Amedment_W9114F-16-T-0012-0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purposes of this amendment are: (i) to make changes to the Blanket Purchase Agreement's (BPA) Terms and Conditions; and (ii) to make changes to the Performance Work Statement.

1. CONTRACT ID CODE PAGE OF PAGES

1 13

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 17-Feb-2016

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W9114F-16-T-0012

X 9B. DATED (SEE ITEM 11)

11-Jan-2016

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

17-Feb-2016

CODE

W40M EUR REGIONAL CONTRACT OFC

KIRCHBERG KASERNE

BUILDING 3705

LANDSTUHL 66849

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W9114F-16-T-0012

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 10-Feb-2016 10:00 AM to 19-Feb-2016 10:00 AM.

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

PLACEMENT OF CERTIFIED ALLERGY TESTING SYSTEM (CATS)

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Vendor shall provide non-personal services to include as a minimum, all personnel, equipment, tools, materials, supervision, and other items and services necessary to provide one (1) new fully automated Certified Allergy Testing System (CATS) and the reagents as required. The Vendor shall perform to the standards of this PWS. The analyzer shall comply with the specific requirements listed in Section 5. The analyzer will be deployed at the following locations:

Landstuhl Regional Medical Center (LRMC) Department of Pathology, Core Laboratory Building 3738, Room 113 66849 Landstuhl, Germany

1.2. VENDOR PERSONNEL:

1.2.1. Contract Manager. The Vendor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the Vendor when the manager is absent, shall be designated in writing to the Contracting Officer.

1.2.1.1. The contract manager or alternate shall have full authority to act for the Vendor on all contract matters relating to daily operation of this contract.

1.2.1.2. The contract manager or alternate shall be available during normal duty hours within four (4) hours to LRMC. After normal duty hours, the manager or alternate shall be available within 48 hours.

1.2.1.3. The contract manager and alternate(s) must be able to read, write, speak, and understand English.

1.2.2. Vendor Employees. The Vendor shall not employ persons for work on this contract if such employee is identified to the Vendor by the Contracting Officer as a potential threat of the health, safety, security, general well-being or operational mission of the installations and their population.

1.2.2.1. Vendor personnel shall present a neat appearance and be easily recognized as Vendor employees. Vendor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any U.S. Government facility.

1.2.2.2. The Vendor shall make sure employees have the following current and valid professional certifications before starting work under this contract. The Trainers and Product Specialists shall have a 2 or 4 year certification in Medical Technology or Clinical Laboratory Sciences or similar European certification.

1.2.2.3 The Vendor shall not employ any person who is an employee of the US Government if employing that person would create a conflict of interest. Additionally, the Vendor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7-R, “Joint Ethics Regulation”. The Vendor shall not employ any person who is an employee of the Department of Defense if such employment would be contrary to local policies.

1.2.2.4 The Vendor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment. Military Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the Vendor’s ability to perform; however, their absence at any time shall not constitute an excuse for nonperformance under this contract.

1.2.3. Security Requirements. The Vendor’s employees shall possess a valid passport and local national identification card.

1.2.4. Employee Training. Training will be provided by the Vendor on site at LRMC for all personnel designated to operate analyzer.

1.3. QUALITY ASSURANCE. According to FAR Part 52.212-4(a) Inspection/Acceptance, the Vendor shall only tender for acceptance those items that conform to the requirements of this agreement. The Government will evaluate the Vendor's performance under this agreement. For those tasks listed on the Performance Requirements Summary (PRS) at Technical Exhibit 2, the Contracting Officer’s Representative (COR) or evaluators will follow the methods of surveillance specified in this agreement. Government personnel will record all surveillance observations. When an observation indicates defective performance, the COR will require the contract manager or representative at the site to initial the observation. The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that he or she has been made aware of the defective performance. Government surveillance of tasks not listed in the PRS or by methods other than those listed in the PRS (such as provided for by the Inspection of Services clause) may occur during the performance period of this agreement. Such surveillance shall be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this agreement.

1.3.1. Performance Evaluation Meetings. The Contracting Officer may require the contract manager to meet with the Contracting Officer, contract administrator, COR, and other Government personnel as deemed necessary. The Vendor may request a meeting with the Contracting Officer when he or she believes such a meeting is necessary.

Written minutes of any such meetings shall be recorded in the contract and signed by the contract manager and the Contracting Officer or contract administrator. If the Vendor does not concur with any portion of the minutes, such non-concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.4. PHYSICAL SECURITY. The Vendor shall be responsible for safeguarding all Government property provided for Vendor use or access. At the end of each work period, all Government facilities, equipment and materials shall be secured.

1.5. HOURS OF OPERATION:

1.5.1. Normal Hours of Operation. The Vendor shall perform the services required under this agreement during the following hours: Monday through Friday between the hours of 0800 – 1630, excluding US Federal Holidays.

1.5.1.1. Holidays. Routine services and reagent delivery in Germany will not be required on standard US and German Federal Holidays. If an emergency arises, services and reagent delivery will be rendered between the hours of 0800 -1200. The following is a list of legal federal holidays:

American Holidays German Holidays

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

New Year's Day (all provinces), January 1 Epiphany (BW,BY,ST), January 6 Good Friday (all provinces), varies yearly Easter Monday (all provinces), varies yearly Labor Day (all provinces), May 1 Ascension Day (all provinces), varies yearly Whit Monday (all provinces), varies yearly Corpus Christi (BW, BY, HE NW, RP, SL), varies yearly Assumption Day (BY, SL), August 15 Day of German Unity (all provinces), October 3 Reformation Day (BB, MV, SN, ST, TH), October 31 All Saints Day (BW, BY, NW, RP, SL), November 1 Penance Day (SN), November 18 Christmas (all provinces), December 25 St. Stephen’s Day (all provinces), December 26

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a Vendor employee is scheduled to work is closed due to the holiday and the employee is not required to report in. Closures of the installation due to inclement weather or natural disasters shall be handled in the same manner.

1.5.2. The Vendor shall provide direct customer service, technical support, routine and emergency service during normal hours of operation, to include hotline telephone service to assist operators in correcting equipment operation problems. A technically-qualified person shall be available at all times and will be fluent in speaking English.

1.6. CONSERVATION OF UTILITIES. The Vendor shall make sure employees practice utilities conservation.

The Vendor shall be responsible for operating under conditions that prevent the waste of utilities to include:

1.6.1. Lights shall be used only in areas where work is actually being performed.

1.6.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

1.6.3. Water faucets or valves shall be turned off when not in use.

1.6.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the system cannot be safely dumped into each of the facility’s drain system, the Vendor must provide a means/mechanism of safely disposing these wastes or by-products in accordance to local national guidelines

1.7. RECORDS. The Vendor shall be responsible for creating, maintaining, and disposing of only those Government-required records that are specifically cited in this PWS or required by the provisions of a mandatory directive listed in section 6, Applicable Publications and Forms. If requested by the Government, the Vendor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic definitions.

2.1.1. CONTRACTING OFFICER: A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR): A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, TJC, U.S. Army

Medical Command, quality assurance and risk management program, and ensure compliance with the terms and conditions of the contract

2.1.4. QUALITY CONTROL. Those actions taken by a Vendor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5. SERVICES: Includes services performed and materials furnished or utilized in the performance of those services

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with AR 40-68, to assure services meet the requirements of the Performance Work Statement (PWS).

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AR - Army Regulation CAP - College of American Pathologists CLIN - Contract Line Item Number CLIA ‘88/’03 - Clinical Laboratory Improvement Amendment COR - Contracting Officer's Representative DA - Department of the Army DoD - Department of Defense DoD CLIP - Department of Defense Clinical Laboratory Improvement Program DODI - Department of Defense Instruction FAR - Federal Acquisition Regulation HIPAA - Health Insurance Portability & Accountability Act of 1996 MEDCOM - Medical Command TJC - Joint Commission KO - Contracting Officer MAS - Minimum Acceptable Standard MEDDAC - Medical Department Activity MTF - Medical Treatment Facility OSHA - Occupational Safety and Health Administration PWS - Performance Work Statement PPIMS - Past Performance Information Management System QA - Quality Assurance QA&I - Quality Assessment & Improvement QC - Quality Control

3. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the analyzer as indicated in paragraph 5.1 of the PWS. The Vendor shall not alter the facilities without written approval of the Contracting Officer. The Vendor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only.

3.2. UTILITIES. The Government will provide the normal range of utilities, to include electricity, water, heating, refuse collection, etc., as is provided other personnel.

3.3. SERVICES

3.3.1. The Government will provide Security Police and Fire Protection, as is provided other personnel.

3.3.2. The Government will provide emergency healthcare for Vendor employees. The MTF will provide emergency healthcare for injuries occurring while on duty. The Vendor shall reimburse the government for such services.

4. VENDORFURNISHED PROPERTY.

4.1. General. Except for those Government-furnished items and services specified in Section 3, the Vendor shall furnish all items and services required under this contract.

4.2. Transportation. Transportation is the responsibility of the Vendor. The Government will not provide transportation.

4.3. NAMETAGS. The Vendor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee.

5. SPECIFIC TASKS:

5.1. DESCRIPTION: The Vendor shall provide one (1) CATS analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature shall be in the English language. The CATS will provide users with rapid, reliable test results that are critical for patient care. The system will be able to test for total IgE and Specific IgE allergens. The system must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturers stated linearity. The Vendor’s customer service and support during local standard business hours is equally important as the analyzer’s capabilities.

5.2. INSTRUMENT CAPABILITY: The instrument provided shall be capable of the following:

5.2.1. Must be able to perform 60 tests/hour (200 tests/5 hours after the 1 3/4 hour start time and 370 tests/7 to 8 hours).

5.2.2. The system will have the capacity to hold reagents for up to 2880 caps onboard and be able to maintain reagents at refrigerated temperatures.

5.2.3. Comes equipped to perform continuous access and statistical analysis; capable of real time or (on-line) Quality Control (QC). Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot numbers, means, ranges, SD, and CVs%.

5.2.4. The system will have the capability to store calibration curves for 28 days.

5.2.5. Must have the ability to detect liquid level, clots and perform onboard dilutions.

5.2.6. The system must require only 40 uL of sample per test.

5.2.7. Method Validation will include, as a minimum, normal range verification, demonstration of linearity with establishment of limits of quantitation (reportable range), correlation with current methods (comparison of methods study), validation of precision (replication study) and accuracy (recovery study). All reagents, calibrators and verification materials will be provided by the Vendor.

5.3. MAINTENANCE and SERVICE

5.3.1. The Vendor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the system in accordance with College of American Pathologists (CAP), Clinical Laboratory Improvement Program (CLIP), Clinical Laboratory Improvement Amendments (CLIA), Clinical Laboratory Standards Institute (CLSI) guidelines; technical assistance; preventive maintenance (as per manufacturer’s maintenance manual); unscheduled services (on-call emergency repair system); corporate and in-house training of personnel on the equipment; pertinent test methods; and equipment removal at the termination of the contract. The Vendor shall be responsible for ensuring a DD 2163 is affixed and properly completed for each analyzer.

5.3.2. The Vendor is required to maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the U. S. Government. Decision for repairs will be made based on a mutual agreement with Medical Maintenance as arbitrator if Vendor and Laboratory do not agree.

5.3.2.1. The Vendor “must” obtain authorization from the Chief, Equipment Management Branch or an authorized representative, prior to starting “any” repair that is attributable to instrument abuse and/or instrument misuse, theft, neglect, fire and anything else not covered in this contract. If these types of repairs are performed without the prior approval of the Chief, Equipment Management Branch or his/her designated representative, the Vendor shall not be paid by the U.S. Government. If approved, a separate purchase order shall be issued prior to performance.

5.3.3. The Vendor shall be responsible for the collection and transportation of equipment upon termination of lease period.

5.3.4. The Vendor shall perform all services in accordance with the technical requirements set in accordance with the instructions and specifications provided. All equipment and reagents shall be Food and Drug Administration (FDA) approved and from the manufacturer’s most current production.

5.3.5. MAINTENANCE: The Vendor shall provide a full preventative maintenance service (at least every six months) during the lease period at no additional cost to the Government. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), calibration as required and hotline telephone service, to assist operators in troubleshooting problems.

5.3.5.1. Prior to and upon completion of “any” scheduled or unscheduled service, the Vendor service representative must report to the Chief, Equipment Management Branch or his/her designated representative at:

Landstuhl Regional Medical Center Equipment Management Branch Building 3760 Ward 4B Kirchberg Kaserne 66849 Landstuhl, Germany Tel. 06371-867-327

FAX: 06371-867-258

5.3.5.2. Prior to performing work, a Vendor’s representative shall report to and get from the Equipment Management Branch, (LRMC, Ward 4B) a Visitor’s Badge. The badge shall be returned to the Equipment Management Branch prior to departing LRMC.

5.3.5.3 On the day services (scheduled and/or unscheduled) are completed, the Vendor’s service technician shall prepare and initial a legible, preferably typed service report in English and present it to the Chief, Equipment Management Branch or his/her designated representative for signature. This report shall include the following information:

(1) Services performed

(2) What systems or components failed (reason for call)

(3) Start date/time

(4) Completion date/time

(5) Name of service technician

(6) Part numbers, nomenclatures, quantities and prices of replaced parts

(7) Travel time

(8) Repair time

(9) Travel, repair and parts cost

5.3.6. REPAIR: Upon equipment failure, the Vendor shall respond to unscheduled telephonic requests for repair within 48 hours notification for routine or within 24 hours for emergency failures. If the equipment cannot be repaired, a replacement instrument will be provided at a mutually agreed upon time. If applicable, the Vendor shall provide replacement parts as necessary for operator level maintenance.

5.3.6.1. LRMC telephonic support and repair. Should the Equipment become inoperable, the Vendor's technical specialist must be on-site within eight (8) hours after determining on-site that service is needed. If the equipment cannot be repaired, a replacement instrument will be provided at a mutually agreed upon time. The Vendor shall provide service support including replacement parts, at no additional cost.

5.3.7. In accordance with MEDCOM directives: Upon completion of calibration, the Vendor shall affix or update a DD Form 2136 to the equipment in accordance with instructions provided in TB 38-750-2. Required DD Forms and extracts from pertinent directives will be furnished to the Vendor by the Clinical Engineering Branch.

5.4. REAGENTS:

5.4.1. Ninety percent (90%) of the Reagents ordered by LRMC based on previous twelve (12) months product ordered shall have a shelf life of 1.5 years upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

5.4.2.1. An alternate quality control material must be provided by the Vendor if the new lot of controls cannot be delivered two weeks prior to the expiration date of the lot currently in use.

5.4.3. All test kits will be provided as follows:

5.4.3.1. Inclusive of an English language package inserts.

5.4.3.2. Be provided by the manufacturer of the equipment.

5.4.3.3. Delivered on time (see 5.4.3.3.1), at the appropriate storage temperature, and marked with any required temperature controls as necessary.

5.4.3.3.1. Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery.

Emergency orders will be delivered within forty-eight (48) hours after the order is placed.

5.4.3.4. Be compatible with all reagent packs used with the Analyzers.

5.4.3.5. Preservation and packing. Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

5.4.3.6. All reagents provided shall be FDA-approved. If the bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.

5.4.3.7. The Vendor shall provide the reagents as outlined on the Approved Price List. Delivery of the reagents will be as scheduled/required by the individual BPA Call Orders issued by the designated BPA Caller. The Contracting Officer representing the Regional Health Contracting Office-Europe (RHCO-E) shall designate individuals in writing as BPA Callers and will be authorized to issue BPA Calls against the resulting agreement.

5.5. DATA MANAGEMENT:

5.5.1. Driver. The Vendor shall have an established driver compatible for interfacing the equipment with the military hospital computer system Composite Health Care System (CHCS). The interface between CHCS and the instrument must be bi-directional. An example of a firm that has an acceptable driver is Data Innovations Inc. This information is provided as an example only, the Government is in no way recommended or endorsing this product.

5.5.2. Provides or comes with an on-line Levy-Jennings graph, applies user defined Quality Control Rules, and delta checks. Has a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics – all available to user; capable of downloading the QC data to a disk which can then be used to submit the file for analysis against a QC peer group.

5.5.3. One high resolution touch screen monitor per machine.

5.5.4. Flags that indicate abnormal activities.

5.5.8. One high resolution printer per analyzer.

5.5.8.1. Printer cartridges (laser or ink jet), ribbons, or special printer paper (thermal etc.) will be provided by the Vendor.

5.5.9. Comes equipped with an uninterruptible power supply capable of providing all necessary electrical power to each Data Management System for 15-20 minutes.

5.6. MATERIAL SAFETY DATA SHEETS (MSDS). The Vendor shall provide MSDS for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative Government. The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

5.7. TRAINING:

5.7.1. The Vendor shall provide training for equipment operators, as required. All training, instructional literature and related memos shall be in the English language, one of which must be a hard copy and the other another hard copy or disc. Training shall include basic operation, trouble shooting, preventive maintenance and software support.

5.7.3. Required training shall include on-site training of 2 or more Government technicians annually at LRMC or training at the Vendor’s training center. The Government will bear the cost for lodging, transportation and per diem.

5.8. DELIVERY OF EQUIPMENT:

5.8.1. The Certified Allergy Testing System must be delivered to LRMC with equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, must be completed by Vendor personnel within 4-8 weeks after agreement award. During the initial implementation, an English-speaking technical representative shall be available telephonically during standard local business hours.

5.8.2. Exact installation locations at the hospitals shall be coordinated by the Vendor with the point of contacts listed below:

LRMC: Technical Supervisor, Immunology Infectious Disease Section Phone: (0049) 6371-9464-4147

DSN: 314-590-4147

5.9. The Vendor shall supply the following requirements with the delivery of the above mentioned items:

5.9.1. The electrical requirement for this equipment must be 220V/50Hz.

5.9.2. Two (2) paper and CD copies of the Operator’s manual in the English language will be provided at each site.

5.9.3. Two (2) paper and CE copies of the Maintenance manual in the English language will be provided at each site.

5.9.4. English programs, keyboards, displays, and control labels on each instrument and printer.

6.0. Instrumentation. Phadia US Inc. Phadia (hereafter referred to as “Phadia”), a Delaware corporation, agrees to provide to the Government and Government facility agrees to use, for the term of this agreement, the Instrumentation designated as “Included in BPA” on Attachment A-2. Phadia reserves the right to replace the Instrumentation with the appropriate instrument configuration for the lower or higher volume of testing at Phadia’s expense.

7.0. Ownership.Ownership of the Instrumentation is retained at all times by Phadia. Upon the termination or expiration of this agreement, the Instrumentation is to be immediately returned to Phadia in the same condition it was originally provided to Government facility, reasonable wear and tear excepted. If all of the terms and conditions of this agreement are fulfilled, upon the expiration or termination of this agreement, Phadia shall be responsible for the freight cost to return the Instrumentation. Phadia reserves the right to immediate return of the Instrumentation if Government facility (1) fails to timely pay for the reagents purchased, or (2) is the subject of a voluntary or involuntary bankruptcy petition. No liens may be placed on the Instrumentation during the term of this agreement except by Phadia. Government facility will bear all risk of loss and responsibility for any and all damage to the Instrumentation while in its possession.

Government facility may not transfer possession of the Instrumentation to any other person/entity or location, or assign any of its rights or obligations hereunder, without the prior written approval of Phadia.

8.0. Training, Installation and Service. The terms and conditions for Training, Installation, and Service contained on Attachment A-2 are incorporated herein.

9.0. Limited Warranty: Phadia shall repair or replace, at its cost (including labor), all parts and components found to be defective due to a condition existing at time of delivery (and not due to normal wear and tear, misuse or abuse) during the initial term of this agreement. All limited warranty work for Phadia® 250 and 1000 Instrumentation shall be performed at Government facility’s site. The Instrumentation is only configured for software and hardware provided by Phadia, and any use of other software or hardware with the Instrumentation will void this limited warranty. Software and hardware upgrades required by Phadia shall be provided free of charge by Phadia to Government facility.

10.0. Reagent. The following terms and conditions shall only apply to reagent purchases by Government facility:

Payment, Shipment and Delivery: Government facility agrees to purchase reagents from Phadia as described in Blanket Purchase Agreement W9114F-16-A-0007. All shipments are “FOB Origin”, and all delivery dates are estimated. Phadia shall select the method of shipment, carrier and shall be responsible for the cost of reagents lost or damaged during transit. Shipping cost shall be added to invoice and paid by Government facility. Phadia shall not be liable for damages arising from the failure to make or delay in making delivery because of fire, flood, strikes, embargoes, accidents, or any circumstances beyond its control.

10.1. FOB Origin. Vendor has the risk of loss during transit in accordance with the terms of paragraph 2, subparagraph Payment, Shipment and Delivery until the supplies are delivered to the Government at the specified delivery address.

10.2. Claims and Returns. All claims for damages, errors or shortages must be made by Government facility within seven (7) days after the reagent is delivered. No reagent may be returned without the prior written authorization of Phadia. Perishable items and opened vials cannot be returned. Any authorized returns are subject to inspection by Phadia before a credit is issued. The shipping costs of all returns which result from the fault of Phadia shall be paid by Phadia. The shipping costs of all other returns will be borne by Government facility.

10.3. Limited Warranty, Remedies and Damages. Phadia warrants that the reagents shall, at the date of shipment, conform to the specifications and other descriptions set forth in the labeling, including any Directions for Use included in the package. The obligation of Phadia, in the event of breach of warranty, shall be strictly and exclusively limited to the replacement of any of the reagent(s) that Phadia determines to have been defective at the date of shipment on inspection by an authorized representative. All warranty claims involving the reagents must be made within 90 days from the date of receipt by Government facility, or the claim shall be deemed waived. This warranty is not transferable from Government facility.

10.4. Instrumentation and Reagent Warranty Disclaimer. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE DISCLAIMED. UNDER NO CIRCUMSTANCE SHALL PHADIA BE LIABLE FOR INCIDENTAL OR

CONSEQUENTIAL

DAMAGES.

10.5. Reagents Vendor. Government facility agrees to use Phadia as Government facility’s sole source vendor for all Specific IgE testing. Phadia is the sole manufacturer of reagents compatible with Phadia instrumentation. Use of any reagents other than those supplied by Phadia will void instrument warranty.

11.0. Operator Training and Installation. Initial operator training for one to four (1-4) people has been provided by Phadia at Government facility at no cost. Any retraining shall be provided by Phadia at no charge, except that Government facility will be responsible for all travel, lodging, reagents, and other out-of-pocket expenses incurred by the trainer. Phadia or its designee shall unpack, install and verify Instrumentation operation at Government facility’s site.

11.1. Continual Training and Education. Phadia DoD Education and Training personnel will provide onsite training to clinical staff, at CONUS/OCONUS Military Treatment Facilities ordering this test, on application of NIH and DoD/VA guidelines with coordination through MTF Chief of Medical staff or delegate.

12.0. Service. In addition to the Limited Warranty obligations described in the PWS of this agreement, Phadia shall provide complete repair service Monday through Friday, 8:00 a.m. to 8:00 p.m., EST, excluding holidays, for the Instrumentation at no cost to Government facility for the term of the Agreement (hereafter the “Initial Service Period”). Any obligation of Phadia to service and maintain the Instrumentation under this Contract or a future service contract shall be void if Government facility uses reagents purchased from other companies with the Instrumentation.

ATTACHMENT A-2 – Service and Training for Phadia® 250 System SCHEDULE C – Pre Install Checklist for Phadia® 250 System

Instrumentation List Price Quantity Included in Contract Phadia 250 System-Moderate Complexity Valued at

$169,995.00 1 X

Computer, Monitor and Printer Included 1 X ImmunoCAP Data Manager Software Included X Phadia Lab Community Software License (Remote Access) and Cisco ASA 5505 Firewall

Included X

Computer Stand Included X Uninterrupted Power Source (UPS) Included 1 X

13.0. APPLICABLE REGULATIONS

13.1. GENERAL. In case of differences between local and national regulations, the regulations containing the most stringent requirements shall govern. Vendor shall comply with all U.S. laws pertaining to medical FDA-approved equipment. Vendor shall also comply with all Department of Defense (DOD), Department of Army (DA), U.S.

Army Europe (USAREUR), US Army Medical Command (USAMEDCOM), European Regional Medical Command, and Landstuhl Regional Medical Center (LRMC) regulations and policies pertaining to medical equipment. Current issues of applicable publications can be requested from the COR. These regulations include, but are not limited to, the following:

13.2. The Publications have been coded as mandatory or advisory. The Vendor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

13.2.1. Mandatory:

Public Law 91-596 29 Dec 70, Occupational Safety and Health Administration Public Law 104-191 (Aug 1996), Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JC) Manual AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-2 Army Medical Treatment Facilities and General Administration AR 40_4 Army Medical Department Facilities/Activities AR 40-68 Quality Assurance Administration

AR 340-21 The Army Privacy Program (05 Jul 85) AR 380-19 Information Systems Security AR 380-76 The Department of the Army Personnel Security Program AFIP PAMPHLET 40-24: Clinical Laboratory Improvement Program (CLIP) policy mandated by DODI 6440.2NFPA 99. Chapter 7.

13.2.2. Advisory AR 310-25 Dictionary of United States Army Terms MEDCOM Pam 25-31Index of Command Administrative Publications (15 AUG 01)

14.0. ACCOUNTING FOR CONTRACT SERVICES/VENDORMANPOWER REPORTING (UNCLASSIFIED).

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

(1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative;

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

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

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

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

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

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

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

(9) Estimated data collection cost;

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

(11) Locations where Contractor and sub-contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website),

(12) Presence of deployment or contingency contract language; and

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

As part of its submission, the Contractor shall also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a contractor’s systems to the secure web site without the need for separate data entries for each required data element at the web site. The specific formats for the XML direct transfer may be downloaded from the web site.”

15.0. Quality Assurance Surveillance Plan/Performance Requirements Summary (PRS).

Quality Assurance Surveillance Plan (QASP)

For the month of: _________________ Placement of one (1) CATS and Delivery of Reagents

Performance Requirements Summary

Contract Requirements

Acceptable Quality

Level (AQL)

Method of Surveillance

Compliance/COR Comments (to be filled out by COR) Provide direct customer services, technical support, routine & emergency service during normal hours of operation, to include hotline telephone service. PWS 1.5.2.

Vendor shall provide required performance and response.

98% Periodic Inspection

Furnish maintenance, services, repairs, and parts required in order to maintain

Vendor shall provide required

95% 100% the system IAW with CAP, CLIP, CLIA and CLSI guidelines. Shall ensure that a DD2163 is affixed and properly completed for the analyzer.

PWS 5.3.1.

performance and response.

Provide full maintenance service (at least every 6 months) during the lease period. Service includes repair and replacement of defective parts, complete maintenance program, calibration. PWS 5.3.5.

Vendor shall provide required performance and response.

100%

Complete a service technician’s report for scheduled and unscheduled repair.

PWS 5.3.6.

Vendor shall provide required performance and response.

98% Periodic

Respond to unscheduled telephonic requests for repair within 48 hours of notification for routine or within 24 hours for emergency failures. PWS 5.3.6.

Vendor shall provide required performance and response.

100%

Reagents shall have a shelf life of 2.5 years upon receipt at the Requiring Activity. PWS 5.4.1. to 5.4.3.7.

Vendor shall establish and maintain a complete QCP.

95% Analysis of Vendor’s Reports

SIGNED:

NAME:

Contracting Officer’s Representative

DATE:

(End Performance Work Statement)

TERMS AND CONDITIONS

(1) Description of agreement. The Vendor shall provide all labor, materials and transportation necessay to provide one (1) new Phadia 250 Analyzer on a no-charge lease basis and purchase of reagents as listed on the attached approved price-list, at the prices indicated to include any future updates to the price-list, if and when requested by the BPA callers, and authorized in writing by the Contracting Officer, for a period of up to five years from the date of BPA issuance, within a total aggregate amount of $600,000.00. Ownership of Phadia 250 Analyzer is retained by the Vendor at all times as outlined in the Performance Work Statement (PWS). The Government will return the old Phadia 250 Analyzer to the Vendor at Vendor's expense.

a. PWS for the placement of one (1) new Phadia 250 Analyzer and delivery of reagents.

b. Unit prices shall be in accordance with the Approved Price List, to include any future updates to the price-list.

c. The BPA Callers designated and authorized in writing by the Contracting Officer shall make the BPA

Calls.

(2) Extent of obligation. The Government is obligated only to the extent of authorized purchases actually made under the BPA.

(3) Purchase limitation:

a) The call limitation for purchases will be $25,000 per decentralized call.

b) U.S. Government BPA callers will compete each BPA call placed and award the BPA call to the BPA holder’s lowest priced product(s) in accordance with FAR 13.303-2 (c)(1).

c) Centralized calls will be issued by the Contracting Officer for calls greater than $25,000.00.

(4) Individuals Authorized to purchase under the BPA. A list of names and of individuals authorized to place calls under this agreement and the per call dollar limitation for each individual shall be furnished to the Vendor by the Contracting Officer. The Vendor shall not accept calls from an individual not identified on the list of individuals authorized to place calls. Additionally, the Vendor shall not accept calls that exceed the individual’s call limit.

(5) Delivery Tickets: The delivery tickets shall contain the following minimum information:

(i) Name of supplier.

(ii) BPA number.

(iii) Date of purchase.

(iv) Purchase number (i.e. BPA Call Number).

(v) Itemized list of supplies furnished.

(vi) Quantity, unit price and extension of each item, less applicable discounts.

(vii) Date of delivery or shipment.

(6) DELIVERY TIME: Delivery time shall be in accordance with the BPA Call's required delivery date. The Vendor shall notify the BPA caller immediately of any item on backorder that can not be shipping within this timeframe. See also PWS 5.4.3.7. In case of shipment loss or expiration of reagents due to delivery delays, the Vendor shall replace the ordered tissue at no cost to the US Government.

(7) INVOICES. Invoices shall be submitted to the BPA Callers placing the order, per each BPA Call for each delivery made during a billing period (one calendar month), identifying the delivery tickets covered therein, stating their total monetary value, and supported by receipt copies of the delivery tickets to the appointed BPA Caller.

The cutoff date is the last day of the month, or upon expiration of this BPA, whichever occurs first, for all supplies delivered during a billing period - the previous month - and for which payment has not been received. The invoice shall be submitted at the time of the BPA Call delivery. No more than one invoice per Call shall be submitted.

A summary invoice shall be submitted at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period, identifying the delivery tickets covered therein, stating their total dollar value, and supported by receipt copies of the delivery tickets;

(8) Modifications: Modification requests shall be in writing and submitted to:

Regional Health Contracting Office- E Attn: Mr. Nicholas Rowton Bldg. 3705, Room 301 Kirchberg Kaserne 66849 Landstuhl Germany

(End of Summary of Changes)