3617_DanielsSharpsmart_MedWaste_PTCPTOApp_DIN26531_20160729

0 | Page

Monday, July 25, 2016

Attention: Larry Frost
NC DEQ, Division of Waste Mgt.
Solid Waste Section Permitting
2090 US Highway 70
Swannanoa, NC 28778

Regulated Medical Waste Processing & Treatment Permit Application for:
Daniels Sharpsmart, Inc.
1851 Chespark Dr.
Gastonia, NC 28052

Corporate Address:
Daniels Sharpsmart, Inc.
111 West Jackson Blvd. Suite 720
Chicago, IL 60604

1 | Page

Daniels Sharpsmart, Inc.
111 West Jackson Blvd.
Suite 720
Chicago, IL 60604

Regulated Medical Waste Processing & Treatment Facility for 1851 Chespark Drive Gastonia, NC 28052

Monday July 25, 2015

The following information has been prepared in accordance with North Carolina Administrative Code 15A
NCAC 13B .1207 (1) & (2) for Daniels Sharpsmart, Inc. 1851 Chespark Drive Gastonia, NC 28052. This
operations plan will be prepared, maintained and updated as necessary to ensure continued proper
management of Regulated medical waste at the facility. This written plan will also be maintained at the
facility and units of the facility as necessary to ensure consistent procedures are used to manage
regulated medical waste.
The facility must also keep a copy of the permit, operations plan, and site drawings on site at all times.

2 | Page

Table of Contents

Section I
General Information………………………………………………………………………………………………………………………………..4
Section II
Property Information & Maps………………………………………………………………………………………………………………….5
Section III
Introduction…………………………………………………………………………………………………………………………………………….6
Definitions……………………………………………………………………………………………………………………………………………….7
General…..……….………………………………………………………………………………………………………………………………………8
Volumes…………………………………………………………………………………………………………………………………………………11
Responsibilites……………………………………………………………………………………………………………………………………… 12
Contact Persons/Hours of Operation……………………………………………………………………………………………………. 13
Site Security and Access Control…………………………………………………………………………………………………………….14
Operational Process (Overview)………………………….…………………………………………………………………………………15
Device Reclamation Program…………………………………………………………………………………………………………………16
Waste Acceptance Protocol…………………………………………………………………………………………………………………..17
Storage………………………………………………………………………………………………………………………………………………….20
Unauthorized Waste……………………………………………………………………………………………………………………………..21
Disposal (solid waste)…………………………………………………………………..……………………………………………………….23
Equipment………………………………….…………………………………………………………………………………………………………23
Cleaning and Decontamination……………………………………………………………………………………………………………..25
Emergency Actions……………….……………………………………………………………………………………………………………….27
Employee Training……….………………………………………………………………………………………………………………………..32
Record Retention/Manifesting………………….………………………………………………….……………………………………….33
Reporting……….……………………………………………………………………………………………………………………………………..33
Container Identification Sheet……………………………………………………………………………………………………………….34
Section IV
Facility Drawings…………………………………………………………………………………………………………………..…....Attached
Section V
Financial Assurance…………………………………………………………………………………………………..…….……….…Attached
Section VI
Signature Pages…………………………………………………………………………………………………………………………..Attached
Appendices
Appendix A: Land Deed……………………………………………………………………………………………...……………….Attached
Appendix B: Facility Mapping…………………………….………………………………………………………………………..Attached
Appendix C: Siting and Zoning Confirmation…………………………..…………………………………………………..Attached
3 | Page

4 | Page

Section I
General Information
The North Carolina Medical Waste Rules cover all aspects of medical waste management including:
packaging, storage, transportation, treatment and disposal. The application and operations plan has
been prepared to satisfy the requirements in NCDENR 15A NCAC 13B. .1200 for operation of an off-site
Regulated Medical Waste Treatment and Processing Facility. Medical waste is regulated as solid waste
and not as hazardous waste.
Medical waste is also subject to all general requirements for solid waste found in the solid waste
management regulations. The NC medical waste management regulations are administered by the
North Carolina Department of Environment and Natural Resources, Division of Waste Management.

Name of Proposed Facility
Daniels Sharpsmart, Inc., 1851 Chespark Dr. Gastonia, NC 28052

Name, address, telephone number, and email address of the applicant and contact person.
Kyle Little; 111 West Jackson Blvd. Suite 720 Chicago, IL 60604; 312 – 285 – 9087;
[e-mail]

Name, address, telephone number, and email address of the contract operator and contact person, if
applicable.
Not applicable.

Name, address, telephone number, and email address of the landowner. A landowner authorization
form must be signed and notarized if the property is to be leased (see attached form).
Grantee – Daniels Chespark NC, LLC, A Delaware Limited Liability Company.
111 West Jackson Blvd. Suite 720 Chicago, IL 60604
Name, address, telephone number, and email address of the engineer, if applicable.
NA
Name, address, telephone number, and email address of person to receive permit fee invoices and
annual fee invoices.
Kyle Little; 111 West Jackson Blvd. Suite 720 Chicago, IL 60604; 312 – 285 – 9087;
[e-mail]

5 | Page

Section II
Property Information and Maps
Describe the location of the facility. If the property was previously used for solid waste management
activities, provide a description of the operation including permit information and a map with
boundaries.
The location of the facility is located at 1851 Chespark Drive Gastonia, NC 28052. The facility is within
the City of Gastonia’s Planning Jurisdiction and located within the I – 2 Exclusive Industrial Zoning
District. The use, “Manufactured Goods, Class I”, is allowed by right within the I – 2 Zoning District. The
purpose occupancy of the subject property by Daniels Sharpsmart, Inc. for the purposes of the
collection, device management, and treatment of medical waste.
Latitude (North): 35.2884000 - 35° 17’ 18.24’’
Longitude (West): 81.2197000 - 81° 13’ 10.92’’
Universal Tranverse Mercator: Zone 17
UTM X (Meters): 480022.1
UTM Y (Meters): 3904850.0
Elevation: 762 ft. above sea level
The City Directory Image Report was reviewed, which included directories dating from 1987 to 2013 for
properties located on Chespark Drive and Sparta Court. The subject property was listed as MA Hanna
Color in 1999, Poly One in 2003, Gutter Guardian in 2008 and Cynergy Systems Inc. Construction in 2013.

The city directories for the adjacent properties were also reviewed. The property to the northwest (1708
Sparta Ct) was listed as Recore Electrical Contractors, Inc. from 1995 to 2013 Properties to the east and
west are undeveloped and not listed in the city directories. A copy of the EDR City Directory Image
Report is provided as Appendix B. The property was not previously used for Solid Waste Management.

Based upon the historical information obtained and reviewed, the subject site was farmland from prior
to 1956 to 1998. A commercial/industrial building was constructed on the subject property in 1994. The
structure is similar to the one observed at the time of the site reconnaissance. From prior to 1956,
properties immediately surrounding the subject site were wooded and/or agricultural with scattered
rural residences. Between 1993 and 2005, commercial development occurred to the north, west and
east of the site.

Provide the total acreage of the property and the size of the actual area to be used for the facility and
storage operation.
The total acreage of the property is 5.4 acres + / - .
Daniels current facility space will be a total of 13,584 square feet with an estimated 3,000 square feet
designated for storage. Daniels will expand into additional areas of the building and may occupy up to
28,584 sq. feet +. Closure costs for the facility are currently estimated using the additional and potential
floor space.

6 | Page

Provide a legal description of the property and a complete copy of the land deed.
Appendix A - Tax parcel number of the Property is: 135942, and,
Some or all of the Property, consisting of approximately 5.4 acres, is described in Deed Book 4641,
Page No. 0939 Gaston County.

Provide a copy of the USGS topographic quadrangle map of the area. The property boundaries of the
site and the approximate location of the building should be drawn onto the map. The map may be a
high quality photocopy.

Appendix B
GRI utilized EDR historical topographic maps to review the subject site and surrounding area. A
description of the site as shown on the maps is detailed below in chronological order. Copies of the
topographic maps reviewed have been included as Appendix B.

Provide a letter from the appropriate City or County official confirming that the siting of the facility
will be in conformance with all zoning and local laws, regulations, and ordinances, or that no such
zoning, laws, regulations, or ordinances are applicable.
Appendix C

Section III
Introduction
Daniels Sharpsmart, Inc. has countless years of experience in Regulated Medical Waste Management
with over 20 facilities operating in 40 states, in addition to a large global presence in countries including
Australia, Canada, South Africa, and the United Kingdom.
Daniels is the world's largest provider of reusable systems for sharps disposal and the second largest
company in the medical waste disposal industry in the United States. Daniels provides leading sharps
and total waste solutions to the healthcare market. Daniels Sharpsmart, Inc. is proud to provide the
safest, most environmentally friendly products and services to a wide variety of small, medium and large
healthcare providers.

Daniels Sharpsmart, Inc. is proposing a Regulated Medical Waste Processing (Storage, Decanting and
Washing - Washsmart), and treatment (Autoclave – Steam Sterilization) at 1851 Chespark Drive
Gastonia, NC 28052.

7 | Page

Definitions
15A NCAC 13B .1201 Definitions
For the purpose of the Section, the following definitions apply:
"Blood and body fluids" means liquid blood, serum, plasma, other blood products, emulsified human
tissue, spinal fluids, and pleural and peritoneal fluids. Dialysates are not blood or body fluids under this
definition.
"Generating facility" means any facility where medical waste first becomes a waste, including but not
limited to any medical or dental facility, funeral home, laboratory, veterinary hospital and blood bank.
"Integrated medical facility" means one or more health service facilities as defined in G.S. 131E-176(9b)
that are: (a) located in a single county or two contiguous counties; (b) affiliated with a university medical
school or that are under common ownership and control; and (c) serve a single service area.
"Medical waste" as defined in G.S. 130A-290(18).
"Microbiological waste" means cultures and stocks of infectious agents, including but not limited to
specimens from medical, pathological, pharmaceutical, research, commercial, and industrial
laboratories.
"Microwave treatment" means treatment by microwave energy for sufficient time to render waste non-
infectious.
"Off-site" means any site which is not "on-site".
"On-site" means the same or geographically contiguous property which may be divided by public or
private right-of-way.
"Pathological waste" means human tissues, organs and body parts; and the carcasses and body parts of
all animals that were known to have been exposed to pathogens that are potentially dangerous to
humans during research, were used in the production of biologicals or in vivo testing of
pharmaceuticals, or that died with a known or suspected disease transmissible to humans.
"Regulated Medical Waste" means blood and body fluids in individual containers in volumes greater
than 20 ml, microbiological waste, and pathological waste that have not been treated pursuant to Rule
.1207 of this Section.
"Sharps" means and includes needles, syringes with attached needles, capillary tubes, slides and cover
slips, and scalpel blades.
"Treatment" as defined in G.S. 130A-309.26(a) (2).

8 | Page

General
15A NCAC 13B .1202 General Requirements for Medical Waste
Medical waste is subject to all applicable rules in 15A NCAC 13B.
At the generating facility, sharps will be placed in a container which is rigid, leak-proof when in an
upright position and puncture-resistant. Contained sharps will not be compacted prior to off-site
transportation. After leaving the generating facility, the container and its contents will be handled in a
manner that avoids human contact with the sharps.
Blood and body fluids in individual containers of 20 ml or less which are not stored in a secured area
restricted to authorized personnel prior to off-site transportation will be packaged in accordance with
the regulated medical waste packaging requirements as described in Rule .1204(a)(1) of this Section or
in a container suitable for sharps. Containers of blood and body fluids which are packaged in accordance
with Rule .1204(a)(1) of this Section or in a container suitable for sharps as required by this Rule will not
be compacted prior to off-site transportation.
Regulated medical waste will not be compacted.
15A NCAC 13B .1203 General Requirements for Regulated Medical Waste
1. Regulated medical waste will be treated prior to disposal. Acceptable methods of treatment are
as follows:
a. Blood and body fluids in individual containers in volumes greater than 20 ml -
Incineration or sanitary sewage systems, provided the sewage treatment authority is
notified;
b. Microbiological waste - Incineration, steam sterilization, microwave treatment, or
chemical treatment;
c. Pathological wastes - Incineration.
2. Other methods of treatment will require approval by the Division.
3. Regulated medical waste treated in accordance with Paragraph (a) of this Rule may be managed
in accordance with 15A NCAC 13B .0100 - .0700.
4. Crematoriums are not subject to the requirements of Rule .1207(3) of this Section.
5. A person who treats Regulated medical waste at the generating facility or within an integrated
medical facility is not subject to the storage and record keeping requirements of Rule .1207(1) of
this Section.
6. Generating facilities and integrated medical facilities in operation on October 1, 1990 that
incinerate Regulated medical waste are not subject to the requirements of Rule .1207(3)(a-l) of
this Section until January 1, 1995.

9 | Page

15A NCAC 13B .1204 Requirements for Medical Waste Generators (NA)
A person who ships regulated medical waste from the generating facility for off-site treatment shall
meet the following requirements:

(1) Regulated medical waste shall be packaged in a minimum of one plastic bag placed in a rigid
fiberboard box, rigid drum, or other rigid container constructed in a manner that prevents leakage of the
contents. The plastic bag shall be impervious to moisture and have a strength sufficient to preclude
ripping, tearing or bursting the waste-filled bag under normal conditions of usage and handling. Each
bag shall be constructed of material of sufficient single thickness strength to pass the 165-gram dropped
dart impact resistance test as prescribed by Standard D 1709-91 of the American Society for Testing and
Materials, which is incorporated by reference including subsequent amendments and editions, and
certified by the bag manufacturer. A copy is available for inspection at the Department of Environment,
Health, and Natural Resources, Division of Solid Waste Management, 401 Oberlin Road, Raleigh, North
Carolina. Copies may be requested by mail at American Society for Testing and Materials, 1916 Race
Street, Philadelphia, P.A. 19103 or by calling [phone] for a cost of twelve dollars ($12.00) plus
one dollar and fifty cents ($1.50) for shipping and handling unless prepaid, then the fee is twelve dollars
($12.00).

(2) Regulated medical waste shall be stored in a manner that maintains the integrity of the packaging at
all times.

(3) Each package of regulated medical waste shall be labeled with a water-resistant universal biohazard
symbol.

(4) Each package of regulated medical waste shall be marked on the outer surface with the following
information:
(A) the generator's name, address, and telephone number;
(B) the transporter's name, address, and telephone number;
(C) storage facility name, address, and telephone number, when applicable;
(D) treatment facility name, address and telephone number;
(E) date of shipment; and
(F) "INFECTIOUS WASTE" or "MEDICAL WASTE".

Records of regulated medical waste shall be maintained for each shipment and shall include the
information listed in this Paragraph. This information shall be maintained at the generating facility for no
less than three years.
(1) amount of waste by number of packages (piece count);
(2) date shipped off-site;
(3) name of transporter;
(4) name of storage or treatment facility.

The requirements of this Paragraph shall not apply to persons who generate less than 50 pounds of
regulated medical waste per month.

A plan to ensure proper management of regulated medical waste shall be prepared and maintained at
the generating facility.

10 | Page

Transportation

15A NCAC 13B .1205 Requirements for Transporters of Regulated Medical Waste
A person who transports Regulated medical waste that has not been treated at the generating facility
shall meet the following requirements:
1. Transporters shall not accept waste which is improperly packaged.
2. Regulated medical waste shall be transported in a manner that prevents leakage of the contents of
the package.
3. The integrity of the package shall be maintained at all times.
4. The labeling and marking of the package shall be maintained at all times.
5. All loads containing Regulated medical waste shall be covered during transportation.
6. The universal biohazard symbol shall be displayed on all transportation vehicles, in accordance with
Department of Transportation Standards and 49 CFR 172 Subpart F.
7. Regulated medical waste shall be delivered to a permitted storage or treatment facility within seven
calendar days of the date of shipment from the generator.
8. Refrigeration at an ambient temperature between 35 and 45 degrees Fahrenheit shall be
maintained for Regulated medical waste that will not be delivered for treatment within seven
calendar days.
9. A contingency plan shall be prepared and maintained in each vehicle used in the transporting of
Regulated medical waste. The operator of each vehicle shall be knowledgeable of the plan.
10. Vehicles used for the transportation of Regulated medical waste shall be thoroughly cleaned and
disinfected with a mycobacteriocidal disinfectant before being used for any other purpose and in
the event of leakage from packages.
11. While transporting regulated medical waste, vehicles are prohibited from transporting any material
other than solid waste and supplies related to the handling of medical waste.

11 | Page

Volumes
Estimate in tons per month expected amount of waste to be managed at the operation:

Estimated 2017 Tonnage
Waste Stream
Weight
Per Month
(lbs.)
Weight
Per
Month
(Tons)
RMW Bio
91,650.00

45.83
RMW Chemo
2,670.00

1.34
RMW Pathology
5,720.00

2.86
RMW Pharmaceutical
1,000.00

0.50
Sharps Waste - Bio
131,000.00

65.50
Sharps Waste - Chemo
5,000.00

2.50
Sharps Waste - Pharm
13,000.00

6.50
Est. Total
250,040.00

125.02

Daniels Sharpsmart, Inc. may expect to grow past these volumes up and to 40 tons per day.

12 | Page

Responsibilities
The procedures established in this plan apply to all personnel handling and/or managing medical waste
at the Gastonia, NC Medical Waste Processing & Treatment Facility.
The DSI Facility Manager will be responsible for day to day operations to include personnel have the
required training and are competent in the practices for managing the waste streams. The Facility
Manager is responsible for training of all workers and ensuring that medical wastes are handled,
transported, packaged, stored, processed, treated and/or transferred properly and safely in accordance
with all applicable local, state and federal regulations. Facility Managers will promote a safety culture for
the safe handling of Medical Waste. Facility Management must also provide the equipment necessary to
maintain compliance and to work safely with the facility for site workers. The Facility Manager will also
oversee all operations within the facility.
Site workers (i.e. production asst., Washsmart operator, autoclave operator, drivers, etc.) are responsible
for the safe handling and processing of RMW. Site workers are obligated to follow the instructions of the
Facility Manger concerning medical waste handling, storage, transport, processing, treatment, and/or
transfer of Medical waste.
Compliance Manager is responsible for providing guidance, and for monitoring site compliance with
mandated medical waste regulations. The Compliance Manager will also maintain relationships with NC
DENR Regulators to ensure compliance and communication. Compliance is available to provide training
when requested.

13 | Page

Contact Persons/Hours of Operation
Primary Contact

Facility Manager: TBD
Regional Operations Director: Evan August, 423 – 432 – 1099, [e-mail]
Director of Compliance: Alan Larosee, 312 – 515 – 8912, [e-mail]
Compliance Manager: Kyle Little, 312 – 285 – 9087, [e-mail]

Backup Contact

VP of Operations: Daniel Kennedy, 312 – 590 – 4069, [e-mail]

Emergency or After Hours Contact

1. In the event of any emergency or perceived emergency, call 911.
2. In the event of any emergency the Facility Manager, Regional Manager, Compliance Manager,
and property manager will be notified within one (1) hour of the incident – in that order.
a. All incidents will be followed-up by a written report to the Compliance Manager within
five (5) working days.
3. For any after-hours concerns regarding the facility, contact the 24-hour emergency number 888-
952-5580 or any of the Primary or Backup contacts listed above.

North Carolina Department of Environmental and Natural Resources (NCDENR)

Engineering Project Manager: Larry Frost, 828 – 296 – 4704
Waste Mgt. Coordinator: William (Bill) Patrakis, 919 – 707 – 8290
Solid Waste Inspector: Bill Wagner, 828 296-4705

Hours of operation
Daniels Sharpsmart, Inc. processing and treatment facility in Gastonia, NC is not seasonal and will
operate all months of the year. General hours of operation are 24 hours per day, 7 days per week.

14 | Page

Site Security and Access Control
Waste is collected and transported in closed, secure and permitted trucks/trailers. The doors to the
storage area of each collection truck or trailers are secured during transport or whenever a Daniels
Sharpsmart, Inc. employee is not in attendance with the vehicle, including waiting to be
loaded/unloaded. All trucks are labeled to alert the public regarding the type of waste being
transported or handled in accordance with state and federal markings.
All property will be secured accordingly to prevent theft/and or damage. Surrounding the facility is fully
fenced with barbed wire at its top in addition to a gated entrance/exit with Key Pad Access. All access
roads are of all – weather construction. Daniels will also work to ensure cameras at installed and alarms
are working properly. The facility interior and exterior will be monitored continuously by cameras and
plant management.
All company equipment including doors, entrances, trucks and trailers will be secured by locks/bolt locks
when not in use or unattended.
Signage
Exterior Warning signs, stating in English that “Caution- Biohazardous Waste Storage Area-
Unauthorized Persons Keep Out” must be posted on entry doors. Signs will be readily legible during
daylight from a distance of at least 25 feet.
Interior signage will be within the site to direct traffic within the facility and waste flow throughout.
Signs will also provide a description of the type of waste received, the type of waste prohibited,
operating hours, permit number, and emergency contact phone numbers.

15 | Page

Operational Process (Overview)

Daniels Sharpsmart, Inc. revolutionary, reusable and disposal systems set new standards in health &
safety including infection control, environmental effectiveness, and logistical cost savings. These types
of containment systems incorporate a unique process flow from point of generation to ultimate
disposal.

Regulated Medical Waste (RMW) is source segregated and disposed by licensed medical waste
generators in Daniels UN certified, DOT tested reusable sharps containment systems. Once the sharps
container is full, authorized personnel at the healthcare facility (generator) close and lock the contents
inside. Trained staff wearing appropriate PPE place the containers on an internal cart that is transferred
down to the hospital storage area. The containers are taken off the cart and placed inside a
“transporter”, which closes and locks the containers inside.

“Soft” or “bulk” Regulated Medical Waste is contained in DOT tested RMW containers (non – sharps
waste in corrugated reusable plastic or single – use boxes). These containers have a primary liner which
accompanies every container for bulk RMW. The transporters filled with sharps containers and the bulk
RMW containers are then loaded on a permitted truck for transport to the Daniels Treatment Facility.

Once delivered to the Daniels Facility by approved Medical Waste Transporter (i.e. Daniels Sharpsmart,
Inc., other permitted carrier), authorized trained personnel (wearing appropriate PPE) will off-load the
Transporters and bulk RMW containers from the docked trucks to stage in designated areas for
segregation, transfer and/or processing. Waste transferred off – site will be treated by approved
alternative technology (i.e. incineration, microwave, etc.). The waste that is segregated for processing,
will be robotically decanted by Washsmart Machine (from re-usable sharps containers only) or directly
loaded into specialized autoclave bins (from bulk RMW container) intended for treatment within the
autoclave.

Waste from Daniels reusable sharps containers are automatically decanted into the autoclave bin then
processed through the Washsmart Machine, the empty containers are sterilized by high temperature
water (180 Degrees F) and non – hazardous detergent.

Waste from Daniels bulk RMW containers are decanted by bin tipper (or manual means) into the
autoclave bin and processed through the autoclave. Empty reusable bulk RMW containers are sterilized
by a high powered pressure washer and non – hazardous detergent.

Once the waste is loaded into the autoclave bins, the bins are manually moved into the autoclave for
treatment. The door of the autoclave is secured, and the vessel is brought up to proper temperature,
pressure, and for appropriate duration dictated by set operating parameters outlined in accordance with
15A NCAC 13B .1207 (2). The autoclave is a Mark Costello Model AS510

This process treats the waste as such so that it is no longer considered RMW, but is now considered
municipal solid waste. As the newly classified waste is removed from autoclave vessel it is disposed of
within a sealed compactor ready for final disposal in approved landfill. The standard operations of the
industrial autoclave, boiler, Washsmart uses electrical, gas, and water of adequate source. Water
generated is directly discharged into the local POTW. All floor drains will discharge directly to an
approved sanitary sewage system. Ventilation will be provided and will discharge so as not to create
nuisance odors.
16 | Page

Device Reclamation Program – Device Mining

Third Party Reprocessors (TPR) reprocess used medical equipment (UME) by disassembling, cleaning,
sharpening, repairing, sterilizing and repackaging, then selling the UME back to hospitals at a fraction of
original cost. The TPR industry is FDA regulated, saved US hospitals over $250 million annually in 2012
and markedly reduces waste to landfill.

Daniels Sharpsmart, Inc. S32 and S64 Access Plus Sharpsmart containers are routinely used to collect
and transport used medical devices from healthcare facilities for autoclaving and landfilling. This
process was wasteful of UME, inconsistent with hospital sustainability, and expensive.

Under DSI UME process, DSI will harvest UME from used medical equipment containers R14 and R14 in
addition to Daniels S32 and S64 Access Plus reusable Sharpsmart containers, repackage, then ship to
FDA registered TPR. Used Medical Equipment for Reprocessing are not regulated as medical waste
under DOT exemption 173.134 (12) (i).

OSHA requirements applicable to medical equipment provide an adequate level of safety in
transportation and it is unreasonable and impractical to require RMW packaging and hazard
communication for medical equipment that are intended for reuse (see 60 FR 48780; 9/20/1995).
Additionally, Daniels containers are rated DOT PG II for puncture resistance, thus further eliminating the
need for secondary packaging while in transport.
§173.134 Class 6, Division 6.2—Definitions and exceptions.
(12) Laundry and medical equipment and used health care products, as follows:
(i) Laundry or medical equipment conforming to the regulations of the Occupational Safety and Health
Administration of the Department of Labor in 29 CFR 1910.1030. This exception includes medical
equipment intended for use, cleaning, or refurbishment, such as reusable surgical equipment, or
equipment used for testing where the components within which the equipment is contained essentially
function as packaging. This exception does not apply to medical equipment being transported for
disposal.
DSI has developed a purpose-built machine to decant the containers and enable the MD to be safely
harvested prior to compliantly packaging them for transport to TPR. In addition to engineering and
management controls implemented by DSI, staff will be trained to safely carry out their duties and
offered relevant vaccination. This process is within full compliance of OSHA BBP Standard 1910.1030(d)
(4) (iii) (A) (4).

Standard Operation Procedures
Medical Device Mining Operation and processes are outlined in DSI SOP 17.0 Harvesting Medical
Devices. This SOP will be made available upon request.

17 | Page

Waste Acceptance Protocol
Daniels Sharpsmart, Inc. Treatment and Processing Facility in Gastonia, NC will accept, process, and
transfer or treat Regulated Medical Waste as defined in NCDENR. Regulated Medical Wastes accepted at
this facility include Regulated Medical Waste, Sharps, Trace Chemotherapy, Non – Hazardous
Pharmaceuticals, and Pathological Waste.
Regulated Medical Waste including sharps, Trace Chemotherapy, Non – Hazardous Pharmaceutical, and
non – gross anatomical waste will be treated on – site via autoclave (steam sterilization)
Gross anatomical (Pathological) waste will be accepted, processed, transferred, and then treated in
accordance with state approved treatment technologies (i.e. incineration).
All waste brought to this facility or transferred will be properly packaged and labeled in accordance with
local, state, and federal requirements. Packaging is completed at the generation site.

Medical Waste:

Any biohazardous, pathology, pharmaceutical, or trace chemotherapy waste not regulated by
the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended;
sharps and trace chemotherapy wastes generated in a health care setting in the diagnosis,
treatment, immunization, or care of humans or animals; waste generated in autopsy or
necropsy; waste generated during preparation of a body for final disposition such as cremation
or interment; waste generated in research pertaining to the production or testing of micro
biologicals; waste generated in research using human or animal pathogens; sharps and
laboratory waste that poses a potential risk of infection to humans generated in the inoculation
of animals in commercial farming operations; waste generated from the consolidation of home-
generated sharps; and waste generated in the cleanup of trauma scenes. Biohazardous,
pathology, pharmaceutical, sharps, and trace chemotherapy wastes that meet the conditions of
this section are not subject to any of the hazardous waste requirements

Sharps:

Sharps are placed into an appropriately labeled sharps container before being stored and/or
removed from the generator. Sharps will be brought into the facility in rigid, puncture-resistant
containers that are appropriately labeled and transported to the DSI treatment facility in a
manner that retains the integrity of the container.

Blood and Bodily Fluids:

Blood and Body Fluids brought to the facility are already properly packaged and treated in
accordance with NCDENR regulation.

Cultures and Stocks:

Brought to this facility in closed, puncture resistant containers and treated in accordance with
NCDENR regulation.

18 | Page

Pathological Waste:

Brought to this facility in bagged, tied, closed, puncture-resistant, properly labeled containers,
and transferred at our facility for off-site treatment.

Contaminated Animal Waste:

Brought to this facility in appropriately labeled containers and removed by our medical
waste disposal company. The waste is treated prior to disposal in a sanitary landfill.

Non Hazardous Pharmaceutical Waste:

Pharmaceutical means a prescription or over-the-counter human or veterinary drug, including,
but not limited to, a drug as defined in Section 109925 of the Federal Food, Drug, and Cosmetic
Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).

For purposes of this part, “pharmaceutical” does not include any pharmaceutical that is
regulated pursuant to either of the following:
1. The federal Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C.A.
Sec. 6901 et seq.). This waste stream shall be handled as a hazardous waste under the
authority of Chapter 6.5 (commencing with Section 25100) of Division 20.
2. The Radiation Control Law (Chapter 8 (commencing with Section 114960) of Part 9).

Clear labeling and an easy identifiable design (and color) for Daniels Reusable Non – Hazardous
Pharmaceutical containers encourage and ease proper waste segregation by the generator.
Reusable Non – Hazardous Pharmaceutical Containers are designed and labeled to handle Non –
Hazardous Pharmaceutical Waste only.

Non-RCRA hazardous pharmaceutical wastes are placed into an appropriately labeled
pharmaceutical container (reusable or single use) at the respective healthcare generator.

Pharmaceutical waste will be brought into the facility in rigid, puncture-resistant containers that
are appropriately labeled and transported to the DSI treatment facility in a manner that retains
the integrity of the container.

Trace Chemotherapy Waste:
Trace chemotherapeutic waste means waste that is contaminated through contact with, or
having previously contained, chemotherapeutic agents, including, but not limited to, gloves,
disposable gowns, towels, and intravenous solution bags and attached tubing that are empty. A
biohazardous waste that meets the conditions of this paragraph is not subject to the hazardous
waste requirements
Trace chemotherapy is defined below as vials or other containers that have less than 3% of the
original contents by weight, after removing as much of the chemotherapy feasible. It also
includes the chemotherapy remaining in all needles, bags, tubing, containers, gloves, and gowns
used during chemotherapy infusions. When less than 3% of the original content remains in total,
the items may be considered RCRA empty.
19 | Page

Clear labeling and an easy identifiable design (and color) for Daniels Reusable Trace
Chemotherapy containers encourage and ease proper waste segregation by the generator.
Reusable Trace Chemotherapy Containers are designed and labeled to handle Trace
Chemotherapy waste only.

Brought into the facility in rigid, DOT tested (single – use or reusable) containers that are
appropriately labeled and transported to the DSI treatment facility in a manner that retains the
integrity of the container.

20 | Page

Storage
15A NCAC 13B .1206 Requirements of Storage of Regulated Medical Waste
A person who stores Regulated medical waste that has not been treated at the generating facility will
meet the following requirements:
1. Regulated medical waste will be stored in a manner that prevents leakage of the contents of the
package.
2. Regulated medical waste will be stored in a manner that maintains the integrity of the packaging at
all times.
3. The labeling and marking of the package required in Rule .1204 of this Section will be maintained at
all times.
4. Prior to treatment, all Regulated medical waste will be confined to the storage area.
5. Regulated medical waste will be stored prior to treatment for no more than seven calendar days
after receipt.
6. Regulated medical waste will not be stored longer than seven calendar days from the date of
shipment from the generator unless the Regulated Medical Waste is refrigerated at an ambient
temperature between 35 and 45 degrees Fahrenheit. Daniels Sharpsmart will have a refrigerated
trailer on site in the event refrigeration is needed.
7. Regulated medical waste will be stored no longer than seven calendar days after treatment.
8. Only authorized personnel will have access to areas used to store Regulated medical waste.
9. All areas used to store Regulated medical waste will be kept clean. Vermin and insects will be
controlled.
10. All floor drains will discharge directly to an approved sanitary sewage system. Ventilation will be
provided and will discharge so as not to create nuisance odors.
11. This plan will be prepared, maintained and updated as necessary to ensure continued proper
management of Regulated medical waste at the facility.
12. Only authorized personnel will have access to areas used to store Regulated medical waste.
13. All areas used to store Regulated medical waste will be kept clean. Neither carpets nor floor
coverings with seams will be used in storage areas. Vermin and insects will be controlled.

21 | Page

Unauthorized Waste
Wastes such as any hazardous waste (RCRA) and any waste regulated by the Nuclear Regulatory
Commission cannot and will not be accepted for transport or processing at this facility. Such wastes will
be managed in accordance with the Unauthorized Waste Plan. Daniels Sharpsmart, Inc. reserves the
right to reject waste for pick-up or treatment if the package is:
• Leaking
• Incorrectly packaged
• Mislabeled or unlabeled
• Damaged
• No applicable permits
• Out of compliance with regulatory or agreement procedures

Wastes not accepted for treatment include:
• Radioactive wastes;
• Hazardous (RCRA) wastes as defined by the Environmental Protection Agency (EPA);
• Chemicals, Explosives, Radioactive, Mercury, and other hazardous waste.

Unauthorized Waste Plan

Unauthorized waste. In the event of receiving waste that is unauthorized for transfer, treatment, or
incorrectly labeled on the manifest the following will be followed:

1. The facility will keep an incident log if any unauthorized waste (hazardous, etc.) or improperly
labeled waste (i.e.; RMW and incinerable waste in the same container) or improperly packaged
waste (bags not tied off) is encountered.
2. The log will state the date of waste reception, generator information, and actions taken by the
facility.
3. Random inspection of containers will be conducted and documented when the items are off loaded
from route trucks for storage. Employees are not authorized to manually open any box or bagged
waste. This will be conducted at the facility manager’s discretion by mechanical means.
4. Major or repeated violators Action Protocol
a. Major or repeated violations are defined as more than 2 unauthorized waste incidents from
one generator in a month.
b. The facility manager will contact the generator’s Field Service Manager or the Area
Operations Manager in order for them to contact the generator.
c. The generator will be informed of the incident and requested to submit a written follow up
report on waste segregation.
d. The NCDENR and Daniels Compliance will be notified of major or repeated violators within 7
business days of the incident. The notification will include the generator information,
actions taken by the facility, and any written response from the generator.

22 | Page

Unauthorized Waste Log

Date of
Unauthorized
Waste Received
Generator (if
known)
Action Taken by
Facility
Generator
Contacted (Date
and whom)
Generator Action
Taken
DNR Contacted
(Date and
whom)

23 | Page

Disposal Facility

Regulated Medical Waste that is treated on – site through steam sterilization technology will be
removed from autoclave vessel and disposed within an on – site sealed compactor ready for final
disposal in approved landfill. Currently, Daniels does not have any contracts/agreements with specific
disposal facilities to accept municipal solid waste out of our Gastonia, NC processing & treatment
facility. Once the operational process is confirmed, we will note the disposal facility details within this
operations manual.

Daniels Sharpsmart, Inc. will ensure wastes taken to the disposal facilities are in accordance with the
disposal facilities service area and any applicable local, state, and federal regulations. Daniels
compliance team will acquire the proper permits, licenses, and documents to ensure this compliance.
Additionally, Daniels will maintain a signed copy of the Certificate of Destruction on file for a minimum
of 3 years that will be made available upon request.

Equipment
Please see attached autoclave specifications
Steam sterilization requirements:
(a) Steam under pressure will be provided to maintain a minimum temperature of 250 degrees
Fahrenheit for 45 minutes at 15 pounds per square inch of gauge pressure during each cycle; or other
combinations of parameters that are shown to effectively treat the waste.
(b) The steam sterilization unit will be provided with a chart recorder which accurately records time and
temperature of each cycle.
(c) The steam sterilization unit will be provided with a gauge which indicates the pressure of each cycle.
(d) Monitoring under conditions of full loading for effectiveness of treatment will be performed no less
than once per week through the use of biological indicators or other methods approved by the Division.
(e) Regulated medical waste may be disposed of until or unless monitoring as required in Sub-Item (2)
(d) of this Rule does not confirm effectiveness.
(f) A log of each test of effectiveness of treatment performed will be maintained and will include the
type of indicator used, date, time, and result of test.

24 | Page

Boiler
Please see attached Parker Boiler Specifications
Boiler BTU input (not output): 860 (1,000 BTU/HR)
Fuel used (probably natural gas): Natural Gas
Any backup fuel: No
Estimated volatile organic compound emissions: Below 5PPM
Percent of each load are VOCs: 3%

Washsmart
Please see attached Washsmart 6000 Specifications

Autoclave
Please see attached Mark Costello Autoclave Specifications
Mfr Part No.: AS510
Manufacturer: MARK COSTELLO COMPANY
Contract No.: GS-07F-5447P (ends: Nov 23, 2013)
MAS Schedule/SIN: 073/384 9
Weight: 1.000 LB
Process temperature: 250F
Estimated Volume – Two (2) bins per load @ 375 lbs. per bin.
Actual and maximum number of loads per day: Actual 8, Maximum 24

Process control and records will be maintain on the autoclave circular chart to record time,
temperature, and pressure. All records will be maintained at the facility for a minimum of three (3)
years. Operation and efficacy testing will be in accordance with NCDENR rules and regulations

25 | Page

Cleaning and Decontamination
Plan for maintaining facility property in a sanitary condition and actions to be taken to minimize noise,
vectors, and odors. All waste should be segregated, stored, and contained properly throughout the day
and checked at the beginning and ending of each shift.
1. Daily cleaning at the end of every shift and/or as needed will be accomplished to minimize odor,
potential litter, insects and/or rodents at this facility.
2. Disinfection will be accomplished through the use of a hypochlorite cleaning solution.
3. Frequency of cleaning will depend on usage and the operational environment. There are four
distinct operations to be conducted at the facility. This also includes all areas where waste has
traveled.
a. Inbound and outbound staging areas including storage areas.
i. Cleaning and disinfection on a daily basis.
ii. Containers will be checked to ensure integrity of packaging
iii. Leaks, spills, material will be cleaned to ensure floor and housekeeping
iv. All drains/vents will be check for potential buildup
v. Scales and weigh stations will be cleaned
b. Waste containers will be decanted into autoclave bin (by manual or automatic means)
before treatment
i. Cleaning of such operations will be conducted on a daily basis.
ii. Disinfection of spill, leaks or otherwise potential health hazards will be
conducted on an as need basis.
c. Washing of the re-usable sharps containers in the Washsmart System and power
washing station. Parts of the Washsmart System in direct contact with Medical Waste
and effluent should be cleaned every shift (i.e. Washsmart pit and conveyor)
i. Caution will be used due to the waste containing contaminated sharp items.
ii. Cleaning of such operations will be conducted on a daily basis.
iii. Disinfection of spill, leaks or otherwise potential health hazards will be
conducted on an as need basis.
d. Treating Regulated Medical Waste via Steam Sterilization
i. Cleaning of such operations will be conducted on a daily basis.
ii. Disinfection of spill, leaks or otherwise potential health hazards will be
conducted on an as need basis.
iii. Attention will be in and around the autoclave including the pit for any residual
or accumulated water.
4. Provision of cleaning equipment and suitable convenient cleaning facilities will be made to ensure
that the cleaning tasks are carried out safely and effectively. A list of the basics follows:
a. Hot water trigger action hose long enough to reach inside washer and 90 degree conveyor.
b. Stiff (wire) brushes for cleaning washer filters.
c. Long handled tongs for picking up sharps.
d. Long handled brush for sweeping floor.
e. Dust pan and brush.
f. Reusable hand spray bottle to fill with detergent and water.
g. Heavy duty waterproof gloves.
h. Goggles.
i. Decontamination of Reusable Secondary Containers
26 | Page

j. Reusable secondary containers (garbage cans, bins, etc.) should be decontaminated each time
they are emptied unless they are protected from contamination by disposable liners, bags, or
other devices removed with the waste. These containers should be maintained in a clean and
sanitary manner.
k. Approved methods of decontamination include, but are not limited to, agitation to remove
visible soil combined with one of the following procedures:
i. Exposure to hot water of at least 82 °C (180 °F) for a minimum of 15 seconds.

27 | Page

Emergency Actions
Contingency plans for equipment breakdown, spills, noise, odors, unusual traffic patterns, and/or long-
term power outages affecting the equipment.
In the event of any emergency or perceived emergency, call 911. For any after-hours concerns, contact
the 24-hour emergency number 888-952-5580 or any of the Primary or Backup contacts listed on page
15.

Personnel Exposures or Contamination

1. Remove the exposed or contaminated personnel from the contaminated area, unless it is unsafe
to do so due to the medical condition of the victim or potential hazard to the rescuer
2. If the incident occurs during normal working hours, notify COMPLIANCE or the site operations
manager.
3. Administer first aid as appropriate
4. Remove any contaminated clothing
5. Proceed to the nearest emergency eyewash/shower to flush contamination from the eyes and
skin
6. Stand by to provide emergency information.
7. Call Medcor for additional instructions (company triage)

Contamination of Facilities

• DO NOT attempt any cleanup or decontamination procedures alone or without wearing Personal
Protective Equipment (PPE), including respiratory protection if respiratory pathogens may be
present. Unless the spill is minor and well defined do not clean up the material without Compliance
or facility management approval.

• Avoid spreading contamination by limiting access to the contaminated equipment or area only to
individuals who are properly protected and trained to respond to all types of hazards that exist

• If the spill involves a liquid, place absorbent material on the spill and decontaminate with an
approved disinfectant for a minimum of a 10-minute contact time.

• If sharps are involved, pickup using a mechanical means, such as tongs, forceps, or dustpan and
broom. DO NOT USE YOUR HANDS to pick up any sharp items, even if gloves are worn.

• Decontaminate area under a supervisor’s direction using appropriate methods.

• Stand by to provide emergency information and assistance to Emergency Response Personnel, if
required.

28 | Page

Release to the Environment (air, water, soil)

• Stop the release, if safe to do so.

• Follow procedures described above for contamination of facility.

• Make immediate notifications. Any information of a release or discharge of Regulated Medical
Waste from or of a fire or explosion at a Special Medical Waste facility which could threaten the
environment or human health outside the facility. The description of the occurrence and its cause
will include:

a. Name, address, and telephone number of the owner or operator;
b. Name, address, and telephone number of the facility;
c. Date, time, and type of incident;
d. Name and quantity of material(s) involved;
e. The extent of injuries, if any;
f. An assessment of actual or potential hazards to the environment and human health outside
the facility, where this is applicable; and
g. Estimated quantity and disposition of recovered material that resulted from the incident.

Transferred Waste Due to Emergency

1. In the unlikely event that Regulated Medical Waste must be transported off site, all Regulated
Medical Waste and sharps will be moved in compliant containers for processing.
2. Waste would be taken to the following back-up location:
a. Daniels Sharpsmart, Inc. Baltimore, MD
b. Daniels Sharpsmart, Inc. Gadsden, AL
c. Curtis Bay Energy Baltimore, MD (Incinerator)
3. DSI will not store biohazardous or sharps waste at the facility for not more than 7 days before
refrigeration unless approved by the department.
4. Refrigerated trucks will be leased as a contingency should weather or other unforeseen
condition result in need to store material on-site in excess of 7 days.

Natural Disasters

The on-site employee will immediately notify, via his/her cell phone, the local emergency services or
911, if necessary. The employee will immediately notify Daniels Sharpsmart, Inc. corporate office or
operations manager of any emergency occurrence.

29 | Page

Personnel Accountability during emergencies

Employee safety is priority: The Emergency Response Coordinator will determine if implementation of
evacuation is appropriate. Employees will be notified of evacuation by loud speaker or yelling. Each
Daniels Facility will have a designated safety committee for safety/emergency events.

Personnel accountability is the initial responsibility of the employee in charge:

a. Identify all personnel;
b. Locate all personnel and get them to the rally point at the end of the employee parking lot
towards Chespark Dr.
c. Know the name and last known location of anyone who does not rally.
d. Daniels Sharpsmart, Inc. personnel will not engage in rescue operations. This will be left to
Emergency Management Services.

Spills
In the event of a spill, the following procedure will be followed. Daniels Treatment Facility will have Spill
Kits available in all processing areas.

Spill Procedures

Employees can minimize small spills by carefully inspecting all containers and following safe handling
procedures. If a spill occurs, it will be small and can be handled by employees immediately.
Following a spill of regulated medical waste or its discovery, the following procedures will be
implemented:
1. Identify the nearest Spill Kit.

2. Take appropriate precautions to ensure personnel do not come into contact with any contaminants
by wearing appropriate personal protective equipment.

3. Contain spilled waste in accordance with the packaging requirements of DOT, OSHA, and NCDENR.

4. Clean and disinfect any areas having been contacted by regulated medical wastes. Materials used to
decontaminate the area will be disinfectants effective against mycobacteria.

5. Take necessary steps to replenish containment and cleanup kit.
If a larger spills result, for example, from a vehicular accident during transit, where waste is scattered
over a large area; the employee must contact the Daniels Facility Manager or Compliance Manager
immediately for instructions and assistance. Daniels will notify NC state DOT and NCDENR and contact
the contracted major spill service, if necessary, to perform any necessary biohazard abatement. The
employee will don personal protective equipment and secure the area to the best of his/her ability.
He/she will clear the area of all non-essential personnel and contain the spill as much as possible.
He/she should also inform the authority present of the nature of the material involved. When company
30 | Page

personnel arrive, the spill cleanup procedures will be followed.

Spill Containment and Clean up Kit
All regulated medical waste management facilities are required to keep a spill containment and cleanup
kit within the vicinity of any area where regulated medical wastes are processed, and the location of the
kit will provide for rapid and efficient cleanup of spills anywhere within the area. All vehicles
transporting regulated medical wastes are required to carry a spill containment and clean up kit in the
vehicle whenever regulated medical wastes are conveyed. The kit will consist of at least the following
items:
1. Material designed to absorb spilled liquids. The amount of absorbent material will be that having a
capacity, as rated by the manufacturer, of one gallon of liquid for every cubic foot of regulated
medical waste that is normally managed in the area for which the kit is provided or 10 gallons,
whichever is less.
2. One gallon of disinfectant in a sprayer capable of dispersing its charge in a mist and in a stream at a
distance. The disinfectant will be hospital grade and effective against mycobacteria.
3. Enough red plastic bags to enclose 150% of the maximum load accumulated or transported (up to a
maximum of 500 bags), that meet the applicable requirements of 49 CFR Part 173 or an exemption
approved by the United States Department of Transportation. These bags will be large enough to
over pack any box or other container normally used for regulated medical waste management by
that facility.
4. Appropriate personal protective equipment.
5. For vehicles only, a first aid kit, fire extinguisher, boundary marking tape, lights and other appropriate
safety equipment.

Cleanup

1. Do not leave the area unattended.
2. Do not allow unauthorized personnel into the area.
3. Access spill response kit immediately.
4. Priority will be given to prevent spill from reaching a floor drain.
5. Use broom and dustpan to pick up any spilled sharps and place them in a sharps container. If spill is
a solid, collect and dispose of it in a medical waste container.
6. Apply absorbent material to isolate spilled materials to the smallest possible extent.
7. Areas contaminated with spills will then be disinfected with the approved disinfectant. Remaining
disinfecting solution will be collected with absorbent material and placed in a plastic bag for
decontamination treatment.
8. Clean hands with antibacterial wipes, hand sanitizer, or wash thoroughly with soap and water.

31 | Page

Repackaging

1. Collect spilled material and place in appropriate plastic bags and lined containers. Also collect
absorbent material and place into proper packaging containers.
2. Spills resulting from leaking containers will be remediated by placing the leaking container into double
plastic bags (both sealed).
3. If protective clothing becomes soiled with the spilled material, the clothing will be removed and
placed in a plastic bag for decontamination treatment.
4. All spill materials collected will be treated by the steam decontamination process (off-site)
5. All spills must be immediately reported to the facility manager.

Personal Protective Equipment and Procedures

All Daniels Facility employees are trained on proper PPE (usage, donning, doffing, etc.) before they step
foot on any plant floor. Appropriate personal protection equipment will be worn at all times while in the
facility (on plant floor) or anytime there is potential for exposure. The following

• Uniforms - Uniforms or other protective clothing including coveralls and aprons will be supplied and
laundered by an outside contracted service. Daniels employees are to never take their uniforms or
other PPE home.
• Work Gloves - Hand protection (disposable latex or leather gloves) will be provided to employees
and will be worn when handling infectious waste containers.
• Personal Hygiene – PPE used for handling waste materials must be kept in the work area or an
employee's personal storage area when not in use.
• Safety boots – All employees working in a safety sensitive function are provided safety boots free of
charge. It is required they to be worn at all times on the plant floor.
• Safety Glasses – Safety glasses or goggles must be worn at all times while in the plant or potential
for exposure

All employees are to wash their hands or use hand sanitizer as frequently as possible. Hands must be
washed before eating, drinking, smoking or using the restroom.

Employees are not allowed to eat/drink in the work area (shop floor/dock). Smoking, eating, or drinking
is prohibited while the employee is handling waste containers or servicing a customer.

32 | Page

Employee Training
Trained employees must be onsite at all times the site is open, overseeing the management and process
flow of waste.

All Daniels Sharpsmart, Inc. employees receive the following training initially and on an annual basis (if
applicable):

• Bloodborne Pathogens/Diseases (Exposure Control Plan)
• Hepatitis B and tetanus (TDAP) Vaccination
• Hazard Communication
• HIPAA/HITECH and Omnibus
• PPE
• Forklift Training, if applicable
• Autoclave training, if applicable
• Washsmart training, if applicable
• DOT Training, if applicable
• Internal Policies and Procedures as applicable (i.e. harassment and sensitivity, injury reporting, etc.)

All training is documented and records will be maintained on-site and at Daniels Sharpsmart, Inc. in
Chicago, IL indefinitely.

Safety Procedures

Personnel will also receive the appropriate immunizations including tetanus and hepatitis B vaccinations
as accepted/required in addition to initial and annual required training.

All facility personnel are required to:
• Wear personal protective equipment (supplied daily at no cost to the employee) when handling
medical waste and includes a company uniform, gloves, safety glasses and safety boots.
• Employees will be given training in first aid and spill/emergency response procedures.
• Wash their hands after de-gowning from handling waste containers.
• Gloves used when handling waste containers are not allowed in the eating and office areas.

Injuries and Exposures

If injured or exposed to infectious waste materials, the employee must report the incident immediately
to a supervisor/manager. Medical treatment will be provided at a designated health care facility of
applicable.

Exposure situations will require evaluation, testing and proper preventative treatment. All exposure
situations will be reported to the facility manager and MedCor (Daniels triage service) – [phone]
Company policy requires all injuries and exposures to be reported immediately. Failure to comply will
result in disciplinary action.

33 | Page

Record Retention/Manifesting
Daily tonnages of waste received by County of origin will be tracked and recorded by Daniels
manifest/tracking document procedures. Daniels captures generator information on all waste
manifests/tracking documents by a barcoding system. Also, tonnages of waste sent to a disposal facility
is also tracked and recorded.
Records of Regulated medical waste will be maintained for each shipment and will include the
information listed in this Paragraph.
This information will be maintained at the treatment facility for no less than three years.
a. Name and address of generator;
b. Date received;
c. Amount of waste received by number of packages (piece count) from each generator;
d. Date treated;
e. Name and address of ultimate disposal facility.

Reporting

Regulated medical waste treatment facilities that treat waste generated off-site will submit to the
Division an annual report, by August 1 of each year on a form prescribed and approved by the Division.
The form can be found at the below link:
http://portal.ncdenr.org/c/document_library/get_file?uuid=29a57661-98f1-4894-a293-
70c966cb0c59&groupId=38361

34 | Page

Container Identification Sheet – Including, but not limited to the following: (i.e. R14 & R64 not
pictured)

S14 S14PH

S22 S22PH

S32 S32PH

S14A+ (No Tray) S22PHA+ (No Tray)

S22A+ (No Tray) S32PHA+ (No Tray)

S32A+ (No Tray)
S64A+ (No Tray) S64PHA+ (No Tray)

35 | Page

M64 (Red Top No Tray) C22

C64 (No Tray)

Bulk RMW Containers:
28 GAL
Reusable
38 GAL
Single Use

43 GAL

96 GAL
200 GAL

Transporters:
Small Medium Large

36 | Page

Section IV
Facility Drawing/Layout – Please see Appendix B

37 | Page

Section V
Financial Assurance

OWNER:
PERMIT NO.
ITEM QUANTITY UNITS UNIT COST COST
Cost to remove and haul 5 days waste 62,500 Pounds Table 1 5,005.00$
Treatment costs (Off-site treatment facility Baltimore,MD)62,500 Pounds 0.15 9,375.00$
Landfill costs (Disposal)62,500 Pounds 0.03 1,875.00$
Landfill Transportation Cost $650 (Compactor)62,500 Pounds 0.02 1,250.00$
Costs to clean and disinfect building (Cleanup)28,584 Sq. Ft $0.25 7,146.00$
Misc. Costs (Contingency Container Inventory)2500 Containers 5 Truckloads 1350 6,750.00$
Total Current Closure Costs 31,401.00$
Table 1
Broker, removal/loading, and Transport Fee below
Assumptions 62,500 lbs. of waste (1 day transit from NC to AL)
Daniels Sharpsmart, Inc. Gastonia, NC Treatment Facility to
Daniels Sharpsmart, Inc. Gadsden AL Treatment Facility 2318 E.
Broad Street Gadsden, AL 35903 Permit # TRTS 112811 - 2801
62,500 per 5 day week
Transport 12,000 lbs. per trip - about 5 trips
Per trip cost + fuel = $751 x 5 trips = $3,755 3,755.00$
Tractor and trailer Rental per week 1,250.00$
Total 5,005.00$
*Estimated Monthly Volume 2017: _____Est. 250,000.00 lbs._________
Financial Assurance - Daniels Sharpsmart, Inc. Gastonia, NC Cost Estimate
*Estimated Incoming Volume (5 days) 2017: _____250,000.00 lbs. /20 workdays in a month X 5 workdays in aweek = 62,500 lbs._________
1851 Chespark Dr. Gastonia, NC 28052
Daniels Sharpsmart, Inc.
N/A
38 | Page

Section VI
Signature Pages
Applicant signature page (see attached).

Contract operator signature page (see attached).

If the landowner of the property is not the applicant, the attached certification form by the land owner
is required (see attached).

LlF'TlNG EYE
~ <( w t->-'-"...J Q. l!IQ. -:J
ATMOSPHERIC VENTS
MARK COSTELLO CO. ~"'
STERlLlZER MODEL AS-510 0
\l)
,.____..
7'-1' CART
GEti:RA!. NQTESJ
I. ALL DIMENSIONS ARE APPRDXIMA TE.
C!. LErT HAND HING£ IS SltJ\o/N. RIGHT HAND HING£ AVAILALBE.
3. DESIGN I. CCJISTRUCTIDN PER ASHE SECTION VIII. DIV.I fOR
75 PSIG HAXIHUH ALLO\o/ABI..E lo/DRKING PRESSURE AT 3C!O'f.
4. ALL VENT LINES TO BE SEPARATELY PIPED. IX! ti]I DIN YENT PIPING
:!. TRAP, STRAINER I. VALVES SHD\o/N ARE INCLUDED lo/ITH UNIT.
DRAIN, VENT I. SUPPLY LINES BY CUSTIJ4ER
cr=======r=======~
I I I I I I ~~~~~~I 1--------1--------1 I I I F-------e------~
__ L~~}_~~~.J -----
I~ I ! ~ Cl PLUMB • CONDENSATE TO DRAlN :·.::. ~:~ : ... -~ .. ·:~··.:.~·-:~.·
ELE VATION VIE\o/
1---------17'-9 1/2'----------1
1---------12'-11 '--------!
~ ~
MARK COSTELLO CO. l/111 STERILIZER MODEL AS-510 1\
CONTROL
PANEL
6. PROVIDE 60 PSIG REGULATED STEAH SUPPLY loiiTH 3/4• REDUCER IHHEDIATEL Y UPSTREAH OF' STEAH SOLENOID VALVE.
SUPPLY LIN£ SHALL B£ lo/ELL TRAPPED I. SIZED fOR THE: LESSER OF' 1000 LBS/HR DR HAXIHUH BOILER CAPACITY lo/ITH HAXUIJH 10 PSI PRESSURE DROP. HINIHUH RECOIM:NDED LINE SIZE IS I 114•,
7. INSTALLATION I. SIZING OF' SAfETY RELIEf VAlVE <SRV> DISCHARGE
VENT PIPING SHALL BE IN ACCORDANCE lollTH ASHE SECTICJI VIII DIV I
I. ANSI/ASH£ 831.1 APPENDIX IL OPEN DISCHARGE SYSTEM IS RECOHI£NDED
TO REDUCE BACK PRESSURE ON SRV.
I
I
I
mLE: MC MEDICAL WASTE STEAM STERILIZER
MODEL AS-510 WITH HIGH VOLUME CARTS
DR. MK CAD.
CK. APP.
DATE: 01·03·05
SCALE: AS SHOWN
TOL: + · 1/16 lMUcc
DRAWlNG NO. 0105-003
MARK-COSTELLO co.lwww.MARK·COSTELLO.COM
VENT TO
ATMOSPHERE VENT TO
ATMOSPHERE
llillES
BLOW DOWN
TANK
FROM BOILER
BLOW DOWN
TO DRAIN
1)2" LINE
*"TO
DRAIN
1. ALL DRAINS TO BE PIPED SEPARATELY
DO NOT TIE DRAINS TOGETHER
2" LINE
2. ALL VENT LINES TO BE PIPED SEPARATELY
TO ATMOSPHERE
3. STERILIZER TO BE SET LEVEL WITH SLIGHT
PITCH TOWARD FRONT TO ALLOW CONDENSATE
TO DRAIN INTO SUMP.
SAFElY RELIEF
VALVE
1" SLOWDOWN
SOL. VALVE
1)2" LINE
VENT TO *" PIPE,
ATMOSPHERE 12" TO 18"
LONG
1)2" LINE
STERILIZER D
STEAM TRAP
STEAM SUPPLY
60 PSIG MIN
1)2" MIN LINE
DRAIN SUMP
] 1 STERILIZER AND BLOW DOWN TANK PIP ING SCHEMATIC
2 f_"-;'IJ
5
0 Ametek Gauge 4 • { ;
0-100
1 (~'~]( /;/l .):-:, Jpl ·--.~
~() '6 -r .0 Gauge Cock Y.' {j)
GOOde Neck ~J
-. ~.::: t , , ) cz;t! -· e:=: &... "· ':!.0-11 -11·1 ~.:.~~.·,
3 \.~ifillf ~ .... !) t?4
Figure A
Gauge Assembly
Figure B
Ratchet Rack & Pinion
Door Opener
Q) .5 -' c ~
"-'
1. Pinion Shaft
2. Gear Rack
3. Pinion Gear
4. O-R Ratchet Assembly
~-5. Fender Washer 3/8" ! 6. HHC 3/8" X 16 X 11ft" lg.
~I I 2·· 21~ ~ L . ~~ I I 60 PSI Steam Supply ~ ~~ ~ 15 .. I (\
I_. F-.-·\ .-1
.._;J:.:__-_1 niUh(V~J C~)l~ ---~~_{ _______ __};}._ c~~
f~-.. . -. im.:f' ..fiQ\JIC t; II u~tl -
16 ! ~=---.~:6 ~~24 :l .l5 ~~ lft_....FI!JUtell ~ ' ~-~~ 'n ~ ... ' ( t<::\ --"U (:) . }
r~~ ~->;" I~ ::!--~ /. ·o
"i .. 'CJ ~:;-y-----~-. _1
:11r rt~ r. -~-1 ----~-_ ? '1_ -11-S
f·J 1il~~ thi~ 1-J .. ,,_ ;r:· oralnLmer 1 "../$ 1_ _ _j l
• Qllt<li·OI. (.... { ~-G t "'" • Jl • ·-= 19 l I • •-
23 io 18
y_e().._v v~~l..\ IT OJV ~ 1v1oC1e 1 11 ") ~tOKJ-tC
~~LITA-T -l'b-t-1 o
7 8 .-,., -9
, ~~0)./C-)
, ' 1.:) ~r..-,_,
(•)
r~~ ClL __ lff.r~
~~ ~'i~ li~=;;!J 10 (:~~I (~}f!il' C(:;)
---v lt o 12 13
-~ r~~=-·1 . t;-:\ 11 './
Figure C
Door Safety Assembly
7. Humphrey Air Cylinder# 5S1 F with Vi ton
8. Safety Assembly Mounting Block
~-Jamesbury Ball Valve, Y2" #A2236TT
10. Actuator Shaft
"""11. Select a Swit~h (limit switch) #SS83-BZG 1-2RN
..... 12. Actuator Block
13. Jergens Aluminum Handle #1 0403
14. Armstrong "Y" Strainer, o/.."
15. Magnatrollnlet Valve #114S43
16. Control Panel (Dual Pen)
17. Bimetal Thermometer# 883204
-i 8. Sump Drain, 9" -lift out Basket Screen & 1 Y2" port
19. Armstrong "Y" strainer. 1 12"
20. Njcholson Steam Trap, 112" # 57 18100
21. Kunkel v..·. 75 PSI , Steam Safety Relief Valve #6030ED
22. Magnatrol1 " Slowdown Valve #116SR44
23. "Optional" Parker Condensate Cooler #V47AC-3
24. M-C Name plate, with Model No. and Serial No.
25 . Switch 52SC6AX w/contacts
26. l<ey Start Switch. 2 pass. spring
The Mark-Costello Co. sterilizers parts breakdown does
not Include door hinge parts. gasket controiiN pmts or
Hi-Volume units. ~JO SCALE
H~~ LX SERIES
BISHAMON INDUSTRIES CORPORATION
5651 E. FRANCIS ST.
ONTARIO, CA. 91761
[phone] [phone]
\0bo ·~5~~C6
SLEEVE OPENING-DIMENSIONS
(FOR USE WITH HYDRAULIC CART DUMPER)
0 0
SIDE
A_L~.<1
B ~'6
c \ ~ c;j'il
1
I
I
b 0 0
VIEW
initials:
~ ~ ~ <[
,Y JtJ ~
'/ ~ ;,~ ~s-~~~ .
} X ~,db \}-~ k
I /. ") '\) of. :'}}' 7 \.
-\) \\ ( . ~=======H=========]~-~j(-,, ()":-,\., ~' c
X~ .,t ~ f-.; 1,,}
B ~
48' 4~
END VIEW
~I ~
Ul\?-~~~
HIGH VOLUME STERIUZER CARTS
SLEEVE OPENING-DIMENSIONS
J~. ,< \ri
\)J :'·J~ . ~ ...
(')' \
DR. MK CAD.
CK. APP.
DATE: 11·29-06
SCALE: AS SHOWN
TOL: + -1/16 ~(C
DRAWING NO. 1106·021
MARK -COSTELLO CO .I www .MARK-COSTELLO.COM
SPEC. SHEET D-103-IE
9C
PARKER INDUSTRIAL HORIZONTAL DRUM STEAM BOILER
7 TO 25 H P -ATMOSPHERIC GAS FIRED-OUTDOOR MODEL
~-----------ns------------~ I ~--------nA--------~ ~~
10. 314" I V WATER FEEl!>-+__,_
INLET :::>-,------------....r-/;--t-,. ~ l ·~ ~_(, ~+~
..------}[~ ~-------1~ l I
LGAS-' INLET \.._17. WATER LEVEL -CONTROL
~ ~DRAFT / X.. HOOD .1§A.
1 \ ~ r:u~RE
KOMPACT
TOP VIEW
CONTROL
ENCLOSURE
W/UFTOUT
PANEL
f-~-'? p CONTROL
9A.
~ e
l j--AMERICAP
r--v 3•-o• STUB STACK
.liA. ~
1WK
~
l I j
~-r"
tl -""-'
I
I ~
ELECT. I I
CONTROL-I
PANEL I ~
..,
..
ENCLOSURE
WJUFTotn
PANEL BAROMETRIC DAMPER r-~ D SHOWN WITH VERTICAL r : ~ 0 ....... "'_0~..,
I INSPECTION WIND ~ • DOOR • II :'VISKIRTS ~ 10H -r-r---i'---
LI: ~----------
.r -.. ...
II I 3HA ;! 1 1 {BOTH l t:l t l
II I _WINOS~ I t l SlOES) I ttl tl II I ,...--SKIRTS 11 1 I 1 Ill I I :: : v ;~ :: " : ::: :'~11A.BLOW.OFFVALVE
t ,, '• ·r··· ::~,., ,,
7}f C:! I I -I \1 r--,,
3HB
or
3HC
l
I -.:!-----''-r-.J: l SIDE $ •'-.-------:~., .. ,. oo
_ _:~----i;~Cff"H VIEW • '!-~---.G!J:u;;--,; ~~~----~--~--------------------~ 18. DRAIN VALVE -' I FOR OUTDOOR SERVICE ... ~ -}
MODEL NO. 103-7 103-9.5 103-15 103-20 103-25
NO. HORSEPOWER 7HP 9.5 HP* 15HP 20HP 25 HP
A BTU Input 1000's BTU/HR. 301 398 645 860 1075
B BTU Output at rating from and at 212uF 1000's BTU/HR. 241 318 516 688 860
47 68 82.5 106 132
D Rated Steaming Capacity from and at 212uF LBSJHR. 242 328 518 690 863
1 WA Width Cabinet Only IN. 21 24 27 30 36
1WB Width Overall Including Wind Skirts IN. 41 44 47 50 56
1WK Width Pari<er Kompact -(Boiler With Return System) Including Wmd Skirts IN. 45 48 51 57 63
2LA Length of Cabinet Qnly IN. 42 53 53 61 62
2LB Length Overall Including Wind Skirts IN. 57 68 69 76 78
3HA Height of Cabinet Only IN. 42 42 42 46 46
3HB Height OveraD Including Draft Hood-(Std.Y 3'0w Stub Stack & Americap (approx.) IN. 72189 74191 76193 821100 821100
3HC Height Overall Including Barometric Damper (Vert. Outlet!Horizont Outlet)-(Spec. Order) IN. 58155 61/59 64/61 68/65 72168
4A Vent Stack Diameter with Draft Hood -(Standard) IN. 8 10 12 14 14
4B Vent Stack Diameter with Barometric Damper -(Special Order) IN. 6 8 10 10 12
7 A Gas Inlet Size-Standard Nat Gas/ Supply Press. Min: r WC; Max: 14• WC IN. 3/4 3/4 1 1-1/2 1-1/2
7 A 1 Natural Gas Manifold Pressure at Burner IN. WC 4 4 4 4 4
78 Gas Inlet Size-High Press. Nat Gas & Propane Gas I Supply Press. 1-5 PSI IN. 3/4 3/4 314 1-1/2 1-1/2
7B1 I Propane Gas Manifold Pressure at Burner IN. WC 18 18 18 18 18
7H Gas Inlet Height From Floor IN. 11 11 12 13 13
9A HP Steam Valve Size -High Pressure 60 to 250 PSI IN. 3/4 1 1 1 1-1/4
9 LP Steam Outlet Size-Low Pressure 15 PSI or less-(Special Order) IN. 1-1/2 2 2 2 2-1/2
98 Steam Outlet Location -From Center of Boiler IN. 7 9 9 12 12
10H Water Inlet Height From Aoor IN. 45 45 45 50 50
11 A Blow-off Valve Size IN. 1 1 1 1-1/4 1-1/4
11H Slowdown Une Height From Aoor ·IN. 3 3 3 3 3
12A HP Safety Valve Drain Size-High Pressure-100 PSI-Standard OUTLET IN. 1 1 1 1-1/4 1-1/4
12A LP Safety Valve Drain Size-Low Pressure -15 PSI ("H" Code)-(Special Order) OUTLET IN. 3/4 1-1/2 1-112 1-1/2 2
18 Water Column Drain Valve Size IN. 314 3/4 3/4
J Net Weight Of Boiler LBS. 910 1205 1400 1820 2095
K Domestic Crated Shipping Weight of Boiler LBS. 1055 1360 1555 2000 2325
L Same with Retum System or Kompact Mounting LBS. 1350 1650 1850 2360 2865
MINIMUM usTED CLEARANCEs To 1 12· 48" s· 12·
COMBUSTIBLE CONSTRUCTION: Cabinet Sides & Rear Cabinet Top Draft Hood Vent Connector Baro. Damper Chimney Connector
Recommended Clearances for Access: Inspection Doors 18": Controls 24"; Electrical Panel 30": Additional Space may be required by Local Codes
= ---·-----n s:: w o '"'""ant A":lnru11=tTIIIInn,,t ~MRT1J/Outoul340 Lbs./Hr .. 1" Low Pressure Nat Gas lnletSrze.