PWS 2024 Chem.docx

PERFORMANCE WORK STATEMENT

FOR

Chemistry Analyzer

AIR FORCE MEDICAL

CLINICAL SUPPORT SERVICES

Non-Personal Services

13 Aug 2024

TABLE OF CONTENTS

Sections Title

1 Description of Services

2 Contractor Personnel

3 Contractor Furnished Items & Services

4 General Information

5 Service Summary

5 Definitions

6 Government Furnished Properties & Services

1. DESCRIPTION OF SERVICES: Equipment Lease/Service program.

1.1. General Service Requirement: The contractor shall provide all personnel, equipment, tools, test equipment, transportation, regularly scheduled preventive maintenance parts, reagents, panels, consumables, and services necessary to perform preventive maintenance and calibration (on-site) for Chemistry Analyzer. This unit is located at Ehrling Bergquist Clinic, 2501 Capehart Rd, Bellevue Nebraska, 68113. This service agreement will cover all costs including parts, labor, and transportation for the equipment.

1.2. Period of Performance: Performance period for this contract will be the effective date of award and will consist of a Base Year plus four Option Periods of one year each plus 6-month extension. This paragraph in no way commits the Government to exercise any of the options on the contract.

2. CONTRACTOR PERSONNEL

2.1. Contract Manager: The contractor shall provide a Contract Manager who shall be responsible for the performance of the work. The name of the person, and an alternate who shall act for the contractor when the manager is absent, shall be designated at time of award in writing to the Contracting Officer.

2.1.1. The contract manager will contact Bioenvironmental Equipment Maintenance (BMETs) at 402-294-7440 to schedule preventive maintenance. Provide preventive maintenance at a minimum once a year at no additional charge.

2.1.2. The contract manager and alternates must be able to read, write, speak, and understand English.

2.2. Employee Training: The contractor shall provide on-site instrument training at time of installation of analyzer. The contractor shall provide off-site instrument training for one employee during the first year. This shall include transportation, food, and lodging. One additional training slot will be included in the pricing that can be used any time during the remaining option years. If additional off-site training slots are desired at any time during the contract, they will be made available at additional cost to the laboratory.

2.3. Quality Control: The contractor shall maintain all systems in accordance with Defense Health Agency (DHA) requirements and manufacturer specifications. Preventive maintenance shall be completed annually, as specified in the manufacturer service manuals, to maintain a 95% uptime with no more than 2 customer complaints per quarter. Upon completion of service, the contractor shall provide service reports, to include calibration results, to the BMETs.

2.4. Quality Assurance: The BMETs personnel will inspect the contractor’s work to ensure requirements of this contract are being met. The BMETs section will also accept customer complaints from the equipment users to determine the quality of the contractor’s work.

2.5. Physical Security: The BMETs or Medical Laboratory will provide a representative to sign-in the contractor’s representative at the security check point when doing maintenance at the Ehrling Bergquist Clinic. The Contractor will need to process through base security before being allowed access on base to perform maintenance at the Medical Laboratory. The contractor shall be responsible for safeguarding all government property. At the end of each work period, all government facilities, equipment, and materials shall be secured. The contractor must also check out with BMETs when finished.

3. CONTRACTOR FURNISHED ITEMS AND SERVICES

3.1. General Information: The Contractor shall furnish all items needed to perform this contract according to all its terms. The contractor shall provide all supplies necessary to perform correlation, precision and other studies related to installation and operation of the analyzer at no additional charge.

· One Chemistry Analyzer with specifications listed below.

· One Water purification system, if necessary for operation, and applicable maintenance, supplies, and service.

· All computer system peripherals including, but not limited to, the computer, monitor, printer, software, and cables.

Test Requirements: The contractor shall provide all means necessary for ~128K annual based on historical usage from FY 2023 at the Ehrling Bergquist Clinic, 2501 Capehart Rd, Bellevue Nebraska, 68113.

Test menu:

Albumin, serum/plasma Alkaline phosphatase, serum/plasma ALT, serum/plasma Amylase, serum/plasma AST, serum/plasma Bilirubin, direct, serum/plasma Bilirubin, total, neonatal, serum/plasma Bilirubin, total, serum/plasma Calcium, serum/plasma Chloride, serum/plasma Cholesterol, serum/plasma CO2, serum/plasma Creatine kinase (CK), serum/plasma Creatinine, serum/plasma Creatinine, urine, quantitative GGT, serum/plasma Glucose, serum/plasma hCG, quantitative, serum HDL cholesterol, serum/plasma LD, serum/plasma LDL cholesterol, serum/plasma, measured Lipase, serum/plasma Magnesium, serum/plasma Microalbumin (urine albumin), quantitative Phosphorus, serum/plasma Potassium, serum/plasma Potassium, urine Protein, total, quantitative, urine Protein, total, serum/plasma Sodium, serum/plasma Sodium, urine Triglycerides, serum/plasma Urea, serum/plasma Uric acid, serum/plasma Alcohol/ETOH, serum/plasma C-reactive protein, high sensitivity Prostate specific antigen (PSA) T4, free TSH, serum/plasma Hemoglobin A1c*

* ~ 4,000 tests/yr

The Chemistry Analyzer Must:

· New (not previously owned) Food & Drug Administration (FDA)-approved analyzer(s) and components, with auto-loading feature.

· Must be a discrete analyzer, capable of performing at least 150 patient tests/(hr)

· Capable of processing adult and pediatric (micro-sample) specimen collection tubes.

· For applicable tests, must meet performance requirements for federally regulated analytes.

· Utilize a bar code reader for patient identification and safety.

· Utilize a bar code reader for reagent identification and tracking. This will help eliminate the human error associated with manual entry.

· Allow for programmable patient limits and panic values.

· Be capable of providing routine and STAT testing.

· The instrument must have on-board tracking of reagents, calibrators, controls, and ancillary reagents.

· Included reagents/ancillaries are primarily ready-to-use, with minimal technician preparation required.

· Provide reagents with stability through estimated usage (i.e., minimal reagent waste due to expiration).

· Calibration material is provided for each assay.

· Must have capabilities for user-defined test parameters.

· Require minimal maintenance (daily, weekly, and monthly). Operator performed maintenance should not exceed 20 minutes on any given day.

· Must include some "walk away" maintenance procedure capabilities, allowing for after-hours scheduling of maintenance tasks.

· Have an analyzer available for installation within a maximum of 45 days after acceptance of this contract.

· Must have attained FDA approval for installation of exact model of analyzer at least 12 months prior to acceptance of contact.

· Be able to show successful installation and integration of exact model in at least 2 other DOD facilities.

3.1.1 Specific Requirements: The Chemistry Analyzer Must:

· Must have current approved Authorization to Operate (ATO) on Med-COI and MHS Genesis.

· Must have an interface readily available and be able to link the Laboratory Information System (LIS), MHS Genesis.

· Provide one Uninterruptible Power Supply unit to allow work to continue for at least 20 minutes during a power failure.

· Must offer the ability to use bar coded specimens and host-query bidirectional or unidirectional interface between instrument and MHS Genesis.

· Provide documentation that the instrument and its reagents have necessary FDA approval.

· Provide service for the instrument during normal business hours, excluding holidays and weekends for the duration of the contract. Technical support via telephone must be available for any reagent, software, and instrument problems between the hours of 8:00 AM and 6:00 PM CST Monday-Friday. On-site service must be available within 24 hours (M-F) of notification. Defective parts and software shall be replaced at no charge.

· Provide preventative maintenance according to the manufacture stated requirements for the duration of the contract at no additional charge. There will be no less than 1 visit for annual maintenance.

· Provide instrument software upgrades at no cost during the term of the contract.

· Off-site training for one- (1) individual to include transportation, food, and lodging during the first year.

· Perform correlation, precision, and normal range studies required during installation of system.

· Provide documentation that the instrument and its reagents have necessary FDA approval. They meet Defense Health Agency (DHA) requirements and are Defense Information Assurance Certification and Accreditation Process (DIACAP) compatible.

· All service and maintenance shall be performed by personnel provided and trained by the manufacturer.

· Upon termination of the contract, the manufacturer/vendor must provide services to decontaminate and remove all equipment provided within the means of the contract.

3.1.2. Other Requirements: Printer and printer cartridges, reagents, and consumables. Contract must be a lease with the ability for laboratory technicians to order supplies directly from manufacturer. Provide all equipment necessary to perform Chemistry testing according to this Performance Work Statement.

3.2. Scope: On each scheduled service call for maintenance service, the Contractor Service Representative will service or attempt to service each covered item of equipment in accordance with the contractor’s current Maintenance Guidelines for such equipment. The Maintenance Guidelines will be provided to the BMETs. If a covered service call is not specified in the Contractor’s current Maintenance Guideline, the Service Representative will determine whether such repairs can be made and, if so, whether such repairs should be made on-site or at the Contractor’s Service Center.

3.3. Equipment updates: At a minimum, annually, the contractor shall furnish and install all software updates and equipment modifications normally provided by the manufacturer at no additional cost to the government.

3.4. Replacement Parts: The contractor shall have available any special tools, supplies, parts, and test equipment which are required for the scheduled maintenance and servicing of the equipment. The contractor shall use only original or factory refurbished replacement parts and be quality assurance tested by the manufacturer. If required replacement parts are not immediately available to the contractor while performing Preventative Maintenance Inspections (PMIs) or service repair calls, the contractor shall notify the BMETs of the deficiency. Maintenance actions shall not be delayed by more than 48 hours due to delivery of a repair part or item.

3.5. Technical Data: The contractor shall have and maintain a complete file of technical documentation on each system listed in the contract to include schematics, wiring diagrams, service manuals, troubleshooting guides, and service update memos.

3.6. Special Working Conditions: All equipment, parts, materials, and services supplied by the contractor shall conform to the applicable safety standards as indicated in the current code of Federal Regulations, Occupational Safety and Health Administration (OSHA) Standards.

3.7. Access to Software: The contractor shall have full access to all original software and all software necessary for troubleshooting, calibrating, and revising original software.

3.8. Maintenance Services: When possible, once maintenance actions are started, it shall be continued until the task is completed. A Medical Laboratory representative will stay with the contractor if the maintenance action is not completed during Clinic hours. Contractor employees desiring to work after normal hours do so at the contractor’s expense.

3.8.1. Preventive Maintenance Inspection: PMI is the care and servicing of the equipment in a serviceable condition in accordance with manufacturer’s scheduled and specifications listed in their technical literature. Inspection`s include, but are not limited to, verification of proper operation, detection and correction of incident failures either before they occur or before they develop into major defects; and includes actions pertaining to yearly inspections, lubrications, adjustments, calibrations, interior cleaning, and replacement of manufacturer’s recommended preventive maintenance parts. The contractor shall incorporate all the manufacturer’s published PMIs and be in sufficient detail as to meet industry standards set forth by the Joint Commission (TJC), National Fire Protection Association (NFPA) 99, and OSHA. The contractor shall comply with the manufacturer’s specified frequency, duration, and PMI procedures required for each system. PMIs shall be performed at least annually between the hours of 0730 and 1630, Central Standard Time. All preventive maintenance visits will be coordinated with the BMETs prior to any action being taken.

3.8.2. PMIs will consist of the following minimum requirements:

3.8.2.1. Consulting with equipment operators regarding equipment performance.

3.8.2.2. Visually inspecting exterior of all systems for damage and cleanliness.

3.8.2.3. Performing operational checks on all systems and correcting any deficiencies noted.

3.8.2.4. Cleaning and lubricating mechanical parts in accordance with manufacturer’s service manual.

3.8.2.5. Making mechanical adjustments to ensure proper operations.

3.8.2.6. Verifying the system’s internal and external calibrations are within manufacturer’s specifications.

3.8.2.7. Performing an electrical check of the equipment and all accessories included in this contract and making electrical adjustments as required to ensure compliance with manufacturer’s specifications.

3.8.2.8. Replace excessively worn or defective parts. Excessively worn parts are those parts that if not replaced immediately may fail prior to the next scheduled visit.

3.8.3. Scheduled Maintenance: The contractor shall perform yearly PMIs and system calibrations. The performance objective is to maintain a 95% uptime, and no more than 2 valid customer complaints per quarter.

3.8.4. Unscheduled Maintenance: The contractor will provide on-site repair support to correct all malfunctions that may occur. All tools, test equipment, parts, and supplies necessary to return the equipment to original operating specifications will be the responsibility of the contractor.

3.8.4.1. The contractor shall provide telephone assistance 24 hours a day for equipment covered under this contract. Telephone assistance shall be toll free to the government and shall be manned by a qualified repair technician. If the problem is not corrected by telephone assistance, the contractor’s representative is to arrive within 24 hours after a service request is originated to correct the issue.

4. GENERAL INFORMATION

4.1. Hours of Operation: The contractor shall perform preventive maintenance services and software upgrades required under this contract between normal duty hours, 0730 to 1630, Central standard time. This is Monday through Friday excluding Federal Holidays and Air Combat Command (ACC) Down Days.

4.2. Holidays: The contractor shall not be required to perform preventive maintenance services and/ or software upgrades on-site during the following federal holidays: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day.

4.3. Conservation of Utilities: The contractor shall make sure employees practice utility conservation. Ensuring that all lights are turned off when leaving an unoccupied room.

4.4. Records/Documentation: The contractor will maintain a sign-in log noting date called, date scheduled, date and time of arrival, and date and time completed. This log will provide the government data to determine if uptime and response times are being met and will be available for review by the BMETs.

4.5. Service Report: Upon completion of all worked performed, the contractor shall provide a legible service report. The government representative shall countersign the report. Failure to provide the service report may result in payment for service being delayed until the service report is received. Service reports shall include the following:

4.5.1. Type of service, PMI, scheduled or unscheduled service call.

4.5.1.1. System nomenclature, model, serial number, and room number.

4.5.1.2. Description of all services rendered during the visit.

4.5.1.3. Listing of all discrepancies, if any discrepancy, still exists. The contractor will return to fix the discrepancies at no cost.

4.5.1.4. If replacement parts are used, a complete list of parts used, by part number. The completed service report will be turned into Bioenvironmental Maintenance prior to the contractor leaving the Clinic.

5. SERVICE SUMMARY

3.8.2.

3.8.3.

No more than 2 valid Customer Complaint Records per quarter

5. DEFINITIONS

5.1. Up-time: The time that the system is performing according to specifications.

5.2. Down-time: The time when the system is deemed non-operational due to breakdown, ongoing corrective maintenance, or failure to perform according to specifications. The period of downtime shall be from notification to the contractor until the equipment is presented to the government’s representative in operation condition, ready to use. This shall include waiting for a loner, time for delivery and installation of replacement parts, and time elapsed after initial notification. Total downtime is the cumulative number of hours per months that the system is non-functional.

5.3. Reliability: All equipment must maintain a monthly percentage uptime of 95%.

6. GOVERNMENT FURNISHED PROPERTY AND SERVICES. There is no government provided property.