6632--Chemistry CPRR with Automation

STATEMENT OF NEED

Clinical Chemistry CPRR with Automation System

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

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

GENERAL REQUIREMENTS:

The contractor is required to furnish all of the following to all locations defined within the contract (Per Quoted Pricing):

Instrumentation hardware and software (analyzers, track line system, operating system, UPS, etc.).

Upgrades to and maintenance of hardware or software necessary to fulfill the test requirements.

Reagents, Calibrators, and Quality Control materials, including the use of 3rd-party Quality Control material

All consumables and user-defined replacement parts necessary to operate the contractor's equipment.

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.

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.

Annual test volumes provided are based upon historical reported result data and are not guaranteed a minimum.

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.

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 -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 LP 501AB

04P47-01

13

MS THY 901AB

04P36-10

4

MS UC 1 701AB

04P39-01

10

MS UC 4 704AB

04P40-01

10

MS UC 5 705AB

04P41-01

7

MS VIT D 506

04P36-11

2

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

EQUIPMENT SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

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.

James A. Haley Veterans Hospital:

Alinity C Modules 4 Each

Alinity I Modules 2 Each

Architect 1 Each

Automation System Components:

IOM Module with Software System 1 Each

Centrifugation Modules 2 Each

Refrigerated Storage Module 1 Each

Specimen Decappers 2 Each

Specimen Sealers 2 Each

Automation Track Components (complete system) 1 Each

Automation System Software Operating System (Data Innovations) 1 Each

DI Water System 1 Each

New Port Richey VA Outpatient Clinic:

Alinity C Modules 1 Each

Alinity I Modules 1 Each

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

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.

Lakeland Community-Based Outpatient Clinic:

Alinity C Modules 1 Each

Alinity I Modules 1 Each

DI Water System 1 Each

Temple Terrace VA Clinic and Mental Health Facility

Alinity C Modules 2 Each

Alinity I Modules 1 Each

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

Miscellaneous Services Performed by Abbott on an As-Needed Basis

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

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

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

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

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

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.

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.

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.

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.

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.

The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government.

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.

SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE

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.

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).

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.

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.

The vendor must provide all printers, including all components for printer functionality (printer drivers) and printing (excluding toner and printer paper).

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.

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.

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.

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.

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).

PREVENTATIVE MAINTENANCE:

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.

The preventive maintenance shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

Contractor shall have remote access to system for troubleshooting purposes.

The contractor is responsible for performing quarterly preventative maintenance per the quoted pricing, including expenses for (travel, labor and parts).

SERVICE AND SUPPORT:

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.

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.

The government shall provide the contractor access to the equipment to perform the repair.

The contractor will provide all parts and labor needed to repair the malfunction.

Travel, per diem and other expenses associated with the repair will be borne by the contractor.

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.

DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE

(In the event new equipment / tests are installed during the life of the contract):

General:

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.

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.

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.

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.

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.

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.

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.

Equipment:

Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training.

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.

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.

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.

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.

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.

Reagents/Supplies/Consumables:

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.

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.

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).

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.

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.

All deliveries (routine and emergent) of reagents, supplies, consumables must be delivered directly to the laboratory at the expense of the contractor.

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.

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.

TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

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.

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.

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.

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

RECORDS MANAGEMENT OBLIGATIONS

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.

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:

includes James A. Haley Veterans Hospital System records.

does not include personal materials.

applies to records created, received, or maintained by Contractors pursuant to their James A. Haley Veterans Hospital contract.

may include deliverables and documentation associated with deliverables.

Requirements

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

Flow-down of requirements to subcontractors:

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.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

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. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING: the training identified in this section does not apply to this contract until such time as when personnel would be working in the site(s), locations, of the VA on a regular basis. Regular basis would include daily work, physically in the hospital, for the duration of the period of performance identified.

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SON.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions so they are in compliance with James A. Haley Veterans Hospital policies listed on the JAHMC Document Management Center share point site:

HPM NO. 90-25; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; SECURITY MANAGEMENT PROGRAM

HPM NO. 132 05; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. . The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor s badge as well as their company s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued on a daily basis and must include the following information: Company name, project number, date and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch. The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact. Awarded contract 36F79719D002436C24826N0460 to ABBOTT LABORATORIES INC. for 3378770.75 on 2026-03-31.