Combined Synopsis Solicitation W81XWH22Q0033.docx
DOCX document 103 KB Posted
- Solicitation number
- W81XWH22Q0033
- Issued by
-
Department of the Army Medical Command
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Amendment 0001 to Combined Synopsis Solicitation W81XWH22Q0033.docx | DOCX document | |
| Attachment 1 - The U.S. Army Public Health Center (APHC) Scopes of Accreditation Plan.xlsx | XLSX spreadsheet |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
W81XWH22Q0033
This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 13-Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and no other solicitation will be issued. T
The solicitation number is W81XWH22Q0033.
The solicitation is issued as a Request for Quotes (RFQ). Provisions and clauses in effect through Federal Acquisition Circular 2021-07; 11 August 2021. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at: https://www.acquisition.gov/far/.
The NAICS Code is 541990, with a small business size standard of $16,500,000 million dollars. The requirement is full and open with no set-aside restrictions.
Section SF 1449 - CONTINUATION SHEET
PWS AND QASP
Title: Laboratory Accreditation in accordance with ISO/IEC 17025:2017, TNI Standards: 2016, EPA National Lead Lab Accreditation Program Accreditation
Requiring Activity Name: U.S. Army Public Health Center (APHC)
1. INTRODUCTION
The U.S. Army Public Health Center (APHC) is part of the U.S. Army Medical Command (MEDCOM) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health Enterprise.
2. PURPOSE AND BACKGROUND
The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Army’s Public Health Enterprise.” The U.S. Army Public Health Center (APHC) Laboratory Sciences Directorate’s (LAB) mission is to provide quality sample analysis data to allow decision makers to enhance Army readiness and assure the quality and effectiveness of the APHC Laboratory. Laboratory accreditation is vital to provide certification and verification of the quality of the LAB analyses in its mission to support the soldiers, civilians, and military family members in the Army community.
As part of the APHC mission, the LAB performs analyses of environmental, biological, and Environmental Lead samples in Army operating environments and military bases to ensure the safety and security of all who work there. The LAB is mandated by DA PAM 40-11 Preventive Medicine, Federal and State Laws, and other DOD regulations to obtain and maintain accreditations appropriate for their scope of testing and customer needs.
3. SCOPE
The APHC is seeking to renew its LAB’s accreditations to the ISO/IEC 17025:2017 standard, The EPA National Lead Laboratory Accreditation Program (NLLAP), and demonstrated compliance to The NELAC Institute (TNI) Standards: 2016 for various environmental and biological methods.
During the period of performance of this contract, the laboratory will be moving into a new laboratory facility, located at 8300 Ricketts Point Road, Building E-2850, APG, MD 21010. This is less than ¼ mile from the current facility where the LAB is currently accredited. In an effort for continuous operations, the LAB has developed a transition move schedule that estimates 15 months for the lab to physically move and be fully operational in the new laboratory facility. The transition move schedule anticipates moving the analytical operations in multiple phases, based on methods and technology. The moves are scheduled to start May 2022 but this date is dependent on the completion of the construction efforts. Currently the estimated date for the LAB to be fully operational in the new facility is September 2023. These dates are subject to change for reasons outside the control of the Laboratory Management. Changes made to the current APHC transition move plan can potentially impact the laboratory’s certification dates and scheduling of assessment/audits. If there are delays to the transition move schedule that affect the operational date in the new facility of 10 or more business days and impact the laboratory’s certification dates or audit schedule, COR will immediately notify the Contractor. Contractor must have the ability to grant APHC Laboratory extension(s) of current accreditations. Given IT constraints, the APHC laboratory is unable to host virtual laboratory assessments/audits.
In order to be considered for award, the Contractor shall possess the following capabilities:
· The ability to assess the LAB’s compliance to the ISO/IEC 17025:2017 standard, The EPA National Lead Laboratory Accreditation Program (NLLAP), and The NELAC Institute (TNI) Standards: 2016 for the laboratory’s environmental scope/methods.
· The ability to assess the LAB’s compliance to the ISO/IEC 17025:2017 standard for their biological scope/methods.
· The ability to accredit various matrices to include air, drinking water, non-potable water, wastewater, soil, sediment, wipes, saliva, nasopharyngeal swabs, ticks, and paint chips.
· The ability to certify not only published methods, but also laboratory developed methods that meet validation and strict quality control requirements of the Contractor;
· Be internationally recognized by the International Laboratory Accreditation Cooperation (ILAC) and Regional Accreditation Groups according to ISO/IEC 17011 requirements;
· Provide proof of a current existing capabilities that confirms that the Contractor accredits to the ISO/IEC 17025:2017, The NELAC Institute (TNI) Standards:2016, and The EPA National Lead Laboratory Accreditation Program (NLLAP).
· Be an EPA authorized accrediting body for accrediting NLLAP laboratories.
· Have assessors possessing technical knowledge and experienced in environmental and biological analyses for matrices and methods on the LAB’s scope of accreditations.
· Have the ability to perform assessments of the LAB not using virtual platforms (e.g. TEAMS, ZOOM).
4. PERIOD OF PERFORMANCE
The periods of performance for this contract are as follows:
| Base period |
| 31 March 2022 – 30 March 2023 |
| Option period 1 |
| 31 March 2023 – 30 March 2024 |
| Option period 2 |
| 31 March 2024 – 30 March 2025 |
| Option Period 3 |
| 31 March 2025 – 30 March 2026 |
5. WORK SCHEDULE AND LOCATION
5.1. Work Location
The Contractors shall work at their facility in preparation for the audit and to perform paperwork reviews/activities, but at the APHC LAB in Edgewood, MD for the onsite audit portion of the requirement.
Current Lab Address:
Army Public Health Center 8988 Willoughby Road, Building E2100 Aberdeen Proving Ground, MD 21010
NEW LAB Address:
8300 Ricketts Point Road, Building E-2850 Aberdeen Proving Ground, MD 21010
6. PERFORMANCE REQUIREMENTS
Objectives
6.1. The objective of this requirement is to provide auditing of and accreditation to the appropriate standards for the LAB identified in this Performance Work Statement (PWS).
6.2. Specific Tasks / Requirements
Objective 1 – Accredit the LAB identified in this PWS as required.
6.2.1. Key Task 1 – Contractor will accept current accreditations and scopes of accreditation to the applicable standards identified in this PWS for the APHC Laboratory (Attachment 3).
6.2.2. Key Task 2 – Contractor will extend expiration date on LAB’s current accreditations, as long as the LAB is in good standing, until assessment by Contractor has been completed to ensure no lapse in LAB’s accreditation. Contractor will define how assessment will be performed (i.e. on-site assessment, document review).
6.2.3. Key Task 3- Contractor will provide Contracting Officer’s Representative (COR) and APHC Quality Manager with certificate and scopes of accreditation with new effective date (Contract’s PoP start date) and new expiration date for current scopes accreditations within 10 calendar days of contract’s award. (Deliverable 1).
6.2.4. Key Task 4- Contractor will notify APHC LAB of requirements for submission of accreditation applications and suspense dates for submission of applications.
6.2.5. Key Task 5 – Contractor will provide an electronic mechanism for any required LAB documentation to be submitted (e.g. for application, audits) to Contractor for upload (e.g. web portal). This mechanism must provide the capability to submit large (MB) file sizes. Document submission mechanism cannot be through the use of email, hard copies, CD, or thumb drive.
Objective 2 – Performance of assessment of LAB against the ISO 17025: 2017 standard, TNI: 2016 standards, and NLLAP requirements
6.2.6. Key Task 1- Contractor shall work with APHC LAB through the COR to schedule on-site assessment (bi-annual assessment of laboratory technical operations and quality management system) of APHC LAB to occur at mutually agreed upon dates.
6.2.7. Key Task 2- Contractor shall perform onsite assessments for all of APHC LAB’s scopes during the same onsite visit.
6.2.8. Key Task 3 – Contractor shall review the quality documentation from the APHC LAB in preparation for the onsite audits.
6.2.9. Key Task 4- Contractor shall provide qualified and appropriately certified auditors to perform the required onsite audits
6.2.10. Key Task 5- Contractor shall assess the LAB through the use of Subject Matter Experts for the LAB’s particular field of testing using appropriate comprehensive checklists.
6.2.11. Key Task 6 – Contractor shall review documentation, observe performance of test procedures on the scope, and interview laboratory personnel to determine compliance to the standards and any deficiencies.
6.2.12. Key Task 7 - Contractor shall perform laboratory assessments without the use of video virtual platforms (e.g. TEAMS, ZOOM) and shall suggest alternatives for assessments if on-site assessments are not possible due to pandemic.
6.2.13. Key Task 8 – Contractor shall provide a final verbal out-brief upon completion of the onsite assessments.
6.2.14. Key Task 9 – Contractor shall forward a final detailed written audit report (Deliverable 2) to the COR and APHC Quality Manager within 30 calendar days of audit completion.
6.2.15. Key Task 10 – Contractor shall reference the schedule in section 6.2.20.8 in this PWS that details the LAB’s Field of Testing, expiration of accreditations, last onsite audit and next required audit.
6.2.16. Key Task 11- Contractor shall abide by all safety and health protection requirements mandated by APHC to gain access to installation and when on-site. This may include the requirement that the Contractor provide information on COVID vaccination status or provide proof of a negative COVID test result from within the three (3) days prior to entering installation by completing a Certification of Vaccination form in accordance with (IAW) Executive Order (EO) 13991. This form will not collected or be maintained by APHC but is required to be kept by the Contractor during their time on installation. The Contractor may be asked to show the form prior to entry onto the installation and/or laboratory facility.
Objective 3 – Accredit published methods and internally developed methods on additional environmental and biological scopes as requested by APHC LAB (i.e. requests for scope expansions).
6.2.17. Key Task 1 – Contractor shall allow LAB through the COR to seek information regarding additional methods for accreditation that may be either a published method or an internally developed method that the LAB does not already have on scope. These new methods will be requests for these methods to be added to the respective LAB’s scope at any time during the year. This is anticipated 1-2 times a year.
6.2.18. Key Task 2- Contractor shall provide a fee structure and process that outlines the addition of these new methods. This process shall detail whether an onsite audit would be required and any associated costs with the addition of the new method to the scope.
6.2.19. Key Task 3 – Contractor shall provide a quote (Deliverable 3) to the Government COR for any requested addition for evaluation and approval. Once approved by the COR and sufficient funding exists, the Contractor agrees to add new testing methods to the scope within 30 calendar days of receiving complete and accurate verification/validation packets or completion of any required onsite audit and subsequent corrective action resolution as deemed necessary by the Contractor and provide updated scope to COR and APHC Quality Manager. (Deliverable 4).
Objective 4 – Provide information identifying requirements for LAB to maintain accreditations during transition to new laboratory facility.
6.2.20. Key Task 1- Contractor shall provide a written transition plan (Deliverable 5) that will address the following:
6.2.20.1. Required laboratory documentation to be provided to Contractor necessary for LAB to maintain accreditations prior to, during, and after transition to new facility.
6.2.20.2. Timeline for when required LAB documentation (section 6.2.20.1 of this PWS) is to be provided to Contractor (i.e. after lab transition has been completed, after a method has transitioned to new facility, after an instrument has been moved to new facility).
6.2.20.3. The requirements for the LAB to be able to perform operations/procedures/sample analysis in the new laboratory facility (e.g. after method validation documentation has been reviewed by Contractor, after full assessment of technical operations and quality system in new facility by Contractor, or LAB is authorized to immediately analyze samples for a method once LAB has completed validation without review by Contractor).
6.2.20.4. Plan must include details on how Contractor will handle changes in LAB’s transition move schedule which may impact the date when LAB will be operational in new laboratory facility and therefore may affect the certification dates and scheduling of assessment/audits.
6.2.20.5. Required Contractor assessments of the LAB (i.e. on site assessment of technical operations and quality system, on-site assessment of technical operations, desk audit of validation documents remotely through the submission of documentation to Contractor).
6.2.20.6. When Contractor assessments are required to occur in relation to the LAB’s transition/move schedule (e.g. during the laboratory’s transition to new laboratory facility, after LAB’s transition has been completed and LAB is fully operational in new laboratory facility).
6.2.20.7. Advise if there will be any changes to the next required bi-annual on-site assessment schedule if on-site assessment is required after the LAB transitions to new facility.
6.2.20.8. The following table provides Contractor information to assist in development of transition plan.
| PoP of contract |
| Dates of Accreditation Certificates Based on PoP |
| Requirements of laboratory based on annual and bi-annual requirements. These requirements are based on previous Accreditation Body’s requirements to maintain accreditations. |
| Information Regarding Transition to New Laboratory Facility |
*Move dates are tentative and may be shifted to the right.
Information on the number of methods estimated to be moved during PoP
| Base Year: 31 March 2022 – 30 March 2023 |
| Current Accreditations expire 31 March 2022. New Accreditations from 31 March 2022 – 30 March 2023 |
| Bi-annual on site assessment of LAB’s technical operations and quality management system in current laboratory facility. Assessment will need to be scheduled during a time that the LAB is not transitioning to new laboratory facility. |
| LAB is tentatively scheduled to begin transitioning operations/methods to new laboratory facility May 2022. |
Estimate 30% of analytical methods to be moved, with an average of three (3) instruments per method.
| Option Year 1: 31 March 2023 – 30 March 2024 |
| 31 March 2023 – 30 March 2024 |
| Renewal application required to be submitted to Contractor for Environmental and Biological scopes of accreditation. |
| LAB transition to new facility continues and LAB is tentatively scheduled to be fully operation in new laboratory facility in September 2023. |
| Remaining analytical methods and all operations to be transitioned into new laboratory facility. Estimate 3 instruments per method. |
| Option Year 2: 31 March 2024 – 30 March 2025 |
| 31 March 2024 – 30 March 2025 |
| Bi-annual on site assessment of LAB’s technical operations and quality management system in new laboratory facility. |
N/A
| Option Year 3: 31 March 2025 – 30 March 2026 |
| 31 March 2025 – 30 March 2026 |
| Renewal application required to be submitted to Contractor for Environmental and Biological scopes of accreditation. |
6.3. Management Reports and Plans
Quality Control Plan (Deliverable 6). The Contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the Contractor’s QCP. At a minimum, the QCP must include a self- inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction. For EACH TASK ORDER awarded under the resulting CONTRACT, the Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the TASK ORDER to achieve the established standards set forth in the Performance-Standards Summary Matrix and Quality Assurance and Surveillance Plan (QASP) provided with each TASK ORDER Request for Proposal (TORFP).
7. DELIVERABLES
The Contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.
DELIVERABLES TABLE
| PWS Ref. |
| Number |
| Title/Description |
| Due |
| 6.2.3 |
| Deliverable 1 |
| Accreditation Certificates and Scopes of Accreditation. Accept current Environmental and Biological scopes of accreditation to all standards identified in this PWS and provide new scopes of accreditation with extended certification date. |
| 10 Calendar days after award of contract. |
| 6.2.14 |
| Deliverable 2 |
| Final Audit Report. Provide a detailed final audit report to the COR and APHC Quality Manager following each onsite audit. |
| 30 Calendar Days after each audit completion. |
| 6.2.19 |
| Deliverable 3 |
| Quote for Scope Expansion. The Contractor shall provide a quote for additional scope requests to the COR for approval prior to proceeding. |
| Prior to any action to add additional items to a scope. |
| 6.2.19 |
| Deliverable 4 |
| Accreditation for Scope Expansion. Contractor shall provide updated scope with added new testing methods/matrices for scope expansion requests. |
| 30 Calendar Days after laboratory successfully completes all Contractor requirements for scope expansion. |
| 6.2.20 |
| Deliverable 5 |
| Transition Plan. A written plan from the Contractor that identifies the requirements for the LAB to maintain accreditation prior to, during, and after transition to new laboratory facility. |
| The Contractor shall provide the Transition Plan at time of proposal submission. |
| 6.3 |
| Deliverable 6 |
| Quality Control Plan. A plan from the Contractor to include at a minimum a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. |
| Draft due 15 calendar days after contract award. |
| 9.2 |
| Deliverable 7 |
| Travel Estimate. The Contractor must submit a travel estimate for any travel costs associated with this PWS support. |
| No Later Than 30 calendar days prior to travel. |
| 9.2 |
| Deliverable 8 |
| Trip Report. The Contractor shall submit a trip report detailing the costs associated with the trip. |
| Within 10 calendar days of completion of the trip. |
| 13.9.1 |
| Deliverable 9 |
| AT Level I Awareness Training Certificate |
| Due NLT 5 calendar days prior to start date of on-site laboratory assessment. |
| 13.10 |
| Deliverable 10 |
| Sexual Assault or Sexual Harassment Reporting. The Contractor shall immediately (within 24 hours) report an incident of sexual assault or sexual harassment to the COR. |
| Conditional Deliverable due only in the event of an incident. |
7.1. Reports and Documents
Reports and documents delivered by the Contractor in the performance of this contract shall be considered Technical Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the Contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.
7.2. Inspection and Acceptance
The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.
Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.
7.3. COR Information
TBD
8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX
The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the Contractor. The QASP is a living document and may be updated by the Government as necessary.
The Government will use the following performance requirements to measure the performance of the Contractor. The Contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).
PERFORMANCE REQUIREMENTS SUMMARY MATRIX
| # |
| PWS Ref. |
| Performance Objective |
| Performance Standard |
| Acceptable Quality Level |
| Performance Measurement |
| Incentive |
| 1 |
| 6.2.3 |
| Scopes of Accreditation -Contractor must provide scopes of accreditation to all the standards identified in this PWS with 100% of approved methods listed on scope. |
| Percentage of approved methods are listed on the Scope of Accreditation. |
| 100% |
| Review scopes upon receipt by COR and APHC Quality Manager. |
| Past Performance |
| 2 |
| 6.2.14 |
| Final Audit Report. Provide a detailed final audit report following each onsite audit. |
| Calendar days |
| Within 30 calendar days of audit completion. |
| Review report upon receipt by COR and APHC Quality Manager |
| Past Performance |
| 3 |
| 6.2.19 |
| Quote for Scope Expansion Requests. |
The Contractor shall provide a quote for additional scope requests for approval prior to proceeding.
| Percentage of additional scope activities will be initiated with a quote forwarded to COR for approval. |
| 100% |
| Review quote upon receipt by COR |
| Past Performance |
| 4 |
| 6.2.19 |
| Accreditation for Scope Expansion. Contractor shall provide updated scope with added new testing methods/ matrices for scope expansion requests. |
Calendar Days
| 30 calendar days of receiving complete and accurate verification/ validation packets or completion of any required onsite audit and subsequent corrective action resolution based deemed necessary by the Contractor. |
| Review scopes upon receipt by COR and APHC Quality Manager. |
| Past Performance |
| 5 |
| 9.2 |
| Travel Estimate. The Contractor must submit a travel estimate for any travel costs associated with this PWS support. |
Calendar Days
| No Later Than 30 calendar days prior to travel. |
| Review upon receipt by COR. |
| Past Performance |
| 6 |
| 9.2 |
| Trip Report. The Contractor shall submit a trip report detailing the costs associated with the trip. |
Calendar Days
| Within 10 calendar days of completion of the trip. |
| Review upon receipt by COR. |
| Past Performance |
9. TRAVEL/TEMPORARY DUTY (TDY)
The COR is the CONUS travel order approval authority as designated in writing by the KO. All CONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR.
9.1 Travel Arrangements
Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled CONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel CONUS. Estimated travel is dependent on the starting location of each auditor assigned.
9.2 Travel Claim Procedures, Approval, and Reimbursement. The Contractor shall submit an estimate (Deliverable 7) for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and price.
The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip report (Deliverable 8) to include costs associated with the travel to the COR within ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.
9.3 DOD Contractor Foreign Travel / OCONUS
N/A
10. GOVERNMENT FURNISHED PROPERTY
The Government will not furnish any property in support of this contract requirement.
11 Contract Management
11.1 Government Management
The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.
11.2 Contractor Management
The Contractor shall designate a single Program Manager (PM) to be the Contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning Contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.
11.3 Contractor Organization
The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain of command and who they should contact if they have questions.
12 COMPLIANCE DOCUMENTS
12.1 General Compliance
12.1.1 Federal Law
The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.
Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.
12.1.2 DoD Compliance Documents
A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html
A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html
a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html
b) Army Regulation 25-2, Information Assurance.
c) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
d) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html
12.2 Medical and Laboratory Compliance
12.2.1 Army Regulation 340-21, Army Privacy Program
Compliance information regarding Army Privacy program may be found at: http://www.army.mil/usapa/epubs/340_Series_Collection_1.html
12.2.2 Laboratory Requirements
a) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html
b) Army Regulation 40-5 Army Public Health Program, 12 May 2020 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN16450_R40_5_FINAL.pdf
c) Department of the Army Pamphlet 40-11 Army Public Health Program, 18 May 2020 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN22182_P40_11_FINAL.pdf
13 OTHER TERMS, CONDITIONS, AND PROVISIONS
13.1 Non-Personal Services
This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise Contractor personnel nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor's responsibility to notify the Contractor Officer (KO) immediately.
13.2 Severable / Non-Severable Services
This award identifies services that are severable in nature.
13.3 Inherently Governmental Functions
This requirement has been reviewed and contains no services that are inherently governmental functions.
13.4 Invoices
The Contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.
The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The Contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.
Where applicable, Contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.
13.5 Dissemination of Information/Publishing
There shall be no dissemination or publication, except within and between the Contractor and any Subcontractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.
13.6 Contractor Identification
The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.
13.7 Attendance at Meetings
Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their Contractor status known during introductions.
13.8 Anti-Terrorism and Operational Security
13.8.1 AT Level I Training.
All Contractor employees, including Subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days of the start date of an on-site assessment. .
The Contractor shall submit certificates of completion for each affected Contractor employee and Subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, NLT 5 calendar days prior to the start date of an on-site assessment (Deliverable 9). AT Level I awareness training is available at the following website: https://jko.jten.mil.
13.8.2 iWATCH Training. This standard language is for Contractor employees with an area of performance within an Army-controlled installation, facility, or area.
The Contractor and all associated Subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of the start date of on-site assessment with the results reported to the COR NLT 5 calendar days prior to the start date of an on-site assessment.
13.8.3 For contractors that do not require CAC, but require access to a DoD facility or installation.
Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.
| 13.8.4 | Access and general protection/security policy and procedures. |
| This standard language is for contractor employees with an area of performance within an Army-controlled | installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. |
14 Acronym List
| Acronym |
| Definition |
| AFARS |
| Army Federal Acquisition Regulation Supplement |
| AKO |
| Army Knowledge Online |
| APHC |
| Army Public Health Center |
| AT OPSEC |
| Antiterrorism and Operational Security |
| CAC |
| Common Access Card |
| CFR |
| Code of Federal Regulations |
| CONUS |
| Continental United States |
| COR |
| Contracting Officer Representative |
| DFARS |
| Defense Federal Acquisition Regulation Supplement |
| DoD |
| Department of Defense |
| FAR |
| Federal Acquisition Regulation |
| FPCON |
| Force Protection Condition |
| GFE |
| Government Furnished Equipment |
| GFI |
| Government Furnished Information |
| OCI |
| Organizational Conflict of Interest |
| OCONUS |
| Outside Continental United States |
| OPSEC |
| Operational Security |
| PWS |
| Performance Work Statement |
| QASP |
| Quality Assurance and Surveillance Plan |
| SHARP |
| Sexual Assault Prevention and Response Program |
| SOP |
| Standing Operating Procedure |
| UIC |
| Unit Identification Code |
| US |
| United States |
| WAWF |
| Wide Area Work Flow |
ADDENDUM TO 52.212- 1
INSTRUCTIONS TO OFFERORS – ADDENDUM TO 52.212-1
In addition to the guidance included in FAR Provision 52.212-1, titled “Instructions to Offerors – Commercial Items,” the following are applicable for the preparation and submission of quotations.
This RFQ is in support of the APHC’s Laboratory Accreditation in accordance with ISO/IEC 17025:2017, TNI Standards: 2016, EPA National Lead Lab Accreditation Program Accreditation.
A single award is anticipated to result from this RFQ.
Quotation Content and Instructions for Preparation of Quotations.
Instructions for preparation of quotations. This section specifies the format and content that offerors shall submit their quote. The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a quotation that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance.
The quotation shall be submitted in two separate volumes:
Volume I –Non-Price Factors (Technical Approach / Past Performance) Volume II – Price
A complete Volume I – Non-Price Factors and Volume II – Price shall be submitted by the closing date specified in this solicitation.
1. Volume I: Non-Price Factors. Volume I shall not include any pricing information.
Volume I shall contain the following on the cover page:
· Complete company name and address
· Company POC including title, email address and phone number
· Cage Code
· DUNS Number
In accordance with file submission requirements given in this section, the offeror shall submit the following:
1.1. Evaluation Factor I: Technical Approach: The offeror shall provide sufficient technical documentation which effectively demonstrates the following:
- An understanding of the requirement and of the functional and technical tasks to be performed (including the lab transition).
- The methodology and flexibility they will use in performing the requirement performed (including the lab transition).
- How the approach is likely to yield the required results within the required timeframe performed (including the lab transition).
- The offeror shall provide a statement that they are registered in SAM (System for Award Management, https://www.sam.gov/portal/SAM/#1#1). The statement must also state that the SAM registration is current and that the offeror is listed under NAICS code utilized for this RFQ.
-The offeror will submit a transition plan as an attachment to Volume I (PWS Deliverable 5) (Transition Plan Page Limit 25 pages).
The offeror shall complete all provisions in the RFQ and return them as part of Volume I.
1.2 Evaluation Factor II: Past Performance: The offeror shall describe its past performance on up to 2 contracts it as held within the last three years that are for the same or similar services to that which is detailed in this solicitation, or affirmatively state the offeror possesses no relevant past performance directly related to or similar past performance.
The offeror shall provide the following information in their quotation:
a. POC information: name, title, phone number, e-mail address, agency name, and address.
b. Contract Number and Task Order number(s), if applicable.
c. Name of contractor to whom the contract was awarded. Name of contractor who performed services, if different from awardee. Provide the CAGE Code and DUNS numbers of both the awardee and the contractor who performed the service(s). If the contractor to whom the contract was awarded and the contractor who performed the services are different, it must be clear which company is which. The correlation of the awardee / to the offeror (prime or subcontractor) must be clear.
d .Dates when services were provided.
e. Place(s) of performance.
f. List the quantity and description of services provided. Please be specific and provide the labor categories (or position descriptions), level of effort per labor category (number of FTEs), and a detailed description of the services provided. Please explain how the effort is similar to the requirements of this solicitation.
g. Describe the offeror’s role – prime, subcontractor, partner, mentor, protégé, etc.
h. The offeror shall provide information on problems encountered on the identified contract(s) and the offeror’s corrective actions (if applicable).
The Government will evaluate the past performance to determine if the reference is recent and relevant. The Government will not call POCs or access databases to determine recency or relevancy. The Offeror is responsible to ensure that a recency and relevancy determination can be made from the information in the offerors proposal.
Recent and Relevant Past Performance will be verified through CPARS reports or through contacting the POC (at the Governments discretion). Recent and Relevant Past Performance that cannot be verified by the Government, will not be applied to the rating.
The Government reserves the right to obtain information for use in the evaluation of past/present performance from any and all sources at their disposal.
Page limit for Volume I – Non-Price Factors: not to exceed 15 pages (excluding a Cover Sheet and Table of Contents and Attachments, i.e. the Transition Plan (PWS Deliverable 5).
II. Volume II- Price:
The Offeror shall provide a unit price and total price for each Contract Line Item Number (CLIN) identified within this solicitation. Offerors shall use Section B of this solicitation to provide the unit price and total price for CLINs 0001 through 3002 as well as provide the total quoted price. The Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall quote FFP pricing on all CLIN items.
Travel (concurrent with the onsite assessment) CLINs 0004 and 2004 will be priced on a FFP basis. Travel is estimated at one trip for two people to the laboratory address provided in the PWS, which will occur once in the Base Period (CLIN 0004) and once in Option Period 2 (CLIN 2004).
All CLINs shall be priced.
*If the offeror possesses a Commercial Price List for the quoted Items, the offeror shall include a copy in their Volume II.
Volume II has no page limit.
Questions: Questions may be submitted to Daniil Pikus and Thomas Hood via E-mail daniil.y.pikus.civ@mail.mil and thomas.l.hood26.civ@mail.mil, no later than 11 March 2022 at 10:00 AM Eastern. The Offeror is responsible for verifying receipt by the POC.
Questions will be answered via an amendment, uploaded to SAM.gov.
Quotation Submission: Quotations are due to Daniil Pikus and Thomas Hood via E-mail daniil.y.pikus.civ@mail.mil and thomas.l.hood26.civ@mail.mil, no later than 17 March 2022 at 10:00 AM Eastern. Late quotations will not be accepted.
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
Annual Fee - Environmental Scope
FFP
FOB: Destination
PURCHASE REQUEST NUMBER: 0011733887
PSC CD: R420
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
Annual Fee - Biological Scope
FOB: Destination
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 94 |
| Each |
On-site Assessment
FOB: Destination
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
Travel
Travel FOB: Destination
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Environmental Scope |
FFP
FOB: Destination
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Biological Scope |
FFP
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Environmental Scope |
FFP
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Biological Scope |
FFP
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 94 |
| Each |
| OPTION |
| On-site Assessment |
FFP
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Travel |
FFP
Travel
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Environmental Scope |
FFP
NET AMT
| ITEM NO |
| SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1 |
| Each |
| OPTION |
| Annual Fee - Biological Scope |
FFP
NET AMT
INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
| CLIN |
| INSPECT AT |
| INSPECT BY |
| ACCEPT AT |
| ACCEPT BY |
| 0001 |
| N/A |
| N/A |
| N/A |
| Government |
| 0002 |
| N/A |
| N/A |
| N/A |
| Government |
| 0003 |
| N/A |
| N/A |
| N/A |
| Government |
| 0004 |
| N/A |
| N/A |
| N/A |
| Government |
| 1001 |
| N/A |
| N/A |
| N/A |
| Government |
| 1002 |
| N/A |
| N/A |
| N/A |
| Government |
| 2001 |
| N/A |
| N/A |
| N/A |
| Government |
| 2002 |
| N/A |
| N/A |
| N/A |
| Government |
| 2003 |
| N/A |
| N/A |
| N/A |
| Government |
| 2004 |
| N/A |
| N/A |
| N/A |
| Government |
| 3001 |
| N/A |
| N/A |
| N/A |
| Government |
| 3002 |
| N/A |
| N/A |
| N/A |
| Government |
DELIVERY INFORMATION
| CLIN |
| DELIVERY DATE |
| QUANTITY |
| SHIP TO ADDRESS |
| DODAAC / CAGE |
| 0001 |
| POP 31-MAR-2022 TO |
30-MAR-2023
| N/A |
| U.S. ARMY PUBLIC HEALTH CENTER |
U.S. ARMY PUBLIC HEALTH CENTER
5158 BLACKHAWK ROAD
BLDG E5165
ABERDEEN PROVING GROUND MD 21010-5403
210-808-2837
W23MWP
| 0002 |
| POP 31-MAR-2022 TO |
30-MAR-2023
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 0003 |
| POP 31-MAR-2022 TO |
30-MAR-2023
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 0004 |
| POP 31-MAR-2022 TO |
30-MAR-2023
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 1001 |
| POP 31-MAR-2023 TO |
30-MAR-2024
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 1002 |
| POP 31-MAR-2023 TO |
30-MAR-2024
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 2001 |
| POP 31-MAR-2024 TO |
30-MAR-2025
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 2002 |
| POP 31-MAR-2024 TO |
30-MAR-2025
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 2003 |
| POP 31-MAR-2024 TO |
30-MAR-2025
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 2004 |
| POP 31-MAR-2024 TO |
30-MAR-2025
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 3001 |
| POP 31-MAR-2025 TO |
30-MAR-2026
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
| 3002 |
| POP 31-MAR-2025 TO |
30-MAR-2026
| N/A |
| (SAME AS PREVIOUS LOCATION) |
W23MWP
CLAUSES INCORPORATED BY REFERENCE
| 52.204-7 |
| System for Award Management |
| OCT 2018 |
| 52.204-13 |
| System for Award Management Maintenance |
| OCT 2018 |
| 52.204-16 |
| Commercial and Government Entity Code Reporting |
| AUG 2020 |
| 52.204-19 |
| Incorporation by Reference of Representations and Certifications. |
| DEC 2014 |
| 52.204-21 |
| Basic Safeguarding of Covered Contractor Information Systems |
| DEC 2021 |
| 52.204-22 |
| Alternative Line Item Proposal |
| JAN 2017 |
| 52.209-2 |
| Prohibition on Contracting with Inverted Domestic Corporations--Representation |
| NOV 2015 |
| 52.209-2 |
| Prohibition on Contracting with Inverted Domestic Corporations--Representation |
| NOV 2015 |
| 52.212-1 |
| Instructions to Offerors--Commercial Products and Commercial Services |
| DEC 2021 |
| 52.212-4 |
| Contract Terms and Conditions--Commercial Products and Commercial Services |
| DEC 2021 |
| 52.217-5 |
| Evaluation Of Options |
| JUL 1990 |
| 52.222-22 |
| Previous Contracts And Compliance Reports |
| FEB 1999 |
| 52.222-25 |
| Affirmative Action Compliance |
| APR 1984 |
| 52.232-40 |
| Providing Accelerated Payments to Small Business Subcontractors |
| DEC 2021 |
| 52.233-1 |
| Disputes |
| MAY 2014 |
| 52.237-1 |
| Site Visit |
| APR 1984 |
| 252.201-7000 |
| Contracting Officer's Representative |
| DEC 1991 |
| 252.203-7000 |
| Requirements Relating to Compensation of Former DoD Officials |
| SEP 2011 |
| 252.203-7002 |
| Requirement to Inform Employees of Whistleblower Rights |
| SEP 2013 |
| 252.203-7005 |
| Representation Relating to Compensation of Former DoD Officials |
| NOV 2011 |
| 252.204-7000 |
| Disclosure Of Information |
| OCT 2016 |
| 252.204-7002 |
| Payment For Contract Line or Subline Items Not Separately Priced |
| APR 2020 |
| 252.204-7003 |
| Control Of Government Personnel Work Product |
| APR 1992 |
| 252.204-7006 |
| Billing Instructions |
| OCT 2005 |
| 252.204-7008 |
| Compliance With Safeguarding Covered Defense Information Controls |
| OCT 2016 |
| 252.204-7012 |
| Safeguarding Covered Defense Information and Cyber Incident Reporting |
| DEC 2019 |
| 252.204-7015 |
| Notice of Authorized Disclosure of Information for Litigation Support |
| MAY 2016 |
| 252.204-7016 |
| Covered Defense Telecommunications Equipment or Services -- Representation |
| DEC 2019 |
| 252.204-7017 |
| Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation |
| MAY 2021 |
| 252.204-7018 |
| Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services |
| JAN 2021 |
| 252.225-7036 |
| Buy American--Free Trade Agreements--Balance of Payments Program--Basic |
| DEC 2017 |
| 252.232-7010 |
| Levies on Contract Payments |
| DEC 2006 |
| 252.244-7000 |
| Subcontracts for Commercial Items |
| JAN 2021 |
CLAUSES INCORPORATED BY FULL TEXT
52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)
The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services.
This is the start of the file's text. The full file is on GovTribe.
File details come from the government source that posted it. Updated .