel aimed at decreasing the bacterial
surgical site infection. ASA, American Society of Anesthesiologists; shed of Staphylococcal species into the surgical site,
OR, operating room.
have not proven to be effective, but have significantly
increased healthcare costs. Our study reaffirmed impor-
from $1.11 to $1.38 per person, a 10- to 20-fold increase tant patient and procedural factors that do contribute to
in cost per person. increasing the risk of SSIs; most importantly, wound clas-
We also evaluated the overall cost of the disposable jackets sification and emergent procedures appear to be the stron-
alone. The cost of procuring the necessary 1,076,728 jackets gest independent predictors of SSI. Our data suggest that
at the 2 centers in this study is $1,110,851 annually. The the traditional operating room attire policy is equally as
cost of disposing of the jackets as solid waste, based on an effective and less costly than the one required by the
estimated $0.08 per pound,24 is $17,227. The total annual AORN policy, now adopted by regulatory and accrediting
cost of the AORN policy-mandated jackets (procurement organizations.
Figure 3. Microbiome of surgical site infection by attire policy. Pie charts represent the 3 most common
microbiological isolates from positive wound cultures of patients with surgical site infection before and after the
policy change. Streptococcus mitis was the third most common bacteria before the policy change vs Pseudo-
monas aeruginosa after the policy change; however, there was no difference in the proportion of Staphylococcus
aureus isolates.
104 Elmously et al Operating Room Attire and Healthcare Cost J Am Coll Surg
With more than 30,000 patients available for analysis, study used mock operating rooms to test the permeability
our study had >97% power to detect a 50% reduction in and potential for microbial contamination and demon-
SSI with the institution of the new operating room attire strated that bouffant-style caps, as mandated by the new
policy (from 1% to 0.5%). We demonstrated no reduc- policy, have a significantly higher microbial shed to the
tion in SSIs, and in a subanalysis of every SSI subtype sterile field.19 As a results of these studies, the American
available from the NHSN, we showed no differences in College of Surgeons, ASA, AORN, Association of Profes-
deep SSIs, superficial SSIs, mediastinitis, osteomyelitis, sionals and Infection Control Epidemiology, Association
endocarditis, spinal and intracranial abscesses, or pros- of Surgical Technologists, Council on Surgical and Peri-
thetic joint infections. Importantly, after the institution operative Safety, and the Joint Commission met in
of the AORN policy, there was a strong trend toward February 2018 and, after reviewing the current available
increasing intra-abdominal abscesses (p ¼ 0.07). This evidence, released a consensus statement stating that
value should not be discounted because this is despite “the requirement of ear coverage is not supported by suf-
the fact that our propensity score-matched cohort had ficient evidence” and that “other issues regarding areas of
equivalent proportions of colorectal cases and wound clas- surgical attire need further evaluation.”26
sifications, as well as a higher rate of emergent procedures When efforts to improve care are not chosen appropri-
in the BC group. In addition, an oral antibiotic bowel ately, initiatives aimed at quality improvement have the
preparation protocol for colon resections was in use dur- potential to consume resources, while conferring little to
ing the entirety of the study period. no benefit. This is also true when a benefit is falsely attrib-
Our results are in line with a growing body of literature uted to choosing action over the status quo without
that demonstrates no difference in SSI rates with the insti- knowledge of the harms and opportunity costs of quality
tution of different operating room attire, specifically improvement, especially in the context of the net benefit
examining the use of the bouffant vs traditional surgeon to patients and healthcare systems.26 Despite the well-
skull cap.16-19 One study of 15,000 class I neurosurgical intentioned goal of the AORN guidelines, they are the
procedures demonstrated that the use of bouffants did first to specifically implicate operating room attire as a
not significantly decrease SSIs during a 13-month causative factor for SSIs, while basing these assumptions
period.16 Two studies, one using American College of on relatively low-level evidence.27-29 The 1965 study cited
Surgeons NSQIP data and one using the Americas Hernia by AORN was a retrospective study comparing bacterial
Society Quality Collaborative conducted multivariable isolates from the nares and hair of hospital employees
logistic regressions of approximately 6,000 patients each and patients. This study identified hair as a reservoir for
and did not reveal an association between hat type worn Staphylococcal species without identifying a causal rela-
in the operating room and SSIs.17,18 In fact, one previous tionship between this finding and postoperative wound
Vol. 228, No. 1, January 2019 Elmously et al Operating Room Attire and Healthcare Cost 105
infections.28 The 1973 study was a single-institution case was observational we cannot rule out potential residual
series of 11 patients describing an outbreak of postopera- bias or confounding. Second, although the new operating
tive infections that had the same bacteria isolated from the room attire policy was strictly enforced on all personnel
hair of a single general surgeon.29 Not only do these at all campuses in our hospital system, we cannot ensure
studies not discuss the headgear worn by the operating absolute compliance with every aspect of the policy (eg
surgeon to support the basis of banning the skull cap maintaining long-sleeved jackets at all times when not
and mandating the bouffant, but relying on them to scrubbed or covering all exposed facial hair). In line
create a rigid set of guidelines circumvents the traditional with this, we cannot track the proportion of operating
models of evidence that drive quality improvement. room personnel who used a bouffant, wore a long-
The investment of healthcare dollars for a quality sleeved jacket, or used a beard cover before the imple-
improvement project in one hospital center is multiplied mentation of the new guidelines, and cannot truly
by thousands of hospitals in the US once a policy is measure the proportion of change that was enforced by
mandated by regulatory and accrediting organizations. the new policy. Further, although cultures were used
Our study evaluated the clinical and cost-effectiveness of for bacterial analysis, certainly not every patient with an
the AORN policy and demonstrated an increased cost SSI had cultures available to be analyzed. Finally, our
of 10- to 20-fold per operating room entry per person cost data are available as an aggregate and not by patient;
associated with the new policy. Purchasing and disposing however, it remains a valid representation of the poten-
of long-sleeved jackets for all personnel at our hospital sys- tially unnecessary added healthcare costs of this policy
tem’s main campuses was associated with a cost of more in a large hospital center.
than $1 million annually. According to our estimation,
this translated to $540 million of estimated added costs
for all US hospitals. The change in policy was based on CONCLUSIONS
the hypothesis that covering all exposed skin on the In a large, propensity score-matched analysis of a diverse
arms of all non-scrub personnel would decrease the shed cohort of patients undergoing a variety of procedures,
of microbial contaminants from the skin onto the oper- we found that the mandatory use of bouffant caps
ating field, namely Staphylococcal species.13-15 However, covering the ears, coverage of all facial hair, and the
our microbiological analysis demonstrated that the attire use of long-sleeved jackets by all non-scrubbed
policy change was not associated with a change in the personnel has resulted in no tangible benefit with regard
prevalence of S aureus in all surgical cases, nor was it asso- to decreasing SSIs. More importantly, the added health-
ciated with a change in the prevalence of any Staphylo- care costs of using the AORN operating room policy in a
coccal species in clean or clean-contaminated cases. The large hospital system are substantial. The movement
AORN policy itself states that “the collective evidence to improve quality and safety should continue to
does not support wearing cover apparel to protect scrub be evidence-based. A collaborative, multidisciplinary,
attire from contamination, and there is evidence that consultative process when it comes to areas such as
lab coats worn as cover apparel can be contaminated operating room attire, should be performed by a team
with large numbers of pathogenic microorganisms.” A representing surgery, anesthesia, nursing, and infection
previous multi-institutional study of 22 hospitals is in prevention, as mentioned in the consensus statement
line with this and demonstrated that adherence to recently released by the American College of Surgeons,
infection-control practices in the operating room relating ASA, AORN, Association of Professionals and Infection
to coverage of arm hair and head hair did not correlate Control Epidemiology, Associated of Surgical Technol-
with SSI rates.30 With no evidence of improvement in ogists, Council on Surgical and Perioperative Safety, and
the rate of SSIs, and in view of the added cost created the Joint Commission.
by the policy, the policy and its mandate should be re-
evaluated.
The movement to improve quality and patient safety Author Contributions
has gained substantial momentum in recent years, howev- Study conception and design: Elmously, Watkins, Pomp
er, quality improvement should continue to be held to the Acquisition of data: Elmously
same standards as the rest of medical practice. Analysis and interpretation of data: Elmously, Gray,
Michelassi, Afaneh, Kluger, Salemi, Watkins, Pomp
Limitations Drafting of manuscript: Elmously
Several important limitations are noteworthy. First, Critical revision: Gray, Michelassi, Afaneh, Kluger,
despite propensity score matching, because our study Salemi, Watkins, Pomp
106 Elmously et al Operating Room Attire and Healthcare Cost J Am Coll Surg