The file's text, extracted by GovTribe without its formatting.
SUBJECT*
Chemistry CPRR with Automation
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 33637 |
| SOLICITATION NUMBER* |
| 36C248-26-AP-2936 |
BASE NOTICE TYPE
| ARCHIVE |
| 30 DAYS AFTER THE AWARD DATE |
| PRODUCT SERVICE CODE* |
| 6632 |
SET-ASIDE
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
Network Contracting Office 8 (NCO 8)
8875 Hidden River Pkwy Ste 160A Tampa FL 33637
POINT OF CONTACT*
Contract Specialist David Griganavicius david.griganavicius@va.gov 813-796-2945
AWARD INFORMATION
| AWARD NUMBER* |
| 36F79719D0024 36C24826N0460 |
| AWARD AMOUNT* |
| $3,378,770.75 |
LINE ITEM NUMBER
| AWARD DATE (MM-DD-YYYY)* |
| 03-31-2026 |
| AWARDEE NAME* |
| ABBOTT LABORATORIES INC. |
| CONTRACTOR’S UEI |
| NH3LDK8CFAK7 |
AWARDEE ADDRESS LINE 1*
AWARDEE ADDRESS LINE 2*
| AWARDEE ADDRESS LINE 3* |
| 100 ABBOTT PARK RD |
| AWARDEE ADDRESS LINE 4* |
| BUILDING AP6D; DEPARTMENT 32L |
ADDITIONAL INFORMATION
| AGENCY’S URL |
| https://www.va.gov |
| URL DESCRIPTION |
| Department of Veterans Affairs |
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
Award Notice Award Notice See attached document: P03 HCA Signed NCO 8 P03 LSJ GSAM.71043b over SAT BK 3.30.26_Redacted.
*= Required Field Award Notice Award Notice
STATEMENT OF NEED
Clinical Chemistry CPRR with Automation System
1. SCOPE:
The contractor shall provide Clinical Chemistry and Immunochemistry cost-per-reportable-result (CPRR) with clinical laboratory automation with instrumentation and software for an integrated, automated platform for flexibility, simplicity and improved productivity for the Tampa VA Healthcare Network (TVAHCN), Department of Pathology and Laboratory Medicine Service (P&LMS) locations:
· James A. Haley Veterans Hospital (JAHVH), 13000 Bruce B. Downs Blvd., Tampa, Florida 33612
· New Port Richey VA Outpatient Clinic (NPROPC), 7900 Little Road, New Port Richey, FL 34654
· Lakeland Community-Based Outpatient Clinic (LCBOC), 2080 Meadowland Park Blvd, Lakeland, FL 33803
· Temple Terrace VA Clinic and Mental Health Facility (TTMHF), 8451 Temple Terrace Highway Tampa, FL 33637 All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.
The Government intends to award an Firm-Fixed Price contract for the following Periods of Performance (POP): 04/01/2026 – 03/31/2027
2. REQUIRED TEST MENU:
| Description – Cost Per Reportable Result |
| Product List |
Number Reportable Annual Volume
| Alinity c Acetaminophen Reagent |
| 07P54 |
| 997 |
| Alinity c Albumin (BCG) Reagent |
| 04U30 |
| 201,531 |
| Alinity c Alkaline Phosphatase Reagent |
| 08P20 |
| 187,099 |
| Alinity c Alpha-1 Antitrypsin Reagent |
| 01R07 |
| 1,670 |
| Alinity c ALT, Activated (Alanine Aminotransferase) Reagent |
| 08P18 |
| 188,459 |
| Alinity c Amikacin Reagent |
| 09P44 |
| 147 |
| Alinity c Ammonia Reagent |
| 08P22 |
| 1,887 |
| Alinity c Amphetamine/ Methamphetamine Reagent |
| 09P45 |
| 25,366 |
| Alinity c Amylase Reagent |
| 07P58 |
| 2,595 |
| Alinity c AST, Activated (Aspartate Aminotransferase) Reagent |
| 08P23 |
| 188,641 |
| Alinity c Barbiturates Reagent |
| 09P51 |
| 25,292 |
| Alinity c Benzodiazepines Reagent |
| 09P52 |
| 25,296 |
| Alinity c Buprenorphine Reagent |
| 04Z42 |
| 2,266 |
| Alinity c Calcium Reagent |
| 07P57 |
| 249,924 |
| Alinity c Cannabinoids Reagent |
| 09P54 |
| 25,389 |
| Alinity c Carbamazepine Reagent |
| 08P58 |
| 274 |
| Alinity c Carbon Dioxide (CO2) Reagent |
| 07P72 |
| 250,227 |
| Alinity c Ceruloplasmin Reagent |
| 09P93 |
| 1,291 |
| Alinity c Cholesterol Reagent |
| 04T88 |
| 113,855 |
| Alinity c CK (Creatine Kinase) Reagent |
| 08P42 |
| 4,693 |
| Alinity c Cocaine Reagent |
| 09P55 |
| 25,483 |
| Alinity c Complement C3 Reagent |
| 09P56 |
| 793 |
| Alinity c Complement C4 Reagent |
| 09P57 |
| 815 |
| Alinity c Creatinine (Jaffe) Reagent |
| 04T91 |
| 343,810 |
| Alinity c CRP (Vario) Reagent |
| 07P56 |
| 20,544 |
| Alinity c Digoxin Reagent |
| 08P37 |
| 369 |
| Alinity c Direct Bilirubin Reagent |
| 07P97 |
| 186,977 |
| Alinity c Direct LDL Reagent |
| 07P71 |
| 69,690 |
| Alinity c Electrolytes Reagent |
| 09D28 |
| 354,249 |
| Alinity c Ethanol Reagent |
| 08P41 |
| 28,913 |
| Alinity c Fentanyl Reagent |
| 04Z44 |
| 25,736 |
| Alinity c Gentamicin Reagent |
| 08P55 |
| 176 |
| Alinity c GGT (Gamma-Glutamyl Transferase) Reagent |
| 04T96 |
| 1,708 |
| Alinity c Glucose Reagent |
| 07P55 |
| 249,180 |
| Alinity c Haptoglobin Reagent |
| 09P59 |
| 921 |
| Alinity c HDL (Ultra) Reagent |
| 07P75 |
| 113,456 |
| Alinity c Hemoglobin A1c (Monitoring & Diagnostics) Reagent |
| 08P43 |
| 202,588 |
| Alinity c Immunoglobulin A (IgA) Reagent |
| 09P61 |
| 3,493 |
| Alinity c Immunoglobulin G (IgG) Reagent |
| 09P62 |
| 3,669 |
| Alinity c Immunoglobulin M (IgM) Reagent |
| 09P63 |
| 3,820 |
| Alinity c Iron Reagent |
| 04T98 |
| 16,087 |
| Alinity c Lactate Dehydrogenase (LD) Reagent |
| 07P74 |
| 3,284 |
| Alinity c Lipase NG Open Channel Reagent |
| 04Y85 |
| 5,390 |
| Alinity c Lithium Reagent |
| 08P53 |
| 1,255 |
| Alinity c LPa Reagent |
| 01R14 |
| 54,713 |
| Alinity c Magnesium Reagent |
| 08P19 |
| 70,172 |
| Alinity c Methadone Reagent |
| 09P64 |
| 462 |
| Alinity c Microalbumin (Urine) Reagent |
| 08P04 |
| 59,656 |
| Alinity c Opiates Reagent |
| 09P65 |
| 25,335 |
| Alinity c Oxycodone Reagent |
| 04Z45 |
| 26,112 |
| Alinity c Phenobarbital Reagent |
| 09P85 |
| 138 |
| Alinity c Phenytoin Reagent |
| 08P54 |
| 278 |
| Alinity c Phosphorus Reagent |
| 04U03 |
| 36,255 |
| Alinity c Prealbumin Reagent |
| 09P86 |
| 3,305 |
| Alinity c Protein (Urine/CSF) Reagent |
| 07P59 |
| 10,581 |
| Alinity c Rheumatoid Factor (RF) Reagent |
| 04R99 |
| 3,569 |
| Alinity c Salicylate Reagent |
| 08P59 |
| 1,066 |
| Alinity c Theophylline Reagent |
| 09P89 |
| 162 |
| Alinity c Tobramycin Reagent |
| 09P90 |
| 159 |
| Alinity c Total Bilirubin Reagent |
| 04U05 |
| 187,904 |
| Alinity c Total Protein Reagent |
| 04T81 |
| 178,490 |
| Alinity c Transferrin Reagent |
| 08P38 |
| 12,871 |
| Alinity c Triglycerides Reagent |
| 07P77 |
| 54,713 |
| Alinity c Unsaturated Iron Binding Capacity Reagent |
| 08P44 |
| 12,871 |
| Alinity c Urea Nitrogen Reagent |
| 08P16 |
| 249,342 |
| Alinity c Uric Acid Reagent |
| 04U09 |
| 9,365 |
| Alinity c Valproic Acid Reagent |
| 09P92 |
| 1,006 |
| Alinity c Vancomycin Reagent |
| 08P52 |
| 1,360 |
| Alinity i Anti-HAV IgG Reagent |
| 06S93 |
| 9,416 |
| Alinity i Anti-HAV IgM Reagent |
| 08P28 |
| 1,319 |
| Alinity i Anti-HBc IgM Reagent |
| 07P86 |
| 1,395 |
| Alinity i Anti-HBc Reagent |
| 07P84 |
| 6,065 |
| Alinity i Anti-HBs Reagent |
| 07P88 |
| 1,668 |
| Alinity i Anti-HCV Reagent |
| 08P05 |
| 14,911 |
| Alinity i CA 125 II Reagent |
| 08P49 |
| 133 |
| Alinity i CA 19-9 (CA 19-9 XR) Reagent |
| 08P32 |
| 907 |
| Alinity i CEA Reagent |
| 07P62 |
| 806 |
| Alinity i Cortisol Reagent |
| 08P33 |
| 3,191 |
| Alinity i DHEA-S Reagent |
| 09P37 |
| 303 |
| Alinity i Estradiol Reagent |
| 07P50 |
| 1,589 |
| Alinity i Ferritin Reagent |
| 07P65 |
| 18,560 |
| Alinity i Free T3 Reagent |
| 07P69 |
| 1,535 |
| Alinity i Free T4 Reagent |
| 07P70 |
| 11,106 |
| Alinity i HBsAg (Qualitative) Reagent |
| 08P10 |
| 9,674 |
| Alinity i hCG (Total Beta-hCG) Reagent |
| 07P51 |
| 1,810 |
| Alinity i HIV Ag/Ab Combo Reagent |
| 08P07 |
| 5,641 |
| Alinity i Intact PTH Reagent |
| 08P31 |
| 9,589 |
| Alinity i NT-ProBNP Reagent |
| 04S79 |
| 12,707 |
| Alinity i PCT (BRAHMS) Reagent |
| 01R18 |
| 6,674 |
| Alinity i Progesterone Reagent |
| 08P36 |
| 251 |
| Alinity i PSA, Free Reagent |
| 07P93 |
| 11,869 |
| Alinity i PSA, Total Reagent |
| 07P92 |
| 51,125 |
| Alinity i SHBG Reagent |
| 09P38 |
| 8,365 |
| Alinity i Sirolimus Reagent |
| 09P41 |
| 67 |
| Alinity i STAT CK-MB Reagent |
| 04V38 |
| 1,712 |
| Alinity i STAT Myoglobin Reagent |
| 04V37 |
| 379 |
| Alinity i Tacrolimus Reagent |
| 09P42 |
| 2,200 |
| Alinity i Testosterone 2nd Generation Reagent |
| 07P68 |
| 9,349 |
| Alinity i Total T3 Reagent |
| 07P94 |
| 3,321 |
| Alinity i Total T4 Reagent |
| 07P95 |
| 1,287 |
| Alinity i Troponin-I (High Sensitive) Reagent |
| 04Z21 |
| 15,856 |
| Alinity i TSH Reagent |
| 07P48 |
| 82,110 |
| Alinity i Vitamin D Reagent |
| 08P45 |
| 55,044 |
| Architect IA Cyclosporine Reagent |
| 01L75 |
| 66 |
| Description – Cost Per Test |
| Product List |
Number Reportable Annual Volume
| Alinity i HBsAg (Qualitative Conf.) Reagent |
| 08P11 |
| 1,460 |
3. GENERAL REQUIREMENTS:
a. The contractor is required to furnish all of the following to all locations defined within the contract (Per Quoted Pricing):
i. Instrumentation hardware and software (analyzers, track line system, operating system, UPS, etc.).
ii. Upgrades to and maintenance of hardware or software necessary to fulfill the test requirements.
iii. Reagents, Calibrators, and Quality Control materials, including the use of 3rd-party Quality Control material
iv. All consumables and user-defined replacement parts necessary to operate the contractor's equipment.
b. The Tampa VA Healthcare Network facilities will only pay for the patient test results reported to the patient’s medical record. There shall be no minimum monthly charge.
c. CPRR shall be based on a tiered volume with additional savings as testing volume increases. Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges. Inflated reagent estimates if not consumed will not be charged.
i. Annual test volumes provided are based upon historical reported result data and are not guaranteed a minimum.
ii. All reagents for instrument verification and test method validation, per The Joint Commission and VA guidelines, are to be supplied by the contractor at no additional cost to the government.
iii. If at any time during the contract period, testing for the defined test menu is not available on this list, the Contractor shall provide, or reimburse the government, any additional costs associated with the procurement of another source of satisfactory test performance (i.e. reference laboratory, alternate testing instrument, etc.)
| Description – Annual Allowable No-Charge Consumable Quantities |
| Product List |
Number Annual Allowable “No-Charge” Qty
| Alinity c Acetaminophen Calibrator |
| 07P54-01 |
| 3 |
| Alinity c Acid Probe Wash |
| 01R60-70 |
| 33 |
| Alinity c Acid Wash Solution |
| 08P77-40 |
| 149 |
| Alinity c Alkaline Wash Solution |
| 08P78-40 |
| 145 |
| Alinity c Benzodiazepines Qualitative Calibrator Kit |
| 09P52-01 |
| 28 |
| Alinity c Benzodiazepines Quantitative Calibrator Kit |
| 09P52-02 |
| 20 |
| Alinity c Bilirubin Calibrator Kit |
| 08P61-01 |
| 24 |
| Alinity c Buprenorphine Calibrator |
| 04Z42-01 |
| 28 |
| Alinity c Buprenorphine Calibrator (0, 5,10,20, 40 ng/mL) |
| 04Z42-02 |
| 28 |
| Alinity c Buprenorphine Control (3.75 and 6.25 ng/mL) |
| 04Z42-10 |
| 8 |
| Alinity c Cannabinoids Qual Calibrator Kit |
| 09P54-01 |
| 13 |
| Alinity c Cannabinoids Semiquant 100 Calibrator Kit |
| 09P54-02 |
| 13 |
| Alinity c Cannabinoids Semiquant 200 Calibrator Kit |
| 09P54-03 |
| 13 |
| Alinity c Carbon Dioxide Calibrator Kit |
| 08P72-01 |
| 20 |
| Alinity c Consolidated Calibrator |
| 04V62-01 |
| 8 |
| Alinity c Acetaminophen Calibrator |
| 07P54-01 |
| 3 |
| Alinity c Acid Probe Wash |
| 01R60-70 |
| 33 |
| Alinity c Acid Wash Solution |
| 08P77-40 |
| 149 |
| Alinity c Alkaline Wash Solution |
| 08P78-40 |
| 145 |
| Alinity c Benzodiazepines Qualitative Calibrator Kit |
| 09P52-01 |
| 28 |
| Alinity c Benzodiazepines Quantitative Calibrator Kit |
| 09P52-02 |
| 20 |
| Alinity c Bilirubin Calibrator Kit |
| 08P61-01 |
| 24 |
| Alinity c Buprenorphine Calibrator |
| 04Z42-01 |
| 28 |
| Alinity c Buprenorphine Calibrator (0, 5,10,20, 40 ng/mL) |
| 04Z42-02 |
| 28 |
| Alinity c Buprenorphine Control (3.75 and 6.25 ng/mL) |
| 04Z42-10 |
| 8 |
| Alinity c Cannabinoids Qual Calibrator Kit |
| 09P54-01 |
| 13 |
| Alinity c Cannabinoids Semiquant 100 Calibrator Kit |
| 09P54-02 |
| 13 |
| Alinity c Cannabinoids Semiquant 200 Calibrator Kit |
| 09P54-03 |
| 13 |
| Alinity c Carbon Dioxide Calibrator Kit |
| 08P72-01 |
| 20 |
| Alinity c Consolidated Calibrator |
| 04V62-01 |
| 8 |
| Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (US) |
| 07P56-05 |
| 10 |
| Alinity c CRP Vario High Sensitivity Calibrator Kit (US) |
| 07P56-04 |
| 10 |
| Alinity c CRP Vario Wide Range Calibrator Kit |
| 07P56-01 |
| 10 |
| Alinity c CRP Vario Wide Range Calibrator Kit (US) |
| 07P56-03 |
| 10 |
| Alinity c CRP Vario Wide Range Calibrator Kit HS |
| 07P56-02 |
| 10 |
| Alinity c Customer Maintenance Kit |
| 04S46-02 |
| 8 |
| Alinity C Cuvette Dry Tip |
| 04S52-01 |
| 8 |
| Alinity C Cuvette Segment |
| 04S47-01 |
| 8 |
| Alinity C Cuvette Segment Alignment Tool |
| 04S70-02 |
| 8 |
| Alinity c Detergent A |
| 08P96-70 |
| 146 |
| Alinity c Detergent B |
| 08P97-81 |
| 125 |
| Alinity c DOA MC Negative Cal Kit |
| 08P63-06 |
| 47 |
| Alinity c DOA MC Qual Cal 2 Kit |
| 08P63-02 |
| 37 |
| Alinity c DOA MC Qual Low Cal 1 Kit |
| 08P63-01 |
| 40 |
| Alinity c DOA MC Semiquant Cal 3 Kit |
| 08P63-03 |
| 37 |
| Alinity c Ethanol Calibrator Kit |
| 08P41-01 |
| 16 |
| Alinity c Fentanyl Calibrator (1 ng/mL) |
| 04Z44-01 |
| 28 |
| Alinity c Fentanyl Calibrator (Negative Urine) |
| 04Z44-04 |
| 28 |
| Alinity c Hemoglobin A1c Calibrator Kit |
| 08P43-01 |
| 30 |
| Alinity c ICT Reference Solution |
| 08P76-40 |
| 56 |
| Alinity c ICT Sample Diluent |
| 07P53-20 |
| 43 |
| Alinity c ICT Serum Calibrator Kit |
| 08P69-01 |
| 47 |
| Alinity c ICT Urine Calibrator Kit |
| 08P70-01 |
| 52 |
| Alinity c Iron Calibrator |
| 04U75-01 |
| 10 |
| Alinity c Lipase NG Open Channel Calibrator Kit |
| 04Y85-01 |
| 3 |
| Alinity c Lipid Multiconstituent Calibrator Kit |
| 09P14-03 |
| 9 |
| Alinity c Lp(a) Calibrator Kit |
| 01R14-01 |
| 24 |
| Alinity c Lp(a) Control Kit |
| 01R14-10 |
| 2 |
| Alinity c Maintenance Solutions (US) |
| 08P98-71 |
| 28 |
| Alinity c Microalbumin Calibrator Kit |
| 08P04-04 |
| 10 |
| Alinity c Multiconstituent Calibrator Kit |
| 08P60-01 |
| 42 |
| Alinity c Negative Urine Calibrator |
| 04Z47-01 |
| 28 |
| Alinity c Opiates Qual Calibrator Kit |
| 09P65-01 |
| 28 |
| Alinity c Opiates Semiquant Calibrator Kit |
| 09P65-02 |
| 28 |
| Alinity c Oxycodone Calibrator (0, 100, 300, 500, 1000 ng/mL) |
| 04Z45-03 |
| 28 |
| Alinity c Oxycodone Calibrator (100 ng/mL) |
| 04Z45-01 |
| 28 |
| Alinity c Oxycodone Calibrator (300 ng/mL) |
| 04Z45-02 |
| 28 |
| Alinity c Oxycodone Control (75, 125 ng/mL) |
| 04Z45-11 |
| 8 |
| Alinity c Plasmaproteins Calibrator |
| 08P66-01 |
| 4 |
| Alinity c Prealbumin Calibrator |
| 04S01-01 |
| 2 |
| Alinity c Proteins Standard Calibrator |
| 08P67-01 |
| 1 |
| Alinity C Reagent Probe |
| 04S49-01 |
| 32 |
| Alinity C Reagent Probe Screw |
| 04S54-01 |
| 8 |
| Alinity C Reagent Probe Tubing |
| 04S50-01 |
| 24 |
| ALINITY C Rgt Cartridge Black |
| 04S17-50 |
| 8 |
| ALINITY C Rgt Cartridge Clear |
| 04S17-40 |
| 8 |
| Alinity c Rheumatoid Factor (RF) Calibrator Kit (US) |
| 04S00-02 |
| 1 |
| Alinity c Salicylate Calibrator Kit |
| 08P59-01 |
| 1 |
| Alinity C Sample Probe |
| 04S51-01 |
| 8 |
| Alinity C Sample Probe Screw |
| 04S53-01 |
| 8 |
| Alinity c Sentinel Clinical Chemistry Calibrator Kit |
| 08P65-03 |
| 9 |
| Alinity c Specific Proteins Multiconstituent Calibrator |
| 08P62-01 |
| 8 |
| Alinity c TDM Multiconstituent Calibrator Kit |
| 08P74-04 |
| 7 |
| Alinity c Tobramycin Calibrator |
| 09P90-01 |
| 5 |
| Alinity c UIBC Calibrator Kit |
| 08P44-01 |
| 2 |
| Alinity c Urine/CSF Protein Calibrator Kit |
| 08P71-01 |
| 2 |
| Alinity ci Sample Cups |
| 01R38-01 |
| 136 |
| Alinity i 25-OH Vitamin D Calibrator Kit |
| 08P45-01 |
| 3 |
| Alinity i Anti-HBc Calibrator Kit (US) |
| 07P84-01 |
| 1 |
| Alinity i Anti-HBc IgM Calibrator Kit (US) |
| 07P86-02 |
| 5 |
| Alinity i Anti-HBs Calibrator Kit (US) |
| 07P88-01 |
| 2 |
| Alinity i Anti-HCV Calibrator Kit (US) |
| 08P05-01 |
| 3 |
| Alinity i CA 125 II Calibrator Kit |
| 08P49-01 |
| 2 |
| Alinity i CA 19-9XR Calibrator Kit |
| 08P32-01 |
| 1 |
| Alinity i CEA Calibrator Kit |
| 07P62-01 |
| 1 |
| Alinity i Common Diluent |
| 09P15-40 |
| 4 |
| Alinity i Concentrated Wash Buffer |
| 06P13-68 |
| 417 |
| Alinity i Cortisol Calibrator Kit |
| 08P33-01 |
| 2 |
| Alinity i Customer Maintenance Kit |
| 04S37-02 |
| 5 |
| Alinity i DHEA-S Calibrator Kit |
| 09P37-01 |
| 1 |
| Alinity i Estradiol Calibrator Kit |
| 07P50-01 |
| 2 |
| Alinity i Ferritin Calibrator Kit |
| 07P65-01 |
| 3 |
| Alinity i Free PSA Calibrator Kit |
| 07P93-01 |
| 6 |
| Alinity i Free T3 Calibrator Kit |
| 07P69-01 |
| 2 |
| Alinity i Free T4 Calibrator Kit |
| 07P70-01 |
| 2 |
| Alinity i HAVAb IgG Calibrator Kit (US) |
| 06S93-01 |
| 2 |
| Alinity i HAVAb IgM Calibrator Kit (US) |
| 08P28-01 |
| 2 |
| Alinity i HBSAG Qual Conf Man Diluent (US) |
| 08P11-41 |
| 6 |
| Alinity i HBsAg Qualitative Calibrator Kit (US) |
| 08P10-02 |
| 6 |
| Alinity i HIV Ag/Ab Combo Calibrator Kit (US) |
| 08P07-02 |
| 5 |
| Alinity i NT-proBNP (Alere) Calibrator Kit |
| 04S79-02 |
| 7 |
| Alinity i PCT (BRAHMS) Calibrator Kit |
| 01R18-01 |
| 3 |
| Alinity i Probe Conditioning Solution |
| 01R58-40 |
| 18 |
| Alinity i Progesterone Calibrator Kit |
| 08P36-01 |
| 2 |
| Alinity i Progesterone Manual Diluent |
| 08P36-40 |
| 1 |
| Alinity i SHBG Calibrator Kit |
| 09P38-01 |
| 3 |
| Alinity i Sirolimus Calibrator Kit |
| 09P41-01 |
| 2 |
| Alinity i Sirolimus Whole Blood Precipitation Kit |
| 09P41-40 |
| 4 |
| Alinity i STAT CK-MB Calibrator Kit |
| 04V38-01 |
| 5 |
| Alinity i STAT High Sensitive Troponin-I Calibrator (US) |
| 04Z21-01 |
| 5 |
| Alinity i STAT Intact PTH Calibrator Kit |
| 08P31-02 |
| 5 |
| Alinity i STAT Myoglobin Calibrator Kit |
| 04V37-01 |
| 3 |
| Alinity i STAT Total β-hCG Calibrator Kit |
| 07P51-01 |
| 4 |
| Alinity i Tacrolimus Calibrator Kit |
| 09P42-01 |
| 1 |
| Alinity i Tacrolimus Whole Blood Precipitation Kit |
| 09P42-40 |
| 44 |
| Alinity i Testosterone Calibrator Kit |
| 07P68-01 |
| 10 |
| Alinity i Total PSA Calibrator Kit |
| 07P92-01 |
| 6 |
| Alinity i Total T3 Manual Diluent |
| 07P94-40 |
| 2 |
| Alinity i Total T3 Calibrator Kit |
| 07P94-01 |
| 4 |
| Alinity i Total T4 Calibrator Kit |
| 07P95-01 |
| 4 |
| Alinity i TSH Calibrator Kit |
| 07P48-01 |
| 7 |
| Alinity Pre-Trigger Solution (REACH) |
| 06P12-70 |
| 50 |
| Alinity Reaction Vessels |
| 06P14-01 |
| 115 |
| Alinity Reagent Replacement Caps |
| 04R47-01 |
| 5 |
| Alinity Trigger Solution (REACH) |
| 06P11-70 |
| 69 |
| Architect IA Probe |
| 08C94-47 |
| 1 |
| Architect IA Probe Conditioning Solution |
| 01L56-40 |
| 1 |
| Architect IA Reaction Vessels |
| 07C15-03 |
| 1 |
| Architect IA Replacement Caps |
| 04D19-01 |
| 1 |
| Architect IA Septums |
| 04D18-03 |
| 1 |
| Architect IA Trigger Solution (REACH) |
| 06C55-63 |
| 4 |
| Architect IA Wash Buffer 1x10L |
| 06C54-88 |
| 32 |
| Architect IA Wash Buffer 4x975mL |
| 06C54-58 |
| 11 |
| Architect IA/CC Sample Cups |
| 07C14-01 |
| 1 |
| ARCHITECT Pretreatment Tubes |
| 01P06-02 |
| 6 |
| ARCHITECT Pre-Trigger Straw |
| 08C94-67 |
| 12 |
| ARCHITECT Probe, Wash Zone |
| 08C94-36 |
| 3 |
| ARCHITECT Probe/Tubing, Waste Arm |
| 08C94-89 |
| 1 |
| ARCHITECT Trigger Straw |
| 08C94-66 |
| 12 |
| ARCHITECT Tubing Probe |
| 08C94-49 |
| 1 |
| ARCHITECT Tubing, STAT Probe |
| 03M77-49 |
| 1 |
| ARCHITECT Wash Buffer Prep Container |
| 08C94-56 |
| 1 |
| ARCHITECT Wash Buffer Transfer Tubing |
| 08C94-21 |
| 1 |
| Transplant Pretreatment Tubes |
| 01P06-03 |
| 39 |
| 104AB EXTRNGLNRTY |
| 03L45-02 |
| 2 |
| MS GC1 1100AB |
| 04P36-05 |
| 12 |
| MS GC2 1200AB |
| 04P36-06 |
| 17 |
| MS GC4 1400AB |
| 04P36-07 |
| 19 |
| MS UC 1 701AB |
| 04P39-01 |
| 10 |
| MS UC 4 704AB |
| 04P40-01 |
| 10 |
| MSCHEM TDM1 301AB |
| 04P38-01 |
| 5 |
| Description – Third-Party Products |
| Product List |
Number
| Manufacturer / Supplier |
| Qty |
| Cystatin C Reagent |
| 06U41-25 |
| Gentian/Abbott |
| 107 |
| CYSTATIN C CAL KIT 1051 |
| 06U41-01 |
| Gentian/Abbott |
| 0 |
| CYSTATIN C CAL KIT 1012 |
| 06U41-02 |
| Gentian/Abbott |
| 55 |
| Cystatin C Control |
| 06U41-10 |
| Gentian/Abbott |
| 153 |
| LIQCHK CRDMKR LT+2 BR14 |
| 04P11-04 |
| BioRad |
| 43 |
| MULTIQUAL UNASSY L1 697 |
| 04P13-02 |
| BioRad |
| 18 |
| MULTIQUAL UNASSY L3 699 |
| 04P13-04 |
| BioRad |
| 18 |
| BR544 ETH/NH3 1 |
| 04P14-01 |
| BioRad |
| 20 |
| BR546 ETH/NH3 3 |
| 04P14-03 |
| BioRad |
| 20 |
| LIQCHK IA PLUS CTL, L1 |
| 04P15-01 |
| BioRad |
| 27 |
| LIQCHK IA PLUS CTL, L3 |
| 04P15-02 |
| BioRad |
| 27 |
| BR594 IMMUNO 1 |
| 04P16-01 |
| BioRad |
| 18 |
| BR595 IMMUNO 2 |
| 04P16-02 |
| BioRad |
| 18 |
| BR596 IMMUNO 3 |
| 04P16-03 |
| BioRad |
| 18 |
| LIQCK SPEC IA CTL 1 |
| 04P17-03 |
| BioRad |
| 18 |
| LIQCK SPEC IA CTL 2 |
| 04P17-04 |
| BioRad |
| 18 |
| LIQCHK SPEC IA CTL, L3 |
| 04P17-05 |
| BioRad |
| 18 |
| BR355 PEDIATRIC 2 |
| 04P19-02 |
| BioRad |
| 13 |
| LIQCK TUMOR MRKR CTL 1 |
| 04P19-05 |
| BioRad |
| 18 |
| LIQCK TUMOR MRKR CTL 3 |
| 04P19-07 |
| BioRad |
| 18 |
| LIQCK SPINAL FLD CTL L1 |
| 04P21-01 |
| BioRad |
| 24 |
| LIQCK SPINAL FLD CTL L2 |
| 04P21-02 |
| BioRad |
| 24 |
| BR397 CHEM1 |
| 04P22-01 |
| BioRad |
| 17 |
| BR398 CHEM2 |
| 04P22-02 |
| BioRad |
| 17 |
| MICROALBMN CTL LVL1 378 |
| 04P23-13 |
| BioRad |
| 6 |
| MICROALBMN CTL LVL2 379 |
| 04P23-14 |
| BioRad |
| 6 |
| LIQCHK CARD MRKR CTL L2 |
| 04P23-19 |
| BioRad |
| 43 |
| LIQCK URINE TOX NEG CTL |
| 04P25-01 |
| BioRad |
| 7 |
| LIQCK URINE TOX S1E CTL |
| 04P27-02 |
| BioRad |
| 7 |
| LIQ CARDIAC MRK+ CTL |
| 04Z52-02 |
| BioRad |
| 43 |
4. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:
a. The Contractor will continue to provide the following list of equipment (Equipment Rental) for the terms of the contract (billed monthly) and Contractor agrees to service and maintain the list of equipment per the manufacturer’s published FDA-approved specifications.
i. James A. Haley Veterans Hospital:
1. Alinity C Modules – 4 Each
2. Alinity I Modules – 2 Each
3. Architect – 1 Each
4. Automation System Components:
a. IOM Module with Software System – 1 Each
b. Centrifugation Modules – 2 Each
c. Refrigerated Storage Module – 1 Each
d. Specimen Decappers – 2 Each
e. Specimen Sealers – 2 Each
f. Automation Track Components (complete system) – 1 Each
g. Automation System Software Operating System (Data Innovations) – 1 Each
5. DI Water System – 1 Each
ii. New Port Richey VA Outpatient Clinic:
1. Alinity C Modules – 1 Each
2. Alinity I Modules – 1 Each
3. DI Water System – 1 Each Description – Existing Equipment – Monthly Rental (Abbott-Owned / Serviced by Abbott) List Number Quantity Installed
| a3600 (Automation System) NO ANNUAL FEE |
| 06P33-01 |
| 1 |
| Alinity i Analyzer (James A Haley) |
| 03R67-01 |
| 2 |
| Alinity c Analyzer (James A Haley) |
| 03R65-01 |
| 4 |
| Alinity i Analyzer (New Port Richey Outpatient Clinic) |
| 03R67-01 |
| 1 |
| Alinity c Analyzer (New Port Richey Outpatient Clinic) |
| 03R65-01 |
| 1 |
| Architect i2000 Analyzer (James A Haley) NO ANNUAL FEE |
| 03M74-02 |
| 2 |
b. The Government will furnish the following list of equipment, and the Contractor agrees to service and maintain the list of equipment per the manufacturer’s published FDA-approved specifications.
i. Lakeland Community-Based Outpatient Clinic:
1. Alinity C Modules – 1 Each
2. Alinity I Modules – 1 Each
3. DI Water System – 1 Each
ii. Temple Terrace VA Clinic and Mental Health Facility
1. Alinity C Modules – 2 Each
2. Alinity I Modules – 1 Each
3. DI Water System – 1 Each Description – Existing Equipment (Government-Owned / Serviced by Abbott) List Number Quantity Installed
| Alinity i Analyzer (JAH VA Mental Health) |
| 03R67-01 |
| 1 |
| Alinity c Analyzer (JAH VA Mental Health) |
| 03R65-01 |
| 2 |
| Alinity i Analyzer (Lakeland VA Clinic) |
| 03R67-01 |
| 1 |
| Alinity c Analyzer (Lakeland VA Clinic) |
| 03R65-01 |
| 1 |
c. Miscellaneous Services Performed by Abbott on an As-Needed Basis
i. Water System Maintenance (Included in CPRR Pricing – No Charge
| Ancillary Items Included in the CPRR pricing (No-Charge) |
| Quantity |
| Water System Maintenance- JAH VA Mental Health CLX 7080 / Model Number: ZAFS61080 |
| 1 |
| Water System Maintenance- Lakeland VA Clinic CLX 7080 / Model Number: ZAFS61080 |
| 1 |
| Water System Maintenance- New Port Richey CLX 7080 /Model Number: ZAFS61080 |
| 1 |
| Water System Maintenance- JAH VA Hospital CLX 7150 Model Number: ZAFS62150 |
| 1 |
ii. Quarterly Maintenance by Abbott Service Personnel – Billed per Item
| Ancillary Items Included in the CPRR pricing (No-Charge) |
| List Number |
| Quantity |
| a3600 Automation (James A Haley) - Same Day Response - 24x7 |
| 01DM9-02 / 01DM9-25 |
| 1 |
| Alinity i Analyzer (James A Haley)- Same Day Response - 24x7 |
| 01DP5-02 / 01DP5-25 |
| 1 |
| Alinity c Analyzer (James A Haley)- Same Day Response - 24x7 |
| 01DP4-02 / 01DP4-25 |
| 1 |
| Architect i2000 Analyzer (James A Haley)- Same Day Response |
| 01DL6-02 |
| 1 |
| Alinity i Analyzer (New Port Richey Outpatient Clinic)- Same Day Response |
| 01DP5-02 |
iii. As-Needed Instrument Manager Advisory Service – Billed per Item
| Ancillary Items Included in the CPRR pricing |
| List Number |
| QTY |
| IM Advisory Service - On-site (Days) |
| 01DD4-42 |
| 2 |
| IM Advisory Service - Remote (Hours) |
| 01DD4-40 |
| 16 |
iv. Abbott Always On In-Lab Services
| Description |
| List Number |
| Qty |
| a3600 Automation (James A Haley) - Same Day Response - 24x7 |
| 01DM9-02 / 01DM9-25 |
| 1 |
| Alinity i Analyzer (James A Haley)- Same Day Response - 24x7 |
| 01DP5-02 / 01DP5-25 |
| 2 |
| Alinity c Analyzer (James A Haley)- Same Day Response - 24x7 |
| 01DP4-02 / 01DP4-25 |
| 4 |
| Architect i2000 Analyzer (James A Haley)- Same Day Response |
| 01DL6-02 |
| 2 |
| Alinity i Analyzer (New Port Richey Outpatient Clinic)- Same Day Response |
| 01DP5-02 |
| 1 |
| Alinity c Analyzer (New Port Richey Outpatient Clinic)- Same Day Response |
| 01DP4-02 |
| 1 |
| Alinity i Analyzer (JAH VA Mental Health)- Same Day Response |
| 01DP5-02 |
| 1 |
| Alinity c Analyzer (JAH VA Mental Health)- Same Day Response |
| 01DP4-02 |
| 2 |
| Alinity i Analyzer (Lakeland VA Clinic)- Same Day Response |
| 01DP5-02 |
| 1 |
| Alinity c Analyzer (Lakeland VA Clinic)- Same Day Response |
| 01DP4-02 |
| 1 |
v. Abbott AlinIQ – Monthly Service
| Description |
| List Number |
| Qty |
| Instrument Manager Subscription (James A Haley) |
| 01P63-78 |
| 1 |
| Instrument Manager Always On Support Contract (James A Haley) |
| 01DN8-02 |
| 1 |
| Instrument Manager Always On Support Contract (New Port Richey Outpatient Clinic) |
| 01DN8-02 |
| 1 |
| Instrument Manager Always On Support Contract (Lakeland VA Clinic) |
| 01DN8-02 |
| 1 |
| Instrument Manager Always On Support Contract (JAH VA Mental Health) |
| 01DN8-02 |
| 1 |
d. Upgrades / Replacement of Equipment within the TLA System: Request for upgrades or replacement hardware/software, due to workload increase, excessive instrumentation failures will be evaluated as needed or at least annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer or assay within the test menu supplied may indicate probable non-compliance with the terms of this contract and will entitle the government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.
i. “Downtime” is defined as any time the equipment is not available for patient testing due to malfunction, unacceptable quality control, software system errors, or hardware failures. This includes time used for end-user troubleshooting, conversations with technical support or on-site engineer repair/support.
ii. Standard acceptable performance for the life of the contract, following acceptance as defined in section below, is defined as a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification without prolonged downtime (>4 hours) per instance more than 3 times within 30 days or more than 10 instances of downtime (of any length of time) within 30 days. In the event the equipment or an assay does not meet the standard acceptable performance for 30 consecutive days, the government will notify the contractor of the ongoing unacceptable performance and the performance will be monitored for an addition 90 consecutive days. If after 120 calendar days from the initial date of unacceptability, the vendor does not resolve the performance concerns to meet the governments expectations, the government, through the contracting officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.
iii. Removal of the existing instrument by the Contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.
iv. Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.
v. The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government.
e. Adding New Assays to the Existing Analyzers: A contract modification may be used to add additional assays to the existing test menu at any time during the contract period. Upon completion of the modification, the contractor is responsible for the assay installation and validation in accordance with Section 2, General Requirements for a CPRR contract. The assay shall be acceptable for use within 30 days from the completion of the contract modification.
5. SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE
a. The Data Management System must include a test environment and product account. The contractor is responsible for assisting the government with the initial virtual server build and on-going maintenance of both servers.
i. The system must have sufficient data storage for 2 years of workload data and provide immediate access to more than 7,500 patient records per day, including instrument identification (houses PHI and PII).
ii. The Contractor’s equipment shall be compatible, or have the ability to, act as a pass-through to the government’s Data Innovations (DI) Instrument Manager for instances when the government’s DI is the primary rule management software. DI connection is not required for vendor’s who connect directly to the government’s LIS and when the vendor’s middleware is the primary rule management software.
b. As a responsible owner of the track operating system, the contractor is responsible for assisting the government with track software modifications (i.e. routing rules) when 3rd-party connections are added and/or modified.
c. The vendor must provide all printers, including all components for printer functionality (printer drivers) and printing (excluding toner and printer paper).
d. The contractor and lab information manager must have remote access connectivity for troubleshooting systems, interface connections, and analyzers. Contractors require network access to the instruments and to the interface manager.
e. The contractor’s system software must include a comprehensive Quality Control Data Manager or provide compatibility with Bio-Rad Unity Real Time Quality Control (QC) program. The proposed system must include real-time reports, printable monthly reports, and peer-group evaluations with like controls, instruments and assays.
f. All software and software licenses, interfaces, and hardware (e.g. servers, printers, print drivers, monitors, UPS, etc.) shall be included with cost of hardware required disclosed for removal if needed.
g. Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are software systems that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e., no further security patches will be released for the OS by the manufacturer after the OS end of life nor will be available by other methods such as extended warranty purchases from the OS manufacturer). If the proposed medical device runs an unsupported OS, the medical device vendor must provide a support plan for the device (i.e., purchase of extended warranty from the OS manufacturer, an upgrade path to a supported OS, etc.) prior to deployment of the system. Contractor is responsible for maintaining operating system software in compliance with VA TRM (Technical Reference Model) and agrees to upgrade or replace the OS for ongoing approval with OI&T and BioMed network guidelines.
h. The Contractor is responsible for, at no cost to the government, any upgrades to any unsupported or unapproved operating systems on contractor-owned data management system or equipment. The contractor agrees to assist the Government with major software modifications and upgrades to meet changes in VA OI&T guidelines or laboratory operations. (per Contractors Fee Schedule/Quote).
6. PREVENTATIVE MAINTENANCE:
a. The contractor shall provide maintenance, at their expense (travel, labor and parts), to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services.
b. The preventive maintenance shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.
c. Contractor shall have remote access to system for troubleshooting purposes.
d. The contractor is responsible for performing quarterly preventative maintenance per the quoted pricing, including expenses for (travel, labor and parts).
7. SERVICE AND SUPPORT:
a. Contractor shall provide full service on-site technical support Monday – Friday, 8:30 am – 5:00 pm local time for all equipment, including the track automation system, to keep the equipment in good operating condition and subject to security regulations.
b. Telephone technical support shall be available 24 hours/day, 7 days/week with follow up on all calls within one hour of initial call. Following determination that service is required, technical on-site support must be provided within 24 hours.
c. The government shall provide the contractor access to the equipment to perform the repair.
d. The contractor will provide all parts and labor needed to repair the malfunction.
e. Travel, per diem and other expenses associated with the repair will be borne by the contractor.
f. The contractor shall furnish a malfunction incident report to the institution upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.
8. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE
(In the event new equipment / tests are installed during the life of the contract):
a. General:
i. The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.
ii. The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance.
iii. Returned goods: The VA is responsible for inspecting all products shipped hereunder and will give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.
iv. Standard and Acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement.
v. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.
vi. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.
vii. Government's Responsibility: The user will perform daily and weekly routine operation maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate daily records to satisfy the requirements of this paragraph.
b. Equipment:
i. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training.
ii. The VA reserves the right to request a ninety (90) day test and evaluation of all pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.
iii. The contractor shall be responsible for installation, which consists of in-house delivery, positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.
iv. Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guarantee date commencing ten calendar days after installation.
v. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.
vi. Ownership of Equipment shall remain with the contractor. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.
c. Reagents/Supplies/Consumables:
i. The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included (with the exception of fault by the Government), as needed (including emergency over-night delivery orders) from CALL orders within 24 hours.
ii. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission.
iii. In the event that the supplies, to include consumables, are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government and in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).
iv. The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology or technology will be at the expense of the Contractor. Alert and Notification of all technical advisory recalls and, or alerts, prior to or simultaneously with field alerts should be forwarded to Laboratory Supervisor and the Laboratory Manager. On or about the first day of each month, the contractor will ensure that each site is furnished with sufficient consumable supplies to produce a volume of tests for that month. Separate deliveries of products will be shipped to each testing site, as applicable. Failure to reserve adequate inventory will result in default.
v. If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival of the monthly standing order and routine supplies are delivered.
vi. All deliveries (routine and emergent) of reagents, supplies, consumables must be delivered directly to the laboratory at the expense of the contractor.
9. TRAINING: The contractor, without additional charge to the government, shall provide training off-site for at least two (2) key operating personnel per instrument module installed and all automation system components during the life of the agreement.
10. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation/contract, are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.
11. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.
12. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.
13. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.
14. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.
15. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority
16. RECORDS MANAGEMENT OBLIGATIONS
A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.
B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.
The term Federal record:
1. includes James A. Haley Veterans’ Hospital System records.
2. does not include personal materials.
3. applies to records created, received, or maintained by Contractors pursuant to their James A. Haley Veterans’ Hospital contract.
4. may include deliverables and documentation associated with deliverables.
C. Requirements
1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.
2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.
3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.
4. The Healthcare System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of James A. Haley Veterans’ Hospital or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to James A. Haley Veterans’ Hospital. The agency must report promptly to NARA in accordance with 36 CFR 1230.
5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to James A. Haley Veterans’ Hospital control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).
6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Healthcare System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.
7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with James A. Haley Veterans’ Hospital policy.
8. The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ Hospital information that are not specifically tied to or authorized by the contract.
9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.
10. The James A. Haley Veterans’ Hospital owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which James A. Haley Veterans’ Hospital shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.
D. Flow-down of requirements to subcontractors:
1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.
2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
17. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE
VA INFORMATION CUSTODIAL LANGUAGE:
a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
c. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
d. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
SECURITY INCIDENT INVESTIGATION:
a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures.
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