02. SOW.pdf

Statement of Work (SOW)

CHEMISTRY ANALYZER

CSU LABORATORY

CROW/NORTHERN CHEYENNE HOSPITAL

1. PROJECT TITLE: CSU Laboratory Cost per Test Base+4 Lease of Chemistry analyzer.

2. SCOPE: The contractor shall provide the government with chemistry analyzer services over a period of one (1) base year and four (4) option years, on a cost per test/cost per reportable result basis. The cost per test/per reportable basis must include all necessary equipment, reagents, 24/7 technical/specialist support, equipment maintenance and repair or replacement and training. All items and services shall be provided in accordance with all federal, state, local laws, and regulations, manufacturers recommended standards, commercial requirements, and this Statement of Work (SOW).

3. REQUIREMENTS: The CSU laboratory estimates the performance of 10,000 cost-per tests per month, and the contractor shall provide one (1) chemistry analyzer. If a water system is required, the contractor will provide that system. The contractor shall maintain, replace, repair, provide supplies, as required, in order to ensure the equipment is full operational and within manufacturer specifications.

2.1. Maintenance: Contractor personnel shall be fully capable to test equipment, tools, perform troubleshooting, repair, preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment is fully operational during no less than 95% of the total hours of the laboratory operation each month The percentage will be determined by the total number of hours the equipment is fully operational divided by the number of hours the laboratory was staffed to provide services.

2.2.Maintenance Scheduling and Documentation: The contractor shall perform scheduled preventative maintenance (PM) inspections, per the manufacturer’s recommendations, for the equipment provided under this SOW. The contractor shall provide a maintenance schedule, in writing to the assigned government representative for review.

2.3.Repairs: The contractor is responsible for all repair costs to include parts and labor for the Chemistry analyzer.

2.4.Service calls for Emergency Repairs: The contractor shall effect repairs within twenty four (24) hours after notification of an emergency service call. This includes on-site emergency response, twenty four (24) hours/seven (7) days a week.

2.5.Telephone Support: Contractor shall provide toll-free remote telephone support 7 days a week, 24 hours a day for diagnosing problems., delivering technical assistance to resolve complex equipment and scientific issues, and scheduling/responding to emergency repairs.

2.6.Training: The contractor shall provide training for at least two (2) government users at contract start, and one additional user with each contract option period.

4. APPLICABLE DOCUMENTS: Health Insurance Portability And Accountability Act

(HIPPA) Requirements, Business Associate Agreement,

5. SPECIFIC TASKS:

5.1 Analyzer: The contractor shall provide one (1) analyzer that meets the requirements and the performance characteristics identified in this SOW for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA ‘88) and the Clinical Laboratory Standards Institute (CLSI formerly NCCLS) .

5.2 The contractor shall maintain, replace, repair, provide supplies, and replacement as required in order to ensure the equipment is fully operational and within the manufacturer’s specifications.

5.3 Instruments and assays shall be FDA approved (the contractor shall provide proof of approval), and had no FDA warning letters or no more than 3 FDA recalls over the past 24 months.

5.4 The chemistry analyzer shall not have a standby mode system, always be available/in normal operation including no manual priming, purging, or tube maintenance.

5.5 The unit shall have an on-board test capacity for 110 reagent/diluent positions for multiple assays. Must be able to house all current assay packs plus at least one spare. Must be able to load reagents while instrument is running. No preparation, missing or reconstituting shall be required for integrated reagent packs. The unit shall have automated onboard calibrators and controls.

5.6 The unit shall have short sample, clot and bubble detection and sample interference measurement. (hemolysis, icterus, and lipemia)

5.7 The unit shall have on-board maintenance records, maintain at least 200,000 sample results, and online error code help.

5.8 Have on-board auto-dilution

5.9 Must be capable of interfacing with current laboratory management software.

5.10 The contractor shall provide, during initial install, on-site technical support and a new test validation on reagents and materials needed to bring the analyzer to full operational status.

5.11 Must be able to perform all of the analytes in APPENDIX A, TEST

MENU REQUIREMENTS.

6. INSTALLATION AND REMOVAL:

6.1 Placement and installation of a clinical chemistry analyzer and all equipment components inclusive, but not limited to; the entire laboratory associated mechanical, electromechanical parts and supplies shall conform to industry standards and shall meet or exceed with all applicable codes.

6.2 The contractor shall provide and Uninterrupted Power Supply for the analyzer and must installed in the same room, next to the instrument, with 4 inched clearance on all 4 sides.

6.3 Complete daily clean-up and a final (upon installation completion) clean-up of the work area. To include any need for cosmetic repair on walls, flooring, ceiling, etc.

6.4 The contractor is responsible for the removal of the clinical chemistry analyzer at the end of the contract period.

7. GOVERNMENT-FURNISHED EQUIPMENT AND INFORMATION: The government will provide utility (electricity, telephone, internet connection) and needed administrative support necessary for the contractor to perform maintenance and support.

8. PLACE OF PERFORMANCE: All work will be performed at the HIS, CSU Laboratory. Hours of operation are Monday thru Sunday, 24 hours.

PERIOD OF PERFORMANCE:

Performance of this delivery order shall be for 12 months with four 12-month options (to be completed at time of award).

If the Government exercises the options pursuant to Federal Acquisition Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract (MAR 2000), the period of performance shall be extended in accordance with the following schedule:

Year Option Period Option Year One (1) To be completed at time of award Option Year Two (2) To be completed at time of award Option Year Three (3) To be completed at time of award Option Year Four (4) To be completed at time of award

APPENDIX A-TEST MENU REQUIREMENTS.

DRUGS OF ABUSE

Acetaminophen 6-Acetylmorphine Amph/Meth Barbiturates Benzodiazepines Benzodiazepines, Serum Buprenorphine Cannabinoids Cocaine Ecstasy

EDDP

Ethanol Fentanyl Methadone Opiates Oxycodone Phencyclidine Propoxyphene Salicylate Tramadol Tricyclic

GENERAL

CHEMISTRY

Albumin Alkaline Phos

ALT

Ammonia Amylase

AST

Bilirubin, Direct

Bilirubin, Total Calcium Carbon Dioxide Chloride Cholesterol

CK

Creatinine

GGT

Glucose Iron Lactate Dehydro Lactic Acid LDL, Direct Lipase Magnesium Phosphorus Potassium Sodium Total Protein Triglyceride

UIBC

HDL

Urea Nitrogen Uric Acid Urine, CSF Protein HbA1c

CRP

Microalbumin Rheumatoid Factor Transferrin

THERAPEUTIC DRUG

MONITORING

Digoxin Phenobarbital Phenytoin Vancomycin

Immunoassay

Total PSA

CK-MB

High Sensitivity Troponin-I Rubella IgG Rubella IgM Total b-hCG Anti-HBc Anti-HBc IgM Anti-HBs Anti-HCV HAVAb IgG HAVAb IgM HBsAg B12 Ferritin Folate Procalcitonin 25-OH Vitamin D Syphilis HIV Ag/Ab Free T4

TSH

APPENDIX B

ESTIMATED Annual Patient Test Volumes only:

Digoxin 15 Creatinine 7750

BUN 7000

Glucose 7000 Sodium 6800 Potassium 6800 Co2 6800 Chloride 6800 Calcium 6800

PO4 400

Uric Acid 100 Cholesterol 2000 Total Protein 6050 Albumin 6050 Total Bili 6050 Alk Phos 6050

AST 6050

ALT 6050

BHOB 250

EtOH 650 Amylase 1100 Lipase 1100

CK 200

Magnesium 1100 Ammonia 300 Phenobarbitol 10 Vancomycin 50 Neonatal Bili 5 Phenytoin 10 Lactic Acid 700 Acetamin 150

HDL 2000

D-LDL 2000

Triglyceride 2000

DBIL 100

BhCG 200 Troponin I 1200

HA1C 3000

BNP 600

Ur Creatinine 1300 Iron 350 Transferrin 250 Ferritin 370

TIBC 250

Folate 75 Hep C 1500

FT4 900

TSH 3000

HIV 1500

Vitamin D 1200

TPSA 350

Vitamin B12 1000 Microalbumin 1400

HS CRP 600

Procalcitonin 100

CKMB 100

DOA screen 1000

LDH 25

Syphilis Scn 1500 Hep pnl 1500 Rubella 100