Requires each clinical laboratory to have one or more supervisors upon the premises during business hours; provides for such supervisors' qualifications and duties.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A10781A
SPONSOR: Gottfried TITLE OF BILL: An act to amend the public health law, in relation to
clinical laboratory supervision
PURPOSE OR GENERAL IDEA OF BILL:
The purpose of this bill is to statutorily establish the requirements
for clinical laboratory supervision.
SUMMARY OF SPECIFIC PROVISIONS:
Section 1 of the bill amends the public health by adding a new section
576-d that would establish supervision requirements for a clinical lab.
Section 2 is the effective date.
JUSTIFICATION:
Currently, the clinical lab supervision requirements laid out in New
York's Codes, Rules, and Regulations greatly exceed the requirements
contained in the federal Clinical Improvement Act (CLIA). The require-
ment that a supervisor be physically present at all times poses a severe
burden on clinical labs operated both by smaller upstate community
hospitals especially in rural locations - and urban hospital systems
with labs at multiple sites. These clinical labs have severe difficulty
in maintaining adequate staff to operate labs 24 hours a day as neces-
sary to perform critical tests.
Faced with this problem, clinical labs are either forced to operate out
of compliance or hire contract staff at a cost of 2-3 times that of an
employee. This bill would authorize supervision via phone or synchronous
2-way AV communication pursuant to regulations by the Department, and
cap the number of labs a supervisor can oversee at five.
PRIOR LEGISLATIVE HISTORY:
New Bill
FISCAL IMPLICATIONS:
None.
EFFECTIVE DATE:
This act shall take effect immediately.
STATE OF NEW YORK
________________________________________________________________________
10781--A
IN ASSEMBLY
May 18, 2018
___________
Introduced by M. of A. GOTTFRIED -- read once and referred to the
Committee on Health -- reported and referred to the Committee on Codes
-- committee discharged, bill amended, ordered reprinted as amended
and recommitted to said committee
AN ACT to amend the public health law, in relation to clinical laborato-
ry supervision
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new section
2 576-d to read as follows:
3 § 576-d. Clinical laboratory supervision. 1. Each clinical laboratory
4 shall have one or more supervisors who shall, under the general direc-
5 tion of the director, supervise the technical personnel and reporting of
6 findings, perform tests requiring special scientific skills, and, in the
7 absence of the director, be responsible for the proper performance of
8 all laboratory procedures.
9 2. A director who qualifies as provided in regulations promulgated
10 pursuant to section five hundred seventy-three of this title shall also
11 be deemed qualified as a supervisor.
12 3. Depending upon the size and functions of the clinical laboratory,
13 the department may authorize the director to also serve as the supervi-
14 sor of such laboratory.
15 4. The supervisor shall be on the clinical laboratory premises or
16 available by phone or synchronous two-way electronic audio visual commu-
17 nications in accordance with any applicable regulations made by the
18 department; provided, that if the supervisor is not on the laboratory
19 premises and the person performing the test qualifies as a medical tech-
20 nologist as provided in regulations promulgated pursuant to sections
21 five hundred seventy-four and five hundred seventy-six of this title,
22 and thirty-one hundred twenty-one of this chapter, the results of his or
23 her work are reviewed by the supervisor or director during his or her
24 next duty period, and a record is maintained to reflect the actual
25 review; and, provided further, that a supervisor shall not supervise
26 more than five laboratories.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD13946-03-8
A. 10781--A 2
1 5. An individual who qualifies as a supervisor as provided in regu-
2 lations promulgated pursuant to sections five hundred seventy-four and
3 five hundred seventy-six of this title, and thirty-one hundred twenty-
4 one of this chapter shall supervise technical personnel in the specialty
5 of cytology only.
6 § 2. This act shall take effect immediately.
