D.02.05_Modification_W81K00-18-Q-0017-0001.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: GERALDINE I. HERNANDEZ

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011159521

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 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 has been revised to read 23 May 2018.

3.A revised Statement of Objectives has been incorporated.

4.All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

1 15

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

16C. DATE SIGNED

BY 03-May-2018

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 W81K0018Q0017

X 9B. DATED (SEE ITEM 11)

25-Apr-2018

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

03-May-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0018Q0017

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 16-May-2018 12:00 PM to 23-May-2018 12:00 PM.

The following have been added by full text:

ATTACHMENT 1 - QUESTIONS

W81K00-18-Q-0017 Attachment 1

Questions presented to the Government with Replies.

1. Clin Lines on pages 1-10: Not all vendors make controls for the all of their instrumentation. These controls would have to be provided by a third party vendor from some vendors. We cannot respond until we get a quote from a 3rd party source, which can take up to a week or so. The following pages are where the Clin Lines are found.

Teaming arrangements between a control company and some vendors would have to be agreed to which can take a couple weeks. We respectfully asks until May 23rd to respond if this control requirement is not able to be changed.

Reply: The extension will be granted. The closing date of the RFQ will be changed to 23 May 2018.

Page 3, Clin Line 1, Page 5, Clin Line 1001 Option, Page 7 Clin Line 2001 Option, Page 9, Clin Line 3001 Option Page 10, Clin Line 4001 Option

- 2. Page 35, xix: This requirement suggests an integrated platform. However, other vendors in the market place can provide standalone instruments, which can perform the same testing and even provide a back-up analyzer if required.

Reply: The Government's requirement is an integrated platform. There are multiple vendors in the marketplace that provide integrated solutions. This requirement will remain unchanged.

- 3. Page 37 xxiv: The diagram you provide is not to scale or provide any dimensions. What dimensions are required?

Reply: This has been updated to reflect the dimensions of the area.

- 4. Page 39 II Assays: The following requirements are specific to only a single vendor. All other vendors, are locked out because of these requirements.

- #1: What infectious disease testing is required? There are no infectious disease tests listed on the menu.

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

The Government replaced "Infectious disease" with "Immunoassay."

- #2: Only one vendor does a direct ISE measurement, therefore, this requirement locks out all other vendors.

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

The Government replaced "the direct ISE" with " a FDA Approved".

- #3: Only one vendor uses dry slide technology. This requirement locks out all Vendors. There are other vendors in the Diagnostic Market, that use a different methodology that offer excellent results on FDA approved platforms.

Reply: 3. Be able to utilize: Direct ISE Potentiometric (Na/K/Cl), dry slide Colorimetric/Rate, Immuno-rate testing methods. The Government removed the statement from the SOO.

- #4: Enzymatic creatinine, Estradiol, and testosterone Reply: 4. Enzymatic creatinine, Estradiol, and testosterone The Government removed the statement from the SOO.

- For #5: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

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

The Government removed the statement from the SOO.

- For #6: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

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

The Government replaced statement with " Hemolysis, icterus and turbidity must be measured using a FDA approved methodology".

- For #7: This assay is not on the menu as a requested test.

Reply: 7. Random access hepatitis testing.

This was removed from the SOO.

- For #10: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

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

The Government replaced "directly measure" with "Uses FDA approved method to measure"

5. Page 40, iii Samples:

- 2c: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

Reply: The Government removed the statement from the SOO.

- 3: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

Reply: The Government removed the statement from the SOO.

6. V, Operational:

- 2: Only a single vendor uses this methodology, whereas there are other vendors that can also offer testing for this using a different methodology which is also FDA approved.

Reply: The Government removed the statement from the SOO.

7. The Statement of Objective states that the agreement will be a Cost Per Reportable (CPR) but it also states:

“The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed herein represent anticipated test volumes for the period of performance listed.”

This statement would indicate a Cost Per Test (CPT) agreement which is how the customer orders currently. Please confirm if this is a CPR or CPT contract.

Reply: This is a COST PER TEST Requirement.

8. Please confirm that the volumes on the spreadsheet are patient volumes and not annual usage volumes (which include controls and calibrators).

Reply: The volumes on the spreadsheet are annual usage volumes based on historical usage.

9. Page 36

- x: We respectfully ask this requirement be removed from the solicitation, as it is restrictive to only one vendor, is not essential to lab operations and it limits the ability of other companies to compete for the business.

Reply: This requirement was removed from the SOO.

- xi: Please further confirm what is meant around “no manual steps to complete linearity studies”.

Reply: This requirement was removed from the SOO..

- xii: We respectfully ask this requirement be removed from the solicitation, as it is restrictive to only one vendor, is not essential to lab operations and it limits the ability of other companies to compete for the business.

Reply: This requirement was removed from the SOO.

- xvi: This states “high sensitive” Troponin but on the list of reagents it is Troponin I and the customer is currently using Troponin I today, please confirm that Troponin I is acceptable.

Reply: Yes. Troponin I is acceptable.

10. Page 39

- ii: #1 The solicitation asks for two systems, do these systems need to be able to run all assays on both systems, Therefore mirror back-up?

Reply: Yes, a mirror backup is what we are requesting.

11. Pg. 40

- ii: #6 Please confirm if Hemolysis, Icterus and Turbity checks required on all menu items / indices check on all assays.

Reply: This is only required on assays that are affected by hemolysis, icterus and turbidity.

12. Chemistry Analyzer Location Diminsions.

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF

OBJECTIVES

The successful offeror shall furnish all equipment for two (2) fully automated, discrete random access immunoassay analyzer systems capable of performing all of the required assays. 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, and Automated Pre-analytical Processing Systems.

The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. to the Department of Pathology, Weed Army Community Hospital, 390 North Loop Rd, Fort Irwin, CA 92310 for the purpose of Immunoassay testing under a Cost Per Test (based on the number of patients listed for each Mandatory Test) Agreement.

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 equipment and reagents/consumables shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure WEED Army Community Hospital is able to meet its objectives as listed herein.

Period of Performance:

Base: 1 October 2018 – 30 September 2019 Option 1: 1 October 2019 – 30 September 2020 (CLIN 1001 and subCLINs) Option 2: 1 October 2020 – 30 September 2021 (CLIN 2001 and subCLINs) Option 3: 1 October 2021 – 30 September 2022 (CLIN 3001 and subCLINs) Option 4: 1 October 2022 – 30 September 2023 (CLIN 4001 and subCLINs)

The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed herein represent anticipated test volumes for the period of performance listed.

1. Instruments/Equipment and Reagents/Consumables (Subfactor 1A).

Instruments/Equipment.

i. These instruments, to include any connections between the instruments/equipment, shall be approved the US Food and Drug Administration (FDA).

ii. Each analyzer shall have the ability to test multiple analytes from a single tube.

iii. Each analyzer shall have fully automated, discrete random access capabilities. There shall be a single point of specimen entry for the routine analysis of all required tests.

iv. Each analyzer shall be equipped to perform continuous, random statistical analysis using common statistical control rules as well as patient-derived quality control procedures. Quality control reporting shall meet or exceed all accreditation requirements

v. Each analyzer shall have a bi-directional host interface that is compatible to the Composite Healthcare

System (CHCS) be able to recognize CHCS generated bar-code labels (both code 39 and 128) on primary sample tubes.

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

vii. 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).

viii. 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%.

ix. 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.

x. N/A

xi. N/A

xii. N/A

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

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

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

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

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

xviii. 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.

xix. Each analyzer shall be able to perform all testing listed in the solicitation/contract.

xx. Each analyzer shall have Positive sample identification.

xxi. Each analyzer shall be able to store at least 1 years’ worth of workload sample testing results at any one time.

xxii. The entire system shall be independent of remote connections (internet, cloud, etc.) to be functional and serviceable.

xxiii. Each analyzer shall have automated inventory tracking.

xxiv. The two (2) fully automated, discrete random access immunoassay analyzer systems shall be installed as indicated in the diagram below. Each analyzer, including printer, monitor, UPS, and computer system, shall fit within the dimensions outlined in figure below and complete operations on one platform. Sufficient room for proper exhaust and heat clearance based on manufacture’s site specifications shall be maintained, with at minimum a 6” clearance between the existing wall and instruments. Any sliding compartments or access drawers for servicing cannot extend beyond the width of each individual unit outlined in figure below when fully expanded.

xxv. Lab Layout. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote.

xxvi. All software updates or file exchange shall be completed using CD/DVDs only. At no time will USB, internet or cloud-based services be allowed.

Reagents/Consumables.

i. The contractor shall have FDA approved Reagents/consumables that shall meet the requirements of the Reference laboratory mission, workload, and test menu (see Table 1, 2 and 3).

ii. All related approvals or modifications to equipment, reagents, or parts of the assay related to the testing product shall be provided by the contractor in the event any changes are made during performance of the contract. (Mirror Backup)

iii. The Contractor shall provide all reagents/reagents packs, calibrators/standards, quality control materials, user- replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section.

iv. Reagents/consumables shall meet the requirements of the 24/7 Weed mission, workload, and test menu.

v. The Contractor shall provide quality control materials acceptable to the section Medical Director. This includes third-party controls when requested/required by the laboratory.

vi. In determining reagent requirements, the Contractor shall consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy, and troubleshooting of out-of-control assays when calculating the yearly requirements.

vii. Reagents used for troubleshooting analytical systems shall be reimbursed (or replaced) by the Contractor at no additional cost.

viii. The Contractor shall sequester lots of required quality control materials and test reagents so that a change in lot will not be more frequent than once a year.

ix. The Contractor shall provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials. Deliveries of required items shall be in monthly drop shipments on the second Wednesday of the month. Orders called in by the COR or ACOR shall arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

x. Emergency orders shall be delivered within 24 hours after the order is placed.

xi. The Contractor shall provide paper and electronic copies of material safety data sheets (MSDSs) for each reagent item delivered under this contract (as appropriate).

LISTED BELOW ARE TEST KIT AND REAGENT REQUIREMENTS ASSOCIATED WITH THE

INFORMATION ABOVE.

i. Facilities

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

ii. Assays:

1. Immunoassy and general chemistry testing on same platform.

2. Use an FDA Approved method to measure sodium, potassium and chloride.

3. N/A

4. N/A

5. N/A

6. " Hemolysis, icterus and turbidity must be meausred using a FDA approved methodology"

7. N/A

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. Uses FDA approved method to 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 Micro-tube

c. N/A

3. N/A

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. N/A.

3. Bidirectional LIS interface.

4. On-demand STAT capacity.

These instruments, to include any connections between the instruments/equipment, shall be approved the US Food and Drug Administration (FDA).

2. Service and Maintenance (Subfactor 1B). The Contractor shall meet the following service and maintenance requirements for all testing locations at Weed Community Hospital.

i. The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems.

ii. The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

iii. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

iv. Any service technician provided by the Contractor shall adhere to all required reporting procedures for

Weed Community Hospital prior to reporting to the laboratory for work. Current procedures will be available through the COR or ACOR.

v. For equipment supporting the access Immunoassay Laboratory, the service technician shall be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should all analyzers become inoperable, the Contractor’s service technician shall be on-site within four (4) hours of initial notification. The repair of at least one (1) analyzer shall be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory using FDA- approved assays, with priority testing service provided for ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable.

vi. In all cases, the Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used shall be replaced at no cost by the Contractor.

vii. The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

viii. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the

COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information:

o Nomenclature and serial number o Date of service o Description of services performed (i.e., preventive maintenance service, or unscheduled repair service) o Location of services performed o Duration of performance (hours) o List of parts replaced or other actions taken to restore operability of the instrument o Name of technician

ix. In the event the laboratory is relocated, the Contractor shall relocate/revalidate any instrument if requested by the Government at no additional cost. The Government is requesting two (2) moves per the life of the contract. This includes any location within the WEED healthcare network.

x. Shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

3. Training (Subfactor 1C). The Contractor shall provide the following for all testing locations at Weed Army Community Hospital

The Contractor shall provide initial operator training (on or off-site) to all technicians assigned to the Government site normally assigned to perform the associated testing prior to implementation of the analyzer for patient testing.

In addition, the Contractor shall provide training for two (2) primary (key) operators, per analyzer prior to or no later than one week following implementation of the analyzer.

All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and use any data management/quality control software.

Upon renewal of the option year and in the case of any significant software or assay procedural updates, the Contractor shall provide one (1) primary (key) operator training slot per major analyzer. This training can be on or off-site at the Contractor’s full expense.

4. Delivery and Installation (Subfactor 1D).

i. All systems shall be delivered to the appropriate location indicated below.

Weed Army Community Hospital Department of Pathology 390 North Loop Rd Fort Irwin, CA 92310

ii. The Contractor shall assign a Program Manager who will remain onsite to oversee all operations required for successful implementation and execution of the delivery and installation to include correlation and validation of this requirement.

iii. During the initial implementation, a primary, dedicated technical representative shall be assigned and available on site throughout the entire implementation period. Substitutions shall be coordinated with and approved by the COR or ACOR.

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

v. Method validation/verification will be conducted in accordance with procedures outlined in the Department of Pathology policies and standard operating procedures and as required by the CLIA and/or the College of American Pathologists (CAP) and to the ultimate satisfaction of the acting Reference Chemistry medical director.

vi. The Contractor shall provide a qualified Technical Service Representative (TSR), who possesses a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®), to provide technical assistance for the method validation/verification studies. The assigned TSR will be responsible for the entire method validation to the standards of the acting medical director. Additional TSRs may be brought in to assist in method validations/verifications.

vii. All necessary data for validations/verification of all assays above will be completed within 30 days of analyzer and component installation and functionality.

viii. Method validation/verification will be completed by qualified TSR within two weeks of analyzer functionality using company and immunoassay analyzer lab provided validation samples.

ix. Method validation/verification will include, but not be limited to: normal range (reference interval) verification, verification of reportable range (AMR), correlation to current methods, verification of precision, carryover studies and establishment of initial ranges using control materials, to include third party controls as required.

x. The method validation/verification 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.

xi. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Contractor at no additional cost to the Government. Assay lots will be quality checked upon delivery. Contractor’s customer samples may also be used. These materials will not be used in the analysis of specimens for patient care.

xii. Provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of

Award. For example, if the offeror is notified that they are awarded the contract on 1 July 2017, delivery of the equipment would occur on 15 July 2017, with installation on 1 August 2017, the timeline would be: Day 0 = Notification of Award; Day 15 = Delivery of equipment; Day 33 = Installation.

Mandatory Test/Functions & Estimated Volumes

Table 1 –Assays That shall be Approved for Use With Plasma/Serum Samples

Acetaminophen Creatine Kinase Phosphorus

Alanine Aminotransferase CK-MB Mass Potassium

Albumin Creatinine Salicylates

Alkaline Phosphatase Digoxin Sodium

Amylase Ethanol Thyroid Stimulating Hormone

Aspartate Aminotransferase Gammaglutamyl Transferase Thyroxine, Free

Bilirubin, Direct Gentamicin Thyroxine, Total Bilirubin, Neonatal Glucose Total Protein

Bilirubin, Total Human Chorionic Gonadotropin, Quantitative

Triglycerides

Calcium Lactate Dehydrogenase Troponin I

Chloride Lipase Urea Nitrogen

Cholesterol, HDL Magnesium Uric Acid

Cholesterol, Total Phenobarbital Vancomycin

CO2 Phenytoin

Table 2 – Listing of Assays That Shall be Approved for Use With Urine Samples

Creatinine

Protein, Total

Table 3 – Listing of Assays That Shall be Approved for Use With CSF and Body Fluid Samples

Glucose

Protein

Attachment 1

CHEMISTRY REAGENT SLIDES

Chemistry Testing

IMMUNODIAGNOSTICS REAGENTS

Immunoassay Reagent

Mandatory Test/Functions & Estimated Volumes

Immunoassay Name

Mandatory Test Estimated Quantities

Option Year

Option Year

Option Year

Option Year 4

TOTAL T4 2,100 2,205 2,315 2,431 2,553

FREE T4 2,200 2,310 2,426 2,547 2,674

TSH 3,500 3,675 3,859 4,052 4,254

TOT B‐hCG II 2,000 2,100 2,205 2,315 2,431

CKMB 1,900 1,995 2,095 2,199 2,309

TROPONIN I 1,500 1,575 1,654 1,736 1,823

(End of Summary of Changes)