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 small business firms to perform services for the VA Pittsburgh Healthcare System (VAPHS) located at University Drive C, Pittsburgh, PA 15240.
Responses must be submitted by 2:00 PM (EST) April 7, 2017. Submit responses to the information requested above via email to
[email protected] . All SDVOSB and VOSB firms that respond shall include proof of CVE certification via www.vip.vetbiz.gov. All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with (FAR 4.1102 Policy). While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes, and shall include as part of their response 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.
SAMPLE STATEMENT OF WORK
FOR
ANATOMIC PATHOLOGY REFERENCE LABORATORY TESTING
AT
VA Pittsburgh Healthcare System (VAPHS) located at University Drive C, Pittsburgh, PA 15240
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 VA Pittsburgh Healthcare System (VAPHS) located at University Drive C, Pittsburgh, PA 15240.
The VAPHS 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 VAPHS 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 Processing Dept., currently located on 2nd Floor, room 2NW101.
All Blocks and prepared slides will be returned to the located at University Drive C, Pittsburgh, PA 15240, Attention: Pathology & Laboratory Medicine 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 connection. Whenever possible, it is preferred that results are transmitted through an interfaced connection. 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 VHAPTH 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:
Description/Part Number*
CPT
Qty
ALK by FISH
88271x2; 88274
1
APL(PML-RARA) QUANT
81315
5
B-CELL GENE REARRANGEMENT, PCR
81261
7
BCL 1 GENE REARRANGEMENT
N/A
1
BCL-2 GENE REARRANGEMENT
N/A
1
BCR-ABL1, CML/ALL, PCR, QUANT
81206; 81207
1
CALR MUTATION ANALYSIS
81219
1
CEBPA MUTATION ANALYSIS
81218
5
CHROMOSOME ANALYSIS, BM
88237; 88264
81
CHROMOSOME, LEUKEMIC BLOOD
88237; 88264
2
C-KIT MUTATION, LIQUID TUMOR
81272
6
Consult EGL Slides
88323
1
EGFR FISH
88271(x2); 88274
1
EGFR Mutation Analysis
81235
1
EGFR Mutations
81235; 88381
1
Factor II, DNA Analysis
N/A
1
Factor V Leiden Mutation
N/A
1
FISH ANALYZE 100-300 CELLS X1
88275
2
FISH ANALYZE 100-300 CELLS X2
88275
2
FISH ANALYZE 100-300 CELLS X3
88275
26
FISH ANALYZE 100-300 CELLS X4
88275
21
FISH ANALYZE 100-300 CELLS X5
88275
7
FISH ANALYZE 100-300 CELLS X6
88275
23
FISH ANALYZE 100-300 CELLS X7
88275
20
FISH ANALYZE 100-300 CELLS X9
88275
1
FISH ANALYZE 25-99 CELLS X10
88275
1
FISH ANALYZE 25-99 CELLS X5
88275
1
FISH DNA PROBE X1
88271
13
FISH DNA PROBE X10
88271
31
FISH DNA PROBE X2
88271
1
FISH DNA PROBE X3
88271
3
FISH DNA PROBE X4
88271
18
FISH DNA PROBE X5
88271
2
FISH DNA PROBE X6
88271
26
FISH DNA PROBE X7
88271
4
FISH DNA PROBE X8
88271
4
FISH DNA PROBE X9
88271
16
FLOW COMPREHENSIVE SCREENING
88184; 88185x23; 88189
1
FLOW CYTOMETRY, EA ADD MARKER
88185
13
FLOW CYTOMETRY, EA ADD MARKER
88185
12
FLOW CYTOMETRY, EA ADD MARKER
88185
12
FLOW CYTOMETRY, EA ADD MARKER
88185
12
FLOW CYTOMETRY, EA ADD MARKER
88185
12
FLOW CYTOMETRY, EA ADD MARKER
88185
10
FLOW CYTOMETRY, EA ADD MARKER
88185
3
FLOW PLASMA CELL
88184; 88185x16; 88189
1
FLOW TISSUE/FLUID
88184; 88185x18; 88189
5
FLOW TISSUE/FLUID 8 COLOR
88184; 88185x23; 88189
25
FLOW ZAP70 EXPRESSION
88184; 88185(x3); 88187
1
FLT3 INTER.TANDEM DUP(ITD) PCR
81245;81246
9
HANDLING/CONVEYANCE OF SPEC
99001
14
HER2 by FISH
88377
1
HER2 IHC
88360
1
IDH1 and IDH2 Mutation Exon 4
N/A
1
IGK GENE REARRANGEMENT, PCR
81264
4
IGVH MUTATION ANALYSIS
81263
5
IHC 1ST ANTIBODY - TECH ONLY
88342-TC
14
IHC 1ST TECH-PP
88341-Interpretation
2
IHC EA ADDL SINGLE - TECH PP
88341
3
IHC EACH ADDTL AB - TECH ONLY
88341
9
IHC EACH ADDTL AB - TECH ONLY
88341
4
IHC EACH ADDTL AB - TECH ONLY
88341
2
IHC EACH ADDTL AB - TECH ONLY
88341
2
IHC EACH ADDTL AB - TECH ONLY
88341
1
IHC EACH ADDTL AB - TECH ONLY
88341
1
IHC Multiplex x1 Tech
88344
1
IHC Prog/Pred TS/EGFR/p27/p53
88360
1
IHC TUMOR TECH COMPONENT ONLY
88360
15
IntelliGEN (SM)
81445; 88381
1
ISH 1st Probe
88365
1
ISH Addtl Probe
88364
1
JAK2 EXON 12 MUTATION ANALYSIS
81403
2
JAK2 V617F MUTATION DETECTION
81270
3
KIT (D816V) MUTATION, PCR FL
N/A
1
KRAS Mutation Analysis
81275
1
KRAS Mutation Analysis, CRC
81275
1
Microdissection Global
88381
1
Microsatellite Instability
81301; 88381
1
MM ENRICH CMA
N/A
1
Morp Ana, Tumor IHC Manual
88360
1
MPL MUTATION ANALYSIS
81402
1
MYD88 L265P Mutation Detection PCR
N/A
1
MYD88 Mutation Detection PCR
81479
1
Myeloid Malignancies Mut NGS
N/A
1
NPM1 MUTATION ANALYSIS
81310
6
P53 MUTATION ANALYSIS
81404
3
PDGFRA Analysis in GIST
N/A
1
PD-L1 BY IHC (KEYTRUDA (R))
88342
1
REVEAL (R) SNP CMA - ONCOLOGY
81406
4
ROS1 Oncology FISH
88271x2; 88275
1
Special Stains Group II TC
88313-TC
1
T-CELL GENE REARRANGEMENT, PCR
81340;81342
4
TCRB GENE CLONALITY
N/A
1
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