ATT 1 TVHS PMRS EMG Replacement SOW 8-7-21.pdf

STATEMENT OF WORK (SOW)

Tennessee Valley Healthcare System (TVHS)

1. Contract Title: Procurement of replacement Electromyography Systems (EMGs) for TVHS Physical

Medicine and Rehab Service (PMRS).

2. Background: TVHS PMRS currently uses four outmoded electromyography (EMG) systems that were procured in 2008 (or before). The units are well past their estimated life expectancy of eight (8) years as they are all at least 13 years old. The existing EMG systems are powered by computers (workstations) that are running unsupported operating systems. Moreover, all EMG systems currently utilized by PMRS are end-of-life (EOL), meaning they are no longer supported by the Original Equipment Manufacturer (OEM). The application software on the workstations is no longer supported and cannot be interfaced with the TVHS electronic medical record (EMR) system.

TVHS PMRS is aiming to procure four (4) newer replacement EMG carts that can interface with the VA EMR system (known as VistA/ CPRS) for the sending of reports. PMRS requires EMG systems that are powered by workstations with supported Operating Systems (OS), such as Windows 10 (Windows 7 builds are not acceptable). PMRS requires latest generation EMG systems that can meet the requirements as detailed in this SOW.

PMRS requires any server software and HL7 interfaces/ licensing necessary to allow for EMG study storage and HL7 communications with VistA. The HL7 interfaces shall allow for orders to come into the system and results/ reports to be sent back to VistA/ CPRS.

Note: PMRS has two machines at the Nashville VA Medical Center (Nashville Campus) and two machines at the Alvin C. York VA Medical Center (York Campus).

3. Scope: This contract is to provide TVHS PMRS with four (4) new portable EMG systems and HL7 interfaces to allow integration with the TVHS EMR (VistA / CPRS). This contract will require any vendor on-site (and remote) preparation and installation services necessary to facilitate a successful installation of the two portables EMG systems (per this SOW) at each campus. The contract also requires any vendor installation and support services necessary to setup, test, and implement the required HL7 interface(s). The scope includes vendor provided server hardware to support all provided software and interfaces.

This procurement contract will include End-User training for PMRS Staff for how to use the newly provided EMGs (at each campus). The procurement contract will include four (4) labor hours (professional service hours) for OEM representatives to train TVHS Biomedical Engineering BESS on how the EMG systems and servers operate and how to maintain them properly.

The procurement contract shall include a starting amount (initial stock) of required disposables needed to utilize the systems.

The EMG systems shall be able to meet any technical and clinical elements, specific tasks, and terms and conditions included in the SOW for this procurement. Prospective Contractors shall be able to meet any clinical elements, specific tasks, or terms and conditions included in the SOW for this procurement.

4. Technical and Clinical Elements:

i. The proposed portable EMGs shall be 110 / 120 V (60 Hz) operating devices (no exceptions).

ii. The proposed portable EMGs shall meet the following technical specifications:

a) Workstations with Windows 10 64-bit OS that can allow for Bitlocker Encryption.

b) EMGs shall be two (2) channel systems.

c) Nerve conduction studies shall allow for a trace resolution of 1920 points per trace.

d) EMGs shall support dual and triple time bases for Needle EMGs. For Needle EMGs, the devices shall allow for saving and replaying up to 6 minutes of EMG from multiple channels.

e) EMGs shall allow for a High Pass frequency of 0.06 Hz and a 48 kHz sample rate. EMGs shall support a low filter limit of 0.1 Hz.

f) EMGs shall allow for analog sound with minimal delay.

g) EMGs shall allow for multi-modality Interoperative Neurophysiological Monitoring

(IONM).

h) EMGs shall allow for Multi Motor Unit Potentials (Multi-MUP) analysis. For Multi-MUP, EMGs shall be able to extract up to 12 potentials for a single recording.

i) EMGs shall have 24-bit Analog to Digital converters (ADC) or better.

iii. The proposed portable EMGs shall have the following features and capabilities:

a) EMGs shall support multiple time bases for EMG traces.

b) Users shall be able to customize menus for patient data entry.

c) Efficient search filters for patient identification.

d) EMGs shall allow clinicians to compare traces and measurements with previous nerve conduction studies (NCS). EMGs shall allow for different settings to support nomograms.

EMGs shall allow for calculation of z scores as well and calculations for ranges, means, and standard deviations.

e) EMGs shall support constant voltage and constant current stimulation.

f) EMGs shall allow for Triple Stimulation Technique (TST), Compound Muscle Action

Potential (CMAP) recording, Motor Unit Number Index (MUNIX) computation, and Conduction Velocity Distribution (CVD).

g) EMGs shall have a visual editing tool to help make Multi-MUP analysis easier and to help remove traces affected by noise.

h) EMGs shall support 360 second multichannel live play off-line reviews.

i) EMGs shall support repetitive nerve stimulation to help analyze neuromuscular transmission. For repetitive nerve stimulation, the EMG systems shall allow for decrement calculations and the calculation of facilitation within and between trains.

• Decrement calculation using any two responses in a train

• Decrement calculation using smallest and or last response.

j) EMGs systems shall have an auto save function to prevent loss of data during studies.

k) EMGs shall allow for the exporting of results in PDF format.

l) EMGs shall be connected to SQL database that can save data and allow for analysis of data.

m) EMG systems shall support (whether included or upgradeable options) Electroretinography and electrooculography capabilities in the event TVHS were to require those capabilities in the future.

iv. The proposed portable EMGs shall have / be delivered with the following components:

a) Single Footswitch.

b) Windows 10 64-bit workstations and LCD displays (minimum of 21”).

c) EMG Control Software and any required third-party software necessary to conduct EMGs and build reports (Adobe, MS Word, etc.).

d) Amplifiers, temperature probes, EMG probes and stimulators, Powercords and any required Uninterruptible Power Supplies (UPS).

e) Printers.

f) Portable Carts.

g) Removable Nerve Conduction Stimulator Tips / detachable stimulator heads.

v. The proposed EMG systems shall have the following capabilities with respect to EMR and network integration.

a) Contractor shall provide necessary inbound HL7 interface to allow for messaging with

VistA (for orders).

b) Contractor shall provide necessary outbound HL7 interface to allow for sending of PDF reports to VistA / CPRS (ORU interface).

c) Contractor shall provide SQL database software to support EMG database.

d) Contractor shall provide any software required to support databases and or HL7 interfaces that is not readily available and free (ex: HL7 Gateway software, SQL, proprietary software needed to support HL7 or databases).

e) Systems shall be able to integrate with Active Directory (AD).

vi. EMG systems shall already have completed Enterprise Risk Assessment (ERA) for the major version of software being offered, no exceptions.

vii. Contractor shall provide the following spare parts for the EMG system (additional parts/ components):

a) One (1) spare 2 channel amplifier.

b) Two (2) spare probes/ probe kits.

viii. Contractor shall provide an initial of disposables needed for the EMG machines thus that they may be used upon completion of delivery, installation, and configuration.

5. Specific Tasks:

i. The Contractor shall be responsible for installing all provided portable EMG systems.

Contractor shall coordinate with PMRS and Biomedical Engineering staff regarding installation. This shall include all travel, parts, and labor necessary for on-site installation and implementation.

ii. The Contractor shall provide all travel, proprietary software, and labor necessary to support installation, configuration, and implementation of EMG system databases and HL7 interfaces.

iii. Contractor shall provide end-user training to nursing staff for how to use the newly provided

EMG systems and software. A total of six (6) training days is required to support training at both campuses. Training days may be split up at will by VA (may be non-consecutive and used at any TVHS location).

iv. Contactor shall provide training to Biomedical Technicians for how the newly provide EMGs work and how to service / maintain them (on-site and or remote review).

v. Contractor is responsible for testing all provided EMG systems to ensure they are functioning properly prior to acceptance of work and equipment by VA.

vi. A one-year warranty that includes all parts and labor is required. Vendor telephone support shall be free of charge.

vii. Contractor is responsible for configuring all EMG hardware and software thus that they are customized to meet the needs of TVHS PMRS users.

viii. Contractor shall provide project management services, which may include conference calls and on-site visits, to support installation and implementation of the EMG systems.

ix. The Contractor shall provide the new EMG systems as required in the PO within 45 days after receipt of order and ship to TVHS.

x. Offering vendor shall provide documentation regarding cleaning requirements for the proposed EMG devices. A list of approved cleaners shall be provided.

6. Terms and Conditions:

i. The Contractor shall only invoice for the total amount agreed to on this procurement contract. The Contractor shall not conduct any work not included within this SOW / provided by the original pricing of this contract, including but not limited to labor, travel, parts provision, and shipping. If any additional services or equipment is necessary, the Contractor shall contact the Contracting Officer (CO) and Contracting Officer Representative (COR) immediately. The Contractor shall be liable for any work conducted (or equipment provided) outside the scope of this SOW (original order) without approval from the CO.

ii. The offering vendor shall provide details of the proposed EMGs clinical and technical alarms.

iii. Switches and controls of the proposed EMGs should be protected against accidental setting changes (e.g., due to someone brushing against the panel / screen). Device design should prevent misinterpretation of displays and control settings. The controls (i.e., switches, knobs, etc.) should be visible and clearly identified, and their functions should be self-evident.

iv. The offering vendor certifies that the proposed EMGs shall withstand normal hospital power interruptions, including generator testing, without manual intervention and that normal device operation will be restored automatically, without loss of data, once power is restored. The offering vendor shall specify and provide power conditioning if required.

v. The offering vendor shall confirm that the performance of the proposed EMGs shall not be affected by EMI radiated or conducted through the power lines from another device.

vi. The offering vendor shall provide a listing of all Recalls, Safety Alerts, and Field Engineering Change notices pertaining to the proposed EMGs over the past 12 months.

vii. Cleaning and disinfecting protocols for the proposed EMGs shall be provided and demonstrated to staff by the offering vendor. A list of acceptable cleaning and disinfecting chemistries shall be included with the purchase of the proposed EMGs.

viii. The offering vendor shall provide two copies of all service literature, including any necessary service and maintenance software, keys, and or passwords (in accordance with: 21-CFR 820.170(a), NFPA99 (2012 edition) Chapter 10.5.3, VAAR 852.211-70, and the VA NAC AS3000 clause).

ix. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Veteran Affairs (VA).

x. The contractor shall be able to read, write, speak and understand English. All contractor representatives shall be sufficiently fluent in the English language to effectively communicate with Charlie Norwood VA Medical Center’s representatives.

xi. The contractor shall present a neat appearance commensurate with that required of a professional. Contractor personnel shall comply with medical treatment facility policies regarding personal appearance and conduct.

xii. The contractor is required to report to Biomedical Engineering Section office, Bldg. 801, Room 1B162, and sign in, and obtain an ID badge for repairs or services required during/after normal working hours. If unable to check in with Biomedical Engineering Section office, Bldg. 801, Room 1B162, then the contractor needs to check in with VA Police Office.

xiii. Repairs that cannot be performed at the VA site may be performed at the contractor’s site provided the POC approves removal of the equipment. In accordance with VA Handbook 6500.1, Electronic Media Sanitization, equipment that has removable media (i.e. Hard Disk Drives; USB devices; etc.) shall be removed prior to equipment leaving VA premises for repair. The contractor’s representative shall sign a receipt for the equipment. The repaired equipment shall be returned to the original premises within two (2) working days or the contractor shall provide a temporary replacement at no additional cost to the VA.

xiv. Safety shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Biomedical Engineering Section. When required, the contractor’s service representative shall comply with the Occupational Safety and Health Administration lockout/tagout standards while performing maintenance on equipment. The VA and the contractor’s service representative shall exchange hazard communication information before the commencement of any repair.

xv. All correspondence, service reports and invoicing shall be in English and clearly legible.

xvi. The use of cellular phones and 2-way radios is expressly forbidden in certain areas of

Medical Treatment Facilities and Health Clinics. The contractor shall not use cellular phones or radios in these areas. (i.e. Direct patient care areas, etc.).

xvii. Smoking Policy Enforcement: Smoking is prohibited within Charlie Norwood VA Medical Center and its clinics and within 15 meters of any building.

7. Performance Monitoring:

i. Contact with the vendor will continue after the equipment is purchased and setup to ensure systems are working correctly. Biomedical Engineering and representatives from PMRS will ensure that the EMG systems are setup correctly and working properly as part of the acceptance process.

ii. Impaired Contractor personnel: At any time during the performance of this contract, the Contracting Officer, Contracting Officer Representative (COR) or Director of the medical treatment facility may direct the contractor to immediately remove any contractor employee whose actions or impaired state raises reasonable suspicion that clear and present danger of physical harm exists to a patient, medical treatment facility personnel and equipment or to the impaired individual. This provision shall be used in emergency situations only and not for the purpose of bringing performance issues or other non-urgent concerns to the attention of the contractor.

8. Security Requirements:

Vendor shall follow all rules set forth by TVHS regarding on-site installation and setup of databases and HL7 Gateway(s).

9. Invoicing

i. Invoices shall be submitted electronically in arrears to the address indicated VA FSC P.O. Box

149971 Austin Texas 78714. Please reference the Purchase Order Number (i.e. 509-A0000 or 509-C75…)

ii. Payment will be made upon receipt of a properly prepared, itemized invoice, validated by the COR, and submitted electronically.

iii. A proper invoice will contain:

• Contractor’s Name and Address

• Accurate Purchase Order Number

• Dates of performed services

• Total Amount Due

• Location of Service Performed

10. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

11. Other Pertinent Information or Special Considerations:

a. Identification of Possible Follow-on Work.

b. Identification of Potential Conflicts of Interest (COI).

No potential conflicts of interests have been identified.

c. Identification of Non-Disclosure Requirements:

d. Packaging, Packing and Shipping Instructions.

e. Inspection and Acceptance Criteria.

Biomedical Engineering will ensure all hardware and software is setup correctly and working properly as part of the acceptance process. Biomedical Engineering will consult with PMRS about any potential issues before completing the acceptance process.

12. Risk Control:

13. Place of Performance:

The work will be performed at two separate TVHS locations, see below for information:

i. Nashville VA Medical Center

1310 24th Avenue South Nashville, TN 37212

(615) 327-4751

ii. Alvin C. York VA Medical Center 3400 Lebanon Road Murfreesboro, TN 37129

(615) 867-6000

14. Period of Performance:

POP shall be 210 days total

15. Delivery Schedule:

• Delivery shall be executed within 30 days.

• Installation/ configuration of all machines (without server integration) shall be executed with 60 days.

• Server integration shall be completed within 180 days

• Final Trainings/ Post integration work shall be completed with 210 days.