SF0047 • 2021

Clinical laboratory regulation.

AN ACT relating to professions and occupations; modifying the authority of clinical laboratories as specified; providing exceptions for the collection and testing of human specimens by clinical laboratories; requiring rulemaking authority; and providing for effective dates.

Healthcare

Enacted

This bill passed the Legislature and reached final enactment based on the latest official action.

Sponsor: Senator Case
Last action: 2021-04-05
Official status: enrolled
Effective date: 7/1/2021

Plain English Breakdown

The official source material does not provide details on how clinical laboratories should handle specimens collected by people without medical training.

Clinical Laboratory Regulation

This law changes how clinical laboratories can collect and test human specimens, allowing them to do so at any person's request without needing a licensed physician to collect the specimen.

What This Bill Does

Allows clinical laboratories to examine human specimens when asked by anyone, not just doctors or dentists.
Exempts direct-to-consumer tests from needing a licensed physician to collect the specimen.

Who It Names or Affects

Clinical laboratories that examine human specimens.
Consumers who use direct-to-consumer diagnostic tests.
The Wyoming Department of Health responsible for creating new regulations.

Terms To Know

Direct to consumer test: A diagnostic device sold directly to consumers, where the person uses it themselves to collect and test their own specimen.

Limits and Unknowns

The law does not specify how clinical laboratories should handle specimens collected by people without medical training.
It is unclear what specific rules the Department of Health will create for implementing this act.

Amendments

These notes stay tied to the official amendment files and metadata from the legislature.

SF0047HW001

Committee of the Whole • Representative Larsen

Adopted

Plain English: The amendment changes the wording in a bill about clinical laboratories to allow for more than one exception and to give laboratories more flexibility in certain situations.

Changes 'an exception' to 'exceptions', allowing multiple exceptions instead of just one.
Replaces 'shall' with 'may', giving clinical laboratories more choice or discretion in their operations.

The amendment text does not specify what the new exceptions are, so it's unclear exactly which situations will be allowed under these changes.

SF0047SS001

Standing Committee • Senate Labor, Health and Social Services Committee

Adopted

Plain English: The amendment changes how clinical laboratories can handle human specimens by limiting their examination to requests from licensed professionals and adding exceptions for testing purposes.

Removes the 'direct-to-consumer exception' from the bill's title.
Adds a new section that restricts clinical laboratories to examining human specimens only at the request of authorized medical professionals, but allows them to test samples requested by any person under certain conditions.

The amendment text does not provide full details on how exceptions for testing purposes will be implemented or regulated.

Bills Worth Reading With This One

These pairings are meant to flag bills from the same session that may have a bigger real-world effect when you read them together.

SF0015

SF0015 and SF0047 both address licensing and regulatory issues in healthcare, with SF0015 providing temporary authority for boards to waive or modify statutory requirements under certain conditions, while SF0047 modifies the authority of clinical laboratories.

Medium confidence Needs review

Possible combined effect: SF0015 allows licensing and permitting boards to temporarily waive or modify statutory requirements, which could include those affecting clinical laboratories. SF0047 specifically addresses the regulation of clinical laboratories by allowing them more flexibility in specimen collection and use of diagnostic devices marketed directly to consumers. Together, these bills create a broader framework for temporary regulatory adjustments that can impact healthcare practices.

Why this got flagged:

Both bills address regulatory flexibility in healthcare, with SF0015 providing broader authority for temporary waivers or modifications and SF0047 specifically addressing clinical laboratory practices. Reviewing them together can provide a comprehensive understanding of how these changes interact to affect healthcare regulation.

authorizes licensing and permitting boards to waive or modify statutory requirements as specified
reports are made to the Joint Labor, Health and Social Services Interim Committee
Allows clinical laboratories to collect and examine human specimens at the request of any person
exempts these direct to consumer tests from the requirement that a licensed physician collect the specimen

Bill History

2021-04-05 LSO
Assigned Chapter Number 104
2021-04-05 Governor
Governor Signed SEA No. 0036
2021-04-01 House
H Speaker Signed SEA No. 0036
2021-04-01 Senate
S President Signed SEA No. 0036
2021-04-01 LSO
Assigned Number SEA No. 0036
2021-03-30 Senate
S Concur:Passed 30-0-0-0-0
2021-03-29 Senate
S Received for Concurrence
2021-03-29 House
H 3rd Reading:Passed 59-0-1-0-0
2021-03-26 House
H 2nd Reading:Passed
2021-03-25 House
H COW:Passed
2021-03-23 House
H Placed on General File
2021-03-23 House
H10 - Labor:Recommend Do Pass 9-0-0-0-0
2021-03-17 House
H Introduced and Referred to H10 - Labor
2021-03-09 House
H Received for Introduction
2021-03-08 Senate
S 3rd Reading:Passed 29-0-1-0-0
2021-03-05 Senate
S 2nd Reading:Passed
2021-03-04 Senate
S COW:Passed
2021-03-01 Senate
S Placed on General File
2021-03-01 Senate
S10 - Labor:Recommend Amend and Do Pass 5-0-0-0-0
2021-02-04 Senate
S Introduced and Referred to S10 - Labor
2021-01-12 Senate
S Received for Introduction
2021-01-11 LSO
Bill Number Assigned

Official Summary Text

Bill Summary - 21LSO-0318
Bill No.:

SF0047

Effective:

Multiple Dates

LSO No.:

21LSO-0318

Enrolled Act No.:

SEA No. 0036

Chapter No.:

104

Prime Sponsor:

Case

Catch Title:

Clinical laboratory regulation.

Subject:

Clinical laboratory regulation.

Summary/Major Elements:

Allows clinical laboratories to collect and examine human specimens at the request of any person and does not require a licensed physician from the laboratory to physically collect the human specimen.

Permits the use of diagnostic devices that are marketed directly to consumers, where the consumer initiates the testing process and collects their own human specimen for the purpose of testing and analysis by a clinical laboratory.
E
xempts these direct to consumer tests from the requirement that a licensed physician collect the specimen.

The above summary is not an official publication of the Wyoming Legislature and is not an official statement of legislative intent.

While the Legislative Service Office endeavored to provide accurate information in this summary, it should not be relied upon as a comprehensive abstract of the bill.

Current Bill Text

Read the full stored bill text

21LSO-0318

ORIGINAL Senate

ENGROSSED
File No
.
SF0047

ENROLLED ACT NO. 36,

SENATE

SIXTY-SIXTH LEGISLATURE OF THE STATE OF WYOMING
2021 General Session

Be It Enacted by the Legislature of the State of Wyoming:

Section 1
.

W.S. 33
‑
34
‑
107(a) and by creating a new subsection (e) is amended to read:

33
‑
34
‑
107.

Acceptance, collection, identification and examination of specimens.

(a)

A clinical laboratory
shall
may
examine human specimens
only
at the request of a licensed physician, dentist or other person authorized by law to use the findings of laboratory examinations.
A clinical laboratory may examine human specimens at the request of any person for the purpose of testing and analysis and a licensed physician or other authorized person shall not be required to collect the specimens as provided under subsection (d) of this section.

(e)

Subsection (d) of this section shall not apply to a direct to consumer test. For the purpose of this subsection and as further defined by the department of health, a "direct to consumer test" means a diagnostic device that is marketed directly to consumers, where the consumer initiates the testing process and collects their own human specimen for the purpose of testing and analysis by a clinical laboratory.

Section 2
.

The department of health shall promulgate rules and regulations necessary to implement this act on or before July 1, 2021.

Section 3.

(a)

Except as provided in subsection (b) of this section, this act is effective July 1, 2021.

(b)

Sections 2 and 3 of this act are effective immediately upon completion of all acts necessary for a bill to become law as provided by Article 4, Section 8 of the Wyoming Constitution.

(END)

Speaker of the House

President of the Senate

Governor

TIME APPROVED: _________

DATE APPROVED: _________

I hereby certify that this act originated in the Senate.

Chief Clerk