HT940624Q0065 - LeicaSakura Maintenence Services.pdf

SEE ADDENDUM

(No Collect Calls)

HT940624Q0065 11-Jul-2024

b. TELEPHONE NUMBER

910-381-0759

8. OFFER DUE DATE/LOCAL TIME

02:00 PM 17 Sep 2024

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT94069. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

HEATHER CLIPSON

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

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

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0012149052

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

DHA CONTRACTING OFFICE TIDEWATER HT9406

7700 ARLINGTON BLVD

FALLS CHURCH VA 22042

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0311 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NAV HOSP JACKSONVILLE FL

NAV HOSP JACKSONVILLE FL

2080 CHILD STREET

JACKSONVILLE FL 32214-5000

JACKSONVILLE FL 32214-5000

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$34,000,000

NAICS:

811210

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

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

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF50

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

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 . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

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

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT940624Q0065

Section SF 1449 - CONTINUATION SHEET

ADMINISTRATIVE INFORMATION

This requirement is set-aside 100% for Small Business. The associated NAICS code is 811210 and the associated small business size standard is $34,000,000.00

Award without Discussions: The Government intends to award without discussions and offerors shall submit their best price in their initial offer. Offerors must submit all informaiton identified within FAR 52.212-2 Evaluation – Commercial Items, in order for the Government to determine technical acceptability.

Amendments: The Offeror shall submit, as part of their quote, signed copies of all subsequent amendments issued to this solicitation.

In response to this solicitation, a quote shall be provided for all line items.

The quoter must be registered in the System for Award Management (SAM) database at the time of award and the following provisions and clauses shall be completed:

- FAR 52.204-20 PREDECESSOR OF OFFEROR (AUG 2020)

- FAR 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICESREPRESENTATION.(

OCT 2020)

- FAR 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR

A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

- FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT

2015) ALTERNATE I (FEB 2024)

INSTRUCTIONS TO QUOTERS

Quoters shall only submit one quote/solution to the Government in response to this solicitation. In the event an offeror is capable of providing multiple solutions, it is their responsibility to determine which solution to submit for evaluation. The Government will only accept one quote/solution per quoter.

This section specifies the format and content that quoters shall use in response to this Request for Quote (RFQ).

Quoters shall submit a response that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Any quote which does not provide, as a minimum, that which is required in the RFQ may be determined to be substantially incomplete and not warrant any further consideration.

Quotes shall be submitted via e-mail only to heather.y.clipson.civ@health.mil, referencing the solicitation, HT940624Q0065. Quotes are due by the date and time specified in Block 8 of the SF 1449.

Any questions regarding this solicitation must be addressed to heather.y.clipson.civ@health.mil by email only no later than 4 calendar days prior to the closing date. No phone calls accepted. Answers to questions will be addressed via an amendment, as soon as possible after the deadline for questions has closed. In the event multiple questions address the same issue, the Government reserves the right to answer a representative question that best exemplifies the issue. Please submit only one set of questions per company.

All quoters shall provide the following company details on its cover page:

Complete company name and address Company Point of Contact (POC) Email Phone Number Cage Code

DUNS number Place of Manufacture Size status of Business

If the quoter’s POC information changes at any time during the Pre-Award/Solicitation phase, the offeror is solely responsible for providing updated Company POC information. The Government is not responsible for following up with the quoter for updated information.

EVALUATION:

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i) Technical Capability

(ii) Price

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

ADDENDUM TO FAR 52.212-2, BASIS OF AWARD:

A. General Information:

1. The basis of award will be the Lowest Priced, Technically Acceptable offer. Offerors must receive a rating of Technically Acceptable in all factors/subfactors in order for their overall quote to be determined Technically Acceptable.

2. By submission of its offer, the offeror accedes to all solicitation requirements, including terms and conditions, and technical requirements.

3. The Government intends to make award without discussions, unless the Contracting Officer determines that discussions are necessary. Offerors should provide their most favorable prices in their initial offers.

B. Non-Price Evaluation Factors:

Technical: The contractor shall demonstrate that they have capabilities to perform to the specific tasks listed in Section 2.0 of the Performance Work Statement. If the offeror proposes to ‘partner’ or use a commercial service with a separate entity not owned, controlled or operated by the offeror, then the offeror should explain the nature of the arrangement with the separate entity. The explanation should explain the scope of services to be provided by the contractor and any other entities; and describe any formal/written or informal agreements between the contractor and other entities to provide the services required by this solicitation. Additionally, the explanation should specify the percentage division of payments between entities (any fractional percentages should be rounded to at least one decimal place). If the government requires additional information regarding an offeror’s arrangements with separate entities or division of contract payments, the government may issue clarifications to obtain additional information.

C. Price Evaluation Factor:

Price: Offerors shall complete the pricing schedule for each Contract Line Item Number (CLIN).

D. Quotes will be evaluated initially independently of the price to determine the Offeror’s ability to meet theGovernment’s requirement set forth in the solicitation. The Government may make a final rating determination based on the quote as submitted without requesting any further information. For all quotes determined to be Technically Acceptable, the offeror providing the lowest price will receive the contract award.

1. Offerors’ technical quotes will receive a technical rating based on one of the following:

(a) Technically Acceptable: Offeror meets all requirements or technical specifications or has submitted all documentation requested in any technical evaluation criteria and all documentation meets the standard set forth in the solicitation.

(b) Technically Unacceptable: Offeror fails to meet all requirements or technical specifications or has failed to comply in submitting requested documentation in any technical evaluation criteria or the submitted documentation fails to meet the standard set forth in the solicitation.

E. For the purposes of the award of this Contract, the Government intends to evaluate the option to extend services, provided under FAR 52.217-8, as follows:

1. The evaluation will consider the possibility that the option can be exercised at any time during any contract performance period and can be exercised in increments of one to six months, but for no more than a total of six months during the life of the contract.

2. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in effect under the contract when the option is exercised.

3. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all quotes relative to each other, and will not affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise.

4. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8.

(End of provision)

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency

Performance Work Statement

Government-owned Leica and Sakura Finetek Laboratory Equipment Preventive Maintenance and Corrective Maintenance Service

07 June 2024

Naval Hospital Jacksonville, FL

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide: Maintenance on designated government owned Leica and Sakura Finetek Laboratory Equipment.

1.1.1 Description of services/introduction: The Contractor shall provide preventive and corrective maintenance services on the Leica and Sakura Finetek Laboratory Equipment. The Contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with the newest US, State, and Local law and regulations, Defense Health Agency (DHA) regulations, College of Pathologists (CAP), and The Joint Commission (TJC) requirements.

1.1.2 Background: Naval Hospital Jacksonville (NHJAX), is requesting maintenance and service support for medical devices used for labroratory clinical diagnosis. NH JAX is comprised of the Naval Hospital and associated Naval Branch Health Clinics located in in Florida and Georgia. NH JAX supports warfighters’ medical readiness to deploy and clinicians’ readiness to save lives.

1.1.3 Scope: The contractor shall provide preventive maintenance and corrective maintenance on designated Government-owned Leica and Sakura Finetek Laboratory Equipment. Technical Exhibit 1 references the full list of Government-owned medical equipment. The Contractor shall provide preventive maintenance to include regularly scheduled preventive maintenance and inspections every six (6) months or annually as per manufacturer’s recommendations. Corrective maintenance includes, repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturer’s specifications following a reported failure and repair.

1.1.3.1 The contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with the newest US, State, and Local law and regulations, DHA regulations, College of American Pathologists (CAP), and The Joint Commission (TJC) requirements. The Joint Commission’s requirements are specified in its Comprehensive Accreditation Manual for Hospitals (CAMH), readily found on https://www.jointcommission.org/. DHA regulations and instructions will be available upon request to maintain equipment within OEM specifications.

1.1.3.2 The contractor shall provide unlimited telephone support between the hours of 0800 and 1700, Eastern Time, Monday through Friday, preventive maintenance and inspections, corrective maintenance tasks, and unlimited emergency responses by the Contractor’s Field Service Engineers for all medical devices listed in the PWS, to include Technical Exhibit 1. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

1.1.3.3 When product recalls, updates, or upgrades are necessary to maintain the contractual equipment inventory within the OEM’s specifications, the Contractor shall obtain and install the OEM required parts, software to comply with the recall, update.

1.1.3.4 The aggregate amount of equipment covered under the contract shall fluctuate over time, as hardware and software eclipse useful life and as new equipment comes off warranty. . Any changes to the equipment list will be executed through an official contract modification.

1.1.3.5 Should the contractor chose to subcontract any services within this PWS, the subcontractor must also meet all requirements herein.The contractor is responsible for ensuring that all contract requirements are met, regardless of whether services are to be provided by the contractor or subcontractor..

1.1.4 Period of Performance (PoP): One base year and two 12 month option years. The Period of Performance is estimated as follows:

Base Period: 01 September 2024 – 31 August 2025 Option Period 1: 01 September 2025 – 31 August 2026 Option Period 2: 01 September 2026 – 31 August 2027

1.2 Administrative specifications

1.2.1 Place of performance:

Naval Hospital Jacksonville 2080 Child Street, Jacksonville, Florida, 32214

1.2.2 Recognized Federal holidays: The contractor is not required to work on the following Federally observed holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.2.3 Hours of operation: The contractor shall provide unscheduled support/service coverage between the hours of 0800 and 1700 (Eastern Time), Monday through Friday, excluding United States Federal Government holidaysor when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. 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.

1.2.4 Emergency Services: N/A

1.3 Contractor Identification

1.3.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Governemnt understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1 The contractor shall provide regularly scheduled preventive and corrective maintenance on all equipment listed in Technical Exhibit 1. The contractor shall complete manufacture required prevenative maintenance semi-annually or annually, as identified in Technical Exhibit 1 and as recommended by manufacture. Maintence shall include replacing manufacture recommended replacements parts, installation kits or any other items, as required to maintain the equipment within the original equipment manufacturer’s (OEM) specifications. The contractor shall obtain and install product recalls, updates, or upgrades necessary to maintain the contractual equipment inventory within the OEM’s specifications.

2.1.1 Quarterly: N/A .

2.1.2 Scheduling Maintenance: Preventive maintenance visits shall be scheduled at least one week in advance. If the routine scheduling for the equipment items is in excess of 1 week in advance, then the preventive and/or corrective maintenance visits must be coordinated at least that far in advance to prevent the rescheduling of patient care. The Government’s Point of Contact (POC) for preventive and/or corrective maintenance is Mr. Steven Rath, steven.j.rath.civ@health.mil, (904) 542-9053.

2.1.3 Reporting: The contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs, in accordance with OEM specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error. Upon completion of each preventive maintenance visit and each corrective maintenance service, Field Service Engineers must submit a signed field service report (FSR), in English, to officially record all instances of contracted troubleshooting, work, and services conducted on equipment within three (3) working days to the COR and Biomedical Equipment Technician (BMET), Technician Liaison

(TL), and Biomedical Department for data entry into DMLSS. The contractor will report to BMET to check in and out with every service provided.

The FSR shall include all information outlined below:

Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, Field Service Engineers must submit a signed Field Service Report (FSR) to BIOMED. The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action. Each service report must at a minimum document the following data legibly, in English, and in complete detail:

1. Name of Contractor

2. Name of Contractor personnel performing service

3. Contractor personnel log/control number

4. Equipment identification factors to include: Manufacturer, make, model, serial number and Facility

Equipment Control Number (ECN)

5. Description of problem reported by user

6. Date & time of initial trouble call

7. Date & time, beginning and ending, of hours on-site for service call

8. Itemized description of service performed to include, but not be limited to: parts used, problem found, corrective action(s) taken or recommended, communications had with Medical Treatment Facility (MTF) personnel

9. Resolution and/or pending action(s)

10. Estimated total billing cost, if the MTF did not have an existing maintenance agreement:

a. Include the list price of services, labor, travel, and parts

b. Note - This pricing information is not to be confused with an invoice and no separate payments will be made for the services provided. This is a firm fixed price contract, meaning the contract will be reimbursed at an agreed upon monthly rate regardless of the amount of work performed each month.

11. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

2.1.3.1. Test equipment: The Contractor shall ensure that all test equipment comply with calibration standards, which are to be used in the performance of this contract, are traceable and certified in accordance with National Institute of Standards and Technology (NIST). Upon request by COR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on MTF equipment. In the event the test equipment and/or calibration standards are calibrated/certified throughout the course of this contract, the latest calibration/certification documentation must be submitted to BIOMED.

2.1.3.2. Removal of equipment from site: No equipment shall be removed without the approval of the COR, duty BMET, and Command Equipment Manager. Security/property passes for equipment removal shall be obtained by the Contractor personnel via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of service Contractor personnel are the sole responsibility of the service Contractor personnel.

2.1.3.3 Removal Report: The Contractor shall provide a detailed description of removed medical devies in writing on the Contractor’s company letterhead. The description will includes manufacturer’s serial numbers and equipment control number (ECN).. In the event that items/sub-assemblies/accessories are repaired via “Repair by Replacement”, a detailed description of replaced items is to be included upon return of repaired components.

2.2 Coverage: Maintenance is Monday through Friday, between 8am to 5pm EST to include regularly scheduled preventive maintenance and inspections and any needed unscheduled repairs to maintain the equipment operational per OEM specifications, Monday through Friday coverage 8am-5pm.

2.2.1 Loaner Equipment: Not required

2.2.2 Up time: Uptime is defined as that time, during the clinical areas’ normal business hours, when the equipment is available for clinical use without restrictions to the quality of the results, and without safety hazards to the patient, staff, or visitors.

2.2.3 Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed service report to the COR or his/her designee within three (3) working days. The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action.

2.3 Replacement Parts: the contractor will provide all Manufacturer recommended replacements parts, prevenative maintenance kits, batteries, orings, seals, tubing or any other items needed to maintain the equipment within the original equipment manufacturer’s (OEM) specifications.

2.4. DEFINITIONS. As used throughout this work statement, the following terms shall have the meaning set forth below:

2.4.1 Calibration: This activity should be the procedures for the mechanical adjustments of the device to ensure consistent, standardized performance or output as per the original equipment manufacturer recommendations.

2.4.2 Contracting Officer (KO): A warranted representative of the federal Government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.4.3 Contracting Officer’s Representative (COR): A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

2.4.4 Contractor Performance Assessment Reporting System (CPARS): Web enabled application that collects and manages the library of automated CPAR’s.

2.4.5 Corrective Maintenance: Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

2.4.6 Defense Medical Logistics Standard Support (DMLSS): The automated procurement, maintenance, and supply system utilized to document various material management functions within the command, and throughout the Department of Defense.

2.4.7 Field Service Report (FSR): Documentation completed by vendor personnel to officially record all instances of contracted troubleshooting, work, and services conducted on equipment. Specifics on required reporting details can be seen in Section 3.9.2.

2.4.8 Inspections: The activity of doing functional testing and safety inspections of a medical device at regular intervals to ensure that the equipment is safe for use in accordance with manufacturer’s recommended procedures.

2.4.9 ISO 9001: The ISO 9000 series is a set of five individual, but related, international standards on quality management and assurance. These standards were developed to effectively document the quality system elements to be implemented in order to maintain an efficient quality system in a company. ISO 9001 is the most comprehensive standard covering design, manufacturing, installation, and servicing systems.

2.4.10 Medical Treatment Facility (MTF) or Patient Care Facility: All gross square footage for building with a primary function of delivering Government health care services. (i.e. hospital or clinic, including all activities providing outpatient and/or inpatient health services for authorized patient care)

2.4.11 Original Equipment Manufacturer (OEM): The company which has created a specific model of product/device.

2.4.12 Preventive Maintenance: Preventive maintenance is used to describe those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating software for security, safety or system functionality issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

2.4.13 Quality Assurance (QA): Actions, including inspections, performed by the Government to determine whether products and services conform to contract requirements.

2.4.14 Quality Assurance Evaluator (QAE): A Government employee responsible for performing quality assurance functions for a contracted service.

2.4.15 Quality Control (QC): Actions, including inspections and preparation of inspection records, performed by the Contractor to ensure that products and services conform to contract requirements.

2.4.16 Scheduled Parts Replacement (SPR): This is the listing of parts that need replacing at certain intervals.

This may be either hour-based or date-based, in accordance with manufacturer’s specifications.

2.4.17 Uptime: Uptime is defined as that time, during the clinical areas’ normal business hours, when the equipment is available for clinical use without restrictions to the quality of the results, and without safety hazards to the patient, staff, or visitors.

3.0 Qualifications/Considerations

3.1 Special Qualifications/Considerations: The contractor must be an OEM-certified service provider. Contractor must verify that an individual whom they plan to employ or continue to employ in the United States is authorized to accept employment in the United States. Individuals such as those who have been admitted as permanent residents, granted asylum or refugee status, or admitted in work-related nonimmigrant classifications may have employment authorization, as direct result of their immigration status. Contractor Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product.

3.1.1 Field Service Engineers (Engineers) shall be authorized by the OEM-certified service vendor to perform the required maintenance services. The Contractor shall ensure that all field engineers possess current OEM-certification level training on all devices encompassed in the equipment list. Field Service Engineers shall have sufficient experience to demonstrate proficiency in maintenance of the Government-owned product(s).

3.1.1.1 Service vendors shall provide, to the COR, written assurance of the competency of their personnel as well as a list of credentials of approved Field Service Engineers. The KO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

3.1.1.2 Government Right of Refusal: NH JAX reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter the premises or work on NH JAX equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include, but not be limited to: behavior, attire, security concerns, and immigration status.

3.1.1.3 Field engineers shall provide all parts, labor, materials, travel, personnel, supervision, and freight shipping necessary to complete repairs and preventive maintenance on all equipment listed within this contract.

3.1.1.4 Field engineers shall provide services in accordance with the performance requirements specified in this performance work statement.

3.1.2 Technician documentation: The Contractor shall obtain, have on file, and make available to its Field Service Engineers all operational and technical documentation, which is required to meet the performance requirements of this contract. This documentation shall include any software needed or beneficial in speeding the diagnosis, repair, or calibration of the equipment, equivalent to that used by the OEM to perform the same work. The Contractor shall ensure that all Field Service Engineers possess the ability to perform corrective software updates/upgrades and OEM or FDA recall notices, and are in possession of legally licensed diagnostic software necessary for rapid, efficient, and effective maintenance. NOTE: Software and/or hardware must be an approved product by the Defense Health Agency (DHA), and authorized to be used on the DHA Network. The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

3.1.3 Tools: The Contractor will provide suitable, OEM-recommended repair equipment or tools required for the satisfactory execution of all repairs made on Government-owned equipment.

3.1.4 In order to travel freely onto and off of the military installation at NH JAX , Field Service Engineers may have to undergo background checks, the Rapid Gate process, the Defense Biometric Identification System (DBIDS) process, or a similar process.

3.1.5 The Contractor Point of Contact (POC): The Contractor shall provide, in writing, the name and telephone number of a primary and alternate, English-speaking, individual to act as their representative for the scheduling and coordination of service calls.

3.2 Preventive Maintenance: Contractor shall ensure that 100% of all periodic maintenance is performed within thirty (30) days of due date. Preventive maintenance visits shall include complete inspection and testing of the equipment in accordance with DMLSS maintenance procedures and/or manufacturer’s recommended guidelines.

3.2.1 Equipment in Use: If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance for the entire thirty (30) days before the maintenance due date, the Contractor shall immediately notify the COR.

3.2.2 Equipment Unable to Locate (UTL): If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the COR. Contractor shall arrange the performance via coordination with the Contracting Officer’s Representative (COR) or Technical Liaison (TL) during circumstances of unexpected delays (i.e. non-availability of the patient care areas due to room occupancy, etc.), at no additional cost to the Government. The COR may determine that the property has been disposed of or is otherwise inactive or unavailable for use and adjust Technical Exhibit 1, accordingly.

3.2.3 Preventive Maintenance Scheduling: The Contractor shall schedule service vendor preventive maintenance visits as specified for each equipment item. For all equipment listed in Technical Exhibit 1, the frequency of preventive maintenance will be determined by the DMLSS property database, dependent on device codes, unless the OEM PM (preventive maintenance) periodicity is more frequent. The Contractor shall coordinate with BIOMED and/or the TL to ensure the preventive maintenance completion month(s) are aligned with the due date(s) for each device set forth in DMLSS. The schedule is to be documented at the beginning of the contract period with a copy provided to the Contractor, COR, TL, and BIOMED.

3.2.3.1 Preventive maintenance visits shall be scheduled with the NH JAX Biomedical Engineering Department (BIOMED) at least one month in advance. If the routine procedural scheduling for clinical use of equipment items is in excess of 1 month in advance, then the preventive maintenance visits must be coordinated at least that far in advance, so as to not require rescheduling patients. Recommended annual preventive maintenance frequencies for each device, based upon device code and/or ECRI classification, are listed in Technical Exhibit 1.

3.2.4 Preventive Maintenance: Under the circumstances of 3.2.1 or 3.2.2, the Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the Government. Equipment determined missing, lost, or stolen shall be removed from Technical Exhibit 1 via official contract modification.

Upon completion of PMs, the contractor shall affix a PM completion sticker to the serviced device. This PM sticker shall include the name of Field Engineer completing the PM, Field Engineer ID number (if applicable), PM completion date, and due date of next PM. This sticker shall withstand normal wear and tear and application of hospital-grade cleaning products.

3.3 Corrective maintenance: The Contractor shall provide for any corrective maintenance services necessary to maintain equipment within the original manufacturer’s specifications, and in accordance with any applicable FDA and/or Joint Commission requirements. Corrective maintenance shall include repairs for all listed equipment to include problems resulting from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc.

3.3.1 The Contractor will not accept any trouble calls other than through BIOMED. Contractor trouble call intake from BIOMED shall include a work order number, indicating that the equipment failure and service needed is properly recorded and included in the equipment’s maintenance history.

3.3.2 Modifications: The Contractor shall maintain equipment within the original manufacturer’s specifications, and shall make no modifications to the original design.

3.3.3 Repair by exchange: All “repair by exchange” shall be approved in advance by the COR and/or TL.

Replacement(s) shall be sent to NH JAX within 24 hours of malfunction/damage disposition. Replacement(s) must be the exact same part/model number, generation, and quality of equipment as the previous system prior to its damage.

3.3.4 Response time: Within one (1) hour of notification by the NH JAX BIOMED, Contractor technical personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone technical support, the contractor personnel shall arrive onsite within eight (8) hours to complete the requested service or repair. The onsite response time is measured from the time the Contractor is originally called, not from the time the contractor returns the call. On-site responses will only be rendered under this contract during the 0800-1700Eastern Time support hours. For the select sterilization units noted in Technical Exhibit 1, on-site response time shall occur at any hour Monday to Friday.

3.3.5 Telephone Support: Telephone consultation shall provide instruction in determining operator error, determine the most likely cause of the problem, determine if resolution of the problem requires the dispatch of a FSE, and identify replacement parts likely to be required in order to return the equipment to 100% operational condition, as specified by the OEM.

3.3.6 Software maintenance is within the scope of the contract, including updates and patches as needed. The contractor shall provide software revisions and updates, via field service changes, as required by the FDA or manufacturer announced safety-hazard recalls. Updates shall be performed as soon as possible after release, no later than the first scheduled Preventive Maintenance Inspection following release. Any updates that have been identified as critical, or required for the proper operation of equipment, shall be installed within thirty (30) calendar days of release.

3.4 Overtime: No overtime services are authorized.

3.5 Recalls and Updates: For all equipment covered under this contract, the contractor shall resolve all FDA recalls, manufacturer recalls, and other mandatory updates within thirty (30) calendar days of the OEM’s public notification. The contractor shall provide documentation to the Biomed shop of such installation and mandatory updates.

3.6 Parts: The contractor shall provide coverage for all repair and replacement parts necessary to maintain the equipment, listed in Technical Exhibit 1, within the parameters of the original manufacturer’s specifications. The contractor shall supply new, non-refurbished OEM parts, lubricants, and lubricant wear points for all repairs.

Contractor installed replacement parts shall become the property of the Government. The contractor shall extend to the Government all commercial warranties on replacement parts, consistent with standard industry practices.

Replaced items shall be properly disposed of at no additional cost to the Government (contractor shall pay all “environmental fees”, where required). Replacement parts shall be furnished within one (1) business day of initial request or next day by 10:30 AM (local time), whichever is quicker. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts, shall be the responsibility of the Contractor.

3.7 BMET Training: The contractor shall provide one initial training session for the all MTF BIOMED personnel on the procedures and processes of the contractor’s maintenance program, immediately upon contract award. This training will provide the BMETs with insight into the OEM specified procedures for preventive maintenance and frequently observed issues that require corrective maintenance.

3.8 Completion During Hours of Work: Except for select sterilization equipment, work required in the performance of this contract shall be performed Monday through Friday, 0730 – 1600 (Eastern Time), excluding United States Federal Government holidays. The contractor shall also provide a telephone consulting service, twenty-four (24) hours per day, seven (7) days a week. This telephone consulting service shall be provided to avoid undue delays in contract service coverage during after-hours and weekend/holiday periods, as applicable. Under no circumstances shall the contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract.

3.9 Service Events: Upon arrival on-site, prior to performing any work, Field Service Engineers shall physically sign in with BIOMED during normal working hours. The COR, TL, and/or any BIOMED Personnel may accompany the field service person as an observer during any work performed on-site.

3.9.1 Lock Out/Tag Out: The contractor shall personally notify BIOMED, via FSR, of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment (i.e., Lockout, removal to BIOMED) shall be implemented in compliance with Occupational Safety and Health Administration (OSHA) and DHA regulations, specifically Title 1910.147 of the Code of Federal Regulations, to prevent any patient, staff, or visitor hazards. Where lockout procedures are not possible, tag-out procedures shall be followed in accordance with the above regulations. Additionally, a label shall be adhered to the disabled equipment specifying the equipment is not serviceable. Reference (i) is available at:

http://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.147

3.9.2 Off-site repairs: No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Contractor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor. The Contractor shall provide insurance coverage for damage to or loss of equipment while in Contractor or service Contractor’s custody. The Contractor shall provide alternate, interim loaned unit(s) for any equipment requiring repairs outside of the Materials Management Department, BIOMED, NHJAX.

3.9.3 Hard Disk and Solid State Drives (HDD & SSD): In regard to patient information confidentiality and privacy, Contractor personnel shall not remove equipment containing patient information from the NHJAX. Neither HDDs nor SSDs shall ever be removed from the MTF, by the Contractor under this maintenance agreement.

Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager.

3.9.4 Return of Government-owned property: Upon completion of any and all regularly scheduled preventive or unscheduled corrective maintenance, the Contractor shall return all equipment owned by the United States Government.

3.10 Uptime: Equipment shall be returned to operational condition within 48 hours after telephone notification from

BIOMED.

3.10.1 Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better for all equipment listed in Technical Exhibit 1. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MBTF).

3.10.2 Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at NHJAX, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

Variables Definitions:

U= Possible Equipment Uptime (100%) H= Hours of Coverage per day H1= Begin Coverage Time during each day H2= End Coverage Time during each day A= # of covered days of the week W = Weeks of Coverage in a Year C= Uptime Commitment (per Section 3.13.1.)

Known (for this contract, per Section 1.1.3.5. & 3.13.1.):

H1= 0800 hours H2= 1500 hours A= 5 days per week W= 52 weeks per year C = 95%

Calculations:

H = 𝐻2 – 𝐻1 = 1600 – 0730 = 8.5 Hours of Coverage per day 100 100

𝑈 = 𝐻 ∗ 𝐴 ∗ 𝑊 = 8.5 ∗ 5 ∗ 52 = 2,210 𝐻𝑜𝑢𝑟𝑠 𝑜𝑓 𝑃𝑜𝑠𝑠𝑖𝑏𝑙𝑒 𝐸𝑞𝑢𝑖𝑝𝑚𝑒𝑛𝑡 𝑈𝑝𝑡𝑖𝑚𝑒

D = Hours of Calculated Downtime (Unknown) T = Total Actual Uptime Percentage (Unknown) Δ = % difference from Uptime Commitment (Unknown)

T = U – D = 2210 – D U 2210

Δ = (𝐶 − 𝑇) ∗ 100 = (.95 − 𝑇) ∗ 100

*Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 1.1.3.5. Downtime hours outside of the coverage timeframe listed in Section 1.1.3.5. shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

3.14 End of Service Life: For all equipment, hardware, software, and accessories, covered under the terms and conditions of this contract, the vendor shall notify the COR, NHJAX, and Contracting Officer prior to this equipment’s commercial end of service life (EOSL). This notice shall be delivered in a timely manner, in writing on the Vendor’s letterhead, via email to the following address: usn.jacksonville.navhospjaxfl.list.biomedical-repair@health.mil

3.14.1 This specific contract deliverable shall supplement, but not supersede, any existing, external ‘End of Service Life Notification’ requirements, as set forth by other Government agencies, such as the Food & Drug Administration (FDA) or the Joint Commission.

3.14.2 Delivery of this letter shall not immediately remove the vendor’s liability of covering the equipment under the terms and conditions of this contract. Its delivery shall simply be a means to start a dialogue with the COR and DHA about the parameters associated with the commercial EOSL for the specific make/model of medical equipment.

4.0 Points of Contact

4.1 Contracting Officer’s Representative (COR): The following individual is designated as the COR for this Contract:

Name of Primary COR: Steve Rath Primary COR Email Address: steven.j.rath.civ@health.mil Primary COR Telephone Number: 904-542-9053

Contracting Officer: The following individual is the KO for this TO:

Name of KO: Carrie Gaither Email Address: carrie.e.gaither.civ@health.mil

TECHNICAL EXHIBIT 1

TECHNICAL EXHIBIT 1- EQUIPMENT INVENTORY LISTING

DEPARTMENT

EC

N

MANUFACTURE

R NOMENCLATURE

MOD

EL

SERIA

L #

SUPPORT

COVERAGE

SERVICE

COVERAGE

PATHOLOGY/L

AB CLINIC 104

LEICA

MICROSYSTEM

S INC MICROTOME, ROTARY

RM22

55 5784 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC 104

LEICA

MICROSYSTEM

S INC MICROTOME, ROTARY

RM22

55 5785 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC 104

LEICA

MICROSYSTEM

S INC

SLIDE STAINER,

CYTOLOGY/HISTOLOGY

ST50

1832-

062012 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC

SAKURA

FINETEK USA

INC

TISSUE EMBEDDING

EQUIPMENT

TEC-

510117

M-F 8-5

Full Service

PATHOLOGY/L

AB CLINIC 104

LEICA

MICROSYSTEM

S INC

COVER SLIPPING

MACHINE

CV50

3609-

072012 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC NO

NE

LEICA

MICROSYSTEM

S INC TRANSFER STATION

TS50

152407

2012 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC 114

LEICA

MICROSYSTEM

S INC

MICROTOME,

CRYOSTAT

CM19

000000 08028 M-F 8-5 Full Service

PATHOLOGY/L

AB CLINIC 114

LEICA

MICROSYSTEM

S INC

MICROTOME,

CRYOSTAT

CM19

000000 08123 M-F 8-5 Full Service

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months Leica and Sakura Maintenance Services

FFP

The contractor shall provide on-site service to include all travel and labor required for preventative and corrective maintenance services on Leica and Sakura Finetek Laboratory equipment in accordnace with the PWS. Period of Performance: 30 September 2024 through 29 September 2025.

FOB: Destination

PURCHASE REQUEST NUMBER: 0012149052

J065

NET AMT

1001 12 Months OPTION Leica and Sakura Maintenance Services

FFP

The contractor shall provide on-site service to include all travel and labor required for preventative and corrective maintenance services on Leica and Sakura Finetek Laboratory equipment in accordnace with the PWS. Period of Performance: 30 September 2025 through 29 September 2026.

FOB: Destination

2001 12 Months OPTION Leica and Sakura Maintenance Services

FFP

The contractor shall provide on-site service to include all travel and labor required for preventative and corrective maintenance services on Leica and Sakura Finetek Laboratory equipment in accordnace with the PWS. Period of Performance: 30 September 2026 through 29 September 2027.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001…