Attch_1_-_Statement_of_Work.pdf

STATEMENT OF WORK (SOW) FOR

AUTOMATED CHEMISTRY, IMMUNOASSAY, AND MOLECULAR TESTING

PLATFORM AT

UNITED STATES SCHOOL OF AEROSPACE MEDICINE

EPIDEMIOLOGY LABORATORY

WRIGHT PATTERSON AFB, OH

PERFORMANCE-BASED WORK STATEMENT TABLE OF CONTENTS

SECTION TITLE PAGE

1. GENERAL/AVAILABLE TESTS 2

2. MINIMUM REAGENT REQUIREMENTS 7

3. MINIMUM MIDDLEWARE REQUIREMENTS 7

4. MINIMUM INSTRUMENTATION REQUIREMENTS 7

5. MINIMUM AUTOMATION REQUIREMENTS 9

6. MINIMUM INSTALLATION AND TRAINING

REQUIREMENTS 9

7. MINIMUM REPAIR AND MAINTENANCE

REQUIREMENTS 10

1. GENERAL REQUIREMENTS

a. The United States Air Force School of Aerospace Medicine Epidemiology

Division (USAFSAM/PHE) requires a fully automated, walk away, fully integrated, random access platforms, hereafter referred to as platform, capable of high throughput. USAFSAM/PHE’s mission is to provide timely clinical diagnostic testing and patient care for DoD beneficiaries world-wide (225 customers).

USAFSAM/PHE requires a cost per reportable contract, base plus four option years for instrumentation, reagents, consumables, and support to perform chemistry, immunology, and molecular assays in an integrated platform with a single point of entry.

b. Below table delineates required assays

AAT Alpha 1 Antitrypsin

ACTH adrenocorticotropic hormone

AFP Alpha Fetoprotein

ALB Albumin

AMP Amphetamines

Anti-CCP Antibodies to Cyclic Citrulinated Peptide

Anti-HAV Antibodies to Hepatitis A Virus

Anti-HAV IgM Antibodies (IgM) to Hepatitis A Virus

Anti-HBc Antibodies to Hepatitis B Core Antigen

Anti-HBc IgM Antibodies (IgM) to Hepatitis B Core Antigen

Anti-HBs Antibodies to Hepatitis B Surface Antigen

Anti-HCV Antibodies (IgG) Hepatitis C Virus

Anti-TG Antibodies to Thyroglobulin

Anti-TPO Antibodies to Thyroid Peroxidase

Anti-TSHR Antibodies to Thyroid Stimulating Receptor Hormone

Apo A Apolipoprotein a

Apo B Apolipoprotein b

ASO Antistreptolysin O

B-CTX Beta Crosslaps (type I collagen) - C Telopeptide

B2MG Beta-2-Microglobullin

BARB Barbituates

BENZ Benzodiazepine

C3c Complement C3

C4 Complement C4

Ca Calcium

CA 125 Cancer Antigen 125

CA 15-3 Cancer Antigen 15-3

CA 19-9 CA 19-9

Cerulo Ceruloplasmin

CHE Cholinesterase

CMV IgG Cytomegalovirus IgG

CMV IgM Cytomegalovirus IgM

COCA Cocaine

CORT Cortisol

C-Peptid C-Peptide

CRP C-Reactive Protein

CT/NG Chlamydia Trachomatis/Neisseria Gonorrhoeae

CYSTC Cystatin-C

DHEAS/DHEA DHEA Sulfate

E2 Estradiol

ETOH Ethanol

FE Iron with TIBC

FERR Ferritin

FPSA Prostatic Specific Antigen, Free

FRUC Fructosamine

FSH Follicle Stimulating Hormone

FT3 T3, Free

FT4 T4, Free

HBA1C Glycosolated Hemoglobin

HBeAg Hepatitis B E Antigen

HBsAg Hepatitis B Surface Antigen

HBsAg Conf Heaptitis B Surface Antigen Confirmation

HCG+B BHCG

hCT Human Calcitonin

HE4 Human epididymal protein 4

HGH Human Growth Hormone

HGLOB Haptoglobin

HIV HIV-1 Antigen and Total Antibodies to HIV- 1 and

HIV-2

HOMOC Homocysteine hs-CRP High Sensitive C Reactive Protein

HSV-1 IgG Herpes Simplex Virus Type Specific 1

HSV-2 IgG Herpes Simplex Virus Type Specific 2

IgA Immunoglobulin A - pediatric

IgE Immunoglobulin E

IgG Immunoglobulin G

IgM Immunglobulin M

INS Insulin

LH Leutinizing Hormone

LIP Lipase

LSD Lysergic acid diethylamide

METH Methadone

MTQL Metaqualone

Microalbumin Microalbumin (LC just calls it 24 or random urine albumin)

MYO Myoglobin

OPIA Opiates

Osteocalcin Osteocalcin

Oxycodone Oxycodone

PCP Phencyclidine

PCT Procalcitonin

PPX Propoxyphene

PRO Progesterone

PRL Prolactin

ProBNP ProBNP

PSA Prostatic Specific Antigen, Total

PTH Parathyroid Hormone - Intact

RF-II Rheumatoid Factors

Rubella IgG Rubella IgG (for torch only)

Rubella IgM Rubella IgM

SHBG Sex Hormone Binding Globulin (SHBG) syphillis Syphilis

T3 Triidothyronine

T4 Throxine

Testosterone Testosterone Total

THC Cannabinoids

Toxo IgG Toxo IgG

Toxo IgM Toxo IgM

TRANS Transferrin

TSH TSH

UIBC UIBC

Vit D Vitamin D

c. Each platform must be capable of throughput of at least 960 results in an 8-hour shift.

The vendor shall provide enough instrumentation, reagent, and consumables to complete an average daily test load within a 12-hour window. A guaranteed minimum of 95% uptime is required for all instruments.

d. With the use of middleware which meets the requirements of section 3 of this SOW, the user should be notified when quality control (QC) values exceed the acceptable range set on each specific assay, and must block the user from performing patient testing on said assay until such a time where QC is performed and values are within range

e. With the use of middleware, the platform must indicate to the user when QC has expired (if it has been more than 24 hours since last acceptable QC value) for each specific analyte.

i. Platform must block the user from performing patient testing on said analyte until such a time when QC values are within range.

f. The platform shall come equipped to perform statistical analysis of QC data including QC lot numbers, means, ranges, standard deviation and coefficient of variation percentages.

g. The application shall validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred.

h. QC software shall provide the capability to write user defined Westgard QC Rules

i. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics – all available to the user.

j. The platform shall include a data management system for control, operation of the platform, management of quality control program, management of the on-instrument useful life of reagents, and management of patient results.

k. The desired instrumentation shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

l. The platform must have a bidirectional computer interface that is compatible with Composite Health Care Platform (CHCS). Test orders and results must be sent automatically to the instrument and laboratory information system using auto download and auto verification (based on pre-written rules).

m. The platform must sample directly from specimen tube

n. The platform must detect if patient sample has adequate volume for required testing

o. The platform must have continuous specimen loading capability.

p. Each analytical platform shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to perform an emergency shutdown to include the data management station.

q. Safety Data Sheets (SDS) will be provided for each item delivered under this cost per reportable agreement that is considered HAZARDOUS MATERIAL by the United States or the Contractor’s representative. The SDS shall contain information on the hazards associated with each specific chemical or material.

r. If the platform requires a water source, the maintenance and service will be covered under this contract

s. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the platforms cannot be safely dumped into the facility’s drain platform, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines

t. If the platform requires a water source, the water system will contain at a minimum the following components:

i. An automated system capable of utilizing reverse osmosis to purify and deionize water

ii. No less than two (2) ix bed sorbent tanks

iii. No less than (1) reverse osmosis polish tank.

iv. A component capable of removing CO2 gas from the water

u. CT/NG Nucleic Amplification Testing capable of detection in vaginal, endocervical, and male/female urine specimens for ages down to 14 years old.

2. MINIMUM REAGENT REQUIREMENTS

a. Instrument/reagent kits must be FDA approved and will provide analytical sensitivity along entire manufacturers’ stated measuring range.

b. Upon request, the vendor shall provide sufficient reagents for in-house evaluation of each analyte.

c. Following evaluation, each test kits shall exhibit at least 95% agreement with test kits currently in use in the Laboratory.

i. In the event that there is not 95% agreement, the vendor shall provide technical support to assist USAFSAM/PHE personnel in identifying reason behind discrepant results

d. Vendor shall provide assay kits that are optimized for use on instrumentation being provided.

e. The vendor shall provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency testing.

f. Collection Kits: The vendor shall provide all collection kits for the required testing.

Collection kits must met minimum stability requirements of 60 days at 20-24°C (room temperature) for genital samples collected with a swab and 30 days at room temperature for urine samples.

g. The vendor must ship Collection Kits directly to CONUS and OCONUS Epidemiology Laboratory customers (regardless of number).

h. Collection Kits shall be delivered within 14 calendar days after receipt of order for statewide locations and 20 calendar days after receipt of order for OCONUS locations. There are approximately 88 locations worldwide that will currently receive these collection kits. Actual number of delivery locations may change (Ship to/Mark for), and will be defined in the individual order.

3. MINIMUM MIDDLEWARE REQUIREMENTS

a. Capable of integrating multiple instrument interfaces: Specifically Euroimmun sprinter, Diasorin Liaison, Roche 4800/6800/8800

b. Capability to submit College of American Pathologist proficiency tests electronically

c. Capability to locate specimen tubes within 2 minutes

d. Capability to have rules based programming

e. Ability to autovalidate/verify assays according to programmed rules

f. Ability to display the following real-time metrics to the user: Test turnaround time, percent of auto-verification, test volume, most recent quality control value (s) for all analytes listed in this SOW, sample integrity, and sample indices (Hemolysis, Icterus, Lipemia).

4. MINIMUM INSTRUMENTATION REQUIREMENTS

a. Sample Preparation for CT/NG testing must include direct tube sampling with no sample manipulation/preparation prior to instrumentation analysis. This includes no off-board incubation or lysing, no removal of specimen swabs, and no manipulation of urine sample prior to testing on the instrument.

b. Molecular testing, if de-capping is required, a pre-analytic system with a throughput of at least 1,000 tubes per hour must be included.

c. Molecular Instrument must have liquid level sensing to confirm adequate sample and reagent levels, must be able to process urine and swab samples simultaneously and must be one integrated system with a single point of entry.

d. Clinical Chemistry and Immunoassays integrated into a single platform with a single point of entry.

e. Immunoassay incubation time of not more than 28 minutes. See above for tests and annual estimated volume.

f. Immunoassay platforms capable of high through put of at least 240 tests per hour.

g. CT/NG platforms must be capable for throughput of at least 960 results per 8 hour shift. The Contractor shall provide enough instrumentation, reagent and consumables to complete an average daily test load, 1800 tests, within a 24 hour window. Enough instrumentation, reagent and consumables to complete an average daily test load within a 12-hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in TUE - SAT testing, except on federal holidays).

h. Bidirectional computer interface that is compatible with Composite Health Care System (CHCS).

i. Sample directly from primary patient tube or an aliquot tube.

j. Capability to read sample bar codes.

k. Capability to read more than one bar code symbology.

l. Capability of reloading sample, reagent and supplies without interruption from sample processing for at least 50% of available testing menu.

m. Detect if primary patient sample has inadequate volume for required testing.

n. Automatically dilute patient sample if initial testing is outside the reportable range.

o. Automatic clot detection.

p. Continuous specimen loading capability.

q. Automatic test reflex capability that are programmable by the user

r. Auto-verification capabilities.

s. Specimen-tracking capabilities between instrumentation and automation line.

t. QC tracking for primary and secondary onboard reagents

u. Instrumentation upgrades as new technology becomes available will be subject to mutual agreement between the government and the vendor within the specifications of the contract.

v. Instrumentation shall demonstrate exceptional productivity and a successful first time test run 95% of the time.

5. MINIMUM AUTOMATION PLATFORM REQUIREMENTS

a. Preanalytic decapping of sample tube

b. Preanalytic evaluation of sample integrity

c. Postanalytic sealing/capping of sample tube

d. Postanalytic aliquoting and capping of secondary tube

e. Sort samples base on ordered test to analyzer

f. Sort samples based on collection date and tube type

g. Preanalytic evaluation sorted to error holding lane for review

h. Capable of programmable rule base interface

i. Accepts the following tube types: BD Vacutainer or Greiner blood draw tubes; 13 x

75 mm, 13 x 100 mm, 16 x 7 mm and 13 x 100 mm aliquot (pour off) tubes

6. MINIMUM INSTALLATION AND TRAINING SUPPORT REQUIREMENTS

a. Instrument transportation, delivery, and installation, to include calibration, test, and system validation support.

b. Training will include both onsite and off-site training at contractor’s facility. Off-site training will be a minimum of two per instrument provided plus two per year over the length of the contract. The contractor will provide, all expense to include but not limited to travel, lodging, meals and any additional expense that are training specific.

c. Training and support for automation rules programming.

d. Installation will use current electrical and water supplies.

e. The vendor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Section I, Par B of this SOW.

This is required at initial installation and if a new piece of equipment is installed or a reagent is added for testing.

i. Simple Precision/Reproducibility

ii. Accuracy

iii. Method Comparison

iv. Instrument Correlation

v. Reportable Range

7. MINIMUM INSTRUMENT REPAIR AND MAINTENANCE REQUIREMENTS

a. Must provide regular, scheduled maintenance to ensure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency conforming to the manufacturer’s operation and maintenance instructions for the supported equipment.

b. Provide all required tools, parts and labor as necessary to keep the instrument in good operating condition. During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment.

c. Provide over the phone, instrument technical support during normal duty hours (0730

- 2200 EST)

d. Instrument downtime shall not exceed 48 hours for a single occurrence.

e. In the event of an instrument failure, the vendor shall provide onsite technical support with a response time of <24 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online in <48 hours from service call. If a machine remains inoperative due to a malfunction through no fault or negligence of the Government for a total of more than twenty-four hours, the contractor shall be assessed damages at the rate of 1/30 of the preceding average 3 month cost-per-test/reportable billings times the total number of days certified as downtime. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the contractor’s designated representative at the prearranged contact point until the machine is returned in good operating order. However, if the delivery/task order provides for emergency repair during normal business hours in lieu of twenty-four hour service, the non contracted maintenance (Emergency Repairs) days will not be included in the downtime calculation.

f. In the case of all instruments simultaneously failing, the vendor shall provide onsite emergency repair within 8 hours of the time of notification of the malfunction. The vendor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring at least one instrument back online within 24 hours of the time of notification of the malfunction.