Attachment J-3A Samp Task Order SOW CDER 75F40123R00003.pdf
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- Attached to
- Hazardous Waste Management Services Federal contract opportunity
- Solicitation number
- 75F40123R00003
About this file
This document includes a solicitation for a hazardous waste management services contract and the related statement of work. The solicitation seeks proposals for a single award indefinite delivery/indefinite quantity task order contract to provide chemical, radioactive, medical pathological, device waste collection, minimization and disposal services, dangerous goods shipping and multi-hazardous material inventory management services for multiple Department of Health and Human Services Food and Drug Administration locations across the United States and Puerto Rico. The statement of work specifies the services required, including waste pickup and transportation, treatment and disposal, emergency response, inventory management, and dangerous goods shipping. The period of performance includes a one year base period and four one year option periods.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 75F40123R00003 Questions and Responses.pdf | ||
| 75F40123R00003A00001.pdf | ||
| Attachment J-2 Labor Categories rev75F40123R00003.pdf | ||
| Attachment J-4 Pricing Schedule rev 75F40123R00003.xlsx | XLSX spreadsheet | |
| Attachment J-2 Labor Categories 75F40123R00003.pdf | ||
| Attachment J-4 Pricing Schedule 75F40123R00003.xlsx | XLSX spreadsheet | |
| Attachment J-6 Glossary of Abbreviations and Acronyms75F40123R00003.pdf | ||
| Attachment J-8 Past Performance Questionnaire 75F40123R00003.pdf | ||
| 75F40123R00003.pdf | ||
| Attachment J-1 Locations and Place of Performance 75F40123R00003.pdf | ||
| Attachment J-3B Samp Task Order SOW CFSAN 75F40123R00003.pdf | ||
| Attachment J-5 Government Furnished PropertyEquipInfo 75F40123R00003.pdf | ||
| Attachment J-7 Non-Public Information 75F40123R00003.pdf | ||
| Attachment J-9 FDA Subcontract Plan 2023 75F40123R0003.pdf |
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Text version
Attachment J-3A Task Order SOW (CDER)
TASK ORDER FOR CDER AT WO FOR COMPREHENSIVE WASTE
MANAGEMENT SERVICES
CHEMICAL, RADIOACTIVE MEDICAL PATHOLOGICAL WASTE
COLLECTION, MINIMIZATION AND
DISPOSAL SERVICE, DANGEROUS GOODS SHIPPING AND MULTI-
HAZARDOUS MATERIAL INVENTORY MANAGEMENT SERVICES
NOTE: The Government reserves their right to revise the number and types of services being requested.
CDER
Site Specific Waste Scope of Work
1 General
The Contractor shall provide, either directly or through qualified sub-Contractors, all aspects of a comprehensive, cradle to grave chemical, radiological and medical pathological waste management service for CDER.
Contractor shall ensure that all contractual personnel fully understand and comply with the contingency and spill prevention control and countermeasures plans of each FDA facility. When Contractor becomes aware of a spill or uncontrolled release of a waste, hazardous chemical or biohazardous agent resulting from waste handling operations, Contractor shall first perform a rapid assessment of the incident. If the Contractor has ready access to spill cleanup materials and the situation is not an immediate health risk to its employees and the Contractor has available the proper personnel protection equipment, Contractor may respond to the spill/release of material.
If Contractor assesses the situation to be serious enough to alert other occupants in the building to evacuate, the Contractor shall pull the fire alarm pull station lever. If Contractor does not have access to the equipment or the situation is beyond control and too hazardous to respond, the Contractor shall notify the SPO or designated individual (to be identified in facility-specific task orders) immediately.
Contractor shall notify the SPO or designated individual by telephone, or other rapid means, of any significant spill, environment release, contamination, employee exposure, occupationally related illnesses or injury, or other unusual activity occurring within FDA facilities which involve waste handling activities. A written follow-up report for any incident shall be submitted to the COR and SPO on the next working day after the incident. The report shall include following information:
1. Description of exposures, injuries, deaths, or property damage as a result of the incident.
2. A description of the item(s) spilled or released and quantity.
3. A description of the time and location of the spill, the area involved, and any pertinent weather conditions; a description of what containment practices initiated.
4. A summarization of any communications with other involved parties; a description of clean-up procedures employed and final disposition of the spill clean-up materials and residues; and a description of corrective actions taken to prevent the incident from reoccurring.
Contractor is not authorized to report releases or spills occurring within FDA facilities to regulatory authorities.
The Contractor should defer the reporting to regulatory authorities to the COR or designated individual. The Contractor is authorized to call 911 to initiate the assistance of emergency response personnel (e.g., local
HAZMAT teams) when the Contractor determines it necessary based on the nature and magnitude of the spill and/or medical emergencies associated with the situation. Appropriate FDA personnel should then be notified.
Such procedures will be defined in more detail in specific task orders, as necessary. The Contractor shall also have information regarding the notification of local emergency response personnel in the Health and Safety Plan for this BPA Order and for specific FDA facilities, as necessary.
Contractor shall provide emergency response activities involving hazardous materials within FDA facilities as directed by the SPO or COR. Such services may include provision of labor, materials, equipment, and vehicles;
sampling and analyses; clean-up; and removal of resulting wastes. The Contractor shall provide support services and coordinate with local emergency responders to any spill or release incident, as directed by the SPO. Services may include technical guidance, initial site surveillance, and all clean-up and decontamination activities.
If a spill or release resulting from Contractor negligence occurs, the Contractor shall immediately notify the SPO.
Contractor shall provide, at no cost to FDA, all labor, materials, and services for clean-up of all releases and spills of hazardous materials or biological agents under his control from the point of pick-up to the point of final treatment, storage, recycling, or disposal. The clean-up of spilled or released materials shall be performed in compliance with all applicable regulations and to the maximum extent possible to return the contaminated area to its original condition prior to the spill or release.
Contractor shall perform other remedial work, as directed by the SPO or COR, to clean-up spills and releases of wastes and hazardous materials where the spills or releases are not due to Contractor negligence and the spill situation is not an emergency situation. Examples of such would be the clean-up of mercury or hazardous chemical contaminated laboratory areas, or the clean-up of underground storage tanks. Services for underground tank clean-up shall include: pumping of leaking tanks; transfer of contents for disposition; removal of contaminated soil from the site; groundwater monitoring; and verifying clean-up of the site meets regulatory standards.
Contractor shall provide emergency spill response and cleanup services to the FDA facilities within the Metropolitan Washington, DC area to mitigate any radioactive spills or releases. Contractor shall respond to any situation where there is a release or spill of radioactive materials within four (4) hours of telephone notice by the SPO or COR.
2.0 Specific Requirements/Tasks
2.1 Chemical Waste Scope of Work
1) Pick-up locations for CDER:
a. For CDER laboratories located in Building 64, 1st and 2nd Floors:
i. Contractor shall schedule and collect chemical waste every third Wednesday of the month.
ii. Additional waste pick-ups can be scheduled as determined by the Site Project Officer (SPO).
Currently it is programmed that one additional pick-up per month will be conducted.
b. For CDER laboratories in Building 52/72 2nd Floor and offices in Buildings 21, 22, 51, 71, 75:
i. Client shall indicate that a chemical waste pick-up is needed by calling the chemical waste service line at (240) 402-9999. Service shall be conducted during normal workdays, 8:00 am-4:30 pm ET, weekdays.
ii. Additional waste pick-ups can be scheduled as determined by the Site Project Officer (SPO).
c. For CDER laboratories in St. Louis, Missouri and Beltsville, Maryland, notification must be made to Contractor via phone or e-mail and FDA should provide at list 30 days’ notice. Skip to item 29 below.
2) Pick-up hazardous/chemical waste as directed by the site project officer (SPO), as requested by recorded message by the research community, and by sweeping the laboratory satellite accumulation areas.
3) Identified waste shall be removed from laboratories only when accompanied with a completed FDA Chemical Waste Form (must be signed).
4) Contractor shall provide an empty 5gallon container, blank FDA Waste Form, and blank self-adhesive label for each container removed.
5) Contractor shall remove empty reagent containers from the center utility corridors and laboratories which indicate empty container are located inside the laboratory. The containers will be taken to the 90-day area where the bar codes will be removed. The containers will be properly disposed of, empty “P-Listed” will be treated as acute wastes. The chemical inventory will be updated by processing the empty container via the barcode system.
6) Chemical waste shall be moved to the Chemical Waste Room using secondary containment and appropriate cart.
7) Contractor shall conduct “Waste Analysis Procedures”. A review of the FDA Waste Form will be conducted. For used chemical waste, the waste will be “finger-printed”/spot tested in the 90-day accumulation area to assure accuracy of the constituents listed on the waste form (e.g., pH meter, pH test paper test, KI-Starch paper spot oxidizer test) to assure accuracy of the constituents listed on the waste form. Finger printing of un-used, virgin material will be conducted if the product is not consistent with the package labeling.
8) The FDA Waste Form shall be completed by Contractor by adding the date entered into the 90-day area and initialing underneath.
9) Waste shall be segregated by hazard class/compatibility in the 90-day hazardous waste storage area.
Hazardous waste shipping containers and/or temporary secondary storage containers will be marked with the words “Hazardous Waste” and the accumulation start date (the date the container was brought to the 90-day area). Universal Waste will be stored in appropriate closed containers, marked with the start date, type of Universal Waste and the words “Universal Waste”. Universal Waste shall not be store for more than one year. Non- Hazardous waste containers and/or temporary secondary storage containers shall be marked with the words “Non-Hazardous.” Surplus chemicals shall be segregated from chemical waste, stored in a safe manner (stored away from incompatible material) and labeled “surplus chemical”
10) Containers will be profiled and scheduled into Contractor’s or other waste processing facility or recycling facility as necessary.
11) The containers shall be entered on a Hazardous Waste manifest, labeled, and marked per DOT, EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.
12) The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.
13) Following a waste shipment, Contractor Project Manager will be available to meet with the SPO to make necessary changes to the paperwork and to receive executed copies of the manifests.
14) Records of the shipment will be maintained in consolidated records files. Currently the records folder is located Building 62, Room G122.
15) The Waste will be transported to the assigned Treatment, Storage, or Disposal Facility.
16) A Detailed summary of the shipment will be entered into a data base for Biennial reporting requirements.
17) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format
18) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. A spreadsheet will be prepared in the format of Line Item Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.
19) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.
20) Contractor shall provide all necessary shipping containers. Containers that were consolidated will be either rinsed and reused or disposed of.
21) Contractor shall maintain adequate materials and supplies to perform this scope of work as well as spill mitigation supplies.
22) Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.
23) Biennial reports will be prepared and delivered to the CPO by February 15 of each odd numbered year.
24) Contractor shall perform a weekly inspection of the 90-day accumulation area per 40 CFR262.34.
25) Contractor shall stock safety glasses in buildings 64 and 52/72.
26) Contractor shall provide emergency response services per request of SPO.
27) Contractor shall provide chemical waste pick-up for CDER laboratory located in St. Louis, MO and
Beltsville, MD.
a. It is currently programed to pick-up waste in St. Louis and Beltsville two times.
b. FDA St. Louis and Beltsville Staff will provide CONTRACTOR with at least a 30 days’ notice of a chemical waste pick-up.
c. FDA shall coordinate its waste pick-up with other Mid-West and WO FDA laboratories.
d. FDA will provide an inventory of material requiring disposal. They will also indicate other waste services that will be required (See #26).
e. FDA will make available security and computer access.
f. Contractor shall bulk, package, lab pack, and label waste in appropriate DOT packaging. Any storage of RCRA waste must be incompliance with Missouri state RCRA regulations (waste must be in DOT compliant packaging, dated, and DOT labeled and marked a DOT Hazardous Waste shipping marking.). The Contractor shall provide shipping papers, Hazardous Waste Manifest, Profiles, Packing Lists, Land Band Restriction Form, and a cross reference sheet (container content sheets) will be prepared.
g. The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.
h. The Waste will be transported to the assigned Treatment, Storage, or Disposal Facility or other processing facility.
i. Contractor shall make an electronic copy of paperwork for COR.
j. Contractor shall provide all necessary shipping containers. Containers that were consolidated will be either rinsed and reused or disposed of.
k. Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.
30) At the request of SPO and with the funding resources available; Contractor may be asked to provide:
a. Dangerous Goods Shipping.
b. Redistribution/Disposal of DEA Controlled Substances.
c. Moving of chemicals and samples between laboratories or facilities to include transport of hazardous material over public roads.
d. Remedial services for laboratories and facilities requiring OSHA protected workers and/or expertise in handling hazardous material/hazardous waste. This may include equipment and rooms which requires chemical decontamination.
e. Environmental chemical analysis, such as TCLP analysis, PCB analysis, and etc.
f. Supplies and equipment for chemical safety, servicing of this contract and spill contingency.
2.2 Radioactive Waste Scope of Work
The Contractor shall provide all aspects of a comprehensive, agency-wide, cradle to grave radioactive and mixed waste service for the FDA. The Contractor shall perform all contract operations in compliance with applicable occupational health and safety, transportation, environmental protection and radiation control regulations.
The specific objectives are, but not limited to:
i. Laboratory waste pickup of radioactive and mixed waste
ii. Transport of waste from laboratories to radiation waste facility
iii. Processing of radioactive and mixed waste
iv. Sampling and analysis of the waste stream to identify and characterize waste for storage, transportation, treatment or disposal
v. Off-site disposal of radioactive and mixed waste
vi. Management and operation of radioactive waste facilities at FDA Facilities.
vii. Responding to spills, leaks, or other environmental releases involving radioactive/mixed waste and radioactive materials
viii. Provide all labor, management support, data tracking services, vehicles, equipment, containers and supplies necessary for the collection, receiving, processing, packaging, transportation, treatment, sampling, analysis, of waste being managed
ix. Consultation services on LLRW management issues.
x. Provide labor, materials, equipment, supplies and supervision to perform ancillary radiation services in accordance with established line items
Site Specific Radioactive Waste Scope of Work
1) Report to site on date scheduled by Radiation Safety Officer (RSO)/ Site Project Officer (SPO).
a. Active laboratories are located on the 2nd floor of Building 52/72.
b. Other locations may include Building 64, which is not currently active.
c. Additional location may be added at the direction of the Radiation Safety Officer (RSO)/SPO if funding resources are available and within the scope of this contract.
2) Contractor shall pick-up prepackaged radioactive waste as directed by the RSO from radioactive material use laboratories and/or storage areas.
3) For radioactive waste which will be “stored and decayed” on-site, Contractor shall appropriately store and monitor the waste. Once the waste is decayed, Contractor shall test, document and properly dispose of the decomposed material.
4) The waste will be inspected and segregated into waste types for final shipment packaging. Waste will be packaged according to profile and waste acceptance criteria of the assigned receiving facility.
5) The shipment paperwork, including a radioactive shipment record (manifest) and hazardous waste manifest (if required) and land ban (if required) will be presented in an orderly fashion to the RSO, or designee, once all packages have been inspected and entered onto the manifest.
6) Once the RSO or designee has signed the paperwork, the waste will be loaded for transport to the assigned Disposal Facility.
7) A copy of the completed Manifest(s) will be mailed to the SPO once the waste has been disposed.
8) Contractor shall conduct radiological health services in support of FDA’s Radiation Safety Program at the direction of the RSO/SPO, in accordance with NRC (Nuclear Regulatory Commission) license requirements. Currently services required for radiological laboratories are located on the 2nd floor in Building 52/72. The following radiological health services that will be provided are:
a. Radiation Safety Surveys will be performed in areas designated by the RSO. Surveys will be conducted in accordance with SOPs. Access to all areas to be surveyed is required. Currently weekly and quarterly surveys will be conducted. Results of Radiation Safety Surveys will be provided to the RSO within five business days of the date of survey.
b. Results of Radiation Safety Surveys will be provided to the SPO within five business days of the date of survey.
c. Radiation Safety Training will be provided as directed by the SPO. Training will follow an outline approved by the SPO.
d. An audit of the Radiation Protection Program will be completed as directed by the SPO.
e. Leak tests will be performed on a date scheduled by the RSO. Results of leak tests will be provided to the SPO within five business days of the date of testing. Currently three items are leaked tested twice a year.
f. Pick-up prepackaged radioactive waste as directed by the SPO from radioactive material use laboratories and/or storage areas.
g. Conduct instrument calibration. Currently Contractor shall calibrate approximately 40 contamination meters on-site on an annual basis. Collect 3 to 5 radiation dose meters for off- site calibration on an annual basis.
h. The waste will be inspected and segregated into waste types for final shipment packaging. Waste will be packaged according to profile and waste acceptance criteria of the assigned receiving facility.
i. The shipment paperwork, including a radioactive shipment record (manifest) and hazardous waste manifest (if required) and land ban (if required) will be presented in an orderly fashion to the SPO, or designee, once all packages have been inspected and entered onto the manifest.
j. Once the SPO, or designee has signed the paperwork, the waste will be loaded for transport to the assigned Disposal Facility.
k. A copy of the completed Manifest(s) will be mailed to the SPO once the waste has been disposed.
l. Results of Radiation Safety Surveys will be provided to the SPO within (5) five business days of the date of survey.
m. Enter data into the Radiation Safety computer database as directed by the RSO.
n. Conduct quality assurance performance checks of predetermined radiation safety instrumentation on daily basis.
o. Radiation security checks. Currently Contractor conducts daytime, evening and weekend surveillance check three times a month.
p. Conduct inventories of radioactive material and devices. Sealed sources are inventoried every 6 months. Non-sealed sources are inventory annually.
q. Conduct personal monitoring, Contractor shall distribute and collect dosimetry badges every 3 months. Also include is area monitor. Contractor shall maintain records of dosimeter.
r. Provide radioactive package receipt and shipment services. Contractor shall receive the package;
conduct radiological survey of package; document results; inventory the radioactive material and deliver it to the end user.
s. Maintain radiological records in accordance with SOPs and/or direction of the RSO.
t. Ensure that researchers’ notebook is maintained with required records.
9) At the request of RSO/SPO and with the funding resources available; Contractor may be asked to provide:
a. Radiation Safety Training.
b. Bioassay.
c. Decommissioning projects.
d. Provide emergency response services.
e. Conduct material transfer of radioactive material and devices.
f. Supplies and equipment for radiological safety, servicing of this contract and spill contingency.
10) The Contractor shall provide the FDA Radiation Safety Program radiological support services to ensure that FDA is complying with NRC, DOT, and OSHA regulations. Support is not limited to, but shall include the areas listed below:
a. Posting of signs and labels
b. Laboratory Close-out or decommissioning of labs for unrestricted use releasing of rooms for unrestricted use
c. Shipping and Receiving of radioactive material packages, and delivery of received packages to researcher
d. Use a database or spreadsheet to track and inventory radioactive material from time of approval to disposal (cradle to grave)
e. Perform routine security checks of posted radiation laboratories to ensure that RAM is secure against unauthorized access
f. Respond to emergency spills and accident involving spills, internal exposures, and skin contamination
g. Developing of emergency procedures that are commensurate with the scope of program activities
h. Interview researchers and check laboratories to ensure that Good work practices are being followed
i. Leak testing
j. Maintaining equipment, supplies for routine work, spills, contamination, and emergencies procedures
k. Perform calibrations and quality control of instruments and equipment to ensure data integrity
l. Perform scheduled or as needed surveys, and collect and review required surveys that are conducted by researchers
m. Calibrate and maintain proper instruments as necessary for package surveys, contamination surveys, dose rate measurements, bioassay or specialized air sampling
n. Participate in audits and inspections
o. Provide record keeping, management, and retention
p. Provide reports as required to document regulated activities
q. Provide instructions or procedures for work performed to ensure consistency of work performance.
2.3 Medical Pathological Waste Scope of Work
The Contractor shall provide medical pathological waste services. It may include, but is not limited to, bio contaminated lab ware, broken glass, sharps, human tissue, blood and blood derivatives and small and large animal tissues and carcasses. The Contractor shall provide a means of disposing carcasses, such as a large, 1-cubic yard rolling cart, that is compliant with federal and local regulations and poses minimal additional handling or preparation on the part of the generator.
The specific objectives are:
i. Pick up, loading, manifesting, transportation, treatment, and/or disposal of such waste at specified facilities.
ii. Emergency response to spills, leaks, accident cleanup, or other environmental releases involving biohazardous materials.
Site Specific Medical Pathological Waste Scope of Work
1) Contractor shall provide Medical and Pathological Waste (MPW)/ Biological Regulated Waste disposal services. MPW is normally packaged in 40-pound DOT packaging. CDER stores its MPW waste in walk-in freezer Room 0007, Building 64.
2) Routine scheduled MPW pick-ups are to be scheduled every two weeks. The MPW driver/dispatcher is to contact CDER safety in order to provide a time day so that shipping paper can be sign by FDA DOT trained staff at the time of pick-up.
3) Pick-up prepackaged biological waste as directed by the site project officer (SPO) from a single predetermined marshalling area.
4) Additional MPW shipments may be requested by SPO. At least 3 workdays will be given for additional pick-ups.
5) The waste will be inspected for proper packaging and weighed. Boxes weighing more than 40 gross pounds will either be refused for collection or accepted for transport and billed at a per pound rate. For each package accepted for transport, one box and one liner will be left in replacement. Contractor shall provide replacement MPW boxes and liners.
6) The number of packages and weight of all packages will be entered on a Medical Waste manifest and all packages will be marked per DOT and State specifications.
7) The shipment paperwork will be presented in an orderly fashion to the SPO, or designee, once all packages have been inspected and entered onto the manifest.
8) Once the SPO, or designee, has signed the manifest, the waste will be loaded for transport to the assigned Disposal Facility.
9) A copy of the completed Manifest will be mailed to the SPO once the waste has been disposed.
10) At the request of SPO and with the funding resources available; Contractor may be asked to provide:
a. Bulk (cubic yard cart) MPW disposal.
b. Clean/decontaminate laboratories using disinfecting solutions. Activities include washing down equipment, casework, and floors.
c. Decontamination of biological safety cabinets using formaldehyde, chlorine dioxide or other FDA approved sterilization product.
d. Decommissioning of biologically contaminated equipment.
e. Provide emergency response services.
f. Supplies and equipment for chemical safety, servicing of this contract and spill contingency.
g. Provide special boxes for non-contaminated broken glass and pick-up the boxes for disposal when full.
2.4 Dangerous Goods Shipping Scope of Work
The Contractor shall be responsible for shipping dangerous goods.
UPS and FDEX require shipper (FDA) to have dangerous goods software and a subscription to ship dangerous goods. The software will be purchased by the FDA and installed by FDA IT.
The specific objectives are:
i. Classifying the material – Is it regulated? Is it forbidden for transport?
ii. Identifying the material – select the proper shipping name
iii. Choosing the right packaging
iv. Packaging it correctly
v. Marking & Labeling the shipment correctly
vi. Supplying additional required documentation – dangerous goods declaration forms
vii. Making shipping arrangements – i.e. permits, customs documents for overseas shipments
viii. Transporting things safely around FDA locations – hand carrying & vehicle transport
Dangerous Goods Shipping Scope of Work
1) Offer assistance when needed to the SPO for outgoing Dangerous Goods Shipments (DGS).
2) Work with SPO in maintaining an inventory supply of DGS supplies.
3) Transport DGS between local FDA and Government Facilities.
4) Be available to classify, identify, select packing, pack, mark and label, complete paperwork and ship
DGS via approved FDA/CDER carrier upon request.
2.5 Multi-Hazardous Material Inventory Management Scope of Work The Contractor shall be responsible for inventory control and delivery.
Laboratory operations at the Food and Drug Administration (FDA) frequently receive hazardous materials that need to be kept in an inventory according to Federal regulations (Emergency Planning and Community Right to Know Act, otherwise known as EPCRA, Sections 311 and 312).
This data will be collected and either put directly into the inventory database program or populated into an Excel spreadsheet in a format that can be imported into the chemical inventory database program. The ESO will provide additional guidance on proper use of the chemical inventory database program as needed. The Contractor shall also be capable of identifying any chemicals that may be hazardous in their current condition e.g. (peroxide forming chemicals stored past their expiration due date, damaged or corroded chemical containers, improperly stored chemicals, etc.). Any hazardous materials identified as hazardous in their current condition shall be reported to the ESO and COR.
The specific objectives are:
i. Procure services to complete a comprehensive inventory of laboratory hazardous materials (chemical, radioactive, and biological materials).
ii. Manage the chemical inventory system.
This data will be collected and either put directly into the inventory database program or populated into an Excel spreadsheet in a format that can be imported into the hazardous material inventory database program. The FDA Biosafety Officer (BSO) will provide additional guidance on proper use of the biological inventory database program as needed. The Contractor shall also be capable of identifying any biological materials. Any biological materials identified as hazardous in their current condition should be reported to the BSO and COR.
Multi-Hazardous Material Inventory Management Scope of Work
1. Report to site as necessary.
2. Chemical inventory will be processed in three ways. Contractor employee shall have to
i. Coordinate with Shipping & Receiving to take inventory of chemicals
ii. Coordinate with the researchers to take inventory of chemicals
iii. Coordinate with the researchers to take inventory of existing chemicals in the lab
3. Contractor shall perform an annual and comprehensive inventory of all of the existing chemicals in the laboratories.
4. Contractor shall barcode and enter new chemicals into the system as they arrive to the White Oak Campus.
5. Contractor employee shall input data on each chemical in the following ways:
a. Barcode
b. CAS
c. IUPAC name
d. Manufacturer
e. Grade/concentration,
f. Quantity
g. Unit
h. Hazard class,
i. Potentially hazardous to environment
j. Location
k. Lab
l. Responsible party
m. Received date*
n. Expiration date*
6. Contractor employee shall assign the dates following the steps above for all chemicals except peroxide formers. Special rule: Peroxide forming chemicals will have 1-year expiration date from the day that they are opened.
7. If there is any chemical spill or leakage during the inventory process, isolate the chemical container in a gray tote, place it under the fume hood and contact Contracting Officer Representative (COR) or Site Project Officer (SPO) immediately.
8. For chemicals in the labs, Contractor employee shall coordinate lab inventory with Principal Investigator (PI) of the lab.
9. Contractor employee shall identify and collect chemicals that are expired in the lab.
10. PI will decide which chemicals to keep as their Standard. If some chemicals are considered to be
Standard, 5-year expiration date does not apply to those chemicals.
11. Contractor employee shall work with the PI to assign an expired date which will be 5 more years added.
12. Contractor employee shall issue a sticker (which identifies Standards) to the PI.
13. Contractor employee shall l coordinate with the PI and waste management team to dispose the unwanted expired chemicals safely.
14. Waste management will then dispose the expired chemicals as a result of the inventory.
15. Contractor employee shall barcode the existing chemicals in the lab and uploads the data into inventory database.
16. Contractor employee shall conduct reconciliation annually in each work site and update the database as needed.
| 2.0 Specific Requirements/Tasks |
| 2.2 Radioactive Waste Scope of Work |
| The specific objectives are, but not limited to: |
| Site Specific |
| 2.3 Medical Pathological Waste Scope of Work |
| The specific objectives are: |
| Site Specific |
| 2.4 Dangerous Goods Shipping Scope of Work |
| The specific objectives are: |
| Dangerous Goods Shipping Scope of Work |
| 2.5 Multi-Hazardous Material Inventory Management Scope of Work |
| The specific objectives are: |
| Multi-Hazardous Material Inventory Management Scope of Work |
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