December 1, 2005
REPORT OF THE INJECTIONS CREDENTIALING COMMITTEE
When the North Carolina Optometry Practice Act was amended in 1977 to grant prescriptive authority to properly trained and licensed optometrists to use and prescribe pharmaceutical agents in the diagnosis, treatment and management of diseases of the eye and its adnexa there was no prohibition as to the mode of administration of these agents except that in using or prescribing pharmaceutical agents other than those which are topically prescribed the optometrist was to communicate and collaborate with a licensed physician agreed to by the patient. Within the amended definition only the use of "surgery" was prohibited. Until the law was further amended in 1997 to remove the requirement that an optometrist communicate and collaborate with a licensed physician agreed to by the patient it was the position of the Board of Optometry that an optometrist could prescribe and/or administer pharmaceutical agents for the diagnosis, treatment and management of diseases of the eye and its adnexa either orally or by means of injection if the requirement that communication and collaboration with a licensed physician had taken place. In the fall of 1993 at the request of the North Carolina State Optometric Society the Board furnished the Department of Human Resources a list of CPT Codes representing services that properly certified optometrists were licensed to perform and for which they should be reimbursed under the State's Medicaid Program. Included in this list of codes were a number of Codes which in the opinion of the Board would require the optometrist to "communicate and collaborate" with a physician. Publishing of these codes brought immediate reaction from the Society of Ophthalmology and from the State Medical Society who sought in January 1994 to have the Courts enjoin the Department of Human Resources from approving some 150 of the Codes submitted until the matter could be settled in the Courts. The Board of Optometry was named as one of the respondents in the lawsuit. Because neither the North Carolina Medical Society nor the North Carolina Society of Ophthalmology had a statutory authority to regulate the practice of medicine or to enjoin those engaged in its unauthorized practice, the North Carolina Medical Board was encouraged to join the litigation. Soon after their joining in the lawsuit the Court issued a Temporary Injunction preventing optometrists from performing any of the 150 CPT Codes at issue. Negotiations between the two sides took place over the next several months when finally in June a Settlement Agreement was reached and the injunction dissolved. Among the disputed Codes foreign body removal and the use of punctal plugs were agreed to as being within the lawful scope of optometry. The Agreement was later amended to include the removal of rust rings following foreign body removal. Among the Codes that did not appear on the approved list were those codes representing those injection procedures that were at issue in the recently dismissed lawsuit against the Board of Medicine. In July 2001 the Board passed a resolution that in effect declared that the use of injections by properly trained and licensed optometrists in the diagnosis, treatment and management of diseases of the eye and its adnexa could not be considered as constituting surgery therefore within the lawful scope of practice of optometry in North Carolina. Over the period of 1999 into early 2000 representatives of the Optometry Board met with representatives of the Medical Board to discuss the issue in light of the 1997 amendments to the Optometry Practice Act. Consultants from the Southern College of Optometry were brought in and meaningful discussions took place. In June of 2000 the Medical Board voted to acknowledge (and thus to approve) that the injection procedures that were under discussion (and the subject of the recently settled lawsuit) were within the lawful scope of practice of optometry in North Carolina. Two months later following a storm of protests from the State Medical Society and the Society of Eye Physicians and Surgeons (SEPS), the Ophthalmology Society's new name, the Medical Board rescinded its earlier action and instead formed a committee comprised of representatives from the two Boards, the Optometric Society and SEPS. Meetings over the next year produced no hope of resolving the issue so the committee was dissolved. In July 2001 our Board unanimously passed a resolution that in its opinion the injection procedures represented by the CPT Codes previously under discussion with the Medical Board when performed by properly trained and licensed optometrist was within the lawful scope of the practice of optometry. Further, it was the Board's intention to proceed with establishing educational and training criteria for certifying optometrists to perform the procedures in question. A copy of the resolution was forwarded to the Medical Board immediately upon passage. It was at this point that the Optometry Board reviewed its options and made the decision to bring suit against the Medical Board in an effort to determine that the use of injections was within the scope of optometry and therefore did not constitute the unauthorized practice of medicine. After nearly two years in the Courts that included petitions to intervene in the lawsuit by SEPS and the Medical Society and our request for a Temporary Restraining Order to prevent the Medical Board from issuing a Declaratory Ruling at the request of SEPS and appeals on both issues pending at the Court of Appeals the Medical Board and the Optometry Board agreed to mediation. On July 27, 2005, following some 12 hours of negotiation, representatives of the two Boards signed a memorandum of Settlement drawn by the mediator. On Saturday, August 13, 2005 the Presidents of the two Boards signed the Settlement Agreement agreeing to the use of three injection procedures by properly trained and credentialed optometrists. On Wednesday August 17, 2005 the Optometry Board dismissed its lawsuit against the Medical Board and on Friday , August 19, 2005 the Medical Board and the Medical Society filed motions with the Court to dismiss their appeals, thus ending the litigation. On Tuesday, November 22 the Injection Credentialing Committee met with the "Designee appointed by the Medical Board" in accordance with the Settlement Agreement to review educational requirements and to establish protocols for the credentialing of North Carolina licensed optometrists to perform injections including procedures for the treatment of chalazia, peri-ocular injections and fluorescein angiography.
EDUCATION AND TRAINING
The North Carolina State Board of Optometry has had nearly 30 years of experience in the licensing and regulation of optometrists who gained their initial authority to use and prescribe pharmaceutical agents in the practice of optometry beginning July 1, 1977. Prior the effective date of that historic legislation nearly 300 of the then licensed optometrists qualified to become "certified" to use and prescribe pharmaceutical agents by taking and passing the Pennsylvania College of Optometry's course in "Pharmacology and Therapeutics for the Practicing Optometrist". Over that period the Board has licensed over 1000 additional optometrists to serve the citizens of this state. The responsible use of their prescribing privileges and the level of care rendered to their patients by the nearly 1200 currently licensed optometrists speaks for itself through the lack of any credible evidence that the privileges have been abused or that patient harm has resulted. Malpractice lawsuits have rarely occurred and the Board is not aware of any that were based upon an optometrist's utilizing pharmaceutical agents for the purpose of diagnoses or for prescribing them for a disease or condition of the eye or its adnexa. Contrarily, most involved negligence and the failure to diagnose by failure to properly examine a patient. The removal of the "communication and collaboration" clause in 1997 has made no discernable difference in the safe manner in which optometric services are being rendered. Based upon past experience the Board believes that the utilization of injection procedures by properly trained and licensed optometrists will be in the interest of better and more comprehensive patient care, not unlike the experiences observed following the changes made in the practice act in 1977 and again in 1997. In an effort to bring appropriate education to the practitioner the Board sought input from the Schools and Colleges of Optometry. Two institutions with courses offering training in the use of injections that were designed to be taken to the practitioners in the field were being offered by the Southern College of Optometry in Memphis, Tennessee and by the Pacific College of Optometry in Forest Grove Oregon. After reviewing course outlines from both institutions Southern College of Optometry was chosen to offer an injection course that was intended to form the basis for credentialing North Carolina optometrists to perform injections. Among the reasons for the selection of this institution was its proximity to North Carolina and the large number of their graduates who practice here; and more importantly, the nearly 10 years of experience that the College had in offering this course in Tennessee to Tennessee licensed optometrists following the change in the Tennessee law. It was the successful completion of this course that served as the basis for the Tennessee Board of Optometry's certifying their licensees to utilize those injections that were at issue in this Board's lawsuit in the care of their patients. Over that period the record of patient safety in Tennessee is undisputable with no evidence that harm came to any patient as a result of an optometrist undertaking the use of an injection in their care. To date some 80 North Carolina licensed optometrists have taken and passed this course. Of the 80 nearly 50 took a review course in Asheville earlier this month. At the conclusion of the review course the Board spent sufficient time to appear before the attendees and speak in no uncertain terms that at such time they might become certified to perform injections that the Board would be carefully monitoring their practices and that should there be any evidence that patient safety was in anyway compromised they would face immediate discipline by the Board. Further, that they were not to undertake a procedure unless they were both certain of their diagnosis and confident in their ability to render the treatment. In short "do no harm".
RECOMMENDATIONS OF THE COMMITTEE
The Committee makes the following recommendations to the Board that in certifying North Carolina licensed optometrists to perform injections including injections for the purpose of treating chalazia, peri-ocular injections and in performing fluorescein angiography currently licensed optometrist be required to offer the following credentials to the Board:
•To perform injections including injections for the treatment of chalazia and to perform peri-ocular injections for purposes other than for cosmesis, submit evidence of having successfully completed the course on the use of injections in the diagnosis and treatment of diseases of the eye and its adnexa including the wet lab and final examination offered by the Southern College of Optometry or such other course(s) similar in content and purpose with an examination offered by other institutions of higher learning that might be approved by the Board in the future.
•To perform fluorescein angiography submit evidence of having successfully completed the course on the use of injections in the diagnosis and treatment of diseases of the eye and its adnexa including a wet lab and final examination offered by the Southern College of Optometry or such other course(s) similar in design, content and purpose with an examination offered by other institutions of higher learning that might be approved by the Board in the future and the compliance with the following criteria:
•Submit evidence satisfactory to the Board of current CPR certification or the presence of a staff member similarly certified.
•Submit evidence satisfactory to the Board of current ACLS certification or the presence of a staff similarly certified.
•Confirmation that a Hospital Emergency Room is located within 20 miles or 20 minutes, whichever is less, and 911 access (EMS response service located within 15 miles of practice).
•Offer evidence satisfactory to the Board that the optometrist has made "best efforts" to establish with a physician who will be reasonably available to provide medical assistance in the event of a medical complication during the performance of the procedure.
•Verification of successful completion of a hands-on phlebotomy course by the licensee or by a staff member similarly trained.
•Successful completion of a minimum of 16 hours in a Post-Graduate program provided by an institution of higher learning approved by the Board on fluorescein angiography, said program to include angiogram analysis and interpretation and a written examination.
•Partnering with one or more ophthalmologists deemed by the Board to be proficient in the analysis and interpretation of fluorescein angiograms for a minimum of 30 hours within a 12-month period, seeing at least 30 patients.
OVER-UTILIZATION or INAPPROPRIATE UTILIZATION
•Maintain a log of patients that includes, but is not limited to, diagnosis, adverse side effects (if any) that might occur, disposition and/or follow up. Adverse side effects (if any) are to be reported to the Board within one week of the time they occur.
•Awareness that there will be a random monitoring of utilization by the Board on an annual basis of not less that 10% of those licensees certified to perform the procedure.
STANDARD OF CARE
•Within each five year period following initial certification complete no less than 20 hours of continuing education approved by the Board in subjects directly related to the diagnosis of retinal disease and retinal imaging in order to maintain Board Certification to perform fluorescein angiography.
•Maintain a "crash cart" that includes, but is not limited to:
i. Emesis Basin
ii. Reusable Ice Pack
iv. Ambu Bag
v. BP Cuff
vii. Smelling Salts
ix. Syringes, Needles
c) Diphenhydramine (Benadryl)
d) Hydrocortisone (Solu-Cortef)
e) Metaraminol (Aramine)
f) Promethazine (Phenergan)
•That those North Carolina licensed optometrists who qualify for certification in the performing of injections including peri-ocular injections and injections for the treatment of chalazia and in the practice of optometry be certified on approval of these recommendations by the Board, said certification to take effect on January 1, 2006; further, that proper identification of such certification appear on the license renewal cards of those individuals who are certified for calendar year 2006.
•That those North Carolina licensed optometrists who wish to qualify for certification in the performing of fluorescein angiography be notified of the requirements for certification set forth above. The Committee is not aware of any licensee who would immediately qualify for certification in the performing of the procedure and anticipates that it will take a period of at least 12 months before the Board would be called upon to certify anyone to perform this procedure.
If there are questions or if further information is needed from the Committee, please do not hesitate to call upon us.
Respectfully submitted this 1st day of December, 2005
John D. Robinson, O.D. Member David R. Anderson, O.D. Chairman William B. Rafferty, O.D. Member Jeffery Viscardi, M.D., Member (Designee of the North Carolina Medical Board).
Recommendations of Committee Regarding Certification Adopted on 12/12/2005
Credentialing Educational Track
PURPOSE: The North Carolina State Board of Optometry, with assistance from
the Southern College of Optometry and the North Carolina State Optometric
Society, have developed the following comprehensive credentialing curriculum in
Fluorescein Angiography for the purpose of privileging North Carolina
optometrists to perform this procedure. Successful completion of all parts of
this curriculum is required to achieve initial privileging. Also, compliance
with Board policy is required to maintain privileges. Individual parts of this
curriculum are not intended to be offered as stand alone continuing education
courses for those optometrists who are not seeking Fluorescein Angiography
PART I. GENERAL INJECTIONS COURSE:
Prerequisite: NC Licensed Optometrist (License In Good Standing)
Requirement: Successful completion of one of the General Injection Courses
taught and accredited by Southern College of Optometry (SCO), Memphis, TN.
PART II. CORRESPONDENCE COURSE:
Prerequisite: General Injections Certification Part I Above
Requirement: Practitioners must take and pass the following course:
Pacific University College of Optometry Correspondence Course, “Using
Fluorescein Angiography to Assess Retinal Disease”
This course is available via Internet,
http://www.opt.pacificu.edu/ce/catalog/12059-PS/FA.html Satisfactory completion
of the course requires passing the 30 question post test. A letter certifying
successful completion of the course will be mailed to the NCSBEO 10 days prior
to taking Part II below.
PART III. ON-SITE EDUCATION:
Prerequisite: Successful completion of Correspondence Course Part II Above
Requirement: 16 “certified” hours (2 days) of Interactive didactic, hands-on
workshops with GRs and successful completion of a post course assessment - given
and accredited by SCO
Day 1 - Course 1 – Introduction: 4 Hours (OD and/or MD Experienced in FA)
A. Retinal Anatomy, Circulation & Physiology - 1½ hrs.
B. Characteristics of FA & ICG – ½ hr.
C. Concepts of Pathology – 2 hrs.
-Patterns of Abnormal NaFl Perfusion – Phases & Localization
-Hemorrhages & their location
Day 1 – Course 2 – Interpretation: 4 Hours (OD and/or MD Experienced in FA)
A. Normal FA Circulation and Characteristics – 1 hour
B. Retinal Diseases – Phases – What to Expect - Known Dx – 3 hrs. -Diabetes
-RPE serous detachment
-Retinal ischemia in BRVO/CRVO
Day 2 – Course 3 – Interpretation - Clinical Decision Making/Grand Rounds - Case
Presentations/Challenges: 4 hrs. (MD - Retinologist)
-Retinal Diseases – Interactive GRs - Unknown Dx
-Assessment, Plan & Prognosis
-Referral Decision & Treatment Options
-Communication to Pt.
Day 2 –Course 4 – FA Procedure - Injection Wetlab - Safety - 4 hours
(OD and MD Team)
A. FA Procedure – 1 hr. (OD)
-Set Up & Safety Considerations
-Safety Precautions and Concerns
-Review of Universal Precautions
-Instrument and IV setup
-Instructions to patient
-Preparation for IV Injection & FA
-Actual Procedure - Imaging
B. IV Injections – 1 hr. (OD)
-Maintaining the IV Site
C. Complications Management – 1 hr. (MD)
-Complications & Contraindications of FA
-Extravasations of dye
D. FA: Medical/Legal Considerations and/or Demonstration – 1 hr.
CEE Exam – Web Based Assessment –Completion required within 10 days
PART IV. On-site training w/ Retinologist – 30 Cases
Prerequisite: Part III above)
PART V. ACLS Certification (Acquire and Maintain)
PART VI. NCSBEO Office Inspection/Accreditation
Prerequisite: Parts I – V Above)
(NCSBEO Checklist Evaluation Form)
(PARTS I – VI) Final Accreditation with Privilege License from NCSBEO
Note: Privileges granted to NC ODs to perform FA by the NCSBEO (Board) must be
maintained. In addition to the requirements listed above, the NCSBEO requires
the practitioner to maintain a FA patient log and report any adverse events to
the Board. The Board will monitor no less than 10% of FA privileged optometrists
annually. Also, the Board may require ongoing requirements to maintain
Adopted June 1, 2006