Forum of the North Carolina Medical Board

              FROM THE PRESIDENT
IN THIS ISSUE
As my term as NCMB President approached last fall,
I spent some time thinking about what my first words to
you, my colleagues, should be. My thoughts quickly turned
to a lesson learned over years of involvement with the Boy
Scouts, which is the importance of having before me at
all times the equivalent of a standard—the stick a scout
holds before him to guide his way on a hiking trip, uphill or
downhill, treacherous or easy. I decided that professional-ism
was to be the metaphorical “standard” I hold before me
over the coming year, and that I should begin my dialogue
with licensees with an article on that subject.
Commitment to professionalism is acknowledgment of
the honor and responsibility we have as medical practi-tioners.
It is unequivocal and enduring. Professionalism
encompasses principles of unselfish concern for others,
dedication to quality patient care and commitment to
patient autonomy and confidentiality. I can think of few
qualities that are more essential to the competent, compas-sionate
practice of medicine.
I want to challenge every licensee of this Board to recom-mit
to the values stated above. In this article, I also want to
share three examples of professionalism from my own life
and career. I happen to be a third generation physician, so I have been fortunate to have
not just one, but two examples of professionalism in my own family. I was also extremely
blessed to find, during my residency training in neurosurgery, a peer whose actions have
been a beacon of professionalism. The lessons learned from these three men are as essential
to my life today as the many standards I have carried with the scouts over the years.
Grandfather Loomis: Care with compassion and respect
As a five-year-old in the mid-1950’s I accompanied my physician grandfather, Ralph
Henry Loomis, MD, on house calls. At the time, of course, I did not know what “profes-sionalism”
meant, but I saw it in my grandfather’s every interaction with his patients and
their loved ones. As a physician, he interacted as easily with the president of the local bank
as he did with the cook at the local diner. He was able to articulate the health challenges
each faced and the choices each needed to make, always in the appropriate manner for that
patient. He treated each patient as if he or she was his only patient. He sat at many bedsides
carefully taking in the list of symptoms conveyed by the patients, always showing compas-sion
and concern. I realize now that, during the early years of his practice, the best method
of diagnosis was often a listening ear. Watching him was an ideal training ground for how to
behave in patient interactions. I saw how he dropped his six foot frame to the floor to talk on
NCMB President, Dr. Ralph C.
Loomis, says “The realities of
today’s health care marketplace
may make it challenging to up-hold
the seemingly impractical
value of professionalism.”
Annual Position Statement Issue — Pg. 4
3 Urgent notice to
professional corps, PLLCs
21 NCMB gets new members;
reappointments
22 Are ‘pill mills’ Florida’s newest export?
24 Quarterly adverse report
28 Need an Intent to Practice
acknowledgement letter?
Professionalism:
Why we do what we do
Board oficers
President
Ralph C. Loomis, MD | Asheville
President Elect
William A. Walker, MD | Charlotte
Secretary/Treasurer
Thomas R. Hill, MD | Hickory
Immediate Past President
Janice E. Huff, MD | Charlotte
Board members
Pamela Blizzard | Raleigh
Paul S. Camnitz, MD | Greenville
Eleanor E. Greene, MD | High Point
Thelma Lennon | Raleigh
John B. Lewis, Jr, LLB | Farmville
Shiva K. Rao, MD | Roanoke Rapids
Peggy R. Robinson, PA-C | Durham
Cheryl Walker-McGill, MD | Charlotte
Forum staff
Publisher
NC Medical Board
Editor
Jean Fisher Brinkley
Associate Editor
Dena M. Konkel
Editor Emeritus
Dale G Breaden
Contact Us
Street Address
1203 Front Street
Raleigh, NC 27609
Mailing Address
PO Box 20007
Raleigh, NC 27619
Telephone / Fax
(800) 253-9653
Fax (919) 326-0036
Web Site:
www.ncmedboard.org
E-Mail:
info@ncmedboard.org
Have something for the editor?
forum@ncmedboard.org
The Forum of the North Carolina Medical Board is published four times a year. Articles appearing in the Forum,
including letters and reviews, represent the opinions of the authors and do not necessarily reflect the views of the
North Carolina Medical Board, its members or staff, or the institutions or organizations with which the authors are
affiliated. Official statements, policies, positions, or reports of the Board are clearly identified.
We welcome letters to the editor addressing topics covered in the Forum. They will be published in edited form
depending on available space. A letter should include the writer’s full name, address, and telephone number.
North Carolina Medical Board Forum Credits Volume XIV | Winter 2012
Primum Non Nocere
FROM THE PRESIDENT
eye level with a child. I observed as he held the older patient’s
hand as he gave his advice. I noticed how he sympathized
with caregivers as he gave instructions on the care to be giv-en.
He was paid for his services in farm animals, vegetables,
canned goods and cash. His unselfish concern for patient care
went beyond compensation.
Father: Striving for excellence through lifelong learning
My father, Charles Henry Loomis, MD, was a general
surgeon who began his practice as the doctor for a manufac-turing
company in Benham, Kentucky. As a teenager, I stood
wide-eyed beside him as an observer in his operating room,
and it was there that the seeds of my own career as a surgeon
were sown. My father’s young life and education were in
large cities, but he saw the need for doctors in rural areas and
stepped up to the plate. As a small town doctor, he was privy
to confidences of many. In fact, he likely knew more details
about the people in a room than anyone else there; neverthe-less,
he held the confidences shared with him as tightly as the
logs on a log truck are bound.
My father was never board certified (certification was not
available until he was well into his career) but he sought out
every opportunity to improve his clinical skills. He allied
himself with organizations that would require surgical data
from him, to have the opportunity to objectively analyze his
practice and compare it with others. Most of our family vaca-tions
were his continuing education jaunts. Through him, I
saw the value of committing to lifelong learning in order to
improve patients’ lives.
Practice partner: Living professionalism every day
When I entered my neurosurgery residency in 1976, I
worked day to day beside a fellow resident, Lary Schulhof,
MD, whom I respected and whom I later followed to the city
that would become my home. This man, my eventual partner
in the neurosurgery group I joined, adhered to the highest
standards of patient care. He discussed with his patients all
available care options, but recommended only those that he
believed had a high likelihood of improving the patient’s con-dition.
He never yielded to that frequent temptation among
surgeons to think that he could produce a positive result in
a patient, even when reliable data suggested otherwise. He
made a conscious effort not to “ride in on a white horse.”
Instead, he went at his work from the vantage point of a wise
and well-trained work horse. For him, this meant explaining
all risks of complications in a manner understood by his lis-teners.
It meant answering questions as many times and in as
many ways as they were asked. He was wise enough to know
that he did not know everything, and never lost an opportu-nity
to learn from his colleagues. I received many a call from
him – at night, while I was on vacation – seeking my opinion
and my experience. He once told me that the only bad thing
about not being on call every night is that you miss half the
cases. He kept a relentless schedule, yet his patience in pro-viding
care and, as a result, the number of patients under his
care, abounded. Moreover, he remained humble and gracious
in all that he did. I have spent my career striving to model his
fine example.
Conclusion
The realities of today’s health care marketplace may make
it challenging to uphold the seemingly impractical value of
professionalism. But I would argue that doing so has infinite
Dr. Loomis’s father, Charles Henry Loomis, with his dad (Dr.
Loomis’s grandfather) Ralph Henry Loomis.
BOARD NEWS
FORUM | Winter 2012 3
rewards. Living these values on a daily basis reminds each of
us what drew us to the practice of medicine. It feeds the soul
and provides a counterbalance to the stresses of dealing with
insurance company hassles or fretting over how to comply
with the latest government mandates.
On a recent night dining out with my family, a middle-aged
man came to the table and offered that, nearly 30 years ago,
I had cared for his mother after she was diagnosed with a
malignant brain tumor. At the time, his mother was an unin-sured
widow.
He and other family members, who at the time had little
ability to help, had wondered whether his mother would get
the care she needed. I listened quietly as this gentleman,
who is now a retired and highly regarded law enforcement
official, told my two teenage sons that his mother did indeed
get the highest quality of care, and that her bill was summar-ily
written off by my group when her financial situation was
known. He described me as “just the doctor they would have
ordered.” He said that I took the time to explain his mother’s
diagnosis and treatment options, that I was supportive and
compassionate as those options were chosen and acted upon,
and that no one would have known that her care from me was
given without remuneration.
I offer this anecdote not to highlight my own actions or
those of my practice group (I know plenty of others that rou-tinely
provide charity care). Rather, I mention this experience
to show the real and lasting impact professionalism can have
on the lives of patients and their loved ones. It was a potent
reminder to me, and to my family, of why I do what I do.
As I mentioned at the beginning of this article, I’d like this
column to facilitate a dialogue. So now, I’d like to hear your
thoughts on professionalism. Who are your personal models
of professionalism? How do you find ways to honor profes-sionalism
in your practice? Send replies to me at forum@
ncmedboard.org or comment on the online version of this
article. The next issue of the Forum will publish a selection of
responses.
City: Asheville, NC
Term ends: October 31, 2012
Specialty: Neurological Surgery
Certification: American Board of Neurological
Surgery
Personal: Wife, Doris; Father of six sons, ages
13-30
RALPH C. LOOMIS, MD
Interesting facts about your new Board
president
Urgent notice to professional corps, PLLCs
As of mid-January, more than 40 percent of all pro-fessional
medical corporations and professional limited
liability corporations (PLLCs) operating in the state had
failed to complete their annual registration as required un-der
North Carolina law. The registration renewal deadline
for all medical corporations and PLLCs was December 31.
If you have not renewed, please do so as soon as pos-sible
to avoid adverse action against your business. Any
professional medical corporation or PLLC that fails to
renew by the end of February will be suspended by the
Medical Board and the N.C. Secretary of State. When a
professional corporation or PLLC is suspended, it is not
…if you have not provided your current practice address and
telephone number to the Board, you may be out of com-pliance
with state law. NC law requires all physicians and
physician assistants with an active state medical or PA license
to provide the Board with this information. If the practice
DID YOU
KNOW ?
lawful for it to provide professional services in North
Carolina.
Final notices were sent to registrants via regular mail at
the end of January. Registrants who missed the Decem-ber
31 deadline must pay a late fee.
The NC Medical Board is in the process of implement-ing
an annual renewal for all professional medical corpo-rations
and PLLCs, which will replace the current biennial
renewal system.
Please email questions to corporations@ncmedboard.
org Please include the full name of the business you are
inquiring about and, if known, the registration ID number.
address/phone changes, it is the licensee’s responsibility to
notify the Board of the change within 60 days.
Please check the NCMB website at www.ncmedboard.org
to verify that your information is correct. From the Home
Page, select “Look Up a Licensee” from the green Quick
Links box at the right of the screen and look yourself up by
name or license number. Click on the Practice Information
tab to see the address currently on file with the Board.
TO CHANGE YOUR ADDRESS: Click on “Update Licensee
Info Page” from the Quick Links box. Once you have logged
in, select “Address” from the menu.
POSITION STATEMENTS
NC Medical Board Position Statements
A guide to the Board’s Position Statements as of 12/31/2011
Each year, the NC Medical Board publishes its complete position statements as a quick reference guide for all licensees. The position state-ments
are a collection of interpretive statements developed and approved by the Board, with input from licensees and other interested parties,
that attempt to explain laws and rules, or explain the Board’s expectations for licensee conduct under specific circumstances. The complete
position statements are also available online at www.ncmedboard.org
The Board’s Policy Committee regularly reviews the content of the statements, making necessary revisions to address changes in medical
practice or matters of policy, and to acknowledge new or evolving methods or procedures. This year, in an effort to make this guide more user-friendly,
we have employed a color-coding system to identify position statements that were added, reviewed or revised in 2011. New statements
are identified in green; statements that were revised are coded purple; statements that were reviewed with no changes are marked in blue.
..............................................................
The principles of professionalism and performance expressed in the position statements of the North Carolina Medical Board apply to all persons licensed
and/or approved by the Board to render medical care at any level.
Disclaimer
The North Carolina Medical Board makes the information in this publication available as a public service. We attempt to update this printed material as
often as possible and to ensure its accuracy. However, because the Board’s position statements may be revised at any time and because errors can occur, the
information presented here should not be considered an official or complete record. Under no circumstances shall the Board, its members, officers, agents, or
employees be liable for any actions taken or omissions made in reliance on information in this publication or for any consequences of such reliance. A more
current version of the Board’s position statements will be found on the Board’s Web site: www.ncmedboard.org, which is usually updated shortly after revi-sions
are made. In no case, however, should this publication or the material found on the Board’s Web site substitute for the official records of the Board.
WHAT ARE THE POSITION STATEMENTS OF THE BOARD AND TO WHOM DO THEY APPLY?
The North Carolina Medical Board’s Position Statements are interpretive statements that attempt to define or explain the meaning of laws or rules that
govern the practice of physicians,* physician assistants, and nurse practitioners in North Carolina, usually those relating to discipline. They also set forth
criteria or guidelines used by the Board’s staff in investigations and in the prosecution or settlement of cases.
When considering the Board’s Position Statements, the following four points should be kept in mind.
1) In its Position Statements, the Board attempts to articulate some of the standards it believes applicable to the medical profession and to the other
health care professions it regulates. However, a Position Statement should not be seen as the promulgation of a new standard as of the date of is-suance
or amendment. Some Position Statements are reminders of traditional, even millennia old, professional standards, or show how the Board
might apply such standards today.
2) The Position Statements are not intended to be comprehensive or to set out exhaustively every standard that might apply in every circumstance.
Therefore, the absence of a Position Statement or a Position Statement’s silence on certain matters should not be construed as the lack of an enforce-able
standard.
3) The existence of a Position Statement should not necessarily be taken as an indication of the Board’s enforcement priorities.
4) A lack of disciplinary actions to enforce a particular standard mentioned in a Position Statement should not be taken as an abandonment of the prin-ciples
set forth therein.
The Board will continue to decide each case before it on all the facts and circumstances presented in the hearing, whether or not the issues have been the
subject of a Position Statement. The Board intends that the Position Statements will reflect its philosophy on certain subjects and give licensees some guid-ance
for avoiding Board scrutiny. The principles of professionalism and performance expressed in the Position Statements apply to all persons licensed and/
or approved by the Board to render medical care at any level.
*The words “physician” and “doctor” as used in the Position Statements refer to persons who are MDs or DOs licensed by the Board to practice medicine and surgery in North
Carolina. (Adopted November 1999) (Reviewed May 2010)
The Physician-Patient Relationship...................................................................5
Medical Record Documentation.......................................................................5
Access to Medical Records................................................................................6
Retention of Medical Records............................................................................6
Departures From or Closings of Medical Practices.............................................6
The Retired Physician.......................................................................................7
Advance Directives and Patient Autonomy........................................................7
Availability of Physicians to Their Patients.........................................................7
Guidelines for Avoiding Misunderstandings During Physical Examinations........7
Sexual Exploitation of Patients..........................................................................8
Contact with Patients Before Prescribing..........................................................8
Writing of Prescriptions.....................................................................................8
Self-Treatment and Treatment of Family Members and Others
with Whom Significant Emotional Relationships Exist...................................8
The Treatment of Obesity..................................................................................9
Prescribing Legend/Controlled Substances for Other Than Valid
Medical or Therapeutic Purposes, with Particular Reference
to Substances or Preparations with Anabolic Properties.................................9
Policy for the Use of Controlled Substances for the Treatment of Pain...............9
End-of-Life Responsibilities and Palliative Care................................................10
Joint Statement on Pain Management in End-of-Life Care..........................11
Office-Based Procedures.............................................................................11
Laser Surgery..............................................................................................15
Care of the Patient Undergoing Surgery or Other Invasive Procedure. .........16
HIV/HBV Infected Health Care Workers........................................................16
Professional Obligation to Report Incompetence,
Impairment, and Unethical Conduct........................................................17
Advertising and Publicity.............................................................................17
Sales of Goods from Physicians Offices.......................................................18
Referral Fees and Fee Splitting....................................................................18
Unethical Agreements in Complaint Settlements........................................18
Medical Supervisor-Trainee Relationship.....................................................18
Competence and Reentry to the Active Practice of Medicine .....................18
Capital Punishment ....................................................................................18
Physician Supervision of Other Licensed Health Care Practitioners............19
Drug Overdose Prevention..........................................................................19
Medical Testimony......................................................................................19
Collaborative Care within the Health Care Team..........................................20
Telemedicine..............................................................................................20
Physician Scope of Practice.........................................................................20
TABLE OF CONTENTS
FORUM | Winter 2012 5
POSITION STATEMENTS
THE PHYSICIAN-PATIENT RELATIONSHIP
The duty of the physician is to provide competent, compassionate, and
economically prudent care to all his or her patients. Having assumed
care of a patient, the physician may not neglect that patient nor fail for
any reason to prescribe the full care that patient requires in accord with
the standards of acceptable medical practice. Further, it is the Board’s
position that it is unethical for a physician to allow financial incentives
or contractual ties of any kind to adversely affect his or her medical judg-ment
or patient care.
Therefore, it is the position of the North Carolina Medical Board that
any act by a physician that violates or may violate the trust a patient
places in the physician places the relationship between physician and pa-tient
at risk. This is true whether such an act is entirely self-determined
or the result of the physician’s contractual relationship with a health care
entity. The Board believes the interests and health of the people of North
Carolina are best served when the physician-patient relationship remains
inviolate. The physician who puts the physician-patient relationship at
risk also puts his or her relationship with the Board in jeopardy.
Elements of the Physician-Patient Relationship
The North Carolina Medical Board licenses physicians as a part of
regulating the practice of medicine in this state. Receiving a license to
practice medicine grants the physician privileges and imposes great
responsibilities. The people of North Carolina expect a licensed physician
to be competent and worthy of their trust. As patients, they come to the
physician in a vulnerable condition, believing the physician has knowl-edge
and skill that will be used for their benefit.
Patient trust is fundamental to the relationship thus established. It
requires that:
• there be adequate communication between the physician and the
patient;
• the physician report all significant findings to the patient or the pa-tient’s
legally designated surrogate/guardian/personal representative;
• there be no conflict of interest between the patient and the physician
or third parties;
• personal details of the patient’s life shared with the physician be held
in confidence;
• the physician maintain professional knowledge and skills;
• there be respect for the patient’s autonomy;
• the physician be compassionate;
• the physician respect the patient’s right to request further restrictions
on medical information disclosure and to request alternative com-munications;
• the physician be an advocate for needed medical care, even at the
expense of the physician’s personal interests; and
• the physician provide neither more nor less than the medical problem
requires.
The Board believes the interests and health of the people of North
Carolina are best served when the physician-patient relationship, founded
on patient trust, is considered sacred, and when the elements crucial to
that relationship and to that trust—communication, patient primacy,
confidentiality, competence, patient autonomy, compassion, selflessness,
appropriate care—are foremost in the hearts, minds, and actions of the
physicians licensed by the Board.
This same fundamental physician-patient relationship also applies to
mid-level health care providers such as physician assistants and nurse
practitioners in all practice settings.
Termination of the Physician-Patient Relationship
The Board recognizes the physician’s right to choose patients and
to terminate the professional relationship with them when he or she
believes it is best to do so. That being understood, the Board maintains
that termination of the physician-patient relationship must be done in
compliance with the physician’s obligation to support continuity of care
for the patient.
The decision to terminate the relationship must be made by the physi-cian
personally. Further, termination must be accompanied by appropri-ate
written notice given by the physician to the patient or the patient’s
representative sufficiently far in advance (at least 30 days) to allow other
medical care to be secured. A copy of such notification is to be included
in the medical record. Should the physician be a member of a group, the
notice of termination must state clearly whether the termination involves
only the individual physician or includes other members of the group.
In the latter case, those members of the group joining in the termina-tion
must be designated. It is advisable that the notice of termination
also include instructions for transfer of or access to the patient’s medical
records.
(Adopted July 1995) (Amended July 1998, January 2000, March 2002,
August 2003, September 2006)
MEDICAL RECORD DOCUMENTATION
The North Carolina Medical Board takes the position that an accurate,
current and complete medical record is an essential component of patient
care. Licensees should maintain a medical record for each patient to
whom they provide care. The medical record should contain an appropri-ate
history and physical examination, results of ancillary studies, diag-noses,
and any plan for treatment. The medical record should be legible.
When the care giver does not handwrite legibly, notes should be dictated,
transcribed, reviewed, and signed within a reasonable time. The Board
recognizes and encourages the trend towards the use of electronic medi-cal
records (“EMR”). However, the Board cautions against relying upon
software that pre-populates particular fields in the EMR without updating
those fields in order to create a medical record that accurately reflects the
elements delineated in this Position Statement.
The medical record is a chronological document that:
• records pertinent facts about an individual’s health and wellness;
• enables the treating care provider to plan and evaluate treatments or
interventions;
• enhances communication between professionals, assuring the patient
optimum continuity of care;
• assists both patient and physician to communicate to third party
participants;
• allows the physician to develop an ongoing quality assurance pro-gram;
• provides a legal document to verify the delivery of care; and
• is available as a source of clinical data for research and education.
The following required elements should be present in all medical
records:
1. The record reflects the purpose of each patient encounter and appro-priate
information about the patient’s history and examination, and
the care and treatment provided are described.
2. The patient’s past medical history is easily identified and includes
serious accidents, operations, significant illnesses and other appropri-ate
information.
3. Medication and other significant allergies, or a statement of their
absence, are prominently noted in the record.
4. When appropriate, informed consent obtained from the patient is
clearly documented.
5. All entries are dated.
The following additional elements reflect commonly accepted stan-dards
for medical record documentation.
1. Each page in the medical record contains the patient’s name or ID
number.
2. Personal biographical information such as home address, employer,
marital status, and all telephone numbers, including home, work, and
mobile phone numbers.
3. All entries in the medical record contain the author’s identification.
Author identification may be a handwritten signature, initials, or a
unique electronic identifier.
4. All drug therapies are listed, including dosage instructions and, when
appropriate, indication of refill limits. Prescriptions refilled by phone
should be recorded.
5. Encounter notes should include appropriate arrangements and speci-fied
times for follow-up care.
6. All consultation, laboratory and imaging reports should be entered
into the patient’s record, reviewed, and the review documented by the
practitioner who ordered them. Abnormal reports should be noted
in the record, along with corresponding follow-up plans and actions
taken.
7. An appropriate immunization record is evident and kept up to date.
8. Appropriate preventive screening and services are offered in accor-dance
with the accepted practice guidelines.
(Adopted May 1994) (Amended May 1996, May 2009)
ACCESS TO MEDICAL RECORDS
A physician’s policies and practices relating to medical records under
their control should be designed to benefit the health and welfare of
patients, whether current or past, and should facilitate the transfer of clear
and reliable information about a patient’s care. Such policies and practices
should conform to applicable federal and state laws governing health
information.
It is the position of the North Carolina Medical Board that notes made
by a physician in the course of diagnosing and treating patients are pri-marily
for the physician’s use and to promote continuity of care. Patients,
however, have a substantial right of access to their medical records and
a qualified right to amend their records pursuant to the HIPAA privacy
regulations.
Medical records are confidential documents and should only be re-leased
when permitted by law or with proper written authorization of the
patient. Physicians are responsible for safeguarding and protecting the
medical record and for providing adequate security measures.
Each physician has a duty on the request of a patient or the patient’s
representative to release a copy of the record in a timely manner to the pa-tient
or the patient’s representative, unless the physician believes that such
release would endanger the patient’s life or cause harm to another person.
This includes medical records received from other physician offices or
health care facilities. A summary may be provided in lieu of providing ac-cess
to or copies of medical records only if the patient agrees in advance to
such a summary and to any fees imposed for its production.
Physicians may charge a reasonable fee for the preparation and/or the
photocopying of medical and other records. To assist in avoiding misun-derstandings,
and for a reasonable fee, the physician should be willing to
review the medical records with the patient at the patient’s request. Medi-cal
records should not be withheld because an account is overdue or a bill
is owed (including charges for copies or summaries of medical records).
Should it be the physician’s policy to complete insurance or other forms
for established patients, it is the position of the Board that the physician
should complete those forms in a timely manner. If a form is simple, the
physician should perform this task for no fee. If a form is complex, the
physician may charge a reasonable fee.
To prevent misunderstandings, the physician’s policies about provid-ing
copies or summaries of medical records and about completing forms
should be made available in writing to patients when the physician-patient
relationship begins.
Physicians should not relinquish control over their patients’ medical
records to third parties unless there is an enforceable agreement that in-cludes
adequate provisions to protect patient confidentiality and to ensure
access to those records. 1
When responding to subpoenas for medical records, unless there is
a court or administrative order, physicians should follow the applicable
federal regulations.
1See also Position Statement on Departures from or Closings of Medical
Practices.
(Adopted November 1993) (Amended May 1996, September 1997, March
2002, August 2003)
RETENTION OF MEDICAL RECORDS
Physicians have both a legal and ethical obligation to retain patient
records. The Board, therefore, recognizes the necessity and importance
of a licensee’s proper maintenance, retention, and disposition of medical
records. The following guidelines are offered to assist licensees in meeting
their ethical and legal obligations:
• State and federal laws require that records be kept for a minimum
length of time including but not limited to:
1. Medicare and Medicaid Investigations (up to 7 years);
2. HIPAA (up to 6 years);
3. Medical Malpractice (varies depending on the case but should be
measured from the date of the last professional contact with the
patient)—physicians should check with their medical malpractice
insurer); North Carolina has no statute relating specifically to the
retention of medical records;
4. Immunization records always must be kept.
• In addition to existing state and federal laws, medical considerations
may also provide the basis for deciding how long to retain medical
records. Patients should be notified regarding how long the physician
will retain medical records.
• In deciding whether to keep certain parts of the record, an appropriate cri-terion
is whether a physician would want the information if he or she were
seeing the patient for the first time. The Board, therefore, recognizes that
the retention policies of physicians giving one-time, brief episodic care
may differ from those of physicians providing continuing care for patients.
• In order to preserve confidentiality when discarding old records, all
records should be destroyed, including both paper and electronic medical
records.
• Those licensees providing episodic care should attempt to provide a copy
of the patient’s record to the patient, the patient’s primary care provider,
or, if applicable, the referring physician.
• If it is feasible, patients should be given an opportunity to claim the
records or have them sent to another physician before old records are
discarded.
• The physician should respond in a timely manner to requests from
patients for copies of their medical records or to access to their medical
records.
• Physicians should notify patients of the amount, and under what circum-stances,
the physician will charge for copies of a patient’s medical record,
keeping in mind that N.C. Gen. Stat. 90-411 provides limits on the fee a
physician can charge for copying of medical records.
Physicians should retain medical records as long as needed not only to
serve and protect patients, but also to protect themselves against adverse
actions. The times stated may fall below the community standard for
retention in their communities and practice settings and for the specific
needs. Physicians are encouraged (may want to) seek advice from pri-vate
counsel and/or their malpractice insurance carrier.
(Adopted May 1998) (Amended May 2009)
DEPARTURES FROM OR CLOSINGS
OF MEDICAL PRACTICES
Departures from or closings of medical practices are trying times. If
mishandled, they can significantly disrupt continuity of care and endanger
patients.
Provide Continuity of Care
Practitioners continue to have obligations toward their patients during
and after the departure from or closing of a medical practice. Practitio-ners
may not abandon a patient or abruptly withdraw from the care of a
patient. Patients should therefore be given reasonable advance notice (at
least 30 days) to allow other medical care to be secured. Good continuity
of care includes preserving and providing appropriate access to medical
records.* Also, good continuity of care may often include making appro-priate
referrals. The practitioner(s) and other parties that may be involved
should ensure that the requirements for continuity of care are effectively
addressed.
It is the position of the North Carolina Medical Board that during
such times practitioners and other parties that may be involved in such
processes must consider how their actions affect patients. In particular,
practitioners and other parties that may be involved have the following
obligations.
Permit Patient Choice
It is the patient’s decision from whom to receive care. Therefore, it
is the responsibility of all practitioners and other parties that may be
involved to ensure that:
• Patients are notified in a timely fashion of changes in the practice and
given the opportunity to seek other medical care, sufficiently far in
advance (at least 30 days) to allow other medical care to be secured,
which is often done by newspaper advertisement and by letters to
patients currently under care;
• Patients clearly understand that they have a choice of health care
providers;
• Patients are told how to reach any practitioner(s) remaining in prac-tice,
and when specifically requested, are told how to contact departing
practitioners; and
• Patients are told how to obtain copies of or transfer their medical
records.
No practitioner, group of practitioners, or other parties involved should
interfere with the fulfillment of these obligations, nor should practitioners
put themselves in a position where they cannot be assured these obliga-tions
can be met.
POSITION STATEMENTS
Written Policies
The Board recommends that practitioners and practices prepare writ-ten
policies regarding the secure storage, transfer and retrieval of patient
medical records. Practitioners and practices should notify patients of
these policies. At a minimum, the Board recommends that such written
policies specify:
• A procedure and timeline that describes how the practitioner or
practice will notify each patient when appropriate about (1) a pending
practice closure or practitioner departure, (2) how medical records
are to be accessed, and (3) how future notices of the location of the
practice’s medical records will be provided;
• How long medical records will be retained;
• The procedure by which the practitioner or practice will dispose of
unclaimed medical records after a specified period of time;
• How the practitioner or practice shall timely respond to requests from
patients for copies of their medical records or to access to their medical
records; In the event of the practitioner’s death or incapacity, how the
deceased practitioner’s executor, administrator, personal representa-tive
or survivor will notify patients of the location of their medical
records and how patients can access those records; and
• The procedure by which the deceased or incapacitated practitioner’s
executor, administrator, personal representative or survivor will dis-pose
of unclaimed medical records after a specified period of time.
The Board further expects that its licensees comply with any applicable
state and/or federal law or regulation pertaining to a patient’s protected
healthcare information.
*NOTE: The Board’s Position Statement on the Retention of Medical
Records applies, even when practices close permanently due to the retire-ment
or death of the practitioner.
(Adopted January 2000) (Amended August 2003, July 2009)
THE RETIRED PHYSICIAN
The retirement of a physician is defined by the North Carolina Medi-cal
Board as the total and complete cessation of the practice of medicine
and/or surgery by the physician in any form or setting. According to the
Board’s definition, the retired physician is not required to maintain a cur-rently
registered license and SHALL NOT:
• provide patient services;
• order tests or therapies;
• prescribe, dispense, or administer drugs;
• perform any other medical and/or surgical acts; or
• receive income from the provision of medical and/or surgical services
performed following retirement.
The North Carolina Medical Board is aware that a number of physi-cians
consider themselves “retired,” but still hold a currently registered
medical license (full, volunteer, or limited) and provide professional medi-cal
and/or surgical services to patients on a regular or occasional basis.
Such physicians customarily serve the needs of previous patients, friends,
nursing home residents, free clinics, emergency rooms, community health
programs, etc. The Board commends those physicians for their willingness
to continue service following “retirement,” but it recognizes such service
is not the “complete cessation of the practice of medicine” and therefore
must be joined with an undiminished awareness of professional responsi-bility.
That responsibility means that such physicians SHOULD:
• practice within their areas of professional competence;
• prepare and keep medical records in accord with good professional
practice; and
• meet the Board’s continuing medical education requirement.
The Board also reminds “retired” physicians with currently registered
licenses that all federal and state laws and rules relating to the practice of
medicine and/or surgery apply to them, that the position statements of the
Board are as relevant to them as to physicians in full and regular practice,
and that they continue to be subject to the risks of liability for any medical
and/or surgical acts they perform.
(Adopted January 1997) (Amended September 2006)
ADVANCE DIRECTIVES AND PATIENT AUTONOMY
Advances in medical technology have given physicians the ability to
prolong the mechanics of life almost indefinitely. Because of this, physi-cians
must be aware that North Carolina law specifically recognizes the
individual’s right to a peaceful and natural death. NC Gen Stat § 90-320
(a) (2007) reads:
The General Assembly recognizes as a matter of public policy
that an individual’s rights include the right to a peaceful and
natural death and that a patient or his the patient’s representa-tive
has the fundamental right to control the decisions relating to
the rendering of his the patient’s own medical care, including the
decision to have extraordinary means life-prolonging measures
withheld or withdrawn in instances of a terminal condition.
Physicians must also be aware that North Carolina law empowers any
adult individual with capacity to make a Health Care Power of Attorney
[NC Gen Stat § 32A-17 (2007)] and stipulates that, when a patient lacks
understanding or capacity to make or communicate health care decisions,
the instructions of a duly appointed health care agent are to be taken as
those of the patient unless evidence to the contrary is available [NC Gen
Stat § 32A- 24(b)(2007).
It is the position of the North Carolina Medical Board that it is in the
best interest of the patient and of the physician/patient relationship to
encourage patients to complete or authorize documents that express their
wishes for the kind of care they desire at the end of their lives. Physi-cians
should encourage their patients to appoint a health care agent to act
through the execution of a Health Care Power of Attorney and to pro-vide
documentation of the appointment to the responsible physician(s).
Further, physicians should provide full information to their patients in
order to enable those patients to make informed and intelligent decisions
preferably prior to a terminal illness. The Board also encourages the use of
portable physician orders to improve the communication of the patient’s
wishes for treatment at the end of life from one care setting to another.
It is also the position of the Board that physicians are ethically ob-ligated
to follow the wishes of the terminally ill or incurable patient as
expressed by and properly documented in a declaration of a desire for a
natural death; however, when the wishes of a patient are contrary to what
a physician believes in good conscience to be appropriate care, the physi-cian
may withdraw from the case once continuity of care is assured.
It is also the position of the Board that withholding or withdrawal of
life-prolonging measures is in no manner to be construed as permitting
diminution of nursing care, relief of pain, or any other care that may pro-vide
comfort for the patient.
(Adopted 7/1993) (Amended 5/1996; 3/2008)
AVAILABILITY OF PHYSICIANS TO THEIR PATIENTS
It is the position of the North Carolina Medical Board that once a
physician-patient relationship is created, it is the duty of the physician
to provide care whenever it is needed or to assure that proper physician
backup is available to take care of the patient during or outside normal
office hours.
The physician must clearly communicate to the patient orally and pro-vide
instructions in writing for securing after hours care if the physician
is not generally available after hours or if the physician discontinues after
hours coverage.
(Adopted July 1993) (Amended May 1996, January 2001, October 2003,
July 2006)
GUIDELINES FOR AVOIDING MISUNDERSTANDINGS
DURING PHYSICAL EXAMINATIONS
It is the position of the North Carolina Medical Board that proper
care and sensitivity are needed during physical examinations to avoid
misunderstandings that could lead to charges of sexual misconduct against
licensees. In order to prevent such misunderstandings, the Board offers
the following guidelines.
1. Sensitivity to patient dignity should be considered by the licensee
when undertaking a physical examination. The patient should be
assured of adequate auditory and visual privacy and should never be
asked to disrobe in the presence of the licensee. Examining rooms
should be safe, clean, and well maintained, and should be equipped
with appropriate furniture for examination and treatment. Gowns,
sheets and/or other appropriate apparel should be made available to
protect patient dignity and decrease embarrassment to the patient
while a thorough and professional examination is conducted.
2. Whatever the sex of the patient, a third party, a staff member, should
be readily available at all times during a physical examination, and
it is strongly advised that a third party be present when the licensee
performs an examination of the breast(s), genitalia, or rectum. It is the
licensee’s responsibility to have a staff member available at any point
POSITION STATEMENTS
FORUM | Winter 2012 7
during the examination.
3. The licensee should individualize the approach to physical examina-tions
so that each patient’s apprehension, fear, and embarrassment are
diminished as much as possible. An explanation of the necessity of a
complete physical examination, the components of that examination,
and the purpose of disrobing may be necessary in order to minimize
the patient’s possible misunderstanding.
4. The licensee and staff should exercise the same degree of professional-ism
and care when performing diagnostic procedures (eg, electro-cardio-grams,
electromyograms, endoscopic procedures, and radiological stud-ies,
etc), as well as during surgical procedures and postsurgical follow-up
examinations when the patient is in varying stages of consciousness.
5. The licensee should be on the alert for suggestive or flirtatious behav-ior
or mannerisms on the part of the patient and should not permit a
compromising situation to develop.
(Adopted May 1991) (Amended May 1993, May 1996, January 2001, Feb-ruary
2001, October 2002, July 2010)
SEXUAL EXPLOITATION OF PATIENTS
It is the position of the North Carolina Medical Board that sexual
exploitation of a patient is unprofessional conduct and undermines the
public trust in the medical profession. Sexual exploitation encompasses
a wide range of behaviors which have in common the intended sexual
gratification of the physician. These behaviors include sexual intercourse
with a patient (consensual or non-consensual ), touching genitalia with
ungloved hands, sexually suggestive comments, asking patients for a date,
inappropriate exploration of the patients or physician’s sexual phantasias,
touching or exposing genitalia, breast, or other parts of the body in ways
not dictated by an appropriate and indicated physical examination, ex-changing
sexual favors for services. Sexual exploitation is grounds for the
suspension , revocation, or other action against a physician’s license. This
position statement is based upon the Federation of State Medical Board’s
guidelines regarding sexual boundaries.
Sexual misconduct by physicians and other health care practitioners is
a form of behavior that adversely affects the public welfare and harms pa-tients
individually and collectively. Physician sexual misconduct exploits
the physician-patient relationship, is a violation of the public trust, and is
often known to cause harm, both mentally and physically, to the patient.
Regardless of whether sexual misconduct is viewed as emanating from
an underlying form of impairment, it is unarguably a violation of the
public’s trust.
As with other disciplinary actions taken by the Board, Board action
against a medical licensee for sexual exploitation of a patient is published
by the Board, the nature of the offense being clearly specified. It is also
released to the news media, to state and federal government, and to medi-cal
and professional organizations.
(Adopted May 1991) (Amended April 1996, January 2001, September 2006)
CONTACT WITH PATIENTS BEFORE PRESCRIBING
It is the position of the North Carolina Medical Board that prescribing
drugs to an individual the prescriber has not personally examined is inap-propriate
except as noted in the paragraphs below. Before prescribing a
drug, a licensee should make an informed medical judgment based on the
circumstances of the situation and on his or her training and experience.
Ordinarily, this will require that the licensee personally perform an appro-priate
history and physical examination, make a diagnosis, and formulate
a therapeutic plan, a part of which might be a prescription. This process
must be documented appropriately.
Prescribing for a patient whom the licensee has not personally exam-ined
may be suitable under certain circumstances. These may include
admission orders for a newly hospitalized patient, prescribing for a patient
of another licensee for whom the prescriber is taking call, or continuing
medication on a short-term basis for a new patient prior to the patient’s
first appointment. Established patients may not require a new history and
physical examination for each new prescription, depending on good medi-cal
practice.
Prescribing for an individual whom the licensee has not met or person-ally
examined may also be suitable when that individual is the partner of a
patient whom the licensee is treating for gonorrhea or chlamydia. Part-ner
management of patients with gonorrhea or chlamydia should include
the following items:
a) Signed prescriptions of oral antibiotics of the appropriate quantity
and strength sufficient to provide curative treatment for each partner
named by the infected patient. Notation on the prescription should
include the statement: “Expedited partner therapy.”
b) Signed prescriptions to named partners should be accompanied by
written material that states that clinical evaluation is desirable; that
prescriptions for medication or related compounds to which the part-ner
is allergic should not be accepted; and that lists common medica-tion
side effects and the appropriate response to them.
c) Prescriptions and accompanying written material should be given to
the licensee’s patient for distribution to named partners.
d) The licensee should keep appropriate documentation of partner man-agement.
Documentation should include the names of partners and a
copy of the prescriptions issued or an equivalent statement.
It is the position of the Board that prescribing drugs to individuals the
licensee has never met based solely on answers to a set of questions, as is
common in Internet or toll-free telephone prescribing, is inappropriate
and unprofessional.
(Adopted November 1999) (Amended February 2001, November 2009)
(Reviewed July 2010)
WRITING OF PRESCRIPTIONS
It is the position of the North Carolina Medical Board that prescriptions
should be written in ink or indelible pencil or typewritten or electronically
printed and should be signed by the practitioner at the time of issuance.
Prescription that are handwritten should indicate the quantity in both
numbers AND words, e.g., 30 (thirty). Such prescriptions must not be
written on pre-signed prescription blanks.
Each prescription for a DEA controlled substance (2, 2N, 3, 3N, 4, and
5) should be written on a separate prescription blank. Multiple medica-tions
may appear on a single prescription blank only when none are DEA-controlled.
No prescriptions should be issued for a patient in the absence of a
documented physician-patient relationship.
No prescription should be issued by a practitioner for his or her per-sonal
use. (See Position Statement entitled “Self-Treatment and Treat-ment
of Family Members and Others with Whom Significant Emotional
Relationships Exist.”)
The practice of pre-signing prescriptions is unacceptable to the Board.
It is the responsibility of those who prescribe controlled substances
to fully comply with applicable federal and state laws and regulations.
Links to these laws and regulations may be found on the Board’s Web site
(www.ncmedboard.org).
((Adopted May 1991, September 1992) (Amended May 1996; March 2002;
July 2002; March 2011)
SELF-TREATMENT AND TREATMENT OF FAMILY MEM-BERS
AND OTHERS WITH WHOM SIGNIFICANT EMO-TIONAL
RELATIONSHIPS EXIST*
It is the position of the North Carolina Medical Board that, except for
minor illnesses and emergencies, physicians should not treat, medi-cally
or surgically, or prescribe for themselves, their family members,
or others with whom they have significant emotional relationships. The
Board strongly believes that such treatment and prescribing practices are
inappropriate and may result in less than optimal care being provided. A
variety of factors, including personal feelings and attitudes that will inevi-tably
affect judgment, will compromise the objectivity of the physician and
make the delivery of sound medical care problematic in such situations,
while real patient autonomy and informed consent may be sacrificed.
When a minor illness or emergency requires self-treatment or treat-ment
of a family member or other person with whom the physician has a
significant emotional relationship, the physician must prepare and keep a
proper written record of that treatment, including but not limited to pre-scriptions
written and the medical indications for them. Record keeping is
too frequently neglected when physicians manage such cases.
The Board expects physicians to delegate the medical and surgical care
of themselves, their families, and those with whom they have significant
emotional relationships to one or more of their colleagues in order to
ensure appropriate and objective care is provided and to avoid misunder-standings
related to their prescribing practices.
*This position statement was formerly titled, “Treatment of and Prescrib-ing
for Family Members.” (Adopted May 1991) (Amended May 1996; May
2000; March 2002; September 2005)
POSITION STATEMENTS
THE TREATMENT OF OBESITY
It is the position of the North Carolina Medical Board that the corner-stones
of the treatment of obesity are diet (caloric control) and exercise.
Medications and surgery should only be used to treat obesity when the
benefits outweigh the risks of the chosen modality.
The treatment of obesity should be based on sound scientific evidence
and principles. Adequate medical documentation must be kept so that
progress as well as the success or failure of any modality is easily ascer-tained.
(Adopted [as The Use of Anorectics in Treatment of Obesity] October
1987) (Amended March 1996) (Amended and retitled January 2005) (Re-viewed
November 2010)
PRESCRIBING LEGEND OR CONTROLLED SUBSTANCES
FOR OTHER THAN VALIDATED MEDICAL OR THERAPEU-TIC
PURPOSES, WITH PARTICULAR REFERENCE TO SUB-STANCE
OR PREPARATIONS WITH ANABOLIC PROPERTIES
General
It is the position of the North Carolina Medical Board that prescribing
any controlled substance for other than a validated medical or therapeutic
purpose is unprofessional conduct.
The licensee shall complete and maintain a medical record that estab-lishes
the diagnosis, the basis for that diagnosis, the purpose and expected
response to therapeutic medications, and the plan for the use of medica-tions
in treatment of the diagnosis.
The Board is not opposed to the use of innovative, creative therapeu-tics;
however, treatments not having a scientifically validated basis for
use should be studied under investigational protocols so as to assist in the
establishment of evidence-based, scientific validity for such treatments.
Substances/Preparations with Anabolic Properties
The use of anabolic steroids, testosterone and its analogs, human
growth hormone, human chorionic gonadotrophin, other preparations
with anabolic properties, or autotransfusion in any form, to enhance
athletic performance or muscle development for cosmetic, nontherapeutic
reasons, in the absence of an established disease or deficiency state, is not
a medically valid use of these medications.
The use of these medications under these conditions will subject the
person licensed by the Board to investigation and potential sanctions.
The Board recognizes that most anabolic steroid abuse occurs outside
the medical system. It wishes to emphasize the licensee’s role as educator
in providing information to individual patients and the community, and
specifically to high school and college athletes, as to the dangers inherent
in the use of these medications.
(Adopted May 1998) (Amended July 1998, January 2001; September 2011)
POLICY FOR THE USE OF CONTROLLED SUBSTANCES
FOR THE TREATMENT OF PAIN
• Appropriate treatment of chronic pain may include both pharma-cologic
and non-pharmacologic modalities. The Board realizes that
controlled substances, including opioid analgesics, may be an essential
part of the treatment regimen.
• All prescribing of controlled substances must comply with applicable
state and federal law.
• Guidelines for treatment include: (a) complete patient evaluation, (b)
establishment of a treatment plan (contract), (c) informed consent, (d)
periodic review, and (e) consultation with specialists in various treat-ment
modalities as appropriate.
• Deviation from these guidelines will be considered on an individual
basis for appropriateness.
Section I: Preamble
The North Carolina Medical Board recognizes that principles of quality
medical practice dictate that the people of the State of North Carolina have
access to appropriate and effective pain relief. The appropriate application
of up-to-date knowledge and treatment modalities can serve to improve
the quality of life for those patients who suffer from pain as well as reduce
the morbidity and costs associated with untreated or inappropriately
treated pain. For the purposes of this policy, the inappropriate treatment
of pain includes nontreatment, undertreatment, overtreatment, and the
continued use of ineffective treatments.
The diagnosis and treatment of pain is integral to the practice of
medicine. The Board encourages physicians to view pain management as a
part of quality medical practice for all patients with pain, acute or chronic,
and it is especially urgent for patients who experience pain as a result of
terminal illness. All physicians should become knowledgeable about as-sessing
patients’ pain and effective methods of pain treatment, as well as
statutory requirements for prescribing controlled substances. Accordingly,
this policy have been developed to clarify the Board’s position on pain con-trol,
particularly as related to the use of controlled substances, to alleviate
physician uncertainty and to encourage better pain management.
Inappropriate pain treatment may result from physicians’ lack of
knowledge about pain management. Fears of investigation or sanction by
federal, state and local agencies may also result in inappropriate treatment
of pain. Appropriate pain management is the treating physician’s respon-sibility.
As such, the Board will consider the inappropriate treatment of
pain to be a departure from standards of practice and will investigate such
allegations, recognizing that some types of pain cannot be completely
relieved, and taking into account whether the treatment is appropriate for
the diagnosis.
The Board recognizes that controlled substances including opioid
analgesics may be essential in the treatment of acute pain due to trauma
or surgery and chronic pain, whether due to cancer or non-cancer origins.
The Board will refer to current clinical practice guidelines and expert
review in approaching cases involving management of pain. The medi-cal
management of pain should consider current clinical knowledge and
scientific research and the use of pharmacologic and non-pharmacologic
modalities according to the judgment of the physician. Pain should be
assessed and treated promptly, and the quantity and frequency of doses
should be adjusted according to the intensity, duration of the pain, and
treatment outcomes. Physicians should recognize that tolerance and
physical dependence are normal consequences of sustained use of opioid
analgesics and are not the same as addiction.
The North Carolina Medical Board is obligated under the laws of the
State of North Carolina to protect the public health and safety. The Board
recognizes that the use of opioid analgesics for other than legitimate
medical purposes pose a threat to the individual and society and that
the inappropriate prescribing of controlled substances, including opioid
analgesics, may lead to drug diversion and abuse by individuals who seek
them for other than legitimate medical use. Accordingly, the Board expects
that physicians incorporate safeguards into their practices to minimize the
potential for the abuse and diversion of controlled substances.
Physicians should not fear disciplinary action from the Board for
ordering, prescribing, dispensing or administering controlled substances,
including opioid analgesics, for a legitimate medical purpose and in the
course of professional practice. The Board will consider prescribing, order-ing,
dispensing or administering controlled substances for pain to be for a
legitimate medical purpose if based on sound clinical judgment. All such
prescribing must be based on clear documentation of unrelieved pain. To
be within the usual course of professional practice, a physician-patient
relationship must exist and the prescribing should be based on a diagnosis
and documentation of unrelieved pain. Compliance with applicable state
or federal law is required.
The Board will judge the validity of the physician’s treatment of the
patient based on available documentation, rather than solely on the
quantity and duration of medication administration. The goal is to control
the patient’s pain while effectively addressing other aspects of the patient’s
functioning, including physical, psychological, social and work-related
factors.
Allegations of inappropriate pain management will be evaluated on
an individual basis. The Board will not take disciplinary action against a
physician for deviating from this policy when contemporaneous medical
records document reasonable cause for deviation. The physician’s conduct
will be evaluated to a great extent by the outcome of pain treatment,
recognizing that some types of pain cannot be completely relieved, and by
taking into account whether the drug used is appropriate for the diagnosis,
as well as improvement in patient functioning and/or quality of life.
Section II: Guidelines
The Board has adopted the following criteria when evaluating the phy-sician’s
treatment of pain, including the use of controlled substances:
Evaluation of the Patient —A medical history and physical examina-tion
must be obtained, evaluated, and documented in the medical record.
POSITION STATEMENTS
FORUM | Winter 2012 9
POSITION STATEMENTS
The medical record should document the nature and intensity of the pain,
current and past treatments for pain, underlying or coexisting diseases or
conditions, the effect of the pain on physical and psychological function,
and history of substance abuse. The medical record also should document
the presence of one or more recognized medical indications for the use of
a controlled substance.
Treatment Plan —The written treatment plan should state objectives
that will be used to determine treatment success, such as pain relief
and improved physical and psychosocial function, and should indicate
if any further diagnostic evaluations or other treatments are planned.
After treatment begins, the physician should adjust drug therapy to the
individual medical needs of each patient. Other treatment modalities or
a rehabilitation program may be necessary depending on the etiology of
the pain and the extent to which the pain is associated with physical and
psychosocial impairment.
Informed Consent and Agreement for Treatment —The physician
should discuss the risks and benefits of the use of controlled substances
with the patient, persons designated by the patient or with the patient’s
surrogate or guardian if the patient is without medical decision-making
capacity. The patient should receive prescriptions from one physician and
one pharmacy whenever possible. If the patient is at high risk for medi-cation
abuse or has a history of substance abuse, the physician should
consider the use of a written agreement between physician and
• patient outlining patient responsibilities, including
• urine/serum medication levels screening when requested;
• number and frequency of all prescription refills; and
• reasons for which drug therapy may be discontinued (e.g., violation of
agreement); and
• the North Carolina Controlled Substance Reporting Service can be
accessed and its results used to make treatment decisions.
Periodic Review —The physician should periodically review the course
of pain treatment and any new information about the etiology of the pain
or the patient’s state of health. Continuation or modification of controlled
substances for pain management therapy depends on the physician’s eval-uation
of progress toward treatment objectives. Satisfactory response to
treatment may be indicated by the patient’s decreased pain, increased lev-el
of function, or improved quality of life. Objective evidence of improved
or diminished function should be monitored and information from family
members or other caregivers should be considered in determining the
patient’s response to treatment. If the patient’s progress is unsatisfactory,
the physician should assess the appropriateness of continued use of the
current treatment plan and consider the use of other therapeutic modali-ties.
Reviewing the North Carolina Controlled Substance Reporting Ser-vice
should be considered if inappropriate medication usage is suspected
and intermittently on all patients.
Consultation —The physician should be willing to refer the patient as
necessary for additional evaluation and treatment in order to achieve
treatment objectives. Special attention should be given to those patients
with pain who are at risk for medication misuse, abuse or diversion. The
management of pain in patients with a history of substance abuse or
with a comorbid psychiatric disorder may require extra care, monitor-ing,
documentation and consultation with or referral to an expert in the
management of such patients.
Medical Records —The physician should keep accurate and complete
records to include
• the medical history and physical examination,
• diagnostic, therapeutic and laboratory results,
• evaluations and consultations,
• treatment objectives,
• discussion of risks and benefits,
• informed consent,
• treatments,
• medications (including date, type, dosage and quantity prescribed),
• instructions and agreements and
• periodic reviews including potential review of the North Carolina
Controlled Substance Reporting Service.
Records should remain current and be maintained in an accessible man-ner
and readily available for review.
Compliance With Controlled Substances Laws and Regulations
To prescribe, dispense or administer controlled substances, the physician
must be licensed in the state and comply with applicable federal and state
regulations. Physicians are referred to the Physicians Manual of the U.S.
Drug Enforcement Administration and any relevant documents issued
by the state of North Carolina for specific rules governing controlled sub-stances
as well as applicable state regulations.
Section III: Definitions
For the purposes of these guidelines, the following terms are defined
as follows:
Acute Pain —Acute pain is the normal, predicted physiological response
to a noxious chemical, thermal or mechanical stimulus and typically is
associated with invasive procedures, trauma and disease. It is generally
time-limited.
Addiction —Addiction is a primary, chronic, neurobiologic disease, with
genetic, psychosocial, and environmental factors influencing its develop-ment
and manifestations. It is characterized by behaviors that include
the following: impaired control over drug use, craving, compulsive use,
and continued use despite harm. Physical dependence and tolerance are
normal physiological consequences of extended opioid therapy for pain
and are not the same as addiction.
Chronic Pain —Chronic pain is a state in which pain persists beyond
the usual course of an acute disease or healing of an injury, or that may
or may not be associated with an acute or chronic pathologic process that
causes continuous or intermittent pain over months or years.
Pain —An unpleasant sensory and emotional experience associated with
actual or potential tissue damage or described in terms of such damage.
Physical Dependence —Physical dependence is a state of adaptation that
is manifested by drug class-specific signs and symptoms that can be pro-duced
by abrupt cessation, rapid dose reduction, decreasing blood level of
the drug, and/or administration of an antagonist. Physical dependence,
by itself, does not equate with addiction.
Pseudoaddiction —The iatrogenic syndrome resulting from the misin-terpretation
of relief seeking behaviors as though they are drug-seeking
behaviors that are commonly seen with addiction. The relief seeking
behaviors resolve upon institution of effective analgesic therapy.
Substance Abuse —Substance abuse is the use of any substance(s) for
non-therapeutic purposes or use of medication for purposes other than
those for which it is prescribed.
Tolerance —Tolerance is a physiologic state resulting from regular use
of a drug in which an increased dosage is needed to produce a specific
effect, or a reduced effect is observed with a constant dose over time.
Tolerance may or may not be evident during opioid treatment and does
not equate with addiction.
(Adopted September 1996 as “Management of Chronic Non-Malignant
Pain.”) (Redone July 2005 based on the Federation of State Medical
Board’s “Model Policy for the Use of Controlled Substances for the Treat-ment
of Pain,” as amended by the FSMB in 2004.) (Amended 9/2008)
END-OF-LIFE RESPONSIBILITIES AND
PALLIATIVE CARE
Assuring Patients
Death is part of life. When appropriate processes have determined that
the use of life prolonging measurers or invasive interventions will only
prolong the dying process, it is incumbent on physicians to accept death
“not asa failure, but the natural culmination of our lives.”*
It is the position of the North Carolina Medical Board that patients
and their families should be assured of competent, comprehensive pal-liative
care at the end of their lives. Physicians should be knowledgeable
regarding effective and compassionate pain relief, and patients and their
families should be assured such relief will be provided.
Palliative Care
Palliative care is an approach that improves the quality of life of
patients and their families facing the problems associated with life-threat-ening
illness, through the prevention and relief of suffering by means of
early identification an impeccable assessment and treatment of pain and
other physical, psychosocial and spiritual problems. Palliative care:
• provides relief from pain and other distressing symptoms;
• affirms life and regards dying as a normal process;
• intends neither to hasten nor postpone death;
• integrates the psychological and spiritual aspects of patient care;
• offers a support system to help patients live as actively as possible
until death;
• offers a support system to help the family cope during the patient’s
FORUM | Winter 2012 11
POSITION STATEMENTS
illness and in their own bereavement;
• uses a team approach to address the needs of patients and their fami-lies,
including bereavement counseling, if indicated;
• will enhance quality of life, and may also positively influence the
course of illness;
• [may be] applicable early in the course of illness, in conjunction with
other therapies that are intended to prolong life, such as chemother-apy
or radiation therapy, and includes those investigations needed to
better understand and
• manage distressing clinical complications.**
Opioid Use
The Board will assume opioid use in such patients is appropriate if the
responsible physician is familiar with and abides by acceptable medical
guidelines regarding such use, is knowledgeable about effective and com-passionate
pain relief, and maintains an appropriate medical record that
details a pain management plan. (See the Board’s position statement on
the Policy for the Use of Controlled Substances for the Treatment of Pain
for an outline of what the Board expects of physicians in the management
of pain.) Because the Board is aware of the inherent risks associated with
effective pain relief in such situations, it will not interpret their occurrence
as subject to discipline by the Board.
(Adopted 10/1999) (Amended 5/2007; 3/2008)
*Steven A. Schroeder, MD, President, Robert Wood Johnson Foundation.
** Taken from the world Health Organization definition of Palliative Care
(2002) www.who.int/cancer/palliative/definition/en
JOINT STATEMENT ON PAIN MANAGEMENT
IN END-OF-LIFE CARE
(Adopted by the North Carolina Medical, Nursing, and Pharmacy Boards)
Through dialogue with members of the healthcare community and consum-ers,
a number of perceived regulatory barriers to adequate pain management in
end-of-life care have been expressed to the Boards of Medicine, Nursing, and
Pharmacy. The following statement attempts to address these misperceptions
by outlining practice expectations for licensees and other health care profes-sionals
authorized to prescribe medications, as well as nurses and pharmacists
involved in this aspect of end-of-life care. The statement is based on:
• the legal scope of practice for each of these licensed health professionals;
• professional collaboration and communication among health professionals
providing palliative care; and
• a standard of care that assures on-going pain assessment, a therapeutic plan
for pain management interventions; and evidence of adequate symptom
management for the dying patient.
It is the position of all three Boards that patients and their families should
be assured of competent, comprehensive palliative care at the end of their lives.
Licensees, nurses and pharmacists should be knowledgeable regarding effective
and compassionate pain relief, and patients and their families should be as-sured
such relief will be provided.
Because of the overwhelming concern of patients about pain relief, the
licensee needs to give special attention to the effective assessment of pain. It
is particularly important that the licensee frankly but sensitively discuss with
the patient and the family their concerns and choices at the end of life. As part
of this discussion, the licensee should make clear that, in some end of life care
situations, there are inherent risks associated with effective pain relief. The
Medical Board will assume opioid use in such patients is appropriate if the re-sponsible
licensee is familiar with and abides by acceptable medical guidelines
regarding such use, is knowledgeable about effective and compassionate pain
relief, and maintains an appropriate medical record that details a pain manage-ment
plan. Because the Board is aware of the inherent risks associated with
effective pain relief in such situations, it will not interpret their occurrence as
subject to discipline by the Board.
With regard to pharmacy practice, North Carolina has no quantity restric-tions
on dispensing controlled substances including those in Schedule II. This
is significant when utilizing the federal rule that allows the partial filling of
Schedule II prescriptions for up to 60 days. In these situations it would mini-mize
expenses and unnecessary waste of drugs if the prescriber would note on
the prescription that the patient is terminally ill and specify the largest antici-pated
quantity that could be needed for the next two months. The pharmacist
could then dispense smaller quantities of the prescription to meet the patient’s
needs up to the total quantity authorized. Government-approved labeling for
dosage level and frequency can be useful as guidance for patient care. Health
professionals may, on occasion, determine that higher levels are justified in
specific cases. However, these occasions would be exceptions to general prac-tice
and would need to be properly documented to establish informed consent
of the patient and family.
Federal and state rules also allow the fax transmittal of an original prescrip-tion
for Schedule II drugs for hospice patients. If the prescriber notes the
hospice status of the patient on the faxed document, it serves as the original.
Pharmacy rules also allow the emergency refilling of prescriptions in Schedules
III, IV, and V. While this does not apply to Schedule II drugs, it can be useful
in situations where the patient is using drugs such as Vicodin for pain or Xanax
for anxiety.
The nurse is often the health professional most involved in on-going pain
assessment, implementing the prescribed pain management plan, evaluating
the patient’s response to such interventions and adjusting medication levels
based on patient status. In order to achieve adequate pain management, the
prescription must provide dosage ranges and frequency parameters within
which the nurse may adjust (titrate) medication in order to achieve adequate
pain control. Consistent with the licensee’s scope of practice, the RN or LPN
is accountable for implementing the pain management plan utilizing his/her
knowledge base and documented assessment of the patient’s needs. The nurse
has the authority to adjust medication levels within the dosage and frequency
ranges stipulated by the prescriber and according to the agency’s established
protocols. However, the nurse does not have the authority to change the medi-cal
pain management plan. When adequate pain management is not achieved
under the currently prescribed treatment plan, the nurse is responsible for
reporting such findings to the prescriber and documenting this communica-tion.
Only the licensee or other health professional with authority to prescribe
may change the medical pain management plan.
Communication and collaboration between members of the healthcare
team, and the patient and family are essential in achieving adequate pain man-agement
in end-of-life care. Within this interdisciplinary framework for end of
life care, effective pain management should include:
• thorough documentation of all aspects of the patient’s assessment and care;
• a working diagnosis and therapeutic treatment plan including pharmaco-logic
and non-pharmacologic interventions;
• regular and documented evaluation of response to the interventions and, as
appropriate, revisions to the treatment plan;
• evidence of communication among care providers;
• education of the patient and family; and
• a clear understanding by the patient, the family and healthcare team of the
treatment goals.
It is important to remind health professionals that licensing boards hold each
licensee accountable for providing safe, effective care. Exercising this standard
of care requires the application of knowledge, skills, as well as ethical principles
focused on optimum patient care while taking all appropriate measures to
relieve suffering. The healthcare team should give primary importance to the
expressed desires of the patient tempered by the judgment and legal respon-sibilities
of each licensed health professional as to what is in the patient’s best
interest.
(October 1999) (Amended January 2011)
OFFICE-BASED PROCEDURES
Preface
This Position Statement on Office-Based Procedures is an interpretive state-ment
that attempts to identify and explain the standards of practice for Office-
Based Procedures in North Carolina. The Board’s intention is to articulate
existing professional standards and not to promulgate a new standard.
This Position Statement is in the form of guidelines designed to assure pa-tient
safety and identify the criteria by which the Board will assess the conduct
of its licensees in considering disciplinary action arising out of the performance
of office-based procedures. Thus, it is expected that the licensee who follows
the guidelines set forth below will avoid disciplinary action by the Board.
However, this Position Statement is not intended to be comprehensive or to
set out exhaustively every standard that might apply in every circumstance.
The silence of the Position Statement on any particular matter should not be
construed as the lack of an enforceable standard.
General Guidelines
The Physician’s Professional and Legal Obligation
The North Carolina Medical Board has adopted the guidelines contained
in this Position Statement in order to assure patients have access to safe,
high quality office-based surgical and special procedures. The guidelines
further assure that a licensed physician with appropriate qualifications
POSITION STATEMENTS
takes responsibility for the supervision of all aspects of the perioperative
surgical, procedural and anesthesia care delivered in the office setting,
including compliance with all aspects of these guidelines.
These obligations are to be understood (as explained in the Preface)
as existing standards identified by the Board in an effort to assure patient
safety and provide licensees guidance to avoid practicing below the stan-dards
of practice in such a manner that the licensee would be exposed to
possible disciplinary action for unprofessional conduct as contemplated in
N.C. Gen. Stat. § 90-14(a)(6).
Exemptions
These guidelines do not apply to Level I procedures.
Written Policies and Procedures
Written policies and procedures should be maintained to assist office-based
practices in providing safe and quality surgical or special procedure
care, assure consistent personnel performance, and promote an awareness
and understanding of the inherent rights of patients.
Emergency Procedure and Transfer Protocol
The physician who performs the surgical or special procedure should
assure that a transfer protocol is in place, preferably with a hospital that is
licensed in the jurisdiction in which it is located and that is within reason-able
proximity of the office where the procedure is performed.
All office personnel should be familiar with and capable of carrying out
written emergency instructions. The instructions should be followed in
the event of an emergency, any untoward anesthetic, medical or surgical
complications, or other conditions making hospitalization of a patient
necessary. The instructions should include arrangements for immediate
contact of emergency medical services when indicated and when advanced
cardiac life support is needed. When emergency medical services are not
indicated, the instructions should include procedures for timely escort of
the patient to the hospital or to an appropriate practitioner.
Infection Control
The practice should comply with state and federal regulations regarding
infection control. For all surgical and special procedures, the level of steril-ization
should meet applicable industry and occupational safety require-ments.
There should be a procedure and schedule for cleaning, disinfecting
and sterilizing equipment and patient care items. Personnel should be
trained in infection control practices, implementation of universal precau-tions,
and disposal of hazardous waste products. Protective clothing and
equipment should be readily available.
Performance Improvement
A performance improvement program should be implemented to
provide a mechanism to review yearly the current practice activities and
quality of care provided to patients.
Performance improvement activities should include, but are not limited
to, review of mortalities; the appropriateness and necessity of procedures
performed; emergency transfers; reportable complications, and resultant
outcomes (including all postoperative infections); analysis of patient sat-isfaction
surveys and complaints; and identification of undesirable trends
(such as diagnostic errors, unacceptable results, follow-up of abnormal
test results, medication errors, and system problems). Findings of the per-formance
improvement program should be incorporated into the practice’s
educational activity.
Medical Records and Informed Consent
The practice should have a procedure for initiating and maintaining
a health record for every patient evaluated or treated. The record should
include a procedure code or suitable narrative description of the procedure
and should have sufficient information to identify the patient, support the
diagnosis, justify the treatment, and document the outcome and required
follow-up care.
Medical history, physical examination, lab studies obtained within 30
days of the scheduled procedure, and pre-anesthesia examination and
evaluation information and data should be adequately documented in the
medical record.
The medical records also should contain documentation of the intraop-erative
and postoperative monitoring required by these guidelines.
Written documentation of informed consent should be included in the
medical record.
Credentialing of Physicians
A physician who performs surgical or special procedures in an office
requiring the administration of anesthesia services should be credentialed
to perform that surgical or special procedure by a hospital, an ambulatory
surgical facility, or substantially comply with criteria established by the
Board.
Criteria to be considered by the Board in assessing a physician’s
competence to perform a surgical or special procedure include, without
limitation:
1. state licensure;
2. procedure specific education, training, experience and successful
evaluation appropriate for the patient population being treated (i.e.,
pediatrics);
3. for physicians, board certification, board eligibility or completion
of a training program in a field of specialization recognized by the
ACGME or by a national medical specialty board that is recognized
by the ABMS for expertise and proficiency in that field. For purposes
of this requirement, board eligibility or certification is relevant only if
the board in question is recognized by the ABMS, AOA, or equivalent
board certification as determined by the Board;
4. professional misconduct and malpractice history;
5. participation in peer and quality review;
6. participation in continuing education consistent with the statutory
requirements and requirements of the physician’s professional orga-nization;
7. to the extent such coverage is reasonably available in North Carolina,
malpractice insurance coverage for the surgical or special procedures
being performed in the office;
8. procedure-specific competence (and competence in the use of new pro-cedures
and technology), which should encompass education, training,
experience and evaluation, and which may include the following:
a. adherence to professional society standards;
b. credentials approved by a nationally recognized accrediting or
credentialing entity; or
c. didactic course complemented by hands-on, observed experience;
training is to be followed by a specified number of cases supervised
by a practitioner already competent in the respective procedure, in
accordance with professional society standards.
If the physician administers the anesthetic as part of a surgical or
special procedure (Level II only), he or she also should have documented
competence to deliver the level of anesthesia administered.
Accreditation
After one year of operation following the adoption of these guidelines,
any physician who performs Level II or Level III procedures in an office
should be able to demonstrate, upon request by the Board, substantial
compliance with these guidelines, or should obtain accreditation of the
office setting by an approved accreditation agency or organization. The ap-proved
accreditation agency or organization should submit, upon request
by the Board, a summary report for the office accredited by that agency.
All expenses related to accreditation or compliance with these guide-lines
shall be paid by the physician who performs the surgical or special
procedures.
Patient Selection
The physician who performs the surgical or special procedure should
evaluate the condition of the patient and the potential risks associated
with the proposed treatment plan. The physician also is responsible for
determining that the patient has an adequate support system to provide
for necessary follow-up care. Patients with pre-existing medical problems
or other conditions, who are at undue risk for complications, should be
referred to an appropriate specialist for preoperative consultation.
ASA Physical Status Classifications
Patients that are considered high risk or are ASA physical status clas-sification
III, IV, or V and require a general anesthetic for the surgical
procedure, should not have the surgical or special procedure performed in
a physician office setting.
Candidates for Level II Procedures
Patients with an ASA physical status classification I, II, or III may
be acceptable candidates for office-based surgical or special procedures
FORUM | Winter 2012 13
POSITION STATEMENTS
requiring conscious sedation/ analgesia. ASA physical status classification
III patients should be specifically addressed in the operating manual for
the office. They may be acceptable candidates if deemed so by a physician
qualified to assess the specific disability and its impact on anesthesia and
surgical or procedural risks.
Candidates for Level III Procedures
Only patients with an ASA physical status classification I or II, who have
no airway abnormality, and possess an unremarkable anesthetic history
are acceptable candidates for Level III procedures.
Surgical or Special Procedure Guidelines
Patient Preparation
A medical history and physical examination to evaluate the risk of
anesthesia and of the proposed surgical or special procedure, should be
performed by a physician qualified to assess the impact of co-existing dis-ease
processes on surgery and anesthesia. Appropriate laboratory studies
should be obtained within 30 days of the planned surgical procedure.
A pre-procedure examination and evaluation should be conducted prior
to the surgical or special procedure by the physician. The information and
data obtained during the course of this evaluation should be documented
in the medical record
The physician performing the surgical or special procedure also should:
1. ensure that an appropriate pre-anesthetic examination and evaluation
is performed proximate to the procedure;
2. prescribe the anesthetic, unless the anesthesia is administered by an
anesthesiologist in which case the anesthesiologist may prescribe the
anesthetic;
3. ensure that qualified health care professionals participate;
4. remain physically present during the intraoperative period and be
immediately available for diagnosis, treatment, and management of
anesthesia-related complications or emergencies; and
5. ensure the provision of indicated post-anesthesia care.
Discharge Criteria
Criteria for discharge for all patients who have received anesthesia
should include the following:
1. confirmation of stable vital signs;
2. stable oxygen saturation levels;
3. return to pre-procedure mental status;
4. adequate pain control;
5. minimal bleeding, nausea and vomiting;
6. resolving neural blockade, resolution of the neuraxial blockade; and
7. eligible to be discharged in the company of a competent adult.
Information to the Patient
The patient should receive verbal instruction understandable to the
patient or guardian, confirmed by written post-operative instructions and
emergency contact numbers. The instructions should include:
1. the procedure performed;
2. information about potential complications;
3. telephone numbers to be used by the patient to discuss complications
or should questions arise;
4. instructions for medications prescribed and pain management;
5. information regarding the follow-up visit date, time and location; and
6. designated treatment hospital in the event of emergency.
Reportable Complications
Physicians performing surgical or special procedures in the office should
maintain timely records, which should be provided to the Board within
three business days of receipt of a Board inquiry. Records of reportable
complications should be in writing and should include:
1. physician’s name and license number;
2. date and time of the occurrence;
3. office where the occurrence took place;
4. name and address of the patient;
5. surgical or special procedure involved;
6. type and dosage of sedation or anesthesia utilized in the procedure; and
7. circumstances involved in the occurrence.
Equipment Maintenance
All anesthesia-related equipment and monitors should be maintained to
current operating room standards. All devices should have regular service/
maintenance checks at least annually or per manufacturer recommenda-tions.
Service/maintenance checks should be performed by appropriately
qualified biomedical personnel. Prior to the administration of anesthesia, all
equipment/monitors should be checked using the current FDA recommen-dations
as a guideline. Records of equipment checks should be maintained
in a separate, dedicated log which must be made available to the Board upon
request. Documentation of any criteria deemed to be substandard should
include a clear description of the problem and the intervention. If equip-ment
is utilized despite the problem, documentation should clearly indicate
that patient safety is not in jeopardy.
The emergency supplies should be maintained and inspected by qualified
personnel for presence and function of all appropriate equipment and drugs
at intervals established by protocol to ensure that equipment is functional and
present, drugs are not expired, and office personnel are familiar with equip-ment
and supplies. Records of emergency supply checks should be maintained
in a separate, dedicated log and made available to the Board upon request.
A physician should not permit anyone to tamper with a safety system or
any monitoring device or disconnect an alarm system.
Compliance with Relevant Health Laws
Federal and state laws and regulations that affect the practice should be
identified and procedures developed to comply with those requirements.
Nothing in this position statement affects the scope of activities subject to
or exempted from the North Carolina health care facility licensure laws.
Patient Rights
Office personnel should be informed about the basic rights of patients
and understand the importance of maintaining patients’ rights. A patients’
rights document should be readily available upon request.
Enforcement
In that the Board believes that these guidelines constitute the accepted and
prevailing standards of practice for office-based procedures in North Caro-lina,
failure to substantially comply with these guidelines creates the risk of
disciplinary action by the Board.
Level II Guidelines
Personnel
The physician who performs the surgical or special procedure or a health
care professional who is present during the intraoperative and postoperative
periods should be ACLS certified, and at least one other health care profes-sional
should be BCLS certified. In an office where anesthesia services are
provided to infants and children, personnel should be appropriately trained
to handle pediatric emergencies (i.e., APLS or PALS certified).
Recovery should be monitored by a registered nurse or other health care
professional practicing within the scope of his or her license or certification
who is BCLS certified and has the capability of administering medications as
required for analgesia, nausea/vomiting, or other indications.
Surgical or Special Procedure Guidelines
Intraoperative Care and Monitoring
The physician who performs Level II procedures that require conscious
sedation in an office should ensure that monitoring is provided by a separate
health care professional not otherwise involved in the surgical or special
procedure. Monitoring should include, when clinically indicated for the
patient:
• direct observation of the patient and, to the extent practicable, observation
of the patient’s responses to verbal commands;
• pulse oximetry should be performed continuously (an alternative method
of measuring oxygen saturation may be substituted for pulse oximetry
if the method has been demonstrated to have at least equivalent clinical
effectiveness);
• an electrocardiogram monitor should be used continuously on the patient;
• the patient’s blood pressure, pulse rate, and respirations should be mea-sured
and recorded at least every five minutes; and
• the body temperature of a pediatric patient should be measured continuously.
Clinically relevant findings during intraoperative monitoring should be
documented in the patient’s medical record.
Postoperative Care and Monitoring
The physician who performs the surgical or special procedure should
evaluate the patient immediately upon completion of the surgery or special
procedure and the anesthesia.
Care of the patient may then be transferred to the care of a qualified health
care professional in the recovery area. A registered nurse or other health care
professional practicing within the scope of his or her license or certification
and who is BCLS certified and has the capability of administering medica-tions
as required for analgesia, nausea/vomiting, or other indications should
monitor the patient postoperatively.
At least one health care professional who is ACLS certified should be
immediately available until all patients have met discharge criteria. Prior
to leaving the operating room or recovery area, each patient should meet
discharge criteria.
Monitoring in the recovery area should include pulse oximetry and
non-invasive blood pressure measurement. The patient should be assessed
periodically for level of consciousness, pain relief, or any untoward complica-tion.
Clinically relevant findings during post-operative monitoring should be
documented in the patient’s medical record.
Equipment and Supplies
Unless another availability standard is clearly stated, the following equip-ment
and supplies should be present in all offices where Level II procedures
are performed:
1. Full and current crash cart at the location where the anesthetizing is being
carried out. (the crash cart inventory should include appropriate resusci-tative
equipment and medications for surgical, procedural or anesthetic
complications);
2. age-appropriate sized monitors, resuscitative equipment, supplies, and
medication in accordance with the scope of the surgical or special proce-dures
and the anesthesia services provided;
3. emergency power source able to produce adequate power to run required
equipment for a minimum of two (2) hours;
4. electrocardiographic monitor;
5. noninvasive blood pressure monitor;
6. pulse oximeter;
7. continuous suction device;
8. endotracheal tubes, laryngoscopes;
9. positive pressure ventilation device (e.g., Ambu);
10. reliable source of oxygen;
11. emergency intubation equipment;
12. adequate operating room lighting;
13. appropriate sterilization equipment; and
14. IV solution and IV equipment.
Level III Guidelines
Personnel
Anesthesia should be administered by an anesthesiologist or a CRNA
supervised by a physician. The physician who performs the surgical or special
procedure should not administer the anesthesia. The anesthesia provider
should not be otherwise involved in the surgical or special procedure.
The physician or the anesthesia provider should be ACLS certified, and at
least one other health care professional should be BCLS certified. In an office
where anesthesia services are provided to infants and children, personnel
should be appropriately trained to handle pediatric emergencies (i.e., APLS
or PALS certified).
Surgical or Special Procedure Guidelines
Intraoperative Monitoring
The physician who performs procedures in an office that require major
conduction blockade, deep sedation/analgesia, or general anesthesia should
ensure that monitoring is provided as follows when clinically indicated for
the patient:
• direct observation of the patient and, to the extent practicable, observa-tion
of the patient’s responses to verbal commands;
• pulse oximetry should be performed continuously. Any alternative
method of measuring oxygen saturation may be substituted for pulse
oximetry if the method has been demonstrated to have at least equivalent
clinical effectiveness;
• an electrocardiogram monitor should be used continuously on the
patient;
• the patient’s blood pressure, pulse rate, and respirations should be mea-sured
and recorded at least every five minutes;
• monitoring should be provided by a separate health care professional not
otherwise involved in the surgical or special procedure;
• end-tidal carbon dioxide monitoring should be performed on the patient
continuously during endotracheal anesthesia;
• an in-circuit oxygen analyzer should be used to monitor the oxygen
concentration within the breathing circuit, displaying the oxygen percent
of the total inspiratory mixture;
• a respirometer (volumeter) should be used to measure exhaled tidal
volume whenever the breathing circuit of a patient allows;
• the body temperature of each patient should be measured continuously; and
• an esophageal or precordial stethoscope should be utilized on the patient.
Clinically relevant findings during intraoperative monitoring should be
documented in the patient’s medical record.
Postoperative Care and Monitoring
The physician who performs the surgical or special procedure should
evaluate the patient immediately upon completion of the surgery or special
procedure and the anesthesia.
Care of the patient may then be transferred to the care of a qualified
health care professional in the recovery area. Qualified health care pro-fessionals
capable of administering medications as required for analge-sia,
nausea/vomiting, or other indications should monitor the patient
postoperatively.
Recovery from a Level III procedure should be monitored by an ACLS
certified (PALS or APLS certified when appropriate) health care professional
using appropriate criteria for the level of anesthesia. At least one health care
professional who is ACLS certified should be immediately available during
postoperative monitoring and until the patient meets discharge criteria.
Each patient should meet discharge criteria prior to leaving the operating or
recovery area.
Monitoring in the recovery area should include pulse oximetry and
non-invasive blood pressure measurement. The patient should be assessed
periodically for level of consciousness, pain relief, or any untoward compli-cation.
Clinically relevant findings during postoperative monitoring should
be documented in the patient’s medical record.
Equipment and Supplies
Unless another availability standard is clearly stated, the following equip-ment
and supplies should be present in all offices where Level III procedures
are performed:
1. full and current crash cart at the location where the anesthetizing is being
carried out (the crash cart inventory should include appropriate resusci-tative
equipment and medications for surgical, procedural or anesthetic
complications);
2. age-appropriate sized monitors, resuscitative equipment, supplies, and
medication in accordance with the scope of the surgical or special proce-dures
and the anesthesia services provided;
3. emergency power source able to produce adequate power to run required
equipment for a minimum of two (2) hours;
4. electrocardiographic monitor;
5. noninvasive blood pressure monitor;
6. pulse oximeter;
7. continuous suction device;
8. endotracheal tubes, and laryngoscopes;
9. positive pressure ventilation device (e.g., Ambu);
10. reliable source of oxygen;
11. emergency intubation equipment;
12. adequate operating room lighting;
13. appropriate sterilization equipment;
14. IV solution and IV equipment;
15. sufficient ampules of dantrolene sodium should be emergently
available;
16. esophageal or precordial stethoscope;
17. emergency resuscitation equipment;
18. temperature monitoring device;
19. end tidal CO2 monitor (for endotracheal anesthesia); and
20. appropriate operating or procedure table.
Definitions
AAAASF – the American Association for the Accreditation of Ambulatory Surgery Facilities.
AAAHC – the Accreditation Association for Ambulatory Health Care
ABMS – the American Board of Medical Specialties
ACGME – the Accreditation Council for Graduate Medical Education
ACLS certified – a person who holds a current “ACLS Provider” credential certifying that
POSITION STATEMENTS
they have successfully completed the national cognitive and skills evaluations in accordance
with the curriculum of the American Heart Association for the Advanced Cardiovascular
Life Support Program.
Advanced cardiac life support certified – a licensee that has successfully completed
and recertified periodically an advanced cardiac life support course offered by a recognized
accrediting organization appropriate to the licensee’s field of practice. For example, for those
licensees treating adult patients, training in ACLS is appropriate; for those treating children,
training in PALS or APLS is appropriate.
Ambulatory surgical facility – a facility licensed under Article 6, Part D of Chapter 131E
of the North Carolina General Statutes or if the facility is located outside North Carolina,
under that jurisdiction’s relevant facility licensure laws.
Anesthesia provider – an anesthesiologist or CRNA.
Anesthesiologist – a physician who has successfully completed a residency program in
anesthesiology approved by the ACGME or AOA, or who is currently a diplomate of either
the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiol-ogy,
or who was made a Fellow of the American College of Anesthesiology before 1982.
AOA – the American Osteopathic Association
APLS certified – a person who holds a current certification in advanced pediatric life sup-port
from a program approved by the American Heart Association.
Approved accrediting agency or organization – a nationally recognized accrediting
agency (e.g., AAAASF; AAAHC, JCAHO, and HFAP) including any agency approved by the
Board.
ASA – the American Society of Anesthesiologists
BCLS certified – a person who holds a current certification in basic cardiac life support
from a program approved by the American Heart Association.
Board – the North Carolina Medical Board.
Conscious sedation – the administration of a drug or drugs in order to induce that state
of consciousness in a patient which allows the patient to tolerate unpleasant medical proce-dures
without losing defensive reflexes, adequate cardio-respiratory function and the ability
to respond purposefully to verbal command or to tactile stimulation if verbal response is not
possible as, for example, in the case of a small child or deaf person. Conscious sedation does
not include an oral dose of pain medication or minimal pre-procedure tranquilization such
as the administration of a pre-procedure oral dose of a benzodiazepine designed to calm the
patient. “Conscious sedation” should be synonymous with the term “sedation/analgesia” as
used by the American Society of Anesthesiologists.
Credentialed – a physician that has been granted, and continues to maintain, the privilege
by a hospital or ambulatory surgical facility licensed in the jurisdiction in which it is located
to provide specified services, such as surgical or special procedures or the administration
of one or more types of anesthetic agents or procedures, or can show documentation of
adequate training and experience.
CRNA – a registered nurse who is authorized by the North Carolina Board of Nursing to
perform nurse anesthesia activities.
Deep sedation/analgesia – the administration of a drug or drugs which produces
depression of consciousness during which patients cannot be easily aroused but can respond
purposefully following repeated or painful stimulation. The ability to independently main-tain
ventilatory function may be impaired. Patients may require assistance in maintaining a
patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is
usually maintained.
FDA – the Food and Drug Administration.
General anesthesia – a drug-induced loss of consciousness during which patients are
not arousable, even by painful stimulation. The ability to independently maintain ventila-tory
function is often impaired. Patients often require assistance in maintaining a patent
airway, and positive pressure ventilation may be required because of depressed spontaneous
ventilation or drug-induced depression of neuromuscular function. Cardiovascular function
may be impaired.
Health care professional – any office staff member who is licensed or certified by a
recognized professional or health care organization.
HFAP – the Health Facilities Accreditation Program, a division of the AOA.
Hospital – a facility licensed under Article 5, Part A of Chapter 131E of the North Carolina
General Statutes or if the facility is located outside North Carolina, under that jurisdiction’s
relevant facility licensure laws.
Immediately available – within the office.
JCAHO – the Joint Commission for the Accreditation of Health Organizations
Level I procedures – any surgical or special procedures:
a. that do not involve drug-induced alteration of consciousness;
b. where preoperative medications are not required or used other than minimal preop-erative
tranquilization of the patient (anxiolysis of the patient) ;
c. where the anesthesia required or used is local, topical, digital block, or none; and
d. where the probability of complications requiring hospitalization is remote.
Level II procedures – any surgical or special procedures:
a. that require the administration of local or peripheral nerve block, minor conduction
blockade, Bier block, minimal sedation, or conscious sedation; and
b. where there is only a moderate risk of surgical and/or anesthetic complications and
the need for hospitalization as a result of these complications is unlikely.
Level III procedures – any surgical or special procedures:
a. that require, or reasonably should require, the use of major conduction blockade,
deep sedation/analgesia, or general anesthesia; and
b. where there is only a moderate risk of surgical and/or anesthetic complications and
the need for hospitalization as a result of these complications is unlikely.
Local anesthesia – the administration of an agent which produces a transient and
reversible loss of sensation in a circumscribed portion of the body.
Major conduction blockade – the injection of local anesthesia to stop or prevent a
painful sensation in a region of the body. Major conduction blocks include, but are not
limited to, axillary, interscalene, and supraclavicular block of the brachial plexus; spinal
(subarachnoid), epidural and caudal blocks.
Minimal sedation (anxiolysis) – the administration of a drug or drugs which
produces a state of consciousness that allows the patient to tolerate unpleasant medical
procedures while responding normally to verbal commands. Cardiovascular or respiratory
function should remain unaffected and defensive airway reflexes should remain intact.
Minor conduction blockade – the injection of local anesthesia to stop or prevent a
painful sensation in a circumscribed area of the body (i.e., infiltration or local nerve block),
or the block of a nerve by direct pressure and refrigeration. Minor conduction blocks in-clude,
but are not limited to, intercostal, retrobulbar, paravertebral, peribulbar, pudendal,
sciatic nerve, and ankle blocks.
Monitoring – continuous, visual observation of a patient and regular observation of the
patient as deemed appropriate by the level of sedation or recovery using instruments to
measure, display, and record physiologic values such as heart rate, blood pressure, respira-tion
and oxygen saturation.
Office – a location at which incidental, limited ambulatory surgical procedures are per-formed
and which is not a licensed ambulatory surgical facility pursuant to Article 6, Part
D of Chapter 131E of the North Carolina General Statutes.
Operating room – that location in the office dedicated to the performance of surgery or
special procedures.
OSHA – the Occupational Safety and Health Administration.
PALS certified – a person who holds a current certification in pediatric advanced life
support from a program approved by the American Heart Association.
Physical status classification – a description of a patient used in determining if an
office surgery or procedure is appropriate. For purposes of these guidelines, ASA clas-sifications
will be used. The ASA enumerates classification: I-normal, healthy patient;
II-a patient with mild systemic disease; III a patient with severe systemic disease limiting
activity but not incapacitating; IV-a patient with incapacitating systemic disease that is
a constant threat to life; and V-moribund, patients not expected to live 24 hours with or
without operation.
Physician – an individual holding an MD or DO degree licensed pursuant to the NC
Medical Practice Act and who performs surgical or special procedures covered by these
guidelines.
Reasonable Proximity-The Board recognizes that reasonable proximity is a somewhat
ambiguous standard. The Board believes that the standard often used by hospitals of thirty
(30) minutes travel time is a useful benchmark.
Recovery area – a room or limited access area of an office dedicated to providing medi-cal
services to patients recovering from surgical or special procedures or anesthesia.
Reportable complications – untoward events occurring at any time within forty-eight
(48) hours of any surgical or special procedure or the administration of anesthesia in an
office setting including, but not limited to, any of the following: paralysis, nerve injury,
malignant hyperthermia, seizures, myocardial infarction, pulmonary embolism, renal
failure, significant cardiac events, respiratory arrest, aspiration of gastric contents, cerebral
vascular accident, transfusion reaction, pneumothorax, allergic reaction to anesthesia,
unintended hospitalization for more than twenty-four (24) hours, or death.
Special procedure – patient care that requires entering the body with instruments in a
potentially painful manner, or that requires the patient to be immobile, for a diagnostic or
therapeutic procedure requiring anesthesia services; for example, diagnostic or therapeu-tic
endoscopy; invasive radiologic procedures, pediatric magnetic resonance imaging; ma-nipulation
under anesthesia or endoscopic examination with the use of general anesthesia.
Surgical procedure – the revision, destruction, incision, or structural alteration of
human tissue performed using a variety of methods and instruments and includes the
operative and non-operative care of individuals in need of such intervention, and demands
pre-operative assessment, judgment, technical skill, post-operative management, and
follow-up.
Topical anesthesia – an anesthetic agent applied directly or by spray to the skin or
mucous membranes, intended to produce a transient and reversible loss of sensation to a
circumscribed area.
[A Position Statement on Office-Based Surgery was adopted by the Board on
September 2000. The statement above (Adopted January 2003) replaces
that statement.] (Anended May 2011)
LASER SURGERY
It is the position of the North Carolina Medical Board that the revi-sion,
destruction, incision, or other structural alteration of human tissue
using laser technology is surgery.* Laser surgery should be performed
only by a physician or by a licensed health care practitioner working
within his or her professional scope of practice and with appropriate
medical training functioning under the supervision, preferably on-site, of
a physician or by those categories of practitioners currently licensed by
this state to perform surgical services.
Licensees should use only devices approved by the U.S. Food and
Drug Administration unless functioning under protocols approved by in-stitutional
review boards. As with all new procedures, it is the licensee’s
responsibility to obtain adequate training and to make documentation of
this training available to the North Carolina Medical Board on request.
Laser Hair Removal
Lasers are employed in certain hair-removal procedures, as are vari-ous
devices that (1) manipulate and/or pulse light causing it to penetrate
POSITION STATEMENTS
FORUM | Winter 2012 15
human tissue and (2) are classified as “prescription” by the U.S. Food and
Drug Administration. Hair-removal procedures using such technologies
should be performed only by a physician or by an individual designated
as having adequate training and experience by a physician who bears full
responsibility for the procedure. The physician who provides medical
supervision is expected to provide adequate oversight of licensed and non-licensed
personnel both before and after the procedure is performed. The
Board believes that the guidelines set forth in this Position Statement are
applicable to every licensee of the Board involved in laser hair removal,
whether as an owner, medical director, consultant or otherwise.
It is the position of the Board that good medical practice requires that
each patient be examined by a physician, physician assistant or nurse
practitioner licensed or approved by this Board prior to receiving the first
laser hair removal treatment and at other times as medically indicated.
The examination should include a history and a focused physical examina-tion.
Where prescription medication such as topical anesthetics are used,
the Board expects physicians to follow the guidelines set forth in the
Board’s Position Statement titled “Contact with Patients Before Prescrib-ing.”
When medication is prescribed or dispensed in connection with laser
hair removal, the supervising physician shall assure the patient receives
thorough instructions on the safe use or application of said medication.
The responsible supervising physician should be on site or readily avail-able
to the person actually performing the procedure. What constitutes
“readily available” will depend on a variety of factors. Those factors
include the specific types of procedures and equipment used; the level of
training of the persons performing the procedure; the level and type of
licensure, if any, of the persons performing the procedure; the use of topi-cal
anesthetics; the quality of written protocols for the performance of the
procedure; the frequency, quality and type of ongoing education of those
performing the procedures; and any other quality assurance measures in
place. In all cases, the Board expects the physician to be able to respond
quickly to patient emergencies and questions by those performing the
procedures.
*Definition of surgery as adopted by the NCMB, November 1998:
Surgery, which involves the revision, destruction, incision, or structural
alteration of human tissue performed using a variety of methods and
instruments, is a discipline that includes the operative and non-operative
care of individuals in need of such intervention, and demands pre-opera-tive
assessment, judgment, technical skills, post-operative management,
and follow up.(Adopted July 1999) (Amended January 2000; March 2002;
August 2002; July 2005)
CARE OF PATIENT UNDERGOING SURGERY OR OTHER
INVASIVE PROCEDURE*
The evaluation, diagnosis, and care of the surgical patient is primarily
the responsibility of the surgeon. He or she alone bears responsibility for
ensuring the patient undergoes a preoperative assessment appropriate to the
procedure. The assessment shall include a review of the patient’s data and
an independent diagnosis by the operating surgeon of the condition requir-ing
surgery. The operating surgeon shall have a detailed discussion with
each patient regarding the diagnosis and the nature of the surgery, advising
the patient fully of the risks involved. It is also the responsibility of the oper-ating
surgeon to reevaluate the patient immediately prior to the procedure.
It is the responsibility of the operating surgeon to assure safe and readily
available postoperative care for each patient on whom he or she performs
surgery. It is not improper to involve other licensed health care practitioners
in postoperative care so long as the operating surgeon maintains responsibil-ity
for such care. The postoperative note must reflect the findings encoun-tered
in the individual patient and the procedure performed.
When identical procedures are done on a number of patients, individual
notes should be done for each patient that reflect the specific findings and
procedures of that operation.
(Invasive procedures includes, but is not limited to, endoscopies, cardiac
catheterizations, interventional radiology procedures, etc. Surgeon refers to
the provider performing the procedure )
*This position statement was formerly titled, “Care of the Surgical Patients.”
(Adopted September 1991) (Amended March 2001, September 2006)
HIV/HVB INFECTED HEALTH CARE WORKERS
The North Carolina Medical Board supports and adopts the following
rules of the North Carolina Department of Health and Human Services
regarding infection control in health care settings and HIV/HBV infected
health care workers.
10A NCAC 41A .0206: INFECTION CONTROL—
HEALTH CARE SETTINGS
(a) The following definitions shall apply throughout this Rule:
(1) “Health care organization” means hospital; clinic; physician, dentist, podia-trist,
optometrist, or chiropractic office; home health agency; nursing home;
local health department; community health center; mental health agency;
hospice; ambulatory surgical center; urgent care center; emergency room; or
any other health care provider that provides clinical care.
(2) “Invasive procedure” means entry into tissues, cavities, or organs or repair
of traumatic injuries. The term includes the use of needles to puncture skin,
vaginal and cesarean deliveries, surgery, and dental procedures during which
bleeding occurs or the potential for bleeding exists.
(b) Health care workers, emergency responders, and funeral service personnel
shall follow blood and body fluid precautions with all patients.
(c) Health care workers who have exudative lesions or weeping dermatitis shall
refrain from handling patient care equipment and devices used in performing
invasive procedures and from all direct patient care that involves the potential for
contact of the patient, equipment, or devices with the lesion or dermatitis until the
condition resolves.
(d) All equipment used to puncture skin, mucous membranes, or other tissues
in medical, dental, or other settings must be disposed of in accordance with 10A
NCAC 36B after use or sterilized prior to reuse.
(e) In order to prevent transmission of HIV and hepatitis B from health care work-ers
to patients, each health care organization that performs invasive procedures
shall implement a written infection control policy. The health care organization
shall ensure that health care workers in its employ or who have staff privileges
are trained in the principles of infection control and the practices required by the
policy; require and monitor compliance with the policy; and update the policy as
needed