Attachment_02_Statement_of_Need.docx

STATEMENT OF NEED

FOR LEASED

URINE ANALYZER

1. GENERAL REQUIREMENTS

1.1. The contractor shall provide one leased fully automated discrete random access urinalysis analyzer system with automated microscopy function, including all required computers, scanners, printers, supplies, reagents/reagent packs, unscheduled maintenance, preventive maintenance, delivery, installation, operation validation, all calibrators/standards, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/CLSI/College of American Pathologists (CAP) guidelines, operator training, and analyzer removal at the termination of the contract. The equipment displays and supporting literature must be in the English language. The analyzer will be located at the main lab of the Ireland Army Health Clinic (IRAHC) building 871, Laboratory, 1st Floor, Room 1407, Fort Knox, Kentucky 40121. The instrument must include a support table, stand, or cart as no counter space is available. The instrument including computer will occupy a space NO LARGER THAN 5 ft., 10 in. long X 4 ft. deep X 5 ft. 3 in. high (including table, stand, or cart) and not exceed a maximum weight of 500 lbs.

1.2. Method Validation will include, but not be limited to, normal range/reference interval verification, demonstration of linearity with establishment of limits of quantitation (reportable range), correlation with current method (comparison of method study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using contractor supplied controls. All reagents, calibrators and linearity materials will be provided by the contractor.

1.3. The Contractor will provide one (1) paper and one (1) electronic copy of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language.

1.4 The analyzer system must be capable of interfacing with the military hospital computer system, i.e., the Military Health System (MHS) GENESIS System (Cerner). The instrument/manufacturer must have an approved Authorization to Operate (ATO) with the Department of Defense (DoD) and Defense Health Agency (DHA). The Contractor must have established drivers compatible for interfacing the analyzer with MHS GENESIS. The interface between MHS GENESIS and the analyzer must be bi-directional.

1.5 The analyzer will have a Data Management system that provides on-line Levy-Jennings graphs and applies Westgard Quality Control Rules as selected by the user and delta checks. Also required is a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics – all available to user, capable of downloading the QC data to a writeable disc or other removeable media which can then be used to submit the file for analysis against a QC peer group.

1.6 The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered HAZARDOUS MATERIAL by the United States or the Contractor’s representative 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 contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the 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.

1.7 The Contractor shall provide a water system (e.g., filtered, deionized, etc.), if required by the analyzer, that will provide appropriate water quality for testing and uninterrupted service.

1.8 The Contractor shall provide all required reagents for instrument operation. Delivery of the reagents will be done by a schedule approved by Ireland Army Health Clinic (IRAHC).

1.9. The Contractor shall be responsible for the collection and transportation of equipment upon termination of lease period.

1.10. The Contractor shall provide service to include, but not limited to, all personnel, equipment, tools, supervision and other items necessary to maintain medical equipment as listed on the equipment list.

1.10.1 The Contractor’s representative shall perform preventative maintenance inspections (PMI), calibrations and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

1.10.2 The Contractor shall maintain the equipment listed below in proper operating condition as described in the manufacturer’s literature. The contractor shall provide: One safety test and preventive maintenance and all unscheduled routine and all emergency services as required. The scheduled preventive maintenance shall include written documentation of servicing, cleaning, lubrication, adjustments, and operational tests in accordance with manufacturer’s specification and all applicable government and Army regulations.

1.10.3. Preventive maintenance shall be performed in accordance with the manufacturer’s specification and all applicable U.S. government and Army regulation at a minimum of semi-annually.

1.10.4. All preventive maintenance inspections/verifications/calibrations shall be performed in accordance with the manufacturer’s service manual, which will be located with the equipment, or provided by the contractor.

1.10.5. In accordance with MEDCOM directives and extracted from TB 38-750-2, the contractor performing the calibration, verification, or certification (CVC) action will complete a Field Service report within 24 hours of completion of services. The Field Service Report entries will be legible. The following information must be included:

(1) ID NUMBER. Enter the ID number of the equipment assigned by the government.

(2) MODEL NO. Enter the model number of the equipment as assigned by the manufacturer.

(3) SERIAL NUMBER. Enter the serial number assigned to the equipment by the manufacturer.

(4) AUTHORITY. Enter the authority authorizing the CVC. If unsure of the authorizing authority, seek guidance from Medical Maintenance Division personnel.

(5) UIC. Enter the name of the company with whom the contractor is affiliated.

(6) CERTIFIED BY. Enter the initials of the person performing the CVC.

(7) DATE COMPLETE. Enter the calendar date (MMM/YY) on which the CVC was complete.

(8) DATE DUE. Enter the calendar date (MMM/YY) on which the next CVC procedure is due.

1.11. System damage due to non-performance of routine maintenance procedures or improper handling by the customer is not covered by the contract unless it is modified to include such repairs. If the contractor finds that damage is due to improper handling or non-performance of routine maintenance procedures, the contractor’s representative shall within one (1) working day report the extent of the damage and submit a cost estimate for the repair work to the Chief, Medical Maintenance Division. The repair shall not be performed without a written modification to this contract or a purchase order authorizing such repair. The Chief, Medical Maintenance Division will review the estimate and submit a separate repair request (as processed to include the funding) to the Administering Contracting Officer, in order that the contract can be modified or another purchase order issued to authorize such repair.

1.12. The Contractor shall only accept calls for service/repairs from the Chief, Medical Maintenance Division or his/her authorized designated representative, or a Contracting Officer Representative (COR) as listed in Attachment 1.

1.12.1. Prior to, and upon completion of any scheduled or unscheduled service, the contractor service representative must report to the Chief, Medical Maintenance Division, or his/her designated representative at:

Ireland Army Health Clinic Medical Maintenance Division Bldg. 871 Fort Knox, Kentucky 40121 Tel. (502) 626-9720/9717

1.12.2. On the day services (scheduled and/or unscheduled) are completed, the contractor’s service technician shall prepare and initial, legible service report, and present it to the Chief, Medical Maintenance Division, or his/her designated representative for signature. This report shall include the following information:

(1) Services performed

(2) What systems or components failed (reason for call)

(3) Start date/time

(4) Completion date/time

(5) Name of service technician

(6) Part numbers and quantities of replaced parts

(7) Travel time

(8) Repair time

1.12.3. If all the necessary information is not available to the service technician at the time of completion of service, the initial service report shall include all information available. The contractor shall provide/fax the remainder of the required information to:

Attn: Chief, Medical Maintenance Division U.S. Ireland Army Health Clinic Building 871 Fort Knox, Kentucky 40121 within 10 days after completion of service.

1.12.4. The contractor must obtain authorization from the Chief, Medical Maintenance Division, or his/her authorized representative, prior to starting any repair that is attributable to instrument abuse, and/or instrument misuse, theft, neglect, fire, and anything else not covered in this contract. If these types of repairs are performed without the prior approval, the contractor shall not be paid by the U.S. government.

2. ANALYZER

2.1. The analyzer must provide all required urinalysis test menu capabilities including, but not limited to, color, clarity, specific gravity, pH, protein, glucose, ketones, bilirubin (detection of true bilirubin), blood, nitrite, urobilinogen, and leukocyte esterase on the same individual instrument platform. The instrument must also have the capability to perform automated microscopy, preferably utilizing urine particle counting via fluorescent flow cytometry methodology, to include, but not limited to, identification and quantification of white blood cells, red blood cells, epithelial cells, bacteria, yeast, and casts. To reduce mucus interference and manual procedures, the urine particle counter (automated microscopy) must have a method to remedy potential interference. The analyzer must also provide automatic color correction to reduce the incidence of false positive results, particularly for dark urines (bilirubin). Additionally, the analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control program, and management of patient results; and a printer to produce hard copy patient reports and other reports generated via the analyzer system’s data management system. The data management system’s quality control program must include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

2.2. The analyzer systems will provide users with rapid, reliable test results that are critical for patient care. The analyzer systems must be capable of performing in low, medium, and high-volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity.

2.3. All analyzer/data management system displays and supporting literature must be in the English language.

2.4. The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes.

2.5. The analyzer systems and all reagents shall be FDA approved. The analyzer and associated parts and accessories will be new. No used, refurbished, or like-new equipment will be provided in support of this contract at any time.

2.6. There must be at least 30 days overlap with the new analyzer and the old analyzer we are currently using. We must be able to continue testing and validate the new analyzer at the same time. To meet regulatory compliance, we are required to perform a verification of instrument performance and quality (e.g. precision, accuracy, carry over studies, linearities, etc.) when receiving a new instrument before patient testing can begin. This verification also requires method correlation with the current instrument (basically we have to see if the new instrument matches testing (results) obtained on the current instrument). Finally, all the data has to be compiled and approved by our Medical Director before patient testing can begin on the new instrument.

2.6.1. The analyzer system must be delivered to the location as indicated within two (2) weeks after contract award or as needed as situation dictates. Robust coordination with both the COR and the Department of Pathology is essential for the success of the installation. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, must be completed by vendor personnel to ensure that equipment is fully operational within 30 days after receiving confirmation/notification of the contract. During the initial implementation, a technical representative must be available telephonically 24 hours/7 days a week.

3. REAGENTS

3.1. The contractor shall provide an estimate of the yearly quantities of reagent, calibrators/standards, and quality control materials required to perform the volume of tests for each assay. The Contractor will ensure that requirements for routine quality control runs (as defined by IRAHC QA program), routine calibration, periodic calibration/calibration verification, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified.

3.2. The manufacturer will sequester the required quality control materials and test reagents and ensure that no more than one lot change occurs every 12 months.

3.3. Reagents must be provided by the manufacturer of the equipment.

3.4. Reagents must be marked with the required storage temperature.

3.5. Reagents must 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.

3.6. The Contractor shall provide all reagents, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as needed on a monthly basis for patient testing.

3.7. Deliveries of required items will be per monthly periodic orders called in to the Contractor by the designated Contracting Officer’s Representative or others as authorized. Orders will arrive within one week of requested date of delivery.

3.8. The minimum shelf life of the reagents will be 3 months after the date of delivery.

3.9. Emergency orders will be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

3.10. Preservation and packing – preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

3.11 Chemistry strips should have loading mechanism to reduces or eliminate misalignment and strip jams.

4. RECEIPT OF SERVICES

4.1. Receipt of services will be acknowledged after receipt of all complete service reports for any scheduled calibration, preventive maintenance and unscheduled routine and emergency services performed during the respective quarter. Receiving reports will not be prepared and submitted until all such completed service reports containing all required information are in the possession of the Chief, Medical Maintenance Division or his/her designated representative. Services to be acknowledged by, service reports and invoices sent to:

Chief, Medical Maintenance Division Tel: (502) 626-9720/9717

4.2. Job Site Location. Main Lab, Bldg. 871, Room 1407, Ireland Army Health Clinic, Fort Knox.

4.3. The Contractor shall notify the COR, the Chief, Medical Maintenance Division, or the Laboratory Manager or his/her designated representative(s) of the exact date and time within ten (10) days prior to the scheduled preventive maintenance services.

4.4. The Contractor shall respond to unscheduled repair service calls from the COR, the Chief, Medical Maintenance Division, the Laboratory Manager or his/her designated representative(s) telephonically within two hours, 24 hours/day, 7 days/week. Unscheduled repair service calls shall be accepted only from the COR, the Chief, Medical Maintenance Division, the Laboratory Manager or his/her designated representative(s).

4.4.1 Completion of Unscheduled Repairs: The Contractor’s technician must be on site and commence repair services within 24 hours.

4.5. Replacement Parts.

4.5.1. All replacement parts shall be installed in accordance with the manufacturer’s standards/procedures.

4.6. Smoking is prohibited within the U.S. Army Medical Department Activity, Fort Knox, and its clinics.

4.7. Prior to performing work, the Contractor’s representative shall report to the Medical Maintenance Division (Building 871) during normal business hours. Repairs that cannot be performed at the Government site may be performed at the Contractor’s site provided the COR approves removal of the equipment. The Contractor’s representative shall sign a receipt for the equipment. The repaired equipment shall be returned to the original premises within two (2) working days, or the Contractor shall provide a temporary replacement at no additional cost to the government. Returned (repaired) equipment and temporary replacement equipment must be validated by the Contractor as stated in section 1, item 1.2.

4.8. The Contractor shall complete a Field Service Report to include the manufacturer, model, serial number, and date of calibration, expiration of all items of test and measurement equipment used to perform the calibration. Required forms and extracts from pertinent directives will be furnished to the Contractor by the government in accordance with regulation TB 38-750-2. Full text version of TB 38-750-2 will be made available by the authorized Medical Maintenance Division COR upon request.

4.9. Within one (1) working day after completion of repair, the Contractor’s representative shall furnish the COR, the Chief, Medical Maintenance Division, and the Laboratory Manager or his/her designated representative(s) one (1) copy each of a service report for all services performed. The service report shall be in English and shall contain, as a minimum, the following information:

· Nomenclature and serial number

· Date

· Description of services performed (i.e., preventive maintenance inspection, or unscheduled repair service)

· Location of services performed

· Duration of performance (hours)

· List of parts replaced

· Name of technicians

4.10. Preventive Maintenance Inspection.

4.10.1. Preventive maintenance inspections shall be performed at a minimum semi-annually in accordance with the manufacturer’s standards/procedures. This also includes the installation of all non-operator parts required to ensure proper operation.

4.10.2. Safety testing shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Medical Maintenance Division.

4.10.3. The Contractor’s representative shall complete a Field Service Report upon completion of calibration services. The Field Service Report will be provided to the Contractor’s representative by the POC.

4.11. SAFETY DATA SHEETS (SDS): The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative 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 contain as a minimum the following information: identification of the specific hazard, the required practice 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. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

5.1. The Contractor will comply with all U.S. laws pertaining to medical equipment FDA Approved. Contractor will also comply with all Department of Defense (DOD), Department of Army (DA), Defense Health Agency (DHA), US Army Medical Command (USAMEDCOM), and Ireland Army Health Clinic (IRAHC) regulations and policies pertaining to medical equipment. Current issues of many DA publications can be accessed at http://www.usapa.army.mil/gils. Current issues of many forms can be accessed at http://www.usapa.army.mil/forms. Publication and forms not on the internet can be obtained from the MTF. These regulations include, but are not limited to, the following:

5.2. Mandatory

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration Public Law 104-191 (Aug 1996) Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO)

Manual AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-2 Army Medical Treatment Facilities and General Administration AR 40-4 Army Medical Department Facilities/Activities AR 40-68 Quality Assurance Administration AR 380-19 Information Systems Security

AFIP PAMPHLET 40-24; Clinical Laboratory Improvement Program (CLIP) policy mandated by DODI 6440.2 NFPA 99, Chapter 7.

5.3. Advisory

AR 310-25 Dictionary of United States Army Terms MEDCOM Pam 25-31 Index of Command Administrative Publications (15 AUG 01)

5.4. The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

5.5. The Contractor shall be responsible for creating, maintaining, and disposing of only those government required records that are specifically cited in this statement of need or required by the provisions of a mandatory directive listed in Section 5.9. If requested by the Government, the Contractor shall provide the original record, or a reproducible copy of any such record within 5 working days of receipt of the request.