FBO_1084029.pdf

Subject: Management and Coordination of the Maintenance and Repair Services for Scientific Instruments

Solicitation Number: FDA1084029

PART 1 – DESCRIPTION

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE

WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND

SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION;

QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE

ISSUED.

This solicitation is requesting proposals as a result of this document, incorporated provisions and clauses in effect through Federal Acquisition Circular 05-53.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541611.

This requirement is for Management and Coordination of the Maintenance and Repair Services for Scientific Instruments. The requirement is a 100% small business set-aside as a result of this combined synopsis/solicitation and will be a single award contract.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

2. DESCRIPTION OF SERVICES

The U.S. Food and Drug Administration (FDA) is a regulatory agency with responsibility for the safety of food for humans and animals and the safety and efficacy of drug, devices and other medical products. In support of this regulatory mission FDA operates laboratories which conduct analyses using scientific instruments. FDA laboratories are located at sites across the United States. The FDA now requires the use of a Contractor to manage and coordinate on-site maintenance and repair services for scientific instruments at FDA facilities nationwide.

2.1. Contract Type

2.1.1. It is anticipated that this will be an indefinite delivery/indefinite quantity (IDIQ) contract vehicle with the issuance of Firm Fixed-Price or Time & Materials Task Orders for a base year contract with four option years.

2.2. Pricing Terms

2.2.1. The FDA intends to award individual Task Orders from each FDA Center under this contract which will provide each FDA Center the level of support they require meeting their scientific instrument maintenance and repairing requirements.

2.2.1.1. The guaranteed minimum is the concurrent award of the initial task order for services.

2.2.2. The pricing break-down is based upon the Attachment 2, Pricing Matrix and Master Instrument List from each of the FDA’s Centers. FDA reserves the right to add or delete instruments during the course of this contract. Any changes to the list of instruments will be coordinated between the Agency’s COTR and approved by the Contracting Officer.

2.2.2.1. Individual FDA Centers or FDA Offices will determine the coverage and service level required for each instrument at the Task Order level.

2.2.2.2. For each covered instrument, an FDA Center or FDA Office will choose a) Preventive Maintenance only, b) Repair on-call only, or c) Full Service Coverage.

FDA will specify the number of Preventive Maintenance visits annually for each instrument.

2.2.2.3.Each FDA Center or FDA Office will specify the service level (see definition of these “service levels” in section 2.5 of this document) required per instrument.

2.2.2.4. The Contractor shall be responsible for providing a price for each individual instrument based on the service level, acceptance standard and documentation requirements identified by the Agency on the master instrument list. The price provided by the Contractor will be for the following categories of support: a) Preventive Maintenance, b) Repair on-call, or c) Full Service Coverage. The pricing for Repair on-call support may consist of hour labor rates (plus markup), travel rates (plus markup), and other standard costs (plus markup) that would be charged by an OEM or third party servicing entity for the specified instrument. The authorized Agency Lab staff at each site (the Instrument Point-of-contact) shall submit a request for quote directly to the Contractor. The request for quote may be a necessary step to ensure that there is adequate funding available for the additional service required.

This request for support to the Contractor may come after the Agency Lab staff has contacted a third party for assistance, such as the free customer support provided by the manufacturers of some of these instruments. Thus, the Contractor may be directed to contact a specified third party such as an identified instrument’s OEM staff with whom a discussion of the instrument’s malfunction has already taken place.

2.2.2.5. The Pricing Matrix is located in Attachment #2.

2.3. Maximum Contract Ceiling

2.3.1. This IDIQ Contract will have an overall ceiling price of $20 Million. The maximum aggregate dollar value of the task orders awarded to the Contractor can not exceed the established contract ceiling.

2.4. Definitions

2.4.1. The purpose of this section is to provide clarity in the use of FDA words or terms that may have conflicting meanings in the commercial sector. The following words or terms will have the same meaning throughout this solicitation. Terms are italicized if they have a definition in this list.

Acceptable Component. A component which meets OEM specifications and is OEM certified for replacement of an equivalent component on a non-performing or non-operational instrument.

Acceptable Part. A part which meets OEM specifications and is OEM certified for replacement of an equivalent part on a non-performing or non-operational instrument.

Acceptable Maintenance Engineer. An engineer employed by a third party service provider who holds a current OEM certification and has received the most recent OEM training in maintenance procedures applicable to an instrument which is the subject of a scheduled maintenance call. Engineers who do not hold current OEM certification or have current OEM training may be acceptable under an alternative maintenance case.

Acceptable Repair Engineer. An engineer employed by a third party service provider who holds a current OEM certification and has received the most recent OEM training in procedures applicable to a non-performing or non-operational instrument which is the subject of an unscheduled repair services call.

Acceptable Technical Support. Technical support which is current with the latest information available from the OEM.

Acceptable Third Party Service Provider. Acceptability is determined by FDA. Acceptability is based on provider’s ability to provide acceptable engineers, acceptable components and acceptable parts, and customer satisfaction reports.

Acceptance Testing. A procedure which ensures that full operation can be demonstrated before a scheduled maintenance or unscheduled service call can be completed. To carry out acceptance testing, instrument performance is compared to a performance standard. Acceptance testing could consist of requirements specified in a quality management program such as (1) method-specific performance qualification tests, (2) instrument specific operational qualification tests, or other tests such as (3) calibration tests, (4) comparison with recent, prior performance data, or (5) comparison to OEM specifications. The nature of the acceptance testing to be performed must be specified before service begins. In the absence of a performance standard, acceptance is documented by the signature of the instrument point-of-contact.

Accessory. An item associated with a covered instrument without being an integral part of that instrument or its components. Some instruments require certain accessories in order to carry out sample analysis. In contrast to parts and components, accessories have single-use or limited-use and need to be acquired on a recurring basis. An accessory is compatible with a specific instrument according to OEM specifications or determination by the instrument point-of-contact.

Agency COTR (Contract Officer’s Technical Representative). The individual who officially represents FDA in the execution and oversight of the programmatic aspects of the contract..

Center. The major sub-divisions of the FDA. Each Center is responsible for specific aspects of FDA’s mission. FDA Centers includes the Center for Veterinary Medicine (CVM), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), the National Center for Toxicological Research (NCTR), the Office of Regulatory Affairs (ORA) and the Center for Tobacco (CTP).

Center Project Manager (PM). Individual at each FDA Center who collaborates with the Agency COTR and the instrument points-of-contact.

Component. Depending on context, may refer to a removable section of an instrument (examples:

power supply module, motherboard), or a wholly self-contained unit of an instrument which is itself made up of several components (example: auto-sampler).

Contract Line Item. A single-entry on a form for the reporting, redistribution, and disposal of Contractor inventory that indicates a quantity of property or services having the same description and condition code from any one contract at any one reporting location.

Contract Officer. The individual who officially represents FDA in the execution and oversight of the contractual and financial aspects of the contract with the contractor.

Component Removal & Replacement. A process conducted by the FDA instrument point-of-contact or their FDA designee. An acceptable component is first shipped to the site. Upon arrival, the current component is removed from the instrument and replaced by the acceptable component. The replaced component is then shipped back to an address designated by the contractor.

Component Shipment & Exchange. A process conducted by the FDA instrument point-of-contact or their FDA designee. The instrument itself or an instrument component is shipped to an address designated by the contractor. An acceptable component is then shipped back to the site and replaced on the instrument by FDA.

Covered Instrument. An instrument listed on the current master Instrument list (MIL).

Diagnostic & Troubleshooting Support. Communication between the instrument point-of-contact and an acceptable technical support provider to localize the cause of non-performance or non-operation, in order to determine possible solutions and estimate the cost of repair services.

Documentation of Completed Services (Maintenance or Repair). A full description of all procedures that were carried out, parts and components installed, and tests conducted to verify subsequent instrument performance and operation. This would include descriptions and results of acceptance testing. This documentation must be provided before a service call can be completed.

Factory. See Original Equipment Manufacturer in the definition list.

Full Operation. The quality of meeting a current performance standard, i.e., not being a non-performing instrument and not being a non-operational instrument.

Instrument. A device whose purpose is to carry out measurements based on the physical or chemical properties of a sample. May contain electrical, electronic, or electro-mechanical components. Includes firmware loaded on components intrinsic to the instrument. Includes data system software loaded on a dedicated computer workstation used to control the instrument’s operation and acquire data from it.

Instrument Type. Under this contract, includes mass spectrometer, liquid chromatograph (high pressure or ultrahigh pressure), nitrogen generator, gas chromatograph, etc.

Instrument Point-of-contact. One designated FDA employee who is responsible for a specified instrument on the MIL. POCs will initiate or receive communications involving the contractor, the Agency COTR, the Center PM, or the third-party servicing contractor.

Maintenance Protocol. The specific actions, acceptance tests, documentation, performance standards and service level required for scheduled maintenance on a covered instrument.

Maintenance Services. Carried out in response to an instrument’s requirement that maintenance be carried out by a specified date under an instrument specific maintenance protocol. Carried out by an acceptable maintenance engineer who carries out procedures and/or installs acceptable parts or acceptable components required under the maintenance protocol. Maintenance services include documentation of completed maintenance services.

Manufacturer. See Original Equipment Manufacturer in the definitions list.

Master Instrument List (MIL). A list in spreadsheet form which contains all information about each instrument required to provide all maintenance and repair services called for under this contract. The data elements on the MIL are listed in Appendix 1.

Non-performing instrument. An instrument which is not capable of meeting performance standards which it could previously meet. For an instrument to meet this definition, there must be prior qualification data or OEM instrument specifications to establish a performance standard.

Non-operational instrument. An instrument from which no data can be acquired, or for which diagnostic & troubleshooting services indicate the failure of a part or component.

Office. An organizational unit within an FDA Center whose specific focus lies within the Center’s mission. Different Offices of one Center may or may not be at different sites.

Original Equipment Manufacturer (OEM). The commercial entity which designed and built the instrument. May not correspond to the commercial entity from whom FDA purchased the instrument.

The terms OEM, factory and manufacturer all refer to the same entity.

OEM Approved Service Provider. In some cases the OEM may approve a commercial entity other than themselves to provide maintenance or repair services on a specified instrument. If so, this entity is an acceptable third party service provider.

Part. A single, basic item in a component or instrument whose removal and replacement may be conducted by an acceptable engineer as part of a site visit (examples: gas pressure regulator, ion gauge), unless the instrument POC is capable of the installation.

Preventive Maintenance. Maintenance services which are required a specified number of times a year, and by a specified date, so they can be scheduled in advance by the contractor.

Prime Contractor. The awardee that will provide management and coordination of maintenance and repair services on behalf of the FDA.

Repair Services. Services carried out after a service request in response to an instrument becoming non-performing or non-operational. Carried out on-site by an acceptable repair engineer who carries out procedures and/or installs acceptable parts or acceptable components required so the instrument is returned to full operation. Repair services include acceptance testing and documentation of completed repair services.

Performance Standard. Criteria for determining whether an instrument is non-performing or has been returned to full operation. Is normally defined by a quality management program or by OEM performance specifications. In the absence of any other performance standard or quality management program, data acquired by the instrument point of contact during a period of full performance prior to maintenance or repair services being delivered will be used as the performance standard. Otherwise, acceptance is based on the signature of the instrument point of contact.

Return to Full Operation. A procedure conducted by FDA or an acceptable engineer, which may or may not involve new parts or components, or replacement or exchange of components, which results in the instrument meeting the performance standard (i.e., no longer being in a non-performing or a non-operational state).

Service Call. A contact, request, or sub-contract initiated by the Contractor to a third party service provider to provide maintenance or repair services to FDA. The service call is placed in order to provide an acceptable part, acceptable component, acceptable maintenance engineer, acceptable repair engineer, or diagnostic & troubleshooting services for a covered instrument in a non-performing or non-operational state.

Service Level. One of three possible levels describing how important it is to FDA that the instrument be returned to full operation. Service levels describe how soon a response is needed for diagnostic & troubleshooting support, component removal & replacement, component shipment & exchange, or on-site repair services. The three FDA service levels are:

• Regulatory Analysis. Service level 1. The highest service level for repair services. FDA needs the instrument repaired within two (2) working days.

• Research Analysis. Service level 2. The second-highest service level for repair services. FDA needs the instrument repaired within seven (7) working days.

• Analytical Capacity. Service level 3, the third-highest service level for repair services. FDA needs the instrument repaired within a flexible time frame that cannot be more than twenty (20) working days.

Service Request. A contact initiated by an instrument point-of-contact to the Contractor so that any of the following services may be provided to FDA: technical support, diagnostic & troubleshooting, component removal & replacement, component exchange & shipment, acceptable maintenance services, or acceptable repair services. In any and all interactions between the instrument PoC and the Contractor, the instrument PoC is responsible to carbon copy (“cc”) the Center COTR.

Signature. Acceptance of maintenance or repair services in the absence of a performance standard or acceptance testing. Equivalent to acceptance of the instrument “as-is” when the engineer is finished.

Site. A single physical location identified by a corresponding street address at which instruments are located. Examples: laboratory building or research facility. Each Center and Office may operate scientific instruments at more than one site.

Site Visit. An acceptable engineer travels to the site to perform maintenance or repair services.

Technical Support. Communication by telephone, email or remote diagnostics (if allowed by FDA IT security officer) between the instrument point-of-contact and a third party service provider in order to instruct the instrument point-of-contact on carrying out procedures pertaining to a non-performing or non-operational instrument.

PART 3 – STATEMENT OF WORK

OBJECTIVE/S

FDA’s objective is to have a Contractor to manage and coordinate the maintenance and/or repair services for specific scientific instruments in such a manner that it will meet the requirements and specifications detailed in this document, and to do so within varying time frames, also specified in this document.

SCOPE

The FDA has a Public Health mission therefore the scientific instruments of the Agency need to be maintained in full operation level at all times, i.e., capable of meeting applicable performance standards based on specific activities the instrument is used to support. If at any time, any of the Agency’s instruments are not operational or do not meet applicable performance standards, the instruments must be returned to their full operations level in a timely manner with all the appropriate documentation of actions taken on the instrument to bring it back to its normal operational level.

A master instrument list (is also part of the pricing matrix) will be maintained by the Contractor in coordination and agreement with FDA’s COTR. This list will include all details needed to provide the required services, including instrument-specific performance standards, maintenance protocol, and required documentation (see attachment #1). Changes to this master instrument list may occur due to that instruments are replaced, put out of service, and/or new instruments are procured by the Agency. Any changes by the Agency will be discussed and agreed to between the Agency’s COTR, Contracting

Officer, and Contractor’s Program Manager. Upon this agreement, the list will be updated accordingly by a task order modification. Such additions or deletions will be executed once a month if required. Pricing for added instruments or services depend on the following: 1) new instrument model or service not already identified on the list. Pricing will require a quote and FDA COTR approval prior to the Contracting Officer modifying the Center’s task order. 2) An already identified instrument model that can be priced out based upon prices established in the pricing matrix. Once the price has been confirmed by the FDA COTR, then the Contracting Officer will modify the Center’s task order.

The Contractor will be responsible to provide any and all material, services, and personnel required to keep all these instruments at the operation level required and to repair any instrument back to its operational level required within the time lines provided using the manufacturers suggested methods and procedures. Any actions taken by the Contractor to coordinate Preventive Maintenance and/or Repairs will be documented as described in this contract. The Contractor will provide a written detailed and standardized process and procedure for providing this Preventive Maintenance and Repair on-call support so to meet the requirements described in this document. This written standardized process procedure will be reviewed and approved by the Agency’s COTR. Any changes will have to be reviewed and approved in writing by the Agency’s COTR and Contractor’s Program Manager.

3. Technical Requirements:

During the contract period, the Contractor shall furnish all personnel and services required for the performance of the work as described below.

3.1. Specific tasks

The Contractor shall provide maintenance management and payment of services consisting of (tasks are in bold):

Task 1: Maintenance of a Service Providers List. The Contractor shall maintain and provide a list of service providers. Service providers consist of 1) the original equipment manufacturer (OEM), 2) certified service providers by the OEM and 3) acceptable third party service providers.

Additional service providers may be added by mutual agreement. The criterion for other than OEM service providers is described in the definition of acceptable engineer.

Task 2: Management and Coordination of Services. The Contractor is responsible for managing and coordinating all aspects of the service requirements, including the coordination of a schedule of preventive maintenance services for each instrument. The applicability of the need for technical support, diagnostic and troubleshooting services, and service levels for repairs, regular weekday repairs, preventive maintenance, and optional services are described in the Requirements, Performance Management, and Definitions sections and in the Master Instrument List. The Contractor is not required to replace obsolete Instrument when the OEM has determined that the item is obsolete. The Contractor shall furnish an itemized list of labor and parts costs for services performed. The information is necessary to support expense tracking, cost evaluations, and to record pertinent data on the maintenance history (see definitions for documentation of completed services).

Task 3: Administrative Tasks and Maintenance Data Management. The Contractor shall perform administrative tasks and management of maintenance data relevant to the contract. The Contractor shall establish and maintain a database of covered Instrument for each activity. The database shall include a list of all parts or components replaced and all services performed. The information in this database shall be sufficiently detailed to support laboratory inspection/accreditation requirements and should be available to the FDA Center of Office within 24 hours of request. The Contractor will assure completion of required field service reports, assure receipt of appropriate purchase orders and invoices, and initiate the vendor payment process.

Task 4: Off-Site Repairs. There are two types of off-site repairs when the repair required for an instrument need not be performed on-site: 1) the instrument or its defective component will be shipped for repairs and returned to the FDA or 2) the instrument or its defective component will be exchanged with a replacement component. Instrument or component exchanges are solely dependent upon laboratory standard operational protocols (SOPs) and shall to be confirmed by the laboratory PoC prior to an exchange agreement.

The location of off-site repairs has to be disclosed upfront by the Contractor prior to moving the instrument off FDA facilities and shall be approved by the Agency COTR. Upon completion of repair services, a written service report shall be given to the laboratory PoC and accompany the instrument being returned. This documentation’s primary purpose serves as regulatory confirmation of the instrument’s maintenance history. The service report shall provide detailed information regarding the cause of Instrument malfunction and corrective action taken (to bring the instrument to OEM standards), to include the time required to complete the work, price of labor (hourly rate), a list of parts replaced with the cost of each part, and chargeable travel expenses.

Task 5: On-Site Repairs. Contractor’s service engineers must have FDA approval to enter an FDA site. On-site repairs shall be carried out during normal operation hours (Monday through Friday from 0730-1630). During other than normal operating hours, the service engineer must report to the site’s security desk to sign in.

Upon completion of services, a written service report shall be provided to the Instrument Point-of-contact or their designated representative on site. The service report will provide detailed information about the cause of Instrument malfunction and corrective actions taken, to include the time required to complete the work, price of labor (hourly rate), and a list of any parts replaced with prices for each part. In the event all information is not available to the Contractor service engineer when services are performed, the initial field service report shall include all information stated above except for prices (parts and labor hour). Contractor shall provide the balance of the required information in writing to the COTR or the Center Project Manager, not later than 10 business days after services are completed.

The instrument PoC will initiate all requests for services. The Contractor will contact the COTR for any issues, or concerns regarding repair of Instrument covered under this contract. The Contractor shall not provide any services not covered by the contract without prior approval from the Contracting Officer.

A copy of the calibration worksheet and a list of all test instruments will be provided to the instrument PoC and COTR. The list of test instruments will include the Nomenclature, Model Number, Serial Number, and Date of Next Calibration of each piece of test instrument. This is particularly important on any repairs and calibrations.

The FDA will provide to the Contractor service engineer any FDA-specific forms associated with maintenance or repair for a covered instrument, if completion of such forms is required to comply with an applicable quality management system or standard operating procedure.

Task 6: Delivery of Parts, Components or Accessories. Under some circumstances, to be determined by the COTR and Contracting Officer, the contractor needs to provide for the delivery of acceptable parts, components or accessories to the site for installation by FDA staff.

Participation by acceptable servicing engineers would not be necessary under these circumstances, although technical support services may be requested by FDA staff.

3.2. Third Party Payments: The Contractor is responsible for payment of maintenance program costs directly to third party service providers who service the Instrument listed in the Master Instrument List. Payment for maintenance program costs shall include all travel, labor, overtime, parts, freight, PM kits, updates, optional items and sales taxes for remedial repairs and for preventive maintenance checks and services.

3.3. Contractor Coverage: The Contractor shall provide coverage, at no additional charge, for functioning software and diagnostic software that is needed to return the Instrument to its normal operating condition. This includes necessary software updates, validated by the instrument manufacturer, necessary to maintain the cyber-security of network-attached instruments. This coverage shall include identification and installation of software or hardware updates. Unless a Center, Office or site has selected Operator Replacement Items and Optional Items coverage, no coverage exists for installation of upgrades of software and hardware independent of Instrument failure and repair.

3.4. Payment and Bill Processing for Operator Replacement Items and Optional Items: A

Contract Line Item (CLIN) will be established for each Center or Office activity to pay for all services, parts, components and accessories required by that Center or Office. This CLIN may be incrementally funded at the discretion of the Center or Office. The cost of these items will be billed against that Center or Office’s CLIN and tracked by the prime contractor. The Contractor will maintain a record of expenditures and advise each Center or Office monthly of the balance remaining. Items other than those presently identified in the definitions may be paid for via this CLIN only upon mutual agreement between the prime contractor, the FDA COTR, and FDA contract officer.

3.5. Technical Assistance and Advice. The prime contractor shall assist the FDA in parts sourcing assistance and vendor selection. The prime contractor may recommend qualified service providers and vendors who may provide additional savings to the FDA. However, this recommendation does not obligate FDA to agree to accept such providers.

3.6. Invoice Processing and Work Order Tracking: The prime contractor shall promptly process payment of substantiated service calls and shall notify the FDA of any denied claims within 24 hours of rejection of invoice. The prime contractor shall contact the service vendor if the service response is not provided within 24 hours of notification.

3.7. Contractor Monthly Reports to the Contracting Officer. The Contractor shall provide monthly reports to the Contracting Officer within 2 business days after the beginning of each month. This monthly report will provide per Center and per instrument a detailed maintenance description, hours of service utilized, list of parts repaired/replaced, and service costs for each instrument. The report will verify any and all interactions between the instrument PoC and the Center COTR.

PART 4 – DELIVERABLES

4. Deliverables shall be specified as reports and service.

4.1. Annual Reports. The contractor shall provide annual reports to the Agency COTR within 30 days prior to the end of period of performance. This annual report will provide per Center and

4.2. Monthly Reports. The Contractor shall provide monthly reports to the Agency COTR within 2 business days after the end of each month. This monthly report will provide per Center and per instrument a detailed maintenance description, hours of service utilized, list of parts repaired/replaced, and service costs for each instrument.

PART 5 – INSPECTION AND ACCEPTANCE

5. The Agency’s COTR will perform inspection and acceptance of materials and services provided by the contractor.

5.1. For the purpose of this part, (COTR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

5.1.1. A COTR will be appointed at IDIQ and Center Task Order levels for purpose of

Inspection and Acceptance.

5.2. Inspection and acceptance will be performed at the locations identified in Part 6. Acceptance is communicated via the COTR in writing to the Contractor and the Contracting Officer within 30 days.

5.2.1. The COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract;

and (5) assisting in the resolution of technical problems encountered during performance.

5.2.2. The Contracting Officer is the only person authorized to approve changes to any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract; the said authority remains solely the Contracting Officer’s”. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFP; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract;

or (5) otherwise change any terms and conditions of this contract.

5.2.3. The contact information for the Contracting Officer is:

David Kordel

5630 Fishers Lane Rockville, MD 20857

David.kordel@fda.hhs.gov

PART 6 – CONTRACTOR PERFORMANCE

6. PERFORMANCE REQUIREMENTS SUMMARY (PRS)

6.1. Performance Evaluation. Performance will be evaluated to determine whether or not it meets the threshold of the contract. When the performance threshold is not met, the COTR will contact the Contractor via e-mail with a copy to the Contract Specialist and/or Contracting Officer. The Contractor shall reply to all with the resolution within 15 calendar days of receipt. Failure to meet the Acceptable Quality Level will be reflected in annual contract past performance evaluations.

6.1.1. FDA will collect customer satisfaction reports from the end user after each maintenance or service call.

mailto:David.kordel@fda.hhs.gov

6.2. Performance Measures

6.2.1. Timeliness of services

6.2.2. Acceptability of parts, components, engineers

6.2.3. Management of data on instruments & services

6.2.4. Account Management

6.3. Performance Specifications

6.3.1. Timeliness:

6.3.1.1. The time to respond to a request for services is within the applicable service level agreement and preventive maintenance is carried out before the required date 100%.

6.3.2. Acceptability:

6.3.2.1. Service requests are fulfilled by providing servicing engineers, replacement parts and replacement components which are acceptable to FDA.

6.3.2.2. Replacement parts or components meet OEM specifications and are OEM certified for replacement of an equivalent component.

6.3.2.3. Servicing engineers hold current OEM certification and have received the most recent OEM training in maintenance or repair procedures applicable to the FDA instrument which needs service.

6.3.2.4. Completed service will be considered acceptable with a data report provided which demonstrate that the applicable instrument performance standard can be met.

6.3.2.5. Documentation meets the applicable specification.

6.3.3. Accuracy of Tracking Data:

6.3.3.1. The instrument performance standard and the specification for required documentation for each instrument is provided in Attachment #2 (Master Instrument List).

6.3.3.2. Data is maintained in an organized and accessible form, pertaining to services provided, replacement parts and components purchased, other costs, and payments.

6.3.4. Account Management

6.3.4.1. The contractor is paid within a normal and reasonable time frame.

6.3.4.2. Required documentation is provided for services provided, parts or components purchased, fees paid, or other costs incurred.

6.3.4.3. Funds allocated by each FDA organizational unit for maintenance and repair services, accessories, or optional services are tracked separately so each FDA unit can receive a proportionate share of services, parts, components, or accessories.

6.3. PERIOD OF PERFORMANCE

6.3.6. The period of performance for this IDIQ shall be the effective date of award for a base year and four option years.

6.4. PLACE OF PERFORMANCE

6.4.6. The place of performance for this contract shall be at the FDA’s site and will vary among individual laboratory Instruments (see PART 10).

6.5. CONTRACTOR POINT OF CONTACT

6.5.6. The contact information for the Contractor is:

Name

Address Email & Phone mailto:David.kordel@fda.hhs.gov

PART 7 – CONTRACT ADMINISTRATION DATA

7.1. INVOICE SUBMISSION

7.1.1. In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration no later than 14 days prior to submission of the first invoice:

A. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt payment) AND 52.232-33 (Payment by electronic funds transfer – Central Contractor Registration) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase order/award number;

(IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) Period of performance for high costs claimed;

(b) Itemized travel costs, including origin and destination;

(c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped to Government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order/award, or in a proper notice of assignment);

(VIII) Name, title, and phone number of the person to notify in the event of a defective invoice;

(IX) Taxpayer identification number (TIN);

(X) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Technical Representative (COTR), as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is □ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject award, including the following:

(1) Invoice number, amount, and date submitted

(2) Corresponding payment amount and date received

(b) Total amount of all payments received to date under the subject contract or order

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

C. An electronic invoice is acceptable if in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

FDA/OC/OA/OFO/OFS

ATTN: Division of Payment Services 12345 Parklawn Drive, HFA-720 Rockville, MD 20857

301.827.3742 OR 866.807.3742

fdavendorpaymentsteam@fda.gov mailto:fdavendorpaymentsteam@fda.gov

B. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Officer:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: David Kordel, Contracting Officer 5630 Fishers Lane Room 2095, HFA-500

E-mail: david.kordel@fda.hhs.gov

*** Acceptable methods of delivery include: mail, hand delivery and email***

(II) One copy to the contracting officer technical representative (COTR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration

ATTN: [INSERT NAME], COTR

10903 NEW HAMPSHIRE AVENUE

ROOM XXXX

Silver Spring, MD 20993 Email: xxxx.xxxx@fda.hhs.gov

*** Acceptable methods of delivery include: mail, hand delivery and email***

7.2. Staffing and Key Personnel

7.2.1. The key personnel specified in this contract are considered to be essential to work performance. At least 45 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

Project Manager

Task Responsibility Manages multiple aspects of a single/multiple projects at one time, including overseeing quality control. Communicates clearly and articulately in written and oral form. Assesses complex coordination issues, applies appropriate strategies and plans, and interprets data.

7.3. Request for Task Orders (RTOP)

7.3.1. In response to an FDA request for quote, the Contractor shall provide a quote to the Center or Office for new instruments to be added to the Master Instrument List using the same specified Service Levels described in Part 2.5.

7.3.1.1. Such additions will be executed once a month if required. Pricing for added instruments or services depend on the following: 1) new instrument model or service not already identified on the list. Pricing will require a quote and FDA COTR approval prior to the Contracting Officer modifying the Center’s task order. 2) An already identified instrument model that can be priced out based upon prices established in the pricing matrix. Once the price has been confirmed by the FDA COTR, then the Contracting Officer will modify the Center’s task order.

PART 8 – SPECIAL CONTRACT REQUIREMENTS

8.1. CERTIFICATE OF MAINTAINABILITY:

8.1.1. At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five (5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract. The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the instrument is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the instrument without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government. Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any instrument fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the instrument up to the required OEM maintenance level. If instrument is acquired under this contract, without maintenance of such instrument being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such instrument at the time of delivery for each piece of instrument. The certificate shall state that the instrument is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the instrument without billing any charges to the Government. All charges required to obtain the requisite performance of the instrument, up to the later of the time the instrument is accepted by the Government or the warranty expires, shall be borne by the Contractor. The time the instrument is accepted by the Government is the date that the Government determines that the instrument has passed acceptance testing, not the effective date of acceptance. The fact that the instrument may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

8.2. SECTION 508

8.2.1. Pursuant to the HHSAR clause at 352.270-19 incorporated into PART 3 of the underlying contract. The complete text of Section 508 Final Standards can be accessed at http:// www.access-board.gov/sec508/standards.htm. The standards applicable to this requirement will be identified in individual Task Order Statements of Work. The contractor must have knowledge of the 508 Standard when performing the management portion of this requirement and are exempt from work on laboratory instruments. The standards are as follows:

8.2.1.1. § 1194.21 Software applications and operating systems

8.2.1.2. § 1194.22 Web-based intranet and internet information and applications & notes.

8.2.1.3. § 1194.24 Video and multimedia products

8.2.1.4. § 1194.25 Self-contained, closed products

8.2.1.5. § 1194.26 Desktop and portable computers.

8.2.1.6. § 1194.31 Functional performance criteria

8.2.1.7. § 1194.41 Information, documentation, and support http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm

8.3. Mandatory use of Government equipment identification numbers. The FDA inventory system assigns barcodes to each instrument. These FDA bar codes are preferred for cross reference purposes, if provided. Otherwise, FDA will provide other unique identification numbers. The FDA and the prime contractor shall include and annotate the appropriate acronym for the Center and Office (see Appendix 2 for the complete list), and the instrument bar code on all service reports, statements of work, Instrument lists, schedules, field service reports, tracking lists, quotes and other documents pertinent to the contract. Purchase order numbers (PO#) and tracking numbers specific to a Center or Office shall be annotated on pertinent documents and the record fields shall be large enough to accommodate the various requirements of each Center or Office (at least 25 characters for the purchase order number/tracking number). The serial number (SN#) field must accommodate at least 24 characters. The FDA barcode field shall accommodate a minimum of 15 characters.

8.3.1. The contractor accepts responsibility for the Instrument described in the Appendices, in “as is” condition.

8.3.2. The contractor shall only tender for acceptance those items that conform to the requirements of this contract. The FDA reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The FDA may require repair or replacement of nonconforming supplies or re-performance of nonconforming services at no increase in contract price. The FDA must exercise its post-acceptance rights (a) within a reasonable time after the defect was discovered or should have been discovered; and (b) before any substantial change occurs in the condition of the item (part, component, accessory or instrument), unless the change is due to latent defect in the item in accordance with the inspection clauses in the contract. Failure to meet the Acceptable Quality Level will be reflected in annual contract past performance evaluations.

PART 9 – CONTRACT CLAUSES

9. FAR CLAUSES INCORPORATED BY REFERENCE

9.1. 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (Jun 2010) 52.216-24, Limitation of Government Liability (Apr 1984) 52.227-14, Rights in Data—General (Dec 2007) 52.227-16, Additional Data Requirements (June 1987) 52.227-17, Rights in Data—Special Works (Dec 2007) 52.227-18, Rights in Data—Existing Works (Dec 2007) 52.233-2, Service of Protest (Sep 2006) 52.245-1, Government Property (Aug 2010) 52.246-4, Inspection of Services—Fixed-Price (Aug 1996)

9.2. FAR CLAUSES BY FULL TEXT

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (May 2011).

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

http://uscode.house.gov/

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41…