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REDBAG - Medical Waste services are needed for RMW On-site collection and destruction

New York, United States
Government : Federal
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General Information
Document Type:     Combined Solicitation/Synopsis
Solicitation Number:    VA528-16-R-0002
Posted Date:    Nov 5, 2015
Original Response Date:    Nov 25, 2015
Current Response Date:    Nov 25, 2015
Classification Code:    S
Set Aside:    NONE
NAICS Code:    562211
Contracting Office Address
Steven S. Tompkins
Department of Veterans Affairs
Network Contracting Office (NCO 2)
1304 Buckley Rd, Suite C104
Syracuse, NY 13212
This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6, "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," and 13.501 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation document will not be issued.

This solicitation is a request for proposal (RFP) in accordance with FAR part 12 in conjunction with FAR part 13.5. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-80 as corrected.

The associated North American Industrial Classification System (NAICS) code for this procurement is 562211, Size Standard 38.5 Million dollars.


The Department of Veterans Affairs, VA Western NY Healthcare System, Albany VA Medical Center, 113 Holland Ave, Albany, New York 12208 has a requirement to process all Regulated Medical Waste (RMW) (except chemo; pathology, animal lab) generated by VAMC Albany at main facility and its outbuildings with volumes contracted to be up to 130,000 LBS annually.

All interested companies shall provide proposals for the following:

Services for collecting and processing all conforming medical waste (RMW) generated by the Stratton VA Medical Center and its' outbuildings located at Albany VAMC. Contractor will be responsible for collecting, transporting, removal and disposal of RMW using the on-site SSM-150 machine as well as maintenance and service on the SSM-150 Machine. Per SOW.
Contract Period: Base
POP Begin: Date of Contract Award
POP End: 1 Year from Date of Award        1 Year         Unit                Est. Price ______________
Services for collecting and processing all conforming medical waste (RMW) generated by the Stratton VA Medical Center and its' outbuildings located at Albany VAMC. Contractor will be responsible for collecting, transporting, removal and disposal of RMW using the on-site SSM-150 machine as well as maintenance and service on the SSM-150 Machine. Per SOW.
Contract Period: Option 1
POP Begin: At Conclusion of Base Period
POP End: 1 Year from Start of Option 1        1 Year         Unit                 Est. Price ______________
Services for collecting and processing all conforming medical waste (RMW) generated by the Stratton VA Medical Center and its' outbuildings located at Albany VAMC. Contractor will be responsible for collecting, transporting, removal and disposal of RMW using the on-site SSM-150 machine as well as maintenance and service on the SSM-150 Machine. Per SOW.
Contract Period: Option 2
POP Begin: At Conclusion of Option 1
POP End: 1 Year from Start of Option 2        1 Year         Unit                 Est. Price ______________

Contractor will be responsible for collecting and transporting of medical waste, removal and disposal, disinfecting and re-installation of sharps containers throughout the hospital to designated area (SB-9) to be processed. Contractor shall comply with all applicable laws, regulations and policies of federal, state, local and other entities in the performance of this contract. The contractor will have and provide records of the required hazardous waste training required by DEC/EPA and the medical waste training required by Department of Health (DOH).
Contractor agrees to collect and change all sharps containers that are full to (full line). All containers must be emptied before becoming seventy five percent (75%) full or within thirty (30) calendar days of the last empty date, whichever is first. Contractor agrees to supply all sharps containers needed for the Medical Center as follows (Sizes and locations (Attachment 1 below).

68- 2 gallon
329-3 gallons
39-8 gallons
27-17 gallons
Containers may be re-usable or disposable (via destruction utilizing SSM-150.) If containers are to be re-utilized, then:
1)    Containers are to have direct drop with a top feed.
2)    Containers must be installed, collected, emptied, disinfected and re-installed by the contractor.
3)    Contractor is required to adjust container locations and pickups to meet the unique and changing requirements of each of all areas.
4)    Contractor is required to fix/repair all locks on needle boxes in dis-repair.
5)    Reusable sharps containers must be properly disinfected and must be sample tested to show that a 6 log reduction of vegetative organism and a 3 log reduction of mycobacterium are met.
6)    Contractor must provide a log of all pickups, including physical description of containers at the time.
7)    Contractor must provide Material Safety Data sheets (MSDS) on any chemicals it uses.
8)    Performance must comply with all state, federal, local, JCAHO, EPA and all other regulatory agencies.
9)    Contractor must provide all services supporting the possession, transport, or disposal of the hospital's Medical Waste.
10)    Contractor must supply the VA with all training records of itself and staff to insure compliance with mandatory training requirements (hazardous waste training required by DEC/EPA and the medical waste training required by Department Of Health.)
11)    Contractor shall ensure that all of its employees complete all training required by the VA. No employee of the contractor shall be allowed to perform any services under the contract unless that employee has completed all required training and has all education, licenses, and certifications required to perform those services.
12)    Contractor's employees must provide proof of current vaccinations for influenza, Hepatitis B and C, Measles, Mumps, and Rubella.
13)    Contractor's employees must undergo a security background investigation in accordance with VA policy, and provide proof of drug testing.

Contractor will transport all full sharps containers to (SB-9) to be processed.
Contractor will provide labor for medical waste and sharps, Contractor will submit a proposed schedule for the collection of sharps for the Chief Housekeeping Officer/COR's approval. Contractor will supply carts, in sufficient quantity, for use in VAMC Albany to satisfy these collection requirements (carts need to be emptied and available for use by 6:00AM, 11:00AM and 2:00PM Monday thru Friday). Contractor will be responsible for the cleaning of carts as well as the soiled utility rooms daily (This scheduled activity must avoid disruption to the VA's Monday -Friday activities as much as possible) Contractor will be responsible for the cleanliness of the medical waste processing room (SB-9) as well as surrounding area. VA will maintain ownership of the SSM-150 and furnishes it to the vendor only for completion of requirements of this contract. Contractor will be responsible for operation of the (IAW attached SOP), as well as all maintenance and repairs including parts and labor for the SSM-150. Contractor will be responsible for contract negotiations, collection and disposal as relates to Municipal Waste.
Contractor will be responsible for all testing on treated Medical Waste to insure all bio-burdens are rendered inert (in accordance with attached Standard Operating Procedure).
To insure regulatory compliance, the Contractor will operate the SSM-150 in accordance with the attached standard operating procedure and in accordance with the special conditions stated in the New York State Department of Environmental Conservation Permit number 4-0101-00164/00006 issued on May 9, 2012 and any future updates.
All required records will be submitted to and available for review by the Chief, Housekeeper Officer and/or his designated representative and on demand by the GEMS Coordinator and VA contracting officials.
The delivery/task order period of performance is from the date of award through one year from date of award with two (1) one year option periods to be exercised at the discretion of the Government.
Place of Performance
Address:    Stratton VA Medical Center
113 Holland Ave
Albany, NY
Postal Code:    12208

The full text of FAR provisions or clauses may be accessed electronically at

The following solicitation provisions apply to this acquisition:
1.    FAR 52.203-98 Prohibition on Contracting with Entities that require certain internal confidentiality agreements - Representation (Deviation)
2.    FAR 52.212-1, "Instructions to Offerors-Commercial Items" (OCT 2015) Offerors must complete annual representations and certifications on-line at in accordance with FAR 52.212-3, "Offerors Representations and Certifications-Commercial Items." If paragraph (j) of the provision is applicable, a written submission is required.
3.    FAR 52.216-1 Type of Contract (APR 1984) The Government contemplates award for a Firm Fixed Price Indefinite Quantity contract resulting from this solicitation.
7. FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)
Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:


        Hand-Carried Address:
        Department of Veterans Affairs Syracuse
        Network Contracting Activity
        1304 Buckley Rd, Suite C104
        Syracuse NY 13212

        Mailing Address:
        Department of Veterans Affairs Syracuse
        Network Contracting Activity
        1304 BUCKLEY RD, SUITE C104
        Syracuse NY 13212

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

The following contract clauses apply to this acquisition:
"    FAR 52.212-4, "Contract Terms and Conditions-Commercial Items" (MAY 2015)
"    FAR 52.212-5, "Contract Terms and Conditions Required to Implement Statutes or Executive Orders" (MAY 2015)

The following subparagraphs of FAR 52.212-5 are applicable:
Subparagraph (b)(1), (b)(4), (b)(8), (b)(9), (b)(14), (b)(16), (b)(19), (b)(22), (b)(25), (b)(27 through 34), (b)(40), (b)(44), (b)(51), (c)(2 through 4), and (c)(8)

"    FAR 52.204-9 Personal identity verification of Contractor Personnel
"    FAR 52.203-99 Prohibition on Contracting with Entities that require certain internal confidentiality agreements (Deviation)
"    FAR 52.212-2, Evaluation-Commercial Items (Oct 2014)
"    FAR 52.216-22, Indefinite Quantity (Oct 1995)
"    FAR 52.245-1, Government Property (Apr 2012)
"    VAAR 852.216-70, Estimated Quantities (Apr 1984)
"    FAR 52.216-18 ORDERING (OCT 1995)
"    FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)
(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than five (5) pounds, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.
        (b) Maximum order. The Contractor is not obligated to honor-
        (1) Any order for a single item in excess of thirty (30) thousand pounds;
         (2) Any order for a combination of items in excess of fifty (50) thousand pounds; or
(3) A series of orders from the same ordering office within two (2) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.
(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.
(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five (5) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.
"    52.216-21 REQUIREMENTS (OCT 1995)
"    52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)
(a) The Government may extend the term of this contract by written notice to the Contractor within thirty (30) days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 3 years and 6 months.

FAR 52.228-5 INSURANCE - WORK ON A GOVERNMENT INSTALLATION (JAN 1997) In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:
(a) Workers' compensation and employers' liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.
(b) General Liability: $500,000.00 per occurrences.
(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.
(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance.


Evaluation will be determined based on Best Value to the Government based on price, technical, and past performance IAW FAR Subpart 13.106-1(a)(2). The Government reserves the right to make award without discussions.

INSTRUCTIONS TO OFFERORS: Quote package must include the following or responses will be considered non-responsive:

Technical: Identify capability to comply with requirements of the SOW (Inclusive of documented verification of capability) to include but not limited to:
i)    Provide a quality control plan to ensure that safety is upheld throughout the performance period.
ii)     Demonstrate ability to provide services in accordance with all applicable state and federal regulations.
iii)    Provide a proposed Quality Assurance Surveillance Plan (QASP). Provide emergency back-up action plan.
iv)    Provide proof of licenses, auto insurance, general liability insurance, and permits in accordance with all state and federal regulations.
v)    Handling and Treatment Process - demonstrate handling and treatment process of containers in accordance with the State of New York regulations.
vi)    Qualifications - provide a copy of your program management resume, including the qualifications, certifications, licenses, capabilities, and years of experience of the proposed program manager. Demonstrate the capability to perform the work required by providing a narrative of the experience similar to the size, scope and complexity of the work required in the SOW.
vii)    Service Technicians - provide evidence of experience personnel supporting this contract in the handling, treatment, and transporting of disposal regulated medicals waste, including training, certifications, and licenses.

Pricing: Include for Base Year and both options.

Past Performance: (Provide References) Identify three (3) VA or other Federal, State, or Local Government customers for whom the Offeror has provided services as described in this solicitation at any time.

If Offeror has less than three (3) government customers, Offeror may submit commercial customers within the past three (3) years, making a total of three (3) references.

An offerors's past performance is important in determining its ability to successfully perform required services. The government is especially interested in recent and relevant past performance that relates very closely to the requirements set forth in the statement of work (SOW) and the degree of responsiveness to customer requirements.

All offerors shall be sent to the Contracting Officer: Steven S. Tompkins @ Confirmation of receipt is required.

This is an open-market combined synopsis/solicitation for on-site collection and processing of all conforming medical waste (RMW) (except chemo; pathology, animal lab) generated by VAMC Albany at main facility and its outbuildings with volumes contracted to be up to 130,000 LBS annually. The government intends to award a Requirements Service Contract, as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all proposals must include a statement regarding the terms and conditions herein as follows:
"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."
"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"
Offeror shall list exception(s) and rationale for the exception(s).

Submission shall be received not later than 3:00 PM EST on November 25, 2015 at Department of Veterans Affairs, Contracting Officer, 1304 Buckley Road, Suite C104, Syracuse, NY 13212. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mailed offers will be accepted and are due to no later than 3:00 PM EST on November 25, 2015 - Offeror responsible to confirm receipt. All offers must provide company name, point of contact information and the VAMC solicitation number.

Any questions or concerns regarding this solicitation shall be received not later than 3:00 PM EST on November 20, 2015 and should be forwarded in writing via e-mail to the contracting officer, Steven S. Tompkins Offeror's requesting a site visit must coordinate with the contracting officer and complete the visit NLT Nov 19, 2015.

Point of Contact
Steven S. Tompkins, Phone 315-425-4693,
Attachment 1

7D - ward currently closed
A606 - storage room that will need to be changed back to soiled utility
B626 - research room with RMW waste container
C505 - RMW will need to be added to this eye clinic room that is already marked as bio-hazard
4A and 4D - currently the Field Office but that will change
C405 - designated room but Nurse Manager has moved it somewhere else in the clinic
A305 - Medical Media - one small bio hazard receptacle
B316 - Microbiology - RMW receptacles in each room of the lab
A227 - one RMW receptacle for Radiology department
2B Lab - RMW receptacles in B228, B227, B220, Outside B204, B201-B1, B201-2
Dental Lab - A102 - RMW receptacles in all exam rooms
A137 - all used sharps in this closet
B38 and B40 - Morgue and Morgue Classroom
D1B - soiled equipment return
C51 - Distribution Unit
Radiation Building #26 - one receptacle between the two big rooms in the back
Nuclear Med Building #27 - room 27-145
Attachment 2

Department of Veterans Affairs         Standard Operating Procedure
VA Healthcare Network             Service Line - EMS
Upstate New York at Albany                     

1.    SSM-150 Medical Waste Disintegrator

1. PURPOSE: To establish handling and operating procedures for the SSM-150 medical waste disintegrator. For the safe destruction of regulated, medical and infectious waste that ensures an infection free environment for patients, staff and visitors throughout the facility and complies with the New York State Department of Environmental Conservation(NYSDEC) Operating Permit No. 4-0101-00164/00006 and Title 6 New York Codes, Rules and Regulations Part 360 (6NYCRR 360)..

2. RESPONSIBILITY: The Facility Hospital Housekeeping Officer will ensure that all regulated medical waste is handled in a safe and secure manner to ensure an infection free environment for patients and staff throughout the Medical Center. The Facility Hospital Housekeeping Officer will ensure that the medical waste treatment process operates within the scope and special provisions of the NYSDEC operating permit.

3. PROCEDURES: All Medical Center staff will follow OSHA prescribed guidelines as described by the Blood Borne Pathogens Standard during the course of their workday. These guidelines will include:

    A. Definitions:

1.    Medical Waste - refers to all waste generated as a result of patient care that is
dis-carded and not intended for further use.

2.    Infectious Waste - refers to that portion of medical waste and regulated medical waste that has the potential of transmitting diseases.

3.    Regulated Medical Waste - refers to medical waste that is controlled by applicable laws, codes, rules, regulations and is handled in a manner that protects the health care provider and visitor and safeguards the environment community.

4.    The following categories of waste are considered regulated medical waste as defined by New York State and Federal regulations:

"    Cultures and Stocks - cultures and stocks of infectious agents and associated biological, including cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biological; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate and mix cultures..

"    Human Blood and Blood Products - liquid waste human blood; products of human blood; items saturated and/or dripping with human blood or items that were saturated and/or dripping with blood that are now caked with dried human blood, including serum, plasma and other blood components and their containers which were used in patient care, testing and laboratory analysis or the development of pharmaceuticals including intravenous bags.

"    Sharps - sharps that have been used in animal or human patient care or
treatment or in medical, research industrial laboratories including hypodermic needles, syringes, Pasteur pipettes, scalpel blades, blood vials, needles with attached tubing and culture dishes. Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips.

"    Contact Wastes - wastes from surgery or autopsy that were in contact with infectious agents including soiled dressings, sponges, drapes, lavage tubes, drainage sets, under pads and surgical gloves.

"    Laboratory Wastes - laboratory wastes from medical, pharmaceutical or other research, commercial or industrial laboratories that were in contact with infectious agents including slides and cover slips, disposable gloves, laboratory coats and aprons.

"    Dialysis Wastes - dialysis wastes that were in contact with the blood of patients undergoing hemodialysis or renal dialysis including contaminated disposable equipment and supplies such as tubing, filter, disposable sheets, towels, gloves, aprons and laboratory coats.

"    Isolation Wastes - biological waste and discarded materials contaminated with blood, excretion, exudates or secretions from humans who are isolated to protect others from certain highly communicable diseases or isolated animals known to be infected with highly communicable diseases.

"    Unused Sharps - the following unused, discarded sharps; hypodermic needles, suture needles, syringes and scalpel blades.

B. Handling and Disintegration

1.    Housekeeping Aid will place medical waste into a locked soiled utility closet within their assigned area.

a.    All medical waste is placed within red bags imprinted with the bio-hazard symbol. All other waste is placed into clear bags and disposed of properly.

2.    Custodial Worker transports medical waste in locked red cart, labeled biological hazard, on the service elevator to the biological hazard storage room. This room is located in the sub-basement of the Medical Center. Medical waste is then transferred to the red storage cart in the locked bio-hazard room.

a.    All medical waste is logged in with date and time in medical waste log, by custodial worker, upon arrival to the locked bio-hazard room.

3.    Within 24-72 hours, medical waste laborer uses a Geiger and surveys the medical waste containers in the manner prescribed by the Radiation Safety Officer to ensure radiation levels are within acceptable range. The date, time and type of waste are entered into the medical waste log.

4.    Medical waste to be processed in the RBS, is weighed by medical waste laborer and entered in the medical waste log.

a.    Medical waste is transported from scale in hallway outside of bio-hazard room, through the Environmental Management Service (EMS) Suite to the SSM-150 room (Red Bag Room) within the EMS Suite.

5.    Medical waste laborer loads the medical waste into the SSM-150 disintegrating machine at 100 pounds or less, depending on volume.

6.    Prior to starting the SSM-150, the medical waste laborer will place a test Magna Amp ampoule, pre-warmed to room temperature, in the SSM-150 door holder and secure.

7.    Medical waste laborer will operate the SSM-150, in accordance with the manufacturer's instructions, to grind and sterilize the medical waste.

a.    Medical waste is considered processed as sterile and ground and sent to hydra extractor section of the SSM-150, to separate solid and liquid.

8.    Remaining sterile and ground product is collected in 50 gallon totes and marked with the batch number and date. Each batch is collected separately, weighed/recorded on the operational log and stored within the RBS treatment room until bio-indicator proof of treatment.

9.    Magna Amp ampoules are removed from the SSM-150 door holder after each batch run, labeled with date and batch number and brought to the Microbiology Laboratory for assessment and incubation.

10.    Bio-indicator results are provided to the medical waste laborer after 48 hours. A no-growth or negative result indicates effective medical waste treatment and releases that batch for disposal.

11.    Bio-indicator results that show growth or are positive indicates treatment failure and requires that the batch must be re-treated and not released.

12.    Processed waste cleared through bio-indicator results is moved to the 25 yard container locked outside the building by the EMS loading dock. The waste is loaded into the container with the waste batch number and date recorded. The Receiving container is kept secured/locked except when adding processed waste.

13.    When the container is near full, the contracted waste hauler is contacted and a DOH Form 3939, Regulated Medical Waste Treatment Certification is completed, signed and available for the waste hauler. A copy of this document is maintained for two (2) years.

C. Emergency Response

2.    Red Bag Solutions is able to monitor the SSM-150 at any time through a data line connected to the unit. This allows Red Bag Solutions to detect any problems within a few minutes and to keep the unit running 80% of the time.

3.    Should the SSM-150 machine become disabled, the following will occur;

a.    If the laborer cannot rectify the problem, a Technician will be dispatched from Red Bag Solutions to the Albany VAMC within 24 hours.

b.    If the medical waste cannot be processed within 72 hours, the Albany VAMC will use a licensed and approved contractor for the processing and disposal of medical waste. The contractor will comply with Federal and New York State regulations.

D. Treatment and Associated Spills, Work Surface Maintenance, Decontamination and Handling of Infectious Waste.
1.    Work surfaces including floors, tables and contact surfaces will be maintained in a clean and sanitized condition at all times.

2.    The SSM-150 will be maintained in accordance with the RBS SSM ED-FS-6s PLC3 Operators Manual.

3.    In the event of a spill or release associated with RMW, the Chief of Environmental Management Service,(518-626-6932) and the GEMS Coordinator, (518-626-6940) will contacted or their designees will serve as Emergency Coordinator. In the event neither contact can be reached, the Administrator On Duty (AOD) should be contacted (518-626-6620).

4.    Spill response and cleanup will be performed by trained employees using appropriate personal protective equipment (PPE) or, at the discretion of the Emergency Coordinator, an outside agency may be called to respond to the release.

5.    Spilled materials, spill response materials, and PPE will be placed into impermeable red bags bearing the "biohazard" symbol and managed as RMW in accordance with the VA Medical Center's RMW procedures.

6.    Following clearance by the Emergency Coordinator, the area of the spill will be rinsed with a decontaminating solution such as a 10% sodium hypochlorite or a similar, commercially available disinfectant. A supply of biological decontaminating product and red biohazard bags will be maintained and readily available.

4. QUALITY ASSURANCE REQUIREMENTS: To insure proper treatment results and to comply with the special conditions of the facilities Permit to Operate, quality assurance measures and testing is required. These include, but are not limited to, parametric controls and bio-indicator testing.

A.    Parametric Controls: these include real time monitoring devices that record process feed rate or flow, cycle time and temperature/pressure. The devices that measure and record these processes must be calibrated annually by the manufacturer and recorded.

B.    Bio-Indicator/Challenge

1.    With each batch/load of RMW treated, a MAGNAAmp (SGM Biotech Corp) containing a minimum of 6 log 10 spores of Geobacillus stearothermophilus, warmed to room temperature, will be placed in the designated door holder prior to the start of the treatment process.

2.    Upon conclusion of the batch run, the ampule will labeled with the batch number and brought to the Microbiology Laboratory for incubation and analysis.

3.    A control ampule for each day's worth of MAGNAAmps will be included in the analysis for each day.

4.    Process RMW will be collected in the designated 50 gallon totes and labeled with batch number and date and placed in the holding area until the MAGNAAmp results indicate successful treatment at which time, the tote can be emptied into the 25 yard locked container outside the EMS loading dock.

5.    MAGNAAmp analysis will be accessed and log as a clinical laboratory sample and the completed analysis provided electronically to EMS and the GEMS coordinator

6.    MAGNAAmp ampules must be stored between 20 and 25 degrees centigrade and between 20 and 70% relative humidity.

7.    Each lot of bio-indicators must be independently tested when received and after six (6) months and 200 hours of SSM-150 operation.

8.    Independent testing of the MAGNAAmp lots will follow the protocol shown in ANNEX 2 by the Presque Isle Testing Laboratories.

5. RECORDKEEPING AND REPORTING: As a permitted regulated medical waste treatment facility, the Medical Center is mandated by New York Codes, Rules and Regulations Part 360 (Solid Waste Management Facilities) and Subparts 360-1, 360-10 and 360-17 to maintain accurate records of the operation of the SSM-150.

A.    Recordkeeping

1.    A written record of when the treatment system is operated must be maintained

2.    Each batch or load shall have a record of the treatment parameters indicating successful treatment has been obtained (sterilization reports).

3.    Maintain records of daily, weekly monthly, quarterly, semi-annual and annual maintenance.

4.    Maintain a record of calibration of each of the parametric controls (e.g., Temperature and pressure, flow gauges).

5.    Maintain manufacturers' certificate of performance for each MAGNAAmp lot and the results of independent laboratory testing.

6.    Maintain records of treatment system failures to include:

a.    Documentation of the failure, including date and system identifier
b.    Document facility response including corrective action
c.    Insure no untreated waste leaves the facility

7.    Record temperature and humidity of storage for bio-indicators

8.    Maintain an operating log (ANNEX 3) that includes:

a.    Date
b.    Time
c.    Name of Operator
d.    Type and amount of RMW
e.    Operating parameters
f.    Bio-challenge test results

9.    Record weekly, monthly and summarized quarterly the quantity of RMW treated and disposed (Summary Form) ANNEX 5

B.    Reporting

1.    Annual Report to the Department of Environmental Conservation (NYSDEC) is required by the 28 of February of each year. The report format is shown in ANNEX 6
a.    The quantity and type of waste received by source and weight. The data must include monthly summaries and the annual totals
b.    The quantity of treated waste, by volume and weight, and the location of disposal. The data must include monthly summaries and the annual totals.

2.    Any changes to the operating, contingency, closure, personnel and/or waste controls plans must be submitted to the attention of the NYSDEC Region 4 Regional Permit Administrator for approval prior to implementation.

3.    Any unscheduled shutdown of the treatment system that will exceed seven (7) days must be reported to the NYSDEC to the attention of the Region 4 Regional Materials Management Engineer.

4.    Any proposed operational changes (i.e., flow of waste, change in waste stream to be treated) or modifications (i.e., structural changes, additional or new treatment systems, etc.) to the facility must be forward to the NYSDEC Region 4 Permit Administrator for approval prior to the implementation of the changes.


OSHA Blood Borne Pathogen Standard (29 CFR 1910.1030); New York State and Federal Regulations.
6NYCRR Part 360 - Solid Waste Management Facilities
6NYCRR Part 360, Subpart 360-1 - General Provisions
6NYCRR Part 360, Subpart 360-10 - Regulated Medical Waste Storage, Transfer and Disposal
6 NYCRR Part 360, Subpart 360-17 - Regulated Medical Waste Treatment Facilities


8. FOLLOW-UP RESPONSIBILITY: The Facility Hospital Housekeeping Officer (137) Ext 66932.
                    GEMS Coordinator (131) Ext 66940

7. REVIEW: This SOP is scheduled for review March, 2015.

8. CONCURRENCE: Director
             Careline Manager
             Facility Manager
             Associate Director for Patient/Nursing Services

ANNEX 1 Operating Permit

ANNEX 2 MAGNAAmp Testing Protocol

ANNEX 3 Operational Log

ANNEX 4 DOH Form 3939 Certification of Treatment

ANNEX 5 Monthly, Quarterly Summary

ANNEX 6 Annual Report for NYSDEC


Contracting Officer

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