Attachment_01_Performance_Work_Statement.pdf

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Mobile Sterile Processing Unit
Solicitation number
W91YTZ25RA008
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This is a Performance Work Statement (PWS) for a Mobile Sterile Processing Unit (SPU) at Blanchfield Army Community Hospital (BACH), Fort Campbell, KY. The contractor must provide transportation, installation, decommissioning, and all maintenance of a mobile SPU trailer with appropriate pass-through windows between separate/partitioned decontamination, sterilization, and sterile packing/storage areas.

The SPU must be fully functional within 2 weeks of award and maintain 95% uptime. Key requirements include integrated HVAC with HEPA filtration, emergency power capability, capability to generate steam and critical water treatment, and specific sterilization equipment including ultrasonic cleaners capable of processing DaVinci Xi instruments. The contractor must provide 30-day startup supplies of detergents and other materials, maintain service response times of 180 minutes, and complete repairs within 24 hours. The unit must operate from 6:30 AM to 6:30 PM normally but be capable of 24/7 operation. The contractor must comply with extensive security, privacy, and HIPAA requirements and provide required training for personnel. The SPU trailer must be no more than 3 years old at start of services and meet all National Electric Codes, International Plumbing Codes, and NFPA standards.

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PERFORMANCE BASED WORK STATEMENT

BLANCHFIELD ARMY COMMUNITY HOSPITAL (BACH)

HEALTHCARE TECHNOLOGY MANAGEMENT BRANCH

FORT CAMPBELL, KY 42223-5349

1. GENERAL

1.1. Description of Work. The Contractor shall provide transportation, installation, and decommissioning of a Mobile Sterile Processing Unit (herein referred to as “SPU”) with appropriate pass-through windows between separate/partitioned decontamination, sterilization, and sterile packing/storage areas and all maintenance (for Sterilization equipment in SPU and trailer) and upkeep necessary to perform non-personal professional sterilization services at Blanchfield Army Community Hospital (BACH), Fort Campbell, KY.

Minimum structural, utility, and Medical Sterilization trailer and equipment requirements shall provide:

- An on-site visit from Contractor to Blanchfield Army Community Hospital to determine capacity needs, validate space and utility requirements, and identify necessary site prep for installation and decommissioning of the Mobile SPU. Mobile SPU to be fully functional within 2 weeks of award date.

- Trailer shall meet current National Electric Codes (NEC), International Plumbing Codes (IPC), and National Fire Protection Agency (NFPA) standards for Life Safety. Trailer shall have emergency Ingress/Egress and Fire Suppression equipment contained in SPU.

- Integrated Heating, Ventilation, and Air Conditioning with appropriate HEPA filtration, humidity control, and air pressure relationships to meet ASHRAE standards for sterile processing

- Integrated power system with electrical cabling necessary for hookup to US Government-owned building main power. Mobile SPU shall have internal emergency power system capability.

- Necessary cabling, piping, and other such connections to connect local utilities (Water, Electrical, Telecommunications, etc.) to mobile trailer to sustain its daily operations.

- Mobile SPU capability of generating its own steam and critical water system treatment (softening, Reverse Osmosis/Deionization) for Sterilization Equipment IAW ANSI/AAMI ST108 and TIR34 standards.

- Method of instrument transport between the Mobile SPU and main BACH Operating Room.

- Sterilization Equipment required:

At least (1) ultrasonic cleaner with (5) sets per load capacity. If the Washer/Disinfectors are not capable of processing Intuitive DaVinci Xi instruments, the Ultrasonic Cleaner provided SHALL be capable of processing Intuitive Medical DaVinci Xi robotics instruments.

f. At least (1) 3-bay deep sink in decontamination area.

g. At least (1) separate hand washing sink.

h. At least (1) eye wash station.

i. Initial 30-day start-up supply of detergents necessary for the Washer/Disinfectors and Ultrasonic cleaner to sustain operations at set load processing capacities to allow BACH time to establish supply chain for replenishment of detergents. A detergent list shall be sent to BACH Infection Control Officer for review and approval with current MTF Cleaner/Chemical List prior to use on instrumentation.

j. Initial 30- day start-up of any other equipment specific supplies needed (i.e. chemical, biological, cleaning supplies), if required.

k. Copies of all Instructions for Use (IFUs) and Operator Manuals for Sterilizers, Washer/Disinfectors, and Ultrasonic Cleaner provided in the Mobile SPU Trailer.

If the contractor only indicates one price on the bid schedule, it will be construed as a price for monthly lease of SPU with aforementioned requirements under Para. 1.1. unless otherwise indicated. This contract may be used by other Government agencies.

This contract shall provide for maintenance services, which include routine preventative maintenance services and remedial repair. Maintenance shall include all systems, subsystems components, and assemblies, and sterilization equipment which were part of the original system leased. All subsequent maintenance provisions shall apply to hardware, firmware, and software as appropriate, unless otherwise stated.

1.1.1. Performance shall be according to the requirements contained in the Performance Work Statement (PWS), and in accordance with professional standards of The Joint Commission on Accreditation of Healthcare Organization (TJC) and Defense Health Agency (DHA).

1.1.2. This solicitation and any resulting contract will be a non-personal services contract, as defined in FAR 37.101, under which the Contractor is an independent Contractor. The Government may evaluate the quality of professional and administrative service provided, but retains no control over the medical, professional aspects of services rendered. The Contractor shall indemnify the Government for any liability producing act or omission by the Contractor, its employees and agents occurring during contract performance. The Contractor shall maintain medical liability insurance, in a coverage amount acceptable to the Contracting Officer, (minimum of $1 million per incident, $3 million aggregate). The Contractor shall ensure that its subcontractors have medical liability insurance in these amounts. Proof of insurance shall be submitted prior to beginning services.

1.1.3. Any resultant contract shall not establish an employer-employee relationship between DHA and the Contractor. The Government assumes no responsibility for negligent acts of the Contractor, its employees, or agents. Services rendered by the Contractor shall be rendered in the capacity of an independent contractor. The Contractor shall be solely liable for any liability producing act or omission and shall possess liability insurance, which covers medical care. A copy of the liability insurance shall be submitted to the Contracting Officer (KO) and BACH prior to beginning services. The Government assumes no responsibility for negligent acts of the Contractor.

1.1.5. 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 180 minutes of being called

100% compliance COR maintain log

Provide technical guidance

Provide up to two weeks of technical orientation to the SPU

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.

1.1.6. 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.

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

1.1.8. 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.

1.2. PERSONNEL

1.2.1. 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 installation of the mobile CT 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.

1.2.2. 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.

1.2.3. 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.

1.3. SECURITY

1.3.1. 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 shall have the minimum liability coverage required by the state in which the performance is located.

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

1.3.3. 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.

1.3.4. 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.

1.3.5. 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.

1.3.6. 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 shall have vehicle registration, driver’s license and proof of insurance.

1.3.7. Antiterrorism/Operations Security (ATOPSEC) Requirements.

1.3.7.1 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

1.3.7.2. 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 shall 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.

1.3.7.2.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.

1.3.7.2.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.

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

1.3.7.3. 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.

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

1.3.7.5. For information assurance (IA)/information technology (IT) training. All contractor employees and associated sub-contractor employees shall complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working in IA/IT functions shall 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.

1.3.7.6. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR381-12 Threat Awareness and Reporting Program (TARP), contractor employees shall receive annual TARP training by an agent or other trainer specified by 2-4b of AR381-12. Contractor employees shall 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.

1.3.7.7. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR381-12 Threat Awareness and Reporting Program (TARP), contractor employees shall receive annual TARP training by an agent or other trainer specified by 2-4b of AR381-12. Contractor employees shall 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.

1.3.8. Data Breach Response and Notification.

1.3.8.1. 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.

1.3.8.2. 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 shall 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.

1.3.8.3. 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.

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

1.3.9. 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.

1.3.10. 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.

1.4. HOURS OF PERFORMANCE

1.4.1. Upon completion of delivery, trailer set-up and connection of utilities, 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 6:30 p.m. The SPU shall be capable of being operated 24-hours a day, 7 days a week for after-hours processing as needed.

1.4.2. The Contractor shall maintain a 95% uptime rate 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.

1.4.1.1 Preventive Maintenance and Repairs: Those services routinely performed at OEM-set intervals to keep equipment systems performing within specifications. All repairs shall be made using OEM-approved parts to bring system back to fully functional status. All Preventive maintenance shall include, but need not be limited to, the following when applicable:

(1) Cleaning of equipment.

(2) Reviewing the operating system software diagnostics to ensure that the system is operating to the manufacturer’s specifications.

(3) Calibrating and lubricating the equipment.

(4) Performing remedial maintenance of non-emergent nature.

(5) Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn.

(6) Inspecting all electrical and water treatment systems

(7) Measurement, adjustment and calibration as necessary for optimal instrument processing quality

(8) Inspecting and replacing where indicated, electric wiring and cables for wear and fraying.

(9) Returning equipment to fully operating condition.

(10) Providing documentation of services performed.

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

1.5. PUBLIC INTERFACE

1.5.1. 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.

1.5.2. 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.

1.6. CONFLICTS OF INTEREST

1.6.1. The Contractor shall not bill the patient for services rendered under this contract. The Contractor shall be prohibited from receiving compensation of any kind for patients treated, procedures performed or any other actions performed except under the terms and conditions of this contract at the rate specified.

1.6.2. The Contractor shall not while performing services under this contract, advise, recommend or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor at any place other than as designated under this contract.

1.6.3. The Contractor’s employees are not prohibited by reason of their employment under this contract from conducting private practice provided there is no conflict with the performance of services under this contract, subject to any agreement between the Contractor and its employees. The Contracting Officer will unilaterally resolve any issues concerning potential conflicts pertaining to the performance of this contract, not including disputes solely (as determined by the Contracting Officer) between the Contractor and its employees.

1.6.4. The Contractor shall not use Government facilities or other Government property in connection with conducting a private practice and shall ensure that its employees do not do so.

1.6.5. 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.

1.7. RESPONSIBILITIES AND PROCEDURES

1.7.1. 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.

1.7.2. 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.

1.8. QUALITY MANAGEMENT

1.8.1. 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.

1.8.2. 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.

1.9. CONTRACTOR REPRESENTATION

1.9.1. 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 shall be designated as the company representative and this representative may be off-site.

1.9.2. 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.

1.9.3. 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.

2. DEFINITIONS/ACRONYMS

2.1. Definitions. Following is a list of basic definitions.

2.1.1. Ancillary Personnel. This includes all employees except for Medical Doctors (MD) and Doctors of Osteopathy (DO).

2.1.2. Backup Personnel. Pre-approved employees designated to move into the position of the primary employee to perform required services for the duration of his/her absence.

2.1.3. Beneficiaries of The Military Healthcare System. Those individuals entitled to care at the MTF in accordance with AR 40-3.

2.1.4. Clinical Privileges. Authorization by the Government to provide specific patient care and treatment services in the organization, within well-defined limits, based on the individual's license, education, training, experience, competence, judgment and physical and mental health.

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

2.1.6. 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.

2.1.7. 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

2.1.8. 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

2.1.9. Physician. Medical professionals possessing a doctorate degree as a Medical Doctor (MD) or Doctor of Osteopathy (DO).

2.1.10. 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.

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

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

BCLS - Basic Cardiac Life Support.

BLS - Basic Life Support CFR - Code of Federal Regulations CLIN - Contract Line Item Number CME - Continuing Medical Education 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

3. GOVERNMENT PROPERTY.

3.1. 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 spillage or leaks from filling the generator on the mobile SPU or operation of the generator,

c) 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

3.1.1. 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.

3.1.2. 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.

3.1.3. 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.

3.1.4. 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.

3.1.5. 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.

3.1.6. 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.

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

3.1.8. 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.

3.2. 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 insure a complete match with the government provided power supply prior to connecting to the power source. Power surges can unexpectedly occur and the contractor shall take precautions to prevent/block/handle power surges.

4. CONTRACTOR-FURNISHED SUPPLIES/SERVICES

4.1. 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.

4.1.2. 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.

5. SPECIFIC TASKS

5.1. The SPU trailer shall be capable of connecting to Government-furnished electric power supply. The Contractor shall be responsible for providing power receptacles, adapters, converters, transformers, wiring, plug ends, and panel boxes etc. which will adapt to the Government supplied power drop. The government has 2 power sources that are available. One is a 480 Volt AC 3 Phase 200 amp disconnect located near the entrance to the Emergency Center. The other source is a 480 Volt AC 3 Phase 800 Amp disconnect located on the west side of B building. More plug information can be found at:

http://www.sourceresearch.com/russells/russellstoll-pdf.cfm?PdfPage=maxgard-200Amp.pdf

5.2. The contractor will need to provide their own connection to an existing sanitary sewer manhole located around building 650. An existing manhole is located just west of Building 650B. An existing hose bib is located on the side of building 650B. If this hose bib will not supply adequate water for the trailer operations, the contractor shall be responsible for coordinating with Jacobs to tie into the existing 10” water main for their required water tap needed. The contractor will be responsible for providing and maintaining a heat tape on the water line if needed during the winter months. The contractor will be responsible for all costs associated with these water and sewer services. Jacobs POC is Matt Freemon, Project Manager Cell: 931.360.2919 matt.freemon@jacobs.com The contractor will also be responsible for removing these utilities after the trailer is removed, and restoring the area to prior conditions.

5.3. 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.

5.4. 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.

5.5. 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.

5.6. 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%.

5.7. Uptime calculation shall be calculated as follows: number of days of uninterrupted service (defined as 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). Failure to meet the 95% requirement shall be immediate grounds for termination under the Termination for Default clause. If services are not available for any duration of time on 3 consecutive days, this too shall be considered immediate grounds for termination for default.

Weekends, holidays or hospital/clinic closure days shall not be construed as a break in determining 3 consecutive days of service.

5.7.1. On-site response times to repair the SPU trailer or its sub-systems and equipment shall be within 180 minutes of the call for repair being made to the contractor. The SPU sterilization equipment shall be fully repaired with 24 hours, or the equipment item shall be replaced by the contractor with another of the same make, model and capabilities.

http://www.sourceresearch.com/russells/russellstoll-pdf.cfm?PdfPage=maxgard-200Amp.pdf mailto:matt.freemon@jacobs.com

5.8. 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.

5.9. The entire mobile system shall meet or exceed these requirements as a minimum:

a) no more than 3 years old at the start of services (proof shall be submitted as to age when services begin)

b) trailer clearance of 15 feet or less

c) able to perform sterilization services

d) have a phone jack on the trailer (the Contractor shall have a corded phone in the trailer to speak with medical staff inside the facility to discuss exams and in case of an emergency)

f) self-leveling capability (wood blocks, plywood, etc. shall be provided by the contractor and placed underneath any leveling legs to disperse the trailer weight and preclude punching holes in any asphalt, concrete, etc.)

g) an awning over entrance and exits

h) virus protection for any Contractor computer which meets Information Assurance And Validation Alert (IAAVA) guidelines

5.10. 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.

5.11. 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.

5.12. 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.

5.13. Contractor Responsibility.

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

5.13.2. 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

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5.13.3. 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.

5.13.4. 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.

5.14. Scheduled Services.

5.14.1. 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.

5.14.2. The Contractor shall perform schedules services for other than peak patient examination times determined by the COR at each site. The Contractor shall confirm scheduled dates with the COR at least five working days prior to performing scheduled services.

5.14.3. 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.

5.15. Service beyond the Scope of the Contract.

5.15.1. 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.

5.15.2. 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.

6. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND

MANUALS.

6.1. 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.

6.1.1. 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.

6.2. Publications.

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

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)

6.3. Standard Forms.

SF 85-P - Questionnaire for Public Trust Positions

6.3.3. Department of Defense.

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

6.3.4. Other Forms.

FD Form 258 - FBI US Department of Justice Fingerprint Card

7. ADDITIONAL INSTRUCTIONS.

7.3. ADP Security Requirements.

7.3.1. 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…

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