What's happening
This bill requires each clinical laboratory to have qualified supervision, sets standards for supervisors, and outlines their responsibilities and availability.
Why it matters
Strengthens oversight of clinical labs. By mandating that every clinical laboratory have at least one qualified supervisor, the bill aims to enhance accountability and safety in laboratory practices, potentially reducing errors in test results that could impact patient care.
Clarifies supervisor responsibilities and presence. The bill specifies that supervisors must oversee technical personnel, be responsible for lab procedures in the director’s absence, and be accessible either on-site or via real-time electronic communication, ensuring ongoing expert oversight even when not physically present.
Limits supervisor workload to prevent overextension. By capping the number of laboratories a supervisor can oversee at five, the bill helps ensure supervisors are not stretched too thin, which could otherwise compromise oversight quality and laboratory performance.
Defines qualifications and specialties. The legislation clarifies that only individuals meeting specific regulatory qualifications can supervise, and imposes additional restrictions for those supervising in specialized areas like cytology, reinforcing quality and expertise in sensitive diagnostic fields.
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Who cares
Clinical laboratory operators
Each laboratory would need one or more supervisors, with remote supervision permitted under specified conditions and a limit of five laboratories per supervisor.
Laboratory supervisors and directors
Supervisors would oversee technical staff, reporting and laboratory procedures, while the department could authorize directors to also serve as supervisors depending on laboratory size and functions.
Medical technologists
When a supervisor is off-site, qualifying technologists’ test results would require documented review by the supervisor or director during their next duty period.
Cytology supervisors
Individuals qualifying as supervisors under the regulations cited in the bill would be limited to supervising technical personnel in cytology.
Headline styles
Supervisors Required in Labs
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to health
- Referred to health
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
1808
2019-2020 Regular Sessions
IN SENATE
January 16, 2019
Introduced by Sen. RIVERA -- read twice and ordered printed, and when printed to be committed to the Committee on Health
AN ACT to amend the public health law, in relation to clinical laboratory supervision
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. The public health law is amended by adding a new section 576-d to read as follows:
§ 576-d. Clinical laboratory supervision. 1. Each clinical laboratory shall have one or more supervisors who shall, under the general direction of the director, supervise the technical personnel and reporting of findings, perform tests requiring special scientific skills, and, in the absence of the director, be responsible for the proper performance of all laboratory procedures.
2. A director who qualifies as provided in regulations promulgated pursuant to section five hundred seventy-three of this title shall also be deemed qualified as a supervisor.
3. Depending upon the size and functions of the clinical laboratory, the department may authorize the director to also serve as the supervisor of such laboratory.
4. The supervisor shall be on the clinical laboratory premises or available by phone or synchronous two-way electronic audio visual communications in accordance with any applicable regulations made by the department; provided, that if the supervisor is not on the laboratory premises and the person performing the test qualifies as a medical technologist as provided in regulations promulgated pursuant to sections five hundred seventy-four and five hundred seventy-six of this title, and thirty-one hundred twenty-one of this chapter, the results of his or her work are reviewed by the supervisor or director during his or her next duty period, and a record is maintained to reflect the actual
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD03863-01-9
S. 1808 2
review; and, provided further, that a supervisor shall not supervise more than five laboratories.
5. An individual who qualifies as a supervisor as provided in regulations promulgated pursuant to sections five hundred seventy-four and five hundred seventy-six of this title, and thirty-one hundred twentyone of this chapter shall supervise technical personnel in the specialty of cytology only.
§ 2. This act shall take effect immediately.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the public health law, in relation to clinical laborato- ry supervision
Purpose
To amend the Public Health Law, in relation to statutorily establishing the requirements for clinical laboratory supervision.
Summary of provisions
Section one of the bill amends the Public Health Law by adding a new section 576-d that would establish supervision requirements for a clin- ical laboratory.
Section two of the bill establishes 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 find severe difficulty in maintaining the adequate staff to operate labs 24 hours a day, as is necessary to perform critical tests.
Faced with this problem, clinical labs are forced to either 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.
Legislative history
New bill.
Fiscal implications
None.
Effective date
This act shall take effect immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.