Attachment 3 - RFQ IHS1519384 Statement of Work.pdf

Phoenix Area IHS Dental Equipment Preventative Maintenance and Repair Services Phoenix Area Service Units

1 | P a g e

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 dental equipment preventative maintenance and repair services. In order to ensure that the dental 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 dental equipment maintenance is to ensure the equipment is fully functional and safe and effective for its intended use. Routine maintenance and calibration services are required on an annual 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 dental equipment services required to support the Phoenix 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.

C) The Contractor shall provide qualified personnel to perform comprehensive on-site visits to each Phoenix Area Service Unit to provide preventative maintenance and repair services. The Contractor shall provide technical services necessary for the optimum operation of dental equipment within Phoenix Area IHS. The Contractor shall possesses the capability to service the cold storage device

2 | P a g e types listed in Section VIII - Dental 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 dental 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 dental 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 Dental equipment 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 dental 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 shall perform all OEM required safety, operational, and functional checks and visual inspections on the dental equipment. Maintenance and inspection procedures shall be performed 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 dental 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 within the service report and certificate of calibration. The Contractor shall provide Preventative Maintenance

3 | P a g e 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 dental equipment remain in proper operational and functional order. All checkout/maintenance procedures and visual inspections shall be performed by certified dental equipment service personnel a minimum of one time per year thereafter on 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 as “Out of Service” and the local IHS engineering team shall be notified. 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 dental equipment shall at minimum include the following when applicable:

1) Routine Tasks:

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

A. Change oil and air intake filters on air compressor B. Change water filters for vacuum system C. Change air and water filters in delivery systems D. Check delivery system handpiece and vacuum tubing for cracks or stiffness E. Check intra-oral x-rays for drift in tubeheads and arms and all bushings and pins F. Check oil and filter on the vacuum system. Change per manufacturer’s recommendation.

G. Replace sterilizer door and cassette seals H. Perform air abrasion units maintenance per manufacturer;s recommendations I. Check/replace amalgam separator cartridge J. Check/replace master water filter element K. Check/clean plaster trap L. Clean/lubricate lab handpieces as needed M. Check output of curing lights with light meter N. Check pressure relief valve on sterilizer O. Replace and lubricate the syringe O-ringns and button-valves assemblies P. Replace and lubricate the HVE and saliva ejector O-rings Q. Replace air and water filters in the floor box or utility area R. Operatory equipment maintenance:

a. Dental Chair

i. Use touchpad and footswitch to check operation of the chair lift, tilt, and programming functions and advise on recommended repairs or replacements.

4 | P a g e

ii. Check all equipment stop plates/switches and chair lockout function to ensure proper functionality

iii. Check the range of travel and adjust limits as necessary to minimize the possibility of collision damage

iv. Check for hydraulic cylinder squeak and other irregular noises (such as hydraulic hoses rubbing on covers) and adjust as necessary

v. Check for hydraulic fluid leaks

vi. Check the hydraulic fluid reservoir level and fill as necessary.

vii. Check the headrest glide bar tension and adjust as necessary.

viii. Check the swivel brake operation (if equipped) and adjust as necessary.

ix. Check the armrest tension and movement (if applicable) and adjust as necessary.

x. Check the upholstery condition and recommend replacement as appropriate.

xi. Check the tubing and wiring routing to ensure unobstructed movement and adjust as necessary.

xii. Check for power button functionality, if equipped.

b. Delivery System

i. Check for damaged, brittle, or stiff handpiece tubing and recommend replacement as necessary.

ii. Check the condition of handpiece coupler O-rings and advise on repair as necessary.

iii. On the control block valve inspect the water flow control stem, water adjustment stem, air coolant flow control stem, or air coolant adjustment stem and O-rings. Lubricate O-rings and replace O-rings on loose adjustment knobs as necessary.

iv. Check handpiece pressures and adjust to manufacturer’s specification as necessary.

v. Check intraoral light source voltages (if equipped) and adjust as necessary to handpiece manufacturer’s specification.

vi. Continental delivery system only: check whip arm movement and adjust spring tension as necessary.

vii. Check the handpiece holder bar tension (if applicable) and adjust as necessary.

viii. Replace syringe O-rings and button-valve assemblies (p/n 90.1613.00), lubricate with A-dec silicone lubricant, and verify operation.

ix. Check that the handpiece flush system and the valve are operating normally.

x. Check operation of air brake (if equipped) and tension of flexarm spring (if equipped) and adjust as necessary.

xi. Replace the self-contained water bottle O-rings and lubricate O-rings with A-dec silicone lubricant.

xii. Use the touchpad (if equipped) and foot control to check the operation of handpiece identification (if applicable) and activation.

xiii. Check that the delivery system is level and balanced. If the system drifts or does not hold position, adjust it starting with the lower arm and moving up to the control head.

5 | P a g e

xiv. Remove the syringe tip and use the syringe nut torque adaptor (p/n 23.1354.00) to torque the syringe nut, if applicable.

xv. Check the tubing strain relief on the warm water syringe and handpiece tubing (if applicable). Secure the strain relief with the screw (p/n 002.094.02).

c. Foot Control

i. Check the condition of the foot control tubing.

ii. Inspect the O-ring (030.012.00) and retaining ring (38.0237.00). Replace as necessary. Lubricate O-rings with A-dec silicone lubricant, and check for correct operation.

iii. Replace the foot control components available in preventive maintenance kit 95.0593.00 as necessary.

iv. Lever foot control only: clean or replace feet as necessary.

v. Check for loose screws and tighten as necessary. If the center screws are loose, replace them with new screws that have blue patch lock or apply Loctite to them.

vi. Check for chip air function if applicable.

vii. Check for coolant water on/off toggle function.

d. Assistant’s Instrumentation and Vacuum

i. Inspect vacuum tubing for damage or leaks and recommend replacement as necessary.

ii. Check for damaged or brittle tubing and recommend replacement as necessary.

iii. If the nut is loose or does not lock, replace syringe O-rings and button-valve assemblies (p/n 90.1613.00), lubricate with A-dec silicone lubricant, and verify operation.

iv. Replace the HVE and saliva ejector O-rings, confirm that tailpieces are secure, lubricate with A-dec silicone lubricant, and verify proper operation.

v. Replace the HVE screen, O-rings in the vacuum canister, and tailpieces (preventive maintenance kits 90.1641.00 , 90.1642.00, and 90.1643.00).

Lubricate with A-dec silicone lubricant and verify proper operation.

vi. Inspect solids collector screen. Replace disposable screen or clean reusable screen and recommend replacement as necessary.

vii. Check amalgam levels and the operation of the amalgam separator (if equipped).

viii. Check that a vacuum system cleaner is being used and advise on proper use as necessary.

ix. Check the operation of the lower support arm and rear support link stop switch (if equipped).

x. Check the assistant's instrumentation arm level. If adjustment is required, start with the lower arm and move up to the holder bar.

xi. Remove the syringe tip, then use the syringe nut torque adaptor (p/n 23.1354.00) to torque the syringe nut if applicable.

e. Dental Light

i. Check the operation of the on/off switch and the controls including the dental light auto on/off actuation by chair preset position controls.

ii. Check all intensity/mode settings and controls

6 | P a g e

iii. Halogen lights only: ensure that the toggle switch is securely installed and tighten the retaining nut as necessary.

iv. Check light handles to ensure they are securely attached.

v. Check light shield for cracks and wear. Replace as necessary.

vi. Check the tension for each axis of rotational movement of light head assembly and adjust as necessary.

vii. Check the spring tension for vertical movement of the light arm and adjust as necessary.

viii. Check that rotation limit stops are in place and adjust as necessary.

ix. Halogen lights only: check that a spare bulb is present.

f. Support Center/Cuspidor

i. Check for damaged or brittle tubing and recommend replacement as necessary.

ii. Check the operation and timing of the cupfill and bowl rinse and adjust to customer preference as necessary.

iii. Inspect the cupfill and bowl rinse spout O-rings, replace as necessary, and lubricate O-rings with A-dec silicone lubricant.

iv. Clean and flush the drain, check for proper operation, and ensure that the drain vent is functional.

v. Check for leaks in the cuspidor drain line and advise on repair as necessary.

vi. Check the cuspidor limit switch operation.

vii. Check the level of the support center posts and adjust as necessary.

viii. Ensure that the cuspidor does not impede chair movement, if applicable.

ix. Check the lower support link / arm safety switch operation.

g. Floor Box

i. Replace air and water filters (p/n 24.0234.00) and filters screens (p/n

41.0004.00).

ii. Check incoming air and water pressures and adjust as necessary.

iii. Check for air and water leaks.

iv. Check for damaged, brittle, or stiff tubing.

v. Check incoming air to ensure clean and dry air is being delivered to the delivery system.

vi. Check the moisture separators at the floor box and compressor, and replace moisture separator filters as necessary.

h. Stool

i. Check caster rotation to ensure debris is not inhibiting movement.

ii. Check the stool cylinder for leaks. Ensure that the rod is free of visible dirt/grease.

iii. Check all stool seat, back/torso, and height adjustments to ensure proper operation.

iv. Check armrest rotation and adjustments (if applicable) to ensure proper operation.

v. Check upholstery condition and recommend replacement as appropriate.

vi. Inspect the covers to ensure proper fit and adjust as necessary.

i. Other Equipment

i. Check the monitor mount tilt tension and adjust as necessary.

7 | P a g e

ii. Check the spring tension for vertical movement of the monitor mount arm (if equipped) and adjust as necessary.

iii. Check all arm pivot points for correct tension and adjust as necessary.

iv. Check the level of arms, delivery system, and trays and adjust as necessary.

v. Inspect and adjust fasteners as necessary.

vi. Inspect the covers to ensure proper fit and adjust as necessary.

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.

2) Calibration/Metrology Services

i) Calibration is required when performing maintenance on the dental 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.

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) 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 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: Asset Tag Number, Technician Name/Code, Date of Service (Month, Day, Year), and Next PM Date (Month and Year only).

8 | P a g e

D. 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.

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

3) In the event that dental equipment fails its Preventative Maintenance Inspection, the Contractor shall:

A. Document the failure in the service report as ‘Failed PM’ B. Enter the results 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.

C) Remote Support- The Contractor shall provide unlimited phone support during normal operating hours, Monday-Friday 8Am-5PM EST, for both the clinical and local biomedical engineering staff.

D)

E) On-site Troubleshooting- The Contractor shall provide on-site device evaluation and troubleshooting on non-operational dental equipment. All troubleshooting procedures shall be in accordance with OEM requirements. The Contractor shall document the troubleshooting procedures performed within the 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 service report. 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 onsite repair and troubleshooting services within 72-hours.

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

9 | P a g e

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

G) Parts

The Contractor stipulates that they have 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.

H) 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 dental equipment services based on the needs of the Phoenix Area IHS facilities.

I) 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 dental equipment within 72 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 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.

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.

10 | P a g e

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.

J) 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 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 preventative maintenance services and repairs for all listed 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.

K) 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 medical devices and specifies the quality requirements during all aspects of medical device repair process.

(a) The Contractor shall hold active ISO 13485:2016 Certification and meet all requirements of the Medical Device Quality Management System standard. 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 compliance to quality management system regulations with the submission of offer at the time of solicitation.

(b) The Contractor shall be ISO 13485:2016 certified throughout the life cycle of the contract.

(c) The Contractor shall provide the active ISO 13485:2016 certification at the time of solicitation.

11 | P a g e

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.

M) Payment Criteria for Dental 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 PM/repair and documentation. This will be determined by review of 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 service report to ensure 100% compliance.

(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 information (manufacturer name, make/model, and serial #)

5) Bill to detailing the following:

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

N) Quality Assurance:

i) The Contractor and the local biomedical/facility engineering representative 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 Department and Safety Officer before removing any bio-hazardous material. If applicable, the Contractor is

12 | P a g e 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 13485:2016 - Medical Device Quality Management System standard

(c) ISO 17025:2017 - Testing and calibration laboratories standard

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

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

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

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

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

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

R) Submittals

i) Equipment Calibration Certifications:

(a) Before work is performed, certificates shall be provided of all test equipment to be used in the testing and calibration of dental 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 technician certification shall be provided upon solicitation.

iii) Equipment spreadsheet

(a) An excel spreadsheet shall be provided at the completion of each visit that lists all equipment that received preventative maintenance and repair services. The excel spreadsheet shall include the following information:

1) Asset tag

2) Asset type

3) Manufacturer name

4) Model name

5) Serial number

6) Department

7) Facility name

8) Technician name

13 | P a g e

9) Date services performed

10) Test results (pass, fail, not located, device in use, or retired)

iv) Procedures:

(a) The Contractor shall electronically document all preventative maintenance and repair procedures performed. All service descriptions shall reference OEM documentation such as service manuals, operator’s manual, and/or technical data sheets to ensure the service was performed in accordance with OEM requirements.

IV. DELIVERABLES:

A) The Contractor shall submit legible field service reports and invoices to the COR, Phoenix Area Clinical Engineer, and/or IHS designee. All deliverables shall contain the required information detailing the preventative maintenance, test inspection, certification, and/or repair services performed, including replaced parts and detailed estimated prices required for recommended repair/replacement work not included in the preventative maintenance service.

i) Service Reports: The Contractor shall provide a service report indicating the device meets, exceeds, or fails to meet all previously listed service descriptions, Original Equipment Manufacturer specifications, and Conformance Standards. The service report shall include any test measurement and diagnostic equipment (TMDE) used during the service and provide calibration dates and certificates indicating the equipment has been calibrated using measurement standards traceable to the National Institute of Standards and Technology (NIST), or to NIST accepted intrinsic standards of measurement, or derived by the ratio type of self-calibration techniques. The Service Report shall include at minimum the following information:

(a) Asset Tag Number, Asset Type/Device Description, Manufacturer, Model, Serial Number, Service Procedure, Standard used for calibration, Relevant measurements/data, Pass/Fail assessments, Technician Comments on condition/calibration procedure (found to be in tolerance, battery fitted before calibration, etc), Calibration Date, Next Calibration Due Date, Certificate Number, and Technician Name/ID

(b) The Contractor shall provide a spreadsheet of all devices serviced following the end of each site visit or service request. The spreadsheet shall be provided in an excel format (.xlsx) and include relevant information such as service(s) performed, date of service, technician name, and next service date.

(c) The Contractor shall maintain historical data on all services performed throughout the lifespan of the contract.

(d) The Contractor shall provide copies of the service report to the COR within five (5) business days of completion of the service and upon request.

(e) The Contractor shall provide dental equipment service documentation electronically and the documentation shall be available to the COR 24/7 in order to comply with The Joint Commission requirements.

ii) Invoice Requirements

(a) The Contractor shall email all invoices to the COR and Phoenix Area Clinical Engineer. The

Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include:

i) Name and address of the Contractor;

ii) Date of Services

iii) Invoice date and number;

14 | P a g e

iv) Contract number, line item number and, if applicable, the order number/requisition number;

v) Description, quantity, unit of measure, unit price and extended price of the items delivered;

vi) Equipment information (manufacturer, make/model, and serial number information)

vii) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

viii) Terms of any discount for prompt payment offered;

ix) Name and address of official to whom payment is to be sent;

x) Name, title, and phone number of person to notify in event of defective invoice; and

xi) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

xii) Electronic funds transfer (EFT) banking information.

A. The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

B. If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer— System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer— Other Than System for Award Management), or applicable agency procedures.

C. EFT banking information is not required if the Government waived the requirement to pay by EFT.

xiii) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C.

3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

V. Phoenix Area IHS Service Units

The Contractor shall provide dental equipment services to the following Phoenix Area IHS facilities.

Facility Address

Phoenix Indian Medical Center (PIMC) 4212 North 16th Street Phoenix, Arizona 85016

Hopi Health Care Center (Keams Canyon Service Unit)

Hwy 246 Mile Marker 388 Polacca, Arizona 86042

Whiteriver Indian Hospital (Whiteriver Service Unit)

200 W Hospital Dr Whiteriver, Arizona 85941

Parker Indian Health Center (Colorado River Service Unit)

12033 Agency Road Parker, Arizona 85344

Fort Yuma Health Center 401 Picacho Road Winterhaven, California 92283

Peach Springs Health Center 943 Hualapai Way Peach Springs, Arizona 86434

15 | P a g e

Fort Duchesne PHS Indian Health Center (U&O Service Unit)

6932 E 1400 S Fort Duchesne, Utah 84026

Southern Bands Health Center (Elko Service Unit)

515 Shoshone Circle Elko, Nevada 89801

Cibecue Health Center 2 West 3rd Street Show Low, AZ 85091

Supai Clinic 1 Main Street Supai, AZ 86435

Chemehuevi Clinic 1970 Palo Verde Drive Havasu Lake, California 92363

Irene Benn Health Clinic (Moapa) #10 Lincoln Street Moapa, Nevada 89025

VI. Dental equipment – Clinical Devices Asset Types

The Contractor shall provide dental equipment preventative maintenance, repair, and equipment loaner services to include but not limited to the device types listed in the table below. The device types are classified according to the ECRI Institute Universal Medical Device Nomenclature System (UMDNS).

Contractor provided service capabilities on the following device types shall be available throughout the lifespan of the contract.

Dental equipment – Device Types Air Compressors Amalgam Separators Analgesia Units, Inhalation Auto Vacuum Switch Systems Cameras, Video, Intraoral Carts, Treatment, Dentistry Chairs, Examination/Treatment Chairs, Examination/Treatment, Dentistry Cleaning/Lubricating Units, Dental Handpiece Compressor, Air, Dental Compressors, Medical-Air Dental Air Abrasion Units Dental Delivery Units Dental Model Trimmers Dental Prosthesis Design/Manufacturing Systems, Computer-Aided Detectors, X-Ray, Digital Radiography, Intraoral Distilling Units Film Processor, X-ray Grinders, Dental Laboratory Hand Drills, Surgical, Bone Laser Delivery Systems, Fiberoptic Lasers, Diode, Dental Light Sources Lights, Examination, Dental/Intraoral

16 | P a g e

Lights, Surgical Milling/Drilling Machines, Dental, Computer-Aided Radiographic Units, Dental, Extraoral Radiographic Units, Dental, Intraoral Scalers, Dental, Ultrasonic Sensor, X-ray, Intraoral, Dental, USB Sterilizing Units, Steam, Tabletop Stools, Adjustable, Dentistry Thermoplastic Forming Units, Injection, Dental Laboratory Trays, Instrument Vacuum Pumps, Central Vacuum, Dental Washer/Decontamination Units Washer/Sterilizing Units, Surgical Instrument Washers, Labware/Surgical Instrument, Ultrasonic Water Purification Systems, Reverse Osmosis X-Ray Film Duplicators X-Ray Film Processors, Automatic X-Ray Film Processors, Automatic, Dental