18-005114SOLICITATION.pdf

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Sterilizer Maintenance
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NIHCL2018-005114
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El 28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

29. AWARD OF CONTRACT: REF. OFFER

'DATED YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

NIHCL2018-005114

6, SOLICITATION ISSUE

DATE

04/24/2018

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Ogochukwu Nwankm, Contract Specialist

b. TELEPHONE NUMBER (No collect calls)

(301) 496-1446

8. OFFER DUE DATE/

LOCAL TIME

05/09/2018 10:00 A.M.

9. ISSUED BY CODE 10. THIS ACQUISITION IS _I UNRESTRICTED OR LI SET ASIDE: 100 % FOR:

National Institutes of Health, Clinical Center Two Democracy Plaza, Suite 106 6707 Democracy Boulevard, MSC 5480 Bethesda, MD 20892-5480

X WOMEN-OWNED SMALL BUSINESS

SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

HUBZONE SMALL SMALL BUSINESS PROGRAM NAICS:

BUSINESS

EDWOSB 811310

SERVICE-DISABLED

VETERAN-OWNED SIZE STANDARD:

SMALL BUSINESS Eli 8(A) 7,500,000

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

13b. RATING

0 SEE SCHEDULE

RATED ORDER UNDER

DPAS (15 CFR 700) 14. METHOD

X

OF SOLICITATION

RFQ EIIFB LIRFP

15. DELIVER TO CODE 16, ADMINISTERED BY CODE

National Institutes of Health 10 Center Drive.

Building 10 Room MSC 1352 Bethesda, MD 17a. CONTRACTOR/ CODE FACILITY 18a. PAYMENT WILL BE MADE BY - CODE

OFFEROR CODE

TELEPHONE NO.

National Institutes of Health Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

._ 17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

I_ OFFER

18b, SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED SEE ADDENDUM

19, ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

POTS Request 18-005114

PROGRAM TITLE: Sterilizer Maintenance

CONTRACT TYPE:

Firm-Fixed Price Purchase Order

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4, FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

X ARE X ARE NOT ATTACHED

X ARE ARE NOT ATTACHED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

PERIOD OF PERFORMANCE:

BASE PERIOD: 12 Months from date of award

Base Year Option Year One (1)

Option Year Two (2)

Option Year Three (3)

Option Year Four (4)

Total Base Plus all Option Years

YR

YR

YR

YR

YR

YR

32a. QUANTITY IN COLUMN 21 HAS BEEN fl RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELPHONE NUMBER OF AUTHORZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

36. PAYMENT

COMPLETE PARTIAL 1---- FINAL

37. CHECK NUMBER

LII PARTIAL LI FINAL

38. S/R ACCOUNT NO. 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 42a. RECEIVED BY (Print)

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42b. RECEIVED AT (Location)

42c. DATE RECD (YY/MMIDD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Addendum to FAR 52.212-1, Additional Instructions for Quoters

Technical Instructions

Objectives: Provide a comprehensive statement of the scope and purpose of the project to demonstrate your complete understanding of the intent and requirements as outlined in Part 5.

This understanding indicates a clear comprehension and awareness of the contract objectives

Methods: Describe in detail the methodologies you will use for the project, indicating your level of experience with each and any areas of anticipated difficulties

Schedule: Describe your onsite staff scheduling approach to the requirements to be performed during the business hours. The contractor may propose alternate schedules such as staggering workday schedules to minimize overtime paid for weekend and holiday workers to develop more cost-efficient methods for providing service

Key Personnel: Provide resumes of the proposed key personnel. Identify the key personnel and the hours they are expected to charge to this contract. Describe the technical capability ancLexperience_of_alL proposecLkeyTersonnel.

Timeliness of Services Propose the method used to meet all time standards detailed in Statement of Work. Provide an emergency response plan for unexpected requirements that must be serviced in a short period of time.

Past Performance Instructions

Provide 3 references within the last 5 years. Include the Point of Contract information including emails and phone numbers.

ADDENDUM TO FAR 52.212-2, Evaluation

Offerors are advised that award will be made to that offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

TECHNICAL EVALUATION CRITERIA ARE AS FOLLOWS: The technical proposal will be evaluated on compliance with providing the specified items/services in the task areas of the Statement of Work. The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes.

1. Understanding the Performance Requirements: 35 total points

2. Experience and Knowledge of Key Personnel: 30 total points

3. Past Performance/Experience: 20 total points

4. Ability to Deliver Timely Service: 15 total points

PAST PERFORMANCE CRITERIA: Evaluation of past performance/experience will be based on perfoHnance documentation or any other pertinent information available. It will not be based solely on information provided by the offeror. It will not be based on absolute standards of acceptable performance. NIH is seeking to determine whether an offeror has consistently demonstrated a strong commitment to customer satisfaction and high performance of services.

This is a matter of judgment. Failure to provide required information to assist in such evaluation in the proposal may result in disqualification. The government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past perfomiance.

PRICE CRITERIA: This will be evaluated separately from the technical and past perfonnance factors and will be evaluated for fairness and reasonability in terms of the Government's requirement. The prices offered in each proposal shall be totaled and compared.

Performance Work Statement (PWS)

Part 1 - General Information

1. GENERAL: This is a non-personnel services contract to provide preventative maintenance on specified pieces of sterilizer, autoclave, and washer equipment as identified in this contract.

The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non- personal services necessary to perform the functions and tasks required in this contract as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: Preventative Maintenance for sterilizer, autoclave, and washer equipment is critical to the Clinical Center operations. A large portion of the center is dedicated to invasive procedures utilizing tools, equipment, and products that are cleaned/sanitized via the washer equipment. That is in addition to the multitudes of other items that need to be cleaned/sanitized during the course of routine care provided at the center. As many patients are immuno-deficient and especially susceptible to infection it is important that the sterilizer, autoclave, and washer equipment be maintained to a high degree.

1.3 Objectives: Basic Service Object is the Following

• Preventative Maintenance

• Quarterly Services

• Emergency Support Service

• Equipment Validation per Service visit or PM

1.4 Scope: The contractor shall supply all labor, materials, tools, test instruments, equipment, supplies per service request, to perform the functions and tasks required in this contract, unless otherwise specified:

PREVENTIVE MAINTENANCE: Contractor shall perform four (4) quarterly scheduled preventive maintenance (PM) inspections and cleaning during the contract year for each piece of equipment. A schedule of such maintenance should be provided with the offer. It is the sole responsibility of the Contractor to schedule and perform all preventive maintenance inspections. The specific dates for scheduling the PM will be coordinated between the Contractor, the designated department contact and the Contracting Officer's Representative (COR) of Hospital Engineering and Facility Services (HEFS). Preventive maintenance inspections will be performed during the hours of 8:00 a.m. until 5:00 p.m., Monday through Friday, excluding holidays and any day declared an official Federal Holiday.

Preventive maintenance procedures shall include a thorough manufacturer's inspection of all items outlined in the original equipment manufacturers' PM procedures, calibration, and replacement of wear parts, necessary equipment adjustments and proper documentation.

Preventive maintenance will include at a minimum the manufacturer's recommendations, including but not limited to:

Quarterly Services: (once per quarter for each unit)

a) Cleaning of equipment;

b) Testing and inspecting as required herein to ascertain the general condition of the equipment and report results.

c) Completing installation and documentation of all minor operational and reliability engineering notice changes;

d) Running of system diagnostics, hardware and software;

e) Calibrating and lubricating the equipment to manufacturer's specifications;

ocumenting-aftfield service preventive-and-corrective-mainterrance-and-&alibratio results via hard copy and electronically as required for compliance with Joint Commission (JC), the US Food and Drug Administration (FDA) and the US Environmental Protection Agency (EPA).

PARTS: Parts for preventative maintenance shall be provided by the Contractor at no additional charge up to $500.00 per service request. Any parts utilized shall be of equal or exceed in quality those parts used by Original Equipment Manufacturer (OEM) and shall be installed by the Contractor as part of this contract. No modification of the equipment shall be permitted without the prior approval of the COR. IF OEM parts are not available, the contractor will notify the COR prior to performing the work. All replacement parts less than $500.00, except major components and parts required for unanticipated events (i.e. flood, fire or customer abuse) will be provided at no additional cost. Service labor to replace parts is included, but equipment costs greater than $500.00 will require approval approved by the contracting officer.

Report all discrepancies noted that are not within the scope of this agreement, along with estimated repair costs to the COR. The repair or replacement of components not within the scope of this agreement, which result in additional cost, shall not proceed until approved by the Contracting Officer.

UNSCHEDULED REPAIRS:

Unscheduled repairs are those repairs required when the equipment is not in a usable condition and timely response during normal business hours by the Contractor is required. The Contractor will provide emergency support service by phone 24 x 7 x 365, with a telephone response time the next business day. A qualified service technician must call back within four

(4) hours and be on site (if needed) by the next business day after initial notification of a problem by the department's point of contact. The term "response time" will result in the physical presence of a fully qualified technician arriving on the CC campus within the specified time. The contractor shall provide a response time for unscheduled service calls placed through the call center.

Equipment is to be fully operational within a maximum of 8 hours of the on-station response time. If the Contractor requires additional parts/time to complete required repair/service, the Contractor should contact the COR to coordinate completion of work within an agreed upon completion time/date, as these units support mission critical operations.

All repairs shall be in accordance with accredited standards, manufacturers' specifications, and codes applicable to equipment covered in this contract.

All contractor's responses will be documented in writing with a point by point description of work completed and any required additional work, with-in 24 hours of call completion.

All repairs performed shall meet or exceed accredited standards, manufacturers' specifications, and codes applicable to equipment covered in this contract.

1.5 Period of Performance. The period of performance shall be-for-one-(4)-Base-Year of 12 months and four (4) 12-month option years. The Period of Performance reads as follows:

1.6 General Information

1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non- recurrence of defective services. The contractor's quality control program is the means by which he assures himself that his work complies with the requirement of the contract. Contractor shall furnish a quality control plan as part of the proposal, this quality control plan shall detail how the contractor will implement, and maintain an effective preventative maintenance program for the specified sterilizer, autoclave, and washer equipment. After acceptance of the quality control plan the contractor shall receive the contracting officer's acceptance in writing of any proposed change to his QC system.

1.6.2 Quality Assurance: The government shall evaluate the contractor's performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: Contractor may be required to perform maintenance in the event of an Emergency during federally recognized holidays listed below:

• New Year's Day

• Labor Day

• Martin Luther King Jr.'s Birthday

• Columbus Day

• President's Day

• Veteran's Day

• Memorial Day

• Thanksgiving Day

• Independence Day

• Christmas Day

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 8:00 a.m. until 5:00 p.m. Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons.

The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the National Institutes of Health Clinical Center, Bldg. 10.

1.6.6 Type of Contract: The government will award a Fixed Price.

1.6.6.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property Provided for contractor use.

1.6.62 Key Control: The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re- keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor's employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.8 Special Qualifications: The Contractor must provide evidence of experience and qualifications for the company in providing comparable preventative maintenance, emergency service and post maintenance/repair validation of these systems in a comparable sized health care institution with the same or similar complexity and needs.

All personnel must be in place and fully qualified prior to award of this contract

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contra cting_Officers_Represe ntative_(COR)_ancLoth er_G ovemment_persornet,as appropriate_ may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies;

coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard 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 order.

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government:

• Contract Manager

• Site Supervisor

• Site Superintendent

• Systems Manager

• On-Site Technician

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8 AM and 5 PM, Monday thru Friday accept Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

• All Key Personnel listed above must show experience in their respective roles as it pertains to Preventative Maintenance, Quarterly Services, Emergency Support Service, and Equipment Validation per Service visit or PM for the specified pieces of sterilizer, autoclave, and washer equipment as identified in this contract. Experience to be shown in proposal with list of previous work done for similar equipment, setting and location.

1.6.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.13 Other Direct Costs: All costs (Direct and Indirect) for this contract must be listed as part of proposal. Costs need to be broken down material unit and labor hour costs.

1.6.14 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government.

These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.15 Organizational Conflict of lntcrcst: Contractor and eubcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor's mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.17 PHASE IN /PHASE OUT PERIOD: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 30 Day phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

PART 2- DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government.

Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S.

Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has aut oi ly to pi ovi e teuhiik,al directiorrto-the-eontractoras long as that-direction-is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.5. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.8. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.9. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.11. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

CHS - Central Hospital Supply

CO - Contracting Officer

CONUS - Continental United States (excludes Alaska and Hawaii) COR

Contracting Officer Representative

COTR - Contracting Officer's Technical Representative

COTS - Commercial-Off-the-Shelf

DFARS - Defense Federal Acquisition Regulation Supplement

HEFS — Hospital Engineering and Facility Services

OCONUS - Outside Continental United States (includes Alaska and Hawaii) ODC Other

Direct Costs

PIPO - Phase In/Phase Out

PM — Preventative Maintenance

POC - Point of Contact

PRS - Performance Requirements Summary

PWS - Performance Work Statement

QA - Quality Assurance

QAP - Quality Assurance Program

QASP - Quality Assurance Surveillance Plan

QC - Quality Control

QCP - Quality Control Program

TE - Technical Exhibit

PART 3- GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. Government Responsibilities

The government is responsible for:

a) Providing reasonable access to the equipment on each date that service calls are made or maintenance service has been scheduled.

b) Providing information as to all known hazards or hazardous materials which contractor personnel may encounter when working on equipment and in the environments within which equipment is located.

c) Providing mandatory training as required by Joint Commission for security clearance and background check.

d) If required NIH badge to be provided.

PART 4- CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Responsibilities

a. At EACH SERVICE VISIT (maintenance or repair)

1. The Contractor's service representative shall notify the designated department contact in the area and the COR of HEFS, located in Bldg. 10 Room 3N202 (phone 301-827-0647) upon arrival at the facility and prior to beginning work and upon completion of work.

2. Clean-Up: Contractor shall leave the work site in as clean a condition as when work began. Debris accumulated during work procedures shall be removed and the equipment or furniture moved during work procedures shall be repositioned to original locations.

3. Removal of Equipment by Contractor: Any equipment required to be removed from this facility for repair work shall not be removed without the proper approval from the OSFM Facility Manager.

4. Disposal of all residue will be done off-site in strict accordance with all applicable Federal, State and local regulations.

5. Protect adjacent structures, equipment, vehicles and vegetation during the performance of specified work.

6. Report all discrepancies noted, that are not within the scope of this agreement, along with estimated repair cost to the COR.

7. Any repair or replacement of components not within the scope of this agreement, which will result in additional cost, shall not be accomplished until approved by the contracting officer.

b. The Contractor must have experience, facilities, manufacturer-trained and experienced Service Technicians, equipment, supervision and management to adequately provide preventive and unscheduled service/repairs to maintain the Clinical Center sterilizer units in accordance with manufacturer's specifications.

1. Provide all labor, parts, materials, supervision, technical manuals, tools, test instruments, and transportation required to perform preventive maintenance and all unscheduled repairs on the government sterilizer units (as listed in Appendix 1) in the Clinical Center. All materials to be replaced shall be furnished by the Contractor. Provide documentation (electronic and hard copy) of all preventive maintenance and repairs.

2. Routine maintenance (must be at least according to manufacturer's specifications or better), troubleshooting and unscheduled repairs are performed according to the manufacturer's specifications and documented in writing and supplied to the COR designated department contact and Department of Biomedical Engineering (BIOMED), as outlined above.

3. All Sterilizer Units are maintained in good working order, or returned to good working order after a break in service.

4. Contractor required to provide detailed written service record per site visit and preventative maintenance.

5. After each Service or PM visit equipment validation must be completed that insures that the system works per the manufacturer's recommendation. Validation of equipment to be included in written service record.

c. Periodic Meetings: The Contractor may be asked to meet periodically with the COR and designated department contact to discuss schedules, progress or updates.

d. PARTS:

The Contractor shall replace all equipment and devices with new manufacturer's equipment or factory approved devices, if available. Factory refurbished components may ONLY be used in the event that new components are not available. No modification of the equipment shall be permitted without the prior approval of the COR OSFM. The Contractor must have access to Original Manufacturers (OEM) parts during the term of this contract.

e. SAFETY REQUIREMENTS:

In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or his designee may determine be reasonably necessary to protect the lives and health of occupants of the building.

The Contracting Officer or his designee will notify the Contractor of any non-compliance with the foregoing provisions and the actions to correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at this site of work, shall be deemed sufficient for the aforesaid. If tho Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contract in default.

PART 5- SPECIFIC TASKS

5. Specific Tasks:

5.1. Basic Services. The contractor shall provide services for Preventative Maintenance, Quarterly Services, Emergency Support Service, and Equipment Validation per Service visit or PM

5.2. Preventative Maintenance - Contractor shall perform four (4) quarterly scheduled preventive maintenance (PM) inspections and cleaning during the contract year for each piece of equipment. A schedule of such maintenance should be provided with the offer. It is the sole responsibility of the Contractor to schedule and perform all preventive maintenance inspections. The specific dates for scheduling the PM will be coordinated between the Contractor, the designated department contact and the Contracting Officer's Representative (COR) of HEFS. Preventive maintenance inspections will be performed during the hours of 8:00 a.m. until 5:00 p.m., Monday through Friday, excluding holidays and any day declared an official Federal Holiday.

Preventive maintenance procedures shall include a thorough manufacturer's inspection of all items outlined in the original equipment manufacturers' PM procedures, calibration, and replacement of wear parts, necessary equipment adjustments and proper documentation.

*Report all discrepancies noted that are not within the scope of this agreement, along with estimated repair costs to the COR. The repair or replacement of components not within the scope of this agreement, which result in additional cost, shall not proceed until approved by the COR.

5.3. Quarterly Services: (once per quarter for each unit)

a) Cleaning of equipment; Testing and inspecting as required herein to ascertain the general condition of the equipment and report results.

b) Completing installation and documentation of all minor operational and reliability engineering notice changes;

c) Running of system diagnostics, hardware and software;

d) Calibrating and lubricating the equipment to manu1au1urers speu tua 101 lb,

e) Documenting all field service preventive and corrective maintenance and calibration results via hard copy and electronically as required for compliance with Joint Commission (JC), the US Food and Drug Administration (FDA) and the US Environmental Protection Agency (EPA).

PARTS: Parts for preventative maintenance shall be provided by the Contractor at no additional charge up to $500.00 per service request. Any parts utilized shall be of equal or exceed in quality those parts used by Original Equipment Manufacturer (OEM) and shall be installed by the Contractor as part of this contract. No modification of the equipment shall be permitted without the prior approval of the COR OSFM. IF OEM parts are not available, the contractor will notify the COR prior to performing the work. All replacement parts less than $500.00, except major components and parts required for unanticipated events (i.e. flood, fire or customer abuse) will be provided at no additional cost. Service labor to replace parts is included, but equipment costs greater than $500.00 will require approval approved by the contracting officer.

g) SAFETY REQUIREMENTS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or his designee may determine be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer or his designee will notify the Contractor of any non-compliance with the foregoing provisions and the actions to correct the conditions to which attention has been directed.

Such notice, when served on the Contractor or his representative at this site of work, shall be deemed sufficient for the aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contract in default.

5.4. Emergency Support Service:

a) Emergency Support Service consists of unscheduled repairs. Unscheduled

Repairs_are those repairs required when the equipment is not in a usable condition and timely response during normal business hours by the Contractor is required. The Contractor will provide emergency support service by phone 24 x 7 x 365, with a telephone response time the next business day. A qualified service technician must call back within four (4) hours and be on site (if needed) by the next business day after initial notification of a problem by the department's point of contact. The term "response time" will result in the physical presence of a fully qualified technician arriving on the CC campus within the specified time. The contractor shall provide a response time for unscheduled service calls placed through the call center.

b) Equipment is to be fully operational within a maximum of 8 hours of the on-station response time. If the Contractor requires additional parts/time to complete required repair/service, the Contractor should contact the COR to coordinate completion of work within an agreed upon completion time/date, as these units support mission critical operations.

c) All repairs shall be in accordance with deuledited standards, manufacturers' specifications, and codes applicable to equipment covered in this contract.

d) All contractor's responses will be documented in writing with a point by point description of work completed and any required additional work, with-in 24 hours of call completion.

e) All repairs performed shall meet or exceed accredited standards, manufacturers' specifications, and codes applicable to equipment covered in this contract.

5.5. Equipment Validation per Service Visit or PM - After each Service or PM visit equipment validation must be completed that insures that the system works per the manufacturer's recommendation. Contractor required to provide detailed written service record per site visit and preventative maintenance. Validation of equipment to be included in written service record.

PART 6- APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

62. For validation purposes contractors must follow all applicable guidelines as set by manufacturer information provided per piece of equipment.

PART 7- ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 — Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 — Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective Standard — Method of Surveillan ce

Perforri la rice Threshold

PRS # 1.

The contractor shall provide Preventative Maintenance

The contractor provided preventative maintenance shall consist of four quarterly scheduled inspections and cleaning.

Zero Deviation from standard Contractor to provide written service record per visit.

PRS # 2

The contractor shall provide Quarterly services shall consist of cleaning, testing, Zero Deviation from standard

Contractor to provide written quarterly services. impucling, runniiig system diagnostics, calibrating and lubricating, documentation and validation.

service record per visit.

PRS # 3

The contractor shall provide emergency support services, Emergency support service consists of unscheduled repairs and capacity to provide these services 24/7/365.

Zero Deviation from standard

Contractor to provide written service record per visit.

PRS # 4 Zero Deviation from Validation of Validation must be completed standard equipment

The contractor shall provide that insures that the system to be equipment validation per service visit or PM.

works per the manufacturer's recommendations.

included in written service record.

_TECHNICAL EXHIBIT 2

Deliverables Schedule

Deliverable Frequency # of Copies Medium/Format Submit To

Provide all labor, parts (up to $500.00 per service request), materials, supervision, technical manuals, tools, test instruments, and transportation required to perform preventive maintenance and all unscheduled repairs

Per Scheduled and Unscheduled visits

N/A N/A N/A on the government owned Sterilizer Units in the Clinical Center (See Attachment 1) by manufacturer trained service technicians experienced with comparable units. All materials to be replaced shall be furnished by the Contractor.

Replacement parts $>500.00 per service request shall not proceed until approved by the Contracting Officer.

Provide detailed documentation (electronic and hard copy) of all preventive maintenance, repairs, and validations with itemization of necessary equipment, procedures, repairs and inventory management for each on-site visit (See Reports for documentation specifications).

Written service record to be provided per visit.

Documentation for each site visit is to include validation of system as described in PWS.

Per site visit.

Within 24 hours performed on

The contractor will provide hard copy at the time of the PM, and an electronic version of all field service corrective and preventative maintenance each of the designated pieces of sterilizer equipment listed in Appendix 1

Designated department contact, with a copy to the COR (at Gabriel.birriel-torres@nih.gov) and BIOMED (at (dram@cc.nih.go v)

Routine maintenance (4 times per year or according to manufacturer's specifications, whichever is greater), troubleshooting and

Per site visit.

Within 24 hours

2 See above Designated department contact, with a copy to the COR (at Gabriel.birriel-torres@nih.gov) and BIOMED (at unscheduled service is performed according to the manufacturer's specifications and is documented in writing and supplied to the designated department contact, COR and BIOMED, as outlined above.

(dram@cc.nih.go v)

All Sterilizer units are maintained in good working order, or returned to good

N/A N/A N/A N/A working order within 8 hours of the on-site time, or a repair plan with expected completion dates is presented for repairs that require additional time and materials.

Documentation of all Per site visit. 2 The contractor Designated unscheduled repair visits: Within 24 hours will provide department

Contractor shall submit to hard copy at contact, with a the designated the time of the copy to the COR department contact at the PM, and an (at time of work completion. electronic Gabriel.birriel- This work report is to be version of all torres@nih.gov) legibly signed and dated field service and BIOMED (at by the COR or the contact corrective and (dram@cc.nih.go person in the area indicating that the work has been completed_ This signed work report must contain:

1. Date and time of service/ inspection;

2. Brief description of work performed;

preventative maintenance performed on each of the designated pieces of sterilizer equipment listed in Appendix 1 v)

3. Equipment type, model and serial number;

4. Status of system upon completion of work;

5. Copy of inspection report, if applicable; and

6. Signature of designated COR or designated department contact accepting work during normal working hours.

*All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR

4.302(b).

1P

Sterilizer Equipment List

LOCATION

RM AGE DEPARTMENT MANUFACTURER SERIAL # MODEL # BLDG Comments

2021 10 2C334 1980

Clinical Pathology (Lab)

Amsco, Eagle Series

Amsco, Eagle Series Napco, E Series tabletop

124180010

123280016

A0009236B

9000D

2C334

2C334

1980 10

Dept of Imaging (Healthcare) Gettinge USA 04M05700 533HC 10580 2005

Unit Located in immarked room directly across from room B1C287A

Powerex Pure Air Technology — Air Compressor Calif 50 CFM, Dispose Amsco/Steris washer/sterilizer Amsco/Steris washer/sterilizer

STS050132

Synergy Synergy

2751216-60 4611702001 3602308003 3602108013

N/A B1N244 B1N254

B1N254

Materials Management (Healthcare)

Amsco/Steris ultrasonic processor

Amsco/Steris Et0 sterilizer /aerator

T207CO224

0103506-03

B1N254

B1N254

Caviwave

3017 10 2006 Amsco/Steris Et0 sterilizer/aerator 0100606-04 B1N254 Amsco/Steris steam sterilizer pr--vac 0316208-03 V-160H 10 B1N254 2008

Steris V-Pro 1 2009 B1N254 30540902 10

10 2008 Amsco Century Steris Reliance, Endoscope processor

Steris 20 (V-120)

Steris 36" (Arasco 3033)

31350807

3606410007

011120219

011290203

V-160H

Century Series Eagle

Series 3033

BN1254

4-3521

2C722

2C722

Respiratory Therapy

Surgical Services

(Healthcare) instrument room

2002 instrument room ckc

Sterilizer Equipment List

LOCATION

DEPARTMENT MANUFACTURER SERIAL # MODEL # BLDG R1VI Comments AGE

444 1 0 2C718 Amsco, Reliance 444 Washer Disinfector 3622901002 2001 decontamination room

Steris Reliance, Endoscope processor 3611508004 2C718 1 0

OR 2

0R3

2C610A

2C614A

1 0

G-116

G-116

Steris Amsco (G-116)

Steris Amsco (G-116)

10740507

12760205

G-116 2C560A OR 4/5 2002 10 Steris Amsco (G-116) 12700221

G-116

G-116

0R6

OR 7/8

1 0 Steris Amsco (G-116)

Steris Amsco (G-116)

12700219

12700222

2C566A

2C576A

2002 1 0 2C767B OR10 Steris Amsco (G-116) G-116 12770267

2005 G-116 2C714B OR 11/12 10 Steris Amsco (G-116) 10480505

444 10 2C718 Steris Reliance 444 Washer Disinfector 3612902006 2002 decontamination room

FAR Clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCTOBER 2016)

(a) North American Industry Classification System (NA/CS) code, and small business size standard.

The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of Offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF

1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show---

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5-) Term-s-of any-express-vvarranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR

52.212-3(b)for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and con-ditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative…

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