SOW FINAL.pdf

Statement of Work (SOW) Project: Hematology Analyzer for NMRTC Corpus Christi

GENERAL INFORMATION

1.0 Scope of Work: The requirement is for a cost-per-test result (CPT). For one (1) clinical 6-part differential hematology analyzer, hematology reagents, quality control, maintenance, calibration and consumables for Navy Medicine Readiness and Training Command (NMRTC) Corpus Christi, TX and Ft. Worth, TX locations.

2.0 Background: The intent is to establish a hematology cost per test result service for NMRTC

Corpus Christi and Ft. Worth. The contracted units shall be capable of performing Complete Blood Count (CBC) panels consisting of the following tests with the minimum workload indicated:

a. Corpus Christi:

Test Name Test Name Tests/Year

WBC NEUT% 5757

RBC NEUT# 5757

HCT LYMPH% 5757

HGB LYMPH# 5757

MCV MONO% 5757

MCH MONO# 5757

MCHC EO% 5757

PLT EO# 5757

RDW-SD BASO% 5757

RDW-CV BASO# 5757

IG% 5757

IG# 5757

b. Ft. Worth:

Test Name Test Name Tests/Year

WBC NEUT% 1004

RBC NEUT# 1004

HCT LYMPH% 1004

HGB LYMPH# 1004

MCV MONO% 1004

MCH MONO# 1004

MCHC EO% 1004

PLT EO# 1004

RDW-SD BASO% 1004

RDW-CV BASO# 1004

IG% 1004

IG# 1004

The contract will have an initial Base year with Four (4) subsequent Option years.

CONTRACTOR REQUIREMENTS

3.0 Technical Requirements/Tasks:

3.1 The analyzer will be compatible with and maintain bi-directional interface with Health Level

Seven (HL7), the DOD Laboratory Information System (LIS)/ Composite Healthcare System (CHCS)/ and other LIS as designated by DHA, and capable of reading specimen barcode labels. Provide integrated hematology testing using a Food and Drug Administration (FDA)-approved methodology, e.g. flow cytometry, etc. The analyzer shall be capable of processing various adult and pediatric test tube sizes. Analyzer must possess onboard sample management, quality control, inventory control, and maintenance documentation. Analyzer must include the ability to flag results as being suspicious to allow for optimal sample troubleshooting. The analyzer unit will be supplied with an uninterruptible power supply (UPS) that is sufficient to power the analyzer during times of short-term power loss and include battery replacement when manufacturer recommended.

3.2 The vendor shall provide installation, validation testing, onsite and offsite user training and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range verification, replication studies, recovery studies and establishment of initial control ranges using control materials. Corrective system maintenance coverage shall include response times, as specified in the below.

3.3 The system, including claims made for the product, shall be compliant with Food and Drug

Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) requirements. Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

4.0 Government Furnished:

Materials and Services.

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements, necessary for the system to function properly as specified by the OEM.

b. The Government will operate the system in accordance with the instruction manual provided by the

OEM.

c. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of vendor supplies, materials, or for the personal belongings brought onto Government property by vendor personnel.

5.0 Deliverables / Schedule:

5.1 One (1) operational and one (1) service manual in English with delivery of equipment.

The vendor shall provide to the Technical POC a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English.

5.2 Reagent and supply delivery

a. All supplied items and reagents shall be certified for use with the OEM equipment provided.

b. All supplied items and reagents shall be delivered IAW manufacturer’s shelf life recommendations. Deliveries will be based on volume of testing performed coordinated with the Laboratory Department Head.

c. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label that is easily read and understandable. Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

d. The contractor shall provide deliveries to the delivery points identified below:

Navy Medicine Readiness and Training Command Corpus Christi Attention: Laboratory Department 10651 E Street Corpus Christi, TX 78419

Navy Medicine Readiness and Training Unit Ft Worth Attention: Laboratory Department 1711 Doolittle Ave.

Ft Worth, TX 76127

5.3 Facility Constraints

a. Laboratory Footprint: The unit shall be mobile and easily configured to the modular furniture currently in use at NMRTU. Laboratory Footprint: the instrument, computer and printer, as applicable, should not have a footprint exceeding twenty-four (24) inches in length; twenty-four (24) inches in depth; eighteen (18) inches in height and not exceed two-hundred (200) pounds in weight.

b. The facility currently has adequate plumbing, such as drainage.

c. The facility has biohazard collection protocol and capabilities.

d. Equipment must be able to operate within the following environmental conditions:

Ambient room temperature ranging from 15 to 32 degrees C; humidity levels ranging from 30-85%.

e. Power requirements: 110-120V AC, 60 Hz. An UPS is required, with OEM recommended battery changes.

5.4 Maintenance.

a. The vendor shall provide OEM-trained, experienced, English-speaking personnel. The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

b. The vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer (OEM) specifications/equipment certification.

d. The vendor shall provide maintenance services Monday through Friday from 0730-1630 local time, excluding Federal Government holidays as seen at the following site:

https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required performance maintenance. Customer and technical support shall be available by phone Monday through Friday from 0730-1630 local time, excluding Federal Government holidays. The instrument daily maintenance shall not exceed thirty (30) minutes a day.

5.5 Preventive Maintenance Services.

a. Normal Business Hour Preventive Maintenance Coverage will be Monday through Friday, from 0730-1630 local time, excluding Federal Government holidays. Vendor shall provide full service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. The vendor shall perform PM service checks during the contract at the OEM’s recommended intervals and at a date and time mutually agreed upon by the vendor and the Laboratory Department Head.

d. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with the Joint Commission (JC), OEM, the College of American Pathologists (CAP), and Food and Drug Administration (FDA).

5.6 Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance from 0730-1630 Local Time, Monday-

Friday, to include unlimited service calls. Telephonic technical support shall be available Monday through Friday, except Federal holidays, from 0730 to 1630.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within forty-eight (48) hours after receipt of trouble call.

c. The Government’s request for corrective maintenance will be placed by laboratory personnel, directly to the vendor or its representatives. Corrective maintenance shall be completed during the hours specified in the contract.

d. The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a vendor Field Service Engineer (FSE). Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of a FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

f. The vendor shall have and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

5.7 Replacement Parts/Upgrades.

a. The vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor.

d. All replacement parts shall be new and certified as OEM replacement parts.

e. The vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the vendor shall provide installation within 30 days of release regardless of PM schedules.

f. With approval from the Technical POC, the vendor may perform hardware/software upgrades as they become available at no additional cost to the government.

5.8 Training

The vendor shall provide initial on-site operator training to all technicians assigned to the laboratory prior to the initial use of the equipment as well as web-based training. All cost for training shall be included in the CPT totals and at no additional cost to the government.

5.9 Connectivity/Interface/Barcodes:

a. Analyzer will be compatible with and maintain bi-directional interface with Health Level

Seven (HL7), the DOD Laboratory Information System (LIS)/ Composite Healthcare System (CHCS)/ and Defense Health Agency (DHA) Cerner Genesis software.

b. Analyzer using vendor provided Middleware Software for bi-directional functionality should be compatible with the DHA Cerner Genesis software slated to replace the CHCS Laboratory Information System (LIS). Systems must demonstrate compliance with Cerner through their Care Aware Medical Device Certification program.

c. Analyzer must be capable of reading barcoded specimens of the following barcode types:

interleaved 2 of 5, Code 39, and Code 128. Analyzers must be capable of reading barcoded quality control materials and barcoded calibrators, automatically transferring results to designated files in the onboard Quality Management Software program utilized for regulatory compliance documentation.

5.10 Vendor Furnished Property and Material.

a. The vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor Field Service Engineers and as required for the completion of the services in accordance with this contract.

b. The vendor shall provide one complete set of user manuals for use by laboratory personnel.

The vendor shall provide one (1) operational and one (1) service manual, each in English.

5.11 Vendor Report Requirements.

a. During normal duty hours, the vendor’s Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division (BIOMED) and the security office, upon arrival and again prior to departure. In the event that the service visit is unable to resolve the issue and leaves the analyzer in non-service status, the vendor FSE shall notify the duty laboratory representative prior to departing the laboratory.

b. The vendor shall provide to BIOMED personnel a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

i. Name of Vendor

ii. Contract Number

iii. Name of field service engineer performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include manufacturer, make, model, serial number and

Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include labor and travel costs, parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Calibration and Quality Control Reports

xii. Signatures:

1. Field Service Engineer performing services

2. Laboratory Department Head acceptability of repair/ PM

3. BIOMED verifying service rendered

xiii. In the event that agents/sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name, point of contact, and contact information (i.e. telephone number and email)

5.12 Vendor Responsibility.

The vendor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property, resulting from the negligence of the vendor or its representatives. All such replacement or repair shall be completed at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

5.13 Removal of Contractor Furnished Equipment

a. No equipment shall be removed without the approval of the Contracting Officer and Materiel Management Department (MMD) of the Medical Treatment Facility (MTF).

b. In regards to patient information confidentiality and privacy, all vendors and/or service vendors shall not remove equipment containing personally identifiable information (PII) or patient health information (PHI) from the Government site until the vendor has demonstrated to the government that their equipment has been sanitized of such data.

The equipment hard drive (HDD) shall be removed and provided to the MTF for proper disposal prior to equipment removal from the site. If the HDD is to be replaced, the HDD in disrepair shall be left at the MTF for disposal.

5.14 Service Beyond the Scope of the Contract

a. The vendor shall immediately, but no later than twenty-four (24) consecutive hours after discovery, notify BIOMED in writing of the existence of or the development of any defects in the scheduled equipment, for which the vendor considers they are not responsible for repairing under the terms of this contract.

b. At the same time of this notification, the vendor shall furnish BIOMED with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

c. No work outside of the contract shall be performed without a contract modification.

6.0 Travel: The contractor is responsible for all travel cost associated with this contract.

7.0 Security Requirements:

The Contractor shall be required to enroll in the Defense Biometric Identification System (DBIDS) for Base Access. If you were issued an NCACS credential PRIOR to 17 April 2017, your NCACS credential will remain in effect for base access through 14 August 2017, when NCACS credentials will no longer be valid. Only DBIDS credentials will be issued to ALL Contractors, vendors and suppliers seeking base access AFTER 30 June 2017. Defense Biometric Identification System (DBIDS) increases installation security and communications by receiving frequent database updates on changes to personnel/credential status, law enforcement warrants, lost/stolen cards, and force protection conditions. The system provides a continuous vetting anytime the DBIDS card is scanned at an installation entry point.

If you currently have a Navy Commercial Access Control System (NCACS) card, the following is required to get a DBIDS credential:

a. Present your NCACS Card and a completed copy of the SECNAV FORM 5512/1 to the base

Visitor Control Center (VCC) representative.

b. The VCC will retrieve your information in the computer, ensuring all information is current and correct.

c. Once your information is validated, a temporary DBIDS credential is provided.

d. Your temporary credential will have an expiration date, prior to which you will need to obtain your permanent DBIDS credential (~ 180 days).

e. For each additional U.S. Navy installation to which you need access, the first time you visit you only need to bring your DBIDS credential and statement of purpose for base access when arriving at the VCC.

f. The representative will enter base access authorization and then you may proceed to work.

If you do NOT have an NCACS Card, the following is required to obtain a DBIDS credential:

a. Present a letter or official document from my government sponsoring organization that provides the purpose for your access.

b. Present valid identification, such as a passport or Real ID Act-compliant state driver's license.

c. Present a completed copy of the SECNAV 5512/1 form to obtain your background check.

d. Upon completion of the background check, the Visitor Control Center representative will complete the DBIDS enrollment process, which includes your photo, finger prints, base restrictions, and several other assessments; after all this is done, you will be provided with your new DBIDS credential.

e. You may now proceed to work.

FOR ADDITIONAL QUESTIONS ABOUT OBTAINING A DBIDS CARD, CONTACT YOUR LOCAL

BASE VCC OR https://www.cnic.navy.mil/om/dbids.html.

8.0 Data Rights: N/A