Performance Work Statement (PWS)

MEDICAL WASTE DISPOSAL FOR THE WAGNER HEALTH CENTER.

Background:

The Mission of the Wagner Health Center is to provide the best possible healthcare services to the Native American population of the Yankton Sioux Oyate located on the Yankton Sioux Reservation. To meet this mission, Wagner Health Center has identified a need for a Base Year Plus Four (4) One (1) year options, Non-Personal Service Contract for Medical Waste Disposal Services.

Objective:

The contractor will furnish all resources to provide infectious waste disposal, including disposal containers, tracking manifests, certificates of destruction, monthly billings, copies of permits and other documents as necessary.

Scope of Work:

The contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to provide complete handling, transport and disposal of infectious medical waste from the Wagner Health Center located in Wagner, South Dakota. The vendor will provide/make available all appropriate documentation sufficient to satisfy the local, state and federal laws and regulations/requirements for disposal of both regulated and non-regulated medical waste.

Period of Performance:

The period of performance of this contract consists of a base year and four option years, beginning on 01/01/2027 TO 12/31/2027. The contract schedule with option year is listed below.

Base Year: 01/01/2027 to 12/31/2027 Option Year 1: 01/01/2028 to 12/31/2028 Option Year 2: 01/01/2029 to 12/31/2029 Option Year 3: 01/01/2030 to 12/31/2030 Option Year 4: 01/01/2031 to 12/31/2031

Place of Performance:

Wagner Health Center 111 Washington AVE NW Wagner, South Dakota 57380

Specific Requirements/Tasks:

1. The contractor is required to follow all federal, state and local requirements pertaining to the safe handling, transport and disposal of regulated and non-regulated medical waste. Specifically, compliance with all applicable Resources Conservation and Recovery Act (RCRA), South Dakota Department of Agriculture and Natural Resources (SDDANR), Occupational Safety and Health Act (OSHA), and Department of Transportation (DOT) restrictions and guidelines must be obeyed.

2. The Contractor shall be responsible for making a complete survey of the premises where medical waste receptacles are stored and to be pickup at the Wagner Health Center at 111 Washington Ave. NW Wagner, SD 57380. Contractor will survey the premises to be thoroughly familiar with the coverage of the service requested in this specification. Any misunderstandings arising from not fully meeting the requirements outlined in this specification due to failure in conducting a survey shall not excuse the Contractor from fully complying with the requirements of the specification outlined.

3. All regular pick-up services shall be performed two (2) times a month, on a monthly basis, for 12 months. The contractor shall obtain permission from the Facilities Manager and the Contracting Officer prior to performing additional services that may be needed outside the specified scope of work or period of performance.

4. Contractor shall sign medical waste pickup log located in holding closet when picking up medical waste.

5. Contractor shall provide a schedule of pickup services with bid proposal.

6. The Contractor shall provide a monthly waste manifest report, for each pickup and obtain a signature from the Facilities Manager, or any designated Wagner Service Unit personnel, for all medical waste collected.

7. Contractor shall provide medical waste receptacles for the facility building that will be used throughout this contract.

8. Contractor shall provide all equipment required to remove solid waste; and maintain the medical waste areas and dispose of materials that are in and around the area. Contractor shall ensure that items being disposed of will have proper coverings to prevent debris from falling onto the roads, etc. No equipment shall be stored or kept at any Indian Health Service facility when the Contractor is not working without the express approval of the Facilities Manager at the Wagner Service Unit.

9. All materials shall be disposed of in an EPA-Certified landfill according to landfill regulations.

10. The Contractor shall be responsible for all travel, lodging, per diem, fringe benefits, Federal/State/Local taxes, plus any other costs pertinent to the performance of this contract.

PRIVACY ACT & HIPAA:

The Contractor shall not maintain a system of records on Indian Health Service patients; however, the Contractor is bound by the Privacy Act of 1974 in that no information regarding patient prescription may be released to any unauthorized individual. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule is also applicable concerning patient prescription information.

Government Furnished Property/Equipment/Information: NONE

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Medical Waste Disposal Services Wagner Health Center 111 Washington Ave. NW Wagner, South Dakota 57380

Document status: Government surveillance plan and working attachments. This QASP does not change the PWS, contract terms, price, scope, or contractor obligations. Contract changes remain within the authority of the Contracting Officer.

Contents

1. Introduction

2. Roles and Responsibilities

3. Required Performance Standards and Quality Levels

4. Surveillance Methodology

5. Quality Assurance Surveillance and Documentation

6. Contractor Performance Evaluation Attachment 1 – Performance Requirements Summary (PRS) Attachment 2 – Medical Waste Pickup Inspection Checklist Attachment 3 – COR Surveillance Guide Attachment 4 – Contractor Evaluation Criteria

1. Introduction

1.1 Purpose

The purpose of this QASP is to describe systematic methods the Government will use to monitor contractor performance, identify surveillance documentation, and evaluate whether medical waste disposal services meet the performance requirements stated in the PWS. The contractor remains responsible for quality control of all work performed.

1.2 Scope

The contractor is to furnish the labor, personnel, equipment, tools, materials, supervision, disposal containers, tracking manifests, certificates of destruction, monthly billings, permits, and other documentation necessary for complete handling, transport, and disposal of infectious medical waste from Wagner Health Center. The PWS also requires documentation sufficient to satisfy applicable local, state, and federal requirements for regulated and non-regulated medical waste.

1.3 Goals and Objectives

Medical waste is collected on the required schedule and removed from designated areas.

Handling, transport, and disposal comply with the requirements cited in the PWS.

Each pickup is traceable through the facility pickup log and required manifest documentation.

Required receptacles and removal equipment are available and used without creating debris or unsafe conditions.

Monthly invoices can be reconciled to pickup logs and manifests.

Deficiencies are documented, communicated, corrected, and elevated to the CO when contractual action may be required.

1.4 Performance Management Approach

Government surveillance will focus on observable results and contract outcomes. Process review will be used where needed for legal, regulatory, health, safety, documentation, or other contract requirements. The COR may use 100% inspection, periodic inspection, document review, contractor-provided records, and validated customer input as appropriate.

1.5 Performance Management Strategy

The contractor is responsible for the quality of its services. Government surveillance is not a substitute for contractor quality control. Surveillance results will be used to determine whether required outcomes are being achieved and to support performance discussions, corrective action, invoice review, and past-performance evaluation as applicable.

2. Roles and Responsibilities

2.1 Contracting Officer (CO)

The CO is the only individual authorized to bind the Government, change contract terms or conditions, approve modifications, resolve contractual discrepancies, and take contractual action. Performance issues that may affect price, scope, schedule, terms, conditions, or remedies will be referred to the CO.

2.2 Contracting Officer’s Representative (COR)

The COR provides technical administration and Government surveillance within the limits of the written COR designation. The COR documents inspections and performance observations, reconciles surveillance records, communicates technical findings, and refers contractual matters to the CO. The COR may not direct work outside the contract or authorize changes in price, scope, terms, or conditions.

2.3 Facility Manager / Subject Matter Expert

The Facility Manager or designated Wagner Service Unit personnel may verify pickups, sign manifests, identify site conditions, and provide factual input to the COR.

2.4 Contractor Representative

The contractor representative should coordinate service scheduling, ensure required documentation accompanies service, respond to Government-identified deficiencies, and provide corrective-action information when requested. This description supports administration of existing PWS requirements and does not expand contractual duties.

3. Required Performance Standards and Quality Levels The PWS is the controlling source for contractor performance requirements. Attachment 1 translates those requirements into observable surveillance points. Because the PWS does not state a payment-deduction formula or contractual AQL percentages, the AQL column in this QASP is used only as a Government surveillance threshold. Any contractual remedy or payment action is reserved to the CO and must be supported by the contract.

3.1 QASP Changes

This QASP is a Government administration document. The Government may adjust surveillance emphasis, sample size, or frequency without changing the contractor’s contractual requirements. Any proposed change to the PWS, service level, scope, schedule, price, or other contract term must be handled by the CO through appropriate contractual action.

4. Surveillance Methodology

4.1 Surveillance Frequency

At each scheduled pickup: verify service occurrence, pickup-log signature, manifest documentation, observable site condition after removal, and any immediate safety/compliance concerns.

Monthly: reconcile the month’s pickup logs and manifests to the invoice; review unresolved deficiencies and corrective actions.

Periodically or as risk warrants: inspect receptacles, waste holding areas, contractor documentation files, and adherence to transport/removal controls observable at the facility.

Immediately: document and elevate suspected serious regulatory, safety, missed-service, unauthorized-scope, or contractual issues to the appropriate Government officials.

5. Quality Assurance Surveillance and Documentation

5.1 Surveillance Process

Observe or review the performance event or record.

Compare the observed result to the applicable PWS requirement and the PRS in Attachment 1.

Record the date, requirement, evidence reviewed, result, and any deficiency on the inspection checklist or COR file record.

For a deficiency, obtain facts and contractor explanation/corrective-action information without directing a contract change.

Verify correction or recurrence status during follow-up surveillance.

Refer matters requiring contractual interpretation, modification, payment action, cure/show-cause consideration, or other contractual remedy to the CO.

5.2 Documentation to Retain

Completed pickup inspection checklists.

Medical waste pickup log entries or copies/records used for surveillance.

Monthly waste manifests and evidence of required signatures.

Certificates of destruction and permits/other documents furnished under the PWS, when applicable to the service record.

Pickup schedule furnished by the contractor.

Monthly invoice reconciliation records.

Written deficiency notices, contractor responses, corrective-action documentation, and follow-up verification.

Relevant emails, meeting notes, and validated customer complaints used in performance evaluation.

5.3 Resolving Performance Issues

Deficiencies should be described factually by identifying the PWS requirement, date/event, observed condition, and supporting record. The COR may request clarification or corrective-action information within delegated authority, but should not prescribe a change to contract scope or method unless the contract requires it. Recurring or significant deficiencies should be elevated to the CO with the surveillance record and recommended administrative follow-up.

5.4 Invoice Review

The PWS requires one monthly invoice. Before recommending payment, the COR should reconcile billed medical-waste collection services to the applicable pickup log and manifest records and note discrepancies for resolution. The PWS states that manifests will be verified against the sign-in log and submitted invoices for accuracy.

6. Contractor Performance Evaluation Performance evaluation should be supported by documented surveillance rather than isolated impressions. The QASP template identifies CPARS evaluation areas including quality, schedule, cost control if applicable, business relations, management of key personnel, and utilization of small business. For this service, Attachment 4 provides operational criteria that can support those broader ratings where relevant.

Attachment 1 – Performance Requirements Summary (PRS) Surveillance thresholds below are administrative QA thresholds. They do not establish new contractual deductions or remedies.

Attachment 2 – Medical Waste Pickup Inspection Checklist

Mark Yes, No, or N/A. For each “No,” describe the observed condition and identify supporting evidence in the deficiency section.

Deficiency / Observation Record Item # / Requirement

Observed Condition and Evidence

Contractor Explanation / Immediate Action

COR Follow-Up / Due Date

Disposition / Date Closed

Inspector Certification I certify that this checklist reflects the surveillance performed and the facts observed/reviewed on the date shown. It does not authorize a change to the contract.

Attachment 3 – COR Surveillance Guide A. Before Performance Begins ☐ Confirm the final contract/PWS, COR designation, contractor contact information, accepted pickup schedule, and period of performance are in the COR file.

☐ Identify the location of the holding-closet pickup log and the Wagner Service Unit personnel authorized to sign manifests.

☐ Establish a contract file location for inspection checklists, manifests, certificates, permits, correspondence, invoices, and corrective-action records.

☐ Do not add contractor requirements through the QASP; raise any needed contract change with the CO.

B. At Each Pickup ☐ Verify the pickup occurred and record the date/time.

☐ Verify the contractor signed the pickup log.

☐ Review the manifest and required Government signature.

☐ Observe the waste area after removal for remaining material/debris within the contracted service.

☐ Observe, when practicable, whether coverings/controls are used to prevent debris from falling during transport from the site.

☐ Note unsafe, unauthorized, or noncompliant conditions without directing work beyond the contract.

☐ Complete Attachment 2 and retain supporting evidence.

C. Monthly ☐ Confirm two regular pickups occurred during the month, subject to any valid contract changes/authorizations.

☐ Reconcile all manifests to pickup-log entries.

☐ Reconcile the monthly invoice to pickup-log and manifest evidence before making a COR payment recommendation.

☐ Check status of required certificates of destruction, permits, and other documents due or necessary under the PWS.

☐ Review open deficiencies for recurrence, timeliness of corrective action, and closure evidence.

☐ Provide significant performance information to the CO and retain a concise monthly surveillance summary.

D. Handling Deficiencies State the requirement: cite the PWS task/section.

State the fact: what happened, when, where, and what record or observation supports it.

State the impact: missed service, documentation gap, safety/compliance concern, invoice discrepancy, or other effect.

Ask for explanation/corrective-action information within COR authority; avoid directing methods not required by the contract.

Verify correction and document closure or recurrence.

Escalate to the CO when an issue may require contract interpretation, modification, payment action, formal remedy, or other exercise of CO authority.

E. COR Boundaries Do not authorize additional pickups outside scope or otherwise commit Government funds.

Do not change frequency, scope, disposal requirements, documentation requirements, or other contract terms.

Do not promise payment, waive a contract requirement, or direct a contractor to incur additional cost.

Route requests affecting contract price, terms, conditions, or scope to the CO.

Attachment 4 – Contractor Evaluation Criteria Use these criteria to organize surveillance evidence and support periodic performance discussions and, where applicable, CPARS. Ratings should be based on the contract and documented facts. The descriptors below are working evaluation criteria, not substitutes for official CPARS definitions or CO determinations.

Working Rating Guide

Performance Summary Strengths / positive performance:

Deficiencies / recurring issues:

Corrective actions and effectiveness:

Schedule performance:

Documentation / invoice accuracy:

Recommended overall assessment and supporting evidence:

Contract Administration:

1. Authority A. No person other than the Contracting Officer has the authority to bind the Government with respect to this contract.

B. No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

C. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

· An understanding or agreement between the Contractor and anyone other than the Contracting Officer;

· A purported modification or change order issued by anyone other than the Contracting Officer;

· A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

· An order, direction, consent, or permission from anyone other than the Contracting Officer to:

· Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or

· Expend hours in excess of a specified level of effort.

2. Contracting Officer (CO): Contracting Officer means a person with the authority to enter into, administer and/or terminate contracts and make related determinations and findings. The Contracting Officer signs all contractual documents, approves and signs all modifications to contracts, processes and approves payment requests, reviews and makes final decisions on contractual discrepancies, and administers the contract. The Contracting Officer is the only authorized individual to make changes to the contract.

3. Designation of Contracting Officer's Representative (COR): The person identified below is hereby designated as the COR for this contract. The responsibility of the COR (or his duly representative) is to ensure that the Government technical objectives are met. The COR will provide necessary information, direction, coordination, etc., within the contractual work description. Issuance of changes which affect the articles, terms, or conditions of this contract will be accomplished through the Contracting Officer who is the only party authorized to bind the Government to the contract.

The designated COR for this contract is:

Dwight Josh Janis COR Level 1 Wagner Health Care Facility 111 Washington Ave. NW Wagner, SD 57380

Subject matter expert for this contract is:

Chad Zephier, Facility Manager Wagner IHS Health Center 111 Washington AVE NW Wagner, South Dakota 57380 Payment Process:

The Contractor shall submit one invoice, monthly, for incurred charges related to medical waste collection.

Invoice submission and payment:

In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum Improving Government Efficiency and Saving Taxpayer Dollars Through Electronic Invoicing, directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests.

IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register, however, we encourage you to make sure your organization and designated IPP user accounts are valid and up to date.

The IPP website address is: https://www.ipp.gov.

If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973- 3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov.

The Contractor shall include the following information on each invoice in accordance with the Prompt Payment Act (5 CFR Part 1315.9(b)):

1. Contractor/Vendor Name

2. Mailing Address

3. Telephone Number

4. Tax Identification Number (TIN)

5. Invoice Date and Number

6. Purchase Order Number (in Block #3 of the OF-347 form)

7. Data Universal Number (DUNS)

8. Description of services provided, quantity, unit of issue, unit price, and total amount due.

Source Selection Information—See FAR 2.101 and 3.104 [This footer applies during internal development of the SOW. Remove the footer when officially releasing the SOW to vendors as a draft for comment or in the formal solicitation]