Draft SOW AP Flow Reference Testing.docx

1. SCOPE:

The Contractor should be able to provide a wide range of testing services as well as specialized laboratory testing including but not limited to immunohistochemical stains, special stains, diagnostic and prognostic markers for breast cancer prognosis to include interpretation, IHC breast assays, HER2 Profiling, Micrometastasis analysis, gastric cancer profile, molecular PCR pathway testing, mismatch repair (MMR/microsatellite instability (MSI), diagnostic and prognostic molecular testing for all types of malignancy and other specialty testing, on a cost per test basis. See Test Schedule (Attachment A: Minimum Tests Required) for the minimum test list. This list is not all inclusive. Rocky Mountain Regional VA Medical Center (RMRVAMC) reserves the right to order any test provided by the Contractor.

2. GENERAL REQUIREMENTS:

A. Turnaround Time

a. The Contractor shall have 2-5 days maximum from time of receipt to provide stains to the Government for review by RMRVAMC pathologists and 7-14 days maximum from time of receipt to provide molecular testing, global testing, and specialized testing to the Government.

b. The Contractor shall have 2-3 days maximum from time of receipt to provide a FAXED report of the diagnostic test results to RMRVAMC Pathology Department.

c. The Contractor shall have 2-5 days maximum from time of receipt of Government provided patient stains and specimens, to ship back/return patient stains/slides and molecular specimens (once testing is complete) to RMRVAMC Pathology Department.

B. Performance Measures

a. The Government will monitor the accuracy of invoices and quality of reports in relation to the clinical history for the patient.

b. The Contractor’s performance will be monitored on the following criteria:

i. No more than 5% of tests sent are falsely negative or falsely positive

ii. Contractor cannot request additional testing material in more than 10% of all cases sent

iii. Contractor cannot exceed defined Turnaround times in more than 10% of all cases sent C. Ordering Paper requisitions shall be provided by the Contractor. The Government will utilize the paper requisitions and check off tests needed for the specimen(s). The Government will send/ship the paper requisition/form along with the specimen(s) to the Contractor.

D. Prices and Terms The Contractor shall provide pricing for available tests in accordance with Cost per Test (CPT) contained in the Test Schedule (Attachment A: Required Tests). RMRVAMC will provide an annual test volume. The values are estimated. Attachment A is not an all-inclusive list, but the minimal tests the Contractor provides. RMRVAMC reserves the right to order any test provided by the Contractor. Newly developed testing shall be added as required/needed. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

E. Resources

a. Government Furnished Resources

i. The Government shall package the specimens (tissue and cytology specimens) in packaging and shipping materials provided by the Government and ship the package to the Contractor.

ii. There will be no shipping costs to the Contractor for specimens shipped to the Contractor for testing.

b. Contractor Funded Resources

i. Contractor shall ship back the specimens (for stains and molecular tests) and slides (from the stains) in Contractor furnished packaging and shipping material.

ii. Shipping costs for sending specimens and slides back to the Government will be the sole responsibility of the Contractor.

3. TECHNICAL REQUIEMENTS

A. The Contractor must be Clinical Laboratory Improvement Act (CLIA) and College of American Pathologists (CAP) or equivalent certified. The Contractor shall provide a copy of their CLIA number when sending their proposals to the solicitation.

B. The Contractor must have the required tests available with accompanying Current Procedural Terminology (CPT) codes. Each laboratory test must have defined turnaround times, defined specimen requirements, and defined specimen stability. These requirements should be available electronically.

C. The Contractor must have the ability to perform all testing listed without splitting the specimen and sending to subcontracted labs as these are irretrievable specimens from surgical/invasive procedures and cannot be recollected.

D. The Contractor must have a system in place for the ordering of testing.

E. The Contractor shall have the ability to add new tests as they are developed/become available for the diagnosis of cancer.

F. The Contractor must perform the testing with sufficient quality of results as judged by the reviewing pathologist. Testing much correlate with clinical findings and other supportive diagnostic tests used to render a diagnosis.

G. The Contractor shall be HIPAA compliant.

Attachment A: Tests Required

· Mammostrat

· KRAS by PCR

· EGRF by PCR

· ALK FISH

· BRAF V600 Mutation

· BRAF by PCR

· EGRF by FISH

· MMR global

· Her 2 neu global

· Her 2 neu FISH

· ER global

· PR global

· MSI by PCR

· Kappa FISH (stain only)

· Lambda FISH (stain only) Immunostain:

· AACT

· AAT

· ACTH

· Actin (MSA)

· Actin (SMA)

· Adenovirus

· AE1/AE3 (pan-CK)

· AFP

· ALK-1

· Amyloid A

· AR

· ß-Amyloid P

· B72.3

· B-Amyloid

· BCA-225

· BCL1 (Cyclin D1)

· BCL6

· BCL2

· BerEP4

· Beta-Catenin

· BE-8, BOB1

· BRCA1

· Breast Triple Stain

· CA15.3

· CA19.9

· CA125

· Calcitonin

· Caldesmon

· Claponin

· Calretinin

· CAM 5.2

· Cathepsin D

· Cat Scratch

· Cyclin D1/BCL1

· CD1a

· CD2

· CD3

· CD4

· CD5

· CD7

· CD8

· CD10

· CD11c

· CD14

· CD15

· CD19

· CD20

· CD21

· CD22

· CD23

· CD25

· CD30

· CD31

· CD33

· CD34

· CD35

· CD38

· CD42b

· CD43

· CD45

· CD45RB

· CD45RO

· CD56

· CD57

· CD61

· CD68

· CD74

· CD75

· CD79a

· CD99

· CD117(C-KIT)

· CD123

· CD138

· CD163

· CDX2

· CDX2/CK7

· CEA monoclonal

· CEA polyclonal

· Chromogranin A

· CK5

· CK5/6

· CK7

· CK8

· CK14

· CK17

· CK18

· CK19

· CK20

· CK903(CK-HMW)

· CK-Double Stain (HMW/LMW)

· CK OSCAR (pan-CK)

· CMV

· Collagen IV

· COX2

· CXCR4

· Cyclin E

· D2-40

· DBA.44

· DCC

· Desmin

· DOG1

· DPC4 (SMADU)

· EBV(LMP-1)

· E-Cadherin

· eIFd4E

· EGFR

· EMA

· ER

· ERCC1

· Factor VIII

· Factor XIIIa

· Fascin

· Fli-1

· FOX P3

· FSH

· GCDFP-15

· GFAP

· GH

· Gastrin

· Glucagon

· GSTπ

· Glycophorin-A

· Glypican-3

· Granzyme

· H.Pylori

· HBVc

· HBVs

· HBME-1

· HER2(hercepTest)

· HCGβ

· Hemoglobin A

· HepPar-1

· HHV8

· HPV

· HLA-DR

· HMB-45

· HAFG2

· HPL

· HSV I

· HSV II

· IgA

· IgD

· IgG

· IgG4

· IgM

· Inhibin

· Insulin

· Kappa

· Ki-67

· Ki-67/Caspase-3

· LH

· Lambda

· Lysozyme

· Mammaglobin

· Melan A

· Mesothelin

· MGMT

· MITF

· MOC-31

· MSH2

· MSH6

· MDR

· MLH1

· M PO

· mTOR

· MUC-1

· MUC-2

· MUC-5

· MUC-6

· MUM1

· MyoD1

· Myogenin

· Myoglobin

· Napsin A

· NB

· NF

· NSE

· OCT 2

· OCT 4

· p16

· p21

· p27

· p53

· p57

· p63

· p120(caterin)

· p501S

· p504S

· Pakt

· Pan Melanoma

· Parvovirus

· PAX2

· PAX5

· PD1

· PDGFRA

· PDGFRB

· Perforin

· PHH3

· PLAB

· P.Carinii

· PMS2

· PP

· PR

· Prealbumin (TTR)

· Prolactin

· Prostate Triple Stain

· PSA

· PSAP/HPAP

· PTEN

· PTH

· RCC1

· S100

· Serotonin

· SMMHC

· Somatostatin

· Surfactant

· Spirochete

· Survivin

· Synaptophysin

· Tau

· TdT

· TM

· TGB

· TGF- α

· TRAP

· TS

· TSH

· TTF-1

· TIA-1

· Toxoplasma

· Tryptase

· Tuberculosis

· Tyrosinase

· Uroplakin III

· VEGF

· Villin

· Vimenti

· Wilm’s Tumor (WT-1)

· ZAP-70

Hematopathology:

· Flow Cytometry Panels

· FISH (Hematologic, Plasma Cell)

· Individual Probes

· Cytogenetics

· Molecular Genetic Testing

· Cancer Profiles

· Liquid Biopsy Testing Solid Tumor:

· Consultation

· Cancer Profiles

· Prostate Cancer Testing

· Breast Cancer Testing

· Colon Cancer

· Sarcoma

· Brain Cancer

· Bladder Cancer

· GI Cancer

· Melanoma

Rocky Mountain Regional VAMC Immunohistochemical, Special Stain, Hematopathology, Genetic, Molecular, & Solid Tumor Reference Laboratory Services Statement of Work

· Lung Cancer