P09 PWS- Stryker Instruments.docx

PERFORMANCE WORK STATEMENT

1. TITLE: Stryker Instruments Equipment Service Repair and Maintenance

2. GENERAL OBJECTIVES AND REQUIREMENTS:

The Phoenix VA Health Care System (Agency) requires a service contract for its Stryker surgical instruments.

3. PLACE OF PERFORMANCE:

Phoenix VA Health Care System.

650 E. Indian School Rd.

Phoenix, AZ 85012

4. BACKGROUND:

The Surgical service line use drills, saws, and drivers in surgical procedures. The availability and quality of the equipment is crucial to the uptime of the service and safety of the patients. The Agency does not have employees who are trained nor own specialized tools necessary to service the surgical instruments. The Agency also does not own the specialized tools needed to service scopes. Therefore, a service contract is necessary to maintain the instruments.

5. SCOPE:

A. IAW 15 USC 657s and 13 CFR 125.6 - limitations on subcontracting, the Contractor shall perform over 50% of the work.

B. The Contractor shall be certified to service the Stryker equipment covered under this service agreement.

C. The Contractor shall provide service Monday-Friday, 7:00am-4:00pm Arizona Standard Time excluding federal holidays.

D. The Contractor shall provide technical service via telephone 24 hours a day, 7 days a week.

E. The Contractor shall perform repair/maintenance on equipment as directed by Stryker.

F. The Contractor shall provide full repair coverage with no cap for all equipment.

G. The Contractor shall provide accident damage repair coverage with no cap for all equipment.

H. The Contractor shall use next-day shipping both ways at no extra charge to the Agency. The Contractor shall provide the customer with pre-paid and pre-printed next-day P.M. freight stamps to send to the Contractor for off-site repair service.

I. The Contractor shall provide 24-48-hour turnaround time for most off-site repairs. A complimentary loaner for repairs requiring longer than 48 hours shall be provided.

J. The Contractor shall provide an online repair and history tracker.

K. The Contractor shall provide on-site training and support.

L. The Contractor shall not remove any hard drives off station. All hard drives shall be turned into the COR.

M. The Contractor shall notify the Agency their intent to come on-site before arrival.

N. Upon arrival at the facility, all contractor personnel shall check-in with a valid Driver License or Company ID to the Biomedical Engineering department. Prior to conducting services, the contractor shall be issued a visitor’s badge which shall be worn above the waist during the contractor’s visit. The Biomedical Engineering department is located in Building 1, Room 1163.

O. The Contractor shall verify that the equipment that was serviced is fully functional before returning it to the Agency.

P. The Contractor shall deliver a hard copy or electronic copy of a Field Service Report that delineates the service performed and confirms quality assurance tests results to Agency.

Q. The Contract shall provide for the addition and removal of equipment.

R. The contractor shall return to the same location to sign out and turn-in issued visitors badge along with the documented service report (as described in paragraph 13. DELIVERABLES) for the service performed. The Biomedical Engineering department located in Building 1, Room 1163.

6. EQUIPMENT INVENTORY LISTING TO BE SUPPORTED: Current list of equipment is as follows:

5400-052-000W

CORE 2 Console ProCare 1803500419

7400-031-000W

TPX Oscillating Saw ProCare 2027515643

7400-099-000W

TPX Universal Driver ProCare 2114719923

8208-000-000W

System 8 Sagittal Saw ProCare 2112713273

7. SECURITY REQUIREMENTS:

A. Security Requirements for Unclassified Information: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

B. Services provided under this contract do not require the connection of one or more contractor-owned IT devices (such as a laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., non-public) network. Therefore, Certification and Accreditation (C & A) requirements do not apply and a security accreditation is not required for this contract.

C. Services provided under this contract does not involve equipment that stores, generates, transmits or exchanges sensitive data. Therefore, the following privacy considerations from Appendix C apply.

D. All contracted personnel requiring access to VA facilities more than two consecutive days, must complete VHA privacy training, course VA10203. All service agents having access to protected health information (PHI) in the performance of their official duties or have access to VA systems (e.g. CPRS or Vista Web) must provide proof of training upon request. VA Privacy Training is available from the TMS website at: https://www.tms.va.gov.

E. Signing in/out shall be during normal business hours: Monday – Friday 7:00 am to 4:00 pm Arizona Standard Time excluding Holidays, reference federal holiday link in paragraph 14.

F. Failure to sign in/out shall result in failure to perform.

G. Contractor FSE shall perform repair/maintenance on scientific equipment which is NOT connected to any VA network.

H. No photography of VA premises is allowed without written permission of the Contracting Officer.

8. PERFORMANCE MONITORING: The Agency shall oversee work done by the vendor and accept the quality of work as appropriate. Section D for performance standards QASP.

9. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI):

A. The Agency shall initiate service calls.

B. The Agency shall clean and sterilize equipment before sending it out for repair.

C. The Agency shall have the means to accommodate a 53 semi-truck.

D. The Agency shall have a loading dock.

E. The Agency shall provide the Contractor with adequate delivery information if equipment requires “inside delivery”.

10. Other Pertinent Information or Special Considerations:

A. Packaging, Packing and Shipping Instructions: All parcels and packages shall come through the Agency’s warehouse to be distributed either through Biomedical Engineering or the field service engineer if they are on station to receive the package. All parcels and packages shall ship overnight to:

ATTN: Biomedical Engineering Phoenix VA Health Care System 650 E. Indian School Rd.

Phoenix, AZ 85012 B. Inspection and Acceptance Criteria: The Agency shall sign off on the work completed if service is determined to be satisfactory.

11. PERIOD OF PERFORMANCE:

12. SERVICES DELIVERY STANDARDS/SUMMARY: The contractor's performance shall be monitored by the COR as follows:

A. Timely delivery of invoices, within 30 days of services rendered.

B. Timely scheduling and performance of repair/maintenance services.

C. Timely arrival for repair services as described in paragraph 5 response times.

D. Failure to comply with PWS and other monitoring items shall result in failure to perform.

13. DELIVERABLES:

A. Filed Service Reports shall be provided for all service activities including repair/maintenance, emergency repair, and safety inspections, and shall contain the following information:

B. Date(s) and time period of service.

C. Complete description of equipment serviced including model number and serial number.

D. Complete description of equipment services performed including upgrades, updates and software changes made.

E. Complete list of all materials, parts, or assemblies installed or replaced including serial numbers of parts where applicable.

F. A statement of the complaint that initiated the service call.

G. Total standard labor hours expended during the repair.

H. Failure to provide documentation shall result in invoice certification delays for contractor payment and failure to perform.

14. HOURS OF COVERAGE:

A. Delivery schedule consists of actual repair/maintenance visit and validation. Scheduling shall be coordinated with the subject matter expert (SME) or through the COR. Schedule timing shall be based on the equipment certification/calibration dates and equipment. See paragraph 7 equipment details.

B. Normal hours of coverage are Monday through Friday from 7:00 am to 4:00 pm Arizona Standard Time. All service/repairs shall be performed during normal hours of coverage unless requested or approved by the SME in coordination with the COR.

C. Repairs & Maintenance shall be performed as scheduled by the SME or COR. Repairs & Maintenance shall be performed during normal hours of coverage.

D. Work performed outside the normal hours of coverage shall be approved by the Contracting Officer. Funding for services that are outside the normal coverage hours or on holidays shall have approved modification prior to any service being allowed.

NOTE: All hardware/software modifications, upgrades, updates, enhancements, installations etc., for the enclosed inventory listing shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

E. Federal Holidays observed are located at the following link:

https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/ F. A copy of a packing slip with purchase order number shall be furnished at the time the order is delivered.

15. OVER AND ABOVE REPAIRS/EMERGENCY REPAIRS AND MAINTENANCE:

A. Contractor shall maintain the equipment in accordance with equipment Specific Task, paragraph 5.

B. Contractor shall provide unlimited telephone technical support and onsite service calls. These service calls shall be used for any maintenance or repair service as determined by Biomedical Engineering.

C. Telephone Response Time: Contractor 's FSE or Technical Support shall respond by telephone to Biomedical Engineering within four (4) hours after receipt of telephone notification during normal duty 7:00 AM to 4:00 PM Arizona Standard Time Monday through Friday.

D. For the enclosed equipment listing emergency services, repairs and maintenance that are over and above the PWS, if quote pricing is within the COR’s Government Purchase Card (GPC) threshold, the COR will authorize payment.

E. For emergencies over the COR’s GPC threshold, only the Contracting Officer (CO) is authorized to approve contract modifications.

F. Additional services shall be approved by the Contracting Officer prior to the contractor initiating any work.

G. The contractor shall provide an on-schedule-quote to both the CO and COR for review and consideration. Additional funding will be provided by the facility as-needed for payment.

H. Once an emergency modification has been issued to the contractor, the FSE shall be on site within 48 hours of modification emergency notification.

I. Any work to be performed, which is not covered by this PWS, SHALL be approved by the Contracting Officer, through a modification, prior to the work being performed.

16. PARKING, SMOKING, AND VA REGULATIONS:

It is the responsibility of the Contractor to park in the appropriate designated parking areas. Contractor shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any VA facility. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations shall result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

17. ACRONYMS:

A. BAA - Business Associate Agreement B. CO-Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts C. COR-Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract D. FSE - Field Service Engineer E. GMP - Good Manufacturing Practice F. HIPAA - Health Insurance Portability and Accountability Act of 1996 G. IPRM - Information Protection Risk Management H. ISA - Interconnection Agreement I. ISO - International Standards Organization J. MOU - Memorandum of Understanding K. OEM - Original Equipment Manufacturer L. PWS – Performance Work Statement M. PVAHCS- Phoenix Veterans Affairs Healthcare System N. SME - Subject Matter Expert