Text Box: Purpose: To provide protection to the public by requiring minimum qualifications of personnel and a high level of professional competency. To provide information about practitioners needed for emergency preparedness and workforce planning. Practice of medical laboratory science has an impact on public health, safety and welfare The professions included in this bill provide vital information for the diagnosis, prevention and treatment of disease and the assessment of health. Current federal regulations (CLIA ’88) provide only very minimal personnel requirements, lower than the standard of practice in MN. The bill includes the following lab professional categories: Medical Laboratory Scientist (terms used in the workplace include Clinical Laboratory Scientist, Medical Technologist) Medical Laboratory Technician (also called clinical laboratory technician) Categorical and Specialist designations for Medical Laboratory Scientist Cytotechnologists Histology technicians and histotechnologists Exemptions to this proposed legislation include: Other licensed professions whose scope of practice includes laboratory testing Medical laboratory science professionals employed by the U.S. government Medical laboratory science professionals exclusively engaged in research or education Students or trainees Phlebotomists Pathologist assistants Professionals solely performing waived tests as designated by CLIA ‘88 Personnel , not otherwise licensed under the act, performing only Point of Care or Moderately Complex testing as long as they are directed by a qualified Medical Laboratory Scientist or laboratory director A license will be required for the above categories of personnel if involved in testing in a medical or clinical setting. The grandfather clause allows for personnel currently working in the field to continue to work in the field going forward and be granted a license, even if they do not meet the licensure requirements in this bill. If they were practicing in the field on the effective date or have practiced for at least 6 months in the past three years, they are eligible for the grandfathering provision for up to 24 months after the effective date. After 24 months posteffective date, new license applicants must meet the qualification requirements of the bill. The administration section of this bill proposes to house the program in the Minnesota Department of Health with an advisory Medical Laboratory Board. The number of board members is currently proposed at 9 members including representatives of the licensed personnel categories, physician/pathologist representation and a public member. The section on standards of licensure relies on the educational and clinical experience requirements for one of the recognized national certification exams, which are also recognized by other states as qualification for licensure. (The recent bill passed in New York State is not consistent with those of other states, with current categories of practice and/or certification, or with this bill. It was drafted without input from the laboratory community. . Nearly a year and a half of work has gone into the Minnesota bill, which is very carefully written by a coalition of those who will be licensed to accommodate the needs of all laboratory settings, from physician offices, to small rural laboratories, community hospitals, to large academic health centers and reference laboratories.) Requirements are waived for those possessing a license from another state. When their current license expires, those individuals will be required to obtain a Minnesota license. Temporary licenses will be granted for 12 months, with up to two renewals. The intent is to allow for new graduates to complete a certification exam, or for current practitioners to meet the requirements to sit for a certification exam. This allows them to practice during that time. Concerns about the supply of qualified practitioners have been addressed by the grandfathering and temporary license provisions. The number and capacity of training programs in the state is increasing (expansion of University of MN program, addition of CLS programs at Winona State and Mayo, addition of histotechnology program at North Hennepin Community College), and is supplemented by the growing availability of distance learning programs. Patients deserve to have their testing performed by qualified personnel. Shortages of personnel in other healthcare professions such as nursing and pharmacy have not led to dilution of standards or removal of licensure requirements. The licensure renewal section defines the ongoing competency requirement of documented continuing education in the field. There will be a 12 hour annual requirement for all categories. A 3 year licensure renewal term is proposed, with annual documentation of continuing education. Outstanding issues to be resolved: Fee structure will be determined as part of the fiscal note process. The intent is that licensure fees will make the program self-supporting. Text Box: Executive Summary: June 2007 Licensure of Medical Laboratory Science Professionals S1830 and H2109 Text Box: June 2007

Laboratory Licensure

Coalition co-chairs:

· Rick Panning, CEO, American Red Cross, North Central Blood Services panningri@usa.redcross.org (651-291-6764)

· Kathy Hansen, Director, Lab Operations, University of Minnesota Medical Center, Fairview Khansen3@fairview.org (612-273-5090)

Coalition member organizations (Members participated in the development of the draft bill)

· American Society for Clinical Laboratory Science-MN

· American Association of Clinical Chemistry-Midwest Section

· American Society for Clinical Pathology

· American Medical Technologists – Minnesota Chapter

· Clinical Laboratory Management Association-MN

 

· Minnesota Society for Cytology

· Minnesota Society for Histology

· Minnesota Society for Pathology

· Minnesota Interlaboratory Microbiology Association

· Minnesota Association of Blood Banks

· Representatives for the phlebotomy profession

· Representative for Molecular Diagnostics

· Representative from the Minnesota Department of Health