5- SOW Medical Gases 2022.pdf

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STATEMENT OF WORK

MEDICAL GAS SERVICES

Federal Medical Center Devens

Federal Bureau of Prisons

42 Patton Rd.

Ayer, MA 01432

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STATEMENT OF WORK

Table of Contents

1.1 General Information

1.2 Place of Performance

1.3 Special Qualifications

2.1 Scope of Work

2.1 Institution Security

2.2 Schedule of Performance

2.4 Uniform Requirements

3.1 Equipment and Supplies

3.2 Contractor-Furnished Equipment

3.3 Installation of Contractor Equipment

4.0 Delivery of Medical-Grade Liquid and Compressed Oxygen

4.1 Applicable Regulations and Standards

4.2 Academic, Experience, and/or Special Qualifications Required

4.3 Environmental Control

4.4 Damages to Government Property

4.5 Method of Performance

4.6 Non-Personnel Services

4.7 Contractual Information

5.1 Length of Contract

5.2 Payment Terms

5.3 Miscellaneous Information

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1.1 General Information

The Federal Bureau of Prisons, Federal Medical Center (FMC) Devens, intends to award a single firm-fixed price type contract to a responsible entity for the provision of specialized services to maintain and service medical vacuum delivery systems and supply liquid oxygen to be used in conjunction with medical treatment for the inmate population of FMC Devens, MA. FMC Devens is a varied security facility housing approximately 900 federal male inmates.

1.2 Place of Performance

Services shall be performed, including delivery of medical gas, at the Federal Medical Center Devens, located at 42 Patton Road, Ayer, Massachusetts.

1.3 Special Qualifications

Contractor shall have all current licenses and certifications required by the Commonwealth of Massachusetts for handling liquid gases to include installation, maintenance, and certification of delivery system. Contractor shall maintain certifications required by Federal, State, County and City Codes including the most current version of NFPA 99. The Contractor will be required to provide professional certifications prior to award.

2.1 Scope of Work

The Federal Bureau of Prisons, FMC Devens, intends to award a firm-fixed price indefinite delivery/requirements type contract resulting from this solicitation. The services which meet the requirements are outlined in this statement of work (SOW). The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid oxygen for the Federal Medical Center, Devens, MA. The responsible entity will provide specialized services to maintain and service medical vacuum delivery systems and supply liquid oxygen to be used in conjunction with medical treatment for the inmate population.

The Federal Medical Center currently uses medical-grade liquid oxygen and vacuum there are approximately 170 medical oxygen and vacuum access points throughout the hospital

General Information regarding the Federal Bureau of Prisons (BOP), its facilities, and referenced Program Statements can be located at www.bop.gov. The Government reserves the right to award without discussion and to make a single award. Therefore, each initial quote should contain the quoter's best terms from a cost or price standpoint. The base period of performance shall begin on the effective date of award through a 12 month period, with the Government's unilateral right to exercise up to four, 12 month option periods.

The Federal Medical Center does not own any of the storage vessels currently used at the facility. The Contractor shall provide Contractor owned bulk vessel in sufficient size to meet the medical-grade l i q u i d oxygen requirements of the institution.

The usage figures are estimates of the facility's annual requirements. There is no express or implied guarantee that these quantities will be purchased. Please note the installation of Contractor-owned equipment will include a 90 day transition period at the beginning and end of the contract period.

http://www.bop.gov/

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Contractor shall provide and install all necessary equipment, including the liquid oxygen tank and back up tanks, for the delivery of medical gasses within 15 calendar days after receipt of a delivery order or task order. A truck concrete pad (size 37' X11’) and a tank concrete pad (size 26' X15') located outside the building is provided for the contractor provided tanks. The contractor shall connect and wire the contractor furnished equipment to the medical facility’s existing connections. FMC Devens has approximately 170 points of use through the hospital building located on four separate floors. Equipment for the air and vacuum system is located in a temperature controlled basement area. There are two electronic monitoring locations for the system. Contractor shall verify the monitoring system function for integrity prior to use with patients.

The services will be provided on an as needed basis with the Contractor. Telephone calls/emails with the meter readings will be made to the Contractor from the Bio-Medical Maintenance Department on a weekly basis. Contractor must be available for telephone calls 24 hours per day, 7 days per week, to include holidays. In case of emergency, delivery shall be within 24 hours after receipt of a delivery order.

A Contracting Officer Representative (COR) has been designated in the solicitation schedule for the facility. The COR is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR's specific responsibilities will be provided to the Contractor and COR at the time of contract award by the Contracting Officer. Within 15 days after notification of contract award, the Contractor shall meet with the COR to ensure mutual understanding of facility requirements relating to the ordering method and specific details of any delivery instructions that are included in the solicitation schedule.

Prior to first filling, the Contractor must perform in-service training to include the following for Contractor owned and government owned systems: the refill procedure, any preventive maintenance support requirements that may be needed from the FMC, and an explanation of all the volume alarm and low pressure set-points. The Contractor will provide written procedures and training for FMC staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. The Contractor will provide 24/7 emergency contact name(s) and telephone number(s).

Prior to first filling, and annually thereafter, alarm set-point testing and written verification must be presented through the use of a qualified third party expert per NFPA 99, 2005 Edition for Contractor Owned and Government Owned Systems. Any code deficiencies in the FMC's existing system, as defined by NFPA 50, 1.3.3, "Bulk Oxygen System", must be identified by the Contractor. A detailed explanation of these deficiencies must be presented in writing to the COR. Receipt of this written explanation must be signed for by the COR.

Prior to first filling, and annually thereafter, the Contractor must verify, in writing, the accuracy of all gauges on Contractor owned tanks. If the gauge(s) are government owned, Contractor will provide, if requested after award, a written proposal with price to verify accuracy of the gauge(s). The Government may choose to exercise this option at its desire.

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2.2 Institution Security

All delivery vehicles will enter through the Rear Gate at FMC Devens. The Government reserves the right to inspect any vehicle used to provide services under this contract and reject equipment;

without advance notification. The vehicle will be escorted to the designated area in the designated medical facility. The contractor must follow all security procedures as mandated by FMC Devens and the Federal Bureau of Prisons’ institutional security policies.

Services provided under this contract will not normally require contact with inmates. The contractor, including any employee or representative of the contractor who will render services at FMC Devens, shall submit to a National Crime Information Center (NCIC) inquiry prior to entering the institution.

The contractor may be required to participate in a security and BOP procedures orientation session, consisting of approximately four hours, prior to performing certain services under extenuating circumstances. The date and time for this orientation will be mutually agreed upon by both parties, and compensation to the contractor for time spent in this, and any other required security related training, will be negotiated by the contracting officer.

All personnel operating a vehicle shall be a licensed driver and all vehicles shall be licensed and insured. The Contractor's employees shall be restricted to those areas necessary to perform work under this contract as approved by the FMC.

2.3 Schedule of Performance

These services are a contractual agreement. The services will be provided on an as needed basis with the Contractor. Telephone calls/e-mails with the meter readings will be made to the Contractor from the Bio-Medical Maintenance Department on a weekly basis. Contractor must be available for telephone calls 24 hours per day, 7 days per week, to include holidays. In case of emergency, delivery shall be within 24 hours after receipt of a delivery order.

Contractor shall provide training, as needed, to FMC Devens staff on proper use of equipment and alarm system.

2.4 Uniform Requirements

The contractor employee(s) must wear appropriate and professional attire at all times. The attire worn shall also be appropriate for the correctional environment in which the contractor employee will be performing. The contractor employee(s) are prohibited from wearing khaki or green clothing of any type as this is the color of clothing the inmate population wear.

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3.1 Equipment and Supplies

Unless otherwise specified in this contract, title to the LOX Tank and/or Backup shall remain with the contractor.

All equipment and components of equipment are the sole property of the contractor, and no supplemental agreement or relationship between the Government and the contractor shall give the Government any property interest in such equipment thereof.

3.2 CONTRACTOR-FURNISHED EQUIPMENT

The Contractor shall provide, install, and maintain a 1,500 gallon bulk oxygen tank and appropriate 24 hour cylinder reserve supply with telemetry monitoring system. The capacities outlined in the schedule are minimum capacities required by FMC and are subject to change based on the needs of the institution. Through the duration of the contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor owned tanks, reservoirs, and cylinders that will insure compliance with applicable regulations, standards, and normal good practices. In regards to the bulk liquid oxygen system, the manifold, tank for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, telemetry system, and any other devices or connections required for proper tie-ins with the facility's gas system shall be furnished by the Contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

All equipment and materials required to perform on the contract shall be provided by the Contractor. Contractor owned equipment shall be installed, inspected and maintained by the Contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contract's monthly equipment rental fee for the facility.) Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards, and normal good practices.

The Contractor shall be provided reasonable access for this purpose.

3.3 INSTALLATION OF CONTRACTOR EQUIPMENT

A truck concrete pad (size 37' x 11') and a tank concrete pad (size 26' x l5') located outside the building are provided for the Contractor provided tanks. The Contractor shall connect and wire the contractor furnished equipment to the medical facility's existing connections. FMC has approximately 170 points of use throughout the hospital building located on four separate floors. Equipment of the vacuum system is located in a temperature controlled basement area.

There are two (2) electronic monitoring locations for the system. Contractor shall verify the monitoring system function for integrity prior to use with patients.

Unless otherwise directed by FMC, Contractor owned equipment shall be installed by the effective date of the contract and shall be connected to the medical gas system on that date;

provided: that the Contractor shall be allowed a maximum of 90 days after receipt of notice of award to complete installation. If the Contractor's equipment replaces e quipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the facility. Contractor installed equipment shall remain the property of the Contractor and

P a g e | 5 shall be removed upon termination of the contract, when directed by the facility and in full cooperation with the succeeding Contractor so as to avoid interruption of gas supply.

To permit orderly transition from one Contractor to another, the Contractor shall continue to honor the contract's monthly equipment rental fee and oxygen contract price for a maximum of 90 days beyond the scheduled expiration of the contract period, unless transition from one Contractor to another is completed prior to the 90 day transition period. For any partial month, the Contractor shall prorate the monthly equipment rental fee accordingly. The Contractor shall continue to provide and maintain its equipment during this transition period.

No guarantee is given or implied that data included in the schedule regarding Contractor owned equipment currently located at the facility is complete and accurate as to the factors affecting the cost of furnishing and installing the required Contractor owned tanks and appurtenances. Contractors submitting quotes are strongly encouraged to visit the facility site prior to submitting a quote and take other steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve the contractor from the responsibility of estimating properly the difficulty and cost of successfully performing the work.

All Contractor owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001, NFPA 99 Standard for Health Care Facilities, 2005 Edition, and FDA's Current Good Manufacturing Practices (CGMP) Regulations. The Contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment.

4.0 DELIVERY OF MEDICAL-GRADE LIQUID AND COMPRESSED OXYGEN

The bulk liquid oxygen tank level will be monitored by the Contractor, preferably through the use of a telemetry system. The Contractor shall deliver medical-grade liquid oxygen for the bulk system when levels meet a predetermined reorder point to ensure a continuous uninterrupted flow of liquid oxygen to the facility. The Contractor shall schedule bulk deliveries for Monday through Friday between the hours of 8:00 a.m. and 2:00 p.m. The Contractor shall provide 24-hour notice to the COR or facility representative of delivery prior to arrival at the facility in order to comply with facility security requirements.

If for any reason the Contractor is unable to deliver at the agreed upon day or time, the Contractor shall provide 24-hour notice to the COR or facility representative, so that the facility can initiate an alternate backup action. All deliveries must be monitored by a qualified and trained technical representative that will be designated by the COR. Contractor will be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution.

At the time of each delivery, the Contractor must provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the facility representative supervising the delivery.

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Emergency delivery will be provided within 24 hours after receipt of Government notification.

The Contractor must respond to the facility by either telephone or email within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak. Failure of the Contractor to remain current with agreed delivery schedule and requirements does not constitute an "emergency" for purposes of charging an emergency delivery fee.

All medical gas manufacturers and fillers of medical gases must be registered with FDA as drug manufacturers. All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA's Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA's labeling regulations (21 CFR Part 201).

All liquid oxygen delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.).

A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include, at a minimum:

I. Supplier's name and complete address II. Name of the Product (i.e. Oxygen U.S.P.)

III. An Air Liquefaction Statement where appropriate IV. Lot number or other unique identification number V. Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.)

VI. Test method used to perform the analysis. (A statement such as "Meets U.S.P.

specifications" is not acceptable; nor would "Tested via Servomex" be acceptable since the specific model number is not provided.)

VII. Signature of authorized supplier representative and date.

VIII. Material Safety Data Sheets shall be provided to the facility COR upon request.

IX. A copy of all inspection reports shall be provided to the facility COR upon the completion of any Contractor owned or government owned bulk oxygen system inspections that are required by regulation.

All Contractor owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA's Current Good Manufacturing Practices (CGMP) Regulations.

4.1 APPLICABLE REGULATIONS AND STANDARDS

The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the Contractor is responsible for ensuring that all products, equipment and services provided under the contract are in compliance with applicable Federal, state, and local regulations. If applicable, the editions in effect as of the

P a g e | 7 date of this solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance.

Title 21, Code of Federal Regulations, Parts 210 & 211 - CGMP regulations for supplying medical grade oxygen.

29 CFR 191 0.104 Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises

49 CFR -Transportation

Federal Food, Drug, and Cosmetic Act

NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 Edition NFPA 99:

Standard for Health Care Facilities, 2005 Edition U.S.P. 23

Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No. P-6, titled "Standard Density Data, Atmospheric Gases and Hydrogen," shall be used when necessary to convert measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to cubic feet.

Calculation based on data in CGA P-6

1 ft3 liquid O2 = 860.6 ft3 gas (Table 1)

1 ft3 liquid O2 = 7.48052 gal

(Table 2)

Therefore:

7.48052 gal (1 ft3) liquid O2 = 860.6 ft3 gas

1 gal liquid O2 = 860.6 ft3 gas/7.48052

1 gal liquid O2 = 115.05 ft3 gas or more commonly quoted as 1 gal liquid O2 =

115.1 ft3 gas maintenance and testing of Contractor owned cylinders.

4.2 ACADEMIC, EXPERIENCE, AND/OR SPECIAL QUALIFICATIONS REQUIRED

The Contractor personnel shall maintain all required certifications deemed appropriate by Federal and State regulatory agencies to meet all Federal and Local certification requirements in supply and delivery of liquid oxygen. Contractor shall have all current licenses and certifications required by the Commonwealth of Massachusetts for handling liquid gases to include installation, maintenance, and certification of delivery systems. Contractor shall maintain certifications required by Federal, State, County, and City Codes including the most

P a g e | 8 current version of NFPA99. All Contractor personnel providing services at FMC shall wear a uniform and a Contractor furnished visible identification badge, which shall include, as a minimum, the individual's first name and the name of the Contractor. The Contractor personnel shall wear shirts and closed shoes. The wearing of military uniforms, camouflage clothing, or military insignia, or parts thereof is prohibited under this contract.

4.3 ENVIRONMENTAL CONTROL

The Contractor shall comply with the Federal, State, and Local environmental regulations.

Upon occurrence of spills that could enter or endanger the institution, the Contractor or his authorized representative shall immediately call the FMC Safety Department and report the incident. CLEAN UP. All supplies, equipment and oxygen reservoir tanks shall be kept out of areas where they might create a public hazard.

4.4 DAMAGES TO GOVERNEMENT PROPERTY

All damages to a facility or government property associated with the liquid oxygen delivery process shall be reported immediately to the FMC Facilities Manager. The Contractor shall be responsible for all damages, which occur as a result of their employee's actions or inaction.

All damage to real property shall be repaired by the Contractor with materials of like type, quality, or finish by skilled craftsman of the trades involved at Contractor expense in a timely manner at no cost to the government. Should the Contractor fail to correct damages, the Government will correct the damages and the cost will be deducted from the Contractor's payment.

4.5 Method of Performance

The contractor shall provide services in a method considered normal in the community. These services, although not directly supervised, will be under the administrative review of the Health Services Administrator and the designated Federal Acquisition Certification for Contracting Officer's Representative (FAC-COR).

4.6 Non-Personnel Services

This service request is a contractual arrangement and not a personnel appointment. Payment is based on the provision of an end product or the accomplishment of a specific result. The service does not constitute an employer/employee relationship. The contractor will not be subject to Government supervision, except for security related matters. However, contractor performance shall be monitored. All duties outlined in this Statement of Work shall be performed in accordance with standards and methods generally accepted within the contractor employee(s) own field of expertise. The FAC-COR will periodically evaluate the contractor employee(s) performance. In this evaluation, if the performance of services is deemed unacceptable, that provider will no longer perform those duties. In that event, the contractor will be responsible for replacing the contractor employee(s) with credentialed contractor employee(s).

4.7 CONTRACTUAL INFORMATION

FMC Devens will be responsible for the following vouchering and law enforcement checks, as well as ensuring that fingerprinting and urinalysis testing is completed in accordance with the Human Resource Manual. In accordance with Bureau of Prisons Acquisition Policy 13.103 (b), P a g e | 9 the following investigative procedures may be applied and appropriate forms completed before any Contractor employees are permitted inside an institution:

1. National Crime Information Center (NCIC) check

2. Declaration of Federal Employment (OF-306)

3. FD-258 (Fingerprint Check)

4. Law Enforcement Agency Checks

5. Vouchering of employees over past 5 years

6. Employment Resume/Personal Qualifications

7. Completed Contractor Pre-employment questionnaire

8. OPM-329-A (Authority for Release of Information)

9. Questionnaire for Sensitive Positions (SF-85 for low Risk,SF-85P for above low risk)

10. Credit Check, if applicable

11. Urinalysis, if applicable

5.1 Length of Contract

The contract term will be for a base year, plus four possible one year options.

Base Year - Effective Date of Award (EDOA) through 12 months

Option Year #1: 13 months through 24 months from EDOA

Option Year #2: 25 months through 36 months from EDOA

Option Year #3: 37 months through 48 months from EDOA

Option Year #4: 49 months through 60 months from EDOA

Contract award will be made pending the availability of funds. Should funds not be immediately available, contract award for the entire fiscal year will be postponed until such time as funds become available.

5.2 Payment Terms

The FMC will be billed on a monthly basis. Invoices shall be submitted within 30 days of each reading for reimbursement for services rendered. Invoices should be submitted in accordance with FAR 52.212-4(g) and payment will be rendered in accordance with the Prompt Payment Act (31 U.S.C. 3903). The contractor may offer discount payment terms for prompt payments as specified in Block 12 on the SF-1449 of this solicitation.

Invoices shall be submitted to Federal Medical Center Devens via email or mail. See SF-1449 for invoice locations.

5.3 Miscellaneous Information:

In accordance with FAR 42.1502 and 42.1503: Agencies shall prepare an evaluation of Contractor Performance and Submit to PPRIS. The Department of Justice, Federal Bureau of Prisons utilizes the Department of Defense (DOD) web based Contractor Performance Assessment Reporting System (CPARs) to provide contractor performance evaluation.

Contractor shall provide and maintain a current e-mail address throughout the life of the contract

P a g e | 10 for the institution contracting staff/focal point. The contractor shall register with the DOD within 30 days of receiving an e-mail from the focal point. The e-mail will contain the user ID to register. The contractor must be registered to access and review its evaluation and/or provide a response. If assistance is required when registering, please contact the institutional contracting office for assistance, guidance, and instructions.

The Contractor must understand that the Contracting Officer is the only person who can legally commit or obligate the Government to an expenditure of public funds. The Contracting Officer is the only person who can legally change the terms and conditions of the contract and only then by a written modification.

This service contract does not constitute an employer/employee relationship.