Combined Synopsis Solicitation 75D301-20-R-68044.docx

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a written solicitation will not be issued.

The solicitation number for this requirement is 75D301-20-R-68044 and is hereby issued as a Request for Proposal (RFP).

The Centers for Disease Control and Prevention intends to award a single source, firm-fixed-price, indefinite delivery, indefinite quantity contract for the following requirement, please either fill in the dollar amounts or provide a separate excel spreadsheet containing the same information including a list of line item number(s) and items, quantities, units of measure, and options, if applicable:

Base Period (09/24/2020 – 09/23/2021) Items:

NSP

NSP

Pricing – to be determined upon award

Provide the number of participants that can be processed for each option.

Provide any applicable discounts for bulk testing rates.

Provide any applicable bulk/scalable discount rates.

Provide any applicable domestic and international rates.

*If any other costs are anticipated, price them in this table. Multiple rows can be added for various test names/examples.

Minimum and Maximum Ordering Amounts Minimum Single Order Amount: $2,500.00 Maximum Single Order Amount: $2,000,000.00 The ceiling price for this contract (i.e. cumulative value of all task orders) is $30,000,000.00.

Minimum Guarantee This contract guarantees that task order(s) amounting to a minimum of two thousand five hundred dollars ($2,500.00) will be issued during the first 12 months of the contract period of performance. In the event the Contractor(s) receives obligations of less than this minimum, during the 12 months, the Government will fund the difference between the actual obligation and the guaranteed minimum. Once a task order is issued for $2,500.00 or more during the 12 months of the period of performance, the government has satisfied its minimum guarantee.

Maximum Contract Value The aggregate maximum value of all combined awards made under this solicitation shall not exceed $30,000,000.00. If the Government's requirements for services set forth in the solicitation do not result in orders in the amounts described as “maximum," the event shall not constitute the basis for an equitable price adjustment under this contract.

Task Order Pricing Task orders issued under this contract shall be Fixed-Price.

Firm Fixed Price (FFP) The Firm-Fixed Price for each task order will be negotiated based on the price to complete the work. After acceptance of a fixed price task order by the Contractor(s), the task order price will only be adjusted to reflect changes in scope or conditions.

Place of Work and Government-Furnished Equipment Work under the contract shall be conducted off-site at Contractor(s) locations, or at other off-site locations. On-site meetings with CDC staff may be required. Each task order will specify location requirements.

Service Contract Act The contract labor categories are considered professional services and are generally exempt from the Service Contract Act. However, each task order will be reviewed for applicability.

Contract Structure The term of this IDIQ contract is 12 months. It is anticipated that multiple task orders will be issued throughout the period of performance to the Contractor(s)s to work on areas identified in the Scope of Work.

Issuance of Task Orders Each task order shall have a discrete period of performance independent of the basic contract and no task order shall extend beyond the expiration date of the basic contract. Each task order will be negotiated separately, funded individually, and will have its own tracking number. Task orders will be issued electronically by a contracting officer.

All tasks orders will be solicited by email. Contractor(s) will have a maximum of 7 days to respond; however, the expected response deadline will typically be twenty-four (24) hours. The response deadline will be identified in each request for task order proposal (RFTOP).

Health Resources Priorities and Allocations System HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

It is the offeror's responsibility to be familiar with the applicable clauses and provisions. Clauses and provisions may be accessed via the Internet at website http://farsite.hill.af.mil.

An IDIQ contact will be issued in writing to the successful offeror. To be eligible to receive an award resulting from this solicitation, contractor must be registered in the System for Award Management. To register apply via the Internet at http://www.sam.gov. For questions on registration contact Federal Service Desk at 866-606-8220.

Include FAR 52.212-3, Offeror Representations and Certifications with Offer or indicate if it is available online at SAM.gov.

No telephonic proposals will be processed. All Questions must be received by email no later than 1:00 P.M., EDT on 07 July 2020. Questions will not be taken by telephone. All responses must be received no later than 1:00 P.M., EDT on 17 July 2020. Please send any questions and proposals to Eric Lyons at kpy2@cdc.gov.

STATEMENT OF WORK (SOW)

Title of Project: Establishing a Commercial COVID-19 Emergency Response Team (C-C19ERT)

1 Background and Need

The CDC is contracting commercial emergency response team services for the collection of samples possibly containing COVID-19. This work establishes a commercial contract for supporting CDC emergency response team duties, including sample collection and the logistics and quality control metrics that ensure subsequent, high-quality, CLIA laboratory testing. This commercial service will be critical to ensuring continuity of operations during CDC’s response to the COVID-19 pandemic and will be referred to as the C-C19ERT (pronounced C-CERT, or \ 'sē -ˌsərt \ phonetically).

2 Project Objective

The objective of this indefinite delivery, indefinite quantity (IDIQ), sole source, service contract is to acquire professional services in the staffing, deployment, and management of a Commercial COVID-19 Emergency Response Team (C-C19ERT).

3 Scope of Work

The unique nature, scope, and complexity of the scientific, technical, expert, operational, and logistical services needed will vary to support remote COVID-19 sample collection. The C-C19ERT will be activated by CDC and work either in tandem with or independent of CDC in the collection, processing, shipping, tracking, storage, testing, and reporting of specimens suspected of COVID-19 exposure. The C-C19ERT will perform these specimen services as they are defined at the task order level. In the completion of the project tasks, the Contractor shall provide all labor, materials, and equipment using current infrastructure and in-house logistics.

Because deployment environments vary, tasks will be planned by the services performed, rather than the volume of supplies or reagents used. If specific sampling requirements are needed by CDC, those needs will be defined at the task order level. For example, a task order may specify the sample type, participant demographics, locale, or as defined. The Contractor will review and prepare the C-C19ERT prior to their site deployment. If a task order’s requirements exceed the Contractor’s immediate capabilities, the Contractor must be prepared to provide equal or greater subcontracted capabilities.

CDC will designate the C-C19ERT’s on-site and remote reporting structures for each task order, including appropriate points of contact (POCs). This will ensure that the C-C19ERT has a delegated CDC POC at the site of deployment and at CDC headquarters in Atlanta, Georgia. If any challenges arise that threaten the completion of a task order and cannot be resolved by the task order POCs, the Contractor will contact this basic IDIQ’s contracting officer and contracting officer’s representative as soon as possible.

4 Technical Requirements

Independently, and not as an agent of the Government, the Contractor shall furnish all qualified and acceptable personnel to perform the tasks identified in the Performance Work Statement (PWS). All Contractor staff deployed in the C-C19ERT must have certificates of completion for all the following trainings from the Federal Emergency Management Agency (FEMA) before arriving on the site designated in each task order (Attachment F1).

1. IS-100.C: Introduction to the Incident Command System, ICS 100 At the completion of this course, students will be able to:

· Explain the principles and basic structure of the Incident Command System (ICS).

· Describe the NIMS management characteristics that are the foundation of the ICS.

· Describe the ICS functional areas and the roles of the Incident Commander and Command Staff.

· Describe the General Staff roles within ICS.

· Identify how NIMS management characteristics apply to ICS for a variety of roles and discipline areas.

2. IS-200.C: Basic Incident Command System for Initial Response At the completion of this course, students will be able to describe the course objectives and summarize basic information about the Incident Command System (ICS) and National Incident Management System (NIMS):

· Describe how the NIMS Management Characteristics relate to Incident Command and Unified Command.

· Describe the delegation of authority process, implementing authorities, management by objectives, and preparedness plans and objectives.

· Identify ICS organizational components, the Command Staff, the General Staff, and ICS tools.

· Describe different types of briefings and meetings.

· Explain flexibility within the standard ICS organizational structure.

· Explain transfer of command briefings and procedures.

· Use ICS to manage an incident or event.

3. IS-700.B: An Introduction to the National Incident Management System At the completion of this course, students will be able to:

· Describe and identify the key concepts, principles, scope, and applicability underlying NIMS.

· Describe activities and methods for managing resources.

· Describe the NIMS Management Characteristics.

· Identify and describe Incident Command System (ICS) organizational structures.

· Explain Emergency Operations Center (EOC) functions, common models for staff organization, and activation levels.

· Explain the interconnectivity within the NIMS Management and Coordination structures: ICS, EOC, Joint Information System (JIS), and Multiagency Coordination Groups (MAC Groups).

· Identify and describe the characteristics of communications and information systems, effective communication, incident information, and communication standards and formats.

C-C19ERT members should also complete CDC training on How to Complete CDC’s Revised Specimen Submission Form.

If needed, additional training may be required at the task order level. All completed training certificates will be maintained by the Contractor, supplied to the CDC upon request, and provided as an appendix in the final report for each task order.

Before the C-C19ERT is deployed on a task order, each member will be cleared with a temperature check that does not indicate fever and be able to answer no to the following questions (*):

1. Have you experienced any of the following symptoms in the past 48 hours:

· feeling feverish (subjective or measured at >100.0°F)

· cough

· shortness of breath or difficulty breathing

· sore throat

· muscle or body aches

· change in smell or taste

2. Within the past 14 days, have you been in close physical contact (6 feet or closer) with a person who is known to have laboratory-confirmed COVID-19 or in close contact with anyone who has any of the symptoms listed in question #1.

3. Within the past 14 days, have you received instruction from a public health or medical professional to self-monitor, self-isolate, or self-quarantine because of concerns about COVID-19 infection? This includes you receiving a COVID-19 test, with results still pending.

*These questions may change at the task order level as new public health information becomes available.

All activities, work products, reports, and deliverables developed/performed/conducted by the Contractor on behalf of CDC shall be subject to review and approval by CDC. Any communication on be-half of CDC by the Contractor with non-CDC individuals, organizations, groups, companies, or agencies must have prior approval by CDC.

The Contractor shall provide a technical and customer service process for all sample collections and test reports. All inquiries and feedback shall be logged throughout the contract award and reported back to the CDC in each task order’s final report. The Contractor shall comply with any federal, state, or local regulations applicable to the task’s completion. For instance, the Contractor must comply with federal regulations when interacting with or collecting samples from human subjects and will submit their human subjects research and clinical protections documentation with each task order proposal.

The Contractor shall maintain an electronic platform to support the CDC in reviewing the samples collected and/or the test results reported. This platform should be able to adapt to simple data analytics requests. For instance, CDC may need to sort test reports by positive results, geographic location, or as defined in the task order.

Within the two general areas of support, the Contractor may be required to perform the types of tasks listed below. Performance of all areas of support and tasks may be required concurrently on multiple projects and tasks. Although the Contractor shall be expected to provide all services listed in the PWS, it is not expected that the successful Contractor shall have the capabilities to perform all of the required services included in the scope of work for this acquisition. Therefore, the Government anticipates that subcontracting for some limited services (e.g. laboratory services, expert panel members, highly specialized expertise) may be necessary.

Task Area 1: Sample Collection Logistics

The Commercial COVID-19 Emergency Response Team (C-C19ERT) will be deployed alongside or independently of the CDC. When a need is determined, a request for proposal will be issued to the Contractor. Task orders may be specific to a COVID-19 outbreak at a single or series of geographic locations.

Once on-site, the priority for sample collection and testing will follow the incident command (or lead agency’s) direction. In the absence of incident command or lead agency specifications, the Contractor will prioritize collection based on the CDC task order or by the priority listed at CDC’s website for “Evaluating and Testing Persons for Coronavirus Disease (COVID-19)” at https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html.

These priorities could include (as listed on 6/11/2020):

1. High priority samples:

· Hospitalized patients with symptoms

· Healthcare facility workers, workers in congregate living settings, and first responders with symptoms

· Residents in long-term care facilities or other congregate living settings, including prisons and shelters, with symptoms

2. Priority samples:

· Persons with symptoms of potential COVID-19 infection, including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat

· Persons without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals according to state and local plans During sample collection, the C-C19ERT will collect the following intake information or as defined by site incident management, lead agency, or at the task order level:

1. Indicate the C-C19ERT member logging the specimen

2. Indicate the C-C19ERT member processing the specimen

3. Indicate the C-C19ERT member testing the specimen, if applicable

4. Assign/record a patient number

5. Patient Name (Last, First)

6. Patient Date of Birth (YEAR/MM/DD)

7. Patient Gender (Male/Female)

8. Ordering Physician and contact information, if applicable

9. Assign a specimen number, if different than the patient number

10. Date and Time Collected (YEAR/MM/DD, 00:00 AM or PM)

11. If collection site is a nursing home or communal living facility, indicate if the sample is obtained from a resident or staff

12. Patient full address, telephone number, and email address

13. Patient’s physician and contact information, if possible

14. Indicate the tests (viral and/or serological) to be run.

15. Indicate the number of specimens collected for each specimen source and identify the specimen source(s):

· Nasopharyngeal swab

· Nasal swab

· Sputum

· Other

· Gold SST serum

· Orange RST serum

· Red serum

· Pearl PST plasma

· Lavendar plasma

At the task order level, the C-C19ERT may be required to perform testing on-site (or at their laboratory site following sample shipment).

1. The Contractor shall report the test protocols used and the test results obtained to CDC (example: CLIA protocol, Lab SOP, and as defined further in each task order).

2. The Contractor shall report to CDC all sample logs and results (example: Sample Logs, Shipping Manifests, and as defined further in each task order).

3. Collection and/or testing from each task order should begin no later than 48 hours after task order award.

4. The Contractor shall report the test results and services to CDC (example: summaries at technical conferences and meetings, customer distribution email lists, other federal clients, and as defined further in each task order).

5. All related marketing and communication materials or supporting documents shall be approved by CDC prior to release.

6. Each task order requesting Contractor testing may include a pilot test of 10 samples and test report. If the Contractor performance in this pilot test does not yield data comparable to the CDC’s evaluation of the same samples within a 90% confidence interval, the CDC may require a re-work and/or additional statement on test confidence, including a documentation of the Contractor’s quality controls and their direct impact on test confidence.

The C-C19ERT will follow the site incident management, lead agency, or task order instructions for site decontamination processes. Examples of the disinfectants that can be used to decontaminate a work site can be found at https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19. All laboratory waste from testing suspected or confirmed COVID-19 patient specimens should be handled like all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that laboratory waste needs any additional packaging or disinfection procedures.

Task Area 2: Sample Collection Quality Control (Respiratory and Whole Blood Specimens)

The C-C19ERT shall follow sample collection guidelines specified by the site incident management, lead agency, or as listed at the task order level. These guidelines will include at a minimum those listed for respiratory specimens on the CDC’s website for “Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)” at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html and a modification of those listed for whole blood specimens at https://emergency.cdc.gov/labissues/specimens_shipping_instructions.asp. This list of guidelines is regularly updated.

Other specimens may be needed at the task order level, although they are not currently included in the CDC public-facing specimen collection webpages. These specimens could include but not be limited to additional matrices like saliva, urine, hair, skin swabs, and/or fecal samples. There may also be a need for pediatric patient sampling.

In brief, the specification for sample collection will include:

Respiratory Specimens for Viral Testing For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing an upper respiratory specimen. The following are acceptable specimens:

· NOTE: Use only synthetic fiber swabs with plastic or wire shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. CDC is now recommending collecting only the NP swab, although OP swabs remain an acceptable specimen type. If both NP and OP swabs are collected, they should be combined in a single tube to maximize test sensitivity and limit use of testing resources.

1. A nasopharyngeal (NP) specimen

· Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

2. An oropharyngeal (OP) specimen

· Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

3. A nasal mid-turbinate swab

· Use a flocked tapered swab. Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at turbinates). Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.

4. An anterior nares (nasal swab) specimen

· Using a flocked or spun polyester swab, insert the swab at least 1 cm (0.5 inch) inside the nostril (naris) and firmly sample the nasal membrane by rotating the swab and leaving in place for 10 to 15 seconds. Sample both nostrils with same swab.

5. Nasopharyngeal wash/aspirate or nasal wash/aspirate (NW) specimen collected by a healthcare provider.

· Attach catheter to suction apparatus. Have the patient sit with head tilted slightly backward. Instill 1 mL-1.5 mL of non-bacteriostatic saline (pH 7.0) into one nostril. Insert the tubing into the nostril parallel to the palate (not upwards). Catheter should reach depth equal to distance from nostrils to outer opening of ear. Begin gentle suction/aspiration and remove catheter while rotating it gently. Place specimen in a sterile viral transport media tube.

· Swabs should be placed immediately into a sterile transport tube containing 2-3mL of either viral transport medium (VTM), Amies transport medium, or sterile saline, unless using a test designed to analyze a specimen directly, (i.e., without placement in VTM), such as some point-of-care tests.

· If VTM is not available, see the standard operating procedure for public health labs to create viral transport medium (Attachment F2) in accordance with CDC’s protocol.

· The NW specimen and the non-bacteriostatic saline used to collect the specimen should be placed immediately into a sterile transport tube.

· Generic Collection Guidelines on timing and swab types can be found in Attachment F1.

6. Testing lower respiratory tract specimens is also an option. For patients who develop a productive cough, sputum should be collected and tested for SARS-CoV-2.

· Educate the patient about the difference between sputum and oral secretions (saliva). Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap collection cup or sterile dry container.

· The induction of sputum is not recommended. When under certain clinical circumstances (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen.

· Bronchoalveolar lavage, tracheal aspirate, pleural fluid, lung biopsy

· Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container.

· Due to the increased technical skill and equipment needs, collection of specimens other than sputum from the lower respiratory tract may be limited to patients presenting with more severe disease, including people admitted to the hospital and/or fatal cases.

Collecting and Handling Specimens Safely:

1. For providers collecting specimens or within 6 feet of patients suspected to be infected with SARS-CoV-2, maintain proper infection control and use recommended personal protective equipment (PPE), which includes an N95 or higher-level respirator (or facemask if a respirator is not available), eye protection, gloves, and a gown, when collecting specimens.

2. For providers who are handling specimens, but are not directly involved in collection (e.g. self-collection) and not working within 6 feet of the patient, follow Standard Precautions; gloves are recommended. Healthcare personnel are recommended to wear a form of source control (facemask or cloth face covering) at all times while in the healthcare facility.

3. PPE use can be minimized through patient self-collection while the healthcare provider maintains at least 6 feet of separation.

Handling Bulk-Packaged Sterile Swabs Properly for Upper Respiratory Sample Collection:

1. Sterile swabs for upper respiratory specimen collection may be packaged in one of two ways:

· Individually wrapped (preferred when possible)

· Bulk packaged

2. Bulk-packaged swabs may be used for sample collection; however, care must be exercised to avoid SARS-CoV-2 contamination of any of the swabs in the bulk-packaged container.

· Before engaging with patients and while wearing a clean set of protective gloves, distribute individual swabs from the bulk container into individual disposable plastic bags.

· If bulk-packaged swabs cannot be individually packaged:

· Use only fresh, clean gloves to retrieve a single new swab from the bulk container.

· Close the bulk swab container after each swab removal and leave it closed when not in use to avoid inadvertent contamination.

· Store opened packages in a closed, airtight container to minimize contamination.

· Keep all used swabs away from the bulk swab container to avoid contamination.

· As with all swabs, only grasp the swab by the distal end of the handle, using gloved hands only.

· When patients are self-collecting their swabs under clinical supervision:

· Hand a swab to the patient only while wearing a clean set of protective gloves.

· The patient can then self-swab and place the swab in transport media or sterile transport device and seal.

· If the patient needs assistance, you can help the patient place the swab into transport media or a transport device and seal it.

Storage:

· Store specimens at 2-8°C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70°C or below.

Shipping:

· Shipping instructions will be defined by the site incident management, lead agency, or at the task order level. General shipping instructions in the absence of the above are as follows:

· Samples may be shipped to CDC by contacting CDC at respvirus@cdc.gov prior to submitting samples.

· If shipping samples to CDC: If specimens will ship without delay, store specimens at 2-8°C, and ship overnight to CDC on ice pack. If a delay in shipping will result in receipt at CDC more than 72 hours after collection, store specimens at -70°C or below and ship overnight to CDC on dry ice.

· Additional useful and detailed information on packing, shipping, and transporting specimens can be found at Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).

· Specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations.

· Pack and ship suspected and confirmed SARS-CoV-2 patient specimens, cultures, or isolates as UN 3373 Biological Substance, Category B.

· Label each specimen container with the patient’s ID number (e.g., medical record number), unique CDC or state-generated nCov specimen ID (e.g., laboratory requisition number), specimen type (e.g., serum) and the date the sample was collected. Complete a CDC Form 50.34 for each specimen submitted (Attachment F4). In the upper left box of the form, 1) for test requested select “Respiratory virus molecular detection (non-influenza) CDC-10401” and 2) for At CDC, bring to the attention of enter “Unit 84 (Non-flu Resp Virus)”.

· Specific labels for each task order should be taken with the C-C19ERT to facilitate labeling tubes more time effectively.

· For additional information, consultation, or the CDC shipping address, contact the CDC Emergency Operations Center (EOC) at 770-488-7100.

· If the box is received at the Contractor’s laboratory for testing as defined at the task order level, the above criteria should be verified as being present, and the temperature of the box contents should be verified to be 1 °C – 10 °C.

· This verification should be included in the task order final report, if applicable.

Whole Blood Specimens for Serological Testing

1. Whole blood specimens should be collected by a phlebotomist into a 5 mL blood vacutainer, including:

· Gold SST serum

· Orange RST serum

· Red serum

· Pearl PST plasma

· Lavendar plasma

2. Samples should be spun within 24 hours (and prior to shipment if this time frame may be exceeded prior to laboratory arrival).

· The sample is stable for 7 days at 2-8°C once separated from a clot or red blood cells, or in a gel separator tube. If testing will be delayed more than 7 days, store at -20°C or colder.

4. Label each specimen container with the patient’s ID number (e.g., medical record number), unique CDC or state-generated nCov specimen ID (e.g., laboratory requisition number), specimen type (e.g., serum) and the date the sample was collected. Complete a CDC Form 50.34 for each specimen submitted (Attachment F4).

· Specific labels for each task order should be taken with the C-C19ERT to facilitate labeling tubes more time effectively.

5. Packaging consists of the following components: primary receptacles (blood tubes or urine cups), secondary packaging (materials used to protect primary receptacles), and outer packaging (polystyrene foam-insulated, corrugated fiberboard shipper).

· To facilitate processing, package all blood tubes from the same patient together.

· Place absorbent material between the blood tubes and the first layer of secondary packaging. Use adequate absorbent material to absorb the entire contents of the blood tubes.

· Separate each tube of blood collected from other tubes to prevent tube-to-tube contact.

· Wrap and seal the first layer of secondary packaging (e.g., gridded box) with absorbent material.

· Seal one wrapped gridded box or alternative container inside a clear, leak-proof biohazard polybag equivalent to Saf-T-Pak product STP-701, STP-711 or STP-731.

· Place this bag inside a white Tyvek® outer envelope (or equivalent) and seal the opening with a continuous strip of evidence tape initialed half on the packaging and half on the evidence tape by the individual making the seal.

· According to 49 CFR 173.199(b), if specimens are to be transported by air, either the primary receptacle or the secondary packaging used must be capable of withstanding, without leaking, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). Verify in advance that the manufacturer of either the blood tube or secondary packaging used in your facility is in compliance with the pressure differential requirement.

6. For outer packaging of the blood tubes, use polystyrene foam-insulated, corrugated fiberboard shipper (may be available from your transfusion service or send-outs department).

· For cushioning, place additional absorbent material in the bottom of the shipper.

· Add a single layer of refrigerator packs on top of absorbent material.

· Place the packaged specimens on top of the refrigerator packs.

· Use additional cushioning material to minimize shifting while the shipper is in transit.

· Place additional refrigerator packs on top of the secondary packaging to maintain a shipping temperature of 1 °C – 10 °C

7. Place blood shipping manifest in a sealable plastic bag and put on top of packs inside the shipper. Place lid on the shipper.

8. Place a return address in the upper left-hand corner of the shipper top and put CDC’s receiving address in center.

9. Affix labels and markings adjacent to the shipper’s/consignee’s address that appears on the shipper.

10. Place the UN 3373 label and the words “Biological Substance, Category B” adjacent to the label on the front of the shipper.

11. If the box is received at the Contractor’s laboratory for testing as defined at the task order level, the above criteria should be verified as being present, and the temperature of the box contents should be verified to be 1 °C – 10 °C.

· This verification should be included in the task order final report, if applicable.

5 Reporting Schedule

In addition to specific reporting requirements defined in each Task Order, the Contractor shall furnish weekly progress reports detailing current status of each Task Order under the IDIQ. The report(s) shall be narrative in form, and shall include summary of progress towards completion of each Task Order and any problems encountered to date, including the Contractor’s assessment of the specific impact of such problems on scheduled date of completion of milestones. The Contractor will also schedule phone calls with the CDC to communicate the current status of task orders and any safety, security, or delays that pose risks to satisfactory task order completion.

6 Deliverables and Milestones Specific deployment deliverables and milestones will be determined at the task order level.

7 Special Requirements

All activities, work products, reports, and deliverables developed/performed/conducted by the Contractor on behalf of CDC shall be subject to review and approval by CDC. Any communication on be-half of CDC by the Contractor with non-CDC individuals, organizations, groups, companies, or agencies must have prior approval by CDC.

If the Contractor suggests any revisions to the base PWS or subsequent Task Order PWS documents, the Contractor will submit their proposed revisions (tracked) with their proposal for CDC consideration. These changes could be due to policy or technical changes in U.S. emergency response guidance.

CLAUSES

FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jun 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101note).

X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C.657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (13) [Reserved] __ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) (15 U.S.C.644).

__ (ii) Alternate I (Mar 2020).

__ (iii) Alternate II (Nov 2011).

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Mar 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Mar 2020) of 52.219-9.

__ (v) Alternate IV (Aug 2018) of 52.219-9 __ (18) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C.637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f).

X (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2020) (15 U.S.C. 632(a)(2)).

(ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

(26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15 U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (June 2003) (E.O.11755).

X (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) (E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (30) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

X (31) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

__ (ii) Alternate I (July 2014) of 52.222-35.

X (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

__ (ii) Alternate I (July 2014) of 52.222-36.

X (33) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

X (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (35) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37)

(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

X (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

__ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

__ (57) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

__ (58) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

__ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

__ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

X (61) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (62) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Feb 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] X (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

__ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

X (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

X (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

X (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items.