NY - New York State Accreditation

All the umbilical Cord Blood banks should meet all the New York State laws and requirements that are established or operate within New York State. The bank should also meet all the requirements if it releases or accepts the collections of Cord Blood units.

Relevant Regulation:
New York State Health Regulations NYCCR Title 10, Volume A-1, Part 58 Clinical Labs and Blood banks, Subpart 58-5 Hematopoietic Progenitor Cell banks


Accreditation required: Tissue Bank License

• Once applied, the bank is offered a provisional license on the initial stage
• The license is to be renewed every four yearly but if the bank has provisional license, it may require the renewal more frequently.
• At any given time, the bank should be ready for the state inspection. However, there is no mandatory timeline is inflicted. It is to be noted that the inspection is generally done when the bank is running on provisional license and the permanent license is only granted after a thorough and successful inspection.
• The state has all the power to change any bank’s status to provisional at any time if there is even a bit inadequacy noted during inspection. Once those deficiencies are corrected, they are again checked and then only the permanent license is allotted.
• The New York licensing requirements are very stringent and therefore, the permanent license is one of the most difficult tasks as far as getting Accreditation for the umbilical Cord Blood bank is concerned.
• The bank should meet all the state specific requirements for personnel.
• The bank should also meet some special testing requirements that are set-up for checking out any contagious disease.