Restricted License Requirements for Clinical Laboratory Technologists

Practice as a clinical laboratory technologist within the areas of Cytogenetics; Flow Cytometry/Cellular Immunology; Histocompatibility; Molecular Diagnosis to the extent such Molecular Diagnosis is included in Genetic Testing-Molecular and Molecular Oncology; Molecular Diagnosis including but not limited to Genetic Testing-Molecular and Molecular Oncology for employment in cancer centers and designated training hospitals; Stem Cell Process; and Toxicology in New York State requires a license as a clinical laboratory technologist or a restricted license as a clinical laboratory technologist, unless otherwise exempt under the law.

To receive a clinical laboratory technologist restricted license to practice in one of the previously mentioned areas in New York State you must:

• be of good moral character;
• be at least 18 years of age;
• meet education requirements; and
• meet experience requirements.

You must file an Application for a Restricted License (Form 1) and the other forms indicated, along with the appropriate fee, to the Office of the Professions at the address specified on each form. It is your responsibility to follow up with anyone you have asked to send us material.

The specific requirements for licensure are contained in Title 8, Article 165 of New York's Education Law and Subpart 79-13 of the Regulations of the Commissioner of Education.

You should also read the general licensing information applicable for all professions.

The fee for a clinical laboratory technologist restricted license and first registration is $371.

Fees are subject to change. The fee due is the one in law when your application is received (unless fees are increased retroactively). You will be billed for the difference if fees have been increased.

• Do not send cash.
• If you apply for licensure electronically using the online Application for Licensure, you will be required to pay by credit card.
• Other payments must be made by personal check or money order payable to the New York State Education Department. Your cancelled check is your receipt.
• Mail any required forms and fees to the indicated address on the form.

NOTE: Payment submitted from outside the United States should be made by check or draft on a United States bank and in United States currency; payments submitted in any other form will not be accepted and will be returned.

Individuals who withdraw their licensure application may be entitled to a partial refund.

• For the procedure to withdraw your application, contact the Clinical Laboratory Technology Unit by e-mailing opunit2@nysed.gov or by calling 518-474-3817 ext. 260 or by faxing 518-402-2323.
• The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency.

If you withdraw your application, obtain a refund, and then decide to seek New York State licensure at a later date, you will be considered a new applicant, and you will be required to pay the licensure and registration fees and meet the licensure requirements in place at the time you reapply.

To meet the professional education requirements for a clinical laboratory technologist restricted license, you must present evidence of completion of a baccalaureate or higher degree program in the major of biology, chemistry, the physical sciences, or mathematics from a program registered by the State Education Department or determined by the Department to be the substantial equivalent.

In addition to the degree requirement, you must complete an approved training program in the specific area in which you are seeking a restricted license. The content of the training program shall be described and attested to by the clinical director of the laboratory in which the program is located prior to the beginning of the your program* using the respective Form 4.

*NOTE: You may not begin a program until the application has been approved and a certificate has been issued.

The training program shall consist of not less than one year of full-time training in the specific area in which you are seeking certification, which shall consist of no less than 1750 hours in a calendar year, in the specific area in which you are seeking certification, or the part-time equivalent thereof, as determined by the department.

The respective areas for each field are:

Cytogenetics

A program in cytogonetics must contain knowledge of:

• chromosome structure/behavior and its correlation with phenotype and of chromosomal abnormalities.

The program shall also include but need not be limited to:

• general laboratory principles and skills;
• including infection control and aseptic technique; quality control and quality assurance;
• clinical cytogenetics;
• general knowledge of human genetics;
• laboratory mathematics;
• the collection, handling, preparation and processing of pertinent specimens;
• the use of appropriate cell culture techniques;
• the principles and techniques for harvesting specimens or cell cultures; and,
• the principles and techniques of chromosome banding, staining, analysis, and instrumentation

Flow Cytometry/Cellular Immunology

A program in flow cytometry/cellular immunology must contain knowledge of:

• The technique for counting, sorting, and characterization of cells suspended in a fluid stream based on their physical properties and expression of cell surface molecules;

The program shall also include but need not be limited to:

• general laboratory principles and skills;
• infection control and aseptic technique;
• quality control and quality assurance;
• instrumentation and equipment;
• the basic principles of flow cytometry, including specimen preparation, fluidics and electronics;
• fluorochrome selection;
• antibody selection;
• the design of flow cytometry procedures, including routine standardization and quality management; and
• specific clinical applications.

Histocompatibility

A program in histocompatibility must contain knowledge of:

• clinical immunology;
• immunogenetics;
• basic molecular biology; and
• laboratory mathematics.

The program shall also include but need not be limited to:

• general laboratory principles and skills, including infection control and aseptic technique;
• the practice of HLA typing and HLA antibody testing;
• specimen collection, processing and handling;
• instrumentation and equipment;
• reagent preparation and quality control;
• quality assurance, principles and techniques of histocompatibility assays, and crossmatching;
• antibody screening and identification; and,
• determination of degree of HLA matching.

Molecular Diagnosis Restricted to Molecular Diagnosis Included In Genetic Testing-Molecular and Molecular Oncology

A program in molecular diagnosis must contain knowledge of:

• the role of molecular genetics in tumor diagnosis and individualized tumor therapies that are being defined and implemented.

The program shall also include but need not be limited to:

• general laboratory principles;
• infection control and aseptic technique;
• quality control and quality assurance;
• applicable laboratory skills;
• general principles of molecular biology, clinical molecular genetics and molecular diagnosis;
• laboratory mathematics;
• basic principles of nucleic acid extraction, modification, amplification, identification, and unidirectional workflow techniques to avoid cross contamination;
• electrophoresis and other separation techniques;
• transfer and hybridization techniques and specific techniques of nucleic acid amplification and identification.

Molecular Diagnosis Not Restricted to Molecular Diagnosis Included in Genetic Testing-Molecular and Molecular Oncology for Employment in Cancer Centers and Designated Training Hospitals

A program in molecular diagnosis must contain knowledge of:

• the role of molecular genetics in tumor diagnosis and individualized tumor therapies that are being defined and implemented.

The program shall also include but need not be limited to:

• general laboratory principles;
• infection control and aseptic technique;
• quality control and quality assurance;
• applicable laboratory skills;
• general principles of molecular biology, clinical molecular genetics and molecular diagnosis;
• laboratory mathematics;
• basic principles of nucleic acid extraction, modification, amplification, identification, and unidirectional workflow techniques to avoid cross contamination;
• electrophoresis and other separation techniques;
• transfer and hybridization techniques and specific techniques of nucleic acid amplification and identification; and
• additional training in molecular diagnosis acceptable to the Department that would enable you to practice competently.

Stem Cell Process

A program in stem cell process must contain knowledge of:

• stem cell biology

The program shall also include but need not be limited to:

• general laboratory principles and skills;
• infection control and aseptic technique;
• instrumentation and equipment;
• quality control and quality assurance;
• laboratory mathematics;
• the process of handling stem cell specimens in the laboratory;
• enumeration and characterization of stem cells;
• ABO/Rh confirmatory typing; and,
• reagent preparation.

Toxicology

A program in toxicology must contain knowledge of:

• laboratory methods in toxicology, including qualitative and quantitative determination of xenobiotics present in biological specimens.

The program shall also include but need not be limited to:

• general laboratory principles and skills;
• basic principles of chemistry, biology, and the physical sciences;
• basic principles of pharmacology;
• basic principles of purification, separation, and extraction techniques;
• instrumentation and equipment;
• quality control and quality assurance;
• laboratory mathematics;
• the principles of immunoassay techniques;
• preparation and processing of biological specimens for toxicological analysis;
• the principles of analytical techniques;
• review and certification of toxicology results; and,
• aseptic technique and infection control and specific clinical applications

The Department must receive, directly from the clinical laboratory director of the program, verification of completion of an approved training program using the respective Form 4A.

Applicants must be familiar with the following general rules and regulations of any clinical laboratory, as well as rules and standards of specific relevance to areas of testing and reporting in which they are or expect to be engaged.

New York State Public Health Law and Regulations

The laws, rules and regulations listed below can be accessed on the Web at www.wadsworth.org/regulatory/clep/laws

• Article V, Title V Clinical Laboratory and Blood Banking Services
• Article 31 Human Blood and Transfusion Services
• Article 27F HIV and AIDS Related Information
• Article 43-B, Organ, Tissue, and Body Parts
• Article V, Title VI Laboratory Business Practices
• Section 79.1 of the New York State Civil Rights Law, Confidentiality of Genetic Testing
• Part 19 of 10 (NYCRR) Clinical Laboratory Directors
• Subpart 34-2 of 10 (NYCRR) Laboratory Business Practices
• Subpart 58-1 of 10 (NYCRR) Clinical Laboratories
• Subpart 58-2 of 10 (NYCRR) Blood Banking
• Subpart 58-5 of 10 (NYCRR) Hematopoietic Progenitor Cell Banks
• Subpart 58-8 of 10 (NYCRR) Human Immunodeficiency Virus (HIV) Testing
• Subpart 63 of 10 (NYCRR) AIDS/HIV Testing, Reporting and Confidentiality

Federal Laws and Regulations

The laws and regulations listed below can be accessed on the Web at www.cms.hhs.gov/clia/

• Current CLIA Regulations
• Part 493 Laboratory Requirements

You may print and keep this checklist as a reminder of what forms you need to file. This is for your reference and should not be submitted with your application forms. You should also keep a copy of all application forms submitted.