BILL NUMBER: S8966A
SPONSOR: RIVERA
 
TITLE OF BILL:
An act to amend the public health law, in relation to certificates of
qualification for clinical laboratories and blood banks
 
PURPOSE OR GENERAL IDEA OF BILL:
To set specific standards that meet federal requirements so that New
York State can be exempt from the Clinical Laboratory Improvement Amend-
ments.
 
SUMMARY OF SPECIFIC PROVISIONS:
Current law requires clinical laboratory or blood bank directors to have
a specialty background in the type of specific testing or activities the
facility is engaging in. Sections one through three of this bill would
amend the law to require general certificates of qualification rather
than specialized ones.
Section four eliminates specific limitations and requirements on cyto-
technologists and directs the Department of Health to establish regu-
lations for cytotechnologist workload standards that shall be at least
as stringent as federal regulations. It also removes the registration
requirement for cytotechnologists and the standard for the records cyto-
technologists are to maintain under current law.
Section five provides an effective date of immediately.
 
JUSTIFICATION:
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are feder-
al regulations that created standards for US facilities that test human
specimens for research or to diagnose or treat disease. It required
these facilities to be certified by the US Department of Health and
Human Services. However, if a state's requirements are at least as
stringent as the federal rules for clinical laboratories, that state can
be exempt from CLIA requirements. New York State has been exempted from
the CLIA for several years but must reapply for an exemption every six
years.
In March of 2021, New York State was told the different sections of law
that need to be amended so that the state can remain exempt from CLIA.
This legislation amends the public health law to increase the licensing
fee, remove certain cytotechnologist requirements, and will clarify the
license categories and who can qualify for specific licenses. These
changes will ensure that New York State can be granted a CLIA exemption.
If the exemption is not granted, this will create a confusing dual
registration system in New York for clinical laboratories, causing them
to need to apply to two separate programs. The current CLIA exemption
expires in March 2027. The application process for the expiration waiver
opens in May 2026, so getting this legislation done as quickly as possi-
ble allows for the DOH to have time to draft and publish these new regu-
lations and ensure they meet federal requirements.
 
PRIOR LEGISLATIVE HISTORY:
New bill.
 
FISCAL IMPLICATIONS:
None.
 
EFFECTIVE DATE:
This act shall take effect immediately.

Statutes affected:
S8966: 572 public health law, 573 public health law, 575 public health law, 575(2) public health law, 576-a public health law
S8966A: 572 public health law, 573 public health law, 575 public health law, 575(2) public health law, 576-a public health law