Current through 2024-38, September 18, 2024
A.
Filing
of Application
Any person or other entity desiring certification to operate
a Syringe Services Program must, prior to the commencement of such operation,
file an application for certification with the Department. Applications
submitted on behalf of a corporation or association must be made by any two
officers thereof or by the Administrator of the Program. Applicants must submit
one copy of the full application. Previously certified applicants who relocate
to a new site within their current geographic area of certification must submit
all information related to Section
2(B), to the
Department, in lieu of a full application.
The Certification Review Team will review the application
and within thirty (30) working days thereof forward their advisory
recommendations to the director of the Maine CDC. The director will issue a
final decision regarding certification within ten (10) working days of receipt
of the Review Team's recommendations. The director or designee must send notice
of program certification to the Maine Department of Public Safety, the Maine
Drug Enforcement Agency and appropriate law enforcement agencies, within ten
(10) working days of certification or change in certification.
B.
Contents of
Application
Each application must contain:
1. The name by which the Program is to be
legally known and the name under which it will be doing business.
2. For proprietary corporations: the full
name and address of each person, firm or corporation having (directly or
indirectly) an ownership interest of 5% or more in the Program;
3. For business entities with one owner or
business partnerships: the full name and address of each partner;
4. For not-for-profit organizations: the full
name and address of the President of the Board of Directors or appropriate
municipal government representative;
5. The name, home address, home telephone
number and office telephone number of the individual designated by the
applicant as the administrator of the Program.
6. A description of all facilities utilized
by the Program, including all locales and venue(s) for mobile service. This
description must include the address (es), telephone number(s), and name of the
owner(s) of all buildings utilized by the Program. All branches and subunits
must be identified by address (es), telephone number(s), and identifying
names.
7. The names, addresses, and
dates of birth of all staff of a Syringe Services Program.
8. The hours of operation for all branches,
subunits and locales if mobile service.
9. An approved letter of registration with a
valid biomedical waste generator number from the Maine Department of
Environmental Protection, to demonstrate compliance with 38 MRS §1319- O(3) and any applicable
rules for the handling and disposal of biomedical waste.
C.
Additional Application
Information
Each application must also include:
1. A copy of a Program's Consumer
Confidentiality Protocol.
2. A copy
of a Program's Consumer Education and Referral Plan.
3. A copy of a Program's Needle or Syringe
Disposal Plan.
4. A copy of a
Program's Staff Training Plan.
5. A
copy of a Program's Data Collection Protocols.
6. Proof of Public Notice.
7. A copy of the Program's Policy and
Procedures Manual.
D.
Suitability of Applicant
In acting upon any application for SSP certification or
recertification, the Department will determine the suitability of the applicant
to operate a Syringe Services Program.
1. A determination of suitability requires
the applicant to demonstrate willingness and ability to operate and manage the
Program in compliance with this rule and all relevant laws. In making this
determination, the Department must consider each of the following factors:
a. Record and reputation for lawful conduct
in business and personal affairs of the corporation, the Administrator and the
management staff over the previous five (5) years, including, but not limited
to, any criminal conviction(s).
b.
Information which relates to the ability to comply with all applicable laws and
regulations.
c. Any information
reasonably related to the ability to provide safe services to the
public.
d. Management and oversight
experience, including the capacity to manage the general operations and staff
of the Program for which the Certification is sought.
e. Experience in the field of health care,
public health, social services or areas related to the provision of HIV or
substance use disorder prevention and treatment.
f. Conduct which demonstrates an
understanding of, and compliance with, consumers' rights and
confidentiality.
E.
Operating Requirements
In operating a Syringe Services Program:
1. Programs must adhere to a distribution
policy that allows the one-for-one exchange of a used syringe for each new
syringe provided to the Consumer. In instances where the Consumer cannot offer
a used syringe to be exchanged, a Program may provide a Consumer with new
syringes as needed, but may not exceed 100 syringes per Consumer per
encounter.
2. The Program may
further limit the number of syringes provided to each Consumer based on its
Policy and Procedures Manual, defined in Section
1(A)(16) and
referenced in Section
2(C) of this
rule.
3. Consumers must enroll in
the Syringe Services Program to receive Syringe Services.
4. Enrolled Consumers may receive Syringe
Services from any certified Program via mobile site or fixed site, regardless
of where the Consumer resides.
5.
Programs may not knowingly distribute syringes to persons less than 18 years of
age.
6. Programs must comply with
all applicable Maine Statutes, rules, and regulations.
7. Programs may furnish new syringes to a new
enrollee when the enrollee exchanges used syringes for new syringes or
disposal. However, a syringe exchange is not required by this rule.
8. Programs may not accept remuneration from
Consumers for delivering Syringe Services.
9. Program staff and their representatives
must carry identification and a copy of their program's certification document
while conducting program business. All mobile units must carry a copy of the
Certification while conducting Program business.
10. Program Consumer enrollment guidelines
must require notifying all Consumers regarding rules and laws applicable to
Syringe Services.
11. Staff hired
at the Syringe Services Program must be trained in confidentiality protocols
and blood borne pathogen infection control including post-exposure protocols.
Staff training must also include HIV prevention education, substance use
disorder treatment education, and any and all training necessary for the safe
and lawful operation of a Syringe Services Program.
F.
Notification Obligation of
Program
1. Each Program will notify the
Maine CDC in writing of any changes in:
a.
Ownership;
b. Relocation or change
of the Program address and telephone number;
c. Administrator, management or staff of the
Program;
d. Operating hours;
and
e. Policy and Procedures
Manual.
2. Each Program
will notify the Maine CDC of all data gathered for the prior year using the
Program Data Collection Protocol. The Maine CDC must receive this data by
November 15 of each and every year of the Program's operation.
G.
Posting of
Certification
The Certification granted by the Department must be
conspicuously posted in the offices of the Administrator of a Program.
H.
Refusal to Certify
The Department will refuse certification of an applicant if
it finds that any or all of the following conditions exist:
1. The Department finds that the information
submitted in the Program's application is incorrect or incomplete;
2. The applicant does not meet all the
requirements of applicable laws and regulations;
3. The applicant or its staff has violated
laws, rules, and regulations pertaining to or in connection with the operation
of a Syringe Services Program in the five (5) years preceding date of
application.
I.
Suspension or Revocation of Certification
1. The Department may suspend or revoke any
certification issued pursuant to 22 MRS ch. 252-A §1341 for:
a. Violation of applicable laws, regulation
and rules; or
b. Conduct
committing, permitting, aiding or abetting any illegal practices in the
operation of a Syringe Services Program; or
c. Conduct detrimental to the welfare of the
Consumers of the Syringe Services
2. Written notice of the Department's
decision must be mailed to the program's last known address.
3. Upon suspension or revocation of a
Certification, the Certification must be immediately surrendered to the
Department and all operations must cease.
4. The Maine CDC will inform law enforcement
agencies and representatives of the Certification Review Team of the
revocations of, or changes in, Program Certification within ten days.
J.
Right of
Inspection
Any duly designated employee of the Department must be
permitted to enter upon and into the premises of any certified Syringe Services
Program. These employees may inspect relevant Program documents to determine
whether the Program is in compliance with these rules and regulations.
Inspections may be announced or unannounced at the sole discretion of the
Department.
K.
Length
of Certification
The Department will certify Programs for a period of up to
five (5) years, pursuant to 22 MRS §1341(2)(H). The
Department will renew Program certification every five years, provided it
determines continued compliance, upon the Program's application for renewal. A
Certification will be considered valid until it expires or is suspended or
revoked by the Maine CDC.
L.
Appeals Procedure
Any person aggrieved by the Department's decision to deny,
suspend or revoke Certification to a Program or SSP applicant may request a
hearing as provided by the Maine Administrative Procedure Act,
5 MRS §9051, et seq. A
request for a hearing must be made in writing within thirty (30) days of the
date that the Department's decision was issued. The request for hearing must be
made in writing to the Maine CDC and must state clearly the reasons for the
request. Hearings will be conducted pursuant to the rules of the Office of
Administrative Hearings, as set forth in the Administrative Hearing
Manual and in conformity with the Administrative Procedure
Act, 5 MRS §8001et seq. Any
person or party dissatisfied with the Administrative Hearings Officer's
decision has the right of Judicial Review under 5 MRS §11001et seq. and
Rule 80C of the
Maine Rules of Civil Procedure.
M.
Records and Review
The Department must be afforded full access to, and the
right to examine and copy, all records, documents and reports required to be
kept by a Program under this rule, at no expense to the Department.
N.
Compliance with All State
and Federal Regulations
The Syringe Services Program and its staff must operate and
furnish services in compliance with all applicable federal and State
regulations.
O.
Change in Ownership of the Syringe Services Program
No certification may be assigned or transferred.