Attachment 1 - Performance Work Statement (PWS) - 48 MDG Chemical Analyzer.pdf

Attachment 0001 Clinical Chemical Analyzer

Performance Work Statement (PWS) 48th Medical Group

PREPARED BY:

48th Contracting Squadron

48th Medical Group

RAF Lakenheath, England

DATE:

October 04, 2022

Table of Contents

SECTION 1. Description of Services 2

SECTION 2. Installation 5

SECTION 3. User Training 5

SECTION 4. Maintenance and Support 5

SECTION 5. Contractor Personnel 6

SECTION 6. Environmental Control 7

SECTION 7. Workload History 8

SECTION 8. Ordering Guide 9

SECTION 1. DESCRIPTION OF SERVICES

The Contractor shall furnish two identical chemistry analyzers, associated external printers, refrigerators, freezers, uninterrupted power supplies, on/off site training and technical support inclusive of compatible reagent kits required to provide outpatient and inpatient chemical test analysis for United States Government (hereinafter referred to as “Government”) beneficiaries. The contractor shall provide analyzers and contractor care in Government supplied facilities at the 48th Medical Group, also referred to as the “Medical Treatment Facility” (MTF) herein. Contractor care includes furnishing all equipment, maintenance, supplies for operation of equipment, labor, transportation, reports, and technical assistance, including items listed in Section 1 below.

1.1 Scope of Chemistry and Immunodiagnostic Analyzer Units.

The Chemical Analyzer Units shall be identical and meet the following specifications:

1.1.1. All medical equipment shall be approved for use by the United States Food and Drug Administration.

1.1.2. The system shall not require an external water source or drainage system or any plumbing for operation. If water is required on-board the analyzer, the vendor must supply the water and disposal of the water must not require a water treatment system/plant. The standard of care provided must be in accordance with the College of American Pathologists (CAP) accrediting agency, the Joint Commission (JC) and with existing laboratory practicing guidelines. The standard of care will be periodically evaluated by the Chief of Clinical Laboratory Services and reported through the hospital Executive Committee of the medical staff.

1.1.3. Each analyzer shall not exceed 12.5 feet in length, 4 feet in depth, and 6 feet in height, including printer.

1.1.4. Analyzers shall ensure clot/bubble detection and the integrity of sampling and reagent carryover.

1.1.5. Analyzers shall not require fixed probes, but will use disposable tips to eliminate sample and reagent carryover.

1.1.6. Analyzers shall use disposable cuvettes.

1.1.7. Analyzer system shall require minimal daily and weekly and monthly maintenance of no more than 30 minutes each.

1.1.8. Analyzers will utilize quality check (QC) at least once daily and long calibration intervals of five to six months for General Chemistry testing as stated in Paragraph 1.2.1. Analyzers shall have capabilities to utilize a minimum of two levels of QC material daily.

1.1.9. Analyzers shall be capable of decontamination in the event a high-risk sample is presented.

1.1.10. Analyzer system shall have less than 5% wastage due to system or reagent problems. The Contractor shall assume the cost of any wastage greater than 5%.

1.1.11. The Contractor shall provide the laboratory with exact or upgraded equipment in the event of replacement due to service/repair.

1.1.12. Analyzers shall be capable of testing serum, plasma, urine and cerebrospinal fluid (CSF).

1.1.13. Analyzers shall be capable of performing a dedicated “STAT” procedure during a routine testing cycle followed by automatic completion of the routine testing cycle.

1.1.14. Analyzers shall be capable of running pediatric and minute samples.

1.1.15. Analyzers shall be capable of preserving a pediatric sample when there is a problem with aspiration (i.e. returning the sample to the test tube or analyzer cup).

1.1.16. Analyzers shall be capable of handling 10, 7, 5, 4, 2, and 1 milliliter collection tubes.

1.1.17. Analyzers shall be capable of automatic test dilution and repeat tests automatically (i.e. user definable reflex testing).

1.1.18. The Contractor shall provide the analyzer’s bi-directional interface for the hospital Composite Health Care System.

1.1.19. Analyzers shall be new and compatible with any future upgrades or additions.

1.2 Test Capabilities

1.2.1. The units shall be capable of providing the following tests:

1.2.1.1. General Chemistry: Acid Phosphatase AcP, alanine aminotransferase ALT, albumin ALB, alcohol ALC, alkaline phosphatase ALKP, ammonia AMON, amylase AMYL, aspartate aminotransferase AST, bilirubin, unconjugated and conjugated, calcium CA, carbamazepine CRMB, carbon dioxide CO ‘ chloride Cl-, cholesterol CHOL, cholinesterase CHE, creatine kinase CK, creatine kinase MB-CKMB, creatinine CREA, C reactive protein CRP, digoxin DGXN, CSF protein PROT, direct HDL cholesterol dHDL, gamma glutamyl transferase GGT, glucose GLU, iron FE, lactate LAC, lactate dehydrongenase LDH, lipase LIPA, lithium LI, magnesium Mg, acetaminophen ACET, Phenobarbital PHBR, phenytoin PHYT, phosphate PHOS, potassium K+, salicylate SALI, sodium NA+, theophylline THEO, total bilirubin TBIL, total protein TP, triglyceride TRIG, urea BUN/UREA, uric acid URIC, urine protein UPRO, vitamin B12.

1.2.1.2. Protein Chemistry: ApoA1, ApoB, C3, C4, hemoglobin A1C (%A1C), high sensitive C reactive protein, IgA, IgG, IgM, m albumin, p albumin, rheumatoid factor RF, transferrin TRFN.

1.2.1.3. Therapeutic Drugs: Caffeine CAFFN, gentamicin GENT, phencyclidine, procainamide, quinidine, tobramycin TOBRA, valproic VALP, vancomycin VANC.

1.2.1.4. Toxicology and Drugs of Abuse: Amphetamine, barbiturates (serum and urine), benzodiazepines (serum and urine), cannabinoids, cocaine metabolite, methadone, opiates, tricyclics.

1.2.1.5. Infectious Disease: Hepatitis B surface antigen HBsAg, hepatitis B surface antigen confirmatory HBsAg confirmatory, anti-hepatitis B surface antibody, anti-hepatitis C-IgM, anti-hepatitis B core, hepatitis Be, anti-hepatitis A virus HAV IgM, anti-hepatitis A virus HAV total, anti-hepatitis corevirus HCV, total hepatitis core virus HCV core antigen, anti HIV ½, cytomegalovirus CMV IgG, cytomegalovirus CMV IgM, toxoplasma IgG, toxoplasma IgM, rubella IgG, rubella IgM.

1.2.1.6. Thyroid Tests: Thyroid stimulating hormone TSH 3rd generation, free thyroxin FT3, total thyroxin TT4, total thyroxin TT3, total thyroxin T3 uptake

1.2.1.7. Anemia Tests: Ferritin, vitamin B12, RBC folate.

1.2.1.8. Cardiology Tests: CKMB, troponin-I,yoglobin.

1.2.1.9. Oncology Tests: Alpha feto protein, carcinogenic embryonic antigen CEA, prostate specific antigen PSA, cancer tumor markers CA 125 II, CA 15-3, CA 19-9.

1.2.1.10. Reproductive Endocrinology Tests: Follicular stimulating hormone FSH, leutinizing hormone LH, progesterone, testosterone, prolactin, estradiol, alpha feto protein AFP, total Beta-human chorionic gonadotropin B-HCG, and free B-HCG.

1.2.1.11. Other Miscellaneous Tests: direct LDL, homocysteine and unbound iron binding capacity UIBC, Vitamin D.

1.2.1.12. Test kits provided must minimize sample size and test time to the greatest extent possible. Test platform must accommodate said test kits.

1.3 Accessories

1.3.1. The Contractor shall provide an external printer for each analyzer that is compatible with the analyzer.

1.3.2. The Contractor shall provide a full uninterruptable power supply (UPS) for each analyzer system.

1.3.3. The Contractor shall provide storage refrigeration/freezer capable of accommodating one quarter of the reagents required annually.

1.3.3.1. Refrigeration/freezer unit shall be temperature monitored with digital readout and alarm enabled.

1.3.3.2. Refrigeration/freezer shall not exceed 12.5 feet in length, 4 feet in depth, and 6 feet in height

1.3.4. The Contractor shall repair or provide replacement for accessories listed in sections 1.3.1 through 1.3.3 that become obsolete or cease to function.

1.4 Reagents

The Contractor shall provide reagents that meet the following specifications:

1.4.1. All medical equipment shall be approved for use by the United States Food and Drug Administration.

1.4.2 Reagents shall have a minimum shelf life of six months upon delivery.

1.4. 3. Reagents provided shall be sequestered lots to reduce lot-to-lot validation, calibration and quality control testing. Sequestered lots allow for specific lots to be set aside for a laboratory for up to one (1) year. Lots are generated when the contractor manufactures an analyzer, similar to the lot number and expiration date of an over the counter headache medicine. The size of each lot will depend on how many tests the 48 MDSS Laboratory performs each quarter for each analyzer tested as well as all of the consumables, quality controls, diluents, and calibrators. The size and quantity of each lot will depend on how many tests are available on each reagent pack and how many tests the 48 MDSS Laboratory performs per year per analyzer. Therefore, the exact size of each lot shall be coordinated between 48 MDSS and the contractor prior to the required date of delivery for each lot.

1.4. 4. Reagents shall require minimal manual manipulation prior to placing on the analyzer.

1.4.4.1. Reagents shall be bar-coded and traceable once on board the analyzer.

1.4.5. Reagent calibration stabilization/frequency of 5-6 months for General Chemistry tests in Section 1.2.

1.4.6. The Contractor shall have a system for managing the reagent inventory level on board the analyzer. Shipments of reagents, consumables, calibrators, and quality controls must be shipped on a quarterly basis due to storage constraints within the 48 MDSS Laboratories.

1.5 Sample Integrity

1.5.1. Analyzers shall be capable of clot detection, air bubble detection and short sample detection. When a clot, air bubble or short sample is detected for a pediatric sample the sample must be capable of being reintroduced and prioritized for testing.

1.5.2. Analyzers shall be capable of assessing and flagging hemolysis, icterus and turbidity in testing samples. If an interfacing agent/substance is present it shall flag the associated sample and any individual test results affected by that interfacing agent/substance only. The level of acceptance or rejection must be user definable.

SECTION 2. INSTALLATION

2.1. The Contractor shall ensure the analyzer(s) system is fully installed and operational by competent and authorized company engineers and product specialists. The Contractor shall provide initial setup of analyzer(s), perform initial validation calibration, linearity, instrumental validation, within run precision, between run precision, and patient comparison between existing on site analyzers and normal range studies. The product/report must be in accordance with CAP/JC guidelines. The presentation/data will be bound in notebook and/or digital form and presented to the lab’s accrediting bodies within two weeks from installation.

2.2. The Contractor shall be responsible for the disposal of all waste and debris created by the installation of the equipment. Additionally, the contractor is required to clean, using standard industry cleaning practices, any areas affected through the installation of the equipment. The contractor is responsible for any damage done by the contractor to the Chemical Analyzer equipment during the delivery, installation, and maintenance of the equipment.

SECTION 3. USER TRAINING

3.1. The Contractor shall provide four slots initially and one slot annually thereafter for off-site in-depth key operator training for analyzers at no cost to the Government. Individuals to attend the training will be identified by the Government.

3.2. The contractor shall provide training support on site and at the laboratory during the pre and post deployment of the analyzer(s).

SECTION 4. MAINTENANCE AND SUPPORT

4.1. The Contractor shall provide 24-hour, 7-day per week hotline support in which a live person is available to provide verbal assistance.

4.1.1. The Contractor shall provide in-house technical maintenance support if laboratory personnel are unable to bring the analyzer(s) online via telephone support within 12 hours if the call is placed prior to 12 pm GMT and not later than 8 am GMT the next duty day if the call is after 12 pm GMT.

4.2. The Government will not be responsible for any reasonable damage or loss occurring to the analyzer(s) system while performing under this contract. This does not include malicious willful destruction of contractor equipment by a Government employee.

4.3. Contractor personnel shall comply with all MTF infection control and safety procedures, practices, and standards while providing maintenance and support within the MTF.

4.3.1. The Government will provide Personal Protective Equipment (PPE) as required by the 48th Medical Group (48 MDG) for work in performance of this PWS. However, if the Contractor requires further PPE, the Contractor shall supply this to their personnel.

4.4. In the event the equipment fails, the contractor shall repair or provide a suitable replacement within 72 hours.

4.5. The Contractor shall schedule and provide all preventive and standard maintenance on the analyzer(s) as required, and provide all parts and labor for service. Calibration of the Chemical Analyzer equipment may be necessary and is included as a part of “preventative and standard” maintenance of the equipment. The frequency for the calibration of the Chemical Analyzer equipment is not specific and is subject to change depending on the brand of equipment provided by the contractor.

4.6. The Contractor shall provide all software and hardware upgrades for the analyzer systems

4.7. The Contractor shall provide the Government with a copy of all maintenance and service visits at the time of service.

SECTION 5. CONTRACTOR PERSONNEL

5.1. The Contractor shall provide a technical support and engineer point of contact (POC) that shall be responsible for coordinating any service conducted on the analyzer systems. The contractor shall designate these individuals in writing to the Contracting Officer 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. The technical support and engineer point of contact must be designated prior to the delivery and installation of the Chemical Analyzer equipment.

5.2. Contractor personnel performing service, maintenance, telephone support and training in performance of this PWS shall be able to read, understand, fluently speak, and legibly write English.

5.3. The Contractor has the responsibility and prerogative of selection, assignment, transfer, supervision, management and control of contractor personnel in performance of this PWS. However, the contractor shall not employ persons for work on this contract if such persons are identified to the contractor by a Government representative as a potential threat to the health, safety, security, or operational mission of the installation and its population.

5.4. The contractor shall not employ any person who is an employee of the Government if 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 or civilian, unless such person seeks and receives approval in accordance with DOD 5500-7-R. 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.

5.5. All personnel performing services under the requirements of this contract shall be fully trained, qualified and competent to perform the work. The level of competence for each personnel shall be evaluated and determined to be acceptable/unacceptable by the contractor. Proof of training/qualifications for each personnel shall be provided by the contractor and presented to the Contracting Officer after award of the contract, prior to the delivery and installation of the Chemical Analyzer equipment. Only personnel which have been trained and employed by the contractor can be authorized to provide services. The contractor’s service and support personnel shall have experience in providing site services as well as being able to make decisions on site.

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

5.6.1. Patient information and test results shall be treated as privileged information and therefore are subject to the Privacy Act of 1974, the Freedom of Information Act, and the Health Insurance Portability and Accountability Act, policy as delineated in Department of Defense (DoD) Directive 6025.18-R, Health Information Privacy Regulation, AFPD 37-1, Air Force Information Management, Air Force Instruction 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 personnel information from unauthorized use or release and prescribe use and disclosure of Protected Health Information. Records created as a result of prescribed processes must be maintained and disposed in accordance with Air Force Records Information System (AFRIMS). These publications are available at http://www.e-publishing.af.mil.

SECTION 6. ENVIRONMENTAL CONTROL

6.1. If any contractor personnel spills or releases 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.

6.2. The Contractor shall remove all waste, debris and tidy up any area affected as a result of Contractor personnel servicing the analyzer systems.

6.3. Bioenvironmental Engineering/Hazmat Requirements

6.3.1. 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. All OSHA laws and regulations can be found at the following: https://www.osha.gov/law-regs.html. The contractor shall protect the health and safety of employees and the community, minimizing the risk of environmental pollution.

6.3.2. 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.

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

6.3.4. Ionizing and Non-Ionizing Radiation: Contractors must obtain authorization from Bioenvironmental Engineering (BE) prior to bringing on site ionizing or non-ionizing sources/equipment onto the installation. Contractors must provide list of items and description of how they will be used to Contracting Officer’s Representative (COR) (contact details will be made available after date of award) at least 10 days prior to the date required to bring them on base.

6.3.4.1. Non-Ionizing Radiation: Electromagnetic Frequency (EMF) Radiation and LASERS: Contact COR 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)

6.3.4.2. Ionizing sources: Contact COR at least 10 days prior to bringing on site ionizing sources/equipment. For regulated sources, provide copies of permits or sealed source certifications.

(Example: Troxler density gauges, sealed sources in various gauges/devices). Reference: AFI 48 -148, Ionizing Radiation Protection.

6.3.5. 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.

6.3.5.1. 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. The Contractor shall submit completed inventories and SDSs to the COR at least 10 days prior to the date required to bring them on base.

6.3.5.2. 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.

6.3.5.3. 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.

6.3.6. Controls of other hazards: Contractors must coordinate with the COR 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.

SECTION 7. WORKLOAD HISTORY

The following workload data represents the Government’s best estimate of the annual volume of work shown for each item listed as performed on the current analyzer. This exhibit is not intended to cover all of the workload items, but lists the major categories of work. The total quantities are estimates and not inclusive of all tests that are available to the provider staff. The data does not include QC, Calibration, Calibration Verification, External Proficiency Testing, etc.

Assay Patient Tests Annually

Assay Patient Tests Annually

Assay Patient Tests Annually

ACET 75 CREA 8500 Mg 500 ALB 7800 CRP 750 Myoglobin 350 ALC 310 dHDL 5850 Na+ 8000 ALKP 7650 dLDL 5850 PHOS 175 ALT 8050 dTIBC 800 PROT (CSF) 30

AMYL 350 ECO2 8000 SALI 75

AST 8050 Ferritin 925 TBIL 7600 B12 800 Folate 800 TP 6300 β-Hcg 850 FREE T4 2046 TRIG 5850 BuBc 2300 GLUCOSE 9500 Troponin-I 500 Ca 8500 GGT 240 TSH 4200 CHOL 5850 Iron 800 UPRO 275

CK 625 K+ 8000 UREA (BUN) 7900

CK-MB 350 LDH 270 URIC 450

Cl- 8000 LIPASE 850

NOTE: Please note that the numbers above are estimated usage only.

SECTION 8. ORDERING GUIDE

8.1. Contract Terms

8.1.1. Contract Ceiling: The total amount of all orders placed against this contract shall not exceed $2,500,000.00 over the five year life of the contract. The 48 Contracting Squadron (CONS) Contracting Officer (CO) is responsible for tracking the contract ceiling to ensure it is not exceeded and requesting any increases to the ceiling throughout the life of the contract, as applicable.

8.1.2. Ordering Period: The contract contains one five year ordering period from 01 July 2023 to 30 June 2028. IAW FAR 52.217-8, Option to Extend Services, the Government may require extending the ordering period up to 6 months as long as proper notice is given. Orders may be placed up to the last day of the ordering period. The 48 CONS CO is responsible for exercising option ordering periods.

8.1.3. Delivery: Standard delivery shall be 30 days after receipt of order (ARO) unless specified within each individual delivery order.

8.1.4. Pricing Structure: Firm-Fixed Price (FFP), meaning the price is not subject to any adjustment on the basis of cost while performing the contract.

8.2. Ordering Procedures and Limitations

8.2.1. Purchases of $25,000.00 or less may be procured utilizing the Government wide Purchase Card

(GPC).

8.2.1.1. The Contracting Officer’s Representative maintains complete responsibility of receiving CO approval before making an order via GPC.

8.2.2. The Clinical Chemical Analyzer, phase-in period, and the majority of the reagents will be ordered by placing a Task/Delivery Order through the 48 CONS.