From the NJSSA
January 31, 2011
Dear NJSSA Member:
An Update to the NJSSA Membership regarding the anesthesia regulations
It's been almost five months since the NJ Department of Health and Senior Services (NJ DHSS) proposed regulations regarding the delivery of general major anesthesia in a hospital setting. The regulations were part of the re-adoption of the larger Hospital Licensing Standards regulations.
At the time of the proposal, NJSSA expressed significant concerns over the apparent weakened supervision requirements.
NJSSA has been hard at work educating the Governor's office, the Department, its members and the public on the importance of physician presence during the delivery of anesthesia. The NJ DHSS regulation proposal prompted an open comment period and a public hearing, during which the Department received hundreds of comments from physicians, nurses and others. NJSSA leaders met numerous times with the Department, the Governor's office, legislators and other stakeholders on the regulations.
NJSSA lobbied, concurrently, for movement of legislation that would codify the existing supervision regulations, including a public hearing before the Senate Health and Human Services Committee on December 9.
The Department met with NJSSA in mid-December and discussed language changes to the regulations to clarify the position of Commissioner Poonam Alaigh, MD. We learned that it is the Commissioner's intent, and has been since this issue began, to require the presence of an anesthesiologist for hospital based anesthesia, during induction, emergence and critical phases of anesthesia. The Department indicated that the manner (and exact wording) in which the regulation was drafted was being misinterpreted, and NJSSA was involved in changing the wording to require the presence of an anesthesiologist to support the Commissioner's intended policy.
On January 13, the revised language was considered by the Health Care Administration Board ("HCAB"), which must sign off on all DHSS regulations before they can be published/adopted by the Department. The HCAB members spent hours considering the exact language of the regulations, as well as the comment response section, which provides clarification as to the Department's intent. Following the work of the HCAB, the Department finalized their regulation and comment response section, and again, NJSSA worked closely to ensure the Commissioner's required anesthesiologist presence was clarified.
Last week, the NJSSA Executive Committee met personally with Commissioner Alaigh, MD, and her senior staff to review the finalized regulation and comment section, which clarifies the requirement that the presence of an anesthesiologist must be maintained during induction, emergence and critical stages. Further, the comment period clarifies the definition of "presence," and other desired intents. The NJSSA leadership left the meeting reassured, that while the final language is not as "crystal clear" as we would hope, it does require anesthesiologist presence and eliminates "independent practice" by the APN/anesthesia.
Below is the final language and the clarifying responses to the comment section.
NJSSA will be sending the entire membership a template for use in developing a "joint protocol" with APN/anesthesia. We recommend that you not execute a joint protocol with any allied health professionals until you receive and review the NJSSA version. Until the regulations are adopted in their final form, the current supervision regulations are the law of the land.
We are also working with the Department on a communication to the hospital administration to clarify the presence requirements, and continue to have open and candid dialogue with the Commissioner and her staff on any miscommunication that occurs on this issue. She is very receptive to readdressing the issue should confusion create unsafe patient environments.
Again, we thank you for your support throughout this arduous and highly political process. We thank the Commissioner, her senior staff, and the many NJSSA leaders who worked tirelessly on this important issue.
Obviously, additional work is yet to be done - including regulations regarding the delivery of anesthesia in ambulatory surgery centers, and ongoing legislative activity. Through it all, NJSSA has always maintained the issue is not one of "turf" but rather one of patient safety. The Commissioner concurs.
Stay tuned for additional information, including the finalized/adopted regulations (expected in mid-February) and a protocol template.
[The Regulatory Language]
8:43G-6.3 Anesthesia staff; qualifications for administering anesthesia
(a) - (d) (No change from proposal)
(e) General or major regional anesthesia shall be administered and monitored only by the following:
1. - 2. (No change from proposal)
3. An APN/anesthesia, in accordance with a joint protocol established in accordance with N.J.A.C. 13:37-6.3, Standards for joint protocols between advanced practice nurses and collaborating anesthesiologists, which joint protocol shall *[address]* *require* sections governing *[the]* *:
i. The* availability of an anesthesiologist to consult with the APN/anesthesia on site, on-call or by electronic means
*;* and *[the]*
*ii. The* presence of an anesthesiologist during induction, emergence and critical change in status.
[bracketed] language is deleted
______________
[The Response to comments section]
RESPONSE TO COMMENTS 9 THROUGH 12: As stated above in response to a previous comment, these comments relating to the "presence" of an anesthesiologist during the performance of anesthesia suggest that the proposed amendments at N.J.A.C. 8:43G-6.3(e)3, (h)3 and (j)3, describing the required content of a joint protocol, are subject to misinterpretation. Therefore, in response to the commenters' requests for clarification, the Department will make a change on adoption to replace the word, "address" with the word "require" and to reorganize these subsections to improve readability by breaking some of the clauses into paragraphs and subparagraphs.
The Department is satisfied that this change on adoption would resolve the commenters' apparent misinterpretation of and objection to the proposed amendment, as reflected in their comments, above. At the same time, the change would accurately reflect the Department's intended meaning.
This change on adoption would ensure that the rule is understood to mean that the required joint protocol governing anesthesia services would require the presence of an anesthesiologist during induction of and emergence from anesthesia and during critical changes in status. The level of presence (such as in the room where the procedure is being performed, in the operating suite or merely in the building) would be determined in the joint protocol depending on the type of procedure and related risk factors, including any exigent circumstances. Contrary to the issue of consultation, presence is understood to mean physical presence rather than by electronic or other means.
Sincerely,
Patricia M. Browne, MD
Past President
