75H709BAIHS23Q-007.pdf

Solicitation No.

75H709-BAIHS23Q-007

Project Title Reference Laboratory Services Page 3 of 31

PART I – THE SCHEDULE

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

75H709-BAIHS23Q-007 is issued as a request for proposal (RFP) in accordance with FAR part 12, Commercial Items, FAR 15, Contracting by Negotiation, FAR 37.4 Non-Personal Healthcare Services Contracts. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01.

Set-Aside 100% Unrestricted

NAICS 621511 – Medical Laboratories SB Size Standard $41.5 million

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

1. SUPPLIES/SERVICES DESCRIPTION

Reference Laboratory Services for the Billings Area Indian Health Services.

2. PRICE SCHEDULE SUMMARY

**See attached Price Schedule Tool**

BASE YEAR

CLIN Description Total Base Year Cost

01 Blackfeet (BFSU)

02 Crow (CSU)

03 Fort Belknap (FBSU)

04 Fort Peck (FPSU)

05 Little Shell (LSSU)

06 Northern Cheyenne (NCSU)

07 Wind River (WRSU)

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OPTION YEAR 1

CLIN Description Total Option Year 1

Cost

01 Blackfeet (BFSU)

02 Crow (CSU)

03 Fort Belknap (FBSU)

04 Fort Peck (FPSU)

05 Little Shell (LSSU)

06 Northern Cheyenne (NCSU)

07 Wind River (WRSU)

OPTION YEAR 2

CLIN Description Total Option Year 2

Cost

01 Blackfeet (BFSU)

02 Crow (CSU)

03 Fort Belknap (FBSU)

04 Fort Peck (FPSU)

05 Little Shell (LSSU)

06 Northern Cheyenne (NCSU)

07 Wind River (WRSU)

OPTION YEAR 3

CLIN Description Total Option Year 3

Cost

01 Blackfeet (BFSU)

02 Crow (CSU)

03 Fort Belknap (FBSU)

04 Fort Peck (FPSU)

05 Little Shell (LSSU)

06 Northern Cheyenne (NCSU)

07 Wind River (WRSU)

Project Title Reference Laboratory Services Page 5 of 31

OPTION YEAR 4

CLIN Description Total Option Year 4

Cost

01 Blackfeet (BFSU)

02 Crow (CSU)

03 Fort Belknap (FBSU)

04 Fort Peck (FPSU)

05 Little Shell (LSSU)

06 Northern Cheyenne (NCSU)

07 Wind River (WRSU)

SECTION C – STATEMENT OF WORK

A. OBJECTIVE:

The Contractor shall provide anatomic pathology and clinical laboratory testing services as required to the following Indian Health Service facilities within the Billings Area: Blackfeet Community Hospital, Browning Montana; Crow/Northern Cheyenne Hospital, Crow Agency Montana; Fort Belknap Hospital, Harlem Montana;

Lodge Grass Health Center, Lodge Grass Montana; Pryor Health Center, Pryor, Montana; Fort Washakie Health Center, Fort Washakie Wyoming; Northern Cheyenne Health Center, Lame Deer Montana; Vern E. Gibbs Health Center, Poplar Montana; Chief Redstone Health Center, Wolf Point Montana; and Little Shell Service Unit, Great Falls Montana. Two sites in the area; Heart Butte Health Center, Heart Butte, Montana and Eagle Child Health Clinic, Hays, Montana currently do not utilize reference laboratory testing, but will remain as optional sites if those service will be required in the future.

B. THE CONTRACTOR SHALL BE QUALIFIED AS FOLLOWS:

1. The Contractor’s laboratory shall be under the direct supervision of a physician who is board certified in Clinical and Anatomical Pathology by the American Board of Pathology.

2. The Contractor’s laboratory shall be licensed as a medical laboratory as specified in the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88). The laboratory must also be accredited by the College of American Pathologists. Each IHS facility Lab Supervisor will receive a copy of the laboratory’s accreditation. The Contractor shall provide copies of all updated certificates of accreditation throughout the duration of the contract. Laboratory survey reports by CMS (Centers for Medicare & Medicaid Services)/CMS deemed accreditation agencies will be provided to the Billings Area Office of Contracts & Grants after each accreditation review;

3. The Contractor shall: (1) maintain a quality assurance plan with documentation of quality assurance activities for the previous two years; (2) maintain a stringent internal quality control program for all procedures performed in-house; and (3) participate in an external proficiency testing program(s) approved by the Centers for Medicare & Medicaid Services (CMS)(formerly, Health Care Finance Administration (HCFA)). The Contractor shall provide proof of current enrollment in a Proficiency Testing Program approved under CLlA-88;

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4. The Contractor's facility shall be staffed by testing clinical laboratory personnel that meet or exceed the requirements established under CLlA-88 and CAP. Copies of curriculum vitae on all key staff (Pathologists, Department Supervisors, Section Leaders, etc.) shall accompany the technical information.

Updates will be provided within one week of any change of key personnel;

5. For all referral or sub-contracted testing, the Contractor shall refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.

6. The contractor shall possess a functioning Bi-Directional Reference Lab mechanism. The laboratory result data format must be compatible with current and future versions of the IHS Lab Package.

C. SCOPE:

1. The Contractor shall provide a Medical Laboratory Director for any high or moderately complexity laboratory as needed, as well as a Technical Supervisor of Immunohematology as needed for any of the Billings Area IHS facilities. The Medical Laboratory Director and Technical Supervisor of Immunohematology will be compliant with all credentialing and personnel requirements. The Medical Laboratory Director and the Technical Supervisor of Immunohematology may be the same person if qualified.

The contractor shall provide a list of the Pathologist qualified to serve as laboratory directors and their CV’s, a list of the proposed consulting technologists and their CV’s, details and timeframes for transition of laboratory director turnovers and how long proposed laboratory directors will be onsite for required paperwork to be filled out such as CLIA certificate, procedure manual signatures, and etc. Provide a report format for the laboratory director’s report and also the consulting technologist’s report. Provide a list of QAPI monitors and examples of the report that would be sent to the laboratory manager. Provide an example of the antibiogram report that shall be sent quarterly to each facility. Provide how regulatory/accreditation issues will be identified, recommended fixes communicated and tracked for completion.

The contractor will provide on a quarterly basis, a clinical laboratory technical consultant, to provide a technologist report for the 3 hospitals in the area. The technical consultant provides consultative services to the Supervisory Clinical Laboratory Scientist and Laboratory Medical Director on issues pertaining to quality management in the clinical laboratory setting such as proficiency testing tracking/reports and inter-laboratory quality assurance programs. The technical consultant participates in audits of laboratory operations by reviewing a sampling of testing, quality control, and other testing reports for accuracy, completeness and compliance to ensure that quality assurance standards and regulatory requirements are met and documents audit findings and reports to the Supervisory Clinical Laboratory Scientist and Laboratory Medical Director. The technical consultant will immediately communicate concerns identified in the testing process to the Supervisory Clinical Laboratory Scientist and Laboratory Medical Director.

In accordance with Indian Health Service credentialing policy, the Contractor shall complete a primary source verification for each pathologist performing services under the contract. Upon the assignment of a Laboratory Director to a Billings Area service unit, the Laboratory Director shall complete a credentials packet and be credentialed by the service unit Governing Body. Contractor pathologists shall be board certified by the American Board of Pathology.

The Medical Laboratory Director and/or the Technical Supervisor of Immunohematology will make a minimum monthly (12) on-site visits per year (with PACE approved continuing education being provided at the time of the on-site visit) for each facility he/she is responsible. The Medical Laboratory Director

Reference Laboratory Services Page 7 of 31 and/or the Technical supervisor of site with no Immunohematology must make a minimum of 4 site visits (quarterly) and the Medical Director and/or the Technical Supervisor of non-Immunohematology sites must have monthly contact with the laboratory supervisor, via telephone, mail or e-mail. The Laboratory Director of Immunohematology must provide 24-hour availability of a qualified physician to address blood banking issues such as transfusion reactions and the work-up of transfusion reactions. The Laboratory Director must also attend (virtually or by phone if necessary) blood utilization committee meetings.

The Medical Laboratory Director and/or Technical Supervisor must provide a detailed written consultation report upon completion of the on-site visit. The report shall be based on assuring the facility passes their laboratory accrediting body survey. It shall include, but not be limited to, services performed, contacts made, problems and deficiencies identified, recommendations made, any follow-up needed and corrective action plans for addressing identified deficiencies and problems which may cause the facility to fail an accreditation survey. The reports shall be submitted to the Chief Executive Officer, Clinical Director and/or the Chief Medical Officer, Laboratory Supervisor and Contract Officer Representative of each facility.

The contractor shall have a board certified Pathologist on staff and accessible to Billings Area Clinical Directors, Laboratory Directors and Laboratory Supervisors at all times. The contractor's Pathologist shall be available for telephone support to the Billings Area medical staff during facilities regular working hours. This support shall include but not be limited to technical and medical problems, test selection, interpretations and overall support to the laboratory.

Any facility performing therapeutic phlebotomy will be subject to approval by the Technical Immunohematology Supervisor.

2. The Contractor shall provide pick-up and delivery service 6 days a week at the three Indian Health Service Hospitals (Blackfeet Community Hospital, Crow/Northern Cheyenne Hospital, and Fort Belknap Hospital) and Monday-Friday pick-up and delivery services (with the exception of federal holidays) at the seven Health Centers (Lodge Grass Health Center, Pryor Health Center, Fort Washakie Health Center, Northern Cheyenne Health Center, Vern E. Gibbs Health Center, Chief Redstone Health Center, Little Shell Service Unit) covered under the contract, unless otherwise specified by a courtesy call by the facility supervisor..

Pick-up and Delivery Requirements:

Specimen pickup times shall be mutually agreed upon between the Contractor and the Laboratory Supervisor at each facility.

Specimens shall not be in transit more than 12 hours from the time of pickup at each facility to the time of arrival at the Contractor's facility.

The Contractor shall guarantee that the specimen is kept at optimum conditions of evaluation during the entire transit time.

The contractor shall provide a process to document receipt of each patient specimen and tracking of each individual specimen until testing is completed.

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3. The Contractor shall perform non-emergency laboratory testing procedures including surgical pathology listed on the attached schedule, and any other laboratory testing as required when ordered by Billings Area Laboratories. The Contractor shall provide reports by electronic printer, to the requesting Indian Health Service facility within 24 hours from the time the specimen is received in the contract laboratory unless methodology requires a longer time. The Contractor will have in place a method for notification of critical values to the appropriate Billings Area Laboratory within one hour of the result being available.

The Contractor shall notify the requesting Billings Area Laboratory, by telephone, email or fax, immediately, when an unacceptable (i.e. mislabeled, incomplete requisition, missing specimen, etc.) or Quantity Not Sufficient (QNS) specimen is received. No specimen is to be discarded until communication with the sending Laboratory has been established and the sending Laboratory approves of the disposal. A complete report of the incident will be sent to the effected Billings Area facility within one week of the incident;

Local laboratories can be utilized for tests/procedures requiring more immediate results and where specimen integrity may be jeopardized during transit at the discretion of staff at each Indian Health Service site without affecting this contract.

4. The Contractor is responsible for providing electronic transmittal of laboratory results from the

Contractors laboratory to the Indian Health Service facilities. The data needs to adhere to the HL7 format that is required by the IHS Lab Package that resides in the Resource Patient Management System (RPMS). The laboratory result data format must be compatible with current and future versions of the IHS Lab Package.

This interface shall require tech review of orders and results before release. This interface shall include all blood and body fluid reports, cytology reports, tissue reports, and microbiology reports. This interface needs to be compatible with data innovations. The contractor shall provide a means of electronic back-up and retransmission readily available and easily accessible for retransmission of results. All equipment, software, and/or hardware required to implement/maintain the bi-directional interface shall be provided by the contractor at no charge to the government. In addition, any upgrades or replacements to software or hardware, and necessary computer supplies (printers, paper, toner, labels, drums) shall be provided by the contractor at no charge to the government. Computer tech support shall be available during business hours including phone numbers and contacts. UI test code must be provided for all tests.

For Billings Area laboratories that are using or planning to use the IHS Bi-directional or Uni-directional

Interface, the Contractor shall assign a project manager/specialist and dedicate system resources to the set-up, testing, and maintenance of the Contractor laboratory interface at each facility

5. The Contractor shall provide to each Indian Health Service facility, the Contractor’s test requisition form that will include pre-printed name, address and identification number for the facility from which the specimens are sent. These forms shall be designed with check-off system containing the commonly ordered tests on one page. The form must accommodate the following patient demographic information.

Patient Last and First Name, medical record number, date of birth, name of Physician, and IHS accession number.

6. The Contractor shall provide the Area Contracting Officer and each Indian Health Service facility laboratory a catalog of all tests available with instructions for specimen handling and requirements, to include methods and normal or interpretive values, and test fees that reflect the contract price. Test procedures not performed by the Contractor’s laboratory shall not include a handling fee.

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7. The Contractor shall provide training and certification to all IHS laboratory staff in the shipping of biohazards and infectious materials on an annual basis.

8. The Contractor shall furnish all the necessary supplies and equipment for the collection, transport and reporting of specimens at no additional cost to the Indian Health Service facility. The shipping containers must meet IATA requirements.

9. The Contractor shall provide, at a minimum, quarterly site visits to all facilities by a representative of the

Contractor. These quarterly visits will include a report of activities performed during that visit to include any maintenance of equipment in place that is the Contractors, any training done, and any other items of discussion that result in a change in business model. This report shall be submitted to the Contracting Officer Representative (COR). The contractor will have available continuing education topics that are PACE approved, available through videos, CD-ROM or telemedicine. The Contractor must provide “Client Services” via telephone at no additional charge to Indian Health Service. Client services would include responding to inquiries of patient test results, responding to specimen collection requirements of tests not listed in manuals, requests for additional supplies, responding to inquiries with regards to availability of testing services. Client services should be available 24 hours per day.

10. The Contractor shall provide repeat testing when clinicians feel results do not correlate with the clinical status of the patient.

11. The Contractor shall submit the following monthly reports that will not be charged as a separate cost and are due no later than the 15th day of the following month:

A. The facility specific invoice shall be mailed and/or emailed to the identified IHS Lab Supervisor directly. The invoice will include the following patient health record number, the name of the test performed, the CPT code of the test, fee for the test, date of completion, name of requesting provider, and the facility account number.

B. An itemized electronic “transaction report” shall be exported to the IHS facility lab supervisor. Data should be exported in an “EXCEL compatible format. The monthly report must include the name of test performed, cost per test; the number of tests performed during the month; a cumulative (“year-to-date”) number of tests performed and a cumulative (“year-to-date”) cost of tests.

C. A report which will include account number and/or account name, test number, test name, cost of test, quantity of each test ordered, amount spent on each test for the month, a year to date quantity ordered for each test and year to date amount spent for each test. Data should be exported in an “EXCELTM” compatible format.

D. A report of tests not performed for the month.

E. All report data exported and submitted to the facility shall be HIPAA compliant.

12. The Contractor shall provide on a quarterly basis an anti-biogram report for each organism isolated for each facility laboratory. This report shall be sent to the Billings Area Chief Medical Officer, Contracting Officer Representative and the Laboratory Supervisor at each facility. The report should contain specimen description, number of specimens collected, culture identification, date of specimen collection and antimicrobial sensitivity.

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13. The Contractor shall provide surgical pathology for facilities requiring this service. The electronic and paper pathology reports are to include a gross and microscopic description of each specimen and a diagnosis. In the case of a diagnosis of a malignant tumor, the stage of the disease must be included whenever possible. Contractor will provide reports and/or slides upon request, for all patients being treated for malignant disease with in the Indian Health Service or by non-IHS health providers. Reports of surgical specimens are to be returned to the appropriate facility within seven (7) working days except for diagnosed malignant specimens which require the contractor to immediately telephone the requesting physician with the written report provided within five (5) days. A monthly report including the list of patients who have had surgical pathology services performed, with the date of specimen and a summary of results by the provider will be provided to the appropriate service unit laboratory manager. This report shall be individualized for each hospital and clinic.

14. The Contractor shall provide cervical/vaginal cytology services for the screening and detection of malignant cells and abnormal conditions consistent with current recommendations of the American Society for Colposcopy & Cervical Pathology.

All cytology collection supplies, requisitions and reporting forms shall be provided at no additional cost to the IHS facility. Cervical/vaginal screening methods should include Thin Prep PAP as well as traditional slide PAP smear.

Reflex testing of ASC-US results to high risk HPV-DNA testing shall be an option for each of the referring facilities.

Results of cytology studies shall be returned to the appropriate IHS facility within ten (10) working days from date of shipment from the IHS facility.

A monthly report including the list of patients who have had cytology services performed, with the date of specimen and by degree of dysplasia by the provider will be provided to the appropriate service unit laboratory supervisor. This report shall be individualized for each hospital and clinic.

The “Bethesda System 2014” (or current terminology as accepted by accrediting bodies) terminology shall be used for reporting cervical/vaginal cytological diagnoses. The quality of the cytology service shall be assured through direct supervision by a Pathologist certified in Anatomical Pathology. Each cytotechnologist shall meet the requirements as specified in the Clinical Laboratory Improvement Amendments of 1988.

Results of cytology studies shall be returned to the appropriate IHS facility within four (4) business days from the date of receipt at the Contractors laboratory.

The Contractor shall provide, upon written or verbal request, a copy of the original report(s) and the original slide(s) to the party designated by the attending physician.

The Contractor shall maintain a permanent cytology register, which will include patient name, IHS patient identification number and date of birth, facility location and results. A data retrieval system must be available. Thus allowing the cytology report for a specific patient seen at a given IHS facility on a specified date is available within one (1) day using the five (5) identification criteria listed above. The Contractor shall provide a monthly cytology report to the facilities Chief Medical Officer, Lab Supervisor and any other facility designated personnel.

The Contractor shall provide by the 10th of each month to each facility’s designated individual, a list of all patients who have had cytology services performed the previous month, with date of specimen, and results. This list will be grouped into diagnostic categories that are consistent with the Bethesda System 2001 terminology.

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15. The Contracting laboratory is subject to on-site inspections by authorized representatives of the U.S.

Government prior to contract award and during the contract period to review the Contractor’s facility and services, to examine records for quality assurance practices, current licenses and accreditation and make any other analysis required to determine the adequacy of personnel, instrumentation, and the quality and accuracy of services provided to meet the terms of this contract.

16. The Billings Area Laboratories listed above will have the option to send communicable type disease testing to their respective State Labs. Communicable type disease tests that will continue to go to the State labs include but not limited to: GC/Chlamydia, Influenza, tick-borne diseases, TB, RSV, Pertussis, O&P, Herpes, PKU’s, West Nile virus, Hanta virus, Stool cultures. In the event that a communicable disease specimen is sent to the Contractor Lab, the Contractor Lab will notify the State Surveillance Officers and the facilities laboratory personnel of all reportable diseases. The Contractor shall make arrangements for reporting formats with personnel at the state telephone numbers listed below. The Contractor will be responsible for obtaining the reportable disease conditions required for reporting by the states of Montana and Wyoming.

Reportable Diseases for State of Montana

Conditions Requiring Immediate Reporting (406) 444-0273

Anthrax Botulism Measles (Rubeola) Plague Rabies Typhoid fever

Other Reportable Conditions Montana Department of Public Health Communicable Disease Program

(406) 444-0273

Wyoming Department of Health Reportable Diseases and Conditions Immediate Notification number: 1-888-996-9104

Diseases/Conditions Requiring Immediate Notification:

ANTHRAX (Bacillus anthracis) BOTULISM (Clostridium botulinum) DIPTHERIA (Cornynebacterium diptheriae)

HEMORRHAGIC FEVER VIRUSES

PLAGUE (Yersinia pestis)

SEVERE ACUTE RESPIRATORY SYNDROME (SARS)

SMALLPOX

TULAREMIA (Francisella tularensis)

TOXIN-ASSOCIATED ILLNESS

UNUSUAL ILLNESS OF PUBLIC HEALTH IMPORTANCE

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SECTION E – INSPECTION AND ACCEPTANCE

ASSESSMENT OF CONTRACTOR PERFORMANCE AND REVIEW RIGHTS:

A. The Government shall periodically evaluate the Contractor‘s performance by chart review; patient consultation review and review of unsuccessful medical cases and compliance with established hospital protocol.

B. The Area Lab Consultant, or their professional representative, shall be entitled to review the Contractor’s facility(s) and all administrative and clinical records, which pertain to IHS beneficiaries, covered by this contract.

SECTION F – DELIVERIES OR PERFORMANCE

1. ORDERING PERIODS

Ordering Periods for this contract is intended to start March 1, 2023, through February 28, 2024 with four (4) 12-month option ordering periods.

If the Government exercises the options pursuant to Federal Acquisition Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract (MAR 2000), the period of performance shall be extended in accordance with the following schedule:

Year Option Period Option Period 1 March 1, 2024, through February 28, 2025 Option Period 2 March 1, 2025, through February 28, 2026 Option Period 3 March 1, 2026, through February 28, 2027 Option Period 4 March 1, 2027, through February 28, 2028

2. DELIVERY REQUIREMENTS

When a delivery date occurs on a weekend or Government holiday, the deliverable will be due on the following Government business day.

GOVERNMENT HOLIDAYS:

New Year’s Day January 1 Martin Luther King’s Birthday Third Monday in January Presidents Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday October Veterans Day November 11 Thanksgiving Day Fourth Thursday November Christmas Day December 25

*Holidays with specific dates may fall on a weekend, but still be recognized by the Government on that Friday or Monday.

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SECTION G – CONTRACT ADMINISTRATION DATA

1. POINTS OF CONTACT (POC)

Contract Specialsist (CS) Kenny Nicholson Phone: 406-247-7071 Email: Kenneth.Nicholson@ihs.gov

Contracting Officer (CO) Kristen Smith, CCO Phone: 406-208-6583 Email: Kristen.Smith@ihs.gov

Contracting Officer’s Representative (COR) Casey Kills Pretty Enemy Phone: 406-247-7175 Email: Casey.Killsprettyenemy@ihs.gov

Contractor’s Point of Contact “Name” Phone:

Email:

2. IDIQ ORDERING PROCEDURES

In accordance with FAR 52.216-18, Ordering, this contract type allows the Service Units to place orders with the Contractor on an as needed basis. Only warranted Contracting Officers have the authority to issue task orders. The contractor shall provide services only as authorized by approved task orders. Any services provided without an approved task order are unauthorized and the Contractor is proceeding at risk of non-payment.

3. INVOICES

Contractor shall submit invoices based on individual Task Orders issued and distributed for each Service Unit.

mailto:Kenneth.Nicholson@ihs.gov

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SECTION H – SPECIAL CONTRACT REQUIREMENTS

1. INVOICE SUBMISSION AND PAYMENT

Invoices shall be submitted through IPP, 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. The use of IPP shall take precedence over previously established invoicing procedures in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests”. The IPP website address is:

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

Please send a courtesy copy of the invoice by email to wanda.lahr@ihs.gov

Failure to include the required information may delay payment.

Payment shall be made by the Billings Area Financial Management Branch, P.O. Box 36600, Billings, Montana 59107. Payments are made in arrears.

2. PERSONAL CONTACTS:

Personal contacts include patients, patient’s families, IHS employees, and representatives of other federal organizations and non-federal organizations, and tribal representatives.

3. CONTRACTING OFFICER AUTHORITY:

Authority to negotiate changes in the terms, conditions or amounts cited in this contract is reserved for the Contracting Officer.

4. SUPERVISION & QUALITY CONTROL:

The primary agent/official responsible for monitoring this procurement in a project officer capacity and who will be verifying that all supplies and/or services have been received and delivered will be Dr. Ernest Gray, Physician, Blackfeet Service Unit.

Contractor time and attendance logs shall be utilized, kept on file, and verified by the COR. The Contracting Officer, or his/her designated representative is authorized to review by onsite survey, through review of records, or through any other reasonable manner the quality of care rendered under this contract. Adequate records shall be maintained to reflect the accuracy with respect to claims submission as well as for quality of care. The IHS Chart Review Tool shall be used in evaluation of records. The Contractor shall comply with and assist in all Quality Assurance activities necessary for the Government to maintain accreditation.

https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov mailto:wanda.lahr@ihs.gov

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5. SPECIAL CONTRACTOR REQUIREMENTS:

Contractors cannot serve as expert witnesses in any suit against the Federal Government. Many of the IHS patients receiving services may only speak a native language and/or reside on a Native American Reservation, therefore, the Contractor must demonstrate sensitivity to cross-cultural and language differences.

The Privacy Act of 1974 mandates that the Contractor maintain complete confidentiality of all administrative, medical and personnel records, and all other pertinent information that comes to his/her attention or knowledge.

The Privacy Act carries both civil and criminal penalties for unlawful disclosure of records. Violation of such confidentiality shall be cause for adverse action. The Contractor shall comply with IHS facility infection control and safety procedures, practices, and standards.

6. NON-PERSONAL HEALTHCARE SERVICE CONTRACT

This procurement is a non-personal Healthcare service contract, as defined in FAR 37.101, under which the Contractor is an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical and professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment). The Contractor shall indemnify the Government for any liability producing acts or omissions by the Contractor, its employees and agents occurring during contract performance. The Contractor shall maintain medical liability insurance, which is not less than the amount normally prevailing within the local community for the medical specialty concerned. The Contractor is required to ensure that its subcontracts for provisions of Healthcare services contain the requirements of the clause at 52.237-7, Indemnification and Medical Liability Insurance (Jan 1997).

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PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

FEDERAL ACQUISITION REGULATION (FAR) CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: www.acquisition.gov.

(End of clause)

CLAUSES INCORPORATED BY REFERENCE

CLAUSE Title Date 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper May 2011 52.204-9 Personal Identity Verification of Contractor Personnel Jan 2011 52.204-13 System for Award Management Maintenance Oct 2018 52.204-19 Incorporation by Reference of Representations and Certifications Dec 2014 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations Nov 2015 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services Nov 2021 52.219-8 Utilization of Small Business Concerns Oct 2018 52.219-28 Post-Award Small Business Program Rerepresentation Nov 2020 52.223-5 Pollution Prevention and Right-to-Know Information May 2011 52.223-6 Drug-Free Workplace May 2001 52.224-1 Privacy Act Notification Apr 1984 52.224-2 Privacy Act Apr 1984 52.227-14 Rights in Data – General May 2014 52.227-17 Rights in Data – Special Works Dec 2007 52.229-3 Federal, State, and Local Taxes Feb 2013 52.232-18 Availability of Funds Apr 1984 52.237-3 Continuity of Services Jan 1991 52.237-7 Indemnification and Medical Liability Insurance Jan 1997 52.242-15 Stop Work Order Aug 1989 52.242-17 Government Delay of Work Apr 1984 52.243-1 Changes – Fixed Price Alternate I (Apr 1984) Aug 1987 52.245-1 Government Property Jan 2017 52.245-9 Use and Charges Apr 2012 52.249-2 Termination for Convenience of the Government Apr 2012 http://www.acquisition.gov/

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Clauses Incorporated by full text

52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014)

(a) This contract and employees working on this contract will be subject to the whistleblower rights and remedies in the pilot program on Contractor employee whistleblower protections established at 41 U.S.C. 4712 by section 828 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-

239) and FAR 3.908.

(b) The Contractor shall inform its employees in writing, in the predominant language of the workforce, of employee whistleblower rights and protections under 41 U.S.C. 4712, as described in section 3.908 of the Federal Acquisition Regulation.

(c) The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts over the simplified acquisition threshold.

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Items. (DEC 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78

( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020), with Alternate I (NOV

2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (NOV

2021) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L.

109-282) ( 31 U.S.C. 6101 note).

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim

Project Title Reference Laboratory Services Page 18 of 31

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

X_ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub.

L. 111-117, section 743 of Div. C).

X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (13) [Reserved]

__ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

X_ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)).

X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (OCT 2022) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) (15 U.S.C. 657f).

__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (OCT 2022) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women- Owned Small Business Concerns (OCT 2022) (15 U.S.C. 637(m)).

https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

Reference Laboratory Services Page 19 of 31

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns

Eligible Under the Women-Owned Small Business Program (OCT 2022) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (SEP 2021) (15U.S.C. 637(a)(17)).

X_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022) (E.O.13126).

X_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X_ (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

X_ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.

13496).

X_ (35) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (MAY 2022). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May

2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693)

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693)

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and

13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/22.1803#FAR_22_1803 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14

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__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.

13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

X_ (48) (i) 52.225-1, Buy American-Supplies (OCT 2022) (41 U.S.C. chapter 83).

__ (ii) Alternate I (OCT 2022) of 52.225-1.

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (DEC 2022)

(41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 not e, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112- 42, and 112-43.

__ (ii) Alternate I [Reserved] __ (iii) Alternate II (DEC 2022) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

__ (v) Alternate IV (OCT 2022) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (DEC 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016)

(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.

Subtitle A, Part V, Subpart G Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

__…