SOW NewbornScreening_Final.pdf

December 03, 2021

STATEMENT OF WORK (SOW)

Newborn Screening Testing

1. DESCRIPTION OF SERVICE.

The Contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to perform newborn screening as a non-personal service in support of the 31st Medical Group’s (MDG) Laboratory at the Medical Treatment Facility (MTF) Aviano Air Base, Italy. The contractor shall analyze samples, which will be collected by Government personnel at the MTF and shipped to the contractor’s facility for analyzing. The contractor shall report the results of the samples and also provide clinical counseling to the 31 MDG’s healthcare providers upon request.

2. SPECIFIC REQUIREMENTS.

2.1. Process of Service.

2.1.1. Materials/Supplies/Equipment. The contractor shall provide necessary materials and supplies for sample taking to the 31 MDG Laboratory. One hundred (100) testing cards shall be provided not later than 14 calendar days after award of the contract, and replenished as needed within 14 calendar days upon notification by the 31 MDG Laboratory personnel. The contractor shall perform all required newborn metabolic screening with the necessary equipment and instrumentation at their facility.

2.1.2. Taking Samples. 31 MDG’s Laboratory personnel will properly collect samples from newborns and all pertinent patient information on the provided testing cards. The Government personnel will send the testing cards on the following business day the samples were collected, but no later than 48 hours.

2.1.3. Analyze Samples. The samples shall be tested for disorders specified in paragraph 3. The contractor shall analyze the samples and provide the results on the online database within ten

(10) days. Results must be submitted in the English language.

2.2. Clinical Counseling. Upon request the contractor shall provide clinical counseling or assistance to the 31 MDG’s healthcare providers with-in 24 hours. This counseling will include questions from the 31 MDG healthcare provider and recommended treatment plans by the contractor’s experts in metabolic disease. Healthcare providers from 31 MDG will consult the contractor by telephone or email. The contractor must provide the appropriate contact information.

2.3. Online Database. Results must be made available through an online database, set up and maintained by the contractor. User name(s) and password(s) will be available for 31 MDG Laboratory personnel for access to patient results.

2.4. Mailed Results. The contractor must also mail hard copy patient results to the Aviano MTF Laboratory.

2.5. Contractor Qualification. The contractor shall have a valid certificate in accordance with the Clinical Laboratory Improvement Amendments (CLIA) of 1988 as specified below. The contractor shall be accredited with one of the below organizations if it is a mandatory requirement by law. The Clinical Laboratory Improvement Amendments of 1988 (CLIA), under Section 353 of the Public Health Service Act, requires that any laboratory performing testing on human specimens for health purposes, must meet the requirements established by the Department of Health and Human Services (HHS) and have in effect an applicable certificate.

Certificates may be obtained with the assistance of approved accreditation organizations under CLIA such as American Association of Blood Banks (AABB), American Association for Laboratory Accreditation (A2LA), American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP), American Society for Histocompatibility and Immunogenetics (ASHI), Commission on Office Laboratory Accreditation (COLA), College of American Pathologists (CAP), The Joint Commission (TJC).

3. LIST OF DISORDERS.

The contractor must analyze the collected samples for the following disorders at a minimum:

a. Organic acid metabolism disorders Isovleric acidemia (IVA) Glutaric acidemia (GAI) 3-OH 3-CH3 glutaric aciduria (HMG) Multiple carboxylase deficiency (MCD) Methylmalonic acidemia due to mutase deficiency (MUT) Methylmalonic acidemia (Cbl A,B) 3-methylcrotonly-CoA carboxylase deficiency (3MCC) Propionic acidemia (PROP) Beta-ketothiolase deficiency (BKT)

b. Fatty acid oxidation disorders Medium-chain acyl-CoA dehydrogenase deficiency (MCAD) Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD) Long-chain L-3-OH acyl-CoA dehydrogenase deficiency (LCHAD) Trifunctional protein deficiency (TFP) Carnitine uptake defect (CUD)

c. Amino acid metabolism disorders Phenylketonuria (PKU) Maple syrup urine disease (MSUD) Homocystinuria due to CBS deficiency (HCY) Citrullinemia (CIT)

Argininosuccinic acidemia (ASA) Tyrosinemia type I (TYR I)

d. Hemoglobinopathies

_ Sickle cell anemia (Hb SS) _ Hemoglobin S/beta-thalassemia (Hb S/Th) _ Homoglobin S/C (Hb S/C)

e. Others Congenital hypothyroidism (CH) Biotinidase Deficiency (BIO) Congenital adrenal hyperplasia due to 21-hydroxylase deficiency (CAH) Classical galactosemia (GALT) Cystic Fibrosis Glucose 6-Phosphate Dehydrogenase Deficiency (G6PD)

4. GENERAL INFORMATION

4.1. Security Requirements. The Contractor shall be responsible for the security of all patient information, including meeting all Health Insurance Portability and Accountability Act (HIPAA) requirements.

4.1.1. Neither the Contractor nor any of its contract service providers shall disclose or cause to disseminate any information concerning patient healthcare information. Such action(s) could result in violation of the contract and possible legal actions.

4.1.2. All inquiries, comments or complaints arising from any matter observed, experienced, or learned of as a result of or in connection with the performance of this contract, the resolution of which may require the dissemination of official information, shall be directed to the Service Contract Manager (SCM) at the 31 MDG and the contracting officer.

4.1.3. U.S. Government records, copies of original results, verified original data, corrected data, and corrected supporting final reports are maintained by the Contractor and provided to 31 MDG Laboratory personnel, but remain the property of the U.S. Government. The contractor shall destroy the files/results in accordance with their storage plan, but not earlier than two (2) years after the testing results are known.

4.2. Performance Quality: The Contractor shall establish and maintain a complete Quality Control Plan that shall ensure the requirements of the contract are provided as specified in Section 2 of the SOW.

5. APPLICABLE LAWS, RULES AND REGULATIONS.

The contractor shall comply with all applicable laws, rules and regulations, to include the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

6. HISTORICAL WORKLOAD DATA:

Number of newborn screenings: Approximately two hundred fifty (250) per year

7. SERVICE SUMMARY:

The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

PWS PARA

THRESHOLD

REMEDY

Timeliness of Service.

2.1.1; 2.1.3; 2.4 NTE more than 3 valid customer complaints per month

1.Will be reported in the annual evaluation

Samples analyze and results available within ten days.

2.1.3 100% of the requirement

1. Will be reported in the annual evaluation.

2. Sample will be reduce in price by 10% for everyday over the standard, until 100% is reached.

Clinical Counseling provided, if applicable

2.2 100% of the requirement

1. Will be reported in the annual evaluation

Online database available and accessible

2.3 100% of the requirement

1. Will be reported in the annual evaluation

2. Payment will be withheld until corrected

HIPAA requirements met 4.1 100% of the requirement

1. Will be reported in the annual evaluation

*STANDARD: The contractor shall perform all work required by the PWS in a satisfactory manner in accordance with (IAW) the appropriate PWS paragraph. The MO shall notify the Contracting Office for appropriate action in accordance FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Jan 2017) if any of the above performance objectives will not be met.