Attachement I -- Statement of Work -- HT941025Q2053.pdf

STATEMENT OF WORK (SOW)

FOR

Hematology Analyzer

1 SCOPE OF WORK: The contractor shall provide all personnel, equipment, tools, materials, startup reagents, supervision, transportation, one service/operator’s manual, and other services necessary for the installation of a Hematology Analyzer and ancillary equipment in the Clinical Laboratory located at Building 210, Los Angeles AFB, El Segundo, CA. The contractor shall comply with the current National Electric Code (NEC), National Fire Protection Association (NFPA) standards, and all applicable environmental and safety codes, laws, and regulations

1.1 The specifications of the Hematology analyzer must meet the following:

High-capacity analyzer to result 55 samples per hour.

50 tube load and walk away capacity with continuous loading.

Technology including Flow Cytometry (cell volume and axial light loss) and Dynamic Gating.

Storage for 30,000 patient results including graphics, flags, codes and messages.

Test parameters must include WBC, RBC, HBG, CBT, MCN, MCH, MCHC, RDW-

SD, RDW, CV, PCT, MBP, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#,

BA%, BA#.

Directly measures MCV

Carryover must be <1.00% for WBC, RBC, HGB, PLT and 5-part differential

QC package with 12 control files, each with a maximum of 150 runs, LG plots, XB.

XM.

Sample introduction through automation mode (rack based) or manual mode on demand

Analyzer size cannot exceed: Height-18 inches Width-20 inches Depth-20 inches

2 OPERATIONAL REQUIREMENTS AND SPECIFIC TASKS

2.1 The contractor shall provide the government a minimum of fourteen (14) calendar days' advance notice for the commencement of work. The contractor shall provide written notification to the laboratory officer identifying the names and number of individuals who will be working during the installation.

2.2 The contractor shall provide a manufacturer’s certified installation specialist and a Clinical Application Specialist. The Clinical Application Specialist must perform system validation procedures, including but not limited to:

a. Setting up QC files and entering QC limits.

b. 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.

c. 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 LIS INTERFACE: The contractor shall furnish interface assistance during installation.

If an interface cannot be completed prior to installation teams’ departure, the contractor shall provide telephone support to allow for interfacing of the system.

2.4 INSTALLATION, TRAINING AND SUPPORT: The contractor shall provide a dedicated point of contact and liaison for laboratory staff at the 61st MDS Clinic. The contractor shall also provide training to laboratory personnel on the operation of the instruments, as specified in the contract.

2.5 For the installation of new analyzers, the contractor shall provide technical support to bring and maintain them in a fully operational status. The contractor shall ensure the analyzers are new and do not require a separate water purification/filtration system.

2.6 TRAINING:

Initial Training: The contractor shall provide five training slots for two individuals, on-site at the 61st MDS El Segundo clinic (Los Angeles AFB, CA) during the installation. Training must be performed for all other testing personnel by a certified system specialist.

Option Year Training: The contractor shall provide one additional training slot during each executed option year.

2.7 SERVICE AND MAINTENANCE: The service contract shall include:

Coverage: 1 base year + 4 option years.

Routine Service: Routine service shall be provided in accordance with manufacturer's standards, Monday through Friday, between 7:00 am and 4:00 pm.

On-Site Repair Response: If on-site repair is needed based on the vendor's service escalation process, the response time shall be within 24 hours.

Technical Support: 24 hours a day/7 days a week (including holidays) of telephone technical support shall be provided.

Preventative Maintenance: Preventative maintenance visits shall occur every six months, with 48 hours' notice provided prior to arrival.

Parts: The contractor shall be responsible for all parts required to maintain the analyzers in a serviceable condition.

2.8 SUPPLIES, REAGENTS, AND SHIPPING: The contractor shall provide an operator’s manual for each analyzer, an accessory kit (if applicable), and all necessary reagents, calibrators, controls, and consumables required to validate the analyzer(s).

The contractor shall ensure proper packaging of all reagents, supplies, and equipment.

All items must be shipped at the appropriate refrigerated or frozen temperatures, according to manufacturer specifications. All shipments must arrive Monday through Friday between the hours of 7:00 am to 4:00 pm PST, excluding holidays and weekends, specified in paragraph 3. Reagents shall meet the quality control guidelines set forth by the manufacturer. 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 the 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.

3 HOURS OF OPERATION: The laboratory operates on a 9 hour basis. Normal work hours are from 0730 to 1630 hours, Monday thru 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 0700 to 1600 hours, Monday thru Friday, excluding holidays. No preventative maintenance or consumable deliveries shall be made on Saturday, Sunday, scheduled government closure (schedule will be provided upon request), 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 the month in February Memorial Day – Last Monday in May Juneteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Christmas Day

4 The laboratory POC shall be the Officer in Charge, 310-653-6617.

4.1 SUPERVISION: Laboratory leadership will ensure a minimum of one (1) technician remains on-site during the 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. The contractor shall obtain signatures from the Base Environmental office of any hazardous waste disposal prior to the 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. The contractor shall comply with all Hazmat Pharmacy requirements and procedures.

6 PHASE OUT: If the contracted operation reverts to in-house operations, the Contractor shall cooperate with 61st Medical Squadron and DHA personnel to ensure an orderly change over.

In the event a follow-on contract is awarded to other than the incumbent, the incumbent Contractor shall cooperate to the extent required to permit an orderly transition to the successful Contractor. Recruitment notices may be placed in each facility to allow successor Contractor’s access to incumbent employees.

7 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.

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

7.2 APPEARANCE: The contractor’s personnel shall present a neat appearance and be easily recognized. Compliance 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.