Attachment 1_Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT

Mobile Sterile Processing Unit Trailer Services

BLANCHFIELD ARMY COMMUNITY HOSPITAL (BACH)

HEALTHCARE TECHNOLOGY MANAGEMENT BRANCH

FORT CAMPBELL, KY 42223-5349

1) DESCRIPTION

Blanchfield Army Community Hospital is seeking to lease a Mobile Sterile Processing Unit (SPU) Trailer.

The Government’s Sterile Processing Department (SPD) will be closed awaiting existing equipment replacement. The use of a Mobile SPU will allow the Government 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.

2) PERFORMANCE WORK STATEMENT

Mobile SPU Trailer:

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

• 3-Bay Decontamination Sink

• Washer/Disinfectors capable of processing a minimum 250 sets per day.

• Ultrasonic Cleaner with DaVinci Xi Robotics cleaning capabilities of at least 5 sets per load capacity

• At least (1) Low-temperature Sterilizer

• Pass-Thru Window

• Four Prep and Pack Tables

• Self-generating Bulk Steam Sterilizers capable of a minimum of processing of 250 sets per day.

• RO/DI Water System (for final/critical rinse on washers)

• Steam Generators for Sterilizers

• Hand wash sink with eye wash

• Necessary water treatment systems for Washer/Disinfectors and Sterilizers IAW Manufacturers Technical Specifications

• Sterile room HVAC system

• Decontamination room

• Emergency Exit stairs and platform

Power:

The contractor shall be responsible for providing a Mobile SPU that includes:

• Electrical Service: 480VAC, 3-phase, (2) 250 AMP

• Configuration: 4-wire (L1, L2, L3, G)

• Frequency: 60hz

• Shoreline Cable: (2) cables will be provided; facility end hard wired 100’ if possible.

• Disconnects must be within 50’ of the front/nose of the unit Request this be 100’ if possible.

• Earth ground provided; installation per NEC Article 250

• (1) single point female bayonet type located directly under the roadside power connection

• (1) 20’ ground cable with (2) clamps

The Government will provide:

Electrical Service: 480 Volt AC 3 Phase 800 Amp

Service disconnection and termination of shoreline and ground cables to facility electrical MDP

Manhole for sanitary sewer

1 ¼ inch Domestic Water connection from 10” water main.

Power for cold weather package

Power for piping heat tape

Emergency power

Appropriate cable covers and fencing

Cold Weather Package:

The contractor will provide:

Cold weather package.

Hot Weather Package:

Hot weather package

Plumbing:

4-inch wastewater connection

Functional validation of all sinks

1 ¼ inch domestic connection (#5 Roadside Belly Box)

Industrial Hot Water Heaters capable of supplying necessary demand to Washers, Sterilizers, Steam Generators, and sinks

All steam and domestic water connections from any MSGU or MWT units to the SPU Trailer and Equipment

• External lines must be facility protected

• Minimum 60 psi dynamic at SPD

The Government will provide:

Potable domestic cold water from 10” water main

Insulation and heat tape to external pipe from domestic water connection to Mobile SPU Trailer Connection

Dedicated circuit for pipe heat tape

Termination of heat tape to facility panel

External sanitary piping from the Mobile SPU Trailer to the sanitary sewer Manhole

Containment space for external water systems (i.e.: water heaters, RODI unit, water softeners, etc.)

Water Testing:

The contractor will provide water testing services and a monthly report showing compliance with AAMI guidelines and standard TIR34.

Fire Alarm and Sprinkler System:

Conventional analog fire alarm system with local audible visual, horn-strobe alarm devices for occupant warning.

Physical Security:

The contractor will supply:

Intrusion alarm system (IAS) or locking mechanism on Mobile SPU Trailer exterior doors

Exterior audible alarm at the trailer if equipped with IAS.

Security alarm dry contacts

Termination wiring from Mobile SPU Trailer intrusion alarm dry contacts to facility

Telephone and data:

• two unmanaged IT switches:

• 1 switch dedicated to trailer equipment

• 1 switch dedicated to Customer equipment

• At least 20 network ports for computers, printers, and VOIP phones

The Government will provide:

Managed switches

Termination wiring from termination block

Termination wiring from Mobile SPU Trailer data router to facility

Functional validation of communications

Integrated Medical Equipment:

The contractor will supply and maintain (preventive maintenance and repairs):

• 3 Bay Decontamination Sink

• Washer/Disinfection Units

• Low-temperature Sterilizer

• Ultrasonic Cleaner with DaVinci Xi capabilities

• Pass Thru Window

• Four Prep and Pack Tables

• Sterilizers and steam generators

• RO/DI Water System or other water treatment systems included in the trailer which are necessary to Sterilizer and Washer function

Heating and cooling system:

Nominal ¾” pipe(s) at front and rear of unit

Connection and routing of ¾” condensate drains

Unit Anchoring:

8) at 5,000 lb. tensile capacity (2 each per corner). (For wind rating. If in Seismic zone it is 10,000 LB.

tensile capacity).

Strapping and hardware attaching each trailer tie down ring to its corresponding ground anchor point

The Government will provide:

Anchor points or cement Eco-Barriers to be located on the ground at 30-45 degrees from the unit tiedown points

Education:

Provide education and support for Government staff on use of trailer/equipment.

3. ADDITIONAL INFORMATION

Please provide:

Response times for routine and emergency repairs for trailer and associated equipment.

Capabilities of your system that are not listed above.

Floorplans, schematics and technical information

Regular and preventative maintenance schedule and requirements

Point of contact for service and typical response times

Cleaning instructions

Delivery and set-up as specified above

Removal and pick-up at the end of the lease

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. See Enclosure 1, Quality Assurance Surveillance Plan (QASP), for additional details.

PERFORMANCE

MEASUREMENT

OBJECTIVE

STANDARD

ACCEPTABLE

QUALITY LEVEL

METHOD OF

ASSESSMENT

Maintain sterilization equipment

Keep all systems in compliance and operational to meet uptime standard

100% compliance Monitored by COR.

Perform scheduled and remedial SPU maintenance as required

Perform all required maintenance to meet the uptime standard

100% compliance Monitored by COR.

Meet mobile SPU system requirements

Meet all criteria listed

100% compliance COR maintain log

Service call response time

Be on site at BACH within stated times of being notified

100% compliance COR maintain log

Ensure 95% uptime guarantee is met

Maintain equipment to provide uninterrupted service.

Fill rate of at least 95% for the performance period.

COR Maintain Log

Contractor Manpower Reporting

(CMR)

Complete Contractor Manpower Report.

Notify COR by the 5th working day due date whether or not completed.

Review CMR records to ensure was completed. Contract

Specialist and COR Monitors.

5. The inspection and acceptance point for all services rendered under this contract will be by the Department Chief (DC) where clinical services are performed. 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 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 BACH 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. Campbell 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 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.

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

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 with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor 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.a. For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

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.

9.7.3. iWatch Training: The contractor and all associated sub-contractors shall brief all employees on the local iWATCH Army program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

http://www.knox.army.mil/partners/902d/Default.aspx.

9.7.4. For contracts that require OPSEC Training. Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

9.7.5. For information assurance (IA)/information technology (IT) training. All contractor employees and associated sub-contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working in IA/IT functions must http://www.knox.army.mil/partners/902d/Default.aspx comply with DoD and Army training requirements in DoD 8570.01, DoD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions.

9.7.6. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by an agent or other trainer specified by 2-4b of AR381-12. Contractor employees must complete TARP Training within 30 calendar days of contract award. New contract employees will complete training within 30 calendar days of their reporting for duty.

9.7.7. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by an agent or other trainer specified by 2-4b of AR381-12. Contractor employees must complete TARP Training within 30 calendar days of contract award. New contract employees will complete training within 30 calendar days of their reporting for duty.

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 HIPAA officer at BACH (270-956-0204) 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 BACH 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 HIPAA officer at BACH (270-956-0204) 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 BACH 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 HCP’s 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. Patients may also be a source of legitimate complaints that constitute a failure to perform. 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. The Contractor shall not use patient care rendered pursuant to this contract as part of a study, research project or publication and shall ensure that its employees do not do so.

13. RESPONSIBILITIES AND PROCEDURES

13.1. If any suit or action is filed or any claim is made against the contractor which occurred as a result of work performed by the contractor under this contract, the contractor shall immediately notify the Contractor, the KO and the DC of the appropriate services and promptly furnish them copies of all pertinent documents received.

13.2. The Contractor shall cooperate with the Government without further compensation, in the processing, review, settlement or defense of the suit, action or claim and authorize Government representatives to settle or defend the claim and to represent the contractor in or take charge of any litigation involved in such an action.

The contractor may at the contractor’s own expense, participate in defense of such claim or litigation.

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 40-68.

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.

16.3. Military Time is on a 24-hour clock, e.g.:

8:00 a.m. 0800 9:10 a.m. 0910 Noon 1200 8:00 p.m. 2000 9:10 p.m. 2110 Midnight 2400 12:01 a.m. 0001

16.4. Military Dates are written by placing the day of the month, followed by the first three letters of the month, followed by the last two digits of the year, e.g.:

January 2, 2015 - 2 Jan 15 January 10, 2015 - 10 Jan 15

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 BACH power system(s) caused by feedback/connectivity issues from the mobile SPU,

d) any virus to BACH computer systems that is transmitted from the mobile SPU when images are sent to local BACH 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 BACH-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 BACH 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 BACH 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 BACH. 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 BACH’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 BACH upon initiation of services. The Contractor’s maintenance logs shall be kept in the SPU trailer and made available for inspection at the Government’s request. The entire mobile system to include the trailer, utilities, and sterilization equipment shall have an up-time guarantee of 95%.

18.7. Mandatory upgrades to the mobile SPU, sub-systems, or equipment, as mandated by the manufacturer, shall be made at the expense of the Contractor and such costs shall not be passed on to the Government. Optional upgrades offered by the manufacturer may be added by the Contractor at any time but without an increase in the contract price. The Contractor shall not be reimbursed for optional upgrades unless the optional equipment was requested by BACH and included in this contract via modification to reflect the new equipment/capabilities.

18.8. Safety. The Contractor shall comply with all installation safety and fire prevention regulations.

Copies of these regulations are on file in the medical activity safety office or with the COR. The contractor and contractor personnel shall be cognizant of and observe all requirements for handling and storing combustible supplies and materials, and daily disposal of combustible waste, trash, etc.

18.9. Quality Control/Assurance. The contractor is required to follow current Quality Control/Assurance Plans in place at the medical facility in the performance of this contract.

18.10. Vehicle operation: CSP operating motor vehicles on federal property will possess an operator's license for the category of vehicle being operated and auto insurance as required by regulations/laws governing said Federal property. CSP will 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 any condition.

19. Contractor Responsibility.

19.1. The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control.

19.2. The Contractor shall be responsible for any damages to Government owned equipment and property and shall replace or repair any property damaged due to a fault of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and approved by the

KO.

19.3. The Contractor shall ensure all areas where equipment is serviced on-site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon Contractor departure from the work site. Equipment being repaired shall be safely secured at all times.

19.4. The Contractor is not responsible for service required due to Government misuse or abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor has four hours to make this determination and submit it to the COR for resolution.

20. Scheduled Services.

20.1. The Contractor shall, at a minimum, perform all scheduled services as prescribed by the OEM using a detailed services checklist. The completed checklist will be provided to the Government with the Contractor's service report.

20.2 The Contractor shall confirm scheduled service dates with the COR at least five working days prior to performing scheduled services.

20.3. Documentation of Services: Contractor's representative, upon completion of any calibration, will affix and/or update Medical Equipment Verification/Certification Label DD Form 2163. Forms will be provided by the Medical Maintenance Branch upon request. Upon completion of services, a written service report shall be provided to the COR or the On-Call Technician. The service report shall provide detailed information regarding the service provided, the cause of equipment malfunctions and corrective action taken to include the time required to complete the work, price of labor (hourly rate) and a list of parts replaced with a price for each part. In the event all information is not available to the contractor’s representative when the services are performed, the initial service report shall include all information stated above except price. The Contractor shall provide the balance of the required information in writing to the COR, Healthcare Technology Management Branch, Bldg. 650 Joel Dr., BACH, FTCKY, 42223- 5349, within five business days.

21. Service beyond the Scope of the Contract.

21.1. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the COR (in writing) of the existence or the development of any defects in, or repair required to the equipment which the Contractor considers they are not responsible for under the terms of this contract.

21.2. At the same time of the notification, the Contractor shall furnish the COR with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract but shall be ordered under a separate purchase instrument.

22. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

22.1. Following is a list of basic publications applicable to this contract. Current issues of many DA publications and forms can be accessed at http://www.apd.army.mil . Publications and forms not on the internet can be obtained from the MTF.

22.1.1. The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

22.2. Publications.

http://www.apd.army.mil/

22.2.1. Mandatory.

10 USC 1089 - Defense of Certain Suits Arising Out of Medical Malpractice 10 USC 1091 - Personal Services Contracts PL 91596 - Occupational Safety and Health Act of 1970 PL 101647, Section 231 - Crime Control Act of 1990 PL 102190, Section 1094 - National Defense Authorization Act PL 104191k - Health Insurance Portability and Accountability Act of 1996 DoD Directive 5200.28 - Security Requirements for Automated Information Systems (AISs) DoD 5200.2R - Personnel Security Program DoD 6025.18R - Department of Defense Health Information Privacy Regulation DoD 8580.02R - DoD Health Information Security Regulation DoDI 1402.5

OTSG/MEDCOM Policy Memo 13-062, dated 12 November 2013

- Criminal History Background Checks on Individuals In Child Care Services Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP)

22.3. Standard Forms.

SF 85-P - Questionnaire for Public Trust Positions

22.3.3. Department of Defense.

DD 577 - Appointment/Termination Record – Authorized Signature DD 2163 - Medical Equipment Verification/Certification

22.3.4. Other Forms.

FD Form 258 - FBI US Department of Justice Fingerprint Card

23. ADDITIONAL INSTRUCTIONS.

23.3. ADP Security Requirements.

23.3.1. If a contractor employee requires access to and/or process information requiring protection under the Privacy Act of 1974, these positions are considered “ADP Sensitive” positions. Compliance with DoD Directive 5200.28, DoD 5200.2-R, AR 25-2, and AR 380-67 is mandatory for ADP Sensitive positions. Therefore, a National Agency Check with Inquiries (NACI) is required for each employee. The Contractor shall ensure that each employee fully adheres with the provisions of referenced publications by making an appointment (through the COR) with the appropriate security organization at the installation. The employee will be fingerprinted and required to complete the appropriate forms, usually a Standard Form 85-P, Questionnaire for Public Trust Positions. The Contractor is advised that a positive report for its employee is needed as a condition of employment under this contract. The Contractor shall ensure that its employee applies for the NACI within three workdays after start of performance.

23.3.2. Contractor employees may be required to sign a Computer User Agreement Acceptable Use Policy and complete End User Awareness Training prior to being given access to a government computer or the local network. Despite anything to the contrary in the Computer User Agreement Acceptable Use Policy, Government computers and other resources shall only be used for official Government business related to the performance of this contract.

23.4. Criminal History Background Check Requirement.

23.4.1. A Criminal History Background Check is MANDATORY for those personnel involved in the delivery of healthcare to children under the age of 18 on a frequent and regular basis and may be required for other healthcare providers in accordance with MTF policies. Such policies currently require a CHBC for anyone accessing Government information systems and networks.

23.4.2. The Government will conduct a criminal background check on the employee in accordance with the procedures set forth in PL 101-647, Section 231; PL 102-190, Section 1094; DoD Directive 5200.28, Enclosure 6, paragraph E.6.4.1.2; DoD Directive 5200.2-R; and DoDI 1402.5. The Contractor is responsible for ensuring background check submittals are initiated in accordance with the MTF procedures prior to providing services at the MTF, and that each of its employees is properly cleared and meets the requirements of the law. Background checks shall be based on fingerprints of individuals obtained by a law enforcement officer or MTF authorized security officer on a properly completed FD Form 258 (FBI US Department of Justice Fingerprint Card) together with SF 85P (Questionnaire for Public Trust Positions), and on inquiries conducted through the Federal Bureau of Investigation (FBI) and State Criminal History Repository check, and a local Installation Record Check if required. The procedures for completing the required background check are outlined in the Department of Defense Instruction (I) 1402.5, dated January 19, 1993; Subject: Criminal History Background Checks on Individuals In Child Care Services; Enclosure 6, paragraph E.6.4, Government Contract Employees. (DoDI 1402.5 is available on the Internet at: http://www.dtic.mil/whs/directives/ )

23.4.3. If the employee has a DoD affiliation such as living or working on an installation within the last 5 years, or is a family member of active-duty military, an Installation Record Check (IRC) shall be conducted by DoD Component personnel at the installation level. No IRC is required on individuals without DoD affiliation. Upon favorable completion of the IRC, an individual may be selected to provide services to a minor child under line-of-sight supervision (LOSS) until the required background checks are completed.

Line-of-sight supervision is defined at DODI 1402.5, Enclosure 5.

23.4.4. Personnel may be employed under the contract pending completion of the background checks provided the activity uses line-of-sight supervision while minor children are in the care of that individual.

The employee shall be within line-of-sight supervision of a staff person whose background check has been successfully completed or is in the presence of the child's parent or guardian.

http://www.dtic.mil/whs/directives/

23.4.5. All clearance requests shall be submitted in accordance with the applicable directives specific to the MTF. The name and address of the MTF security section representative or the COR shall be included in the request as the recipient of the results in accordance with MTF procedures. If neither position exists, the KO shall be designated to receive a copy of the results.

23.4.6. The employee has the right to obtain a copy of the background check report. The Contractor may obtain a copy of the background check report from the employee or from the Government with the written consent of the employee. The employee should contact the COR for a copy of the results. The employee, but not the Contractor, may challenge the accuracy and completeness of the information in the report by contacting the individual identified in the previous paragraph.

23.4.7. If an employee has previously received a background check, proof of the check shall be provided, or a new one obtained. A new investigation is required if a break in service to the Department of Defense results in a time lapse of more than 2 years. Re-verification shall be accomplished every five years.

24. BUSINESS ASSOCIATE AGREEMENT. This Business Associate Agreement (BAA) incorporates HIPAA/HITECH Act requirements under the HHS Final Omnibus Rule (78 FR 5566, published 25 Jan 2013), effective 7 Jul 2014.

INTRODUCTION.

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003 this document serves as a business associate agreement (BAA) between the signatory parties for purposes of the Health Insurance Portability and Accountability Act (HIPAA) and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C.3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean for intents of this contract, the US Government Contracting Officer Representative is Sue Mosier. The Healthcare Technology Management POC is Wanda Brookhyser.