PWS_-_LIMS.doc

PERFORMANCE WORK STATEMENT

For vendor to provide delivery and installation of a Laboratory Information Management System (LIMS) to the Armed Forces Medical Examiner System (AFMES), Division of Forensic Toxicology (DFT), Dover AFB, DE.

TABLE OF CONTENTS

SECTION

TITLE

1.0

GOVERNMENT STATEMENT OF OBJECTIVES

2.0

BACKGROUND

3.0

QUALITY MANAGEMENT

4.0

PERFORMANCE OBJECTIVES

5.0

ADMINISTRATION

6.0

AT/OPSEC REQUIREMENT

7.0

QUALITY ASURANCE SURVEILLANCE PLAN

1.0. GOVERNMENT STATEMENT OF OBJECTIVES

1.1. PURPOSE: Acquire delivery and installation of a Laboratory Information Management System (LIMS).

1.2. SCOPE: The contractor or its subcontractors shall be a specialist in delivering and installing LIMS in the spaces at AFMES, DFT and also provide data migration/integration services from existing databases to the new LIMS. The contractor or its subcontractors should be an active certified LIMS dealer and have factory trained technicians to deliver and install the licenses and software.

1.3. PERIOD OF PERFORMANCE: The delivery date for the LIMS is on or before TO BE DETERMINED (TBD).

2.0. BACKGROUND

The AFMES DFT is the centralized laboratory serving the interests of the Department of Defense (DoD) investigating military-related deaths, intoxicated drivers, victims of sexual assault and incidents involving aircraft, ground, and sea mishaps, among other special cases of national interest. The DFT also provides quality oversight of the DoD Drug Testing Program through certification, proficiency testing, and inspections, as well as developing assays for monitoring emerging drugs of abuse.

Currently, DFT laboratory data is produced largely as paper products and physical case folders. The history, trends, and analyses are managed through several custom databases built out of necessity over time. The files are not integrated or organized, so many of the daily operations are handled by physical checks and balances on paper. This practice would not be sustainable if there were an abrupt increase in caseload, while expectations of high quality and rapid turnaround time remain unchanged. Also, with regulatory policies becoming more stringent a LIMS would provide a central solution to meet requirements for accrediting bodies such as American Board of Forensic Toxicology, American National Standards Institute-American Society for Quality National Accreditation Board, and American Society of Crime Lab Directors/Lab Accreditation Board:ISO17025. A LIMS is required to meet current and future needs for tracking workflow for years to come.

3.0. QUALITY MANAGEMENT

3.1. The Contractor or its subcontractors shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

3.2. INSPECTION AND ACCEPTANCE: The inspection and acceptance point for all deliverables and services rendered under this contract will be the Contacting Officer’s Representative (COR). The performance by the contract personnel, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the COR. The customer reserves the right to inspect or test any software that has been tendered for acceptance. The COR may require repair or replacement of nonconforming software at no increase in contract price.

4.0. PERFORMANCE OBJECTIVES

4.1. DELIVERY: Deliver the required LIMS meeting manufacturer’s specifications by the delivery date and IAW the terms of the contract.

The warranty for the LIMS will become active immediately after project completion for one year after installation. During the warranty period the contractor or its subcontractors shall provide ongoing maintenance and support to include security related configurations, patches, updates and upgrades at no additional charge and warrants that the media will be substantially free from material defects in materials or workmanship and the program, updates and upgrades provided in the warranty period will operate in substantial conformity with the documentation. Following expiration of the one year warranty, the contractor or its subcontractors shall provide maintenance and support IAW the contract. Additionally, the contractor or its subcontractors will maintain the application so that it is compatible with the most recent operating system (OS) released and supported by the OS developer. The contractor or its subcontractors shall be a specialist in delivering and installing the LIMS in the DFT laboratory spaces at AFMES. The contractor or its subcontractors shall be an active certified LIMS dealer and have factory trained technicians to deliver and install the instrument.

4.2. INSTALLATION: Complete installation of the LIMS meeting manufacturer installation specifications within the existing laboratory spaces in the DFT. Installation includes gap analysis documentation with solutions, design documentation and testing, assistance with installation of system development, testing and production, instrument interfaces, general configuration of users, labels, equipment, inventory management and quality analysis, unit configuration for toxicology, data migration/integration services, and on-site application training.

4.3. MIGRATION/INTEGRATION SERVICES

4.3.1. The contractor shall provide software and data integration services, workflow analysis and integration services to DFT as part of the transition to LIMS.

4.3.2. The contractor shall provide for the migration of all data which currently resides within DFT systems.

4.3.3. The contractor shall ensure the product is configurable to the DISA Application Security and Develop Security Technical Implementation Guide (STIG) is a cybersecurity methodology for standardizing security protocols within networks, servers, computers, and logical designs to enhance overall security (STIG).

4.3.4. The contractor shall ensure the product has the capability to run in a VMWare VSphere virtual environmental that is DoD STIG compliant and secured.

4.4. TELEPHONIC OR ELECTRONIC TECHNICAL SUPPORT: The contractor shall provide DFT 24/7 access to a telephonic technical support phone number as well as a website and/or email address that is available during the normal business hours of the laboratory. The technical support staff shall be familiar with and capable of assisting laboratory personnel with the operation of the system and applicable software.

4.5. RESPONSE TIMES: The contractor shall respond telephonically or electronically to all telephone or electronic service calls within two (2) business hour of notification of a problem. The contractor shall provide on-site service within 2 business days of initial notification form the laboratory (when required). The contractor shall complete all corrective measures within 3 business days of initial notification from the laboratory.

5.0. ADMINISTRATION

5.1. COMPUTER NETWORK: Contractors will not be allowed to access the internet and/or be granted computer access to the AFMES Network. The Forensic Toxicology Technical Representative or designee will be available for requests to see specific items on the network. The representative or designee will log-in to the computer, pull-up and if necessary print out additional information as needed as long as it does not violate Information Assurance or The Health Insurance Portability and Accountability Act of 1996 (HIPAA; Pub.L. 104–191, 110 Stat. 1936, enacted August 21, 1996) (HIPPA) policy. Contractors will not enter the facility or introduce mobile or other computing devices without prior approval from the AFMES Information Assurance Manager

5.2. FACILITY ACCESS: All commercial vehicles and buses will be directed to the commercial search area. Each commercial vehicle operator must have a computer generated bill of lading for delivery, valid driver’s license, current proof of insurance, current vehicle registration and current trailer registration (if applicable). If visitors do not have all of these credentials, they will be denied entry into the installation.

a. Commercial Gate hours are 0530-1730 7 days a week.

b. Personnel entry requirements: Personnel must be in possession of a valid State ID or valid International Passport for entry.

c. Valid entry credentials include any of the following;

(1) Dover Air Force Base Contractor Badges (Yellow, Red, Green, or Blue – valid until their expiration date or otherwise revoked or suspended.)

Personnel not in possession of a valid ID will be denied access to the installation. Note: Yellow & Blue Contractor badges are not applicable to the AFMES.

(2) Vendor Base badges may be requested through the AFMES Physical

Security Office. These badges are meant to facilitate less involvement of

AFMES staff having to leave the facility to pick up, vouch for, and escort trusted vendors from the Commercial Gate.

(3) Vendor base badge requests can only be requested by an active duty or GS employee of the AFMES by emailing the Physical Security Officer requesting a specifically identified vendor be issued a Vendor Badge and a complete explanation why the badge is needed.

(4) Email requests for Vendor badges must include the following information of the specific person for which the badge is being requested:

· Full Name

· Date of Birth

· Place of Birth

· Driver's License Number

· Driver's License State

· Company Name

· Duration of Visit

· Access Privileges: 0700-1700

· Badge Color: Red (requires approved AFMES escort) Green (can actually escort other co-workers {assistants} onto base).

(5) Once the Security Officer receives the email request from the appropriate

AFMES staff they will prepare and send the formal request to DAFB

Security Forces at the following email address 436 SFS/PID ORG

[436SFS.PID-02@us.af.mil].

(6) DAFB Security Forces will initiate a background check on the named vendor and if approved will issue a Vendor Base Access Badge and send a reply confirmation email back to the AFMES Security Officer notifying them that the badge would be available for pickup at the Visitor Center located by the DAFB Main Gate entrance. The badge will be available for 30 days, if not picked up by the vendor within those 30 days the badge will be destroyed.

(7) Vendors in possession of an issued Vendor Access badge are required to enter through the Commercial Inspection Gate if they are in a Company truck or van. If the vendor is driving a privately owned vehicle (POV) they may come through the

DAFB Main Gate.

d. Personnel must present a dated /computer generated (Not hand written) bill of lading, invoice, work order or service call contract etc. and a Point of Contact (POC) with a base landline phone number. Those who possess a hand written documentation will require escort by authorized personnel.

5.3. CONTRACTING OFFICER’S REPRESENTATIVE (COR): The COR will be the Contracting Officer’s (KO) authorized representative in administering the contract. The Contractor’s representative shall be available to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

KO:

Contract Specialist:

COR:

Cassandra Crawford-Bice

AFMES

Phone: 302-346-8734

Email address: cassandra.crawfordbice.civ@mail.mil

5.4. CONTRACTOR MANPOWER REPORTING. "ACCOUNTING FOR CONTRACT SERVICES: The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address “https://cmra.army.mil. The required information includes: (1) Contracting Office, KO, KO’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-contractor); (7) Total payments (including sub-contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the KO’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the KO."

AFMES UIC =W03K06

DODAAC = W56DNJ

6.0. AT/OPSEC REQUIREMENT

6.1. ACCESS AND GENERAL PROTECTION/SECURITY POLICY AND PROCEDURES: Contractors and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identify Verification of Contractor Personnel) as directed by DoD HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes 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.

6.2. CONTRACTOR THAT DO NOT REQUIRE A CAC, BUT REQUIRE ACCESS TO A DOD FACILITY OR INSTALLATION: Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation facility and area commander installation/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.

7.0. QUALITY ASSURANCE SURVEILLANCE PLAN

7.1. PLAN OBJECTIVE: This plan provides a quality surveillance strategy for the delivery of, installation of, training on, data migration/integration, telephonic/electronic support, response time to service calls and technical support agreement on the LIMS at DFT Dover AFB, DE. The primary purpose of this plan is to provide a basis for the government’s evaluation of the Contractor’s key areas of performance under this contract. The KO, in conjunction with input provided by the COR, will evaluate the Contractor’s performance. Oversight of the Contractor’s performance will assure quality and consistency of contract performance.

7.2. PERFORMANCE MEASUREMENT OBJECTIVE: The key area(s) of the Contractor’s or its subcontractors’ performance that will be evaluated during the term of the contract. The performance work statement reference will be provided for each performance measurement objective.

7.3. ASSESSMENT METHOD: Contractor or its subcontractors’ performance is inspected periodically. Methods of surveillance are passive by customer feedback, passive by reports provided by the Information Technology Division, and review by the COR at time of service(s).

7.4. ACCEPTABLE QUALITY LEVEL (AQL): The degree to which the Government will allow the Contractor’s or its subcontractors key areas of performance to vary; the variance from the standard that the Contractor or its subcontractors is allowed and the grading/measurement associated with deviation from the specific performance standard.

7.5. KEY AREAS OF PERFORMANCE (Performance Requirements Summary):

7.6. CONTRACTOR PERFORMANCE ASSESSMENT REPORT. This report shall be submitted to the KO annually by the COR, or upon exception.

7.7. RE-PERFORMANCE OF SERVICES. If any of the services do not conform to contract requirements, the Government will require the contractor to re-perform the services in conformity with contract requirements, at no additional cost to the Government. When the defects in services cannot be corrected due to circumstances, the Government may (1) require the contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed. The KO may exercise appropriate contractual remedy should the contractor fail to promptly take the necessary action to ensure future performance is in conformity with contract requirements.

When apparent non-satisfactory work is identified, the COR shall prepare a Contract Discrepancy Report (CDR) and submit to the KO for review, see attached for CDR form. The Contractor shall then be required to respond to the CDR. The Contractor shall explain reasons for substandard performance, how performance will be returned to acceptable levels, and how recurrence of the same or like problems will be prevented. The KO will evaluate the Contractor's explanation, assess its validity, and determine whether it is acceptable.

The contractor shall be required to correct/eliminate any deficiencies in services in a timely manner. Notification begins when pertinent documents (e.g., Customer Complaint Record or CDR) are issued to the contractor. Time of notification and correction of all applicable deficiencies should be entered on all Government documents and retained in the contract file. The Government may execute a deduction in payment for non-compliance when validated by the KO.

END OF PERFORMANCE WORK STATEMENT