PWS_DRAFT.pdf

Performance Work Statement

This is a requirement for Maintenance Service and Repairs, at General Leonard Wood Army Community Hospital (GLWACH), 4430 Missouri Avenue, Fort Leonard Wood, Missouri, 65473.

EQUIPMENT LISTING:

Draeger Anesthesia Machines Located at General Leonard Wood Army Community Hospital Ft Leonard Wood, MO 65473 –

ECN: 023687

Apollo 8606500 Site ID 91041817 Serial Number ASHK-0342 Total Care PM / Repairs and Parts

ECN: 023688

Apollo 8606500 Site ID 91041817 Serial Number ASHK-0336 Total Care PM / Repairs and Parts

ECN: 023695

Apollo 8606500 Site ID 91041817 Serial Number ASHL-0135 Total Care PM / Repairs and Parts

ECN: 023696

Apollo 8606500 Site ID 91041817 Serial Number ASHL-0100 Total Care PM / Repairs and Parts

ECN: 023697

Apollo 8606500 Site ID 91041817 Serial Number ASHL-0174 Total Care PM / Repairs and Parts

ECN: 023698

Apollo 8606500 Site ID 91041817 Serial Number ASHL-0155 Total Care PM / Repairs and Parts

Vaporizers used with the various units:

Vapor 2000 ASHJ-0109 Vapor 2000 ASHJ-0110 Vapor 2000 ASHJ-0205 Vapor 2000 ASHJ-0213 Vapor 2000 ASHJ-0204 Vapor 2000 ASHJ-0247 Vapor 2000 - ISO ASHK-0175 Vapor 2000 - ISO ASHK-1367 Vapor 2000 - ISO ASHK-1282 Vapor 2000 - ISO ASHL-0631 Vapor 2000 - ISO ASHK-1283 Vapor 2000 - ISO ASHL-0621 Vapor 2000 - SEVO ASHK-0762 Vapor 2000 - SEVO ASHK-0761 Vapor 2000 - SEVO ASHL-0120 Vapor 2000 - SEVO ASHL-0312 Vapor 2000 - SEVO ASHL-0111 Vapor 2000 - SEVO ASHL-0183

CONTRACTOR POINT OF CONTACT:

PERFORMANCE WORK STATEMENT:

1.0 SCOPE OF WORK: Contractor shall provide all labor, supplies, tools, material, transportation, parts, and equipment to perform Preventive Maintenance (PM), Calibration/Verification/ Certification (CVC) and repairs, to maintain the Government-Owned, Siemens modalities listed above. This includes unlimited telephonic assistance and unlimited on-site maintenance repairs for the Draeger Anesthesia machines and components. The equipment is located on the Second Floor Operating rooms and the 3rd Floor C-Section room, General Leonard Wood Army Community Hospital (GLWACH), 4430 Missouri Avenue, Fort Leonard Wood, Missouri, 65473.

1.1. POINT OF CONTACT: At the start of the contract, the Contractor shall have a contract representative and alternate responsible for scheduling and coordination of service calls. The name and phone number of the designated individual and alternate shall be provided to the Chief, Equipment Management Branch.

1.1.2. All scheduled services shall go through the Clinical Engineering Section.

1.1.3. Only a representative of the Clinical Engineering Section will make all requests for repairs.

1.2. PERSONNEL: Individuals who have demonstrated knowledge and competence in the repair of equipment identified shall perform on this Contract.

1.2.1. The Contractor shall ensure repair technicians have attended training on the specific model of contract equipment or have 3 years of maintenance experience and provide training certifications to validate prior to working on the equipment.

1.2.2. While on duty, contractor employees shall maintain a neat, well-groomed appearance.

1.2.3 The Contractor shall request a visitor’s pass for each one year duration of each contract period of performance in order to access the Fort Leonard Wood military installation.

2.0 DEFINITIONS:

2.1. CALIBRATION/VERIFICATION/CERTIFICATION (CVC): Systematic procedure as defined by the OEM’s specifications for defined operation. Ensures equipment operates within all OEM’s parameters for maximum performance and patient quality of care.

2.2. GLWACH: General Leonard Wood Army Community Hospital.

2.3. LEGAL PUBLIC HOLIDAYS:

New Years Day, January 1 Martin Luther King's Birthday, 3rd Monday in January Washington's Birthday, 3rd Monday in February Memorial Day, last Monday in May Independence Day, July 4 Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran's Day, November 11 Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

2.4. OEM: Original Equipment Manufacturer.

2.5. PREVENTIVE MAINTENANCE (PM): Maintaining equipment in accordance with the EOM’s standards and providing systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects.

2.6. QUALITY CONTROL: Contractor’s actions to control and ensure contract compliance.

2.7. MD/MDS: Medical Device and/or Medical Device Systems.

3.0 GOVERNMENT FURNISHED PROPERTY AND SERVICES:

3.1. The Government will provide expendables such as reagents, sample cups, pipette tips, wooden sticks, printer paper, and any other consumables routinely used during the course of normal machine operation and use.

3.2. On a Government authorized, case-by-case basis, the Contractor may use the Government medical equipment maintenance shop in order to expedite repairs.

4.0 SPECIFIC TASKS TO BE PERFORMED:

4.1. Services, labor, parts and materials. The Contractor shall provide services, labor, parts, and materiel necessary to cause subject equipment to be in proper working condition in accordance with the OEM's specifications at the completion of each service call.

4.2. Preventive Maintenance and Calibration. Preventive Maintenance (PM) and Calibration shall be in accordance with the OEM’s checklist. The Contractor shall coordinate the scheduled date and schedule the PM and Calibration at incremental intervals as determined by the equipment maintenance plan. It is understood that this plan addresses various subsystem maintenance at varying intervals. Clinical Engineering base date for the Anesthesia Machine calibration is November. Draeger FSE must contact the Operating Room to coordinate repairs and scheduled services and notify the NCOIC or Shop Foreman of Clinical Engineering Section.

4.2.1. The Contractor shall perform PM in accordance with the OEM’s checklist.

4.2.2. Upon completion of calibration, the Contractor shall affix a DD Form 2163 (Medical Equipment Calibration/Verification/ Certification) to the control panel of the equipment in plain view. If the form is already present, it will be replaced. Forms to be provided by Clinical Engineering as needed.

4.2.3. The Contractor shall perform operational checks with the user and document on the service order that unit meets all required operational checks to all the unit to be used immediately.

4.3. Work shall be performed at GLWACH. Equipment shall not be removed from site unless approved by the Government.

4.3.1. The Contractor shall complete repairs within the time frames indicated (See para 4.5.1).

4.3.2. Only equipment requiring a major disassembly or major overhaul shall be removed from the customer’s site.

4.3.3. The Contractor shall not remove equipment without proper documentation. Proper documentation will be a Temporary Hand Receipt (DA Form 3161) prepared in accordance with DA Pamphlet 710-2-1. The DA Form 3161 will include the following statement: "The Contractor, Steris Corporation, has been authorized to remove the item as described on this form for repair and return." The DA Form 3161 will be the Contractor's authorization to remove the item from GLWACH to his facility for repair and return.

4.4. Modifications and upgrades. The Contractor shall perform OEM specified modifications and software upgrades with the consent of and without charge to the Government. Resultant Contractor must have direct contact with the OEM to accomplish field modifications to equipment in accordance with the time schedule set forth by the OEM. All modifications and upgrades will be documented in the government owned operator and service literature.

4.5. Service calls. The GLWACH Clinical Engineering Section will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Clinical Engineering Section will determine if the required maintenance service is emergency or routine.

4.5.1. The Contractor shall perform routine and emergency maintenance services between 7:30 AM and 4:30 PM Monday through Friday, excluding Legal Public Holidays. Any services provided outside normal business hours must be authorized by the Chief, Equipment Management Branch.

4.5.1.2. Contractor response time shall be within 48 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

4.5.2. Repair completion time for repair service shall not be more than 96 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

4.6. Badges. Contractor's representative shall report to General Leonard Wood Army Community Hospital Front Des to sign for a contractor’s authorization badge, 4430 Missouri Avenue, General Leonard Wood Army Community Hospital, telephone number (573) 596-0482, prior to commencing services during normal operating hours (7:30 AM to 4:30 PM). During other than normal operating hours, contractor's representative shall report to the Administrative Officer of the Day (AOD), 4430 Missouri Avenue, General Leonard Wood Army Community Hospital, at the front desk of the hospital. The service representative will obtain a badge before reporting to service area.

4.7. Service reports. Upon completion of services by the contractor’s service representative, a written service report shall be provided to the clinical engineering staff. The service report shall provide detailed information regarding the cause of the MD/MDS malfunction and corrective action taken. Include, at a minimum, the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with part numbers and prices for each part. Emailed reports are acceptable. Email reports to: In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the clinical engineering manager no later than 48 clock hours after services are completed.

4.7.1. The service report shall indicate the Contract Number, service performed (e.g., PM and/or repair), provide detailed information regarding the cause of equipment malfunction, corrective action taken, to include the time required to complete the work. The service report shall also include the estimated price of labor (hourly labor rate); a list of parts replaced with price for each part, the unit Site ID and ECN number, and the name of the technician performing the service.

4.7.2. On weekends and after normal duty hours, service tickets shall be given to the Government AOD/SDNCO, at the front desk of the hospital.

4.7.3. In the event that all information is not available to contractor's representative when services are performed, the initial service report shall include all information available. Contractor shall provide the balance of the required information in writing to the Chief, Equipment Management Branch, not later than 10 days after services are completed.

4.7.4. Contractor shall provide a copy of the invoice to the Chief, Equipment Management Branch, for verification of services performed. (See Invoices and Payment Information listed below as additional guidance).

4.8. The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control. The Contractor shall be responsible for any contractor-caused damage to Government-owned property and shall replace or repair at the contractor’s expense.

The Contracting Officer will approve replacements or repairs.

4.9. 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 at the end of the workday. All equipment under repair shall be secured at all times.

4.10. If the Contractor determines that the item being serviced is uneconomically repairable, the Chief, Equipment Management Branch shall be notified. The Chief, Equipment Management Branch, GLWACH will determine economic reparability in accordance with US Army Directives.

5. 0 APPLICABLE DIRECTIVES/DOCUMENTS:

5.1. Documents applicable to this PWS are listed below and all Army publications and forms will be available from the Chief, Equipment Management Branch upon request.

5.2. ARMY REGULATIONS:

AR 40-61 Medical Logistics Policies and Procedures AR 190-13 Army Physical Security Program AR 190-51 Security of Army Property at Unit and Installation Level

5.3. ARMY PAMPHLET:

DA Pam 710-2-1 Using Unit Supply System Manual Procedures

5.4. FORMS:

DD Form 1150 Request for Issue or Turn-In DD from 2163 Medical Equipment Calibration/Verification DD Form 2164 X-Ray Verification/Certification Worksheet DD Form 2579 Report of Assembly of a Diagnostic X-Ray System

5.5. OTHER REGULATORY DOCUMENTS:

21 CFR Code of Federal Regulations, Title 21, Food and Drugs, Part 0800 to 1299 (Includes Regulations for the Administration and Enforcement of the Radiation Control for Health and Safety Act of 1968) (M)

[Unnumbered] Standards for the Joint Commission on Accreditation of Healthcare Organizations

6.0 INVOICE AND PAYMENT INFORMATION:

6.1 Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis, Army Vendor Pay) (address in Block 18a), in the arrears , after receipt of services, or by previously scheduled payments as identified in the contract schedule herein. Contractor submits their 2n1 invoice in the Wide Area Workflow system for payment.

(See Wide-Area Workflow Clause in schedule), The Government Point of Contact (GPOC) shall verify for acceptance to be submitted to DFAS Indianapolis, IN. Government Payment will only be authorized for services actually rendered. ADVANCE PAYMENTS ARE NOT AUTHORIZED. PAYMENTS WILL BE MADE

QUARTERLY, IN ARREARS.

7.0 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

7.1 The purpose of this QASP is to provide a planned process for surveilling the contractor’s actual performance and comparing that performance against the contractual requirements to determine conformity in accordance with the Performance Work Statement (PWS). The Government has the right to change or modify this quality assurance surveillance plan and methods at its discretion. The overall policy of the government for contractor control and Government quality assurance and applicable definitions are provided in the Federal Acquisition Regulations (FAR) in Part 46 Quality Assurance and applicable clauses in the PWS.

7.2 Surveillance Methods: The contractor’s performance will be monitored by the Contracting Officer’s Government Point of Contact (GPOC) in conjunction with input from the customers. Completed delivery of services will be verified with the PWS prior to making any payment approvals. Incomplete or delayed performance will be forwarded to the Contracting Officer.

7.3 Remedy: Should unacceptable performance occur, the government will document the contractor’s past performance, issue cure notices or may terminate the contract by default.

8.0 CONTRACTOR MANPOWER REPORTING

ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil the required information includes the following:

(1) Contracting Office, Contracting Officer, Contract, and Government Point of Contact (GPOC);

(2) Contract number, including task and delivery order number;

(3) Beginning and ending dates covered by reporting period;

(4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data;

(5) Estimated direct labor hours (including sub-contractor);

(6) Estimated direct labor dollars paid this reporting period (including sub-contractor);

(7) Total payments (including sub-contractor);

(8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different);

(9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information);

(10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website);

(11) Presence of deployment or contingency contract language, and,

(12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country).

https://cmra.army.mil/

As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. This cost will be reflected on a separate line item and can be invoiced upon completion of the report.

Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year.

The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer.

The following information is provided for the Contractor’s use in completing the above report:

Predominant Federal Service Code: J065 Unit Identification Code for the Army Requiring Activity: W1MLAA

9.0 OPERATIONAL SECURITY (OPSEC)

9.0. OPSEC Training. New Contractors shall complete Level I OPSEC training within 30 calendar days of their reporting for duty. All Contractors with CAC access will complete training online in APEQS, all others can complete the training located at http://cdsetrain.dtic.mil/opsec/index.htm. (IAW AR 530-1).

For contracts that cross fiscal years, or for contracts with option years, all Contractor personnel shall complete annual OPSEC awareness training. Course certificates shall be provided to the COR within five calendar days of completion.

9.1. Anti-terrorism (AT) Level I Training. All contractor employees, to include sub-contractor employees, requiring access to army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 24 hours after starting performance under this contract or effective date of incorporation of this requirement into the contract whichever is applicable. The contractor shall submit certificates of completion for each affected contract employee and subcontractor employee, to the COR or to the KO within five calendar days after completion of training by all contractor/subcontractor personnel. AT level I awareness training is available at the following website: https://atlevel1.dtic.mil/at

9.2 ACCESS AND GENERAL PROTECTION/SECURITY POLICY AND PROCEDURES. All Contractor and sub-contractor personnel performing tasks on this PWS shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures which will be provided to the Contractor by a Government representative within five working days of Task Order award. Contractor shall provide all information required for background checks to meet installation access requirements as performed by the installation Provost Marshal Office, Director of Emergency Services or Security Office. Requesting Contractor shall submit request for installation pass to the COR or KO at https://vcc1.icmvcc.com/im3500/. Contractor personnel shall comply with all personal identity verification requirements as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of the base contract to this task order, should the Force Protection Condition (FPCON) at any facility or installation change, the Government may require changes in Contractor security matters or processes.

9.3. IWatch Training. Within 10 calendar days of Task Order award and within 24 hours of new Contractor employees commencing work on this Task Order, all Contractor and sub-contractor employees shall review the FLW Directorate of Emergency Services (DES) web link for iWatch training located at http://www.wood.army.mil/LEC/iWatch/iWatch.htm. This locally developed training will inform https://atlevel1.dtic.mil/at https://vcc1.icmvcc.com/im3500/ http://www.wood.army.mil/LEC/iWatch/iWatch.htm employees of the types of behavior to watch for and how to report suspicious activity. Suspicious activity shall be reported to the COR or KO

9.4. Information Assurance (IA) Awareness Training. All Contractor and sub-contractor personnel requiring network access to Government information systems shall successfully complete DoD IA Awareness training available at https://ia.signal.army.mil prior to accessing systems and annually thereafter. Training certificates shall be provided to the COR immediately upon completion. CAC issued Contractor employees will be registered in the Army Training Certification Tracking System (ATCTS) by the organization’s Information Assurance Officer prior to commencement of work and shall sign the acceptable use policy in accordance with Army Regulation 25-2, Para. 3-3.

CMR ITEM REQUIREMENTS:

1. Contracting Office / Contracting Officer, Technical Point of Contact

Regional Health Command, Central (RHC-C) Contracting Office /

2. Contract Number

3. Beginning/Ending Dates covered

4. Contractor Name, Address, Phone Number, email, & POC

5. Estimated Direct Labor Hours (including sub-contractors)

6. Estimated direct labor dollars paid this reporting period (including sub-contractor

7. Total Payments (including sub-contractor)

8. Federal Service Code J065

9. Army’s Organizational UIC W1MLAA

10. Location of Work 65473

11. Deployment/Contingency None

12. Number of Contractor/Sub-contractor Employees deployed in theater None

Reports required under this contract are as follows:

Report #1: Service reports – provided within 5 days after the service has been performed.

https://ia.signal.army.mil/