N.J. Admin. Code § 13:35-4A.6

Current through Register Vol. 56, No. 21, November 4, 2024

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

(a) A practitioner who performs surgery or special procedures (other than minor procedures) in an office shall be privileged to perform that surgery or special procedure by a hospital or an ambulatory surgery center. If a practitioner is not so 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 privileging.

(b) Before any practitioner may perform surgery or special procedures (other than minor procedures), the practitioner shall have:

1. A written transfer agreement with a licensed hospital with acute care capabilities 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 privileged is not reachable within 20 minutes or if the practitioner is privileged by the Board; and

2. A written policy for handling emergency transport to a hospital at which the practitioner is 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 or special procedures (other than minor procedures) in an office shall provide pre-procedure counseling and preparation as follows:

1. The practitioner shall appropriately assess, or review a referring physician's or an advanced practice clinician'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 preexisting 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 an American Society of Anesthesiologists (ASA) physical status classification of I or II are appropriate candidates for an office surgery or special procedure for which general or regional anesthesia are to be used. Patients with an ASA physical classification of I, II, or III are appropriate candidates for moderate sedation.

2. A history and physical examination shall be performed within the 30 days preceding the proposed surgery either by the practitioner performing the surgery or special procedure (as appropriate to that practitioner's scope of practice) or by another physician or an advanced practice clinician. Necessary laboratory tests, as guided by the patient's underlying medical condition, shall be conducted within seven days preceding the proposed surgery;

3. The risks and benefits of the surgery or special procedure and alternative methods or treatments shall be fully explained by the practitioner or other health care personnel, and written informed consent for the specific surgery or special procedure contemplated shall be obtained from the patient, guardian or authorized representative;

4. An appropriate fasting protocol shall be explained and provided to the patient;

5. If the history and physical are not done on the same day as the procedure, an interim assessment shall be performed by the practitioner or a physician assistant under the supervision of a physician immediately prior to the procedure, which assessment shall be documented and dated; and

6. Prior to surgery, the practitioner shall ensure that the patient removes all cosmetics, jewelry, contact lenses, dental appliances and prosthetic devices which might reasonably jeopardize patient safety.

(d) A practitioner who performs surgery or special procedures (other than minor procedures) in an office shall ensure the following during recovery and prior to discharge:

1. Immediately after the surgery or special procedure, the patient shall be evaluated by either the practitioner who performed the surgery or the physician or CRNA who administered the anesthesia;

2. At least one practitioner shall remain on the premises until the patient is discharged from the recovery area;

3. The patient shall be provided with written and verbal instructions for follow-up care and with advice concerning possible complications; and

4. The patient shall be discharged into the company of a responsible individual.

(e) A practitioner who performs surgery or special procedures (other than minor procedures) in an office shall prepare a patient record which shall include the following:

1. A pre-procedure medical history and physical, appropriate to the practitioner's scope of practice, including such data as allergies, physical and mental impairments, vital signs, drug use, mobility limitations and, as applicable, electrocardiogram results, radiologic findings, laboratory values and the identity of the examining practitioner;

2. Documentation reflecting that informed consent has been obtained;

3. A description of the surgery or special procedure performed, including pre-operative diagnosis, techniques used, names and titles of medical personnel participating, complete findings, post-operative diagnosis, and any unusual occurrence, complications or untoward events. Where similar procedures are performed at the office routinely, partially pre-printed forms may be utilized as a guide, provided that original data and conclusions applicable to the specific patient are contemporaneously entered to create a complete report;

4. A post-procedure note, entered prior to discharge from the office, which shall include at least such post-procedure data as the patient's general condition, vital signs, any treatments ordered, and all drugs prescribed, administered or dispensed including dosages, quantities and strengths;

5. The identity of healthcare personnel providing services, as evidenced by a legible signature following that staff member's notation in the patient's record; and

6. The plan for follow-up care and documentation of results of follow-up efforts.

(f) No practitioner who performs surgery or special procedures (other than minor 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 the performance of surgery or a special procedure a patient to whom an anesthetic agent had been administered for that surgery or special procedure prior to arrival at the office or outside of the anesthetizing location, other than in life threatening circumstances, unless the patient is accompanied by medical personnel from an acute care facility.

N.J. Admin. Code § 13:35-4A.6

Public Notice: Suspension of enforcement.
See: 30 N.J.R. 4485(b).
Amended by R.2002 d.404, effective 12/16/2002.
See: 33 N.J.R. 3870(a), 34 N.J.R. 4449(a).
Rewrote the section.
Amended by R.2011 d.155, effective 6/6/2011.
See: 42 N.J.R. 1310(a), 43 N.J.R. 1359(b).
In (c)2, substituted "30" for "14".

Amended by 53 N.J.R. 2013(a), effective 12/6/2021