State of New Jersey
Department of Law and Public Safety
Division of Consumer Affairs


New Jersey Register
Volume 33, Number 22
Monday, November 19, 2001
Rule Proposal

Law And Public Safety
Division Of Consumer Affairs
State Board Of Medical Examiners

Surgical And Anesthesia Standards In Physicians Offices; Alternative
Privileges; Compliance Timetables; Prohibition on The Use of Anesthetic Agents
Outside of Anesthetizing Locations; Revisions of Standards For Non-Invasive
Special Procedures; Emergency Conversion To General Anesthetic by CRNAS

Additions are indicated by <<+ Text +>>; deletions by <<- Text - >>.
Changes in tables are made but not highlighted.

Proposed Amendments: N.J.A.C. 13:35-4A.2, 4A.3, 4A.6, 4A.7, 4A.8, 4A.9, 4A.10, 4A.11 and 4A.17

Proposed New Rule: N.J.A.C. 13:35-4A.12

Authorized By: State Board of Medical Examiners, William V. Roeder, Executive Director.

Authority: N.J.S.A. 45:1-15 and 45:9-2.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2001-445.

A public hearing concerning this proposal will be held on Friday, December 7, 2001 at 9:00 A.M. at:

Novotel Hotel
100 Independence Way
Princeton, New Jersey 08540

Submit written comments by January 18, 2002 to:

William V. Roeder, Executive Director
State Board of Medical Examiners
PO Box 183
Trenton, New Jersey 08625-0183

The agency proposal follows:

Summary

The primary purpose of the proposed amendments and new rule is to bring to fruition the full measure of the reforms that the New Jersey State Board of Medical Examiners (Board) has been striving to implement through its promulgation of rules establishing standards for the performance of surgery and anesthesia in practitioner offices. On June 15, 1998 the first phase of these reforms, N.J.A.C. 13:35-4A, became effective imposing specific equipment mandates and requirements for policies and procedures. Because the Board at that juncture had not developed eligibility criteria and a mechanism by which those who did not hold hospital privileges could submit credentials for its review, the Board chose to suspend enforcement of those provisions which set forth the specific personnel requirements under the original proposed rules (see 30 N.J.R. 4485(b), December 21, 1998). Accordingly, over the last several years, the complete benefits of the initiative have not been achieved.

Pursuant to N.J.S.A. 45:9-2, 45:1-15.1 and 52:14B-4, the Board is now proposing the eligibility requirements and the mechanism by which practitioners seeking privileges who do not hold such privileges at licensed hospitals will be able to apply for privileges to the Board. The proposed new rule sets forth what will need to be supplied in support of such an application and it establishes that the Board may delegate responsibilities to a reviewing entity for preliminary review of the application and preparation of summary reports with regard to the credentials that have been submitted (N.J.A.C. 13:35- 4A.12(e)). The new rule further delineates what may be required of applicants at N.J.A.C. 13:35-4A.12(f). Reviewers may require a personal interview, the sample of records or specific records where complications have been identified. In some circumstances, an inspection of the office may be required. At subsection (g), the actions that the Board may take upon review of the application and summary report of the application are also specifically delineated. The Board, upon its review, may grant the privileges requested, condition approval on additional training or a period of observation. Alternatively, the privileges may be denied or additional information requested.

The proposed new rule is specific in the types of proofs that applicants will need to supply. N.J.A.C. 13:35-4A.12(a) sets forth these requirements for those seeking privileges in general and regional anesthesia; subsection (c) sets forth the requirements for those seeking privileges to perform surgery or special procedures. In general, applicants will be required to provide proof of clinical experience as reflected by an attestation as to the number of procedures performed and evidence of training. That evidence can be supplied through the submission of documentation establishing certification granted by a certifying entity recognized by the American Board of Medical Specialties or the American Osteopathic Association or another certifying entity of comparable scope and rigor (N.J.A.C. 13:35-4A.12(a)2). A third track is available if the applicant is able to provide proof of certification in another field and active participation in the examination process leading towards certification in the field in which privileges are requested (N.J.A.C. 13:35-4A.12(a) 2iii).

In addition, applicants are required to demonstrate proof of competence through the submission of references from three individuals who have observed their practice within the two years preceding the application (N.J.A.C. 13:35-4A.12(a)3). In addition, applicants shall submit a log of all the cases done in the relevant field in the office or ambulatory care facility during the two years preceding the application. As is more specifically described in the Regulatory Flexibility Analysis, cases in which there have been complications are specifically identified. The applicant is also to submit no fewer than five redacted charts to be identified to the applicant after the log has been reviewed by the Board or the reviewing entity.

In keeping with the Board's recognition that the risks of conscious sedation are not as grave as those involved during the administration of general and regional anesthesia, the Board has established different standards for those practitioners who may be seeking privileges to administer or supervise the administration of conscious sedation. Pursuant to N.J.A.C. 13:35-4A.12(b), such applicants are also to demonstrate clinical experience through an attestation of the number of procedures performed. They are also to supply a log for the preceding two years although the log need only include those cases in which there were complications. The training required can include board certification in anesthesia or critical care management or emergency medicine or certification in advance cardiac life support (ACLS) and a home study course obtained from the Board or a course in conscious sedation.

The Board is also establishing different criteria for those practitioners who seek privileges to utilize lasers in the performance of surgery or special procedures pursuant to N.J.A.C. 13:35-4A.12(d). Practitioners seeking these privileges are to provide demonstration of completion of a program or documentation that this training was part of their residency program. At subsection (h), the rule makes clear that the privileges to be granted are for a period of two years, after which renewal process will apply.

N.J.A.C. 13:35-4A.17 establishes the compliance timetable for these requirements. Upon adoption of these amendments and new rule, the suspension of the enforcement of the rules cited in the notice at 30 N.J.R. 4485(b) ( N.J.A.C. 13:35-4A.6(a), 4A.7(a), 4A.8, 4A.9 and 4A.10) will be lifted and all the rules will be effective. Under the terms of N.J.A.C. 13:35-4A.17, initial applications are to be made within one year of the promulgation of the amendments and new rule and practitioners may continue to perform services and provide supervision as they have been doing until such time as the Board acts on their application. Accordingly, the Board does not envision that there will be an abrupt impact as a result of the implementation of its alternate privileging program.

Although the establishment of the alternate privileging mechanism is the prime purpose for this proposal, there are a number of other substantive reforms that are to be accomplished as well. Amendments appearing in the definitions of "minor surgery" and "special procedures" at N.J.A.C. 13:35-4A.3 make clear that the privileging mechanism need not be sought if the practitioner is not performing surgery or special procedures with anesthesia services--as defined in this rule to be general or regional anesthesia or conscious sedation. The definition of "special procedure" also makes clear that the use of benzodiazepines for the purpose of relieving patient anxiety does not implicate the requirement to become privileged under this regulatory scheme. In addition, through an amendment to N.J.A.C. 13:35-4A.2, adding a subsection (b), the Board makes clear that it is not intending to require those performing non- invasive special procedures to submit to the privileging requirement.

Additional substantive clarifications are offered in the definition of "minor surgery" appearing at N.J.A.C. 13:35-4A.3. Express examples have been included, such as flexible sigmoidoscopy and non-invasive ophthalmologic procedures, as well as closed reductions of fractures. In addition, minor surgery is also defined to exclude a number of procedures which, although they may be performed under local anesthesia, involve extensive manipulation or removal of tissue such as liposuction or lipo-injection, breast augmentation or reduction and removal of breast implants. One other amendment makes clear that a practitioner would need to submit to the privileging process even though anesthesia services are not involved for the specific identification of retrobulbar blocks which is an anesthetic agent used in the course of cataract procedures. At N.J.A.C. 13:35-4A.11(b), the rule makes clear that even though it is defined as minor conduction blocks, retrobulbar blocks, are only to be administered by physicians privileged by a hospital or through the alternative privileging program.

Another substantive addition to be achieved through this proposal was brought to the attention of the Board by practitioners concerned about the practice of pre-anesthetizing patients before they arrive at the office. N.J.A.C. 13:35- 4A.6(f) and 4A.7(i) make it clear that a practitioner who performs surgery shall not prescribe or advise the patient to take an anesthetic agent prior to arrival, nor shall they accept a patient for treatment to whom an anesthetic agent had been so prescribed. An exception is provided in those instances in which life-threatening circumstances are involved. The risks that patients may face in being anesthetized outside of any facility with appropriate mechanisms and safeguards clearly warrant this precaution.

Finally another substantive addition, set forth at N.J.A.C. 13:35-4A.8(b) was brought to the Board's attention by representatives of the community of certified registered nurse anesthetists (CRNAs). The Board is told that there are circumstances in which the patient's safety may be placed at risk if, when undergoing a procedure with conscious sedation, there is a change in medical condition which requires conversion to general anesthesia. In those circumstances, where the patient's safety requires it, the rule amendment would allow a certified registered nurse anesthetist, even if under the supervision of a practitioner not privileged to supervise general anesthesia, to make the necessary conversion.

In addition to the more substantive changes described above, some clarifications that have proven necessary are proposed. More specifically, within the definition of "complication," as it appears at N.J.A.C. 13:35- 4A.3, additional circumstances are identified which would warrant a report to the Board. Specifically, the Board is of the view that wound infections requiring intravenous antibiotic treatment or hospitalization, unintended returns to the operating room, or temporary or permanent loss of function not considered to be a likely or usual outcome of the procedure are all circumstances which may benefit from regulatory review.

"Minor conduction block" has been redefined at N.J.A.C. 13:35-4A.3 to include digital blocks and metacarpal blocks. An inadvertent omission at N.J.A.C. 13:35-4A.6(c) which suggested that conscious sedation would only be performed on American Society of Anesthesiologists (ASA) Class III patients has been remedied. The new language makes clear that appropriate candidates include any patients who have a physical classification of I, II or III. Finally, additional clarifications are offered for the overnight stay provisions appearing at N.J.A.C. 13:35-4A.7(f) which, while not altering the Board's original intention, do make clear that the patient who might avail themselves of this option is one who is clearly dischargeable to home, and not in need of additional medical care.

Finally through this proposal, the Board is altering some of its original nomenclature. In the current rule, the alternative privileging mechanism is referred to as the alternative credentialing mechanism. The term has been replaced throughout. In addition, the Board has recognized that in a number of instances, particularly at N.J.A.C. 13:35-4A.7 where it had made reference to physician, the privileges described could be obtained by a properly privileged podiatrist and therefore the term practitioner has been substituted. Similarly, the Board has been made aware that the original language relating to the continuing medical education may not be accurate and, accordingly at N.J.A.C. 13:35-4A.8(a), 4A.9(a) and 4A.10(a), new language has been inserted making reference to the Physicians Recognition Award of the American Medical Association. Also, at N.J.A.C. 13:35-4A.8(a)2, 4A.9(a)2 and 4A.10(a)2 and 3, the term "eligible" has been replaced by a more apt term--"qualified." And finally, the reference appearing at N.J.A.C. 13:35-4A.11 to nurse practitioners has been replaced by the now accepted statutory term advanced practice nurse.

The Board has provided a 60-day comment period for this proposal. Therefore, this notice of proposal is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

When it first proposed the rules establishing surgical and anesthesia standards, the Board noted:

The Board expects that these proposed rules will benefit both patients and practitioners and physicians offering surgical and special procedures requiring anesthesia in the office. The Board is fully aware that, in this age of managed care, more and more special and surgical procedures are being offered and performed in the office setting and it recognizes that there are some clear cut benefits to this trend in terms of lower medical costs and shorter and more comfortable recuperation periods.

At 29 N.J.R. 2238(a), 2240, the Board went on:

The Board deems it crucial that such offices employ appropriately and adequately trained staff who are qualified to provide services consistent with current standards of practice in their respective professional discipline.

The Board also noted that the rules "require that the physician supervising the administration of anesthesia must be immediately available and cannot be concurrently responsible for the administration of anesthesia. Likewise, the rules require constant presence of personnel trained in advanced cardiac life support during surgery and in the recovery room." The Board expressed its confidence that these reforms would assure high level of protection for patients and, indeed, save lives.

With the portion of the rules affected by this proposal, the Board now moves towards the goals that it articulated back in 1997, when it first proposed these standards. It seeks to assure that practitioners that offer these services within their offices are knowledgeable and trained and can provide the necessary direction and supervision to other members of the surgical and anesthesia team. By making the physician responsible and assuring that he has the necessary training and competence, the Board hopes to continue to offer assurances to New Jersey patients regarding the comparability of safety when they choose to have procedures done in the office instead of a hospital.

As described more fully in the Summary, other reforms are also designed to enhance patient safety. Prohibitions on pre-anesthetizing patients and permitting CRNAs to convert to general anesthesia, even in the absence of the privileged practitioner, are all measures responsive to concerns raised by the community of unintended and potentially negative impacts that the original regulatory standards could have had upon patients. Clarifications with respect to the scope and reach of the rules will afford the regulated community a better understanding of practitioner responsibilities in terms of reporting complications. By specifically excluding procedures such as liposuction and breast augmentation from the definition of minor surgery, the Board believes it is extending important protection to New Jersey patients, for the procedures which the medical literature confirms involve substantial risks.

In crafting the alternative privileging mechanism, the Board has attempted to strike a balance between establishing standards that will enhance patient safety while not being overly restrictive. It has allowed ample time for the regulated community to seek Board review, without major practice disruptions, as the compliance standards allow practitioners a year to file an application with the Board and permit continued practice during the pendency of the review of the application. The submissions that will be required are designed to give the Board a full and complete understanding of a practitioner's training and competence so that these important determinations can be made in the best interests of the patients.

Economic Impact

With the promulgation of the alternative privileging mechanism, there may be some impact on the staffing of various office practices. Once fully operational, a practitioner who does not have training and experience in the administration or supervision of general or regional anesthesia cannot continue to serve as a supervisor for a CRNA without appropriate Board certification or the alternatives as described in the Summary. There may be some practices in New Jersey in which CRNAs have been operating under the supervision and direction of physicians who are neither privileged at a licensed hospital or eligible to obtain privileging through the Board process. In those instances, offices may be required to make alterations in their staffing. If the levels of anesthesia used include general or regional anesthesia, and no physician presently available is or could be privileged in those services, an office will need to include an anesthesiologist on staff. Throughout the years that the Board has been involved in designing this regulatory initiative, however, it has yet to be apprised of any significant number of CRNAs who administer general or regional anesthesia in the office setting, under the supervision of non-anesthesiologists. So it is difficult to know with any certainty the exact number of individuals who may be impacted in this manner.

There may be other economic impacts in the process of enhancing practitioner qualifications. The proposed amendments and new rule will require practitioners to obtain continuing medical education and, in some instances, supplemental training--all of which may involve costs. The criteria for conscious sedation privileging, however, although in the Board's view should be easily obtainable may require some physicians to become certified in ACLS. While there may be costs associated with these enhancements, it is also the Board's view that the increased assurance of patient safety outweighs any economic impact on the individual practitioners.

Finally, it can be anticipated that there will be a charge associated with the review of credentials for those physicians who apply for alternative privileges because they do not hold privileges at a hospital. It is not known at this juncture how much will be charged for this review, but the Board has endeavored to create a process which, while thorough, is as efficient as possible.

Federal Standards Statement

A Federal standards analysis is not required for the proposed amendments and new rule. There are no Federal practice standards or requirements that directly affect the particular subject of this rulemaking. The proposed amendments and new rule is consistent with the Federal recognition, as reflected in the rules of the Health Care Financing Administration pertaining to reimbursement by the Medicare and Medicaid programs, that determinations pertaining to standards of professional practice are reserved to the states. (See 42 CFR 416, 482 and 485).

Jobs Impact

There are some 30,000 physicians currently registered by the Board of Medical Examiners to practice in this State, many of whom may currently perform surgery or special procedures or administer or supervise the administration of anesthesia in an office setting and, if not credentialed by a hospital, would be affected by the amendments and new rule. To the extent that physicians do not have the requisite experience or training to supervise CRNAs they may be required to alter their current staffing until they do acquire the necessary training. Conversely, those physicians who can demonstrate competence and are appropriately trained may find their services more in demand. Because it does not yet have a firm understanding of the number of practitioners not credentialed by hospitals who are performing these office procedures or supervising CRNAs in the administration of anesthesia, the Board is unable to predict the extent to which jobs will be affected by the proposed amendments and new rule.

Agriculture Industry Impact

The Board does not believe that the proposed amendments and new rule will have any impact on the agriculture industry of this State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to give a description of the types and an estimate of the number of small businesses to which the proposed amendments and new rule will apply. If, for purposes of the Act, Board licensees are considered "small businesses" within the meaning of the statute, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed amendments and new rule including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs, to outline the manner in which it has designed the rules to minimize any adverse economic impact upon small businesses and to set forth whether the rules establish differing compliance requirements for small businesses.

The proposed new rule at N.J.A.C. 13:35-4A.12 does impose requirements upon practitioners who do not hold hospital privileges who apply to the Board for privileges to perform surgery or special procedures. The rule will require such individuals to prepare a log reflecting cases done over the last two years. As to those who administer or supervise the administration of anesthesia, applying for privileges for general or regional anesthesia or surgery or special procedure the log is to include all procedures done in the office and ambulatory care facility. Complications are to be identified, patient names redacted and the cases referenced by numbers. The log for those seeking conscious sedation privileges is less extensive; only the cases in which complications occurred are required. Additional documents including proof of training, references and patient charts are to be produced. The costs and effort associated with the collection of this data may be substantial, but without such documentation the Board will not be in a position to properly evaluate practitioner experience, training and competence.

In addition, the proposed amendments expand the list of events that must be reported as complications (N.J.A.C. 13:35-4A.3). The costs associated with this obligation are not significantand it will provide the Board with important data concerning the relative safety of office surgery. No additional professional services will be necessary to comply with the proposed amendments and new rule, except for those that the Board will enlist in the review of credentials.

The amendments and new rule minimize adverse economic impact upon small businesses by requiring only fundamental information. Effort has been taken not to duplicate effort by requiring information already supplied as a prerequisite to licensure. Because the Board has designed the proposal to afford an opportunity to those practitioners who do not hold hospital privileges, it has greatest impact on that group. The provision relating to the reporting of complication applies uniformly to all licensees offering these services. In order to ensure that the patient safety concerns intended to be realized by the amendments and new rule are achieved, the provisions will apply to all practitioners and no differing compliance standards have been provided.

Full text of the proposal follows:

<< NJ ADC 13:35-4A.2 >>

13:35-4A.2 Scope

<<+(a)+>> This subchapter establishes policies and procedures and staffing and equipment requirements for practitioners and physicians who perform surgery (other than minor surgery), special procedures and administer anesthesia services in an office setting.

<<+(b) For purposes of this subchapter, the standards set forth at N.J.A.C. 13:35-4A.6 do not apply to those performing non-invasive special procedures, such as non-invasive radiologic procedures. However, the standards set forth at N.J.A.C. 13:35-4A.7, including the privileging standards set forth at (a) above, do apply to the anesthesia services provided in connection with all special procedures, whether invasive or non-invasive.+>>

<< NJ ADC 13:35-4A.3 >>

13:35-4A.3 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Complications" means an untoward event occurring at any time within 48 hours of any surgery, special procedure or the administration of anesthesia services which was performed in an office setting including, but not limited to, any of the following events: paralysis, nerve injury, malignant hyperthermia, seizures, myocardial infarction, renal failure, significant cardiac events, respiratory arrest, aspiration of gastric contents, cerebral vascular accident, transfusion reaction, pneumothorax, allergic reaction to anesthesia, <<+wound infections requiring intravenous antibiotic treatment or hospitalization,+>> unintended <<+return to an operating room or+>> hospitalization <<-for more than 24 hours or->><<+,+>> death <<+or temporary or permanent loss of function not considered to be a likely or usual outcome of the procedure+>>.

<<-"Credentialed" means that a practitioner or physician has been granted, and continues to maintain, the privilege by a hospital licensed in the jurisdiction in which it is located to provide specified services, such as surgery or the administration or the supervision of administration of one or more types of anesthetic agents or procedures.->>

"Minor conduction block" means the injection of local anesthesia to stop or prevent a painful sensation in a circumscribed area of the body (that is, local infiltration or local nerve block), or the block of a nerve by direct pressure <<-and->> <<+or+>> refrigeration. Minor conduction blocks include, but are not limited to, <<-retobulbar->> <<+retrobulbar+>> blocks, peribulbar blocks, pudendal blocks<<+, digital blocks, metacarpal blocks+>> and ankle blocks. <<+"Minor conduction block" does not include regional anesthesia that affects larger areas of the body, such as brachial anesthesia or spinal anesthesia.+>>

"Minor surgery" means surgery which can safely and comfortably be performed on a patient who has received <<+no more than the maximum manufacturer recommended dose of+>> local or topical anesthesia, without more than minimal pre-operative medication or minimal intra-operative tranqualization and where the likelihood of complications requiring hospitalization is remote. <<+Minor surgery specifically excludes all procedures performed utilizing anesthesia services as defined in this section. Minor surgery also specifically excludes procedures which may be performed under local anesthesia, but which involve extensive manipulation or removal of tissue such as liposuction or lipo- injection, breast augmentation or reduction, and removal of breast implants.+>> <<-For example, minor->> <<+Minor+>> surgery includes the excision of moles, warts, cysts, lipomas, <<+skin biopsies,+>> the repair of simple lacerations<<+,+>> or <<+other+>> surgery limited to the skin and subcutaneous tissue<<-,->><<+. Additional examples of minor surgery include closed reduction of a fracture,+>> the incision and drainage of abscesses, certain simple opthalmologic surgical procedures, such as treatment of chalazions and non-invasive <<+ophthalmologic+>> laser procedures performed with topical anesthesia, limited endoscopies such as <<+ flexible sigmoidoscopies, anoscopies,+>> proctoscopies, <<-skin biopsies,->> arthrocenteses, thoracenteses and paracenteses. Minor surgery shall not include any procedure identified as "major surgery" within the meaning of N.J.A.C. 13:35-4.1.

<<+"Privileges" means the authorization granted to a practitioner or physician by a hospital licensed in the jurisdiction in which it is located to provide specified services or alternatively by the Board pursuant to N.J.A.C. 13:35-4.12, such as surgery or the administration or the supervision of administration of one or more types of anesthetic agents or procedures.+>>

"Regional anesthesia" means the administration of anesthetic agents to a patient to interrupt nerve impulses without loss of consciousness and includes epidural, caudal, spinal and brachial anesthesia. <<+Regional anesthesia does not include minor conduction blocks as defined in this section.+>>

"Special procedure" means patient care which requires <<+anesthesia services because it involves+>> entering the body with instruments in a potentially painful manner, or <<-which->> requires the patient to be immobile, for a diagnostic or therapeutic procedure <<-requiring anesthesia services; for example,->>. <<+Examples of special procedures include+>> diagnostic or therapeutic endoscopy <<+or bronchoscopy performed utilizing conscious sedation or general anesthesia+>>; invasive radiologic procedures <<+ performed utilizing conscious sedation+>>; pediatric magnetic resonance imaging <<+performed utilizing a sedative dose of medication adequate to cause the patient to sleep or not to move+>>; <<+or+>> manipulation under anesthesia (MUA) <<-or endoscopic examination with the use of general anesthesic->>. <<+The term special procedure does not include a procedure which only requires medication to reduce anxiety such as a benzodiazepine unless the dose given is intended to provide conscious sedation.+>>

<< NJ ADC 13:35-4A.6 >>

13:35-4A.6 Standards for <<-practitioners->> performing surgery and special procedures in an office; <<-credentials->> <<+privileges+>> necessary; pre-procedure counseling; patient records; recovery and discharge

(a) A practitioner who performs surgery (other than minor surgery) or special procedures in an office <<-requiring the administration of anesthesia services->> shall be <<-credentialed->> <<+privileged+>> to perform that surgery or special procedure by a hospital. If a practitioner is not <<- credentialed->> <<+privileged+>> but wishes to perform surgery or special procedures in an office, the practitioner shall apply to the Board pursuant to N.J.A.C. 13:35-4A.12 to seek Board-approved <<-credentialing->> <<+ privileging+>>.

(b) Before a <<-credentialed->> <<+privileged+>> practitioner may perform surgery (other than minor surgery), or special procedures, the practitioner shall have:

1. A written transfer agreement with a licensed hospital which can be reached within 20 minutes during all hours in which surgery or special procedures are performed in the office, if the hospital where the practitioner is <<- credentialed->> <<+privileged+>> is not reachable within 20 minutes or if the practitioner is <<-credentialed->> <<+privileged+>> by the Board; and

2. A written policy for handling emergency transport to a hospital at which the practitioner is <<-credentialed->> <<+privileged+>> through 9-1-1 call or a written transfer agreement with a licensed ambulance service which assures immediate transport of patients experiencing complications to the hospital which the practitioner has established a transfer agreement. The written transfer agreement shall be posted in the office and all health care personnel in the office shall specifically be informed of the procedure to be followed.

(c) A practitioner who performs surgery (other than minor surgery) or special procedures in an office <<-requiring the administration of anesthesia services->> shall provide pre-procedure counseling and preparation as follows:

1. The practitioner shall appropriately assess, or review a referring physician's assessment of, the physical condition of the patient on whom surgery or a special procedure is to be performed. The practitioner shall refer a patient who, by reason of pre-existing medical or other conditions, are at undue risk for complications (for example, morbidly obese patients; patients with severe cardiac, pulmonary, airway or neurological problems; substance abusers) to an appropriate specialist for a pre-procedure consultation or to another treatment setting or other appropriate facility for the performance of the surgery or the special procedure. Only patients with <<-a->> <<+an American Society of Anesthesiologists (ASA)+>> physical status classification of I or II are appropriate candidates for an office <<-surgical->> <<+surgery+>> or special procedure for which general or regional anesthesia are to be used. Patients with <<-a->> <<+ an ASA+>> physical classification of <<+I, II or+>> III are appropriate candidates for conscious sedation.

2.-6. (No change.)

(d) A practitioner who performs surgery (other than minor surgery) or special procedures in an office <<-requiring the administration of anesthesia services->> shall ensure the following during recovery and prior to discharge:

1.-4. (No change.)

(e) <<-Practitioners->> <<+A practitioner+>> who perform<<+s+>> surgery (other than minor surgery) or special procedures in an office <<- requiring the administration of anesthesia services->> shall prepare a patient record which shall include the following:

1.-6. (No change.)

<<+(f) No practitioner who performs surgery (other than minor surgery) or special procedures in an office shall:+>>

<<+1. Prescribe, or advise a patient to take, an anesthetic agent to be administered prior to arrival at the office or outside of the anesthetizing location; or+>>

<<+2. Accept for treatment a patient to whom an anesthetic agent had been prescribed or administered prior to arrival at the office or outside of the anesthetizing location, other than in life threatening circumstances.+>>

<< NJ ADC 13:35-4A.7 >>

13:35-4A.7 Standards for<<-physicians->> administering or supervising the administration of anesthesia services in an office; pre-anesthesia counseling; patient monitoring; recovery; patient record; discharge of patient

(a) A <<-physician->> <<+practitioner+>> who administers or supervises the administration and monitoring of anesthesia services in an office shall be <<-credentialed->> <<+privileged+>> by a hospital to provide the particular anesthesia service. If a <<-physician->> <<+practitioner+>> is not <<-credentialed->> <<+privileged+>> but wishes to administer or supervise the administration of anesthesia services, the physician shall apply to the Board pursuant to N.J.A.C. 13:35-4A.12 to seek Board-approved <<- credentialing->> <<+privileging+>>.

(b) A <<-physician->> <<+practitioner+>> who administers or supervises the administration or monitoring of anesthesia services in an office shall provide pre-anesthesia counseling and preparation as follows:

1. Any patient to whom anesthesia services are to be provided shall be appropriately screened by the individual administering anesthesia services. Patients who, by reason of pre-existing medical or other conditions, are at undue risk for complications (for example, morbidly obese patients; patients with severe cardiac, pulmonary, airway or neurological problems; substance abusers) shall be referred to an appropriate specialist for a pre-procedure consultation or to another treatment setting or other appropriate facility. Only patients with <<-a->> <<+an ASA+>> physical status classification of I or II are appropriate candidates for an office <<-surgical->> <<+ surgery+>> or special procedure for which general or regional anesthesia are to be used. Patients with <<-a->> <<+an ASA+>> physical classification of <<+I, II or+>> III are appropriate candidates for conscious sedation.

2.-9. (No change.)

(c)-(d) (No change.)

(e) <<-Physicians->> <<+A practitioner+>> who administer<<+s+>> or supervise<<+s+>> the administration of anesthesia services in an office shall establish within that office a recovery area and ensure that recovery services are provided as follows:

1.-7. (No change.)

(f) A <<-physician->> <<+practitioner+>> who administers or supervises the administration of anesthesia may allow a <<+patient+>> dischargeable <<-patient->> <<+to home pursuant to N.J.A.C. 13:35- 4A.4(a)9 and 4A.6(d)+>> to remain in the office <<-overnight->> for a period not to exceed 23 hours in a <<-special->> overstay area, if the patient may benefit from additional <<-nursing->> care <<-because of symptoms such as nausea->>. The <<-special->> overstay area shall be staffed by at least one registered professional nurse or <<- physical->> <<+physician+>> assistant for each two patients<<-. The->> <<+in the overstay setting, the+>> patient's vital signs shall be taken and recorded at least every four hours<<-. A->> <<+and a+>> physician shall be able to reach the office within 20 minutes <<-at all times that a patient is remaining overnight in the office->>. Appropriate sleeping accommodations, as well as food, shall be provided for the patient.

(g) <<-Physicians->> <<+A practitioner+>> who administer<<+s+>> or supervise<<+s+>> the administration of anesthesia services in an office shall ensure the following prior to discharge:

1.-4. (No change.)

(h) <<-Physicians->> <<+A practitioner+>> who administer<<+s+>> or supervise<<+s+>> the administration of anesthesia services in an office shall ensure that a patient record is prepared which contains the following:

1.-6. (No change.)

<<+(i) No practitioner who administers or supervises the administration of anesthesia services in an office shall:+>>

<<+1. Prescribe, or advise a patient to take, an anesthetic agent to be administered prior to arrival at the office or outside of the anesthetizing location; or+>>

<<+2. Accept for treatment a patient to whom an anesthetic agent had been prescribed or administered prior to arrival at the office or outside of the anesthetizing location, other than in life threatening circumstances.+>>

<< NJ ADC 13:35-4A.8 >>

13:35-4A.8 Performance of general anesthesia; authorized personnel

(a) General anesthesia shall be administered and monitored in an office only by the following individuals:

1. A physician <<-credentialed->> <<+privileged+>> by a hospital or the Board pursuant to N.J.A.C. 13:35-4A.12 to provide general anesthesia services and who, during every consecutive three-year period beginning July 1, <<-1998->> <<+(yet unspecified date one year after the adoption)+>>, completes at least 60 Category I hours of continuing <<+ medical+>> education <<-courses->> in anesthesia<<-, as->> <<+ which either meet the criteria for credit towards the Physician's Recognition Award of the American Medical Association or have been+>> approved by the <<-Accreditation Council for Continuing Medical Education or the->> American Osteopathic Association; or

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician <<-eligible->> <<+qualified+>> under (a)1 above.

(b) The administration and monitoring of general anesthesia shall be provided by an individual who meets the requirements of (a) above and who is at all times present in the anesthetizing location and who is not the practitioner performing the surgery or special procedure. <<+This subsection shall not be construed to preclude the conversion of conscious sedation to general anesthesia in an emergency to protect the health of the patient, even if there is no physician present who would be qualified to administer and monitor general anesthesia pursuant to (a)1 above.+>>

(c)-(d) (No change.)

<< NJ ADC 13:35-4A.9 >>

13:35-4A.9 Administration of regional anesthesia; authorized personnel

(a) Regional anesthesia shall be administered and monitored in an office only by the following individuals:

1. A physician <<-credentialed->> <<+privileged+>> by a hospital or the Board pursuant to N.J.A.C. 13:35-4A.12 to provide regional anesthesia and who, during every consecutive three-year period beginning July 1, <<- 1998->> <<+(yet unspecified date one year after adoption)+>>, completes at least eight Category I hours of continuing <<+medical+>> education <<-courses->> in anesthesia exclusively, or in anesthesia as it relates to <<-a specific->> <<+the physician's+>> field of practice, <<-as->> <<+which either meet the criteria for credit towards the Physician's Recognition Award of the American Medical Association or have been+>> approved by the <<-Accreditation Council for Continuing Medical Education or the->> American Osteopathic Association; or

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician <<-eligible->> <<+qualified+>> under (a)1 above.

(b)-(d) (No change.)

<< NJ ADC 13:35-4A.10 >>

13:35-4A.10 Administration of conscious sedation; authorized personnel

(a) Conscious sedation shall be administered in an office only by the following individuals:

1. A physician <<-credentialed->> <<+privileged+>> by a hospital or the Board pursuant to N.J.A.C. 13:35-4A.12 to provide conscious sedation and who, during every consecutive three-year period beginning July 1, <<- 1998->> <<+2001+>>, completes at least eight <<+Category I or II+>> hours of continuing <<+medical+>> education <<-courses->> in any anesthesia services, including conscious sedation exclusively, or in anesthesia as it relates to the physician's field of practice, <<- as->> <<+which either meet the criteria for credit towards the Physician's Recognition Award of the American Medical Association or have been+>> approved by the <<-Accreditation Council for Continuing Medical Education or the->> American Osteopathic Association;

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician <<-eligible->> <<+qualified+>> under (a)1 above; or

3. A registered professional nurse or physician assistant, who is trained and has experience in the use <<+and monitoring+>> of anesthetic agents, at the specific direction of a physician <<-eligible->> <<+qualified+>> under (a)1 above, but only for the purpose of administering through an established intravenous line, a specifically prescribed supplemental dose of conscious sedation which was selected and initially administered by the physician who remains continuously present in the procedure room.

(b)-(e) (No change.)

<< NJ ADC 13:35-4A.11 >>

13:35-4A.11 Administration of minor conduction blocks; authorized personnel

(a) Minor conduction blocks <<+(with the exception of retrobulbar blocks)+>> shall be administered in an office for surgery <<-(other than minor surgery)->> or special procedures only by the following individuals:

1. A practitioner;

2. A certified registered nurse anesthetist (CRNA); or

3. A certified nurse midwife, <<-a nurse practitioner, clinical nurse specialist->> <<+an advanced practice nurse+>> or physician assistant who has training and experience in the administration of minor conduction blocks.

(b) <<-A practitioner shall be physically present on the premises and shall supervise the administration of minor conduction blocks.->> <<+Retrobulbar blocks shall be administered in the office only by a physician privileged by a hospital or by the Board pursuant to N.J.A.C. 13:35-4.12.+>>

<< NJ ADC 13:35-4A.12 >>

13:35-4A.12 Alternative privileging procedure <<-(Reserved)->>

<<+(a) A practitioner who seeks to provide or supervise the administration of general or regional anesthesia, as well as conscious sedation, in an office, but does not hold privileges at a licensed hospital to do so, shall submit to the Board an application for these privileges. To be eligible to apply for these privileges, an applicant shall meet the following criteria and submit an application that documents the applicant's fulfillment of these criteria:+>>

<<+1. Demonstration of clinical experience, through an attestation as to the number of procedures for which general or regional anesthesia was provided by the applicant in the last two years for all age groups of patients within the applicant's practice for which privileges are requested;+>>

<<+2. Any one of the following:+>>

<<+i. Current certification in anesthesiology granted by the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology or any other certification entity that the applicant demonstrates has standards of comparable rigor;+>>

<<+ii. Successful completion of a residency training program in anesthesiology accredited by the Accreditation Council on Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA); or+>>

<<+iii. Supervised training in residency, fellowship or other equivalent experience in another field and active participation in the examination process leading to certification in anesthesiology; and+>>

<<+3. Possess clinical competence to perform the anesthesia services or procedures authorized by the requested privileges, with such competence confirmed by the following:+>>

<<+i. Three references submitted directly by plenary licensed physicians addressing the applicant's current competence based on personal knowledge obtained either during a residency training completed during the two years preceding the application or through personal observation during the two years preceding the application;+>>

<<+ii. Submission of a log listing all patients for whom the applicant provided any of the anesthesia services in an office setting or licensed ambulatory care facility setting for which privileges have been requested during the two years preceding the date of the application. The log shall include a patient number, the type of anesthesia service provided, the surgery or special procedure performed and the date(s) of service. Patient names and other identifying data shall be redacted. The applicant shall maintain a list or other means to identify the patient, based on the number included in the log;+>>

<<+iii. Identification of any patients in the log who have experienced complications relating to the applicant's provision of anesthesia services in an office setting or licensed ambulatory care facility setting and their resulting outcomes; and+>>

<<+iv. Submission of no fewer than five patient records or charts (or the pertinent portions thereof with patient names redacted) which have been identified and requested by the Board or other reviewing entity, designated pursuant to (e) below, along with a completed case summary form for each submitted case, utilizing such forms as are provided in the application materials.+>>

<<+(b) A practitioner who seeks to administer or supervise the administration of only conscious sedation in an office, but does not currently hold clinical privileges at a licensed hospital to do so, shall submit to the Board an application for this privilege. To be eligible to apply for this privilege, an applicant shall meet the following criteria and submit an application that documents the applicant's fulfillment of these criteria:+>>

<<+1. Demonstration of clinical experience, through an attestation as to the number of procedures for which conscious sedation was provided by the applicant in the last two years for all age groups with the applicant's practice of patients for which privileges are requested, except as specifically excluded from practice;+>>

<<+2. Any one of the following:+>>

<<+i. Current certification in anesthesiology granted by the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology or any other certification entity the applicant demonstrates has standards of comparable rigor;+>>

<<+ii. Current certification in Critical Care Medicine or Emergency Medicine by a specialty board or certifying entity recognized by the American Board of Medical Specialties ("ABMS") or the American Osteopathic Association ("AOA") or any other certification entity the applicant demonstrates has standards of comparable rigor; or+>>

<<+iii. Current certification in Advanced Cardiac Life Support or Pediatric Advanced Life Support and either:+>>

<<+(1) Successful completion of an educational home study program, with a test of basic knowledge obtained from the Board; or+>>

<<+(2) A course in conscious sedation offered by a licensed hospital or for continuing medical education credits; and+>>

<<+3. Submission of a list of all patients who have experienced complications relating to the applicant's provision of conscious sedation in an office setting or licensed ambulatory care facility setting and their resulting outcomes. Patient names and other identifying data shall be redacted. The applicant shall maintain a list or other means to identify the patient, based on the number included in the log.+>>

<<+(c) A practitioner who seeks to perform surgery (other than minor surgery) or special procedures in an office, but does not hold privileges at a licensed hospital to perform these procedures shall submit to the Board an application for these privileges, including a completed privilege request form appropriate to the privileges requested. To be eligible to apply for this privilege, an applicant shall meet the following criteria and submit an application that documents the applicant's fulfillment of these criteria:+>>

<<+1. Demonstration of clinical experience, through an attestation as to the number and type of procedures performed by the applicant in the last two years for all age groups of patients for which privileges are requested;+>>

<<+2. Any one of the following:+>>

<<+i. Current certification in the field(s) of practice in which the privileges are sought granted by a specialty board or certifying entity recognized by the American Board of Medical Specialties (ABMS), the American Osteopathic Association (AOA), the American Podiatric Medicine Association (APMA) or any other certification entity that the applicant demonstrates has standards of comparable rigor;+>>

<<+ii. Successful completion of an Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) residency or fellowship training program in the field(s) of practice in which privileges are sought; or+>>

<<+iii. Supervised training in a residency or fellowship training or other equivalent experience in another field and active participation in the examination process leading to certification in the practice field(s) in which privileges are sought; and+>>

<<+3. Possess clinical competence to perform the procedures authorized by the requested privileges, with such competence confirmed by the following:+>>

<<+i. Three references submitted directly by plenary licensed physicians (or licensed podiatrists as to podiatric applicants) addressing the applicant's current competence based on personal knowledge obtained either during a residency training completed during the two years preceding the application or through personal observation during the two years preceding the application;+>>

<<+ii. Submission of a log listing all patients for whom the applicant has performed surgery or special procedures in an office setting or licensed ambulatory care facility setting for which privileges have been requested during the two years preceding the date of the application. The log shall include a patient number, the surgery or special procedure performed and the indications for that procedure and the date(s) of service. Patient names and other identifying data shall be redacted. The applicant shall maintain a list or other means to identify the patient, based on the number included in the log;+>>

<<+iii. Identification of any patients in the log who have experienced complications relating to the applicant's performance of surgery or special procedures in an office setting or licensed ambulatory care facility setting and their resulting outcomes; and+>>

<<+iv. Submission of no fewer than five patient records or charts (or the pertinent portions thereof with patient names redacted) which have been identified and requested by the Board or other reviewing entity, along with a completed case summary form for each submitted case, utilizing such forms as are provided in the application materials.+>>

<<+(d) A practitioner who seeks to utilize laser surgery techniques in an office, but does not hold privileges at a licensed hospital to do so, shall submit to the Board an application, which shall include:+>>

<<+1. Certification of successful completion of an accredited laser training program, in which the curriculum includes instruction in laser care, physics and clinical indications for utilizationof the specific laser; or+>>

<<+2. Documentation from the program director of an accredited residency training program which the applicant has successfully completed, attesting to the inclusion of training in the specific laser therapy for which privileges are being sought during residency training.+>>

<<+(e) The Board may delegate to a reviewing entity the responsibility to conduct a preliminary review of an application to ascertain whether the applicant has met the criteria established in (a) through (d) above, which review shall be undertaken at the expense of the applicant. The Board shall thereafter review the summary report including any recommendation concerning the applicant prepared by the reviewer and make a decision on the application for privileges.+>>

<<+(f) If the Board or any entity or person to which the Board may delegate the preliminary application review finds that the applicant has not submitted sufficient information upon which a determination as to the applicant's current competence may be made, the Board or the reviewing entity may require:+>>

<<+1. A personal interview;+>>

<<+2. The submission of a representative sample of patient records substantiating the experience of the applicant;+>>

<<+3. The submission of any patient records relating to an identified complication;+>>

<<+4. An inspection of the office, which may include a review of additional patient records and written policies and procedures; and/or+>>

<<+5. The submission of such additional information as may be necessary to determine an applicant's clinical competence to perform the privileges requested.+>>

<<+(g) Upon review of the summary report prepared by the Board or the reviewing entity, the Board may take any of the following actions:+>>

<<+1. Grant all or some of the privileges requested;+>>

<<+2. Condition its approval of all or some of the privileges requested on the applicant's successful completion of additional training;+>>

<<+3. Condition its approval of all or some of the privileges on the applicant's successful completion of a period of observation;+>>

<<+4. Deny all or some of the privileges requested; and/or+>>

<<+5. Require such additional information as may be necessary to act on the application.+>>

<<+(h) Practitioners who have been granted privileges through the alternative privileging procedure of this section shall submit a renewal application to the Board within two years from the date on which privileges were granted. Practitioners shall notify the Board within 21 days should there be any change in the information provided in the application and renewal.+>>

<< NJ ADC 13:35-4A.17 >>

13:35-4A.17 Compliance timetables

(a) <<-(Reserved)->> <<+A practitioner who does not hold privileges at a hospital and, as of (the effective date of this rule), was offering and elects to continue offering or chooses to begin offering anesthesia services or surgery or special procedures in the office setting, shall submit an application to the Board seeking approval pursuant to the alternative privileging process set forth at N.J.A.C. 13:35-4A.12, no later than one year after (the effective date of this rule). Notwithstanding any other provision in this subchapter, a practitioner who has submitted an application for alternative privileging pursuant to this subsection, may continue to offer services for which privileges have been requested until such time as the Board acts upon that application.+>>

(b)-(c) (No change.)

33 N.J.R. 3870(a)


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Posted November 19, 2001