SOW-Chemistry.docx

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FULL AND OPEN - OCAO IHS CHEMISTRY ANALYZER COST PER TEST REQUIREMENT
Solicitation number
246-26-P-0010
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This is a Statement of Work (SOW) for a cost-per-test chemistry analyzer leasing agreement with the Oklahoma City Area Office (OCAO) of the Indian Health Service (IHS) under solicitation number 246-26-P-0010.

The contractor must provide chemistry analyzers meeting specific technical requirements including capability for General Chemistry, Drugs of Abuse, Therapeutic Drug Monitoring, Cardiac, Diabetic, and Communicable Disease assays, with workflow priority designation, minimal reagent preparation, dry system analysis capability, and throughput exceeding 350 tests per hour. Equipment specifications include analyzers with footprints accommodating either 83.5" × 33.5" × 64.5" or 110" × 34.9" × 68" dimensions, plus all necessary accessories (computers, printers, UPS power supplies, water systems, and LIS interface hardware/software). The contractor shall provide installation with on-site correlations, calibrations, precision and linearity studies, and AMR studies; preventative maintenance and corrective maintenance per manufacturer guidelines; 24/7 technical support via toll-free phone with on-site response within 24 hours when needed; on-site operator training during installation; and offsite technical training for new users annually (at government expense). All reagents and supplies for routine operations, quality control, and proficiency testing across six facility locations (Clinton, El Reno, Haskell, Lawton, Anadarko, and Wewoka) are contractor-supplied, with annual test volumes exceeding 400,000 tests across a comprehensive list of assays. The base contract period is 12 months from award with four option years, renewable annually. Service representatives must be manufacturer-trained and certified, and contractor personnel require HSPD-12 compliance, background investigation clearance, and compliance with tobacco-free facility policies and security protocols.

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QUESTIONS-ANSWERS PART 2.docx DOCX document
SOW-Chemistry.docx DOCX document
QUESTIONS-ANSWERS PART 1.docx DOCX document
Pricing Sheet.docx DOCX document
COMBINED SYNOPSIS SOLICITATION.docx DOCX document

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Department of Health and Human Services Indian Health Service

Statement of Work (SOW) Chemistry Analyzers Cost Per Test Leasing Agreement

1. PURPOSE OF THE PROJECT

The Oklahoma City Area Office (OCAO), Indian Health Services (IHS) has a requirement to provide a clinical Cost-Per-Test chemistry analyzer agreement that includes equipment, lease, preventative maintenance, technical support services, and reagent/supplies services for the Oklahoma City Area Office.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The contractor shall provide the equipment, supplies & training required to provide chemistry testing for the Oklahoma City Area Office laboratories, while ensuring an uncompromising quality of patient care.

Contractor shall provide:

1. Chemistry analyzers that meet the following criteria:

a. Assay availability must include at minimum General Chemistry Assays, Drugs of Abuse, Therapeutic Drug Monitoring, Cardiac Assays, Diabetic Assays and Communicable Disease.

b. Analyzer must have ability to designate workflow priority (Routine, STAT, ASAP).

c. Analyzer must have minimal reagent preparation or pretreatment.

d. Analyzer must have a minimum of 3-point calibrations for the majority of analytes.

e. Capability to perform dry system analysis. Capability of in-line plumbing to a water suitable for analyzers with production capabilities of 4-5 liters if a water usage analyzer, low water usage analyzer also acceptable.

f. Analyzer hardware or software can support all sites with capability of expanding support with an increase of workloads. Current throughput requirement for theses sites is greater than 350 tests per hour.

g. Single platform/analyzer that support the testing volume capabilities for each site. Sites that perform <100,000 tests/year require a smaller footprint analyzer with full testing capabilities. Sites that perform >100,000 tests/per year need redundant systems that fit testing volume and size/space requirements. The most advantageous model available for all sites, taking into consideration size, space & software.

h. Smaller footprint labs have space available to fit an analyzer 83.5 inches wide, 33.5 inches depth, and 64.5 inches height.

i. Larger footprint labs have space available to fit an analyzer 110 inches wide, 34.9 inches depth, and 68 inches height.

j. Include all equipment needed for operation of analyzer, including but not limited to computer, printer, UPS power supply, and any other necessary accessory items.

k. All items needed to interface properly with LIS system and bidirectional connection must be included. Vendor is responsible for building and maintaining the interface.

l. Up to date technology for reducing exposure to potentially communicable blood-borne pathogens.

m. Install and setup must be included with cost per test setup.

n. On site correlations, calibrations, set-up, precision studies, linearity studies, and AMR studies included with install.

o. Onsite preventative maintenance performed according to manufacturer guidelines, to include routine cleaning, replacement of worn parts & calibration as well as corrective maintenance.

p. 24/7 Technical assistance for all trouble shooting needs and technical support for analyzer avaliable by phone.

q. Onsite support availability within 24 hours when problem resolution/troubleshooting is not possible by phone technical assistance.

r. Onsite training for all operators during installations.

s. Offsite technical training at alternate date from onsite training avaliable for new users per year. (Any offsite training will be at the expense of the government, such offsite contractor sponsored training, if any, identified as a credit in the RFQ response.

3. PERIOD OF PERFORMANCE

The base year Period of Performance will be 12 months from date of award with 4 option years. Lease renewal shall be yearly.

4. LEVEL OF EFFORT

4.1. The contractor shall provide Chemistry Analyzers from a line of technologically standardized platforms that meet the appropriate, previously listed criteria as part of a cost-per-test leasing agreement with the Government.

4.2. The contractor shall install and set-up provided analyzers with on-site correlations, calibrations, precision & linearity studies and AMR studies.

4.3. The contractor shall provide a preventative maintenance & service agreement that includes routine cleaning, replacement of worn parts & calibration as well as corrective maintenance.

4.4. The contractor shall provide all reagents & supplies required for the routine operation of the analyzers, the testing of patient samples, calibrations, quality control, and proficiency testing. This will include, but not be limited to, Ferritin, Vitamin D, NT-ProBNP, CMKB, High Sensitivity Troponin I, Hemoglobin A1c, Acetaminophen, ETOH, Salicylate, Alanin Amintransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Ammonia, Amylase, Aspartate Aminotransferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, Carbon Dioxide, Chloride, Cholesterol, Creatinine, Creatine Kinase, Gamma Glutamyltransferase (GGT), Glucose, HDL Cholesterol, Iron, Lactate, Lactate Dehydrogenase, LDL Cholesterol, Lipase, Magnesium, Microalbumin, Phosphorus, Potassium, Procalcitonin, Sodium, Total Iron Binding Capacity, Total Protein, Total Protein CSF Urine, Triglycerides, Urea Nitrogen (BUN), Uric Acid, Total PSA, HCG, CRP, Digoxin, Phenytoin, Vancomycin, Free T4, TSH, Free T3, Thyroxine, Hepatitis C Ab, Hepatitis B sAG, Rubella IGG, Drugs of Abuse & COVID.

4.5. The contractor shall provide all equipment needed for operation of the analyzers, to include, but not limited to computers, printers, UPS power supplies, water system and other accessory items as needed.

4.6. The contractor shall provide technical support through a toll-free telephone number that is answered 24 hours a day, 7 days a week with the ability to escalate to on-site service calls if telephone support is unable to resolve problems or issues as needed.

4.7. Onsite training for all operators during installation with further opportunity for on or offsite technical training at alternate date for new users.

4.8. The contractor shall be capable of providing all needed reagents, supplies, and consumables in order to allow the analyzers to perform testing equivalent to the below estimated test volumes:

Clinton
El Reno
Haskell
Lawton
Anadarko
Wewoka
Test / Supply Item
Est. Qty/Year
Est. Qty/Year
Est. Qty/Year
Est. Qty/Year
Est. Qty/Year
Est. Qty/Year
Total
Ferritin
1,200
720
4,560
Vitamin D
3,300

6,615

NT-ProBNP

2,400

CMKB

2,080

High Sensitive Troponin I

3,024

Hemoglobin A1c
300
300
9600
1680
2160
14,040

Acetaminophen

1,840

ETOH

1,440

Salicylate

1,680

Alanine Aminotransferase (ALT)
2,640
2640
11520
2640
2400
21,840

Albumin

3000
12000
2880
3360
25,320
Alkaline Phosphatase (ALP)
3,960
3000
12240
3600
2520
25,320

Ammonia

2,040

Amylase

2400
1440
480
4,320
Aspartate Aminotransferase (AST)
4,320
3000
12600
3240

23,160

Bilirubin, Direct

Bilirubin, Total
2,400
3000
12000
1920

19,320

Calcium
4,800
14880
2880

22,560

Carbon Dioxide
3,240
3000
13680
3600
3240
26,760
Chloride
4,320
3000
15360
3360
3360
29,400
Cholesterol
4,800
1800
7200
2880
2400
19,080
Creatinine
4,320
3000
15360
3360
3360
29,400

Creatine Kinase

4320
1920
960
7,200
gamma Glutamyltransferase (GGT)
576
500
5760
1152
576
8,564
Glucose
5,760
3000
17280
5760
5760
37,560
HDL, Cholesterol
2,880
1800
5760
1920

12,360

Iron
1,200

3,840

Lactate

2,400

Lactate Dehydrogenase

7680
1920

9,600

LDL, Cholesterol
2,400

8,160

Lipase
1,320

3,720

Magnesium

840
3,960
Microalbumin
1,320

4,220

Phosphorus
1,920
960
5,760
Potassium
4,320
3000
15360
3360
3360
29,400
Sodium
4,320
3000
15360
3360
3360
29,400
Total Iron Binding Capacity
960

3,840

Total Protein
3,360
3000
9120
3360
2880
21,720

Total Protein, CSF/Urine

Triglycerides
3,840
1800
8160
2400
16,200
Urea Nitrogen (BUN)
4,320
3000
14880
3840
2880
28,920

Uric Acid

4320
1920
960
7,200
Total PSA
960

2,760

Hcg

100
2400

2,500

CRP
960

1,460

Digoxin

1,760

Phenytoin

Vancomycin

1,920

Free T4
1,680
600
7800
1320
11,400
TSH
2,400
2000
8200
3000
1800
17,400

Free T3

Thyroxine

3,120

Hepatitis C Ab

Hepatitis B sAG

Rubella IGG

COVID
200
200
200
200
200
1,000

5. SPECIAL REQUIREMENTS (Examples)

5.1. In accordance with HHSAR 304.1303, To ensure compliance with Homeland Security Presidential Directive-12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD-12) It is the IHS policy that all staff and contractors who require physical access to federally controlled facilities and logical access to the IHS Information Technology (IT) networks and systems must obtain an HSPD-12-compliant access card. Individuals will be issued an access card upon meeting the HSPD-12 requirements and a favorable background investigation.

5.2. The OKC Area Office is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by OKC Area Office official, presenting valid identification, smoking restriction and any safety procedures.

5.4. The contractor shall not disclose or cause to disseminate any information concerning operations of OKC Area Office. Such action(s) could result in violation of the contract.

5.5. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the Contracting Officer Representative (COR).

5.6. Termination Amortization Schedule: A termination amortization schedule shall be included as an attachment of the awarded contract. If the Government does not exercise any of the options listed in the price / cost schedule, the Government’s not exercising the options will have the same effect as if the Government terminated for convenience. All remedies afforded to contractor in regards to a termination for convenience shall be available to the contractor.

5.7. Personnel Qualifications: Service reps shall be trained and certified by instrument manufacturers to provide maintenance, repair, calibration and other services related to preventative maintenance and service agreement.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.1. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of services. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.2. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday but preferably 24 hours a day 7 days a week.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

The Government shall provide the facilities, equipment and PPE for the use by the contractor for the provision of the services required under this contract.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

1. Appropriately selected chemistry analyzer provided

2. Install & set up with onsite correlations, calibrations, precision studies, linearity studies, and AMR studies.

3. Technical support and corrective maintenance provided as needed.

4. Proper interface with the RPMS system and bidirectional connection.

5. Correct items provided as ordered within 7 days of order.

Department Supervisor Signature:_________________________

Chief Operating Officer Signature:_________________________ image1.png image10.png image2.png image20.png

File details come from the government source that posted it. Updated .