IHS1493590 - SOW.pdf

Crownpoint Pharmaceutical & Controlled Substance Waste Disposal Service Statement of Work

Crownpoint Service Unit

FY 2024

1.0 General: The Contractor shall provide support services to the Crownpoint Healthcare Facility located in Crownpoint, NM. This Statement of Work (SOW) describes the request for Pharmaceutical Waste Disposal Services for the Pharmacy Department. Period of Performance is from: Date of Award - 12 month service.

1.1 Scope: The Contractor shall dispose of all hazardous drug waste in accordance with Federal, State, and Tribal regulation. The Contractor shall provide the containers as agreed upon during negotiations and pick up the waste at least twice a month on an agreed upon schedule during negotiations.

1.1.1 Place of Performance and Hours of Operation: The main hospital and two satellite locations listed as:

Crownpoint Health Care Facility Hwy Jct371&Rt9, Crownpoint, NM 87313 Mon-Fri 9am-6pm Thoreau Health Station 3 E Navarre St, Thoreau, NM 87323 Mon-Fri 9am-4pm Pueblo Pintado Health Center 10 Pueblo Pintado School Rd, Rt 9, Cuba, NM 87013 Mon-Fri 1 0am-4pm

2.0 Definitions:

2.1 Contracting Officer - the individual with a DHHS-I HS issued warrant- the only authorized Government representative who can make binding commitments for the Government.

2.2 Contractor - the awardee of this contract, responsible for performing services described herein and as described in each individual purchase order.

2.3 Technical Representative - Government technical personnel, who formulate, clarify, monitor and evaluate the technical requirements of acquisition actions process by the Contractor.

2.4 Vendor - business that will provide supplies and services to the Government through contracts, purchase orders, delivery orders, and other procurement vehicles.

2.5 Acquisition Process - Basic framework for managing an acquisition program, from identification of a mission need through contract award and ending with project close-out.

2.6 Acquisition Program - A directed, funded effort that is designed to provide a new, improved, or continuing program in response to a validated operational need.

2.7 Performance-Based Contract - Describes the services to be performed as an end result and provides to the Contactor the standards for acceptable performance for the quantities, limits, or areas that the service covers. The Contactor shall be responsible for achieving the stated results.

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3.1 The Contractor shall wear the Navajo Area lndian Health Service (NAIHS) ldentification Badge provided by NAIHS, Division of Administrative Services, A $10.00 fee will be charged for losl or destroyed lD badge.

3.2 The Conkactor shall be obligated to reimburse the government for any damage, aside from normal wear and tear, to Government furnished property that may occur during the execution of this contract resulting from negligence on the part of the Contractor.

4.0 Contractor Furnished Property: The Contractor shall be responsible for all off-site (non-NAIHS facilities) supplies, materials, equipment, and facilitres, to specifically include telephone service (to include Long Distance) and Cell-Phone for on-call basis.

5.0 Specific Requirements:

The pick-up, transportation and disposal of pharmaceutical waste, including but not limited to

Hazardous (RCRA [Recource Conservation and Recovery Act]) Pharmaceutical Waste and other waste streams identified on the Waste Acceptance Policy as listed below. Containers for Additional Services may consist of a single container system suitable for Hazardous (RCRA) Pharmaceutical Waste or 2 gallon containers suitable for incompatible Hazardous (RCRA) Pharmaceutical Waste (e.9., oxidizers, corrosives, or aerosols), or both, as needed.

The lvlonthly Fee for Pharmaceutical [azalelous Wasle ueludes lhcl o Phase lwaste characterization . Phase ll program design & start-up . Phase lll OnJine training o Phase lV on-going waste characterization and training . Education, design and implementation . All containers . Six Hazardous waste pickups per year for Crownpoint. Each pickup to include:

o disposal of upto twenty-four 8 gallon containers of compatible waste o disposal of separate 2 gallon containers of incompatible waste as needed . aerosols with propellant . corrosives . oxidizers . lab packs o disposal of a 1.5 quart container of P-List waste . container to be weighed and logged monthly by pharmacy

. Four Hazardous waste pickup per year at Thoreau and Pintado Satellite Clinics.

Each pickup to include:

o disposal of upto twelve 8 gallon containers of compatible waste o disposal of separate 2 gallon containers of incompatible waste as needed . aerosols wilh propellant . corrosives

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3.0 Government Furnished Property: For onsite work in NAIHS facilities, the Government shall provide, without cost, office space, computers, phones, and any necessary office supplies to support the services described in this contract.

■ oxidizers

■ lab packs o disposal of a 1.5 quart container of P-List waste

■ container to be weighed and logged monthly by pharmacy

Other Charges for Pharmaceutical Hazardous Waste MAY be applied:

• Taxes

• EPA E-Manifest Fee

• Record Retention Fee

• State Intrastate Fees

• Energy Fee (Percent of Invoice Fuel Surcharge)

• Other Miscellaneous Fees

Crownpoint will be billed at the current monthly rate to include 6 hazardous waste pickups and the disposal of 24 full RCRA containers. Each satellite clinic (Thoreau and Pintado) will be billed at the current monthly rate to include 4 hazardous waste pickup and the disposal of 12 full RCRA containers at each site. Additional hazardous waste collections exceeding the amounts above will be will incur additional pickup and container disposal charges.

The Monthly Fee for Controlled Substance Waste (CsRx Service) includes the following:

CsRx Service is for controlled substances that have been dispensed to a patient at the registrants location and need to be wasted at that location. This is not for disposal of controlled substances brought in by patients.

• Staff training

• Containers and lockable brackets

• One-way disposal path on containers for tablets, capsules, liquids and patches

• Designed to prevent sharps, vials or ampoules from entering the container

• Secure containers and brackets to ensure low potential for waste diversion

• 1.4 quart size CsRx containers

• Deactivating, deterring and solidifying agents

• Full CsRx containers will be sealed and placed in a RCRA pharmaceutical container provided under the Hazardous Waste component of this SOW. The RCRA container will then be picked up according to its location specific schedule for incineration of contents.

• Automatic CsRx container shipments

• A new 1.4 quart CsRx container will automatically ship every 16 weeks.

• Three 1.4 quart containers for Crownpoint (Outpatient pharmacy, ER nursing, Inpatient nursing)

• One 1.4 quart container each for Thoreau and Pintado Sattelite Clinics

• Record Retention Fee

• Energy Fee (Percent of Invoice Fuel Surcharge)

For program rollout, a Healthcare Compliance Specialists will be available on-line or via web-ex to provide training. To support ongoing training for part-time staff, employees on vacation, new hires, etc., offers an extensive Train-the-Trainer program with supporting documents, posters, CD's and other tools to reinforce the training message. All education will be provided on-line or via web-ex.

Pharmacy Training

Pharmacists & Pharmacy Techs

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Topics to review: how are the hazardous medications identified in the pharmacy, what is the identifier for the hazardous medications in the patient care areas, what medications are going to be returned to pharmacy for disposal, review how to manage bulk and trace chemotherapy within the pharmacy, and how to update the formulary on a regular and annual basis.

Environmental Services Training Managers/Supervisors & Designated Employees Topics to review: location of supplies, location of CAA for non hazardous and hazardous waste, how to exchange a pharmaceutical waste container, how to package the non hazardous waste and their role in servicing the containers.

Train the Trainer

Nursing, Educators, Department Managers/Supervisors and "Super Users" Topics to review: regulatory review, program overview, nursing identifier for the hazardous medications, what medications need to be returned to pharmacy for disposal and why, review changes to work flow, review what is not going to change (RMW, sharps containers, chemo practices, controlled substances) and review locations of container in units per EPA.

Unit to Unit Nursing Training Staff Nurses Departmental level training on floors Topics to review: nursing identifier for the hazardous medications, location of pharmaceutical waste containers on the units, review what is not going to change (RMW, sharps containers, chemo practices, controlled substances) and review the list of hazardous medications to let them identify the commonly used meds on their unit.

Ongoing Follow-Up

Upon completion of service installation our Healthcare Compliance Specialists will perform ongoing follow-up to maintain compliance with EPA (RCRA) and DOT regulations.

HAZARDOUS WASTE ACCEPTANCE POLICY

ACCEPTED WASTE STREAMS:

✓ RCRA Hazardous Pharmaceuticals • Must be characterized and certified as RCRA hazardous by the generator and, be packaged and labeled for transportation in accordance with applicable US EPA, US DOT and State regulations. Consult Representative for specific requirements.

✓ Non-RCRA Hazardous Pharmaceuticals - Must be characterized and certified as nonRCRA hazardous material by the generator. Consult Representative for specific requirements.

✓ Trace-Chemotherapy Contaminated Waste - RCRA Empty drug vials, syringes and needles, spill kits, IV tubing and bags, contaminated gloves and gowns, and related materials as defined in applicable laws, rules, regulations, or guidelines.

✓ Bulk Chemotherapy Waste - Non-RCRA Empty drug vials, syringes and needles, spill kits, IV tubing and bags, contaminated gloves and gowns, and related materials as defined in applicable laws, rules, regulations, or guidelines. Must be characterized and certified as

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RCRA hazardous by the generator and, be packaged and labeled for transportation in accordance with applicable US EPA, US DOT and State regulations. Consult Representative for specific requirements.

✓ Universal Pharmaceutical Waste - Must be packaged and labeled for transportation in accordance with applicable US EPA, US DOT and State regulations. Consult Representative for specific requirements. (NOTE: Only available in States where RCRA hazardous pharmaceuticals are defined as Universal Waste.)

✓ Universal Waste - Non-pharmaceutical universal waste (batteries, light bulbs, etc.)

✓ RCRA Hazardous Waste - Must be characterized and certified as RCRA hazardous by the generator and, must be packaged and labeled for transportation in accordance with applicable US EPA, US DOT and State regulations. Consult Representative for specific requirements.

► Chemicals - Formaldehyde, formalin, acids, alcohol, waste oil, solvents, reagents, fixer, developer

► Hazardous Waste - Drums or other containers with a hazard warning symbol, batteries, and other heavy metals

► Radioactive Waste - Any container with a radioactivity level that exceeds regulatory or permitted limits; lead-containing materials

► Compressed Gas Cylinders, Canisters, Inhalers, and Aerosol Cans

► Any Mercury-Containing Material or Devices - Any mercury thermometers, sphygmomanometers, laboratory or medical devices

► Mercury-Containing Dental Waste - Non-contact and contact amalgam and products, chairside traps, amalgam sludge or vacuum pump filters, extracted teeth with mercury fillings, and empty amalgam capsules

RCRA Hazardous waste will be transported for disposal by a owned or contracted RCRA hazardous waste transporter.

Customer is solely responsible for ensuring the proper segregation of non-RCRA hazardous waste. If any RCRA hazardous pharmaceutical or RCRA hazardous non-pharmaceutical waste is found in the non RCRA hazardous waste stream, then Customer will be solely responsible for all resulting costs associated with the clean-up, transportation, treatment, and disposal of the waste by a company or companies permitted to clean-up, transport, treat, and dispose of such Non-conforming Waste.

Additional waste acceptance policies may apply based on state or permit specific requirements.

Hazardous waste transportation services may be offered in certain geographical locations, under separate contract. Please refer to your local Representative for additional information.

For additional information on container labeling requirements, contact our Customer Service Department at (866) 783-7422.

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6.0 Other:

6.1 Estimated Workload: All quantities listed are estimated only and are subject to variatlon to meet the NAIHS mission.

6.2 Priority of Work: The Government (via the NAIHS/CCO) reserves the right to specify the priority of all work in order to meet urgent or specific mission needs. Changes in work priority shall be made by the Contractor at no additional cost to the Government.

6.3 Duplication of Records: The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in the SOW. If requested by the Government, the Contractor shall provide a duplicate copy of any such record within five (5) working day of receipt of the request.

6.5 Time and Attendance: The services shall conduct services in an agreed upon schedule and will not deviate from any such services, These services shall be conducted in a timely and prompt manner,

6.6 Workload Report: As part of the conkactor's invoice, the Contraclor shall submit to the

NAIHS/CCO or designee a list of all actions completed per weeUper month. The listing shall identify the prolect by project name, date project assigned to the Contractor, and date pro.lect submitted to CCO (actions not completed and submitted to the CO shall be identified as "pending").

Required Service Performance

Standard

Performa nce lndicator Method of Surveillance lncentive*

Contractor shall provide Pharmaceutical Waste disposal scrvices in an accurate and timely nlanner

Timely and prompt time frame. Pick-ups will be scheduled within 30 days of requested pic ku p.

All actions completed 100% compliant with IHS contracting policies and regulations -quality, timeliness, and accuracy

Valid Customer Compliant by Acq uisitio ns staff.

All written su bm issions:

100% inspection by Contracting Officer or designee.

none Payment(s) -

DOT Tra in ing

SegreBation ed ucation for staff

All actions completed 100% compliant with lH5 contracting policies and regulations -quality, timeliness, and accuracy

All written submissions 100% inspection by Contracting Officer or designee.

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6.4 Billing: The Contractor shall submit invoices on a monthly basis.

7.0 Performance Requirements summary (Matrix):

Staff who complete the DOT Tra ining will receive their Certification

For business conduct:

Customer Complaint by Acquisitions staff

Payment(s) -no ne

Contract Administration

All actions completed 100% compliant with lH5 contracting policies and regulations -quality, timeliness, and accuracy

For business cond uct:

Customer Complaint by Acq uisitions staff

All written su bmissions:

100% inspection by Contracting Officer or d esignee.

Contract Closeout

All actions completed 100% com plia nt with lHs contracting policies and regulations -qua lity, timeliness, and accuracy

For business conduct:

Customer Complaint by Acquisitions staff

All written submissions:

100% inspection by Contracting Officer or designee.

Payment(s) -none

8,0 STANDARDS OF CONDUCT

8.1 Contractor while performing work under this conkact shall not solicit new business, "Solicit" is deflned as performing marketing/selling function.

8.2 The Contractor shall refrain from discussing with unauthorized persons, any information obtained in the performance of work under this contract.

8,3 The Contractor shall conduct only such business as covered by this contract during periods paid for by the Government, Business not directly related to this contract will not be conducted on Government premises,

8.4 The Contracting Oflicer may require removal from work any employee that is deemed unacceptable or is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the facility and its population.

8.5 Contractor will be allowed use of the internet in performance of duties under this contract.

Unauthorized usage of the internet may be grounds for dismissal of Contractor employees.

8.6 Contractorwill comply with all applicable Federal and lndian Health Service regulations and policies

8.7 Contractor shall have no claim or rights to forms, templates, or other data generated during this contract period,

9.1 Travel is only authorized when requested by the Contracting Officer in support of the activities described herein. The Contracting Officer will issue requests for travel as required to meet program objectives.

Contractols travel will be in conformance with the Federal Travel Regulations to the greatest extent possible.

Written travel documentation that substantiates the costs to be reimbursed shall be submitted with invoices.

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9.0 TRAVEL.

9.2 All travel shall be performed on a reimbursable basis. The Contractor shall provide receipts and other supporting documentation when invoicing for havel. Payment for travel, per diem, and other expenses shall be considered reasonable and allowable only to the extent that they do not exceed on a daily basis the maximum per diem rates in effect at the time of travel set forth in the Federal Travel Regulations, prescribed by the General Services Administration, available online at: http://www.gsa.gov/ftr.

9.3 lt is the policy of the lndian Health Service to exercise economy in travel. All travel requests will be reviewed toward furthering this policy, Consideration shall be given to the use of telephones and mail in lieu of traveling where possible. All proposed travel costs, Per Diem, and other expenses are to be submitted to the COR who shall concur prior to forwarding to the Contracting Officer, 1O.O FEDERAL TAX REPORTING:

'10.1 The Contractor shall submit a written quarterly report giving evidence that the Contractor has made the required payment on their federal, state & local taxes, including applicable employment taxes for all days that services were provided. This report shall be delivered to the Contracting Offlcer as follows:

a, For Acquisition Support services provided during the calendar quarter of Seplernlcr lhrough

Deeemlq, the report is due no later than 15 January showing that Federal taxes have been paid for September through December,

b. For Acquisition Support services provided during the calendar quarter of Januarylh-tough-Maloh, the report is due no later than 15 April showing that Federal taxes have been paid for January through March.

For Acquisition Support services provided during the calendar quarter of Apnltbrougi ,lunc, the report is due no later than '15 July showing that Federal taxes have been paid for April through

Ju ne.

d. For Acquisition Support services provided during the calendar quarter of Julylhrguqh tuqlsl the report is due no laterthan 15 September showing that Federal taxes have been paid forJuly through August.

Nonpayment of Federal taxes or the failure to submit the required report shall become the formal basis for a cure notice, show cause notice, withholding of payments, and possible termination for default. Final contract payment will be withheld untll the required report has been submitted to and accepted by the Conkacting

Ofilcer,

11.0 Contracting Officer's Representative (COR):

11.1 COR is primarily responsible for monitoring the technical progress including the surveillance and assessment of performance under this purchase order, 1 2.0 INVOICE SUBMISSION:

This contract is subject to the electronic payment process by the Department of Treasury. All invoices complying to the requiremenls al52.212-4(9) must be submitted through www.ipp.oov.

(a) Definitions. As used in this clause - Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR c

32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

13.0 ADDITIONAL/APPLICABLE FEDERAL ACQUISITION REGULATIONS CLAUSES:

52.204-9 Personal Identify Verification of Contractor Personal (JAN 2011)

52.204-13 System for Award Management Maintenance (JUL 2013)

52.224-1 Privacy Act Notification (APR 1984)

52.224-2 Privacy Act (APR 1984)

52.229-3 Federal, State and Local Taxes (FEB 2013)

52.232-33 Payments by Electronic Funds Transfer-Central Contractor Registration (JUL 2013)

52.237-2 Protection of Government Building, Equipment and Vegetation (APR 1984)

52.249-4 Termination for Convenience of the Government (Services) (Short Form) (APR 1984)

Questions regarding Payments Contact Accounts Payable at (505) 786-6287

Questions regarding this Purchase Order contact assign COR.

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