SB 166-LABORATORY SCIENCE PROFESSIONAL LICENSING  2:06:40 PM CHAIR EGAN announced consideration of SB 166, [CSSB 166( ), labeled 27-LS1163\I was before the committee]. 2:07:12 PM TOM OBERMEYER, staff to Senator Bettye Davis, said SB 166 establishes a seven-member board of clinical laboratory science professionals that includes one public member, five members that are licensed by the board (a medical laboratory scientist, a laboratory technician, a medical laboratory assistant, a phlebotomy technician, a public health scientist and (in the CS) a medical laboratory director. He said that SB 166 requires licensing of medical laboratory science professionals under Title 8. Today, medicine is a team effort, which requires the highest quality and coordination of all occupations in provider services. Most health care professions are licensed in Alaska to protect the public and define the scope of practice and training required to engage in them. However, medical laboratory science professionals and radiologic technologists are not licensed, yet they perform the majority of diagnostic testing in Alaska. MR. OBERMEYER said at least 70 percent of laboratory results are used for direct patient care, diagnostic, therapeutic or management decisions and that inaccurate test results by unqualified medical professionals can delay appropriate care and lead to inappropriate or harmful diagnoses or treatments that could result in injury or death. The complexity and importance of laboratory science in modern medicine makes it necessary that medical laboratory personnel possess the qualifications necessary to ensure their professional competence. That is what SB 166 does. The CS also has transition clauses that provide for continuing part-time, full-time and non-resident temporary medical technician workers. SENATOR PASKVAN moved to bring version CSSB 166( ), version 27- LS1163\I, before the committee for discussion purposes. CHAIR EGAN objected for discussion purposes. MR. OBERMEYER explained that the CS would increase the composition of the board from five members to seven; the board will now have five licensed medical laboratory science professionals, the medical laboratory director and one public member. Their scope of practice is set out on pages 3 and 4. He explained that version I of SB 166 increases the initial staggered terms for three members who will serve three years instead of two (the previous M version provided for two members who will serve one year). The number of members on the board was increased as well as the terms staggered to provide for this change. The CS also changes the definition of "medical laboratory science director" to a management director "in charge of personnel and the performance of laboratory tests" (page 8, lines 5-8). MR. OBERMEYER said the medical director also need not be a licensed allopathic physician, which was required in the original version but was changed in version M. The CS deletes the duties of the board to establish continuing education requirements, because another section (830) of this new chapter already covers competency. The CS changes responsibility for examination and licensing from the department to the board. On page 7, lines 16-18, under the list of exemptions from license requirements, number (8) specifies that allopathic physicians or osteopaths with a specialty in pathology will assist in preparing for postmortem examinations. Number (9) provides an exemption for a certified cytotechnologist with a revised list of their duties under the supervision of a physician or osteopath (page 7, lines 19-20). Finally, Mr. Obermeyer said, the CS provides grandfathering for currently employed persons under the applicability section to the licensing requirement on page 8. Grandfathering is limited to two years for those employed in the state for three of the last five years who have documented advanced education, training and experience in lieu of certification by a national credentialing agency (page 8, line 30 to page 9, line 7). The transition section on page 9 says licensing is not required for up to one year following the effective date of the act for a half-time worker with at least 1,040 hours of acceptable medical laboratory testing experience during two of the preceding three calendar years and who submits the documented job descriptions for the positions in which he acquired the experience to the board. It also exempts non-resident workers from certification or the licensing requirement who come into the state on a temporary basis for up to 13 weeks in a 12-month period. That refers back to exemption number (6). 2:14:28 PM He noted that penalties are not included in either versions I, B or M, because the boards under Title 8 already have a number of disciplinary powers including revoking a license and imposing a civil fine not to exceed $5,000. 2:15:02 PM SENATOR MENARD asked how many other states require this type of licensing and if he could share the range of costs for licensing in other states. MR. OBERMEYER said he had some of that information in the office, but the department could better answer those questions. Alaska has 600 to 900 individuals who would fall under this proposal, so it shouldn't be an expensive process for them. SENATOR MENARD said her concern was that medical students incur a tremendous debt for their schooling, and even if the fee is a little more than in other states, it would be just one more negative that would keep someone from coming back to Alaska to work. MR. OBERMEYER again said that the department could respond to that, but his understanding was that this bill avoided a great number of costs. Because the certifying agencies are outside Alaska, this board just checks to make sure these people actually have the hours and qualifications they have submitted, and then they are licensed or not at that point. CHAIR EGAN asked Mr. Hurlburt if he could answer any of Senator Menard's questions. 2:19:34 PM WARD HURLBURT, Director, Division of Public Health, Department of Health and Social Services (DHSS), said some of the specific cost questions could be answered by the Department of Commerce, Community and Economic Development (DCCED). He appreciated the intent to assure quality for laboratory testing, but the Center for Medicare and Medicaid Services (CMMS) states that they regulate all laboratory testing in the country. A hospital lab, for instance, goes through a certification process through either the Joint Commission or the Council of American Pathologists. He explained that CLIA (Clinical Laboratory Improvement Amendments) mandate standards for clinical laboratories in physicians' offices and certain fairly basic tests can have a CLIA waiver. In his experience, those are not just paper requirements but real quality requirements. So he believed that establishing this board could have a potential adverse impact on small physicians' offices, because it might increase costs and make recruitment harder. SENATOR PASKVAN asked what percentage of currently practicing professionals would have to be brought up to speed in two years. MR. HURLBURT replied that he didn't have that information available. Large labs would have the baccalaureate level and technician level (two-year training) technologists, as well as laboratory assistants. The state lab is run by a PhD. A small physician's office would employ people with on-the-job training who use waivered CLIA tests for competency. 2:23:34 PM SENATOR GIESSEL asked why these individuals should fundamentally be licensed. MR. OBERMEYER answered that it was felt that people are supposed to have national standards going through this process and that there really isn't a great deal of control, particularly in offices that have waiver standards (which tends to be the bulk of the testing). He wasn't suggesting that they weren't highly qualified people, but that there are no standards for what they are supposed to be doing. He had asked Heidi Amen from the DHSS and Gloria Tomich, University of Alaska Anchorage, to respond to this issue and to include the number of the types of associate and bachelor degrees that are required. The concept behind it is competency and protection of the public. SENATOR DAVIS added that this bill was requested by those in the profession and their testimony could shed more light on the issue. SENATOR GIESSEL said she would defer to Senator's Davis' recommendation to hear from those individuals. 2:26:12 PM GLORIA TOMICH, University of Alaska Anchorage, said because 70 percent of medical decisions are based on laboratory results, an educated and competent workforce in laboratory testing was needed. This is accomplished through certification. Licensure under this bill does require certification. The goal of licensure is to have more stringent requirements for the performance of laboratory testing that will reduce laboratory errors and increase patient safety. MS. TOMICH said the journal article submitted to the committee gives examples of laboratory errors, particularly in point of care testing. Noncertified testing personnel have a higher rate of error than those who are under the supervision of certified personnel. She said this will not prevent health care providers from hiring noncertified staff but it will require oversight of competency and quality control by licensed personnel who are certified. MS. TOMICH said she believed that all medical personnel working in Alaska should be licensed. It is important for quality laboratory testing, which ultimately results in better patient safety. Currently, in Alaska, most health care professionals except laboratory scientists and radiologic technicians are licensed. 2:28:17 PM She said that 13 states have licensure for laboratory professionals and 25 states are in the process of requiring it. SENATOR GIESSEL asked why have a board if national certification by a recognized credentialing agency or organization is the criteria by which competency is measured. It seems redundant. MS. TOMICH replied that laboratory professionals are certified by the national agency and one of this bill's strong points is that every three years people must provide evidence of continuing education to maintain their certification. She explained that laboratory world is very dynamic; it changes all the time and people need to keep current with it. The current certification requiring continuing education is sufficient to support those who are licensed. SENATOR GIESSEL questioned the need for a regulating board when Ms. Tomich was already saying that this national organization certifies competence and continued competence, MS. TOMICH replied that not all laboratory testing is done by certified personnel and a large number of errors are made by people who are not certified. 2:30:52 PM SENATOR GIESSEL said it's up to the employer to determine the credentials of the individual they are employing to perform certain duties and asked in practical application, if she was requiring that all physician offices hire only certified lab techs. MS. TOMICH responded that the bill doesn't require that all lab techs have certification, but it does require having oversight of quality control and competency, and a consultant could come in and do that oversight. It's a closer monitoring of quality control and competency of the staff that is doing the testing. She clarified that physician office laboratories do point of care testing including CLIA waived tests, but a lot of point of care testing is not waived. SENATOR GIESSEL said the Joint Commission on Accreditations of Healthcare Organizations (JCAHO), the national lab certifying agency, and the CMMS already monitor physician lab operations, and this is all done to verify validity, and asked if this just another hoop that adds cost to the health care system and creates a board that isn't really necessary. MS. TOMICH replied that the Joint Commission and CLIA regulate and license laboratories; however, they don't closely monitor competency, education and continuing education. They don't require continuing education, and they believe that continuing education is very important for laboratory professionals. If someone doesn't know the current protocols, then they won't perform laboratory testing properly. Again, they have testimony from people who have talked about a lot of errors in point of care testing and they are hoping this licensure will cut down on those errors. 2:34:38 PM WILLIE RUMBO, representing himself, Anchorage, said he is a medical technologist and that he opposed SB 166. He agreed that it would raise costs and create another hoop for medical professionals to go through just to be able to practice their jobs. CLIA does create those regulations already; it requires minimum training and education standards. The focus seems to be on point of care testing, but CLIA does require a minimum education standard for that. He explained that point of care testing not only occurs in doctors' offices, but at the hospital and in emergency rooms. Will they require certified technicians to perform testing in emergency rooms and on the floors in hospitals and say this won't raise the cost of medicine? That is preposterous, and they are assuming that everyone who performs point of care testing is somehow incompetent. Twenty of his colleagues also oppose this. He said the Food and Drug Administration regulates them and there is already enough regulation from the federal government. CHAIR EGAN asked if he thought SB 166 was unnecessary. MR. RUMBO replied it is very unnecessary. He reiterated that they are already regulated through the Center for Medicare and Medicaid Services and by the Food and Drug Administration that both require minimum education standards for performing his job, which includes point of care testing. SENATOR PASKVAN asked what education level he had attained. MR. RUMBO replied a Bachelor's Degree in Medical Technology. 2:39:21 PM DON HABEGER, Director, Division of Corporations, Business and Professional Licensing, Department of Commerce, Community and Economic Development (DCCED), commented that currently the fee on page 5, line 9, is established by the division; central licensing requires annual review of revenue and expenses. He explained that essentially, the formula for setting fees has to match approximate revenue and expenses. If the board is setting those fees, it should have a similar standard. Otherwise it may not cover expenses and that would make management of the program difficult. SENATOR GIESSEL said language on page 5, line 5, identifies a three-year licensure duration and asked if other licenses are provided by the division that endure for three years. MR. HABEGER replied the he administers 40 programs and only one, the geologist, has a lifetime license; all others have a two- year bi-annual cycle. 2:41:55 PM SENATOR MENARD asked if the department had a position on this. MR. HABEGER replied no. MR. OBERMEYER said he could see how raising standards could cost more, but if some of the results are not adequately understood, then the public is at risk. CHAIR EGAN thanked them and said he would hold this bill until the next meeting. He asked Hilary Martin if she had any clarifications and found she did not have any comment. [CHAIR EGAN held SB 166 in committee.]