GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK
NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) to determine capability of potential sources and is for information and planning purposes only.
Veterans Health Affairs, Network Contracting Office 4, is issuing this request for information/sources sought notice in order to identify capable SDVOSB, VOSB, Woman-Owned, Disadvantaged Small Business, 8(a), and general small business firms to perform services for the Michael J. Crescenz VA Medical Center (CMCVAMC) located at 3900 Woodland Ave., Philadelphia, PA 19104.
Responses must be submitted by 4:00 PM (EST) March 24, 2017. Submit responses to the information requested above via email to
[email protected] . All small business firms that respond shall include proof of small business status via their Representations and Certifications (per FAR 4.1102 Policy) and if applicable CVE certification for SDVOSB and VOSB status. Please also provide a brief capability statement that covers the information in the following tentative statement of work.
The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses.
Michael J. Crescenz VA Medical Center, Philadelphia PA
Pathology and Laboratory Medicine
TENTATIVE STATEMENT OF WORK
Specialized Services and Testing for Anatomic Pathology and Cytology Specimens
Contractor shall provide all employees, supervision, supplies and equipment necessary to perform specialized services for Anatomic Pathology specimens to include Immunohistochemistry Stains, Cytochemical Stains, Flow Cytometry, FISH testing, Cancer Marker Testing and other esoteric testing for the Michael J. Crescenz VA Medical Center (CMCVAMC) located at 3900 Woodland Ave., Philadelphia, PA 19104.
The CMCVAMC will package specimens according to the guidelines required by the contractor. Contractor shall provide all necessary supplies for biomedical materials to be transported from the CMCVA Medical Center, Laboratory to the Contractor s laboratory. These supplies shall include, but may not be limited to:
Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory.
Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 49 CFR Part 72, CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.
Contractor must ensure the security of the specimen contains and protect against the accessibility of the specimens and the information that accompanies the specimens.
Routine transportation services shall occur once per day, Monday Friday, except for Federal Holidays. Specimen pick-up times will be late afternoon between 5PM 7PM. Vendor may transport specimens by courier or via FED-X/ UPS. If using FED-X or UPS, the vendor will supply pre-paid envelopes for shipping specimens. Pick-up of specimens will be from the Histology Laboratory, currently located on 3rd Floor, room 3b132.
All Blocks and prepared slides will be returned to the CMCVAMC located at 3900 Woodland Ave, Philadelphia, PA 19104, Attention: Pathology & Laboratory Medicine (113) via courier drop-off or UPS or FEDX. These materials shall be returned within 7 days after completion of diagnostic studies.
Contractor must provide a phone number for consultation Pathology services regarding test results. Services will be minimally Monday through Friday, excluding Federal Holidays,
9AM 5PM.
Contractor test reports must contain the following information at a minimum:
Patient s full name
Patient s identification number (e.g. social security number/ DOB)
Physician s name
VA Surgical Pathology accession number
Submitting Laboratory Name
Submitting facility account number
Patient s location (clinic/ ward)
Tests(s) ordered
Date/ time of specimen collection
Date/ time test completed
Test result
Reference intervals (if applicable adjusted for age, sex or race)
Interpretation of Results if applicable
Name and address of testing laboratory
Any other information the laboratory has that may indicate a questionable validity of test results
Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.
Hard copy Reports should be sent via secure fax to 215-823-4271. An on-line account for the Pathologists should also be made available to access results via lab s website.
Results will be available within the listed turnaround times. Turnaround time will be from the time the specimen leaves the CMCVAMC Laboratory
Test Name
Turnaround Time
Immunohistochemistry Stains
1-2 Days
Flow Cytometry
2 Days
Morphology
3-4 Days
FISH
6 Days
Cytogenetics
8 Days
Molecular
8 Days
The Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:
Routine questions and clarifications regarding collection requirements
Inquiries regarding the status of pending orders
Result interpretation inquires/ Consultative services
Inquiries regarding supplies
Contractor shall be reimbursed per technical component, professional component or Global component, of the applicable CPT code, depending on the services rendered.
CPT codes will include with the projected annual volumes of each:
TEST_NAME
CPT
TOTAL ESTIMATED ANNUAL QUANTITY
ALK by FISH (NSCLC)
88271x2; 88274
33
APL(PML-RARA) Quant
81315
3
B-Cell Gene Rearrangement, PCR
81261
2
BCR-ABL1, CML/ALL, PCR, Quant
81206; 81207
12
Breast IHC P2-IHC
88360x3
1
Breast IHC/FISH Profile 1
88360x1; 88377
3
CALR Mutation Analysis
81219
4
CEBPA Mutation Analysis
81218
4
Chromosome Analysis, Bone Marrow
88237;88264
32
Chromosome, Leukemic Blood
88237; 88264
26
c-KIT Mutation, Liquid Tumor
81272
6
Colorectal Cancer 7
88342; 88341 x3
17
Consult EGL Slides
88323
2
EGFR FISH
88271 (x2)
88274
2
EGFR Mutation Analysis, NSCLC
81235
6
EGFR Mutations
81235;88381
30
Factor II, DNA Analysis
#N/A
1
Factor V Leiden Mutation
#N/A
1
FISH analyze 100-300 cells additonal probes
88275
347
FISH analyze 100-300 cells 1
88275
21
FISH DNA Probe additional probe
88271
116
Flow Comprehensive Screening
88184; 88185x23; 88189
4
Flow Cyto Interp (16+ Markers)
88189
1
Flow Cyto Interp (2-8 Markers)
88187
5
Flow Cyto Interp (9-15 Marker)
88188
4
Flow Cytometry PNH FLAER
88184; 88185x7; 88187
5
Flow Cytometry, Ea Add Marker
88185
16
Flow Cytometry, Ea Add Marker Blood/ Bone Marrow
88185
427
Flow Cytometry, Ea Add Marker Tissue and/or Fluids
88185
111
Flow Cytometry, First Marker
88184
10
Flow Plasma Cell
88184; 88185x16; 88189
13
Flow Tissue/Fluid Tissue and/or Fluids
88184; 88185x18; 88189
54
Flow Tissue/Fluid 8 Color Blood/ Bone Marrow
88184; 88185x23; 88189
114
FLT3 Inter.Tandem Dup(ITD) PCR
81245; 81246
4
Handling/Conveyance of Spec
99001
62
HER2 by FISH
88377
6
HER2 IHC
88360
4
HPV Subtype- 1st probe GLBL
88365
1
IDH1 and IDH2 Mutation, Exon 4
#N/A
1
IgVH Mutation Analysis
81263
7
IHC 1st Antibody - TECH ONLY
88342-TC
900
IHC ea addl AB Stain x1 GLBL
88341- Interpretation
558
IHC ea addl AB Stain x2 TECH
88341-TCx2
6
IHC ea Addl Single - TECH ARUP
88341-TCx1
4
IHC ea Addl Single - TECH Professional
88341-TCx1
50
IHC each Addtl AB - TECH ONLY
88341-TC
2108
IHC Multiplex x1 Tech
88344-TCx1
11
IHC Prog/Pred TS/EGFR/p27/p53
88360
13
IHC Prog/Pred TS/EGFR/p27/p53
88360
1
IHC Tumor Tech Component ONLY
88360-TC
3
IntelliGEN(SM)
81445;88381
1
ISH 1st Probe TECH Only
88365-TC
26
ISH Addtl Probe TECH Only
88364-TC
19
ISH Addtl Probe TECH Only
88364-TC
4
JAK2 Exon 12 Mutation Analysis
81403
5
JAK2 V617F Mutation Detection
81270
25
KRAS Mutation Analysis
81275
5
KRAS Mutation Analysis, CRC
81275
5
Microdissection - Global
88381
6
Microsatellite Instability
81301;88381
2
MM Enrich CMA
#N/A
3
Morp Ana, Tumor IHC Manual
88360
1
MPL Mutation Analysis
81402
5
MYD88 L265P Mutation Det. PCR
#N/A
6
MYD88 Mutation Detection PCR
81479
2
Myeloid Malignancies Mut NGS
#N/A
1
NPM1 Mutation Analysis
81310
5
P53 Mutation Analysis
81404
12
PDGFRA Analysis in GISTs
#N/A
1
PD-L1 by IHC (Keytruda (R))
88342
17
Reveal (R) SNP CMA - Oncology
81406
15
ROS1 Oncology FISH
88271x2; 88275
8
Special Stains-Group II TC
88313-TC
15
T-Cell Gene Rearrangement, PCR
81340; 81342
5
TCRB Gene Clonality
#N/A
2
Quality Assurance Monitoring
Contractor must have and maintain licensure and certifications required to operate its laboratory.
Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. Services will be monitored through one or a combination of the following mechanisms:
Surgical Pathology/ Cytology Department will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Services such as:
Specimen pick-up is minimally daily and not earlier than 5PM. Compliance rate for this is minimally 90%.
Turn-around times for resulting of tests are at a minimal compliance rate of 90%.
Documentation of services performed will be reviewed prior to certifying payment. VA will pay only for services actually provided, and in accordance with the pricing schedule.
Quality Factors that will be monitored.
PERFORMANCE OBJECTIVE
TASKS:
PERFORMACE STANDARD
ACCEPTABLE (MINIMAL) QUALITY LEVEL
MONITORING METHOD
Ensure the safety and integrity of specimens
No loss or destruction of specimens
100% of the time
Contractor reporting; Government inquiries
Testing services will be performed in accordance with the defined turnaround times (TAT)
Results will be reported within the TAT as stated in the contract
90% of the time
10% of randomly selected tests
Pick-up times for specimens are within the designated times +/- 30 min
Contractor pick-up specimens with the designated time +/- 30 min
90% of the time
Direct Observation
Bid Protests Not Available