NORTH CAROLINA RESPIRATORY CARE BOARD RALEIGH, NORTH CAROLINA
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1 NORTH CAROLINA RESPIRATORY CARE BOARD RALEIGH, NORTH CAROLINA IN RE: REQUEST FOR DECLARATORY ) RULING REGARDING CARE PROVIDED BY ) DECLARATORY RULING CHILDREN S HYPERBARIC CENTER, LLC ) I, Joseph Coyle, as Chair of the North Carolina Respiratory Care Board (the Board ), and based on a resolution by the Board of this date, duly adopted pursuant to N.C. Gen. Stat. 150B-4, do hereby issue this declaratory ruling. This declaratory ruling will interpret N.C. Gen. Stat (10) and (1) in regard to the activities of Children s Hyperbaric Center, LLC of Creston, NC. Mr. Tony Hartsoe, the attorney representing Children s Hyperbaric Center, LLC of Creston, NC has provided the facts on which this ruling is based. This ruling is binding upon the Board so long as the facts that the Board deems to be material are accurately stated, but the ruling only pertains to this request. The Board also reserves the right, prospectively, to change the conclusions which are contained in this ruling. Mr. Hartsoe has asked the Board to address the following questions: 1. Is all administration of oxygen using a hyperbaric oxygen chamber included in the meaning of N.C. Gen. Stat (10)(e), including SCUBA diving instruction, paramedic and other rescue training and certification, or recreational use by individuals, so as to require a licensed respiratory care therapist to be involved in all such applications? If not, what exactly does that definition include and exclude? More specifically, does that definition include Children s Hyperbaric Center, LLC s operations, making it subject to the licensure requirements of Chapter 90? 2. May a licensed respiratory therapist operate a hyperbaric oxygen chamber without obtaining more training than is currently required by the licensure requirements of the Respiratory Care Practice Act? If no, exactly what additional training is required and what standards were used in setting such requirements? 3. Does Children s Hyperbaric Center, LLC qualify for exemption from licensure under N.C. Gen. Stat (1) where a licensed physician serves as its "Medical Director," no person receives services without a prescription from their own personal physician, and the pressure in the chamber is substantially less than that used in traditional hyperbaric oxygen therapy used to treat wounds and other medical conditions?
2 FACTUAL BASIS FOR THE RULING Based on information submitted by Mr. Hartsoe, Children s Hyperbaric Center, LLC provides the following services: Patient assessment; Hyperbaric Oxygen Therapy for treatment of Neurologic disorders ; and Patient education related to HBOT. The services provided at Children s Hyperbaric Center, LLC were provided by individuals who were trained on the job and/or a by Nursing Assistant up until October , at which time Mr. Hartsoe states the facility was closed until the Board could make a ruling. GENERAL CONCLUSIONS ON THE QUESTIONS POSED The Board has reviewed the information provided and concludes that the administration of oxygen using a hyperbaric oxygen chamber is included in the meaning of N.C. Gen. Stat (10)(e) and requires a licensed respiratory care therapist to be involved in all such applications except for the specific and limited exemptions identified in this ruling. The Board further concludes that Children s Hyperbaric Center s operations are subject to the licensure requirements of the Respiratory Care Practice Act. In response to Mr. Hartsoe s second question, the Board concludes that a licensed respiratory care practitioner may only operate a hyperbaric oxygen chamber if he/she is competent to do so and has documented training and competency to perform Hyperbaric Oxygen Therapy (HBOT). It is a violation of Board rules (21 NCAC (12) for a RCP to accept and perform professional responsibilities which the licensee knows or has reason to know that he is not competent to perform. In response to Mr. Hartsoe s third question relating to the involvement of a physician at Children s Hyperbaric Center, LLC Children s Hyperbaric Center, LLC, the designation of a physician as medical director does not qualify for exemption from application of The Respiratory Care Practice Act under (1). In order to be exempt under this provision due to the involvement of a physician, the physician would be required to provide or operate the service as part of the physician s practice, or the relationship of the physician to Children s Hyperbaric Center, LLC Children s Hyperbaric Center, LLC would need to be one in which the physician is in a position to supervise directly the operations of the facility, and to be on the premises of the facility during any HBOT procedure and fully accountable for its operations. DISCUSSION OF APPLICABLE EXEMPTIONS FROM LICENSURE The provisions of N.C. Gen. Stat (1) essentially exempt individuals identified from the requirements of the North Carolina Respiratory Care Practice Act. In order to come within the exemption granted under this provision, a person must meet each of several different criteria: The person must be registered, certified, credentialed, or licensed to engage in another profession or occupation in this State, or must be working under the supervision of such a person ; The person must be performing work incidental to or within the practice of that profession or occupation; and The person may not represent himself or herself as a respiratory care practitioner. 2
3 The Board has reviewed and analyzed each of these requirements as they pertain to the administration of Hyperbaric Oxygen Therapy. The first requirement addresses whether an individual is engaged in a profession or occupation that is sufficiently well-defined by virtue of some registration, certification, credentialing, or licensing. The Board notes that the General Assembly chose to recognize several different ways in which such a distinct profession or occupation could be defined. It did not require that the distinct profession or occupation should itself also be subject to professional licensure under the North Carolina Regional Statutes. The additional references to registration, certification, or credentialing clearly imply a legislative intent to exempt more activities than those for which there is a licensing requirement in the North Carolina Regional Statutes. Thus, in analyzing this part of the exemption provision in N.C. Gen. Stat (1), the Board may not require that the profession or occupation in question demonstrate that it is subject to State licensing in order to be exempt. The National Board of Diving Medical Technology (NBDMT) administers an examination that tests competency based upon national job analysis data about the tasks performed by Hyperbaric Oxygen Technologists. Certified Hyperbaric Technologist (CHT) and Certified Hyperbaric Registered Nurse (CHRN) are credentialed by the NBDMT. The typical procedures performed by CHT s and CHRN s include use of Hyperbaric Oxygen therapy for the treatment of: 1. Acute carbon monoxide intoxication, 2. Decompression illness, 3. Gas embolism, 4. Gas gangrene, 5. Acute traumatic peripheral ischemia. HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened, 6. Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened,. 7. Progressive necrotizing infections (necrotizing fasciitis), 8. Acute peripheral arterial insufficiency, 9. Preparation and preservation of compromised skin grafts (not for primary management of wounds), 10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management, 11. Osteoradionecrosis as an adjunct to conventional treatment, 12. Soft tissue radionecrosis as an adjunct to conventional treatment, 13. Cyanide poisoning, 14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment. The NBDMT compiles certification examinations based upon demonstrated skills in performing these tasks, and these examinations include test questions that are specifically designed to measure competent job performance in each of the above-listed practice functions. In order to be credentialed as a Certified Hyperbaric Technologist or Certified Hyperbaric Registered Nurse, a candidate must achieve a passing score on the exam; and successful candidates receive a certificate issued by the NBDMT, confirming their successful completion of the examination. Only persons who have successfully completed the certification examination hold the CHT or CHRN credential. 3
4 Hyperbaric Oxygen Technologist trainees follow a defined course of study covering the skills and knowledge needed to pass the Examinations during their period of training. While training, they function under the direct supervision of a Certified Hyperbaric Technologist (CHT), a Certified Hyperbaric Registered Nurse (CHRN) or a licensed Respiratory Care Practitioner (RCP). A person who holds the CHT or CHRN credential has successfully completed the Examination(s) and has therefore been certified as competent and credentialed to perform each of the numerated services listed. Viewed in this light, the Board concludes that a person who has passed the Certification Exam for Certified Hyperbaric Technologist or Certified Hyperbaric Registered Nurse that is administered by the NBDMT and has been credentialed has demonstrated that he or she is credentialed to carry on a distinct occupation, within the meaning of N.C. Gen. Stat (1). All of the activities of the Hyperbaric Oxygen Technologist or trainee at Children s Hyperbaric Center, LLC Children s Hyperbaric Center, LLC would occur in the clinical environment of an HBOT facility with the ongoing direction provided by a qualified Medical Director, and in an area established for the provision of these services. Based on the information provided, the practice functions performed by each Hyperbaric Oxygen Technologist or trainee at Children s Hyperbaric Center, LLC Children s Hyperbaric Center, LLC would include the treatment of Neurologic disorders such as Cerebral Palsy, Brain Injury, Peri-Ventricular Leucomalacia and Stroke. Although these practice functions do not relate directly to areas covered by the National Board of Diving Medical Technology Certification Exams, the Board has determined not to address whether or not HBOT is effective in the treatment of Neurologic disorders. The Board has concluded that the performance of these functions by a credentialed Hyperbaric Technologist at Children s Hyperbaric Center, LLC Children s Hyperbaric Center, LLC is within the scope of the statutory exemption. By the same token, a Hyperbaric Oxygen Technologist trainee, who performs tasks which are part of a defined educational track that is recognized as leading to eligibility to take the Certification Exam, and who works under the direct supervision of a CHT, a CHRN or a Respiratory Care Practitioner licensed by the Board, also is within the scope of the statutory exemption. Under no circumstances would any CHT, CHRN, or trainees, ever represent themselves as respiratory care practitioners, unless they are licensed by this Board. Therefore, under the circumstances based on the information provided, the Board finds that any Hyperbaric Oxygen Technologist who holds the CHT or CHRN credential and performs only the enumerated functions, and who refrains from any representation of being a Respiratory Care Practitioner, has met each of the three requirements outlined in the statutory exemption under N.C. Gen. Stat (1). In addition, any Hyperbaric Oxygen Technologist trainee who is following a recognized course of study leading to eligibility for the Certification Exam and is working at all times under the direct supervision of a Hyperbaric Technologist who holds the CHT or CHRN credential, or a Respiratory Care Practitioner licensed by the Board, also has met each of the three requirements outlined in the statutory exemption under N.C. Gen. Stat (1). However, in keeping with the approach that it has adopted in other declaratory rulings, the Board also concludes that the duration of the time period during which any trainee qualifies for the statutory exemption under N.C. Gen. Stat (1), is two years from the start of training or the date of this ruling, whichever is later. 4
5 The Board has also examined the training of the owners of Children s Hyperbaric Center, LLC and has determined that the training completed by Robert Hartsoe and Sue Hartsoe makes each eligible to sit for the CHT exam given by NBDMT. The Board therefore has determined to allow the Hartsoe s to continue to provide HBOT services for the treatment of Neurologic disorders until April 2, 2004 by which time the Hartsoe s must passed the CHT exam or have hired a CHT, CHRN or trained RCP to provide HBOT services CONCLUSION For the foregoing reasons the North Carolina Respiratory Care Board concludes that pursuant to the current provisions of N.C. Gen. Stat (1), in performing the functions enumerated above, and so long as they do not represent themselves as Respiratory Care Practitioners, neither Hyperbaric Technologists who have passed the Certification Examination, nor Hyperbaric Technologist trainees who are engaged in a course of study as described above, need to be licensed as Respiratory Care Practitioners. This the 2 nd day of April Joseph Coyle, MD Chair North Carolina Respiratory Care Board 5
6 CERTIFICATE OF SERVICE I certify that I have served a copy of the foregoing Declaratory Ruling on the following persons by depositing the copy by certified mail, return receipt requested in an official depository under the exclusive care and custody of the United States Postal Service in the properly addressed postage-paid wrapper. Tony Hartsoe Attorney & Counselor at Law 1068 West Fourth Street Winston-Salem, NC This day of Floyd E. Boyer, RRT, RCP Executive Director North Carolina Respiratory Care Board 6
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