Solicitation Amendment W91YTZ25QA1200001 SF 30.pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Continuation of Description

Miscellaneous text in this section has been added to:

Questions and Responses

Question 1 - Is the solicitation a new requirement set by the government or is this a contract currently being performed that the government is renewing. If this is a renewal, do you have the contract number associated with the old contract?

Government's Response: This solicitation is for a new requirement set by the Government. The Government's internal facilities are being scheduled for repair/remodeling.

Question 2 - Do you happen to have a site walk scheduled for the Solicitation W91YTZ25QA120 that was issued yesterday?

Government's Response: A site walk is not currently scheduled. As this requirement is awarded, and the separate trailer site construction preparation contract is awarded, a site preparation visit will be coordinated. Please see Addendum to 52.212-1 Volume II Technical (d) which in includes, "Offeror shall state in writing that personnel will be available at installation for on-site preparation coordination within twenty (20) days calendar days' notice from date of award or communication from Contracting Officer Representative (COR)." Also, PWS Para 2.3 has been updated for clarity.

List of Contract Documents, Exhibits, or Attachments

Miscellaneous text in this section has been modified to:

Performance Work Statement

Mobile Sterile Processing Unit Trailer Lease

Winn Army Community Hospital, Fort Stewart, GA

1. PROJECT DESCRIPTION

1.1 General: Winn Army Community Hospital is seeking to lease a Mobile Sterile Processing Unit (SPU) Trailer. The facility's Sterile Processing Department (SPD) will be closed awaiting existing equipment replacement. The use of a Mobile SPU will allow the facility to continue to perform decontamination, manual cleaning, and sterilization procedures during equipment replacement. The Mobile SPU trailer will be located at the west side of B Building of the main hospital.

1.2 This is a non-personal service contract under which the personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration, to the supervision and

W91YTZ25QA1200001

control usually prevailing in relationships between the government and its employees. The United States (U.S.) Government shall not exercise supervision or control over the contractor's employees performing the tasks herein. Such contract employees shall be accountable solely to the contractor who, in turn shall be responsible to the U.S. Government.

1.3 Place of Performance: Winn Army Community Hospital, Fort Stewart, Georgia

1.4. Hours of Operation: Then contractor is responsible for conducting business, between the hours of 8:

00am to 5:00pm, Monday through Friday, except Federal Holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

2. Mobile SPU Minimum Essential Characteristics and Contractor Responsibilities

2.1 Mobile SPU Trailer:

The selected contractor will deliver and set-up a fully enclosed functioning Mobile Sterile Processing Services unit that includes:

- Integrated Sterile Processing Equipment

- (2) Sterilizers

- 24 US Tray Capacity / Cycle (12 Tray1 / Sterilizers)

- (2) Washer / Disinfectors 2

- 48 US Tray Capacity / Hour (12 Tray1 / 30 Min Washer Cycle)

- (1) Ultrasonic Cleaner

- (1) Low Temperature Sterilizer

- (1) Three Sink Workstation w/ air or water guns, critical water, sprayer, and utility water faucets

- (4) Height Adjustable Prep & Pack Workstations w/ accessories3

- (1) Pass-through Window

HVAC

- ASHRAE 170-2021 Compliant Environmental Controls

- 3 Zone - 2 Barrier Infection Control

- 4 discrete / independently controlled multi-stage temperature and humidity controls

- Differential airflow and pressure relationships w/ integrated monitoring

- HEPA filtration

- Heat Index Package

- Cold Weather Package (CWP)

- skirting with electric heating

ANSI/AAMI ST108 Compliant Critical Water System

- 3-Bay Decontamination Sink

- Ultrasonic cleaning system

- Enzymatic dosing system

- Wall mount system with 23" LCD Monitor

- Washer/ Disinfector x2 (Minimum chamber dimensions H: 667mm, D: 810mm, W: 650mm)

- Transfer carts for washer x4 (x2 in decon, x2 in prep & pack)

- Pass-thru window with set down counter

- Prep and Pack tales/ workstations x4

- Sterilizer loading and transfer carts x4

- RO water treatment system

- Hand wash sink with eye wash x2 (x1 I decon, x1 in prep and pack)

Remote Monitoring & Reporting

Remote Monitoring of Key Water, HVAC & System Performance

Detailed Monthly Reporting for Water Quality 8

Telecommunications & Data

- (18) 9 Data / Telephone connections located throughout the unit

- (8) Clean Area connection ports

- (6) Decontamination Area ports

- (4) Sterile Area ports

Safety

- (1) Eye Wash - Decontamination Work Area

- NFPA 72 & NFPA 13 Compliant Fire Alarm & Sprinkler System10

- Security Alarm

- Intrusion alarm system on all MSPS(TM)-02 exterior doors

- Battery Powered Emergency Egress Lighting

Wind Anchoring

- (10) 5,000 lb. tensile capacity tie down rings are located along the perimeter and inner frame of the unit super structure provide restraint for up to 55 mph wind

- Hurricane & Seismic Anchoring

- (12) 15,500 lb. tensile capacity

- 2.0 chassis tie downs that provide restraint for up to 200 mph hurricane strength wind and equivalent seismic forces

Contractor shall be responsible for connecting all required Mobile SPD connections to Government provided utilities and completing all commissioning requirements.

Physical Requirements and Life Safety: The mobile SPU contractor must provide access to the trailer that is American Disabilities Act (ADA) compliant as well as safety rated per Occupational Safety and Health Administration (OSHA) requirements.

The Mobile SPU Trailer must have proper egress paths and emergency exists per NFPA 99 requirements.

The Mobile SPU Trailer must have cart lift capabilities.

Power: The government will provide power hookups/connections to the trailer from service panelboards with underground polyvinyl chloride (PVC) conduit.

Weather Proofing: The contractor must certify that their proposed equipment is weatherproofed to the extent necessary to maintain full operational uptime despite impacts from local weather patterns and climate. In the event that the contractor is not fully aware of all climate protection needed and therefore fail to provide certain features in the base bid, the contractor will be responsible to provide at no additional cost to the Government.

Weather Resistance: The Mobile SPU contractor must provide Wind Zone 2 compliant overhead strapping capabilities due to the location of the facility.

Water Management and Testing: The Mobile SPU contractor must provide a supplement to the WACH Water Management Plan (WMP) in accordance with ASHRAE 188 and AAMI ST108 requirements.

The WMP must be provided to the Government for review and comment. Finalization of the WMP must be completed before Mobile SPU operations can begin.

The Mobile SPU contractor will provide water testing services monthly reporting during the performance period to demonstrate compliance with their requirements with regards to ionic contamination, and AAMI ST108 Table 2 bacteria and endotoxin requirements. Reporting of these contaminants will be used to demonstrate to the Government that proper water management procedures are being performed by mobile trailer operators. The mobile trailer contractor will be required to maintain ionic to their own specifications, and bacteria and endotoxin levels at or below the AAMI ST108 Table 2 requirements. In the event these levels are exceeded, the Government must be notified, and mobile trailer operations must cease immediately. The contractor will be responsible for defining and performing all corrective actions necessary to re-establish compliance with ionic, bacteria and endotoxin levels. Water quality limits, testing and reporting schedules, mitigating procedures, and corrective actions must be codified in the WMP. Prior to processing of instrumentation testing must be completed and result within the acceptable parameters. For continual monitoring, the following measurements need to be tested: pH, total alkalinity, conductivity, bacteria, total hardness, endotoxin, and color/turbidity. Color and turbidity will be done daily at the point of use by the sterile processing department for the utility water, critical water, and steam. All other testing would need to be done by the Mobile SPU contractor on the following schedule:

Utility water requires quarterly testing, and the critical water requires monthly testing from both the point of use and the water generation system. The steam requires testing quarterly only from the point of use.

Fire Alarm and Sprinkler System: The Mobile SPD Unit must come complete with a built-in wet-pipe fire sprinkler system.

Physical Security: The Mobile SPD Unit must come with the following physical security features:

- Intrusion alarm system (IAS) or locking mechanism on exterior doors.

- Security alarm dry contacts.

Telephone and data: Conduit for cables and trailer connectors

Plumbing/Water Treatment:

The Government will provide a single hot and cold-water utility hookup for the SPU Trailer only. The water quality provided is slightly outside of Utility water requirements as codified in AAMI ST108.

The Government will provide the following structural, mechanical, electrical and plumbing needs:

Water Connections:

a. Utility Cold Water:

1. Fabricate from Domestic Cold Water [DCW] spool piece located in B-302 Mechanical Room 1B20 through the Mechanical Room CMU wall to the MSPS Utility Cold Water connection located in the roadside belly box

2. Provide (1) each 1 1/2 inch FNPT feed connection and backflow preventer

3. Provide 40 GPM 75F Max, 60-80 psig (dynamic)

4. Note: DCW connection made in roadside belly box.

5. NOTE: Cold Water: The existing DCW main located in the adjacent mechanical room of Building 302 is wet tapped to serve all of the water for the temporary site. The tap must be provided with a shutoff valve, backflow prevention device, and a pressure gauge. Type L hard drawn copper tubing is utilized for the runouts to the temporary units. Water runouts are insulated with a minimum of 1-inch-thick preformed closed cell, flexible, unicellular pipe insulation and provided with heat tape to prevent water freezing.

6. NOTE: Water Softener: After exiting the existing mechanical room, the DCW branches off to serve the administration units. The remaining DCW enters a water softener that reduces the hardness of the water to <1 gpg. This water softening system must be located inside the existing mechanical room.

b. Utility Hot Water:

1. Fabricate from Domestic Hot Water [DHW] spool piece located in B-302 Mechanical Room 1B20 through the Mechanical Room CMU wall to the MSPS Utility Hot Wate connection located in the roadside belly box.

2. Provide (1) each FNPT feed connection and backflow preventer

3. Provide 20 GPM @ 120-140F, 50-60 psi (dynamic)

4. Ensure DHW connection made in roadside belly box Hot Water: The existing DHW main located in the adjacent mechanical room of Building 302 is wet tapped to serve all of the water for the temporary site. The tap must be provided with a shutoff valve, backflow prevention device, and a pressure gauge.

Type L hard drawn copper tubing must be utilized for the runouts to the temporary units. Water runouts must be insulated with a minimum of one-inch-thick preformed closed cell, flexible, unicellular pipe insulation and provided with heat tape to prevent water freezing. The domestic hot water must be served by an expansion tank and must enter two electric water heaters that raises the temperature to 140 F (as required by the Mobile Sterilization Unit). The hot water must be supplied with a circulation loop and pump so that water temperature at the Mobile Sterilization Unit is always 140 F. This hot water circulation pump must be provided with heat tape to prevent water freezing. These electric water heaters and the circulation pump must be located outside, adjacent to the hospital, and underneath the existing overhang.

a. Booster Pump System:

1. Provide a booster pump system. It must increase pressure in the water exiting the water softener so that the pressure requirements of the MSPS (40-60 psi) are met.

2. This booster pump system must be located inside the existing mechanical room 1B20

b. Fire Suppression System

1. Fabricate from Fire Suppression Water pipe a new spool piece to supply

2. Provide (1) each 2-inch Victaulic Coupling

3. Provide 321.5 GPM @ 61 psi dynamic @ base of riser from 3-inch main line 900 GPM [75 psi minimum static, 60 psi dynamic) assumed in hydraulic calculation

4. NOTE: Fire Water connection is located at curbside rear of MSPS

5. Fire Water: Fire water supply will be provided from existing fire water piping located in the first-floor mechanical room in Building 302. Fire water piping will be 4-inch diameter ductile iron pipe, installed on rubber pipe supports. Insulation and heat tape will be provided on piping.

c. Waste-water Connections:

1. Provide (1) each 4-inch PVC Fernco or equivalent connection to site 6-inch outdoor Sanitary Sewer connection

2. Waste: Sanitary piping must be run underground from the connection points on the mobile units and floor sinks

3. associated with the water softener and water heaters to the existing Sanitary main on site.

4. NOTE: External drain piping from MSPS connection effluent is located in the MSPS roadside belly box

d. Water Management and Testing:

1. The government will conduct monthly testing services and monthly reporting during the performance period to demonstrate compliance with ionic contamination, and AAMI ST108 Table 2 bacteria and endotoxin requirements. In the event these levels are exceeded, the Government must notify the contractor immediately, and mobile trailer operations must cease immediately.

e. Electricity Connections:

1. Normal underground power will be served from the second-floor hospital service panelboard 302-DN4-B-2B01 to the MSPS

2. Transition Facility in new, underground PVC conduit. Exact location of the circuits will be coordinated with the hospital as they will only be used temporarily. Feed the MSPS from Panelboard 302-DN4-B-2B01 located in the B-302 Mechanical Room 2B01

3. Verify suitable conductor for (2) each 480 VAC , 60Hz, 3ph, 250A circuits

i. NOTE: (2) each 35 ft 250A feed cables are included by the Original Equipment Manufacturer [OEM]

ii. Provide Meltric DR250 or equivalent connectors on MSPS side; pigtail connected to fused disconnect on Hospital side.

iii. NOTE: power connections are made at front of MSPS

iv. Provide Maximum Overcurrent Protection of 500 Amperes total

v. Provide circuit breaker testing for existing Panelboard 302-DN4-B-2B01 two each Cutler-Hammer KD3400F [molded case circuit breaker frame from Eaton's Series C product line]

vi. Provide 4 wire [L1, L2, L3, G] 6 aug conductors copper or equivalent

vii. Provide grounding by single point female bayonet type connection.

viii. NOTE: (1) each 20ft ground cable provided by OEM

ix. NOTE: (2) each grounding clamps provided by OEM

x. Provide (1) each 480 VAC, 60Hz, 3ph, 40A circuit

xi. Verify existing conduit integrity in accordance with the applicable NFPA code

f. Site Requirements (Size & Support) provide:

1. Site Size: provide:

i. 2600 ft2 clear & level (asphalt or concrete) adjacent to the host facility connection / access.

ii. NOTE: discern whether existing footing and metal mesh mat is sufficient

2. Site Slope Requirement:

i. Level not to exceed 4in. drop in 40ft. and no greater than 1in. drop in 8ft.

3. Ground Weight Support Requirement

i. Footings / weight distribution material to support leveling & landing gear (45000 lb./ft)

4. Ground Anchors (If Necessary)

i. Wind Anchoring - (10) 5000 lb. tensile capacity tie down anchor points corresponding to the tie down rings on the MSPS(TM)-0215

ii. Ground anchors should be placed 45-60 from vertical of the unit anchor point for rated capacity

iii. Hurricane & Seismic Anchoring - (12) 9,400 lb. horizontal component capacity ground tie down anchor points corresponding to the chassis tie downs on the MSPS

g. Sidewalk Extension

1. Provide paved sidewalk extension from SPD to mobile SPU Trailer for transportation of cart-to-cart lifter.

Water Effluent

The SPU Trailer contractor will be responsible for testing the water effluent the Government-provided connection for water quality, flow, and pressure and provide the required features to make the SPU Trailer usable. The SPU Trailer must provide the necessary water treatment, heating, and pressure and flow corrections (as applicable) downstream of the Government connection to ensure proper performance of the SPU Trailer.

The SPU Trailer contractor must connect all waste/drainage to the nearest wastewater outlet, to be identified by the Government.

Integrated Medical Equipment:

The Mobile SPU Trailer must supply and maintain (preventive maintenance and repairs) the following equipment, at a minimum, to support WACH SPD throughput:

- 3 Bay Decontamination Sink

- Washer/Disinfection Units

- Ultrasonic Cleaner with DaVinci Xi (brand name or equivalent) capabilities

- Pass Thru Window

- Four Prep and Pack Tables

- Sterilizers with On-Board Steam Generators

Heating and cooling system: The SPU Trailer must be equipped with heating, ventilation, and air conditioning (HVAC) able to maintain proper temperature and humidity levels, regardless of seasonal changes, suitable for the entirety of the sterile processing function.

Education: Provide education and support for facility staff on use of trailer/equipment

2.3 Deliverables

Requirement Date Format

Post-award site visit (in person), The contractor shall propose a specific site visit date within 5 days of contract award. See Para. 2.31

5 days post award

Note: Contractor's personnel shall arrange to travel to installation for on-site preparation coordination within twenty (20) days calendar days' notice from date of award or communication from Contracting Officer Representative (COR).

Written Via Email to COR &

KO

Program Manager by name, phone (during and after hours, and email.)

See para 8

10 days post-award Written Via Email to COR &

KO

Provide checklist of specifications and a plan for site preparation requirements, to include floorplan, schematics, technical information, and cleaning instructions. See Para 2.3.1

5 Days after site-visit Written Via Email to COR &

KO

Fully operational and commissioned mobile SPD Unit

100% capability of all equipment and systems. No later than (NLT) 30 days after delivery or KO Notice to proceed (NTP).

Written Via Email to COR &

KO

Response time for routine and emergency repairs

Within 24-hours of reporting incident

Written Via Email to COR &

KO

Schedule for routine preventative maintenance

NLT 24 Hours before start of performance

Written Via Email to COR &

KO

Delivery and set-up (*KTR will require a small forklift/tractor to place the trailer). KTR is responsible for connecting all utilities and anchoring during commissioning

Upon KO Direction Physical Delivery and commissioning.

Removal and pick-up KTR is responsible for disconnecting all utilities and anchoring during decommissioning.

NLT the day after the POP ends or at the direction of the KO.

Physical removal and decommissioning.

2.3.1. The selected contractor will complete a post-award in person site visit and provide a checklist and plan to document all construction required for site preparation specific to their mobile unit specifications and Winn ACH's facility specifications. The plan will detail the necessary site development, utility connections, ancillary needs (i.e. parking, covered access to the building to comply w/ ADA standards, exterior lighting, infection control, safety, etc.) along with scheduling and construction necessary to support the placement of the temporary mobile SPD unit sufficient to meet the requirement of and ensure the continuous, reliable operations during the entire period of this contract. The contractor shall provide the specifications required for a temporary covered awning between the mobile SPD and the nearest appropriate Hospital entrance. This area needs to be large enough to provide covered access for the movement to load and unload dirty and clean carts, specifications are required.

3. Government Provided Equipment and Responsibilities - The government will provide all necessary basic power plumbing/water utilities necessary for the function of the mobile SPD.

4. Performance Measurements Requirement Summary (PRS). The following performance objectives and measures will be used to evaluate Contractor performance and compliance under the contract. This information will be used to prepare annual past performance evaluations.

PERFORMANCE

MEASUREMENT

OBJECTIVE

PWS

Paragraph

STANDARD

ACCEPTABLE

QUALITY

LEVEL

METHOD OF

ASSESSMENT

Perform scheduled and remedial SPU maintenance as required

2.3

Perform all required maintenance to meet the uptime standard KTR stated times, a deliverable required in table 2.3 of this PWS

100% compliance Monitored by COR.

Fully operational and commissioned mobile SPD Unit

100% capability of all equipment and systems.

NLT 30 days post KO

NTP.

100% compliance. NLT 30 post KO NTP

Inspection and validated by the

COR, Winn Facilities, Safety, and the SPD Department.

Maintain sterilization equipment

Keep all systems in compliance and operational to meet uptime standard

100% Compliance Monitored by COR

Service call response time

2.3

Be on site at WINN ACH within stated times of being notified as provided in Deliverable noted in Para. 2.3 of this PWS

100% Compliance COR maintain Log

Provide technical guidance

2.1 Education

and 18.4

Provie up to two weeks of technical orientation to the SPU

100% compliance COR maintain Log

Ensure 95% uptime guarantee is met

1.4.2 Maintain equipment to provide uninterrupted service.

Uptime of at least 95% for the performance

COR Maintain Log

Submit invoices to PIEE. (Supplement to the PWS)

252.232-7006 Wide Area Workflow Payment

Instructions

Invoices shall be submitted IAW Clause 252.232-7006

98% compliance Periodic Inspection /COR surveillance

Deliverables 2.3

Deliverables are received with in the timelines established in this PWS.

95% compliance Monitored by COR

100% inspection

5. The inspection and acceptance point for all services rendered under this contract will be by the SPD Department Chief (DC) and the Winn Facility Manager, where clinical services are performed no later than 30 days post the Contracting Officer's (KOs) notice to proceed (Paragraph 2.3). The performance by the contractor, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the Contracting Officer Representative (COR) or designated representative. Any services rendered by the contractor to patients or interaction with military/civilian personnel deemed unprofessional/ threatening /dangerous by the DC will be considered as grounds for immediate removal of the contractor and termination under clause 52.212-4(m) Termination for Cause. Other performance evaluation factors will be monitored that are not quantified by numerical measurements, which include: Contractor relationship with hospital staff/government contracting personnel; compliance with Federal, State and local laws;

compliance with Winn policy and procedures. Services provided by the contractor shall be reviewed and rated in accordance with the MTF by-laws and JC standards. A poor rating shall be grounds for immediate termination of the contract.

6. Neither military nor government civilian employees shall be used as a consultant or employee in matters related to this contract.

7. The contractor shall not accept any instructions issued by any person other than the Contracting Officer, or the COR acting within the limits of their authority.

8. PERSONNEL

8.1. Program Manager: The Contractor will provide, in writing, the name and phone number of a Program Manager within (10) ten calendar days of the award of the contract. The Program Manager will be a qualified and experienced manager to oversee the personnel assigned to perform the delivery and commissioning of the mobile sterilization trailer and maintenance services. The contractor's Program Manager will correspond with the Contracting Officer's Representative on a regular basis to discuss any problems that the contractor or contractor's personnel may be experiencing during the performance of this contract. Unresolved problems will be referred to the contracting officer for resolution.

8.2. Contractor Service Personnel (CSP): CSP will be English speaking and required to show documentation of Original Manufacturer Certification Training (OEM). All Subcontractors performing work for primary contractor will meet all specifications and standards that apply to CSP under this agreement. CSP will maintain clean and neat appearance and will wear an identification badge at all times when performing services at the Government site. Identification badges will be worn in a clearly visible area of the outer garment. The COR will furnish this badge.

8.3. Safety. The Contractor shall ensure that it complies with all installation safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal. Copies of these regulations are on file in the medical activity safety office or may be obtained through the COR.

9. SECURITY

9.1. The contractor shall ensure that all employees comply with the local installation requirements for vehicle registration and operation on the military facility. Any vehicle operated by the contractor or its employees in performance of this contract must have the minimum liability coverage required by the state in which the performance is located.

9.2. The contractor shall ensure that its employees comply with installation and MTF personnel identification and access requirements.

9.3. The contractor shall be responsible for any keys issued by the Government to employees for use in the MTF. The keys shall not be duplicated. The Contractor shall be financially responsible for the replacement of any lost or duplicated keys and any associated locks. Lost or duplicated keys and/or locks shall be reported to the issuing party, DC or COR immediately upon recognition of the loss or duplication. No unauthorized personnel shall be allowed entry into locked areas. The Contractor shall ensure that its employees secure or lock all areas for which they possess a key when they are not using the area and at the close of the work period.

9.4. Safeguarding Material. The contractor shall be responsible for safeguarding all government property provided for contractor use. The contractor shall safeguard information of a confidential or sensitive nature. Neither the contractor nor any of its employees shall disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the likelihood of the possibility of breach of security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974. However, the contractor may be required to provide testimony or deposition in lawsuits or other administrative, civil, or criminal proceedings.

9.5. The government will not be responsible in any way for damage to the contractor's supplies, materials, equipment and property or to contractor's personnel personal belongings that are damaged or destroyed by fire, theft, accident or other disaster.

9.6. Contractor personnel or any representative of the contractor entering Ft. Stewart shall abide by all security regulations and shall be subject to security checks. When entering post, contractor personnel must have vehicle registration, driver's license and proof of insurance.

9.7. Antiterrorism/Operations Security (ATOPSEC) Requirements.

9.7.1 Antiterrorism (AT) Level I Training. This provision is for Contractor Health Care Workers (HCWs) with an area of performance within an Army controlled installation, facility or area. All Contractor HCWs, to include subcontractor HCWs, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after start date. The Contractor shall submit certificates of completion for each affected Contractor HCW and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 7 calendar days after completion of training by all HCWs and subcontractor personnel. AT Level I awareness training is available at the following website: https://jkodirect.jten.mil/Atlas2/page/desktop/DesktopHome.jsf

9.7.2. Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area.

Contractor and all associated sub-contractors' employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply

W91YTZ25QA1200001

https://jkodirect.jten.mil/Atlas2/page/desktop/DesktopHome.jsf

(FARwith all personal identity verification requirements clause 52.204-9, Personal Identity Verification torof Contrac Personnel) as directed by DOD, DHA, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

9.7.2.b. For contractors that do not require CAC but require access to a DoD facility or installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

9.7.4. For contracts that require OPSEC Training. Per AR 530-1, (Operations Security) contractor employees must complete Level I OPSEC Training within 30 calendar days of contract award. Proposed language: "All new contractor employees will complete Level I OPSEC Training within 30 calendar days of their reporting for duty. Additionally, all contractor employees must complete annual OPSEC awareness training. The contractor shall submit certificates of completion for each affected contractor and subcontractor employee, to the COR or to the contracting officer (if a COR is not assigned), within 5 calendar days after completion of training. OPSEC awareness training is available at the following websites: https://www.iad.gov/ioss/ or http://www.cdse.edu/catalog/operations-security.html; or it can be provided by the RA OPSEC Officer in presentation form which will be documented via memorandum."

9.8. Data Breach Response and Notification.

9.8.1. The Contractor shall adhere to the reporting and response requirements for PII set forth in Memorandum, Office of the Secretary of Defense, Subject: Safeguarding Against and Responding to the Breach of Personally Identifiable Information (PII), June 5, 2009, ALARACT 050/2009, DoD 5400.11- R, and any amendments.

9.8.2. The contractor or its subcontractor shall immediately notify the COR and the Privacy officer at Winn ACH (571-801-6225) upon discovery that a suspected or actual breach of PII has occurred. The notification shall include, to the greatest extent possible, the identification of each individual who's PII has been or possibly has been breached. In addition, the contractor or its subcontractor shall provide notify the HIPAA officer at Winn ACH with any other available information that must be included in required breach reporting and notifications. The contractor shall provide this information at the time of the initial notification to the Government or promptly thereafter as information becomes available.

9.8.3. The Government will determine whether a breach of PII has occurred, and whether breach notification to affected individuals is required. If breach notification to affected individuals is required, the Government will determine if the contractor shall make the required notification. If the contractor is to notify the impacted population, it shall submit the notification letters notify the Privacy officer at Winn ACH (571-801-6225) for review and approval.

9.9. Contracting Officer's Representative (COR). The KO will designate and authorize an individual to act as the COR at time of award. Any such representative appointed will be specifically designated by letter from the KO. The COR exclusively represents the KO in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the KO. All observations made by persons other than the KO or the COR are strictly advisory and shall not influence the Contractor's operations except for administrative requirements and responsibilities specified herein. The KO will provide a copy of this designation and COR contact information to the Contractor upon contract award.

9.10. Billing. The government will only pay for full uninterrupted days of services provided. The contractor shall only submit payment requests each month for the number of days of uninterrupted service actually provided that month. Submitting a payment request for more than the amount due may constitute fraud or a false claim and may result in administrative or criminal action or both.

10. HOURS OF PERFORMANCE

10.1. Upon completion of delivery, trailer commissioning, and performance verification by contractor, the SPU unit shall remain at Winn ACH for the entire duration of this contract. Normal hours of operation are 6:30 a.m. to 11:00 p.m. The SPU shall be capable of being operated 24-hours a day, 7 days a week for after-hours processing as needed.

10.2. The contractor shall maintain a 95% uptime rate for the duration of the period of performance.

Uptime calculation shall be calculated as follows: number of days of uninterrupted service (e.g. days when the SPU is operational 24 hours without an equipment failure or downtime for maintenance) divided by number of days on the contract. Example: 54 days of uninterrupted service/60 days on the contract = 90% uptime rate). The contractor shall not charge for, nor shall the government pay for any day where an interruption occurs regardless of the length of time to correct the interruption. Scheduled routine preventive maintenance and calibrations shall not be considered downtime. Also, minor failures with ancillary components which do not affect system availability shall not be considered in determining downtime.

10.2.1. Service Completion Date: The date and hour the COR accepts the work as completed and signs the Contractor's service report.

11. PUBLIC INTERFACE

11.1. Inquiries. Contractor shall ensure that its personnel do not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the COR, who will relay them to the MTF Commander. There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the Government supervisor.

11.2. Complaints. Complaints will be validated by the COR and be reported in writing to the KO and to the contractor for action, if it constitutes a failure to perform, as determined by the government. The contractor shall have no more than two substantiated complaints during the period of performance. Any patient complaints received on services provided by the contractor will be taken very seriously at the MTF and as such will be considered a part of the inspection process. The DC will submit documentation to the COR regarding all patient and/or clinical complaints. Receipt of two valid complaints during the period of performance may be considered grounds for immediate termination.

12. CONFLICTS OF INTEREST

12.1. Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel and /or technical data which are furnished, produced or otherwise available to the contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract. The contractor shall not release any of the above information without prior written consent of the Contracting Officer and shall ensure that its employees do not do so.

13. (Reserved)

14. QUALITY MANAGEMENT

14.1. Quality Control Plan (QC): The contractor is required to follow the current QC program in place at the MTF to ensure that the medical services are provided at a level of quality that meets MTF standards.

14.2. Quality Assessment and Improvement (QA&I). The Government will monitor the Contractor's performance under this contract using the QA&I procedures established by the medical activity and pursuant to the Contract Terms and Conditions - Commercial Items clause, paragraph entitled Inspection /Acceptance. Additionally, the Contractor's performance is subject to scheduled and unscheduled review by the QA&I Committee as defined by the medical activity Quality Assurance (QA) Plan and AR 4068.

15. CONTRACTOR REPRESENTATION

15.1. The Contractor shall designate a representative for this contract. This representative may be employed under another contract/task order with the contractor at the same MTF. At least ten working days prior to performance start date, the contractor shall provide in writing to the COR the contractor's representative contact information. Changes in the contract representative, at any time after contract commencement, shall be in writing to the COR at least five working days prior to the change. If at any time there is only one employee working in the facility for the contractor, someone other than this employee must be designated as the company representative and this representative may be off-site.

15.2. The contractor's representative shall, at no additional cost, meet with the COR when requested by the COR to discuss any problems that the contractor's personnel may be experiencing during the performance of this contract. Problems experienced by the government with the contractor's performance will be discussed and resolved. Unresolved problems will be referred to the Contracting Officer for resolution.

15.3. The contractor shall provide points of contact (POC) information for administration of the contract during normal business hours and after normal business hours. The POC for other than normal business hours will be contacted only in the event of emergencies. Accordingly, the named individual(s) shall possess sufficient corporate authority to effectively deal with emergency situations and the telephone number provided shall be functioning at all times other than normal business hours. If there are different POCs for different conditions, such as weekdays, weekends, holidays, clearly provide such information.

16. DEFINITIONS/ACRONYMS

16.1. Contracting Officer (KO). A person with the authority to enter into, administer, and/or terminate contracts/task orders and make related determinations and findings.

16.2. Contracting Officer's Representative (COR). A Government employee selected and designated in writing by the KO to act as his/her designated representative in administering a contract. A COR has no authority to change or modify the terms of a contract.

16.5. Quality Assessment and Improvement. Those actions taken by the government to check services to determine if they meet the requirements of the Joint Commission and DHA quality assurance and risk management program and ensure that the Contractor and its employees comply with the terms and conditions of the contract.

16.6. Quality Control. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract.

16.7. Acronyms/Abbreviations. Following is a list of basic acronyms/abbreviations used in this contract.

CFR - Code of Federal Regulations

CLIN - Contract Line-Item Number

CPARS - Contractor Performance Assessment Reporting System

CSP - Contract Service Personnel

DA - Department of the Army

DC - Department Chief

DoD - Department of Defense

DODI - Department of Defense Instruction

EFT - Electronic Funds Transfer

ETS - Expiration Term of Service

FAR - Federal Acquisition Regulation

HCAA - Health Care Acquisition Activity

HHS - Health and Human Services

HIPAA - Health Insurance Portability & Accountability Act of 1996

IAW - In Accordance With

TJC - Joint Commission

MEDDAC - Medical Department Activity

MTF - Medical Treatment Facility

NACI - National Agency Check with Inquiries

NCOIC - Noncommissioned Officer in Charge

OEM - Original Equipment Manufacturer

OIC - Officer in Charge

OSHA - Occupational Safety and Health Administration or Act

Pam - Pamphlet

PAR - Performance Assessment Report

PL - Public Law

POC - Point of Contact

PWS - Performance Work Statement

QA - Quality Assurance

QA&I - Quality Assessment & Improvement

QC - Quality Control

RFP - Request for Proposal

SF - Standard Form

TO(s) - Task Order(s)

USC - United States Code

USPS - United States Postal Service

17. GOVERNMENT PROPERTY.

17.1. The contractor shall be responsible for government costs incurred for:

a) damage to government property caused by parking or removing the mobile SPU,

b) any damage to Winn ACH power system(s) caused by feedback/connectivity issues from the mobile

SPU,

c) any virus to Winn ACH computer systems that is transmitted from the mobile SPU when images are sent to local WIN ACH PACS

17.1.1. Government property and materials made available to the Contractor under the terms of this contract shall be for use only in the performance of this contract.

17.2. The contractor service personnel shall park in the appropriately designated parking areas as determined by the COR. The government will not invalidate or make reimbursement for parking violations of the contractor under this contract. Violations of the government's site regulations and policies may result in citation answerable in the United States (Federal) District Court, not a local, state or municipal court.

17.3. The government will furnish expendable supplies (i.e., parts, chemicals) consumed during normal procedural sequence and necessary for the completion of the required maintenance services. Expendable supplies will only be provided for work accomplished at the Government site.

17.4. The Government will provide the Contractor with all government forms and make available all government publications referenced in this contract when not normally available to the public or the Contractor.

17.5. The Contractor shall not be responsible for delays encountered due to the non-availability of Government furnished materials. The time allowed for the completion of remedial repairs will be extended to equal the amount of time delayed due to the Government caused delays.

17.6. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

17.7. The Government will operate the system in accordance with the instruction manual provided by the

OEM.

17.8. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor's personnel.

17.9. The Government shall provide water supply and electrical power for the mobile SPU at no cost to the contractor. The contractor shall hold the Government harmless to any damage caused to the mobile SPU when connecting or connected to the Winn ACH-provided water or power supply. The contractor shall ensure a complete match with the government provided power supply prior to connecting to the power source. Contractor shall take precautions to prevent/block/handle power surges.

18. CONTRACTOR-FURNISHED SUPPLIES/SERVICES

18.1. The Contractor shall provide transportation, a full body mobile SPU trailer, sterilization equipment, communications peripherals, and all maintenance (for the sterilization equipment and trailer) during the period of performance.

18.2. The Contractor shall provide all service literature, reference publications, and diagnostic software to be used by the contractor service technicians as required for the completion of the services in accordance with this contract.

18.3. The SPU trailer shall park at Winn ACH in a reserved area near the electrical power supply. The area is outside and exposed to all weather conditions. The parking area may change over time and the contractor shall relocate the trailer at no charge to a newly designated area within 48-hours of the time requested.

18.4. The contractor shall provide technical consultation on the capability of the SPU trailer to providers and staff at Winn ACH as needed. This can be for up to eight hours a day for two weeks. This shall include the type and protocols required to produce sterile instruments for the MTF.

18.5. The Contractor, personnel and mobile SPU shall abide by all the safety codes of Winn ACH. The contractor shall be responsible for discharge of materials from the trailer such as fuel for the generator, water, etc. and shall immediately clean up all materials. The contractor shall be held liable for any damage caused by such discharges and shall comply with Winn ACH's hazardous materials program.

18.6. Maintenance on sterilization equipment or the SPU trailer shall not be performed on Government property during normal time scheduled for Government use unless these systems are inoperable. The Contractor shall follow the maintenance schedule recommended by the manufacturer(s) of the mobile SPU trailer and equipment contained within and provide a copy of such to Winn ACH upon initiation of services.