3._Performance_Work_Statement.pdf

Performance Work Statement

I. Statements Applicable to All Contractors

1. Contractor shall have licensure/certification with the College of American Pathologists, and Health Care financing agencies such as Medicaid and the Clinical Laboratory Improvement Amendments (CLIA) Program, and contractor shall have State licensure where required. Any secondary laboratory u s e d by the contractor to provide services to WPAFB shall also have appropriate licensure/certification.

2. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Air Force via a secure data collection site. The contractor is required to completely fill in all required data fields at http://v.rww.ecmra.mil.

3. Reporting inputs will be for the labor executed during the period of performance for each Government fiscal year (FY), which runs 1 October through 30 September. While inputs may be reported any time during the FY, all data shall be reported no later than 31 October* of each calendar year. Contractors may direct questions to the CMRA help desk."

a. *Reporting Period: Contractors are required to input data by 31 October of each year.

4. Uses and Safeguarding of Information: Information from the secure web site is considered to be proprietary in nature when the contract number and contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the contractor name and contract number associated with the data.

5. User Manuals: Data for Air Force service requirements must be input at the Air Force CMRA link.

However, user manuals for government personnel and contractors are available at the Army CMRA link at http://www.ecmra.mil.

II. Expert Second Opinion for Pathology Consultation Services, Ancillary Diagnostic Immunohistochemical (IHC) Testing, Prognostic and Therapeutic Testing, and Electron Microscopy(EM), Direct Immunofluorescence, and Microscopic exam of Brain/Nerve, Renal, Muscle, and Hematopathology for Anatomic Pathology.

1. Contractor shall furnish all supplies, transportation, processing facilities, equipment and any repair/maintenance incidental to providing medical laboratory tests beyond the capability of the histopathology/clinical laboratories, 88th Medical Group, Wright Patterson AFB, Ohio 45433.

2. The contractor shall provide a listing of, in house:

a. Expertise for second opinion consultation services.

b. Immunohistochemical diagnostic (LHC) stains.

c. Molecular Diagnostic, Prognostic and Therapeutic laboratory tests currently a vailable.

d. A complete list of comprehensive services covering Brain/Nerve, Renal, Muscle http://v.rww.ecmra.mil/ tissue, H e m a t o p o i e t i c , and Direct Immunofluorescence (skin).

e. The listing shall also reflect current price of each test/service. All tests on any order form must be available.

3. The contractor shall work through the histopathology laboratory referral section at the USAF Medical Center, WPAFB, for services and interaction with contractor in regard to logistics of sample transportation, supplies and inquiries on status.

4. The contractor shall present a consolidated invoice of services rendered on at least a monthly basis. Invoice will include name of patient, patient’s social security number, date of service, contractor lab ident i f icat ion number, test performed, test fee and WPAFB pathology laboratory accession number of patient. All materials returned (slides, blocks, reports) will contain WPA FB laboratory accession number of patient. Monthly summary reports shall be provided detailing month-to-date volume by contractor test codes. CPT4 coding information may be required.

5. Contractor shall have the ability in-house to perform test required (the capability to do tests in one of the laboratories owned by the contractor versus referring the test to another reference laboratory). Should tests require referral to another reference laboratory, the contractor shall forward the specimen to another appropriately licensed , accredited laboratory, with no transfer fees charged to the 88th Medical Group.

6. Contractor shall provide client services representative to be accessed by toll free telephone or emai l for any questions, problems, or changes.

7. Contractor shall provide the pathology laboratory at WPAFB with the following documents:

a. Comprehensive Laboratory Guide that lists test, instruction for collection of specimens, and any special handling requirements (web-based information acceptable).

b. Test schedule showing routine expected turnaround time. A normal turnaround on routine cases is required to be two days.

8. For expert second opinion consultation service, Contractor shall provide consultative expert service representatives who are accredited health care professionals trained to provide in-depth information on all testing listed in para a, below. For anatomic pathology ancillary testing the contractor s h a l l provide service representatives who are accredited health care professionals trained to provide in- depth information on all testing listed in para b, below.

Ancillary testing is often performed to allow 88 MDG pathologists the information needed to render a diagnosis without requiring outside expert opinion or to provide extra information in pathology reports that is needed for cancer therapeutic decisions. Contractor may bid on one of the four service categories or all. All service sets will be required to fulfill t h e needs of the Pathology Laboratory. These representatives shall be accessible to WPAFB through contractor client services.

a. Expert second opinion consulting service: Contractor shall provide, expertise in these subspecialties of diagnostic pathology: Soft Tissue, Bone, Hematopathology , Gynecologic Pathology, Dermatopathology, Gastrointestinal Pathology, Urologic Pathology, Head and Neck Pathology , Cytopathology , Endocrine Pathology, Pulmonary Pathology, Renal Biopsy, Breast Pathology, and Neuropathology.

b. Ancillary testing Contractor shall provide, a list of and availability of the following ancillary tests, for: Immunohistochemical Diagnostic Antibody stains: A-AT, ACTH, Actin , Adeno, AEI , AEl /AE3, AE3, AFP, ALK,ALK-1 ,AMYLOID A, ANNEXfN A l , B72.3, BCLl (Cyclin D I ), BCL-2, BCL-6, B-CATENfN , BER-EP4, BOB.l,C4d, CA l 9.9,CA125(0Cl 25), CAIX, CALCITONIN, CALDESMON , CALPONIN , CALRETININ , CAM 5.2, CAM5.2/AE1 , CO i a, CD2, CD3, CD4, CD5 (4C7), CD7, CDS, CD lO, CD15, CD20, CD21, CD22, CD23, CD25, CD30, CD31, CD33, CD34, CD35, CD43, CD45, CD45RO, CD56, CD57, CD61 , CD68, CD71, CD79a, CD99, COi 17, CD123, CD138, CD163, CDX2, CEA (M), CEA(P), CHROMOGRANIN , CHROMOTRYPSIN, CK5, CK5.6, CK7, CK l4, CK l 7, CK19, CK20, CK903, c-MET, CMV, COLL IV, 02-40, DBA44 , DESMIN , DOG I , EBY, E-CADHERIN , EGFR, EMA, ER, FACTOR V I 11, FACTOR V l I l a, FLI-1, FSH, GALECTIN-3, GASTRIN , GCDFP-15, GFAP, GH, GLUCAGON , GLYPICAN-3, GPH-A, GRANZYME B, HEMAGLOBIN A, HP B CORE, HEP B

SURF, HBME-1, I-IBP (H. pylori), HCAg, HCG, HEP PAR 1, HER2, HHV8, HLA-DR, HMB-45, HPAP, HPL,HSV, IgA, IgD, IgG, IgG4, IgM, INHIBIN, INSULIN,Ki-67, LH, LIPASE , MAMMAGLOBIN, MART-I , M-CELL TYRPTASE, MELAN-A, MITF, MLH-1, MOC31, MPO, MSH-2, MSH-6, MUC-1, MUC-2, MU M!, MURA, MYODI , MYOGENIN, NAPSIN-A, NEU-N, NEU ROFILAMENT, NKI, N PM, NSE, OCT-2, OCT3/4, P l 6, P504S, P53, P57, P63, P120, Pan Melanoma, PAX2 , PAXS, PAX8, PC, PD I,PIN-4, PLAP, PML, PMS- 2, PNRA (RCC), PR, PROLACTIN, PTS (Prostate Triple Stain), PSA, PTH, RB, Sl OO, SEROTONIN , SMA, SMM, SOMA, SP-A, SYNAPTOPHYSIN, TAU, TCL-1 , TOT, THROMBOMODULIN, THYROGLOBULIN, TIA-1, TOXO, TRAP, TRYPSIN, TS, TSH, TTF-1,UBIQUITIN, UROPLAKIN

III, VIMENTIN, VZV, WT-1 C-terminus, WT-1 N-terminus, ZAP-70.

c. Additional Diagnostic , Prognostic and Therapeutic testing to include: ER, PR, HER2 by IHC and FISH, Ki-67, p53, EGFR, DNA plyoidy/S-Phase, E-Cadherin, Circulating Tumor Cells, HERmark, Tamoxifen , BRAF (PCR), KRAS(PCR), NRAS(PCR), MSI(PCR), EGFR(FISH), TS, DNA, EGFR(IHC), Circulating Tumor Cells, Lynch Syndrome (HNPCC), MLH l

/MSH2/MSH6/PMS2 (II-IC), MSI (PCR), ALK(FISH), ROSI (FISH), RET (FISH), BRAF

Mutation Analysis (cobas), c-Kit Mutation Analysis, PDGFRA Mutation Analysis(PCR), 1p19q deletions (FISH), MGMT Methylation, TP2A (FISH),DNA (Cell Cycle Ana lysis),PIK3CA(PCR),Lynch Syndrome, Microsatellite lnstability(MSI) FFPE, NSCLC(FISH), REA(FISH)EGFR(PCR),EML4-ALK(PCR),PIK3CA(PCR),ALK 2p23 Rearrangement NSCLC (FISH), ERCC 1 (IHC), VYSIS (FISH), Chomosome Analysis (Lymphnode/Solid Tumor), Sarcoma Mutation Analysis(pediatric PCR),Melanoma (BRAF V600 Mutation), BRAF(Mutation Analysis), HPV Low and High Risk DNA (FISH),Flow Cytometry (Leukemia/Lymphoma Phenotyping), Flow Cytometry (ZAP-70 Analysis), Flow Cytometry (PNH Evaluation), Cytogenetics (Chromosome Analysis), Cytogenetics/FISH(Chromo some Analysis),AML l/ETO(PCR)quantitative, CBFB/MYH 11 inv( 16)(PCR) quantitative, CEBPA Mutation(PCR), FLT3 (PCR), NPM 1 Mutation(PCR), PML/RARA quantitative(PCR) , Wilms Tumor (WTI )mutation (PCR), IgVH Mutation Status, p53 Mutation Analysis, BCL2/JH t(14;18), BCR-ABL 1 Gene Rearrangement quantitative, A BLI Kinase Domain mutation, ABLI T3151 mutation in CML, JAK2 V617F, JAK2 V617, JAK2 exons 12,13, MPL analysis only, Lympocyte Clonality Panel (PCR), Qualitative B-Cell Gene Rearrangement, Qualitative T-Cell Gene Rearrangement , BCL l/JH T( 11;14).

d. Specialized testing for Electron Microscopy (EM), Direct Immunofluorescence (skin), and Microscopic exam of Brain/Nerve, Renal, Muscle, and Hematopathology Tissues.

III. Referral Laboratory Testing for Clinical Laboratory Consultation Services.

1. Vender must be able to perform specialized tests not performed in-house as well as tests not performed by Department of Defense Laboratories. Examples of testing include Lymphocyte Mitogen Proliferation, Synovasure, Flow Cytometry, and Genetic and Coagulation testing.

2. Contractor shall provide the pathology laboratory at WPAFB with the following documents:

a. Comprehensive Laboratory Guide that lists test, instruction for collection of specimens, and any special handling requirements (web-based information acceptable).

b. Test schedule showing routine expected turnaround time. A normal turnaround on routine cases is required to be two days.