Hamilton Star PWS.pdf

Laboratory Equipment (Hamilton STAR & STARlet) Maintenance

Department of War Drug Demand Reduction Program

1. GENERAL. The Department of War (DoW) Drug Demand Reduction Program (DDRP) has a requirement for a consolidated non-personal maintenance services contract for designated laboratory equipment (Hamilton STAR and STARlet systems) at the following six (6) DoW sites:

Navy Drug Screening Laboratory, Naval Station Great Lakes, IL;

Navy Drug Screening Laboratory, Naval Air Station Jacksonville, FL;

Army Forensic Toxicology Drug Testing Laboratory, Fort Meade, MD;

Army Forensic Toxicology Drug Testing Laboratory, Tripler Army Medical Center, HI;

Headquarters Air Force Drug Testing Laboratory, Lackland Air Force Base, TX; and Armed Forces Medical Examiner System, Division of Forensic Toxicology, Dover Air Force Base, DE.

2. SCOPE. The Contractor shall provide for all-inclusive parts, labor, materials, travel, personnel, supervision, and shipping costs necessary to perform all maintenance actions covered under this contract, unless otherwise specified, for all equipment identified.

2.1. The Contractor shall provide and install all materials, parts, and services for preventive and corrective maintenance, telephone support, hardware upgrades, software updates (i.e., patches) and upgrades (i.e., new versions) for all equipment identified. The Contractor shall maintain the equipment within the original equipment manufacturer (OEM) specifications, in like new or better condition.

2.2. Under no circumstances shall the Contractor assume a verbal or written inquiry as authorization to provide services not specifically covered by the terms of the contract.

2.3. The Firm Fixed Price (FFP) Maintenance includes regularly scheduled preventive maintenance, inspections, calibrations, and corrective/repair maintenance tasks. The aggregate number of equipment covered under the contract shall fluctuate throughout the term of the contract. This fluctuation may result from the removal of aged, non-repairable, past service life, or past useful life equipment from the service contract, and the addition of new, warranty free equipment or equipment currently on inventory. Modifications to the equipment list will be submitted to the contract on an as-needed basis. The Contractor must provide a quarterly price breakdown for each piece of equipment under contract (see Attachment 1 - Equipment & Pricing Spreadsheet). Established price per line item shall not fluctuate throughout the duration of the contract.

2.4. Certification of compliance with ISO 9001 or ISO 13485 standards is required and shall be maintained throughout the duration of the contract.

3. SERVICE VENDOR PERSONNEL QUALIFICATION.

3.1. Personnel assigned to or utilized by the Contractor in the performance of this contract shall be fully capable of performing in an efficient, reliable, and professional manner.

3.2. Contractor personnel must be fluent and easily understandable in English.

3.3. All work shall be performed by service personnel with OEM service training on the products for which they will perform service.

3.4. Service personnel shall have at least one year of experience working on the Hamilton STAR and/or STARlet class of equipment on which they will perform service. Occasional experience with a limited set of equipment does not meet the requirements of this contract.

3.5. The Contractor shall ensure their personnel have appropriate hazardous materials training.

4. DEFINITIONS. As used throughout this performance work statement, the following terms shall have the meanings set forth below:

4.1. Calibration. This activity should be the procedures for mechanical and electronic adjustments of the device to ensure consistent, standardized performance or output per the OEM recommendations.

4.2. Contracting Officer (KO). A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

4.3. Contracting Officer’s Representative (COR) / Alternate COR (ACOR). A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

4.4. Corrective Maintenance. Repair, adjustment, calibration, software manipulation, and/or other action taken to return a piece of equipment to OEM specifications following a failure, damage, or other incident that causes the equipment to no longer perform within the original specifications.

4.5. Downtime. That time, during the laboratory’s normal business hours (NBH), when the equipment is not fully operational or available for production use without limitations on sample throughput, restrictions to the quality of the results, or safety hazards to the staff or visitors, due to instrument malfunction, ongoing preventive and/or corrective maintenance, or safety concerns.

4.6. Normal Business Hours (NBH). 0800-1700 (local), Monday through Friday (excluding federal holidays) during which the respective laboratory is typically open, conducting business, and a service technician would have access to the equipment.

4.7. Preventive Maintenance. Those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating and upgrading software for security, safety, compliance, and compatibility issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

4.8. Quality Assurance (QA). Actions, including inspections performed by the Government, to determine whether products and services conform to contract requirements.

4.9. Quality Assurance Evaluator (QAE). A Government employee responsible for performing quality assurance functions for a contracted service.

4.10. Quality Control (QC). Actions, including inspections and preparation of inspection records, performed by the Contractor to ensure that products and services conform to contract requirements.

4.11. Update. Modification to current software which provides new features or improves performance or security.

Updates are often software patches.

4.12. Upgrade. Replacement of hardware, software, or firmware with a newer or better version, in order to bring the system up to date or to improve its characteristics, provide new capabilities, improve performance, or bring systems into compliance with requirements. Upgrades are often new software versions and hardware components.

4.13. Uptime. That time, during the laboratory’s NBH, when equipment is fully operational and available for production use without limitations on sample throughput, restrictions to the quality of the results, or safety hazards to the staff or visitors.

5. PERFORMANCE REQUIREMENTS. The Contractor shall provide equipment maintenance services to include all periodic planned preventive maintenance and unscheduled corrective maintenance, as well as repairs necessitated by operator error. The Contractor shall also provide technical assistance to operators of the equipment as needed.

5.1. Preventive Maintenance (PM).

5.1.1. The Contractor shall perform scheduled PM on each system in accordance with OEM specifications/standards at least two (2) times per year and approximately every six (6) months. The laboratory may specify the hours/days during which PM shall take place to minimize the impact on laboratory operations. PM visits shall be scheduled at least two weeks in advance.

5.1.2. PM shall consist of, but is not limited to, examination, analysis, evaluation, adjustment, calibration, parts replacement, cleaning, lubrication, and correction of all malfunctions to maintain systems in like-new or better condition.

5.1.3. Prior to PM completion, the Contractor shall run QC checks, instrument tunes, and QC samples to demonstrate system function.

5.1.4. Corrective Maintenance service calls shall not substitute for scheduled PM unless the service call is within the approved PM timeframe and all PM procedures are followed.

5.2. Equipment in Use. If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance, the Contractor shall immediately notify the COR or ACOR.

5.3. Equipment Unable to Locate (UTL). If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the COR or ACOR. The COR or ACOR will determine the availability of the equipment. Equipment determined to be missing, lost, or stolen shall be exempt from maintenance.

5.4. PM Sticker. The Contractor shall affix a PM sticker to each piece of equipment upon PM completion which includes the name of the technician and the date of the PM.

5.5. Corrective Maintenance. The Contractor shall provide for any corrective maintenance services necessary to maintain equipment within OEM specifications and in accordance with any applicable U.S. Food and Drug Administration (FDA) requirements. Corrective maintenance shall include repair to equipment that results from unintentional damage, whether by the Government or contractor, such as: Component part failures, environmental issues, normal wear and tear, etc. Specifically excluded from coverage are environmental hazards such as fires, floods, acts of nature (earthquakes, hurricanes, tornados), unregulated power, gas/atmosphere contamination, and physical damage that is not in the normal course of instrument operation.

5.6. Hours of Work. Work required in the performance of this contract shall be performed during the NBH of each laboratory. Performance includes: Telephonic and electronic technical support and customer service, on-site technical support, and preventive and corrective maintenance services.

5.7. Telephonic Support. The Contractor shall provide each laboratory access to a telephonic technical support line that is available during the NBH of each laboratory. The telephone support staff shall be familiar with and capable of assisting laboratory personnel in the operation of the equipment listed and applicable software, firmware, and hardware.

5.8. Response Time. The Contractor shall respond telephonically or electronically to all telephonic or electronic service calls within two (2) normal business hours of notification of a problem. The Contractor shall provide on-site service within 24 hours of initial notification from the laboratory. The Contractor shall complete all corrective measures within 48 hours of initial notification from the laboratory or a suitable loaner or replacement equipment item shall be provided (at no additional cost), as required by the laboratory.

5.9. Uptime. The Contractor shall maintain the equipment in good operating condition (no major cosmetic or operating defects, no safety hazards, operating to OEM specifications, operating to good forensic laboratory practice) for at least 90% of the NBH of each laboratory each month.

5.10. Parts. The Contractor shall supply OEM-approved parts for all repairs necessary to restore equipment to OEM specifications. All replacement parts shall be guaranteed to be equal or better in all respects (performance, durability, quality, compatibility) to new parts specified for use by the OEM.

5.10.1. Technicians shall have access to an inventory of parts such that they can affect repairs on their first visit at least 75% of the time.

5.10.2. The Contractor shall provide all tools, equipment, parts, and supplies required to perform maintenance and repairs. The Contractor shall provide all diagnostic and operating software required to test, troubleshoot, and repair systems. The Contractor shall provide expendable consumables which may include batteries, light bulbs, fuses, etc.

Replacement parts shall be furnished within the time specified.

5.11. Recalls and Updates. The Contractor shall provide and install mandatory updates within three (3) business days upon OEM or FDA recall or alert notification. The Contractor shall provide documentation to the COR of such installations and mandatory updates.

5.12. Modification. Equipment covered by this contract shall not be modified from OEM specifications.

Equipment improvements/modifications shall be made only upon written approval and direction from the COR.

5.13. Software. The Government does not guarantee that government-owned software licenses allow for use of the software by third parties. The Contractor is responsible for ensuring that all appropriate software licenses are intact for operation, and the Government shall not be held liable in the event that the appropriate software licenses were not obtained.

5.13.1. Software and firmware maintenance is included in the scope of the contract, including patches, updates, and upgrades.

5.13.2. All updates and upgrades shall be compatible with existing systems, shall comply with all federal government information assurance (IA) security requirements, shall not jeopardize authorities to operate (ATOs) on the networks, and shall be installed only after approval is obtained from the COR, ACOR, or laboratory representative or designee.

5.13.3. The Contractor shall provide all manuals, training, and onsite support, as needed, to accomplish the updates and upgrades.

5.14. Technical Documentation. The Contractor shall obtain, have on file, and make available to its field service personnel all operational and technical documentation. This documentation shall include OEM software needed and test equipment and certifications required in diagnosing, repairing, and calibrating equipment.

5.15. Check-In/Out. Upon arrival on-site, Contractor personnel shall check-in with the laboratory receptionist or designated personnel prior to accessing laboratory spaces and initiating service. Contractors may be required to be escorted by laboratory personnel while servicing equipment. Contractor personnel shall wear a laboratory visitor’s badge and have a contractor-furnished identification badge that includes, at a minimum, the employee’s name, title, and company. Contractors shall check-out with the laboratory receptionist or designated personnel upon completion of service.

5.16. Service Event Documentation. Upon completion of each preventive and corrective maintenance visit, the Contractor personnel must provide a copy of the Service Report (SR) to the designated laboratory representative, within 2 business days. The Contractor shall e-mail a copy of all SRs for the month to the COR or ACOR, by the 10th day of the following month, to usn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil. Each SR must legibly and thoroughly document the following information:

Contract Number Name of Contractor personnel performing service Arrival date/time, Departure date/time Problem reported by user

Identification of Equipment Problem identified Service performed and parts used Problem resolution or pending action

5.17. Test Equipment. Records of test equipment calibrations shall be traceable to the National Institutes of Standards and Technology (NIST). Upon request by COR or ACOR, the Contractor and/or service vendors shall provide the Government a copy of the current calibration certification for all test equipment used.

5.18. Removal of Equipment. No equipment shall be removed from the laboratory without the approval of the laboratory representative or designee. Property passes for equipment removal must be obtained by the Contractor via the laboratory representative. Any failure to obtain such passes, which results in detainment or prosecution of Contractor personnel, are the sole responsibility of the Contractor personnel. No additional charge shall be allowed for work performed off-site, nor any additional time allotted. The Contractor shall provide a detailed description of removed items in writing on the Contractor’s company letterhead. For associated items / accessories, the Contractor will provide a detailed written description and quantities of items to be removed. Descriptions will include, at a minimum, manufacturer’s serial numbers of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement”, a detailed description of replaced items is to be included upon return of repaired components. The Contractor shall provide insurance coverage for damage to or loss of laboratory equipment while in Contractor’s custody. Regarding patient information confidentiality and privacy, all Contractors personnel shall comply with all applicable HIPAA requirements.

5.19. Deleting/Adding Equipment under Contract. The Government may add or delete equipment from this contract.

5.19.1. The Contractor shall verify and update the equipment inventory at each laboratory twice per year and submit to the Government for verification.

5.19.2. Modifications to the equipment list will be submitted on an as-needed basis.

5.20. Contract Modifications. Only the KO has the authority to make changes to the contract or obligate the Government and shall do so only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO.

5.21. Confidentiality. Contractors and/or service vendors will comply with all applicable Privacy Act requirements, in regard to any personally identifiable information (PII) and protected health information (PHI).

Information regarding Privacy Act, PII, and PHI is available to Contractor personnel for review at the laboratories.

5.22. Safety Requirements. The Contractor shall take safety precautions as the laboratory representative may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. The laboratory representative shall notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If the Contractor refuses to comply promptly, the COR or ACOR may stop all or any part of the work for safety reasons. Under such circumstances, the KO can hold the Contractor in contract default. Nothing in this section shall be construed so as to limit the Contractor’s or sub-contractor’s responsibilities to comply with any existing law, nor to switch jurisdictions for any dispute.

5.23. Compliance with Applicable Laws. The Contractor shall be knowledgeable of and compliant with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of the Contractor’s business.

5.24. Physical Security. The Contractor shall safeguard all Government property provided for Contractor use. The Contractor shall receipt and account for any Government-furnished equipment.

5.25. Work Performed by Others. When work performed by the Government or other Contractors is expected to affect the Contractor’s performance of work, the Government shall coordinate with the Contractor and provide necessary information (plans, specifications, etc.) for such work to the Contractor such that the Contractor may make scheduling allowances. The COR or ACOR shall resolve any schedule conflicts between the Contractor and work performed by the Government or other Contractors. Such actions shall not result in additional cost to the Government under this contract.

5.26. Government Right of Refusal. The Government reserves the right to reject any third-party service vendor’s personnel and refuse them permission to enter the premises or work on laboratory equipment. This right may be exercised at any time.

5.27. Government Right to Change Standard Operating Procedures. The Government reserves the right to establish and/or change Standard Operating Procedures which shall be binding on the Contractor (i.e., work order procedures, emergency and fire procedures, security procedures, and power outages).

5.28. Meetings. The Government reserves the right to schedule meetings to discuss or resolve issues/problems as it deems to be critical, at no additional cost to the Government.

5.29. Phase Out of Service. Upon expiration or termination of this contract, the Contractor, at the Contractor’s expense, shall provide certifications from the OEMs for all equipment covered that the OEM would assume a full service contract for the products at the rates/discounts normally provided to federal government customers. If repairs or corrections to the equipment have to be made to obtain such certifications, the Contractor shall arrange to have those repairs or corrections made at the Contractor’s expense.

5.30. Certification of Maintainability. At such time as the services of the Contractor are terminated, expire contractually, or are otherwise not extended, the Contractor shall issue, within five (5) business days, a Certificate of Maintainability for all equipment covered under this contract.

5.30.1. The Certificate shall state that PM, in accordance with the specifications of the OEM, has been performed and that the equipment is performing in accordance with the OEM’s specifications such that the OEM (or the OEM’s successor in interest) commits that it would assume maintenance of the equipment without any one-time charges (including but not limited to repair and inspection charges) if such maintenance were assumed effective the day after the Contractor’s performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certifications.

5.30.2. Should the Contractor fail to issue the Certificate of Maintainability, or should any of the equipment covered under this contract fail to perform in accordance with the certification, the Contractor shall be liable for any costs incurred by the Government in bringing the equipment up to maintainable levels.

5.31. Standards of Conduct. The Contractor shall maintain and enforce standards of conduct for Contractor personnel. The Contractor shall take appropriate corrective action in cases of violation of standards of conduct. A report of corrective action taken shall be provided to the COR for concurrence.

5.31.1. The Contractor shall not employ persons convicted of violations of criminal statutes, felonies, or misdemeanors involving crimes against persons or moral turpitude. At the Contractor’s expense, a background check of prospective employees shall be conducted to ensure compliance with this paragraph.

5.31.2. The Contractor shall not employ any alien in the performance of the contract in violation of the Immigration Laws of the United States.

5.31.3. Contactor personnel charged or indicted for a felony involving crimes against persons or moral turpitude, or drug-related misdemeanors should be removed until the legal process is complete. If legal proceedings result in a finding of not guilty on the merits of the case, the employee may be allowed to return to work. The COR shall be notified. In all other cases, the employee may be allowed to return only with prior Government approval.

5.31.4. Unless otherwise specified, all financial, statistical, personnel and/or technical data which is available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract nor be released by the Contractor without prior written consent of the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from the studies covered by this contract, will be subject to review and approval by the COR before publication or dissemination.

6. CONTRACTOR-FURNISHED ITEMS AND SERVICES.

6.1. Contractor shall furnish all supplies, materials, repair or replacement parts, tools, equipment, and labor necessary to efficiently and satisfactorily perform the requirements of this contract.

6.2. The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damages caused by the Contractor’s activities. During performance of services, the Contractor shall keep the laboratory site safe, neat, clean, and orderly. The Contractor shall be responsible for appropriate behavior and dress at all times.

6.3. The Contractor supplies and equipment shall comply with Federal, State, municipal, and OEM specifications.

7. SECURITY MEASURES.

7.1. Contractor Requirements for Background Checks: It is the Contractor’s responsibility to ensure its employees undergo proper criminal history background checks. Contractor employees who have previously received a background check must provide proof of the check or obtain a new one.

QUALITY ASSURANCE SURVEILLANCE PLAN

Risk Factors Performance

Objective Performance

Standard Acceptable

Quality Level

Monitoring Method /

Performance Assessment

Positive / Negative Incentives

Preventive Maintenance

Provide preventive maintenance services for equipment covered under this contract.

Submit service reports for preventive maintenance services.

Contractor must complete preventive maintenance per

OEM

specifications for all equipment

Systems must be fully operational;

system defects must be identified for timely repair;

OEM preventive maintenance, inspection, and calibration standards must be observed.

A complete and accurate service report must be submitted to the laboratory representative.

report must be submitted to the COR or ACOR.

complete 100% of preventive maintenance as defined by OEM specifications/ standards for all equipment covered under this contract.

Accurate service reports are delivered to the laboratory representative within 2 business days of PM completion 100% of the time.

Accurate service reports are delivered to the COR by the 10th day of the month following PM completion 100% of the time.

Zero outdated preventive maintenance findings during Quality Assurance Inspections.

Continuous review of service reports by COR.

Communication between COR and laboratory representatives via phone, e-mail, and in person during site visits.

When performance is below standard for the current month, the Contractor must remedy the deficiency and meet or exceed the performance standard within the prescribed timeframe at no additional cost to the Government.

Remedy must be completed within 5 business days of notification by the

If performance is below the performance standard, the Government may require a meeting with the Contractor at no additional cost to the Government and may require the Contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.

Contractor performance will be documented in

CPARS.

Objective Performance

Standard Acceptable

Quality Level

Monitoring Method /

Performance Assessment

Corrective corrective maintenance services and repairs for equipment covered under this contract as circumstances dictate.

Submit service reports for corrective maintenance services.

complete corrective maintenance required for all equipment

Systems must be fully operational;

repairs must be in accordance with OEM specifications;

new OEM recommended parts shall be used to repair equipment, refurbished parts shall not be authorized for use in effecting repairs.

report must be submitted to the laboratory representative.

report must be submitted to the

Contractor shall ensure a 90% or better monthly Uptime for all equipment covered under this contract.

Downtime for any system or instrument shall not exceed 10% of NBH at each laboratory per month.

complete equipment recall upgrades and corrective measures upon OEM, FDA, or COR or ACOR notification.

Contractor shall use 100% new parts to restore equipment in accordance with OEM specifications.

provide accurate and complete service reports to the laboratory representative within 2 business days of service completion 100% of the time.

provide accurate and complete service reports to the COR or ACOR by the 10th day of the month following the performance of service 100% of the time.

review of service reports by COR.

and laboratory representatives via phone, e-mail, and in below standard for the current month, the Contractor must remedy the deficiency by re-performing the service at no additional cost to the Government.

business days of performance standard, the Government may require a meeting with the Contractor at no additional cost to the Government and may require the Contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.

Objective Performance

Standard Acceptable

Quality Level

Monitoring Method /

Performance Assessment

Customer Service Response to Preventive Maintenance and Corrective

Inquiries preventive and corrective maintenance services for all equipment

Provide access to a technical support customer service center.

Respond to technical service support and corrective maintenance inquiries through Internet-based or phone technical service support center, or on-site routine/ repair service visit during the NBH at each laboratory.

The Contractor personnel shall confirm the requested service call to the laboratory representative within 2 business hours of service request notification to the Contractor’s Internet-based on-line or phone technical service support center.

If the equipment cannot be restored via phone technical support services, the Contractor personnel shall arrive on-site within 24 hours to assess and/or complete service requested.

shall complete all corrective measures within 48 hours of initial notification from the laboratory or a suitable loaner or replacement equipment item shall be provided at no additional cost to the Government.

shall be compliant 95% or better for 2-hour telephone responses.

shall prioritize corrective maintenance requests and be compliant 95% of the time for 24-hour on-site response time.

shall complete repair service within 72 hours of laboratory notification 85% of the time review of service reports by COR.

and laboratory representatives via phone, e-mail, and in below standard for the current month, the Contractor must remedy the deficiency by re-performing the service at no additional cost to the government.

business days of performance standard, the Government may require a meeting with the Contractor at no additional cost to the Government and may require the Contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.