W9114F-18-T-0014_Amendment_0001.pdf

0011108978

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions ofthe document referenced in Item9A 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

1. CONTRACT ID CODE PAGE OF PAGES

J 1 27

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

16C. DATE SIGNED

BY 20-Dec-2017

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-18-T-0014

X 9B. DATED (SEE ITEM 11)

15-Dec-2017

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 Item14. The hour and date specified for receipt ofOffer is extended, X 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 ofthe following methods:

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

or (c) By separate letter or telegramwhich 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. Ifby virtue ofthis amendment you desire to change an offer already submitted, such change may be made by telegramor letter, provided each telegramor 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.(Ifapplicable)

6. ISSUED BY

3. EFFECTIVE DATE

20-Dec-2017

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (Ifother than item6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

The purpose of this amendment is to publicize the questions and answers.

W9114F-18-T-0014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS

Questions and Answers

Question 1: Are disposable pipette tips mandatory or are also other technologies accepted to minimize sample carryover?

Answer 1: In accordance with Performance Work Statement paragraph 5.1.2 and 5.2.12, “The system must utilize automated pipetting with disposable pipette tips, designed to eliminate sample carryover.”

Question 2: Does CCP mean an assay to detect Cyclic Citrullinated Peptide Antibodies (CCP Antibody, Anti-

CCP)?

Answer 2: Yes, CCP means having an assay to assay to detect Cyclic Citrullinated Peptide Antibodies (CCP Antibody, Anti-CCP). PWS paragraph 5.2.13.7., technical evaluation subfactor 1 in the Addendum to 52.212-1 and 52.212-2 were updated.

Question 3: Is it mandatory to have CCP (Anti-CCP) on the same analyzer as the other immunoassays or can it be analyzed on a separate system?

Answer 3: The PWS and Technical factors we request a single "system" not "system(s)". We do not have the space for multiple analyzers.

(End of Questions and Answers)

The following have been modified:

ADDENDUM TO FAR 52.212-1

The following paragraphs are hereby amended:

Paragraph 52.212-1(a) Does not apply to this Request for Quotation.

Paragraph 52.212-1(b)(4) is hereby replaced with the following:

Technical Factor. The quoter must demonstrate compliance with the requirements in the Request for Quotation by submitting a written quote which addresses compliance with each of the following technical factors:

Technical Evaluation Factors Standard Standard Acceptable Unacceptable

Subfactor 1: In accordance with the Performance Work Statement (PWS), the system must be able to perform FDA approved tests, including, but not limited to, the following:

5.2.13.1 Rubella IgM/IgG

5.2.13.2 Toxo IgM/IgG

5.2.13.3 TG/TPO

5.2.13.4 Hepatitis A IgM/Total

5.2.13.5 HCV Ab

5.2.13.6 Hepatitis B (surface antigen, confirmation, antibody, core M, core Total)

5.2.13.7 Cyclic Citrullinated Peptide Antibodies (CCP Antibody, Anti-CCP)

5.2.13.9. Total T3

5.2.13.10. Total T4

Subfactor 2: The system must be a random access immunoassay system using direct chemiluminescence (or other non-ELISA technology) capable of running 240 tests per hour while providing continuous operation even when loading/unloading samples and consumables.

Subfactor 3: The system must utilize ready-loaded reagent packs with the onboard capacity of at least 30 assays stored between 4 degree Celcius and 8 degree Celcius with automated mixing capabilities.

Subfactor 4: The system should also contain barcode reagent identification, automatic inventory tracking and flagging, calibration validity tracked and flagged, reagent onboard stability tracked and flagged, and reagent expired/reagent low flagging.

Subfactor 5: The system must utilize a software system for automatic dilution and performing repeat and reflex testing.

Subfactor 6: The system must have an integrated software system that calculates the final result, is able to archive data for a minimum of 14 days, and is fully compatible with Composite Health Care System (CHCS).

Subfactor 7: The system must have sensors to detect and notify the user of conditions that may result in erroneous results such as bubbles, blockages, and short-sample.

Subfactor 8: The software must maintain records of quality control materials and provide analysis following Westgard Rules and construction of Levy-Jennings plots.

Subfactor 9: The system’s daily, weekly, or monthly maintenance requires no more than 15 minutes operator time to perform.

Failure to receive an Acceptable rating of any of the above evaluation criteria will result in an Unacceptable technical rating unless the error(s), deficiency (ies) or omission (s) can be corrected.

Paragraph 52.212-1 (b) subparagraph (10) add:

(i) List at least three references, but not more than five, to include Point of Contact, Email address, Telephone Number, Nature of Work, Annual Dollar Value, Contract Number, Location and Time Period involved. Past performance information should be for work performed within the past three years. Any/all references received beyond the maximum number will not be evaluated.

Past Performance Questionnaire Areas of Focus for Response:

1. Ability of the contractor to comply with contract terms and conditions?

2. Quality of the contractor’s management relationship with Government (or customer) counterparts?

3. Ability of the contractor to consistently meet performance timeline requirements?

4. Accuracy and timeliness in providing contract deliverables?

5. Responsiveness to contract changes?

6. Accuracy of invoices?

7. What is your overall rating of the contractor’s performance?

Paragraph 52.212-1(c) is hereby replaced with the following:

The quoter agrees to hold the prices in its quotation firm for 90 calendar days from the date specified for receipt of quotations, unless another time period is specified in an addendum to the Request for Quotation.

Paragraph 52.212-1(d) does not apply to this Request for Quotation.

Paragraph 52.212-1(i) does not apply to this Request for Quotation.

Add the following:

Paragraph 52.212-1 (h)(ii) Only one Purchase Order will be awarded from this RFQ. Award will be on an “All OR NONE” basis. Quotes for less than all of the solicited line items will be rejected as nonconforming and unacceptable to the RFQ.

Paragraph 52.212-1(m) Quotes shall describe how your quoted services meet the above technical Subfactors to support the items listed in the schedule. If you do mark any block “Unacceptable” please explain why the services you quoted do not meet the Subfactors.

Paragraph 52.212-1(n) ELECTRONIC Quotation. Quoters may submit electronic quotation in response to this Request for Quotation. The quotation must be received by the quotation due date/local Germany time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@mail.mil Vendors may call Mr. Henning Mayer-Goldstein at 011-49-6371-9464-6789 to verify receipt of the quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote.

Paragraph 52.212-1(o) QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quotation no later than five business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to henningfalk.mayer-goldstein.ln@mail.mil, or fax +49-6371-86-8070. All questions received will be answered officially through an amendment to the Request for Quotation for distribution to all prospective quoters. Questions received after the local Germany cut-off date/time will not be accepted by the Government.

Paragraph 52.212-1 (p) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this Request for Quotation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

Paragraph 52.212-1(q) Site visit may be requested, and coordinated no later than 10 days prior to the due date of this request for quote by contacting henningfalk.mayer-goldstein.ln@mail.mil.

Paragraph 52.212-1(r) If a Quoter believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Quoter shall immediately notify the Contracting Officer (KO) in writing with supporting rationale.

ACQUISITION PROCEDURE:

This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for certain commercial items.

SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to award.

Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

PWS

PERFORMANCE WORK STATEMENT

FOR

LEASE OF IMMUNOLOGY ANALYZER/REAGENT SYSTEM

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK:

1.1.1 The Contractor shall provide a FDA approved automated immunoassay analyzer. Additionally they shall provide the necessary reagents, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. Assay method must be capable of producing clinical results in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. All equipment displays and supporting literature shall be in English. The analyzer shall be installed at the Landstuhl Regional Medical Center (LRMC), Building 3738 Room 113, 66849 Landstuhl, Germany. Lease of this equipment shall include reagents, and materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS guidelines and analyzer removal at the termination of the contract.

1.1.2 RESERVED

1.1.3 The software must maintain records of quality control materials and provide analysis following Westgard Rules and construction of Levy-Jennings plots. The system must meet DIACAP standards. The Contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of the College of American Pathologists and Landstuhl Regional Medical Center.

The analyzer system shall be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes to allow salvaging of the current batch of specimens in the analyzer. The Contractor shall also provide non-personal services to include, but not limited to, all personnel, equipment, tools, materials, supervision and training necessary to provide scheduled and unscheduled maintenance and repair of the system to ensure system is clinically operational in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

1.2. CONTRACTOR PERSONNEL:

1.2.1. Contract Manager. The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the Contractor 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 Contractor 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 24 hours to LRMC, to meet on the installation with Government personnel (designated by the contracting officer) to discuss problem areas.

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

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

1.2.2.1. Contractor personnel shall present a neat appearance and be easily recognized as Contractor employees.

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

1.2.3. Security Requirements. The Contractor and employees must possess a valid passport and local national identification card. If any contract personnel are required to travel from the U.S., then Antiterrorism training must be accomplished prior to traveling OCONUS.

1.2.4. Employee Training. Training will be provided by the Contractor 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 Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government will evaluate the Contractor's performance under this contract. For those tasks listed on the PRS (Technical Exhibit 1), the contracting officer’s representative (COR) or evaluators will follow the methods of surveillance specified in this contract. 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 contract. Such surveillance will 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 contract.

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 Contractor 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 Contractor 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 Contractor shall be responsible for safeguarding all Government property provided for Contractor 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 Contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0800 – 1630, excluding US Federal and German Holidays.

1.5.1.1. Holidays. Routine services and reagent delivery in Germany will not be required on standard US and German Federal Holidays. 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 contract 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 Contractor 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 shall be fluent in speaking English.

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

The Contractor 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 Contractor must provide a means/mechanism of safely disposing these wastes or byproducts in accordance to local national guidelines.

1.7. RECORDS. The Contractor 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 Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

1.8. SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP).

1.8.1. The Contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 29 March 2016. The SHARP reporting requirements apply only to knowledge obtained by Contractor personnel while performing services under this contract.

1.8.2. The Contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

1.8.3. The Contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

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 Contractor 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 Based Work Statement (PWS).

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

ACL - Acceptable Quality Level 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 - The Joint Commission KO - Contracting Officer 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 QASP - Quality Assurance Surveillance Plan 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 analyzers as indicated in paragraph 5.1 of the PWS. The Contractor shall not alter the facilities without written approval of the Contracting Officer. The Contractor 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 Contractor employees. The MTF will provide emergency healthcare for injuries occurring while on duty. The Contractor shall reimburse the Government for such services.

3.4. GOVERNMENT UNIQUE TRAINING. The Contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after Contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/time and availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at https://www.atsc.army.mil/tadlp/delivery/alms.asp.

4. CONTRACTOR FURNISHED PROPERTY.

4.1. General. Except for those Government-furnished items and services specified in section three (3), the Contractor shall furnish all items and services required under this contract.

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

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

5. SPECIFIC TASKS:

5.1. DESCRIPTION: (Reference Section 1.1. SCOPE OF WORK):

5.1.1 The Contractor shall provide an FDA approved automated immunoassay analyzer. Additionally, he shall provide all necessary reagents, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. Assay method must be capable of producing clinical results in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. The analyzer is already installed at the LRMC, Building 3738 Room 113, 66849 Landstuhl, Germany. Lease of this equipment shall include reagents, and materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS guidelines and analyzer removal at the termination of the contract.

5.1.2 The system must be a random access immunoassay system using direct chemiluminescence (or other non- ELISA technology) while providing continuous operation. The system should be able to load/unload samples and consumables at any time without the need to interrupt system operations to included but not limited to sample racks, STATS, reagent packs, ancillary reagent packs, cuvettes, pipette tips, calibrators, controls, wash fluid, water and waste. The productivity and efficiency shall include a minimum testing capacity of 240 tests per hour and be able to effectively manage both high and low volume tests with no-pause loading and unloading with a universal rack that holds multiple specimen tube types. The system must be capable of STAT priority sampling at any time. The system must utilize onboard reagents in ready-loaded assay packs. Must be able to store reagents and ancillary reagents on the System with a minimum onboard reagent capacity is 30 assays. The reagent tray must remain cooled to 4oC- 8oC with automatic rocking. An onboard ancillary tray should also be available for other reagents and kept cooled to 4oC- 8oC. The system should also contain barcode reagent identification, automatic inventory tracking and flagging, calibration validity tracked and flagged, reagent onboard stability tracked and flagged, reagent expired/reagent low flagging. The system must be able to archive data and to store calibration data for a minimum of 14 days. The system should allow for single sample testing, batch testing and testing of multiple assays at the same time. The system must utilize a software system for automatic dilution, and perform repeat and reflex testing.

The system must utilize automated pipetting with disposable pipette tips, designed to eliminate sample carryover.

The system must be able to perform FDA approved tests, including, but not limited to, the following: Rubella IgM/IgG, Toxo IgM/IgG, TG/TPO, Hepatitis A (IgM, Total), HCV Ab, Hepatitis B (surface antigen, confirmation, antibody, core M, core Total), iPTH, CCP, Total T3 and Total T4. The system must have an integrated software system that calculates the final result and is fully compatible with CHCS. The system should have sensors to detect and notify the user of conditions that may result in erroneous results such as bubbles or blockages. Systems checks and maintenance, such as flushing the lines, should be performed and documented by the system at specified intervals.

5.1.3 The software must maintain records of quality control materials and provide analysis following Westgard Rules and construction of Levy-Jennings plots. The system must meet DIACAP standards. The Contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of the College of American Pathologists and Landstuhl Regional Medical Center.

The analyzer system shall be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes to allow salvaging of the current batch of specimens in the analyzer. The Contractor shall also provide non-personal services to include, but not limited to, all personnel, equipment, tools, materials, supervision and training necessary to provide scheduled and unscheduled maintenance and repair of the system to ensure system is clinically operational in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

5.1.4 RESERVED.

5.1.5 Method Validation (Correlation Studies) will include parallel runs with existing equipment with not less than 20 but not more than 50 samples.

5.1.6 RESERVED

5.1.7 The Contractor shall provide the reagents and controls in accordance with section 5.3 Reagents of this PWS.

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

5.1.9 RESERVED

5.1.10 English programs, keyboards and displays are required.

5.2. ANALYZER

5.2.1. The system must be a random access immunoassay system using direct chemiluminescence (or other non- ELISA technology) while providing continuous operation.

5.2.2. The system should be able to load/unload samples and consumables at any time without the need to interrupt system operations to included but not limited to sample racks, STATS, reagent packs, ancillary reagent packs, cuvettes, pipette tips, calibrators, controls, wash fluid, water and waste.

5.2.3. The productivity and efficiency shall include a minimum testing capacity of 240 tests per hour and be able to effectively manage both high and low volume tests with no-pause loading and unloading with a universal rack that holds multiple specimen tube types.

5.2.4. The system must be capable of STAT priority sampling at any time.

5.2.5. The system must utilize onboard reagents in ready-loaded assay packs.

5.2.6. Must be able to store reagents and ancillary reagents on the System with a minimum onboard reagent capacity is 30 assays.

5.2.7. The reagent tray must remain cooled to 4oC- 8oC with automatic rocking. An onboard ancillary tray should also be available for other reagents and kept cooled to 4oC- 8oC.

5.2.8. The system should also contain barcode reagent identification, automatic inventory tracking and flagging, calibration validity tracked and flagged, reagent onboard stability tracked and flagged, reagent expired/reagent low flagging.

5.2.9. The system must be able to archive data and to store calibration data for a minimum of 14 days.

5.2.10. The system should allow for single sample testing, batch testing and testing of multiple assays at the same time.

5.2.11. The system must utilize a software system for automatic dilution, and perform repeat and reflex testing.

5.2.12. The system must utilize automated pipetting with disposable pipette tips, designed to eliminate sample carryover.

5.2.13. The system must be able to perform FDA approved tests, including, but not limited to, the following:

5.2.13.1. Rubella IgM/IgG

5.2.13.2. Toxo IgM/IgG

5.2.13.3. TG/TPO

5.2.13.4. Hepatitis A (IgM, Total)

5.2.13.5. HCV Ab

5.2.13.6. Hepatitis B (surface antigen, confirmation, antibody, core M, core Total)

5.2.13.7. Cyclic Citrullinated Peptide Antibodies (CCP Antibody, Anti-CCP)

5.2.13.8. RESERVED

5.2.13.9. Total T3

5.2.13.10. Total T4

5.2.14. The system must have an integrated software system that calculates the final result and is fully compatible with CHCS.

5.2.15. The system should have sensors to detect and notify the user of conditions that may result in erroneous results such as bubbles or blockages.

5.2.16. Systems checks and maintenance, such as flushing the lines, should be performed and documented by the system at specified intervals.

5.2.17. The software must maintain records of quality control materials and provide analysis following Westgard Rules and construction of Levy-Jennings plots.

5.2.18. The system must meet DIACAP standards.

5.2.19. The Contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of the College of American Pathologists and Landstuhl Regional Medical Center.

5.2.20. RESERVED.

5.2.21. The analyzer system shall be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes to allow salvaging of the current batch of specimens in the analyzer.

5.2.22. RESERVED

5.2.23. RESERVED

5.2.24. The Contractor shall provide non-personal services to include, all personnel, equipment, tools, materials, supervision and training necessary to provide scheduled and unscheduled maintenance and repair of the system to ensure system is clinically operational in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

5.3. REAGENTS

5.3.1. All reagents provided shall be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they shall 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.

5.3.2. All reagents must be functional through life of reagent (e.g. expiration date). All non-functional reagents (e.g.

failed runs), where non-functionally cannot be attributed to technician error, must be replaced by Contractor.

5.3.3. Reagents must be received at the required temperature indicated on the product insert and have a shelf life of 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e.

Delivery Ticket, Invoice). Reagents falling outside these specifications must be replaced by Contractor.

5.3.4. Controls must be received at the required temperature indicated on the product insert and have a shelf life of 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e.

Delivery Ticket, Invoice). Controls falling outside these specifications must be replaced by Contractor.

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

5.3.5. The manufacturer shall provide the required quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year.

5.3.6. All reagents and quality control material shall:

5.3.6.1. Include an English language package insert.

5.3.6.2. Be provided by the manufacturer of the equipment.

5.3.6.3. Be marked with the required storage temperature and expiration dates.

5.3.6.4. Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature.

5.3.6.5. 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.

5.3.7. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer’s Representatives. Orders will be delivered within five (5) business days of requested date of delivery.

5.3.8. Unscheduled and emergency orders and delivery shall be permitted. Emergency orders shall be delivered as soon as possible, but not more than five (5) business days.

5.3.8.1. Scheduled and unscheduled orders shall arrive within (5) business days before or after the scheduled date of delivery.

5.4. DATA MANAGEMENT:

5.4.1. Driver - the Contractor should 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.

5.4.2. Provides or comes with a 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. MAINTENANCE AND SERVICE

5.5.1. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the system as clinically operational in accordance with CAP and CLIP/CLIA/CLSI guidelines to include all repair and replacement of defective and other parts, complete maintenance program (as required by the manufacturer’s maintenance manuals) and calibration, in addition to hotline telephone service, to assist operators in troubleshooting problems. Lease shall include all initial Method Validation and Correlation per CLIP/CLIA/CLSI guidelines (if required), technical assistance, preventive maintenance (as per manufacturer’s maintenance manual) and 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 Contractor shall be responsible for ensuring a DD 2163 is affixed and properly completed for each analyzer. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment.

5.5.2. The Contractor 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 Contractor and Lab do not agree.

5.5.2.1. The Contractor “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 Contractor shall not be paid by the U.S. Government. If approved, a separate purchase order shall be issued prior to performance.

5.5.2.2. Contact the Chief, Equipment Management Branch or his/her designated representative at:

Landstuhl Regional Medical Center Equipment Management Branch Building 3760 Ward 4B 66849 Landstuhl Tel. 06371-867-327 Fax: 06371-867-258

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

5.5.4. The Contractor shall perform all services in accordance with the technical requirements set in accordance with the instructions and specifications provided. All equipment shall be FDA approved and from the manufacturer’s most current production.

5.5.4.1. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, in order to assist operators in troubleshooting problems.

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

5.5.4.3. On the day services (scheduled and/or unscheduled) are completed, the Contractor’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

5.6. REPAIR

5.6.1. Upon notification of equipment failure, the Contractor shall respond to telephonic requests for unscheduled repair within one (1) business day. Should the analyzer at LRMC become inoperable, the Contractor’s Repair Service Engineer shall be on-site within two (2) business days of initial notification for routine/emergency failures.

If the equipment is out of service for longer than five (5) business days (from the time of service technician’s arrival on site), the Contractor shall notify the COR, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument shall be provided within five (5) business days. If the equipment cannot be replaced within seven (7) business days, the Government may seek remedies for damages in accordance with FAR 52.246-4, “Inspection of Services – Fixed Price”.

5.6.2. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the U.S. Government.

5.6.3. Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

5.6.3.1. The Contractor shall notify the Point of Contact of the exact date and time for performance of a preventive maintenance service within ten (10) business days prior to the scheduled preventive maintenance services.

5.6.4. Smoking is prohibited within Landstuhl Regional Medical Center and its clinics.

5.6.5. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Department of Pathology, (LRMC, Building 3738, and Room 205) a Visitors Badge. The badge shall be returned to Department of Pathology, (LRMC, Building 3738, Room 205) prior to departing LRMC.

5.6.6. Within one (1) business day after completion of a repair, the Contractor’s representative shall furnish the Point of Contact (POC) one (1) copy of a service report for all services performed. The service report shall be in English and shall contain, as a minimum, the following information:

5.6.6.1. Nomenclature and serial number

5.6.6.2. Date

5.6.6.3. Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

5.6.6.4. Location of services performed

5.6.6.5. Duration of performance (hours)

5.6.6.6. List of parts replaced or other actions taken to restore operability of the instrument

5.6.6.7. Name of technician

5.6.6.8. The Contractor representative shall submit the service report to:

Department of Pathology Amerikanisches Krankenhaus Building 3738, Office 205 66849 Landstuhl

5.6.7. The U.S. Government and the Contractor shall exchange hazard communication information before the commencement of any repair.

5.6.8. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tagout procedures while performing maintenance on electrical equipment.

5.6.9. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Equipment Management Branch.

5.6.10. Preventive maintenance inspections and calibrations shall be performed in accordance with Contractor’s guidance as specified in the Contractor’s instrument maintenance manual.

5.6.11. When appropriate, the Contractor’s representative shall attach and complete a DD Form 2163 (sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services.

The Point of Contact will provide the DD Form 2163 to the Contractors’ representative. If the DD Form 2163 is already attached to the equipment, the Contractors' representative shall update the existing DD Form 2163.

Procedures for updating the 2163 will be provided by the Point of Contact.

5.7. SERVICE:

5.7.1. The Contractor shall provide direct customer service and support, during normal business hours and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

5.7.2. The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.7.3. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period. The lease agreement shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

5.7.4. Scheduled routine services shall be performed between 0730-1630 CET Monday-Friday, excluding German and U.S. Holidays.

5.7.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 72 hours after initial response by the Contractor.

5.7.6. Upon analyzer failure between 0730-1630 (CET) Monday-Friday, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within two (2)…