Professional Documents
Culture Documents
Compassionatcaresouth Redacted
Compassionatcaresouth Redacted
By Hand Delivery
William J. Thomas
President & CEO
TABLE OF CONTENTS
TABLE OF CONTENTS
INTRODUCTION .............................................................................................................................................1
The Compassionate Care Foundation Inc. (“Compassionate Care”) very much appreciates the
opportunity to submit this application for a permit from the State of New Jersey in response to
DHSS RFA #3683_001 (“RFA”). We seek a permit to cultivate and dispense medicinal cannabis
in Bellmawr, New Jersey. We are simultaneously submitting additional permit applications to
operate Alternative Treatment Centers (“ATC”) in the state’s Central and Northern Regions.
Compassionate Care is a non-profit corporation organized under the State of New Jersey with the
mission of providing therapeutic pain relief to patients in need and conducting research into the
effectiveness of medicinal cannabis for the individuals and communities we serve. Founded in
2011, Compassionate Care is lead by a Board of Directors whose members are medical
professionals, former health department regulators, community leaders, and researchers. They
are committed to providing New Jersey patients with safe and affordable medicinal cannabis.
The organization of this application mirrors the structure of the RFA – a section for each
criterion, and within that, a subsection for each measure. Thus, Section 1 provides information
requested about the applicant (Compassionate Care) and the cultivation facility and patient care
center for which we are seeking this permit. Section 2 describes requested information about our
operating plans, policies, and funding. Section 3 describes our proposed methods for obtaining
the input and support of our host communities (from members of the public as well as local
government entities). Section 4 details more specifically the patient care, data collection,
security, and educational programs and procedures we will use in operating these facilities and
the interface between this cultivation center and our patient care center. Section 5 focuses on our
cultivation procedures. Section 6 contains eleven appendices (e.g., zoning compliance documents
and letters of support from local communities).
1
INTRODUCTION
This proposal will specifically articulate our knowledge of and conformance with the State of
New Jersey’s medical cannabis program and addresses, item by item, the requirements under the
Request for Applications. In summary, this application demonstrates the reasons why
Compassionate Care is unsurpassed in the experience, capabilities, and qualifications needed to
operate an ATC. Based upon these attributes and the information contained in the remainder of
the document it is our hope that the reviewers will consider our organization for a permit to
operate an ATC for medical cannabis in the south section of State of New Jersey.
2
CRITERION 1
CRITERION 1 ‐ INFORMATION REGARDING APPLICANT & FACILITY
Measure
1:
The
applicant
shall
provide
the
proposed
legal
name
and
the
following
documents
applicable
to
the
applicant’s
legal
status.
Supporting
documents
should
be
included
as
Appendix
A.
▪ Certificate
and
Articles
of
Incorporation
and
By‐Laws
for
corporations
▪ Organizing
documents
for
associations
▪ Evidence
of
nonprofit
status
▪ Certificate
of
good
standing
issued
by
the
New
Jersey
Secretary
of
State
The proposed legal name of our entity is Compassionate Care Foundation, Inc. We have
attached the following supporting documents:
• Certificate of Incorporation of Compassionate Care Foundation, dated February 4,
2011
• By-Laws for Compassionate Care Foundation, dated February 9, 2011
• Certificate of Good Standing for Compassionate Care Foundation, issued by the
New Jersey Secretary of State on February 7, 2011
• Business Registration Certificate1
Measure
2:
The
applicant
shall
provide
the
proposed
physical
address(es)
of
the
ATC,
if
a
precise
address
has
been
determined.
Supporting
documents
should
be
included
as
Appendix
B.
▪ For
each
proposed
physical
address,
the
applicant
shall
provide
legally
binding
evidence
of
site
control
(e.g.,
deed,
lease,
option,
etc.)
sufficient
to
enable
the
applicant
to
have
use
and
possession
of
the
subject
property
including,
but
not
limited
to,
length
of
term
of
use
and
possession.
▪ If
the
applicant
intends
to
cultivate
medicinal
marijuana
at
one
physical
address
and
dispense
it
at
another,
both
facilities
shall
be
located
within
the
same
region
as
defined
in
Subchapter
1
of
N.J.A.C.
8:64,
the
Rules
Related
to
the
Medicinal
Marijuana
Program.
▪ If
a
precise
address
has
not
been
determined,
the
applicant
shall
identify
the
general
location(s)
where
the
facilities
would
be
sited,
and
when.
Compassionate Care plans to operate its cultivation and patient care center at separate
locations within the same region, as follows:
1
Evidence of Compassionate Care’s nonprofit status is included in its Bylaws and Certificate of
Incorporation. Compassionate Care is in the process of filing for its business registration
certification. This process will be complete by April 4, 2011.
3
CRITERION 1
Measure 2 Response cont’d
b) Patient Care Center. While we have not selected the precise address of our patient
care center, it will be located in the same municipality and in the same region as
our cultivation facility, as defined in N.J.A.C. 8:64-1.2. If awarded a permit, we
will identify and secure the final site for the patient care center within thirty (30)
days from permit approval.
Measure
3:
The
applicant
shall
provide
evidence
of
compliance
with
the
local
zoning
laws
for
each
address
or
proposed
location
for
an
ATC.
If
the
current
zoning
is
not
appropriate
for
a
given
address
or
location,
identify
any
required
zoning
variance(s)
and
the
applicant’s
actions
taken
to
date
to
obtain
such
approval(s)
and/or
variance(s).
Supporting
documents
should
be
included
as
Appendix
C.
Compassionate Care's cultivation facility will be located in the Heavy Industrial Zone
District of the Borough of Bellmawr. While the code does not specifically address our
proposed use of harvesting and packaging medical cannabis, we will make the appropriate
site plan /variance applications if required by the Township in order to secure a certificate of
occupancy. In addition, we will locate our patient care center in an area consistent with the
zoning requirements for the area. We currently do not anticipate any major zoning variance
request or approvals needed for the patient care center.
Measure
4:
The
applicant
shall
provide
evidence
that
all
of
the
physical
addresses
and
proposed
locations
provided
in
response
to
Measure
2
are
not
located
within
a
drug‐free
school
zone.
The
applicant
shall
provide
the
distance
to
the
closest
school
from
the
ATC.
Supporting
documents
should
be
included
as
Appendix
D.
Community safety is a top priority for Compassionate Care. Our cultivation facility is not
located within a drug-free school zone. The closest distance to a school is 0.9 miles. We
also will select a patient care center location that is not located within a drug-free school
zone. We have provided a table showing distance to the closest school and other select
locations as defined in the regulations.
4
CRITERION 1
Measure
5:
The
applicant
shall
provide
a
legible
map
or
maps
of
the
ATC
service
areas
by
Zip
Code
to
be
served
by
the
ATC.
Supporting
documents
should
be
included
as
Appendix
E.
We have attached a legible map with zip codes of the areas that will be served by our patient
care center. In order to provide access for the largest number of those in need,
Compassionate Care will welcome and be prepared to serve all registered patients residing in
any of the counties in the region as defined in the New Jersey Compassionate Use Medical
Marijuana Act (the “Act”).
Measure
6:
The
applicant
shall
provide
the
role,
qualifications,
name,
address
and
date
of
birth
of
each
staff
member
and
the
role,
name,
percentage
interest,
address
and
date
of
birth
of
each
principal,
officer,
board
member
or
partner
of
the
ATC.
In
the
event
that
an
individual
has
not
yet
been
identified,
a
statement
of
required
qualifications
and
position
description
shall
be
included
as
Appendix
F.
WILLIAM J. THOMAS
Mr. Thomas has spent the last 41 years developing methods for
delivering healthcare at affordable prices while maintaining the
highest levels of quality. He has demonstrated on many
occasions that he can build and maintain a large organization.
Since selling his consumer-focused health insurance company in
2007, he has been working with the application of social media
to improve the quality and cost of healthcare. In 2009, he started
working as the lead researcher for the Leapfrog Due Diligence
Cooperative. Membership includes the New Jersey Health Care
Quality Institute and many New Jersey companies and unions.
The focus of his research has been the comparative effectiveness of disease management
vendors, prescription benefit managers, and wellness companies. Mr. Thomas was asked to
serve on the board because of his experience with the delivery of health care services and his
ability to grow organizations from the ground up.
5
CRITERION 1
Measure 6 Response cont’d
DAVID KNOWLTON
Mr. Knowlton is the CEO of the New Jersey Healthcare Quality
Institute, a nonprofit health care think tank. The Board of the
Institute includes all of the major health care stakeholders in
New Jersey. Mr. Knowlton is the former Deputy Health
Commissioner of New Jersey and is currently the National
Chairman of the Leapfrog Group, a nonprofit health care
research organization. Leapfrog is an employer member-driven
nonprofit representing over 2,200 employers, including the New
Jersey Health Care Payers Coalition. Mr. Knowlton was asked
to serve on the Board because of his knowledge of the healthcare needs of New Jersey and
his experience with managing nonprofit organizations.
JAMES C. HERRMANN
Mr. Herrmann is the President of James C. Herrmann &
Associates, Ltd., (JCH), a full service insurance agency and
brokerage located in Rockville Centre, New York. Mr.
Herrmann began his insurance career in 1986, specializing in
healthcare professional liability and financial services. Today,
these two areas represent a significant portion of JCH’s
business. JCH insures numerous health care facilities,
physicians, and nonprofit agencies. JCH also maintains a large
presence in the construction and real estate industries,
representing contractors, developers, and real estate companies.
Mr. Herrmann was a Captain in The Rockville Centre Volunteer Fire Department, the past
President of the Friends of Mercy Medical Center, and a former board member of Mercy
Medical Center and Our Lady of Consolation Nursing Home. He is currently a member of
the Board of Trustees of the Long Island Power Authority, the State University of New York
College at Old Westbury Foundation, the United Cerebral Palsy Association of Nassau
County, and the Long Island 9/11 Memorial. Mr. Herrmann was asked to serve on the Board
because of his extensive experience with risk management and his knowledge of nonprofit
operations.
6
CRITERION 1
Measure 6 Response cont’d
JEFFERY WARREN
Mr. Warren has more than 30 years of healthcare leadership
experience, including government, hospital administration,
philanthropy, consulting, and work in the pharmaceutical
industry. Mr. Warren is a principal with JR Market Strategies,
LLC, a healthcare consulting firm. Most recently, he served as
a senior advisor/consultant to the National Pharmaceutical
Council (NPC). Prior to NPC, Mr. Warren was responsible for
strategic marketing and media relations for Pfizer Health
Solutions. Earlier in his career, he was Executive Vice
President of Corporate Development for Cathedral Healthcare
System. During his tenure with Cathedral, Mr. Warren was a National Program Director for
the Robert Wood Johnson Foundation’s New Jersey Health Services Development Program.
Mr. Warren’s past experience includes tenure as Vice President of Corporate Development
with the Hackensack Medical Center. He also was named the first Executive Secretary to the
New Jersey Hospital Rate Setting Commission. Mr. Warren was asked to serve on the Board
because of his knowledge of the pharmaceutical industry and New Jersey healthcare issues,
and because of his service on nonprofit boards.
7
CRITERION 1
Measure 6 Response cont’d
JOANN LANGE
Ms. Lange has an extensive background in consumer
communications and marketing. She has worked on projects for
several pharmaceutical companies and an education company
serving healthcare providers. On one project she drove the
creation and the verification of a consumer database for use by
such clients as Pfizer and Astra-Zeneca. The database tracked
medical conditions for more than two million consumers.. Ms.
Lange is also on the Board of the Robotic Education
Foundation. Ms. Lange received an MBA from Harvard
University. Ms. Lange was asked to serve on the Board because
of her expertise in educating health care consumers and providers.
MARK DUMOFF
Mr. Dumoff is the President of Healing Spaces, Inc., a 501(c)3
nonprofit corporation he founded in 2005. The mission of
Healing Spaces is to “Bring Healing to the Home” by creating
“Dream Bedrooms” that enhance the spirit and quality of life
for children from underprivileged families in New Jersey who
are fighting cancer and other serious illnesses. Healing Spaces
partners with leading pediatric oncology hospitals in New
Jersey such as Tomorrow Children’s Institute at Hackensack
University Medical Center, Children's Hospital of New Jersey
at Newark Beth Israel Medical Center, and the Bristol-Myers Squibb Children's Hospital at
Robert Wood Johnson University Hospital. Mr. Dumoff also is CEO and President of
Relational Insights, Inc. (aka DocInsight), a health information technology strategy,
development, and services company. DocInsight is focused on patient experience
measurement and enhanced care coordination within a Patient Centered Medical Home and
Accountable Care Organization setting. Mr. Dumoff was asked to serve on the Board
because of his experience with managing a nonprofit and for his expertise in assessing and
surveying patient experience.
Our President and Chief Executive Officer, Mr. William Thomas is in place. We have
attached other key staff position descriptions and information requested regarding the role,
qualifications, name, address, and date of birth of each staff member, as well as the role
name, percentage of interest, address, and date of birth of each principal, officer, board
member, or partner of Compassionate Care.
8
CRITERION 1
Measure
7:
Disqualifying
Drug
Offenses:
In
considering
any
application
for
an
ATC
permit,
an
applicant
must
disclose
and
the
Department
shall
consider,
at
a
minimum,
the
following
factors
in
reviewing
the
qualifications
of
those
persons
applying:
▪ Whether
the
applicant
or
any
staff
member,
principal,
officer,
board
member
or
partner
has
been
convicted
under
any
Federal,
state
or
local
laws,
relating
to
drug
samples,
wholesale
or
retail
distribution,
or
distribution
of
a
controlled
substance
▪ Whether
the
applicant
or
any
staff
member,
principal,
officer,
board
member
or
partner
has
been
convicted
of
a
felony
under
any
Federal,
state
or
local
laws
▪ The
past
experience
in
the
manufacturing
or
distribution
of
drugs
or
controlled
substances
by
the
applicant
or
any
staff
member,
principal,
officer,
board
member
or
partner
▪ Whether
the
applicant
or
any
staff
member,
principal,
officer,
board
member
or
partner
has
ever
furnished
false
or
fraudulent
material
in
any
application
concerning
drug
manufacturing
or
distribution
▪ Whether
the
applicant
is
in
compliance
with
any
previously
granted
professional
health
license
or
registration,
if
any
▪ Any
other
factors
the
Department
might
consider
relevant
Compassionate Care is committed to the highest ethical standards, patient safety, and
transparency in its operations and business practices. Based upon preliminary background
checks, our staff members, principals, officers, board members, and partners do not have any
potentially disqualifying drug or other criminal offenses. In addition, to the extent
applicable, all are, and will continue to be, in compliance with previously granted
professional health licenses and registrations. Finally, each principal, director, board
member, owner, and employee will be required to provide written consent to submit to a
criminal history record background check pursuant to N.J.S.A. 24:61-4. To ensure
transparency, the entire background check process will be conducted by an outside,
independent third-party agency. We will immediately notify the Department of Health (the
“Department”) if any principal, officer, board member, or employee has any disqualifying
drug offenses or other reportable events as defined by the Department.
Measure 8: The applicant shall provide the identities of all its creditors, if any.
Compassionate Care does not currently have any creditors. All start-up costs have been
incurred by one or more of Compassionate Care’s Board members. See financial statements
that set forth categories of future creditors.
9
CRITERION 1
Measure
9:
The
applicant
shall
provide
a
list
of
all
persons
or
business
entities
having
direct
or
indirect
authority
over
the
management
or
policies
of
the
ATC.
Compassionate Care is managed by its officers/key staff and Board of Directors. No other
person or business entity has a direct or indirect authority over the management or policies of
Compassionate Care. The name of the President and Chief Executive Officer is William
Thomas. The current names of the Board members responsible for the management of
Compassionate Care are:
• William J. Thomas
• David Knowlton
• James C. Herrmann
Measure
10:
The
applicant
shall
provide
a
list
of
all
persons
or
business
entities
having
an
indirect
interest
in
the
ATC.
An
indirect
interest
includes
an
interest
in
the
land
or
building
where
the
ATC
will
be
sited.
The landlord for Compassionate Care will be Albert E. Price, Inc., which does not have any
interest or ownership in Compassionate Care. If granted a permit, Compassionate Care
anticipates having several categories of third-party vendors to provide management, security,
scientific, and other professional functions. We have provisionally identified vendors for
specific services, including the following:
• Security: Henry Brothers Electronics and Universal Safety Response
• Product Safety Testing: CW Analytical
• Hydroponic Supplies/Cultivation Oversight: weGrow Enterprises, Inc.
• Accounting Firm: Lynn Elliott
• Transportation Security Services: Dunbar Armored
Measure
11:
The
applicant
shall
include
the
required
application
cover
sheet
and
attestation
statement
signed
by
its
chief
executive
officer
or
other
individual
authorized
to
make
legally
binding
commitments
on
its
behalf.
10
CRITERION 2
CRITERION 2 ‐ OPERATIONAL INFORMATION
Measure
1:
The
applicant
shall
provide
a
draft
operations
manual
and
training
plan
which
demonstrates
compliance
with
Subchapter
9
of
N.J.A.C.
8:64,
the
Rules
Related
to
the
Medicinal
Marijuana
Program
and
which
addresses
ATC
General
Administration
Requirements
for
Organization
and
Recordkeeping.
Supporting
documents
should
be
included
as
Appendix
G.
To compliance with Subchapter 9 of N.J.A.C 8:64, we have addressed all of the specific
requirements in our Operations Plan. Because of the confidential and proprietary nature of
our Operations Plan and Training Manual, we have provided all additional documentation
that would ordinarily be included in our Operations Plan as separate appendices for sampling
purposes. Full copies are available for review in hardcopy, at the Department’s request.
Appendix G: Operations Plan and Training Manual (For compliance with Subchapter 9)
Appendix H: Security Plan (Available for full view)
Appendix I: Employee Training Manual
Appendix J: The Health Insurance Portability and Accountability Act (HIPAA) Manual
Appendix K: Human Resources Manual
Appendix L: Cultivation Overview
Appendix M: Hydroponic Design
Appendix N: Product Safety Plan
Appendix O: Fire Safety Plan
Appendix P: Environmental Plan
Measure
2:
The
applicant
shall
provide
a
description
of
how
the
ATC
will
operate
on
a
long‐
term
basis
as
a
not‐for‐profit
entity
and
a
business
plan
that
includes,
at
a
minimum,
the
following:
11
CRITERION 2
Measure 2 Response cont’d
Measure
2‐I:
The
applicant
shall
provide
a
detailed
description
about
the
amount
and
source
of
the
equity
and
debt
commitment
for
the
proposed
ATC.
a) The
immediate
and
long‐term
financial
feasibility
of
the
proposed
financing
plan;
b) The
relative
availability
of
funds
for
capital
and
operating
needs;
and
c) The
applicant’s
financial
capability.
a) THE IMMEDIATE AND LONG‐TERM FINANCIAL FEASIBILITY OF THE PROPOSED FINANCING PLAN
We have compiled comprehensive financial statements that show the immediate and long-
term financial feasibility of our proposed financing plan.
Because of the confidential and proprietary nature of our full business plan, complete copies
are available for review in hardcopy, at the Department’s request.
b) THE RELATIVE AVAILABILITY OF FUNDS FOR CAPITAL AND OPERATING NEEDS
Metropolitan Financial Solutions has blocked and held in support funds for our capital and
operating needs as evidenced in the financial commitment letter provided. See Criterion 2,
Measure 2-I.
12
CRITERION 2
Measure 2‐I Response cont’d
c) THE APPLICANT’S FINANCIAL CAPABILITY
Measure
2‐II:
The
applicant
shall
provide
a
copy
of
its
proposed
policy
regarding
charity
care/servicing
indigent
patients.
Compassionate Care has two basic charitable missions. The first is to provide high quality
medicine to patients in need. The second is to expand the understanding of the clinical effects
of medicinal cannabis and how it should be used in the treatment of different diseases and
conditions. This section briefly summarizes Compassionate Care’s basic approach to our
charitable missions, but it should be understood that our board and management will be
refining our charitable programs on an ongoing basis in response to our experience and
evolving patient and community needs.
As mentioned above, our first charitable mission is to provide the best quality medical
cannabis to patients who can benefit from this treatment. In our cultivation facility we will
use state-of-the-art horticultural equipment and methods as well as scrupulous hygienic
practices to ensure our product is safe and healthful. In our patient care center we are
dedicated to providing informed and caring patient education with exceptional customer
service. We aim to be recognized as the industry leader in our field and will leverage
systematic patient feedback and ongoing dialogue with the medical community to
continuously improve our products and services.
An important aspect of our patient care mission is our commitment to increase access to
medical cannabis for those who are medically underserved. Most immediately we recognize
that people with chronic or terminal illness often have limited financial means, frequently
made worse by the loss of ability to work and the expenditure of income on expensive
medical and custodial care. We will need to refine the details, but we intend to make
generous provisions for patients who need but cannot afford our product or the specialty
equipment to consume it. Access issues for medical cannabis are especially pronounced
because cannabis is currently a self-pay drug product. Neither public nor commercial insurers
provide any subsidies or reimbursement to patients electing to use this medicine. With our
board’s experience in the health care and insurance industries, we expect to bring forth
research that will persuade third-party payers to reimburse patients using medical cannabis
for conditions for which it has been shown to be clinically efficacious, safe, and cost-
effective in comparison to alternative therapies.
13
CRITERION 2
Measure 2‐II Response cont’d
This leads us to Compassionate Care’s research mission. At the present time there is clear
and convincing evidence that cannabis is a safe and effective product for many patients, but
we do not yet have the level of knowledge that would allow physicians to confidently guide
patients on the maximum benefits associated with use of the product. Experts in the field of
pain management agree that cannabis is one of the least addictive of currently available
therapies and has fewer serious risks and toxicities than other drugs, but further research and
education on these issues is needed to rectify long-standing misperceptions about the relative
safety of cannabis. The National Institutes of Health has recently announced a new grant
program for research on the clinical effectiveness of cannabis, and Compassionate Care is
applying for one of these grants, conditioned on our success in obtaining a permit for one or
more patient care centers. Whether we obtain a grant or not, we will use a portion of the
funds from sales to conduct our own research on these matters. We will be eager to work
with the Department and other state agencies to document New Jersey patients’ experiences
with medical cannabis so this knowledge can be used to inform future regulatory policies and
practices.
You can see from reviewing the profiles of members of our Board and our independent
Medical Advisory Board (see below) that we are very serious about research. The key to
gathering the data we need on effectiveness is to obtain patient participation. We need
patients to report their experience with the drug. We need to know how the use of specific
strains and strengths of the drug affects symptoms such as pain and nausea. Since our
organization is new and therefore unknown to the patient population of New Jersey, we will
need the support of the longstanding patient advocacy organizations and charities. To this
end we have reached out to charities such as Gilda’s Club and other similar organizations.
We intend to provide funding to these organizations to advance the understanding of
medicinal cannabis. In return we have asked that they encourage their medical cannabis-
using clients to participate in our outcomes studies. Some of their clients who use medicinal
cannabis will already be known to us because they are also our clients. Therefore, there is no
breach of confidentiality. We anticipate the charities will give us general support, not
specific client interaction. We are not suggesting that they recommend using medical
cannabis. We only need their assistance in encouraging their clients to participate in the
research.
These patient support organizations will be natural places for us to distribute educational
information about medicinal cannabis. There are special organizations such as the Children’s
Cancer Network where distributing information about the use of this drug in patients under
the age of 18 will be critical. There are other organizations such as the New Jersey Health
Care Quality Institute, the New Jersey Nurses Association, the New Jersey Medical Society,
the New Jersey Hospital Association, and the New Jersey Healthcare Payers Association
where there are opportunities for education and support. We will offer our experts and Board
members the opportunity to meet with these organizations and their members to discuss the
use and effectiveness of this drug. Our Board members have worked with all of these
organizations in the past either as members, supporters, or board members.
14
CRITERION 2
Measure 2‐II Response cont’d
We will also reach out with education to employers because they may have employees who
are using the drug and the employers should be aware of its effects on employee
performance. Employers may also elect to fund the prescriptions in their benefit plan if we
can show through comparative effectiveness research that medical cannabis is more cost
effective.
To facilitate our interaction with charities and other important organizations we have asked
current board members of charities to participate in a Charitable Research Support
Committee. This committee will be headed by Mr. Kenneth Merin, the former New Jersey
Insurance Commissioner and current President of the Charles Hayden Foundation.
Measure
2‐III:
The
applicant
shall
provide
a
copy
of
its
proposed
policy
related
to
disposal
of
returned
or
unusable
marijuana.
Compassionate Care has developed a return policy based on our principles and our
understanding of the Medical Marijuana Program (the “MPP”). We anticipate that aspects of
the return policy may be revised as the Department further clarifies the rules of the Program.
Compassionate Care’s policy on unused or returned medication is guided by three orienting
objectives:
• Ensure product safety issues are promptly identified, analyzed, and corrected;
• Provide excellent value and service to our patients; and
• Minimize opportunities for diversion
Before a batch of medicinal cannabis is packaged, a sample will be tested in our laboratory
for pests, molds, and other contaminants, and we will also analyze the cannabinoid profile of
product (details are provided in Criterion 5, Measure 3). Any medicinal cannabis found to be
deficient, whether because of mold, excessive THC, or other issues, will be incinerated. In
addition, excess inventory will periodically be destroyed to prevent any unauthorized use or
distribution. An on-site incinerator in a secure room of the facility will be used for this
purpose.
15
CRITERION 2
Measure 2‐III Response cont’d
If a patient or caregiver returns product claiming that it is defective, our staff will complete a
report on the complaint and take possession of the returned product. The returned product
will be weighed, and if the returned product is >50% of the volume purchased, the customer
will be eligible for a full refund of the purchase price. Also, the customer may apply the
value of the product returned to another medication purchase. As each patient may only
purchase two ounces of medication per month, patients returning >50% of a quantity of
medicine for quality reasons will be able to replace that allotment within their two-ounce-
per-month purchase limit. Patients making returns of less than half of the product purchased
will be eligible for a refund of the purchase price, but they will only be able to buy substitute
product if they have not reached their purchase limit for the month, inclusive of the product
returned. With this policy we hope to balance consumer protections with the Act’s objective
to limit personal consumption of medicinal cannabis to no more than two ounces of medicine
per month.
Any product returned for quality reasons will be sent to our laboratory for inspection and
analysis. If the product has evidence of pests, contaminants, or other problems, we will use
our inventory tracking system to identify all products produced from the same plant, whether
they are in our cultivation facility or patient care center, or have been sold to patients and
caregivers. Upon receipt of returned product from the patient care center the product
received will be weighed and its weight compared to recorded weight of the product when
returned. Management and security will investigate discrepancies and any reportable events
will be communicated to the Department. Once the source plant associated with a product
quality problem has been identified, any related product that remains in our possession will
be returned to the lab for inspection and the product will be destroyed. We will also issue a
consumer alert to patients who have received related product, and they will be encouraged to
return the potentially damaged product to their patient care center. Any returned product
received by our patient care center will be sent to our cultivation facility where it will be
incinerated after appropriate samples have been provided to the laboratory for analysis.
Throughout this process the volume of the product will be recorded in our inventory
management system, so there will be thorough documentation of the product’s disposition
and any diversion can be identified and managed as required by New Jersey law and the rules
of the Department.
Measure
2‐IV:
The
applicant
shall
complete
the
following
projected
income
statements
for
the
first
three
(3)
years
of
operation.
Round
all
amounts
to
the
nearest
dollar.
16
CRITERION 2
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E4F'0.32::-)'3.35-(.45.
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17
COMPASSIONATE CARE FOUNDATION, INC.
NEW JERSEY PAYROLL EXPENSE REPORT
REQUIRED FORMAT
18
CRITERION 2
Measure
3:
The
applicant
shall
document
its
experience
running
a
not‐for‐profit
organization
or
other
business(es).
We are proud of our Board members’ experience working with and managing nonprofits.
The Board members have outlined their experience with nonprofits in their individual CVs.
Here is a partial list of nonprofits they have served:
• New Jersey Health Care Quality Institute
• New Jersey Health Care Payers Coalition
• The Epilepsy Foundation of New Jersey
• Newark AIDS Consortium
• The Leapfrog Group
• Gilda’s Club
• Self Insured Association of America
• National Robotics Education Association
• Healing Spaces
• The Long Island Power Authority
• State University of New York College at Old Westbury Foundation
• The Foundation of United Cerebral Palsy of Nassau County
• The Long Island 9/11 Memorial
• The American Association of Preferred Provider Organizations
• The Adler Aphasia Center
• The Health Enhancement Research Organization
19
CRITERION 3
CRITERION 3 ‐ COMMUNITY INPUT AND APPROVAL
Compassionate Care has contacted municipal authorities and has a plan to solicit and incorporate
meaningful community input into the project. We seek to be a good, responsible neighbor to the
community, while providing much needed medical services to patients with debilitating medical
conditions.
Measure 1: Input from the city(s) or town(s) where the applicant’s ATC would be located.
Compassionate Care has contacted the Town of Bellmawr to secure a meeting with
municipal officials, at which meeting we expect to review the program and proposed
cultivation and patient care center operations with the governing body or its representatives.
We are in the process of seeking a letter of recommendation.
Measure
2:
Input
from
the
general
public
regarding
the
suitability
of
the
applicant
and
the
general
standards
for
location(s)
such
as,
distance
from
a
school,
daycare
center
or
other
child‐oriented
location;
distance
from
a
commercial
shopping
district,
pharmacy;
etc.
20
CRITERION 3
Measure 2 Response cont’d
21
CRITERION 4
CRITERION 4 ‐ PATIENT CARE CENTER SPECIFIC CONSIDERATIONS
Measure
1:
The
applicant
shall
provide
a
plan
for
inventory,
record
keeping
and
security
which
shows
an
understanding
of
the
types
of
records
that
shall
be
considered
confidential
health
care
information
under
New
Jersey
law
and
are
intended
to
be
deemed
protected
health
care
information
for
purposes
of
the
Federal
Health
Insurance
Portability
and
Accountability
Act
of
1996,
as
amended
[HIPAA].
Compassionate Care will use standard industrial supply chain tracking tools to keep proper
inventory levels of products available for our patients. Having an oversupply of inventory
could result in product degradation and increased security risks, but an undersupply might
deny patients access to their medicine. One of the capabilities of our supply chain tracking
system (described in Criterion 5, Measure 3) is to control our inventory and also anticipate
future production needs. Under our system, each plant in our cultivation facility is assigned a
unique, systematic serial number from the moment a cutting is taken. This serial number is
entered into our secure computer database so that we are always aware of the number and
strain of plants within our facility. We are also aware of the current status of the plant (e.g.,
whether it is in the vegetative or flowering growth stage). This information allows us to
forecast inventory levels for the future. If a patient inquires when a particular strain will be
available, we can determine how many plants of that strain are in production, what stage of
production they are in, and how long it will be before they are ready to harvest.
After harvesting, when the medical cannabis is securely transported to our patient care center
(see Criterion 5, Measure 1, Part 3), our supply chain tracking system is integrated with our
high-security delivery company and patient care center database. After a product from our
cultivation facility is placed in transit, the status of the package is updated to reflect pending
delivery confirmation, and then the status is updated when it is received by the patient care
center. Once we sell the product at the patient care center, information on the patient buying
it is associated with the serial number of the plant, so there is traceability from seedling to
sale.
Even in the absence of physical communication, our technology allows us to retrieve current
inventory levels from within our patient care center so the cultivation personnel are made
aware of any possible shortages or overages.
22
CRITERION 4
Measure 1 Response cont’d
Having strict guidelines and policies in place to prevent diversion is important. Our supply
chain tracking system follows every plant from seedling to sale, so we can verify the
destination of every product Compassionate Care manufactures and sells. This system
allows us to:
• Prevent shrinkage within the cultivation facility, whereby plants are stolen, since
each plant has a barcode and if it is missing we will know that a serial number is
unaccounted for;
• Compare average yields of plants, whereby if plants in particular areas are
yielding less end product we can alert Security to a possible concern; and
• Require the shipping and receiving department to obtain delivery confirmations
for each product delivered, and log that information with our record keeping
system.
Furthermore, all patient care center sale transactions will be done through a point-of-sale
cashiering system, and excess inventory will be securely stored in vaults compliant with 21
CFR 1301.72.
23
CRITERION 4
Measure 1 Response cont’d
Since regular inventory and supply chain tracking is crucial to
preventing diversion to non-
medical recipients, inventory will be manually performed every day in the patient care center
by two background-checked employees to verify the accuracy of our computerized inventory
management system. Manual inventory will also be performed in our cultivation facility on
at least a monthly basis to ensure all products, byproducts, and discarded items in our
operations are accounted for. All information pertaining to production, transferring, sales,
and patients will be securely kept for a period of at least 7 years and be available for review
by the State of New Jersey as required by law.
Compassionate Care believes that by having strict guidelines aimed at preventing diversion,
and creating an inventory tracking system that allows us to follow each plant from seedling
to sale, we will be able to create a closed loop system where cannabis does not end up in the
possession of a non-medical user.
Compassionate Care plans to create and preserve adequate and proper documentation of all
of its activities through designated recordkeeping systems to support operational needs, allow
for accountability, and comply with the State of New Jersey’s requirements. Our record
keeping and software system will be designed and managed by our Information Technology
(“IT”) Department. Our IT Director will make sure all data and information are highly
secure and backed up in real time, several times throughout the day. Data will not only be
backed up to private servers but also to an off-site, highly secure server location to prevent a
disaster from compromising Compassionate Care’s database and recordkeeping.
Compassionate Care will limit access to our network and web portal using not only network
passwords, but also by restricting IP addresses and MAC addresses to a specific computer.
The system will be designed to deny access to users not authorized to view certain
documentation and protect the privacy of confidential information. Certain confidential
documents will have file open passwords to add an additional layer of security. Whenever
possible the use of third party email, web, and data servers will be avoided. Compassionate
Care will provide training to internal and external users on these procedures. We have
developed an HIPAA manual and training program.
24
CRITERION 4
Measure 1 Response cont’d
To meet the requirements set forth by the State of New Jersey and to meet the business needs
of Compassionate Care, an enterprise level application will be developed. The system will
have many users with corresponding access levels that fit into four basic groups.
• External Customers (many)
• Internal Customers (many)
• External Administrator (few)
• Internal Administrators (few)
Customers have very limited access and administrators will have more expansive access to
our systems. Outside vendors and patients are described as external customers with the
lowest access level assignment. Compassionate Care’s various departments and employees
are described as internal customers, with the second lowest access level. The State of New
Jersey, our third party lab testing service, and other regulatory bodies will be defined as
external Administrators. They will be given sufficient access to meet the requirements set out
in the Compassionate Use Medical Marijuana Act and associated rules. Internal
Administrators include the Board of Directors and department heads, and these will be given
the highest level of access. Passwords will be changed frequently and access levels
reassigned as necessary.
The system will manage a master database through modules defined for a specific reporting
purpose. One module may track the one-plant flow system that discloses the stage and
destination of all plants from clone or seed to final product. Unique tracking, testing,
barcodes, labeling, and packaging will greatly reduce the risk of diversion to other markets
and counterfeiting of the Compassionate Care brand. The one-plant flow module may be
used by other modules, such as a product availability forecast module.
Data entry from our internal customers will be routinely updated as any status changes occur.
Compassionate Care departmental directors will meet regularly to determine how system
modules should be updated or if new modules need to be created.
Compassionate Care will allow the State of New Jersey to have access to the cultivation
facility’s books, records, accounts, inventory management system, and any and all data
relevant to our permitted activities for the purpose of conducting an audit or examination.
With our record keeping and software design, Compassionate Care should be able to produce
records in sync with our various departments instantaneously or at least within 24 hours, in
the absence of unforeseen circumstances occurring. Compassionate Care shall be prepared
for quarterly financial record audits by the DHSS or other responsible state and local
authorities.
25
CRITERION 4
Measure
2:
The
applicant
shall
submit
a
description
of
its
proposed
program
for
providing
counseling
and
educational
materials
regarding
methods
of
administration
and
research
studies
on
health
effects
of
medicinal
marijuana
to
registered
qualifying
patients
and
their
registered
primary
caregivers.
The
applicant
shall
submit
a
description
of
its
historical
relationship
with
clinical
or
research
activities,
if
present.
Overview
Patient-Centered Care
A medical home practice provides patient-centered care based on relationships and oriented
toward the whole person. Partnering with patients and their families requires understanding
and respecting each patient’s unique needs, culture, values, and preferences. The medical
home practice actively supports patients in learning to manage and organize their own care at
the level the patient chooses. Recognizing that patients and families are core members of the
care team, medical home practices ensure that patients are fully informed partners in
establishing personalized care plans. Patient-centered care requires a Clinical Care
Coordinator (CCC) who is a skilled advanced practice nurse working in partnership with the
patient’s primary care and/or specialty doctor.
Comprehensive Care
A medical home practice provides comprehensive care, assisting patients in meeting their
physical and mental health care needs, including prevention and wellness, acute care, and
chronic care. It needs to address various phases of a patient’s lifespan, including end-of-life
care. Comprehensive care requires care providers to work together as a team. This team
might include physicians, advanced practice nurses, physician assistants, nurses, pharmacists,
nutritionists, mental health workers, social workers, educators, and care coordinators.
The CCC plays a crucial role in comprehensive care. He or she must work collaboratively
with an interdisciplinary team and have the broad-based knowledge and experience necessary
to handle most medical needs of the patient and to resolve conflicting recommendations for
care.
26
CRITERION 4
Measure 2 Response cont’d
Coordinated Care
A medical home practice assists patients in coordinating care across all elements of the
broader health care system, including specialty care, hospitals, home health care, and
community services and supports. Such coordination is particularly critical during transitions
between sites of care, such as when patients are being discharged from the hospital. Medical
home practices excel at building clear and open communication among patients and families,
the patient’s primary care medical home, and members of the broader care team.
A medical home practice delivers accessible services with shorter waiting times for urgent
needs, enhanced in-person hours such as flexible appointment times or physician availability
seven days a week, around-the-clock telephone or electronic access to a member of the care
team, access for non-visit related patient needs, and alternative methods of communication
such as email and telephone. Medical home practice is responsive to patients’ preferences
regarding access and provides for patients with special communication needs.
A medical home practice takes a systems approach to quality and safety. It employs
evidence-based medicine and orients its practice to population-specific health management.
Using clinical decision support tools to guide it, the systems approach shares decision
making with patients and families, engaging in performance measurement and responding to
patient experiences and satisfaction. Sharing robust quality and safety data and improvement
activities publicly is an important marker of a system-level commitment to quality.
Implementation
• Physician and patient discuss the risks and benefits of cannabis for the patient’s
debilitating medical condition.
• If the physician and patient agree that cannabis may be an appropriate treatment
for the patient, the physician enters the patient in the Physician Registry for
Medicinal Marijuana.
• The patient registers with New Jersey MMP, designating a caregiver if so desired.
• Patient obtains authorized personal identification card.
• Patient and/or authorized caregiver visits Compassionate Care’s patient care
center and meets with a CCC.
27
CRITERION 4
Measure 2 Response cont’d
Sharing Information
One of the most important roles of the CCC is to provide information, including answering
patients’ questions about a disease or its symptoms, discussing the physician’s
recommendation and the patient’s decision to try medicinal cannabis, and explaining the
appropriate use and methods for taking medical cannabis. Information is central to patients’
ability to manage well, but information alone is not enough. The goal in sharing information
for self-management support is to ensure that patients not only understand the information
but are also prepared to act on it in daily life. Telling patients what they need to know is not a
guarantee that they will be able to use the information, and conveying all critical information
during a short visit may not have the desired outcome if patients are not able to understand
and use it. The CCC will ask patients to complete a health risk assessment (described
below). We then will interpret that information to confirm the patient’s understanding of
healthy patient behavior.
Studies show that patients rely on professional advice in determining health goals.
Collaboratively setting health improvement goals with patients is an important step in
motivating healthy behaviors. Using agenda-setting tools, CCCs will introduce the
collaborative process of establishing healthy goals. It is important that patients’ priorities in
goal setting lead the decision about which goals are established. By achieving small
successes toward a goal that is important to them, patients will enhance their confidence and
sense of control in managing their illness, and this will pave the way to achieving goals in
other areas.
Helping patients know what to do to stay healthy is important, but the goal of self-
management support is to help them adopt the behaviors that will keep them healthy over
time. Motivating and coaching healthy behaviors is one method of supporting self-
management that can be done very effectively by CCCs. Moreover, for patients with chronic
conditions requiring medical cannabis, while setting health goals with their doctor is an
important step, few achieve their goals without more specific planning. Additional behavior
change coaching is needed to develop patient confidence in reaching goals. Trained CCCs
can effectively work with patients to define their action plans. With practice, tasks required
to support patients and families—such as making a specific plan of action, anticipating
barriers, and connecting them with community resources—can be the responsibility of
members of the care team other than the physician, often with equivalent results.
28
CRITERION 4
Measure 2 Response cont’d
Patients and families need clear information to understand the signs and symptoms of the
disease(s) and treatments, and training to build the skills to monitor clinical indicators such
as wasting, nausea, and intraocular eye pressure. This clinical content distinguishes self-
management education from self-management support, which helps people make behavior
changes and sustain them over time. CCCs with appropriate training can provide self-
management education. Primary care teams may have difficulty finding time and appropriate
staff to provide patient education sessions in the course of an office visit. CCCs will provide
just the right information in response to patient needs or questions, increasing the patient’s
understanding and skills incrementally. For in-depth education, CCCs will refer patients to
community programs offered by public health entities or hospitals that are an underused
resource. Psychosocial and emotional stressors, as well as physical symptoms, should be
considered in these programs.
29
CRITERION 4
Measure 2 Response cont’d
Ongoing Follow-Up
Sustaining healthy behaviors requires courage and tenacity, most often involving small,
incremental changes that build over time into bigger successes. Even the best plans of action
require adjustment to work effectively. Certain strains of medical cannabis may produce side
effects or not produce the desired effect, requiring further support and explanation or
alterations to make the plan workable. For all of these reasons, making regular contact with
patients after each visit or change in treatment is central to sustaining positive change. By
utilizing patient experience assessment and reporting tools, we will engage the voice of all
patients throughout the continuum of care.
Measure
3:
The
applicant
shall
provide
an
acceptable
safety
and
security
plan,
including
staffing
and
site,
and
a
detailed
description
of
proposed
security
and
safety
measures
which
demonstrate
compliance
with
the
Rules
Related
to
the
Medicinal
Marijuana
Program.
The patient care facility will be a fully secured building, equipped with perimeter fencing,
on-site employee and patient parking, sufficient area lighting, surveillance, electronic
keycard access, on-site and parking lot security personnel, and alarms. Employees will be
fully trained on security procedures and Compassionate Care will conduct periodic safety and
training drills. Our Security Plan provides details as to specific proposed security and safety
measures that demonstrate compliance with the Rules Related to the Medicinal Marijuana
Program.
30
CRITERION 4
Measure
4:
If
the
applicant
proposes
to
cultivate
and
dispense
at
two
separate
physical
locations,
the
applicant
shall
provide
an
acceptable
delivery
receipt
plan,
including
measures
to
ensure
sanitary
medicinal
standards,
security
and
inventory
control,
for
the
receipt
of
medicinal
marijuana
from
the
cultivation
site
by
ATC
staff
at
the
dispensing
site.
The
delivery
receipt
plan
shall
demonstrate
compliance
with
the
Rules
Related
to
the
Medicinal
Marijuana
Program.
Delivery from cultivation facility to patient care center will be secure. The inventory control
plan is provided in the Security Plan.
Measure
5:
The
applicant
shall
submit
a
description
of
its
Medical
Advisory
Board,
including
by‐
laws,
setting
forth
the
names
and
expertise
of
its
members
and
describing
how
it
will
function
within
the
organizational
structure
of
the
ATC,
consistent
with
the
Rules
Related
to
the
Medicinal
Marijuana
Program.
For
purposes
of
this
requirement,
it
is
not
necessary
for
the
applicant
to
provide
the
name
of
the
Medical
Advisory
Board
member
who
is
a
registered
qualifying
patient.
The Medical Advisory Board will be made up of physicians, nurses, other licensed healthcare
providers, community members, and patients. We have recruited a number of prestigious
physicians and PhDs to serve on the Board. Many of our Board Advisors are affiliated with
one or more acute care general hospitals located in and around our patient care center area. If
we are granted a permit, we will ask the New Jersey State Nurses Association to nominate
nurses to the Board. As patients are enrolled and develop experience we will recruit patients
to the Board. Once we have finalized the locations for our patient care centers we will recruit
local community members to the Board as well. Our bylaws will require that the Medical
Advisory Board include at least two residents of the community and one active medical
cannabis patient.
The duties of the Board will include but not be limited to:
• Setting protocols for the patient care centers,
• Monitoring and modifying the patient care center treatment protocols as needed,
• Assisting in directing and monitoring research on the clinical effectiveness and
safety of cannabis, and
• Providing educational outreach to other providers on the use of the drug.
31
CRITERION 4
Measure 5 Response cont’d
Measure
6:
The
applicant
shall
submit
a
plan
to
track
and
analyze
data
including
but
not
limited
to
patient
outcome,
utilization
and
trends.
32
CRITERION 4
Measure 6 Response cont’d
In the initial phase of our operations, we will choose three strains of cannabis to cultivate
based upon our knowledge and our assumptions about the patient population that will be
seeking care. It is impossible to forecast which types of eligible patients will actually elect to
enter our program, and currently there is no adequate scientific literature documenting how
different strains affect different classes of patients. Most of what is known about medical
cannabis can be characterized as craft knowledge based on individual practitioners’
experience and not systematic studies. It is central to our mission that we will develop a
more scientific knowledge base, which we will use to refine our practice and better educate
our patients, their physicians, the wider medical community, regulators, and the public. To
generate the necessary data for this enhanced knowledge base, Compassionate Care will
follow the rigorous data collection protocols described below.
Upon enrollment, patients and caregivers will be issued a Registry Identification (“ID”) Card
with a unique Registry ID number (“RIN”). Compassionate Care will use the RIN to track
an individual’s visits and transactions at our patient care center. In order to comply with the
ATC reporting requirements, we will, at the time of registration, conduct baseline symptom
severity assessments and collect data on patient demographics, the patient’s debilitating
medical condition, and such other information as the Department may require.
All purchases made by a patient or the patient’s caregiver will be identified by using the
qualifying patient’s RIN. Whenever a patient or caregiver has a CCC encounter or initiates a
transaction in our patient care center, our personnel will review the patient’s transaction
history, including the date of prior purchases, the cannabis strains purchased, the forms of
cannabis purchased (dried leaves and flowers, lozenges, or topical formulations), the amount
of cannabis purchased, and the patient’s current purchase eligibility limit (a patient may
purchase no more than two ounces of usable marijuana in a 30-day period). Details of new
transactions will be documented at the time of sale, and the patient’s transaction history will
be immediately updated. Pain and other symptom severity measures will be repeated at a
minimum of every three months.
Using these routine records, we will develop a comprehensive basic knowledge of the
products patients are using for different conditions, the forms and amounts of cannabis they
are consuming, and the kinds of clinical outcomes they are experiencing. Based on these
analyses, our clinicians will have a better foundation for making recommendations to patients
as to how they should use the product depending on their underlying disease and symptoms.
These data will also help us to identify those strains which might be contra-indicated for
certain conditions or which present larger safety concerns.
33
CRITERION 4
Measure 6 Response cont’d
At their first visit to the patient care center and periodically afterwards, all patients will be
asked to consent to participate in additional data collection beyond that required by the
MMP. With the patient’s consent, we will collect a brief medical history including current
and prior pharmaceutical treatments and a summary of his or her current (or “baseline”)
medical conditions. Thereafter we will collect patient experience data using our survey
technology and join this with the patient’s consumption history. By systematically gathering
patient self-reports on the risks, benefits, and overall efficacy of the product, as well as
assessments of our service and educational efforts, we will be able to do more in-depth
analysis of different strains’ comparative effectiveness and more intensive continuing quality
improvement of our products and services.
Level 3 – Special, In-depth Clinical Research Partnerships with Clinicians and Other
Researchers
In addition to collecting the data just described, we will also seek out partners to conduct
more detailed clinical investigations of medical cannabis. We anticipate conducting studies
where, with patient consent, we will collect complete medical history and prior treatment
data from the patient’s medical records, and we will also collect clinical assessments of the
effects of cannabis. This will give us access to patient outcome data beyond patient self-
reports and enable more rigorous analyses of the risks and benefits of cannabis for different
types of patients. Drawing on the networks of our Board of Directors and Medical Advisory
Board, we will recruit specialists to explore in depth the therapeutic effects of cannabis for
special populations, such as children or pregnant women, or for particular conditions, such as
Crohns disease or end-stage cancer.
34
CRITERION 5
CRITERION 5 ‐ CULTIVATION SPECIFIC CONSIDERATIONS
Measure
1:
The
applicant
shall
provide
an
acceptable
safety
and
security
plan,
including
staffing
and
a
detailed
description
of
proposed
security
and
safety
measures
which
demonstrate
compliance
with
Rules
Related
to
the
Medicinal
Marijuana
Program.
Supporting
documents
should
be
included
as
Appendix
H.
I. The
description
shall
include
a
detailed
floor
plan
for
the
ATC
cultivation
site,
which
indicates
location
and
design
standards
and
performance
specifications
of
security
devices
to
be
utilized.
II. The
applicant
shall
provide
a
plan
to
involve
and
coordinate
with
local
law
enforcement
authorities
on
security
and
safety
issues,
and
identify
the
law
enforcement
officials
contacted
during
the
development
of
this
plan.
III. If
the
applicant
proposes
to
cultivate
and
dispense
at
two
separate
physical
locations,
the
applicant
shall
provide
an
acceptable
delivery
plan,
including
measures
to
ensure
sanitary
medicinal
standards,
security
and
inventory
control,
for
the
delivery
of
medicinal
marijuana
from
the
cultivation
site
to
the
dispensing
site.
The
delivery
plan
shall
demonstrate
compliance
with
the
Rules
Related
to
the
Medicinal
Marijuana
Program.
IV. All
responses
shall
be
utilized
for
internal
Department
review
only
and
shall
not
be
available
for
public
comment
or
review.
Compassionate Care understands that our most important assets are our patients and
employees, and our overriding responsibility is to provide for their safety and security. We
have consulted with Dunbar, a leading nation-wide security company, and with other security
experts, to make sure our security plan considers all possible threats while utilizing today’s
most up-to-date technology to counteract them. We have developed a plan that meets or
exceeds current standards for policing and securing the type of facility we will be operating.
We have divided our security plan into two components: Cultivation Facility Security and
Operational Security. The key elements of cultivation facility security are:
• Physical inaccessibility of the site (fenced with limited ingress) and optimal
lighting;
• Around-the-clock protection and surveillance by armed security personnel;
• Comprehensive video surveillance, monitored both on site and remotely;
• Tight access control, both to the facility and to the various areas within it, through
keycard and password restriction;
• Electronic intrusion detection; alarms, both silent and audible; panic buttons; and
• Immediate, selective or total lockdown capability.
35
CRITERION 5
Measure
1
Response
cont’d
Measure
2:
The
applicant
shall
provide
a
description
of
the
enclosed,
locked
facility
that
would
be
used
in
the
cultivation
of
medicinal
marijuana,
including
steps
to
ensure
that
the
medicinal
marijuana
production
shall
not
be
visible
from
the
street
or
other
public
areas.
If
the
enclosed
site
is
a
greenhouse,
identify
materials
used
in
construction
of
panels.
Glass,
fiberglass,
metal,
or
polycarbonate
panels
shall
be
used
in
construction
of
the
facility;
polyethylene
film
is
not
permissible.
Describe
window
and
vent
covers.
36
CRITERION 5
Measure
3:
The
applicant
shall
demonstrate
an
ability
to
provide
a
steady
supply
of
medicinal
marijuana
to
registered
qualifying
patients.
Measure
3‐I:
The
applicant
shall
provide
a
start‐up
timetable
which
provides
an
estimated
time
from
issuance
of
an
authorization
for
operation
to
limited
operations
to
full
operation,
as
well
as
the
basis
for
these
estimates.
The planned startup timeline for our cultivation facility is summarized in the following table
showing the dates of the most significant construction and horticultural milestones. Upon
award of an ATC permit, Compassionate Care is prepared to immediately begin construction
planning and we expect to have construction complete by July 29. The General Contractor
will complete the primary growing areas first, so that horticultural activities can begin while
construction in other areas is ongoing. We will start growing in the facility on May 27, we
expect first harvest on August 1, and product will be available for sale by August 15. The
dates shown here are subject to change based on factors such as unexpected shortages of
construction materials, permitting and zoning delays.
37
CRITERION 5
Measure 3‐I Response cont’d
38
CRITERION 5
Measure
3‐II:
The
applicant
shall
describe
its
knowledge
of
(and
experience
with)
organic
growing
practices
or
agricultural
growing
practices
to
be
used
in
their
cultivation
of
medicinal
marijuana.
The Organic Foods Production Act of 1990 prohibits the following production practices and
materials. Compassionate Care will make every effort to use products that are compliant
with the intent of these regulations.
• Seed, Seedlings, and Planting Practices. For a farm to be certified under this
chapter, producers on such farm shall not apply materials to, or engage in
practices on, seeds or seedlings that are contrary to, or inconsistent with, the
applicable organic certification program.
• Soil Amendments. For a farm to be certified under this chapter, producers on such
farm shall not:
o Use any fertilizers containing synthetic ingredients or any commercially
blended fertilizers containing materials prohibited under this chapter or
under the applicable State organic certification program; or
o Use as a source of nitrogen: phosphorous, lime, potash, or any materials
that are inconsistent with the applicable organic certification program.
• Crop Management. For a farm to be certified under this chapter, producers on
such farm shall not:
o Use natural poisons such as arsenic or lead salts that have long-term effects
and persist in the environment, as determined by the applicable governing
State official or the Secretary;
o Use plastic mulches, unless such mulches are removed at the end of each
growing or harvest season; or
o Use transplants that are treated with any synthetic or prohibited material.
Title 7, Part 205 of the National Organics Program prohibits the following substances,
methods, and ingredients in organic production and handling. Compassionate Care will make
every effort to use products that are compliant with the intent of these regulations.
To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified
ingredients or food group(s)),” the product must be produced and handled without the use of:
39
CRITERION 5
Measure
3‐II
Response
cont’d
Compassionate Care’s efficient hydroponic cultivation processes are in alignment with these
principles.
• Compassionate Care will avoid chemical pesticides through a holistic approach to
pest management that emphasizes preventative measures;
• Compassionate Care will use soil-less hydroponics and will incinerate all unused
plant material under a limited-waste policy;
• Compassionate Care will adhere to strict nutrient schedules and will utilize highly
efficient nutrient dosing technologies to minimize, if not eliminate, nutrient waste.
40
CRITERION 5
Measure
3‐II
Response
cont’d
Through efficient hydroponic processes and the use of pure hydroponic nutrients
Compassionate Care will be able to minimize use of substances that would not be allowed by
the Organic Foods Production Act of 1990, by the regulations in Title 7, Part 205 of the Code
of Federal Regulations, or by the National Organic Program. Through detailed product safety
and laboratory testing protocols (described in our Product Safety Plan) Compassionate Care
will ensure that all products are free of harmful yeasts, molds, bacteria, and chemical
residues. These measures will produce a product far superior to organic standards—one that
is cleaner, safer, and greener.
Measure
3‐III:
The
applicant
shall
describe
its
quality
control
program
and
steps
that
will
be
taken
to
ensure
the
quality
of
the
medicinal
marijuana,
including
purity,
potency
and
consistency
of
dose.
Quality control and product safety are vitally important components of the medical cannabis
industry because patients with compromised immune systems often utilize medical cannabis
to improve their condition. As such, the medicine must be safe and free of contaminants to
prevent further complications to patients with already weakened health. Too often medical
cannabis contains mold, bacteria, pesticides, or other harmful substances. This can be
attributed to the lack of lab testing and quality assurance when distributing cannabis.
To address this concern, Compassionate Care has teamed up with a leading national
laboratory specializing in cannabis science. We are committed to providing clean, safe, and
effective cannabis to patients in need. Compassionate Care will test at least 8 different times
along the plant production process before a medical cannabis patient ever receives one of our
products. The testing results and data will be clearly labeled on our packaging so every
patient knows that their medicine is safe for consumption.
Additionally, we will abide by strict product safety and testing standards that currently do not
exist in the emerging cannabis industry. There are no state or federal guidelines defining
acceptable levels of chemical or biological residues for cannabis. Moreover, there are no
state or federal guidelines regarding appropriate analytical methods for detecting these
residues in or on cannabis medicines. We see this lack of official industry requirements and
protocols as a unique opportunity to self-impose these standards, to not only represent our
industry well but to ensure patient safety and medical efficacy. Compassionate Care will,
with the help of the highly-qualified scientists at the laboratory, self-impose product safety
and testing protocols that will ensure all products produced by the proposed facility will be of
known potency and free of chemical and biological contaminants. These protocols will
produce a level of quality control far superior to existing industry standards.
41
CRITERION 5
Measure
3‐III
Response
cont’d
The quality control process involves the examination of products and processes for certain
minimum levels of quality. The goal of the quality control team is to identify products, or the
processes used to develop products, that do not meet specified standards of quality. If a
problem is identified, the job of the quality control team may involve stopping production
temporarily and/or recalling finished products.
Measure
3‐IV:
The
applicant
shall
describe:
• Methods
to
ensure
that
seed
production
and/or
hybridization
is
prevented
during
cultivation
of
medicinal
marijuana
• Methods
of
testing
for
the
presence
of
mold,
bacteria
or
other
contaminants
• Procedures
for
routine
scouting
of
insect
and
plant
disease
conditions
• Methods
to
control
insect
pests
that
do
not
include
the
application
of
pesticides
during
cultivation
of
medicinal
marijuana,
in
accordance
with
the
Rules
Related
to
the
Medicinal
Marijuana
Program
• Procedures
for
proper
sanitation
practices
to
minimize
plant
disease,
and
to
promptly
dispose
of
diseased
plant
material
in
a
secured
disposal
area
• Methods
for
utilization
of
fans
and
cooling
systems
to
maintain
airflow
patterns
sufficient
to
prevent
or
minimize
plant
disease
and
insect
infestation.
• Methods
to
keep
environment
free
from
flowering
male
plants
to
ensure
that
female
plants
are
not
pollinated
and
seed
production
and/or
hybridization
is
prevented
• Recordkeeping
of
any
cultural
measures
used
for
plant
pest
or
disease
control,
including
disposal
of
culled
plants
• The
various
strains
of
marijuana
to
be
dispensed,
and
the
form(s)
in
which
it
will
be
dispensed
• Record
keeping
for
each
package
by
lot,
label
and
bar
code
• Area
security
• Packaging
and
labeling
requirements
• Methods
of
processing
in
a
safe
and
sanitary
manner
42
CRITERION 5
METHODS
TO
ENSURE
THAT
SEED
PRODUCTION
AND/OR
HYBRIDIZATION
IS
PREVENTED
DURING
CULTIVATION
OF
MEDICINAL
MARIJUANA
Unwanted seed production and strain hybridization will be prevented by proper facility
design and maintenance. The proposed facility consists of sealed cultivation rooms that do
not allow exchange of micro-size particles such as pollen. A Class 10 clean room will be
present before entering the cultivation rooms of the facility to ensure that unwanted elements
do not enter the facility. Staff will be required to wear clean suits and pass through a
decontaminating air shower to eliminate or prevent pests and pollen from entering the
cultivation rooms via staff clothing. Temperature, air flow, and humidity will be controlled
by a state-of-the-art environmental control system that eliminates the exchange of outside air.
HEPA filters and activated carbon air scrubbers further reduce the possibility of pollen
entering the cultivation facility and pollinating flowering plants.
Pollination of female plants will be further mitigated through the use of feminized seeds
during the initial startup phases of the project. Feminized seeds are cannabis seeds that have
been bred multiple times to create seeds that predominately produce female plants.
Feminized seeds will ensure that few, if any, male plants exist within the cultivation facility.
Male plants generally can only develop if non-feminized seeds are used. Compassionate Care
will create parent plants from germinated feminized seeds and use cloning processes to
effectively produce a large amount of new plants that share the exact same genetic
characteristics as their parent.
Any male plants identified in the cultivation areas will be promptly removed and incinerated,
thereby minimizing, if not eliminating, the potential for pollination of flowering female
plants. Preservation of male plants is not necessary since breeding of different genetic strains
is not planned at the proposed facility.
METHODS OF TESTING FOR THE PRESENCE OF MOLD, BACTERIA OR OTHER CONTAMINANTS
Laboratory testing is a critical part of the quality assurance plan for the proposed facility.
Testing will be performed by our laboratory and will focus on three basic goals: 1) ensuring
product safety, 2) optimizing horticulture practices, and 3) research and development of new
products. Ensuring product safety will be the priority for laboratory testing. The protocols
for that process include:
43
CRITERION 5
Measure
3‐IV
Response
cont’d
The effectiveness of the product safety protocols outlined here is dependent on the staff
members who carry them out on a regular basis. Compassionate Care will, therefore, hold
regular training programs to educate staff on the importance of these protocols. Staff will be
trained to identify molds, yeasts, bacteria, pests, and irregular growth patterns. Plants
identified by staff as having one or more of these issues will be flagged for further inspection
by laboratory personnel.
PROCEDURES FOR ROUTINE SCOUTING OF INSECT AND PLANT DISEASE CONDITIONS
Close observation is critical to the safety of our products. While Compassionate Care’s
facility and procedures will be designed in a way to prevent pests and contaminants,
examination of our products and environments is essential to detect and quarantine problems
early on before they spread. Close observation will limit the need for extreme intervention
measures later.
Some of the most common pests, molds, and diseases, which Compassionate Care’s staff will
be trained to detect early on and to combat using appropriate intervention measures, are:
• Spider Mites
• Aphids
• White Flies
• Powdery Mildew
• Damping-off and Root Rot
• Bud Rot
• Mildew and Rust
More information on these pests, molds, and diseases, including pictures, is contained in our
Product Safety Plan.
44
CRITERION 5
Measure
3‐IV
Response
cont’d
METHODS
TO
CONTROL
INSECT
PESTS
THAT
DO
NOT
INCLUDE
THE
APPLICATION
OF
PESTICIDES
DURING
CULTIVATION
OF
MEDICINAL
MARIJUANA,
IN
ACCORDANCE
WITH
THE
RULES
RELATED
TO
THE
MEDICINAL
MARIJUANA
PROGRAM
Even though Compassionate Care’s facility and operations are designed to prevent harmful
organisms from entering the facility, we realize that at some point these problems will occur
and intervention will become necessary. Compassionate Care’s first priority in intervention is
to remediate as many compromised plants as possible. This is to be accomplished while still
upholding our product safety standards, and if there is ever a decision or tradeoff between
patient health and minimizing plant loss, Compassionate Care will always put patient safety
first.
In the event of any type of infestation, Compassionate Care will preferentially use organic-
based pesticides and fungicides to control an invading population or disease infestation.
While our first solution is always preventative, in the event that pests and diseases do occur,
our Product Safety Plan includes:
• General procedures for handling common pests, molds, and diseases;
• Policies for minimizing pesticides use; and
• Alternative intervention methods including CO2 overdose and Radionics.
Our Product Safety Plan includes general procedures for handling the most common pests,
molds, and diseases discussed previously. The general approach to all intervention methods
is to use the least toxic (i.e., most organic) approaches first. More aggressive measures will
be taken only after initial approaches have proven unsuccessful. Consideration of the
cultivation cycle will also be given when deciding on a mitigation approach so that
potentially harmful residues have time to degrade to acceptable levels before products are
distributed. Finally, Compassionate Care will seek alternative measures to using pesticides,
fungicides, and insecticides to remediate pests and contaminants and will continuously
develop safer and more effective mitigation measures.
45
CRITERION 5
Measure
3‐IV
Response
cont’d
Compassionate Care will continue to explore innovative and alternative ways of remediation.
As the first course of action is always preventative, alternative methods will be explored to
avoid the use of chemicals. Two of these alternative methods include Controlled CO2
overdose and Radionics.
PROCEDURES
FOR
PROPER
SANITATION
PRACTICES
TO
MINIMIZE
PLANT
DISEASE,
AND
TO
PROMPTLY
DISPOSE
OF
DISEASED
PLANT
MATERIAL
IN
A
SECURED
DISPOSAL
AREA
Compassionate Care seeks to create clean room standards that parallel the protocols used in a
scientific laboratory. All departments within the Compassionate Care facility will have
individual clean room standards that are tailored to department-specific vulnerabilities and
day-to-day responsibilities, and there will be one central clean room that ensures no outside
hazards are brought into our facility. The clean room is a highly controlled area that limits
the level of environmental pollutants such as dust, airborne microbes, aerosol particles, and
chemical vapors. Our on-site laboratory will routinely monitor the clean room as well as
other areas of the facility to make sure the number of particles per cubic meter remains at
levels that are safe and acceptable by our clean room standards.
While access to our facility will be limited, individuals that do need to enter will be briefed to
understand that we manufacture products used as medicine, and that everyone must follow
our clean room protocols accordingly. After passing security clearances required for entry,
staff will enter and exit a central clean room through airlocked doors. There is a mandatory
requirement for any individual entering our facility to wear:
• Company clean suits;
• Hairnets and beard nets (if necessary);
• New disposable gloves;
• Company clean shoes or non-slip shoe coverings; and
• Facemasks, which may be required in certain circumstances.
46
CRITERION 5
Measure
3‐IV
Response
cont’d
Additionally, all personal items must be stored in secure lockers. Clean room air showers are
available on site. In addition to initial security clearances, individuals will undergo another
clearance level just to ensure everyone is complying with Compassionate Care’s clean room
protocols before entering any manufacturing areas.
The cultivation facility must be easy to clean and maintain. This is facilitated by
• Appropriate, durable finishes for each functional space;
• Careful detailing of such features as cultivation room entrances, casework, and
finish transitions to avoid dirt-catching and hard-to-clean crevices and joints;
• Adequate and appropriately located maintenance spaces;
• Special materials, finishes, and details for spaces that are to be kept sterile;
• Incorporation of antimicrobial surfaces.
Additionally, Compassionate Care will encourage a culture of clean hygiene and sanitary
practices through training, seminars, signage, and other means, while implementing
procedures such as:
• Allowing drinking, eating, and gum-chewing only allowed in designated break
room areas;
• Requiring full clean room attire to be worn in the facility;
• Requiring employees to cover themselves when coughing, sneezing, blowing their
noses, etc.;
• Allowing minimal personal items to be brought to the facility and requiring
everything to be stored in designated locker room areas.
METHODS
FOR
UTILIZATION
OF
FANS
AND
COOLING
SYSTEMS
TO
MAINTAIN
AIRFLOW
PATTERNS
SUFFICIENT
TO
PREVENT
OR
MINIMIZE
PLANT
DISEASE
AND
INSECT
INFESTATION.
The utilization of fans and cooling systems can be effective measures of preventing and
controlling plant disease and infestation through ambient air movement, temperature and
humidity control.
47
CRITERION 5
Measure
3‐IV
Response
cont’d
For every 4x8 area on the pallet racking system there will be 20 growing plants. An
oscillating fan will be installed for each area to help facilitate air movement above and below
the plant canopy and reduce the risk of any mold growing within the tray. This also helps the
plant to become strong and hardier. The constant air circulation will take any remaining
stagnant water on the bottom of the tray bed and expedite evaporation. The repetitive
movement of the oscillating fans helps keep the air flowing throughout the grow area and
reduce the risk of mold and mildew from forming as well as discourage pests from hanging
on leaves. The air movement from the same oscillating fan will also be pushing hot air that
accumulates from the light on top of the canopy, removing any hotspots and issues that may
develop from that heat.
Temperature
The ideal temperature for growing cannabis is between 72 degrees and 78 degrees. The
environmental control system will use high BTU's. BTU stands for British Thermal Unit, the
unit of measurement that is designated for cooling. The air conditioner vents in this system
will be strategically placed throughout the cultivation rooms in order to evenly distribute the
cool air and prevent any hot areas from developing leading to plant stress. Each cultivation
room will have a separate air conditioner to avoid contamination of pests or pollen migrating
from one room to another. The system also has a series of high powered exhaust fans that
will extract heat from the room, filter through activated carbon charcoal, and remove it. This
will regulate temperatures, maintain them in the ideal conditions and prevent the actual
ambient air temperature in the room from getting too hot.
Humidity Control
The cultivation rooms must have a relative humidity level which needs to stay 50% or below
in order to prevent mold or mildew from forming on the plant's stalk, leaves, or flowers. The
system will regulate these humidity levels by using either special dehumidifiers for high
concentrations of humidity, or using the exhaust fans on an as needed basis to prevent the
humidity from rising and any mildew or mold from forming.
METHODS
TO
KEEP
ENVIRONMENT
FREE
FROM
FLOWERING
MALE
PLANTS
TO
ENSURE
THAT
FEMALE
PLANTS
ARE
NOT
POLLINATED
AND
SEED
PRODUCTION
AND/OR
HYBRIDIZATION
IS
PREVENTED
Measures to prevent pollination of female plants are detailed in Criterion 5, Measure 3-IV.
48
CRITERION 5
Measure
3‐IV
Response
cont’d
RECORDKEEPING
OF
ANY
CULTURAL
MEASURES
USED
FOR
PLANT
PEST
OR
DISEASE
CONTROL,
INCLUDING
DISPOSAL
OF
CULLED
PLANTS
Product safety related results (e.g., lab results, pesticide application logs, remediations,
recalls, etc.) will be reported quarterly to the State of New Jersey or designee. Reports will
be jointly prepared by Compassionate Care and its laboratory and will include raw data,
statistical representations, and narratives. Product safety results will be reported as required
to the State of New Jersey.
The various data and information generated by our laboratory will be stored remotely on a
secure server that will be backed up regularly. Access to data and information will be
restricted to lab personnel and Compassionate Care. Access to the raw data will be restricted
to principals of our laboratory and Compassionate Care. Staff level employees will have
limited access. Compassionate Care personnel will be provided with a login and password
that enables them to view data and reports. In addition, Compassionate Care’s information
management system will have secure access to the raw data so that customized reports can be
prepared as needed from Compassionate Care’s system.
Compassionate Care will keep detailed records of all intervention measures utilized. Records
will indicate where and when treatments occurred along with the name and quantity of the
products used. Additionally, this information will be reported to our laboratory to aid in lab
analysis. By knowing which pesticides to analyze for, our laboratory can focus on
developing and maintaining analytical methods that can verify the presence of the given
chemicals at concentrations below levels of concern.
While Compassionate Care recognizes the sensitive nature of our information and has
designed a system to keep data secure and confidential, we also recognize the needs of
patients and dispensaries to know about the products they are consuming. For all products
that are distributed from our facility, the product safety test results will be clearly labeled on
all of our packaging. A final Compassionate Care seal will be placed on all of our products
so customers know the product has not been tampered with or altered.
THE VARIOUS STRAINS OF MARIJUANA TO BE DISPENSED, AND THE FORM(S) IN WHICH IT WILL BE DISPENSED
49
CRITERION 5
Measure
3‐IV
Response
cont’d
Compassionate Care will select specific cannabis strains based on their unique ratios of CBD,
THC, and CBN. These strains will be cultivated by Compassionate Care and dispensed to
qualified patients as flowers, lozenges, and topicals. Each of these products will be clearly
labeled with the relative amounts of the three major cannabinoids. Educational material will
be provided to patients, caregivers, and doctors so that they may make an informed decision
when choosing medicines most appropriate for their conditions.
50
CRITERION 5
Measure
3‐IV
Response
cont’d
Products will primarily be dispensed as dried flowers, but we will also offer cannabis
lozenges or topical formations produced with standards that meet good manufacturing
practices.
RECORD KEEPING FOR EACH PACKAGE BY LOT, LABEL AND BAR CODE
Each plant at Compassionate Care will be uniquely identified with a sequential serial number
that is also associated with a lot number. Based upon the strain and plant, eight to twelve
uniquely serialized plants will be associated with a single lot number. In this scenario a single
lot should be able to produce at least 1 pound, or 16 ounces, of medical cannabis (8 plants x
2.0 ounces OR 12 plants x 1.5 ounces ~ 16 ounces). Each plant is bar-coded with a 9-digit
(alpha-numeric) license plate that travels with the plant all the way from seed to final sale to
patient.
All of a plant’s information is entered into a software system that tracks each plant using
these serial numbers. When a new serial number is created our software treats it as a new
product in our cultivation facility. Our software can give us a snapshot of not only how
many plants are presently being cultivated, but of historic cultivation records and future
production expectations as well.
51
CRITERION 5
Measure
3‐IV
Response
cont’d
AREA SECURITY
The cultivation facility is a fully secured building, equipped with perimeter fencing, on-site
employee parking, sufficient area lighting, secure building materials, surveillance, electronic
keycard access, on-site security personnel, and alarms. Employees are fully trained on
security procedures, and Compassionate Care will conduct periodic safety and training drills.
Our Security Plan provides details on operational and facility security procedures.
PACKAGING AND LABELING REQUIREMENTS
There are 3 main steps involved in the cultivation packaging process: weighing, packaging,
and labeling.
Weighing
The only product by Compassionate Care that is weighed is medical cannabis, which is
weighed in increments of 1 gram by using a digital scale that is routinely tested for accuracy.
52
CRITERION 5
Measure
3‐IV
Response
cont’d
Packaging
All of our packaging materials will resemble medical grade packaging such as vials so
patients understand this is a medicine. Compassionate Care wants to provide patients with
various financial and medical needs access to their medicine, so we plan on offering
medicine in as small as sixteenth-of-an-ounce increments. We will evaluate this number after
we are operational. If patients advance concerns about the small increments and prefer being
able to buy different quantities, Compassionate Care will adjust its strategy accordingly. We
realize patients may not know their medical requirements initially, so our strategy is to start
small and adjust accordingly. Only packaging larger amounts will arbitrarily require them to
purchase more cannabis than they need. We will never sell in quantities larger than quarter-
ounce. Our clinical trials and consultations with patients are designed to evaluate a patient’s
true medical needs, so we can recommend not only the appropriate dosage, but the method of
absorption as well.
Labeling
After a product is packaged, the final step before distribution to our patient care center is
labeling. Labeling will be applied to every product after it is packaged. The label of a
package will identify:
• The amount of product and form;
• The genetic lineage of the product (including medicinal variety);
• Weight (for medical cannabis);
• Date the product was packaged and expiration date (if applicable);
• Laboratory testing results;
• Legal disclosures;
• Medical disclosures (if applicable);
• THC levels and cannabinoid profiles; and
• Compassionate Care’s logo and contact information.
53
CRITERION 5
Measure
3‐IV
Response
cont’d
Finally, the serial number of the plant will be placed on the package, for traceability, along
with Compassionate Care’s product seal. After the product is sent to the patient care center,
additional information such as patient and State identification number will be added as
required.
METHODS OF PROCESSING IN A SAFE AND SANITARY MANNER
There is a mandatory requirement for any individual entering packaging areas to wear:
54
CRITERION 5
Measure
3‐IV
Response
cont’d
All packaging areas will be maintained using good manufacturing practices and will be tested
and graded by our laboratory for compliance. Surfaces in the packaging areas (e.g.,
countertops, stove tops, sinks) will be swabbed and analyzed by the on-site lab to ensure
facility cleanliness. Samples of packaged products will be taken at random and analyzed to
ensure packaged products remain clear of mold, yeast, and bacteria.
55
APPENDIX TOC
Appendices
Appendix
A
Corporate Documents
A1
APPENDIX A
BYLAWS
OF
ARTICLE I.
_______________________
ARTICLE II.
_______________________
Section 2.02 OTHER OFFICES. The Corporation may also have offices
at such other places, within or without New Jersey, as the board of trustees may from time to
time appoint or the business of the Corporation may require.
Section 2.03 FISCAL YEAR. The fiscal year of the Corporation shall
end on the last day of December.
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APPENDIX A
ARTICLE III.
_______________________
(a) Notice.
(b) Content. Every required notice of a meeting shall state the place, date and
time of the meeting. Unless otherwise provided by New Jersey law, neither the business to be
transacted at, nor the purpose of, any special meeting of the board need be specified in a notice
of such meeting.
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APPENDIX A
Section 3.03 WAIVER OF NOTICE.
ARTICLE IV.
_______________________
MEMBERSHIP
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APPENDIX A
ARTICLE V.
_______________________
BOARD OF TRUSTEES
(a) General Rule. Unless otherwise provided by New Jersey law, all powers
vested by law in the Corporation shall be exercised by or under the authority of, and the business
and affairs of the Corporation shall be managed under the direction of the board of trustees.
(iii) A committee of the board of trustees upon which the trustee does
not serve, duly designated in accordance with law, as to matters within its designated authority,
which committee the Trustee reasonably believes to merit confidence.
A trustee shall not be considered to be acting in good faith if the trustee has knowledge
concerning the matter in question that would cause his or her reliance to be unwarranted.
(d) Presumption. Absent breach of fiduciary duty, lack of good faith or self-
dealing, any action taken as a trustee or any failure to take any action shall be presumed to be in
the best interests of the Corporation.
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APPENDIX A
(e) Notation of Dissent. A trustee who is present at a meeting of the board of
trustees, or of a committee of the board of trustees, at which action on any corporate matter is
taken, shall be presumed to have assented to the action taken unless his or her dissent is entered
in the minutes of the meeting or unless the trustee files a written dissent to the action with the
secretary of the meeting before the adjournment thereof or transmits the dissent in writing to the
secretary of the Corporation immediately after the adjournment of the meeting. The right to
dissent shall not apply to a trustee who voted in favor of the action. Nothing in this section shall
bar a trustee from asserting that minutes of the meeting incorrectly omitted his or her dissent if,
promptly upon receipt of a copy of such minutes, the trustee notifies the secretary in writing of
the asserted omission or inaccuracy.
(c) Initial Trustees. The initial trustees of the Corporation shall be those
persons named as trustees by the Incorporator.
(a) Number. The board of trustees shall consist of not less than three (3) nor
more than ten (10) trustees.
(b) Term of Office. Except as otherwise provided in Section 5.04 hereof, the
term of office shall be two years and the term of office shall begin at the annual meeting of the
board of trustees. Each trustee shall hold office until the expiration of the term for which he or
she was selected or until a successor shall be selected and shall qualify or until his or her earlier
death, resignation or removal. A decrease in the number of trustees shall not have the effect of
shortening the term of any incumbent trustee. There shall be no limitation on the terms of office
for members of the board of trustees.
(c) Resignation. Any trustee may resign at any time upon written notice to
the Corporation. The resignation shall be effective upon receipt thereof by the Corporation or at
such subsequent time as shall be specified in the notice of resignation.
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APPENDIX A
meeting of the board of trustees where a quorum is present, and such trustee shall hold office for
the unexpired term for which the vacancy occurred, if applicable.
(c) Action by Written Consent. Any action which may be taken at a meeting
of the trustees may be taken without a meeting if a consent or consents in writing setting forth
the action so taken shall be signed by all of the trustees then in office and shall be filed with the
secretary of the Corporation.
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APPENDIX A
(b) Any committee, to the extent provided in the resolution of the board of
trustees, shall have and may exercise all of the powers and authority of the board of trustees,
except that no such committee shall have any power or authority as to the following:
(d) Alternate Committee Members. The board of trustees may designate one
or more individuals as alternate members of any committee who may replace any absent or
disqualified member at any meeting of the committee. In the absence or disqualification of a
member of a committee, the member or members thereof present at any meeting and not
disqualified from voting, whether or not constituting a quorum, may unanimously appoint
another individual to act at the meeting in the place of the absent or disqualified member.
(e) Term. Each committee of the board of trustees shall serve at the pleasure
of the board of trustees.
ARTICLE VI.
___________________________
OFFICERS
(b) Resignation. Any officer may resign at any time upon written notice to
the Corporation. The resignation shall be effective upon receipt thereof by the Corporation or at
such subsequent time as may be specified in the notice of resignation.
(c) Bonding. The Corporation may secure the fidelity of any or all of its
officers by bond or otherwise. Alternatively, the Corporation may obtain fiduciary insurance on
behalf of its officers.
(d) Standard of Care. An officer shall perform his or her duties as an officer
in good faith, in a manner he or she reasonably believes to be in the best interests of the
Corporation and with such care, including reasonable inquiry, skill and diligence, as a person of
ordinary prudence would use under similar circumstances.
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APPENDIX A
Section 6.06 VACANCIES. A vacancy in any office because of death,
resignation, removal, disqualification, or any other cause, shall be filled by majority vote of the
directors present at a duly called meeting of the board of trustees or by the officer or committee to
which the power to fill such office has been delegated pursuant to Section 6.03, as the case may
be, and if the office is one for which these Bylaws prescribe a term, shall be filled for the
unexpired portion of the term.
Section 6.10 THE VICE PRESIDENT. The vice president shall perform
all duties and have all authority given to the president of the Corporation, at any time when the
president is unable to act, and shall have the same authority to sign, execute and acknowledge, in
the name of the Corporation, tax documents, deeds, mortgages, contracts or other instruments as
is granted to the president by Section 6.09. The vice president shall have such other duties and
authority as from time to time may be assigned by the board of trustees.
ARTICLE VII.
__________________________
(a) Indemnification. The Corporation shall indemnify any person who was or
is a party or is threatened to be made a party to any threatened, pending or completed action, suit
or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that
such person is or was a trustee, officer, employee or agent of the Corporation, or is or was
serving, at the request of the Corporation, as trustee, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise, against expenses (including
attorneys’ fees), amounts paid in settlement, judgments, and fines actually and reasonably
incurred by such person in connection with such action, suit or proceeding, provided, however
that no indemnification shall be made in any case where the act or failure to act giving rise to the
claim for indemnification is determined by a court to have constituted willful misconduct or
recklessness.
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APPENDIX A
(b) Advance of Expenses. Expenses (including attorneys’ fees) incurred in
defending a civil or criminal action, suit, or proceeding shall be paid by the Corporation in
advance of the final disposition of such action, suit, or proceeding, upon receipt of an
undertaking by or on behalf of the trustee, officer, employee, or agent to repay such amount if it
shall be ultimately determined that he or she is not entitled to be indemnified by the Corporation
as authorized in this Article VII.
ARTICLE VIII.
__________________________
MISCELLANEOUS
Section 8.01 SEAL. The corporate seal shall have inscribed thereon the
name of the Corporation, the year of its organization, and the words “Corporate Seal, New
Jersey.”
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APPENDIX A
(a) General Rule. Except as otherwise provided by New Jersey law, the board
of trustees may authorize any officer or agent to enter into any contract or to execute or deliver
any instrument on behalf of the Corporation, and such authority may be general or confined to
specific instances.
(c) Seal. Except as otherwise required by New Jersey law, the affixation of
the corporate seal shall not be necessary to the valid execution, assignment or endorsement by
the Corporation of any instrument in writing.
(a) General Rule. A contract or transaction between the Corporation and one
or more of its trustees or officers or between the Corporation and another corporation,
partnership, association, or other organization in which one or more of its trustees or officers are
trustees, directors, or officers, or have a financial interest, shall not be void or voidable solely for
that reason, or solely because the trustee or officer is present at or participates in the meeting of
the board of trustees which authorizes the contract or transaction if the contract or transaction is
fair as to the Corporation as of the time it is authorized, approved or ratified by the board of
trustees of the Corporation, and:
(a) Contents. The board of trustees shall prepare annually a report, verified
by the president and treasurer or by a majority of the trustees, showing in appropriate detail the
following:
(i) The assets and liabilities, including the trust funds, of the
Corporation as of the end of the fiscal year immediately preceding the date of the report.
(b) Place of Filing. The annual report of the board of trustees shall be filed
with the minutes of the meetings of the board of trustees.
ARTICLE IX.
_______________________
END OF BYLAWS
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APPENDIX A
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APPENDIX A
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APPENDIX B
Appendix
B
Evidence of Site Control
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APPENDIX B
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APPENDIX C
Appendix
C
Evidence of Zoning Compliance
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APPENDIX C
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APPENDIX D
Appendix
D
Distance to Sensitive Sites
A23
APPENDIX D
A24
APPENDIX E
Appendix
E
Zip Code Map of Service Areas
A25
APPENDIX E
A26
APPENDIX F
Appendix
F
Qualifications and Position Descriptions
A27
APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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APPENDIX F
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JOB DESCRIPTION RELATED INFORMATION: EXEMPT FROM OPRA PURSUANT TO N.J.S.A 47:1A-1.1
- LIMITED SAMPLING PROVIDED – HARD COPY AVAILABLE UPON R
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Appendix
G
Operations Plan
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APPENDIX G
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CFO COO
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3a-iii) If applicable, a projection of the number of qualified patients to be served
by the ATC;
It is difficult to determine the number of qualified patients to be served by our ATC due to
the relatively recent passage of New Jersey’s medical marijuana program and a lack of data
in this industry. Additionally, the regulations are subject to change prior to issuance of ATC
permits, creating uncertainty surrounding patient registration. If we are awarded a permit,
Compassionate Care will conduct a comprehensive market study to determine a reasonable
estimate of the number of patients we can anticipate will purchase medical cannabis from us.
This study will consider population, medical marijuana program requirements, income levels,
health statistics, target demographics, location, and proximity to prospective patient base. In
other states, the number of medical marijuana program participants has varied drastically.
For purposes of our projections, Compassionate Care anticipates having 5,000 patients when
operational. This takes into consideration that there will be active patient enrollment during
the construction of our ATC, so when we are operational there will be patients ready for our
grand opening. We are confident that once other ATCs are operational, our quality
medication, helpful service offerings, and affordable pricing will attract a higher proportion
of medical cannabis patients in our region than the other permitted ATC.
We have chosen a facility that has significant scalable capacity to prevent any disruption in
the event demand exceeds our estimated supply levels. In the event that we have produced
more cannabis than necessary, Compassionate Care will follow the correct procedures for
destroying and reporting excess cannabis, and reducing our supply accordingly.
3a-iv) Projections by the ATC for a two-year period of the ratio of registered
qualifying patients-to-demand for usable marijuana and procedures by which the
ATC shall periodically review these ratios for consistency with actual patient
demand ratios;
In formulating our projections we took into consideration the amount of time required
between permits being issued and our first harvest being cured and packaged for sale. We
assume during this timeframe there will be 5,000 patients registered and prepared to purchase
from our patient care center on our projected first day of sales, between August and
September 2011, as shown in our timetable in Criterion 5, Measure 3 and Financial Pro-
Forma. Thereafter, we anticipate every quarter having 1,250 more patients register with our
patient care center, allowing us to reach 10,000 patients by the last quarter of 2012. We
anticipate reaching a certain threshold where patient registration rates will decline, probably
after reaching 10,000 patients, but still allow for slow and steady growth to 11,250 two years
after our opening around September 2013.
Our cultivation facility is more than capable of handling such production. Although most of
our facility will be built out allowing for higher production levels, production will be phased
in beginning with 500 4” x 4” trays, each containing ten plants, estimated to produce two
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ounces per plant over eight weeks. Factoring in drying, curing, packaging and transport
times, the first production will be available for sale ten weeks after our first planting. Each
tray will harvest six times a year, allowing for twenty ounces of product a cycle, and one-
hundred twenty ounces of product a year.
The Financial Pro-Forma provides production tables and income statements to demonstrate
how our cultivated cannabis will be able to provide for anticipated demand levels over a two-
year period. The Chief Operations Officers and Director of our patient care facility will
routinely monitor supply levels to give our cultivation facility enough lead time to make
adjustments in our supply process. Due to the ten week lead time for products to be ready,
factoring in eight weeks for plant growth and two weeks for harvest and drying, our directors
and officers will work strategically to anticipate demand levels two and a half months in
advance to prevent shortages or surplus in medicine.
3a-v) Procedures by which the ATC shall ensure the availability of medicinal
marijuana in accordance with projected and actual demand ratios;
Compassionate Care’s sophisticated supply chain tracking system provides us with useful
information to forecast supply levels. At any given time we can take a snapshot of our
current inventory levels, our historical production levels, and our anticipated production
levels in the future. Reverse engineering the process, if we are running low on a particular
medicinal strain, our dispensary is able to contact our cultivation center and find out exactly
what stage of the plant production process plants of that particular strain are in. Based on the
stage and the time required before harvest, we can give an accurate forecast as to when
additional supply will be available to patients. This will prevent shortages from happening.
To ensure that patients have sufficient access to their medicine, we will routinely monitor our
supply levels and analyze demand levels. Some of the factors we will consider are:
Medical marijuana program participation
Growth rate of our patient base
Number of registered doctors participating
Previous sales
Population analysis
As opposed to waiting for a shortage to arise, we will proactively monitor supply to ensure
adequate inventory levels are always sustained. This will also help prevent over-saturation of
the market, creating an excess supply of medicine that can go bad and presents added
security risks.
In order to make sure our production capabilities are sufficient for growth over time, we
chose a facility that is scalable so there would be no disruptions in supply. Due to limited
information available pertaining to the New Jersey patient registration process and this being
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a new program, there is no way to ascertain accurate information to formulate projections, as
discussed in the last section. However, our cultivation facility has the capability of servicing
up to 20,000 patients at two ounces per month, so we will be able to sustain increases in
patient registration levels for a long time.
Some of the information we have taken into account when estimating demand levels is
provided below:
Land area = 8721 square miles
Population = 8.078 million (2009)
Population density = 1184 people/square mile
Over 65 population = 1,137,731 (13.1%)
Over 75 population = 402,000
Over 85 population = 163,000
70,000 deaths/year (NJ Hospice and Palliative Care organization claims
approximately 35,000 patients, or half those that died, received hospice care in
2008)
19,566 ambulatory care facilities
165 hospitals (1 per ~49k people)
1787 nursing or residential homes
27,383 doctors (1 per 316 people)
50 hospice and palliative organizations
1712 pharmacies (source: manta.com; equivalent to 1 per 4708 people)
3a-vi) The name, medical license number, résumé and contact address of the
medical director of the ATC, if applicable;
We have not yet chosen a medical director. Compassionate Care has discussed the
opportunity with a few well-qualified prospective medical directors, and if we are successful
in obtaining an ATC we intend to decide shortly thereafter.
3a-vii) The name, résumé and address of the chief administrative officer of the
ATC; and
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3a-viii) The standards and procedures by which the ATC determines the price it
charges for usable marijuana and a record of the prices charged.
Compassionate Care seeks to offer patients the most affordable medicine possible, while not
economizing on standards for product testing, research and development, adequate security
and safety procedures, or other quality concerns.
The price of our medicine will be equal to our cost. As our organization becomes more
efficient over time and expands its patient base, we intend to reduce our prices and invest
more into areas that promote the long-term well-being of our patients and the surrounding
communities.
Reducing the cost of our medicine and expanding our indigent care program
Investing in our research and development program
Developing and expanding our charitable and philanthropic programs
Compassionate Care intends to find an equilibrium that balances affordable medicine and
enrichment services so our patients, workers, and community members are better served now
and in the future.
All sales will be recorded into the point of sale system used at our dispensary. These sales
will be compared to inventory levels and production levels.
All documents and business records relating to assets and liabilities, monetary transactions,
various journals, ledgers, and supporting documents, including agreements, checks, invoices,
and vouchers will be retained. Compassionate Care shall keep these files in a secured area
placed in a locked filing cabinet. Financial records will be treated with the similar levels of
confidentiality as medical records and other sensitive information and maintained by our
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CFO. Compassionate Care shall make these records available as required.
Appendix K: HR Manual
3c: Business records include sales records that indicate the name of the
qualifying patient or primary caregiver to whom marijuana is distributed, the
quantity, strength and form and the cost of the product.
All documents and records relating to sales records that indicate the name of the qualifying
patient or primary caregiver to whom marijuana is distributed, the quantity, strength and
form, and the cost of the product will be retained by our point of sale system. Each patient’s
purchases will be tracked to ensure they are not purchasing more than allowed by law. Much
of this information will be contained within our package labeling. All of these records will be
backed up electronically and maintained in a secure database. Compassionate Care shall
make these records available as required by law.
Appendix K: HR Manual
3d: The bylaws of the ATC and its affiliates or sub-contractors shall contain
provisions relative to the disposition of revenues and receipts as may be
necessary and appropriate to establish and maintain its nonprofit status, as
applicable.
NONPROFIT STATUS. The Corporation is incorporated under the New Jersey Nonprofit
Corporation Act. The Corporation does not contemplate pecuniary gain or profit, incidental
or otherwise, to its trustees, its officers or other private persons, and no part of the net
earnings of the Corporation shall inure to the benefit of, or be distributed to, any such person,
except that the Corporation shall be authorized and empowered to pay reasonable
compensation for services rendered and make payments and distributions in furtherance of
the purposes set forth in Section 1.01 above.
Section added: No portion of the assets shall inure to the benefit of any trustee or officer of
the Corporation, any other private person, or any enterprise organized for profit.
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Some of these policies are contained within our Qualifications and Position Descriptions,
Employee Training Manual, and Human Resources Manual.
Compassionate Care shall maintain personnel records for at least 12 months after termination
of the individual’s affiliation with the alternative treatment center, for the purposes of this
rule.
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Compassionate Care will offer on-site training as well as contract with outside resources for
very specialized training areas. We have engaged the University of Cannabis, a California-
based company, to provide medical cannabis education. The majority of training, however, is
provided on site by Compassionate Care.
5-b) Each employee, agent or volunteer, at the time of his or her initial
appointment, shall receive, as a minimum, training in the following:
I. PROFESSIONAL CONDUCT, ETHICS AND STATE AND FEDERAL LAWS REGARDING PATIENT
CONFIDENTIALITY;
II. INFORMATIONAL DEVELOPMENTS IN THE FIELD OF MEDICAL USE OF MARIJUANA;
III. THE PROPER USE OF SECURITY MEASURES AND CONTROLS THAT HAVE BEEN ADOPTED; AND
IV. SPECIFIC PROCEDURAL INSTRUCTIONS FOR RESPONDING TO AN EMERGENCY, INCLUDING A ROBBERY
OR WORKPLACE VIOLENCE.
Employee training manuals and workshops will augment our training efforts, and
Compassionate Care will incentivize our workforce to further their learning to excel both
intellectually and professionally by paying for training and further education. We believe
well-trained workers lead to the overall success of a company, so we will conduct frequent
workshops, seminars, retreats, meetings, and events designed to encourage learning and
provide learning aids that reinforce our training efforts. Training topics include:
Legal Training - Legal training will cover all New Jersey State and Federal laws
relating to cannabis. Employees will be trained to understand patient rights, health
information privacy laws to protect the privacy of patients (HIPAA), sexual
harassment, laws surrounding operations of an ATC, and effective interaction with
law enforcement.
Medical Training - Since many of our patients have serious medical conditions,
special training will be given to responding to medical emergencies. Each
employee will be trained on disability sensitivity, blood borne pathogens, ADA
compliance, and effective communication with medical patients. Compassionate
Care has selected a strong Medical Board to oversee and improve its medical
training protocols. Our employees will be well versed in the various medicinal
cannabis strains available and the different medical healing properties of each.
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Customer Service and Sales Training - Staff will be well trained in patient care,
customer service and sales. Each employee will be well versed in health science,
best forms of ingestion, medical cannabis varieties, cannabanoid profiles, and
understanding patient needs. Our sales training will emphasize being
knowledgeable on our products and effectively communicating with patients.
There will be no emphasis on selling larger amounts of medical cannabis, and in
fact Compassionate Care seeks to encourage patients to purchase smaller amounts,
and adjust over time if necessary. High priority will be placed on providing a
positive atmosphere, where workers and employees will enjoy providing good
customer service.
Security Training and Security Drills - Given the nature of our business, security
is a significant aspect of our day-to-day operations. As such, employees will not
only be trained on site on the proper procedures in case of an emergency. All new
employees will also be required to attend off-site safety/security trainings that
must be completed during the early stages of employment. As part of our
commitment to a safe working environment, new employees will also receive
basic training on personal safety/security. This includes parking lot safety and
training for employees walking to work or utilizing public transportation. Lastly,
Compassionate Care will work with the local police to develop appropriate
ongoing training for all employees. All employees will be trained on the security
devices accessible to them, such as alarms, emergency phones, and keycard
access. Only the appropriate security personnel will be trained on all aspects of
security devices, such as surveillance cameras, retrieval of security footage,
monitoring, and controlling keycard access levels.
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Fire Safety and Training Drills - Given that fire safety is important in our line of
work, Compassionate Care will provide continuous training on fire prevention to
all employees, especially those in our cultivation facility. Employees will be
trained generally on fire hazards, with an emphasis on department specific
hazards. For example cultivation areas will have different and arguably greater
risks than the finance department. As such, employees in cultivation areas will
receive fire prevention training specific to wiring, amperage, and voltage.
Department and job classification specific training like this will be provided for
certain employees while general fire safety, hazard training, and drills will be
required for all employees. The general training will encompass detecting
potential fire hazards and appropriate steps to take in the event of an actual fire.
Delivery Truck Training - Compassionate Care will contract with Dunbar for
secure deliveries from our cultivation facility to our patient care center. For the
pick-up and delivery of supplies used for our operation, Compassionate Care plans
on implementing internal delivery truck training guidelines to ensure the safety of
our workers.
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facility, potential hazards can include machinery malfunction, electrical fires,
natural disasters, small flooding, and intrusions. In our patient care facility, more
training will be focused on security procedures involving human interference than
on malfunctions since employees will be interacting with the public.
Compassionate Care plans to compensate their employees during this training process, and
also pay for tuition or class fees when the training is not done internally, such as through the
University of Cannabis.
Each employee will give signed statements indicating the date, time, and place he or she
received training and the topics discussed, including the name and title of presenters. All of
this information will be stored in personnel records kept in secure areas and locked file
cabinets. Compassionate Care will conduct periodic performance evaluations to evaluate the
effectiveness of our training and to measure the development of our employees.
Compassionate Care will implement an ongoing education and training program so
employees and managers are continually challenged to learn new skills and expertise.
Complete training material is contained within our Employee Training Manual.
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6-a) The ATC shall establish, implement and adhere to a written alcohol, drug-free
and smoke-free workplace policy.
Compassionate Care intends to help provide a safe and drug-free work environment for our
clients and our employees. With this goal in mind and because of the serious drug abuse
problem in today's workplace, we are establishing the following policy for existing and
future employees of Compassionate Care.
The Company will conduct drug and/or alcohol testing under any of the following
circumstances:
RANDOM TESTING: Employees may be selected at random for drug and/or
alcohol testing at any interval determined by Compassionate Care and as
allowable by law.
FOR-CAUSE TESTING: Compassionate Care may ask an employee to submit to
a drug and/or alcohol test at any time as allowable by law if we feel that the
employee may be under the influence of drugs or alcohol, including, but not
limited to, the following circumstances: evidence of drugs or alcohol on or about
the employee's person or in the employee's vicinity, unusual conduct on the
employee's part that suggests impairment or influence of drugs or alcohol,
negative performance patterns, or excessive and unexplained absenteeism or
tardiness.
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POST-ACCIDENT TESTING: Any employee involved in an on-the-job accident
or injury under circumstances that suggest possible use or influence of drugs or
alcohol in the accident or injury event may be asked to submit to a drug and/or
alcohol test. "Involved in an on-the-job accident or injury" means not only the one
who was or could have been injured, but also any employee who potentially
contributed to the accident or injury event in any way.
If an employee is tested for drugs or alcohol outside of the employment context and the
results indicate a violation of this policy, or if an employee refuses a request to submit to
testing under this policy, the employee may be subject to appropriate disciplinary action, up
to and possibly including discharge from employment. In such a case, the employee will be
given an opportunity to explain the circumstances prior to any final employment action
becoming effective.
Exhibit J: HR Manual
6-b) The permit holder shall ensure that the policy is available to the
Department upon request.
Compassionate Care will ensure that our alcohol, drug, and smoke free policy is available for
the Department upon request, and provided in our Human Resources Manual.
Exhibit J: HR Manual
These policies are provided in our Human Resources Manual. Compassionate Care shall not
apply our alcohol, drug and smoke free policy to qualifying medical cannabis patients. All of
our procedures will be consistent with applicable state and federal laws. We will always seek
to provide opportunities for assistance to employees with substance abuse problems. Policies
on responding to emergencies, including robberies and workplace violence, are also provided
in our Human Resources Manual.
Exhibit J: HR Manual
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6-d) The ATC shall maintain a contract with an approved New Jersey employee
assistance program.
Compassionate Care intends to work and contract with an approved New Jersey employee
assistance program. We recognize that employee assistance programs can help employees
with issues affecting job-related performance and well-being, which is a cause
Compassionate Care fosters within its own operations and training programs. Some of the
employee assistance programs we have identified and intend to work with include:
Associates for Life Enrichment
CARE EAP
Center for Psychotherapy and Addictions Treatment
Intervention Strategies International, Inc.
Lifeworks Employee Assistance Program
Lynne Pastor
Responseworks, Inc.
We also recognize that working with an employee assistance program can help complement
our efforts in assisting employees deal with problems such as personal relationships,
emotional conflicts, health care resources, parenting, transitions, decision making skills,
addictive behaviors, financial prioritizing, and work stress.
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Chapter 7: Security
7a) Each alternative treatment center shall provide effective controls and
procedures to guard against theft and diversion of marijuana including, when
appropriate, systems to protect against electronic records tampering.
Compassionate Care has consulted with several high-level security experts to develop a
comprehensive plan that protects our products, patients, employees, facilities, administration,
and neighbors. We intend to implement effective controls and procedures to guard against the
theft and diversion of marijuana. They are discussed in our Security Plan.
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7b) At minimum, each alternative treatment center shall:
7b-i) Install, maintain in good working order and operate a safety and security
alarm system at its authorized physical address(es) that will provide suitable
protection 24 hours a day, seven days a week against theft and diversion and that
provides, at a minimum:
Compassionate Care intends to install and maintain safety and security alarm systems at our
cultivation and patient care centers. These systems will provide around the clock coverage,
seven days a week to protect against theft and diversion. In the event that our safety and
security systems are activated, notification will be sent to the directors of Compassionate
Care, our third party monitoring service, and State or local police agencies to alert them of
the security breach. These systems will be routinely maintenanced to limit false alarms, and
there will be battery and emergency generator backups to prevent any downtime of our
security systems.
7b-ii) Implement appropriate security and safety Sections to deter and prevent
the unauthorized entrance into areas containing marijuana and the theft of
marijuana;
Compassionate Care plans to implement security and safety measures to deter and prevent
the theft of cannabis or any the unauthorized access to areas containing cannabis. All
cannabis will be stored in highly secure areas with no public access. Our measures to
safeguard against unauthorized access include: perimeter fencing, security screening,
uniformed armed security personnel, electronic keycard access, and lockdown capabilities.
The primary preventative measure for unauthorized entrance will be through our keycard
access system.
Our keycard access system is a web-based IP access control system that enables real-time
control of each key card and entry point. We are able to define what the various security
zones are, and which individual key cards will grant access to the various areas. This
information can be quickly changed, so if an employee is terminated, for instance, his or her
keycard can be immediately disabled. In high security areas containing cannabis, keypad
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entry will be required in addition to an electronic card, preventing unauthorized individuals
who have come into possession of a keycard from gaining access. In the event of an
unauthorized keycard attempt, security personnel will be alerted to monitor the event to
determine whether it constitutes an attempted breach of security. Our intercoms and phones
will be able to communicate with a keycard holder in the event of a legitimate problem. The
passwords for managing electronic access will be constantly changed and managed by our IT
Department. More information is contained in our Security Plan.
7b-iv) Establish a protocol for testing and maintenance of the security alarm
system;
After our security system installation, Compassionate Care will conduct monthly and annual
tests to ensure all systems are fully operational. We will request a service contract from our
manufacturers that includes regularly testing our system, sensors, electrical connections, and
batteries monthly. Our maintenance and security personnel will also be trained on how to
maintain these systems. In addition to human monitoring, our systems include warning alerts
to notify us of any occurring or imminent problems.
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Compassionate Care will have an industrial-scale power generator in the event of a larger
power problem so our systems do not rely on their battery backups.
7b-v) Conduct maintenance inspections and tests of the security alarm system at
the ATC’s authorized location at intervals not to exceed 30 days from the previous
inspection and test and promptly implement all necessary repairs to ensure the
proper operation of the alarm system;
Compassionate Care will conduct maintenance inspections and tests of the security alarm
system at our cultivation facility and at our care center at intervals of not more than 30 days,
and we will promptly implement all necessary repairs to ensure the proper operation of the
alarm system. All inspections, inspection results, and maintenance records will be securely
kept for review as required.
7b-vi) In the event of a failure of the security alarm system due to a loss of
electrical support or mechanical malfunction that is expected to last longer than
eight hours:
With our routine inspections, prompt repairs, system self-monitoring mechanisms, battery
backups, and backup power generators, we do not anticipate our security alarm system being
down for more than eight hours due to loss of electrical support or mechanical malfunction.
If such an event occurs, we will immediately notify the Department pursuant to N.J.A.C.
8:64-9.8. Our emergency response planning will also include plans to close all access to our
cultivation and patient care centers until our security alarm system is restored to full
operation.
7b-vii) Keep access from outside the premises to a minimum and ensure that
access is well controlled;
Access to our cultivation and patient care centers is strictly controlled. In our cultivation
facility, no patients, guests, visitors, media, or members of the public are allowed to enter
without special clearances. In addition, they must always be accompanied by security
personnel. The cultivation site has high security perimeter fencing, video surveillance,
security lighting, and a guard post to prevent unauthorized access. Our patient care center
will also have a secure perimeter with appropriate security clearance required for entry.
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Detailed information is provided in our Security Plan.
7b-viii) Keep the outside areas of the premises and its perimeter well lighted.
Security lighting will be used as a preventative and corrective measure against intrusions or
other criminal activity. Security lights are one of the most practical and effective ways to
prevent crime. Criminals look for areas with little to no lighting.
Our research has shown that downward directed and shielded security lighting of medium
intensity provides for the best outdoor vision. In addition to the position of the security lights,
controlling glare is an important consideration. This is essential for our security staff and
third party monitoring to be able to see an intruder. Our staff and surveillance technology
must be able to provide authorities with accurate descriptions and visual evidence in the
event of a security breach.
Specific security lighting we have considered for our cultivation and patient care facilities:
L-Shaped steel poles with vertically secured 18 and 20ft. high exterior adjustable
dual mounted 400 HPS lamps
Exterior 150 HPS wall sconces above all entrances and exits
Motion sensitive exterior perimeter lighting
Interior motion-sensitive ceiling and wall mounted luminaries
7b-ix) Provide law enforcement and neighbors within 100 feet of the ATC with the
name and phone number of a staff person to notify during and after operating
hours to whom they can report problems with the establishment;
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7b-x) Equip interior and exterior premises with electronic monitoring, video
cameras and panic buttons.
In our Security Plan, we have provided a layout of our cultivation facility that features a
security overlay. The floorplan shows interior and exterior camera locations and other
security devices, as well as the area for around-the-clock video monitoring and DVR
locations. Our third party monitoring company will have video surveillance access for
additional protection, and Compassionate Care will provide the State of New Jersey with
remote access and at least two video monitors for viewing our facility via telephone lines.
We will obtain all necessary approvals by the MMP and follow the same procedures for our
patient care center. All video footage will be stored in our on-site 1,000 GB DVR, which is
capable of storing at least thirty days of video footage and will be expanded as needed to
comply. All recordings will be backed up to the internet daily to prevent loss of surveillance
footage in the event of an emergency.
Compassionate Care’s facilities will also incorporate an intrusion detection system that
includes a hold-up, panic, and critical condition signal monitoring service to give employees
an opportunity to react to a security breach. Panic buttons will be located in specific locations
throughout the cultivation facility to allow for easy employee accessibility. To prevent
misuse, we will train employees on when a situation warrants activating the alarm. The panic
buttons as well as the entire security system will be tested monthly to ensure that it is
working in the event of a real emergency. More information is provided in our Security Plan.
7b-xi) Limit entry into areas where marijuana is held to authorized personnel;
Areas where marijuana is held are strictly secured, as described in earlier sections and in our
Security Plan. Only authorized employees will be given access to these areas. Keycard
access and PIN numbers are always required for entry. Maximum-security measures will be
taken in these areas, and they will be closely monitored by security and management.
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Armored truck parking
Loading dock
Shipping/receiving
Packaging and curing
Harvest area
Trimming room
Security monitoring rooms
These areas are shown in our security floorplan. In patient care centers, all areas where
marijuana is held will undergo similar security measures.
7b-xii) Consistently and systematically prevent loitering, that is, the presence of
persons who are not on-duty personnel of the ATC and who are not ATC
registrants engaging in authorized ATC-dispensary activity; and
Compassionate Care does not allow loitering around our facilities. For our patients visiting
our patient care center, we will provide our no loitering policy during their orientations and
in the patient handbook. Not complying with this policy could lead to involuntary
disenrollment or other disciplinary measures. For non-patient loitering or any loitering
around our cultivation facility, our security personnel will be trained on how to regulate it.
Any suspicious activity will be reported to law enforcement.
Secured on-site parking will be provided. All entrants are required to pass though a perimeter
fence that is monitored by video surveillance. Access to parking areas in our cultivation
facility requires security clearance from our guard post. Access to parking areas in our
patient care centers is permitted during normal business hours with security personnel nearby
at all times. Parking areas are monitored 24/7, with ample lighting, to ensure individuals get
to and from their cars safely.
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We shall notify the permitting authority within 24 hours by telephone at (609) 826-4935,
followed by written notification within 10 business days, of any of the following:
An alarm activation or other event that requires response by public safety
personnel;
A breach of security;
The failure of the security alarm system due to a loss of electrical support or
mechanical malfunction that is expected to last longer than eight hours; and
Corrective measures taken, if any.
We shall further maintain documentation in an auditable form for a period of at least two
years after the reporting of an occurrence that is reportable pursuant to this section.
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Chapter 9: Inventory
Compassionate Care intends to keep adequate inventory levels of products available for our
patients. Having an oversupply of inventory leads to product degradation and security risks,
but having an undersupply of inventory leads to insufficient access to medicine. In order to
sustain sufficient inventory levels, our cultivation facility and patient care center facility will
communicate regularly and efficiently. When a particular strain is running low, we can
advise our cultivation facility to increase production. When we have an excess of a particular
strain we can decrease production accordingly, or offer pricing incentives to expedite sales.
One of the capabilities of our supply chain tracking system (described in Criterion 5,
Measure 3) is to control our inventory and anticipate future production needs. Under our
supply chain tracking system each plant in our cultivation facility is assigned a unique,
progressive serial number from the moment a cutting is taken. This serial number is entered
into our secure computer database so we are always aware of the number of plants within our
facility and their strain. We are also aware of the current status of the plant (e.g., whether it is
in the vegetative stage of growth or the flowering stage of growth). This information allows
us to forecast inventory levels for the future, so if a patient ever inquires when a particular
strain will be available, we can quickly determine how many of those plants are in
production, what stage of production they are in, and how long until the plants are ready to
harvest.
After harvesting, when the medical cannabis is securely transported to our patient care
center, our supply chain tracking system is integrated with the secured database of our
delivery company and patient care center. After a product from our cultivation facility is
placed in transit, the status of the package is updated pending delivery confirmation, and then
the status is updated when it is received by the patient care center. Once the product is sold at
the patient care center, information as to the patient it was sold to will be associated with the
serial number of our plant, so there is traceability from seedling to sale. Even in the absence
of physical communication,, our secure technology allows us to retrieve current inventory
levels in our patient care center so the cultivation personnel are made aware of any possible
shortages or overages.
Inventory will be manually performed every day in the patient care center to verify the
accuracy of our computerized inventory management system and prevent diversion. Manual
inventory will also be performed in our cultivation facility on at least a weekly basis to
ensure all products, byproducts, and discarded items in our operations are accounted for.
Information will be kept for a period of at least 7 years, or as otherwise required by the State
of New Jersey.
Regular inventory and supply chain tracking allows us to prevent diversion or distribution to
non-medical recipients. We will take the following measures to prevent diversion:
At the time of each purchase, verify an individual’s status as a qualified patient or
caregiver with a valid identification card;
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Have the individual agree not to distribute cannabis to non-patients;
Have the individual agree not to use the cannabis for other than medical purposes;
Maintain membership records on site or have them reasonably available;
Track when members’ medical cannabis recommendation and/or identification
cards expire;
Enforce conditions of membership by excluding members whose identification
card has expired, or who are caught diverting cannabis for non-medical use;
Track each patient’s purchases to make sure he or she is not purchasing more than
legally allowed;
Refuse to transfer medical cannabis to any person, even if legally qualified, if
there is reason to believe such person or entity is using cannabis for non-medical
reasons or is likely to divert such medical cannabis to persons or entities
unauthorized to possess it under state law.
To prevent diversion in our cultivation facility, our supply chain tracking system follows
every plant from seedling to sale, so we can verify the destination of every product
Compassionate Care produces and sells. This system allows us to:
Prevent shrinkage within the facility, whereby plants are stolen, since each plant
has a barcode and if it is missing we will know that a serial number is
unaccounted for;
Compare average yields of plants, whereby if plants in particular areas are
yielding less end product we can alert security to a possible concern; and
Require the accounting department to obtain delivery confirmations for every
product delivered, and log that information with our record keeping system.
Furthermore, all patient care center sale transactions are done through a point of sale
cashiering system; two background checked employees manually verify inventory counts
daily, and we use storage safes for any excess inventory.
Compassionate Care believes that having strict guidelines aimed at preventing diversion, and
creating an inventory tracking system that allows us to follow each plant from seedling to
sale, we will be able to create a closed loop system where cannabis does not end up in the
possession of a non-medical user. All of the information pertaining to production,
transferring, sales, and patients will be securely kept and available for review by the State of
New Jersey as required by law.
Compassionate Care will develop a comprehensive inventory system that keeps track of all
medicinal cannabis, including cannabis available for cultivation and usable cannabis
available for dispensing, from seedlings to mature cannabis plants and unusable cannabis, at
our authorized location, beginning on the date we first engage in the production or dispensing
of medicinal cannabis. We anticipate beginning with no medicinal cannabis on hand, and we
will record this fact as the initial inventory. Cannabis is deemed to be “on hand” if it is in our
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possession or control.
Our inventory shall include damaged, defective, expired, or adulterated cannabis awaiting
disposal, including the name, the quantity, and the reasons for which we are holding the
cannabis. Compassionate Care will comply with the State of New Jersey’s Health and Senior
Services Medicinal Marijuana Program for minimal inventory requirements, which includes:
Establishing inventory controls and procedures for the conduct of inventory
reviews and comprehensive inventories of cultivating, stored, usable, and
unusable cannabis;
Conducting a monthly inventory of cultivating, stored, usable, and unusable
cannabis;
Conducting a comprehensive annual inventory not more than one year from the
date of the previous comprehensive inventory;
Promptly transcribing inventories by use of an oral recording device;
If cannabis is disposed of, maintaining a written record of the date, the quantity
disposed of, the manner of disposal, and the persons present during the disposal,
with their signatures;
Keeping all records for a minimum of two years; and
For all inventory records, at a minimum, including the date of the inventory, a
summary of the inventory findings, and the name, signature, and title of the
individuals who conducted the inventory.
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Before a batch of medicinal cannabis is packaged, a sample will be tested in our laboratory
for pests, molds, and other contaminants, and we will also analyze the cannabinoid profile of
the product (details are provided in Criterion 5, Measure 3). Any medicinal cannabis found
to be deficient, whether because of mold, excessive THC, or other issues, will be incinerated.
In addition, excess inventory will periodically be destroyed to prevent any unauthorized use
or distribution. An on-site incinerator in a secure room of the facility will be used for this
purpose and operated by highly trained personnel.
If a patient or caregiver returns product claiming that it is defective, our staff will complete a
report on the complaint and take possession of the returned product. The returned product
will be weighed, and if the returned product is >50% of the volume purchased, the customer
will be eligible for a full refund of the purchase price. Also, the customer may apply the
value of the product returned to another medication purchase. As each patient may only
purchase two ounces of medication per month, patients returning >50% of a quantity of
medicine for quality reasons will be able to replace that allotment within their two-ounce-
per-month purchase limit. Patients making returns of less than half of the product purchased
will be eligible for a refund of the purchase price, but they will only be able to buy substitute
product if they have not reached their purchase limit for the month, inclusive of the product
returned. With this policy we hope to balance consumer protections with the Act’s objective
to limit personal consumption of medicinal cannabis to no more than two ounces of medicine
per month and prevent diversion.
Any product returned for quality reasons will be sent to our laboratory for inspection and
analysis. If the product has evidence of pests, contaminants, or other problems, we will use
our inventory tracking system to identify all products produced from the same plant, whether
they are in our cultivation facility or patient care center, or have been sold to patients and
caregivers. Upon receipt of returned product from the patient care center the product
received will be weighed and its weight compared to recorded weight of the product when
returned. Management and security will investigate discrepancies and any reportable events
will be communicated to the Department. Once the source plant associated with a product
quality problem has been identified, any related product that remains in our possession will
be returned to the lab for inspection and the product will be destroyed. We will also issue a
consumer alert to patients who have received related product, and they will be encouraged to
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return the potentially damaged product to their patient care center. Any returned product
received by our patient care center will be sent to our cultivation facility where it will be
incinerated after appropriate samples have been provided to the laboratory for analysis.
Throughout this process the volume of the product will be recorded in our inventory
management system, so there will be thorough documentation of the product’s disposition
and any diversion can be identified and managed as required by New Jersey law and the rules
of the Department.
Permit Expiration
If our permit to operate ur ATC expires without being renewed or is revoked, Compassionate
Care will comply with the State of New Jersey’s Health and Senior Services Medicinal
Marijuana Program for destruction of cannabis and recordkeeping, including:
Destroying or disposing of all unused cannabis or surplus inventory in our
possession by providing it to the New Jersey State Police for destruction;
Creating and maintaining a written record of the disposal of cannabis that is
identified for disposal, weighing and inventorying it prior to destruction; and
Discontinuing production of cannabis.
Within 10 business days after destroying the cannabis, we shall notify the Department, in
writing, of the amount of cannabis destroyed.
The person or entity submitting cannabis for disposal pursuant to this section shall present a
valid registry identification card and a within ten business days after destroying the cannabis,
we shall notify the Department, in writing, of the amount of cannabis destroyed.
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Appendix
H
Security Plan
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Security Plan
Compassionate Care understands the most important assets we have are not our products,
but our people. That’s why Compassionate Care has approached our security plan with
the seriousness of not only protecting our equipment, inventory, and products, but, more
importantly, the lives and well-being of our community and team members. We are
keenly aware of the added security challenges that our business faces, and we have taken
extensive measures to have policies, procedures, and systems in place to provide
comprehensive protection.
We have divided our security plan into two components: Cultivation Facility Security and
Operational Security. Both categories are designed to minimize our security exposure
and prevent breaches. However, in the event that preventative measures fail, our
operational solutions are designed to quickly detect, monitor, contain, counter, and report
situations that do occur.
FACILITY SECURITY
This section pertains to our cultivation facility, as our patient care facility has not been
chosen yet. Our cultivation facility is designed to include physical safeguards that protect
against security breaches and trigger an immediate response. After choosing consultants
with appropriate experience levels to manage this project, the next security decision we
made was during our site selection. For each possible site we took physical security into
consideration. We wanted to find a space with as many intrinsic security features as
possible, based on such things as location, layout, existing security systems, neighboring
uses, and building finishes. Each site was analyzed for barriers, control points, points of
entry, roofing, lighting, hardware, building finishes, and other security considerations. It
was important to find a facility located in a secure area, fabricated with durable material
that would reduce our exposure to security risks, and not visible from the street or public
areas.
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Specific selection criteria included: set back from any high traffic intersections; secure
avenues of ingress and egress; located in an industrial park; not located near any schools,
freeways, residential housing, or places of worship; and not accessible via foot traffic.
At the facility we have chosen, the existing building is constructed of masonry. The 12‖
thick concrete exterior perimeter walls provide a solid base for security. There are no
exterior windows anywhere on the building, and the exit doors have no external access—
they exist for egress purposes only. These doors have mechanisms only for exiting the
cultivation facility, with no exterior handles or hinges. If an intruder tried to enter the
cultivation facility, he would not be able to use the doors as an entry point. Since there
are no windows and no doors with exterior entry, potential intruders would have great
difficulty gaining unauthorized access. Limiting access through these existing design
elements deters and reduces the likelihood of unwanted intrusion.
Compassionate Care has submitted its security plan for review by several highly-
experienced security consultants, including leaders in the Metropolitan Transportation
Authority Police Department and the Detectives’ Endowment Association, Inc and TRC
Corporation. These consultants have concluded that Compassionate Care’s plan meets or
exceeds current standards for policing and securing of this type of facility (see Appendix
J). We have reached out to local law enforcement officials as well, and as we move
forward we will develop plans to coordinate our security measures with their policies and
procedures.
Secured parking will be provided for Compassionate Care’s employees. All employees
will be required to enter though the main campus security gate. This gate will be
monitored and on-site security personnel will grant authorized access. Compassionate
Care will encourage the use of carpooling and public transportation, and individuals
arriving at the site through these methods will be dropped off in front of the secured
campus and granted pedestrian access by security. Before entering the cultivation
facility, a final security clearance is required. Authorized individuals will need keycard
access to enter the various areas. To ensure employees get to and from their cars safely,
parking areas will be provided with ample lighting and monitored 24/7 by our security
personnel and surveillance system.
Plants grow 24 hours a day, 7 days a week. Therefore, Compassionate Care plans to have
staff and security on site 24/7. Sufficient security staff will always be available to
monitor the cultivation facility, parking lots, and campus, including at least 3 security
guards overseeing the surveillance systems and servers in the security department. Our
security systems will operate around the clock to prevent and detect threats and alert our
staff to any possible breaches. These systems will be checked regularly to ensure proper
functionality. Our internal security guard force will monitor all of these systems and our
cultivation facility and our corporate headquarters, so even in the event that our security
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personnel are unable to detect a problem, there is an additional layer of observation and
protection.
Security Systems
Compassionate Care plans to have in place a comprehensive security system that includes
alarms, third party monitoring, overhead PA and panic buttons, lockdown capabilities,
video surveillance/recording and security lighting. Intrusion detection mechanisms,
including alarms and video surveillance, will be located strategically throughout the site.
Specifically, entries and exits will be secured, and cameras will be located on the exterior
and interior of the building to capture suspicious behavior.
Alarms
Compassionate Care has reviewed various alarm systems available in the market today
and has chosen Henry Bros. Electronics VISTA 128BPE security alarm system to
monitor access to the cultivation facility, specifically all entry and exit points. Alarms
serve to deter unauthorized access once an intruder has breached at least one of our
security layers. The hope is that once an audible alarm is triggered an intruder will flee.
With our silent alarm system the objective is to catch an intruder in the act or prevent the
aggravation of a dangerous person while simultaneously alerting the authorities and our
security team.
Silent alarm panic buttons will be placed throughout the cultivation facility. They will be
used to alert our corporate headquarters to take appropriate action. Our on-site security
will have access to our video surveillance and can identify the level of threat and
emergency. Generally, silent alarms are advisable in situations where an intruder is
unaware of detection and triggering a siren alarm would put our staff in danger. Given
the level of security barriers, it is unlikely an intruder will overcome them and cause a
situation where a silent alarm is necessary. Silent alarm and panic buttons will likely be
more appropriate if someone granted access becomes unruly and threatens staff.
The system will provide intrusion detection, such as laser beam penetration and
unauthorized keycard access that notifies our on-site security and corporate headquarters
of the specific area of the problem. This system covers multiple points of entry in case
there is more than one intruder. Generally, alarm distress signals will be siren alar ms that
are loud, can scare off or disorient intruders, and alert all staff to a security breach.
In the event that someone has already gotten into the building, our door contacts will
accurately detect exiting and cause appropriate alarms to go off when doors are forced
open. This system alerts security staff and appropriate Compassionate Care personnel.
To prevent the of New Jersey Police Department’s resources, Compassionate Care staff
will contact the New Jersey Police Department only if the threat is deemed legitimate.
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Ongoing maintenance and testing
After our security system installation Compassionate Care will conduct monthly and
annual tests to ensure all systems are fully operational. We will request a service contract
from our manufacturers that includes regularly testing our system, sensors, electrical
connections and batteries monthly. Our maintenance and security personnel will also be
trained on how to maintain these systems. In addition to human monitoring, our systems
include warning alerts to notify us of any occurring or upcoming problems.
Compassionate Care will have an industrial-scale power generator in the event of a larger
power problem so our systems do not rely on their battery backups.
With our routine inspections, prompt repairs, system self-monitoring mechanisms, battery
backups and backup power generators, we do not anticipate our security alarm system
being down for more than eight (8) hours due to loss of electrical support or mechanical
malfunction. If such an instance happens, we will immediately notify the Department
pursuant to N.J.A.C. 8:64-9.8. Our emergency response planning will also include plans
to close all access to our cultivation and patient care centers until our security alarm
system is restored to full operation.
Compassionate Care will conduct maintenance inspections and tests of the security alarm
system at our cultivation and dispensary care center in intervals not to exceed 30 days
from the previous inspection and test and promptly implement all necessary repairs to
ensure the proper operation of the alarm system. All inspections, inspection results and
maintenance records will be securely kept for review as required.
Compassionate Care has decided to utilize monitoring from the corporate headquarters to
help deter, detect, and document security events at the cultivation facility. Trained
professionals from the security staff located at our corporate headquarters will be able to
access our security surveillance system at all times and will report and document any
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suspicious activity. Our internal security department will establish guidelines for what
entails suspicious activity.
There will be triggers around the cultivation facility to alert our monitoring team of a
possible intrusion or unauthorized access. Triggers can be:
Motion-sensor surveillance cameras
Motion-sensor laser beams
Unauthorized electronic access
Security and fire alarms
Silent alarms
In the event of a security breach, an overhead PA system will alert employees to the
emergency and direct them on the appropriate way to respond. Security personnel will be
responsible for operating and providing instructions over the PA system. The PA system
will be primarily accessed through the Security Department, but anyone on the premises
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can access the PA through any telephone within the cultivation facility. As an additional
safeguard, the on-site security supervisor will at all times have a mobile panic remote in
the case an employee cannot reach the panic button in a timely manner.
The PA system is connected to speakers throughout the cultivation facility so all staff can
be made aware of a critical happening. Part of the training protocol for all Compassionate
Care staff will include emergency drill training, so staff is adequately prepared to
respond.
Strategically placed red emergency phones will also be located in every department of the
cultivation facility. Located on the wall next to these phones will be phone numbers of
emergency service providers. While these phones traditionally are used for fire safety,
they can also be used for security purposes.
Our Electronic Access Control system gives us the ability to centrally lock down our
entire cultivation facility. Each access point is controlled from a central membrane, and
in the event of an emergency, our security department can lock down any sector, from a
single door (partial lock down) to the entire cultivation facility (complete lock down).
This allows us to respond to different levels of threats and keep a problem contained. The
system can also be used to keep doors unlocked, allowing free access in the event of an
evacuation. Since each door can have unique access specifications, our system allows us
to lock down the cultivation facility to everyone with the exception of a certain access
class, such as our security personnel, or those with a special keycard, which could be
given to law enforcement.
Compassionate Care will also make sure in the event of an emergency lockdown there is
adequate communication. A lockdown will automatically alert our corporate staff that
there is a critical situation at our facility. The lockdown will register on our overhead PA
system, notifying all personnel what’s happening. Additional communication measures
include sending text messages and emails to the cell phones and mobile communications
devices of directors and management.
By controlling entryways and exits, as well as movement within the cultivation facility,
authorized security personnel will be better able to contain and handle threats. Regular
training for staff will incorporate the most effective lockdown procedures. To manage
emergencies effectively, we will use communication methods that can distribute
emergency instructions quickly and widely during an event.
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Video surveillance is the cornerstone of our security system. Our surveillance systems are
a strong deterrent and will help Compassionate Care monitor the entire facility and its
surroundings. A variety of specialty cameras, such as infrared, motion-sensor, PTZ, fixed
zoom, low-light, megapixel, IP, and night vision cameras will be used in our video
surveillance. All cameras will have the tilt/pan/zoom capabilities and will have secure
off-site internet access. Compassionate Care encourages the State of New Jersey to
participate in surveillance access to its cultivation facility, similar to the practices in
Colorado for compassionate caregiver monitoring. We view this as an additional
monitoring measure to keep our employees and products safe.
Our security consultants have determined that a total of 39 vandal resistant, low power
consumption exterior and interior cameras need to be installed (see Picture X). These 39
cameras will be dynamic and have the ability to respond to motion and communicate
suspicious activity to our corporate monitoring personnel. Our indoor cameras include
discreet 2.0 megapixel cameras. Our exterior cameras offer high resolution and weather
resistant features that ensure a clear picture with every use. In addition to our corporate
monitoring, by the time we are in full operation, our internal Security Department will
always have at least 3 staff members present to oversee the security systems and
monitors, and they have the ability to call up 6 additional guards within 15 minutes. To
adequately secure the cultivation facility 24hrs a day, 365 days a year, the video
component of our security plan includes:
Exterior Monitoring – We believe 4 surveillance cameras are sufficient for monitoring
and recording events on the surrounding lot, and 4 surveillance cameras for
monitoring the exterior of the cultivation facility. Accordingly, four 5-50mm AL VF
Outdoor Dome Cameras will be used. These cameras are all-weather high definition
cameras with day and night capabilities. With these megapixel cameras,
Compassionate Care will have clear, crisp images that let us see the important details
we need for identification. This includes face and license plate recognition, while still
capturing a full field of view for exterior monitoring.
Interior Monitoring – We believe 14 cameras for the interior of the cultivation facility
are sufficient to provide complete coverage. High definition cameras placed in
specific high security areas will have forensic capability. We have chosen Speco
Color Series Indoor cameras for our interior needs. These cameras will be operable
24/7, have the ability to respond to motion, and will alert appropriate security
personnel of suspicious activity. The cameras will have infrared/night vision
capabilities and be heat sensitive, which allows them to respond to human
movements. The camera locations are depicted on the security floor plan included in
Appendix H.
Night Monitoring – Compassionate Care’s cultivation facility will be monitored 24
hours a day. Security personnel will be on site during the evening/night hours and will
monitor the facility through the camera systems as well as through scheduled
cultivation facility and site walks. All exits and entrances will be monitored though
our intrusion detection system 24 hours a day. In addition to being dynamic, these
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cameras will have infrared capability and be heat sensitive, ensuring that personnel
can identify unusual activity and be alerted only when necessary.
Body Cameras – Compassionate Care plans to use body cameras with certain types of
staff, such as exterior security personnel and those working in the shipping and
receiving department, where all of our finished products are kept. By placing body
cameras on individuals that provide products to our unmarked van delivery service,
we can monitor any product that leaves the cultivation facility. This will ensure
employee protection and non-diversion. In case of a security breach during delivery,
the high definition body cameras will record the event and provide forensic evidence.
As with cameras located at the physical site, the data from the body cameras will be
backed up and stored as necessary.
Lighting
Security lighting will be used as a preventative and corrective measure against intrusions
or other criminal activity at the cultivation facility. Security lights are one of the most
practical and effective ways to prevent crime. Statistics have shown that a well-lit
property reduces crime because lighting acts as a deterrent. Criminals most likely look
for areas with little to no lighting. With our security consultants, we have performed a
comprehensive site evaluation to ensure that more than sufficient lighting exists,
especially in areas otherwise overlooked and with dark surroundings.
Our research has shown that downward directed and shielded security lighting of medium
intensity provides the best outdoor vision. In addition to the position of the security
lights, controlling glare is a major consideration. This is essential for security. Our staff
and third party monitoring must be able to see an intruder, and our surveillance must be
able to capture clear images.
The specific security lighting proposed for our cultivation facility includes:
L-shaped steel poles with vertically secured 18 and 20ft. high exterior adjustable dual
mounted 400 HPS lamps
Exterior 150 HPS wall sconces above all entrances and exits
Motion sensitive exterior perimeter lighting
Interior motion sensitive ceiling and wall mounted luminares
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The electronic access control management system we have chosen is the Honeywell
NetAXS Access Control system. NetAXS is a web-based IP access control system that
enables real-time control of each key card and entry point. We are able to define what
the various security zones are, and which individual key cards grant access to the various
areas. This clearance can be quickly changed using NetAXS. If an employee is
terminated, for instance, the employee’s key card can be immediately disabled.
Likewise, if an employee receives a promotion and needs additional access, NetAXS can
make those changes quickly.
Compassionate Care will have 3 levels of security access in our cultivation facility. The
lowest level of security will be Level 1 and include:
The Conference Room
Break Room
Men’s and Women’s Showers, Bathroom, and Lockers
Janitorial Room
At every access point is a card reader that requires a keycard to grant access, and a
surveillance camera that monitors the door. In extremely high security zones (i.e. Level
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3), key pads will be installed and a PIN required to gain entry. This protects against a
situation where an authorized employee loses his/her access card, and it is recovered by
an unauthorized individual before the card has been reported lost to the Director of
Security. Additional security for Level 3 areas include dual person access and dual entry
access. In the event of an unauthorized keycard attempt, security personnel will be alerted
to monitor the event to determine whether it is an attempted breach of security. Our
intercoms and phone can be utilized to communicate with a keycard holder in the event of
a legitimate problem.
Compassionate Care will be able to instantly review access activity by user and by
individual doors. We can see where each individual has traveled or look at a particular
entry point to see which individuals have accessed that area. This information helps us
narrow our focus in the event of a problem.
We will also have the ability to add customized notifications in the event of an
emergency. These customized notifications include email or cell phone alerts that can
notify appropriate staff of specific emergency alerts and access breaches. Linked with
security cameras, instant playback of events, including video and logs of door access,
will be available in the event of an emergency and can also be accessed remotely through
hand held devices.
Compassionate Care anticipates having many different layers of security access. Each
security zone has different security measures to protect that area, and the electronic
access control system regulates which individuals can access these areas. Some keycard
restrictions reflect operational rather than security concerns. For instance, individuals
that enter areas with male plants will not be allowed to enter areas with female plants to
prevent pollination, even though they have the same access. Generally, horticultural staff
will only be given access to the specific departments where they have direct
responsibilities in order to prevent contamination. In most circumstances, they will not
even be able to enter adjacent departments, so if contamination does occur, it is isolated
to the specific area worked by that staff person.
The passwords for managing Electronic Access Control will be constantly changed
through the IT Department. This will ensure only authorized security personnel can
regulate access levels.
Perimeter Security
Our surrounding campus security involves several layers of protection. The first layer is
our gate that surrounds the entire perimeter of the property. The second layer is the
uniformed security personnel that will be supplied by BCI Strategic Risk management.
The last level of perimeter security is our monitoring system that comprises video
surveillance, alarms, and optimal lighting.
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Compassionate Care is located within a secure campus. The entire site will be enclosed
within an 8’ high fence. There is only one entrance into the site. During Phase 1 of our
construction this gate will be reinforced by industrial strength steel. Heavy grade bollards
will be set every 4’ around the perimeter for additional security. The entrance consists of
a security gate that is monitored 24/7 by high definition day/night cameras and intrusion
detection systems. This 12’ high fence will provide an initial barrier to potential
intruders. Our independent security consultants confirm that deterrents such as these
ultimately prevent intruders from entering the site because it decreases the likelihood of
successful access and increases their chances of getting caught.
In the event that an intruder does try to access the site, our security cameras will be able
to capture clear images of the individual. Whether the attempt is successful or not, these
images will be sent to the New Jersey Police Department for further investigation.
Uniformed armed security personnel will be on site monitoring the cultivation facility
24/7. Compassionate Care has consulted with BCI Strategic Risk Management, an
international protective services firm, for its 24/7 security guard needs. All security
personnel will be thoroughly screened, trained, and strictly supervised by BCI to ensure
they are acclimated to our cultivation facility’s unique needs. BCI will work in
conjunction with Compassionate Care’s Security Department. The Director of Security
will screen and conduct trainings to ensure that uniformed personnel can effectively carry
out our security objectives.
In collaboration with our consultants, we have determined that a total of 3 on-site security
guards will be required to monitor and protect the cultivation facility at all times. The
break-down of these 3 security guards is as follows:
1 guard will patrol the perimeter (with at least 1 stationed by the Shipping and
Receiving Department during operation).
1 guard will monitor images from surveillance cameras inside the cultivation facility,
monitor the cultivation facility entrance and login anyone attempting to enter the site,
and monitor the campus gate and cultivation facility gate.
1 will supervise all security staff and freely travel the cultivation facility and campus
as needed
At the end of every shift, security personnel will be required to document any happenings
every 60 minutes and report any unusual activity occurring during their shift. These notes
will automatically be maintained in a database and electronically managed for future
retrieval.
Loitering
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Compassionate Care does not allow loitering around our facilities. For our patients
visiting our patient care center, during their orientations and in their patient handbook we
will provide our no loitering policy. Not complying with this policy could potentially
lead to involuntarily disenrollment or other disciplinary measures. For non-patient
loitering or any loitering around our cultivation facility, our security personnel will be
trained to consistently and systematically regulate this. Any suspicious activity will be
reported to law enforcement.
Product Security
Product security is ensured at every step of the process. By limiting access to the
cultivation facility and monitoring activities inside the facility, the mechanisms discussed
above will protect products from theft and tampering 24 hours a day, 7 days a week.
Added protection will be provided through our supply chain tracking software which will
record, track and monitor our products from seed until sale (see Criterion 4, Measure 1).
All products are required to go through a quality assurance assessment throughout
different stages of the growth and production cycle. Any tampering not immediately
noticed via surveillance camera will be caught during product safety testing.
In the event that a finished product is packaged after the last unmarked van delivery has
left for the day, it will be stored overnight in our safe. In consultation with our insurance
provider, JCH Insurance has suggested the use of the AMSEC AmVault CF5524. This
safe has the proven ability to withstand temperatures up to 1850 F and unwarranted entry
using sledgehammers, power saws, carbide disc cutters, and drills. The safe is equipped
with a three-way active bolt mechanism engaging the bolts horizontally and vertically
into the body of the safe. All finished products will be stored in the safe overnight and
then shipped out the next morning. All other products that are unfinished, immovable, or
in the development stage will be protected overnight by the system of surveillance
cameras, alarms, and armed security just described.
OPERATIONAL SECURITY
Our operational security measures are policies and procedures that are an important
component of reducing the threat to our facility, employees, contractors, products,
patients, administration and data.
In today’s technological era, data and information have become as susceptible as goods
and products. While our IT Department is responsible for protecting our data against
intruders, basic measures that will be taken to protect our information include:
Virus protection
Spam-filtering software
Firewalls
Software and OS Updates
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Passwords
Physical security of data storage centers
No portable laptop computers
Secure Wireless networks
Restricted Web browsing
Data Backups
Having a system in place to back up and protect security data is just as important as
capturing security information. Often times a theft or security breach is not detected at
the time of the incident, and it’s important for Compassionate Care to be able to retrieve
historical information to see what took place. Therefore, our data backup plan is
designed to protect vital information.
The surveillance camera system will have a digital video recorder (DVR) with a
minimum of 1,000GB of storage. While the DVR will allow us to retrieve several weeks
of historic information, all of the recordings will be backed up online onto a much larger
database. That way, in the event our DVR is damaged, stolen or malfunctioning, all of
the recordings will still be retrievable online via a highly secure network access. Online
back-up is automatically done multiple times throughout the day, so there is never an
incident where vital data was not backed up.
We will have secured access to real time alarm history, service ticket information,
suspicious activity reporting, and open/close activity from our security system through
the web. All of this surveillance and security information is backed up, whereas in the
event of an emergency, natural disaster, or criminal breach, all of our security
information is safe in a remote location
Neighborhood Involvement
Emergency Response
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Our 3rd party monitoring center will automatically be notified electronically if the
breach has been initially detected through the security system and determine the
extent of the threat
If security breach is determined to be an actual threat, local and state authorities will
be notified as required as required.
Reporting Problems
Law enforcement and neighbors within 100 feet of our facility will be provided with the
name and phone number of a staff person to notify during and after operating hours to
whom they can report problems with the establishment. At this time, we have chosen:
State or local police agencies will be notified of unauthorized breach of security. These
systems will be routinely maintained to limit false alarms and have battery and
emergency generator backups to prevent any downtime of our security systems.
In the event of a failure of the security alarm system due to a loss of electrical support or
mechanical malfunction that is expected to last longer than eight hours we will also
notify the Department as required.
Background Checks
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security footage, monitoring, and controlling keycard access levels. Information on our
training programs is contained within our Employee Training Manual.
We do not allow any financial transactions to take place at our cultivation facility, and
will institute procedures to limit the amount of cash stored on premises at our patient care
center. Low thresholds will be set for management to remove cash from registers and
place in a safe until pickup. All cash registers, display cases and any areas where
cannabis is stored will be fully secured and monitored by video surveillance.
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Appendix
I
Employee Training Manual
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Appendix
J
HIPAA Manual
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Appendix
K
HR Manual
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Appendix
L
Cultivation Overview
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APPENDIX L
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APPENDIX M
Appendix
M
Hydroponic Design
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APPENDIX M
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APPENDIX N
Appendix
N
Product Safety Plan
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Appendix
O
Fire Safety Plan
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Appendix
P
Environmental Plan
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Appendix
Q
Financial Pro-Forma
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FINANCIAL PRO-FORMA RELATED INFORMATION: EXEMPT FROM OPRA PURSUANT TO N.J.S.A . 47:1A-1.1
APPENDIX Q
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FINANCIAL PRO-FORMA RELATED INFORMATION: EXEMPT FROM OPRA PURSUANT TO N.J.S.A . 47:1A-1.1
APPENDIX Q
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FINANCIAL PRO-FORMA RELATED INFORMATION: EXEMPT FROM OPRA PURSUANT TO N.J.S.A . 47:1A-1.1
APPENDIX Q
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FINANCIAL PRO-FORMA RELATED INFORMATION: EXEMPT FROM OPRA PURSUANT TO N.J.S.A . 47:1A-1.1
APPENDIX R
Appendix
R
Letters of Recommendation
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APPENDIX R
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APPENDIX R
Dear colleagues:
Thank you for selecting CW Analytical Laboratories to provide analytical services for your project. CW
Analytical has scientifically defensible protocols and detailed quality assurance plans that meet or exceed
the Proposed Rules of New Jersey’s Medicinal Marijuana Program. In fact, CW Analytical is actively
engaged with government officials across the country to more clearly define product safety and testing
standards for medical Cannabis. Our team has the ability to analyze a wide range of medical Cannabis
products with the academic and professional expertise required to interpret and defend our results. These
attributes make CW Analytical the ideal candidate for providing third party product assurance for your
permitted medical Cannabis facilities.
This letter is to confirm that, per our conversations, CW Analytical Laboratories will provide the following
analytical services on a regular basis for your facility if you are awarded an operating permit:
In addition, our personnel are available to provide on-site consultation for all quality assurance related
issues. This includes establishment of an Integrated Pest Management strategy that will limit the use of
harmful chemical pesticides. We can also help verify the overall cleanliness of production, trimming,
packaging, and food processing areas of the facility.
Finally, our lab will maintain secure, digital records off all services performed for your facility. You will
have 24/7 access to these data files from anywhere. This will streamline the time needed to prepare reports
for government regulators.
Thank you again for the opportunity. We look forward to working with you.
Sincerely,
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APPENDIX R
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APPENDIX R
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APPENDIX R
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APPENDIX R
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APPENDIX R
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