53 N.J.R. 1982(a)

VOLUME 53, ISSUE 23, DECEMBER 6, 2021
RULE PROPOSALS

Reporter
53 N.J.R. 1982(a)
NJ - New Jersey Register  >  2021  >  DECEMBER  >  DECEMBER 6, 2021  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement 

INTERESTED PERSONS 
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal. 
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of  N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register. 
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at      N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code. 
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF MEDICAL EXAMINERS

Administrative Code Citation


Proposed New Rule: N.J.A.C. 13:35-6.20A
Text

  Radiologist Assistant Performing Procedures
Authorized By: Board of Medical Examiners, Antonia Winstead, Executive Director.
Authority: N.J.S.A. 45:9-2.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-112.
Submit comments by February 4, 2022, to:

Antonia Winstead, Executive Director
Board of Medical Examiners
140 East Front Street, 2nd Floor
PO Box 183
Trenton, New Jersey 08625

or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.  

The agency proposal follows:

   
Summary  
P.L. 2017, c. 281, allows for the licensure of radiologist assistants by the Department of Environmental Protection and permits radiologist assistants to perform delegated fluoroscopic procedures under the supervision of licensed radiologists pursuant to Board of Medical Examiners (Board) rules. The statute defines "delegated fluoroscopic procedures" as "the use of fluoroscopic equipment to perform any of the following procedures to the extent approved by the State Board of Medical Examiners: esophageal study; swallowing function study; upper gastrointestinal study; small bowel study; barium enema lower gastrointestinal study; nasogastric/enteric and oroenteric/enteric  tube placement; t-tube cholangiogram; chest fluoroscopy; hysterosalpingogram procedure and imaging; antegrade pyelogram; arthrogram, joint injection and aspiration; cystography or voiding cystourethrography (catheter placement); loopography; lumbar puncture with contrast; myelogram; abcess, fistula, sinus tract study; paracentesis; thoracentesis; venous access ports; tunneled and non-tunneled central venous catheters; tunneled and non-tunneled peripherally inserted central venous catheters; and tunneled and non-tunneled chest and abdominal drainage catheters."  
The Board has reviewed this statutory definition and has determined that most of these procedures are within the ability of licensed radiologist assistants to perform. However, the Board has determined that radiologist assistants should not be permitted to perform five of these procedures: (1) hysterosalpingogram procedure and imaging; (2) antegrade pyelogram; (3) lumbar puncture with contrast; (4) myelogram; and (5) tunneled and non-tunneled chest and abdominal drainage catheters. These five procedures require either the specialized education or experience of a physician, and the Board is not confident that licensed radiologist assistants could safely and effectively perform these procedures.  
Specifically, hysterosalpingogram procedures and imaging entail the direct injection of contrast material into the uterus, a procedure that should generally be performed by a physician with gynecological training, because of the increased infection risk. Antegrade pyelogram involves injecting contrast material into collecting systems of the kidney, which can carry a high risk of bleeding and kidney infection. Lumber punctures and myelograms involve inserting a needle into the spinal canal, which, if performed incorrectly, could cause trauma to nerves and result in contrast fluid being inadvertently inserted into blood vessels rather than into cerebrospinal fluid. Tunneled and non-tunneled chest and abdominal drainage catheters involve insertion of tubes into abdominal or thoracic cavity walls, an advanced skill honed by radiologists during residency training and employed after surgery or trauma, when risk of complications is already elevated. Additionally, insertion of these drainage catheters is usually aided by CT scan or ultrasound imaging; licensed radiologist assistants' scope of practice and training do not include the reading of such scans or ultrasounds.  
The Board proposes new rule N.J.A.C. 13:35-6.20A to set forth the procedures that it believes are appropriate for licensed radiologist assistants to perform and the level of supervision licensed radiologists must provide when radiologist assistants are performing these procedures and other related tasks.  
The proposed new rule defines "direct supervision," "general supervision", "licensed radiologist," "radiologist assistant," and "personal supervision." Direct supervision requires a licensed radiologist to be on-site and immediately available to provide assistance and direction but does not require the licensed radiologist to be in the room when a procedure is performed. General supervision does not require a licensed radiologist's presence on-site when a procedure is performed. Personal supervision [page=1983] requires a licensed radiologist to be present in the room when a procedure is performed.  
The proposed new rule requires that, prior to a licensed radiologist directing a radiologist assistant to perform a task, a licensed radiologist or other licensed physician in the practice certify and document the radiologist assistant's training and ability to perform the task. The proposed new rule also requires that the supervising licensed radiologist: be responsible for choosing and ordering pharmaceuticals and contrast materials; be certified in Advanced Cardiovascular Life Support (along with the radiologist assistant); and, if a patient is a minor, have experience performing the procedures on such patients. These requirements help to ensure that licensed radiologists are able to properly supervise radiologist assistants.  
In order to protect patient health, safety, and welfare, the Board is specifying different levels of supervision for different types of procedures based upon their complexity or difficulty. The proposed new rule permits licensed radiologists to direct radiologist assistants to obtain a clinical history and perform the physical examination of a patient under general supervision. The proposed new rule permits radiologist assistants to perform specific procedures, such as applying ECG leads, performing urinary catheterization, performing venipuncture, monitoring IV for flow rate and complications, operating a fluoroscopic unit, and administering contrast agents, under general supervision. Radiologist assistants may also perform certain post-imaging activities under general supervision. Under direct supervision, a radiologist assistant may monitor IV therapy, monitor for side effects or complications of pharmaceuticals, administer prescribed radiopharmaceuticals, and perform specific examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment. Under personal supervision, a radiologist assistant may perform urinary catheterization when there is a known anatomic anomaly or recent surgery to this area. Personal supervision is also required if a radiologist assistant performs joint injection and aspiration or arthograms.  
If a licensed radiologist seeks to direct a radiologist assistant, under personal supervision, to perform lower extremity venography, non-tunneled venous central line placement, venous catheter placement for dialysis, breast needle localization, or ductogram, the licensed radiologist must provide written notification to the Board of this intent and receive written notification from the Board that it has reviewed the information provided by the licensed radiologist. The written notification to the Board must include the specific procedures the radiologist assistant will perform, the specific training completed by the radiologist assistant in the procedure, the fact that the licensed radiologist has observed the radiologist assistant performing the procedure, and that the licensed radiologist attests that the radiologist assistant is able to perform the procedure safely and effectively. This notification ensures that the Board is aware when a radiologist assistant will perform these procedures, which are more complicated than the other procedures set forth in the rule.  
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.  
Social Impact  
The proposed new rule will benefit patients by increasing the number of practitioners who can provide fluoroscopic procedures, while ensuring that this pool of practitioners is appropriately supervised by licensed radiologists.  
Economic Impact  
The proposed new rule may have a beneficial economic impact for patients in that they will be able to receive services from radiologist assistants, who may provide services at a reduced cost, rather than when such services are provided by licensed radiologists.  
Federal Standards Statement  
A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed new rule.  
Jobs Impact  
The Board does not believe that proposed new rule will result in the creation or loss of jobs in the State.  
Agriculture Industry Impact  
The proposed new rule will have no impact on the agriculture industry in the State.  
Regulatory Flexibility Statement  
Since physicians are individually licensed by the Board under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.  
The proposed new rule imposes no new costs and the Board does not believe that licensed radiologists will need to employ any additional professional services to comply with the requirements of the proposed new rule. The proposed new rule imposes no reporting or recordkeeping requirements but does impose compliance requirements, as detailed in the Summary above.  
The proposed new rule protects the health, safety, and welfare of patients who will receive services from radiologist assistants under the supervision of licensed radiologists; therefore, no differing compliance requirements are provided to licensed radiologists based upon the size of a business.  
Housing Affordability Impact Analysis  
The proposed new rule will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed new rule would evoke a change in the average costs associated with housing because the proposed new rule concerns radiologist assistants performing procedures under the supervision of licensed radiologists.  
Smart Growth Development Impact Analysis  
The proposed new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed new rule would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rule concerns radiologist assistants performing procedures under the supervision of licensed radiologists.  
Racial and Ethnic Community Criminal Justice and Public Safety Impact  
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.  
Full text of the proposed new rule follows:   
SUBCHAPTER 6.   GENERAL RULES OF PRACTICE  
13:35-6.20A     Radiologist assistant performing procedures  
(a) The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:  
"Direct supervision" means that a licensed radiologist must be present in the office suite or department and immediately available to furnish assistance and direction throughout the performance of a procedure, but the licensed radiologist is not required to be present in the room when the procedure is performed.  
"General supervision" means that a procedure is performed under a licensed radiologist's direction and control, but the licensed radiologist's presence in the office suite or department is not required during the performance of the procedure.  
"Licensed radiologist" means a radiologist as the term is defined at N.J.S.A. 26:2D-26.  
"Personal supervision" means that the licensed radiologist must be present in the room during the performance of a procedure.  
"Radiologist assistant" means a radiologic technologist licensed by the New Jersey Radiologic Technology Board of Examiners who is certified and registered with a national radiologic certifying body approved by the New Jersey Radiologic Technology Board of Examiners and is credentialed to provide primary advanced-level radiology health care under the supervision of a licensed radiologist.  
(b) A licensed radiologist may direct a radiologist assistant to perform the tasks set forth at (c) and (d) below provided that:  
[page=1984] 1. The licensed radiologist (or another plenary-licensed physician in the office, or in a licensed health care facility, the head of the pertinent Department) has personally certified and documented the radiologist assistant's training and competency to perform the task. The documents shall be preserved in the personnel record and retained for at least the duration of such radiologist assistant's employment by or for that licensed radiologist or facility;  
2. The licensed radiologist is responsible for the choice and ordering of all pharmaceuticals and contrast materials and for the determination of dosage and route of administration;  
3. For pediatric patients, the licensed radiologist shall have experience in the performance of the pertinent procedures with such patients; and  
4. The licensed radiologist is currently certified in and has verified that the radiologist assistant is currently certified in Advanced Cardiovascular Life Support (ACLS) by the American Heart Association.  
(c) A licensed radiologist may direct a radiologist assistant to:  
1. Under general supervision, obtain the clinical history and physical examination of the patient by:  
i. Reviewing the patient's medical record to verify the appropriateness of a specific exam or procedure;  
ii. Interviewing the patient to obtain, verify, or update medical history;  
iii. Explaining a procedure to the patient or significant other of the patient, including a description of the risks, benefits, alternatives, and follow-up care;  
iv. Obtaining informed consent, as long as the patient is provided the opportunity to communicate with the licensed radiologist if the patient has any questions;  
v. Determining if the patient has followed instructions in preparation for the exam, such as diet and pre-medications;  
vi. Assessing risk factors that may be contraindications to the procedure, such as health history, medications, pregnancy, psychological indicators, and alternative medicines and informing the licensed radiologist of the findings;  
vii. Obtaining and evaluating vital signs;  
viii. Performing the physical examination of the patient and analyzing data, such as signs and symptoms, laboratory values, and significant abnormalities, provided that the licensed radiologist reviews all reported data prior to a procedure being performed; and  
ix. Participating in quality improvement activities;  
2. Under general supervision, perform the following general procedures:  
i. Applying electrocardiography (ECG) leads and recognizing life threating ECG abnormalities;  
ii. Performing urinary catheterization, except for instances where there is a known anatomic anomaly or recent surgery to this area;  
iii. Performing venipuncture;  
iv. Monitoring intravenous (IV) for flow rate and complications;  
v. Positioning patient to perform required procedures, using immobilization devices and modifying technique, as necessary;  
vi. Assessing patient's vital signs, levels of anxiety, and pain, informing the licensed radiologist, when appropriate, and bringing to the patient's physician any issues of concern;  
vii. Recognizing and responding to medical emergencies, such as drug reactions, cardiac arrest, and hypoglycemia, and activating emergency response systems, including notification of the licensed radiologist;  
viii. Administering oxygen, as prescribed;  
ix. Operating a fixed or mobile fluoroscopic unit;  
x. Assuring documentation of fluoroscopy time;  
xi. Explaining the effects and potential side effects to the patient of pharmaceuticals required for the examination;  
xii. Administering contrast agents as prescribed by the licensed radiologist; and  
xiii. Administering general medications, except for oral medications and excluding radiopharmaceuticals and sedating medications, as prescribed by the licensed radiologist;  
3. Under general supervision, perform the following post-imaging activities:  
i. Reviewing imaging procedures, making initial observations, and communicating observations only to the licensed radiologist;  
ii. Communicating the licensed radiologist's report to referring physician;  
iii. Providing licensed radiologist-prescribed post-care instructions to patients;  
iv. Performing follow-up patient evaluation and communicating findings to the licensed radiologist;  
v. Documenting the procedure in appropriate record and documenting exceptions from established protocol or procedure;  
vi. Writing patient discharge summary for review and co-signature by licensed radiologist;  
vii. Participating in quality improvement activities within the licensed radiologist's practice; and  
viii. Assisting with data collection and review for clinical trials or other research;  
4. Under direct supervision, perform the following general procedures:  
i. Monitoring intravenous (IV) therapy for flow rate and complications;  
ii. Administering oral medications;  
iii. Monitoring patient for side effects or complications of the pharmaceuticals; and  
iv. Administering radiopharmaceuticals as prescribed by the licensed radiologist;  
5. Under personal supervision, perform urinary catheterization when there is a known anatomic anomaly or recent surgery to this area;  
6. Under direct supervision, perform the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment:  
i. Upper GI;  
ii. Esophagus;  
iii. Small bowel studies;  
iv. Barium enema;  
v. Injection of contrast material into percutaneous gastric and enteric tubes;  
vi. Cystogram, except that a radiologist assistant shall not place a suprapubic catheter;  
vii. T-Tube cholangiogram, except that a radiologist assistant shall not place a catheter;  
viii. Retrograde urethrogram, except that a radiologist assistant shall not place a suprapubic catheter;  
ix. Port injections;  
x. Fistulogram/sonogram;  
xi. Loopogram;  
xii. Swallowing study;  
xiii. Peripherally Inserted Central Catheter (PICC) placement; and  
xiv. Monitoring of paracentesis and thoracentesis with appropriate image guidance after catheter has been placed by a radiologist; and  
7. Under personal supervision, perform the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment:  
i. Joint injection and aspiration; and  
ii. Arthrogram, including conventional, computerized tomography (CT), and magnetic resonance imaging (MRI).  
(d) After providing written notification to the Board as required at (e) below and receiving confirmation from the Board that the information has been reviewed, a licensed radiologist may direct a radiologist assistant to perform the following procedures:  
i. Lower extremity venography;  
ii. Non-tunneled venous central line placement in the femoral vein;  
iii. Venous catheter placement for dialysis;  
iv. Breast needle localization; and  
v. Ductogram (galactogram).  
(e) The notification required at (d) above shall include:  
1. The specific procedures at (d) above that the radiologist assistant will perform;  
2. The specific training completed by the radiologist assistant in the procedure that the licensed radiologist wishes to direct the radiologist assistant to perform; and  
3. The fact that the licensed radiologist has observed the radiologist assistant performing the procedure that the radiologist wishes to direct the radiologist assistant to perform and that the licensed radiologist attests that [page=1985] the radiologist assistant has demonstrated the ability to perform the procedure safely and effectively.