SOW_Alinity PM.pdf

STATEMENT OF WORK

1. Maintenance

a. The Vendor shall provide OEM-trained, experienced, English-speaking personnel. The Vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

b. The Vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer's (OEM's) specifications/equipment certification.

d. The Vendor shall provide maintenance services Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site:

https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required preventive maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week.

2. Preventive Maintenance (PM) Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0730-1700 local time, excluding Federal Government holidays. Vendor shall provide full service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. The vendor shall perform PM service checks during the base contract period at the OEM's recommended intervals. Vendor will also perform PM service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

d. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC), OEM, the College of American Pathologist's (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

3. Corrective Maintenance.

a. The Vendor shall provide on-site corrective maintenance from 0730-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within forty eight (48) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within seventy two (72) hours.

c. The Government's request for corrective maintenance will be placed by Armed Services Blood Bank (ASBBC) personnel, directly to the vendor or its representatives. Corrective maintenance shall be completed during the hours specified in the contract.

d. The Vendor's response to requests for service may include telephone consultation with the equipment user/operator and a vendor Field Service Engineer (FSE). Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of a FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. The Vendor's quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

f. The Vendor shall have and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

4. Equipment Uptime Rate and Calculation.

a. The Contractor shall maintain an overall uptime rate of 95% or better for the analyzer.

Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MBTF).

b. Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at USNH Okinawa, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

c. Variables Definitions:

U= Possible Equipment Uptime (100%) H= Hours of Coverage per day H1= Begin Coverage Time during each day H2= End Coverage Time during each day A= # of covered days of the week W =Weeks of Coverage in a Year (52) C= Uptime Commitment (95%)

d. Known:

Hl =0730 hours H2=1700 hours A=5 days per week W=52 weeks per year C =95%

e. Calculations:

f. *Note* - Downtime hours shall fall within the Contractor's hours of coverage listed in Section 5. Downtime hours outside of the coverage timeframe listed in Section 5 shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

5. Replacement Parts/Updates.

a. The Vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with Abbott Laboratories Alinity S system. In the event that replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the Vendor.

d. All replacement parts shall be new and certified as OEM replacement parts.

e. The Vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the

FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the Vendor shall provide installation within 30 days of release regardless of PM schedules.

f. With approval from the Government, the vendor may perform hardware/software updates as they become available.

6. Government Furnished Property, Materials, and Services.

a. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of vendor supplies, materials, or for the personal belongings brought onto Government property by vendor personnel.

7. Vendor Furnished Property and Material.

a. The Vendor shall provide all service literature, reference publications, laptop computers, and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract.

8. Vendor Report Requirements.

a. During normal duty hours, Vendor FSE personnel shall check-in with the Armed Services Blood Bank Center (ASBBC) upon arrival at the Government site and again prior to departure. The Vendor FSEs shall personally notify ASBBC personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Vendor FSEs shall notify the Duty technician of the ASBBC.

b. The Vendor shall provide to ASBBC personnel a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly and in complete detail:

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include: manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include: parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Signatures

xi. Field Service Technician performing services

xii. ASBBC verifying service rendered (Identify Medical Treatment Facility)

xiii. In the event that agents / sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number)

9. Vendor Responsibility.

a. The Vendor shall be responsible for the repair/replacement of damaged Government-owned equipment and property due to the negligence of the Vendor or his representatives.

All such replacement or repair shall be at the Vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

10. Removal of Government Property.

a. No equipment shall be removed without the approval of the Contracting Officer's Representative and Materials Management Department (MMD) of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the Vendor via the MMD of the MTF. Any failure to obtain such passes which results in detainment or prosecution of service Vendor personnel, is the sole responsibility of the service Vendor and their personnel.

b. The Vendor shall provide a detailed description of removed items on the vendor's company letterhead. For associated items/accessories, the Vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer's serial numbers and facility equipment control numbers (ECNs) of all equipment/items removed. In the event that items/sub-assemblies/accessories are "repaired by replacement", a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Vendor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Vendor. The Vendor shall provide insurance coverage for damage to or loss of equipment while in vendor or service Vendor's custody.

d. In regards to donor information confidentiality and privacy, all Vendors and/or service Vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard disk drive (HDD) or solid state drive (SSD) shall be removed by MTF personnel prior to equipment removal from the site: Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD or SSD are to be replaced, the HDD or SSD in disrepair shall be left at the MTF for disposal.

e. Hard Disk and Solid State Drives (HDD & SSD): In regards to donor information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing donor information from the MTF. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager.

11. Service Beyond the Scope of the Contract

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

b. At the same time of the notification, the Vendor shall furnish ASBBC with 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 order.