Statement of Work Phoenix Area Test Equipment Calibration and Repair Service Contract.pdf

Phoenix Area IHS Test Equipment Calibration, Repair, and Training Services Phoenix Area Service Units

IHS1453588

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Statement of Work

I. INTRODUCTION AND BACKGROUND

A) The Phoenix Area Indian Health Service (PAIHS) Office in Phoenix, Arizona, oversees the delivery of health care to approximately 140,000 Native American users in the four state area of Arizona, Nevada, California, and Utah. Throughout a network of health care facilities, the IHS are a health care partner to over forty tribes. The Phoenix Area Office (PAO) is based in Phoenix, Arizona. Our system of care includes Indian Health Service (IHS) and tribally-operated health care facilities that serve tribal communities as well as three Urban Indian Health programs. These services are comprehensive and range from primary care to tertiary care and specialty services. Refer to Section V – Phoenix Area IHS Service Units for complete list of service units (facilities) that shall be covered under this agreement.

B) The Indian Health Service (IHS), Phoenix Area Office (PAO) Department of Acquisition (DAM), is procuring for a Contractor to provide medical and electrical test equipment calibration and metrology services, preventative maintenance, repair, and training services. In order to ensure that the medical and electrical test 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 test, measurement, and diagnostic equipment (TMDE) test 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). All services shall be National Institute of Standards and Technology (NIST) traceable.

B) The contractor shall provide the following medical and electrical test equipment services required to support the Phoenix Area medical equipment management plan:

i) Calibration/Metrology Services: Calibration services shall be performed on a regular basis to evaluate equipment accuracy and precision. All calibration services shall be performed in accordance with OEM requirements and recommendations.

ii) 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.).

iii) 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

2 | P a g e determining the issue with the faulty equipment and providing the necessary parts and service to return the device to operational status.

iv) Optional On-site Datrend Training Services: The Contractor shall provide training services on the Datrend Systems Inc biomedical test equipment. All training services shall be provided by Datrend Systems authorized/certified training personnel.

C) The Contractor shall provide qualified personnel to perform comprehensive on-site visits to each Phoenix Area Service Unit to provide calibration, preventative maintenance, training, and repair services. The Contractor shall provide technical services necessary for the optimum operation of medical and electrical test equipment within Phoenix Area IHS. The Contractor shall possesses the capability to service the device types listed in Section VIII - Medical and electrical test equipment - 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 and electrical test 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 and electrical test equipment within Phoenix Area IHS. 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 Environment of Care (EC) EP 2 and EP 3 standards. All required activities and associated frequencies for maintaining, inspecting, and testing of the Phoenix Area IHS medical and electrical test equipment shall have a 100% compliance rate.

(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 technicians and/or engineers shall perform all OEM required safety, operational, and functional checks and visual inspections on the medical and electrical test

3 | P a g e 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) Calibration/Metrology and Preventative Maintenance Services - The Contractor shall provide calibration/metrology services and preventative maintenance services that when performed on the medical and electrical test equipment shall meet or exceed original equipment manufacturers (OEM) requirements. Detailed descriptions and results of Contractor provided calibration, metrology, and preventative/scheduled maintenance procedures and activities shall be documented within the IHS CMMS. The Government will provide the IHS CMMS Contractor’s software license. 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) Calibration and Preventative Maintenance Procedures:

(a) The contractor shall perform calibration and preventative maintenance procedures to ensure the medical and electrical test equipment remains in proper operational and functional order.

All checkout/maintenance procedures and visual inspections shall be performed by certified test equipment service personnel upon receipt of new equipment (incoming inspections), a minimum one time per year thereafter on all new and existing equipment, (annual calibration/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 and passing calibration. 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). All calibration and preventative maintenance procedures shall be National Institute of Standards and Technology (NIST) traceable.

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

1) Visual Inspection:

i) The contractor shall inspect the medical and electrical test 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.

2) Cleaning:

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i) The contractor shall clean the medical and electrical test 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 IHS CMMS compatible automated electrical safety analyzer and electrical safety testing application. Records of the electrical safety tests shall be automatically uploaded into the IHS CMMS and corresponding PM work order via the CMMS mobile interface.

4) Functional and Operational Checks:

i) The Contractor shall perform functional and operational checkout procedures of the medical and electrical test 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.

G. Verifying the device passes printer test.

H. Verifying the device passes fan test.

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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 and electrical test 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 electrically documented in the CMMS 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 CMMS 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 CMMS 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 and electrical test equipment where performance testing is commonly required by the OEM. The Contractor shall perform all performance tests required in calibration/preventative maintenance procedures as required by the OEM and specified in the service manual and instructions for use).

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. At minimum the Contractor shall possess the resources and technical capabilities to perform full calibration services for the following test equipment:

A. Biomedical

a. Electrical Safety Analyzers

b. Electrosurgical Unit (ESU) Analyzers

c. Defibrillator Analyzers/Pacer Testers

d. Ventilator Testers

e. Defibrillator Analyzers

f. Pulse Oximetry (SpO2) Testers

g. Radiometers

h. Ultrasound Wattmeters

i. X-Ray Test Instruments/mAS Meters

j. Infusion Pump Analyzers

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k. Oxygen Analyzers

l. Temperature Calibrators (including IR models)

m. Audio Meters

n. Bili Light Testers

o. Cardiac Output Testers

p. Endoscopic Test Systems

q. Fetal Simulators

r. Hipot Testers

s. Incubator Testers

t. Light Meters ( Ambient)

u. Non-invasive Blood Pressure Simulators/Testers (NIBP)

v. Parameter Testers

w. pH Meters/Transmitters

x. Probe Testers

y. TEE Electrical Leakage Testers

z. Transducers

aa. Watt Meters

bb. Network Testers

cc. Antenna and Site Analyzers

dd. Line Impedance Stabilization Network Devices

ee. Electronic Loads

ff. High Voltage Insulation Testers

B. Test and Measurement

a. Anemometers

b. Attenuators

c. Barometers

d. Bulb Thermometers

e. Calibrators – All Types

f. Capacitance Meters

g. Capacitance Standards

h. Chart Recorders

i. Clamp Meters (AC/DC)

j. Conductivity Meters

k. Counters

l. Current Clamps/Transformers

m. Data Loggers

n. DC Power Supplies

o. Decade Resistance Boxes

p. Digital Thermometers

q. Dry Block Calibrators

r. Electro Static Meters

s. Frequency Counters

t. Frequency Generators

u. Function Generators

v. Gauge Blocks

w. Ground Resistance Testers

x. High Voltage Dividers

y. High Voltage Meters

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z. High Voltage Probes

aa. Humidity Meters

bb. Inductance Meters

cc. Inductance Standards

dd. IR Thermometers

ee. IR Transducers

ff. LCR Meters

gg. LIG Thermometers

hh. LIM Testers

ii. Loads

jj. Megohmmeters

kk. Micro/Mill – Ohmmeters

ll. Multimeters

mm. Network Analyzers

nn. Oscilloscopes

oo. Panel Meters

pp. Power Meters (RF & AC/DC)

qq. Power Supplies

rr. Resistance Standards

ss. Scopemeters

tt. Shunts

uu. Signal Analyzers

vv. Signal Generators

ww. Sound Level Meters/Calibrators

xx. Spectrum Analyzers

yy. Stop Watches

zz. Stroboscopes aaa. Tachometers bbb. Temp. & Humidity Recorders ccc. Temperature Baths ddd. Thermocouple Calibrators eee. Thermocouples fff. Thermometers ggg. Timers hhh. Torque Gauges, Meters

iii. Torque Wrenches jjj. Waveform Synthesizers kkk. Wrist Strap Testers

C. Pressure and Flow

a. Differential Pressure Gauges

b. Differential Pressure Meters

c. Digital Pressure Gauges

d. Digital Pressure Meters

e. Flow Meters Load Cells

f. Precision Balances

g. Pressure Calibrators

h. Pressure Gauges

i. Pressure Transducers

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j. Vacuum Gauges

k. Velocity Meters

D. Mechanical

a. Calipers

b. Dial Calipers

c. Dial Indicators

d. Height Gauges

e. Levels

f. Micrometers

g. Pinch Gauges

E. Force, Weights, and Mass

a. Balances

b. Dynomometers

c. Force Gauges

d. Mass (Weights)

e. Mass Flow Meters

f. Scales

OEM requirements vary by equipment model and version type. The above list is a general overview of the equipment types to be serviced under this scope of work.

The Contractor is required to perform all calibration/performance tests required by the OEM, in order to verify the device performs within manufacturer’s specifications.

6) Unscheduled Calibration/Metrology Services

i) Calibration services will be required when performing maintenance on the medical and electrical test 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.

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 and/or enter asset data in the CMMS required fields listed in Section C/D

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3) Complete and affix an inspection sticker after the calibration/PM is completed and device Is evaluated to be in-tolerance, operational, safe, and effective.

i) Calibration/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. Sticker residue shall be cleaned from the devices when removing existing stickers/labels.

C. The Contractor shall label all equipment serviced with the following identity information: Contractor/Vendor Name, Technician Name/Code, Date of Service (Month, Day, Year), and Next PM Date (Month, Day, Year), Certificate Number, and Asset Serial Number

4) Provide documentation of all calibration, PM, and repair services performed including service reports and certifications of calibration.

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 and electrical test equipment fails its Preventative Maintenance

Inspection, the Contractor shall:

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

Calibration/PM’ B. Enter the results in the checklist/resolution detail sections of the CMMS 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, Phoenix Area Office Clinical/Biomedical Engineer, and Local

Biomedical Engineering Department Staff.

E. Generate a “Corrective Maintenance” Work Order in the CMMS.

10) In the event that the medical and electrical test 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 CMMS work order and Service Report and include details in the results tab regarding communication with department staff and/or the Phoenix Area/Local biomedical engineering department on the location of the device. Provide names when possible.

B. The Contractor shall apply the ‘Unable to Locate Device’ or ‘Found in Use’ QA Code to the CMMS work order and save complete the work order.

C. Schedule the next preventative maintenance/calibration with approval from the COR/Phoenix Area Clinical Engineer.

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

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b. The Contractor shall obtain approval from the Contracting Officer Representative (COR) prior to performing any additional PM/calibration 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 Phoenix Area IHS Information Technology (IT) and provide relevant information on the medical and electrical test equipment software/firmware versions, MAC Addresses, etc when applicable.

C) Optional On-Site Datrend Training - The Contractor shall provide on-site training services for the Datrend Systems biomedical test equipment utilized by Phoenix Area IHS on an as needed basis. All training services shall be provided by Datrend Systems authorized/certified training personnel. Each contract award year the government will determine the locations and number of training days at the locations where training is required and may award an optional training. The government may award from 0 to 12 training days per year. Training shall be provided during the same service visit as the calibrations are being performed.

D) On-site Troubleshooting- The Contractor shall provide on-site device evaluation and troubleshooting on non-operational medical and electrical test equipment. All troubleshooting procedures shall be in accordance with OEM requirements. The Contractor shall document the troubleshooting procedures performed within the CMMS 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.

E) 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 IHS CMMS. 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. The Contractor shall provide multiple levels of

11 | P a g e repair service including but not limited to the following: same-day repair, next-day repair, weekend service, medical and electrical test equipment repair depot service, and on-site repair.

i) On-site Repair Service Requests (Unscheduled Calibration/PM)

(a) In the event TMDE 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 CMMS work order and service report that the equipment requires repair and include details of the device fault in the CMMS work order.

ii) If the “Corrective Action” work order is assigned to the contractor, the service unit biomedical and electrical test 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 and electrical test 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 CMMS 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. 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 CMMS work order and service report that the equipment requires repair and include details of the device fault in the CMMS work order.

ii) If the “Corrective Action” work order is assigned to the contractor, the service unit biomedical and electrical test equipment support specialist (BESS) or point of contact (POC) will contact the COR to develop a Service Request Task Order that will include the minimum handling and a troubleshooting charge plus shipping, parts, and labor.

iii) After troubleshooting the medical and electrical test equipment the Contractor shall provide a cost estimate to the COR. If approved, the COR will have the original Task

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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 CMMS work order will be “Closed” by the COR.

iv) 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

CMMS 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 and electrical test equipment support specialist or property officer for proper disposal.

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

F) Rental/Loaner Equipment Services – The Contractor shall provide rental/loaner equipment services on an as needed basis. In the event a Phoenix Area IHS facility requires rental/loaner equipment services, the COR will contact the Contractor with a description of the medical and electrical test 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 Phoenix Area IHS.

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 CMMS 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 use.

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(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 IHS facilities and return the devices at the end of the rental period.

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

1) Datrend Systems biomedical test equipment

G) 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 and electrical test equipment services based on the needs of the Phoenix Area IHS facilities. Minimum services to be ordered under this basic contract will include services in the dollar value of $62,000.

H) 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 facilities manager and/or biomedical engineer, and the designated COR.

Service visits shall be coordinated with each Service Unit’s Facility Manager and/or Biomedical Engineer.

(b) The Contractor shall respond to emergency repair and/or rental equipment service requests for critical medical and electrical test 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 calibration/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.

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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 Requiring Mask-Wearing.

I) Staff Qualifications:

i) License and certification of technical skills to complete the required services shall be maintained in an active and current status throughout the performance period. The Contractor shall provide documentation of technician certification and/or engineer certification of all key service staff.

The Contractor shall provide a list of key personnel that shall be utilized to service the Phoenix Area IHS facilities at the time of solicitation. The list shall include details of professional qualifications, certification, training, and education.

ii) The Contractor shall assign a program manager to Phoenix Area IHS. This person shall serve as the main point of contact (POC) and liaison between the COR and Contractor.

iii) Personnel must be qualified to perform the required calibration/preventative maintenance services and repairs for all listed equipment, and to properly install relocated equipment. In the event the service representative is unable to rectify the situation, the Contractor shall provide a senior service engineer, or like, to resolve any problems. All workmanship performed by the Contractor shall be of acceptable industry standard quality and to manufacturer’s instruction, and shall be immediately rectified at no additional cost to the Government upon notification of non-acceptability by the Government.

(a) If at any point in time the Contractor shall utilize subcontracting services, the Contractor shall notify the COR prior to providing services to the Phoenix Area IHS facilities. The Contractor shall inform the COR of what pieces of equipment will be subcontracted out and describe the capabilities of the subcontractor to include the name of the subcontractor to be used and certification/qualifications of the subcontractor. The subcontractor shall also meet all requirements specified in Section R – Conformance Standards.

J) International Organization for Standardization

i) The International Organization for Standardization (ISO) is a worldwide body that facilitates the development of quality standards across multiple industries, including the medical device industry. ISO certification defines the quality control policies for the service and repair of biomedical instrumentation

(a) The Contractor shall hold active ISO/IEC 17025:2017 Certification and meet all requirements of the competence of testing and calibration laboratories. The Contractor shall have an active quality system in place that at the time of solicitation and throughout the lifecycle of the contract. The Contractor shall provide quality certificates indicating

15 | P a g e compliance to quality management system regulations with the submission of offer at the time of solicitation.

(b) The Contractor shall be ISO/IEC 17025:2017 certified throughout the life cycle of the contract.

(c) The Contractor shall provide the active ISO/IEC 17025:2017 certification at the time of solicitation.

K) Datrend Systems Service Authorization

i) The Contractor shall hold active authorization to service all Datrend Systems Inc products. The

Contractor service personnel shall be factory trained to perform routine calibration and repair services on all Datrend Systems Inc biomedical test equipment types. The Contractor shall provide Datrend Systems authorized dealer/service provider letter at the time of solicitation.

L) Insurance Requirements:

i) The Contractor shall be properly insured at all times during the performance of this contract.

The Contractor shall furnish to the Contracting Officer, prior to commencement of performance, evidence of insurance coverage described herein:

ii) Evidence of worker’s compensation insurance and liability insurance for all employees’, facilities, and vehicles.

iii) For the purpose of fulfilling obligations under this paragraph, the Contractor shall procure and maintain during the term of performance, liability insurance in form satisfactory to the Contracting Officer. The amount of insurance shall not be less than $100,000.00 each person, $300,000.00 each occurrence and $100,000.00 property damage.

M) Payment Criteria for Medical and electrical test equipment Services:

i) Invoices will be approved based on the completion of 100% of the required services in the task order. Completion compliance includes completion of the calibration/PM, corrective action, service request task and finishing the associated work orders with the appropriate data status (work not done, not located, failed PM/calibration, etc.). This will be determined by the IHS Computerized Maintenance Management System (CMMS) and based on the final service reports provided to the Contracting Officer’s Representative (COR) following completion of the site visit. Equipment that is not found or not available at the time of the site visit shall not impact the completion rate as long as the required documentation is included in the CMMS work order to ensure 100% compliance. Digital copies of all invoices shall be emailed to the Contracting Officer Representative.

(a) All invoices shall detail the following information:

1) Contract Number and Purchase Order Number

2) Service unit/facility where the services were performed

3) Dates of service

4) Equipment serviced (including asset number/serial number)

5) Bill to detailing the following:

IHS Phoenix Area Two Renaissance Square 40 North Central, Suite 512 Attn: Financial Management Phoenix AZ 85004-4424

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N) Quality Assurance:

i) The Contractor and the local Biomedical and electrical test equipment Support Specialist shall agree/sign off that the work was completed at the completion of the visit and before the task order will be closed. The Government will monitor the Contractor’s performance under this contract and shall retain the right to perform unscheduled inspections, as it deems necessary.

Furthermore, the Government retains all rights provided by the FAR (Federal Acquisition Regulations) clause entitled “Inspection of Services – Fixed Price” and any other inspection clause, which may be specified in the contract.

O) Environmental:

i) The Contractor shall at all times comply with all rules and regulations of any local municipality or federal environmental protection, and toxic waste and hazardous substance laws, ordinances and regulations, and how they relate to the work performed according to the terms and conditions provided herein.

ii) Safety Precautions/Bio-Hazard Safety: All systems, either mechanical or electrical that must be deactivated before services are performed shall be rendered by whatever disconnect or shut-off means are provided.

(a) Each deactivated system shall be properly “tagged-out” to prevent accidental reactivation.

The Contractor shall furnish “tag-out” procedures and tags. The Government shall be responsible for removing the contents of any equipment and ensuring it is biologically safe.

If applicable, the Contractor shall notify the PAO Service Unit Bio-Medical Departmen)t and Safety Officer before removing any bio-hazardous material. If applicable, the Contractor is responsible for removing and disposing of all hazardous materials/sources from the facility premises.

P) Confidentiality:

i) The Contractor and its employees shall keep all knowledge, information and documents that the

Government entrusts to its care confidential. Neither the Contractor nor its employees shall disclose any knowledge, information or documents entrusted to them by IHS to any person, firm or corporation other than the person, firm or corporation designated by the Government. The Contractor shall comply with all current and future IHS applicable security and privacy requirements, including the safeguarding of Protected Health Information (PHI) and compliance with Health Insurance Portability and Accountability Act (HIPAA).

Q) Conformance Standards:

i) The Contractor shall maintain the equipment covered by this contract in accordance with the following:

(a) Original Equipment Manufacturers (OEM) specification requirements

(b) ISO/IEC 17025:2017 – Calibration Standard

(c) National Institute of Standards and Technology (NIST) Metrological Traceability Standards

(d) ISO 13485:2016 - Medical Device Quality Management System standard

(e) National Fire Protection Association (NFPA) 99 (2012 Edition) and 101 (2012 Edition)

(f) The Joint Commission Standards (EC.02.04.01, EC.02.04.03)

(g) Association for the Advancement of Medical Instrumentation ANSI/AAMI EQ56:2013

(h) Association for the Advancement of Medical Instrumentation ANSI/AAMI EQ89:2015

(i) Occupational Health and Safety Health Association (OSHA)

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(j) Federal, Tribal, and local regulatory guidance and ordinances in regards to bio hazardous waste, disposal, and applications

R) Submittals

i) Traceability Information:

(a) Before work is performed, certificate/calibration information shall be provided of all test equipment to be used in the testing and calibration of medical and electrical test equipment and shall be traceable to the National Institute of Standards and Technology (NIST) in intervals prescribed by the manufacturer.

ii) Technician/Engineer Qualifications:

(a) License and Certification of Technical Skill to complete the required services must be maintained in an active and current status throughout the performance period. Documentation of biomedical and electrical test equipment technician certification shall be provided upon solicitation.

iii) Certificates of calibration

(a) The Contractor shall provide digital copies of all certificates of calibration following completion of calibration/PM or repair service. Digital copies shall be provided in the requested format (PDF). The Certificates of Calibration shall include details on all maintenance procedures performed. Certificates shall be provided within five business days of completion of the service. Calibration certificates shall include the following information:

1) Certificate Number

2) Calibration Date

3) Calibration Due Date

4) Technician Name/Comments

5) Laboratory Information

6) Device Under Test/Instrument Information including the following:

i) Asset Number

ii) Serial Number

iii) Manufacturer Name

iv) Model Number

v) Device Description

7) Environmental Conditions

8) Traceability Information of all equipment used in the calibration/PM procedure incluing:

i) Instrument Description

ii) Serial Number

iii) Certificate Number

iv) Calibration Date

v) Period (Weeks)

9) Environmental Conditions

10) Calibration Test Results including the following information:

i) Tolerance Values

ii) Applied Values

iii) Readings

iv) Pass/Fail Results

11) Uncertainties

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