Attachment 1 SOW Chemistry Analyzers Reagents.docx

STATEMENT OF WORK

Phase-Out

For Chemistry, Immuno-chemistry, Coagulation, Urinalysis, Automation Line, Data Management System, and Inventory Management System Medical Treatment Facility, David Grant Medical Center Travis AFB

Aug 26, 2021

Table of Contents

SECTION NO. AND TITLE

PAGE NO.

I. Description of Service

II. Service Summary

III. General Information

IV. Appendices

V. Phase-Out Requirements

STATEMENT OF WORK

Chemistry, Immuno-chemistry, Coagulation, Urinalysis, Automation Line, Data Management System, and Inventory Management System Medical Treatment Facility, David Grant Medical Center Travis AFB

I. Description of Services

1. The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in Appendix B for the Clinical Lab located at David Grant Medical Center, Travis AFB. Services include instrument use, preventive maintenance, troubleshooting guidance, 24/7 telephone service as well as response by a technical expert provided by the contractor 7 days per week from 0500 to 2300, including Federal Holidays and calibration services at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options, to include overnight, should emergent supply needs arise. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices. All services listed in this document will be required during the new performance period 1 September to 21 October 2021.

1. Pre-Market Approval. Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

2. Service Reporting. Contractor shall furnish a legible service report to the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

II. Services Summary:

Service technician will arrive within 24 hours to correct the malfunction.

Ensuring an alternative is given when normal means of training is not available.

(Published operating specifications are too detailed and lengthy to be included in this document, but are available in the operating sections, the MERC, and are matter of public record)

1. Procedures. The contractor’s standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure non-performance and continual repeat of defective service does not occur. Procedures as set forth in the FAR 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies.

III. General Information

1. Government Available Services

The government will provide the following equipment, supplies and services listed below:

1.1. Utilities: For the purpose of this contract, the government will furnish all required utilities such as water, telephone, electricity, etc. Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

1.2. Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424-3683; Non-Emergency Security Police: 424-3293. Emergencies (call) 911.

1.3. Emergency Healthcare. The MTF will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate through TRICARE.

2. Operator Training. No training required for current contract.

3. Instrument Installation and Validation. No installation and validation for current contract.

4. Initial Inspection. All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact Program Manager to schedule inspection.

IV. APPENDICES

APPENDIX A

Applicable Instructions, Directives and Regulations

Publications and forms applicable to this Performance Work Statement (PWS) are listed below, and are mandatory. The contractor shall follow those publications to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) to meet requirements in this PWS. Applicable publications are located at http://www.e- publishing.af.mil/pubs. The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up-to-date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause. The Contractor will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the Government all issued publications and unused forms.

Publications Code:

AFI--Air Force Instruction DoD-DoD Instruction DHA-IPM-Defense Health Agency Interim Procedures Memorandum

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive Paragraph / Chapter

Entire Document

Rule in DoD Health Care Programs

Entire Document

Appendix B CORE Laboratory Instrumentation

Objectives:

1. Must provide a complete Core Laboratory solution for patient testing that includes Chemistry, Immuno-chemistry, Coagulation, Urinalysis, and an automation line that includes a specimen storage module, and three centrifuges to assure the continual centrifugation of specimens.

2. All chemistry and immuno-chemistry testing must be performed on ONE single stand-alone analyzer, Please be advised that this does not speak to only having one platform, but having each platform performing all assays.

3. All analyzers and the automation line must be controlled by one data management software that can be accessed from multiple locations throughout the laboratory.

4. Must include an inventory management system for all reagents and supplies included within this contract.

5. Must have a current Authorization to Operate (ATO) for networked information technology to receive, process, store, display, or transmit Defense Health Agency (DHA) information.

6. Software must include a quality management system to improve operational productivity in the section and monitor test result turnaround.

7. Must be compatible with Cerner, Military Health System, and Genesis electronic healthcare record platform.

8. Test performance and results will be 24/7 with no downtime.

9. Performance of preventive maintenance, calibration, and quality will not render the department incapable of performing or resulting any testing.

Dimensions:

1. The analyzers and automation solution must fit within a 24’ by 52’ space while allowing for multiple operator movement, reagent storage, and bench space Further, the analyzer must be able to navigate through doorways that are 24” wide by 83” tall.

Service Requirements:

1. Chemistry/Immuno-chemistry

a. All tests must be FDA approved

b. Maximum time from start of analysis to result for specific STAT tests required for critical patient care:

i. Troponin: 13 min

ii. Mass CK-MB: 13 min

iii. Procalcitonin: 23 min

c. Onboard Calibrators and Quality Control (QC)

i. The operator will have the ability to program frequency of calibration and QC, and the analyzer will automatically perform said functions by accessing onboard calibration and QC material. Once placed on the analyzer, the calibrator and QC material will be stored onboard until it is entirely consumed or reaches expiration.

d. Reagent handling

i. All reagents must be stored at room-temperature or refrigerated, not frozen.

ii. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer.

e. Must have additional features:

i. Built-in barcode scanner to allow hands free processing

ii. Traditional QC with target values assigned to QC materials

iii. Numeric or pass/fail QC

iv. Stops patient testing if QC fails or expires

v. Prevents patient testing for reagent expiration

vi. Critical results and instrument errors flag the operator

vii. Canned or free text user comments

viii. Accepts patient ID or accession number

ix. Must track all reagent and consumable supply expiration dates

x. Must have the ability to perform onboard linearity studies

xi. Must report a numeric hemolysis, icterus, and lipemia level on each specimen

2. Coagulation:

a. All tests must be FDA approved

b. Analyzer must be able to result at least 50 tests per hour

c. D-Dimer assay must have FDA Exclusion for both PE and DVT

d. Must have additional features:

i. Built-in barcode scanner to allow hands free processing

ii. Traditional QC with target values assigned to QC materials

iii. Numeric or pass/fail QC

iv. Stops patient testing if QC fails or expires

v. Prevents patient testing for reagent expiration

vi. Critical results and instrument errors flag the operator

vii. Canned or free text user comments

viii. Accepts patient ID or accession number

ix. User-defined automatic repeat, dilution and reflex testing

x. Specimen clot detection

3. Urinalysis:

a. All tests must be FDA approved

b. Sample Volume: 5 mL in automated mode, 2 mL in manual mode

c. Must be able to result at least 50 tests per hour

d. Instrument must provide true walk-away final results without operator re- classification or photo image review required at the instrument for standardization

e. Must utilize flow cytometry methodology

f. Must have additional features:

i. Built-in barcode scanner

ii. Traditional QC with target values assigned to QC materials

iii. Numeric or pass/fail QC

iv. Stops patient testing if QC fails or expires

v. Abnormal and critical ranges flag the operator

vi. Canned or free text user comments

vii. Accepts patient ID or accession number

viii. Automated Check for low sample level using built-in liquid-level sensing

ix. Auto-Check for humidity exposure

4. Automation Line:

a. Single sample management.

b. Samples must be on the line <25 seconds to arrive at centrifugation location

c. All physically connected analyzers must be able to sample directly from the track to free up specimens to start testing on other analyzers.

d. The track must have the ability to prioritize Routine, STAT and ASAP samples once they arrive to the instrument queue.

e. A specimen storage module will have the ability to automatically dispose of tubes, based on sample-specific rules, by retrieving the tube and placing it in a waste receptacle.

f. After initial installation, the automation line must be able to be reconfigured to include or exclude analyzers and/or change workflow.

g. The specimen storage system must be accessible to specimens regardless if the computer hardware that manages the system is operable.

h. Automatic method for dilution, rerun, reflex, and add-on testing.

i. RFID sample tracking

j. Must have minimum of three centrifuges. Each centrifuge must be capable of handling multiple specimen tube sizes to include 13mm X 75mm and 13mm X 100mm. All testing should be capable of performance with a centrifuge time of <10 minutes. Additionally, an optimal time of ≤7 min centrifugation for 70% of testing listed on Appendix B.

k. Automation Line must be ran by compressed air to decrease the number of mechanical motors required. Air compressor will be provided by the vendor and it should not introduce noise pollution.

l. If automatic line is not working, centrifuge and storage system must be accessible to retrieve specimens.

m. Centrifugation must be possible by manual methods if the automated line and/or connecting hardware is nonfunctional.

n. Automation line must be compatible with Sysmex Hematology Analyzers.

o. Any aliquot module must be compatible with the standard polypropylene transport tube, 13x75, manufactured by Sarstedt Inc 60.504.021.

5. Data Management System

a. Configuration

i. Enables users to manage test results and quality control data from all analyzers via a single centralized workstation.

ii. Enables at least 10 users to be logged in to the system at one time from different workstations.

iii. Ability to customize software access levels for individual users.

b. Auto-verification

i. Verifies test results from analyzers using auto-verification rules.

ii. Applies customized rules automatically against reference ranges, quality control, delta checks, and instrument flags to ensure that potentially inaccurate results are not auto-verified.

iii. Alerts users of results that are not auto-verified.

c. Quality Control

i. Must transmit QC data to BioRad Unity software

ii. Manages quality control data from all interfaced analyzers

iii. Utilizes Westgard rules and Levey-Jennings charts.

iv. Capable of storing data from multiple quality control lot numbers

d. Customizable review highlighting:

i. Delta checks (percentage and absolute basis)

ii. Critical results

iii. QC violations

iv. Instrument flags

e. Patient Moving Averages

i. Provides a graphical view of patient moving averages enabling the user to easily see when patient results are drifting

f. Search/Query tests by:

i. Sample ID

ii. Physician name or ID

iii. Patient name or ID

iv. Location

v. Date and Time

vi. User definable queries

vii. Test

g. Reports

i. Provides user-friendly reports for daily workload volume, Turn- around-times, and percent of results auto-verified.

ii. Can export all data to commonly used file formats such as Microsoft Excel.

h. Data Storage:

i. Must have the capacity to store at least 2 years of patient results and quality control records for each interfaced instrument in accordance with CAP guidelines.

6. Inventory Management System

a. Must include an RFID-based inventory management system for the reagents and supplies included in this contract.

b. Inventory system generates recommended supply orders for users to approve or change.

Contractor Provided Service Requirement:

1. Must be able to provide cost-per-test pricing for all tests listed on the attachment provided. This price must include:

a. Instruments

b. Reagents

c. Quality Control material for Coagulation and Urinalysis

d. Calibrators

e. Consumable supplies

f. Parts and accessories

g. Periodic maintenance performed by the company

Methods of Monitoring:

1. Must have a verifiable ease of maintenance tracking process to meet vendor’s claims.

2. Must have 24/7, 365 days per year available technical support.

3. Must provide onsite technical assistance for troubleshooting instruments, software, and as needed maintenance 7 days per week from 0500 to 2300, including federal holidays.

4. Systems must function with a 100% up-time and ability to perform patient testing 100% of the time.

5. Consider uptime percentage if setting up a service agreement

6. Calibration frequency must be monitored to verify vendor’s claims of stability.

7. Must have a representative perform all lot change calibrations on coagulation analyzers on-site.

8. The analyzer must have a method of audibly or visually alerting the operator for sudden out of range quality control.

9. The analyzer must prevent results from entering the patient record in the event of failed quality control.

10. Must provide standardized offerings (Standing orders for reagents and controls).

11. Must provide rapid, disruption-free and minimal waste generation during automation system installation.

Standards of Performance:

1. The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI)

Appendix C CORE Laboratory Instrumentation Test Menu

V. PHASE-OUT REQUIREMENTS

Requirements

1. Must be able to de-assemble, and remove automation line by 16 Sep 2021.

2. Must be able to make reasonable arrangements to move out current analyzers in a timely manner whereas validation with the new analyzers are conducted without interruption.

3. Must have all analyzers, equipment and debris removed by 31 Oct 2021.