On June 12, 2019, the New York Department of Health published a "Notice of Adoption" granting final approval to several amendments proposed on December 19, 2018, to Section 573 of New York's Public Health Law.
One of the amendments is to Section 19.2 of Part 19 that recognizes the American Board of Bioanalysis (ABB) as a certifying board for directors, and assistant directors, of New York licensed laboratories.
Click here to view the June 12, 2019, announcement in the New York State Register.
Click here to view the amended New York regulations for clinical laboratory directors.
New Information Regarding New York's Recognition of ABB Director Certification
Although ABB is now listed among the approved boards, there is an “asterisk” attached to ABB’s recognition. ABB requires four years of acceptable experience, but ABB does not require that it be post-doctoral. New York requires post-doctoral experience for directors, so ABB-certified directors are required to submit documentation of four years of post-doctoral experience (earned during the six years prior to applying for a New York Certificate of Qualification) to the New York Department of Health for review and approval.
In addition, Section 19.3 lists the categories and sub-categories for New York Certificates of Qualification. ABB certification is approved for the following categories/subcategories:
- bacteriology
- mycobacteriology
- mycology
- parasitology
- virology (limited to antigen detection and molecular methods)
- diagnostic immunology
- clinical chemistry
- blood pH and gases
- endocrinology
- therapeutic substance monitoring-quantitative toxicology
- clinical toxicology
- andrology
- blood lead
ABB certification is not approved for the following categories/subcategories:
- hematology
- immunohematology
- histopathology
- cytopathology
- oral pathology
- dermatopathology
- cytogenics
- histocompatibility
- cellular immunology
- [oncofetal antigens and/or] genetic testing
- fetal defect markers
- forensic identity
- oncology
- parentage/identity testing
- trace elements
- transplant monitoring
- transfusion services
- blood banking collection – comprehensive
- blood banking collection – limited
- forensic toxicology
New York has created a new category of director, the “assistant director.” This category does not exist under current CLIA regulations.
New York defines an “assistant director” as a director who has been designated by the owner(s) of the laboratory as having shared responsibility with a director for the scientific and technical operation of the clinical laboratory or blood bank in one or more categories and/or subcategories.
New York goes on to state: “If a clinical laboratory or blood bank employs more than one director, the laboratory owner(s) are required to designate, in writing, one such individual as the director of record for the laboratory.”
New York’s Laboratory Supervisor requirements were not changed by the June 12 announcement in the New York Register. New York’s qualifications for Laboratory Supervisor can be found here.
The basic educational requirements for Laboratory Supervisors are as follows:
- Earned doctoral degree in a chemical, physical or biological science
PLUS
Two years of post-doctoral experience in a clinical laboratory having a director at the doctoral level. - Master of Arts or Master of Science with a major in a chemical, physical, or biological science,
PLUS
Four years of experience subsequent to graduation, of which at least two years are spent in the designated laboratory specialty in a clinical laboratory having a director at the doctoral level. - Qualified as a Medical Technologist under New York regulations
PLUS
Six years of pertinent experience subsequent to qualifying (as a Medical Technologist) of which at least two years have been spent working in a clinical laboratory having a director at the doctoral level.
