a. NAME

5. SOLICITATION NUMBER

W91YTZ26QA012

4. ORDER NUMBER 3. AWARD/EFFECTIVE

DATE

_, 10. THIS ACQUISITION IS [gj UNRESTRICTED OR SET ASIDE: % FOR

W40M MRCO EAST SMALL BUSINESS WOMEN-OWNED SMALL NORTH AMERICAN

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

2. CONTRACT NUMBER

7. FOR SOLICITATION

INFORMATION CALL:

b. TELEPHONE NUMBER(No collect calls)

PAGE 1 OF

6. SOLICITATION ISSUE

DATE

8. OFFER DUE DATE/

LOCAL TIME

11:00 AM

MEDICAL READINESS CONTR OFFICE EAST, 9275 DOERR ROAD BLDG 1221 □HUBZONE SMALL BUSINESS (WOSB) INDUSTRY CLASSIFICATION

FORT BELVOIR, VA 22060-5580

UNITED STATES

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

SDVOSB

ECONOMICALLY STANDARD (NAICS)

DISADVANTAGED 621511

WOMEN-OWNED SMALL --S-IZ-E-ST_A_N_D_A_R_D_: --

BUSINES (EDWOSB)

8(A)

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

[RjSEE SCHEDULE

15. DELIVER TO

SEE CONTINUATION

12. DISCOUNT TERMS

CODE

17a. CONTRACTOR/ CODE FACILITY CODE

OFFEROR � --------------- � CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND

OFFER

IS CHECKED

ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

SEE ADDENDUM

19.

ITEM NUMBER

SCHE

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

26. TOTAL AWARD AMOUNT (For Government Use Only)

� 27a SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDERINCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

[gj ARE

ARE

ARE NOT ATTACHED

ARE NOT ATTACHED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA- FAR (48 CFR) 53.212

Created On:

17 Feb 2026, 10:50 AM Central Standard Time

1. REQUISITION NUMBER

9. ISSUED BY CODE �W_9_1_YT Z

[gj28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH ---

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

□29. AWARD OF CONTRACT: REFERENCE OFFER

DATED. . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS SEE CONTINUATION

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

Solicitation/Contract Form Continuation

Instrument Name: Newborn Metabolic Screening Tests Winn Army Community Hospital

(WACH) Fort Stewart, GA

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Item Supplies/Service Quantity Unit Unit

Price

Amount

0001 Product Service Description: Base

Year - Newborn Screening Disorders

Tests within the Georgia State

Newborn Screening Standards.

Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended

Universal Screening Panel (RUSP) and the American College of Medical

Genetics (ACMG) as outlined in the

Performance Work Statement (PWS)

Ordering period 01 April 2026 to 31

March 2027. Payments will be made by WAWF for only those items that are ordered, received, and accepted by the

Government. Government POC:

Contractor POC: To Be Determined

(TBD)

Product Service Code: Q403

Pricing Arrangement: Firm Fixed Price

1,500 Each

Option

Line

Item

Product Service Description: (Option

Year 1) - Newborn Screening

Disorders Tests within the Georgia

State Newborn Screening Standards.

Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended

Universal Screening Panel (RUSP) and the American College of Medical

Genetics (ACMG) as outlined in the

Performance Work Statement (PWS)

Ordering Period 01 April 2027 to 31

March 2028. Payments will be made by WAWF for only those items that are ordered, received, and accepted by the

Government. Government POC:

Contractor POC: To Be Determined

(TBD)

Product Service Code: Q403

Item

Product Service Description: (Option

Year 2) - Newborn Screening

Disorders Tests within the Georgia

State Newborn Screening Standards.

Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended

Universal Screening Panel (RUSP) and the American College of Medical

Genetics (ACMG) as outlined in the

Performance Work Statement (PWS)

Ordering Period 01 April 2028 to 31

March 2029. Payments will be made by WAWF for only those items that are ordered, received, and accepted by the

Government. Government POC:.

. Contractor POC: To Be Determined

(TBD)

Item

Product Service Description: (Option

Year 3) - Newborn Screening

Disorders Tests within the Georgia

State Newborn Screening Standards.

Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended

Universal Screening Panel (RUSP) and the American College of Medical

Genetics (ACMG) as outlined in the

Performance Work Statement (PWS)

Ordering Period 01 April 2029 to 31

March 2030. Payments will be made by WAWF for only those items that are ordered, received, and accepted by the

Government. Government POC:.

Contractor POC: To Be Determined

(TBD)

Product Service Code: Q403

Item

Product Service Description: (Option

Year 4) - Newborn Screening

Disorders Tests within the Georgia

State Newborn Screening Standards.

Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended

Universal Screening Panel (RUSP) and the American College of Medical

Genetics (ACMG) as outlined in the

Performance Work Statement (PWS)

Ordering Period 01 April 2030 to 31

March 2031. Payments will be made by WAWF for only those items that are ordered, received, and accepted by the

Government. Government POC:

Contractor POC: To Be Determined

(TBD)

Continuation of Description

Requirements

Follow-on requirement to W91YTZ20P0250 for comprehensive Newborn Metabolic Reference

Testing services

Continuation of Packaging and Marking

Continuation of Inspection and Acceptance

Overall Contract Inspection/Acceptance Locations

Continuation of Deliveries or Performance

0001 Delivery Schedule

Delivery On Or Before

Delivery Date 31 Mar 2027

Quantity 1,500 Each

Address and POC

Place of Performance

DoDAAC: HT0816

ACH WINN STEWART - PA

1061 HARMON AVENUE, BLDG P 302 FORT STEWART, GA 31314-5674

UNITED STATES

Period of Performance

From

01 Apr 2026

To

31 Mar 2027

Option

Line

Item

Delivery Schedule

Delivery On Or Before

Delivery Date 31 Mar 2028

DoDAAC: HT0816

ACH WINN STEWART - PA

01 Apr 2027

To

31 Mar 2028

Option

Line

Item

Delivery Schedule

Delivery On Or Before

Delivery Date 31 Mar 2029

DoDAAC: HT0816

ACH WINN STEWART - PA

01 Apr 2028

To

31 Mar 2029

Option

Line

Item

Delivery Schedule

Delivery On Or Before

Delivery Date 31 Mar 2030

DoDAAC: HT0816

ACH WINN STEWART - PA

01 Apr 2029

To

31 Mar 2030

Option

Line

Item

Delivery Schedule

Delivery On Or Before

Delivery Date 31 Mar 2031

DoDAAC: HT0816

ACH WINN STEWART - PA

01 Apr 2030

To

31 Mar 2031

Continuation of Accounting and Appropriation Data

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective

Date

Alternate

Deviation

Variation

Effective

52.203-3 Gratuities. 1984-04

52.203-6 Restrictions on Subcontractor Sales to the

Government.

2020-06

52.203-6 Restrictions on Subcontractor Sales to the

Government. (Alternate I)

2020-06 Alternate

I

2021-11

52.203-19 Prohibition on Requiring Certain Internal

Confidentiality Agreements or Statements.

2017-01

52.204-10 Reporting Executive Compensation and

First-Tier Subcontract Awards.

2026-02

52.209-6 Protecting the Government's Interest

When Subcontracting With Contractors

Debarred, Suspended, Proposed for

Debarment, or Voluntarily Excluded.

52.212-4 Terms and Conditions-Commercial

Products and Commercial Services.

52.219-8 Utilization of Small Business Concerns.

(Deviation)

52.222-35 Equal Opportunity for Veterans. 2026-02

52.222-36 Equal Opportunity for Workers with

Disabilities.

52.222-37 Employment Reports on Veterans. 2026-02

52.222-40 Notification of Employee Rights Under the

National Labor Relations Act.

52.222-41 Service Contract Labor Standards. 2026-02

52.222-50 Combating Trafficking in Persons. 2026-02

52.222-54 Employment Eligibility Verification. 2026-02

52.226-8 Encouraging Contractor Policies to Ban

Text Messaging While Driving.

2024-05

52.229-12 Tax on Certain Foreign Procurements. 2021-02

52.232-33 Payment by Electronic Funds Transfer-

System for Award Management.

2018-10

52.232-40 Providing Accelerated Payments to Small

Business Subcontractors.

2023-03

52.233-3 Protest after Award. 2026-02

52.233-4 Applicable Law for Breach of Contract

Claim.

DFARS Clauses Incorporated by Reference

Alternate

Deviation

Variation

Effective

252.203-7000 Requirements Relating to

Compensation of Former DoD Officials.

2011-09

252.203-7002 Requirement to Inform Employees of

Whistleblower Rights.

2022-12

252.204-7012 Safeguarding Covered Defense

Information and Cyber Incident

Reporting.

2024-05

252.204-7018 Prohibition on the Acquisition of

Covered Defense Telecommunications

Equipment or Services.

2023-01

252.204-7020 NIST SP 800-171 DoD Assessment

Requirements.

2023-11

252.225-7012 Preference for Certain Domestic

Commodities.

2022-04

252.225-7056 Prohibition Regarding Business

Operations with the Maduro Regime.

2023-01

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous

Region.

2023-06

252.232-7003 Electronic Submission of Payment

Requests and Receiving Reports.

2018-12

252.232-7010 Levies on Contract Payments. 2006-12

252.243-7002 Requests for Equitable Adjustment. 2022-12

252.247-7023 Transportation of Supplies by Sea. 2024-10

DFARS Clauses Incorporated by Full Text

Alternate

Deviation

Variation

252.232-7006 Wide Area WorkFlow Payment

Instructions. (Tailored)

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) Definitions. As used in this clause-

"Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit, activity, or organization.

"Document type" means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

"Local processing office (LPO)" is the office responsible for payment certification when payment certification is done external to the entitlement system.

"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall-

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at https://wawf.eb.mil/

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items-

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

N/A

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

Invoice 2in1

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

https://www.sam.gov/ https://wawf.eb.mil/ https://wawf.eb.mil/

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial financing, submit a commercial financing request.

(2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF "combo" document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

Issue By DoDAAC

Admin DoDAAC

Inspect By DoDAAC

Ship To Code

Ship From Code

N/A

Mark For Code

Service Approver (DoDAAC)

Service Acceptor (DoDAAC)

Accept at Other DoDAAC

LPO DoDAAC

DCAA Auditor DoDAAC

Other DoDAAC(s)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

Points of Contact:

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Addendum to 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services

Paragraph 52.212-4(w) is hereby added:

(w) The non-FAR Part 12 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

(End of Addendum)

*** END OF NARRATIVE 1 ***

Contract Terms and Conditions Required To Implement Statutes or Executive

Orders — Commercial Products and Commercial Services

Addendum to Contract Clauses

FAR Clauses Incorporated by Reference

Alternate

Deviation

Variation

Effective

Date

52.209-10 Prohibition on Contracting With

Inverted Domestic Corporations.

52.222-3 Convict Labor. (Deviation) 2026-02

52.223-5 Pollution Prevention and Right-to-

Know Information.

2024-05

52.223-23 Sustainable Products. 2026-02

52.240-91 Security Prohibitions and Exclusions. 2026-02

DFARS Clauses Incorporated by Reference

Alternate

Deviation

Variation

252.201-7000 Contracting Officer's Representative. 1991-12

252.237-7010 Prohibition on Interrogation of

Detainees by Contractor Personnel.

FAR Clauses Incorporated by Full Text

Alternate

Deviation

Variation

Effective Date

52.217-8 Option to Extend Services.

(Tailored)

1999-11

Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

52.217-9 Option to Extend the Term of the

Contract. (Tailored)

2000-03

Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 90 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

DFARS Clauses Incorporated by Full Text

Alternate

Deviation

Variation

252.237-7023 Continuation of Essential

Contractor Services. (Tailored)

2010-10

CONTINUATION OF ESSENTIAL CONTRACTOR SERVICES (OCT 2010)

(a) Definitions. As used in this clause-

(1) "Essential contractor service" means a service provided by a firm or individual under contract to DoD to support mission-essential functions, such as support of vital systems, including ships owned, leased, or operated in support of military missions or roles at sea; associated support activities, including installation, garrison, and base support services; and similar services provided to foreign military sales customers under the Security Assistance Program. Services are essential if the effectiveness of defense systems or operations has the potential to be seriously impaired by the interruption of these services, as determined by the appropriate functional commander or civilian equivalent.

(2) "Mission-essential functions" means those organizational activities that must be performed under all circumstances to achieve DoD component missions or responsibilities, as determined by the appropriate functional commander or civilian equivalent. Failure to perform or sustain these functions would significantly affect DoD's ability to provide vital services or exercise authority, direction, and control.

(b) The Government has identified all or a portion of the contractor services performed under this contract as essential contractor services in support of mission essential functions. These services are listed in attachment Performance Work Statement , Mission- Essential Contractor Services, dated 01 APRIL 2026.

(c)(1) The Mission-Essential Contractor Services Plan submitted by the Contractor, is incorporated in this contract.

(2) The Contractor shall maintain and update its plan as necessary. The Contractor shall provide all plan updates to the Contracting Officer for approval.

(3) As directed by the Contracting Officer, the Contractor shall participate in training events, exercises, and drills associated with Government efforts to test the effectiveness of continuity of operations procedures and practices.

(d)(1) Notwithstanding any other clause of this contract, the contractor shall be responsible to perform those services identified as essential contractor services during crisis situations (as directed by the Contracting Officer), in accordance with its Mission-Essential Contractor Services Plan.

(2) In the event the Contractor anticipates not being able to perform any of the essential contractor services identified in accordance with paragraph (b) of this section during a crisis situation, the Contractor shall notify the Contracting Officer or other designated representative as expeditiously as possible and use its best efforts to cooperate with the Government in the Government's efforts to maintain the continuity of operations.

(e) The Government reserves the right in such crisis situations to use Federal employees, military personnel or contract support from other contractors, or to enter into new contracts for essential contractor services.

(f) Changes. The Contractor shall segregate and separately identify all costs incurred in continuing performance of essential services in a crisis situation. The Contractor shall notify the Contracting Officer of an increase or decrease in costs within ninety days after continued performance has been directed by the Contracting Officer, or within any additional period that the Contracting Officer approves in writing, but not later than the date of final payment under the contract. The Contractor's notice shall include the Contractor's proposal for an equitable adjustment and any data supporting the increase or decrease in the form prescribed by the Contracting Officer. The parties shall negotiate an equitable price adjustment to the contract price, delivery schedule, or both as soon as is practicable after receipt of the Contractor's proposal.

(g) The Contractor shall include the substance of this clause, including this paragraph (g), in subcontracts for the essential services.

List of Contract Documents, Exhibits, or Attachments

I. NEWBORN METABOLIC SCREENING SCOPE OF WORK:

Non-Personal Services: Contractor will provide laboratory screening services for a core set of inherited metabolic disorders, supplementary screening tests, and continuous re-evaluation for additional testing based on the recommendations set forth by the Recommended Universal Screening Panel (RUSP) and the American College of Medical Genetics (ACMG). Included in the cost of a single test, the contractor shall provide the following:

Provision of specimen collection materials; to include specimen collection cards, envelopes, labels, and pamphlets.

Timely transport of collected specimens.

Accurate and timely laboratory testing of specimens.

Accurate and timely interpretation of test results

Accurate, timely, and comprehensive reporting of results

Data management and technical assistance

Clinical consultation to laboratory and clinical staff within the Military Health Care System

Participation in quality assurance programs and reporting of quality assurance data.

II. SPECIFIC TESTING REQUIREMENTS

Contractor must be inspected and accredited by an appropriate accreditation organization approved by Centers for Medicare and Medicaid Services (CMS). Contractor shall provide results for the following disorders:

Group Condition Code

Organic Disorder Acid Disorder Propionic acidemia PROP

Methylmalonicacidemia (methylmalonyl-CoAmutase) MUT

Methylmalonicacidemia (cobalamin disorders) Cbl A,B lsovalericacidemia IVA

3-Methylcrotonyl-CoA carboxylase deficiency 3-MCC

3-Hydroxy-3-methyglutaric aciduria HMG

Holocarboxylasesynthase deficiency MCD

B-Ketothiolase deficiency BKT

Glutaric acidemia type I GA1

Fatty Acid oxidation disorders Carnitine uptake defect/carnitine transport defect CUD

Medium-chain acyl-CoA dehydrogenase deficiency MCAD

Very long-chain acyl-CoA dehydrogenase deficiency VLCAD

Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency LCHAD

Trifunctional protein deficiency TFP

Amino Acid disorders Argininosuccinicaciduria ASA

Citrullinemia,typeI CIT

Maple syrup urine disease MSUD

Homocystinuria HCY

Classic phenylketonuria PKU

Tyrosinemia,type I TYR I

Endocrine Disorder Primary congenital hypothyroidism CH

Congenital adrenal hyperplasia CAH

Hemoglobin Disorders 5,5 disease (Sickle cell anemia) HbSS

5, eta-thalassemia Hb S/8Th

Hemoglobin Disorders S,C disease HbS/C

Other Disorders Biotinidase deficiency BIOT

Cystic fibrosis CF

Classic galactosemia GALT

III. SECONDARY TESTING REQUIREMENTS

Contractor shall provide secondary condition results for the following disorders:

Group Condition Code

Organic Disorder Acid Disorder Methylmalonic acidemia with homocystinuria CblC,D

MaIonic acidemia MAL lsobutyrylglycinuria IBG

2-Methylbutyrylglycinuria 2MBG

3-Methylglutaconic aciduria 3MGA

2-Methyl-3-hydroxybutyric aciduria 2M3HBA

Fatty Acid oxidation disorders Short-chain acyl-CoA dehydrogenase deficiency SCAD

Medium/short-chainL-3- hydroxyacl-CoA dehydrogenase deficiency M/SCHAD

Glutaric acidemia type II GA2

Medium-chain ketoacyl-CoA thiolase deficiency MCAT

2,4 Dienoyl-CoA reductase deficiency DE RED

Carnitine palmitoyltransferase type I deficiency CPTIA

Carnitine palmitoyltransferase type II deficiency CPTII

Carnitine acylcarnitine translocase deficiency CACT

Amino Acid disorders Argininemia ARG

Citrullinemia,type II CITII

Hypermethioninemia MET

Benign hyperphenylalaninemia H-PHE

Biopterin defect in cofactor biosynthesis BIOPT (BS)

Biopterin defect in cofactor regeneration BIOPT

(REG)

Amino Acid disorders Tyrosinemia,type II TYR II

Tyrosinemia,type Ill TYR Ill

Hemoglobin Disorders Various other hemoglobinopathies VarHb

Other Disorders Galactoepimerase deficiency GALE

Galactokinase deficiency GALK

T-cell related lymphocyte deficiencies

If testing is unavailable, contractor may be working towards obtaining testing capabilities. As new disorders are discovered or new testing procedures develop in the field of newborn screening, the disorder or testing procedure may be added to the contract on a post award basis. Regarding these testing procedures/new disorders, all prices and terms and conditions will be negotiated on a post award basis. *Note: Conditions may be listed by alternate names.

IV. TESTING SERVICES

The military comprehensive panel without G6PD includes the following:

Initial screen

Second Screen

Repeat Screen

Performed as a follow-up to a presumptive positive result (at no additional cost to the government)

Improper sample collection

A technical problem such as patient identification error or degradation of shipment on the initial screen

Disorders confirmed or detected by DNA analysis, as available.

Next day service for samples Monday through Friday (Saturday pickup if available)

V. NEWBORN METABOLIC SCREEN RESULTING

The contractor makes all tests results available within 3 business days and not longer than 5 business days of sample receipt. Test results will be posted on the contractor's HIPPA-compliant website within this timeframe and can be accessed 24 hours/7days a week. Reports for normal and abnormal results shall be reported as follows:

Through an electronically secure, HIPPA compliant web-based system for access by any MTF worldwide. The system shall identify, as appropriate, specimens drawn early (e.g., less than 24hours of age), unsatisfactory specimens, presumptive positive specimens, specimens collected post transfusion, and missing tests.

Results shall also be received in writing to the submitting MTF via fax or overnight delivery.

Results will be sent in writing to a centralized DoD Newborn Screening registry for tracking newborn demographics and screening results. (This registry may not be established at the time of contract award; the contractor shall add this capability when the registry is established.)

The test result report shall include:

Quantitative results (and interpretive guidance) for abnormal metabolites

Detailed interpretations of the results (including an overview of the significance, possible differential diagnoses, recommendations for additional biochemical testing and confirmatory studies)

For abnormal results and unsatisfactory specimens, the contractor will abide by the following:

Timelines and methods of delivery of presumptive positive/significant abnormal results will follow established protocols per disorder, age of child and degree of illness.

Abnormal results will be communicated via phone or pager to the Newborn Screening Coordinator/ordering provider immediately upon testing completion. Abnormal reports shall be faxed to individuals designated to receive abnormal newborn screen results within SAMMC to include the Newborn Screening Coordinator/Ordering provider and the laboratory. Appropriate recommendations for further testing will be made. The contractor will arrange for designated specialists in metabolic, hematology, pulmonology, endocrinology and immunology to contact the health care provider.

within 24 hours of laboratory analysis completion to help arrange clinical evaluation and guide medical management.

The contractor must report unsatisfactory specimens by the following three methods:

(1) By phone or pager to the Newborn Screening Coordinator/Ordering provider within 24 hours when the specimen is determined to be unsatisfactory. (2) By phone to the submitting MTF laboratory within 24 hours of when the specimen is determined to be unsatisfactory. (3) By faxing or mailing of a written report to the submitting MTF laboratory within 24 hours of when the specimen is determined to be unsatisfactory.

The contractor shall maintain documentation of all communication with submitting MTF laboratories and physicians regarding screening results (normal, abnormal, repeat, confirmatory), unsatisfactory specimens, and laboratory errors. All electronic transmissions of data must meet all State and Federal regulations, including the data privacy and security requirements of HIPPA.

The contractor shall report test results to each applicable State Government Newborn Screening Program, as required by State law. The contractor shall report test results to the National Newborn Screening and Genetics Resource Center (NNSGRC), if requested by

NNSGRC.

VI. GENETIC COUNSELING

The contractor shall provide the availability of knowledgeable newborn screening nurses and other healthcare providers for discussion and interpretation of test results. The contractor's newborn screening providers will be available 24hours/7 days a week to provide the necessary medical advice and consultation. Contact numbers for follow-up questions from physicians will be included on any report that contains abnormal test results. Consultative services include, but are not limited to:

Interpretation of screening test results

Recommendations for further evaluation

Recommendation for initial management

Educational support

Patient referral management support

VII. STAFF TRAINING/EDUCATION

The contractor will provide the following training/education requirements to laboratory and clinical staff as requested:

Proper sample collection process

Sample shipment preparation and packaging

Logistical coordination for sample processing

Physician education

PERFORMANCE REQUIREMENTS SUMMARY

Performance Objective Citation Performance Standard and Acceptable Quality Level (AQL) Monitoring/Surveillance Method Incentive/Disincentive

Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to perform a core set of inherited metabolic disorders and supplementary newborn screening tests as recommended by the ACMG. PWS Section I Documentation in accordance with regulations, established guidelines COR Review Document on CPARS

Specific Testing requirements. Testing performed must be able to provide results for the following disorders (see PWS) PWS Section II Comply initially and as required 100% of the time. COR Maintain Log Document on CPARS

Specific Testing requirements. Testing performed must be able to provide results for the following disorders (see PWS) PWS Section V Comply initially and as required 100% of the time. COR Maintain Log Document on CPARS

Genetic Counseling. Contractor will provide the availability of Board-certified medical consultants; available 24 hours/ 7days a week to provide the Newborn Screening Nurses necessary medical advice and consultation. PWS Section VI Comply initially and as required 100% of the time. COR Maintain Log Document on CPARS

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

1. GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year's Day

Martin Luther King Jr.'s Birthday

President's Day

Memorial Day

Juneteenth Day

Independence Day

Labor Day

Columbus Day

Veteran's Day

Thanksgiving Day

Christmas Day

Any of the above holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2. INVOICING AND PAYMENT: The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232-7003 & 252.232-7006, for services rendered under this contract. Information regarding Wide Area Workflow is available on the Internet at https://piee.eb.mil

3. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all contract personnel comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract. In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015;

Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living - USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering https://piee.eb.mil/ medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility.

The contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where contractor personnel may perform under this contract and shall instruct contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

4. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAM Exclusion from Participation in Federal Health Care Programs (October 2015)

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as "person") to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at h ttp://oig.hhs.gov/fraud

/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And- Safety-of-

H ealthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as "the Lists." 2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b)certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter "new persons") providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-

5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall (a) in cases where the Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.

6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC (S) 1320a-

7a):There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at h ttp://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

5. Personally Identifiable Information, Protected Health Information, and Federal Information Requirements (Revised 10/27/2020) General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws. This Section addresses the Contractor's requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and Department of Defense (DoD) issuances. In general, the Contractor shall comply with the specific requirements set forth in this Section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein. This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

For purposes of this Section, the following definitions apply.

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January 29, 2019 and DoDI 5400.11- R, Department of Defense Privacy Program, May 14, 2007.

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 Code of Federal Regulations (CFR) Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-E (Enforcement), as amended.

http://www.dtic.mil/whs/directives

Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoDM 6025.18, "Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs," March 13, 2019, DoDI 6025.18, Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs, March 13, 2019, and DoDI 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, August. 12, 2015.

Defense Health Agency (DHA) Privacy Office is the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Officer for DHA.

2. Records Management: When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 United States Code (U.

S.C.) Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B - Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI-15), "OSD Records and Information Management Program" (May 3, 2013) and Records Management requirements outlined in the current TRICARE Operations Manual

(TOM).

3. Freedom of Information Act (FOIA): The Contractor shall comply with the following procedures if it receives a FOIA request and immediately contact the DHA FOIA Officer for evaluation/action: The Contractor shall inform beneficiaries that DHA FOIA procedures require a written request preferably sent via the National FOIA Portal at: www.FOIA.gov. However, requesters may also submit requests via email at DHA.FOIA@mail.mil; or via postal delivery addressed to the DHA Freedom of Information Service Center, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042-5101. All FOIA requests shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. Contract and/or Modification numbers must be included in all FOIA requests seeking DHA procurement records. Although the administrative time limit to grant or deny a request (ten working days after receipt) does not begin until the request is received by DHA, the Contractor shall act as quickly as possible and respond to DHA within ten working days.

In response to requests received by the Contractor for the release of information, unclassified information, documents and forms which were previously provided to the public as part of routine services shall continue to be made available in accordance with previously established criteria. All other requests from the public for release of DHA records and, specifically, all requests that reference FOIA shall be immediately forwarded to DHA, ATTENTION: Freedom of Information Officer, for appropriate action. Direct contact, including interim replies, between TRICARE contractors and such requestors is not authorized. The Contractor shall process requests by individuals for access to records about themselves in accordance with directions from the DHA Freedom of Information Service Center. If such a requestor specifically makes the request under the Privacy Act or does not make clear whether the request is made under FOIA or the Privacy Act, the Contractor shall process the request in accordance with directions from the DHA Privacy Office. If requestor specifically seeks PHI under HIPAA, the Contractor shall follow paragraph 8.1.6, relating to individual rights of access to PHI.

http://www.foia.gov/ mailto:DHA.FOIA@mail.mil

4. Systems of Records: In order to meet the requirements of the Privacy Act and the DoD Privacy Act Issuances, the Contractor shall identify to the DHA Contracting Officer (CO) systems of records that are or will be maintained or operated for DHA where records of PII collected from individuals are maintained and specifically retrieved using a personal identifier.

Upon identification of such systems to the CO, and prior to the lawful operation of such systems, the Contractor shall coordinate with the DHA Privacy Office to complete systems of records notices (SORNs) for submission and publication in the Federal Register as coordinated by the Defense Privacy, Civil Liberties, and Transparency Division, and as required by the DoD Privacy Act Issuances.

Following proper SORN publication and Government confirmation of Contractor authority to operate the applicable system(s), the Contractor shall also comply with the additional systems of records and SORN guidance, in coordination with the DHA Privacy Office, regarding periodic system review, amendments, alterations, or deletions set forth by the DoD Privacy Act Issuances, Office of Management and Budget (OMB) Memorandum 99-05, Attachment B, OMB Circular A-130, and Privacy Act of 1974 requirements applicable to contractors operating systems of records on behalf of federal agencies. The Contractor shall promptly advise the DHA Privacy Office of changes in systems of records or their use that may require a change in the SORN.

5. Privacy Impact Assessment (PIA): If DHA data is stored on a Contractor owned system, a PIA is required from the Contractor.

6. Data Sharing Agreement (DSA)

6.1 (Applies if contract requirements involve the use of DHA data (including PII/PHI, a limited data set, or de-identified data)

The Contractor shall consult with the DHA Privacy Office to determine if the Contractor must obtain a DSA or Data Use Agreement (DUA), when DHA data will be accessed, used, disclosed or stored, to perform the requirements of this Contract. The Contractor shall comply with the permitted uses established in a DSA/DUA to prevent the unauthorized use and/or disclosure of any PII/PHI, in accordance with the HIPAA Rules and DoD HIPAA Issuances. Likewise, the Contractor shall comply with the DoD Privacy Act Issuances. Prior to using any data involving PHI for research purposes, as defined by HIPAA, the Contractor must gain approval from the DHA Privacy Board. Thus, the Contractor shall comply with DHA Privacy Board requests for additional documentation.

To begin the DSA request process, the Contractor shall submit a DSA Application (DSAA) to the DHA Privacy Office. Upon approval, the requestor shall enter into one of the following agreements, depending on the data involved

DSA for De-Identified Data

DSA for PHI

DSA for PII Without PHI

DUA for Limited Data Set

DSAs executed for contract support will expire after 1 year or at the end of the contract option year, whichever comes first. If the contractual use of DHA data will continue after the DSA expiration date, the Contractor shall submit a DSA Renewal Request template to the Privacy Office; however, if the DSA will not be renewed, the Contractor shall close the DSA by providing a Certificate of Data Disposition (CDD) to the DHA Privacy Office.

6.2 (Applies if contract requirements may include human subject research)

This Contract incorporates by reference the Protection of Human Subject Research clause in the Defense Federal Acquisition Regulation Supplement (DFARS) at 48 CFR 252.235-7004. A separate DFARS provision, 48 CFR 235.072(e), requires that the clause be incorporated in contracts that include or may include research involving human subjects in accordance with 32 CFR 219, DoDI 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b), the clause applies to solicitations and contracts awarded by any DoD component, regardless of mission or funding Program Element Code. Thus, in the event a contractor participates in a study or demonstration project or other activity that involves human subject research, then the contractor shall comply with Protection of Human Subject Research clause. COs may not determine whether an activity is exempt from human subject research requirements. If contractor activity appears to involve human subject research, then the contractor shall consult the DHA Privacy Office, which may contact the Research Regulatory Oversight Office in the Office of the Under Secretary of Defense for Personnel and Readiness

(OUSD(P&R)).

7. Privacy Act and HIPAA Training

The Contractor shall ensure that its entire staff, including subcontractors and consultants that perform work on this Contract receive training on the Privacy Act, HIPAA, and the federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2. Refer to FAR 52.224-3 regarding specific requirements for Privacy Training appropriate to the Contractor's scope of involvement with DHA's PHI and its regulatory responsibilities as either a Covered Entity, or Business Associate.

The Contractor shall ensure all employees and subcontractors supply a certificate of all training completion to the Contracting Officer's Representative (COR) within 30 days of being assigned and on an annual basis based on the trainee's birth month thereafter.

8. HIPAA Business Associate Provisions

8.1 Business Associate - General Provisions

The Contractor meets the definition of Business Associate, and DHA meets the definition of a covered entity under the HIPAA Rules and the DoD HIPAA Issuances. Therefore, a Business Associate Agreement (BAA) between the Contractor and DHA is required to comply with the HIPAA Rules and the DoD HIPAA Issuances.