PWS - Newborn Screening Service Final.pdf

PERFORMANCE-BASED WORK STATEMENT

FOR Newborn Screening Test Services 35th Medical Group, Misawa AB, Japan

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 GENERAL PROVISIONS

5.0 FINANCIAL DETAILS

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

1.0. INTRODUCTION.

1.1. The Contractor shall provide all equipment, materials, supervision, and any other items and services necessary to perform newborn metabolic screening services as defined in this PWS for the Clinical Laboratory Services, 35th Medical Group, Misawa Air Base, Japan.

1.2. All services shall be provided in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission on Accreditation of Healthcare Organizations (JC) standards, applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facilities specific policies, procedures, and job descriptions. Contract health care providers (contract personnel) shall give the highest regard to patient dignity and observe the precepts of the American Hospital Association’s Bill of Rights for Patients. The Contractor shall provide non-personal services for varied ancillary healthcare specialties in accordance with established principles and ethics of the medical profession, the national standards established by the JC, the professional standards at the medical treatment facility (MTF), and the American Board of applicable specialty. The Contractor shall be held accountable for compliance to the standards listed in the Comprehensive Accreditation Manual for Hospitals (CAMH) dated 15 November 2019 or current version.

1.3. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

2.0. BACKGROUND: Newborn metabolic screening tests for inherited disorders in newborns and has been performed since the 1960’s. The screen is collected at birth and later in infancy to ensure a proper sample distribution. The newborn metabolic screen is available in all 50 states and the number of disorders that are screened for can vary by state. If left undetected or untreated, these disorders can impede mental and physical development or can lead to death of the child. This contract will provide a method for newborn metabolic screening for military dependents that are born overseas at Misawa Air Base, Japan.

3.0. SCOPE OF WORK:

3.1. The 35 MDG:

3.1.1. Properly collect the sample type as mandated by testing facility.

3.1.2. Prepare the sample for shipment as mandated by the testing facility.

3.1.3. Ship all samples to the testing facility in a timely manner, in accordance with all pertinent regulations.

3.1.4. Receive/enter results into the patient records and notify the ordering provider of abnormal results, in accordance with local policy.

3.1.5. Track all samples sent to ensure results are received in a timely manner, usually within three (3) weeks of sample submission.

3.2. The Contractor shall:

3.2.1. Provide all necessary testing supplies to the 35 MDG.

3.2.2. Provide accreditation certification(s) (ex. College of American Pathologists), Centers for Disease Control (CDC) import license, and applicable state licensure upon request.

3.2.3. Report “normal” results in a timely manner (within three weeks) and will contact the 35 MDG as soon as possible with any “abnormal” results.

Regardless of result type, the contractor will ensure delivery of each report via an electronic report delivery method.

3.2.4. Provide testing for ALL of the following Disorder Groupings and subtest profiles:

3.2.4.1. Amino Acid Disorders

3.2.4.1.1. Argininemia (ARG)

3.2.4.1.2. Argininosuccinic aciduria (ASA)

3.2.4.1.3. Benign Hyper-phenylalaninemia

3.2.4.1.4. Citrullinemia. type I (CIT)

3.2.4.1.5. Citrullinemia, type 11 (CIT 11)

3.2.4.1.6. Classic Phenylketonuria (PKU)

3.2.4.1.7. Homocystinuria (HCY)

3.2.4.1.8. Hypermethioninemia (MET)

3.2.4.1.9. Maple Syrup Urine disease (MSUD)

3.2.4.1.10. Tyrosinemia, Type I (TYR I)

3.2.4.1.11. Tyrosinemia, Type II (TYR II)

3.2.4.1.12. Tyrosinemia, Type III (TYR III)

3.2.4.2. Endocrine Disorders

3.2.4.2.1. Congenital Adrenal Hyperplasia (CAH)

3.2.4.2.2. Primary Congenital Hypothyroidism (PCH)

3.2.4.3. Fatty Acid Oxidation Disorders

3.2.4.3.1. Carnitine Acylcarnitine Translocase Deficiency (CACT)

3.2.4.3.2. Carnitine Palmitoyl-Transferase I Deficiency (CPT-IA)

3.2.4.3.3. Carnitine Palmitoyl-Transferase II Deficiency (CPT-IIA)

3.2.4.3.4. Carnitine Uptake Defect (CUD)

3.2.4.3.5. Glutaric Acidemia, Type II

3.2.4.3.6. Long-Chain Acl-CoA Dehydrogenase Deficiency (LCHAD)

3.2.4.3.7. Medium-Chain Acl-CoA Dehydrogenase Deficiency (MCAD)

3.2.4.3.8. Short-Chain Acl-CoA Dehydrogenase Deficiency (SCAD)

3.2.4.3.9. Trifunctional Protein Deficiency (TFP)

3.2.4.3.10. Very-Long-Chain Acl-CoA Dehydrogenase Deficiency

(VLCAD)

3.2.4.4. Hemoglobin Disorders

3.2.4.4.1. Hemoglobinopathies (Var Hb)

3.2.4.4.2. S, Beta-Thalassemia (Hb S/ßTh)

3.2.4.4.3. S, C Disease (Hb SIC)

3.2.4.4.4. Sickle Cell Anemia

3.2.4.5. Lysomal Storage Disorders

3.2.4.5.1. Muco-polysaccharidosis, Type I

3.2.4.5.2. Pompe

3.2.4.6. Organic Acid Conditions

3.2.4.6.1. 2-Methyl-3-Hydroxy-butyric Acidemia (2M3HBA)

3.2.4.6.2. 2-Methyl-butyryl-glycinuria (2MBG)

3.2.4.6.3. 3-Hydroxy-3-Methylglutaric Aciduria (HMG)

3.2.4.6.4. 3-Methyl-crotonyl-CoA Carboxylase Deficiency (3-MCC)

3.2.4.6.5. 3-Methyl glutaconic Aciduria (3MGA)

3.2.4.6.6. Beta-Ketothiolase Deficiency (BKT)

3.2.4.6.7. Glutaric Acidemia, Type I (GA 1)

3.2.4.6.8. Holocarboxylasae Synthetase Deficiency (MCD)

3.2.4.6.9. Isobutyryl-glycinuria (IBG)

3.2.4.6.10. Isovaleric Acidemia (IVA)

3.2.4.6.11. Malonic Acidemia (MAL)

3.2.4.6.12. Methylmalonic Acidemia (Cobalamin Disorders) (Cbl A B)

3.2.4.6.13. Methylmalonic Acidemia (Methymalonyl-CoA Mutase

Deficiency) (MUT)

3.2.4.6.14. Methylmalonic Acidemia w/Homocystinuria (Cbl C DA F)

3.2.4.6.15. Proprionic Acidemia (PROP)

3.2.4.7. Other Disorders

3.2.4.7.1. Biotinidase Deficiency (BIOT)

3.2.4.7.2. Classic Galacotsemia (GALT)

3.2.4.7.3. Critical Congenital Heart Disease (CCHD)

3.2.4.7.4. Cystic Fibrosis (CF)

3.2.4.7.5. Hearing Loss

3.2.4.7.6. Severe Combined Immuno-Deficiency (SCID)

3.2.5. Provide clinical counseling or assistance to the healthcare provider as required.

4.0. GENERAL PROVISIONS:

4.1. CORRESPONDENCE: All correspondence to be sent and notices to be will be addressed, if to the 35 MDG, to:

4.1.1. 35 Medical Group/MDSS/SGSL Clinical Laboratory Services Unit 5024, BLDG 99 Misawa Aomori 033012 Japan and, if to the contractor, to—

4.1.2. Contractor Name

Contractor’s Address Or as may from time to time otherwise be directed by the Parties.

4.2. REVIEW OF AGREEMENT: This PWS will be reviewed annually on or around the anniversary of its effective date.

4.3. MODIFICATION OF AGREEMENT: This PWS may only be modified by the written agreement of the Parties, duly signed by their authorized representatives.

4.4. DISPUTES: Any disputes relating to this PWS will, subject to any applicable law, Executive Order, Directive, or Instruction, be resolved by consultation between the Parties or in accordance with DODI 4000.19.

4.5. TRANSFERABILITY: This agreement is not transferable except with the written consent of the Parties.

4.6. ENTIRE AGREEMENT: It is expressly understood and agreed that this PWS embodies the entire agreement between the Parties regarding the PWS’s subject matter.

4.7. EFFECTIVE DATE: This PWS takes effect upon the date of award.

4.8. EXPIRATION DATE: This PWS is valid through the lifetime of the contract.

5.0. FINANCIAL DETAILS:

5.1. AVAILABILITY OF FUNDS: This PWS does not document the obligation of funds between the Parties. The obligation of funds by the Parties is subject to the availability of appropriated funds pursuant to the DoD Financial Management Regulation.

5.2. BILLING: The contractor will bill the 35 MDG on a monthly basis in accordance with the procedures of the billing party. A record of the transaction will be sent to the contractor within 30 days after the month in which the transaction occurred.

5.3. PAYMENT OF BILLS: The 35 MDG paying office will forward payments, along with a copy of billed invoices, to the contractor within 30 days of the invoice. Bills rendered will not be subject to audit in advance of payment.

5.4. ECONOMY ACT DETERMINATION AND FINDINGS: If the PWS is being entered into under 31 U.S.C. § 1535, as amended (the Economy Act), both Parties agree that the requirements listed in paragraph (a) of the Economy Act have been met.

6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

Following is a list of basic publications applicable to this performance based statement of work. Additional publications may be listed by call. The contractor is obligated to follow these publications. The contractor shall comply with Air Force Instruction (AFI) 44-102 and Medical Group Instruction (MDGI) 44-117 as well as all applicable Notice to Airmen (NOTAMs), Policy Letters, Air Force Guide to Physical Therapy Practice Manual and all Medical Instructions for the 35th Medical Group. These documents are available in the MTF and maintained by the Government. Supplements or amendments to instructions or publications from any organizational level may be issued during the life of the contract. The Contractor shall immediately implement those changes. The contractor will utilize USFJ Form 10 and DD Form 2161 as referenced in this PWS. DOD publications can be found at www.defenselink.mil/pubs or www.dtic.mil/whs/directives.

The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Advisory publications may be used for information and guidance but are not binding for compliance.

6.1. Mandatory Publications:

6.1.1. Public Law 91-596, 29 Dec 70

6.1.2. Occupational Safety and Health Administration Public Law 104-191, 21Aug 96

6.1.3. Health Insurance Portability and Accountability Act of 1996

6.1.4. Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual.

6.2. DEPARTMENT OF DEFENSE (DOD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

6.2.1. DOD Instruction 1402.5, Criminal History Jan 93

6.2.2. Background Checks on Individuals in Child Care Services

6.2.3. DOD Directive 5500.7, Standards of Conduct Aug 93

6.3. AIR FORCE REGULATIONS/MANUALS/INSTRUCTIONS

6.3.1. AFI 33-119, Air Force Messaging Jan 05

6.3.2. AFI 33-202, Computer Security

6.3.3. AFI 33-322, Records Management Program

6.3.4. AFI 37-138, Records Disposition—Procedures and Responsibilities

6.3.5. AFI 41-115, Authorized Health Care and Benefits Dec 01

6.3.6. AFI 41-210, Patient Administration Functions Mar 06

6.3.7. AFI 44-102, Air Force Instruction

6.3.8. AFI 44-119, Clinical Performance Improvement Jun 01

6.3.9. AFI 48-123, Medical Examinations and Standards Jun 06

6.3.10. AFI 71-101, Criminal Investigations

6.3.11. AFMAN 37-323, Management of Records

END OF PERFORMANCE WORK STATEMENT