DERMATOLOGIC
SURGERY
Incidence of infection after Mohs micrographic and dermatologic surgery before and after implementation of new sterilization guidelines Austin Liu, MD, and Naomi Lawrence, MD Marlton, New Jersey Background: Clinical guidelines regarding surgical instrument sterilization established by accrediting organizations should be based on peer-reviewed scientific literature. Few data exist in the scientific literature to support the changes in sterilization protocols imposed by accrediting organizations. Objective: We sought to determine whether recently established guidelines for the sterilization of surgical instruments have had any clinical impact on postsurgical infection rates. Methods: Infections rates after excisional and Mohs micrographic surgery before and after implementation of new Joint Commission on the Accreditation of Healthcare Organizations sterilization guidelines were examined retrospectively. All surgeries were performed at an academic outpatient office. Results: In all, 1415 patients underwent a total of 1688 surgeries. No significant differences were observed in mean patient age (P = .113), mean number of Mohs micrographic surgical levels (P = .067), final defect size (P = .305), patient gender (P = .072), repair type (P = .691), or infection rate (P = .453). No major differences in predisposing factors were identified in patients who developed postsurgical infections. Limitations: This was a retrospective study conducted at a single academic institution. Conclusions: In our practice, recent changes in surgical instrument sterilization protocols have had no impact on postsurgical infection rates. The implementation of such guidelines places an additional burden on the health care system without providing any improvement in patient outcomes. ( J Am Acad Dermatol 2014;70:1088-91.) Key words: dermatologic surgery infection rate; Mohs micrographic surgery infection rate; sterilization protocols; surgical instrument sterilization.
istorically, skin surgery has a relatively low rate of infection of about 1% to 3%, reported in the literature.1,2 The development of infection after dermatologic surgery can be influenced by a number of different factors. Some of these include wound location or patient characteristics such as personal hygiene, smoking history, immunosuppressive state, and other medical comorbidities, which are beyond physician control. The surgical environment is a controllable and modifiable factor. Many precautions are taken to minimize the
H
risk of postsurgical infections including the use of sterile prepackaged supplies such as gloves and drapes. Reusable items such as surgical instruments and other clean, prepackaged equipment are sterilized in the office before use. At the authors’ academic outpatient office setting, previous protocols entailed the in-office sterilization of 4 3 4 gauze and 6-in cotton swabs and the use of a single sterilization pouch to create a sterile ‘‘surgical instrument pack.’’ Recently however, the Joint Commission on the Accreditation of Healthcare
From the Division of Dermatology, Cooper University Hospital Medical Center. Funding sources: None. Conflicts of interest: None declared. Accepted for publication February 9, 2014. Reprint requests: Naomi Lawrence, MD, Division of Dermatology, Cooper University Hospital Medical Center, 10000 Sagemore Dr,
Suite 10103, Marlton, NJ 08053. E-mail: lawrence-naomi@ cooperhealth.edu. Published online March 28, 2014. 0190-9622/$36.00 Ó 2014 by the American Academy of Dermatology, Inc. http://dx.doi.org/10.1016/j.jaad.2014.02.014
1088
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VOLUME 70, NUMBER 6
Organizations (JCAHO) implemented the following changes to the process of sterilization at all outpatient facilities:
patients underwent dermatologic surgery (excisional and Mohs micrographic surgery [MMS]) for the treatment of melanoma and nonmelanoma skin cancers. 1. Any items to be sterilized must have manufacAll surgeries from October 1, 2010, to September turers’ instructions for cleaning and sterilization. 30, 2011 (12-month period) were performed before execution of the new JCAHO guidelines. 2. Instruments must be sterilized individually, with A washout period occurred a single indicator for each between October 1, 2011, item. CAPSULE SUMMARY and December 31, 2011, Therefore, items such as during which the changes Current Joint Commission on the gauze and cotton swabs, were implemented in sucAccreditation of Healthcare which do not have sterilizacession. All cutaneous surOrganizations (JCAHO) guidelines tion instructions, could no geries between January 1, mandate specific, nonevidence-based, longer be sterilized in the 2012, and December 31, surgical instrument sterilization office setting. Furthermore, 2012 (12-month period) protocols to minimize postsurgical ‘‘surgical instrument packs’’ were performed with the infections. could no longer be used new guidelines in effect. Surgical instrument sterilization rules because each instrument Patients were excluded imposed by JCAHO do not reduce the must be separately sorted from the study if they incidence of infections after and sterilized in an individwere referred for repair dermatologic surgery. ual package. (to another specialty), unThese changes enforced Well-established methods of surgical derwent a delayed repair by JCAHO add a significant instrument sterilization are not only (delayed flap or graft), had time burden given that it reassociated with a similarly low rate of a surgical defect that was quires more time for the ofpostsurgical infections when compared allowed to heal by secondfice staff to carry out. with JCAHO guidelines but also require ary intention, or had a defect Furthermore, the new guideless health care resources to perform. repaired with an interpolines were not based on any lated repair (2-stage repair) previously published studies (Table I). in peer-reviewed journals demonstrating a statistiAdditional patient information that was recorded cally significant decrease in the rate of infection. and evaluated included: age, sex, surgical site and According to the JCAHO, new standards are develfinal defect size, number of MMS levels, and type of oped as follows: ‘‘Joint Commission standards are surgical repair (primary vs flap). Patients in both developed with input from health care professionals, groups who developed infections were examined providers, subject matter experts, consumers, govfor any differences in the rate of predisposing factors. ernment agencies (including the Centers for The main outcome measure used was the rate of Medicare & Medicaid Services) and employers. postsurgical infections. They are informed by scientific literature and expert consensus and approved by the Board of RESULTS Commissioners. New standards are added only if A total of 2093 patients underwent surgery for they relate to patient safety or quality of care, have a melanoma and nonmelanoma skin cancers during positive impact on health outcomes, meet or surpass the period from October 1, 2010, to December 31, law and regulation, and can be accurately and readily 2012. Based on the exclusion criteria, 443 patients measured.’’3 We sought to provide evidence-based did not qualify for the study; 235 patients underwent data on the impact of these new sterilization guidesurgery during the washout period and were also lines on wound infection rates after dermatologic excluded. Altogether, 1415 patients who underwent surgery. 1688 surgeries were included in the study. Before the guideline changes, a total of 57 standard excisions and 780 MMS cases were performed in 682 patients. METHODS After the guideline changes, 75 standard excisions A retrospective study was designed to examine and 776 MMS cases were performed in 733 patients. the rate of postsurgical infections between October In comparing patients who underwent surgery 1, 2010, and December 31, 2012, at an academic before and after JCAHO changes, respectively, no outpatient office. A diagnosis of infection was only differences were observed in mean patient age made if supported by a positive wound culture. All d
d
d
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Table I. Exclusion criteria
Table III. Infection rates
Patients referred to another specialty for repair Delayed repair performed (flap or graft) Surgical defects allowed to heal by secondary intention Surgical defects repaired with an interpolated flap
Infection
Pre-JCAHO
Post-JCAHO
Total
N Percent Total
17 2.0 837
22 2.6 851
39 2.3 1688
Table II. Repair type and distribution of surgical sites Pre-JCAHO N
Closure type Primary Flap Scalp Forehead Temple Eyelid Cheek Ear Nose Lip Chin Neck Trunk Extremities
n
Percent
614 223 63 99 58 24 159 40 166 23 20 37 75 73
73.4 26.6 7.5 11.8 6.9 2.9 19.0 4.8 19.8 2.7 2.4 4.4 9.0 8.7
837
837 837 837 837 837 837 837 837 837 837 837 837
Post-JCAHO N
n
Percent P value
851
851 851 851 851 851 851 851 851 851 851 851 851
.691 631 220 61 100 55 19 184 33 146 33 14 23 112 71
74.1 25.9 7.2 11.8 6.5 2.2 21.6 3.9 17.2 3.9 1.6 2.7 13.2 8.3
.778 .961 .701 .408 .180 .363 .157 .195 .276 .057 .006 .781
Bold italics indicates the only statistically significant difference. JCAHO, Joint Commission on the Accreditation of Healthcare Organizations; N, total number of subjects in this group; n, number of subjects with surgery sites at a specific location.
(66.78 vs 68 years, P = .113), mean number of MMS levels (1.53 vs 1.47, P = .067), final defect size (1.80 vs 1.95 cm2, P = .305), male gender (50.9% vs 55.7%, P = .072), repair type (73.4% primary repairs and 26.6% flaps vs 74.1% primary repairs and 25.9% flaps, P = .691) (Table II), or infection (2.0% vs 2.6%, P = .453) (Table III). No major differences in predisposing factors were identified in patients who developed postsurgical infections. In total, 5 diabetics and 2 patients on immunosuppressive medications were identified in the pre-JCAHO guideline change group and 6 diabetics were noted in the post-JCAHO change group. With regard to surgical site (Table II), the only significant difference between the 2 groups was in the number of surgeries on the trunk (9.0% of all surgeries in the prechange group vs 13.2% of all surgeries in the postchange group, P = .006).
DISCUSSION Numerous sterilization methods exist, such as steam autoclave, dry heat, chemiclave, cold sterilization, and gas sterilization. The sterilization method
JCAHO, Joint Commission on the Accreditation of Healthcare Organizations. P value = .453. Pearson x 2.
of choice is determined by the type of instruments being sterilized, the clinical practice setting (outpatient office vs hospital operating room), and the turnaround time that is required. In the outpatient dermatologic surgery setting, the steam autoclave is preferred because it is a low-maintenance, rapid, and easy method of sterilization. The infection rate after dermatologic surgery (excisions and MMS) generally falls below 5% and often between less than 1% to 3%.1,2 The low incidence of infection is because of the fact that most surgery sites are classified as ‘‘clean’’ sites. Strict sterilization/surgical procedures and the lack of other significant patient risk factors also contribute to the low rate of infection. Although some surgeons commonly use prophylactic antibiotics for certain surgical sites or types of repair, it has been recommended that the necessity of antimicrobials be determined on a case-by-case basis.4 Given the rising incidence of skin cancer,5 we can also expect an increase in excision and MMS procedures. However, with the rising cost of health care and continuously decreasing reimbursement for such procedures, the dermatologic surgeon needs to control rising overhead costs by streamlining office practices. These changes to increase efficiency and minimize infection need to be guided by evidence-based medicine. Previous evidence-based reports that have helped to reduce office overhead include a study by Rhinehart et al6 showing that use of clean, nonsterile gloves during the tumor extirpation stage of MMS did not affect the infection rate when compared with use of sterile gloves during this step. Xia et al7 further demonstrated that compared with sterile gloves, the use of clean, nonsterile gloves during the repair phase of MMS had no deleterious effect on the infection rate. The differences in equipment costs and personnel time resulting from changes enacted to comply with the JCAHO instrument sterilization guidelines were evaluated. Although no major difference in equipment cost or time required to prepare instruments for sterilization was noted, the average time to set up a tray for each stage of MMS and repair did increase
J AM ACAD DERMATOL VOLUME 70, NUMBER 6
after implementation of JCAHO guidelines. Before the changes, surgical packs containing all equipment needed to perform either a MMS stage or a surgical repair were available and allowed rapid setup of the surgical tray. Previously, a MMS tray could be prepared in approximately 2 seconds, whereas it required over 20 seconds after the new changes. Furthermore, repair trays previously required only 5 seconds to prepare but subsequently required over 1 minute to set up, after implementation of the new guidelines. Over time, these small additional steps lead to an overall decrease in office efficiency. The main goal of our study was to investigate whether the changes enacted by JCAHO reduce infection rates after dermatologic surgery. To ensure comparability of both patient populations, additional demographic information was evaluated, including patient age, sex, surgical site, number of MMS levels, final surgical defect size, and types of repair. With the exception of a statistically significant difference in the number of surgeries on the trunk, no significant differences were noted in any of the other variables. Our exclusion criteria were aimed to control for scenarios where significant extraneous factors are known to further increase infection risk. Based on our data, no significant change in infection rate was noted after the implementation of the new guidelines. The infection rates for patients who underwent surgery before and after the guideline changes were 2.0% and 2.6%, respectively. These figures were consistent with the rates of infection in the author’s clinical practice over the last 4 years (2006-2009), which were noted to be 3.30%, 3.26%, 2.67%, and 2.45%. Overall, these results have important practical implications for clinicians, given the time burden created by the new mandated protocols. Specifically, additional time is required for the medical staff to individually unpack each instrument for use, rather than creating and unpacking a single simple surgical pack. Such tasks are generally performed during
Liu and Lawrence 1091
clinical hours, thereby affecting the overall office flow and efficiency. Conclusions Although the enactment of new guidelines is aimed at improving patient care, such regulations need to be supported by scientific evidence. We aim to call attention to a scenario in which such guidelines provide no additional benefit but rather, place additional unnecessary burden on clinicians and their practices. In addition, our regulatory bodies should be held to the same standard as best clinical practices for medicine. Changes required should be evidenceebased and supported by carefully designed clinical trials published in peer-reviewed literature. At the very least when changes are mandated there should be some effort to develop a metric by which the effect of those changes is measured. In the current changing era of medicine, the clinician and the health care system must make careful decisions to simultaneously improve efficiency and provide superior patient care. REFERENCES 1. Futoryan T, Grande D. Postoperative wound infection rates in dermatologic surgery. Dermatol Surg 1995;21:509-14. 2. Whitaker DC, Grande DJ, Johnson SS. Wound infection rate in dermatologic surgery. J Dermatol Surg Oncol 1988;14:525-8. 3. Joint Commission on the Accreditation of Healthcare Organizations. Standards development process. Available from: URL: http://www.jointcommission.org/assets/1/18/Standards1.PDF. Accessed June 23, 2013. 4. Maragh SL, Brown MD. Prospective evaluation of surgical site infection rate among patients with Mohs micrographic surgery without the use of prophylactic antibiotics. J Am Acad Dermatol 2008;59:275-8. 5. Centers for Disease Control and Prevention. Statistics on skin cancer. Available from: URL:http://www.cdc.gov/cancer/skin/ statistics/. Accessed October 19, 2012. 6. Rhinehart MB, Murphy MM, Farley MF, Albertini JG. Sterile versus nonsterile gloves during Mohs micrographic surgery: infection rate is not affected. Dermatol Surg 2006;32:170-6. 7. Xia Y, Cho S, Greenway HT, Zelac DE, Kelley B. Infection rates of wound repairs during Mohs micrographic surgery using sterile versus nonsterile gloves: a prospective randomized pilot study. Dermatol Surg 2011;37:651-6.
SURGERY
Incidence of infection after Mohs micrographic and dermatologic surgery before and after implementation of new sterilization guidelines Austin Liu, MD, and Naomi Lawrence, MD Marlton, New Jersey Background: Clinical guidelines regarding surgical instrument sterilization established by accrediting organizations should be based on peer-reviewed scientific literature. Few data exist in the scientific literature to support the changes in sterilization protocols imposed by accrediting organizations. Objective: We sought to determine whether recently established guidelines for the sterilization of surgical instruments have had any clinical impact on postsurgical infection rates. Methods: Infections rates after excisional and Mohs micrographic surgery before and after implementation of new Joint Commission on the Accreditation of Healthcare Organizations sterilization guidelines were examined retrospectively. All surgeries were performed at an academic outpatient office. Results: In all, 1415 patients underwent a total of 1688 surgeries. No significant differences were observed in mean patient age (P = .113), mean number of Mohs micrographic surgical levels (P = .067), final defect size (P = .305), patient gender (P = .072), repair type (P = .691), or infection rate (P = .453). No major differences in predisposing factors were identified in patients who developed postsurgical infections. Limitations: This was a retrospective study conducted at a single academic institution. Conclusions: In our practice, recent changes in surgical instrument sterilization protocols have had no impact on postsurgical infection rates. The implementation of such guidelines places an additional burden on the health care system without providing any improvement in patient outcomes. ( J Am Acad Dermatol 2014;70:1088-91.) Key words: dermatologic surgery infection rate; Mohs micrographic surgery infection rate; sterilization protocols; surgical instrument sterilization.
istorically, skin surgery has a relatively low rate of infection of about 1% to 3%, reported in the literature.1,2 The development of infection after dermatologic surgery can be influenced by a number of different factors. Some of these include wound location or patient characteristics such as personal hygiene, smoking history, immunosuppressive state, and other medical comorbidities, which are beyond physician control. The surgical environment is a controllable and modifiable factor. Many precautions are taken to minimize the
H
risk of postsurgical infections including the use of sterile prepackaged supplies such as gloves and drapes. Reusable items such as surgical instruments and other clean, prepackaged equipment are sterilized in the office before use. At the authors’ academic outpatient office setting, previous protocols entailed the in-office sterilization of 4 3 4 gauze and 6-in cotton swabs and the use of a single sterilization pouch to create a sterile ‘‘surgical instrument pack.’’ Recently however, the Joint Commission on the Accreditation of Healthcare
From the Division of Dermatology, Cooper University Hospital Medical Center. Funding sources: None. Conflicts of interest: None declared. Accepted for publication February 9, 2014. Reprint requests: Naomi Lawrence, MD, Division of Dermatology, Cooper University Hospital Medical Center, 10000 Sagemore Dr,
Suite 10103, Marlton, NJ 08053. E-mail: lawrence-naomi@ cooperhealth.edu. Published online March 28, 2014. 0190-9622/$36.00 Ó 2014 by the American Academy of Dermatology, Inc. http://dx.doi.org/10.1016/j.jaad.2014.02.014
1088
J AM ACAD DERMATOL
Liu and Lawrence 1089
VOLUME 70, NUMBER 6
Organizations (JCAHO) implemented the following changes to the process of sterilization at all outpatient facilities:
patients underwent dermatologic surgery (excisional and Mohs micrographic surgery [MMS]) for the treatment of melanoma and nonmelanoma skin cancers. 1. Any items to be sterilized must have manufacAll surgeries from October 1, 2010, to September turers’ instructions for cleaning and sterilization. 30, 2011 (12-month period) were performed before execution of the new JCAHO guidelines. 2. Instruments must be sterilized individually, with A washout period occurred a single indicator for each between October 1, 2011, item. CAPSULE SUMMARY and December 31, 2011, Therefore, items such as during which the changes Current Joint Commission on the gauze and cotton swabs, were implemented in sucAccreditation of Healthcare which do not have sterilizacession. All cutaneous surOrganizations (JCAHO) guidelines tion instructions, could no geries between January 1, mandate specific, nonevidence-based, longer be sterilized in the 2012, and December 31, surgical instrument sterilization office setting. Furthermore, 2012 (12-month period) protocols to minimize postsurgical ‘‘surgical instrument packs’’ were performed with the infections. could no longer be used new guidelines in effect. Surgical instrument sterilization rules because each instrument Patients were excluded imposed by JCAHO do not reduce the must be separately sorted from the study if they incidence of infections after and sterilized in an individwere referred for repair dermatologic surgery. ual package. (to another specialty), unThese changes enforced Well-established methods of surgical derwent a delayed repair by JCAHO add a significant instrument sterilization are not only (delayed flap or graft), had time burden given that it reassociated with a similarly low rate of a surgical defect that was quires more time for the ofpostsurgical infections when compared allowed to heal by secondfice staff to carry out. with JCAHO guidelines but also require ary intention, or had a defect Furthermore, the new guideless health care resources to perform. repaired with an interpolines were not based on any lated repair (2-stage repair) previously published studies (Table I). in peer-reviewed journals demonstrating a statistiAdditional patient information that was recorded cally significant decrease in the rate of infection. and evaluated included: age, sex, surgical site and According to the JCAHO, new standards are develfinal defect size, number of MMS levels, and type of oped as follows: ‘‘Joint Commission standards are surgical repair (primary vs flap). Patients in both developed with input from health care professionals, groups who developed infections were examined providers, subject matter experts, consumers, govfor any differences in the rate of predisposing factors. ernment agencies (including the Centers for The main outcome measure used was the rate of Medicare & Medicaid Services) and employers. postsurgical infections. They are informed by scientific literature and expert consensus and approved by the Board of RESULTS Commissioners. New standards are added only if A total of 2093 patients underwent surgery for they relate to patient safety or quality of care, have a melanoma and nonmelanoma skin cancers during positive impact on health outcomes, meet or surpass the period from October 1, 2010, to December 31, law and regulation, and can be accurately and readily 2012. Based on the exclusion criteria, 443 patients measured.’’3 We sought to provide evidence-based did not qualify for the study; 235 patients underwent data on the impact of these new sterilization guidesurgery during the washout period and were also lines on wound infection rates after dermatologic excluded. Altogether, 1415 patients who underwent surgery. 1688 surgeries were included in the study. Before the guideline changes, a total of 57 standard excisions and 780 MMS cases were performed in 682 patients. METHODS After the guideline changes, 75 standard excisions A retrospective study was designed to examine and 776 MMS cases were performed in 733 patients. the rate of postsurgical infections between October In comparing patients who underwent surgery 1, 2010, and December 31, 2012, at an academic before and after JCAHO changes, respectively, no outpatient office. A diagnosis of infection was only differences were observed in mean patient age made if supported by a positive wound culture. All d
d
d
J AM ACAD DERMATOL
1090 Liu and Lawrence
JUNE 2014
Table I. Exclusion criteria
Table III. Infection rates
Patients referred to another specialty for repair Delayed repair performed (flap or graft) Surgical defects allowed to heal by secondary intention Surgical defects repaired with an interpolated flap
Infection
Pre-JCAHO
Post-JCAHO
Total
N Percent Total
17 2.0 837
22 2.6 851
39 2.3 1688
Table II. Repair type and distribution of surgical sites Pre-JCAHO N
Closure type Primary Flap Scalp Forehead Temple Eyelid Cheek Ear Nose Lip Chin Neck Trunk Extremities
n
Percent
614 223 63 99 58 24 159 40 166 23 20 37 75 73
73.4 26.6 7.5 11.8 6.9 2.9 19.0 4.8 19.8 2.7 2.4 4.4 9.0 8.7
837
837 837 837 837 837 837 837 837 837 837 837 837
Post-JCAHO N
n
Percent P value
851
851 851 851 851 851 851 851 851 851 851 851 851
.691 631 220 61 100 55 19 184 33 146 33 14 23 112 71
74.1 25.9 7.2 11.8 6.5 2.2 21.6 3.9 17.2 3.9 1.6 2.7 13.2 8.3
.778 .961 .701 .408 .180 .363 .157 .195 .276 .057 .006 .781
Bold italics indicates the only statistically significant difference. JCAHO, Joint Commission on the Accreditation of Healthcare Organizations; N, total number of subjects in this group; n, number of subjects with surgery sites at a specific location.
(66.78 vs 68 years, P = .113), mean number of MMS levels (1.53 vs 1.47, P = .067), final defect size (1.80 vs 1.95 cm2, P = .305), male gender (50.9% vs 55.7%, P = .072), repair type (73.4% primary repairs and 26.6% flaps vs 74.1% primary repairs and 25.9% flaps, P = .691) (Table II), or infection (2.0% vs 2.6%, P = .453) (Table III). No major differences in predisposing factors were identified in patients who developed postsurgical infections. In total, 5 diabetics and 2 patients on immunosuppressive medications were identified in the pre-JCAHO guideline change group and 6 diabetics were noted in the post-JCAHO change group. With regard to surgical site (Table II), the only significant difference between the 2 groups was in the number of surgeries on the trunk (9.0% of all surgeries in the prechange group vs 13.2% of all surgeries in the postchange group, P = .006).
DISCUSSION Numerous sterilization methods exist, such as steam autoclave, dry heat, chemiclave, cold sterilization, and gas sterilization. The sterilization method
JCAHO, Joint Commission on the Accreditation of Healthcare Organizations. P value = .453. Pearson x 2.
of choice is determined by the type of instruments being sterilized, the clinical practice setting (outpatient office vs hospital operating room), and the turnaround time that is required. In the outpatient dermatologic surgery setting, the steam autoclave is preferred because it is a low-maintenance, rapid, and easy method of sterilization. The infection rate after dermatologic surgery (excisions and MMS) generally falls below 5% and often between less than 1% to 3%.1,2 The low incidence of infection is because of the fact that most surgery sites are classified as ‘‘clean’’ sites. Strict sterilization/surgical procedures and the lack of other significant patient risk factors also contribute to the low rate of infection. Although some surgeons commonly use prophylactic antibiotics for certain surgical sites or types of repair, it has been recommended that the necessity of antimicrobials be determined on a case-by-case basis.4 Given the rising incidence of skin cancer,5 we can also expect an increase in excision and MMS procedures. However, with the rising cost of health care and continuously decreasing reimbursement for such procedures, the dermatologic surgeon needs to control rising overhead costs by streamlining office practices. These changes to increase efficiency and minimize infection need to be guided by evidence-based medicine. Previous evidence-based reports that have helped to reduce office overhead include a study by Rhinehart et al6 showing that use of clean, nonsterile gloves during the tumor extirpation stage of MMS did not affect the infection rate when compared with use of sterile gloves during this step. Xia et al7 further demonstrated that compared with sterile gloves, the use of clean, nonsterile gloves during the repair phase of MMS had no deleterious effect on the infection rate. The differences in equipment costs and personnel time resulting from changes enacted to comply with the JCAHO instrument sterilization guidelines were evaluated. Although no major difference in equipment cost or time required to prepare instruments for sterilization was noted, the average time to set up a tray for each stage of MMS and repair did increase
J AM ACAD DERMATOL VOLUME 70, NUMBER 6
after implementation of JCAHO guidelines. Before the changes, surgical packs containing all equipment needed to perform either a MMS stage or a surgical repair were available and allowed rapid setup of the surgical tray. Previously, a MMS tray could be prepared in approximately 2 seconds, whereas it required over 20 seconds after the new changes. Furthermore, repair trays previously required only 5 seconds to prepare but subsequently required over 1 minute to set up, after implementation of the new guidelines. Over time, these small additional steps lead to an overall decrease in office efficiency. The main goal of our study was to investigate whether the changes enacted by JCAHO reduce infection rates after dermatologic surgery. To ensure comparability of both patient populations, additional demographic information was evaluated, including patient age, sex, surgical site, number of MMS levels, final surgical defect size, and types of repair. With the exception of a statistically significant difference in the number of surgeries on the trunk, no significant differences were noted in any of the other variables. Our exclusion criteria were aimed to control for scenarios where significant extraneous factors are known to further increase infection risk. Based on our data, no significant change in infection rate was noted after the implementation of the new guidelines. The infection rates for patients who underwent surgery before and after the guideline changes were 2.0% and 2.6%, respectively. These figures were consistent with the rates of infection in the author’s clinical practice over the last 4 years (2006-2009), which were noted to be 3.30%, 3.26%, 2.67%, and 2.45%. Overall, these results have important practical implications for clinicians, given the time burden created by the new mandated protocols. Specifically, additional time is required for the medical staff to individually unpack each instrument for use, rather than creating and unpacking a single simple surgical pack. Such tasks are generally performed during
Liu and Lawrence 1091
clinical hours, thereby affecting the overall office flow and efficiency. Conclusions Although the enactment of new guidelines is aimed at improving patient care, such regulations need to be supported by scientific evidence. We aim to call attention to a scenario in which such guidelines provide no additional benefit but rather, place additional unnecessary burden on clinicians and their practices. In addition, our regulatory bodies should be held to the same standard as best clinical practices for medicine. Changes required should be evidenceebased and supported by carefully designed clinical trials published in peer-reviewed literature. At the very least when changes are mandated there should be some effort to develop a metric by which the effect of those changes is measured. In the current changing era of medicine, the clinician and the health care system must make careful decisions to simultaneously improve efficiency and provide superior patient care. REFERENCES 1. Futoryan T, Grande D. Postoperative wound infection rates in dermatologic surgery. Dermatol Surg 1995;21:509-14. 2. Whitaker DC, Grande DJ, Johnson SS. Wound infection rate in dermatologic surgery. J Dermatol Surg Oncol 1988;14:525-8. 3. Joint Commission on the Accreditation of Healthcare Organizations. Standards development process. Available from: URL: http://www.jointcommission.org/assets/1/18/Standards1.PDF. Accessed June 23, 2013. 4. Maragh SL, Brown MD. Prospective evaluation of surgical site infection rate among patients with Mohs micrographic surgery without the use of prophylactic antibiotics. J Am Acad Dermatol 2008;59:275-8. 5. Centers for Disease Control and Prevention. Statistics on skin cancer. Available from: URL:http://www.cdc.gov/cancer/skin/ statistics/. Accessed October 19, 2012. 6. Rhinehart MB, Murphy MM, Farley MF, Albertini JG. Sterile versus nonsterile gloves during Mohs micrographic surgery: infection rate is not affected. Dermatol Surg 2006;32:170-6. 7. Xia Y, Cho S, Greenway HT, Zelac DE, Kelley B. Infection rates of wound repairs during Mohs micrographic surgery using sterile versus nonsterile gloves: a prospective randomized pilot study. Dermatol Surg 2011;37:651-6.
