Office-Based Pediatric Anesthesia - Smith's Anesthesia for Infants and Children

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

PART THREE – Clinical Management of Special Surgical Problems

Chapter 26 – Office-Based Pediatric Anesthesia

Richard Berkowitz

Why Office-Based Surgery and Anesthesia, 857

Safety and Outcome, 858

Legislation and Regulations, 861

Clinical Aspects, 863

		Patient and Procedure Selection, 863
		Preoperative Preparation, 864
		Intraoperative Care, 865
		Anesthetic Technique, 865
		Level of Consciousness Monitoring,866
		Postanesthesia Care, 866
		Postoperative Pain Control, 866
		Postoperative Nausea and Vomiting,867

Establishing an Office-Based Practice, 867

Equipment and Supplies, 868

Staffing, 869

Reimbursement, 869

Summary, 870

“A pediatrician's dream of the ideal world would be to have individuals knowledgeable about the special needs of infants and children assembled wherever children are to be treated” ( Avery, 1975 ). Little did Dr. Avery know back in 1975, as she wrote these words in the journal Anesthesiology as a guest editor introducing a symposium on pediatric anesthesia, to what extent and in what places children were to be anesthetized and by whom. The prophetic nature of her question, “Where will pediatric surgery be done in the future?” and her statement, “Surely the anesthetist should contribute to the definition of what can be done in what setting,” is astounding when considering how rapidly the surgical and anesthetic care of children has progressed from the hospital to the ambulatory surgery center to the office-based setting over the past 15 to 20 years ( Avery, 1975 ).

The concept of office-based anesthesia and surgery is not a novel one, as dentists, oral surgeons, and plastic surgeons have been office based for decades. In fact, dentists and oral surgeons have been at the forefront of office anesthesia and surgery dating back to one of the first office-based anesthetics, involving Colton and Wells in 1844, for an extraction of a wisdom tooth ( Jacobsohn, 1995 ; Yagiela, 1999 ).

We have now come full circle, as prior to the early 1900s many surgical procedures were performed in offices. Subsequently, as surgical procedures became more complex, the hospital became the major site for surgery ( Yagiela, 1999 ). Despite this shift, the development of ambulatory anesthesia continued throughout the 20th century with the development of the first free-standing surgical center in 1916, by Waters ( White, 1997 ), and ultimately with the first ambulatory surgery center established by Reed and Ford in the late 1960s.

Over the past several years, the concept of office-based anesthesia and surgery is well publicized. In addition to the increasing number of clinical reports looking at the efficacy or regarding the subject of office-based anesthesia ( Laurito, 1998 ; Tang et al., 1999 ; Arens, 2000 ; Joshi, 2003 ), there are, unfortunately, numerous reports of significant morbidity and mortality both in the medical literature ( de Jong, 1999 ; Rao et al., 1999 ; Morrell, 2000; Stoelting, 2000 ) and the lay press ( LaMendola, 1998 ; Schulte et al., 1998 ; Vogt, 2000 ; Neergaard, 1999 ; Hilton, 2001 ). This should be compelling evidence for the anesthesiologist to realize that office-based surgery and anesthesia has arrived and may be here to stay. In addition, for skeptics, a published closed claims analysis of office-based anesthesia and surgery, which lends itself to the fact that the process exists and can be an impetus to process improvement, is the convincing evidence ( Domino, 2001 ).

Interest in office-based anesthesia is also, in part, manifested by the increasing number of societies—specifically, the Society for Ambulatory Anesthesia (SAMBA), and the Anesthesia Patient Safety Foundation (APSF)'that promulgate educational and safety literature in this relatively new arena for anesthesiologists. Also, the American Society of Anesthesiologists (ASA), as well as other groups, including, but not limited to, The American College of Surgeons and its various subspecialties, the American Dental Association, the American Academy of Pediatric Dentistry, and the American Association of Nurse Anesthetists, have published guidelines specifically addressing office-based anesthesia or surgery or both ( Table 26-1 ). However, in some cases these guidelines address only the issue of sedation/analgesia with other organizations updating their sedation/analgesia policies to include general anesthesia ( American Academy of Pediatric Dentistry, 2004 ). All of these societies have developed guidelines or policies in response to the overwhelming interest and growing participation by their memberships in this area, as well as an overall common concern for patient safety.

Also significant and perhaps legitimizing the presence of office-based anesthesia and surgery in present day medicine is the ever-increasing number of states developing legislation that specifically address this area. Consequent to this dynamic period of law making and law revision is that the ASA Office of Legal Affairs is continuing to compile information pertinent to the states that have developed and those that are developing legislation regulating office-based anesthesia and surgery.

Simply stated, office-based anesthesia is the practice of anesthesia in the free-standing physician's office and is defined as the provision of anesthesia service in an operating area or a procedure room that is not licensed as an ambulatory surgery center. It is the most “liberated” form of anesthesia practice and is at the farthest end of the spectrum of “out of the operating room” anesthesia. In a sense, it is anesthesia for the most remote location (except, perhaps, for those individuals delivering anesthesia care in isolated areas of Third World countries).

Traditionally, office-based anesthesia has been the realm of various specialists including, but not limited to, dentists, oral surgeons, plastic surgeons, podiatrists, certified registered nurse anesthetists (CRNAs), and, in some instances, gastroenterologists. Until recently, few anesthesiologists dared to venture out of their conventional roles as hospital-based or ambulatory surgery-based physicians.

To what extent has the office-based surgical volume increased that it is requiring or necessitating the rapid development of this new “subspecialty” of ambulatory anesthesia? According to one marketing study ( SMG Marketing-Verispan, L.L.C., 2002 ), the total number of outpatient procedures exceeded 30 million in the year 2000 and was estimated to break the 35 million mark in 2003 ( Fig. 26-1 ). Office-based surgical procedures representing approximately 10 million office-based procedures were performed in 2003, comprising almost 30% of the total number of outpatient procedures (see Fig. 26-1).

Exact numbers pertaining to pediatric procedures occurring in office-based settings are difficult to obtain, but in 1996 the National Center for Health Statistics (NCHS) estimated that approximately 8.5% of ambulatory surgical procedures were performed on children less than 15 years old ( Hall et al., 1998 ). Although many different types of surgical procedures, including otolaryngologic ( Siegel et al., 2000 ;Garin et al., 2001 ; Friedman et al., 2002 ), urologic ( Cartwright et al., 1996 ; Smith et al., 2000) , cosmetic ( Grevelink et al., 1997 ), and ophthalmologic ( Goldblum et al., 1996 ), are performed on children in the office-based setting, the majority of procedures requiring anesthesia or sedation in the office setting for children are dental procedures ( Yagiela, 1999 ; Ross et al., 2002) .

The most common reason for children to require dental procedures is related to dental caries, and furthermore, a majority of dental caries disease in the United States occurs in a small proportion of the pediatric population ( Yagiela, 1999 ). It is estimated that close to 500,000 children per year require some level of anesthesia for their dental disease. Yagiela (1999) reports that a survey by the American Academy of Pediatric Dentistry estimated in 1995 that this number is probably closer to 200,000, with the discrepancy being due to a paucity of access to the appropriate care secondary to a lack of insurance coverage.

TABLE 26-1 -- Specialty-specific guidelines for sedation/analgesia and office anesthesia and surgery^[*]

Organization	Document	Adopted	Revised
American Society of Anesthesiologists (ASA)	Guidelines for Ambulatory Anesthesia and Surgery	1973	2003
	Guidelines for Nonoperating Room Anesthetizing Locations	1994	2003
	Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists	1995	2001
	Guidelines for Office-Based Anesthesia	1999	2004
	Continuum of Depth of Sedation	1999	2004
	Qualifications of Anesthesia Providers in an Office-Based Setting	1999	2004
American College of Surgeons (ACS)	Guidelines for Optimal Ambulatory Surgical Care and Office-Based Surgery^[†]	1994	2000
American Academy of Pediatrics (AAP)	Guidelines for Monitoring and Management of Pediatrie Patients During and After Sedation for Diagnostic and Therapeutic Procedures	1985	2002
American Academy of Pediatrics (AAP)	Guidelines for the pediatrie perioperative environment	1999	NA
American Academy of Pediatrie Dentistry (AAPD)	Guideline on the Elective Use of Minimal, Moderate, and Deep Sedation and General Anesthesia in Pediatrie Dental Patients	1985	2004
American Academy of Pediatrie Dentistry (AAPD)	Guideline on the Use of Anesthesia-Trained Personnel in the Provision of General Anesthesia/Deep Sedation to the Pediatrie Dental Patient	2001	NA
American Dental Association (ADA)	ADA Policy Statement: The Use of Conscious Sedation, Deep Sedation and General Anesthesia in Dentistry	1999	2002
American Society of Dental Anesthesiologists (ASDA)	Policy Statement on Practice Parameters	1998
American Society of Plastic Surgery (ASPS)	Patient Safety in Office-Based Surgery Facilities: I. Procedures in the Office-Based Setting, II. Patient Selection^[‡] Practice Advisoryon Liposuction^[§]	2001	NA
American Society of Plastic Surgery (ASPS)		2003	NA
American Association of Nurse Anesthetists (AANA)	Standards for Office-Based Anesthesia	1997	2002

^*	Not a complete list, as other professional societies may also have related guidelines.
^†	These guidelines specify surgery by facility class (A, B, C) depending on the invasiveness of the surgery and type of anesthesia used.
^‡	Practice advisory only.
^§	In this practice advisory, the ASPS recommends that in the event that sedation/an algesia is used, the surgeon follow the ASA Guidelnes for Sedation and Analgesia by Non-Anesthesiologists.



FIGURE 26-1 This graph represents past and future trends in surgical volumes in specific patient care sites. Notice increasing surgical volumes in the FOSC (freestanding outpatient surgery center) and POBS (physician office–based surgery center). (Courtesy of SMG Marketing–Verispan, L.L.C., 2002, Chicago, IL.)

▪ WHY OFFICE-BASED SURGERY AND ANESTHESIA?

As one can see from the marketing data previously presented (see Fig. 26-1 ), there is a compelling need to be able to provide quality surgical and anesthesia services in the office-based setting. The actual reasons as to why this boom has occurred and continues to evolve and why anesthesiologists are more aggressively entering this arena are severalfold.

Ostensibly, the most persuasive argument for a shift to the office-based setting is financial. Limitations in reimbursement due to health care reform and economic constraints have caused physicians to become more creative in facilitating cost-effective approaches to surgery. One may reduce costs by reducing or eliminating facility fees that ordinarily accompany the cost sharing charges at hospital-based and ambulatory surgery–based centers. Because much of office-based surgery, especially cosmetic surgery, is performed on a cash-payment, fee-for-service basis, cost containment by limiting facility fee overhead becomes crucial to patient affordability. This affordability is crucial in the case of pediatric dental procedures, where in many instances neither dental nor medical insurance covers out-of-office dental procedures and anesthesia costs ( Ross et al., 2002) .

Although the lack of a facility fee is ideal and helps provide the surgeon with a cheaper alternative for the patient, the reality of the situation is that surgeons often include a facility fee in their global fee to the patient to offset the overhead (personnel, supplies, etc.) required to run an office-based practice. In some instances, insurance companies may reimburse physicians a facility fee, but the cost to the third party payers may still be less than if the procedure is performed in a hospital- or surgery center–based setting. Consequently, the procedure becomes financially advantageous for the surgeon, the anesthesiologist, the insurance company, and the patient.

One surgical study from the United States in the early 1990s compares the cost of performing an inguinal herniorrhaphy in the hospital with that of the cost in an office setting. This study finds the latter a more cost-effective alternative regardless of the technique used. The total cost for a laparoscopic approach to repair in the hospital outpatient setting and the office setting was $5,500 and $1,500, respectively. For a standard open repair, the total cost for the hospital setting was $2,200, and for the office setting, $895 ( Schultz, 1994 ).

Operating in the office affords the surgeon not only financial but also logistical advantages. Office-based surgical practice virtually eliminates the lost time caused by turnover delays, bumping cases secondary to emergencies, overscheduled cases, and travel times between facilities. In the office-based setting, whatever turnover delays do occur can be quickly remedied by the surgeon, as he or she has total control over the personnel and the facility.

The ability of the surgeon to schedule on-site clinic visits between surgical cases allows for the efficient use of time. This eliminates the usual routine of having to rush back to the office between procedures or having office hours at the conclusion of a long and busy day at the hospital or surgery center.

Another advantage of office-based procedures is the more private, less stressful, and more familiar environment. For the anesthesiologist, office-based anesthesia may allow for an enhanced income, a better work environment (working with a limited number of surgeons or, in some instances, the same surgeon), and, in most practices, the lack of a night call schedule. Whether these potential advantages of establishing or taking part in an office-based practice prevail over the relative disadvantages of working in an extremely remote environment, routinely providing anesthesia care for cases of decreased complexity (compared with those cases in a hospital setting), providing anesthesia services under itinerant conditions, and perpetually competing with other anesthesiologists and anesthesia providers for business, becomes an individual decision.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ SAFETY AND OUTCOME

With the medical community, third party payers, and the consumers (our patients) pushing for more expeditious and cost-effective (and hence potentially more profitable) ways in which to provide surgical and anesthesia services, the anesthesia services are moving farther from the hospital safety net. Dr. Ervin Moss, who is the impetus behind tighter regulation of office-based anesthesia and surgery in the state of New Jersey, stated that, “Some say the major difference between the office-based and hospital-based anesthesiologist is that the former must be more courageous or foolhardy” ( Moss, 1998 ).

Whether or not Dr. Moss's characterization of the office-based anesthesiologist holds true, the fact remains that we must provide anesthesia care that is as safe, if not safer, than hospital-based or surgery center–based anesthesia. Others have questioned whether the convenience of office-based surgery and anesthesia is worth the risk ( Arens, 2000 ).

Although the risk of death from anesthesia has decreased and is quoted to be anywhere from 1:20,000 to 1:250,000 ( Arens, 2000 ; Biboulet et al., 2001 ; Newland et al., 2002 ) and the incidence of cardiac arrest in children is described to be 1.4:10,000 ( Morray et al., 2000 ), an accurate assessment of the safety profile of office-based anesthesia and surgery relative to the pediatric population is difficult secondary to the paucity of information. Mandatory reporting for morbidity and mortality related to office procedures does not exist. To make an assessment of the relative safety of office-based anesthesia and surgery, it is imperative to look at data reviewing the safety of pediatric ambulatory surgery, pediatric dental office surgery, and pediatric sedation/analgesia, as well as the adult literature that reviews this topic.

Many of the cases brought to the attention of the medical, dental, and lay community involved children undergoing office dental procedures ( Morell, 2000 ). This information not only is tied intimately with the present topic but also is the point of origin for much of the controversy over the safety and efficacy of office-based anesthesia for children.

In two reports from the United States, Coté and others (2000a, 2000b) retrospectively analyzed information obtained from the Food and Drug Administration, the U.S. Pharmacopoeia, and a survey of pediatric specialists to report on contributing factors to critical incidents and medications used in sedation as they relate to adverse sedation events in children undergoing diagnostic and therapeutic procedures.

Coté and others (2000a) reported on 95 incidents. Over half of these incidents resulted in death (n = 51) and permanent neurologic injury (n = 9). The remaining patients either had prolonged hospitalization without injury (n = 21) or sustained no harm as a result of the adverse event (n = 14). Of note was that those children who were cared for in non–hospital-based facilities (older and healthier) had a much higher rate of death and permanent neurologic injury (93%) than did those cared for in hospital-based facilities (37%). The authors also reported inadequate resuscitation was a major factor in the non–hospital-based facilities (57%) compared with the hospital-based setting (2.5%) and that patients cared for in the nonhospital setting were more likely to sustain a cardiac arrest as the second or third event compared with those in the hospital setting (P < .001).

In the second report, Coté and others (2000b) used the same 95 incidents to determine if there was a relationship between medications and adverse events. Although the authors noted no relationship between the class of drug used, the route of administration, and the incidence of death and permanent neurologic injury, they did note that adverse outcomes were associated with the administration of drug overdoses and administration of three or more sedating medications. Furthermore, 11 of 12 patients (all younger than 6 years) sustained adverse outcomes either at home or in a car. Two of the 12 patients, who had received sedative medication at home prior to their procedure, sustained an adverse event at home before the scheduled procedure.

Of note was that over one third of the reported events occurred during sedation for dental procedures (n = 32). Twenty-nine of these resulted in death or permanent neurologic injury. Most of the involved practitioners were either oral surgeons or dentists, three were pedodontists, and one was a nurse anesthetist under the supervision of a dentist. None of the practitioners were anesthesiologists ( Coté et al., 2000b ).

The dental practices were the only sites in these reports to have used nitrous oxide. In addition to the greater tendency toward the use of nitrous oxide, there was a greater tendency for these practitioners to use multiple drugs (more than three) compared with other practitioners: 39% and 13%, respectively. The authors conclude that many of these adverse events may have been prevented by consistency between monitoring guidelines and by practice and training requirements among health care professionals of differing specialties who administer sedation and anesthesia.

Although there are anecdotal reports ( Denman et al., 1968 ; Johnson et al., 2001 ; Manoharan et al., 2001 ) and studies ( Yee et al., 1985 ; Blayney et al., 1999 ; Girdler et al., 1999) of adverse outcomes, complications, and side effects related to sedation and anesthesia in the dental literature, others have reported on a safety record that is as good as, if not better than, that of the anesthesia community (Laskin, 1999 ; Saxen et al., 1999 ; Whitmire, 1999 ; Yagiela, 2001 ). The incidence of mortality rates in dental anesthesia is reported to be anywhere from 1:250,000 in the United Kingdom ( Cartwright, 1999 ) to 1:300,000 ( D'Eramo, 1999 ) to less than 1:1 million in the United States ( Brandom and Herlich, 1999 ; Laskin, 1999 ).

As if there is not enough controversy within the anesthesia community, within the dental community there is also debate over who can best serve the patient requiring anesthesia for a dental procedure. Yagiela points out that members of the American Society of Dental Anesthesiologists, those who provide “approximately 25,000 pediatric general anesthetics per year,” subscribe closely to the American Academy of Pediatrics and American Society of Anesthesiologists guidelines for sedation and anesthesia ( Yagiela, 2001 ). He also states that “since the organization's inception 2 decades ago, there have been no known incidents of mortality or significant morbidity in children managed in the dental office by a dentist anesthesiologist” and intimates that safety may be improved in dental offices with a greater adherence to these guidelines by the dental community as a whole ( Yagiela, 2001 ).

In contrast to the paucity of information about the safety and outcomes related to office-based anesthesia, the efficacy of anesthesia in pediatric ambulatory surgery in general is well known. As reported byWilletts (1997) , outpatient surgery may date back to James H. Nicoll, a Glasgow surgeon who, in the early 1900s, successfully performed several thousand ambulatory procedures on young children at the West Graham Street Dispensary for Children. Contemporary authors also show that for many surgical procedures, the ambulatory setting for surgery and anesthesia is safe, cost effective, and therefore preferable to in-patient surgery ( Moir et al., 1987 ; Postuma et al., 1987 ; Patel et al., 1988 ; Hannallah, 1991 ; Ghosh et al., 1994) .

In one prospective study examining the efficacy of pediatric day surgery at the Children's Hospital of Eastern Ontario, the overall complication rate was very low. The investigators, over a 5-year period, prospectively studied children undergoing various outpatient procedures including myringotomy, tonsillectomy and adenoidectomy, dental procedures, and inguinal hernia repairs. Most of the children were between 2 and 7 years old, and the total number of cases approached 25,000. The reported complication rate was 1.6% per year. The most common complication was postoperative bleeding, primarily secondary to tonsillectomy and adenoidectomy. None of the complications resulted in permanent disability ( Letts et al., 2001 ).

Much of the information relative to the outcomes for office-based anesthesia and surgery is anecdotal. In a retrospective report, specifically looking at outcomes for plastic surgical procedures, Hoefflin and others (2001) reported no significant morbidity and no mortality in more than 23,000 procedures over an 18-year period in which general anesthesia was used. The anesthesia was physician administered, and the facility was certified by the American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF) ( Hoefflin et al., 2001 ). In this report, most of the patients underwent cosmetic surgery, with some patients having multiple procedures. The only incidents reported as significant by the authors were the rare occurrence of electrocardiograph and oxygen monitor failure. None of these events resulted in any patient complications, although three patients were hospitalized for custodial care. Minor anesthetic complications included nausea and vomiting (<5%), postextubation sore throat (<5%), shivering, one case of dental damage, one case of delayed (10 days) deep vein thrombosis, and one case of carpal tunnel syndrome following intravenous catheter infiltration.

In another report, Coldiron (2001, 2002) [30] [29] reviewed critical surgical incidents that occurred in physicians' offices in the state of Florida subsequent to a mandatory reporting in February 2000. This mandatory reporting resulted from several newspaper article accounts of poor patient outcomes and questions of whether office anesthesia and surgery were safe. Those incidents requiring reporting are listed in Box 26-1 .

BOX 26-1

Incidents in Surgical Offices Requiring Reporting by the State of Florida

	•	Death
	•	Brain damage
	•	Wrong patient surgery
	•	Wrong site surgery
	•	Wrong procedure
	•	Surgery to remove an unplanned foreign object from a surgical procedure

From Coldiron B: Office surgical incidents: 19 Months of Florida data. Dermatol Surg 28:710, 2002.

In the data obtained from Florida's Agency for Health Care Administration, there were 43 reported complications by 41 different physicians. These complications included eight deaths ( Table 26-2 ). The most common complications were adverse drug reactions, several of which were anaphylactic in nature. Unfortunately, the total number of patients undergoing office-based procedures was not reported, so a true incidence could not be determined.

TABLE 26-2 -- Cause of death and specialist involved in Florida report

Surgery	Anesthesia Type/Provider	Etiology	*No. of Patients^[]**
Liposuction	General/M.D. or CRNA	Pulmonary embolus	3
Breast reduction	General/M.D.	Bronchospasm	1
Chin lift	Deep sedation/CRNA	Asystole	1
Peritoneal dialysis catheter	Local/radiologist	Unspecified	1
Radiology procedure	None	Contrast reaction	1

From Coldiron B: Office surgical incidents: 19 Months of Florida data. Dermatol Surg 28:710, 2002.

^*	The eighth death occurred due to exsanguination in an anesthesiologist's office 10 days postoperatively after a tonsillectomy in a hospital. The fact that the death occurred in an office mandated reporting.

Coldiron (2001, 2002) [30] [29] noted that the reported deaths and complications were unrelated to whether the physician was board certified, whether the physician had similar surgical privileges in a hospital, and whether the facility was certified by one of the accrediting bodies—the AAAASF, the American Society of Plastic and Reconstructive Surgery (ASPRS), or the American Association for Ambulatory Health Care (AAAHC).

Bitar and others (2003) retrospectively reviewed close to 5000 office-based plastic surgery procedures that were performed under monitored anesthesia care with sedation. The procedures in thisstudy were performed by board-certified plastic surgeons, and anesthesia was provided by a CRNA. Nearly all patients were reported to be American Society of Anesthesiologists (ASA) Class I or II (99.9%), and the majority of patients were adult females (92%). The most common complications reported in this study were dyspnea (0.05%, n = 2), protracted nausea and vomiting (0.2%, n = 6), and unplanned hospital admission (0.05%, n = 2). One patient required intubation without prolonged sequelae. The author reported no cardiac arrests, deaths, or any incidence of deep vein thrombosis or pulmonary embolus. The author concluded that office anesthesia and surgery were safe when using appropriate protocols and patient selection.

In a review, Koch (2003) reported on several office-based anesthesia practices from various regions of the United States that were performed between 1981 and 2002. In this report, Koch noted no intraoperative deaths in over 64,000 anesthesia cases. Furthermore, in a subset of pediatric patients that comprised this report, one Chicago-based office anesthesia practice reported no intraoperative deaths, significant perioperative morbidity, or emergent hospital transfers in over 600 pediatric anesthesia cases. Children in this subset ranged in age from 18 months to 17 years. Most of the children were less than 6 years old and were classified as ASA Class I or II patients (D. Barinholtz, Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003).

In a review of the ASA's Closed Claims Project database, Domino (2001) compared claims made against anesthesiologists in the office setting (n = 14) with those made in other ambulatory surgery settings (n = 753). Claims for dental damage and for nonoperative pain management were excluded from this analysis.

Although patient demographics were similar in both groups ( Table 26-3 ), most of the claims in the office-based setting were related to plastic surgery or dental procedures, whereas in the ambulatory setting, most claims were related to procedures other than plastic or dental.

TABLE 26-3 -- Patient characteristics in analysis of claims made in office-based anesthesia incidents

	Ambulatory Anesthesia (n = 753)	Office Based (n = 14)
Age (mean yr)	41	45
Female (%)	58	64
ASA Class I/II (%)	82	89
Elective surgery (%)	97	100
Anesthesia type
General (%)	66	71
^[‡]MAC (%)	10	14
Surgical procedure
Dental (%)	3	21
Plastic surgery (%)	32^[*]	64^[*]
Other (%)	64^[†]	14^[†]

From Domino KB: Office-based anesthesia: Lessons learned from the Closed Claims Project. ASA Newsletter 2001 reprinted with permission from the American Society of Anesthesiologists, 520 N. Northwest Highway, Park Ridge, IL 60068-2573.

^*	P<0.05 Ambulatory versus office based.
^†	P<0.01 Ambulatory versus office based.
^‡	MAC, monitored anesthesia care.

The severity of injury appeared greater in the office-based setting compared with other ambulatory sites. Most of the claims made in other ambulatory sites (62%) were for “temporary or nondisabling injury,” whereas most of the claims from the office-based setting were for death (64%). The author pointed out, however, that without a denominator, a true risk assessment for each site cannot be ascertained.

In both office-based settings and ambulatory settings, Domino noted respiratory events were most common ( Table 26-4 ). A summary of airway-related complications and drug-related complications in office-based claims is shown in Table 26-4 . Although the timing for injury was similar for both sites, there tended to be fewer claims for events occurring after discharge in the other ambulatory claims (7%) than for the office-based claims (21%).

TABLE 26-4 -- Damaging events in office-based anesthesia claims

Type of Event	Ambulatory Anesthesia (n = 666)		Office Based (n = 12)
Type of Event	*No.*	%	*No.*	%
Respiratory	150	22	6	50
Cardiovascular	67	10	1	8
Equipment	74	11	1	8
Drug related	58	9	3	25
Block-needle trauma	41	6	1	8

The Closed Claims Project analysis also revealed that a greater number of office-based claims were deemed to be potentially preventable by better monitoring. Also, a greater percentage of office-based claims involved substandard care compared with other ambulatory settings (not statistically significant), and payment was made in a higher percentage of claims (92% versus 59%) and for a higher median payment ($200,000 versus $85,000) for office-based claims than for other ambulatory settings, respectively.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ LEGISLATION AND REGULATIONS

There are many entities presently imparting their influences on the practice of office-based anesthesia and surgery. These include, but are not limited to, state regulatory bodies; federal regulatory agencies such as the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General (OIG); nationalmedical professional societies; national medical and safety organizations such as the Federation of State Medical Boards (FSMB), the National Committee for Quality Assurance (NCQA), and the National Patient Safety Foundation (NPSF); accrediting organizations such as the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF), the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); and the insurance industry.

The main problem with regulation and legislation concerning office-based surgery and anesthesia is the wide regulatory variability that exists among states. Some states are highly regulated, whereas other states have no regulations ( Table 26-5 ). In the states that do have regulations, these regulations are frequently ambiguous. State regulations regarding facility structure, personnel, equipment, and credentialing of individual practitioners differ widely. A more complete compendium of state regulations is available through the ASA Office of Governmental and Legal Affairs. In addition to state agencies and legislation, professional societies can regulate practice by establishing practice guidelines, practice standards, and/or advisories. The disadvantage of professional societies is that they run the risk of being self-interest groups. Consistent regulatory control could also be achieved by recognizing established accrediting bodies as oversight organizations. The organizations most commonly involved in the accreditation of ambulatory surgery centers (ASCs) are AAAASF, AAAHC, and JCAHO.

TABLE 26-5 -- Summary of state activities on office-based anesthesia/surgery regulation^[*]

State	Regulations in Place	Regulations in Development^[†]	Enforceable, Yes/No	Comments	Governor Opt-out^[‡]
Alabama	No	Yes	No	Regulations/guidelines proposed	No
Arizona	Yes (limited)	No	Yes	Offices exempt from regulation/licensure unless using general anesthesia or where general anesthesia is covered under dentistry rules	No
California	Yes	NA	Yes	Accreditation required	No
Colorado	No (guidelines and policy statement only)	No	No	Voluntary	No^[§]
Connecticut	Yes	NA	Yes	Accreditation required for all facilities using a minimum of moderate sedation/analgesia	No
District of Columbia	Yes (limited)	No	No	Medical board advisory to follow ASA guidelines; offices must be licensed as health facilities if complex surgery performed	—
Florida	Yes	NA	Yes	Accreditation or annual state inspection required	No
Georgia	No	Yes	No	Legislation introduced requiring accreditation	No
Illinois	Yes	No	Yes	Only address scope of anesthesia, not surgery	No
Iowa	No	Yes	No	Legislation proposed; annual licensure would be required	Yes
Kansas	No	Yes	No	Medical society adopted regulations/guidelines that encourage accreditation for offices	Yes
Louisiana	No	Yes	No	State medical board approved draft; no final rule	No
Massachusetts	No (guidelines only)	Yes	No	Guidelines endorsed by state board of registration in medicine; legislation introduced requiring licensure or accreditation of ambulatory surgical facilities	No
Mississippi	Yes	No	Yes	Not comprehensive, but does provide for alternate pathway for credentialing of surgeons for procedures outside specific specialty	No
New Jersey	Yes	NA	Yes	Regulations require accreditation by state	No
New York	No	Yes	No	Voluntary guidelines only, urge accreditation; recent legislation proposed specifically addressing office-based surgery	No
North Carolina	No	Yes	No	Guidelines outlined in medical board position statement; noncompliance could result in medical board sanctions	No
Ohio	Yes	NA	No	Medical board regulations effective January 2004	No
Oklahoma	No	No	No	State medical board guidelines only	No
Oregon	Yes	No	Yes	Regulations only	No^[§]
Pennsylvania	Yes	NA	Yes	Accreditation required for Class A facilities; for Class B, C facilities state inspection and licensure required	No
Rhode Island	Yes	NA	Yes	Accreditation required	No
Tennessee	No	Yes	No	Regulations proposed by medical board
South Carolina	No	Yes	No	Guidelines only, which require accreditation and urge legislation on enforceability	No
Texas	Yes	No	Yes	Regulations for anesthesia practitioners; accredited outpatient facilities exempt	No
Virginia	Yes	Yes	Yes	Outlines rules for anesthesia administration and educational requirements for nonanesthesiology physicians	No
Washington	No	Yes	No	State medical society guidelines only; regulations being developed	No^[§]

^*	Adapted from Barinholtz D: American Society of Anesthesiologists, 2003.
^†	NA, not applicable and means that state regulations are extensive. With states that have guidelines or regulations, “No” means that these are not extensive and presently there are no plans to change them.
^‡	There are other states where the governor has opted out of the CMS rule on supervision of nurse anesthetists, but only those states presently addressing the office-based setting are mentioned here.
^§	Opt-out by state's governor is being considered.

Historically, AAAASF, formerly known until the early 1990s as the American Association for Accreditation of Ambulatory Plastic Surgery Facilities, Inc. (AAAAPSF), was initially created to accredit only outpatient plastic surgery facilities. However, as other medical specialties moved procedures to free-standing outpatient settings, this organization became active in accrediting these facilities as well (AAAASF, 2003 ).

In contrast to AAAHC and JCAHO, AAAASF accredits facilities over a much narrower spectrum of medical specialties. The surgical specialties include colon and rectal, obstetrics and gynecology, ophthalmology, orthopedic, otolaryngology, plastic surgery, general surgery, and urology. AAAASF is particularly restrictive in its practitioner credentialing. This organization requires all surgeons to be certified by the American Board of Medical Specialties (ABMS) and requires all of its surgeons practicing at an ambulatory or office-based facility to have hospital privileges for the same procedures being performed in the office facility ( AAAASF, 2003 ).

JCAHO and AAAHC, in addition to the facilities mentioned for AAAASF, approve facilities where oral and maxillofacial, dental, dermatologic, podiatric, cosmetic, vascular, and pain procedures are performed. Although these two organizations are not as restrictive on the practitioner privilege issue as the AAAASF, their credentialing policies are very complete.

In addition to defining requirements for surgical personnel, all three organizations offer accreditation processes that outline expectations for the facilities as they relate to meeting standards for the facility physical plant (e.g., by ensuring that state, Occupational Safety and Health Administration [OSHA], and National Fire Protection Association regulations are followed), anesthesia administration, monitoring, equipment and personnel, ancillary staff, patient transfer policies, patient safety and emergency resuscitation issues, quality improvement, and patient satisfaction issues. A summary of some of the similarities and differences between the three most visible accrediting organizations is given in Table 26-6 .

TABLE 26-6 -- Similarities and differences between various accreditation organizations

Accreditation Body	AAAASF	AAAHC	JCAHO
Medicare deemed status	Yes	Yes	Yes
Requires board certification of surgeon	Yes	No	No
Requires physician supervision of anesthesia^[*]	Yes	Yes	Yes
Additional educational requirements for nonanesthesiologists supervising	Yes	No	No
Accreditation cycle	3 Years	6 Months, 1 year, or 3 years	3 Years
Approximate base cost^[†]	$675 to $1000	$2990	$3975
Corporate Web site	www.aaaasf.org/	www.aaahc.org/	www.jcaho.org/

AAAASF, American Association for Accreditation of Ambulatory Surgical Facilities; AAAHC, American Association for Ambulatory Health Care; JCAHO, Joint Commission on Accreditation of Healthcare Organizations.

^*	This requirement may not apply in the event a state's governor has opted out of the physician supervision of nonanesthesiologist anesthesia providers requirement.
^†	Cost for an accreditation survey may be influenced by the number of offices to be accredited, the number of surgeons and surgical specialties, and whether a facility is asking for Medicare “deemed” status.

Whether accreditation affects outcomes in office-based surgery and anesthesia is uncertain. In a survey study, the AAAASF sent a questionnaire to its accredited facilities that addressed patient safety in plastic surgical office facilities. Two hundred forty-one of 418 facilities responded to the questionnaire. Over a 5-year period that included over 400,000 surgical procedures, the authors reported the risk of significant complications to be 1 of 213 cases and the risk of death to be 1 of 57,000 cases. They concluded that overall risk in an accredited office is comparable to that of other ambulatory surgical sites (free-standing or hospital based) ( Morello et al., 1997 ). In a retrospective review of an accredited office-based plastic surgery facility, Byrd and others (2003) reported no deaths in over 5000 cases. However, these authors noted that several patients required hospital admission for various medical problems.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ CLINICAL ASPECTS

Particular attention must be paid to patient and case selection, preoperative preparation, special problems related to anesthetic administration, and postoperative care. Absence of a plan by the anesthesiologist caring for a child in the office, specifically related to these issues, can lead to a practice that is fraught with safety dilemmas and logistic and scheduling problems that negatively impact the success of an office-based anesthesia practice. Time constraints are the rule rather than the exception in office-based practice.

▪ PATIENT AND PROCEDURE SELECTION

The decision process that occurs when deciding which patients are appropriate to care for in the office-based setting does not differ greatly from that of caring for patients in the “free-standing” ambulatory surgery center. The factors that most commonly determine whether a child is an appropriate candidate for office-based anesthesia and surgery are patient age, associated medical illnesses and ASA physical status, type of surgery, potential for blood loss, potential for significant postoperative complications, and duration of surgery.

Because most office-based procedures for pediatric patients involve dental procedures, a majority of the children undergoing these procedures are older than 1 year. However, as the realm of office-surgery for children expands and because there are no prospective studies as yet in the office-based anesthesia literature looking at outcomes and patient age for children undergoing office-based surgery, it seems that present guidelines for other ambulatory surgery venues should be used. When taking this latter point into consideration, the minimum age requirement (other parameters such as type of procedure not withstanding) for children undergoing office-based procedures can be determined by whether a child requires prolonged postoperative monitoring based on postconceptual age or the administration of opiate analgesics and other respiratory depressant agents ( Welborn et al., 1994 ; Galinkin et al., 1998) . Although postanesthesia care unit complications may be more common in neonates and infants resulting from respiratory complications ( Westman, 1999 ), any other minimum age requirements are often arbitrary and may reflect the comfort level of office staff and anesthesia personnel caring for the child (Ross et al., 2002) . Adherence to policies and guidelines set forth for minimum age requirements for outpatient anesthesia in ambulatory surgery centers and hospital-based ambulatory surgery departments is critical.

Most children cared for in the office-based setting are ASA Class I and II patients. In some situations, it may be acceptable to provide anesthesia care for those children with stable comorbidities who are ASA Class III patients despite the fact that these patients, in general, may be more susceptible to adverse outcomes from anesthesia ( Morray, 2002 ). Some of the pediatric comorbidities considered high risk for the office-based surgical suite include obstructive sleep apnea, labile asthma and other significant pulmonary disease, complex congenital heart disease, labile diabetes mellitus, significant neurologic and neuromuscular disorders, sickle cell disease, and upper respiratory tract infection.

In one prospective study looking at prolonged recovery stay and unplanned hospital admission following ambulatory surgery in pediatric patients, the authors reported annual rates of approximately 4% and 2%, respectively. PONV and respiratory complications were the most common factors leading to prolonged recovery stay, whereas respiratory complications (32%) and surgical reasons (30%) were the factors most commonly responsible for unplanned hospital admission. These authors also found that higher ASA physical status had a direct relationship to unplanned hospital admission and adverse respiratory events ( D'Errico et al., 1998 ).

Dornhoffer and others (2000) , in a retrospective chart review, evaluated unplanned hospital admission following four types of otologic procedures (not including myringotomy tube placement) in adult and pediatric outpatients. The unplanned hospital admission rates for children and adults were 5.7% and 2.3%, respectively. The most common reasons for unplanned hospital admission were postoperative nausea and/or vomiting.

In addition, Dornhoffer and others (2000) noted that tympanomastoidectomy with ossicular reconstruction, procedures lasting longer than 2 hours, and asthma were increased risk factors. In contrast to this study, Mingus and others (1997) reported that surgical cases lasting as little as 1 hour may be associated with a higher rate of unplanned hospital admission.

In a study by Fortier and others (1998) involving over 15,000 patients, unplanned hospital admission following ambulatory surgery was related to longer duration of anesthesia and surgery, higher ASA physical status (Classes II and III), postoperative bleeding, excessive pain, and nausea and vomiting. Of note was that surgical reasons were identified to be more commonly responsible for hospital admission than were anesthesia-related issues (38% and 25%, respectively). The fact that the office-based setting is best suited for those children who are healthy without significant comorbidity and are undergoing minimally invasive procedures may inherently result in few postoperative complications.

▪ PREOPERATIVE PREPARATION

Preanesthetic Interview

As is the case with ambulatory surgery in general, rarely is the preanesthetic interview for office-based surgery for pediatric patients conducted in person. For the anesthesiologist who works in a limited number of offices, preanesthetic interviews may be possible during the patient's presurgical office visit if the anesthesiologist should be attending that particular office on the same day. This is the exception rather than the rule when anesthesiologists provide itinerant care for a multitude of offices. Although some authors have advocated surgical evaluation in certain instances on the same day of surgery (Overdyk et al., 1999 ), most preanesthetic interviews will be initiated by telephone prior to the day of surgery.

The preanesthetic interview for office-based procedures does not differ much from that described for other ambulatory settings ( Welborn, 1996 ). However, a few important points should be made relative to the preanesthetic interview for an office-based procedure.

First, the anesthesiologist should make some initial contact with a child's parents or guardian prior to the day of surgery. Unlike the ambulatory surgery center or hospital-based ambulatory surgery department, the parents often cannot associate their child's scheduled procedure with the community-acquired reputation of a particular private or academic institution. An anesthesiologist's reputation in the office-based environment is based on the advocacy of the child's private physician, surgeon, or dentist and unfortunately is only as good as the anesthesiologist's last case (or self-advocacy literature). The initial telephone interview must be used as a way to instill confidence in his or her abilities and to alleviate parental anxiety by relating one's level of experience or training background or by discussing a cogent and acceptable anesthetic plan. These few “public relations” minutes are invaluable.

Second, the interview process must elicit enough of a history to determine whether a child is a candidate for the scheduled office-based procedure or whether the procedure needs to be delayed. The same-day cancellation leaves an undesirable block of open time for the anesthesiologist and the surgeon. Finally, in many instances, the preanesthetic telephone interview is used not only as the mechanism by which parents receive final preoperative instructions (e.g., NPO guidelines, medication instructions) but also to make final financial arrangements.

Preoperative Laboratory Testing

Because most children receiving office-based anesthesia services are healthy and are undergoing minimally invasive procedures, the necessity for preoperative laboratory testing is rare. As is advocated by other authors, any laboratory testing should be determined on an individual patient basis by clinical need following the preanesthetic interview ( Roizen et al., 1987 ; Welborn, 1996 ; Meneghini, 1998 ,Friedberg, 2003 ). Despite agreement on the lack of clinical utility and increased cost of routine preoperative laboratory screening among anesthesia professionals, an anesthesiologist providing office-based anesthesia services must be aware of any state and local government mandates for such testing. Additionally, each practitioner must establish his or her policy in determining the cost-to-benefit yield (especially in the office setting where cost savings are a key advantage) on more controversial laboratory testing such as pregnancy testing in adolescents and teenagers ( Azzam et al., 1996 ; Hennrikus et al., 2001 ).

Preoperative Sedation

Despite the somewhat less intimidating environment of the office, the anxiety that pediatric patients undergoing office-based procedures experience is probably no less than that in other surgical environments. The need for preoperative sedation or some other useful mechanism by which the anesthesiologist can reduce preoperative anxiety is critical. In fact, the space-limited environment of many office practices and the close proximity to office waiting rooms and other patients may make preoperative sedation of children most at risk for preoperative anxiety even more important.

The group of children most likely to undergo a mask induction of anesthesia is also the age group of children most likely to experience preoperative anxiety ( Kain et al., 1996 ; McCann et al., 2001 ; Kain et al., 2002 ; Watson et al., 2003) . Most children receiving preoperative sedation receive midazolam ( McCann et al., 2001) . Although various routes of administration are advocated, including intranasal (Davis et al., 1995 ; Griffith et al., 1998 ) and rectal ( Marhofer et al., 1999 ), oral administration of midazolam is the most common ( Levine et al., 1993 ; McGraw et al., 1998) . Ease of administration as determined by acceptance by the child in most instances dictates the route of administration. Most often in practice, a dose of 0.5 to 1.0 mg/kg (maximum dose, 20 mg) orally is effective.

Although some have found that certain routes of administration of midazolam have no impact on discharge times ( Davis et al., 1995 ; Kain et al., 2000 ), others find that there are significant delays in recovery or discharge times with the use of orally administered midazolam in combination with various anesthetic techniques ( Viitanen et al., 1999 ). Also, the use of combination preoperative sedation, such as intramuscular ketamine and midazolam, in uncooperative children may be inappropriate for the office-based setting due to prolonged discharge times ( Verghese et al., 2003 ).

For children tolerating preoperative intravenous catheter placement (with or without application of local anesthetic cream), the use of midazolam may not be necessary. Small repeated doses (0.25 to 0.5 mg/kg) of intravenous propofol under constant monitoring provide excellent preoperative anxiolysis without respiratory depression and in many instances provide excellent amnesia to the immediate preoperative period. This technique is especially advantageous in short surgical procedures. However, propofol is associated with pain on injection and lidocaine may have to be added to the infusion.

Although the benefits of parental presence are questionable (to the child and parent), especially compared with pharmacologic approaches to preoperative anxiety reduction ( McCann et al., 2001 ; Kain et al., 2003 ), the office-based environment may provide an excellent opportunity for parental presence during induction of anesthesia, especially in cases where sterility concerns are minimal such as for dental restoration procedures.

When the administration of a preoperative sedative is indicated, the anesthesiologist must take into consideration whether the benefit of sedation (to the patient, parents, waiting patients, and office staff) outweighs the chance that the sedative will delay discharge following anesthesia. This is particularly true in instances where a physician must be present until the patient is discharged home.

▪ INTRAOPERATIVE CARE

The intraoperative care of the pediatric patient in the office-based setting relative to induction and maintenance of anesthesia does not differ much from that in other ambulatory settings. Despite the minimal standards set forth by most states relative to office-based anesthesia, from the anesthesiologist's perspective, monitoring, and equipment standards and guidelines must not be different for the office than for other surgical and anesthesia sites. One should adhere to the Standards for Basic Anesthetic Monitoring ( ASA, 2004 ) and Guidelines for Office-Based Anesthesia ( ASA, 2003 ) (see Chapter 9 , Anesthesia Equipment and Monitoring). With this in mind, one's anesthetic technique is limited only by the equipment, supplies, and resources of the physical plant that he or she has available.

Most office-based surgical procedures using anesthesia require intravenous access and hydration. The child's fluid deficit is based on the NPO period and is replaced with lactated Ringer's solution.

Despite liberalizing the NPO period (clear liquids 2 to 3 hours prior to anesthesia), administration of intravenous fluids both during and after the surgical procedure is important. There is evidence in both adult and pediatric populations that aggressive intraoperative fluid management ( Yogendran et al., 1995 ; Elhakim et al., 1998 ) and delaying oral intake after surgery ( Schreiner et al., 1992 ), especially when perioperative opioids are administered ( Kearney et al., 1998 ), decrease the incidence of postoperative nausea and vomiting (PONV).

▪ ANESTHETIC TECHNIQUE

The concept of “rapid onset, rapid recovery, and minimal side effects,” used often to describe the important characteristics of an appropriate anesthetic technique in an ambulatory setting, is equally important for the office setting. Although all types of anesthesia can be used in the office setting, including regional anesthesia ( Rosenquist, 2001 ), general anesthesia and varying levels of sedation are most often used in children.

Even though anesthesiologists debate the clinical (safety and outcome) and cost efficacy of newer anesthetic agents (sevoflurane, desflurane, remifentanil, and propofol) compared with some of the older agents (halothane, isoflurane), these newer agents offer a distinct advantage as it relates to their predictability ( Tang et al., 1999 ; Moore et al., 2002 ; Fishkin et al., 2003) . All levels of the continuum of anesthesia (minimal sedation to general anesthesia) are used in the office setting. The type of anesthesia is determined by the age and cooperation level of the child, the type of procedure, the ease with which local anesthetic can be administered and its efficacy in a particular surgical procedure, and, as stated previously, the available equipment.

General anesthesia can be accomplished by using a pure volatile technique, a total intravenous technique, or a combination of the two (volatile induction with intravenous maintenance) techniques. The former and latter obviously depend on the availability of an anesthesia machine and on whether a specific office can comply with OSHA requirements relative to appropriate gas scavenging. Some surgical offices, depending on surgical volume and cost efficacy, may provide the anesthesiologist with a standard anesthesia machine; in other instances, the anesthesiologist may transport a single-vaporizer-equipped portable anesthesia machine to each office (D. Barinholtz, Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003).

All of the newer volatile agents have been shown to be efficacious in pediatric ambulatory surgery ( Welborn et al., 1996 ; Moore et al., 2002 ). However, if one is transporting a machine with single-vaporizer capability, then sevoflurane may be the agent of choice due to its efficacy in both induction and maintenance of anesthesia, as well as its rapid onset and offset characteristics. Although some advocate the use of desflurane for maintenance of anesthesia for ambulatory surgery because of its predictability relative to emergence ( Fishkin et al., 2003) , it is impractical as a complete office-based anesthetic agent in children due to its lack of efficacy for inhalation induction ( Zwass et al., 1992 ; Olsson, 1995 ; Smiley, 1996 ). Similarly, the intravenous agents propofol ( Hannallah et al., 1994 ; Cohen et al., 2001 ) and remifentanil (Davis et al., 1997, 2000 [37] [36], 2001; Pinsker, 1999) are shown to be useful in the ambulatory setting.

Although remifentanil can be used successfully in an ambulatory setting when the airway is secured with an endotracheal tube, evidence suggests this narcotic should be used cautiously when the airway is not secured. Litman (1999) evaluated the use of remifentanil for moderate sedation in 17 patients (20 procedures) aged 2 to 12 years who were undergoing short, painful procedures. All patients received intravenous midazolam, 50 mcg/kg, in combination with remifentanil 1 mcg/kg followed by an initial infusion of remifentanil of 0.1 mcg/kg per min. The remifentanil infusion was then titrated every 5 minutes to provide adequate sedation and analgesia. The average appropriate dose of remifentanil utilized was 0.4 mcg/kg per min. Although the author reported successful use of this technique in 17 of 20 procedures, 1 child became unresponsive requiring assisted ventilation, and hypoxemia was avoided in 10 of 13 children by continuous stimulation during the procedure.

In adults, the combination of a propofol infusion, titrated to bispectral analysis (BIS) number, and intermittent ketamine boluses has been reported ( Friedberg, 2003 ). In children (propofol 100 to 200 mcg/kg per min, titrated by BIS; ketamine 0.5- to 1.0-mg/kg boluses) undergoing dental restoration procedures, D. Barinholtz (Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003) noted that combining propofol (100 to 200 mcg/kg per min) with ketamine boluses completely avoided the need for opiate analgesics.

Although any agent can be safely used in the office-based setting, it is imperative that the office-based anesthesiologist develop an anesthetic routine that allows for an expeditious induction with appropriate maintenance levels of anesthesia while at the same time affording a rapid emergence. It is also essential that this anesthetic routine minimize the incidence of postoperative side effects, nausea and vomiting.

Another critical aspect of intraoperative anesthesia care in the office-based setting is airway management. Although multiple factors determine the type of airway, any type of airway from a mask to laryngeal mask airway to endotracheal tube may be appropriate. For some procedures, especially when using only sedation, airway intervention is usually minimal, but deciding on the appropriate airway intervention in some cases may be difficult. This is particularly true when providing anesthesia for dental or other intraoral procedures.

Despite the fact that many dental cases are performed with oral sedation and nitrous oxide ( Saxen et al., 1999 ; Ross et al., 2002) , longer dental restoration procedures may necessitate the use of an endotracheal tube (D. Barinholtz, Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003). This is most often true in offices where the anesthesiologist may have limited access to the patient's airway due to positioning or cramped quarters. Subsequently, ventilation is controlled by hand or mechanical means or the patient can breathe spontaneously. One must be judicious in the use of muscle relaxants to facilitate intubation. Prolonged effects of these agents may lead to delayed emergence and consequently delayed discharge and turnover for subsequent cases.

▪ LEVEL OF CONSCIOUSNESS MONITORING

The central theme of office-based anesthesia is to accomplish excellent, safe, time-efficient, and cost-effective anesthesia. One must look favorably on any technology that can possibly aid in achieving these goals.

The BIS monitor (Aspect Medical, Newton, MA) is described to be able to determine the level of sedation, predict the loss of consciousness, and thus perhaps diminish intraoperative awareness when used with various anesthetic agents ( Glass et al., 1997 ). Despite previous evidence that BIS is shown to decrease anesthetic use and hasten recovery in adult patients ( Glass et al., 1997 ; Song et al., 1997 ), the use of the BIS monitor is only recently making its way into the realm of pediatric anesthesia ( Denman et al., 2000 ; Bannister et al., 2001 ; McCann et al., 2002 ; Religa et al., 2002 ).

In one study, Denman and others (2000) found that in children aged 0 to 12 years who were anesthetized with sevoflurane, the BIS value correlated to the depth of anesthesia. Furthermore, this study also confirmed that for a particular level of anesthesia (BIS = 50), children younger than 2 years had a significantly higher end-tidal concentration of sevoflurane than did children aged 2 to 12 years (1.55% versus 1.25%, respectively).

Bannister and others (2001) studied the effect of BIS on anesthetic use and recovery in 240 children. They noted in patients aged 0 to 6 months that the BIS had no effect on anesthetic emergence. However, in older children, BIS was associated with less anesthetic administration and an earlier emergence time.

Religa and others (2002) evaluated the association between BIS and level of consciousness in pediatric patients (age range, 3 to 6 years) undergoing dental procedures using a sedation protocol. These authors found that there was a significant association between behavioral responses and levels of sedation. However, the authors noted that BIS offered no advantage over routine clinical monitoring and behavioral assessment in this setting.

▪ POSTANESTHESIA CARE

As in any ambulatory setting, the patient undergoing office-based surgery must meet established criteria prior to discharge home, with the goal being to discharge the patient as quickly and as safely as possible ( Patel et al., 2001 ). Actual discharge criteria include an adequate level of consciousness, good pain control, good hydration, minimal to no nausea, and a defined period of time since the last emesis ( Ross et al., 2002 ; Fishkin et al., 2003) . Furthermore, the appropriate personnel (at a minimum of that outlined by the ASA Guidelines for Office-Based Anesthesia, 2003 ) must remain with the child until discharge-ready status is reached.

The causes for delayed discharge can be either anesthesia or surgery related, but in the ambulatory setting two of the most common non-life-threatening reasons are inadequate pain control and PONV. Unlike the typical ambulatory setting, which often has the capability to care for patients with a prolonged recovery period, the office-based setting has little margin for error relative to these two problems.

▪ POSTOPERATIVE PAIN CONTROL

The goals for postoperative pain control in the office setting are not dissimilar from the overall goals for office-based anesthesia and surgery. In situations where the use of local anesthesia is not possible or feasible, one must use analgesic agents that are efficacious, have minimal side effects, and will not delay patient discharge.

Despite the fact that various opiate analgesics are routinely used and can be administered via conventional (intravenous, intramuscular while asleep, oral) and less conventional (intranasal) routes ( Galinkin et al., 2000 ; Finkel et al., 2001 ) in traditional ambulatory surgery settings, their use in the office setting is often minimized or eliminated to help avoid PONV that is drug ( Weinstein et al., 1994 ) and dose ( Anderson et al., 2000 ) related. Furthermore, because a preponderance of complications leading to unplanned hospital admission following ambulatory surgery in infants is related to the respiratory system ( Westman, 1999 ), opiate use in this age group, leading to respiratory depression, could potentially exacerbate these numbers.

Standard use of nonopioid analgesics such as the nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, when not contraindicated, is advocated. Ketorolac is found to be useful for postoperative analgesia in a variety of pediatric surgical procedures when postoperative bleeding is not a concern, and it can be administered intravenously in a dose of 0.5 to 0.8 mg/kg (maximum dose, 30 mg).

Purday and others (1996) compare three alternative doses of ketorolac, 0.75 mg/kg, 1.0 mg/kg, and 1.5 mg/kg, with morphine 0.1 mg/kg in pediatric patients aged 2 to 12 years who are undergoing dental restoration procedures. The authors found that ketorolac, in all three doses, was as efficacious as morphine sulfate in the management of postoperative pain and was associated with statistically less PONV. Similarly, Maunuksela and others (1992) noted ketorolac to be as efficacious as morphine following pediatric eye surgery.

Ibuprofen can also be used to treat postoperative pain, but reports on its effectiveness for some surgical procedures are mixed. Kokki and others (1994) showed that preoperative administration of rectal ibuprofen, 40 mg/kg, divided into 4 equal doses, was effective in the treatment of postoperative pain in children aged 1 to 4 years in that it reduced the need for supplemental morphine postoperatively. In contrast, Bennie and others (1997) , in a double-blind, placebo-controlled study of children older than 6 months who were undergoing bilateral myringotomy and tube placement, found no benefit to the preoperative oral administration of ibuprofen (10 mg/kg) or acetaminophen (15 mg/kg) in the treatment of postoperative pain compared with a placebo group. Joshi and others (2003) reported success with preoperatively administered oral rofecoxib, a newer cyclooxygenase 2 NSAID, given in a dose of 1 mg/kg, in treating postoperative pain and reducing PONV in children (3 to 11 years old) undergoing tonsillectomy.

Acetaminophen administration was also effective for postoperative analgesia, especially in procedures resulting in mild or moderate pain ( Tobias, 2000 ). Although high-dose acetaminophen (40 mg/kg), administered rectally, has been shown to be effective and has opiate-sparing effects ( Korpela et al., 1999 ), the restrictive quarters of some offices may make this route of administration somewhat prohibitive. Similarly, preoperative high-dose acetaminophen (40 mg/kg), administered orally in a one-time dose is shown to be effective in the treatment of postoperative pain following myringotomy and tube placement in children ages 17 months to 6 years, without reaching toxic plasma levels ( Bolton et al., 2002 ). This is contrary to the aforementioned studies ( Bennie et al., 1997 ), where oral acetaminophen in standard doses (15 mg/kg) was shown to be ineffective.

Opiate analgesics are not totally precluded from office-based surgery and may in fact at times be necessary. When either NSAIDs or acetaminophen is inadequate in the treatment of postoperative pain, then traditional combination drugs such as acetaminophen with codeine (0.5 to 1.0 mg/kg of the codeine component) may be appropriate.

▪ POSTOPERATIVE NAUSEA AND VOMITING

PONV remains a major cause of prolonged discharge time and unanticipated hospital admission following ambulatory surgery ( Fortier et al., 1998 ) and plays a significant role in patient dissatisfaction with the perioperative experience ( Myles et al., 2000 ). In one report, approximately 20% of patients surveyed expressed the potential for PONV as their primary concern ( Shevde et al., 1991) . The optimal treatment of this problem, whether prophylactic or rescue, is essential due to the negative influence it can have on an office-based practice ( Tang et al., 1999 ).

Tang and others (2001) compared the use of propofol-N₂O anesthesia with the use of desflurane-N₂O anesthesia plus antiemetic prophylaxis on the incidence of PONV in patients undergoing brief, superficial surgical procedures in an office setting. Patients in the propofol group received no PONV prophylaxis, whereas those in the desflurane group received ondansetron (4 mg), droperidol (0.625 mg), and metoclopramide (10 mg) intravenously at the end of surgery. Neither group received opiate analgesics nor muscle relaxants, and all patients received local anesthetic at the surgical site and ketorolac for postoperative pain management. The overall incidence of nausea and vomiting was very low in both groups and did not differ statistically. Patient satisfaction in both groups was excellent.

In another office-based study, Tang and others (2003) compared the addition of 5-hydroxytryptamine₃ (5-HT₃) receptor antagonists to a control regimen in patients receiving desflurane-N₂O maintenance anesthesia following propofol induction. All patients received droperidol (0.625 mg) and dexamethasone (4 mg) as baseline antiemetic prophylaxis. Subsequently, patients were randomly assigned to receive placebo, dolasetron (12.5 mg), or ondansetron (4 mg) intravenously prior to emergence from anesthesia. The results of this study show that the incidence of nausea and vomiting was the same in all groups.

The best regimen for prophylaxis against PONV in children and adults is not known, although dexamethasone has been shown to be an excellent choice for various procedures in the pediatric and adult populations either by itself ( Subramaniam, 2001) or in combination with 5-HT₃ receptor antagonists ( Splinter et al., 1998 ; Rose et al., 1999 ; Henzi et al., 2000 ; Splinter, 2001 ; Negri et al., 2002 ;Sukhani, 2002) . The dose range for dexamethasone in pediatric patients is reported to be from 0.1 mg/kg when used with ondansetron ( Splinter et al., 1998) to 1.5 mg/kg when used alone ( Henzi et al., 2000 ). In a quantitative systematic review, Henzi and others (2000) found the use of dexamethasone to be safe in otherwise healthy patients.

Those children at high risk are probably most benefited by prophylactic treatment of PONV. Those at high risk include patients with a previous history of PONV, a history of motion sickness, those undergoing certain surgical procedures (strabismus repair, inguinal herniorrhaphy, orchiopexy), and those receiving perioperative opiate analgesics.

Several authors advocate the use of multiple drug regimens in the treatment of PONV in pediatric and adult ambulatory surgical patients ( Rose et al., 1999 ; Scuderi et al., 2000 ; Negri et al., 2002 ; Gan et al., 2003 ). However, whether prophylactic treatment of PONV, single drug or multiple drug, in all patients undergoing office-based surgery and anesthesia is clinically and economically efficacious as opposed to only treating patients who are at risk can only be determined by further study of patients in this more restrictive setting.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ ESTABLISHING AN OFFICE-BASED PRACTICE

The individual or hospital-based surgery center group must decide whether committing resources to this type of practice is a worthwhile endeavor. The initial investment for this type of practice in the United States can be prohibitive, as the cost may run as high as $100,000 to $200,000 (D. Barinholtz, Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003). These costs include, but are not limited to, those for equipment and supplies, professional accreditation discussed earlier, legal services for incorporation of the group, malpractice coverage, professional staff (physician, nursing, biomedical, secretarial, and billing), policy and procedure development, and marketing.

One must also consider the type of office-based practice that should be initiated. The group or individual can be committed to one surgeon's office, depending on case volume, or can be committed to several surgeons, traveling to various office locations. From a logistic perspective, the former is easier because it allows for centralization of resources, the most important of which are equipment and medications.

A group practice considering an office-based venture must decide if it can designate a specific number of full-time equivalent staff to this site and still be able to provide sufficient clinical coverage to fulfill its contractual obligation to its home facility. If not, the group must then decide whether the cost of hiring new staff (physicians, recovery nurses, technical staff) will be offset by the potential revenue generated by the new practice. For the solo practitioner who may be caught up in the excitement of a new practice, overcommitment to too many surgeons may result in scheduling nightmares and a failure to meet obligations.

The individual or group must also meet the challenge of being able to market against other physicians or physician groups, as well as alternative and perhaps less expensive anesthesia providers in this competitive arena. Can the group provide a unique service, such as pediatric anesthesia coverage, that will make it more attractive to a particular surgeon or dentist?

Finally, and probably as important as any of the other issues related to establishing an office-based practice, the potential political fallout related to a new practice cannot be overemphasized. An anesthesia group with obligations to specific hospital or surgery center facilities must be ready to justify to administrators its practice of providing office-based anesthesia services to surgeons who typically operate in these administrators' facilities. This diversion of income-generating surgical procedures may be construed as a violation of a group's service agreement and consequently prompt administrators to solicit the services of a new group.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ EQUIPMENT AND SUPPLIES

Essentially all of the standard anesthesia equipment that is required in hospital ambulatory facilities (operating room and off-site) and surgery centers is required for office-based practice. All monitoring standards must be met in the office-surgical suite. Monitoring equipment must have battery backup capability as some offices may not have emergency generator capabilities in the event of power failure. Working in one facility where the equipment is capitalized by the surgeon or capitalized by the anesthesiologist and stored in the surgeon's office is much easier to deal with than the more common alternative of the anesthesiologist bringing the anesthesia workroom from place to place. Box 26-2 outlines general categories of supplies, standard and emergency, that must be transported to surgical sites by the office-based anesthesiologist.

BOX 26-2

General Categories of Required Supplies Transported by the Office-Based Anesthesiologist

		Anesthesia supply box
		Recovery supply box
		Pediatric supply box
		Airway box
		Portable suction equipment
		Monitoring equipment with disposables
		Malignant hyperthermia tray
		Positive pressure ventilation system
		Miscellaneous (batteries, records, etc.)
		Defibrillator (w/appropriate sized paddles)
		Anesthesia drug box
		Recovery drug box
		Emergency airway equipment (LMAs, fiberoptic bronchoscope, cricothyrotomy kits, etc.)
		Portable anesthesia machine with vaporizer
		Oxygen “E” cylinders

Courtesy of D. Barinholtz, Mobile Anesthesiologists, L.L.C., 2003.

For those practitioners who provide total intravenous anesthesia, an anesthesia machine is not necessary, but the presence of equipment capable of delivering positive pressure ventilation with oxygen is mandatory. For those anesthesiologists providing care to pediatric patients, a vaporizer-containing anesthesia machine is invaluable. Most anesthesia machines are moveable, but there are a few machines that are truly portable and available for care of pediatric and adult patients in the office setting. One such machine is the OBA-1 (OBAMED, Inc., Cardinal Medical Specialties, Inc., Louisville, KY), which weighs approximately 35 pounds, is vaporizer equipped, and is MRI compatible ( Fig. 26-2 ). The OBA-1 allows only spontaneous or manually controlled ventilation, as it is not equipped with an internal ventilator. The Magellan-2200, Model 1/M (Oceanic Medical Products, Inc., Atchison, KS) and the Narkomed-Mobile (Draeger Medical, Inc., Telford, PA) are also marketed for office anesthesia and both contain an internal ventilator. The latter machine, despite its ability to be rolled, is a much heavier unit and may not be practical for the anesthesiologist who is changing office venues on a daily basis.



FIGURE 26-2 The OBA-1 portable, MRI-compatible anesthesia machine. (Courtesy of Charles A. Smith, Vice-President Operations, Research and Development, Cardinal Medical Specialties, Inc., Louisville, KY.)

Regardless of the type of machine one chooses to use, caution must be used during transport; maintaining the machine's vaporizer in an upright position is essential to avoid spillage and the administration of an inappropriately high concentration of volatile agent. Often, draining the vaporizer prior to transport minimizes this risk. Furthermore, familiarity with state and federal safety guidelines relative to the transportation of medical gases is critical.

Whenever a volatile agent or succinylcholine is to be used, one must be prepared to treat malignant hyperthermia (MH). A stock supply of dantrolene must be available, and it is the responsibility of the anesthesiologist or a representative of the practice to proactively educate the surgeon and the surgeon's office personnel on appropriate protocol in the event of an MH episode (see Chapter 31 , Malignant Hyperthermia).

Finally, the office-based anesthesiologist must become aware of and be in compliance with the rules and regulations (federal and state specific) relative to the delivery, transport, clerical requirements (dispensing, wastage), and storage of opiates and other controlled substances that are used in the office setting.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ STAFFING

In the United States, the providers of office-based anesthesia services presently fall into one of three major categories (exclusive of the operator-anesthetist scenario): physician anesthesiologists, dentist anesthesiologists (2 years of anesthesia training following completion of dental school), and CRNAs. The conditions under which each of these three groups can practice are determined by state regulations regarding the administration of anesthesia in dental and surgical offices. Consequently, the composition of office-based anesthesia groups may vary by geographic location and can be comprised of and owned by all physicians, all dentist anesthesiologists, CRNA groups with and without collaborating physician medical directors, or various combinations of these individuals.

Beyond the anesthesia providers, however, are the ancillary personnel who are necessary to make a busy office-based practice successful. The individuals who are often required include nursing staff, biomedical/technical staff, and billing and clerical staff. The number of anesthesia sites a practice covers simultaneously and the volume of cases usually determine the staffing for a particular organization.

In some practices, an anesthesiologist or a CRNA may travel solo to a site. In this instance, the anesthesia provider is responsible for preoperative, intraoperative, and postanesthesia care of the child and requires the assistance of the surgical nursing staff. When multiple cases are performed at a single site, then a surgical office nurse is responsible for monitoring a patient during recovery.

In anesthesiologist-only practices, the preferred scenario is to have a staff nurse, employed by the group, available to assist with induction of anesthesia and to be responsible for monitoring the postanesthesia care of the child. Nurses with critical care or postanesthesia care unit (PACU) experience, who are ACLS-PALS certified, are best suited for this type of position. Anesthesia practices are sometimes able to procure reimbursement for the professional services rendered by these nurses to the PACU care of patients.

Having such personnel relieves the surgical ancillary staff from any anesthesia-related patient care responsibility and facilitates timely turnover when multiple cases are being performed in a single office. Experienced nurses may also be used to initiate telephone screening to provide patients with their preoperative anesthesia and surgical instructions, coordinate anesthesia scheduling, assist in purchasing supplies and equipment, and educate surgical staff on the specifics of the anesthesia process.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ REIMBURSEMENT

Mentioned earlier is the potential for cost savings by moving surgical cases from hospital outpatient or ambulatory surgical facilities to the office. Unfortunately, in some arenas, anesthesia-requiring office procedures are the rule due to the lack of insurance coverage for these procedures. This is especially true in pediatric dentistry, where dentists have had their proverbial “backs against the wall.” With few exceptions in the United States, dental and medical insurance policies traditionally failed to cover the cost of anesthesia and/or hospitalization for children requiring dental procedures ( Saxen et al., 1999 ;Yagiela, 1999 ). This has forced dentists to minimize costs, for these children and their families, by performing procedures in the office with or without the aid of an anesthesia provider.

However, the American Dental Association reports that there are at least 29 states, since the mid-1990s, that have passed laws requiring that medical insurance plans pay for hospital and connected medical expenses (e.g., general anesthesia services) when the dental treatment occurs in the hospital, ambulatory surgery center, or dental office ( Box 26-3 ) (J. Hansen, American Dental Association, personal communication, August 25, 2003).

BOX 26-3

States Adopting Laws or Regulations Requiring Medical Plans to Pay for Hospitalization/General Anesthesia When Dental Treatment Must Be Performed in the Hospital or Medical Expenses Incurred When Treatment Is in the Dental Office (Some States)

		California (1998)
		Colorado (1998)
		Connecticut(1998)
		Florida (1998)
		Georgia (1999)
		Illinois (2002)
		Indiana (1999)
		Iowa (2000)
		Kansas (1999)
		Kentucky (2002)
		Louisiana (1997)
		Maine (2001)
		Maryland (1998)
		Michigan (2001)
		Minnesota (1995)
		Mississippi (1999)
		Missouri (1998)
		Nebraska (2000)
		New Hampshire (1998, 2003)
		New Jersey (1999)
		North Carolina (1999)
		North Dakota (1999)
		Oklahoma (1998)
		South Dakota (1999)
		Tennessee (1997)
		Texas (1997)
		Virginia (2000)
		Washington (2001)
		Wisconsin (1997)

Some of the elements of these state laws are similar and often determine which children are eligible to receive coverage based on minimum and maximum age and medical/behavioral conditions. Many of these laws, despite mandating coverage, also outline that any provisions of the existing policy, such as meeting prior authorization requirements by showing medical necessity or payable deductibles, still hold true.

Some states also determine the acceptable facilities where the procedure can be performed by mandating insurance coverage only for procedures performed in the hospital or surgery center. Some laws also exempt dental-only insurance plans from their provisions. The number of states requiring coverage for the anesthesia portion of dental care may continue to increase, resulting in increased access to care for those children having the greatest need, regardless of qualified surgical site.

Reimbursement and collections for anesthesia and surgery in offices are somewhat complex and often work differently for the surgical provider and the anesthesia provider ( Koch et al., 2003 ). Fee-for-service reimbursement can be lucrative for the anesthesiologist in a high-volume cosmetic surgeon's office. However, because patients undergoing cosmetic surgery are often charged a set global fee for a specific procedure, some surgeons may look toward a lower-cost anesthesia provider, so the surgeon may recover a greater amount of the preset fee. This may intensify competition among anesthesia providers for these types of procedures.

Reimbursement from third-party payers is at negotiated rates that usually vary by geographic location and payer. Despite the fact that some payers reimburse anesthesia practices for professional fees and supplies/equipment, there are those that invoke the CMS policy that a facility be licensed by the state in order to bill for the latter. Consequently, this may mean a greater cost burden to the patient (D. Barinholtz, Mobile Anesthesiologists, L.L.C., personal communication, September 4, 2003). Koch and others (2003) point out that office-based anesthesia practices may become even more ubiquitous and successful by duplicating cost recovery strategies of surgeons—namely, better collection of facility fees and site of service differentials that provide for greater reimbursement for procedures performed in offices.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

▪ SUMMARY

Anesthesiologists have become increasingly involved in the practice of office-based anesthesia and surgery. Consequently, anesthesiologists must be proactive in ensuring that patient safety is the principal concern for all professionals providing anesthesia services in the office setting. It seems unlikely that the various professional societies, whose memberships are actively involved in office anesthesia and surgery, will agree on a specific set of anesthesia delivery guidelines. Consistency between states in the regulation of this practice is crucial and may be the only viable alternative in helping to ensure that “the standard of care is the standard of care.” This standard should be applicable regardless of surgical setting or patient age. Only further study will aid in determining whether the safety and cost profiles for office-based anesthesia are comparable to those of other ambulatory settings and ultimately whether office-based anesthesia will continue to be a worthwhile venture.

Motoyama & Davis: Smith's Anesthesia for Infants and Children, 7th ed.

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