36C25719Q0487-002.pdf

Attachment 1 Performance Work Statement 36C25719Q0487 Page 1 of 7

Performance Work Statement Steam Sterilizers – Installation and Maintenance Services

VA North Texas Health Care System

1. General

1.1 General: This requirement if for supplies and non-personal services to provide and install two (2) steam sterilizers, and all associated maintenance services described herein, at the VA North Texas Health Care System (VANTHCS), Dallas, TX. The government will not exercise any supervision or control over the contractor personnel providing the supplies/services described herein.

1.2 Description of Supplies/Services Introduction: The contractor shall provide all personnel, transportation, equipment, supplies, facilities, supervision, and other items and non-personal services necessary to remove two (2) existing steam sterilizers, dispose of existing steam sterilizers, provide and install two (2) new steam sterilizers, and provide maintenance services for the sterilizers, as defined in this Performance Work Statement (PWS). The contractor assumes all liability risks for the work performed under the contract or order. The contractor must assume total liability for all contractor employees.

1.3 Physical Security: The contractor shall be responsible for safeguarding all government property, equipment and information while performing the services described herein.

1.4 Type of Contract: The government anticipates award of a firm fixed-priced contract.

1.5 Contracting Officer Representative (COR): The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract/order and assists in contract administration. A letter of designation issued to the COR, a copy of which will be provided to the contractor, states the responsibilities and limitations of the COR, especially with regards to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract/order.

1.6 Contract Administration: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements in the contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that will affect price, quantity, or quality of the performance in the contract/order. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. All changes to the contract will be issued via an amendment and/or modification in writing from the Contracting Officer to the contractor.

1.7 Invoices: Invoices are to be submitted electronically; upon accepted installation of the two sterilizers and (to be determined: monthly or quarterly), upon completion of maintenance services that were performed. Electronic invoices can be submitted at no additional cost at the VA Vendor Information System (VIS) website https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx, or at https://www.tungsten-network.com/us.en/veterans-affairs/. Invoices must include the obligation number that is provided on the contract, for the specific period of performance, to ensure timely payment. The COR is responsible for the acceptance and/or certification of invoices for those supplies/services provided to the government.

2. Background

36C25719Q0487 Page 2 of 7

The VANTHCS, Pathology & Laboratory Medicine Service, requests two (2) new autoclaves to replace aging equipment. The existing autoclaves are used two or three times per week to sterilize patient specimens.

3. Scope of Work

Vendor will remove existing steam sterilizers, dispose of existing steam sterilizers, provide and install two (2) new steam sterilizers, provide operational equipment training to government personnel, and provide maintenance services for the steam sterilizers during the period(s) of performance specified in the contract.

Location/Place of Performance:

VA North Texas Health Care System Pathology & Laboratory Medicine Service 4500 S. Lancaster Rd.

Dallas, TX 75216-7167

3. Personnel Qualifications

3.1. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The work history of each contractor employee must contain experience directly related to the task and functions he/she is intended to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purposes of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner. The normal manner of dress is business casual.

3.2. Specific Personnel Qualifications Requirements – Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum:

3.2.1. Be qualified by the contractor as capable to perform as a field service representative.

4. Required Sterilizer Specifications

Equipment must consist of the following to meet the needs of the customer:

• Small Steam Sterilizer features a high capacity chamber that has been validated to sterilize up to three 25lb instrument trays.

• Increased shelf clearance accommodates larger sets. Programmable cycles include “Immediate Use” Pre-vac 4+1, Gravity and Liquids. Cycle names are customizable.

• The chamber is constructed of solid 316L stainless steel and carries a 15 year warranty. The pressure vessel has a full jacket design to minimize the formation of excess condensation on the chamber interior.

• Steam activated gasket requires no lubrication and is warranted for 2 years.

• The automated vertical sliding door is foot pedal activated for hands-free operation.

36C25719Q0487 Page 3 of 7

• Enhanced display is located at ergonomic height and features large cycle countdown visible from 15 feet away. Ink on paper impact printer provides permanent cycle record.

• Utilities usage is minimized with multiple temperature sensors.

• System operation can be continuously monitored with remote service monitoring.

• Must have the following approximate dimensions 20" x 20" x 38"

• Pre-vacuum

• Single Door External Supplied Steam (Facility Steam/Stand-Alone Generator)

5. Task Specifications

Task One

5.1 Vendor shall remove the existing steam sterilizers at the VANTHCS, P&LMS. Manufacturer:

AMSCO, Model Number: V-120

Task Two

5.2 Vendor shall dispose of existing steam sterilizers. Vendor will dispose of equipment in accordance with all Federal, State and local laws and/or regulations.

Task Three

5.3 Vendor shall install two (2) new steam sterilizers at the VANTHCS. Vendor is responsible for making all connections (plumbing, electrical, etc.) from the government provided utilities to the equipment. Vendor shall test equipment prior to government use to ensure equipment and all connections function properly. Vendor shall provide a copy of the initial testing results, or a statement that reflects that the equipment is ready for use. Vendor shall train P&LMS personnel on the operation of the equipment.

Task Four

Maintenance Performance Requirements:

5.4 Maintenance: The Vendor shall perform preventive maintenance (PM) services at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance services includes the following:

5.4.1 Inventory and recording of systems components.

5.4.2 Test all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

5.4.3 After PM services, the vendor shall submit a detailed work report to the COR or Microbiology Supervisor for notice, at no additional cost to the government.

5.4.4 Delivery of PM parts or material. The vendor shall provide all preventive service materials at no additional cost to the government.

5.5. On-call Repairs: On-call repairs are emergency repairs beyond the scheduled maintenance.

5.5.1 The vendor shall provide technical assistance, not limited to test performance or equipment malfunction, twenty-four (24) hours a day, seven (7) days a week, including all Federal and religious

36C25719Q0487 Page 4 of 7 holidays, via direct communication thru a telephone bank with technically capacitated and certified personnel by the vendor.

5.5.2 The vendor shall respond to a call for on-site repair and be at the job site within two (2) hours during regular working hours, Monday – Friday, 0800 – 16:00 hours. In very urgent cases, an immediate repair can be requested after 1600 hours and on Saturdays, Sundays and Federal holidays.

After repair, the vendor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility.

5.5.2.1 If the malfunction is reported to the vendor not later than 1600 hours, the failure elimination shall be started immediately on the same day.

5.6. For delivery of repairs parts or materials the vendor shall provide all parts and materials at no additional cost the government.

5.6.1 Vendor shall remove all parts, equipment or materials replaced, or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any additional cost to the Government.

5.7 Safety

5.7.1 Vendor shall immediately notify the service of any changes in composition, recall notification or any changes that will affect the performance of the instrument according to FDA regulations.

5.8 Performance

5.8.1 All test and procedures must comply and be approved by the FDA.

5.8.2. All equipment must perform at manufacturer specifications, deviations from the performance specifications shall be corrected by the vendor.

6. Deliverables/Supplies

This order is for the purchase, installation and maintenance services of two sterilizers.

6.1 The vendor shall provide initial on-site training for personnel for the operational use and any routine care of the provided equipment. In addition, the vendor shall provide handouts and training materials in sufficient quantity for each participant. The training materials may be off-the-shelf courses. The vendor shall provide lesson plan, course materials and any media (DVD’s, CD’s, videos, etc. if required) for each procedure, at no additional cost to the government.

6.2. The vendor shall deliver all, and not limited to: operation, maintenance, troubleshooting, small repairs, equipment specifications and test manuals.

6.3 The vendor shall provide supplies and ancillary items that are required for operation of the sterilizers.

6.4 The vendor shall electronically submit all invoices for review according to the established contract at the end of each billing cycle.

6.4.1 All items or services described in the contract shall be specifically detailed on the invoice including description, quantity acquired, and cost.

6.5 All supplies or services not covered in the contract must be approved prior to acquisition or the performance of the service by the COR or the Contracting Officer. Approval by the COR may include acceptance by a government purchase card (GPC) payment, with or without a separate obligation record. Approval by the Contracting Officer for items or services not specified in the contract will be made by a bilateral contract modification with the vendor.

6.6 Remedies:

6.6.1 Any changes in equipment modifications shall be immediately disclosed by the vendor electronically as well as by postal mail with supporting documentation of the change and, detailed guidance against implementation within twenty-four hours of its application or according to FDA guidelines.

36C25719Q0487 Page 5 of 7

6.6.2 Additional charges incurred by the government to provide the continuity of contracted equipment and not limited to out sourcing, transportation and or any other additional cost shall be covered by the vendor at no additional charge to the government.

Government Specifications

7.1 Government Provided Equipment: None

7.2 Government Provided Supplies/Utilities:

The government will provide the utilities necessary (i.e., water, steam, electricity) to operate the equipment.

8.Contractor Security Contract Requirements

This vendor requires no access to VANTHCS or any VA information system. There will be supervised access when the vendor is physically present for technical support, service calls, and scheduled preventative maintenance. The instrument hard drive will remain on-site for any external repairs.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

9. Records Management

All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

10. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT

10.1 Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection.

10.2 Performance Evaluation: After acceptance of the contract the system will be monitored for equipment performance including but not limited to; quality assurance (emergency repairs response, hot line troubleshooting response) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training)

36C25719Q0487 Page 6 of 7

Quality Assurance Surveillance Plan (QASP) and its performance are as follows:

Task ID Indicator Standard Acceptable Quality Level

Method of Surveillance

Quality Assurance

5.5.1 Trouble-

shooting via phone.

Within 24 hours 95% Monthly Monitoring

5.5.2 Emergency

Repairs

Within 2 hours <2 Repairs by quarter by equipment.

95% Monthly monitoring

Documentation 6.4 Invoice Accountability

Monthly invoices 100% Invoices received through OLCS via Austin, Texas

6.4.1 Invoice

Verification

Monthly invoices 100% Invoices contain all necessary information for proper processing.

6.2 Equipment

specifications and user manuals

Provided prior to delivery of equipment.

100% Up to date information supplied by vendor, and as changed.

Customer Satisfaction

10.2 Substantiated

complaints from lab users

≤ 1 complaint per quarter

100% Reports of contacts or other documentation.

6.1 Training of

laboratory personnel

Provided upon activation of new system.

100% Reports of contacts or other documentation.

36C25719Q0487 Page 7 of 7

NARA RM Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

References:

VHA Directive 6300 VA Handbook 6300.1 North Texas VA Medical Center Policy VA Directive 6500 36 CFR Part 1222.32 (b)