Solicitation Attachment 1 - Performance Work Statement_HDSA.pdf

Department of Defense

Defense Health Agency (DoD – DHA)

Performance Work Statement (PWS)

Hazardous Drugs Sample Analysis (HDSA) Services

Defense Centers for Public Health – Aberdeen (DCPH-A)

Lab Sciences Directorate (LS)

Version: 30 March 2026

PART 1 – 1.0 GENERAL INFORMATION

1.1. Non-Personal Services. This is a non-personal services contract to perform analysis of wipe/swab samples for the presence of Hazardous Drugs.

1.2. Description of Services/Introduction. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Hazardous Drug Sample Analysis as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3. Background. The mission of the Defense Centers for Public Health – Aberdeen (DCPH-A) is to “Enhance Military readiness by identifying and assessing current and emerging health threats;

developing and communicating public health solutions; and assuring the quality and effectiveness of the Public Health Enterprise.” As part of the DCPH-A mission, the Lab Sciences (LS) Directorate requires the analysis of wipe/swab samples for the presence of hazardous drugs in support of pharmacies and Military Treatment Facilities (MTFs) within the Department of War (DoW). This analysis is mandated for the MTFs using Chemotherapy drugs to ensure their cleaning procedures are effective to ensure safety of the MTF staff and to avoid cross-contamination. The directives that mandate this semi-annual testing requirement are United Stated Pharmacopiea (USP) 800: Handling Hazardous Drugs and Technical Bulletin-Medical (TB-MED) 515: Occupational Health and Indutrial Hygiene Guidance for the Management, Use and Disposal of Hazardous Drugs. There is no acceptable level of occupational exposure to Hazardous Drugs. The LS Directorate of the DCPH-A is the only government laboratory to perform this hazardous drugs analysis as required. While LS does have the analytical capability to perform hazardous drugs analyses, as a sole source for this effort, there is a need to have back-up laboratory capability for instances of instrument down-time or over-capacity situations.

1.4. Objectives:

1.4.1. The Contractor shall perform analysis on wipe/swab samples provided by the Government for Hazardous Drugs contamination.

1.4.2. The Contractor shall perform the sample analysis within the stated turnaround time (TAT) identified in the Outsource Document and identified in the PWS.

1.4.3. The Contractor shall provide Quality wipe/swab analysis for various hazardous drugs as identified in this PWS in accordance with an accredited methodology.

1.4.4. The Contractor shall dispose of unused samples as prescribed by their quality manual/Standing Operating Procedures and return Government shipping containers.

1.4.5. The Contractor shall supply sampling media upon request.

1.4.6. The Contractor shall pay liquidated damages for late or deficient reporting as detailed in Section 5.8 of the PWS.

1.5. Scope. The DCPH-A is requesting a Contractor that shall perform analysis of wipe/swab samples for the hazardous drugs listed in this PWS and identified on the outsource document that will accompany each set of samples sent to the contract laboratory. If the referenced standard procedures have been modified in any way (sample preparation, analysis, types and number of Quality Control (QC) samples employed, QC acceptance criteria, etc), these modifications must be clearly explained in the laboratory Standard Operating Procedures (SOP) and provided to DCPH-A prior to contract award for approval. Contractor shall employ safe handling techniques and quality assurance/quality control (QA/QC) protocol as described in this PWS in Attachment 5 entitled "General Quality Control Requirements". In addition, strict adherence to chain-of-custody and quality control procedures is required at all times.

1.6. Period of Performance (PoP). Twelve (12) Month Base Period with the possibility of a 6-month extension in accordance with FAR 52.217-8, Option to Extend Services.

The Period of Performance is as follows:

1.7. Administrative Specifications

1.7.1. Place of performance. The work shall be performed at the Contractor’s or Sub-Contractor’s laboratory facility.

1.7.2. Recognized Federal holidays. Federal holidays are an exception to the regular duty hours. The Contractor shall not perform services on days designated as a Federal Holidays by Federal Status, Executive Order, Presidential Proclamation or Notice from the Installation Commander. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed below. The following is a list of legal federal holidays that services shall not be performed:

A. New Year’s Day, January 1st

B. Martin Luther King’s Birthday, 3rd Monday in January

C. President’s Day, 3rd Monday in February

D. Memorial Day, Last Monday in May

E. Juneteenth Day, June 19th

F. Independence Day, July 4th

G. Labor Day, 1st Monday in September

Base Period 1 May 2026 – 30 April 2027 6-Month Extension *If Applicable* FAR 52.217-8, Option to Extend Services 1 May 2027 – 31 October 2027

H. Columbus Day, 2nd Monday in October

I. Veteran’s Day, November 11th

J. Thanksgiving Day, 4th Tuesday in November

K. Christmas Day, December 25th

1.7.3 Hours of operation. As required at the contract lab to accomplish the required analysis with in quality standards.

1.8. Contractor travel. Not Applicable

1.9. Other Direct Costs (ODC). Not Applicable

1.10. Quality Assurance. The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.10.1. Quality Control (QC). The Contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The Contractor’s QC program is the means by which the work complies with stated requirements. The Contractor shall provide a draft Quality Control Plan (QCP) no later than 30 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 that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. After acceptance of the QCP the Contractor shall receive the Contracting Officer’s (CO) acceptance in writing of any proposed change to his QC system.

1.10.2. Standard laboratory practices for laboratory cleanliness regarding glassware and apparatus must be in place and followed. Safe laboratory practices regarding reagents, solvents, and gases must also be followed.

1.10.3. When the contract laboratory (including all sub-contract laboratories) is performing sample analysis using the methods (and/or laboratory specific methods approved by DCPH-A for this Performance Work Statement (PWS)), the contract laboratory must follow all quality control guidelines specified in this PWS, the applicable reference methods, and the corresponding laboratory SOPs. Any modification of reference method QA/QC requirements must be documented in the laboratory’s corresponding analytical SOP and identified (in the SOP) as a deviation/difference from the reference method. Any project specific QA/QC requirements will take precedence over the above criteria. In the absence of project specific QA/QC acceptance criteria, the current method and/or in-house laboratory acceptance criteria/limits will be used for batch control.

1.10.4. In the event the contract laboratory does not meet accuracy and/or precision criteria for any QA/QC sample, the contract laboratory shall implement corrective actions according to their Quality System. The contract lab’s in-house, statistically determined QC acceptance criteria for laboratory control samples (LCS) must be provided (in SOPs or otherwise) in the bid package for evaluation by DCPH-A. All QC failures for which re-analysis or re-extraction is required, must be communicated to DCPH-A when they occur, for discussion of corrective actions. QC failures for which re-analysis or re-extraction is required must not be made known to DCPH-A for the first time at the time the report is submitted.

1.10.5. All reported analytes must be spiked in the LCS and LCSD for all methods in this PWS. Any other proposed exceptions must be identified in the bid package for evaluations by DCPH-A.

1.11. Physical Security. The Contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use.

1.12. Government’s COR. The COR monitors all technical aspects of the Order and assists in Order administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the Order; perform inspections necessary in connection with Order performance; maintain written and oral communications with the contractor concerning technical aspects of the Order; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting Order.

1.13. Contractor Personnel. The Contractor shall provide a quality manager and program manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the CO. The program manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. Qualifications for all key personnel are listed below:

1.13.1. Quality Manager (QM).

A. Experience. The individual who functions as the quality manager (or however named) of the laboratory shall have the education, training, and experience, or combination thereof, to enable that individual to identify the occurrence of departures from the implemented quality management system and to initiate actions to prevent or minimize such departures. The quality manager shall be knowledgeable of the quality management system and the technical and management system procedures used.

B. Employee. The Quality Manager must be an employee of the laboratory.

C. Regulations Outlining Requirements. ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

1.14. Program Manager (PM).

A. Experience: PM must have appropriate education, training, and experience, or combination thereof for the measurement technologies used by the laboratory, to:

i. Be able to understand and communicate the analysis to the Government, and;

ii. Enable that individual to communicate the occurrence of departures from the implemented quality management system or test procedures.

B. PM must be an employee of the laboratory.

C. PM must be proactive and able to meet short suspense dates and stringent QA/QC requirements.

1.15. Project Management (PM). Contractor shall manage all assigned projects from initial receipt until project completion. The Contractor shall ensure all projects are completed in accordance with the terms and conditions of the PWS.

1.16. Reporting

1.16.1. Non-Use/Non-Disclosure Agreement (NDA) Deliverable #1. All Contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA prior to beginning work on the subject contract. The Contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period.

Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. The Contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.16.2. Post award conference/periodic progress meetings. The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the COR will apprise the Contractor of how the Government views the Contractor's performance and the Contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government. The Contractor shall provide weekly status reports after receipt of all samples until the final Analytical report and Electronic Data Deliverable (EDD) has been issued to the Government. This report shall be emailed to the COR mailbox at usarmy.apg.medcom-aphc.mbx.lab-cor@health.mil on Friday of each week that DCPH-A samples are in-house. The report shall contain the folder number, Outsource Sample Shipment (pick up order) number, project name, status of the project (for example received, in prep, in analysis, in reporting, etc) and whether it is expected to be reported on time. If it is not expected on time, the report should provide the expected completion date.

PART 2 – 2.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and has determined:

2.1. Services: The Government: WILL NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

2.2. Facilities: The Government: WILL NOT provide Facilities in support of this contract/task orders.

As a result, this paragraph is Not Applicable.

2.3. Utilities: The Government: WILL NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

2.4. Equipment: The Government: WILL NOT provide Equipment in support of this contract/task orders. As a result, this paragraph is Not Applicable.

2.5. Materials: The Government: WILL provide Materials in support of this contract/task order. The Government provided Materials are described below:

A. Outsource Document

B. Testing Swabs / Wipes

PART 3 – 3.0. CONTRACTOR FURNISHED ITEMS AND SERVICES

3.1. Services. The Contractor WILL provide Contractor Furnished Services required in support of this contract. These Services are described below:

A. The analysis of swab/wipe samples for the analysis of hazardous drugs

B. A Technically acceptable Level 4 Report Deliverable

C. A Technically acceptable Electonic Data Deliverable (EDD)

3.2. General. The Contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

3.3. Materials. The contractor shall furnish materials, supplies, and equipment necessary to meet the requirements under this PWS.

3.4. Equipment. The Contractor shall have the required laboratory instruments and equipment that meets accreditation requirements to perform the required sample analysis.

3.5. Facilities. The Contractor shall have a laboratory environment that meets accreditation requirements to perform the required sample analysis.

PART 4 – 4.0. SECURITY AND TRAINING

4.1. The following provides information on training requirements if the Contractor has a courier service that intends to pick up samples at the DCPH-A.

4.1.1. Anti-Terrorism (AT) Level I Training (Deliverable #2). All Contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I Awareness training within 30 calendar days after contract award. The Contractor shall submit confirmation of completion for each Contractor and Subcontractor personnel to the COR or to the contracting officer, if a COR is not assigned. AT level I Awareness training is available at the following website: http://jko.jten.mil. Contractor personnel shall complete refresher training every twelve (12) months.

4.1.2. iWATCH Training (Deliverable #3). The Contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army program (training standards provided by the requiring activity ATO). This local 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 contract award with the results reported to the COR no later than 35 calendar days after contract award, training slides can be found at:

https://www.youtube.com/embed/vlzYhQp7fPw.

PART 5 – 5.0. SPECIFIC TASKS

The following chart shows the Estimated Workload for Hazardous Sample Analysis Testing Services.

The following chart shows the most commonly requested analytes for sample analysis from DCPH-A.

Analyte Name Method Methotrexate (Most commonly requested) Any Approved/Accredited method 5-Fluorouracil (2nd most commonly requested analyte) Any Approved/Accredited method Doxorubicin Hydrochloride Any Approved/Accredited method Cyclophosphamide Monohydrate Any Approved/Accredited method Ifosfamide Any Approved/Accredited method Paclitaxel Any Approved/Accredited method

Description Method Esimated Annual Quantity 1 Hazardous Drug Any Approved/Accredited Hazardous Drug method 17 2 Hazardous Drugs Any Approved/Accredited Hazardous Drug method 26 3 Hazardous Drugs Any Approved/Accredited Hazardous Drug method 7 4 Hazardous Drugs Any Approved/Accredited Hazardous Drug method 8 5 Hazardous Drugs Any Approved/Accredited Hazardous Drug method 14 6 Hazardous Drugs Any Approved/Accredited Hazardous Drug method 103 http://jko.jten.mil/ https://www.youtube.com/embed/vlzYhQp7fPw

The following chart shows the required compounds and the limits of quantitation.

Compound Code (CAS) Compound Description Default Unit

Quantitation/ Reporting Limit (for a 100cm2 wiped area)

51-21-8 5-Fluorouracil ng/cm2 0.30ng/cm2 59-05-2 Methotrexate ng/cm2 0.30ng/cm2

3778-73-2 Ifosfamide ng/cm2 0.30ng/cm2 6055-19-2 Cyclophosphamide Monohydrate ng/cm2 0.30ng/cm2

25316-40-9 Doxorubicin Hydrochloride ng/cm2 0.30ng/cm2 33069-62-4 Paclitaxel ng/cm2 0.60ng/cm2

5.1. Task #1 – Receipt and Storage of Samples Prior to Analysis.

5.1.1. The Government will provide samples for analysis to the Contractor facility. Each container contains specific parameters for which the sample must be analyzed. The Contractor shall store and handle the samples in accordance with the applicable analytical method specifications.

5.1.2. The cost of shipping samples to the Contractor are paid by the Government.

5.2. Task #2 – Sample Pickup Protocol from the DCPH-A Lab.

5.2.1. If applicable, the Contractor’s courier shall be responsible for pickup (from DCPH-A), packaging and delivery of samples.

5.2.2. Samples shall be picked up by the Contractor’s courier within 24 hours of notification by the DCPH-A COR or a designated representative.

5.2.3. The courier is responsible for packaging and transporting the samples under conditions dictated in the applicable methodology.

5.2.4. At the time of sample pickup by the Contractor, the samples and required tests will be identified by the DCPH-A COR on a Government provided Outsource Document. This document shall be signed and dated by the DCPH-A COR or designee to document the date and time of sample transfer to the contract lab. The Contractor courier shall date and sign the Outsource Document to conclude the transfer of possession of the sample(s). A Contractor representative/Project Manager shall document the transfer of possession from the courier to the contract lab facility including sample receipt temperature. The Contractor shall immediately report in writing to the COR all samples lost or broken in transit.

5.3. Task #3 – Sample Shipment Protocol from the DCPH-A Lab.

5.3.1. If applicable (if the Contractor does not offer/use a courier), DCPH-A shall pay the shipping costs for transportation of the samples to the Contractor’s facility.

5.3.2. The Contractor and DCPH-A shall store and/or ship samples in accordance with the preservation guidelines as noted in the applicable analytical method until samples are analyzed, and thereafter until results are approved by the COR.

5.3.3. The Contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible (to include but not limited to photographs, etcetera), to the COR within 4 hours of identification of the breakage. In addition, the sample receipt temperature must be reported to the COR, as applicable, within 24 hours of sample receipt. See Technical Exhibit A.

5.4. Task #4 – Perform Sample Analysis within the stated Turnaround Time (TAT).

5.4.1 Government will designate samples as either “STANDARD” or “HIGH PRIORITY”. TATs are calculated from the date of Contractor receipt of samples to the date of receipt of technically acceptable analysis results acceptance by the Government. For each sample designation, the Contractor shall complete the sample analysis, final reporting and Electronic Data Deliverable (EDD) transmission within the following TAT timeframes:

A. STANDARD: Fifteen (15) Calendar days from date of sample receipt.

B. HIGH PRIORITY: Eight (8) Calendar days from the date of sample receipt.

5.4.2 The Government anticipates that ninety-five percent (95%) of required analyses will be marked STANDARD and five percent (5%) HIGH PRIORITY per calendar year. Natural disasters or military mobilization may alter these estimates.

5.4.3. Final PDF Copy (Deliverable #4) and the EDD (Deliverable #5). TAT is defined as the time between the date of sample receipt in the Contractor’s laboratory (or Outsource Document for Direct Shipped Samples) to the date of receipt of a complete and technically acceptable data package; the Final PDF copy plus the EDD by the DCPH-A laboratory. Technical acceptability will be determined thorough review by qualified DCPH-A Technical Subject Matter Experts (T-SME’s) and will be communicated to the COR for any required actions with the Contractor. Holidays and weekends are considered ‘calendar’ days.

A. Data Packages. The Contractor shall provide reports and other Electronic Data Deliverables as part of its reporting/data package. The Contractor’s Data Packages (Submitted via PDF) shall include the following documentation:

i. Invoice for Services Rendered. The Contractor shall submit original invoice, in a separate PDF from the analytical data package PDF. The invoice should reflect any penalties accrued for late reporting or missed hold times as outlined in the PWS of the contract.

ii. Accreditation Standards. All of the analytical report/data package items specified in the ISO 17025 accreditation standards. On the analytical results pages, the samples are to be identified by the DCPH-A Lab ID and the corresponding field ID.

iii. Management Records. The data package shall also include the sample management records and a copy of the appropriate pickup order form. In the quality control data summary, Continuing Calibration Verification (CCV) spike concentrations and recoveries are also desired (but not required if not in the laboratory’s standard reporting format).

iv. Stage 4 (previously, and equivalent to, Level IV) raw data elements are required in all data packages. Raw calibration data and standards traceability data/information are required in all data packages.

v. Calculations sheets. Sheets that show all calculations and factors involved in calculating the final result, and method detection limit (MDL, or detection limit (DL) summaries showing individual results and calculated MDLs, must be provided either in each data package, or in separate files, with updates provided as the information changes.

vi. Concentration results are to be reported to two (2) significant figures. Please identify any proposed exceptions, with justification, in the proposal.

vii. For J-flagged detections between the MDL/DL and Limit of Quantitation (LOQ) to be reported, all method target analyte identification criteria must be met. Examples are 1) the evaluation of the mass spectrum using the same criteria as with a detection at or above the LOQ; and 2) second column confirmation for Gas Chromatography (GC) methods, using the same criteria as with the confirmation of a detection at or above the LOQ. Discussions may take place between DCPH-A and the contract lab regarding the usefulness of reporting J-flagged estimates for a particular method.

viii. Non-detects are to be reported to <LOQ.

Note: All Final Reports shall be archived at least five years after approval of the data package by the DCPH-A COR

ix. PDF Instructions for the Complete “FINAL” Data Package – This PDF document will include the entire data package as described above, minus the invoice. Please provide the invoice via PDF as a separate file from Final pdf report. Final package PDF and invoice PDF are emailed to the following address: dha.apg.pub-health-a.mbx.lab-cor@health.mil and dha.apg.pub-health-a.mbx.dls-contract-hardcopies@health.mil

x. If the size of the file is too large for emailing, the Contractor may negotiate another secure alternate delivery method with the Government (i.e. file share, contractor server, etc.)

xi. These will be due no later than 2:00 PM Eastern Standard Time on the due date specified on the Pick-up Order. Naming convention of hard copy file and invoice should at least include the lab queue (acronym) and the PHC Pick up Order number, both of which will be provided on the documentation.

xii. Preliminary Sample Analysis Results (pdf file) – Due one day before Complete Hard Copy Data Package PDF, for High and Top Priority Turn Around Time requests. These prelim PDFs will contain final, numerical results in appropriate units, for the requested parameters. Sample data shall be identified by DCPH-A lab ID and field ID.

B. Electronic Data Deliverable (EDD). The electronic data deliverable (EDD) and Final PDF report are REQUIRED to be derived from the same source. Information (sample ID, field ID, etc.) and data (analytical results, units) must match. The process that generates the final report mailto:dha.apg.pub-health-a.mbx.lab-cor@health.mil mailto:dha.apg.pub-health-a.mbx.dls-contract-hardcopies@health.mil and EDD is REQUIRED to be validated to demonstrate that the process provides identical information and data.

i. Analytical Contract Lab Electronic Data Deliverables (EDD) Specifications:

1. Tab Delimited Text File Format Electronic Data Deliverable (EDD)

2. The electronic copy of the Data Package is commonly referred to as the contract Electronic Data Deliverable or EDD.

3. The electronic data deliverable (EDD) and hardcopy reports are required to use and have the same information (sample numbers, field numbers, etc.) and data (analytical results, units). The process that generates the hard copy and EDD is required to be validated to demonstrate that the process provides identical information and data.

4. The EDD will contain quantitated results in appropriate units, or reporting limits, for the requested chemical parameters. Sample data shall be identified by DCPH-Aberdeen lab numbers. Please note that the contractor shall transfer the data electronically from their lab to the DCPH-Aberdeen lab using the file format described below:

a. EDD Naming Convention:

* The file containing the EDD should be named using the following format:

Pickup Order #.txt

* Example 1. The EDD for Pickup Order 112 would be as follows: P112.txt

* Contents of the tab delimited EDD file

* The following table lists the fields in the tab delimited file along with the data type, the maximum size in characters and a description. The EDD file shall include a header row consisting of the field names.

ii. Tab Delimited EDD Line Specifications.

FIELD NAME TYPE SIZE DESCRIPTION

Lab_Code Text 4 DCPH-A queue code for the contract lab which performed the analysis Pickup_Delivery_Order Text 6 Pickup Order to which this sample belongs Sample_Number Text 13 The DCPH-A sample number (assigned by DCPH-A) TestCode Text 10 The DCPH-A LIMS Test Code Analyte_Code Text 15 The LIMS standard Analyte_Code, typically the CAS# Final_Result Number Decimal The numberic result (reound to the proper sig figs and decimal places) Text_Result Text 250 Text result. Not applicable to the results of most contracted Analyte

Codes.

Additional_Qualifiers Text 8 Additional qualifiers, for example any EPA Qualifiers.

Units Text 10 Units of the Results Dilution_Factor Number Decimal Dilution factor applied to the observed result (already applied) Date_Time_Analyzed Date mm/dd/yy Date the analysis was performed.

C. File Delivery. The EDD file should be emailed to the following address: dha.apg.pub-health-a.mbx.dls-contract-data@health.mil. Questions or comments regarding this guidance should be addressed to the COR.

5.5. Task #5 – Provide analytical results (the complete data package) to the COR.

5.5.1. The Contractor shall submit the results of all analyses within the TAT timelines as defined on the Outsource Sample Shipment Document for each set of samples. The results shall be submitted electronically to the COR and include the information requested in the format outlined in the Final Reporting Requirements (See Technical Exhibit #5). The Contractor shall at least report at or below the limits identified in Technical Exhibit #4.

5.5.2. Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case-by-case basis. However, these issues must be communicated to the COR when they occur, prior to the due date and when the lab believes a delay is possible, not after the data package is overdue.

5.5.3. Use industry standard state-of-the-art instrumentation, technologies, and methodologies to analyze samples for any of the parameters listed in Technical Exhibit 2. For each sample, the Contractor shall perform analyses for the compounds and organisms listed Technical Exhibit 4 according to their stated parameters and methodologies. Any special analyses or additional testing requirements will be stated on the sample.

5.5.3.1. It is anticipated that the Contractor will perform between 100 and 225 analyses per year.

Natural disasters or military mobilization may alter these estimates.

5.5.3.2. When the contract laboratory is performing sample analyses using the methodologies specified in Technical Exhibit 2, the contract laboratory shall follow quality control guidelines specified in that method.

5.5.4 Quality Control Data. Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported. If additional quality assurance/quality control protocol is designated in the methodologies, these guidelines shall also be strictly followed.

5.5.5 Holding times. Analyze samples within the maximum holding times specified in the method, even if these times are less than the requested priority report delivery TATs required in this contract.

5.5.5.1 If a sample is not processed within the specified holding time per method, the sample will be considered “lost”, unable to analyze and require recollection by the DCPH-A client/Project Officer. When this occurs, the Contractor shall not bill the Government for tests performed on samples beyond their holding times and be assessed liquidated damages (for

MDL Number Decimal Method Detection Limit Lab_Reporting_Limit Number Decimal Lab Reporting Limit/Practical Quantitation Limit/Limit of

Quantitation LOD Number Decimal Limit of Detection mailto:dha.apg.pub-health-a.mbx.dls-contract-data@health.mil mailto:dha.apg.pub-health-a.mbx.dls-contract-data@health.mil example late penalties) in accordance with the “Liquidated Damages” clause incorporated into this contract.

5.5.5.2 The Contractor shall not be liable if time remaining on the holding times, upon receipt of samples at Contractor, is less than 48 hours. Extenuating circumstances can be negotiated on a case-by-case basis with the DCPH-A COR. (Examples may include – Weekends/Holidays, late arrivals, unannounced arrivals.)

5.6 Task #6 – Disposal of Unused Sample Volumes and Return of Government Shipping Containers.

5.6.1. Disposal. Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volumes no earlier than 60 days following submission of analytical data to DCPH- A COR. Sample disposal and disposal of unused sample bottles/containers is the responsibility of the Contractor and should be done in accordance with all applicable laws and regulations governing disposal of such materials.

5.6.2. Shipping Containers. The Contractor shall return all Government shipping containers, unless otherwise specified, to the COR within three (3) business days of receipt at the cost of the Government who will provide applicable shipping labels for each container.

5.7. Task #7 – Surge Capacity. The potential exists to have other projects unexpectedly come up that will require additional sample analyses. A Contract Line Item Number (CLIN) will be present in the event there is a surge in needed services to execute those requirements. If the Government elects to exercise a surge CLIN, the Government may elect to incrementally fund or fully fund the CLIN based on the Government’s needs and/or the availability of funding.

5.8. Task #8 – Liquidated Damages.

5.8.1 The Contractor shall submit Final and Preliminary reports in an electronic format. If the Contractor does not submit data packages on time and/or submits incomplete/technically deficient/unacceptable data packages, the Contractor may be required to pay liquidated damages (late penalties) to the Government as follows: 5% per day late to a maximum of 100% of the total invoice price.

5.8.2 Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case-by-case basis. However, these issues must be made known to the COR when they occur and when the lab believes a delay is possible, not after the data package is overdue.

5.9. Task #9 – Laboratory Certifications, Qualifications, and Capabilities.

5.9.1. The Contractor must have the method appropriate instrumentation/technologies (at a minimum) to ensure the Contractor’s ability to process sample analyses within a timely manner based on the anticipated volume.

5.9.2. The Contractor must be accredited by a recognized external accrediting body for the hazardous drugs identified in this PWS.

5.9.3. The Contractor shall notify the COR, in writing, within 5 Business days of any loss of certification/accreditation and/or when there are any changes to contract laboratory’s accreditation certificate and scope (to include but change to accreditation expiration date) for all analyses identified in this contract.

5.9.4. The Contractor shall provide the COR with the contract laboratory’s current accreditation certificate and scope for the analyses on this contract.

5.9.5. Quality Documentation. At a minimum, the contract laboratory shall have, in writing, documented procedures (e.g., SOPs, Work Instructions) for the following:

5.9.5.1. Sample receipt, handling, storage and control.

5.9.5.2. Security, chain of custody and document control.

5.9.5.3. Hazardous waste/sample disposal.

5.9.5.4. Sample analysis (to include types of analyses required, sample preparation, modifications to established methods, peculiarities of instrumentation, etc.).

5.9.5.5. Calibration of standards, traceability (show traceability of standards to National Measurement Systems (e.g., National Institute of Standards and Technology)).

5.9.5.6. Ongoing or routine laboratory operations (including maintenance of instrumentation, procurement of supplies, scheduling of calibration for balances, thermometers, etc.).

5.9.5.7. Laboratory Safety and Chemical Hygiene (should address wearing of coats, gloves, goggles, handling of hazardous materials, eye lavaging, storage of hazardous materials, safety showers, fire safety, etc.).

5.9.5.8. Lab QA/QC (to include procedures for conducting in house audits; procedures for allowing technicians and chemists to have an independent means of checking the quality of their results; procedures for the development and implementation of contingency plans; and procedures for the initiation of corrective action).

5.9.5.9. Data production, reduction, transcription, verification, review, distribution and in house storage.

5.9.5.10. Determination of Reporting Limits. (Contractor must document the criteria under which the reporting limits are established/re-established for each analytical process. Must also include acceptance criteria for such reporting limit evaluation).

5.10. Task #10 – Sample Collection Media.

5.10.1. The Contractor shall be able to analyze the Alpha Polyester Knit TX714A Large Cleanrom Swab (Non-Sterile) sample collection media as provided by the Government.

5.10.2. The Contractor shall provide media to the Government upon request, at the price identified in this contract.

5.11. Task #11 – Analytical Training Records. All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing the methodologies detailed in Technical Exhibit 2.

5.12. Task #12 – On-site Inspections. The Government reserves the right to conduct inspections (on-site or virtual) of the Contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in this PWS, the requirements found in the published method, as well as the requirements in the applicable TNI Modules and corresponding checklist(s) from the laboratories accrediting body.

5.13. Task #13 – Subcontractor / Subcontractor Facility. The following section discusses any Sample analysis performed at a separate location other than the prime Contractor’s laboratory location.

5.13.1. The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this contract and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage work distribution to ensure there are no Organizational Conflicts of Interest (OCI) considerations. A notification must be sent to the CO and COR within 30 days of the agreement between the prime and the subcontractor.

5.13.2. Due to the need to maintain the integrity of the sampling and the laboratory certifications, the Contractor may subcontract with no more than three (3) other laboratories. The subcontractor laboratories and personnel shall hold the same qualifications and certifications as required by the prime. The prime Contractor shall not subcontract more than half of the methods listed in Technical Exhibit 2.

5.13.3. The Government reserves the right to conduct inspections (on-site or virtual) of the subcontractor’s laboratory to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in this PWS, the requirements found in the published method, as well as the requirements in the applicable accreditation and corresponding checklist(s). The lab(s) use for subcontracting must first be audited to the same standards as the prime and approved by DCPH-A prior to submitting samples. No exceptions to this requirement will be accepted.

5.13.4. Sending samples to any location for analysis other than the physical location that is placing the bid is considered subcontracting even if it is within the same corporation.

5.13.5. Subcontractor(s) shall adhere to the same quality requirements as the oversight Contractor, to include all applicable sections of this PWS. It should be noted that every time the term “Contractor” is used throughout this PWS, the term “subcontractor” is also applicable.

5.14. Task #14 – Management Reports and Plans.

5.14.1. Monthly Financial Tracking Report (Deliverable #6). The Contractor shall provide a spreadsheet with detail of real time expenditure levels of every Contract Line Item Number (CLIN).

The initial report is due 30 days after contract award and by the first of each month thereafter.

5.14.2. Results Status Report (Deliverable #7). The Contractor shall provide a weekly summary of all DCPH-A analysis currently being analyzed by the Contractor (to include analysis sent to the subcontractor). The summary shall be provided to the DCPH-A COR on the first business day each week and contain the following information at a minimum. If there are no samples in-house, there is no summary status report is required.

5.14.2.1. Outsource Sample Shipment Number

5.14.2.2. DCPH-Aberdeen assigned Contractor Due date.

5.14.2.3. Status of the Report – i.e., on-time, delayed, etc.

5.14.4. If the report will be provided after the DCPH-A assigned due date, a projected completion date must be provided.

5.15. Task #15 – Invoicing. The Contractor shall submit invoices to Wide Area Workflow (WAWF) with sufficient documentation for the WAWF acceptor to review and approve the work performed.

PART 6 – 6.0. PERFORMANCE REQUIREMENTS SUMMARY MATRIX (PRSM)

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

PERFORMANCE

OBJECTIVE / TASK

PWS

REF ACCEPTABLE QUALITY LEVEL (AQL) METHOD OF

SURVEILLANCE

Task #1 – Receipt and Storage of Samples Prior to Analysis.

5.1. The Contractor shall store and handle the samples in accordance with the applicable analytical method specifications. 100% Inspection

Task #2 – Sample Pickup Protocol from the DCPH- A Lab.

5.2. Samples shall be picked up by the Contractor’s courier within 24 hours of notification by the DCPH-A COR or a designated representative. Direct Observation

Task #3 – Sample Shipment Protocol from the DCPH-A Lab.

5.3. The Contractor and DCPH-A shall store and/or ship samples in accordance with the preservation guidelines as noted in the applicable analytical method until samples are analyzed, and thereafter until results are approved by the COR.

Direct Observation

Task #4 – Perform Sample Analysis within the stated Turnaround Time (TAT).

5.4. For each sample designation, the Contractor shall complete the sample analysis, final reporting and Electronic Data Deliverable (EDD) transmission within the following TAT timeframes:

A. STANDARD: Fifteen (15) Calendar days from date of sample receipt.

B. HIGH PRIORITY: Eight (8) Calendar days from the date of sample receipt

Random Sampling

Task #5 – Provide analytical results (the complete data package) to the COR.

5.5. The Contractor shall submit the results of all analyses within the TAT timelines as defined on the Outsource Sample Shipment Document for each set of samples. The results shall be submitted electronically to the

Management Information Systems

PART 7 – 7.0. DELIVERABLES SCHEDULE

COR and include the information requested in the format outlined in the Final Reporting Requirements

Task #6 – Disposal of Unused Sample Volumes and Return of Government Shipping Containers.

5.6. Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volumes no earlier than 60 days following submission of analytical data to DCPH-A COR.

The Contractor shall return all Government shipping containers, unless otherwise specified, to the COR within three (3) business days of receipt at the cost of the Government who will provide applicable shipping labels for each container.

100% Inspection

Task #7 – Surge Capacity.

5.7. The potential exists to have other projects unexpectedly come up that will require additional sample analyses. A Contract Line Item Number (CLIN) will be present in the event there is a surge in needed services to execute those requirements.

Management Information Systems

Task #8 – Liquidated Damages.

5.8. If the Contractor does not submit data packages on time and/or submits incomplete/technically deficient/unacceptable data packages, the Contractor may be required to pay liquidated damages (late penalties) to the Government as follows: 5% per day late to a maximum of 100% of the total invoice price.

Management Information Systems

Task #9 – Laboratory Certifications, Qualifications, and Capabilities.

5.9. The Contractor must be accredited by a recognized external accrediting body for the hazardous drugs identified in this PWS.

The Contractor shall provide the COR with the contract laboratory’s current accreditation certificate and scope for the analyses on this contract.

Management Information Systems

Task #10 – Sample Collection Media.

5.10. The Contractor shall be able to analyze the Alpha Polyester Knit TX714A Large Cleanroom Swab (Non-Sterile) sample collection media as provided by the Government.

Management Information Systems

Task #11 – Analytical Training Records.

5.11. All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing the methodologies

Management Information Systems

Task #12 – On-site Inspections.

5.12. The Government reserves the right to conduct inspections (on-site or virtual) of the Contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed

100% Inspection

Task #13 – Subcontractor / Subcontractor Facility.

5.13. Due to the need to maintain the integrity of the sampling and the laboratory certifications, the Contractor may subcontract with no more than three (3) other laboratories. The subcontractor laboratories and personnel shall hold the same qualifications and certifications as required by the prime.

Management Information Systems

Task #14 – Management Reports and Plans.

5.14. Monthly Financial Tracking Report (Deliverable #6).

Results Status Report (Deliverable #7).

Management Information Systems

Task #15 – Invoicing.

5.15. The Contractor shall submit invoices to Wide Area Workflow (WAWF) with sufficient documentation for the WAWF acceptor to review and approve the work performed.

Management Information Systems

DEL

# DESCRIPTION PWS

REF FREQUENCY MEDIUM / FORMAT SUBMIT TO

1 Non-Use/Non-Disclosure Agreement (NDA) 1.16.1.

Once before the beginning of the Period of Performance (PoP) Email NDA

Document

COR,

Contracting

Officer

2 Anti-Terrorism (AT) Level I Training 4.1.1.

Within 30 days of Contract Award and Every 12 Months Thereafter

Email the Certificates to the

COR

COR

3 iWATCH Training 4.1.2.

Within 30 days of Contract Award and Every 12 Months Thereafter

Email the Certificates to the

COR

COR

4 Final PDF Copy 5.4.2. As needed and necessary by the Technical Subject Matter Experts (SME’s) Email to the COR COR

PART 8 – 8.0. APPLICABLE PUBLICATIONS, DIRECTIVES, REGULATIONS,

AGREEMENTS, AND POLICIES

8.1. Applicable Publications, DHA Administrative Instructions (AI), etc.

8.1.1. United States Pharmacopeia (USP) 800: Handling Hazardous Drugs

8.1.2. Technical Bulletin-Medical (TB-MED) 515: Occupational Health and Indutrial Hygiene Guidance for the Management, Use and Disposal of Hazardous Drugs.

5 Electronic Data Deliverable (EDD) 5.4.2. As needed and necessary by the Technical

Subject Matter Experts (SME’s) Email to the COR COR

6 Monthly Financial Tracking Report 5.14.1. Within 30 days of Contract Award and

Every 30 Days Thereafter Email to the COR COR

7 Results Status Report 5.14.2. The 1st Monday after Contract Award and then Every Monday Thereafter Email to the COR COR