Final_Amendment_0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

J

PAGE OF PAGES

1 32

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

14-Sep-2017

4. REQUISITION/PURCHASE REQ. NO.

0011025343

5. PROJECT NO.(Ifapplicable)

6. ISSUED BY CODE W81K00 7. ADMINISTERED BY (Ifother than item 6) CODE W81K00

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

POC: GERALDINE I. HERNANDEZ

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X

9A. AMENDMENT OF SOLICITATION NO.

W81K00-17-T-0330

X 9B. DATED (SEE ITEM 11)

01-Sep-2017

10A. MOD. OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 is extended, X is not extended.

Offer must acknowledge receipt ofthis 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 ofthis 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.)

The purpose of this amendment is to address the follow ing:

1. The follow ing document is hereby added to the Solicitation as Attachment 1 – Questions presented to the Government w ith Replies.

2. No further questions w ill be accepted as of the date/time of this amendment posting to FBO and the Solicitation closing date remain unchanged.

3. A revised Statement of Work has been incorporated.

4. All other terms and conditions remain unchanged.

Except as provided herein, all terms and conditions ofthe 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) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

TEL: EMAIL:

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

BY

(Signature of Contracting Officer)

16C. DATE SIGNED

14-Sep-2017

EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

30-105-04 STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

W81K00-17-T-0330

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

ATTACHMENT 1

Chemistry Immunoassay

ATTACHMENT 1

Questions/Answers

Q1. What Instrument and volume of test per hour? New or Used?

A1. This requirement is for a new Immunochemistry Analyzer. Per the Statement of Work paragraph 5.2.4. -

Minimum actual through-put shall be 200 tests per hour for immunometric assays, 800 tests per hour for enzymatic/rate and colorimetric/photometric assays and 1200 tests per hour for ISE assays.

Q2. This solicitation references Cost per Reportable Result (CPRR) which requires the end user to submit monthly reports detailing patient volume. Invoices are generated once those reports are tallied rather than when the product is ordered. The volumes provided in Attachment 3 appear to reflect CPT volumes. Given the above information, are you looking for Cost Per Test or Cost Per Reportable Result?

A2. Per the Statement of Work paragraph 5.1.1, this requirement is for a Cost per Reportable (CPRR) agreement.

Q3. SPECIFIC TASKS 5.1.1.1., INFORMATION MANAGEMENT 5.6.4; 5.6.4.1; 5.6.5; 5.6.6; 5.6.6.1; 5.6.6.2;

5.6.6.3

Is your intention to add capability beyond what you have with your current VIRTOS system such as an instrument manager system and/or automation including auto verification, Bio-Rad QC, and Thin Client?

A3. No, there are no intentions to add an instrument manager or any peripherals.

The following have been modified:

STATEMENT OF WORK

REYNOLDS ARMY HEALTH CLINIC - PATHOLOGY

CHEMISTRY - IMMUNOASSAY REQUIREMENT

STATEMENT OF WORK

TABLE OF CONTENTS

1.1 Scope of Work

1.2 Quality Control and Quality Assurance

1.3 Hours of Operation

1.4 Conservation of Utilities

1.5 Records

1.6 Removal of Equipment

1.7 Upgrade of Equipment

1.8 Special Working Conditions

1.9 Contractor Personnel

2.0 Definitions/Acronyms

3.0 Government-Furnished Facilities, Equipment, Material and Services

4.0 Contractor Furnished Property

5.0 Specific Tasks

6.0 Information Security

7.0 Program Management

8.0 Applicable Technical Orders, Specifications, Regulations and Manuals

9.0 Performance Measurements Requirement Summary

10.0 Appendices

GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Chemistry Immunoassay Reagents (including equipment, maintenance, and support at no extra cost to the Government) in support of Reynolds Army Community Hospital, Fort Sill, OK. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition. The Contractor shall perform to the standards of this

Statement of Work (SOW).

1.1.1 The Contractor shall perform to the standards of this Statement of Work (SOW). The Contractor shall be responsible for installation, scientific studies (to include validations, correlations, linearities, etc), and maintenance.

When awarded, the Contractor shall have installation and scientific studies completed no later than 30 days after delivery.

1.2. QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA):

1.2.. The Contractor shall provide a Quality Control (QC) Plan (Attachment 2) that contains, as a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and Contract Officers Representative (COR) for acceptance not later than 10 days AFTER the start of the contract. The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

1.2.1.1.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) (Attachment 1). 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.

1.2.1.1.2. A description of the methods to be used for identifying and preventing equipment failure and/or defects.

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

NOTE: 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, if any, under this contract.

1.2.2. Quality Assurance (QA) - The COR will follow the methods of surveillance specified in this contract.

Government personnel will record surveillance observations, as needed, and provide to the Contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the

Contractor has been made aware of the defective performance. Government surveillance may include observations/tasks not listed in the PRS. 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.

1.2.3. Equipment Troubleshooting. When the Government performs troubleshooting with the Contractor, the

Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the

Government IAW Paragraphs 5.4.2.1 and 5.4.2.2. (below).

1,2,4. Performance Evaluation Meetings.

1.2.4.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or COR, as deemed necessary.

1.2.4.2. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the Contractor does not concur with any portion of the minutes, such nonconcurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. Monday through Friday between the hours of 0730 – 1630 CST.

1.3.1.1. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal

Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with

Section 5.4.3 of this PWS.

1.3.2. The Contractor shall provide equipment maintenance service/direct customer service and support, 24 hours/7 days a week, to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems.

1.3.3. Legal Holidays. The following legal holidays will be observed by the Government:

New Year’s Day 1 January

Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February

Memorial Day Last Monday in May

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day 11 November Thanksgiving Day Fourth Thursday in November

Christmas Day 25 December 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.

1.4. CONSERVATION OF UTILITIES. During maintenance, 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:

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

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

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

1.4.4. 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 shall provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

1.5. RECORDS. The Contractor shall maintain all records necessary to comply with regulatory requirements and

Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in this SOW or required by the provisions of a mandatory directive listed in section 5.4, 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.

1.6. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the COR or his/her designated representative. (i.e. printer, UPS, monitor)

1.7. UPGRADE OF EQUIPMENT. 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.

Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

1.8. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and incidental 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.

1.9. CONTRACTOR PERSONNEL.

1.9.1. 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.

1.9.1.1. 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 Government facility.

1.9.1.2. 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.

1.9.2 Communication. The Contractor’s employee shall be able to read, write and understand and speak English clearly, to effectively communicate with patients and/or other healthcare providers and staff.

1.9.3 Safety. The Contractor shall be responsible for knowing and complying with all installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

1.9.4 Performance Reports. Reports will be provided by the COR annually to ensure acceptable performance of the contract; annual reports provided by COR to Contracting Officer after completion of each performance period will be reported to the DOD Contractor Performance Assessment Reporting System (CPARS).

1.9.5 Technical Requirements. All Contractor employees provided by the Contractor shall meet the qualifications for that specialty and perform essentially the same functions, within the scope acceptable for their professional discipline and standard, as those required by the Department of Defense or Government service health care professionals of similar experience and in similar duty assignments.

1.9.6 Professional Qualifications. Personnel shall have factory training and experience (minimum 3 years) in the servicing of equipment listed in par. 5 that includes maintenance, repair and software/hardware upgrades.

1.9.7 Specific Tasks and Responsibilities. The contractor shall provide all warranty provisions, training, service, maintenance and repairs in compliance with the VA Contract.

1.9.8 Preventative Maintenance

1.9.9 PREVENTIVE MAINTENANCE INSPECTIONS (PMIs). The Contractor will perform two (2) PMIs per year (5 th and 11 th month).

1.9.10 PMIs will include system verification/calibration, alignments, electrical safety checks, software updates, and adjustments and/or parts replacements at no additional cost to the government.

1.9.11 The Contractor will update the Biomedical Engineering Verification/Certification stickers according to the

Biomedical Engineering Scheduled Maintenance.

1.9.12 Upon PM completion, contractor shall REMOVE all OUTDATED stickers from the contract supported equipment and replace with RAHC Biomedical Engineering’s inspection stickers. The Contractor can request stickers from Biomedical Engineering Department prior to the preventive maintenance visit. Please call: 580-558-

2150 or 580-558-2126 (Main Shop).

2. DEFINITIONS/ACRONYMS.

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

2.1.1. CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, 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. NOTE: The COR is not authorized to make any changes to the terms and conditions of the 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, JCAHO, U.S. Army

Medical Command and U.S. Navy Bureau of Medicine 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 incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment.

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with DPALS

Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOW.

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

AR - Army Regulation

BUMED - U.S. Navy Bureau of Medicine and Surgery

CAP - College of American Pathologists

COR - Contracting Officer's Representative

DA - Department of the Army

DN - Department of the Navy

DoD CLIP - Department of Defense Clinical Laboratory Improvement Program

HIPAA - Health Insurance Portability & Accountability Act of 1996

MAS Minimum Acceptable Standards MEDCOM - U.S. Army Medical Command

JC - Joint Commission

OSHA - Occupational Safety and Health Administration

PMS Preventive Maintenance Services

PRS Performance Requirements Summary

QA - Quality Assurance QA&I - Quality Assessment & Improvement

QC - Quality Control

SOW Statement of Work

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

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

3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the Contractor equipment analyzers required in support the SOW. 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. EQUIPMENT. No equipment will be provided.

3.3. MATERIALS. No materials will be provided.

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

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

3.4.2. Security: Police and Fire Protection as provided other personnel.

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, equipment, and incidental support and maintenance services required under this contract.

4.2. Transportation. Transportation in support of any equipment and incidental support and maintenance services 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 will contain the name of the company and the employee.

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall provide two (2) fully automated, discrete random access immunoassay analyzer systems capable of performing all of the required assays. The analyzer system will be from a single Contractor. 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 system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature shall be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract. All costs will be calculated on a cost per patient reportable based on the number of patients listed for each Mandatory Test. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable. The analyzers will be located at the following location:

Reynolds Army Health Clinic

Pathology Laboratory 1 st

Floor

4301 Wilson St., Fort Sill, OK 73507

5.1.1.1. For the purposes of this SOW the analyzer system includes at a minimum:

- Any and all analyzers

- Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, Etc.)

- Robotics Automation Systems

- Automated Pre-analytical Processing Systems

5.1.1.2. The analyzer system will be located at:

Reynolds Army Health Clinic (RAHC)

4301 Wilson St.

Fort Sill, OK. 73503

5.1.1.3 Baseline Requirements

5.1.1.3.1 The Contractor shall furnish the laboratory analyzer(s), data management system, all other equipment, chemistry immunoassay reagents, supplies and consumables necessary to operate the Contractor’s equipment. The

Contractor shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs, and parts as required in order to maintain the systems in optimal operating condition as well as training for government personnel necessary to fully perform testing in accordance with vendor specifications.

5.1.1.3.2 Reagents will be provided bearing the same lot number within the designated shipments. These items will be of the highest quality, sensitive, specific and tested to assure precision and accuracy. The Contractor shall provide stock that meets proficiency testing standards of the College of American Pathologist (CAP), the Joint

Commission on Accreditation of Health Organizations (JCAHO), the National Committee for Clinical Laboratory

Standards (NCCLS), and be approved by the Food and Drug Administration (FDA).

5.1.1.3.3 Testing System will have the following characteristics:

5.1.1.3.4 The testing system shall be fully automated to allow for walk away operations.

5.1.1.3.5 The system shall have a Data management system for storage of patient results, quality control and preventative maintenance data. System will have a bi-directional interface to the analyzer and to the hospital information system (CHCS).

5.1.1.3.6 The Contractor is required to provide new or re-manufactured state of the art equipment. Discontinued models are not acceptable.

5.1.1.3.7 The Contractor will provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the equipment shall be delivered to the government site and be installed by the Contractor within 60 days of their issuance date of first commercial availability. 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. Additionally, the

Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the

Government through a bilateral modification.

5.1.1.3.8 All models shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees

Fahrenheit and at any laboratory relative humidity between 40 and 80%.

5.1.1.3.9 The analyzer(s) shall be fully operational on the first day of the contract's performance period.

5.1.1.3.10 Monthly billing by the vendor will be based on the number of monthly patient reportables and submitted through Wide Area Work Flow. The vendor will provide a courtesy copy of each monthly payment invoice to the operating facility’s COR (Contracting Officer Representative).

5.1.1.3.11 The contract period will be for 5 years (60 months), which consists of 1 primary year and 4 option years.

5.1.1.3.12 In the event that the contract is terminated for any reason, the Contractor shall allow the analyzer(s) to remain in place for a period not to exceed 60 days at no additional cost to the government beyond the contracted price, for the purpose of meeting regulatory requirements of performing correlation and validation studies.

5.1.1.3.13 Supplies necessary to operate the instrument will be shipped within 3 days of order placement.

5.1.1.3.14 The Contractor shall provide an on-board water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Director.

5.1.1.3.15 The middleware should provide an integrated QC Package and have the ability to export results into the

Bio-Rad QC format.

5.1.1.3.16 The middleware should be able to provide lab custom programming to communicate via our interface to our CHCS LIS.

5.1.1.3.17 The Contractor will provide the customer the following support and services to ensure a guaranteed uptime of at least 97%: 24/7 telephonic technical support.

5.1.1.3.18 Provide automated calibration with onboard storage of calibrators, and automated running of controls with onboard storage of control material, and automated calibration of electrolytes.

5.1.1.3.19 Provide automated assay linearity with no manual steps required to perform linearity studies.

5.1.1.3.20 Provide automated unloading of empty reagent containers; instrument shall be able to hold sample aliquot on board for up to 2 hours for add-ons and test re-run.

5.1.1.3.20 Release of primary sample tube < 5 minutes for STAT and < 15 minutes for Routines for sample re-testing or add-on tests.

5.1.1.3.21 No Instrument Pause or stand-by required for loading reagent, calibrators, and controls.

5.1.1.3.22 Reagents shall not require any manual preparation and be ready to load from the refrigerator.

5.1.1.3.23 Cardiac Reagents shall include high sensitive Troponin approved by ACC/WHO for low end detection and adhere to a less than 20 minute TAT.

5.1.1.3.24 Daily maintenance should not exceed 45 minutes to include quality control and calibration.

5.1.1.3.25 The Contractor selected shall have either started the process or have acceptance by the Risk Management

Frame Work Team for current or future remote diagnostic capabilities, i.e. a Risk Management Frame Work.

5.1.1.3.26 Emergency Repairs and service concerns/questions shall be responded to within 24-48 hours of notification which may include having a field service engineer on-site within this time period.

5.1.1.3.27 Special Handling for Emergency Orders of Supplies. In the event that the consumables are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the consumable supplies within 24 hours of receipt of verbal order(s) from the government activity without additional charge to the government. If either circumstance has occurred, the Contractor will deliver to the government, the necessary consumables in sufficient quantity as required allowing operation of the equipment for one week (under normal government test load volume).

5.1.1.3.28 The Contractorr, without additional charge to the government, shall provide basic and advanced training, at no additional cost. During initial set up and installation of the analyzers, the Contractor shall provide on-site training, at no cost, to all personnel who will operate the equipment. The Contractor shall provide advanced training at the Contractor’s training facility for two Government personnel during performance of the basic period, and training of two Government personnel during each option period, at no cost to the Government. The contractor agrees that their proposal specifically includes that they will be responsible for all costs regarding lodging, transportation, meals and incidentals of the Government travelers in accordance with the Department of Defense

Joint Travel Regulation. The Contractor shall provide supplemental training to the above government personnel, without charge to the government, upon installation of upgrade(s) in equipment hardware or operating system software connected with the operation of an instrument already furnished.

5.1.1.3.29 The Contractor will perform complete correlation, precision, carry-over, and validation studies at the time of installation and for all new tests added throughout the contract period on manufacturer supplied and 3 rd party assays. Population Studies will consist of 200 samples for high volume tests and 50-100 samples for low volume tests. All studies will meet recommended NCCLS guidelines.

Site Preparation:

5.1.1.4.1 The Contractor as a part of the equipment proposal, for any equipment not already in place, shall furnish site preparation specifications in writing. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate and conform to the manufacturer's specifications.

5.1.1.4.2 The government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the Contractor.

5.1.1.4.3 Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the Contractor, which would involve additional expense to the government, shall be made at the expense of the Contractor.

Ownership of Equipment:

5.1.1.5.1 Title to equipment shall remain with the Contractor. All accessories furnished by the Contractor shall accompany the equipment when returned to the Contractor .

5.1.1.5.2 The Contractor, at termination and/or replacement of equipment, will remove the equipment at no cost to the government. The Contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

5.1.1.5.3 Preventive Maintenance. The Contractor will provide preventive maintenance at their recommended intervals to assure the continued reliable operation of the equipment.

Unscheduled Repair:

5.1.1.6.1 Unscheduled repairs shall be performed by the Contractor after notification that equipment is inoperative.

The Contractor shall provide the government with a designated point of contact and shall make arrangements to enable their maintenance representative to receive such notification and be on site within 24 hours. The government may incur labor and/or travel expenses if the repair is required outside of normal business hours (published by the manufacturer). In the event that two similar components (i.e. chemistry or immunoassay) of both analyzers are unable to perform minimum testing requirements established by the government, regardless of holidays, weekends, or hour, the Contractor will provide immediate repair service at no cost to the government.

5.1.1.6.2 The Contractor shall furnish a malfunction incident report to the Contracting Officer Representative upon completion of any maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. An initial handwritten report is acceptable.

5.1.1.6.2 Any additional costs associated with equipment or supplies not disclosed in the contract, by the

Contractor, needed for full operation of this equipment, will be paid by the Contractor at no cost to the government.

i. Facilities

a. No additional expense for plumbing, drains, and stirring mechanisms, mixing assemblies floor vents, or deionized water.

ii. Assays:

1. Infectious disease and general chemistry testing on same platform.

2. Use the direct ISE method to measure sodium, potassium and chloride.

3. Be able to utilize: Direct ISE Potentiometric (Na/K/Cl), dry slide Colorimetric/Rate, Immuno-rate testing methods.

4. Enzymatic creatinine

5. Dry thin film layered format for BMP and CMP.

6. Hemolysis, icterus and turbidity levels without additional patient sample, reagents, consumables and no effect on throughput.

7. Random access hepatitis testing.

8. 150 reagent positions, allowing for over 100 chemistry, immunoassay or infectious disease assays to be on board at one time.

9. FT4 assays not compromised by presence of abnormal proteins.

10. Directly measure total bilirubin, Bc, and Bu.

iii. Samples

1. On-board dilution

2. Utilize universal sample trays which accommodate primary tubes of the following sample containers:

a. 10mL, 7mL, 5mL, 2-4mL Collection Tubes

b. 1mL Microtube

c. Microsample cup - 0.5mL and 2mL without adapters.

3. Have liquid reagents be capped while onboard.

4. Disposable tips utilized to eliminate the need for carryover studies.

5. Not allow sample and or reagent carryover.

6. Sample management with clot detection, bubble detection, liquid Level-Sensing (Pressure

Transducer), short-sample detection.

iv. Resulting:

1. Turnaround time (TAT) for a single result of NMT 60 minutes for STAT samples.

v. Operational:

1. No more than 15 minutes for daily maintenance.

2. Calibration stability up to lot change, 84 days on board stability for reagents, and reagents have up to 18 months shelf life from date of manufacture.

3. Bidirectional LIS interface.

4. On-demand STAT capacity.

5.1.2. Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation.

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 Appendix 1 (below) 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.

5.1.3.1.1. 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 and is familiar with the use of statistical evaluation software as determined by the

Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

5.1.3.3. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the

Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

5.1.3.4. The Government’s Technical Supervisor will obtain patient specimens for use in the Method Validation. In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

5.1.3.5. Both the Contractor and Contractor 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) CD copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language. 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 material safety data sheets (MSDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative

Government. The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall be printed in the English language and shall contain, as a minimum, 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 2 water systems (e.g. filtered, deionized, etc.) if required by each analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Director.

5.1.7. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the

COR prior to shipment IAW Paragraph 5.3.14, Deliveries (below).

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

5.2. ANALYZERS.

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

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

5.2.1.2 The total number of analyzers for 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 Hemaguard caps. The analyzer will be capable of accommodating both Becton-

Dickinson and Greinier tubes.

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

5.2.4. Minimum actual through-put shall be 200 tests per hour for immunometric assays, 800 tests per hour for enzymatic/rate and colorimetric/photometric assays and 1200 tests per hour for ISE assays.

5.2.4.1. Analyzer throughput shall be measured as a function of number of STAT panels (see Table 5.1.) fully completed in 30-minutes.

5.2.4.2. The 30-min STAT panel includes the assays listed in Table 5.1. These assays shall be analyzed from the same specimen with a maximum turn-around-time (automated pre-analytical processing to certification) of 30 minutes.

Table 5.1. – Assays that shall be completed from the same specimen within 30 minutes as a STAT panel.

Alanine Amino Transferase (ALT) Creatinine Kinase, Total (CK)

Aspartate Amino Transferase (AST) Creatinine Kinase, MB Fraction (CK-MB)

Bilirubin (Direct) Glucose

Bilirubin (Total) Chorionic Gonadotropin (hCG)

Brain Natriuretic Peptide (BNP) or NT-pro

BNP

Potassium

Calcium (Total) Protein, Total

Carbon Dioxide (CO2) Sodium

Chloride Troponin I or T

Creatinine Urea Nitrogen

‡ Inclusion in profile is preferred, but may not be required, depending on specimen requirements..

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

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

5.2.7. Each analyzer system shall 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 15 to 20 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 third party assays, e.g., Glucose-6-phosphate Dehydrogenase (G6PD). The Contractor shall provide consumables, reagent containers, etc. in sufficient quantities and quality to perform these assays.

5.3. REAGENTS.

5.3.1. The analyzer have the on-board ability to maintain reagents at the proper storage temperatures for the assays.

All assays shall be FDA approved.

5.3.1.1. The workload is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due troubleshooting or specimen dilutions.

5.3.1.1.1. 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 in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations within the Southern Regional Medical Command (SRMC). All workload numbers represent total estimated patient reportable/billable results for the indicated year.

5.3.1.1.2. To account for expected fluctuations in workload, the Contractor shall provide a “volume discount” based on exceeding the planned patient load each period of performance. As workload increases, the cost per reportable patient result should decrease. The workload shall be based on the total number of patient reportable results covered under the provisions of this PWS.

5.3.2. The analyzer shall be capable of maintaining calibration curves for all of the simultaneously.

5.3.3. The assays listed in Table 5.2. be present on the analyzer at all times.

5.3.4. The assays listed in Table 5.2 shall 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.

5.3.5. All other reagents need not be maintained on an analyzer at the same time, but the analyzers provided shall have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., 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 scheduling requirements specific to the location).

Table 5.2 –Assays That shall be Approved for Use With Plasma Samples

Acetaminophen Cortisol; Total Lactate Dehydrogenase (LDH)

Alanine Amino Transferase (SGPT) C-Reactive Protein (CRP) Myoglobin

Albumin C-Reactive Protein, High Sensitive

(HS-CRP)

Phosphorus Inorganic (Phosphate)

Alcohol (Ethanol) Creatinine Potassium

Alkaline Phosphatase Creatinine Kinase (CK) Total Protein, Total

Amylase

Aspartate Amino Transferase

(SGOT)

Creatinine Kinase Mb Fraction (CK-

MB)

Digoxin Salicylate Bilirubin (Total) Gentamicin Sodium

Bilirubin (Direct) Glucose Theophylline

BNP/NTpro-BNP Glutamyl transferase, Gamma (GGT) Troponin

Calcium (Total) Gonadotropin, Chorionic (hCG) Urea Nitrogen

Carbamazepine Homocystine Vancomycin

Carbon Dioxide (CO2) Lactate (Lactic Acid)

Chloride

5.3.6. The assays listed in Table 5.3 shall be approved by the FDA for urine samples.

Table 5.3 – Listing of Assays That Shall be Approved for Use With

Urine Samples Calcium (Total) Potassium

Creatinine Protein, Total

Microalbumin (Quantitative) Phosphorus Inorganic (Phosphate)

Urea Nitrogen Sodium

5.3.7. The assays listed in Table 5.4 be approved by the FDA for CSF and Body Fluid samples.

Table 5.4 – Listing of Assays That Shall be Approved for Use With

CSF and Body Fluid Samples Glucose Protein

5.3.8. The Contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor shall ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers will be specified at the time of installation).

5.3.9. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient reportable tests for each assay.

5.3.9.1. The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. This includes third-party controls where requested/required by the laboratory.

5.3.9.2. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory

Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification (i.e., each assay shall be calibrated or have calibration verification performed at intervals not to exceed a

6-month period of time), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.9.3. The Contractor shall estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3.10. Reagents shall have a minimum shelf life of three (3) months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor shall identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

5.3.11. The Contractor shall sequester the required quality control materials and test reagents and ensure that no more than one (1) lot change for QC material and three (3) lot changes for reagents occurs per contract year. Assays be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays outlined in Table 5.1 shall not be less than once every twenty (20) days under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

5.3.12. All reagents provided shall be identical to those used in…