PWS - Mid-Atlantic Lab Services.pdf

Source Selection Information—See FAR 2.101 and 3.104

[This footer applies during internal development of the PWS. Remove the footer when officially releasing the PWS to vendors as a draft for comment or in the formal solicitation]

Indian Health Service

Mid-Atlantic Service Unit

Monacan Health Center Servers

Performance Work Statement for

Laboratory Services for the Mid-Atlantic Service Unit

November 21, 2024

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Document Revision History

[Example – Post-award]

Mod.

No. Description of Changes Requested

By Approved

By Date

None Initial version Lindsey Taylor 11/21/2024

[Note: The document revision history is most useful for tracking changes in a major acquisition.

It may not be needed for less complex acquisitions. Pre-award, it can be used internally by the agency to track the origin of and/or changes to specific requirements (not included in the solicitation when released). Post-award, it can be used to provide a centralized list of changes incorporated by modification.]

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Table of Contents

1.0 General

2.0 Specific Requirements/Tasks

3.0 Delivery or Deliverables

4.0 Meetings

Note that while, as a matter of policy, some agencies require the government to prepare the PWS, the guidance at FAR 37.602(a) stipulates that “a Performance work statement (PWS) may be prepared by the Government or result from a Statement of objectives (SOO) prepared by the Government where the offeror proposes the PWS.”

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2037_6.html#wp1074648

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Performance Work Statement (PWS) for the

Laboratory Services for the Mid-Atlantic Service Unit

1.0 General

1.1 Introduction

The Mid-Atlantic Service Unit’s mission is to raise the physical, mental, and spiritual health of the Native American population that lives in the geographic area. The mission is implemented by developing Direct Care Services and administering the Purchased/Referred Care (PRC) program. This acquisition will assist the MASU, who is moving to direct care services by establishing two comprehensive health care clinics for seven newly federally recognized tribes.

1.2 Objective

The purpose of this solicitation is to select a vendor that shall provide the Mid- Atlantic Tribal Health Center and the Monacan Health Center a blanket purchase order for laboratory services. The facilities will be full service clinics that provide point of care labs services including testing and blood draws in order to deliver primary care, dental, behavioral health and pharmacy services to the Native American community.

1.3 Scope of Work

1.3.1 The Mid-Atlantic Service Unit and its two clinics, The Mid-Atlantic Tribal Health Center and the Monacan Health Center are in need of laboratory services for their CLIA waived labs.

The following categories of laboratory testing services shall be required:

• Histocompatibility

• Bacteriology

• Mycobacteriology

• Mycology

• Parasitology

• Virology

• Syphilis serology

• General immunology

• Routine chemistry

• Urinalysis

• Endocrinology

• Toxicology

• Hematology

• Abo & RH group

• Antibody non-transfusion

• Antibody identification

• Histopathology

• Oral pathology

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

• Cytology

• Antibiogram Reports

The following psychiatry labs shall be required.

• Carbamazepine(Tegretol)

• CBC with DIFF

• Levetiracetam (Keppra)

• CMP

• Lithium

• Hemoglobin A1C w/eAG

• Oxcarbazepine

• Hepatic Function

• Valproic Acid (Depakote)

• Lipid Panel

• Thyroid Cascade

• Urinalysis, Complete rfx Culture

• Vitamin B12 Folate

• ToxAssure Flex 23 Urine

• Vitamin D 25OH

1.3.2 Supplies/Materials to be Provided by the Contractor

• Directory of available lab services

• Requirements for sample collection, preservation, handling and transport including

• Special handling requirements

• Methods and methodologies

• Criteria for sample rejection

• Limitations in test methods/tests/procedures

• Prior authorization requirements and instructions

• Test codes and corresponding CPT codes

• The contractor shall provide specialty items for collection such as Pap

Smear collection supplies and blood collection supplies as needed by volume of requests.

• Centrifuge

1.4 Background

The MASU is moving to direct care services by establishing two comprehensive health care clinics for seven newly federally recognized tribes. This blanket purchase order for laboratory services is for critical to establish and conduct business at the Mid-Atlantic Tribal Health and Monacan Health Center facilities.

1.5 Type of Contract Contemplated

Blanket Purchase Order

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

1.6 Period of Performance

o Base Year - February 1, 2025 – January 31, 2026 o Option Year 1- February 1, 2026 – January 31, 2027 o Option Year 2- February 1, 2027 – January 31, 2028 o Option Year 3- February 1, 2028 – January 31, 2029 o Option Year 4- February 1, 2029 – January 31, 2030

The Period of Performance shall be for one year and four option years. .

1.7 Place of Performance

Performance and lab specimen pick-up location is:

Mid-Atlantic Tribal Health Center 2401 Roxbury Rd Charles City, VA 23230

Monacan Health Center 108 Dixie Airport Rd Madison Heights, VA 24572

The contractor shall pick-up specimens Monday through Friday at a time in the afternoon to be determined in collaboration with the sites and vendor, with the exception of Federal Holidays. The contractor shall have a demonstrated ability to respond to service unit questions and concerns the same day.

2.0 Specific Requirements/Tasks

2.1 Period of Performance

The period of performance will be for one year and four option years.

2.2 Technical Requirements

• 2.2.1 Delivery Methods of Diagnostic Test Results:

Critical: Report via the telephone same day as result is completed. Electronic transmission must follow within twenty-four (24) hours.

Primary: The contractor must transfer test results and auxiliary information to the Mid- Atlantic Service Unit Electronic Medical Records Systems using such interface languages as required by the applicable Electronic Medical Records System.

Alternate: The contractor shall have the capability to transmit test results reports to designated printer locations or fax machines within the Mid-Atlantic Service Unit and following up with electronic transmission.

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Routine laboratory results should be provided within 24 hours of collection. Complex testing requiring specialty laboratories should be provided within 10 business days. Pap smear Specimens should be provided within 3 business days.

• 2.2.2 Reports

The Contractor shall provide an electronic utilization file that shall be transferred to Mid-Atlantic Service Unit by the fifth (5) working day of each month for the preceding Month. The reports must be broken down to correspond to appropriate facility (Mid-Atlantic Tribal Health Center and Monacan Health Center). The Contractor shall add additional data elements as mutually agreed upon by the Contractor and the Mid-Atlantic Service Unit. The electronic utilization file can be in any easily readable format such as Adobe Acrobat Reader (pdf), Microsoft Word, or Microsoft Excel.

The contractor should provide, at a minimum, a quarterly antibiogram report via Secure Data Transfer methods or USPS mail attention to the Clinical Director.

• 2.2.3 Contract Administration Data

Indian Health Service Invoice Submission Instructions

The Contractor shall submit invoice after services received. A complete invoice with all required back-up documentation shall be sent, electronically via secure data transfer (if it contains sensitive patient data) or by regular postal mail to:

Contract Specialist* (CS): Paul Carr, paul.carr@ihs.gov, Indian Health Service, Indian Health Service, Nashville Area, 711 Stewarts Ferry Pike, Nashville, TN 37214

MHC Administrative Officer: Lindsey Taylor, lindsey.taylor@ihs.gov, Monacan Health Center, 108 Dixie Airport Rd, Madison Heights, VA 24572

MATHC Deputy CEO: Remedios Holmes, remedios.holmes@ihs.gov, Mid-Atlantic Service Unit, 400 N 8th Street, G-63, Richmond, Virginia 23219

*No other non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent to the CS. Failure to submit directly to the offices listed above will delay prompt payment of your invoice.

For invoices submitted by email: the subject line of your email invoice submission shall contain the contractor name, contract/order number, and invoice number (e.g. Company Name, Contract HHSIXXXXX, Invoice #123). The Contractor shall send one email per contract/order after completion. The email may have multiple invoices for the contract. Invoices must be in one of the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF, TIFF, or Word). Any emails sent containing patient information will be sent via secure data transfer to comply with privacy regulations.

mailto:remedios.holmes@ihs.gov

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Additionally, the Contractor is required to include its Data Universal Numbering System (DUNS) number on each invoice. For additional information about the Dun & Bradstreet (D&B) DUNS number, please visit http://fedgov.dnb.com/webform.

• 2.2.4 Special Contract Requirements

Proposal Requirements: The contractor should provide a price catalog or CMS discounted rate in their proposals. The contractor should provide a capabilities statement, identifying the contractor’s ability to meet each requirement of the statement of work.

The Contractor should provide 3 years of Federal, State, or local relevant past performance.

• 2.2.5 Quality Standards

The Contractor’s laboratory facilities must have accreditations by the Clinical Laboratory Improvement Amendments (CLIA) and licensed by the State Department of Health as applicable.

All clinical laboratory tests must be performed at the laboratory facilities under the direction and control of the contractor.

The contractor shall provide these licenses, accreditation and any other applicable certifications along with their proposal. The accreditation and licensing must be maintained current and valid throughout the length of the contract and extension years, if any.

The contractor shall comply with HIPPA/ Privacy Rule Regulations. The contractor shall be expected to treat all proprietary information as confidential and to acknowledge that it is only authorized to disclose or otherwise divulge proprietary information to authorized employees of the Mid-Atlantic Service Unit. The contractor shall establish and maintain policies and procedures to ensure that its personnel do not disclose test results to any unauthorized individual.

• 2.2.6 Accreditation

If the contractor loses the accreditation, licenses and/or any associated certifications during the term of the contract, the Government has the full right to terminate the contract.

The contractor must maintain:

• CLIA Waived Certification

• College of American Pathologist Certification

• Staff performing test should be at the minimum certified Technicians

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

• 2.2.7 Technical Capabilities and Qualifications

The contractor should have the ability to Interface with Indian Health Services Electronic Medical Record/ Resource and Patient Management System already in place.

For further instruction and questions on whether your company can complete the requested interface please see the reference materials listed on the Indian Health Service website located at: http://www.ihs.gov/Lab/.

The RPMS platform is: AIX / Windows

It is running on Ensemble

The interface should be bidirectional.

The contractor shall acknowledge in their quote they meet this technical requirement and can interface with IHS’s Medical Record/ Resource and Patient Management System.

• 2.2.8 HIPAA Clause

Contractor is a Covered Entity under HIPAA and complies with HIPAA requirements related to the privacy and security of “protected health information” under HIPAA (“PHI“). Contractor uses and discloses PHI in accordance with HIPAA and Contractor's publicly available Notice of Privacy Practices. Contractor also complies with all other applicable federal and state laws regarding data privacy and security of information

• 2.2.9 Amendments of Agreement

Upon learning that material changes have been made to the Privacy Rule and/or the HITECH Act which are applicable to this Contract, the parties agree to promptly amend this Agreement to ensure that it remains in compliance with the Privacy Rule and/or the HITECH Act, as amended.

3.0 Delivery or Deliverables

Lab specimen pick-up locations are:

Mid-Atlantic Tribal Health Center 2401 Roxbury Rd Charles City, VA 23230

Monacan Health Center 108 Dixie Airport Rd Madison Heights, VA 24572

The contractor shall pick-up specimens Monday through Friday at a time in the afternoon to be determined in collaboration with the sites and vendor, with the exception of Federal Holidays.

Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

The contractor shall have a demonstrated ability to respond to service unit questions and concerns the same day.

All information and data related to this project that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract.

Press releases, marketing material, or any other printed or electronic documentation related to this project, must not be publicized without the written approval of the contracting officer.]

4.0 Meetings

For all meetings, the contractor shall be responsible for providing meeting materials, and administrative and facilitation support. Meetings shall be conducted through an alternative method of communication (such as a teleconferencing), as approved by the Contracting Officer.

4.1 Initial Contact

The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of delivery and/or maintenance. The POC will be empowered to make daily decisions to ensure the contract implementation and day to day maintenance meet the terms and conditions of this contract.

Source Selection Information—See FAR 2.101 and 3.104

[This footer applies during internal development of the PWS. Remove the footer when officially releasing the PWS to vendors as a draft for comment or in the formal solicitation]