FBO posting NBS N6264520R0019.docx

N6264520R0019

COMBINED SYNOPSIS SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation of Commercial Items and FAR 12 as supplemented with additional information included in this notice, and FAR 15, Contracting by Negotiation. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at http://farsite.hill.af.mil/

The NAICS code is 621511, with a business size standard of $35M.

This Request for Proposal (RFP) is on behalf of the Naval Medical Logistics Command (NMLC). This requirement is for Newborn Screening Services in support of Military Treatment Facilities (MTFs) located in the states of California, Florida, Maryland, North Carolina, Oregon, Virginia, and Washington as well as MTFs located Outside the Continental United States (OCONUS) in Guam, Cuba, Bahrain, Italy, Japan and Spain.

The solicitation number is N6264520R0019.

This solicitation will result in seven sole sourced, Firm Fixed Price (FFP), Single Award Task Order (SATO), Indefinite Delivery/Indefinite Quantity (IDIQ) contracts with a five year ordering period from 01 May 2021 - 30 April 2026.

The scope of the requirement is listed in the Performance Work Statement.

The closing date of the solicitation can be found in ADDENDUM TO 52.212-1-- INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS.

SECTION B

Supplies or services and prices/costs

Newborn Screening Services

FFP

See Attachment 1 for the estimated volume for each state and MTF location FOB: Destination

MAX

NET AMT

SECTION C

Description/specifications/statement of work

PERFORMANCE WORK STATEMENT

NOTE: The following sections A through G are Performance Work Statements for each State Newborn Screening program. The solicitation will be tailored into seven solicitations (one per state).

A - California Genetic Disease Screening Program, California Department of Public Health, 850 Marina Bay Parkway F175, Mail Stop 8200, Richmond, CA 94804

1. INTRODUCTION. Newborn Screening is recognized nationally as an essential preventive public health measure. Newborn screening is the practice of testing all babies for certain disorders and conditions that can hinder their normal development. Babies with these conditions appear healthy at birth but can develop serious medical problems later in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.

2. PWS OVERVIEW. The contractor shall provide non-personal services of Newborn Screening to the patients in accordance with the terms and conditions of this contract at the Naval Medical Treatment Facilities (MTF) indicated in the awarded contract.

3. CONTRACT TYPE. Services will be provided under a Single Award Task Order (SATO) Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract establishes overall terms and conditions, but services are actually delivered by task orders issued under the awarded contract. In the event of a conflict between a task order and the basic contract, the basic contract governs.

4. SCOPE. Locations of performance under this contract are Naval Medical Center San Diego, CA; Naval Hospital Camp Pendleton, CA; and Naval Hospital Twenty Nine Palms, CA.

4.1. Specimen Collection Material Supply and Specimen Transport

4.1.1. The contractor shall provide specimen collection kits and a special filter paper cards in accordance with the contractor’s standard practice.

4.1.2. The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 12-48 hours of age, but not greater than the 4th day of life unless the clinical situation makes later collection necessary. If collected prior to 12-hours, the facility shall submit a second specimen in accordance with the contractor’s standard practice.

4.1.3. The MTF will complete the test request form (TRF) for Newborn screening, which contains fields for recording critical information about the baby.

4.1.4. Transport of specimens collected and to be tested by the contractor will be shipped by the MTF in accordance with the contractor’s standard practice.

4.1.5. The contractor shall retain dried blood spots for at least one year from date of test.

4.2. Training. Prior to submission of samples and as requested by the MTF during the life of this contract, the contractor shall provide the MTF staff with training, education and technical assistance regarding the proper sample collection process, sample shipment preparation and packaging, logistical coordination for sample processing, and physician education. Such training, education, or technical assistance may be provided in person, by phone, e-mail, webcam, video teleconference, videotape, or letter, as appropriate, to improve quality of specimen submission, decrease sample collection and patient identification errors, and reduce the need for newborn re-screens.

4.2.1. The contractor shall be not compensated separately for training.

4.3. Screening Tests

4.3.1. The contractor shall provide the MTF, Newborn screening services to include laboratory testing for the detection of a core set of conditions and report results for additional disorders detected by this testing. The conditions to be tested shall include those on the Recommended Uniform Screening Panel (which is hereby incorporated as reference), as recommended by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children with the approval of United States Department of Health and Human Services and as approved by state law. Any conditions that are added to the Recommended Uniform Screening Panel throughout this contract period shall be added to the set of conditions screened under this contract as they are able to be incorporated and validated by the contractor. Parties agree this contract may be modified upon future cost increase due to inclusion of new conditions for screening and or/if testing technologies change and/or improve.

4.3.2. The MTF shall be given a minimum of 30-days advance notice of a change of testing (Addition/Deletion/Modification of screened disorders and/or screening technologies). Contractor notification will consist of (at the minimum) an official letter, sent on contractor official departmental letterhead to the Contracting Officer, addressed to the MTF laboratory medical director and laboratory administrator. Additional disorders may be added as they are incorporated into the state’s Newborn Screening program and/or new disorders become prevalent. Changes in testing methodology may occur without notice, such as the addition or elimination of ratios, changes in analyte cut offs, etc.

4.4. Laboratory Testing and Analysis

4.4.1. The contractor shall provide newborn screening for all of the disorders as indicated in paragraph 4.3.1 above. In addition, when appropriate for initial screening or secondary testing, biochemical and molecular/genetic tests shall be performed to clarify screening results, according to the contractor’s established protocols.

4.4.2. Repeat testing and/or confirmatory tests on the initially collected patient specimen shall be performed as appropriate if a test does not fall within normal limits on the initial screening test.

4.4.3. The contractor shall provide re-screening of newborns in cases of improper sample collection, technical problems such as patient identification errors or degradation of specimens during shipment/transport.

4.4.4. The contractor shall provide re-screening of infants as necessary per the contractor’s established protocols and not separately invoiced.

4.5. Case Management for Screens

4.5.1. The contractor shall perform the required tests and then provide the results of the initial screen by secure email, or electronic post to authorized personnel at the MTF. Results should be reported within five business days, but not longer than 21 business days of sample receipt. A small number of samples may require further testing, in which case results will take several additional days. As a last resort for notification of results, a copy of the results may also be mailed via United States Postal Service (USPS) to the physician of record or the ordering hospital according to the contractor’s standard practice and as agreed upon by the MTF.

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

4.5.3. Abnormal results of an urgent nature will be reported by phone, as well as by secure email, electronic post, or as a last resort be mailed via USPS, to the MTF newborn screening coordinator and the health care provider (as indicated on the screening card or by medical records at the MTF). Appropriate recommendations for further testing or follow up will be made.

4.5.4. The contractor shall monitor the newborn’s case until screening results are reported or diagnosis is confirmed.

4.6. Specialty Care for Positive Screens

4.6.1. A specialist in metabolic genetics, immunology and hematology will be available for consultation by phone or email to advise patient management, if required. Contact information for a specialist in pulmonology or endocrinology will be made available if indicated.

4.6.2. Specialists and/or the contractor’s newborn screening coordinators will assist in establishing appropriate follow up of screen positive babies.

4.6.3. The contractor shall be readily available for any particular questions by the MTF Healthcare Providers that may not have been covered in the Laboratory testing and provide quality customer service herein to the terms of the intent and terms of this contract.

4.6.4. The contractor shall contact the respective MTF laboratory to ensure a positive transfer of patient results (for all results, both normal and abnormal).

4.6.4.1. The MTF will record the Newborn Screen results into the appropriate Medical Records database (e.g., Composite Health Care System (CHCS), Health Artifact and Image Management Solution (HAIMS), etc.)

4.6.4.2. As part of continued follow-on care, the communication between the contractor and the MTF shall continue regularly without prompting from the MTF.

4.6.5. The contractor shall be not compensated separately for Specialty Care for Positive Screens.

4.7. Other Responsibilities

4.7.1. The contractor shall keep the Contracting Officer Representative (COR) informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

4.7.2. The contractor shall have reference laboratory representatives available to assist in problem solving at no additional cost to the Government with access to knowledgeable laboratory professionals with minimal call transfers and holding.

4.8. Quality Assurance

4.8.1. The contractor shall establish and maintain a Quality Assurance Program designed for medical surveillance to continuously monitor and improve quality of specimen collection, submission of required demographic information from submitting facilities, specimen analysis, and reporting of results. Quarterly review or report to be provided.

4.8.1.1. This program is to be included with the vendor's proposal.

4.8.2. The contractor shall participate in and maintain compliance with the Centers for Disease Control and Prevention's (CDC) quarterly external proficiency testing program for Newborn Screening (dried blot methodology) and also external proficiency testing programs for all Centers for Medicare and Medicaid Services(CMS) regulated testing procedures/analytes.

4.8.3. Residual dried blood spots shall be stored at a facility that provides security, confidentiality, stability of temperature and humidity, and retrievability for 1 year. Stored specimens remain the property of the California Department of Public Health, Genetic Disease Screening Program throughout the storage period. The contractor shall retrieve and provide stored specimens to the Department of Defense (DoD) within seven days upon request. If it is the contractor’s practice to dispose of filter paper blood spots following the 1 year period, the left over filter paper blood spots shall be disposed of and it shall be in a manner that ensures confidentiality. No filter paper blood spots can be used for research without the explicit consent of the newborn's parent/legal guardian, California Committee for the Protection of Human Subject and approval by an approved DoD Institutional Review Board. Documentation of the storage, use and disposal of the residual dried blood spots shall be maintained and shall be made available to the DoD upon request.

4.8.3.1. Name and locations of all storage facilities shall be included as part of the proposal.

5. VOLUME. Annual quantity amounts are historical and not indicative of future requirements as the number of newborns requiring Newborn Screening cannot be accurately predicted. (see Attachment 1).

6. QUALITY ASSURANCE SURVEILLANCE PLAN (see Attachment 2).

B - Florida Newborn Screening Program, Florida Department of Health, 4052 Bald Cypress Way, Bin A-06, Tallahassee, FL 32399

1. INTRODUCTION. Newborn Screening is recognized nationally as an essential preventive public health measure. Newborn screening is the practice of testing all babies for certain disorders and conditions that can hinder their normal development. Babies with these conditions appear healthy at birth but can develop serious medical problems later in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.

2. PWS OVERVIEW. The contractor shall provide non-personal services of Newborn Screening to the patients in accordance with the terms and conditions of this contract at the Naval Medical Treatment Facilities (MTF) indicated in the awarded contract.

3. CONTRACT TYPE. Services will be provided under a Single Award Task Order (SATO) Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract establishes overall terms and conditions, but services are actually delivered by task orders issued under the awarded contract. In the event of a conflict between a task order and the basic contract, the basic contract governs. .

4. SCOPE. Locations of performance under this contract are Navy Hospital Jacksonville, FL; Naval Hospital Pensacola, FL; and United States Naval Hospital Guantanamo Bay, Cuba.

4.1. Specimen Collection Material Supply and Specimen Transport

4.1.1. The contractor shall provide a specimen collection kit and a special filter paper card in accordance with the contractor’s standard practice.

4.1.2. The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 24-48 hours of age, but not greater than the 4th day of life unless the clinical situation makes later collection necessary. If collected prior to 24-hours, the facility shall submit a second specimen in accordance with the contractor’s standard practice.

4.1.3. The MTF will complete the test request form (TRF) for Newborn screening, which contains fields for recording critical information about the baby.

4.1.4. Transport of specimens collected and to be tested by the contractor will be shipped by the MTF in accordance with the contractor’s standard practice.

4.1.5. The contractor shall retain dried blood spots for at least six months from date of test.

4.2. Training. Prior to submission of samples and as requested by the MTF during the life of this contract, the contractor shall provide the MTF staff with training, education and technical assistance regarding the proper sample collection process, sample shipment preparation and packaging, logistical coordination for sample processing, and physician education. Such training, education, or technical assistance may be provided in person, by phone, e-mail, webcam, video teleconference, videotape, or letter, as appropriate, to improve quality of specimen submission, decrease sample collection and patient identification errors, and reduce the need for newborn re-screens.

4.2.1. The contractor shall be not compensated separately for training.

4.3. Screening Tests

4.3.1. The contractor shall provide the MTF, Newborn screening services to include laboratory testing for the detection of a core set of conditions and report results for additional disorders detected by this testing. The conditions to be tested shall include those on the Recommended Uniform Screening Panel (which is hereby incorporated as reference), as recommended by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children with the approval of United States Department of Health and Human Services and as approved by state law. Any conditions that are added to the Recommended Uniform Screening Panel throughout this contract period shall be added to the set of conditions screened under this contract as they are able to be incorporated and validated by the contractor. The contract maybe modified if the cost of screening increases to include those conditions and or/if testing technologies change and/or improve.

4.3.2. . The MTF shall be given a minimum of 180-days advance notice of a change of testing (Addition/Deletion/Modification of screened disorders and/or screening technologies). Contractor notification will consist of (at the minimum) an official letter, sent on contractor official departmental letterhead to the Contracting Officer, addressed to the MTF laboratory medical director and laboratory administrator. Additional disorders may be added as they are incorporated into the state’s Newborn Screening program and/or new disorders become prevalent. Changes in testing methodology may occur without notice, such as the addition or elimination of ratios, changes in analyte cut offs, etc.

4.4. Laboratory Testing and Analysis

4.4.1. The contractor shall provide newborn screening for all of the disorders as indicated in paragraph 4.3.1 above. In addition, when appropriate for initial screening or secondary testing, biochemical and molecular/genetic tests should be performed to clarify screening results, according to the contractor’s established protocols.

4.4.2. Repeat testing and/or confirmatory tests on the initially collected patient specimen shall be performed as appropriate if a test does not fall within normal limits on the initial screening test.

4.4.3. The contractor shall provide re-screening of newborns in cases of improper sample collection, technical problems such as patient identification errors or degradation of specimens during shipment/transport.

4.4.4. The contractor shall provide re-screening of all infants weighting less than 1500 grams at birth, and premature and sick infants requiring prolonged hospitalization according to the contractor’s established protocols and not separately invoiced.

4.5. Case Management for Screens

4.5.1. The contractor shall perform the required tests and then provide the results of the screen by electronic post to authorized personnel at the MTF. Results should be reported within 5 business days, but not longer than 7 business days of sample receipt. As a last resort for notification of results, copy of the results may also be mailed via United States Postal Service (USPS) to the physician of record or the ordering hospital according to the contractor’s standard practice and as agreed upon by the MTF.

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

4.5.3. Abnormal results of an urgent nature will be reported by phone, as well as by secure email, electronic post, or as a last resort be mailed via USPS, to the MTF newborn screening coordinator and the health care provider (as indicated on the screening card or by medical records at the MTF).. Appropriate recommendations for further testing or follow up will be made.

4.5.4. The contractor shall monitor the newborn’s case until screening results are reported or diagnosis is confirmed.

4.6. Specialty Care for Positive Screens

4.6.1. A specialist in metabolic genetics, immunology and hematology will be available for consultation by phone or email to advise patient management, if required. Contact information for a specialist in pulmonology or endocrinology will be made available if indicated.

4.6.2. Specialists and/or the contractor’s newborn screening coordinators will assist in establishing appropriate follow up of screen positive babies.

4.6.3. The contractor shall be readily available for any particular questions by the MTF Healthcare Providers that may not have been covered in the Laboratory testing and provide quality customer service herein to the terms of the intent and terms of this contract.

4.6.4. The contractor shall contact the respective MTF laboratory to ensure a positive transfer of patient results (for all results, both normal and abnormal).

4.6.4.1. The MTF will record the Newborn Screen results into the appropriate Medical Records database (e.g., Composite Health Care System (CHCS), Health Artifact and Image Management Solution (HAIMS), etc.)

4.6.4.2. As part of continued follow-on care, the communication between the contractor and the MTF shall continue regularly without prompting from the MTF.

4.6.5. The contractor shall be not compensated separately for Specialty Care for Positive Screens.

4.7. Other Responsibilities

4.7.1. The contractor shall keep the Contracting Officer Representative (COR) informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

4.7.2. The contractor shall have reference laboratory representatives available to assist in problem solving at no additional cost to the Government with access to knowledgeable laboratory professionals with minimal call transfers and holding.

4.8. Quality Assurance

4.8.1. The contractor shall establish and maintain a Quality Assurance Program designed for medical surveillance to continuously monitor and improve quality of specimen collection, submission of required demographic information from submitting facilities, specimen analysis, and reporting of results. Quarterly review or report to be provided.

4.8.1.1. This program is to be included with the vendor's proposal.

4.8.2. The contractor shall participate in and maintain compliance with the Centers for Disease Control and Prevention's (CDC) quarterly external proficiency testing program for Newborn Screening (dried blot methodology) and also external proficiency testing programs for all Centers for Medicare and Medicaid Services (CMS) regulated testing procedures/analytes.

4.8.3. Residual dried blood spots shall be stored at a facility that provides security, confidentiality, stability of temperature and humidity, and retrievability for six months. Stored specimens remain the property of the Department of Defense (DoD) throughout the storage period. The contractor shall retrieve and provide stored specimens to the DoD within 7 days upon request. If it is the contractor’s practice to dispose of filter paper blood spots following the six month period, the left over filter paper blood spots shall be disposed of and it shall be in a manner that ensures confidentiality. No filter paper blood spots can be used for research without the explicit consent of the newborn's parent/legal guardian, and approval by a DoD approved Institutional Review Board. Documentation of the storage, use and disposal of the residual dried blood spots shall be maintained and shall be made available to the DoD upon request.

4.8.3.1. Name and locations of all storage facilities shall be included as part of the proposal.

5. VOLUME. Annual quantity amounts are historical and not indicative of future requirements as the number of newborns requiring Newborn Screening cannot be accurately predicted (see Attachment 1).

6. QUALITY ASSURANCE SURVEILLANCE PLAN (see Attachment 2).

C - North Carolina Newborn Screening Program, North Carolina Department of Health and Human Services, 4312 District Drive, 2nd Floor, Raleigh, NC 27607

1. INTRODUCTION. Newborn Screening is recognized nationally as an essential preventive public health measure. Newborn screening is the practice of testing all babies for certain disorders and conditions that can hinder their normal development. Babies with these conditions appear healthy at birth but can develop serious medical problems later in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.

2. PWS OVERVIEW. The contractor shall provide non-personal services of Newborn Screening to the patients in accordance with the terms and conditions of this contract at the Naval Medical Treatment Facilities (MTF) indicated in the awarded contract.

3. CONTRACT TYPE. Services will be provided under a Single Award Task Order (SATO) Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract establishes overall terms and conditions, but services are actually delivered by task orders issued under the awarded contract. In the event of a conflict between a task order and the basic contract, the basic contract governs.

4. SCOPE. Location of performance under this contract is Naval Medical Center Camp Lejeune, NC.

4.1. Specimen Collection Material Supply and Specimen Transport.

4.1.1. The contractor shall provide a specimen collection kit and a special filter paper card in accordance with the contractor’s standard practice.

4.1.2. The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 24-48 hours of age, but not greater than the 4th day of life unless the clinical situation makes later collection necessary. If collected prior to 24-hours, the facility shall submit a second specimen in accordance with the contractor’s standard practice.

4.1.3. The MTF will complete the test request form (TRF), which contains fields for recording critical demographic information about the baby.

4.1.4. The MTF will register with and use the North Carolina Hearing Link. The Hearing Link, already installed at this facility, is a program for entering newborn demographic information, details about collection of the newborn screening dried blood spot specimen and details about newborn hearing screening. The Hearing Link will print labels with such demographic information which are applied to the newborn screening filter form.

4.1.5. Transport of specimens collected and to be tested by the contractor will be shipped by the MTF in accordance with the contractor’s standard practice.

4.1.6. The contractor shall retain dried blood spots in accordance with section 4.8.3 below.

4.2. Training. Prior to submission of samples and as requested by the MTF during the life of this contract, the contractor shall provide the MTF staff with training, education and technical assistance regarding the proper sample collection process, sample shipment preparation and packaging, and logistical coordination for sample processing. Such training, education, or technical assistance may be provided in person, by phone, e-mail, webcam, video teleconference, videotape, or letter, as appropriate, to improve quality of specimen submission, decrease sample collection and patient identification errors, and reduce the need for newborn re-screens.

4.2.1. The contractor shall be not compensated separately for training.

4.3. Screening Tests.

4.3.1. The contractor shall provide the MTF, Newborn screening services to include laboratory testing for the detection of a core set of conditions and report results for additional disorders detected by this testing. The conditions to be tested shall include those on the Recommended Uniform Screening Panel (which is hereby incorporated as reference), as recommended by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children with the approval of United States Department of Health and Human Services and as approved by state law. Any conditions that are added to the Recommended Uniform Screening Panel throughout this contract period shall be added to the set of conditions screened under this contract as they are able to be incorporated and validated by the contractor. The contract maybe modified if the cost of screening increases to include those conditions and or/if testing technologies change and/or improve.

4.3.2. Unless enactment of legislation changing the rate does not allow adequate time, the MTF shall be given a minimum of 30-days advance notice of a change of testing (Addition/Deletion/Modification of screened disorders and/or screening technologies). Contractor notification will consist of (at the minimum) an official letter, sent on contractor official departmental letterhead to the Contracting Officer, addressed to the MTF laboratory medical director and laboratory administrator. Additional disorders may be added as they are incorporated into the state’s Newborn Screening program and/or new disorders become prevalent. Changes in testing methodology may occur without notice, such as the addition or elimination of ratios, changes in analyte cut offs, etc.

4.4. Laboratory Testing and Analysis

4.4.1. The contractor shall provide newborn screening for all of the disorders that the contractor provides in its State-wide Newborn Screening Panel of disorders. In addition, when appropriate for initial screening or secondary testing, biochemical and molecular/genetic tests should be performed to clarify screening results, according to the contractor’s established protocols.

4.4.2. Repeat testing and/or confirmatory tests on the initially collected patient specimen shall be performed as appropriate if a test does not fall within normal limits on the initial screening test according to the contractor’s established protocols.

4.4.3. The contractor shall provide re-screening of newborns in cases of improper sample collection, presumptive positive screening results, technical problems such as patient identification errors or degradation of specimens during shipment/transport.

4.4.4. The contractor shall provide re-screening of all infants weighting less than 1500 grams at birth, and premature and sick infants requiring prolonged hospitalization according to the contractor’s established protocols and not separately invoiced. Of these, the contractor shall provide re-screening in cases where initial results are presumptive positive.

4.5. Case Management for Screens

4.5.1. The contractor shall perform the required tests and then provide the results of the screen by electronic post to authorized personnel at the MTF. Results should be reported within 5 business days, but not longer than 7 business days of sample receipt. As a last resort for notification of results, copy of the results may also be mailed via United States Postal Service (USPS) to the physician of record or the ordering hospital according to the contractor’s standard practice and as agreed upon by the MTF.

4.5.2. Timelines and methods of delivery of presumptive positive/significant abnormal results will follow the contractor’s established protocols.

4.5.3. Abnormal results of an urgent nature will be reported by phone, as well as by secure email, electronic post, or as a last resort be mailed via USPS, to the MTF newborn screening coordinator and the health care provider (as indicated on the screening card or by medical records at the MTF) by the contractor’s designated Newborn Screening Program Follow-up Specialists. Appropriate recommendations for further testing or follow up will be made.

4.5.4. For abnormal results of an urgent nature, the contractor’s designated Newborn Screening Program Follow-up Specialists shall monitor the newborn’s case until screening results are reported or diagnosis is confirmed.

4.6. Specialty Care for Positive Screens

4.6.1. Specialist in metabolic genetics, immunology and hematology will be available for consultation by phone or email to advise patient management, if required. Contact information for Specialist in pulmonology or endocrinology will be made available if indicated.

4.6.2. Specialists and/or the contractor’s Newborn Screening Follow-up Program coordinators will assist in establishing appropriate follow up of screen positive babies.

4.6.3. The contractor shall be readily available for any particular questions by the MTF Healthcare Providers that may not have been covered in the Laboratory testing and provide quality customer service herein to the terms of the intent and terms of this contract.

4.6.4. The contractor shall contact the respective MTF laboratory to ensure a positive transfer of patient results (for all results, both normal and abnormal).

4.6.4.1. The Medical Record Technician will record the Newborn Screen results into the appropriate Medical Records database (e.g., Composite Health Care System (CHCS), Health Artifact and Image Management Solution (HAIMS), etc.)

4.6.4.2. As part of continued follow-on care, the communication between the contractor and the MTF shall continue regularly without prompting from the MTF.

4.6.5. The contractor shall be not compensated separately for Specialty Care for Positive Screens.

4.7. OTHER RESPONSIBILITIES:

4.7.1. The contractor shall keep the Contracting Officer Representative (COR) informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

4.7.2. The contractor shall have reference laboratory representatives available to assist in problem solving at no additional cost to the Government with access to knowledgeable laboratory professionals with minimal call transfers and holding.

4.8. Quality Assurance

4.8.1. The contractor shall establish and maintain a Quality Assurance Program designed for medical surveillance to continuously monitor and improve quality of specimen collection, submission of required demographic information from submitting facilities, specimen analysis, and reporting of results. Quarterly review or report to be provided.

4.8.1.1. This program is to be included with the vendor's proposal.

4.8.2. The contractor shall participate in and maintain compliance with the Centers for Disease Control and Prevention's (CDC) quarterly external proficiency testing program for Newborn Screening (dried blot methodology) and also external proficiency testing programs for all Centers for Medicare and Medicaid Services(CMS) regulated testing procedures/analytes per the contractor’s established protocols.

4.8.3. Residual dried blood spots shall be stored at a facility that provides security, confidentiality, stability of temperature and humidity, and retrievability for 5 years. Stored specimens remain the property of the Department of Defense (DoD) throughout the storage period. The contractor shall retrieve and provide stored specimens to the DoD within 30 days upon request using contractor’s established protocols and with written authorization from the parent/guardian. If it is the contractor’s practice to dispose of filter paper blood spots following the 5 year period, the left over filter paper blood spots shall be disposed of and it shall be in a manner that ensures confidentiality. No filter paper blood spots can be used for research without the explicit consent of the newborn's parent/legal guardian, and approval by a DoD approved Institutional Review Board. Documentation of the storage, use and disposal of the residual dried blood spots shall be maintained and shall be made available to the DoD upon request.

4.8.3.1. Name and locations of all storage facilities shall be included as part of the proposal.

5. VOLUME. Annual quantity amounts are historical and not indicative of future requirements as the number of newborns requiring Newborn Screening cannot be accurately predicted (see Attachment 1).

D - Virginia Newborn Screening Program, Virginia Department of General Services, 600 North 5th Street, Richmond, VA 23219

1. INTRODUCTION. Newborn Screening is recognized nationally as an essential preventive public health measure. Newborn screening is the practice of testing all babies for certain disorders and conditions that can hinder their normal development. Babies with these conditions appear healthy at birth but can develop serious medical problems later in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.

2. PWS OVERVIEW. The contractor shall provide non-personal services of Newborn Screening to the patients in accordance with the terms and conditions of this contract at the Naval Medical Treatment Facilities (MTF) indicated in the awarded contract.

3. CONTRACT TYPE. Services will be provided under a Single Award Task Order (SATO) Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract establishes overall terms and conditions, but services are actually delivered by task orders issued under the awarded contract. In the event of a conflict between a task order and the basic contract, the basic contract governs.

4. SCOPE. Location of performance under this contract is Naval Medical Center Portsmouth, VA.

4.1. Specimen Collection Material Supply and Specimen Transport

4.1.1. The contractor shall provide a specimen collection kit and a special filter paper card in accordance with the contractor’s standard practice.

4.1.2. The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 24-48 hours of age, but not greater than the 4th day of life unless the clinical situation makes later collection necessary. If collected prior to 24-hours, the facility shall submit a second specimen in accordance with the contractor’s standard practice.

4.1.3. The MTF will complete the test request form (TRF) for Newborn screening, which contains fields for recording critical information about the baby.

4.1.4. Transport of specimens collected and to be tested by the contractor will be shipped by the MTF in accordance with the contractor’s standard practice.

4.1.5. The contractor shall retain dried blood spots for at least one year from date of test.

4.2. Training. Prior to submission of samples and as requested by the MTF during the life of this contract, the contractor shall provide the MTF staff with training, education and technical assistance regarding the proper sample collection process, sample shipment preparation and packaging, logistical coordination for sample processing, and physician education. Such training, education, or technical assistance may be provided in person, by phone, e-mail, webcam, video teleconference, videotape, or letter, as appropriate, to improve quality of specimen submission, decrease sample collection and patient identification errors, and reduce the need for newborn re-screens.

4.2.1. The contractor shall be not compensated separately for training.

4.3. Screening Tests

4.3.1. The contractor shall provide the MTF, Newborn screening services to include laboratory testing for the detection of a core set of conditions and report results for additional disorders detected by this testing. The conditions to be tested shall include those on the Recommended Uniform Screening Panel (which is hereby incorporated as reference), as recommended by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children with the approval of United States Department of Health and Human Services and as approved by state law. Any conditions that are added to the Recommended Uniform Screening Panel throughout this contract period shall be added to the set of conditions screened under this contract as they are able to be incorporated and validated by the contractor. The contract maybe modified if the cost of screening increases to include those conditions and or/if testing technologies change and/or improve.

4.3.2. The MTF shall be given a minimum of 180-days advance notice of a change of testing (Addition/Deletion/Modification of screened disorders and/or screening technologies). Contractor notification will consist of (at the minimum) an official letter, sent on contractor official departmental letterhead to the Contracting Officer, addressed to the MTF laboratory medical director and laboratory administrator. Additional disorders will be added as they are incorporated into the state’s Newborn Screening program and/or new disorders become prevalent. Changes in testing methodology may occur without notice, such as the addition or elimination of ratios, changes in analyte cut offs, etc.

4.4. Laboratory Testing and Analysis

4.4.1. The contractor shall provide newborn screening for all of the disorders as indicated in paragraph 4.3.1 above. In addition, when appropriate for initial screening or secondary testing, biochemical and molecular/genetic tests should be performed to clarify screening results, according to the contractor’s established protocols.

4.4.2. Repeat testing and/or confirmatory tests on the initially collected patient specimen shall be performed as appropriate if a test does not fall within normal limits on the initial screening test.

4.4.3. The contractor shall provide re-screening of newborns in cases of improper sample collection, technical problems such as patient identification errors or degradation of specimens during shipment/transport.

4.4.4. The contractor shall provide re-screening of all infants weighting less than 1500 grams at birth, and premature and sick infants requiring prolonged hospitalization according to the contractor’s established protocols and not separately invoiced.

4.5. Case Management for Screens

4.5.1. The contractor shall perform the required tests and then provide the results of the screen by electronic post to authorized personnel at the MTF. Results should be reported within 5 business days, but not longer than 7 business days of sample receipt. As a last resort for notification results, a copy of the results may also be mailed via United States Postal Service (USPS) to the physician of record or the ordering hospital according to the contractor’s standard practice and as agreed upon by the MTF.

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

4.5.3. Abnormal results of an urgent nature will be reported by phone, as well as by secure email, electronic post, or as a last resort be mailed via USPS, to the MTF newborn screening coordinator and the health care provider (as indicated on the screening card or by medical records at the MTF). Appropriate recommendations for further testing or follow up will be made.

4.5.4. The contractor shall monitor the newborn’s case until screening results are reported or diagnosis is confirmed.

4.6. Specialty Care for Positive Screens

4.6.1. A specialist in metabolic genetics, immunology and hematology will be available for consultation by phone or email to advise patient management, if required. Contact information for a specialist in pulmonology or endocrinology will be made available if indicated.

4.6.2. Specialists and/or the contractor’s newborn screening coordinators will assist in establishing appropriate follow up of screen positive babies.

4.6.3. The contractor shall be readily available for any particular questions by the MTF Healthcare Providers that may not have been covered in the Laboratory testing and provide quality customer service herein to the terms of the intent and terms of this contract.

4.6.4. The contractor shall contact the respective MTF laboratory to ensure a positive transfer of patient results (for all results, both normal and abnormal).

4.6.4.1. The MTF will record the Newborn Screen results into the appropriate Medical Records database (e.g., Composite Health Care System (CHCS), Health Artifact and Image Management Solution (HAIMS), etc.)

4.6.4.2. As part of continued follow-on care, the communication between the contractor and the MTF shall continue regularly without prompting from the MTF.

4.6.5. The contractor shall be not compensated separately for Specialty Care for Positive Screens.

4.7. Other Responsibilities

4.7.1. The contractor shall keep the Contracting Officer Representative (COR) informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

4.7.2. The contractor shall have reference laboratory representatives available to assist in problem solving at no additional cost to the Government with access to knowledgeable laboratory professionals with minimal call transfers and holding.

4.8. Quality Assurance

4.8.1. The contractor shall establish and maintain a Quality Assurance Program designed for medical surveillance to continuously monitor and improve quality of specimen collection, submission of required demographic information from submitting facilities, specimen analysis, and reporting of results. Quarterly review or report to be provided.

4.8.1.1. This program is to be included with the vendor's proposal.

4.8.2. The contractor shall participate in and maintain compliance with the Centers for Disease Control and Prevention's (CDC) quarterly external proficiency testing program for Newborn Screening (dried blot methodology) and also external proficiency testing programs for all Centers for Medicare and Medicaid Services(CMS) regulated testing procedures/analytes.

4.8.3. Residual dried blood spots shall be stored at a facility that provides security, confidentiality, stability of temperature and humidity, and retrievability for 1 year. Stored specimens remain the property of the Department of Defense (DoD) throughout the storage period. The contractor shall retrieve and provide stored specimens to the DoD within 7 days upon request. If it is the contractor’s practice to dispose of filter paper blood spots following the 1 year period, the left over filter paper blood spots shall be disposed of and it shall be in a manner that ensures confidentiality. No filter paper blood spots can be used for research without the explicit consent of the newborn's parent/legal guardian, and approval by a DoD approved Institutional Review Board. Documentation of the storage, use and disposal of the residual dried blood spots shall be maintained and shall be made available to the DoD upon request.

4.8.3.1. Name and locations of all storage facilities shall be included as part of the proposal.

5. VOLUME. Annual quantity amounts are historical and not indicative of future requirements as the number of newborns requiring Newborn Screening cannot be accurately predicted (see Attachment 1).

E - Washington Washington Newborn Screening Program, Washington State Department of Health, 1610 NE 150th Street, Shoreline, WA 98155

1. INTRODUCTION. Newborn Screening is recognized nationally as an essential preventive public health measure. Newborn screening is the practice of testing all babies for certain disorders and conditions that can hinder their normal development. Babies with these conditions appear healthy at birth but can develop serious medical problems later in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.

2. PWS OVERVIEW. The contractor shall provide non-personal services of Newborn Screening to the patients in accordance with the terms and conditions of this contract at the Naval Medical Treatment Facilities (MTF) indicated in the awarded contract.

3. CONTRACT TYPE. Services will be provided under a Single Award Task Order (SATO) Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract establishes overall terms and conditions, but services are actually delivered by task orders issued under the awarded contract. In the event of a conflict between a task order and the basic contract, the basic contract governs.

4. SCOPE. Locations of performance under this contract are Naval Hospital Bremerton, WA and Naval Health Clinic Oak Harbor, WA.

4.1. Specimen Collection Material Supply and Specimen Transport

4.1.1. The contractor shall provide a specimen collection kit and a special filter paper card in accordance with the contractor’s standard practice.

4.1.2. The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 18-48 hours of age. If collected prior to 18-hours or subsequent to 48 hours, the facility shall submit a second specimen in accordance with the contractor’s standard practice. A second specimen card is recommended for all babies at the first "well-baby" check at between 7-14 days following birth. There is no additional fee for this second screen.

4.1.3. The MTF will complete the test request form (TRF) for Newborn screening, which contains fields for recording critical information about the baby.

4.1.4. Transport of specimens collected and to be tested by the contractor will be shipped by the MTF in accordance with the contractor’s standard practice.

4.1.5. The contractor shall retain dried blood spots for at least one year from date of test.

4.2. Training. Prior to submission of samples and as requested by the MTF during the life of this contract, the contractor shall provide the MTF staff with training, education and technical assistance regarding the proper sample collection process, sample shipment preparation and packaging, logistical coordination for sample processing, and physician education.