Attachment 2_Performance Work Statement.pdf

Department of Defense

Defense Health Agency

Performance Work Statement

Cobas Liat Assays Analyzer/PCR Kits LIAT Equipment Maintenance

April 2026

Shaw Air Force Base/ 20th Medical Group

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Cobas Liat Assays Analyzer, PCR Kits

LIAT and Equipment Maintenance.

1.2 Description of Services/Introduction: The contractor must provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform cost-per-reportable results as defined in this

Performance Work Statement (PWS).

1.3 Background: Shaw Air Force Base - 20th Medical Group has a requirement for cost-per-reportable result for an Analyzer, maintenance, reagents, and supplies via a number of tests performed delivery schedule. Under the existing contract, the Contractor provides the clinical laboratory with a molecular real-time polymerase chain reaction service. The molecular real-time polymerase chain reaction service includes equipment, equipment service/support, test assays, and equipment support products. Real-time polymerase chain reaction system that is classified by the Clinical Laboratory Improvement Amendments (CLIA) as waived testing for Influenza A/B, RSV and Streptococcus A assays.

1.4 Scope: The Contractor must provide an analyzer that is capable of performing Costs-Per-

Reportable Result. All required tests are listed in Appendix A – Test Menu Requirements.

The analyzer provided must comply with the required specifications listed in Appendix B –

An Analyzer Specifications and must be compatible and approved for use with MHS

GENESIS electronic health record system.

1.5 Installation/Removal Contractor Equipment. The Contractor is responsible for the installation and removal of all Contractor equipment as specified in Appendix C –

Installation/Removal – Contractor Equipment. The site must have complete installation and go live of the system within 30 days of contract award.

1.6 Period of Performance (PoP):

• Base Delivery Period - 1 September 2026 to 31 August 2027

• Option Item Period 1 - 1 September 2027 – 31 August 2028

• Option Item Period 2 - 1 September 2028 – 31 August 2029

• Option Item Period 3 - 1 September 2029 – 31 August 2030

• Option Item Period 4 - 1 September 2030 – 31 August 2031

2.0 Administrative Specifications

2.1 Place of Performance: The work must be performed at Shaw Air Force Base - 20th

Medical Group Laboratory, 420 Polifka Drive, Building 1042, Shaw AFB, SC 29152.

2.2 Recognized Federal Holidays: Services must not be required on Federal holidays or the day of observance of federally established holidays and local base holidays (i.e. Easter). In general, federal holidays falling on a Saturday are observed on the preceding Friday whereas holidays falling on a Sunday are observed on the following Monday. Additional federal holidays as authorized by the President of the United States and/or executive orders must be considered part of standard Federal Government holidays.

2.2.1 Federal holidays relate to Government duty days and is not intended to supplement or otherwise alter the provisions of any Wage Determination regarding applicable paid holidays.

2.2.2 Observance of Federal Government holidays by Government personnel must not be a reason for an additional period of performance, or entitlement of compensation, except as set forth within the contract. In the event the Contractor’s personnel work during the holiday, the Contractor may reimburse them; however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked, unless stipulated otherwise.

2.3 Excused Absences, Government Personnel: When the Department of Defense grants excused absence to Government personnel, the Contractor must continue to provide sufficient personnel to perform critical tasks already in operation or scheduled and must be guided by the instructions issued by the Contracting Officer (KO) or the Contracting

Officer’s Representative (COR). Changes in employee work schedules must comply with the terms and conditions of the contract, to include payment provisions.

2.4 Government Escort. If Government employees are unavailable to provide required escort services during routine maintenance or system outages, the COR will assume escort responsibilities or provide alternate escort arrangements. The Contractor must not remain on site without a required escort and must follow all instructions issued by the COR.

2.5 If Government personnel are furloughed, the Contractor must contact the COR to receive guidance. It is the Government’s decision as to whether the contract price/cost will be affected as a result of Government shutdown. In the event of a Government shutdown or furloughed Government employee(s) impacts contract price/cost, a negotiated settlement will be reached as deemed appropriate by the KO.

2.6 Hours of Operation: The contractor is responsible for conducting business from 8:00am-

5:00pm (EST), Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar

Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the

Government facility is not closed for the above reasons.

2.7 Contractor Identification. Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel.

3.0 SPECIFIC TASKS

3.1 The Contractor must provide Cobas Liat Assays Analyzers, PCR Kits LIAT and Equipment

Maintenance that will perform cost-per-reportable-result, which bundles the equipment use, reagents, maintenance, and consumables into a single price negotiated through a contractual agreement.

3.2 The analyzers will be located at the Shaw Air Force Base - 20th Medical Group Laboratory, 420 Polifka Drive, Building 1042, Shaw AFB, SC 29152. All supplies, maintenance, and technical support services must be in accordance with all federal, state, and local laws, to include all regulations, manufacturers recommended standards, commercial requirements, and the PWS.

3.3 Cost-Per-Reportable Results. Cost-per-reportable-result must include all cost-per-test supplies, maintenance, and technical support services. The contractor must maintain, replace, repair, and provide supplies as required in order to ensure the equipment is operational and available for use no less than 98% of the time during normal hours of operation and within manufacturer specifications. Full operational maintenance personnel must be certified and fully qualified to install, service, maintain, and operate equipment, and conduct tests according to the manufacturer’s standards.

3.4 Data Management. To ensure analyzer performance, data must be archived and retrievable for at least one month prior to the current date.

3.5 MHS GENESIS Compatibility. The analyzer must be compatible and approved to work with the Shaw Air Force Base - 20th Medical Group (the customer) electronic health record system, MHS GENESIS. The vendor is responsible for the technical integration of medical devices, ensuring they are "MHS GENESIS ready" and compliant with cybersecurity requirements. At the local MTF (Military Treatment Facility) level, they are responsible for reviewing, approving, and maintaining the procedures for lab equipment, including validating that devices like the Liat analyzer are functioning correctly within the system.

3.6 Replacement Analyzers. Contractor will ensure replacements analyzers are shipped as quickly as possible to ensure operational continuity. Replacement units must be shipped next business day if request is received by 3p.m. ET. If a request is received over a weekend, on a holiday, or after cutoff, replacements will ship on the next business day.

3.7 Authority to Operate. The Contractor must have a current/approved Authority to Operate

(ATO) certificate from Defense Health Agency (DHA) for the specific model of system being submitted.

3.8 Training. The Contractor must provide training for at least three (3) government personnel.

Operator training courses or field-based training. the onsite biomedical repair technicians for them to be able to provide preventive and first line corrective maintenance coverage at Shaw

Air Force Base - 20th Medical Group.

3.9 Maintenance. The Contractor must provide full contract support and full maintenance support. Must provide qualified, certified technicians, test equipment, tools, and materials to perform troubleshooting, repair, preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational and within manufacturer specifications between the duty hours of 8:00am-5:00pm (EST). Contractor is responsible for ensuring a minimum of two competent repair technicians who are appropriately screened IAW the base clearance requirements. Daily, weekly, monthly, routine, and preventive maintenance can be determined by the Lab Team.

3.10 Routine Maintenance. Liat 1 and Liat 3 must be maintained according to the manufacturer's recommended schedule and procedures. Routine maintenance is performed by trained laboratory personnel on a daily, weekly, monthly basis, and annually by the

Contractor. To include basic checks and the processing of quality control materials to verify system performance, inspections, and calibration.

3.11 System Updates. The system must be connected to a standard off-the-shelf or PIN-lockable USB flash drive used for transferring data to and from the analyzer. The USB drive must be provided by the Contractor and is only connected to the instrument to update the drivers inside.

3.12 Repairs. The Contractor is responsible for all repair costs to include parts and labor for the equipment provided. contact the Roche Support Network Customer Support Center Cobas

Liat hotline directly. Only a Roche-qualified service representative is authorized to service or repair the system.

3.13 Service calls for Emergency Repairs. The Contractor must respond to emergency issues within twenty-four (24) hours of notification of malfunction and coordinate all other scheduled maintenance and repairs with the company. The contractor must provide technical response within 2 hours of notification. If the issue cannot be resolved remotely, a qualified technician must be on-site within 24 hours.

3.14 Regular Business Hours Help Line. The Contractor must provide a toll-free contact number for regular business hours help line calls from 8:00am-5:00pm (EST), Monday-

Friday (excluding Federal holidays), to answer technical questions, quality concerns, and maintenance/repair scheduling.

3.15 Base Access and Entry Requirements. The following will be required of each contractor to gain access to Shaw Air Force Base - 20th Medical Group: Complete the Entry Clearance

Form and email it back to the sponsor no later than 21 days prior to travel (45 days for personnel with dual citizenship). Shaw Air Force Base Security Office requires a social security number and one other identity source document. The Contractor is required to have a Real ID per Shaw AFB guidance. Digital Signatures are fine but do not use the premade generic option where you type and it converts to a signature as this will be returned and cause delay. If we don't receive this form in time, you will not be allowed access to the base.

Once the form has been approved the base POC will email you back with signed copy.

4.0 Government Furnished Property and Services

4.1 The Government will provide access to the Shaw Air Force Base - 20th Medical Group

Laboratory.

4.2 The Government will provide general utility and administrative support (Lights, Electric, Computer, Phone, Fax) as necessary to allow the contractor to conduct the maintenance visit.

4.3 No Government furnished property (GFP) will be issued to the contractor for completion of this contract.

APPENDIX A - MENU OF ASSAYS

Ordering

A.1 Quarterly delivery orders MUST be established based on the estimated annual test volume including those tests necessary for repeats, calibration and controls.

A.2 Shipments of reagents and consumables MUST BE made either quarterly or biannually.

A.3 Customers may, at their choice, allow shipment of product per the pre-determined schedule, order via phone, or use the Contractor website.

Test Estimate

SARS-Cov-2 more or less than 700 Influenza A more or less than 700 Influenza B more or less than 700 Respiratory Syncytial Virus more or less than 700

Beta Streptococcus Group A 700

Testing Range : 3,300 – 3,800 tests per year

Material Number Material Description Unit Ship Qty Requested

Delivery Date

09731261190

KIT COBAS LIAT SARS-COV-

2/FLU/RSV

PC 20 Quarterly

07341911190 KIT COBAS LIAT STREP A PC 38 Quarterly

093731270190

KIT COBAS LIAT SARS-COV-

2/FLU/RSV CTL

PC 3 Annual

07402678190

KIT COBAS LIAT STREP A

CTL

PC 2 Annual

07402759190 CLEANING TOOL KIT PC 1 Annual

APPENDIX B – Analyzer Specifications

B.1. Analyzer: The Contractor must provide an analyzer that meets the requirements stated in this PWS and the performance characteristics for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA'88) and the Clinical Laboratory Institute (CLSI formerly NCCLS). The analyzer must meet the following criteria:

B.1.1 Must be able to operate without a water source. Have no plumbing, drains, stirring mechanisms, mixing assemblies floor vents or deionized water. Have waste contained within the system and disposed of daily.

B.1.2 Must be able to store >500 samples with ability to archive.

B.1.3 Must be able to operate in temperatures of 59-86 degrees Fahrenheit, and humidity ranges between

15 – 80 RH%

B.1.4 Can interface bi-directionally with the laboratory information system (LIS)

B.1.5 Must operate at an electrical voltage of 100-120V

B.1.6 Must have the capability to process tests either manually, STAT or automatically.

B.1.7 Have positive patient identification via on-board barcode scanner.

B.1.8 Footprint: Equipment must not be larger than exact footprint required for analyzer, monitor, keyboard, CPU, printer, measuring at approximately L 9.3” x W 4.5” x H 7.5”, Weight 8.3 lbs.

B.1.9 Analyzer, to include pre-analytical/post-analytical system.

B.1.10 Reagents needed to perform the total of all tests specified for a full 12 months. All reagents, standards, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor's equipment and necessary for the generation of a test reportable result.

B.1.11 All necessary maintenance to keep the equipment in good operating condition. This includes both preventive maintenance and emergency repairs.

Appendix C – Installation/Removal – Contractor Equipment

C.1 Installation:

The site must have complete delivery, installation and go live of the system within 30 Days of contract award. Installation includes the placement and setting-up of the Analyzer and all equipment components inclusive, but not limited to, the entire laboratory associated mechanical, electromechanical parts and supplies. Installation must conform to Industry Standards and must meet or exceed with all applicable codes to include local/state regulations, NFPA, building codes, communications codes, and other codes for each utility identified. The Analyzer will remain where it is installed (plugged in).

C.1.1 An Uninterrupted Power Supply (UPS) for the provided analyzer. The UPS must be installed in the same room, to be positioned on the analyzer’s side. This UPS is a self-operated unit that provides enough power, during a commercial power outage, to the analyzer to ensure that the chemistry analyzer system remains operational thus prevents mechanical noise of the chemistry system, therefore, producing accurate patient results.

C.1.2 Perform system installation, correlation, and validation of the analyzer must all be above 90% upon completion of the validation.

C.1.3 A test/validation of all reagent/materials needed to perform these tasks.

C.2 Removal: The contractor is responsible for the removal of the analyzer and any associated equipment at the end of the contract period or at the Government's discretion.