P01 - SOW.pdf

Department of Veterans Affairs JJP VAMC

Veterans Health Administration 01/08/2021

Statement of Work (SOW)

Temperature, Humidity, and Pressure (TPH) Monitoring System

BACKGROUND: The Department of Veterans Affairs, James J. Peters (JJP) VA Medical

Center (VAMC) located in the Bronx, NY is seeking a contract for temperature, humidity, and pressure monitoring sensors. This contract encompasses installation, verification and testing as well as annual calibration. This system encompasses transmitters, temperature/humidity probes and Ultra-low temperature probes located throughout the Medical Center and community-based outpatient clinics (CBOCs).

The TPH Monitoring system will provide means for logging, storing, and providing alarms of pre-set values remotely for temperature, pressure, and humidity. Veterans Health Administration

(VHA) Notice 2020-02 titled “Storage of Vaccines and Medications in Pharmaceutical Grade

Purpose-Built Refrigerators and Freezers at VA Medical Facilities” specifies numerous requirements that the TPH Monitoring system shall alleviate. This includes the means for recording, logging and storing temperatures for medications stored in pharmaceutical grade purpose-built refrigerators and freezers that will house medications, including but not limited to, the COVID-19 vaccine. Vaccines can lose their potency when exposed to excessive heat, cold, or light with subsequent exposures to improper conditions resulting in loss of potency. While exposure to any inappropriate conditions can affect potency of refrigerated vaccines, a single exposure to freezing temperatures (0 degrees Celsius or colder) will destroy some vaccines.

Liquid vaccines that contain an adjuvant can permanently lose potency when exposed to freezing temperatures. The TPH monitoring system shall alleviate this requirement.

SCOPE: Purchase of equipment and installation for the full operation of the temperature monitoring of the patient medicine and food. Including devices for humidity monitoring and pressure differential (PD) monitors to display room air pressure. This system utilizes wireless technology and approved for VA IT functionality. Scope includes all labor and equipment, programming, set up, training and commissioning for the system. System must incorporate 24/7 help desk emergency support and remote access to the system via VA IT approved work. System must provide unlimited software updates, web-based training, and E-Learning training included with the software program.

1. INSTALLATION PLAN:

a. Contract Information: The Department of Veterans Affairs JJP VAMC intends to issue a parts and installation contract.

b. In addition, the contract consists of:

• Providing administrative, technical, and emergency support.

• Installation of base stations (buffers or receivers) at JJP VAMC, and

CBOCs

i. The vendor shall –

a. Provide 24/7 help desk emergency support

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i. Identify system/software failure and troubleshoot

ii. Confirmation of proper identification of all hardware within the system

iii. Calibrations

iv. Training

v. Configuration Assistance

vi. Troubleshooting System Functionality

ii. Provide calibration for all sensors and transmitters

iii. Hardware warranty is extended to three (3) years and is replaced at no charge

(excludes labor) as a result of manufacturer’s workmanship

iv. Remove and replace the existing equipment, devices and software at the applicable location.

a. The existing system is Check Point Software Technologies

b. Check Point is unreliable, and technical representatives (TR) are unavailable

c. It is vital to assign a designated TR for troubleshooting the system.

v. Temperature, humidity, and pressure system will be installed in phases, per the following priority –

Phase I Pharmacy

The pharmacy will have priority due to incoming vaccines. Therefore, Phase I will include pharmacy, nursing station, med room, and vaccines.

Phase II SPS

Sterilization processing and supply (SPS), has a higher priority than most areas in the hospital. Eye clinic (medical storage), and Research (Ultra-low freezers).

Phase III Supply room and logistics

The third phase will include supply room and logistics, dental, audiology/ENT, clean storage, clean utility, soiled utility, and SPD room.

Phase IV General Surgery

CBOCs’ lab fridges and freezer located in Queens, White Plains, and Yonkers. The following locations at the Bronx VA – OR/Peri-op, Recovery Room, Interventional

Radiology/Imaging.

Phase V Additional Areas

Outpatient, Morgue, Pathology/Lab Division, Hematology, Chemistry, Microbiology, Inoculation & Parasitology.

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Phase VI All Remaining Areas

Areas include: Pharmacy, Employee Health, Sleep & Diagnostic Treatment Center ICU, Respiratory Therapy, Med/Surg, Nursing Station, Mental Health, SRS/Geri/Psych, Dialysis, Outpatient Mental Health, GI/Hem/Onc-Suite H, Heme/Onc, Ortho/Podiatry, Women’s Health, Neurology, Prosthetics, Rehab, OT, PT, Morgue, Pathology/Lab

Division, Hematology, Chemistry, Microbiology, Inoculation & Parasitology, Anatomical Pathology/Histology, Nuclear Medicine/US/Imaging, Audiology/ENT, Dental, Cardio/Coumadin/Speech/Dermatology, General Surgery, OR/Peri-op, Recovery

Room, Interventional Radiology/Imaging, Flu Clinic, Urology, Eye Clinic, Primary Care, Investigational Drug Service, Radiation Oncology, SPS, Nutrition, Research (Ultra-low freezers), and three (3) CBOC locations which include Queens, White Plains, and

Yonkers.

c. Buffer Installation:

An experienced technician will come to JJP VAMC and CBOCs during regular business hours, the visit will be coordinated by the vendor’s Administrator, with additional base stations as needed, (buffers or receivers) along with any other equipment necessary to install. The technician will be escorted to the work sites by the vendor’s Administrator and IT specialist. The technician will ensure that all base stations are installed, collect data, and are connected to the web-based application.

d. Vendor On-Site:

i. All work to be performed on Monday – Friday from 8 AM – 5 PM excluding government holidays

ii. All employees of the vendor shall comply with the VA security management program and obtain permission of the VA police, be identified by service and employer, and restricted from unauthorized access.

iii. All employees shall adhere to CDC requirements and wear appropriate mask coverings.

e. Calibration:

Calibrations shall be coordinated with the Contractor and Engineering Services.

In accordance with VHA NOTICE 2020-02 calibration is professional measurement of the accuracy of a temperature monitoring device’s reading against National Institute of Standards and Technology (NIST) standards.

❖ The contractor shall perform calibration in a manner which returns equipment to a performance standard that adheres to manufacturers technical specifications.

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❖ Contractor shall inform the VA of any probe which fails calibration.

❖ Contractor shall provide written certification that each probe is within specification.

❖ Report shall include:

o Probe type, I.D., and model # o Probe location with room number o Calibration date o Next calibration date o Pass/fail

❖ Contractor shall coordinate with the Engineering department to establish a schedule of implementation.

❖ Contractor shall check-in with the contracting officer representative (COR) or authorized personnel in the Engineering Department prior to starting any work.

❖ Standard hours for on-site service visits are 8 AM – 5 PM Monday to Friday local

(eastern standard time) excluding federal holidays.

2. INSPECTION:

Upon completion of the installation and calibration, the point of contact (POC) will perform an inspection of the equipment in the presence of the contractor personnel, prior to the contractor personnel leaving the facility. This inspection should ensure that all equipment is returned to full functioning condition. No invoices will be processed for payment prior to the completion of POC inspection.

3. PERIOD OF PERFORMANCE:

The POP shall be no more than 180 days from award.

4. PLACE OF PERFORMANCE:

Implementation at the VA

a. The Department of Veterans Affairs, James J. Peters VA Medical Center, 130

West Kingsbridge Road, Bronx, NY 10468

b. Queens CBOC at 4103 Queens Blvd, Sunnyside, NY 11104

c. White Plains CBOC at 23 S Broadway, White Plains, NY 10601

d. Yonkers CBOC at 124 New Main St, Yonkers, NY 10701

5. REQUIREMENTS:

The following digital data logger (DDL) requirements are in accordance with VHA

Notice 2020-02 requirements:

a. A detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®).

b. Alarm for out-of-range temperatures.

c. Low-battery indicator.

d. Current, minimum, and maximum temperature display.

e. Recommended uncertainty of +/-0.5 degrees Celsius.

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f. Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures no less frequently than every 30 minutes.

g. Ability to trigger electronic alerts for temperature excursions.

h. A current and valid Certificate of Calibration Testing.

6. ADDITIONAL REQUIREMENTS:

All sensors shall be in accordance with the following –

1. VHA Dir 1108.07, Pharmacy General Requirements

2. ISO 17025 – Testing and Calibration Laboratories

3. National Institute of Standards and Technology (NIST)

4. USP 797

5. USP 800

a. Negative pressure between 0.01 and 0.03 inches of water column relatives to adjacent areas per USP 800.

b. The range for negative pressure is -0.01 to -0.03 and for positive pressure it is

+0.02 to 1.1 mmHg.

The approved vendor shall furnish all tools, parts, materials, test equipment, personnel and software to accomplish all task items associated with the procurement package which encompasses temperature, humidity, and pressure monitoring devices, installation, technical support, calibration, on-site and web-based training, upgrades and builds.

Salient Product Characteristics:

a. Quantity 1 EA of Temperature, Humidity, and Pressure System

i. System must be a remote wireless monitoring system that allows 24/7 remote monitoring.

ii. The software must monitor against preset conditions that are defined by the user and can additionally provide alerts through more than one method.

iii. System must provide instant alert notifications that require acknowledgement as well as corrective actions.

iv. The software must include three alert types: Sensor Alarm, Battery Alarm, and Communication Alarm.

v. Data should be stored in a Microsoft Structured Query Language (SQL)

Server database.

vi. Transmitter information recorded to the database is time-stamped and cannot be altered through the user interface.

b. This system supports and monitors all refrigerators, freezers and warmers for the facility to ensure that medications, lab specimens and food are maintained at proper temperature.

c. Contractor shall be responsible for managing the system and making necessary changes.

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d. Contractor to provide all equipment, transportation, labor, and licenses to install monitoring system.

e. Contractor under this agreement shall provide onsite calibration services for the temperature monitoring probes for the Facility.

f. Contractor should include all designs and full implementation of the system.

Additional Salient Product Characteristics:

1. Refrigerator and Freezer Probes include a calibration port which allows for ISO

17025 and NIST traceable calibration to be performed on-site.

2. Three (3) year transmitter battery life

Salient characteristics of On-site calibrations:

1. For sensors requiring calibration certification, the calibration process is compliant to ISO/IEC Standard 17025:2005 and is traceable through NIST or other National

Standards Institutes when performed by certified technicians. This is available for both temperature as well as temp/humidity monitoring.

2. Calibration of probe and transmitter in tandem in-situ to be calibrated together as one system. Unique process allows recalibration of each solid simulator probe and transmitter monitoring device in tandem and in-situ (while in position). This is done with both transmitter and probe in natural environment on-site to increase accuracy with no downtime.

3. Certificates of Calibration uploaded directly into the software for easy retrieval

4. Calibration does not require any uninstallation of any kind. Must be completed in the place of performance to confirm total system accuracy

Salient characteristics to solid simulator probe: For spec range -55°C to 82°C

1. Non-liquid solid simulator probe. Will not leak, evaporate, spill, or require

MSDS sheet

2. Probe to have U.S. patented calibration port

3. Accuracy rating of +/- 0.5°C for total specification range

7. REFERENCES

a. Schedule: Schedule_VA.xlsx

b. Equipment List of Locations and Devices Required: VA equipment.xlsx

c. Independent Government Cost Estimate (IGCE): IGCE_THP_RevA.xlsx

d. SOW – TempTrak – THP – Albany: SOW - TempTrak- THP- Albany.doc

e. Notice ID 36C25920Q0701 Temperature, Humidity, and Pressure Control System

(Amended). Retrieved from: https://beta.sam.gov/opp file://///r04brxnas21.v03.med.va.gov/groups/Engineer/Project%20Folders%20(Electronic)/526-21-522%20(Install%20THP%20Monitoring%20System)/Project%20Admin/THP%20Schedule_VA.xlsx file://///r04brxnas21.v03.med.va.gov/groups/Engineer/Project%20Folders%20(Electronic)/526-21-522%20(Install%20THP%20Monitoring%20System)/Force%20Package/VA%20equipment.xlsx file://///r04brxnas21.v03.med.va.gov/groups/Engineer/Project%20Folders%20(Electronic)/526-21-522%20(Install%20THP%20Monitoring%20System)/Force%20Package/IGCE_THP_RevA.xlsx file://///r04brxnas21.v03.med.va.gov/groups/Engineer/Project%20Folders%20(Electronic)/526-21-522%20(Install%20THP%20Monitoring%20System)/Force%20Package/SOW%20%20-%20TempTrak-%20THP-%20Albany.doc https://beta.sam.gov/opp

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f. VHA Directive1108.07 Pharmacy General Requirements:

Pharmacy General

2017-03-10.pdf

g. VHA Directive 1109.04 Food Services Management Program:

Food Services

2013-10-11.pdf

h. VHA Directive 1116(2) Sterile Processing Services (SPS):

VHA directive

1116.pdf

i. VHA Notice 2020-02 Storage of Vaccines and Medications in Pharmaceutical

Grade Purpose-Build Refrigerators and Freezers at VA Medical Facilities:

VHA Notice

2020-02.pdf

j. Codes

a. American Society of Heating, Refrigeration, and Air Conditioning

(ASHRAE)

b. College of American Pathologists (CAP)

c. National Fire Protection Association (NFPA)

d. NAICS Code 334519 Other Measuring and Controlling Device

Manufacturing

e. NAICS Code 334513 Instruments and Related Products Manufacturing for

Measuring, Displaying, and Controlling Industrial Process Variables

8. SECURITY CLAUSE

GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

I. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2. All contractors, subcontractors, and third-party servicers and associates working with

VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with

VA Directive and Handbook 0710, Personnel Suitability and Security Program. The

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Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by

Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of

Veterans Affairs does not have a Memorandum of Agreement with Defense Security

Service (DSS). Verification of a Security Clearance must be processed through the

Special Security Officer located in the Planning and National Security Service within the

Office of Operations, Security, and Preparedness.

4. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

II. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

c. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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d. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business

Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

a. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

b. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

II. TRAINING

c. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

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(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training

Requirements.]

d. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

e. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.