Statement of Work Coagulation Blood Reagents Hematology.pdf

Sources Sought Notice: PANHCA-25-P-0000 007671

STATEMENT OF WORK

(SOW)

HEMATOLOGY REAGENTS COST-PER-REPORTABLE ONLY

1. GENERAL REQUIREMENTS:

1.1. Scope of Work: The Contractor shall provide the two (2) Leased Fully Automated

Hematology Analyzer Systems (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition, and any installation and removal). The Contractor shall perform to the standards of the reagent contract. The Contractor shall provide a cost-per-reportable arrangement for hematology testing reagents for the two (2) Leased Werfen Fully Automated

Hematology Analyzer Systems at William Beaumont Army Medical Center, (WBAMC) Fort

Bliss, TX. Contractor should provide Reagents, Plasma Calibrators and Controls, Solutions , Consumables, General Screening and Anti-Coagulant Monitoring, D-Dimer, Plasma Calibrators and Controls as listed in section 5.3 of this SOW and in Attachment 1

Proposed period of performance (PoP) is:

Base Period: 1 September 2025 - 30 September 2025

Option Year 1: 1 October 2025 - 30 September 2026

Option Year 2: 1 October 2026 - 30 September 2027

Option Year 3: 1 October 2027 - 30 September 2028

Option Year 4: 1 October 2028 - 30 September 2029

1.2. Quality Control (QC) and Quality Assurance (QA): The Contractor shall provide a Quality

Control (QC) Plan (QCP) that contains, at a minimum, the items listed below to the

Contracting Officer (KO) and Contracting Officer’s Representative (COR) for acceptance not later than 10 days AFTER the start of the contract. The KO will notify the Contractor of acceptance of required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the KO

1.2.1. The QCP shall include:

1.2.1.1. A description of the inspection system to cover all incidental support and maintenance services listed in the performance requirements summary (PRS) (Exhibit 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 inspectors. Control procedures for any government-provided keys or lock combinations shall be included.

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

1.2.1.3. A description of the records to be kept documenting inspections and corrective or preventive actions taken. 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 claims, if any, under this contract.

1.2.2. QA. For those tasks listed in the PRS (Exhibit 1), 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. 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 performed according to standard inspection procedures or other contract provisions. Any action taken by the KO because of surveillance will be in accordance with (IAW) 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.

1.2.4. Performance Evaluation Meetings.

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

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

1.2.4.3. During installation and validation of equipment and tests to be performed, the

Contractor shall schedule meetings with technical experts of the Laboratory to discuss milestones and provide updates on completion date. Following equipment installation completion and validation of tests to be performed, the Contractor shall meet with technical experts from the Laboratory at times mutually agreeable to discuss areas of interest to the

Laboratory or hospital staff.

1.2.4.4. The Contractor shall provide the ability to request visits from medical and/or scientific advisors/specialists to discuss with the Laboratory and/or hospital staff areas of interest to include, but not limited to, application of current tests in specific specialty areas (e.g., Cardiology, Endocrinology, Nephrology, etc.).

1.3. Hours of Operation:

1.3.1. Normal Hours of Operation. 24/7, Sunday-Saturday for WBAMC Main Hospital Center.

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 IAW Section 5.4.3.

1.3.1.2. 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.

1.3.2. Federal Holidays. The following federal 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

Juneteenth 19 June 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: If any of the above federal holidays fall on a Saturday, the holiday will be observed the preceding Friday; holidays falling on a Sunday will be observed the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in addition to and 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 operate under conditions that prevent waste of utilities, to include:

1.4.1. Lights shall be used only in areas where work is 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 analyzers cannot be safely dumped into each of the facility’s drain system, the

Contractor shall provide guidelines for safely disposing of these wastes or byproducts IAW 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 create, maintain and dispose of only those government required records that are specifically cited in this PD 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 five 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.

1.7. Upgrade of Equipment. Subject to mutual agreement between the government and the

Contractor, equipment/ instrumentation may be upgraded within the specifications of the contract if workload exceeds the equipment/ instrument’s current capacity. The government will delete/add reagent allocations throughout the life of this contract because of workload volume variations or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the Contractor and the government.

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 (CFR), 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 KO 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, military or civilian, unless such person seeks and receives approval according to

DOD 5500.7R, “Joint Ethics Regulation.”

1.9.1.3. Contractor employees, minus maintenance, shall be registered with the SYMPLR© system for access at WBAMC. With SYMPLR© access Contractor representative shall have a badge. Contractors shall check in with SYMPLR© upon arrival to the facility and report to the

Provost Marshall Office (PMO) to check in. There the Contractor will have PMO escort the

Contractor personally or will contact the main laboratory to have an escort come down to receive them. All Contractor personnel shall always be escorted and not permitted on premises without escort. SYMPLR© access will not be paid for by the government and access is by individual not by company.

1.9.1.4. Contractor maintenance personnel shall check in with Medical Maintenance. Medical

Maintenance will issue a temporary badge and check them in. The Contractor will then be escorted by Medical Maintenance to the lab or will contact the main lab for escort. At no time will Contractor maintenance personnel be without escort in WBAMC.

1.9.1.5. WBAMC Contractor maintenance policy may change to the SYMPLR© system for login. The COR will notify the Contractor when and if this happens. SYMPLR© access will not be paid for by the government and access is by individual not by company.

2. DEFINITIONS/ACRONYMS.

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

2.1.1. Contracting officer (KO): The only person with 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 KO to act as their representative in administering a contract. The

COR is not authorized to make any changes to the terms and conditions of this contract.

2.1.3. Quality assessment and improvement (QA&I). Those actions taken by the government to check services to determine if they meet the requirements of the Department of Defense

Clinical Laboratory Improvement Program (DoD CLIP) ’88 & ’03, College of American

Pathologists (CAP), The Joint Commission (TJC), US Army Medical Command (MEDCOM) and US Navy Bureau of Medicine QA and risk management programs and ensure compliance with the terms and conditions of this contract.

2.1.4. Quality control (QC). 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 equipment.

2.1.6. Quality improvement (QI). Those actions taken by the government IAW WBAMC

DPAL Quality Plan, relevant Clinical Laboratory Standards Institute (CLSI) standards for quality, AR 40-68, to assure services meet the requirements of this contract.

2.2. Acronyms/Abbreviations. Following is a list of basic acronyms/abbreviations used in this contract.

ADP - automated data processing

AIS - automated information system

AMR - analytical measurement range

AR - Army Regulation

ATO - authorization to operate

B2B - business to business

&A - certification and accreditation

CAC - common access card

CAP - College of American Pathologists

CD - compact disc

CFR - Code of Federal Regulations

CHCS - Composite Health Care System

CLIA - Clinical Laboratory Improvement Amendments

CLSI - Clinical Laboratory Standards Institute

COR - contracting officer’s representative

CRR - clinical reportable range

DA - Department of the Army

DISA - Defense Information Systems Agency

DMZ - demilitarized zone

DN - Department of the Navy

DoD-CERT - Department of Defense Computer Emergency Response Team

DoD CLIP - Department of Defense Clinical Laboratory Improvement Program

FDA - Food and Drug Administration

FPCON - Force Protection Condition

HIPAA - Health Insurance Portability & Accountability Act of 1996

IA - information assurance

IAVM - information assurance vulnerability management

IAW - in accordance with

INR - International Normalized Ratio

IP - internet protocol

ISP - internet service provider

KO - contracting officer

LAN - local area network

LIS - laboratory information system

LOD - limit of detection

LOQ - limit of quantitation

MAS - minimum acceptable standards

MEDCOM - US Army Medical Command

MHS - Military Health System

MTF - medical treatment facility

NLT - no/not later than

NPP - normal pooled plasma

OPM - Office of Personnel Management

OPSEC - operations security

ORM - order message

OSHA - Occupational Safety and Health Administration

PD - purchase description

PHI - protected health information

PM - preventive maintenance or program/project manager/management

PMBOK® - Project Management Body of Knowledge®

PMP - program/project management professional

PMO - Provost Marshall Office

PMS - preventative maintenance services

POC - point of contact

PRS - performance requirements summary

PT - prothrombin

PTT - partial thromboplastin time

QA - quality assurance

QA&I - quality assessment and improvement

QC - quality control

QCP - quality control plan

QM - quality management

RMF - risk management framework

SDS - safety data sheet

SI - sensitive information

SOP - standard operating procedure

SSAA - system security authorization agreement

TJC - The Joint Commission

UPC - uninterruptible power source

VPN - virtual private network

WBAMC - William Beaumont Army Medical Center

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 Contractor equipment required in support this contract. The Contractor shall not alter the facilities without written approval of the KO. 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. New 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 is provided other personnel.

3.4.3. Emergency healthcare for Contractor employees. The MTF will provide emergency health care for injuries or life-threatening medical emergencies occurring while on duty. The

Contractor shall reimburse the government for such services as billed by the MTF, unless the

Contractor employee is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent).

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. Equipment. The Contractor shall supply a minimum of two (2) bench top or stand alone coagulation analyzers for WBAMC. If the minimum required analyzers are not enough to meet the workload demands, the Contractor shall provide an additional coagulation analyzer. CBA has been obtained through vendor Werfen via MEDLOG and LogiCole.

4.3. The vendor will be responsible for all equipment delivery and installation

4.4. The Contractor shall furnish a nametag for each Contractor 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 a fully automated bench top system that includes coagulation analyzer systems capable of performing all required assays listed in Attachment 1 through continuous random-access operations and the ability to connect to the laboratory information system bi-directionally. The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance (PM) 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 (LogiCole) quality management (QM) guidelines and analyzer removal at the termination of the contract.

All prices shall be calculated on a cost per kit/test/reportable basis, based on the number of patients listed for each mandatory test in Attachment 1. Costs shall be amortized over the total number of tests described in this PD and factored into the cost per kit. N/A to Reagents

Request

5.1.2. For the purposes of this PD, the analyzer system shall minimally include all analyzers, peripherals (e.g. instrument specific computer terminals and CPUs, printers, etc.) and uninterruptable power sources (UPS). N/A to Reagents Request

5.1.3. Analyzer systems will be located at:

WBAMC

18511 Highlander Medics Way

Ft Bliss, TX 79918

5.1.4. 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. This is critical to ensure electrical, drainage, etc. needs are identified early. Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to the government. N/A to Reagents Request

5.1.5. Validation and verification will be October 1, 2025.

5.1.6. Method validation shall be conducted entirely by the Contractor IAW method validation protocols established by the Department of Pathology’s QM program (these protocols are IAW applicable standards as described by the CLSI and/or required by the CAP). Relevant guidelines listed in Attachment 2 are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required depending on regulatory requirements. N/A to Reagents Request

5.1.6.1. Method validation shall include, but not be limited to, initial International Normalized

Ratio (INR) validation, reference range verification, demonstration of linearity with limit of quantitation (LOQ) verification, limit of detection (LOD) verification, reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of imprecision (within day and between day) and accuracy (recovery study), and establishment of initial normal pooled plasma (NPP), initial control ranges using control materials, to include third party controls, as designated by the laboratory director. N/A to Reagents Request

5.1.6.1.1. Method validation shall be completed and approved by the laboratory director prior to reporting of patient results. Payment will not begin until the analyzer system has been approved for reporting of patient results. N/A to Reagents Request

5.1.6.2. The Contractor shall provide a qualified technical service representative who possesses a thorough knowledge of method validation and is familiar with the use of EP

Evaluator® as a statistical evaluation software to provide technical assistance for the method validation studies. The assigned technical service representative shall be responsible for the entire method validation. N/A to Reagents Request

5.1.6.2.1. All reagents, calibrators and linearity materials used in the method validation study shall be provided by the Contractor, to include third party reagents and controls as indicated by the government and agreed upon by the Contractor. These materials shall not be used in the analysis of specimens for patient care. When new tests or new generations of reagents are available/added, the Contractor shall be on-site or remotely assist with all necessary bi-annual validation studies and supply all necessary reagents, calibrators and linearity materials.

5.1.6.2.2. The government’s technical supervisor will obtain patient specimens for use in method validation. If 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 Contractor sources.

5.1.6.2.3. Both the Contractor and Contractor personnel shall abide by HIPAA rules and regulations when conducting the method validation study.

5.1.7. The Contractor shall provide two (2) paper and two (2) compact disc (CD) copies of the operator 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.

5.1.7.1. User daily required maintenance shall not exceed 10 minutes per analyzer.

5.1.7.2. Weekly and monthly maintenance shall require minimal user action.

5.1.8. The Contractor shall provide print and electronic copies of all safety data sheets (SDS) for each item delivered under this contract that is considered hazardous material by the government. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall minimally contain identification of hazardous material, specific hazard, required practices for the safe use of the product, first aid procedures and what to do in the event of a spill or other mishap or accident.

5.1.9. The Contractor shall provide reagents and coordinate exact quantities and shipment schedule with the COR prior to shipment IAW 5.3.11, Deliveries.

5.1.10. The Contractor shall collect and transport equipment upon expiration/termination of this contract.

5.2. The Contractor shall provide a fully automated, bi-directional coagulation analyzer: 1) continuous random access; 2) “Short sample” underfilled tube detection; 3) Hemolyzed, Icteric and Lipemic sample detection. The total number of analyzers shall be determined by the minimum throughput, available menu requirements, patient acuity and be able to continually operate for 12-hrs without having to stop to load reagents or consumables. See equipment minimum requirements paragraph 3.2 Equipment.

5.2.1. Minimum actual through-put shall be: 1) 200 tests per hour for Prothrombin/INR assays;

2) 100 tests per hour for prothrombin (PT) and partial thromboplastin time (PTT) assays; 3) minimal processing time delay from stat order to aspiration.

5.2.2. Each analyzer shall be a continuous random access analyzer system with STAT prioritization capability and a closed primary tube sampling system capable of cap-piercing and capable of loading at least 25 STAT samples at a time.

5.2.3. Each analyzer shall have a reaction curve available for review and be able to recognize laboratory information system (LIS)-generated barcode labels (both code 39 and 128) on primary sample tubes.

5.2.4. Shall have a plasma set for validation of INR, barcoded reagents that include lot number, expiration date and vial size, and onboard reagent refrigeration.

5.2.5. Shall be able to access reaction-curve displays, display a visual clot curve for each result and display derivative curves for determination of clotting assays.

5.2.6. The analyzers shall not require water to operate.

5.2.7. All analyzer/data management system displays and supporting literature shall be in the

English language.

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

5.2.9. Each analyzer system shall be equipped with a UPS capable of providing all necessary electrical power to each analyzer system for 15 to 20 minutes. The Contractor shall ensure the

UPS remains maintained and operable throughout the length of the contract. The power cord for the UPS shall be a minimum 11 feet in length for the WBAMC main hospital because of ceiling outlets.

5.2.10. Analyzer and reagents must be FDA-approved. 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.

5.2.11. 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 shall have on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Attachment 1. All assays shall be FDA-approved.

5.3.1.1. The workload listed in Attachment 1 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 to 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. Workload may expand in subsequent option years due to fluctuations in patient volume and with the inclusion of other locations. Attachment 1 provides the estimated workload for Contract year one as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable results for the indicated year.

5.3.2. The analyzer shall simultaneously maintain calibration curves for all assays listed in

Attachment 1.

5.3.3. The assays listed in Attachment 1 shall always be present on the analyzer.

5.3.4. The assays listed in Table 5.1 shall be FDA-approved for clotting-based, chromogenic, immunologic testing of plasma samples.

5.3.5. The analyzers provided shall add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., shall 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 5.1 –Assays that Shall be FDA-Approved

Clotting-based assays

Prothrombin/INR

Partial Thromboplastin

Time

Fibrinogen

Chromogenic assays

Heparin Anti-Xa

Immunologic assays D-Dimer

Table 5.1 –Assays Continued

Product

Number

Product

Description Kit Configuration or Description

Reagents

20003050

HemosIL®

RecombiPlas

Tin 2G, 20 mL

5 x 20 mL RecombiPlasTin 2G(lyo)

5 x 20 mL RecombiPlasTin 2G(lyo)

20006800

SynthASil

5 x 10 mL APTT Reagent (liq)

5 x 10 mL Calcium Chloride (liq)

Plasma Calibrators and Controls

20013900

Normal

Control 1

10 x 1 mL Normal Control (lyo)

20014100

Abnormal

Control 3

10 x 1 mL Abnormal Control (lyo)

Solutions

9757600

Factor

Diluent

1 x 100 mL

9831700

Cleaning

Solution

(Clean A)

1 x 500 mL

9832700

Cleaning

Agent (Clean

B)

1 x 80 mL

20302400

Rinse

Solution

(ACL® TOP)

1 x 4 L

Consumables

29400100 ACL TOP® Cuvettes

29506900 Cuvette Waste Liner (ACL TOP® 500 CTS)

29403501 ACL TOP® CTS Filters

Reagents, Controls, Calibrators and Consumables included to run PT/PTT (CLINs X002 and X007)

IL Product

Number Product Description

Reagents General Screening and Anti-Coagulant Monitoring

20300600 HemosIL® Herapin Calibrators

20300300 HemosIL® UF Herapin Controls

D-Dimer

20008610 HemosIL® D-Dimer Control

Plasma Calibrators and Controls

20003700 HemosIL® Calibration Plasma

20014000 HemosIL® Abnormal Control 2

20004200 HemosIL® Low Fibrinogen Control

The quantities listed are the maximum quantities that IL will be obligated to supply under this agreement.

Any additional testing requirements may be purchased as needed at the per-box price per attached product addendum.

5.3.5.1. The Contractor must provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/ standards materials required to perform the volume of patient reportable tests for each assay as provided in Attachment 1.

5.3.5.2. The Contractor shall provide QC materials sufficient to run every eight hours and to be used as needed for troubleshooting. This includes third-party controls where requested/required by the laboratory.

5.3.5.3. The Contractor shall pre-program and adjust program as necessary for all QC, maintenance, calibrator material in Contractor-provided racks or testing containers.

5.3.5.4. The Contractor shall ensure requirements for routine QC 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 six-month period of time), specimen dilutions and troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.5.5. The Contractor shall estimate the volume of user-replaceable maintenance items to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks at the level of use specified in Appendix 1. An operator-level maintenance tool/ parts kit shall be provided, and replenishment of all expended items shall be made by the Contractor. Replenishment shall be made as needed or on a periodic basis not to exceed the normal PM cycle.

5.3.6. Reagents must have three-month shelf life upon receipt or vendor coordinate reagents sequester coordination with laboratory personnel.

5.3.7. The Contractor shall sequester the required QC materials and test reagents and ensure that no more than one (1) lot change for PT and PTT reagents and QC material and three (3) lot changes for all other reagents occur per contract year. Assays shall 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.

5.3.8. All reagents shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

5.3.8.1. Be provided by the manufacturer Werfen of the two (2) leased hematology analyzers.

5.3.8.2. Be marked with the required storage temperature.

5.3.8.3. Be maintained at the proper storage temperature during transportation from the

Contractor’s storage facility to the government acceptance site and be delivered on time at the appropriate storage temperature.

5.3.9. The Contractor shall provide reagents/reagents packs, calibrators/standards, QC materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

5.3.10. The Contractor shall provide linearity materials for all testing that spans the

Contractor’s published AMR every six months and as needed to verify repairs per CAP inspection criteria.

5.3.11. Deliveries.

5.3.11.1. Deliveries of required items shall be per monthly standing orders as agreed upon between the Contractor and government. The Contractor shall specify the last date that a standing order can be modified for a single delivery and/or all subsequent orders. Orders shall arrive on the date agreed upon and if the scheduled date is a federal holiday (listed above), the delivery will be scheduled for the day following the federal holiday. Any supplies that are placed on back order shall be clearly identified in the shipping documents and delivered in a timely manner, not to exceed ten (10) working days. If a backorder exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

5.3.11.2. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or QC materials currently in use for the assay(s) for which supplies are being requested. Contractor shall notify the government via email and telephonic message when an order is not available or capable of being shipped within these timelines.

5.3.11.3. For all orders, standing or emergency, the Contractor shall notify via email the designated point(s) of contact (POC) that orders have shipped and provide a tracking number.

5.3.12. Preservation and packing shall be performed IAW the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both shipping documents and containers. All deliveries shall be made Tuesday through

Thursday, to exclude federal holidays.

5.4. Ancillary Maintenance and Service.

5.4.1. Ancillary Maintenance. The Contractor shall furnish maintenance, service, repair and part as required to maintain systems in optimal operating condition.

5.4.1.1. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the government.

5.4.1.2. 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 PM /safety inspections and calibrations of equipment. Performance of scheduled periodic PM, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel IAW requirements as specified in the

Contractor’s instrument maintenance manual. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

5.4.1.3. The Contractor shall provide a full unscheduled and PM service (PMS) for the lease period. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems IAW paragraph 5.4.3.1.

5.4.2. Repair. Upon notification of equipment failure, the Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of government notification to the Contractors customer service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. Equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Should both instruments become inoperable, the Contractor’s technical specialist shall be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours.

The Contractor shall provide replacement parts as necessary for operator-level maintenance.

5.4.2.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.4.2.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the government to troubleshoot the instrument failure prior to notification of the

Contractor.

5.4.2.3. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the

Contractor shall correct the deficiency to a fully operational status IAW manufacturer specifications at no additional cost to the government.

5.4.2.4. All correspondence, service reports, and invoicing shall be in English.

5.4.2.5. PMS shall be performed IAW manufacturer standards/procedures. PMS shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

5.4.2.5.1. The Contractor shall notify the COR of the exact date and time for performance of a

PMS within ten (10) days prior to the scheduled PMS.

5.4.2.6. The use of two-way radios, as well as smoking, is prohibited within WBAMC and its clinics.

5.4.2.7. Prior to performing scheduled maintenance and unscheduled repair services work, the

Contractor's representative shall report to and obtain a visitor’s badge from the Equipment

Management Branch at the medical treatment facility (MTF). The badge shall be returned to the Equipment Management Branch prior to departing the MTF.

5.4.2.8. Within 2 business days after completion of a repair, the Contractor’s representative shall furnish via email 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 minimally contain the following information:

• Nomenclature and serial number

• Date

• Description of services performed (i.e., PMS, or unscheduled repair service)

• Location of services performed

• Duration of performance (hours)

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

• Name of technician

5.4.2.9. The government will and the Contractor shall exchange hazard communication information before commencement of any repair.

5.4.2.10. When required, the Contractor shall comply with OSHA lockout and tagout procedures while performing maintenance on electrical equipment.

5.4.2.11. Safety inspections shall be performed at least annually.

5.4.2.12. PM inspections and calibrations shall be performed IAW Contractor guidance as specified in the Contractor’s instrument maintenance manual.

5.4.2.13. When appropriate, the Contractor’s representative shall attach and complete a DD

Form 2163 (sticker), Medical Equipment Verification/Certification, to equipment upon completion of calibration services. The COR will provide attached to the equipment; the

Contractors' representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the COR.

5.4.3. Service.

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

5.4.3.2. The Contractor shall perform PMS, safety tests, calibrations, and unscheduled repair services IAW procedures and practices prescribed by the manufacturer of the equipment.

5.4.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract.

PMS shall be at no additional cost to the government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

5.4.3.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding federal holidays.

5.4.3.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for PM (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this contract. The equipment shall be repaired and operational within

48 hours after initial response by the Contractor.

5.4.3.6. Upon analyzer failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the government notification to the Contractor’s customer service hotline and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the

Contractor.

5.4.3.6.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.4.3.6.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the government to troubleshoot the instrument failure prior to notification of the Contractor.

5.4.3.6.3. The Contractor’s qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. The service technician or customer service hotline will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call shall be made timely (not to exceed 24 hours) after the service technician departs the lab.

5.4.3.7. Emergency services and unscheduled services outside regular working hours, on weekends, and on federal holidays shall be listed as a separate line item. These services shall be conducted in the same manner as all other emergency services as described in 5.4.3.6.

Estimated emergency visits per year are six (6).

5.4.3.8. Should both analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.4.3.6.

5.4.3.8.1. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service as described in 5.4.3.6.

5.4.3.8.2. 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 arrange the pickup and delivery of critical specimens to a CAP-accredited clinical laboratory.

5.4.3.8.3. During any period when both analyzers are inoperable, the Contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as both analyzers remain inoperable.

5.4.3.8.4. Hardcopy patient results shall provide all information as required in the laboratory

QA plan and approved by the laboratory director. This information shall include, but not be limited to positive patient identification, laboratory results and the testing laboratory’s reference range for the test being performed.

5.4.3.9. If the equipment is out of service for longer than 48 hours (from the time-of-service technician’s arrival on site), the Contractor shall notify the Chief, Clinical Engineering Branch and the COR in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

5.4.3.10. The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the government.

5.4.3.11. The government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

5.5. Training.

5.5.1. The Contractor shall provide initial on-site operator training to all technicians assigned to the government site (i.e., WBAMC Dept of Pathology laboratory staff) prior to initiation of use of the analyzer for patient testing. The Contractor shall provide online training for two (2) primary operators, per analyzer, per site of equipment installation prior to delivery and installation of the analyzer.

5.5.2. The on-site operator training shall be provided by qualified Contractor trained personnel using Contractor- owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

5.5.3. The Contractor shall provide two training slots per analyzer, per site, per contract year, at the Contractor’s training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the government.

5.5.4. The Contractor must provide instrument online training for technicians.

5.5.4.1. The on-site operator training shall be provided by qualified Contractor-trained personnel using Contractor- owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and advanced troubleshooting.

5.5.5. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5.6. Information Management.

5.6.1. The analyzer system shall be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS) and Military Health System (MHS)

Genesis. The Contractor shall have an established driver compatible for interfacing the analyzer with the CHCS. The interface between CHCS and the analyzer shall be bi-directional.

5.6.2. The analyzer system shall include a data management system for control of the operation of the analyzer system, management of the QC program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results, and a printer to produce hard copy patient reports and other reports generated via the analyzers’ data management system. The data management system shall have a comprehensive, fully integrated QC software module that stores and evaluates QC results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

5.6.2.1. QC software shall have a large capacity to store graphics and results, cumulative patient reports and QC files with statistics - all available to users.

5.6.2.2. QC software shall provide the capability to write user defined Westgard QC rules that allows viewing and maintaining of QC data across multiple levels and lots for analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments and eliminate data point(s) from statistics. QC software shall include the ability to apply Westgard

QC result decision rules in real-time with the ability of the user to individually select the rules to be applied.

5.6.3. Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Contractors technical support center or a field representative to remotely access the instruments to diagnose a problem.

5.7. Delivery of Equipment.

5.7.1. Analyzers shall be delivered to the location as indicated below and match renovation timeframes as indicated during post-award site-visit. Equipment setup, on-site training, method validation studies and analytical measurement range/linearity verification, shall be completed by Contractor personnel within a specified period for WBAMC main hospital. During the initial implementation, a dedicated technical representative shall be available on site throughout the entire implementation period. Substitutions shall be coordinated with the COR.

5.7.2. Primary location of analyzer systems:

William Beaumont Army Medical Center

Department of Pathology

18511 Highlander Medics St

Ft Bliss, TX 79918

5.7.2.1. Exact installation locations at the primary locations shall…