FA558720Q1002_Performance_Work_Statement.pdf

PERFORMANCE WORK STATEMENT FOR

LABORATORY CLINICAL COAGULATION STUDIES

23 September 2019

1. DESCRIPTION OF SERVICES: The Contractor shall maintain a coagulation analyzer with technical support required to provide outpatient and inpatient coagulation test analysis for United

States Government (hereinafter referred to as “Government”) beneficiaries. The Contractor shall maintain the analyzer and service in Government supplied facilities at the 48th Medical Group, also referred to as the “Military Treatment Facility” (MTF) herein. Contractor care includes furnishing all equipment, maintenance, supplies for operation of equipment, labor, transportation, reports, and technical assistance including items outlined in paragraph 2.4.2.

Tests required shall cover the range of basic through comprehensive coagulation testing services typically provided in a civilian MTF or stand-alone facility of similar size. Performance shall be according to the requirements contained in this Performance Work Statement (PWS).

2. SCOPE OF COAGULATION ANALYZER UNIT

2.1. The Contractor shall maintain an analyzer capable of performing the following tests:

Protime (PT) with calculated INR, Activated Partial Thromboplastin Time (APTT), and D-

Dimer, as well as the capacity to expand if future coagulation testing is required. The analyzer must not require a water treatment plant or floor drainage system for operation, but may utilize a drainage container. The ideal analyzer supports the Environmental Compliance and

Management Program (ECAMP) by ensuring minimal or no waste water is let into the base wastewater management system. The standard of care maintained must be in accordance with the College of American Pathologist accrediting agency and the Joint Commission on

Accreditation of Health Care Organization and with existing laboratory practice guidelines. This will be periodically evaluated by the Chief of Clinical Laboratory Services and reported through the hospital’s Executive Committee of the medical staff.

2.1.1. The Contract shall maintain the lab with exact or upgraded equipment in the event of replacement due to service/repair.

2.1.2. The Contractor shall maintain an analyzer system that allows for random access processing in a minimum of turn-around time.

2.1.3. The Contractor shall maintain an analyzer that is capable of performing mechanical clot detection for PT and APTT.

2.1.4. The Contractor shall maintain an analyzer that performs STAT PT and APTT testing and allows STAT samples to be placed in any position on the sample tray, at any time.

2.1.5. The Contractor shall maintain an analyzer that has the capability for Bi-directional connectivity to laboratory information systems.

2.1.6. The Contractor shall maintain an analyzer capable of reading bar-coded reagents and patient samples.

2.1.7. The Contractor shall maintain an analyzer that is capable of random loading of reagents.

2.1.8. The Contractor shall maintain an analyzer that has 45 reagent positions, and can hold multiple vial sizes.

2.1.9. The Contractor shall maintain an analyzer that is capable of performing all sample and calibrator dilutions automatically.

2.1.10. The Contractor shall maintain an analyzer that is capable of automatic reflex testing and repeat testing.

2.1.11. The Contractor shall maintain an analyzer that is capable of storing up to 5 years of patient and Quality Control (QC) data.

2.1.12. The Contractor shall maintain an analyzer that is capable of holding 96 samples, including pediatric tubes and micro containers and shall allow for random loading of samples.

2.1.13. The Contractor shall maintain an analyzer that is temperature controlled.

2.1.14. The Contractor shall maintain an analyzer that is no more than 28 inches in height, 39 inches in width, 29 inches in depth, and weighs approximately 300-325 pounds.

2.3. SAMPLE INTEGRITY

2.3.1. The Contractor shall maintain an analyzer capable of liquid level sensing during sample aspiration. When a short sample is detected the instrumentation must be capable of providing error output for technician interpretation and intervention.

2.3.2. The Contractor shall maintain an analyzer with removable tray that can accommodate sample cups and primary tubes of varying sizes and fill volumes.

2.3.3. The Contractor shall maintain an analyzer system capable of testing plasma.

2.3.4. The Contractor shall maintain an analyzer with a barcode reader that will ensure accurate sample identification.

2.3.5. The Contractor shall maintain an analyzer capable of having STAT samples that can be entered at any time in any position on the tray.

2.3.6. The Contractor shall maintain an analyzer with One-touch Run to start the processing with a press of a button.

2.4. INSTALLATION

2.4.3. The Contractor shall maintain the full uninterruptible power supply UPS for the analyzer system or replace if it breaks.

2.4.4. The Contractor shall maintain a replacement printer should the printer breakdown or become obsolete.

2.6. MAINTENANCE

2.6.1. The contractor shall maintain 24-hour, 7 days per week hotline support in which a person is available to maintain verbal assistance. If the 24 hours is not available, then the most coverage shall be provided.

2.6.2. The contractor shall maintain in-house technical maintenance support if lab personnel are unable to bring the analyzer on line via telephone support within 12 hours if the call is placed before 12 pm and not later than 8 am the next duty day if the call is after 12 pm.

2.6.3. The contractor shall schedule and maintain preventive maintenance on the analyzer when required.

2.6.4. The contractor shall maintain all parts, labor and services on the analyzer system.

2.6.5. The contractor shall maintain both onsite and remote support for the analyzer system.

2.6.6. The contractor shall maintain all software/hardware upgrades for the analyzer system.

2.7. COMPUTER INTERFACE TO HOSPITAL INFORMATION SYSTEM

2.7.1. The contractor shall maintain the analyzer bi-directional interface for the hospital’s

Composite Health Care System (CHCS).

2.8. SUPPORT STAFF

2.8.1. The contractor shall maintain the names, contact information and locations and extent of experience of service engineers, product specialists and company personnel with whom the organization will have contact.

2.8.2. Contractor’s personnel shall be trained and knowledgeable of the analyzer system.

2.9. ENVIRONMENTAL SITE VISIT

2.9.1. The contractor must perform a site visit to access the environmental concerns of cooling, space and electrical feasibility.

2.9.2. The contractor shall coordinate the environmental site visit with the Medical Equipment

Repair (MERC) and bio-environmental engineers at the 48 MDG.

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES

3.1. GOVERNMENT FURNISHED PROPERTY: Except as noted below, the contractor shall maintain everything to perform the services in this statement of work. The Contractor will be responsible for safeguarding all government property maintained for contractor use. The

Contractor shall use this property for performance of this contract only.

3.1.1. The MTF will maintain appropriate space allocation for the analyzer system.

3.1.2. The MTF will maintain a UK commercial line connection within 5 feet of the analyzer system. The MTF will be responsible for supplying the appropriate 220/240V electrical outlets for the analyzer system.

3.1.3. Contract personnel will be authorized to use all common areas (i.e. conference room and break room) of the MTF available to active duty and civil service personnel of like position. The contract personnel will not be allowed access to restricted areas of the MTF.

3.1.4. Personnel Protective Equipment (PPE), lab coat, face shields, gloves and sharps containers will be available/required for Contractor use.

3.1.5. All equipment will be inventoried upon check out and return.

3.2. GOVERNMENT FURNISHED SERVICES/ EQUIPMENT ACCOUNTABILITY

3.2.1. The MTF will maintain a point of contact for the Lab, MERC, and Bio-environmental personnel. The MTF will account for all equipment via barcode tags and equipment lists.

3.2.2. Contractor personnel shall be authorized to use all administrative support available to

Government employees. This will include but not be limited to copy machines, fax machines, medical library, installation distribution, Class-A telephone lines and Defense Switching

Network (DSN lines). The same restrictions to use these items for Government official business, apply.

3.3. GOVERNMENT FURNISHED RECORDS: A copy of all preventative maintenance records and service visits will be left with a government representative prior to contractor site visit. Maintenance of such records and visits will be in accordance with MTF and accrediting body criteria.

3.3.1. Patient information and test results, shall be treated as privileged information. Therefore subject to Privacy Act of 1974, the Freedom of Information Act, and the Health Insurance

Portability and Accountability Act. Policy is delineated in Department of Defense (DoD)

Directive 6025.18-R, Health Information Privacy Regulation, AFPD 37-1, Air Force

Information Management, Air Force Instruction (AFI) 33-332, Air Force Privacy Act Program, AFI 37-123, Management of Records, and AFI 41-210, Patient Administration Functions. These establish procedures designed to protect personal information from unauthorized use or release and prescribe use and disclosure of Protected Health Information. Maintain and dispose of records created as a result of prescribed processes in accordance with Air Force Manual

(AFMAN) 37-139, Records Disposition Schedule. These publications are available at http://www.e-publishing.af.mil/

3.3.2. Contractor personnel shall not release medical information obtained during the course of this contract to other organizations.

4. CONTRACTOR-FURNISHED EQUIPMENT AND SUPPLIES

4.1. CONTRACTOR PERSONNEL

4.1.1. The contractor shall maintain technical and engineer support who shall be responsible for any service conducted on the analyzer system. The contractor shall designate these individuals, in writing, to the Contracting Officer’s Representative before the contract start date. An alternate may be designated, but the contractor shall identify those times when the alternate shall be the primary point of contact.

4.1.2. The Government will not be responsible for any reasonable damage or loss to the analyzer system, while performing under this contract. This does not include malicious willful destruction of contractor equipment.

4.1.3. Contractor’s service, telephone support and training personnel shall be able to read, understand, fluently speak, and legibly write English.

4.4. The contractor shall have the responsibility and prerogative of selection, assignment, transfer, supervision, management, and control of contractor personnel in performance of this

PSW. However, the contractor shall not employ persons for work on this contract if such persons are identified to the contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

4.5. The contractor shall not employ any person who is an employee of the Government if the employment of that person would create a conflict of interest nor shall the contractor employ any person who is an employee of the Department of the Air Force, either military of civilian, unless such person seeks and receives approval in accordance with DODD 5500-7. In addition, the contractor shall not employ any person who is an employee of the Department of the Air Force if such employment would be contrary to the policies contained in AFI 64-106.

4.6. CONTRACTOR PERSONNEL TRAINING

4.6.1. The contractor shall ensure that all personnel performing services under the requirements of this contract, particularly in operation of the analyzer system are qualified and adequately trained. The contractor’s service and support personnel shall have experience in providing site services as well as being able to make decisions on site.

4.6.2. All contractor personnel shall comply with MTF infection control and safety procedures, practices, and standards located in the Laboratory Flight. If in the event of a conflict between the MTF’s procedures and the contractor’s procedures, the contractor and contracting officer shall attempt to resolve the matter by mutual agreement.

4. Bioenvironmental Engineering/Hazmat Requirements

4.1. Environmental, Health, And Safety. The contractor shall ensure all employees receive the necessary environmental, health, and safety training to ensure compliance with all

Occupational Safety and Health Acts (OSHA), federal and local laws. The contractor shall protect the health and safety of employees and the community, minimizing the risk of environmental pollution.

4.2. Pollution Prevention. "Pollution Prevention" and "Source Reduction" are defined in the

Pollution Prevention Act of 1990, 42 U.S.C. §§ 13101-13109. Contractor's obligation under this section is limited to identifying pollution prevention opportunities and shall not be construed to require the contractor to conduct activities not otherwise required by the program.

4.3. The contractor shall comply with energy saving conservation practices as deemed necessary by the facility manager.

4.4. Ionizing and Non-Ionizing Radiation: Contractors must obtain authorization from BE prior to bringing on site ionizing or non-ionizing sources/equipment onto the installation.

Contractors must maintain list of items and description of how they will be used to

Bioenvironmental Engineering (BE) at 01638528047 or 48amds.sgpb@us.af.mil at least 10 days prior to the date required to bring them on base.

4.5. Non-Ionizing Radiation: Electromagnetic Frequency (EMF) Radiation and LASERS:

Contact BE/Installation Laser Safety Officer (48amds.sgpb@us.af.mil) at least 10 days prior to bringing on site. (Example: LASER Classes: 1M, 2M, 3R, 3B, or 4; Transmitting antennas, radars etc.) Reference: AFI 48-139, LASER and Optical Radiation Protection Program, Paragraph 2.21)

4.6. Ionizing sources: Contact BE (48amds.sgpb@us.af.mil) at least 10 days prior to bringing on site ionizing sources/equipment. For regulated sources, maintain copies of permits or sealed source certifications. (Example: Troxler density gauges, sealed sources in various gauges/devices). Reference: AFI 48 -148, Ionizing Radiation Protection.

4.7. Hazardous Materials/Chemical Management: Hazardous Materials/Chemical

Management: All hazardous material use requires prior authorization before bringing the hazardous material on base. "Hazardous material" includes many materials for which there is a manufacturer SDS, such as cleaning supplies, paints, solvents, sealants, lead acid batteries, fuels, herbicides, etc.

4.7.1. The Contractor shall submit an inventory list of ALL chemical products to be used, along with copies of the Safety Data Sheet (SDS) for each chemical product, for review before bringing any potentially hazardous material onto RAF Lakenheath, RAF Feltwell or RAF

Mildenhall using the attached “HazMat Authorization Request Template”. The Contractor shall submit completed inventories and SDSs to the 1) CO, 2) CE Environmental / for RAF

Lakenheath (01638 523990) (nolan.swick@us.af.mil), or for RAF Mildenhall 100 CES/CEIE

(01638 545831), jeanne.dye-porto@us.af.mil and 3) Bioenvironmental Engineering (01638

528047) (48amds.sgpb@us.af.mil) at least 10 days prior to the date required to bring them on base.

mailto:48amds.sgpb@us.af.mil mailto:48amds.sgpb@us.af.mil mailto:48amds.sgpb@us.af.mil mailto:nolan.swick@us.af.mil mailto:jeanne.dye-porto@us.af.mil mailto:48amds.sgpb@us.af.mil

4.7.2. Once approved, the Contractor shall maintain an inventory of all hazardous materials along with corresponding Safety Data Sheets (SDSs). The Contractor shall track and report actual hazardous material usage during the performance of the contract. Hazardous material usage for any contract that is less than one month in duration shall be reported at the end of the contract period. Hazardous material usage for any contract over a month in duration shall be reported no less than monthly. Hazardous material usage shall be reported using the attached

“HazMat Monthly Usage Log Template”.

4.7.3. The Contractor shall not leave any excess hazardous materials or empty containers on site following completion of the project. The Contractor is responsible for the removal of all unused hazardous materials and proper disposal of all hazardous waste generated. Reference:

AFI-32-7086, Hazardous Materials Management

4.8. Controls of other hazards: Contractors must coordinate with Bioenvironmental

Engineering (BE) at 01638528047 or 48amds.sgpb@us.af.mil at least 10 days prior to start of project, regarding all contracts with potential health impact to personnel (Example: Noise above 85 dBA, activities with potential airborne contaminants or particulates). Hazardous work areas/perimeters shall be established to control exposures and limit access to nearby facilities and personnel. Work shall be performed IAW all applicable occupational health and safety regulations.

4.9. Contractors must coordinate with facility managers and receive a safety brief of hazards present within work areas.

4.10. If any contractor personnel spill or release any toxic/hazardous substance into the environment, that individual shall immediately contain the spill and report the incident to any

Laboratory staff member who in turn will report the spill to appropriate Government agencies.

4.11. The contractor shall maintain for housekeeping while servicing the analyzer system at no cost to the Government.

4.12. The MTF shall maintain for solid, chemical and hazardous waste disposal.

mailto:48amds.sgpb@us.af.mil