RULES AND REGULATIONS FOR THE LICENSURE OF CLINICAL LABORATORY SCIENCE PRACTITIONERS (R23-16.3-CLS) STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS Department of Health DECEMBER 1993 INTRODUCTION These Rules and Regulations for the Licensure of Clinical Laboratory Science Practitioners (R23-16.3-CLS) are promulgated pursuant to the authority conferred under section 23-16.3 of the General Laws of Rhode Island, as amended, and are established for the purpose of adopting minimum requirements for the licensure of Clinical Laboratory Science Practitioners in this state. Pursuant to the provisions of section 42-35-3 (c) of the General Laws of Rhode Island, as amended, consideration was given in arriving at the regulations to: (1) alternative approaches to the regulations; (2) duplication or overlap with state regulations; and (3) significant economic impact on small business as defined in Chapter 42-35 of the General Laws, which could result from the regulations. No known overlap or duplication, no alternative approach, nor any signifi- cant economic impact were identified. PART I DEFINITIONS AND LICENSURE REQUIREMENTS (R23-16.3-CLS) 1.0 DEFINITIONS Wherever used in these rules and regulations, the terms listed below shall be construed as follows: 1..1 "Act" refers to Chapter 23-16.3 of the General Laws of Rhode Island, as amended, entitled, "Clinical Laboratory Science Practice Act". 1..2 "Board" means the clinical laboratory science board appointed by the director of health. 1..3 "Director" means director of the Rhode Island Department of Health. 1..4 "Department" means the Rhode Island Department of Health. 1..5 "Division" means the Division of Professional Regulation. 1..6 "Independent judgement" means procedure(s), duty(ies), tests are not subject to review, upon completion, by a supervisor. 1..7 "Direct supervision" means the clinical laboratory scientist (technologist), laboratory supervisor, or laboratory director personally authorizes the procedure(s), duty(ies), tests, to be performed and remains in the laboratory while the procedure(s), duty(ies), tests are being performed and reviews the results. 1..8 "Clinical laboratory test" or "laboratory test" means a microbiological, serological, chemical, hematological, radiobioassay, cytological, immunological or other pathological examination which is performed on material derived from the human body, or any other test or procedure conducted by a clinical laboratory or facility which provides information for the diagnosis, prevention or treatment of a disease or assessment of a medical condition. 1..9 "Limited function test" means those tests listed in the Federal Register as wavered test. 1..10 "Clinical laboratory" or "laboratory" means any facility or office in which clinical laboratory tests are performed. 1..11 "Clinical laboratory science practitioner" or "one who engages in the practice of clinical laboratory science" means a health care professional who performs clinical laboratory test or who is engaged in management, education, consulting or research in clinical laboratory science, and includes laboratory directors, supervisors, clinical laboratory scientists (technologists), specialists, and technicians working in a laboratory, but does not include persons employed by a clinical laboratory to perform supportive functions not related to direct performance of laboratory tests and does not include clinical laboratory trainees. 1..12 "Clinical laboratory scientist" and/or "technologist" means a person who performs tests pursuant to established and approved protocols requiring the exercise of independent judgment and responsibility, maintains equipment and records, performs quality assurance activities related to test performance, and may supervise and teach within a clinical laboratory setting. 1..13 "Clinical laboratory technician" means a person who performs laboratory tests pursuant to established and approved protocols which require limited exercise of independent judgment and which are performed under the personal and direct supervision of a clinical laboratory scientist (technologist), laboratory supervisor, or laboratory director. 1..14 "Accredited clinical laboratory program" means a program planned to provide a predetermined amount of instruction and experience in clinical laboratory science that has been accredited by one (1) of the accrediting agencies recognized by the United States Department of Education. 1..15 "Cytotechnologist" means a health care professional specializing in cancer detection. She/he is responsible for diagnostic testing and may also be involved in management, education and research. 1..16 "Histologic technician" means a person who is concerned with the preparation of surgical, autopsy or research tissue for microscopic examination pursuant to established and approved protocols which require limited exercise of independent judgement and responsibility. 2.0 LICENSE REQUIREMENT 2..1 No person shall practice clinical laboratory science or hold himself out as a clinical laboratory science practitioner in this state unless he or she is licensed pursuant to this chapter. 2..2 All persons engaged in the practice of clinical laboratory science on 1 July 1992, who are certified by or eligible for certification by an agency approved by the Department of Health, and who have applied to the Department of Health on or before 1 July 1994, and have complied with all necessary requirements for such application, may continue to perform clinical laboratory tests until the expiration of twelve (12) months after the filing of such application, the denial of the application by the Department of Health, or the withdrawal of the application, whichever occurs first. 2..3 Persons not meeting the education, training, and experience qualifications for any license described in this chapter may, prior to 1 July 1994, be considered to have met qualifications providing they have three (3) years acceptable experience immediately prior to 1 July 1992, and submits to the Department of Health the job description of the position which the applicant has most recently performed attested to by his/her employer and notarized. 3.0 EXEMPTIONS 3..1 Notwithstanding the provisions of sections 2.1, 2.2 and 2.3 above, excluded from these regulations are the following individuals: A. Any person performing clinical laboratory tests within the scope of his practice and for which he is licensed pursuant to any other provisions of the general laws. B. Clinical laboratory science practitioners employed by the United States government or any bureau, division or agency thereof while in the discharge of the employee's official duties. C. Clinical laboratory science practitioners engaged in teaching or research, provided that the results of any examination performed are not used in health maintenance, diagnosis or treatment of disease. D. Students or trainees enrolled in a clinical laboratory science education program provided that these activities constitute a part of a planned course in the program, that the persons are designated by title such as intern, trainee, or student, and the persons work directly under the supervision of an individual licensed by this state to practice clinical laboratory science. E. Any person performing limited function test as defined in section 1.9. 4.0 QUALIFICATIONS FOR LICENSURE On and after 1 July 1994 all applicants for licensure under these rules and regulations must meet the following requirements: 4..1 CLINICAL LABORATORY SCIENTIST (TECHNOLOGIST). A. The Department shall issue a clinical laboratory scientist license to an individual who completes the application required in section 5.0 and who meets the following qualifications: a. A baccalaureate degree in clinical laboratory science (medical technology) from an accredited college or university whose curriculum included a twelve (12) month clinical training program approved by the United States Department of Education; or b. A baccalaureate degree in biological, chemical or physical science from an accredited college or university, and subsequent to graduation (after receipt of the degree specified) has at least twelve (12 months of appropriate clinical education in an accredited clinical laboratory science program; or c. A baccalaureate degree which includes a minimum of thirty-six (36) semester (or equivalent) hours in the biological, chemical and physical sciences from an accredited college or university plus two (2) years of full-time (minimum of thirty-five (35) hours per week) work experience including a minimum of four (4) months in each of the four (4) major disciplines of laboratory practice (clinical chemistry, clinical microbiology, hematology, immunology/immunohematology); or d. A baccalaureate degree consisting of 90 semester (or equivalent) hours, thirty-six (36) of which must be in the biological, chemical or physical sciences, from an accredited university, and a twelve (12) month clinical training program approved by the United States Department of Education; or e. A clinical laboratory scientist (technologist) who previously qualified under federal regulatory requirements such as 493.1433 of the March 14, 1990 federal register as follows: i. Possesses a license as a laboratory technologist issued by the state, if such licensing existed; and (1) earned a bachelor's degree in medical technology from an accredited university; (2) successfully completed 3 years of academic study (a minimum of 90 semester hours or equivalent) in an accredited college or university, which met the specific requirements for entrance into a school of medical technology accredited by an accrediting agency approved by the Secretary, and has successfully completed a course of training of at least 12 months in such a school; (3) earned a bachelor's degree in one of the chemical, physical, or biological sciences and, in addition, has at least 1 year of pertinent full-time laboratory experience or training, or both, in the specialty or sub-specialty in which the individual performs tests; (4) successfully completed 3 years (90 semester hours or equivalent) in an accredited college or university with the following distribution of courses- (a) for those whose training was completed before 15 September 1963. At least 24 semester hours in chemistry and biology courses of which- (i) At least 6 semester hours were in organic chemistry and at least 3 semester hours were in other chemistry courses; and (ii) At least 12 semester hours in biology courses pertinent to the medical sciences; or (b) For those whose training was completed after 14 September 1963. (i) 16 semester hours in chemistry courses that included at least 6 semester hours in inorganic chemistry and that are acceptable toward a major in chemistry; (ii) 16 semester hours in biology courses that are pertinent to the medical sciences and are acceptable toward a major in the biological sciences; and (iii) 3 semester hours of mathematics; and (iv) Has experience, training, or both, covering several fields of medical laboratory work of at least 1 year and of such quality as to provide him or her with education and training in medical technology equivalent to that described in Sections 4.1(e)(2)(a) and (b); or (5) For those individuals who first qualified before 1 July 1971, the technologist: (a) Was performing the duties of a laboratory technologist at any time between 1 July 1961 and 1 January 1968, and (i) Has had at least 10 years of pertinent laboratory experience prior to 1 January 1968. A minimum of 30 semester hours of credit from an approved school of medical technology, or toward a bachelor's degree from an accredited institution with a chemical, physical, or biological science as the major subject is considered equivalent to 2 years of experience. Additional education is equated at the rate of 15 semester hours of credit for 1 year of experience; or (6) Achieves a satisfactory grade in a proficiency examination approved by HHS; and B. successfully completes a nationally recognized certification examination, such as the National Certification Agency (NCA), Department of Health and Human Services (DHHS), American Society of Clinical Pathologist (ASCP), state civil service examination, or others including appropriate categorical and specialty exams. 4..2 CLINICAL LABORATORY TECHNICIAN A. The Department shall issue a clinical laboratory techician license to an individual who completes the application required in section 5.0 and who meets the following qualifications: a. An associate degree or completion of sixty (60) semester (or equivalent) hours from a clinical laboratory technician program (MLT or equivalent) accredited by an agency recognized by the United States Department of Education that included a structured curriculum in clinical laboratory techniques; or b. A high school diploma (or equivalent) and i. completion of twelve (12) months in a technician training program in an accredited school such as clinical laboratory assistant (CLA), American Society of Clinical Pathologists (ASCP), and medical laboratory technician certificants (MLT-C) program approved by the board; or c. Successful completion of an official military medical laboratory procedure course of at least fifty (50) weeks duration and has held the military enlisted occupational specialty of Medical Laboratory Specialist (laboratory technician); or d. A clinical laboratory Technician who previously qualified under federal regulatory requirements such as 493.1433 of the March 14, 1990 federal register as follows: i. Possesses a current license as a technician, issued by the State if such licensing exists; and (1) Has successfully completed 60 semester hours of academic credit including chemistry and biology as well as a structured curriculum in medical laboratory techniques at an accredited institution or has an associate degree based on a course of study including those subjects from an accredited institution; or (2) Is a high school graduate or equivalent and has completed at least 1 year in a technician training program in a school accredited by an accrediting agency approved by HHS; or (3) Is a high school graduate or equivalent and has 2 years of pertinent full-time laboratory experience as a technician trainee in a laboratory; or (4) Is a high school graduate or equivalent and has successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and has held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (5) For a technician not meeting the training and experience requirements defined in paragraphs A.d(1), (2), (3) or (4) of this section; (a) Was performing the duties of a clinical laboratory technician any time between July 1, 1961, and January 1, 1968, and (i) Has had at least 5 years of pertinent laboratory experience prior to January 1, 1968. (This required experience may be met by the substitution of education for experience); or (ii) Achieves a satisfactory grade in a proficiency examination approved by HHS. However, after December 31, 1977, initial certification as a technician must be in accordance with paragraph (A.d(1),(2),(3), or (4) of this section; and B. successfully completes a nationally recognized certification examination, such as National Certification Agency (NCA), Department of Health and Human Services (DHHS), American Society of Clinical Pathologist (ASCP), state civil service examination, or others including appropriate categorical and specialty exams. 4..3 CLINICAL HISTOLOGIC TECHNICIAN. A. The Department of Health shall issue a clinical histologic technician license to an individual who completes the application required in section 5.0 and who meets the following qualifications: a. Associate degree or at least sixty (60) semester hours (or equivalent) from an accredited college/university to include a combination of mathematics and at least twelve (12) semester hours of biology and chemistry, and successfully complete an accredited program in histologic technique or one (1) full year of training in histologic technique under the supervision of certified histotechnologist or an appropriately certified histopathology supervisor with at least three (3) years experience; or b. High school graduation (or equivalent) and two (2) years full time acceptable experience under the supervision of a certified/licensed clinical histologic technician at a licensed clinical laboratory in histologic technique; and B. successfully completes a nationally recognized certification examination, such as National Certification Agency (NCA), Department of Health and Human Services (DHHS), American Society of Clinical Pathologist (ASCP), state civil service examination, or others including appropriate categorical and specialty exams. 4..4 CYTOTECHNOLOGIST. A. The Department of Health shall issue a cytotechnologist license to an individual who completes the application required in section 4.0 and who meets the following qualifications: a. A baccalaureate degree from an accredited college or university with twenty (20) semester hours (30 quarter hours) of biological science, eight (8) semester hours (12 quarter hours) of chemistry and three (3) semester hours (4 quarter hours) of mathematics and successful completion of twelve (12) month cytotechnology program; or b. A baccalaureate degree from an accredited college or university with twenty (20) semester hours (30 quarter hours) of biological science, eight (8) semester hours (12 quarter hours) of chemistry and three (3) semester hours (4 quarter hours) of mathematics and five (5) years full time acceptable clinical laboratory experience including cytopreparatory techniques, microscopic analysis and evaluation of the body systems within the last ten (10) years. At least two (2) of these years must be subsequent to the completion of the academic component and at least two (2) years must be under the supervision of a licensed physician who is a pathologist, certified, or eligible for certification, by the American Board of Pathology in Anatomic Pathology or has other suitable qualifications acceptable to board; or c. A cytotechnologist who previously qualified under federal regulatory requirements such as 493.1433 of the March 14, 1990 federal register as follows: i. Possesses a current license as a cytotechnologist issued by the state, if such licensing exists; and (1) Has successfully completed 2 years in an accredited college or university with at least 12 semester hours in science, 8 hours of which are in biology and (2) Has had 12 months of training in a school of cytotechnology accredited by an accrediting agency approved by the HHS; or ii. Has received 6 months of formal training in a school of cytotechnology accredited by an accrediting agency approved by the Secretary and 6 months of full time experience in cytotechnology in a laboratory acceptable to the pathologist who directed the formal 6 months of training: or iii. Before January 1, 1969, had: (1) Been graduated from high school (or equivalent); (2) Completed 6 months of training in cytotechnology in a laboratory directed by a pathologist or other physician recognized as a specialist in cytology; and (a) Completed 2 years of full-time supervised experience in cytotechnology; or (b) Achieves a satisfactory grade in a proficiency examination approved by HHS and designed to qualify persons as cytotechnologists; and B. successfully completes a nationally recognized certification examination, such as National Certification Agency (NCA), Department of Health and Human Services (DHHS), American Society of Clinical Pathologist (ASCP), state civil service examination, or others including appropriate categorical and specialty exams. 5.0 APPLICATION FOR LICENSE AND FEES A. Application for licensure shall be made on forms provided by the Division and shall be completed, notarized and submitted to the Division not less than thirty (30) days prior to the scheduled date of the Board meeting by applicants seeking licensure. B. Such application shall be accompanied by the following documents and fee; a. Proof of Lawful Entry into the Country: i. For U.S. BORN applicants: a certified or notarized copy of birth certificate. ii. For FOREIGN BORN applicants: Proof of lawful eligibility for employment in the United States. b. Be of Good Moral Character: i. Signed statement on application. c. Photographs: i. a recent identification photograph of the applicant, head and shoulder front view approximately 2 x 3 inches in size; d. Resume: i. a chronological resume of experience; e. Job description: i. where required, a notarized copy of your job description signed by the laboratory director or physician; f. Verification (Applicants licensed in another state): i. the Board of Clinical Laboratory Science Practitioners in each state in which the applicant has held or holds licensure shall submit directly to the Division, a statement attesting to the licensure status of the applicant during the time period the applicant held licensure in said state; g. Transcripts: i. supporting certified transcript of educational credentials as required in the appropriate section of 4.0 herein, signed by the dean or registrar of the college, university or accredited clinical laboratory science program, verifying the dates of attendance and completion of the appropriate program. Such documentation must be sent directly from the school to the Division and must consist of original statements and/or photocopies bearing the signature of the dean or registrar and the imprint of the school seal. Verification of high school graduation or equivalent may be an original signed statement from the high school or equivalent program or a notarized photocopy of the original document; h. Examinations: i. the results of any required examination under Section 4.0 must be submitted directly to the Division. i. Fees: i. For Clinical Laboratory Scientist (Technologist) and Cytotechnologist the application fee of fifty dollars ($50.00) made payable to the General Treasurer, State of Rhode Island (non-returnable nor non-refundable); ii. For Clinical Histologic Technician and Clinical Laboratory Technician the application fee of twenty-five dollars ($25.00) made payable to the General Treasurer, State of Rhode Island (non-returnable nor non-refundable); j. Other: i. Such other information as may be deemed necessary and appropriate by the Board. 6.0 APPLICATION FOR LICENSURE BY ENDORSEMENT A. A license to practice under any category of licensure described in Section 4.0 may be issued to an applicant who holds a valid license or its equivalent, in that category, issued by another state provided: B. the Board of Licensure in each state in which the applicant has held or holds licensure submits directly to the Division, a statement attesting to the licensure status of the applicant during the time period the applicant held licensure in said state; C. the applicant provides acceptable evidence to the Division that the requirements under which the applicant was originally licensed in another state meet or exceed the standards required in this state. 7.0 ISSUANCE AND RENEWAL OF LICENSE AND FEE A. Upon completion of the aforementioned requirements and at the recommendation of the Board the Division shall may issue a license to those applicants found to have satisfactorily met all the requirements herein. Said license unless sooner suspended or revoked shall expire on the first day of January of each even numbered year and may be renewed upon submission of the license renewal fee. a. For Clinical Laboratory Scientist (Technologist) and Cytotechnologist the license renewal fee shall be fifty dollars ($50.00). b. For Clinical Histologic Technician and Clinical Laboratory Technician the license renewal fee shall be twenty -five dollars ($25.00). B. On or before the first day of November of each odd-numbered year, the administrator of the Division shall mail an application for renewal of license to every person to whom a license has been issued or renewed during the current licensure period. Every person so licensed who desires to renew his or her license shall file with the Division such renewal application duly executed, together with the renewal fee on or before the thirty-first day of December of each odd numbered year. C. Upon receipt of such application, and payment of said fee, the administrator of the Division shall grant a renewal license effective the second day of January, and expiring on the first day of January of the next even-numbered year. D. On and after 31 December 1997 each renewal application must be accompanied by proof of completion, in the period beginning 1 January 1995, of at least thirty (30) hours continuing education courses, clinics, lectures, training programs, seminars, or other programs related to clinical laboratory practice which are approved or accepted by the board; or proof of recertification by a national certification organization that mandates an annual minimum of fifteen (15) hours of continuing education, such as the national certification agency for medical laboratory personnel. 8.0 TEMPORARY PERMIT 8..1 The Division may issue a temporary permit for a period of ninety (90) days from the date on the application fee receipt issued by the Division to individuals who qualify for licensure under Section 4.0 of these rules and regulations and; A. has filed an application for licensure in this state and; B. has provided acceptable evidence of being currently licensed under the laws of another state. C. The original privilege to work ninety (90) days from the date on the application fee receipt shall not be extended or renewed. 8..2 The Division may issue a temporary permit for a period of ninety (90) days to individuals who are awaiting the results of certification examinations for licensure under Section 3.0 of these rules and regulations and; A. has filed an application that is complete except for the examination scores. B. If such an applicant shall fail to take the next succeeding examination without due cause or fail to pass the examination and be licensed, all aforementioned privileges shall automatically cease. 9.0 DENIAL, SUSPENSION, REVOCATION OF LICENSE 9..1 The Board shall recommend to the Director to deny, revoke, suspend, place on probation, censure or reprimand of a licensee, or to take such other disciplinary action as the board may deem appropriate, including the imposition of a civil penalty for conduct that may result from, but not necessarily be limited to: A. A material misstatement in furnishing information to the Department of Health; B. A violation or negligent or intentional disregard of this chapter, or of the rules or regulations promulgated hereunder; C. A conviction of any crime under the laws of the United States or any state or territory thereof which is a felony or which is a misdemeanor, an essential element of which is dishonesty, or of any crime which is directly related to the practice of the profession; D. Making any misrepresentation for the purpose of obtaining registration or violating any provision of this chapter. E. Any activity in violation of professional standards of practice at a level consistent with current community and national standards; F. Engaging in dishonorable, unethical or unprofessional conduct of a character likely to deceive, defraud or harm the public; G. Providing professional services while mentally incompetent, under the influence of alcohol or narcotic or controlled dangerous substance that is in excess of therapeutic amounts or without valid medical indication; H. Directly or indirectly contracting to perform clinical laboratory tests in a manner which offers or implies an offer of rebate, fee-splitting inducements or arrangements, or other unlawful remuneration; or I. Aiding or assisting another person in violating any provision of this chapter or any rule adopted hereunder. 10.0 RULES GOVERNING PRACTICE AND PROCEDURES 10..1 All hearings and reviews required under the provisions of Chapter 23-16.3 of the General Laws of Rhode Island, 1956, as amended, shall be held in accordance with the provisions of the Rules and Regulations promulgated by the Rhode Island Department of Health entitled "Rules and Regulations Governing the Practices and Procedures Before the Rhode Island Department of Health (R42-35-PP)". 10..20 SEVERABILITY 10..3 If any provision of this chapter or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of this chapter which can be given effect without the invalid provision or application, and to this end the provisions of the chapter are declared to be severable. The following limited function test are currently listed in the Federal Register as wavered test: (1) Erythrocyte sedimentation rate, nonautomated; (2) Fecal occult blood; (3) Hemoglobin by copper sulfate, nonautomated (4) Ovulation test (luteinizing hormone) by visual color comparison; (5) Spun microhematocrit; (6) Glucose by monitoring devices cleared by the Food and Drug Administration (FDA) specifically for home use; (7) Urine dipstick or tablet analytes, nonautomated; (8) Urine Human Chorionic Gonadotropic (HCG) by visual color comparison tests; (9) Hemoglobin by single analyte instruments with self contained or component features to perform specimen, reagent interaction, providing direct measurement and readout; .