| (1) |
"Administrator" means the person who signs an application for
registration of a Syringe Services Program and bears the ultimate
responsibility for ensuring that the Program operates in compliance with
O.C.G.A. § 16-13-32 and these rules and
regulations. |
| (2) |
"Consumer" means a person who receives assistance through a
Syringe Services Program. |
| (3) |
"Commissioner" means the Commissioner of Public Health. |
| (4) |
"Department" means the
Georgia Department of Public Health. |
| (5) |
"Policies and Procedures
Manual" means a written manual detailing the policies and procedures for
the safe and lawful operation of a Syringe Services Program. |
| (6) |
"Site" means the location(s)
or venue(s) where Syringe Services Programs are offered to Consumers. |
| (7) |
"Staff" means a person who
works for or acts as an agent of a Syringe Services Program, whether
compensated or not. |
| (8) |
"Syringe Services Program" or "Program" means an organization
which provides substance abuse and harm reduction counseling, education, and
referral services for substance abuse disorder treatment; training and
provision of naloxone to reverse opioid overdoses; screening for HIV, viral
hepatitis, sexually transmitted diseases, and tuberculosis; referrals and
linkage to HIV, viral hepatitis, sexually transmitted diseases, and
tuberculosis prevention, treatment, and care services; safer injection
supplies; and evidence-based interventions to reduce negative consequences of
drug related behaviors. |
| (1) |
Any person or entity that operates a
Syringe Services Program shall be registered with the Department. Applications
for registration shall be filed with the Department as specified in Rule
. |
| (2) |
Upon receipt of a complete application,
the Department shall review the application and take action to approve or deny
the registration in accordance with the provisions of O.C.G.A. § 16-13-32 and these rules and
regulations. |
| (3) |
Once issued, a
registration shall be valid for a period of two years or until the biennial
registration date established by the Department. |
Each application for registration of a Syringe Services
Program shall contain:
| (1) |
The legal
name of the Program and the name under which it will be doing
business. |
| (2) |
The name, address,
telephone number, and email address of the Administrator of the Program,
together with:
| (a) |
A signed, notarized
statement attesting that the Administrator accepts full responsibility for
ensuring that the Program operates in compliance with the provisions of
O.C.G.A. § 16-13-32 and these rules and
regulations; and |
| (b) |
All
information necessary for the Department to conduct a fingerprint criminal
background check of the Administrator. The Applicant shall be responsible for
all fees associated with the performance of the background
check. |
|
| (3) |
The address
and telephone number of each Program Site, including both fixed locations with
permanent structures and venues at which services are provided by a mobile
unit, as well as the name, address, and telephone number of the legal property
owner for each fixed location and the Georgia tag number of each mobile
unit. |
| (4) |
The scheduled hours of
operation for all Program Sites, including both fixed locations and mobile
units. |
| (5) |
Documentation showing
that the Program has provided written notice of its intent to establish and
maintain a Syringe Services Program to stakeholders in the community, including
the local governing authority and the local law enforcement agencies with
jurisdiction over each Program Site. The written notice shall include a copy of
the Program's Site security plan. |
| (6) |
A copy of the Program's Policies and
Procedures Manual. |
| (7) |
Such other
information as is deemed necessary by the Department. |
| (1) |
Each Syringe Services Program shall:
| (a) |
Accept and dispose of hypodermic needles
and syringes at no cost to Consumers and in compliance with the U.S.
Occupational Safety and Health Administration's bloodborne pathogen rule,
29 C.F.R. § 1910.1030. |
| (b) |
Furnish new hypodermic needles and
syringes to Consumers at no cost and in quantities sufficient to minimize the
likelihood of reuse. All new hypodermic needles and syringes shall be provided
in sealed sterile packaging. |
| (c) |
Provide Consumers with direct services or referrals and linkages to care for
the following: substance abuse counseling, education, and treatment; training
and provision of naloxone to reverse opioid overdoses; screening, prevention,
treatment, and care services for HIV, viral hepatitis, sexually transmitted
diseases, and tuberculosis; and evidence based interventions to reduce negative
consequences of drug related behaviors. |
| (d) |
Comply fully with the Program's Policies
and Procedures Manual and all applicable federal and state laws and
rules. |
| (e) |
Accept no remuneration
from a Consumer. |
| (f) |
Operate only
from locations of which the Department has been notified and which must be at
least 1,000 feet from any school and any child care learning center licensed by
the Georgia Department of Early Care and Learning. |
| (g) |
Strictly limit the disclosure of
protected health information, including HIV status, in compliance with the
Health Insurance Portability and Accountability Act of 1996 (HIPAA), O.C.G.A.
§ 24-12-21, and all other provisions
of federal and state laws and rules. |
| (h) |
Ensure that all Staff are vaccinated
against or immune to the hepatitis B virus, unless the individual Staff member
has declined the vaccine. |
| (i) |
Ensure physical facilities are clean, sanitary, and appropriately
maintained. |
| (j) |
Be overseen by an
Administrator who has been approved by the Department and has accepted the
responsibility of ensuring that the Program operates in compliance with
O.C.G.A. § 16-13-32 and these rules and
regulations. |
|
| (2) |
Each
Program shall notify the Department via email or other writing within thirty
days of any changes in:
| (a) |
The legal name of
the Program or the name under which it does business; |
| (b) |
The Program Site(s), including both fixed
locations and mobile units and all contact information related
thereto; |
| (c) |
The Administrator of
the Program, including all contact information related thereto; |
| (d) |
The Program's operating hours;
or |
| (e) |
The Program's Policies and
Procedures Manual. |
|
| (3) |
Annually by December 1, each Program shall report the following data to the
Department, in a format specified by the Department:
| (a) |
Aggregated Consumer demographic
information, including age, race, ethnicity, and gender; |
| (b) |
The number of new syringes distributed to
each Consumer in each transaction; |
| (c) |
The number of used syringes returned by
each Consumer in each transaction, including the number of syringes disposed of
and the disposal method; |
| (d) |
The
number of referrals and linkages to care made to HIV, viral hepatitis, STD,
and/or tuberculosis testing, service, and treatment providers; |
| (e) |
The number of Consumers who were tested
for HIV, viral hepatitis, STDs, and tuberculosis through the Program; |
| (f) |
The number of referrals made to substance
abuse treatment providers; |
| (g) |
The
number of needlestick injuries and splash exposures at the Program, if any,
including confirmation that injured individuals received appropriate care
following an incident in accordance with the Program's protocol for management
of needlestick injuries and splash exposures; and |
| (h) |
Such other information as is deemed
necessary by the Department. |
|
| (1) |
Each Program shall develop a Policies and
Procedures Manual for operation of a Syringe Services Program. Such Manual
shall include:
| (a) |
A protocol strictly
limiting the disclosure of protected health information, including HIV status,
in compliance with HIPAA, O.C.G.A. § 24-12-21, and all other provisions
of federal and state laws and rules, accompanied by a protocol for handling
breaches of privacy. |
| (b) |
A plan for
the provision of substance abuse and harm reduction counseling, education, and
referral services for:
| 1. |
Substance abuse
disorder treatment; |
| 2. |
Training and
provision of naloxone to reverse opioid overdoses; |
| 3. |
Screening for HIV, viral hepatitis,
sexually transmitted diseases, and tuberculosis prevention, treatment, and care
services, including immunizations; |
| 4. |
Safer injection supplies; and |
| 5. |
Evidence-based interventions to reduce
negative consequences of drug-related behaviors. |
|
| (c) |
A Site biosafety plan, which shall
include:
| 1. |
Engineering and work practice
controls designed to reduce the likelihood of exposure by Program Staff and
Consumers to bloodborne pathogens and other potentially biohazardous
materials; |
| 2. |
A protocol for the
safe and secure disposal of syringes and related supplies in compliance with
federal and state law; |
| 3. |
A
protocol for the management of needlestick injuries and splash exposures, which
shall include the designation of an exposure manager who must be present during
operating hours, a procedure for Staff to immediately report needlesticks and
splash exposures, and a process for an injured individual to receive
post-exposure prophylaxis or other appropriate medical care; |
| 4. |
A Staff training plan, which shall include
education regarding Universal Precautions, safe handling of syringes,
confidentiality protocols, bloodborne pathogen infection control, and other
subjects deemed necessary by the Department for the safe operation of the
Program. |
|
| (d) |
A Site
security plan, which shall be provided to all law enforcement agencies with
jurisdiction over each Program Site and shall include:
| 1. |
Provisions for reasonable and adequate
security of program Sites, equipment, and personnel; |
| 2. |
Operational procedures to protect
inventory from loss or theft and ensure the secure storage, distribution, and
disposal of syringes; |
| 3. |
Provisions
for the regular retrieval of any syringes or other trash discarded within three
hundred feet of a fixed or mobile Program Site. |
|
| (e) |
A plan for enlisting community support
and addressing community concerns related to the implementation of the Program;
and |
| (f) |
A data collection protocol
for recording the information that must be reported to the Department in
accordance with Rule
. |
|
| (1) |
Any duly designated employee of the
Department shall have the right to enter upon and into the premises of a
Program or Applicant at any time for the purpose of conducting a physical
inspection of the Program Site. A satisfactory inspection demonstrating
compliance with Rule
shall be required prior
to the issuance of an initial registration and upon each biennial
renewal. |
| (2) |
The Department shall
be afforded full access to, and the right to examine and copy, either manually
or by photocopy, all manuals, protocols, records, reports, and other documents
required to be kept by a Program under these regulations, at no expense to the
Department. |
| (1) |
Each Program may renew its registration
biennially by submitting a renewal application and fulfilling all requirements
specified by the Department for renewal, including a physical inspection of the
Program Site. Renewal applications shall be submitted to the Department not
less than 120 days prior to the expiration date of the registration and shall
include updated information regarding:
| (a) |
The
legal name of the Program and the name under which it does business; |
| (b) |
The Program Site(s), including both fixed
locations and mobile units and all contact information related
thereto; |
| (c) |
The Administrator of
the Program, including all contact information related thereto; |
| (d) |
The Program's operating hours;
and |
| (e) |
The Program's Policies and
Procedures Manual. |
|
| (2) |
A
Program registration that is not renewed prior to the expiration date shall be
placed in lapsed status. A lapsed registration may be renewed during the
six-month period immediately following the expiration date, provided that the
Program meets all requirements for renewal. |
| (3) |
A Program registration that is not
renewed within the six-month late renewal period shall be expired and not
eligible for renewal. To regain its registration, the Program shall be required
to reapply for registration as a new applicant. |
| (1) |
The Department
shall grant an application for registration only upon a satisfactory showing
that both the Program and its Administrator are willing and able to operate in
compliance with the Program's Policies and Procedures Manual and all provisions
of these rules. |
| (2) |
The Department
may deny an application for registration or suspend or revoke a registration,
after notice and an opportunity for a hearing, upon a finding that the
Applicant, Program, or Administrator has:
| (a) |
Failed to meet all requirements for Program registration; |
| (b) |
Violated any federal or state law or rule
related to Syringe Services Programs, without regard to whether such violation
is criminally punishable; |
| (c) |
Knowingly made misleading, deceptive, untrue, or fraudulent representations
related to the operation of a Syringe Services Program or on any document
connected therewith, or made a false or deceptive statement to the Department;
or |
| (d) |
Engaged in any practice
harmful to the public which materially affects the ability of the Applicant,
Program, or Administrator to operate a Syringe Services Program or threatens
the public health, safety, or welfare. |
|
| (3) |
In its sole discretion, the Department
may allow a Program an opportunity to correct alleged deficiencies prior to
initiating the suspension or revocation of a registration, in accordance with
the following procedures:
| (a) |
The Department
shall provide written notice to the Administrator, via email and first class
U.S. mail to the Administrator's address on file with the Department, of the
Program's alleged deficiencies. Notice shall be complete upon
mailing. |
| (b) |
Within thirty calendar
days of the notice, the Program shall develop and submit to the Department a
written corrective action plan to address the deficiencies. The corrective
action plan shall include: |
| (c) |
Steps required to correct the deficiencies; and |
| (d) |
A deadline of no more than ninety
calendar days for completion. |
| (e) |
If the Department, in its sole discretion, approves the corrective action plan,
the Program shall implement the plan. The Department may conduct a Site
inspection at any time during the implementation period. If the Department
determines, in its sole discretion, that the deficiencies have been corrected,
no further action shall be taken. |
| (f) |
If the Program fails to submit a
sufficient corrective action plan, fails to correct the deficiencies as
specified in the corrective action plan, or if the Department determines for
any reason that a corrective action program is no longer appropriate, the
Department may take action to suspend or revoke the Program's
registration. |
|
| (4) |
Procedures for the denial of an application or suspension or revocation of a
Program registration.
| (a) |
The Department
shall provide written notice to the Program's Administrator, via email and
certified mail to the Administrator's address on file with the Department, of
the denial of the Program's application or the suspension or revocation of the
Program's registration and the grounds therefor. Notice shall be complete upon
mailing. |
| (b) |
The denial,
suspension, or revocation shall become effective twenty days after notice is
complete, unless the Program submits a timely request for a hearing; provided,
however, that a Program registration may be suspended immediately, prior to a
hearing, upon a written finding set forth in the notice that the public health,
safety, or welfare imperatively require emergency action. All hearing requests
must be delivered to and received by the Director of the Syringe Services
Program no later than thirty days after notice is complete. |
| (c) |
The Department shall refer a timely
request for a hearing to the Office of State Administrative Hearings within
thirty days after receipt, unless the Department and the Program agree
otherwise. After thirty days from the Department's receipt of the hearing
request, the Program may petition the Office of State Administrative Hearings
for an order permitting the request to be filed directly with the Office of
State Administrative Hearings. |
| (d) |
At least one year shall pass from the date of denial of an application before
the Department will consider a new application for registration. At least two
years shall pass from the date of revocation of a registration before the
Department will consider a new application for registration; provided, however,
that a Program whose registration was revoked for failure to renew may submit a
new application prior to the expiration of the two-year waiting
period. |
|
