Requirements for Clinical Laboratory Technologist Restricted License

Practice as a clinical laboratory technologist within the areas of Cytogenetics; Flow Cytometry/Cellular Immunology; Histocompatibility; Molecular Testing; Molecular Testing (Enhanced); 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 a State Education Department approved Training Program in the specific category in which you are seeking a restricted license. 

To obtain State Education Department approval to participate in a Training Program, you must first apply for a  Restricted License.  You must submit:  Form 1- Application for a Restricted License, Form 4-Attestation of Training Program Content, The Department may require you to submit additional documentation (i.e., a training program syllabus, curriculum).  If acceptable, the Department will issue a Restricted License Training Program Certificate to you.    

*NOTE: You may not begin a Training Program until the State Education Department issues you a certificate.

Requirements for Restricted License Training Programs

All Training Programs must meet the following criteria – in addition to criteria applicable  to each type of restricted license as described below. 
All Training Programs must be operated by a clinical laboratory located in New York state, with a New York State Department issued clinical laboratory permit in an appropriate category.

The Clinical Laboratory must employ Laboratory Director or a Sole Assistant Laboratory Director holding a DOH issued Certificate of Qualification in an appropriate category to oversee the Training Program.  This person (hereinafter the Training Program Director”) must sign Restricted License Application Forms 4 and 4A.  In addition, to employing  a Training Program Director, the Clinical Laboratory must ensure that qualified staff provide continuous onsite training and supervision of students participating in the Training Program.  

The Training Program must have a planned sequence of supervised employment or engagement in activities appropriate for the specific restricted license category only.  The Clinical Laboratory is prohibited from allowing students to perform specimen testing and procedures outside the restricted license category for which the Training Program is approved. The Training Program must be at least 1750 clock hours (1 year).   

Cytogenetics Training Programs

The Clinical Laboratory offering a Cytogenetics Training Program must hold a DOH issued clinical laboratory permit in the category of Cytogenetics.

The Training Program Director must hold a DOH issued Laboratory Director Certificate of Qualification (CQ) in Cytogenetics.  

The supervising and training personnel must:    

1. hold a DOH issued Laboratory Director CQ in Cytogenetics, or    
2. be a clinical laboratory technologist or physician who qualifies as a “laboratory supervisor” under DOH regulations (10 NYCRR section 58-1.4) and is authorized by the Clinical Laboratory to perform cytogenetic testing and authorized by the Training Program Director to train or supervise Training Program students. 

The Training Program must cover: chromosome structure/behavior and its correlation with phenotype and recognition and interpretation of chromosomal abnormalities; general laboratory principles and skills; clinical cytogenetics; general knowledge of human genetics; infection control and aseptic technique, quality control and quality assurance; 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 Training Programs

The Clinical Laboratory offering a Flow Cytometry/Cellular Immunology Training Program must hold a DOH issued clinical laboratory permit in the category of Cellular Immunology.

The Training Program Director must hold a DOH issued Laboratory Director Certificate of Qualification (CQ) in Cellular Immunology. 

The supervising and training personnel must:    

1. hold a DOH issued Laboratory Director CQ in Cellular Immunology, or    
2. be a clinical laboratory technologist or physician who qualifies as a “laboratory supervisor” under DOH regulations (10 NYCRR section 58-1.4) and is authorized by the Clinical Laboratory to perform cellular immunology procedures and authorized by the Training Program Director to train or supervise Training Program students

The Training Program must cover: techniques for counting, sorting, and characterization of cells suspended in a fluid stream based on their physical properties and expression of cell surface molecules; general laboratory principles and skills; infection control and aseptic technique; instrumentation and equipment; quality control and quality assurance; 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 Training Programs

The Clinical Laboratory offering a Histocompatibility Training Program must hold a DOH issued clinical laboratory permit in the category of Histocompatibility.

The Training Program Director must hold a DOH issued Laboratory Director Certificate of Qualification (CQ) in Histocompatibility.  

The supervising and training personnel must:    

1. hold a DOH issued Laboratory Director CQ in Histocompatibility, or    
2. be a clinical laboratory technologist or physician who qualifies as a “laboratory supervisor” under DOH regulations (10 NYCRR section 58-1.4) and is authorized by the Clinical Laboratory to perform histocompatibility procedures and authorized by the Training Program Director to train or supervise Training Program students

The Training Program must cover: clinical immunology, immunogenetics, basic molecular biology, and laboratory mathematics; general laboratory principles and skills; 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.
 

Stem Cell Process Training Programs

The Clinical Laboratory offering a Stem Cell Process Training Program must hold a DOH issued clinical laboratory permit in the category of Blood Services.

The Training Program Director must hold a DOH issued  Laboratory Director Certificate of Qualification in Immunohematology.  

Supervising and training personnel must:  

1. hold a DOH issued Laboratory Director CQ  in Immunohematology; or  
2. be a clinical laboratory technologist  or physician who qualifies as a “laboratory supervisor” under DOH regulations (10 NYCRR section 58-1.4) and is authorized  by the Clinical Laboratory to perform  Stem Cell Processes and is authorized by the Training Program Director to supervise or train t to train or supervise Training Program students. 

The Training Program must cover stem cell biology; general laboratory principles and skills; infection control and aseptic technique methods; 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 Training Programs

The Clinical Laboratory offering a Toxicology Training Program must hold a DOH issued clinical laboratory permit in the category of Clinical Toxicology - Comprehensive.

The Toxicology Training Program Director must hold a DOH issued Certificate of Qualification in Therapeutic Substance Monitoring/Quantitative Toxicology and/or in Clinical Toxicology.  

Supervising and Training personnel must:  

1. hold a DOH issued Laboratory Director CQ  in Therapeutic Substance Monitoring/Quantitative Toxicology or Clinical Toxicology, or   
2. be a clinical laboratory technologist  or physician who qualifies as a “laboratory supervisor” under DOH regulations (10 NYCRR section 58-1.4), and is authorized  by the Clinical Laboratory to perform Toxicology procedures and  authorized by the Training Program Director to supervise or train Training Program students. 

The Training Program must cover laboratory methods in toxicology, including qualitative and quantitative determination of xenobiotics present in biological specimens; 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; aseptic technique and infection control and specific clinical application.
 

New York State Clinical Laboratory Technology Board Guidance for Molecular Testing Training Programs 

New York State law establishes a Clinical Laboratory Technologist Restricted License in Molecular Testing and a Clinical Laboratory Technologist Restricted License in Molecular Testing (Enhanced). To qualify for either of these licenses, an applicant must complete: (1) an acceptable bachelor's or higher degree with a major in biology, chemistry, the physical sciences or mathematics, and (2) a New York State Education Department (NYSED) approved Molecular Testing Training Program. 

This Guidance describes minimum requirements for Molecular Testing Training Programs. A Training Program may include molecular testing learning experiences in addition to the education described in this Guidance. Each Molecular Testing Training Program must have a written Molecular Testing Training Program Plan that demonstrates how the Training Program meets all criteria described in this Guidance (or very similar criteria). 

1. Molecular Testing Training Program Approval Process
    
   1. To obtain NYSED approval to participate in the Molecular Testing Training Program, an applicant for a Restricted License in Molecular Testing or Molecular Testing (Enhanced) must submit to NYSED: Form 1- Application for a Restricted License, Form 4-Attestation of Training Program Content in Molecular Testing, and a written Molecular Testing Training Program Plan. NYSED may require the applicant to submit additional documentation to show that the plan meets NYSED Molecular Testing Training Program requirements.
   2. If acceptable, NYSED will issue a Molecular Testing Training Program Certificate to the applicant.
   3. The applicant begins the NYSED approved Molecular Testing Training Program.
   4. To verify to NYSED that the applicant has successfully completed the NYSED approved Molecular Testing Training Program, the applicant must submit to NYSED Form 4A-Certification of Completion of Training Program in Molecular Testing.
       
2. General Requirements for Molecular Testing Training Programs
   
   A Clinical Laboratory located in New York must operate the Molecular Testing Training Program. The Clinical Laboratory must hold a New York State Department of Health (DOH) issued clinical laboratory permit in ONCOLOGY- MOLECULAR & CELLULAR TUMOR MARKERS and/or GENETIC TESTING – MOLECULAR.
   
   The Training Program must have a planned sequence of supervised employment or engagement in activities appropriate for a Restricted License in Molecular Testing or Molecular Testing (Enhanced). Trainees are not legally allowed to perform any specimen testing except for molecular testing and procedures that are within the scope of practice of a Restricted License in Molecular Testing or Molecular Testing (Enhanced). The Training Program must be at least 1750 clock hours (I year).
   
   The Clinical Laboratory must employ a Laboratory Director or Sole Assistant Laboratory Director holding a DOH issued Certificate of Qualification (CQ) in Oncology- Molecular and Cellular Tumor Markers and/or Genetic Testing -Molecular to oversee the Training Program. This person (hereinafter the "Training Program Director") must sign NYSED's FORMs 4 and 4A.
   
   The Clinical Laboratory and Training Program Director must ensure that at least one of the following qualified staff provide continuous onsite training and supervision of the Molecular Testing Training Program trainee while they perform clinical laboratory services:
    
   • A laboratory director or sole assistant laboratory director with a DOH issued Laboratory Director CQ in Oncology-Molecular and Cellular Tumor Markers and/or Genetic Testing-Molecular; or
   • A clinical laboratory technologist or physician who qualifies as a "laboratory supervisor" under DOH regulations (10 NYCRR section 58-1.4) and authorized by the Clinical Laboratory to perform molecular testing and authorized by the Training Program Director to train or supervise Training Program trainees or,
   • A laboratory director or sole assistant laboratory director may supervise or train a trainee who is performing molecular testing in the same testing area in which the director holds a DOH issued CQ. For example, a laboratory director with a CQ in virology may supervise or train a trainee who performs molecular tests to detect COVID-19.

   
   Note: The Training Program Plan should identify by name and credentials the Training Program Director and staff who provide onsite training and supervision of the Molecular Testing Training Program trainee.

3. Molecular Testing Training Program Content Requirements
   
   The Molecular Testing Training Program must provide education (i.e., lectures, reading, and/or practice) in:
    
   1. nucleic acids and proteins, human molecular biology, molecular pathology, molecular diagnosis, molecular oncology (including the role of genetics in molecular diagnosis and molecularly targeted therapies), human and microbial molecular genetics, and molecular test result calculation, interpretation, and reporting;
   2. laboratory operations relevant to molecular testing, including, but not limited to, laboratory procedures, quality control, quality assurance, safety, and instrument operation and maintenance.
   3. molecular techniques, including nucleic acid isolation, separation, detection, amplification, sequencing; and molecular testing trouble shooting;
   4. molecular testing in each of the following scientific fields: infectious disease, oncology, genetics, genomics, transfusion medicine, pharmacogenomics (as described in more detail in the chart below).
       

   Scientific Field	Examples of Applications for Molecular Testing Note: Training Program must cover some examples described below in each scientific field.
   Genetics	Hemoglobinopathies (e.g., Thalassemias, Sickle Cell Anemias) Coagulopathies (e.g., Factor V Leiden, Prothrombin) Trinucleotide repeat disorders (e.g., Fragile X, Huntington, Muscular Dystrophy) Single gene disorders (e.g., Cystic Fibrosis, Gaucher, Hereditary Hemochromatosis) Epigenetic disorders (e.g., Prader-Willi, Angelman) Disease-associated HLA
   Genomics	Identify molecular biomarkers for certain diseases Predict progression and recurrence of a disease Identify treatment options and efficacy of those treatments
   Oncology	Leukemias/lymphomas (e.g., CML, ALL, chromosomal translocations, clonal rearrangements) Solid tumors Hereditary cancer syndromes (e.g., breast, colon, ovarian)
   Infectious Diseases	Qualitative analysis (e.g., MRSA, Clostridioides Difficile, respiratory pathogens, STI) Quantitative analysis (e.g., viral load) Genotypic characterization (e.g., molecular epidemiology, viral typing, resistance testing)
   Pharmacogenomics	Efficacy of pharmacotherapy (e.g., Trastuzumab, Warfarin, Clopidogrel, Carbamazepine, Amitriptyline, Statins, or Ivacaftor)
   Transfusion Medicine hemolytic disease of the fetus and newborn (HDFN) Anemias Hemostasis and coagulation Transfusion incompatibilities	Human Erythrocyte Antigen (HEA) Genotyping Panel RhD Genotyping for D variants RhCE Genotyping for C, c, E, and e variants including hrB and hrS status Rh Characterization RhD Zygosity ABO Common Allele Determination ABO Variants Non-Rh/Non-ABO Variants Human Platelet Antigen 1a/1b (HPA-1a/1b) Genotyping Human Platelet Antigen (HPA) Genotyping Panel

   
   The Training Program may cover additional subjects in the field of clinical laboratory molecular testing, as determined by the Training Program Director. The Training Program Plan must specifically identify reading materials (i.e.,  textbooks, articles, online training modules) that cover relevant science related content. All content outlined in  this Section III should be covered at a minimum through readings and/or lectures. Not all content is required to have hands-on training.
    
4. Hands-on Training/Practicum Requirements
   
   Each trainee must engage in hands-on training in molecular techniques, including nucleic acid isolation; manipulation of RNA/DNA; separation and detection; nucleic acid amplification; sequencing; and techniques to prevent specimen contamination.
   
   The Training Program Director must verify that the trainee has successfully completed a summative competency assessment in molecular testing in the field of Human Genetics and/or Oncology. The Training Program may include hands-on molecular testing training in additional scientific fields if the Clinical Laboratory is authorized to provide molecular testing services in the additional fields. The Training Program Plan must describe in detail how  hands-on training will be provided and include evaluation criteria used to assess the trainee’s learning.
    
5. Additional Requirements for Molecular Testing (Enhanced) Training Programs
   
   To offer a Molecular Testing (Enhanced) Training Program the following criteria must be met:
    
   • The Clinical Laboratory must be part of a National Cancer Institute Designated Cancer Center or located within a teaching hospital offering ACGME accredited medical residency programs and is eligible for New York State funding pursuant to Public Health Law section 2807.
   • The Training Program must cover clinical laboratory molecular testing research, including: (1) the development of new or improved methodologies and procedures for molecular testing and (2) molecular test validation.