&n bsp;
1. Nurses; Physicians and Surgeons--supervision of nursing personnel involved in
anesthesia activities--certified registered nurse anesthetist
The trial court did not err by denying respondent Board of Nursing's motion for
enforcement of a 1994 consent order seeking primarily an order from the trial court directing
petitioner Medical Board to remove language from a Medical Board position statement that
anesthesia administered in an office-based surgical setting should either be administered by an
anesthesiologist or by a certified registered nurse anesthetist (CRNA) under the supervision of a
physician, because: (1) the consent order did not constitute acquiescence by petitioners to
respondent's proposed collaboration standard wherein the relationship between a CRNA and a
physician changed from a relationship where the physician supervised the CRNA to a
relationship in which the CRNA worked in collaboration with a physician; (2) the pertinent
revised rule and the consent order must be read as requiring physician supervision for those
nurse anesthetist activities which involve prescribing a medical treatment or making a medical
diagnosis; (3) lack of details in the pertinent affidavits renders them ineffective as to the issue of
acquiescence to the collaboration standard; (4) physician supervision of nurse anesthetists
providing anesthesia care, when that care includes prescribing medical treatment regimens and
making medical diagnoses, is a fundamental patient safety standard required by North Carolina
law; (5) neither the 1994 consent order nor the position statement changed the statutory
requirement of when physician supervision is necessary; (6) the Medical Board, as an
administrative board established pursuant to N.C.G.S. § 90-2, cannot be estopped from
exercising its duty to regulate the practice of medicine in the interest of the public; and (7) a state
agency is prohibited from adopting a rule that enlarges the scope of a profession, occupation, or
field of endeavor for which an occupational license is required.
2. Trials--denial of objection and motion to strike consent order--failure to show
reliance on incompetent evidence
The trial court did not err by denying respondent's objection and motion to strike the
submission of, and by admitting, considering, and basing its order on the consent order issued by
the Medical Board in the matter captioned In re Peter Loren Tucker, M.D., or any related
material, because: (1) appeal on this issue has been waived since respondent failed to object to
the trial court's authorization of the filing of supplemental materials; and (2) respondent failed to
meet its burden of proving that the trial court relied upon this alleged incompetent evidence in
making its determination.
3. Trials-_pro hac vice motion for counsel--amicus brief--failure to show reliance on
incompetent evidence
The trial court did not err by failing to rule on, or in implicitly overruling respondent's
objection to, the pro hac vice motion for counsel for the American Society of Anesthesiology
(ASA), and in considering the amicus brief tendered by counsel for ASA, because: (1) in the
context of a bench trial, an appellant must show that the court relied on the incompetent or
inadmissible evidence in making its determination; and (2) respondent failed to show that the
trial court relied on this allegedly inadmissible evidence.
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P.,
by Susan H. Hargrove, Dana E. Simpson, and Candice M. Murphy-
Farmer, for petitioners North Carolina Medical Society, North
Carolina Society of Anesthesiologists, Inc., and Eric W.
Mason, M.D.
Marcus Jimison and Thomas W. Mansfield for petitioner North
Carolina Medical Board f/k/a the Board of Medical Examiners of
the State of North Carolina.
Howard A. Kramer; Womble Carlyle Sandridge & Rice, PLLC, by
Johnny M. Loper, Leighton P. Roper, III, and John W. O'Tuel,
III, for respondent
BRYANT, Judge.
North Carolina Board of Nursing (BON) (respondent) appeals an
order filed 31 December 2003, denying respondent's motion for
enforcement of a consent order as against North Carolina Medical
Society (Medical Society), North Carolina Society of
Anesthesiologists, Inc. (NCSA), Eric W. Mason, M.D., and the North
Carolina Medical Board f/k/a the Board of Medical Examiners of the
State of North Carolina (Medical Board), (petitioners).
On 6 August 2003, BON filed a motion for enforcement of
consent order seeking, primarily, an order from the trial court
directing the Medical Board to remove language from a Medical Board
position statement that stated that anesthesia administered in an
office-based surgical setting should either be administered by an
anesthesiologist, or by a certified registered nurse anesthetist
(CRNA) under the supervision of a physician. BON contends the
Medical Board's position statement constituted a violation of the
1994 consent order between the parties. Contemporaneous with the
filing of its motion, BON served upon the Medical Board certain
requests for discovery.
On 6 October 2003, petitioners filed a motion for protectiveorder seeking an order that discovery not be had with respect to
the motion to enforce the consent order. The motion to enforce
the consent order was calendared for hearing on 27 October 2003 in
Wake County Superior Court.
Prior to the hearing date, counsel for the Medical Society
requested a continuance. Counsel for BON wrote the trial court
administrator for Wake County stating that, in his opinion, good
cause did not exist for moving the hearing date and that BON
needed the requested discovery in order to appropriately argue the
motion.
The matter came for hearing at the 27 October 2003 civil
session of Wake County Superior Court with the Honorable Evelyn W.
Hill presiding. At the hearing, counsel for BON did not make a
motion to compel responses to his discovery requests, nor did he
seek a continuance of the hearing so that BON could have discovery
before proceeding with the hearing. After oral argument, the trial
court took the matter under advisement and requested that the
parties submit post-hearing briefs and/or any other materials or
documents that they wished to have the court consider. The trial
court stated it would advise counsel by 1 December 2003 if the
trial court would require additional presentation or argument prior
to rendering a decision.
Both parties provided the trial court with supplemental briefs
on or about 17 November 2003. On 25 November 2003, petitioners
provided the trial court with an exhibit to their 17 November 2003
brief in the form of a consent order between the Medical Board and
Peter Loren Tucker, M.D., which had been entered into on 20
November 2003. On 30 December 2003, the trial court entered an
order denying BON's motion to enforce the 1994 consent order.
Respondent gave timely notice of appeal.
(emphasis added).
In March 1994, the Medical Board moved to intervene in the
judicial review actions. On 21 September 1994, the parties
executed a consent order resolving the petitions for judicial
review. In resolving the dispute between the parties, the consent
order provided, in pertinent part, as follows:
5. It is jointly agreed that the provisions
of the Nursing Practice Act, including the
provisions found at N.C. Gen. Stat. § 90-
171.20(e) and (f), establish the scope of the
practice of nursing by a registered nurse, and
nothing contained in the rules of the
Respondent at 21 N.C.A.C. 36.0226 in any way
constitutes an expansion of such practice.
6. Respondent agrees to adopt as a final
rule the revisions to 21 N.C.A.C. 36.0226 as
proposed in the notice published in the North
Carolina Register on August 15, 1994, and
Petitioners agree not to challenge such revised
rule under the North Carolina Administrative
Procedure Act.
The consent order called for an amendment to rule .0226. The
pre-amendment rule .0226, in pertinent part, reads as follows:
(b) Qualifications and Definitions:
(1) The registered nurse who completes a
program accredited by the Council on
Accreditation of Nurse Anesthesia
Education Programs, is credentialed as a
certified registered nurse anesthetist by
the Council on Certification of Nurse
Anesthetists, and who maintains
recertification through the Council onRecertification of Nurse Anesthetists,
may perform nurse anesthesia activities
in collaboration with a physician,
dentist, podiatrist, or other lawfully
qualified health care provider.
The amendment to rule .0226 (as a consequence of the parties'
settlement) retained all the language of the pre-amendment rule,
but added the following:
(b) Qualifications and Definitions:
(1) The registered nurse who completes a
program accredited by the Council on
Accreditation of Nurse Anesthesia
Education Programs, is credentialed as a
certified registered nurse anesthetist by
the Council on Certification of Nurse
Anesthetists, and who maintains
recertification through the Council on
Recertification of Nurse Anesthetists,
may perform nurse anesthesia activities
in collaboration with a physician,
dentist, podiatrist, or other lawfully
qualified health care provider, but may
not prescribe a medical treatment regimen
or make a medical diagnosis except under
the supervision of a licensed physician.
(emphasis added)
(See footnote 3)
. The effect of the amendment was to add the statutorily required physician supervision language to the
rule, while also leaving intact the collaboration language.
After execution of the 1994 consent order, the parties
interpreted the consent order to mean different things. BON
interpreted the consent order to mean acceptance by the Medical
Board and the other petitioners that the activities described in
rule .0226 do not involve the practice of medicine, and therefore,
do not require physician supervision. The Medical Board and the
other petitioners, however, interpreted the consent order as
preserving the physician supervision requirement for those
activities described in rule .0226 that involve the practice of
medicine.
Subsequent to 1994, there has been no judicial determinationor legislative clarification as to whether any of the described
activities in rule .0226 constitute the practice of medicine, and
thus require physician supervision. In December 1998, the North
Carolina Attorney General (Attorney General) issued an advisory
opinion on the following issue: whether it is lawful for certified
registered nurse anesthetists (CRNAs) to provide anesthesia care
without physician supervision[?] The Attorney General responded
that: [f]or reasons which follow, it is our opinion that it is
not. Anesthesia care largely constitutes diagnosis of, or
prescription of medical treatment for a human ailment, thus
constituting the practice of medicine under the Medical Practice
Act, (Article 1, Chapter 90, of the N.C. General Statutes). 1998
N.C.A.G. 58 (12/31/98). To date, it appears the December 1998
Attorney General opinion remains the only determination by an
entity not associated with a party to the present litigation, that
some of the activities described in rule .0226 constitute the
practice of medicine.
In 2003, as a result of a great increase in the number of
individuals receiving surgery in physicians' offices, the Medical
Board adopted a position statement on office-based procedures
(office-based anesthesia guideline). The position statement was
the Medical Board's attempt to provide guidance to its licensees as
to what might be considered acceptable standards of medical
practice. The position statement covers such topics as
credentialing, equipment maintenance, personnel, emergency
procedures, infection control, performance improvement, informed
consent, medical records, as well as the provision of anesthesia.
While neither a statute nor a rule, the position statement was
meant to serve as a guideline for physicians practicing surgery in
their own offices. On 1 May 2003, the Medical Board issued charges against Peter
Loren Tucker, M.D. (Dr. Tucker) after an investigation stemming
from an April 2001 incident. The Medical Board charged Dr. Tucker
with practicing below minimum standards of medical practice when he
failed to supervise his CRNA adequately. The facts involving the
Tucker case were that a CRNA, employed by Dr. Tucker, had
administered two cubic centimeters (cc's) of fentanyl, a highly
potent analgesic, to a patient post-operatively after the patient
received a mini-facelift performed by Dr. Tucker in his office.
The CRNA did not possess prescribing privileges, yet she
administered a schedule II controlled substance to the patient for
her post-operative pain without authorization from Dr. Tucker.
After the administration of the two cc's of fentanyl, the patient
experienced respiratory arrest and efforts were made to revive the
patient in Dr. Tucker's office. The patient, a 45-year-old mother
of two, died three days later in the hospital as a result of
respiratory arrest brought about by the fentanyl injection.
The Medical Board referred its investigative material of the
Tucker case to BON for appropriate action regarding the CRNA. On
6 August 2003, three months after the Medical Board issued public
charges against Dr. Tucker and referred the case to BON for
appropriate action, BON filed its motion to enforce the 1994
consent order, alleging, among other things, that:
Upon information and belief, in the nearly
nine years since the parties' execution of the
Consent Order, no investigation has been
undertaken, nor has any other action been
initiated or reported, by any Petitioner
against any physician, surgeon, or CRNA on the
grounds that such persons are practicing in
conformity with the collaboration standard
set forth in the [Rule .0226] rather than
under the supervision standard that
Petitioners now assert was required under the
Consent Order.
Furthermore, at the 27 October hearing, counsel for BON made the
following statement:
And, as we say in our motion, not once has the
Medical Board, so far as we know, investigated
a physician for suspicion of violating the
supervision/collaboration issue. Not once
have they investigated a nurse anesthetist.
Not once have they brought anyone up on
charges. There can be no more clear evidence
of what the intent of the parties was back in
1994 than how they've lived that Consent Order
for the ten years -- nine years plus.
On 20 November 2003, the Medical Board and Dr. Tucker entered
into a consent order resolving the charges against him.
12 Arthur L. Corbin, Corbin on Contracts § 1174, at 335 (2002); see
also Cummings v. Dosam, Inc., 273 N.C. 28, 33, 159 S.E.2d 513, 517
(1968) (if the nature and extent of the intended restriction
cannot be determined with reasonable certainty from the language of
the covenant, it will not serve as the basis for the issuance of an
injunction); Munchak Corp. v. Caldwell, 46 N.C. App. 414, 419, 265
S.E.2d 654, 658 (1980) (holding that [a] court of equity is notauthorized to order the specific performance of a contract which is
not certain, definite and clear, and so precise in all of its
material terms that neither party can reasonably misunderstand
it).
Petitioners argue that the only certain, definite, precise and
clear behavior required of petitioners in the 1994 consent order is
to refrain from challenging the revised rule .0226 under the
Administrative Procedure Act (APA). It is undisputed that
petitioners have not challenged the revised rule .0226 pursuant to
the APA. Accordingly, petitioners argue that respondent's motion
to enforce the consent order: (1) promotes an expansive
interpretation of the 1994 consent order, and (2) asks the trial
court to order specific performance of allegedly implied
obligations.
Petitioners also argue that respondent's efforts, to expand
the 1994 consent order to prohibit conduct not described therein
and to inhibit the Medical Board from publishing guidelines for its
licensees, have no basis in law or in fact. In addition,
petitioners contend that because the remedy requested would have no
effect on the ability of the Medical Board to enforce N.C. Gen.
Stat. § 90-14.12, or to pursue criminal penalties pursuant to N.C.
Gen. Stat. §§ 90-18(a) and 90-21, the alleged potential injury
would not be eliminated by invalidation of the position statement
.
We will analyze the arguments below.
Respondent argues the trial court incorrectly construed
revised rule .0226 and relevant statutes
. However, the trial court
was called upon to construe only the 1994 consent order. The
relevant statutes and revised rule .0226 would only come under
consideration to the extent that the 1994 consent order constituted
a definitive agreement as to the construction of the statutes andrevised rule .0226.
The relevant inquiry is, therefore, whether the 1994 consent
order constitutes acquiescence by petitioners in the collaboration
standard as argued by respondent. This Court is of the opinion
that the consent order did not constitute acquiescence by
petitioners to the collaboration standard. Petitioners initiated
the 1993 action due to concerns that the proposed rule could be
interpreted to allow CRNAs to administer anesthesia and prescribe
medication without physician supervision, in violation of N.C. Gen.
Stat. § 90-171.20(7)(e) and (f). The 1993 action was resolved
after respondent agreed to add language to the proposed rule
clarifying that the rule did not purport to allow CRNAs to
prescribe a medical treatment or make a medical diagnosis except
under the supervision of a licensed physician, and acknowledgment
that the revised rule could not abridge the governing statutes.
The 1994 consent order does not purport to interpret the
governing statutes, the proposed rule, or the revised rule.
Petitioners argue if they had intended to acquiesce in a uniform
collaboration standard, they would not have initiated the 1993
action or would have dismissed the action pursuant to Rule 41 of
the North Carolina Rules of Civil Procedure. Instead, they
obtained concessions from respondent in order to resolve the 1993
action, those being, incorporation of the governing statutes into
the revised rule and acknowledgment that revised rule .0226 could
not abridge the governing statutes. Further, paragraph 7 of the
1994 consent order, which specifically provides that the 1994
consent order shall not be construed as acquiescence of either
party in the position of the other, defeats respondent's argument.
Petitioners' position on supervision of nursing personnel
involved in anesthesia activities was set forth in the 19 November1993 declaratory ruling regarding the scope and definition of the
practice of medicine pursuant to N.C. Gen. Stat. § 90-18.
Respondent's position, that the 1994 consent order represents
abandonment by the Medical Board of the physician supervision
standard and a surrender to the collaboration standard, is
inconsistent with and contradictory to the language of the 1994
consent order. The revised rule and the 1994 consent order must
be read as requiring physician supervision for those nurse
anesthetist activities which involve prescribing a medical
treatment or making a medical diagnosis. Therefore, the position
statement, which recommends that anesthesia in an office setting be
administered by an anesthesiologist or a CRNA supervised by a
physician, cannot be held to violate the 1994 consent order.
Respondent asserts that the three affidavits it submitted to
the trial court compelled the conclusion that the Medical Board has
acquiesced in the collaboration standard for a nine-year period.
However, these affidavits fail to support such conclusion. The
affidavits make no mention of what specific medical acts were
performed under the collaboration standard, nor do the affiants
specifically claim that the respondent's licensees were
unsupervised. This lack of detail renders these affidavits
ineffective as to the issue of acquiescence in the collaboration
standard.
Therefore, we cannot agree with respondent's assertion that
the affidavits compel a conclusion that the Medical Board abandoned
the standard of care -- supervision of medical acts performed by
nurse anesthetists. Furthermore, petitioners submitted to the
trial court the consent order issued by the Medical Board in the
matter captioned In Re Peter Loren Tucker, M.D. as an example of
the Medical Board's enforcement of the supervision standard. Physician supervision of nurse anesthetists providing
anesthesia care, when that care includes prescribing medical
treatment regimens and making medical diagnoses, is a fundamental
patient safety standard required by North Carolina law. See
N.C.G.S. § 90-18(b) (2003); N.C.G.S. § 90-171.20(7)(e). Neither
the 1994 consent order nor the position statement changed the
statutory requirement of when physician supervision is necessary.
Respondent asserts the Medical Board must follow the 1994
consent order regardless of whether the 1994 consent order could be
read to impede its obligation to regulate the activities of its
licensee physicians. However, even assuming the 1994 consent order
could be read as evidencing an intent by the Medical Board to
acquiesce in a collaboration standard, the Medical Board cannot be
forbidden from advising its licensees on the standard of care in
medical practice in order to protect the public interest. See
Gaddis v. Cherokee County Road Comm., 195 N.C. 107, 111, 141 S.E.
358, 360 (1928) (Administrative boards, exercising public
functions, cannot by contract deprive themselves of the right to
exercise the discretion delegated by law, in the performance of
public duties.). The Medical Board, as an administrative board
established pursuant to N.C. Gen. Stat. § 90-2, cannot be estopped
from exercising its duty to regulate the practice of medicine in
the interest of the public.
Moreover, a state agency is prohibited from adopting a rule
that enlarges the scope of a profession, occupation, or field of
endeavor for which an occupational license is required. N.C.G.S.
§ 150B-19(2) (2003); see also In re Trulove, 54 N.C. App. 218, 221,
282 S.E.2d 544 (1981) (Administrative regulations must be drafted
to comply with statutory grants of power and not vice versa.).
Accordingly, this assignment of error is overruled.
Here, respondents failed to object to the admission of the
evidence before the trial court, and further failed to meet its
burden of proving that the trial court relied upon this alleged
incompetent evidence in making its determination. This assignment
of error is overruled.
(b) Qualifications and Definitions:
(1) The registered nurse who completes a
program accredited by the Council on
Accreditation of Nurse Anesthesia Educational
Programs, is credentialed as a certified
registered nurse anesthetist by the Council on
Certification of Nurse Anesthetists, and who
maintains recertification through the Council
on Recertification of Nurse Anesthetists, may
perform nurse anesthesia activities in
collaboration with a physician, dentist,
podiatrist, or other lawfully qualified health
care provider, but may not prescribe a medical
treatment regimen or make a medical diagnosis
except under the supervision of a licensed
physician.
(2) The graduate nurse anesthetist is aregistered nurse who has completed a program
accredited by the Council on Accreditation of
Nurse Anesthesia Educational Programs, is
awaiting initial certification by the Council
on Certification of Nurse Anesthetists and is
listed as such with the Board of Nursing. The
graduate nurse anesthetist may perform nurse
anesthesia activities under the supervision of
a certified registered nurse anesthetist,
physician, dentist, podiatrist, or other
lawfully qualified health care provider
provided that initial certification is
obtained within 18 months after completion of
an accredited nurse anesthesia program.
(3) Collaboration is a process by which the
certified registered nurse anesthetist or
graduate nurse anesthetist works with one or
more qualified health care providers, each
contributing his or her respective area of
expertise consistent with the appropriate
occupational licensure laws of the State and
according to the established policies,
procedures, practices and channels of
communication which lend support to nurse
anesthesia services and which define the
role(s) and responsibilities of the qualified
nurse anesthetist within the practice setting.
The individual nurse anesthetist maintains
accountability for the outcome of his or her
actions.
(c) Nurse Anesthesia activities and
responsibilities which the appropriately
qualified registered nurse anesthetist may
safely accept are dependent upon the
individual's knowledge and skills and other
variables in each practice setting as outlined
in 21 NCAC 36 .0224(a). These activities
include:
(1) Preanesthesia preparation and evaluation
of the client to include:
(A) performing a pre-operative health
assessment;
(B) recommending, requesting and evaluating
pertinent diagnostic studies; and
(C) selecting and administering preanesthetic
medications.
(2) Anesthesia induction, maintenance and
emergence of the client to include:
(A) securing, preparing and providing basicsafety checks on all equipment, monitors,
supplies and pharmaceutical agents used for
the administration of anesthesia;
(B) selecting, implementing, and managing
general anesthesia, monitored anesthesia care,
and regional anesthesia modalities, including
administering anesthetic and related
pharmaceutical agents, consistent with the
client's needs and procedural requirements;
(C) performing tracheal intubation, extubation
and providing mechanical ventilation;
(D) providing perianesthetic invasive and
non-invasive monitoring, recognizing abnormal
findings, implementing corrective action, and
requesting consultation with appropriately
qualified health care providers as necessary;
(E) managing the client's fluid, blood,
electrolyte and acid-base balance; and
(F) evaluating the client's response during
emergency from anesthesia and implementing
pharmaceutical and supportive treatment to
ensure the adequacy of client recovery from
anesthesia.
(3) Postanesthesia Care of the client to
include:
(A) providing postanesthesia follow-up care,
including evaluating the client's response to
anesthesia, recognizing potential anesthetic
complications, implementing corrective
actions, and requesting consultation with
appropriately qualified health care
professionals as necessary;
(B) initiating and administering respiratory
support to ensure adequate ventilation and
oxygenation in the immediate postanesthesia
period;
(C) initiating and administering
pharmacological or fluid support of the
cardiovascular system during the immediate
postanesthesia period;
(D) documenting all aspects of nurse
anesthesia care and reporting the client's
status, perianesthetic course, and anticipated
problems to an appropriately qualified
postanesthetic health care provider who
assumes the client's care following anesthesia
consistent with 21 NCAC 36 .0224(f); and
(E) releasing clients from the postanesthesia
care or surgical setting as per established
agency policy.
(d) Other clinical activities for which the
qualified registered nurse anesthetist may
accept responsibility include, but are not
limited to:
(1) inserting central vascular access
catheters and epidural catheters;
(2) identifying, responding to and managing
emergency situations, including initiating and
participating in cardiopulmonary
resuscitation;
(3) providing consultation related to
respiratory and ventilatory care and
implementing such care according to
established policies within the practice
setting; and
(4) initiating and managing pain relief
therapy utilizing pharmaceutical agents,
regional anesthetic techniques and other
accepted pain relief modalities according to
established policies and protocols within the
practice setting.
21 N.C.A.C. 36.0226 (2003).
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