SOW_Hematology_Analyzer_-Final.pdf

STATEMENT OF WORK (SOW)

FOR

Hematology Analyzer

(18-Sep-14)

1. SCOPE OF WORK: The contactor shall provide all personnel, equipment, tools, materials, startup reagents, supervision, transportation, one service/operator’s manual and other items and services necessary for the installation of the Chemistry/Immunoassay Analyzer and ancillary equipment in the Clinical Laboratory located at Holloman AFB, NM.

Contractor shall comply with current National Electric Code (NEC), National Fire Protection Association (NFPA) standards, and all Environmental and Safety codes, laws and regulations.

1.1 The specifications of the chemistry analyzer must me as follows: The analyzer shall perform at least 50 complete blood counts per hour. The analyzer should also use an optical and/or laser technology to provide accurate readings for white blood cell (WBC) counts with a 5 part WBC differential which also enumerates bands, immature granulocytes, blast, variant lymphocytes and nucleated red blood cells that is FDA approved for laboratory use.

Additionally, the white cell counts should provide the correct WBC count in most cases in the presence of nucleated red blood cells, platelet clumps, giant platelets; lyse resistant red blood cells or fragile lymphocytes. The system must have barcode capabilities and must be fully interfaceable to the Composite Health Care System (CHCS).

2. OPERATIONAL REQUIREMENTS AND SPECIFIC TASKS

2.1 The contractor shall provide the government a minimum of (14) calendar days advance notice for commencement of work. Contractor shall identify in writing to the laboratory officer the names and the number of individuals that will be working during the installation.

2.2 The contractor shall provide a manufacturer’s certified installation specialist. A Clinical Application Specialist must perform system validation procedures to include calibrations, accuracy, quality control and mode to mode studies.

The requirements must include:

1. Setting up Quality Control (QC) files and entering QC limits.

2. Performing correlation studies with current method.

3. Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used.

4. To obtain acceptable performance on the analyzer, all studies must be presented to the laboratory officer for acceptance and approval prior to the contractor’s manufacturer’s (installation specialist, clinical application specialist and/or service engineer) departure.

2.3 Laboratory Information Services (LIS) INTERFACE: The contractor shall furnish interface assistance during installation. If interface cannot be completed prior to installation teams departure, the contractor agrees to provide telephone support to allow for interfacing of system.

2.4 MAINTENANCE AND REPAIR/SERVICE: The contractor shall provide the customer with service required to maintain the instrument, contractor provided computer, and software at its full capabilities for the term of this agreement at the business hours agreement stated below. If a replacement system is needed before the end of the term, the contractor will provide a replacement at no cost to the government. The system replacement will take place after the manufacturer has exhausted its troubleshooting options through its service escalation process. All contractor employees must check in with the 49th Medical Group’s Biomedical Equipment Repair Office (BMET) prior to performing any repairs or maintenance. When all necessary repairs or maintenance are, the contractor’s representative will supply the laboratory with a written report explaining the repairs/maintenance performed prior to departing the facility. Additionally, the contractor’s representative must check out with the BMET office and provide a documentation of all work accomplished. The contractor shall provide a maintenance and service agreement to include:

Service must include:

1. Years 1 – 5: Must provide at least a routine service IAW manufacturer’s standards (Mon – Fri, 7:30 A.M. to 4:30 P.M).

2. If on-site repair is needed based on vendor service escalation process, response shall be within 24 hours of initial notification by customer of problem

3. Technical Phone Support 24 hours a day/ 7 days a week (including holidays).

4. Receive preventative maintenance visits every six months with 48 hour notice prior to arrival.

Parts: The contractor shall be responsible for all parts required to maintain a serviceable system.

2.5 SHIPPING AND HANDLING: The contractor shall provide all manufacturer brand reagent and controls necessary to meet the average monthly test volume as stated in the General Services Administration (GSA)/Federal Supply Schedule (FSS) Price List assuming reasonably efficient utilization. The facility will be billed on a cost per test basis for patient tests and reruns based on an estimated 500 tests performed monthly. Minimum monthly testing is estimated at 300 tests. Controls must be provided on a mutually-agreed shipping schedule for the assigned monthly sample volume at no additional cost to the government. A schedule of routine shipments of reagents shall be provided along with a shipping mode based on geographical location. The mode of shipment used shall be appropriate for the product being shipped to arrive within manufacturer’s specifications. The shipment of temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal duty hours.

2.6 TRAINING: Prior to installation, the contractor should provide one training slot for a key operator for one individual, off-site at their training facility; the training must be completed within the first 12 months. The contractor should provide two additional key operator slots over the course of the 5-year agreement. Also, during the installation on-site, training must be performed for all other testing personnel by a certified system specialist.

2.7 The contractor must provide Material Safety Data Sheets (MSDS) for all required supply items that are utilized on the system at no cost to the government.

2.8 The contractor must provide all instrument freight charges incurred to have the instrument delivered for installation.

3. HOURS OF OPERATION: Normal work hours are from 0730 A.M. to 1630 A.M, Monday through Friday. Request for work other than normal work hours must be coordinated and approved by the Contracting Office and Laboratory Management.

Normal business hours are from 0730 to 1630 hours, Monday through Friday, excluding holidays. No preventative maintenance or consumable deliveries shall be made on Saturday, Sunday or federal holidays as shown:

New Year’s Day – 1 January Martin Luther King’s Day – Third Monday of the month in January President’s Day – Third Monday of month in February Memorial Day – Last Monday in May Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Christmas Day

4. THE LABROTORY POC SHALL BE THE OFFICER IN CHARGE.

4.1 SUPERVISION: Laboratory leadership will ensure a minimum of one (1) technician remains on-site during length of installation project to safeguard/secure laboratory supplies.

5. ENVIRONMENTAL COMPLIANCE: The contractor shall be responsible for the removal and disposal of any hazardous waste products generated by the contractor. The contractor shall prepare all disposal manifests for hazardous wastes or chemicals. Contractor shall obtain signatures from the Base Environmental office of any hazardous waste disposal prior to removal of items off the base.

5.1 HAZMAT PHARMACY REGISTRATION: The contractor shall register with the base HAZMAT Pharmacy any chemicals, etc., that are brought onto the base. Contractor shall comply with all Hazmat Pharmacy requirements and procedures.

6. GENERAL INFORMATION: When the contractor representative is working in a potential infectious area of the laboratory, they must wear a lab jacket/coat and gloves which will be provided by the Government.

6.1 CLEAN- UP: The contractor shall maintain the work area in a clean condition by the end of the contract performance period. Contractor shall dispose of all waste at an off-base permitted disposal site.

6.2 APPEARANCE: Contractor’s personnel shall present a neat appearance and be easily recognized. This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges, which contain the company and employee’s name. The wear of open-toed shoes is prohibited for infection control purposes.

7. PERFORMANCE OBJECTIVES

Performance Objectives SOW paragraph Performance Threshold Equipment maintained in serviceable condition

- Efficient processing of blood samples with few errors

2.4

1.1

98%

98%

Contractor Compliance:

- Compliance with calls for emergency service

- Compliance with timely supply of reagents

- Continuity in training of users, 3 trained key operators per 5 year agreement.

2.4

2.5

2.6

100%