Patient safety in dermatology: A review of the literature
Published Web Location
https://doi.org/10.5070/D375z671jbMain Content
Patient safety in dermatology: A review of the literature
Lauren Y Cao BS1, James S Taylor MD2, Allison Vidimos R Ph MD3
Dermatology Online Journal 16 (1): 3
1. MD/MS Clinical Research Scholars Program (CRSP) Student, Case Western Reserve University School of Medicine, Cleveland,
Ohio2. Consultant Dermatologist, Dermatology-Plastic Surgery Institute, Desk A-61, Cleveland Clinic, Cleveland, Ohio 44195. taylorj@ccf.org
3. Chair, Department of Dermatology, Dermatology-Plastic Surgery Institute, Cleveland Clinic, Cleveland, Ohio
Abstract
OBJECTIVE: We performed a literature review of patient safety topics pertinent to dermatology and related to outpatient settings for situations in which data from dermatology are lacking. METHODS: Searches in MEDLINE via PubMed interface, OVID and Google Scholar were carried out from October, 2008 through May, 2009 for English-language articles published between 1948 and 2009. Each search combined 2 or 3 of the following terms: patient safety, medical error, human error, preventable adverse event, dermatology, outpatient, ambulatory care, medication error, diagnostic error, laboratory error, pathology error, office-based surgery, wrong-site procedure, infections, falls, laser safety, scope of practice. Personal communications, websites, books, dermatology newsletters and major textbooks were also scrutinized. Potentially relevant articles and communications were critically evaluated by the authors. References from these articles were searched for "other relevant articles." SUMMARY: Patient safety studies in dermatology and outpatient settings are lagging behind those in inpatient settings. Systems changes are needed to reduce medical errors rather than penalize individual healthcare workers. Although technology may improve patient safety in numerous aspects, it introduces new sources of errors. CONCLUSION: Our review reveals few studies on dermatologic patient safety, supporting the pressing need for such studies and reports in the future.
I. Introduction
In the 1990s, a number of medical errors became highly publicized, including the case of Betsy Lehman, the Boston Globe reporter who died because of an overdose of her breast cancer chemotherapy agent, and Willie King, a diabetic who had the wrong leg amputated leading to the loss of both of his legs [1, 2]. These high-profile cases, along with increasing public pressure, prompted various investigations, publications, and conferences [3, 4, 5, 6]. In 2000, the National Academy of Sciences Institute of Medicine (IOM) published the report entitled To Err Is Human: Building a Safer Health System, which asserted that 44,000 to 98,000 people die each year as a result of medical errors in U.S. hospitals; this is more than annual deaths from motor vehicle accidents, breast cancer, or AIDS [1]. This report was covered extensively by the media and spurred increasingly grave concern and dialogue about patient safety over the past decade.
Although most patient safety studies to date have been conducted in inpatient settings, medical errors present a major problem in outpatient settings as well, including those of dermatology. With technological advances and cost containment measures, increasing and progressively more complex care is provided in outpatient settings. With Medicare's encouragement, outpatient surgical centers, physician offices, and clinics provide care to thousands of patients each day [1, 7].
An abundance of patient safety anecdotes involving medical errors circulate throughout the dermatological community. For example, accidental prescribing of methotrexate for psoriasis daily instead of weekly, mistaken directions on prescription labels to take methotrexate daily instead of weekly, and patients' misunderstanding of methotrexate administration frequency have led to fatalities and permanent disabilities [8, 9]. Tetanus toxoid has been injected intradermally instead of purified protein derivative for tuberculin skin testing, due to similar packaging instruction confusion, which has resulted in reactions with indurations 30 mm to 60 mm in diameter [8, 10]. Consequently, some patients have been precluded from receiving biologic agents to treat their psoriasis or have been prescribed isoniazid to treat non-existent tuberculosis [8]. Yet, few studies and reports have been carried out to assess the extent and impact of medical errors in dermatology and ways to improve patient safety. To our knowledge, this is the second review article that has been written on the issue of patient safety and medical errors in dermatology. It was written independently of a two-part review by Elston et al. [11, 12]; one of us (JST) was co-author of part 1.
This article presents a comprehensive review of patient safety studies and reports on topics pertinent to dermatology, emphasizing the outpatient setting. Topics reviewed include medication errors, laboratory and pathology specimen processing, tracking and communication of results, diagnostic errors, office-based surgery, wrong-site procedures, infections, falls, laser safety errors, and scope of practice expansions that can lead to errors.
I.A. Definitions
The IOM report To Err Is Human defines safety as "freedom from accidental injury," and emphasizes the primary safety goal from the patient's perspective [1]. The National Patient Safety Foundation defines patient safety as "the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the processes of health care" [13]. It stresses that safety depends on the interaction of system components, and not on a person, device or department. Patient safety is a part of health care quality [14, 15].
Error is defined as "the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning)" [1, 16]. It may occur anywhere along the patient care continuum, but may not always result in harm or injury. An error which is intercepted before reaching the patient, or which reaches the patient but does not cause harm, is known as a near miss or close call [1, 16]. An error that does result in patient injury is sometimes called a preventable adverse event [1, 16]. In contrast, an adverse event is patient "injury resulting from a medical intervention," which may not be preventable (i.e., attributable to errors) [1, 16]. The identification of each type of error, when reported and analyzed, represents an opportunity to identify and implement system improvements which may prevent future adverse events. Table 1 lists potential systems improvements for patient safety, which utilize principles of human factors engineering.
II. Methods
MEDLINE via PubMed interface, OVID and Google Scholar were searched from October of 2008 through May of 2009 for English-language articles published between 1948 and 2009. Both free-word thesaurus and index word searches were used. Each combined 2 or 3 of the following terms: patient safety, medical error, human error, preventable adverse event, dermatology, outpatient, ambulatory care, medication error, diagnostic error, laboratory error, pathology error, office-based surgery, wrong-site procedure, infections, falls, laser safety, scope of practice. Additionally, personal communications, websites, books, dermatology newsletters and major textbook chapters related to patient safety were utilized. Those that applied to patient safety in dermatology and other outpatient settings were selected and data extracted. References of the selected articles were scanned for potentially relevant articles. "Other relevant articles" of the selected articles were also searched to find related articles. In the thousands of articles on patient safety, there are undoubtedly sections relevant to dermatology that may have been overlooked.
III. Discussion
III.A. Medication errors
Medication errors have been the most extensively investigated realm in patient safety, because of a number of factors. Firstly, medication use is widespread. In 2003, 3.4 billion prescriptions were purchased in the U.S., with an average of 11.8 prescriptions per person [2]. Also, medication prescribing is usually accompanied by thorough documentation, which may be easily accessed through paper charts or computer databases [1]. Moreover, deaths attributable to medication errors are recorded on death certificates [1]. According to Phillips et al., the number of outpatient visits in the U.S. increased by 75 percent, whereas the number of inpatient days decreased by 21 percent between 1983 and 1993; outpatient deaths related to medication errors increased 8.48-fold during this 10-year period, as compared to a 2.37-fold increase for inpatient deaths [17]. This is particularly relevant to dermatology, in which care including surgical procedures is increasingly provided in the outpatient setting.
Extent and cost. Although few studies to date have examined the extent and cost of medication errors in dermatology, similar studies have been conducted for outpatient settings. Balkrishnan et al. specifically analyzed medication error reporting systems for topical medications associated with dermatological diseases and found that the rate of medication-related incidents was as high as 4.49 to 24.1 per 1000 inpatient days [18]. A review of 14 Australian outpatient studies published between 1988 and 1996 found that 2.4 percent to 3.6 percent of all hospital admissions were drug-related, of which 32 percent to 69 percent were reported as definitely or possibly preventable [19]. In a study carried out in four primary care practices in Boston, Gandhi et al. reported that 25 percent of the patients who responded to the survey had experienced adverse drug event; of a total of 181 documented adverse drug events, 28 percent were deemed ameliorable and 20 percent preventable [20]. Although not all drug-related morbidity and mortality are preventable, a number of studies have reported errors in ambulatory prescribing [21, 22, 23, 24, 25], dispensing [24], and unintentional non-adherence by patients [18, 26]. Population-based studies have shown that common drugs leading to medication-related hospitalizations include cytotoxic, anti-rheumatic, analgesic, antibiotic, and corticosteroid agents, which are often prescribed during routine dermatological care [27, 28].
Types of medication errors. Medication errors may be classified along the medication-use continuum into prescribing, dispensing, and administration errors. Table 2 lists common errors associated with each medication-use stage as it pertains to outpatient dermatology and includes systems recommendations for reducing these errors. One common factor contributing to errors in all three stages is the use of error-prone abbreviations, dose expressions, symbols, drug abbreviations, and stems (Table 3). Confusion between sound- or look-alike medications is another frequent contributor to errors throughout the medication-use continuum. Table 4 lists commonly prescribed dermatological medications and their sound- or look-alike counterparts.
Prescribing errors accounted for 13 percent of all medication errors in one study [37] and occurred in 7.6 percent of outpatient prescriptions in another study [25]. Regarding dispensing errors, Flynn et al. have reported the dispensing accuracy rate to be 98.3 percent, meaning that 1.7 percent of medications are dispensed inaccurately [38]. This translates to 51.5 million errors in the 3 billion U.S. prescriptions filled annually [38]. Administration errors account for more than one third (38%) of medication errors and only 2 percent are intercepted and corrected [39]. In contrast, about the same proportion of errors occur during medication prescribing, but nurses and pharmacists detect about half (48%) of these errors before they reach the patient [39]. More than half of the medication errors that cause patient harm originate during drug administration [39].
Non-compliance by patients and their families accounted for 64 percent of medication errors [37]; and 5.5 percent of admissions (1.94 million) and $8.5 billion in hospital expenditures in 1986 [40]. Intentional non-adherence is infrequent and many of these errors may be attributed to communication breakdowns or other factors (e.g., visual impairment, cultural customs) [8, 37]. Patients should be encouraged to check their pharmacy-dispensed medication against the physician's prescription; take a list of their medications to a clinical appointment; and inform a healthcare provider about a drug allergy without being asked.
Computerized prescriber order entry (CPOE). Although CPOE systems can help prevent many common medication errors, they may also be sources of new errors. CPOE can potentially reduce medication errors by more than 50 percent in hospitals and prevent 95 percent of potential adverse drug events in the outpatient setting [25, 41]. A 2008 systematic review found that compared with handwritten orders, 80 percent of CPOE studies reported a significant decrease in prescribing errors, 43 percent in dosing errors, and 37.5 percent in adverse drug events [42]. Use of CPOE was associated with a 66 percent decrease in total prescribing errors in adults. However, CPOE is not without its share of potential problems. Koppel et al. reported 22 types of medication error risks that are commonly facilitated by CPOE [43]. In looking at outpatient medication errors with emphasis on topical dermatological medications, Balkrishnan and coworkers reported that CPOE systems introduce problems such as faulty computer interface, miscommunication with other systems, lack of adequate decision support, and other human errors (knowledge deficit, distractions, inexperience, typing errors) [18]. Hence, it is vital for healthcare professionals and organizations to recognize and attend to errors that CPOE and other technological systems facilitate.
III.B. Diagnostic errors related to laboratory and pathology specimen processing, tracking, and communication of results
Diagnostic error is defined as a missed, wrong or delayed diagnosis, as detected by some subsequent definitive test [44, 45]. Misdiagnosis-related harm is defined as preventable harm that results from delay or failure to treat a condition (when diagnosis was wrong or unknown) or from treatment of a condition not actually present [44]. Diagnostic errors are often unrecognized or unreported, especially in the outpatient setting [44]. A recent office practice survey revealed that the top two nonspecialty-specific failures are (1) ineffective tracking of diagnostic tests/consultations, (2) incomplete or poor documentation [46]. In dermatology, diagnostic errors primarily apply to diagnoses of melanoma and other skin cancers due to failures, delays and errors in laboratory and pathology specimen processing, interpretation, tracking and communication of results (Susan Marr, Patient Safety/Risk Management Account Executive, The Doctors Company, personal communication, February 5, 2009).
Categories of errors. A late or missed laboratory or pathology test processing or notification may be catastrophic for patients, healthcare professionals, and organizations. Laboratory and pathology testing errors have commonly been categorized into pre-analytical, analytical, and post-analytical errors (Table 5). Overall testing report failures have been estimated to range from 0.1 percent to 2.0 percent of all tests requested—of these, error rates for pre- and post-analytical phases of testing have consistently been higher than that for the analytical phase [48, 49, 50]. To improve patient safety in all phases, more effective integration of automation and information technology, assay standardization, staff education, and interdepartmental cooperation and communication are needed [49].
There are several reports on diagnostic errors related to dermatopathology specimen processing and interpretation that may affect patient safety. Penneys hypothesized that managed care organizations' cost-saving measures to direct dermatopathological specimens to anonymous consultants may decrease the accuracy of results [51]. After examining 364 consecutive specimens, he found 26 cases of errors (7.1% of all examined cases) made by anonymous consultants, which included failure to correlate histological findings with clinical history, failure to resolve conflicts between histological pattern and clinical information, and apparent lack of dermatologic disease understanding.
Carli et al. studied the diagnosis of 100 difficult pigmented skin lesions [52]. They concluded that lesion management based on morphology should be supplemented with direct patient interaction and examination, so as to ensure that equivocal cases of skin malignancies are correctly diagnosed and appropriately managed.
Tracking and notification studies. Ensuring that patients receive accurate and timely laboratory and pathology result notification and return for indicated care is challenging. The need for a structured process in tracking and notification of laboratory and pathology results is well recognized. A 2005 publication revealed that surveyed physicians were unaware of almost 2/3 of the potentially actionable test results that are returned after patient discharge [53]. Seventeen percent to 32 percent of physicians had no reliable method to ensure that results of all tests ordered are received; 1/3 did not always notify patients of abnormal results (some relied on follow-up visits); lack of documentation of patient notifications were common, especially among resident physicians. Only 23 percent of physicians had a reliable method for identifying patients overdue for follow-up [54]. Table 6 lists recommendations to ensure optimal laboratory and pathology result tracking and notification.
In dermatology, an Israeli multidisciplinary team reported systematic interventions to enhance the safety and efficiency of the biopsy result notification process [57]. These included (1) medical staff and patient education: presenting survey results at staff meetings, increasing awareness of missing pathology results and resulting legal, ethical and health implications, encouraging patient involvement and education; (2) establishing standards for biopsy result reporting; and (3) designing a new pathology test form with more complete demographic information. The authors also implemented a computerized alert system that improved timely delivery and physician reading of pathology results over a 3-year period.
III.C. Office-based surgery
Office-based surgeries offer numerous advantages, including cost-effectiveness, more personalized and continuous care, increased patient satisfaction, and decreased incidence of infections [58]. However, because of media highlights of hazards associated with office surgery and anesthesia in 1999-2000, numerous states began drafting regulations restricting office procedures, which led Coldiron to argue that these proposals were based on scarce data on patient injuries in office settings [59]. Others have urged that these state regulations be based on verifiable data sources and well-designed prospective analyses [58]. This debate is pertinent to dermatology because dermatologic surgeons perform around 3.9 million procedures annually, mostly in the office setting [7]. The American Academy of Dermatology [60-66], American Society for Dermatologic Surgery [62, 67, 68], American Society of Plastic Surgeons [69, 70], and the American College of Surgeons [71] have published guidelines of care for office-based surgeries.
Florida Data. Over the past 10 years, various investigators have debated the safety of office-based surgeries, analyzing data primarily from Florida's mandatory reporting system. Coldiron et al. have published a series of articles analyzing seven years of Florida data, which demonstrate several trends [59, 72-77]. Medically necessary office-based surgeries are not more harmful to patients than those performed in other settings, but a disproportionate rate of deaths and injuries from office-based surgeries is related to cosmetic procedures performed primarily by board-certified plastic surgeons. This finding is supported by others [78, 79]. Over the 7-year period, 22.6 percent of surgical deaths and 13.6 percent of hospital transfers were associated with liposuction performed under general anesthesia [77]. In contrast, no adverse incidents were reported for office-based liposuction under tumescent (local administration of dilute lidocaine and epinephrine) anesthesia, which is used by most dermatologic surgeons [77, 80]. Tumescent liposuction may account for one third of all liposuctions performed in the U.S. and should account for a substantial proportion of liposuctions in Florida physician offices [78]. Similar results have been obtained by other investigators [58, 78, 81, 82, 83].
Using Florida's adverse events reporting data from April 1, 2000 to April 1, 2002, Vila et al. found that there was a 10-fold increased risk of adverse events and deaths from surgeries performed in the office setting when compared with those in ambulatory surgical centers [84]. This was subsequently refuted by Venkat and Coldiron et al., who attributed the findings of Vila et al. primarily to biases associated with data collection and differences in the number of surgeries performed in physician offices versus ambulatory surgical centers [85].
III.D. Wrong-site procedures
Mohs surgery. Wrong-site procedures represent a significant threat to dermatological patients' safety. Although most published reports have come from Mohs surgery, wrong-site procedures are just as relevant to other forms of general and surgical dermatology, including the performance of biopsies or laser treatments. According to a survey study of U.S. Mohs surgeons, 11 percent of the 300 respondents had admitted to having medical malpractice lawsuits brought against them [86]. One of the most frequent causes was the performance of wrong-site surgeries, which accounted for approximately 14 percent of all tabulated lawsuits. Although not supported by their malpractice claims data, the authors hypothesized that more detailed pre-operative evaluation and documentation, such as with diagrams and photographs, would reduce the rate of wrong-site surgeries in comparison with written notes alone in finding surgical sites.
This hypothesis was supported by a 2007 observational study, which asserted that photographing skin lesions before biopsy contributed to preventing wrong-site surgeries when the lesion was found to be malignant and the remaining tumor was subsequently excised by Mohs surgery [87]. The investigators felt that factors such as wound healing and actinic skin damage may make biopsy sites difficult to identify at the time of surgery and reported that before Mohs surgery on 271 biopsy sites, 16.6 percent of sites were incorrectly identified by patients when looking into a mirror; 5.9 percent were incorrectly identified by Mohs surgeons when using anatomic descriptions on pathology reports, biopsy site diagrams, and palpation; 4.4 percent of sites were incorrectly identified by both patients and physicians. In contrast, all biopsy sites were correctly identified when using pre-biopsy photographs of skin lesions. However all patients underwent surgery an average of 2-3 weeks after biopsy, suggesting that rates of wrong-site surgery may be even higher with longer wait times between biopsy and surgery.
Other methods for reducing errors in Mohs surgery are through the consistent use of tissue nicks on the patient and excised tissue samples for orientation and the use of detailed annotation of pre-printed anatomic maps and tissue transfer cards [88]. Although recurrence after Mohs surgery occurs only in 1-2 percent of cases, 75 percent of these recurrences are due to human errors, which include incorrect tissue orientation, and incorrect mapping, and mislabeling of tissue sections or slides. Additionally, the surgeon should confirm the site with the patient before performing surgery and document this in the patient's chart.
Non-dermatological procedures. The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) defines wrong-site procedures more broadly to include procedures performed on the wrong site of the body, the wrong patient, or performing the wrong procedure [89]. Wrong-site procedures as defined by JCAHO have been reported from other outpatient settings [90] and Table 7 lists the risk factors. On July 1, 2004, JCAHO implemented the universal protocol for the prevention of wrong-site procedures (Table 8). However, Kwaan et al. asserted that even with careful site verification procedures similar to the JCAHO universal protocol, one third of non-dermatologic wrong-site surgeries still occurred [91]. Table 9 contains a more comprehensive list of methods for reducing wrong-site procedures and the limitations associated with each method.
III.E. Infections
Hand hygiene. Infection control is as pertinent to outpatient dermatological care as to inpatient care. Hand hygiene by healthcare professionals is an important but often overlooked method of preventing infectious agent transmission. In one Israeli study, the hands of all 13 dermatologist physicians sampled were found to be contaminated, of which 9 cases were contaminated with Staphylococcus aureus and 1 case with methicillin-resistant Staphylococcus aureus (MRSA) [99]. Whereas 555 opportunities for hand disinfection were observed, the same 13 dermatologists decontaminated their hands only 31.4 percent of the time on average. In a questionnaire completed by 51 dermatologists, the main reasons given for poor hand hygiene were excessive work scheduled, lack of awareness, reaction to disinfectants, and lack of readily available facilities. Table 10 lists hand hygiene recommendations applicable to dermatological outpatient settings. In most cases, use of an alcohol-based hand rub in the form of a gel, rinse, or foam is preferred because it is convenient, rapid-acting, and highly effectively against most microbes, even those that are antibiotic-resistant [100, 101]. One 6-year observational survey study found that after placement of wall-mounted alcohol-based hand rub dispensers in all inpatient and outpatient clinic rooms of a tertiary medical center, there was a 21 percent decrease in newly acquired nosocomial MRSA and a 41 percent decrease in vancomycin-resistant enterococcus (VRE) infections [102]. The same study found that alcohol-based hand rubs did not have a significant impact on the incidence of Clostridium difficile infections. Hence, hands should be washed with soap and water instead of alcohol-based hand rub in certain circumstances as detailed in Table 10, including when exposure to spores (e.g., Clostridium difficile, Bacillus anthracis) has likely occurred.
Pre-operative marker pens. Pre-operative marker pens are widely used before dermatological procedures and may be a source of bacterial cross-infection. Ethanol-based ink in fresh permanent marker pens has bactericidal actions within minutes and more than 10 minutes should elapse between marking different patients [96, 103, 104]. In contrast, dried-out permanent marker pens, which have been used for more than 3 months, can harbor pathogens such as MRSA and should be discarded [96, 103]. White board marker pens and pens with water as the main solvent have been found to carry greater risks of cross-infection than ethanol-based permanent marker pens [96, 104, 105]. Consequently, disposable marker pens should be used on all patients whenever possible due to the prevalence of MRSA and other skin infections.
III.F. Falls
In outpatient settings, falls represent an increasingly frequent cause of injury, especially among elderly patients. Risk factors for falling include age, orthostatic hypotension, multiple medication use (e.g., beta blockers, nitrates), dementia, autonomic symptoms, non-healing foot sores, self-reported depression, unclipped toenails, previous falls, and impairments in cognition, vision, balance, gait and strength [106, 107, 108]. Hence, healthcare professionals should recognize and be able to assess these risk factors and help prevent falls in their patients by measures such as medication reduction and balance or gait strengthening [108].
III.G. Laser safety
The same properties that give lasers their clinical advantages also represent significant threats to patient safety if appropriate precautions are not taken because of a lack of knowledge or carelessness [109]. A number of organizations have published guidelines or presented materials on the safe use of lasers, including the American Academy of Dermatology [66], American Society for Dermatologic Surgery [62], American National Standards Institute [110, 111, 112], American Society for Laser Medicine and Surgery [113], Laser Institute of America [114] and Rockwell Laser Industries [115]. Laser safety standards are legal requirements for practice, adopted in the U.S. from the American National Standards Institute (ANSI; designation code Z136.3) [116].
Potential fire hazards. Numerous objects commonly present in operative fields are potential fire hazards when contacted by lasers. Rohrich et al. found that during carbon dioxide (CO2) laser skin resurfacing, dry towels and gauze sponges produced flame after a minimal number of laser passes, whereas the same objects elicited no flame or burn when they were moistened [117]. Other lasers, especially the neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, have comparable fire potentials [109, 118]. The ignition potential of lasers is amplified in the presence of oxygen or nitrous oxide [119]. Lasers can even ignite flatus during laser removal of perirectal condyloma acuminatum (Philip Bailin, M.D., M.B.A., Cleveland Clinic Foundation Department of Dermatology, personal communication, February 9, 2009).
Cutaneous laser fires are hypothesized to occur, especially in oxygen-rich atmospheres, because of melanin absorption, heat conduction, and light scattered by epidermis [120]. Since the 585-nm pulsed dye laser (PDL) passes through the epidermis, has low absorption by melanin and brief pulse durations, it is thought to be less of a fire hazard than CO2 and Nd:YAG lasers [121]. However, several groups have reported PDL-induced fires in the presence of oxygen via facemasks or nasal cannulae, often occurring on a hair-bearing surface [120, 122-126]. This ignition potential may relate to laser energy being absorbed by melanin in hair follicles or other colored items in the operative field, leading to secondary ignition of oxygen [120].
Table 11 presents safety recommendations for the prevention and handling of laser-induced fires. The JCAHO National Patient Safety Goals are outlined in Table 12, of which NPSG #11 presents broad strategies for preventing surgical fires.
Plume. Laser treatment produces smoke plume, which consists of carbonized cell fragments, water vapor, and potentially toxic hydrocarbons including polycyclic aromatic hydrocarbons, carbon monoxide, formaldehyde, ammonia, benzene, and toluene [117, 132]. These small particulates have been shown to deposit in the lower respiratory tract and cause pathologic damage to lungs in animal studies, leading to congestive interstitial pneumonia, bronchiolitis and emphysema [133, 134, 135]. Although controversial, laser plume has also been suggested to have the potential to transmit microorganisms such as Staphylococcus aureus, human papillomavirus and human immunodeficiency virus to the laser surgeon and staff [136, 137, 138]. Smoke evacuators, when held within 1 cm of the laser treatment site, can capture 99 percent of the laser plume [117]. Hence, lasers should be used with indwelling smoke evacuators held as close to the operative site as possible to maximize plume capture [117]. Masks, eye protections and spatter shields may also be necessary, especially with Q-switched lasers, which can eject tissue fragments from the skin during cavitation [139].
Eye safety. The eyes are readily injured by lasers hence making protection mandatory. The portion of the eye at greatest risk for injury varies with the wavelength of the laser in use. The CO2 laser generally damages only the cornea when misdirected to the unprotected eye [109, 140]. Although injuries to superficial corneal layers have the ability to regenerate, deeper injuries may produce permanent corneal opacification and blindness [109, 141]. Other lasers, such as Nd:YAG, potassium titanyl phosphate (KTP) and argon lasers, can penetrate cornea and lens and be focused by lens, resulting in severe retinal damage and blindness [109, 141]. Because of the invisibility of near infrared laser light to the human eye, and its vast damage potential, the Q-switched dermatologicial lasers (Q-switched alexandrite, Nd:YAG lasers) are widely considered the most dangerous lasers to the human eye and are most commonly associated with accidental retinal damage [142]. Hirsch et al. state that, "Blindness occurs rapidly and painlessly, even when only 1 percent of the beam is reflected into the eye from glossy metal, glass, or plastic surfaces. Even laser-experienced dermatologists have suffered blindness by inadvertent lack of appropriate eyewear" [116]. Thus, in addition to direct laser beam exposure, eye injuries may also result from reflected or scattered laser light. One should never look directly at laser output, and laser light should not be pointed at polished, metallic or reflective surfaces. All windows and mirrors in the treatment room should be covered; all jewelry should be cleared from the laser field; and laser instruments should have dull, matte, or blackened finishes [139]. Nd:YAG and argon lasers can penetrate windows and any windows in the operating room should have an opaque covering. A warning sign should be placed on the door, informing of laser use inside. It is imperative that laser-protective eyewear, consisting of wrap-around glasses and goggles rated by optical density (OD) at various wave-lengths (corresponding to various lasers) be worn by all persons with any possibility of viewing a laser, including operator, staff, patients, and visitors. By law, OD and wavelength ranges are printed directly on the eyewear [116]. To ensure safety for all, Hirsch et al. recommend: "(1) know the wavelength of the laser being used; (2) check that the glasses or goggles have an OD of at least 4 for that wavelength; and (3) use both the laser and the eyewear properly" [116].
As for the laser surgeon's eye wear, although maximum optical density is desirable for eye protection, it must be balanced with visibility and color distortion so that patients' conditions may be adequately observed and their safety protected. Hirsch and colleagues assert that, "The color of the goggles is not an indication of protection, especially when using an infrared (invisible) laser" [116]. The patient's eyes should be closed during surgery and covered with moist eye patches. The chosen corneal eyeshields must have minimal thermal transfer from the outer surface to the corneal contact surface when struck by laser energy [117, 143, 144]. Hirsch et al. and Isenhath et al. warn that special precaution is required with lasers and intense pulsed light (IPL) sources used for hair removal especially of the lower eyelid, or with vascular lesions near the eye [116, 145]. Anterior type of eye injury from these devices usually involves their use by inexperienced personnel [116, 145]. It is imperative that the sclera be entirely protected because the risk of transcleral eye injury is greater with IPL devices because of their bulky nature and imprecise placement [116]. Moreover, chlorhexidine—an anti-septic agent that may cause corneal epithelial damage or permanent corneal opacification—should not be used to clean corneal eyeshields [143]. It should also not be used prior to laser surgery to disinfect skin areas around the eye because there may be accidental spillage into the eye or incorporation into the laser plume.
Skin safety. Accidental skin exposure to laser energy is another potential hazard, especially to anesthetized or sedated patients who may sustain substantial skin burns and damage because of their inability to pull away. Other common scenarios for accidental patient skin burns are laser use on pigmented skin, laser resurfacing procedures, and poor technique (e.g., pulse stacking—rapid delivery of pulses to one exposure spot; failure to clean contact-cooling handpieces) [139]. Lasers should be kept in standby mode except when ready to be fired. Physicians should remove their feet from the laser foot pedal whenever the laser is not being used.
III.H. Scope of practice expansion of non-dermatologist physicians and non-physician practitioners
There has been a recent proliferation of non-dermatologist physicians and non-physician practitioners who perform medical, surgical, and cosmetic dermatological procedures, because of such factors as physician shortages, cost-effective measures promoted by managed care, and increasing popularity of certain cosmetic procedures [146-153]. Increasing numbers of cosmetologists, technicians and estheticians are performing invasive and non-invasive procedures (e.g., laser hair removal, skin resurfacing, chemical peels, dermabrasion, soft tissue augmentation, injection or insertion of foreign or natural substances) in clinics, spas, and salons without appropriate training and supervision by dermatologists, potentially leading to increased incidence of procedural complications for patients [152, 154, 155]. Brody et al. listed four reasons for increasing non-physician practice of cosmetic procedures: "(1) increased use and acceptance of nonphysician clinicians in the healthcare arena, (2) the variability of uniform state laws defining the practice of medicine, (3) the blur between medical procedures and beauty treatments, and (4) the emergence of hybrid 'medical spas' and 'retail clinics' [154]."
IV. Conclusions
Patient safety studies in dermatology and outpatient settings are lagging behind those in inpatient settings. Systems changes are needed to reduce medical errors rather than penalize individual healthcare professionals. Although technology may improve patient safety in numerous aspects, it also introduces new sources of error. Our review reveals few studies on dermatologic patient safety, supporting the pressing need for such studies and reports in the future.
All parties involved must be aware of and committed to improving patient safety, not just healthcare professionals, organizations, and patients and their families. Regulators and accreditation bodies can define minimum patient safety standards and performance levels for healthcare professionals and organizations in licensing, certification, and accreditation processes. Professional societies can develop educational curriculae, conduct research, set evidence-based practice guidelines, disseminate information, and advocate for patient safety to their members and the public. Public and private purchasers can provide incentives to healthcare professionals and organizations for continuous patient safety improvements. Consumers can push for patient safety through informed selections and advocacy. Table 13 lists organizations with online resources on patient safety. Finally, the commitment to patient safety and improvement of quality in medicine depends on personal and professional responsibility.
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