No. 43468 (Amendment): Rule R386-900. Special Measures for the Operation of Syringe Exchange Programs

(Amendment)

DAR File No.: 43468
Filed: 01/04/2019 01:22:13 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for these amendments are to provide clarification on syringe exchange programs and requirements.

Summary of the rule or change:

These changes clarify the purpose of syringe exchange programs and provide additional clarification on operating requirements for entities operating syringe exchange programs.

Statutory or constitutional authorization for this rule:

• Section 26-7-8

Anticipated cost or savings to:

the state budget:

These revisions provide clarification only and do not add additional requirements to impact the state budget. The Department of Health (Department) is utilizing 1.0 FTE in federal funds to monitor, analyze, and report on syringe exchange programs throughout the state = $54,329.60 (personnel and fringe). The staff time to review and monitor compliance to new requirements would not incur additional state costs beyond the current allocated FTE.

local governments:

These revisions provide clarification only and do not add additional requirements that will impact local governments. May anticipate costs if a local health department chooses to operate a syringe exchange program, including but not limited to: personnel costs, educational materials, syringes, and sharps disposals.

small businesses:

These revisions may impact small businesses currently operating syringe exchange programs who choose to expand syringe services into new counties. Anticipated costs to current small businesses are estimated to be $2,555 for each new service area expansion.

persons other than small businesses, businesses, or local governmental entities:

These revisions provide clarification only, thus there are no requirements that impact persons other than small businesses, businesses, or local government entities.

Compliance costs for affected persons:

These revisions provide clarification only and do not add additional requirements to impact affected persons. Minimal personnel costs for entities operating a syringe exchange program for completing mandatory reporting forms and faxing/emailing forms to the Department.

Comments by the department head on the fiscal impact the rule may have on businesses:

These rule changes provide clarification on the definition of a "syringe exchange program" and provides additional clarification on the operating requirements of a program within a local community.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Epidemiology
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Kassy Keen at the above address, by phone at 801-538-6255, by FAX at , or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

03/04/2019

This rule may become effective on:

03/11/2019

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

$1,749

$1,749

$1,749

Local Government

$0

$0

$0

Small Businesses

$2,555

$2,555

$2,555

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$4,304

$4,304

$4,304

Fiscal Benefits

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$0

$0

$0

Net Fiscal Benefits:

($4,304)

($4,304)

($4,304)

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

These proposed rule amendments are not expected to have any fiscal impacts on non-small business revenues or expenditures. There are zero non-small businesses currently operating as syringe service providers.

 

The Executive Director of the Department of Health, Joseph Miner, MD, has reviewed and approved this fiscal analysis.

 

 

R386. Health, Disease Control and Prevention, Epidemiology.

R386-900. Special Measures for the Operation of Syringe Exchange Programs.

R386-900-1. Authority.

This rule is authorized under Utah Code 26-7-8.

 

R386-900-2. Purpose.

This rule establishes operating and reporting requirements required of an entity operating a syringe exchange pursuant to 26-7-8.

 

R386-900-3. Definitions.

The following definitions apply to this rule:

(1) "Department" means the Utah Department of Health Bureau of Epidemiology Prevention, Treatment and Care Program.

(2) "Syringe exchange" is defined in 26-7-8.

(3) "Operating entity" is defined in 26-7-8.

(4) "HIV" human immunodeficiency virus.

(5) "HCV" hepatitis C virus.

(6) "HBV" hepatitis B virus.

(7) "Opiate antagonist" is defined by Chapter 55, Opiate Overdose Response Act.

 

R386-900-4. Operating Requirements.

(1) [An operating entity shall utilize the department's enrollment form to provide written notice of intent to conduct syringe exchange activities to the department 15 days prior to conducting syringe exchange activities. If an operating entity discontinues syringe exchange activities, written notice shall also be submitted utilizing the department's report form within 15 days of termination of activities to the department.]An operating entity intending to begin syringe exchange programming within a local community shall meet with local stakeholders, which should include: public health, mental health, substance abuse, law enforcement, local governing body, community councils, etc. This meeting should provide education on the purpose and goals of a syringe exchange program, syringe exchange protocols, awareness of operating entity's plans and community partnerships and will assess community readiness, norms, needs and parameters for implementing syringe exchange in that area. The operating entity shall provide UDOH meeting summary(s) which should include: participants, what was discussed, outcomes and plans for implementation. This documentation must be submitted for each major area where exchange will be conducted upon enrollment and submitted 30 days prior to the initiation of syringe exchange program operation in a new area.

(2) An operating entity shall utilize the department's enrollment form to provide written notice of intent to conduct syringe exchange activities to the department 15 days prior to conducting syringe exchange activities. If an operating entity discontinues syringe exchange activities, written notice shall also be submitted utilizing the department's report form within 15 days of termination of activities to the department.

[(2)](3) An operating entity must submit a safety protocol to the department for the prevention of needlestick and sharps injury before initiating syringe exchange activities.

[(3)](4) An operating entity shall submit a sharps disposal plan to the department. Sharps disposal is the financial responsibility of the entity operating and responsible for the syringe exchange program.

[(4)](5) An operating entity shall facilitate the exchange of an individuals used syringes by providing a disposable, medical grade sharps container for the disposal of used syringes.

[(5)](6) [The operating entity shall exchange one or more new syringes in sealed sterile packages to the individual free of charge.]The operating entity shall exchange one or more new syringes in sealed sterile packages and may provide other clean and new prevention materials to the individual free of charge.

[(6)](7) As available, the department will provide syringes, prevention materials, education materials, and other resources to entities operating a syringe exchange program.

[(7)](8) An operating entity must provide and make available to all [recipients of new syringe(s)]clients of the syringe exchange program verbal and written instruction on:

(a) Methods for preventing the transmission of blood borne pathogens, including HIV, HBV and HCV;

(b) Information and referral to drug and alcohol treatment;

(c) Information and referral for HIV and HCV testing; and

(d) How and where to obtain an opiate antagonist.

 

R386-900-5. Reporting Requirements.

(1) All entities operating a syringe exchange program shall report aggregate data elements in accordance to 26-7-8 to the department on a quarterly basis, utilizing the format provided by the department which is to include:

(a) Number of individuals who have exchanged syringes,

(b) A self-reported or approximated number of used syringes exchanged for new syringes,

(c) Number of new syringes provided in exchange for used syringes,

(d) Educational materials distributed; and

(e) Number of referrals provided.

 

R386-900-6. Penalty.

(1) Any person who violates any provision of R386-900 may be assessed a penalty as provided in section 26-23-6.

 

R386-900-7. Official References.

(1) Centers for Disease Control and Prevention (CDC), 2016, Program Guidance for Implementing Certain Components of Syringe Services Programs.

(2) Federal Register, Health and Human Services Department, 2011, Determination That a Demonstration Needle Exchange Program Would be Effective in Reducing Drug Abuse and the Risk of Acquired Immune Deficiency Syndrome Infection Among Intravenous Drug Users.

(3) Harm Reduction Coalition, 2006, Syringe Exchange Programs and Hepatitis C.

(4) Harm Reduction Coalition, 2006, Syringe Exchange Programs: Reducing the Risks of Needlestick Injuries.

(5) Substance Abuse and Mental Health Services Administration (SAMHSA), Summary of Syringe Exchange Program Studies.

(6) United States Department of Health and Human Services (HHS), 2016, Implementation Guidance to Support Certain Components of Syringe Services Programs.

(7) World Health Organization (WHO), 2004, Effectiveness of sterile needle and syringe programming in reducing HIV/AIDS among injecting drug users.

 

KEY: syringe exchange programs, needles, syringes

Date of Enactment or Last Substantive Amendment: [November 7, 2016]2019

Authorizing, and Implemented or Interpreted Law: 26-7-8

---