Cepheid SOW Updated.docx

STATEMENT OF WORK

Cepheid GeneXpert4 (2) Analyzers Maintenance and Service Winn Army Community Hospital 1061 Harmon Avenue, BLDG 302 Fort Stewart, GA 31314

1. GENERAL:

1.1. Scope of work. The contractor shall furnish all service and maintenance necessary to perform preventative maintenance and repair on Government owned Cepheid GeneXpert (2) Analyzers located at Winn Army Community Hospital, MEDDAC, Fort Stewart, GA (FSGA) (Department of Pathology, Microbiology).

1.1.2. All contractor and subcontractor activities shall be in compliance and applicable federal, state, and local laws and regulations.

1.1.3 Equipment Listing:

Cepheid GeneXpert Analyzers, Serial # 836790 and # 842920

2. ACRONYMS:

AR – Army Regulation CFP – Contractor Furnished Property COR – Contracting Officer’s Representative DOD: Department of Defense FSGA – Fort Stewart, Georgia GFP – Government Furnished Property HTM – Healthcare Technology Management IAW – In Accordance With JCAHO – Joint Commission on Accreditation of Healthcare Organizations KO – Contracting Officer MD/MDS – Medical Device/Medical Device Systems MEDDAC – Medical Department Activity MIL STD – Military Standard OSHA – Occupational Safety and Health Administration PPP – Principal Period of Performance QA – Quality Assurance QC – Quality Control WACH – Winn Army Community Hospital

3. DEFINITIONS:

Army Regulation – Regulation that contains policies and administrative procedures necessary to ensure uniform compliance with those policies and procedures.

Performance Requirements Summary – Identifies the key service units of the contract that will be evaluated by the government to assure contract performance standards are met by the contractor.

Principal Period of Performance - Working hours during which operations are performed. WACH operates Monday through Friday 0800-1800.

Quality Assurance – Those actions taken by the government to assure services meet the requirements of the contract.

4. GOVERNMENT FURNISHED:

The Government will not provide any GFP/GFE to the contractor under this contract.

5. CONTRACTOR FURNISHED:

5.1 The contractor shall provide and preform scheduled maintenance and repair service for the Cepheid GeneXpert Analyzers (2). The contractor shall maintain the two GeneXpert Analyzers and all related equipment in optimal operating condition throughout term of the service agreement. The service shall include all adjustments, calibration, repairs, parts replacement and all other methods deemed necessary to maintain the equipment. Contractor must supply a copy of the work performed to the COR and Chief, HTM. Service for this instrument is vendor specific, and cannot be performed by governmental functions or another vendor. The contractor shall ensure that technicians performing work on the GeneXpert4 (2) are certified to perform service on this specific equipment.

6. SECURITY POLICIES AND REQUIREMENTS:

6.1 Access to Military Installation:

6.1.1 Vehicle Registration: The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle operated by contract personnel on the military installation must have the minimum liability coverage required by the state in which the performance is located.

6.1.2 Contractor Identification: The Contractor shall ensure its personnel comply with installation and MTF personnel identification and access requirements. The Contractor is responsible for absences due to expired identification and access documents.

6.1.3 When responding to a service call at WACH, the Contractor shall provide each employee an identification badge which shall be displayed on their outer garment at all times. The badge shall include, at a minimum, the employees name, current picture, the Contractor’s name, and title.

6.1.4 Onsite contractor service technician shall report to WACH Security Office to sign in and receive temporary badge before performing any services.

6.2 Antiterrorism (AT) and Operations Security (OPSEC)

6.2.1 AT Level I training. 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 start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil

6.2.2 For contractors that do not require 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

7. PERSONNEL:

7.1 The contractor shall provide employees working on this contract with personal protective clothing, safety equipment and devices necessary to protect the employees.

7.2 The contractor shall provide employees working on this contract with an initial safety orientation and continuing instruction which shall enable them to conduct their work in a safe manner and to recognize and report hazardous conditions IAW OSHA.

7.3 The contractor shall not employ any alien who does not have a valid US Immigration Alien/Registration card.

7.4 The contractor shall ensure technicians are properly trained/certified in performing work on the Cepheid GeneXpert Analyzers.

7.5. Uniforms, name tags, and appearance

7.5.1 The contractor shall require all employees working on this contract to distinctive and identifiable badges.

8. CONTRACTOR RESPONSIBILITY:

8.1. The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control.

8.2. The Contractor shall be responsible for any damages to Government owned equipment and property and shall replace or repair any property damaged due to a fault of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and approved by the KO.

8.3. The Contractor shall ensure all areas where equipment is serviced on site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon Contractor departure from the work site. Equipment being repaired shall be safely secured at all times.

8.4. The Contractor is not responsible for service required due to Government misuse or abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor has four hours to make this determination and submit it to the COR for resolution.

9. Removal of Government Property:

9.1. Only equipment requiring major disassembly, major overhaul, or repair by replacement shall normally be removed from the Government site.

9.2. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify the COR. who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment.

9.3. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor.

10. SERVICE BEYOND THE SCOPE OF THE CONTRACT:

10.1. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the COR (in writing) of the existence or the development of any defects in, or repair required to the scheduled equipment which the Contractor considers they are not responsible for under the terms of this contract.

10.2. At the same time of the notification, the Contractor shall furnish the COR with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase instrument.

11.0. SPECIFIC TASK:

11.1 The contractor shall perform scheduled maintenance and repair of the GeneXpert (2) Analyzers. Hours of operations are from 0800 to 1800 hours, Monday through Friday, excluding federal holidays.

11.1.2 The contractor shall obtain the approval of the KO, or the Contracting Officer’s Representative, prior to changing the scheduled services.

11.1.3 FSR will be submitted to the COR and EMB no later than 5 calendar days of when services were completed. The contractor shall provide invoices of all services and repairs performed on the GeneXpert4 (2) Analyzers within 7 calendar days. The contractor shall provide a Service Report (FSR) upon completion of services providing detailed information regarding the cause of the MD/MDS malfunction (if applicable) and corrective action taken. It will include the time required to complete the service, price of labor (hourly rate), and a list of parts replaced including the part number and pricing for each part used during services.

11.1.4 The contractor shall provide one Annual Preventative Maintenance Check-up for each Cepheid GeneXpert COVID-19 testing analysis equipment at each given PM interval (ECN: 040682 SN: 836790 APRIL / ECN: 042866 SN: 842920 AUGUST). DD Form 2163 will be affixed to unit signifying verification/calibration/certification and unit is within acceptable tolerances IAW the instructions provided in TB 38-750-2, or with the Clinical Engineering activity's internal SOP.

11.1.5 Contractor shall perform all on-site scheduled service as specified by the manufacturers published maintenance manual as necessary to keep system in good condition including lubrications, cleaning (other than those performed at the operator’s level), calibrations, and diagnostics, during the period of performance at no additional cost.

11.1.6 The contractor shall ensure the GeneXpert (2) Analyzers have factory authorized product updates and system modification and these are installed at no additional cost to the government.

11.1.7 The contractor shall utilize factory trained authorized technicians for all service and instrument repairs.

11.1.8 The contractor shall provide no charge for replacement parts which become marginal or defective due to normal use and wear.

11.1.9 The contractor shall provide technical and application support for the GeneXpert Analyzers. The contractor shall provide 24 hour telephonic troubleshooting.

11.2.0 The contractor will bill all services in Procurement Integrated Enterprise Environment (PIEE) under Wide Area Work Flow (WAWF).

11.2.1 The contractor shall notify the Clinical Engineering if there is a recall on any equipment within 24 hours.

11.2.2 Contractor shall respond to service calls within two hours when specified equipment is not working/operating to standards or the morning of the next duty day if after 6:00pm Monday through Friday

11.2.3 Contractor shall arrive on site within 24 hours of service call being placed or the morning of the next duty day if after 6:00pm Monday through Friday if telephonic troubleshooting is unsuccessful and correct deficiencies within 24 hours after arrival on-site (if applicable).

11.2.4

12. QUALITY CONTROL:

12.1 The contractor shall establish and maintain a complete quality control program to ensure the requirements of the contract are met.

12.1.2 Records. The contractor shall maintain records of all service and maintenance inspections conducted and the corrective action taken. This documentation shall be made available to the Government during the term of the contract.

12.2 A report of inspections conducted, to include findings and corrective action, shall be prepared IAW DI-MISC-80508.

13. QUALITY ASSURANCE:

13.1 The Government will monitor the contractor’s performance under this contract.

13.2 When the contractor’s performance is unsatisfactory, a DA Form 5479, Contract Discrepancy Report (CDR), will be issued by the Government to the contractor IAW DA PAM 5-20. The contractor shall reply within 24 hours to the KO, giving reasons for the unsatisfactory condition, corrective actions taken, and procedures to prevent recurrence. Unsatisfactory performance shall result in an invoice deduction as specified in the PRS, Appendix II.

13.3 Performance Evaluation Meetings. Meetings will be held when the KO or COR requests such meetings. The written minutes of these meetings will be prepared by the KO or COR and shall be signed and dated by all attending parties. Should any of the above not concur with the minutes, it shall be so stated, in writing, to the KO and address the specific areas not concurred in within 3 working days of receipt of the minutes, and failure to do so shall constitute concurrence in the minutes in their entirety.

13.4 Safety. Must be maintained at all times.

13.4.1 Upon commencement of work under this contract, the contractor shall establish a program meeting the requirements to be in compliance with Public Law 91-596, “Occupational Safety and Health Act of 1970 (OSHA)

13.4.2 The contractor shall perform all duties of this contract in a safe manner and provide a safe environment for all personnel.

13.4.3 Performance Requirements

Requirement

Requirement

Contractor shall perform all on-site scheduled service as specified by the manufacturers published maintenance manual as necessary to keep system in good condition including lubrications, cleaning (other than those performed at the operator’s level), calibrations, and diagnostics, during the period of performance at no additional cost.

14. Invoicing and Payment:

14.1 The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232-7003, for services rendered under this contract.

14.2 When it is necessary to resubmit an invoice for payment that the same invoice number listed on the original document with a letter after the number is used and that a new invoice number will not be generated for a previous shipment. (Example: Invoice # 100473, 100473A, 100473B, etc.).

14.3 Contractor shall submit invoices in WAWF within 7 days of shipping date but no later than 30 days of shipping date.

15. Hours of Operation.

Monday – Friday 8:00 am to 18:00 pm

15.1 Recognized Holidays. Facility observes all federal holidays as follows:

15.2 When any of the above holidays fall on a Saturday it will be observed on the preceding Friday; holidays that fall on a Sunday will be observed on the following Monday. Any holidays declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

16. The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours of gaining knowledge of the incident) report the incident in writing to the Government’s COR. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

TOBACCO FREE MEDICAL CAMPUS (TFMC)

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.