PWS Newborn Screening.docx

PERFORMANCE WORK STATEMENT (PWS)

NEWBORN SCREENING TESTING SERVICES

5/22/25

Part 1 General Information

1. General: This is a non-personal services contract under which the personnel rendering these 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.

1.1 Description of Services/Introduction: This is a non-personal services contract to provide newborn screen testing to include blood and hearing testing.

1.2 Background: Contract is required by the Colorado Department of Public Health. Newborn Blood Spot Screening Program and Newborn Hearing Screening Program tracks data on hearing screening and follow-up for all babies born in Colorado up to age three.

1.3 Scope: The Contractor shall provide non-personal services (newborn screening testing) to the Evans Army Community Hospital (EACH), Department of Pathology, Fort Carson, Colorado. All tests shall be executed at the Contractor’s premises, or within the Contractor’s network of laboratories.

1.4 Objectives: The objective of this contract is to provide newborn lab screening and newborn hearing testing for all newborns requiring tests.

1.5 General Information: Colorado Department of Health requires newborn laboratory and hearing testing be available to all parents who want them in the state of Colorado.

1.5.1 Quality Control (QC) Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of this contract.

The Contractor’s Proposed QCP shall be submitted to the contracting officer (KO) through the KO’s representative (COR) for review within 10 days of contract award.

The government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 10 days. If the government has provided comments, the Contractor shall then have 10 days to submit a final QCP. After receipt of the final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than (NLT) 10 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance of proposed changes. At minimum, the QCP shall include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of War (DoW) Contractor Personnel Office (DOWCPER) processes/approvals throughout contract performance;

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7 Key Control);

(f) How the Contractor will inventory and track maintenance of all government-provided equipment (GPE) / materials (GFM);

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all QC-related documents for the life of the contract plus five years.

1.5.1.1 An analysis of QC and timeliness of submittals (i.e. deliverables) shall be provided to the COR within 30 days from completion of each option period.

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within four (4) hours of identifying those issues. Verbal reports shall be followed up with written reports within two (2) days.

1.5.2 Quality Assurance: The government will evaluate the Contractor’s performance under this contract IAW the government’s Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the government will do to ensure that the Contractor has performed IAW performance standards. It defines how performance standards will be applied, frequency of surveillance, and acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on US federally recognized holidays occurring during the normal workweek unless otherwise directed by the KO. When a US holiday occurs on a Saturday or a Sunday, the holiday is observed the preceding Friday or following Monday, respectively.

Christmas Day December 25th

1.5.4 Operating Hours: The government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The government facility office hours are 0800 to 1700, Monday through Friday except US holidays identified in paragraph 1.5.3.1 or when the government facility is closed due to local or national emergencies, administrative closings, or similar government-directed facility closings.

1.5.4.2 Government Facility Operating Hours: The government facility operating hours occur between the hours of 0600 to 1800, Monday through Saturday. The government facility is open for operations during the recognized US holidays identified in paragraph 1.5.3.1. The government facility may close due to local or national emergencies, administrative closings, or similar government-directed facility closings and will be communicated by the KO to the Contractor.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0600 to 1800, Monday through Saturday the facility is open during local or national emergencies, administrative closings, or similar government-directed facility closings.The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: Reserved

1.5.5 Training Holidays: Reserved

1.5.6 Place of Performance: All tests shall be executed at the Contractor’s premises, or within the Contractor’s network of laboratories.

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: Reserved

1.6.2 Personnel Security Clearance Requirements: Reserved

1.6.3 Installation Access: Reserved

1.6.3.1 Installation Pass Log: Reserved

1.6.3.2 Individual Termination or Expiration of Employment: Reserved

1.6.3.3 Contract Termination or Cancellation: Reserved

1.6.3.4 Common Access Cards (CAC) and CAC Log: Reserved

1.6.4 Background Checks: Reseved

1.6.4.1 U.S. Citizen: Reserved

1.6.4.2 Local Nationals and Third Country Nationals: Reserved

1.6.5 Physical Security: The Contractor shall safeguard all government equipment, information, and property provided for Contractor use.

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Key Control: Reserved

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post-award conference convened by the contracting activity or contract administration office IAW FAR Subpart 42.5. The KO, COR, and other government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings, the KO will apprise the Contractor of how the government views the Contractor's performance and the Contractor shall apprise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.8.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the KO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the KO. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any terms and conditions of this contract. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including government drawings, designs, specifications, monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies, coordinate availability of government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: The following personnel are considered key personnel by the government: Newborn Screening Program Manager. The Contractor shall provide a Program/Contract Manager responsible for performance of work. The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the KO NLT five (5) days of contract award (Acceptance of the CV by the KO is required before these individuals are permitted to perform any task on this contract.) The Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Contract Manager or Alternate Contract Manager shall be available IAW paragraph 1.5.4.1. Qualifications for all key personnel are listed below:

a. Contract Manager and Alternate Contract Manager: Reserved

b. Quality Control Manager: Reserved

c. Systems Administrator: Reserved

d. Special Qualifications: Reserved

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering government telephones, and working in other situations where their Contractor status is not obvious to third parties shall identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12. Reserved

1.13 Contractor Travel: Reserved

1.14 Other Direct Costs (ODCs): Reserved

1.15 Data Rights: The government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be government owned and are the property of the government with all rights and privileges of ownership and copyright belonging exclusively to the government. These documents and materials shall not be used or sold by the Contractor without written permission from the KO. All materials supplied to the government shall be the sole property of the government and may not be used for any other purpose. This right does not abrogate any other government rights.

1.16 Non-Disclosure Requirements: Reserved

1.17 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.18 Non-Disclosure Statements: Reserved

1.19 Organizational Conflict of Interest (OCI): Reserved

1.20 Phase In /Phase Out Period: Reserved

1.21 Safety: Reserved

1.22 Environmental Compliance: The following provides information on Environmental Compliance.

1.22.1 Environmental Compliance Plan and Program: Reserved

1.23 Required Training: The following provides information on training requirements.

1.23.1 Anti-Terrorism (AT) Level I Training: Reserved

1.23.2 OPSEC Training: Reserved

1.23.3 iWATCH Training: Reserved

1.23.4 Information Assurance (IA) Training: Reserved

1.23.5 Personally Identifiable Information (PII): Reserved

1.24 Reserved

1.25 Notice to Proceed: A notice to proceed will be provided as indicated below.

1.26 Government Property and Services: Reserved

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the government (Note: The only individual who can legally bind the government).

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the contracting officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or services to the government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the performance work statement.

Deliverable – means anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, government-furnished property “means property in the possession of, or directly acquired by, the government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the government for continued use under this contract.

Government Property - means all property owned or leased by the government.Government property includes both government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the contracting officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key government-developed surveillance process document, and is applied to performance-based service contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the performance work statement (PWS). It provides specific details on how the government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas `necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The government does not have privity of contract with the subcontractor.

Work Day - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: Reserved

3.2 Facilities: Reserved

3.3 Utilities: Reserved

3.4 Equipment: Reserved

3.5 Special Tooling and Test Equipment: Reserved

3.6 Materials: Reserved

3.7 Training: Reserved

3.8 Common Access Cards (CAC): Reserved

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services.

4.2 Secret Facility Clearance: Reserved

4.3 Materials: Reserved

4.4 Vehicles and Equipment: Reserved

4.5 Background Checks): Reserved

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide newborn screening testing services to the Evans Army Community Hospital, Department of Pathology, Fort Carson, Colorado. The contractor shall perform all Newborn Lab testing and hearing.Report normal test results withing seven working days

5.2 Tasks: Tasks consist of the following:

5.2.1 The Contractor shall provide all management services, planning, programming, administration, supervision, personnel, labor, materials, facilities, transportation, general and specialized equipment, supplies and execution necessary to provide the specified services.

5.2.2 The Contractor shall perform all work IAW this contract and all applicable federal and state laws, regulations, and directives to include applicable publications and instructions.

5.2.3 The Contractor shall compile historical data, prepare required reports, and submit information as specified in this contract.

5.2.4 The Contractor shall ensure all laboratory facilities used to perform the requirements of this contract meet and maintain all state, Federal and occupational standards, certification(s), accreditation(s), license(s), etc., required when executing performance under this contract.

5.2.5 The Contractor shall ensure work meets quality and timeliness requirements specified in this contract, to include scheduling changes(s) of technicians, courier services and responding to critical requirements such as emergency contingencies.

5.2.6 Report of normal test results shall be provided within seven working days.

5.2.7 Abnormal rest results shall be reported immediately by telephone to the physician of record and to designated consultants. In case of inability to identify or locate a physician of record, the abnormal test result will be reported to the hospital or submitting agency which originated the specimen, or if the birth did not occur in a health facility, to the father or mother.

5.2.8 The Contractor shall ensure all CSPs are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

5.2.9 The Contractor shall ensure all testing and supervisory personnel at all Contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, and/or accrediting organizations' and State standards.

5.3 Service Contract Reporting

5.3.1 System for Award Management (SAM) Service Contract Report (SCR): Reserved

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria. Select View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

· Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

· Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able to view the current SCR, edit available fields, and resubmit the record. You can also delete previously entered information altogether.

STD: All information provided by the Contractor shall be accurate, complete, and not exceed suspense dates noted in corresponding paragraph above.

AQL: 100% Compliant

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

PART 7

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PWS para 5.1 The Contractor shall provide newborn screening testing services to the Evans Army Community Hospital, Department of Pathology, Fort Carson, Colorado.

Periodic Inspection

PWS para 5.2.2 The Contractor shall perform all work in accordance with this contract and all applicable Federal and state laws, regulations, and directives to include applicable publications and instructions.

Periodic Inspection

AUG 22