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A10781 Summary:

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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A10781 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
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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A10781 Text:

                STATE OF NEW YORK
                   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.

        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.
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