W9114F19Q0001_Amendment_0001.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

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 purpose of this amendment is to do the follow ing:

a. Provide clarif ication and respons to questions asked. See Questions and Answ ers.

b. Change the verbiage of PWS Paragraph 5.2.7.

c. Change the closure date and time to 19 January 2019 at 04:00 PM local Germany time. See Summary of Changes for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 35

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

16C. DATE SIGNED

BY 12-Feb-2019

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 W9114F19Q0001

X 9B. DATED (SEE ITEM 11)

15-Jan-2019

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

12-Feb-2019

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F19Q0001

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 14-Feb-2019 04:00 PM to 19-Feb-2019 04:00 PM.

TABLE OF CONTENTS

The below Table of Contents has been added

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

The following have been added by full text:

QUESTIONS AND ANSWERS

Questions and Answers

Question 1: Which type of tubes are being used?

Answer 1: In accordance with PWS Paragraph 5.2.2 and technical subfactor 9, tubes are specified as follows.

Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, and 64mm x 10.25 test tubes with standard or Hemoguard caps.

Question 2: How many tubes are decapped manually/automatically and which ones are those?

Answer 2: On average 40% of specimen are manually decapped, while 60% undergo an automated decapping through the analyzer.

Question 3: What is the cycle time between the analyzers at LRMC?

Answer 3: Currently one analyzer is used for 12 hours and then the second one is used for the next 12 hours.

Question 4: Would it be beneficial for the Government to have the analyzer cycle time to be extended?

Answer 4: Redundancy is addressed in PWS Paragraph 5.1.1. and Table 8 for LRMC analyzers. There is no requirement specified for an extended analyzer cycle time. However, an extended analyzer cycle time might very well be beneficial to the Government, as long as the analyzers support the increased downtime.

Question 5: It is possible to get a log file from CHCS to be able to analyze the workflow?

Answer 5: The log file is attached to the RFQ amendment.

Question 6: Is the water pre-treated before it gets to the water filtration system?

Answer 6: No, the water is not pretreated before it enters the filtration system.

Question 7: What is the quality of the local water source?

Answer 7: The water is soft. Water tests in November 2018 results were as follows:

1 degree dH/18ppm (Calcium carbonate/Calcium oxide)/0.18 mmoL/L.

Question 8: Some of the tests have quite low annual estimated quantities. Are these really required or can these be sent out to an external laboratory for testing?

Answer 8: The Government has outlined requirements for on-site testing inclusive of those tests needed for immediate testing of drug therapy.

Question 9: How many people need to be trained?

Answer 9: PWS Paragraph 5.5 lists all required training.

Question 10: How are the analyzers currently directly connected to CHCS or through middleware?

Answer 10: In accordance with PWS Paragraph 1.1. leased equipment shall include delivery, installation, reagents, middleware and materials necessary to perform the specified effort. Specific middleware capabilities for LRMC only are specified at PWS Paragraph 5.6.6. Therefore all analyzers are connected through middleware provided by the Contractor.

Question 11: How is the 24 hours a day and 7 days a week hotline telephone service being used?

Answer 11: In accordance with PWS Paragraph 5.4.3.1, the Contractor shall provide direct customer service and support to include hotline telephone service, in English, and on-call emergency repair service support, to assist operators in correcting equipment operation problems. Hotline telephone service must be available, in English, 24 hours a day, 7 days a week.

Question 12: Will remote access to the analyzers be possible?

Answer 12: No.

Question 13: How is the staffing at Belgium and Grafenwoehr?

Answer 13: 4-5 personnel for both facilities.

Question 14: Will the equipment be moved during the lifetime of this requirement?

Answer 14: Moving the equipment is not covered by this requirement.

Question 15: In regards to PWS Appendix A, Table 1, Immunoassay, Parameter Free or bound Testosterone.

Free testosterone can be measured indirectly using the assays for Testosterone (total) and SHBG.

Calculating Free Testosterone Index (FTI) or Free Androgen Index (FAI) requires the measurement of total testosterone and SHBG concentrations.

FAI is calculated using the following equation:

Total Testosterone (ng/mL) x 3.47 x 100

Total Testosterone (nmol/L) x 100 = FAI (%)

SHBG (nmol/L) SHBG (nmol/L)

FAI is generally considered useful in estimating free testosterone in women with hirsutism or hyperandrogenism. Equations have been used to derive the free testosterone concentration (FTc).

Vermeulen et al. described a mathematical algorithm that incorporates the measurement of total testosterone and SHBG concentrations that is comparable to free testosterone values obtained by equilibrium dialysis. The Vermeulen equation is useful for estimating free testosterone, except in pregnant patients. [See reference (1) below] To calculate the “bioavailable” testosterone (BATc), the concentrations of SHBG, total testosterone (TT) and albumin-bound testosterone must be considered. The calculated bioavailable testosterone is the sum of free testosterone and albumin-bound testosterone.[See reference (1) below] A detailed description of both the Vermeulen “free” and “bioavailable” testosterone calculations can be found at http://www.issam.ch/freetesto.htm

Reference (1) Vermeulen A, Verdonck L, Kaufman J, A critical evaluation of simple methods for the estimation of free testosterone in serum. Journal of Clinical Endocrinology & Metabolism 1999; 84: 3666-3672.

Is the above shown alternative approach acceptable?

Answer 15: This approach is acceptable for free and bound testosterone.

Question 16: Discrepant statements:

Item numbers 0008, 1008, 2008, 3008 and 4008 state the following: "Travel Cost: Travel cost for offsite training for all Government testing sites in accordance with PWS Paragraph 5.5. The Government will reimburse the Contractor for actual allowable and allocable expenses in accordance with Federal Acquisition Regulation (FAR) 31.205-46."

versus

PWS Paragraph 5.5.2 states the following: "The Contractor shall provide two (2) training slots per analyzer, per contract year, for each of the listed testing sites, at the Contractor’s training site, at no additional cost to the U.S. Government. The training shall encompass basic operation, maintenance, troubleshooting and software training. The contractor is responsible for all applicable transportations costs (public and private), lodging, and meal costs for the trainees. This requirement applies to all listed Government sites (LRMC, SHAPE and Grafenwoehr). Travel costs shall not exceed the current JTR/JFTR." Travel benefits shall be provided in-kind (rather than in cash)."

Please explain the correct procedure.

Answer 16: The Government does not see a discrepancy between the two cited statements. However, please also see the line item x001 where it states the following: "… The unit price of this item shall contain all associated analyzer costs for lease and usage, delivery and installation, preventive and unscheduled maintenance, repair, spare parts, onsite and offsite training including costs for teacher and training handouts. ..."

In other words, the costs listed in PWS Paragraph 5.5.2 shall be split into training cost (line item x001) and travel cost (line item x008).

Question 17: Discrepant statements:

PWS Paragraph 5.2.7 states the following: "Each analyzer system must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 5 to 7 minutes. The UPS must ensure enough power to have seamless, uninterrupted testing for approximately 10 minutes in the event of a power outage."

versus

Addendum 52.212-1, Technical Subfactor 12 states the following: "Analyzer must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 30 minutes. (PWS Paragraph 5.2.7.)."

Which of these requirements is correct?

Answer 17: The correct verbiage should be: Analyzer must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 30 minutes.

(End of Questions and Answers)

The following have been modified:

PERFORMANCE WORK STATEMENT

Performance Work Statement for

Lease of Chemistry/Immunoassay Analyzers

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK. The Contractor shall provide non-personal services to include, all personnel, equipment, tools, materials, supervision, training, and other items and services necessary to provide a chemistry/immunoassay analyzer systems and reagents as described in Section 5 of this Performance Work Statement (PWS). The analyzer systems will be located in two locations in Germany and one location in Belgium as shown below. Lease of this FDA approved equipment shall include delivery, installation, reagents, middleware and materials necessary to perform the specified chemistry/immunoassays to the standards of this PWS and analyzer removal at the end of the contract. The analyzers must be delivered and installed in the appropriate testing site at least eight (8) weeks before specified period of performance start date. The analyzers shall be fully operational and able to report patient specimens no later than the specified period of performance start date.

Landstuhl Regional Medical Center (LRMC)

Department of Pathology, Core Laboratory Building 3711, Room F203 66849 Landstuhl, Germany

SHAPE Healthcare Facility Unit 21414, Laboratory Services Building 401, Room 1B128 7010 SHAPE (Mons), Belgium

U.S. Army Health Clinic, Grafenwoehr (USAHCG) Grafenwoehr Lager, Building 475 92655 Grafenwoehr, Germany

1.2. CONTRACTOR PERSONNEL:

1.2.1. 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.

1.2.1.1. Contractor employees 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.

1.2.1.2. The Contractor shall not employ any person who is an employee of the US Government. Additionally, the Contractor 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 5500.7R, “Joint Ethics Regulation”. The Contractor shall not employ any person who is an employee of the Department of Defense if such employment would be contrary to local policies.

1.2.1.3 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.

1.2.1.4. 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.

1.2.1.5. 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.

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

1.2.2.1. 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.

1.2.2.2. The Contractor's Program Manager (or equivalent) shall respond to calls and emails from the LRMC COR and Contracting Officer in a timely manner.

1.3. QUALITY CONTROL:

1.3.1. The Contractor shall provide a Quality Control Plan that contains, as a minimum, the items listed in 1.3.2 to the COR and Contracting Officer for acceptance not later than 10 days of the start of the contract (see PWS Attachment 1). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan before the contract start date. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.3.2. The plan shall include:

1.3.2.1. A description of the inspection system to cover all services listed on the Performance Requirements Summary (PRS) listed in Attachment1. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors.

Additionally, control procedures for any Government provided keys or lock combinations shall be included.

1.3.2.2. A description of the methods to be used for identifying and preventing defects in the quality of service performed.

1.3.2.3. A description of the records to be kept to document inspections and corrective or preventive actions taken.

1.3.3. The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

1.4. 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 Performance Requirement Summary (PRS), the COR will follow the methods of surveillance specified in this contract. Government personnel will record all surveillance observations.

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.

1.4.1. Performance Evaluation Meetings.

1.4.1.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer, contract administrator and COR, as deemed necessary. Written minutes of any such meetings shall be recorded and submitted to all in attendance by the COR and uploaded to CORT. If the Contractor does not concur with any portion of the minutes, such non-concurrence shall be provided in writing to the COR within 10 calendar days following receipt of the minutes.

1.4.1.2. 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 by the COR 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.

1.5. SECURITY:

1.5.1. The Contractor shall be responsible for safeguarding all Government property provided for Contractor use or access.

1.5.1.1. 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.

1.5.1.2. Non-U.S. Citizen(s). Immediately after award of the contract, the Contractor shall submit to the COR a request for a U.S. Installation Pass. On successful completion of necessary U.S. Government personnel security clearance requirements, an Installation Pass will be issued by the Installation Coordinator (see PWS Attachment 2). The U.S.

Government will conduct and assume the cost of background investigations for required clearances. The Installation Pass shall be returned to the COR immediately upon termination or expiration of the contract.

1.5.1.3. The Contractor shall not permit unauthorized person(s) entry to the installation nor any facilities.

1.5.2. Vehicle Operation, Registration and Insurance. The Contractor shall comply with the local installation requirements for vehicle registration. Any vehicle operated in performance of this contract must have appropriate liability coverage.

1.6. HOURS OF OPERATION:

1.6.1. 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 0730 – 1630 for all listed testing locations.

1.6.1.1. Holidays: Routine services and reagent delivery will not be required on Local National or Federal Holidays.

If an emergency arises, services and reagent delivery shall be provided in accordance with Section 5.4.3 of this PWS.

1.6.2. The Contractor shall provide direct customer service and support in English to include hotline telephone service.

LRMC will require 24 hours/7 days a week contractor customer support. Service report details are outlined in section

5.3 and 5.4.

1.6.3. Holidays. Routine services and reagent delivery for Landstuhl and Grafenwoehr locations will not be required on U.S. Federal and German National Holidays. Routine services and reagent delivery for SHAPE will not be required on U.S. Federal and Belgian or German National Holidays. The following is a list of legal holidays:

American Federal Holidays German National 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, January 1 Three Kings Day, 6 January (Bavaria only) Good Friday, varies annually Easter Monday, varies annually Labor Day, May 1 Ascension Day, varies annually Whit Monday, varies annually Corpus Christi, varies annually Assumption Day, 15 August (Bavaria only) Day of German Unity, October 3 All Saints Day, November 1 1st and 2nd Christmas Day, December 25 & 26

Belgian National Holidays New Year's Day, January 1 Good Friday, varies annually Easter Monday, varies annually Whit Monday, varies annually National holiday, July 21 Assumption Day, August 15 All Saints, November 1 Armistice Day, November 11 Christmas Day, December 25

NOTE: If any of the above U.S. holidays fall on a Saturday or Sunday the holiday may be observed on the preceding Friday or following Monday. Any U.S. holidays that are declared by Presidential Executive Order shall be observed in the same manner as the U. S. holidays listed above.

1.7. CONSERVATION OF UTILITIES:

1.7.1. 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:

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

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

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

1.7.5. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines. The contractor is responsible for all costs associated with disposal of analyzer waste required by Environmental Final Governing Standards in the country where the analyzer is physically located. Costs include analysis of a representative sample of instrument effluent (waste) to establish waste codes and disposal requirements.

1.8. 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. 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.

1.9. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the Contracting Officer. Equipment shall be disinfected by contractor staff and appropriate certifications of such disinfection shall be provided in accordance with applicable biosafety guidance in the indicated country before equipment is removed from Government work sites. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

1.10. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and services supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970.

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

1.11.1. 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.

1.11.2. 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.

1.11.3. 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. 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 programs, 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 LRMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the PWS.

2.1.7. Individual has the same meaning as the term “individual” in 45 CFR 164.501 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

2.1.8. Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

2.1.9. Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 164.501, limited to the information created or received by the Contractor from or on behalf of the Government.

2.1.10. Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

2.1.11. Required by Law has the same meaning as the term “required by law” in 45 CFR 164.501 and 164.103.

2.1.12. Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

2.1.13. Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164 subpart C.

2.1.14. Terms used, but not otherwise defined, in this PWS shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304.

2.2. ACRONYMS/ABBREVIATIONS.

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

AR - Army Regulation CAP - College of American Pathologists CLSI - Clinical and Laboratory Standards Institute

COR - Contracting Officer's Representative DA - Department of the Army DoD CLIP - Department of Defense Clinical Laboratory Improvement Program DPALS - Department of Pathology and Laboratory Services FDA - Food and Drug Administration HIPAA - Health Insurance Portability & Accountability Act of 1996 MEDCOM - U.S. Army Medical Command JC - Joint Commission OSHA - Occupational Safety and Health Administration PWS - Performance Work Statement QA - Quality Assurance QC - Quality Control QM - Quality Management

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

3.1. GENERAL. The Government will provide, without cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the analyzers as indicated in paragraphs 5.1.1.3 & 5.2 & 5.7.2 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.

3.1.2. EQUIPMENT. No equipment will be provided

3.1.3. MATERIALS. No materials will be provided.

3.1.4. SERVICES. The Government will provide the following services at no cost to the Contractor:

3.1.4.1. UTILITIES. The Government will provide the normal range of facility requirements (e.g. electricity, water, heating, refuse collection, etc.) and other utilities necessary for the full functionality of the equipment/instrumentation.

Electrical current will be supplied at 220 volts and 50 hertz, but stability of the electrical current is not guaranteed.

Water supplied will be unfiltered, unpurified and may contain chemicals to reduce bacterial growth.

3.1.5. Security: Police and Fire Protection, as is provided other personnel.

3.1.6. Emergency Healthcare for Contractor employees. The Medical Treatment Facilities (MTF) will provide emergency healthcare for injuries occurring while on duty. The Contractor shall reimburse the Government for such services.

3.1.7. 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 3, the Contractor shall furnish all items and services required under this contract.

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

4.1.2. 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:

5.1.1. The Contractor shall provide a fully automated, discrete random access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in PWS Appendix A relative to the testing locations’ needs. The analyzer system shall be from a single Manufacturer. For certain specific esoteric tests (e.g. Glucose-6-phosphate Dehydrogenase (G6PD) etc.), the Contractor may subcontract for the specific reagents, calibrators and controls, but not instrumentation. The contractor shall provide training (on-site, off-site, initial and annual), supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

Note: For the LRMC site only, the contractor shall provide redundant systems which are fully automated, discrete random access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in Table 1 of PWS Appendix A in order to ensure continuous operations.

5.1.1.1. All equipment displays and supporting literature must be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial method validations, calibration verification and new reagent verification per CLIA/CLSI/CAP/DPALS QM guidelines and analyzer removal at the termination of the contract.

Please note that a given percentage of the QC at each of the listed testing locations shall be from a source other than the contractor (vendor). All costs shall be calculated on a cost per patient reportable. Costs shall be separated by line item (CLIN Number) where appropriate and as described in this PWS. Costs that are separated by line item (CLIN Number) shall be amortized over the total number of tests described in this PWS and factored into the cost per reportable or patient billable.

5.1.1.2. For the purposes of this PWS the analyzer system includes at a minimum:

- Any and all analyzers

- Uninterruptable Power Sources (UPS)

- Peripherals (e.g. instrument specific computer terminals and CPU’s, etc.)

- Robotics Automation Systems as applicable

- Automated Pre-analytical Processing Systems

5.1.1.3. The analyzer system will be located at:

Landstuhl Regional Medical Center (LRMC) Building 3711, Room F203 66849 Landstuhl, Germany

SHAPE Healthcare Facility Unit 21414, Laboratory Services Building 401, Room 1B128 7010 SHAPE (Mons), Belgium

U.S. Army Health Clinic, Grafenwoehr (USAHCG) Grafenwoehr Lager, Building 475 92655 Grafenwoehr, Germany

5.1.2. Contractor must coordinate and conduct a site visit at each of the listed testing locations in Germany and Belgium for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed instruments must be identified in the Contractor’s Solicitation for Quote response (i.e., must identify all site preparation requirements necessary for potential placement of their instruments in the laboratory).

5.1.3. Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP)). Relevant guidelines listed in PWS Appendix B are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

5.1.3.1. Method Validation will include but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

5.1.3.1.2. The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.1.3.2. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation as directed by Clinical Laboratory Improvement Amendments, who and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), and who is able to provide technical assistance for the method validation studies. The assigned Technical Service Representative(s) shall be responsible for the entire initial Method Validation for all analytes reported on the contractor’s instrument for each of the listed testing locations.

5.1.3.3. All reagents, calibrators and linearity materials used in the Method Validation Study shall be provided by the Contractor at no additional cost to the Government. These materials shall not be used in the analysis of specimens for patient care but for the method validation study.

5.1.3.4. The Technical Supervisor shall obtain patient specimens for use in the Method Validation.

5.1.3.5. Both the Contractor and personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

5.1.4. The Contractor shall provide two (2) paper and two (2) electronic copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language to each site. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user.

All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

5.1.5. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government.

SDS’s shall be furnished in English and in the language of the country where the analyzer is physically located. This includes updated SDS datasheets and SDS data sheets for new reagents or controls. The SDS shall contain information on the hazards associated with each specific chemical or material. The entire SDS shall be printed in the English language and shall contain, as a minimum, identification of:

- the hazardous material

- the specific hazard

- the required practices for the safe use of the product

- first aid procedures

- what to do in the event of a spill or other mishap or accident.

5.1.6. The Contractor shall provide a water system (e.g. filtered, deionized, UV exposure etc.), if required by the analyzer, that shall provide continual, uninterrupted service for the entire contract period. The contractor shall furnish all consumables required by the water system and shall provide the same maintenance and service standards for the water system as is specified elsewhere in this document for the analyzer itself.

5.1.7. The Contractor shall provide the reagents as outlined in the Schedule of Supplies/Services. Delivery of the reagents shall be as scheduled/required by the individual delivery orders issued by the Contracting Officer. The Contracting Officer shall be the only entities authorized to issue orders against the resulting contract.

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

5.2. ANALYZERS:

Table 1: Minimum Site Requirements Location Analyzer Type / Facility

Restriction Typical Thru-put

Landstuhl Regional Medical Center (LRMC) Department of Pathology, Core Laboratory Building 3711, Room F203 66849 Landstuhl, Germany

2 Chemistry 2 Immunoassay

Maximum size:

Immunometric assays: 200 tests per hour

Enzymatic/rate: 800 tests per hour

POC: Chemistry Supervisor Department of Pathology, Core Laboratory Tel: +49 (6371) 86 7511; DSN: (314) 486 7511 Fax: +49 (6371) 86 7502; DSN: (314) 486 7502

POC: Clinical Engineering Branch Tel: +49 (6371) 86 6232

Two spaces each 420 cm x 160 cm

Colorimetric/photometric assays: 800 tests per hour

ISE assays: 600 tests per hour

SHAPE Healthcare Facility Unit 21414, Laboratory Services Building 401, Room 1B128 7010 SHAPE (Mons), Belgium

POC: Dominique Vandoren Shape Healthcare Facility Lab

DSN: (314) 566 5206

COMM: +32 (6532) 5322

POC: Clinical Engineering Branch

1 Chemistry The lab doors are ~ 88 cm wide.

Instrument should not weigh more than 400 kilos.

10-50 test/hour

U.S. Army Health Clinic, Grafenwoehr

(USAHCG)

Grafenwoehr Lager, Building 475 92655 Grafenwoehr, Germany

POC: Laboratory Manager Laboratory Tel: +49 (6371) 9464 3817; DSN: (314) 590 3817

POC: Clinical Engineering Branch Tel: +49 (6371) 9464 3839; DSN: (314) 590 3839

1 Chemistry

Maximum size:

200 cm deep 250 cm wide 260 cm high

Enzymatic/rate: 10-50 tests/hour

Colorimetric/photometric assays: 10-50 tests/hour

ISE assays: 10-50 tests per hour

5.2.1. Individual analyzers shall have fully automated, discrete random access capabilities for chemistry, immunometric, potentiometric, and colorimetric assays within the same instrument, i.e. not separate chemistry, immunometric, potentiometric, and colorimetric analyzers.

5.2.1.1. There must be a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests. There must be an optional separate specimen point of entry for STAT specimens.

5.2.1.2 The type and number of analyzers for each of the listed testing locations shall be determined by the minimum throughput, available menu requirements, and patient acuity.

5.2.2. Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, and 64mm x 10.25 test tubes with standard or Hemoguard caps.

5.2.3. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.

5.2.3.1 The analyzer should be able to analyze a comprehensive metabolic panel with less than 0.5 mL of sample.

5.2.3.2 The bilirubin assay must have a range suitable for analyzing neonate specimens.

5.2.3.3 Creatinine and cholesterol assays shall be traceable to nationally recognized reference methodology.

5.2.4. Minimum actual through-put is specified in Table 1 of this PWS (see above).

5.2.4.1. Analyzer throughput shall be measured as a function of number of STAT panels (see Table 2 of this PWS) fully completed in 45-minutes.

5.2.4.2. The 45-min STAT panel includes the assays listed in Table 2 of this PWS. These assays should be analyzed from the same specimen with a maximum turn-around-time (automated pre-analytical processing to certification) of 45 minutes.

Table 2 – Assays that should be completed simultaneously from the same specimen within 45 minutes as a STAT panel.

Alanine Amino Transferase (ALT) Creatinine

Albumin Creatinine Kinase, Total (CK)

Alkaline Phosphatase Creatinine Kinase, MB Fraction (CK-MB)

Aspartate Amino Transferase (AST) Glucose

Bilirubin (Direct) Chorionic Gonadotropin (hCG)

Bilirubin (Total) Potassium

Brain Natriuretic Peptide (BNP) or NT-pro BNP‡ Protein, Total

Calcium (Total) Sodium

Carbon Dioxide (CO2) Troponin I or T

Chloride Urea Nitrogen

‡ Inclusion in profile is preferred, but may not be required.

5.2.5. All analyzer/data management system displays and supporting literature must be in the English language.

5.2.6. Initial startup from the shutdown state must not exceed 20 minutes.

5.2.7. Analyzer must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 30 minutes.

5.2.8. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

5.2.9. The analyzer systems shall provide open channels to accommodate the Glucose-6-phosphate Dehydrogenase (G6PD) assay. The Contractor shall provide consumables, reagent containers and quality control in sufficient quantities and quality to perform third party assays.

5.2.10. For the LRMC site only: The analyzers shall come equipped with archive and retrieval capability.

5.3. REAGENTS:

5.3.1. The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in PWS Appendix A. All assays shall be FDA approved.

5.3.2. The estimated workload listed in PWS Appendix A for the listed testing site is an estimate based on historical and anticipated patient workload. Actual workload may vary. The workload numbers represent patient reportable results which is less than the test count required to obtain them. Test counts include calibrators, controls, or re-runs due troubleshooting or specimen dilutions in addition to the final test reported. However, in order to generate a patient reportable result, all requirements of the laboratory’s Quality Management Program (QMP) must be met, specifically each laboratory’s policy regarding quality control (see Table 3 of this PWS). Daily QC usage shown below reflects minimum requirements with current analyzers. Regulatory agencies specify that QC will be performed at least as frequently as required by analyzer manufacturer guidance and not less frequently than once every 24 hours.

Table 3 Example of minimum QC usage required by the laboratory’s QMP

LRMC SHAPE USAHCG

Daily QC usage twice every 24 hours once every 24hrs once every 24hrs Trouble shooting yes yes yes After calibrations yes yes yes After major maintenance yes yes yes

5.3.3. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand or contract in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations within the Regional Health Command Europe (RHC-E). PWS Appendix A provides a workload estimate for Contract Option Year 1. All workload numbers represent patient reportable/billable results for the indicated year.

5.3.4. To account for expected fluctuations in workload, the Contractor shall provide a “sliding scale” schedule of reagent cost per test. This schedule shall provide a listing of all available analytes with the cost per reportable patient result for a given workload. As workload increases, the cost per reportable patient result should decrease. Conversely, if the workload decreases then the cost per reportable patient result should increase. The workload shall be based on the total number of patient reportable results from Landstuhl, SHAPE, and Grafenwoehr sites. By utilizing the ‘sliding scale’ schedule, the cost per reportable patient result should be the same for each of the listed testing sites. See PWS Appendix A for estimated annual workload.

5.3.5. To accommodate potential increase workload, and expansion of services, the vendor shall include an estimated cost per reportable patient results for the entire catalogue of available reagents for all listed testing sites combined, as listed in PWS Appendix A.

5.3.6. The analyzer must be capable of maintaining calibration curves, simultaneously, for all of the assays listed in PWS Appendix A. Calibration curves shall be maintained electronically for the entire period of the calibration validity up to 6 months.

5.3.7. All the assays listed in Table 4 of this PWS must be present on the analyzer at all times at the LRMC site. Only the assays listed in Table 4 and in PWS Appendix A for SHAPE and Grafenwoehr must be present on the analyzer at all times for these sites.

5.3.8. The assays listed in Table 4 must be approved by the FDA for plasma as well as serum samples. In addition, the Contractor shall clearly demonstrate an acceptable correlation, as defined in section 5.1.3. between plasma and serum values during the initial set up and correlation studies.

5.3.9. All other reagents (See PWS Appendix A) need not be maintained on an analyzer at the same time, but the analyzers provided must have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement, i.e., must allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet work test…