Title: RENAL PATHOLOGY CONSULTATION SERVICES
This is a Sources Sought Notice
(a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited.
(b) Although "proposal," "offeror," contractor, and "offeror" may be used in this sources sought notice, any response will be treated as information only. It shall not be used as a proposal.
(c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law.
(d) This Sources Sought is issued by VISN 2 Contracting Office in Manhattan, NY for the purpose of collecting information about Renal Pathology Consultation Services at the Veterans Affairs New Jersey Health Care System, East Orange Campus, Pathology & Laboratory Medicine Services, 385 Tremont Avenue, East Orange, NJ 07018. The VA is seeking to provide for this new requirement as of August 1, 2019. The NAICS code identified for this requirement is 621511 Medical Laboratories. The requirement is detailed in the Statement of Work section of this document.
(e) Cursory market research has identified several small businesses that may be able to provide for this requirement. Contractors that are able to meet the requirements in the attachment are encouraged to email a capability statement and full information to Monique Paltan at Monique.Paltan@va.gov.
- Part of the purpose of this sources sought is to determine the viability of set aside to a specific socio-economic category. Contractors shall identify the NAICS code for the services being offered as well as their size status under said NAICS. If contractor is a Service Disabled Veteran Owned Small Business (SDVOSB), a Veteran Owned Small Business (VOSB), or any other special category of contractors, then contractor is responsible for providing documentation in support of this. This information will be used to determine the viability of a set aside for this requirement.
- Contractors shall also identify any Federal Supply Schedules that may carry the desired services.
- Contractors shall identify pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP.
- Contractors shall include any relevant comments about the Attachment(s) if applicable.
STATEMENT OF WORK
RENAL PATHOLOGY CONSULTATION SERVICES
BACKGROUND: VA New Jersey Health Care System (East Orange Campus) is seeking annual services for Renal Pathology Consultation that includes light microscopy, electron microscopy, immunohistochemical staining, immunofluorescence staining, special stains, a professional opinion and a final report. The services shall include personnel, materials, facilities, supplies and all other services and items necessary to perform testing of renal biopsies, as well as interpretation of the results.
PLACE OF PERFORMANCE:
Veterans Affairs New Jersey Health Care System
East Orange Campus
Pathology & Laboratory Medicine Service
Mail Code 113
385 Tremont Avenue,
East Orange, NJ 07018
SCOPE:
SPECIMEN TESTING SERVICES:
The Contractor shall provide the following services on renal pathology specimens: light microscopy, electron microscopy, immunohistochemical staining, special stains and immunofluorescence staining.
B. The contractor shall evaluate of all medical renal diseases and renal transplantation pathology. Routine light microscopic interpretation with immunofluorescence, special stains, and electron microscopy. The findings shall be integrated into the final report and correlated with the clinical information. Telephone consultation within 24 hours of receiving the specimen, as well as preliminary findings must be reported to the nephrologist.
C. The Contractor shall provide a final report that includes a professional opinion and the following information:
The veteran s name.
The veteran s identification number, e.g. social security number.
Patient location, e.g., inpatient ward, outpatient.
Name of the submitting facility, e.g., EOVAMC.
Government laboratory accession number.
Reference labs accession number.
The name of physician who collected the specimen.
The type of specimen received.
Name of test ordered.
Date and time the specimen was collected.
Date and time specimen was received at the Contractor s lab.
Date the test was performed.
Date and time the test was completed.
Name and address of testing laboratory.
Results of specimen testing including any interpretation and/or analysis of the
test results.
Name of the individual providing the final professional report.
Outline of testing protocols and reference ranges. Abnormal results shall be
flagged.
Comments related to the specimen testing as deemed relevant to the validity of
and/or interpretation of the test results.
Specimen inadequacy must be reported with documentation supporting
unsuitability for testing.
TRANSPORTATION SERVICES FOR REFERENCE TESTING SPECIMEN: Contractor shall provide transportation of primarily biomedical materials that include patient specimens originating from Government facilities and destined to the contracted commercial reference laboratory.B These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents.B Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.B
Routine transportation services shall occur on an as needed basis, approximately once per week, from the VA New Jersey Health Care System. Contractor shall supply kits including all necessary packaging for mailing specimens.B The specimen will be shipped to the contractor s testing facility via UPS or FedEx, Monday through Friday during normal business hours. If it is medically necessary for emergency, specimens will be shipped to the contractor s testing facility via UPS or FedEx over the weekend.
Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory.B These supplies shall include, but may not be limited to:
Shipping and packaging containers.B 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 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.
Test request forms preprinted with the appropriate Shipping Section details and
account information.
The Contractor shall comply with the Joint Commission (JC), the College of American Pathologists (CAP), the Clinical Laboratory Improvement Amendments (CLIA) and all Federal, State, and local laws applicable to the performance of work including the Food and Drug Administration (FDA).
The Contractor shall provide a copy of their current College of American Pathologists Accreditation (CAP) Certificate and their current Clinical Laboratory Improvement Amendments (CLIA) certificate.
The Contractor must have at least two (2) fellowship trained renal pathologists available to provide services covered under this requirement. Each renal pathologist working under this contract must have an active state medical license and be currently certified in Anatomical Pathology by the American Board of Pathology. The contractor must provide a copy of each renal pathologist s active medical license, board certification, renal pathology fellowship certificate and current curriculum vitae. Each renal pathologist must maintain their active state medical license and board certification when providing services under this contract. If the renal pathologist has a lapse in their state medical license or Anatomical Pathology certification by the American Board of Pathology, the pathologist must not provide services under this contract.
The contractor shall notify the Veterans Affairs New Jersey Health Care System if a new renal pathologist is added to the list of pathologists providing pathological interpretations. The contractor shall provide an updated copy of the pathologist s curriculum vitae, a copy of the new renal pathologist s active state medical license, current board certification and renal fellowship certificate 4 weeks before the pathologist provides services under this contract. The East Orange VAMC Pathology & Laboratory Medicine Service will review the credentials submitted, determine the suitability of the applicant and issue a written statement accepting or rejecting the pathologist for service on this contract within 2 weeks of receipt of the documents.
The Contractor will send the Final Report to the East Orange VAMC Pathology & Laboratory Medicine Service by a traceable method and fax or e-mail a copy to the East Orange VAMC Pathology & Laboratory Medicine Service within 24 hours of completion of the final report. If the Contractor offers on-line reporting and wishes to offer this method of reporting in addition to the mail, e-mail and FAX service, this is acceptable.
The Contractor will be responsible for typographic errors and is required to make changes within 24 hours of notification.
The Contractor will provide a CD with electron microscopy images and immunofluorescence images for each case in a timely manner to the East Orange VAMC Pathology & Laboratory Medicine Service. The contractor will send the CDs to the East Orange VAMC by a traceable method.
The Contractor must return the specimens/slides in a timely manner to the Administration Office of the East Orange VAMC Pathology & Laboratory Medicine Service.
The Contractor shall provide a point-of-contact client service representative that can be reached by phone and by electronic mail.
New medical testing shall not be introduced without prior approval of the Contracting Officer and Contracting Officer's Representative (COR). The VAMC will only pay for services stipulated in the contract. The contractor is responsible for any charges that are not stipulated in this contract. The VAMC will not pay for services provided outside of the contract unless approved in writing by the Contracting Officer via Modification before the test is performed.
The Contractor shall provide single-site (one lab) in-house specimen testing. Specimens must not be sent from the Contractor s lab to another reference lab.
The Contractor will monitor turn-around-time of each final report. The turn-around-time measurement begins when the Contractor receives the specimen and ends when the final report is submitted to the East Orange VAMC, Pathology & Laboratory Medicine Service. The Contractor will submit an estimated turn-around-time of the specimen (Renal or Kidney Biopsy) received at contractor s testing laboratory.
All records generated during the performance of the contract are considered Government records and shall be turned over to the Government upon termination of the Contract.
HIPAA COMPLIANCE: The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs.
PERIOD OF PERFORMANCE: The Base Period of Performance will be 8/1/19 to 7/31/20 with the provision of two (2) Option Years.
Paltan, Monique
Contract Specialist
Monique.Paltan@va.gov
monique.paltan@va.gov
