Attachment_9_Reports_Deliverables.xls

XLS spreadsheet 67 KB Posted Jul 5, 2016

Attached to: Hazardous Waste Collection Federal contract opportunity
Solicitation number: 16-223-SOL-00016
Issued by: Department of Health and Human Services Food and Drug Administration

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Attachment 9 - Reports/Deliverables

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File	Type	Posted
Attachment_2_Pricing_Schedule_Final_Updated_July_22.xlsx	XLSX spreadsheet	Jul 22, 2016
Attachment_2_Pricing_Schedule_Updated_July_22.xlsx	XLSX spreadsheet	Jul 22, 2016
Wiley_Bldg._Waste_Streams.xls	XLS spreadsheet	Jul 15, 2016
Rad_and_MPW_Waste_Streams.xls	XLS spreadsheet	Jul 15, 2016
Attachment_7_-_Small_Business_Subcontracting_Final.doc	DOC document	Jul 15, 2016
RFQ_16-223-SOL-00016_Final.pdf	PDF	Jul 15, 2016
MRC_Waste_Streams.xls	XLS spreadsheet	Jul 15, 2016
Attachment_2_Pricing_Schedule_Final.xlsx	XLSX spreadsheet	Jul 15, 2016
White_Oak_Waste_Streams.xls	XLS spreadsheet	Jul 15, 2016
Colors_Waste_Streams.xls	XLS spreadsheet	Jul 15, 2016
Attachment_1_-_Statement_of_Work_(SOW)_Final.docx	DOCX document	Jul 15, 2016
Questions_and_Answers_-_16-223-SOL-00016.doc	DOC document	Jul 15, 2016
Attachment_8_Personnel_Security_Clearance_Requirements.doc	DOC document	Jul 5, 2016
Attachment_3_-_Pickup_Sites _Estimated_Types_and_Quantities_of_Waste.doc	DOC document	Jul 5, 2016
Attachment_7_-_Small_Business_Subcontracting_Plan.doc	DOC document	Jul 5, 2016
Attachment_2_Pricing_ScheduleA.xlsx	XLSX spreadsheet	Jul 5, 2016
Attachment_1_-_Statement_of_Work_(SOW).docx	DOCX document	Jul 5, 2016
Attachment_4_Government_Furnished_Property.doc	DOC document	Jul 5, 2016
Attachment_6_Contractors_Commitment_to_Protect_Non_Public_Information.pdf	PDF	Jul 5, 2016
RFQ_16-223-SOL-00016A.pdf	PDF	Jul 5, 2016
Attachment_5_-_Past_Performance_Questionnaire.doc.rtf	RTF text file	Jul 5, 2016

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Sheet1

	Attachment 9 - Reports/Deliverables
	Description	Deliver to	Schedule
	COR = Contracting Officer Representative
	COR/Rep = Contracting Officer Representative designated Person
	Chemical Waste
1.	Receiving facility certification of receipt of waste shipments. The contractor shall send the signed original or photocopy of the receiving facility copy (Copy 3) of the manifest to the COR or designated waste coordinator.	COR	Within 40 days of shipment to Final TSDF.
2.	Reports of chemical waste not picked up: Where FDA requires pick-up of waste from individual laboratory rooms, the contractor shall provide a written report on as needed basis, of the wastes and locations which they were not able to pick-up, and shall include the following:	COR	Deliver a report within 7 days for each occurrence
	a. Waste for which a hazardous waste form is not present.
	b. Waste for which the hazardous waste form is not signed or completely filled out.
	c. Wastes offered for disposal that are controlled substances.
	d. Wastes that are radioactive wastes and not hazardous wastes offered to the contractor for disposal.
	e. Wastes that are not completely identified by name or concentration of materials, (Unidentified Chemical/Wastes).
	f. Wastes that are medical pathological wastes and not hazardous wastes offered to the contractor for disposal.
3.	Analysis report of unidentified chemicals/wastes: The contractor shall provide a laboratory identification and/or classification or profile of unidentified waste in order to identify it for proper treatment, storage or disposal.	COR	Within 10 working days.
4.	Letter of explanation when there is no disposal option. The contractor shall submit a letter explaining the reason why waste must be held on site over 90 days and why there is now no disposal option available for the particular waste. This letter would be used to inform a regulatory agency of FDA’s disposal problems.	COR/COR Rep	Deliver a report within 3 days for each occurrence
5.	Waste Profile Report. The contractor shall prepare a waste profile report on the waste stream for any bulking and consolidation process that requires a sample collection, analysis for disposal or to establish a waste profile sheet.	COR	The report will be generated on an as needed basis.
6.	Audit report for recycling facilities: The contractor shall provide an annual audit report for each recycling facility or outlet used under the contract. The annual audit report is due on the anniversary dates of the start of the contract. The annual audit report shall include the following elements:

a. Copies of the last two regulatory inspections.

b. Copies of environmental impairment insurance binders.

c. Copies of current regulatory permits and licenses.

d. A summary of the facility’s regulatory compliance status, including notices of violation, fines, RCRA corrective actions, compliance agreements, and permit modifications.		COR/COR Rep	The report is due annually on the award date.
	7.	Audit update report for each TSDF facility The contractor shall provide the audit report, which shall include the following elements:

a. Copies of the last two regulatory inspections;

b. Copies of insurance certificates or binders;

c. Copies of current regulatory permits and licenses; and

d. A summary of the facilities regulatory compliance status, including notices of violation, fines, RCRA corrective actions, compliance agreements, and permit modifications.		COR/COR Rep	The report is due annually on the award date.
	8.	Written follow-up accident report for any incident involving: The contractor shall submit a written follow-up report for any incident to the COR within 72 hours after the incident is resolved. The report shall include the following information:

a. Description of the item(s) spilled or released and quantity and description of the time and location of the spill, areas involved.

b. Description of the containment practices that were initiated.

c. Summarization of any communications with other involved parties.

d. Description of the clean-up procedures employed.

e. Final disposition of the spill clean-up materials and residues.

f. May include corrective actions taken to prevent the incident from reoccurring.		COR/PO	Deliver a report within 72 hours for each occurrence; major Incidents to be sent to PO.
	9	Report of unknown chemicals in storage in the waste area. The report shall include the room from which it was removed, the generator’s name and the date it arrived in the waste area.	COR	Deliver a report within 3 days for each occurrence
	10.	Site specific safety and health plan for contractor’s employee’s at each FDA facility. It shall include details for the personnel protective equipment, periodic monitoring, the waste handling procedures for drums and containers of waste, the specific requirements for the lab pack waste, training and an emergency response plan. Within 14 days of contract award, the contractor will submit a finalized site specific safety and health plan.	COR	Within 14 days of Award Date
	11.	Task specific standard operational procedures for task to be performed under this Contract (to be generated as work is performed).	COR	As work is performed
	12	Work log for tasks and projects to be performed under this contract.	COR/COR Rep	Award Date/Monthly Updated
	13.	Contractor Training Report: The contractor shall provide yearly updates for this Training and provide documentation of training updates to the Contracting Officer.
The contractor shall provide written verification of RCRA (40 CFR 264.16) and DOT (49 CFR) training including the new requirements for Hazardous Materials Act of 1990 (HM-181). The report is due annually on the award date.		COR/COR Rep	Annually on Award Date
	14.	Content Discrepancy Report. The contractor shall collect a representative stratified sample from each drum of waste solvents, as needed to verify or establish the waste
Profile sheet. If FDA experiences any problems with particular waste streams, the COR will request additional analyses, as needed. If the analyses indicate that the waste stream is incongruent with the information provided by the researchers or generators of the waste, the contractor shall notify the Contracting Officer in writing within five days after receipt of laboratory reports.		COR/COR Rep	As needed basis
	15.	Biennial Generator Reports: By January 15th of each calendar year, the contractor shall provide to the PO, a draft annual hazardous waste generator report for all facilities services under the contract. The reports shall itemize all hazardous waste shipped off during the calendar year and be prepared according to the format and forms required by the hazardous waste regulatory agency or jurisdiction. The PO shall review the draft reports, make any necessary corrections, and return them to the contractor within five (5) working days of receipt. The contractor shall then finalize the reports and submit them to the PO within fifteen (15) working days.	COR/COR Rep	January 15th of each calendar year
		Radioactive Waste
	16.	Receiving facility certification of receipt of waste shipments. The contractor shall send the signed original receiving facility copy of the manifest to the COR or designated waste coordinator. In cases where final disposal facilities do not issue certificates of receipt/disposal, the contractor shall provide documentation that shows the waste was shipped to the final disposal facility, i.e., copies of manifest identifying FDA waste after processing SEG.	COR	Within 45 working days of Final TSDF receipt of waste
	17.	Radioactive Waste Tracking Form (RWTF) – The contractor shall supply a Radioactive Waste Tag to maintain the necessary tracking of the “Chain of Custody” for radioactive material from cradle to grave. The tag must provide the following information:

a. Name of Principle Investigator;

b. Location of Laboratory;

c. Radionuclide; d. Activity;

e. Date of Pickup;

f. Signiture of Person Complteting the Form; and

g. Signiture of Person Receiving Waste		COR	Each pick up
	18.	Waste Rejection Form (WRF) – The contractor shall provide written correspondence to the PO of the location of any waste not properly labeled or unacceptable for disposal. The reason for not accepting the waste must be clearly indicated by using a Radioactive Waste Rejection Form with copies left with the waste and the waste coordinator. The contractor shall supply the Radioactive Waste Rejection Form identifying the following areas:

a. Name of Principal Investigator;

b. Laboratory;

c. Type of Waste Rejected; and

d. Reason for Rejection.		COR	As Needed
	19.	Liquid Waste Analysis Reports – The contractor shall sample all aqueous liquids and liquid mixed waste at all FDA facilities and provide written results within two (2) working days after sample collection. The report shall contain the following:

a. Name of Principle Investigator.

b. Laboratory.

c. Container Size

d. Container Volume

f. pH

g. Radionuclide(s)

h. Activity (Container Total & Activity/ml)		COR	2 Working days after sampling
	20.	Waste Profile Reports – The contractor shall prepare a waste profile report on any mixed waste streams for any bulking and consolidation process that requires a mixed waste sample, collection, analysis for disposal or to establish a mixed waste profile sheet, on an as needed basis.	COR	As needed
	21.	Annual Audit Report for Recycling Facilities and Reprocessors – The contractor shall provide an annual audit report for each recycling facility or outlet used under the contract. The annual audit report is due on the annual award date of the contract and shall include:

a. Copies of the last two regulatory inspections;

b. Copies of the environmental impairment insurance binders;

c. Copies of the current regulatory permits and licenses; and

d. A summary of the facilities regulatory compliance status, including notices of violations, fines, RCRA corrective actions, compliance agreements and permit modifications.		COR/COR Rep	Annual Award Date
	22.	Written Follow-up Report for any Incidents – The contractor shall submit the written follow up report to the COR 72 hours after the incident. The report shall provide the following information:

1. Description of the exposure, injuries or property damage as a result of the incident;

2. Description of the item(s) spilled or released and quantity;

3. Description of the time and area of the spill;

4. Description of containment practices that were initiated;

5. Description of the cleanup procedures employed;

6. Final disposition of the cleanup materials and residues; and

7. Description of the corrective actions used to prevent the reoccurrence of the incident.		COR/COR Rep	Deliver a report within 72 hours for each occurrence; major incidents to be sent to PO.
	23.	Site specific Safety and Health Plan - The contractor shall provide a site specific
safety and health plan for the contractor’s employees at each facility. It shall include details for personnel protective equipment, periodic monitoring, the waste handling procedures for drums and handling of waste, specific requirements for Radiation and OSHA training, and an emergency response plan.		COR/COR Rep	Award Date
	24.	SOP’s will be required for the following:

1. Waste Pickups;

2. Waste Processing; and

3. Shipments: manifesting and transportation		COR	Award Date and as needed
	25.	Contractor Training Report: The contractor shall provide updates of yearly training and provide documentation of training updates to the Contracting Officer, on the annual award date of the contract. The contractor shall provide written verification of RCRA (40 CFR 264.16) and DOT (49 CFR) training, including the new requirements for Hazardous Materials Act of 1990 (HM-181). The contractor shall insure that the personnel working on this contract attend Radiation Refresher Training and HAWOPER Refresher Training on an annual basis.	COR	Annual Award Date
	26.	Manifesting – The contractor shall submit to the PO a copy of each of the following:Bill of Lading when needed before shipment:

a. Radioactive waste shipment and disposal manifests one hour before shipment;

b. Shipping orders for exclusive use shipments one hour before shipment;

c. Hazardous Waste manifests for Mixed Waste Shipments one hour before shipment;

d. FDA Radioactive Waste Forms returned upon completion of collection and packaging after each pickup;

e. Indication of the final disposal method and site for each drum of radioactive and mixed LLRW shipped; and

d. Radioactive Waste Tags.		COR	1 or 2 hours prior to shipment
	27.	Summary of waste picked up, materials and supplies used and labor expenses incurred on a monthly basis.	COR	Monthly
	28.	Audit Report for Recycling Facilities and Reprocessors – The contractor shall provide an annual audit report for each recycling facility or outlet used under the contract. The annual audit report is due on the annual award date of the contract.	COR	Annually
		Medical / Pathological Waste
	29.	Receiving facility certification of receipt of waste shipments. The contractor shall send the signed original receiving facility copy of the manifest to the COR or designated waste coordinator, within 30 working days of waste pickup.	COR/COR Rep	Within 45 working days of Final TSDF reciept of waste
	30.	Audit report for recycling facilities: The contractor shall provide an annual audit report for each recycling facility or outlet used under the contract. The annual audit report is due on the anniversary dates of the start of the contract. The annual audit report shall include the following elements:

a. Copies of the last two regulatory inspections;

b. Copies of environmental impairment insurance binders;

c. Copies of current regulatory permits and licenses; and

d. A summary of the facility’s regulatory compliance status, including notices of violation, fines, RCRA corrective actions, compliance agreements, and permit modifications.		COR	Annual Award date
	31.	Written follow-up accident report for any incident involving: The contractor shall submit a written follow-up report for any incident to the COR within 72 hours after the incident is resolved. The report shall include the following information:

a. Description of the item(s) spilled or released and quantity and description of the time and location of the spill, areas involved;

b. Description of the containment practices that were initiated;

c. Summarization of any communications with other involved parties;

d. Description of the clean-up procedures employed;

e. Final disposition of the spill clean-up materials and residues; and

f. May include corrective actions taken to prevent the incident from reoccurring.		COR/COR Rep	Deliver a report within 72 hours for each occurrence; major incidents to be sent to PO.
	32.	Contractor Training for Personnel – Lists and updates: The contractor shall provide yearly updates of this training on the annual award date of the contract, and provide documentation of training updates to the Contracting Officer. The contractor shall provide written verification of RCRA (40 CFR 264.16) and DOT (49 CFR) training including the new requirements for Hazardous Materials Act of 1990 (HM-181).	COR	Annual Award date

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File details come from the government source that posted it. Updated Nov 14, 2017.