BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 1246| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ UNFINISHED BUSINESS Bill No: SB 1246 Author: Negrete McLeod (D) Amended: 8/2/10 Vote: 21 SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 8-0, 4/12/10 AYES: Negrete McLeod, Wyland, Aanestad, Calderon, Correa, Oropeza, Walters, Yee NO VOTE RECORDED: Florez SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 SENATE FLOOR : 28-0, 5/28/10 AYES: Alquist, Ashburn, Calderon, Cedillo, Corbett, Correa, DeSaulnier, Ducheny, Dutton, Florez, Hollingsworth, Huff, Kehoe, Leno, Liu, Lowenthal, Negrete McLeod, Padilla, Pavley, Price, Romero, Runner, Simitian, Steinberg, Strickland, Wolk, Wyland, Yee NO VOTE RECORDED: Aanestad, Cogdill, Cox, Denham, Hancock, Harman, Oropeza, Walters, Wiggins, Wright, Vacancy, Vacancy ASSEMBLY FLOOR : 78-0, 8/12/10 (Consent) - See last page for vote SUBJECT : Naturopathic medicine SOURCE : California Naturopathic Doctors Association CONTINUED SB 1246 Page 2 DIGEST : This bill includes naturopathic doctors in the list of health care practitioners who could perform a clinical laboratory test or examination classified as waived and defines a naturopathic assistant for purposes of the Naturopathic Doctors Act, and specifies certain functions for naturopathic assistants. Assembly Amendments make technical changes to the duties a naturopathic assistant may perform. ANALYSIS : Existing law: 1. Establishes the Naturopathic Doctors Act, administered by the Naturopathic Medicine Committee (Committee) within the Osteopathic Medical Board of California to regulate the practice of naturopathic medicine. Sunsets the provisions of the Naturopathic Doctors Act on January 1, 2013. 2. Defines naturopathic medicine as a distinct and comprehensive system of primary health care practiced by a naturopathic doctor for the diagnosis, treatment, and prevention of human health conditions, injuries, and disease. 3. Establishes in federal law, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which regulates laboratories when performing testing on human specimens, and includes laboratory standards for proficiency testing, facility administration, personnel qualifications, and quality control. Applies standards to all settings, including commercial, hospital, or physician office laboratories. 4. Defines under CLIA waived tests as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. 5. Establishes within the Department of Public Health (DPH) SB 1246 Page 3 the Laboratory Field Services which provides for licensing and registration services for clinical laboratories, as specified. 6. Requires a clinical laboratory that performs tests that are of moderate or high complexity to be licensed by DPH. Requires a clinical laboratory that performs tests that are of low complexity, also referred to as "waived tests," or that perform provider-performed microscopy, which is microscopic analysis of a specimen by a health care provider such as a physician, to be registered, rather than licensed, by DPH. 7. Defines a clinical laboratory as any establishment or institution operated for the performance of clinical laboratory tests or examinations, or the practical application of clinical laboratory sciences. Requires clinical laboratories to pay fees, as specified, to DPH for the purposes of initial and renewal licensure, registration, or certification. 8. Prohibits anyone from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, and the test is performed by specified persons, including physicians and surgeons, podiatrists, dentists, physician assistant, or respiratory care practitioner. This bill: 1. Includes a licensed naturopathic doctor in the list of persons who could perform a clinical laboratory test or examination classified as waived under CLIA. 2. Includes a naturopathic assistant, as defined, to the list of persons who could perform a clinical laboratory test or examination classified as of moderate complexity if the waived test is performed to a specific authorization meeting specified requirements. 3. Includes in the definition of laboratory director a duly licensed naturopathic doctor for the purposes of a SB 1246 Page 4 clinical laboratory test or examination classified as waived. 4. Defines a naturopathic assistant as a person who may be unlicensed, who performs basic administrative, clerical, and technical supportive services, in compliance with this bill, for a licensed naturopathic doctor or naturopathic corporation and who is at least 18 years of age, and who has had at least the minimum amount of hours of appropriate training pursuant to standards established by the MBC for a medical assistant, as specified. Requires the naturopathic assistant to be issued a certificate by the training institution or instructor indicating satisfactory completion of the required training. Requires a copy of the certificate to be retained as a record by each employer or the naturopathic assistant. 5. Defines naturopathic technical supportive services as simple routine medical tasks and procedures that may be safely performed by a naturopathic assistant who has limited training and who functions under the supervision of a licensed naturopathic doctor. 6. Defines specific authorization as specific written order prepared by the supervising naturopathic doctor authorizing the procedures to be performed on a patient, which shall be placed in the patient's medical record, or a standing order prepared by the supervising naturopathic doctor authorizing the procedures to be performed. Requires a notation of the standing order shall be placed on the patient's medical record. 7. Defines supervision of a naturopathic assistant as the supervision of procedures authorized by a naturopathic doctor, within his/her scope of practice, as specified, and who is physically present in the treatment facility during the performance of those procedures. 8. Authorizes a naturopathic assistant to do all of the following: A. Administer medication only by intradermal, subcutaneous, or intramuscular injections and perform SB 1246 Page 5 skin tests and additional technical support services upon the specific authorization and supervision of a licensed naturopathic doctor. Authorizes a naturopathic assistant to also perform these services at licensed clinics, as specified. B. Perform venipuncture or skin puncture for the purposes of withdrawing blood upon specific authorization and under the supervision of a licensed naturopathic doctor after meeting existing educational and training requirements for medical assistants, as specified. Requires a copy of any related certificates shall be retained as a record by each employer of the assistant. 9. Authorizes a naturopathic assistant to perform the following naturopathic technical support services: A. Administer medications, as specified. Requires that in every instance, prior to administration of medication by the naturopathic assistant, the naturopathic doctor shall verify the correct medication and dosage. B. Apply and remove bandages. C. Collect by noninvasive techniques and preserve specimens for testing, including urine, sputum, semen, and stool. D. Assist patients to and from patient examination room or examination table. E. As authorized by the naturopathic doctor, provide patient information and instructions. F. Collect and record patient data, including height, weight, temperature, pulse, respiration rate, and blood pressure, and basic information about the presenting and previous conditions. G. Perform simple laboratory and screening tests customarily performed in a medical office. SB 1246 Page 6 H. Perform additional naturopathic technical support services under regulations and standards established by the Committee. Requires the Committee, prior to adopting any regulations request recommendations from other public agencies, and professional associations. 10.States that nothing in this bill shall be construed to do the following: A. Authorize the licensure of naturopathic assistants. B. Authorize the administration of local anesthetic agents by a naturopathic assistant. C. Authorize the Naturopathic Medicine Committee to adopt any regulations that violate the prohibition on diagnosis or treatment, as specified. 11.States that a naturopathic assistant may not be employed for inpatient care in a licensed general acute care hospital. Background Scope of Practice, Education and Training Requirements of Naturopathic Doctors . SB 907 (Burton), Chapter 485, Statutes of 2003, established until July 1, 2009, the Naturopathic Doctor Act (Act), to be administered by the Bureau of Naturopathic Medicine within the Department of Consumer Affairs to establish standards for licensure and regulation of naturopathic medicine. AB 20 X4 (Strickland), Chapter 18, Statutes of 2009-10, Fourth Extraordinary Session, abolished the Bureau of Naturopathic Medicine and created the Naturopathic Medicine Committee within the Osteopathic MBC and extended the sunset date of the Act to January 1, 2013. Under the Act, naturopathic doctors may order and perform physical and laboratory examinations for diagnostic purposes, including, but not limited to phlebotomy, clinical laboratory tests, and speculum examinations. A naturopathic doctor may also order diagnostic imaging studies, dispense, administer, order, and prescribe or SB 1246 Page 7 perform the following: food, extracts of food, nutraceuticals, botanical medicines, homeopathic medicines, all dietary supplements, and non-prescription drugs, as specified; hot or cold hydrotherapy and other physical medicine; devices; health education and health counseling; repair and care incidental to superficial lacerations and abrasions; and removal of foreign bodies located in the superficial tissues. The Act also authorizes a naturopathic doctor to furnish or order drugs when the drugs are ordered in accordance with standardized procedures or protocols developed by the naturopathic doctor and his/her supervising physician; the naturopathic doctor is functioning pursuant to standardized procedures and protocols, as specified; the standardized procedure or protocol specify among other things which naturopathic doctor may furnish the drug, which drugs may be furnished; and the furnishing or ordering of drugs occurs under physician and surgeon supervision. The Act also specifies that a physician and surgeon shall not supervise more than four naturopathic doctors at one time. The Act requires the Committee to approve a naturopathic medical education program that has the following minimum requirements: (1) Admission requirements that include a minimum of three-quarters of the credit required for a bachelor's degree, as specified, and (2) a minimum of 4,100 total hours in basic and clinical sciences, naturopathic philosophy, naturopathic modalities, and naturopathic medicine. Not less than 2,500 hours shall consist of academic instruction, and not less than 1,200 hours of supervised clinical training approved by the naturopathic medical school. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No SUPPORT : (Verified 8/10/10) California Naturopathic Doctors Association (source) Osteopathic Physicians & Surgeons of California ARGUMENTS IN SUPPORT : The bill's sponsor, the California Naturopathic Doctors Association, states that a naturopathic doctor's inability to perform CLIA waived SB 1246 Page 8 tests compromises patient safety by delaying tests and their results. This bill would designate naturopathic doctors as laboratory directors for CLIA waived tests only. The sponsor points out that naturopathic doctors in other states are able to perform CLIA waived and moderate complexity tests. Additionally, this bill includes provisions allowing a naturopathic doctor to supervise an assistant which will provide more time for naturopathic doctors to see patients and run a more efficient practice. Currently, private practice naturopathic doctors must perform all simple patient related tasks, such as vitals, taking blood and giving shots. ASSEMBLY FLOOR : AYES: Adams, Ammiano, Anderson, Arambula, Bass, Beall, Bill Berryhill, Tom Berryhill, Blakeslee, Block, Blumenfield, Bradford, Brownley, Buchanan, Caballero, Charles Calderon, Carter, Chesbro, Conway, Cook, Coto, Davis, De La Torre, De Leon, DeVore, Eng, Evans, Feuer, Fletcher, Fong, Fuentes, Fuller, Furutani, Gaines, Galgiani, Garrick, Gatto, Gilmore, Hagman, Hall, Harkey, Hayashi, Hernandez, Hill, Huber, Huffman, Jeffries, Jones, Knight, Lieu, Logue, Bonnie Lowenthal, Ma, Mendoza, Miller, Monning, Nava, Nestande, Niello, Nielsen, V. Manuel Perez, Portantino, Ruskin, Salas, Saldana, Silva, Skinner, Smyth, Solorio, Audra Strickland, Swanson, Torlakson, Torres, Torrico, Tran, Villines, Yamada, John A. Perez NO VOTE RECORDED: Norby, Vacancy JJA:mw 8/16/10 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****