|SAME AS||SAME AS S07521-A|
|Add §576-d, Pub Health L|
|Requires each clinical laboratory to have one or more supervisors upon the premises during business hours; provides for such supervisors' qualifications and duties.|
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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.
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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. LBD13946-03-8A. 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.