BioMed Services SOW.pdf

Nashville Area IHS Medical Equipment Preventative Maintenance, Repair, Inventory Management, and Rental Services Nashville Area Service Units

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Statement of Work

I. INTRODUCTION AND BACKGROUND

A) The Nashville Area Indian Health Service Office in Nashville, Tennessee, oversees the delivery of health care to approximately 63,593 Native American users in the 27 State area of the eastern, southeastern, and mid-United States. Throughout a network of health care facilities, the IHS are a health care partner to 36 tribes. The Nashville Area Office (NAO) is based in Nashville, Tennessee.

Our system of care includes Indian Health Service (IHS) and tribally operated health care facilities that serve tribal communities as well as four Federally Direct Care Service Facilities, three Urban

Indian Health programs, and one Youth Regional Treatment Center. These services are comprehensive and range from primary care to tertiary care and specialty services. Refer to Section

V – Mashpee Service Unit that shall be covered under this agreement.

B) The Indian Health Service (IHS), Nashville Area Office (NAO) Mashpee Service Unit, is procuring for a Contractor to provide medical equipment preventative maintenance, repair, inventory management, and rental services. In order to ensure that the medical equipment provides reliable and consistent results with minimum downtime, it is necessary to obtain routine maintenance and calibration services by field service engineers and technicians with specific technical expertise and manufacturer-certified replacement parts. The services are required to ensure equipment is maintained to operating specification, which meet or exceed the original equipment manufacturer’s requirements and recommendations.

II. OBJECTIVE

A) The goal of medical equipment maintenance is to ensure the equipment is fully functional, safe, and effective for its intended use. Routine maintenance and calibration services are required on an annual, semi-annual, or quarterly basis in compliance with original equipment manufacturer (OEM) specifications, ANSI (American National Standards Institute) /Association for the Advancement of

Medical Instrumentation (AAMI) EQ89:2015 standards, and The Joint Commission requirements.

Required maintenance checks include but are not limited to performing visual inspections, test and calibration procedures, and performing electrical safety tests. The Contractor shall meet or exceed the manufactory specification requirements, National Fire Protection Association (NFPA) 99, and the Joint Commission Environment of Care standards (EC.02.04.01, EC.02.04.03).

B) The contractor shall provide the following medical equipment services required to support the

Nashville Area medical equipment management plan:

i) Preventative Maintenance/Planned Maintenance: Scheduled routine maintenance in compliance with Original Equipment Manufacturer requirements to verify operation is within acceptable parameters, identify faults or damage, and ensure the device is safe and effective. Maintenance is required to prevent failures by testing and inspecting the device at specified time intervals

(annually, semiannually, quarterly, etc.) and includes replacement of parts on an as-needed or routine basis (batteries, O-rings, etc.).

ii) Repair/Corrective Maintenance: Maintenance required in order to return a device to proper operating condition when a failure or fault is identified. Repair services include testing and determining the issue with the faulty equipment and providing the necessary parts and service to return the device to operational status.

iii) Initial Inspection/Acceptance Testing: Inspection required for asset onboarding to ensure the newly received equipment is safe and in good operating condition, prior to being placed into service for its intended use. Initial inspection procedures include assembly, installation, and setup as required. Equipment may be in new condition, rented, leased, or transferred.

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iv) Rental Equipment Services: Services required to provide short-term and long-term medical equipment rentals on an as-needed basis.

C) The Contractor shall provide qualified personnel to perform comprehensive on-site visits to the

Mashpee Service Unit to provide inspection, preventative maintenance, inventory management, rental, and repair services. The Contractor shall provide technical services necessary for the optimum operation of medical equipment within Mashpee Service Unit. The Contractor shall possesses the capability to service the device types listed in Section VIII - Medical Equipment –

Clinical Devices Asset Types. Service capability on these asset types shall be in accordance with

OEM requirements and available throughout the lifespan of this contract.

D) The services/work that the Contractor shall provide specifically includes those described or specified herein. However, the performance as described and specified shall not be deemed to constitute a detailed specification having the effect of excluding other needed work not specifically mentioned that will be necessary for the successful completion of this project as generally described. The

Contractor is required to furnish all services, parts, labor, and equipment necessary to successfully fulfill the overall objectives set forth in the contract.

III. DESCRIPTION OF SERVICES

A) General Requirements: The contractor shall maintain and service the medical equipment in accordance with Original Equipment Manufacturer (OEM) requirements and recommendations. All scheduled and unscheduled maintenance, inspections, and repair services shall be performed in accordance with the requirements and standards set by the The Joint Commission and other regulatory agencies listed in Section R – Conformance Standards.

i) The Contractor shall furnish all necessary personnel, labor, facilities, equipment, parts, materials, and supplies to provide the required technical support and expertise for preventative maintenance, inspection, repair, installation, and relocation of the medical equipment within

Mashpee Service Unit. The Contractor shall provide an all-inclusive rate to include, but not limited to, travel, labor, lodging, equipment, replacement parts as recommended by the Original

Equipment Manufacturer (OEM).

ii) The Contractor shall obtain approval from the Contracting Officer Representative (COR) prior to any service or repair to the equipment should the device require additional parts excluded from the OEM preventative maintenance replacement list, repair parts, or service not covered under this maintenance agreement. No additional work shall be performed unless authorized by the

COR. The Contractor is cautioned that work performed without approval of the Contracting

Officer Representative may jeopardize payment.

(a) Services shall be in accordance with all Federal, State, and Government regulations. All scheduled maintenance shall be completed in accordance with manufacturer’s required maintenance intervals as stated in The Joint Commission Medical Equipment Environment of

Care (EC) EP 2 and EP 3 standards. All required activities and associated frequencies for maintaining, inspecting, and testing of the Mashpee Service Unit medical equipment shall have a 100% compliance rate.

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(b) The Contractor shall be responsible for providing receipt and documentation of services describing the work performed in accordance with JCAHO (The Joint Commission for

Accreditation of Healthcare Organizations) and AAAHC (the Accreditation Association for

Ambulatory Health Care) requirements.

(c) Certified/trained biomedical technicians and/or clinical engineers shall perform all OEM required safety, operational and functional checks and visual inspections on the medical equipment. Maintenance and inspection procedures shall be performed upon receipt of new equipment (initial inspections, installation/assembly), routinely on existing equipment

(scheduled/preventative maintenance) and each time the equipment is serviced (corrective maintenance).

B) Preventative Maintenance - The Contractor shall provide preventative maintenance services that when performed on the medical equipment shall meet or exceed original equipment manufacturers

(OEM) requirements. Detailed descriptions and results of Contractor provided preventative/scheduled maintenance procedures and activities shall be documented and provided to

IHS. The Contractor shall provide Preventative Maintenance procedures in accordance with

Original Equipment Manufacturer requirements and recommendation, including device restoration activities and performance verification activities.

i) Preventative Maintenance/Planned Maintenance Procedures

(a) The contractor shall perform preventative maintenance procedures to ensure the medical equipment remains in proper operational and functional order. All checkout/maintenance procedures and visual inspections shall be performed by certified biomedical equipment service personnel upon receipt of new equipment (incoming inspections), a minimum one time per year thereafter on all new and existing equipment, (annual preventative/planned maintenance), and each time the equipment is serviced (corrective maintenance). The contractor shall inform the IHS point of contacts of all damage/required repairs discovered during inspections and prior to performing any corrective action. Upon completion of the routine maintenance, the respective unit shall be tagged and returned to service if all aspects of the unit are found to be satisfactory. If at any time a defect is found which is dangerous to the patient, operator, or equipment, the device shall be tagged and removed from service until repaired. Maintenance tasks include both qualitative (visual inspection of the main unit/components of a device) and quantitative (measurements of the parameters of the device to determine device is operating within manufacturer’s specifications)

(b) Preventative Maintenance tasks for the medical equipment shall at minimum include the following when applicable:

1) Visual Inspection:

i) The contractor shall inspect the medical equipment and all of its associated components in compliance with OEM requirements. Tasks a minimum shall include:

A. Inspection of the exterior of the equipment for damage or missing hardware.

B. Inspection of the power supply or power cord assembly (power cord, attachment plug, and strain relief) and cords.

C. Inspection of all external connectors.

D. Inspection of all controls, switches, indicators, etc.

E. Inspection of all cooling fans.

F. Inspection of cable insulation.

G. Inspection of internal components/electronics when required by the OEM.

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2) Cleaning:

i) The contractor shall clean the medical equipment and all of its associated components in compliance with OEM requirements. Certain medical devices are static sensitive and susceptible to electrostatic discharge damage. The Contractor shall follow all

OEM recommendations to prevent potential failure of any electrical/electronic assemblies due to electronic discharge. The Contractor shall follow all precautions to ensure the device is not damaged during cleaning procedures. Tasks a minimum shall include the following when applicable:

A. Cleaning the exterior surfaces of all dust and debris.

B. Cleaning the internal components of all dust and debris.

C. Cleaning the fans and fan intakes of all dust and debris.

D. Cleaning the ventilation ports of all dust and debris.

E. Clean or replace filters in reference to the OEM maintenance schedule.

3) Electrical Safety Tests

i) The contractor shall perform electrical safety tests on medical electrical equipment and its associated components (applied parts) in compliance with OEM requirements and National Fire Protection Association (NFPA) 2012 edition standards (Reference

10.3.2.1, 10.3.5, and 10.3.6). Routine electrical safety tests shall be performed on both Class I (grounded devices) and Class II devices (double insulated) annually as specified by NFPA 99. Electrical safety tests shall be performed before the device is put into service for the first time (initial inspection) and following any repair or modification that might have compromised the electrical safety. Both fixed and portable equipment shall receive an annual electrical safety test. Touch current shall be measured with redundant grounding intact if a device has fixed (permanently attached) redundant grounding. NFPA 99 applicable tests include the following:

A. Visual inspection of the physical integrity of the power cord assembly B. Resistance tests

C. Leakage current tests (including lead leakage when applicable)

Refer to section VI for list of NFPA 99 test conditions/limits

ii) All electrical safety tests shall be performed using the calibrated electrical safety analyzer and electrical safety testing application. Records of the electrical safety tests shall be provided to the Service Unit.

4) Functional and Operational Checks:

i) The Contractor shall perform functional and operational checkout procedures of the medical equipment and all of its associated components in compliance with OEM requirements. The checkout procedures shall be performed to test the system for proper function and operation. Tasks shall at minimum include the following when applicable:

A. Verifying the device powers on and passes self-test with no error codes/messages.

B. Verifying the device passes battery status test.

C. Verifying the device passes display (LCD) diagnostic test.

D. Verifying the device passes keyboard test.

E. Verifying the device passes audio test.

F. Verifying the device passes light emitting diodes (LED) test.

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G. Verifying the device passes printer test.

H. Verifying the device passes fan test.

I. Verifying the device passes Ethernet/internal modem or Wi-Fi test.

J. Verifying correct operation of all buttons, switches, controls, displays, alarms, and indicators.

K. Verifying correct operation of the unit in all functional modalities.

L. Verify mechanical functionality (grease, tighten, and lubricate as required)

M. Verifying time settings to ensure the device matches the local time and the time zone is properly set for handling of DST.

N. Verifying software version is up to date in accordance with OEM requirements.

(Note: The Contractor shall contact the COR prior to performing any software updates)

5) Performance Verification

i) The Contractor shall perform performance verification testing to verify the medical equipment complies with the manufacturer’s specifications. The Contractor shall capture and record measurements or readings to validate proper operation of the device or equipment. All testing results shall be documented in the work order including: measured values/readings, OEM limit/tolerance levels, and interpretation of the test results (pass/fail). The Contractor shall document the range acceptable to pass OEM specifications within the work order and record the measurements that meet OEM requirements as “Passed.” For any measurements/readings that are outside the OEM acceptable limit/tolerance, the measurement shall be classified as “Failed” within the work order. The Contractor shall fail the appropriate PM work order checklist procedure. The Contractor shall also apply the appropriate Failure Code and

Quality Assurance (QA) code to the work order and shall include technician comments in the resolution detail section of the work order. Technician comments shall provide details on the identified device fault and recommended corrective action. Performance tests required in this statement of work include but are not limited to the following (Note the following list is not all inclusive and denotes common medical equipment where performance testing is commonly required by the

OEM. The Contractor shall perform all performance tests required in preventative maintenance procedures as required by the OEM and specified in the service manual and instructions for use):

A. Electrosurgical Units

a. RF Leakage Test

b. Power Output

i. Monopolar Output Test

ii. Bipolar Output Test

c. Cross Coupling Test

d. REM Test

B. Physiological Monitors

a. ECG Tests and Calibration

b. Respiration (Resp) Test

c. Cardiac Output (C.O.) Test

d. Oxygen Saturation (SpO2) Test

e. Non-invasive Blood Pressure (NIBP)/Invasive Blood Pressure (IBP) Tests

f. Temperature Test

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g. Microstream/Sidestream/Microstream Carbon Dioxide (CO2) Test

h. Anesthetic Gas (AG) Test

i. Bispectral Index (BIS) Test

j. Respiration Mechanics (RM) Test

k. Impedance Cardiograph (ICG) Test

l. Continuous Cardiac Output (CCO)/Venous Oxygen Saturation (SvO2) Test

C. Defibrillators

a. Hear Rate Test

b. Shock Test

c. Synchronized Cardioversion Test

d. Pacer Test

e. Leads Test

f. SpO2, SpCO, SpMet Test

g. EtCO2 Test/Calibration Check

h. IBP/NIBP Test

i. Inflation/Deflation Test

j. Temperature Test

D. Anesthesia Units

a. Pipeline and Cylinder Tests

b. Flow control Test

c. Pressure relief Test

d. O2 Supply Alarm Test

e. Flush Flow Test

f. Vaporizer Back Pressure/Efficacy test

g. Trace Gas Test

h. Low-pressure Leak Test

i. Breathing System Tests

j. Auxiliary O2 Flowmeter Tests

k. Power Failure Tests

l. Tidal/Minute Volume Tests

m. Frequency Test

n. Expiratory/Inspiratory Tests

E. Ventilators

a. Compressor Calibration

b. Intake Calibration

c. Smart Pneumatic Module (SPM) Calibration

d. O2 System Calibration

e. Airway Pressure Calibration

f. CO2 Analyzer Calibration

g. Oxygen Cell Calibration

h. Y Sensor Calibration

F. Infusion Pumps (Controller and Modules)

a. Door Ajar/Flo-Stop Sensors Test

b. Air-In-Line Sensor Test

c. Rate Accuracy Test

d. Volume Test

e. Patient Side Occlusion Test

f. Occlusion Pressure Test

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g. Fluid Side Occlusion Test

h. Plunger Force and Position Accuracy Tests

i. Barrel Size Accuracy Test

j. Pressure Sensor Accuracy Test

G. Infant Incubators/Radiant Warmers

a. Temperature Test

b. Humidity Test/Humidifier Calibration

c. Scale Calibration

d. Noise Test

e. Baby Probe Test

f. Air Probe Test

H. Blood and Fluid Warmers

a. Over Temperature Alarm Test

b. Temperature Calibration

I. Infant Resuscitators

a. Manometer Tests

b. Valve System Tests

J. Cardiac and Cardiopulmonary Resuscitators

a. Piston Check

b. Claw Lock Mechanism Check

c. Electronics Check

OEM requirements vary by equipment model and version type. The above list is a general overview of various protocol performance and safety measurements that are required under this scope of work. The Contractor is required to perform all performance tests required by the OEM, in order to verify the device performs within manufacturer’s specifications.

6) Calibration/Metrology Services

i) Calibration is required when performing maintenance on the medical equipment and a parameter is found to be out of the specified ratings. Calibration may also be required after a major repair such as replacement of a circuit board. The Contractor shall perform calibration/metrology services to calibrate the unit to the manufacturer’s specifications in accordance with OEM requirements.

A. The Contractor shall perform calibration services when required and the

Contractor’s field technicians/engineers are certified and trained to perform the full calibration procedures. In the event the device performs out of specification and the Contractor’s field technician/engineer is not qualified or trained to perform the calibration, the Contractor shall fail the preventative maintenance work order. A description of the failed parameters shall be included in the resolution detail and the COR shall be notified of the necessary calibration services for the unit. The Contractor shall provide a cost estimate to the COR for the calibration services through an OEM authorized service center.

B. All calibration services shall be National Institute of Standards and Technology

(NIST) traceable to ensure the calibration is compliant with ISO/IEC 17025 metrology quality standard and OEM requirements.

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ii) Additional Preventative Maintenance Tasks

(a) The Contractor shall perform the following preventative maintenance tasks in addition to all

OEM required checkout/maintenance procedures and visual inspections. Preventative maintenance tasks include the following:

1) Replace any OEM labels, decals, or warning tags that are not legible.

2) Verify asset data is correct.

3) Complete and affix an inspection sticker after the PM is completed and device is evaluated to be operational, safe, and effective.

i) PM Sticker Tag Requirements

A. The Contractor shall utilize laminated ~1" (24mm) label tape with standard adhesive that is suitable for normal indoor/outdoor use in hot and cold environments.

a. All stickers/labels used shall be durable (lasting up to one year) and easily readable.

B. The Contractor shall utilize the label colors required by Mashpee Service

Unit. Label/sticker color requirements will vary year-to-year and by service unit.

C. Sticker residue shall be cleaned from the devices when removing existing stickers/labels.

D. The Contractor shall label all equipment serviced with the following identity information: Clinical Engineering Department Header, Asset Tag Number, Asset

Tag QR Code, Technician Name/Code, Date of Service (Month, Day, Year), and

Next PM Date (Month and Year only).

a. Refer to Section VII for PM sticker requirements example.

E. The Contractor shall apply a PM exempt sticker when applicable containing the following information: Clinical Engineering Department Header, Device is PM

Exempt Header, Technician Name/ID, and Date.

4) Provide documentation of PM services performed including service reports.

5) Battery Powered equipment shall be self-tested, visual inspected and have the battery replaced if necessary.

6) Non-electrical equipment shall receive a visual inspection to report wear.

7) The Contractor shall remove all dated inspection stickers and residue from the equipment

8) The Contractor shall install an appropriate safety inspection sticker to identify that the equipment meets all safety criteria.

9) In the event that medical equipment fails its Preventative Maintenance Inspection, the

Contractor shall:

A. Document the failure in the work order and service report as ‘Failed PM’

B. Enter the results in the checklist/resolution detail sections of the work order and in the results section of the service report with detailed information of the failure.

C. Attach a “Do Not Use” Tag on the device.

D. Inform the COR, Nashville Area Office Facilities Engineer, and Local Service

Unit Staff.

E. Generate a “Corrective Maintenance” Work Order.

10) In the event that the medical equipment is not located/or in use and preventative maintenance cannot be performed on the device, the Contractor shall:

A. Document the device was ‘not located’ or ‘in use’ in the work order and Service

Report and include details in the results tab regarding communication

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B. The Contractor shall apply the ‘Unable to Locate Device’ or ‘Found in Use’ QA

Code to the work order and save complete the work order.

C. Schedule the next preventative maintenance with approval from the

COR/Designated Service Unit staff member or Nashville Area Facilities

Engineer.

a. The preventative maintenance of the equipment ‘not located’ or ‘in use’ during annual site visit shall be performed during a separate site visit. The maintenance shall be performed at the earliest available date to stay in compliance with OEM maintenance requirements.

b. The Contractor shall obtain approval from the Contracting Officer

Representative (COR) prior to performing any additional PM services not covered under the active task order or maintenance agreement. No additional work shall be performed unless authorized by the COR. The Contractor is cautioned that work performed without approval of the Contracting Officer

Representative may jeopardize payment.

(b) Software Updates/Upgrades: The Contractor shall install software updates when required and approved by the OEM and COR. The Contractor shall inform the COR or IHS designee of all software upgrades/updates that are available to IHS. A cost estimate will be provided to the

COR. Software installation or configuration services shall not be performed until approval is provided by the COR or Contracting Specialist. The Contractor shall coordinate all software updates/upgrades with the COR and Mashpee Service Unit Information Technology (IT) and provide relevant information on the medical equipment software/firmware versions, MAC

Addresses, etc when applicable.

C) Initial/Incoming Inspection - The Contractor shall provide initial and incoming inspections procedures that when performed on each device shall meet or exceed original equipment manufacturers (OEM) requirements. Detailed descriptions and results of Contractor provided initial/incoming inspection procedures and activities shall be documented and provided to the

Service Unit. The Contractor shall affix devices with asset tags that display the following identity information: Company Logo, Facility or Service Unit Name, Asset Tag Number. In the event that new medical equipment requires Initial/Incoming Inspection, the Contractor shall at minimum perform the following activities for Level 1-4 inspections:

(a) Level 1 - No Setup/Installation Requirements with Existing Asset Record

1) The Contractor shall perform Initial Inspection/Incoming Inspection with Existing

Clinical Device Record

i) The clinical device asset record exists within the Service Unit (No additional data entry required). The device is already fully operational (No

Installation/Setup Required) and stickered with an asset tag. The Contractor shall perform the following:

A. Perform initial inspection testing in accordance with Original Equipment

Manufacturer (OEM) Requirements and Recommendations

B. Perform visual inspection, operational/performance testing, and electrical safety testing as required by the OEM.

ii) Create and close Initial Inspection work order:

A. Create Initial Inspection work order for the device.

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B. Document/log the tests performed including:

a. Date of service

b. Technician Name

c. Test procedures performed/results (Pass/Fail)

d. Measurements/readings to validate proper operation

e. Close complete the work order

(b) Level 2 - No Setup/Installation Requirements. Asset Record Required.

1) The Contactor shall perform Initial Inspection and Create New Clinical Device Asset

Record

i) The clinical device asset record does not exist within the Service Unit. The device is already fully operational (No Installation/Setup Required). The Contractor shall perform the following:

A. Apply asset tag sticker to the device

B. Create clinical device asset record

C. Enter data into the required fields including the following:

a. Asset Tag

b. Asset Type

c. Serial Number

d. Owning Department

e. Last Known Location (Building/Floor/Room Number)

f. Operational Status

g. Manufacturer Name

h. Model Name

i. Support Group

j. Risk Level (High/Non-High Risk)

k. Property ID (If Applicable)

l. Manufacturing/Production Date (If Applicable)

m. FDA Unique Device Identifier (UDI) (If Applicable)

D. Perform initial inspection testing in accordance with Original Equipment

Manufacturer (OEM) Requirements and Recommendations

E. Perform visual inspection, operational/performance testing, and electrical safety testing as required by the OEM

F. Create and close Initial Inspection work order:

a. Create Initial Inspection work order for the device.

b. Document/log the tests performed including:

i. Date of service

ii. Technician Name

iii. Test procedures performed/results (Pass/Fail)

iv. Measurements/readings to validate proper operation

v. Close complete the work order

(c) Level 3 - Setup/Installation Required (Low - Less than 30 minutes) and Asset Record

Required

1) The Contactor shall perform Installation/Setup, Initial Inspection, and Create New

Clinical Device Asset Record

i) The clinical device asset record does not exist within the Service Unit. The device requires some installation/setup/assembly that includes unboxing and moving to

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A. Apply asset tag sticker to the device

B. Enter data into the required fields including the following:

a. Asset Tag

b. Asset Type

c. Serial Number

d. Owning Department

e. Last Known Location (Building/Floor/Room Number)

f. Operational Status

g. Manufacturer Name

h. Model Name

i. Support Group

j. Risk Level (High/Non-High Risk)

k. Property ID (If Applicable)

l. Manufacturing/Production Date (If Applicable)

m. FDA Unique Device Identifier (UDI) (If Applicable)

C. Perform installation/setup/assembly activities including unboxing and moving to department location (setup time less than 30 mins)

D. Perform initial inspection testing in accordance with Original Equipment

Manufacturer (OEM) Requirements and Recommendations

E. Perform visual inspection, operational/performance testing, and electrical safety testing as required by the OEM.

(d) Level 4 - Setup/Installation Required (Moderate – 30 minutes to 60 minutes) and Asset

Record Required

1) The Contactor shall perform Installation/Setup, Initial Inspection, and Create New

Clinical Device Asset Record

i) The clinical device asset record does not exist within the Service Unit. The device requires moderate installation/setup/assembly that includes unboxing and moving to department location (setup time between 30 mins and 60 mins). The Contractor shall perform the following:

A. Apply asset tag sticker to the device

B. Create clinical device asset record

C. Enter data into the required fields including the following:

a. Asset Tag

b. Asset Type

c. Serial Number

d. Owning Department

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e. Last Known Location (Building/Floor/Room Number)

f. Operational Status

g. Manufacturer Name

h. Model Name

i. Support Group

j. Risk Level (High/Non-High Risk)

k. Property ID (If Applicable)

l. Manufacturing/Production Date (If Applicable)

m. FDA Unique Device Identifier (UDI) (If Applicable)

D. Perform installation/setup/assembly activities including unboxing and moving to department location (setup time between 30 mins and 60 mins)

E. Perform initial inspection testing in accordance with Original Equipment

Manufacturer (OEM) Requirements and Recommendations

F. Perform visual inspection, operational/performance testing, and electrical safety testing as required by the OEM.

G. Create and close Initial Inspection work order:

a. Create Initial Inspection work order for the device.

b. Document/log the tests performed including:

c. Date of service

d. Technician Name

e. Test procedures performed/results (Pass/Fail)

f. Measurements/readings to validate proper operation

g. Close complete the work order

(e) Level 5 - Setup/Installation Required (High – Over 60 mins) and Asset Record

Required

1) The Contactor shall perform Installation/Setup, Initial Inspection, and Create New

Clinical Device Asset Record

i) The clinical device asset record does not exist within the Service Unit. The device requires high-level installation/setup/assembly that includes unboxing and moving to department location (setup time over 60 mins). The Contractor shall perform the following:

A. Apply asset tag sticker to the device

B. Create clinical device asset record

C. Enter data into the required fields including the following:

a. Asset Tag

b. Asset Type

c. Serial Number

d. Owning Department

e. Last Known Location (Building/Floor/Room Number)

f. Operational Status

g. Manufacturer Name

h. Model Name

i. Support Group

j. Risk Level (High/Non-High Risk)

k. Property ID (If Applicable)

l. Manufacturing/Production Date (If Applicable)

m. FDA Unique Device Identifier (UDI) (If Applicable)

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D. Perform installation/setup/assembly activities including unboxing and moving to department location (setup time over 60 mins)

E. Perform initial inspection testing in accordance with Original Equipment

Manufacturer (OEM) Requirements and Recommendations

F. Perform visual inspection, operational/performance testing, and electrical safety testing as required by the OEM.

G. Create and close Initial Inspection work order:

a. Create Initial Inspection work order for the device.

b. Document/log the tests performed including:

c. Date of service

d. Technician Name

e. Test procedures performed/results (Pass/Fail)

f. Measurements/readings to validate proper operation

g. Close complete the work order

D) Inventory Services – The Contractor shall provide medical equipment inventory management services. The Contractor shall at minimum perform the following activities for Level 1-4 inventory management inspections:

i) Level 1 – Inventory Device and Verify Asset Information

(a) The Contractor shall verify all information on the existing clinical device.

(b) The Contractor shall verify the asset tag is present on the device.

(c) The Contractor shall update the last inventory date on the device.

ii) Level 2 – Update Existing Clinical Device Asset Record

(a) The Contractor shall replace the asset tag if sticker is missing from the device.

(b) The Contractor shall update clinical device asset record and verify all required fields are accurate including the following:

1) Asset Tag

2) Asset Type

3) Serial Number

4) Owning Department

5) Last Known Location (Building/Floor/Room Number)

6) Operational Status

7) Manufacturer Name

8) Model Name

9) Support Group

10) Risk Level (High/Non-High Risk)

11) Property ID (If Applicable)

12) Manufacturing/Production Date (If Applicable)

13) FDA Unique Device Identifier (UDI) (If Applicable)

iii) Level 3 – Create New Clinical Device Asset Record

(a) The Contractor shall apply the new asset tag sticker to the device.

(b) The Contractor shall create a new clinical device asset record and enter accurate data into all required fields including the following:

1) Asset Tag

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2) Asset Type

3) Serial Number

4) Owning Department

5) Last Known Location (Building/Floor/Room Number)

6) Operational Status

7) Manufacturer Name

8) Model Name

9) Support Group

10) Risk Level (High/Non-High Risk)

11) Property ID (If Applicable)

12) Manufacturing/Production Date (If Applicable)

13) FDA Unique Device Identifier (UDI) (If Applicable)

iv) Level 4 – Not Located or In Use Clinical Device

(a) The clinical device is not inventoried/serviced due to device in use or not located at the time of the visit.

i) The Contractor shall document not located/in use status by updating the asset record status to Not Located/In-Use. The Contractor shall document the not located/in-use status in the preventative maintenance work order and include the following:

A. Date of search/scheduled service

B. Document how the device was looked for/who was contacted regarding location of device (local department staff, local biomed or property technician, etc.)

C. Update the work order QA Code to Found In Use or Unable to Locate device.

D. Close completed work order

E) On-site Troubleshooting- The Contractor shall provide on-site device evaluation and troubleshooting on non-operational medical equipment. All troubleshooting procedures shall be in accordance with OEM requirements. The Contractor shall document the troubleshooting procedures performed within the work order and service report. All applicable data including device evaluation report, errors codes and notifications shall be included within the electronic record. Prior to performing troubleshooting procedures, the Contractor shall provide a cost estimate detailing estimated service time and total cost. The Contractor shall obtain approval from the Contracting

Officer Representative (COR) prior to performing troubleshooting procedures should the device require additional services not included in the active task order. No additional work shall be performed unless authorized by the COR. The Contractor is cautioned that work performed without approval of the Contracting Officer Representative may jeopardize payment.

F) Corrective Maintenance/Repair Service - The Contractor shall perform corrective maintenance and repair service procedures that when performed on each device shall meet or exceed original equipment manufacturers (OEM) requirements. Detailed descriptions and results of Contractor provided corrective maintenance and repair procedures and activities shall be documented within the work order. The Contractor shall obtain approval from the Contracting Officer Representative

(COR) prior to any service or repair to the equipment should the device require additional parts excluded from the OEM preventative maintenance replacement list, repair parts, or service not covered under this maintenance agreement. No additional work shall be performed unless authorized

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15 | P a ge by the COR. The Contractor is cautioned that work performed without approval of the Contracting

Officer Representative may jeopardize payment. The Contractor shall provide multiple levels of repair service including but not limited to the following: same-day repair, next-day repair, weekend service, medical equipment repair depot service, and on-site repair.

i) On-site Repair Service Requests (Non PM)

(a) In the event a medical device is non-operational and requires repair, the contractor shall notify the COR and local service unit staff that the device must be repaired and tested before the device can be returned to service. Prior to the contractor performing work, the local IHS

Point of Contact (POC) or COR will determine whether the repair will be performed locally or assigned to the Contractor to complete.

(b) Contractor Repaired Corrective Action WO

i) In the event a non-serviceable device is identified, the Contractor shall document in the work order and service report that the equipment requires repair and include details of the device fault in the work order.

ii) If the “Corrective Action” work order is assigned to the contractor, the service unit biomedical equipment support specialist (BESS) or point of contact

(POC) will contact the COR to develop a Service Request Task Order that will include all parts and labor required for the device repair.

iii) After troubleshooting the medical equipment the Contractor shall provide a cost estimate to the COR. If approved, the COR will have the original Task Order modified to reflect the total cost of the on-site repair service and all parts and labor necessary to complete the task. When the device is returned to service, and the service report with invoice is received, payment of the Task Order will be processed and the associated work order will be “Closed” by the COR.

iv) If for any reason a change is required to the existing Task Order, the COR, or his/her designate must be immediately contacted with the appropriate equipment information and dollar amount. The COR verifies with the financial budget analyst that the funds are available. The COR emails the Contract Officer: 1) work to be done, 2) dollar amount, 3) verification of funds, and 4) period of performance.

ii) Repair Service Depot

(a) In the event the device cannot be repaired on-site the Contractor shall notify the COR and local service unit staff that the device must be repaired at the Contractor local service depot and tested before the device can be returned to service. The Contractor shall provide a service depot/district office within 100 miles of the Mashpee Service Unit facilities. Prior to the contractor performing work, the local IHS Point of Contact (POC) or COR will determine whether the repair will be performed locally or assigned to the Contractor to complete.

(b) Contractor Repaired Corrective Action WO

i) In the event a non-serviceable device is identified, the Contractor shall document in the work order and service report that the equipment requires repair and include details of the device fault in the work order.

ii) If the “Corrective Action” work order is assigned to the contractor, the service unit biomedical equipment support specialist (BESS) or point of contact

(POC) will contact the COR to develop a Service Request Task Order that will

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16 | P a ge include the minimum handling and a troubleshooting charge plus shipping, parts, and labor.

iii) After troubleshooting the medical equipment the Contractor shall provide a cost estimate to the COR. If approved, the COR will have the original Task Order modified to reflect the total cost of the repair and return shipping cost to complete the task. When the device is returned to service, and the service report with invoice is received, payment of the Task Order will be processed and the associated work order will be “Closed” by the COR.

iv) The Contractor shall coordinate all equipment pick-up and transportation of devices that require servicing at the depot. The Contractor shall verify with the COR that all property transfer authorizations have been completed prior to removing the device from the IHS facility.

v) If for any reason a change is required to the existing Task Order, the COR, or his/her designate must be immediately contacted with the appropriate equipment information and dollar amount. The COR verifies with the financial budget analyst that the funds are available. The COR emails the Contract Officer: 1) work to be done, 2) dollar amount, 3) verification of funds, and 4) period of performance.

(c) Parts

i) The Contractor stipulates that he/she has ready access to new standard parts

(manufactured and supplied by the original equipment manufacturer). All parts supplied shall be of correct manufacture and have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the COR upon request.

iii) Removing defective/obsolete equipment from service

(a) In the event a non-serviceable device is identified, the Contractor shall document in the work order and service report that the equipment cannot be repaired due to excessive damage, software incompatibility, end of life issues, parts no longer available or supported, or repair cost exceeds 50% of original purchase cost.

(b) The contractor shall take the device out of service and deliver to the local biomedical equipment support specialist or property officer for proper disposal.

(c) The Contractor shall update the recorded status to non-operational and notate in the work order that the device has been removed from service.

G) Medical Device Testing Automation – The Contractor shall document all maintenance procedures

(including electrical safety testing) and ensure compliance with OEM requirements. The Contractor shall complete the medical equipment maintenance checklists. Completed test records shall be provided to the Service Unit.

i) Electronic copies of all original test records shall be provided to the COR upon request and available throughout the lifespan of the contract.

ii) The Contractor shall document all test measurement and diagnostic equipment (TMDE) equipment utilized in all maintenance procedures within the work order, including electrical safety analyzers. Documentation in the work order shall include TMDE last calibration date and NIST traceable compliance information.

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iii) The Contractor shall utilize analyzers/simulators throughout the lifespan of the contract.

H) Rental Equipment Services – The Contractor shall provide rental equipment services on an as needed basis. In the event a Mashpee Service Unit facility requires rental equipment services, the

COR will contact the Contractor with a description of the medical equipment needs including salient characteristics, quantity, and requested rental period. The Contractor shall provide a list of available inventory and include devices that are substantially equivalent to the desired make/model requested by the Mashpee Service Unit.

i) The Contractor shall provide a cost estimate to the COR. If approved, the COR will have the original Task Order modified to reflect the total cost of the rental equipment services (including shipping/handing and labor). When the device arrives at the facility and in-services are completed, and the service report with invoice is received, payment of the Task Order will be processed and the associated work order will be “Closed” by the COR. Rental equipment requirements include the following:

(a) Length of Rental Period

1) Minimum of one month rental period and maximum of 12-month rental period.

2) All rental equipment services shall include incoming inspection testing. The Contractor shall provide documentation that the rental equipment is serviced, safe, and ready for clinical use.

(b) Equipment Delivery and Return

1) The Contractor program manager shall contact the COR to coordinate the delivery and return of rental equipment. The Contractor is responsible for all delivery, pickup, and transportation services required to bring rental devices into service at the Mashpee

Service Unit facilities and return the devices at the end of the rental period.

(c) Available rental medical equipment types shall include but are not limited to the following:

1) Beds and Stretchers

2) Infusion Pumps

3) Ventilators and High Flow Oxygen Therapy Devices

I) Period of Performance and Contract Type

i) This agreement will have a term of one year and four one-year option periods.

ii) The contract type will be Indefinite Delivery, Indefinite Quantity (IDIQ) in accordance with

Federal Acquisitions Regulations (FAR) Part 16.5. The Government will place task orders for medical equipment services based on the needs of the Mashpee Service Unit facilities.

J) Response Time, Schedule, and Notification:

i) Operating Hours:

(a) The contractor shall provide routine and non-critical maintenance, inspection, certification or repair services during normal operating hours Monday through Friday from 8:00am to

5:00pm excluding federal holidays. The service schedule shall be coordinated by the contractor, local Designated Official for Technical Matters and/or the Nashville Area

Facilities Engineer, and the designated COR.

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Service visits shall be coordinated with the Service Unit’s Facility Manager and/or

Designated Official for Technical Matters.

(b) The Contractor shall respond to emergency repair and/or rental equipment service requests for critical medical equipment within twenty-hour (24) hours of notification.

ii) Notification of Schedule Availability

(a) The Contractor shall provide a list of available service dates to the COR within five business days of task order award or requested on-site routine services. The Contractor shall provide pertinent details regarding the scheduled visits including the names of the technicians, technician contact information, estimated arrival date/time, and estimated completion date/time. The Contractor shall contact the COR if the Contractor becomes aware of any circumstances that delay or prevent the on-site services from being performed. This information shall be provided to the COR within 48 hours in order to ensure the requested rescheduling does not conflict with the Period of Performance date requirements.

iii) Preventative Maintenance Schedule

(a) The Contractor shall perform annual, semiannual, or quarterly preventative maintenance services on time in compliance with OEM requirements and The Joint Commission Standard

(EC.02.04.01, EC.02.04.03). Annual is defined as 12 months from the previous occurrence, plus or minus 30 days. Semiannual is defined as six months from the previous occurrence, plus or minus 20 days. Quarterly is defined as every three months (four times a year), plus or minus 10 days.

iv) Schedule and Notification

(a) The contractor shall notify the designated COR prior to beginning and upon completion of services based on the provided PM schedule. Contractor shall comply with IHS visitation policy which may require obtaining a Contractor badge prior to beginning services.

(b) Contractor shall comply with IHS visitation policy.

i) Before performing services the Contractor personnel shall report to the local

Biomedical Department and/or local Facility Manager at the beginning and end of their entire visitation at the Service Unit, to sign-in and receive a facility “Guest” badge.

ii) The Contractor shall be authorized to park only in areas opened to the public.

iii) The Contractor shall be allowed minimal use of government space to store supplies and/or equipment as required under this contract.

iv) The Contractor shall comply with all COVID-19 wellness screening requirements for entry including compliance with Executive Order on Protecting the Federal

Workforce and…