Prep Stain Slide Processor

Added: Mar 23, 2016 11:39 am Modified: Mar 23, 2016 12:36 pmTrack Changes This is a modification to the SOW in the Original RFQ.



This is for a "Brand Name Or Equal" Prep stain slide Processor



STATEMENT OF WORK FOR BD PREPSTAIN PROCESSOR



Introduction/Background



The VA New York Harbor Healthcare System is dedicated to providing quality health care to veterans using the abilities of all employees supported by our commitment to education and research.



We are recognized locally, regionally, and nationally as a leader in quality patient care, positive customer service, medical/allied health education, and health-related research and employment opportunities. We seek to be the provider of choice of veterans and the community by offering an efficient, integrated quality health care system capable of providing a full range of primary, specialty and chronic health care services in a system that is readily accessible and responsive to change.



Our key business drivers are quality, financial integrity, patient satisfaction and employee satisfaction.



INTENDED USE



The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath slides that are intended as replacements for conventional gynecologic Pap smears. SurePath slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.

SurePath Preservative Fluid is an appropriate collection and transportation medium for gynecologic specimens tested with BD ProbeTec Chlamydia trachomatis (CT) Qx and Neisseria gonorrhea (GC) Qx Amplified DNA Assays. Refer to the assay package inserts for instructions on using SurePath® Preservative Fluid to prepare specimens for use with these assays.



Objectives/Requirements



The New York Harbor Healthcare System is ordering a BD PerpStain Processor for Pap smears, screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories.



The PrepStain® System converts a liquid suspension of a cervical cell sample into a discretely stained, homogeneous thin-layer of cells while maintaining diagnostic cell clusters. The process includes cell preservation, randomization, enrichment of diagnostic material, pipetting, sedimentation, staining, and coverslipping to create a SurePath slide for use in routine cytology screening and categorization as defined by The BethesdaSystem.1 The SurePath® slide presents a well-preserved population of stained cells present within a 13mm diameter circle. Air-drying artifact, obscuring, overlapping cellular material and debris are largely eliminated. The numbers of white blood cells are significantly reduced, allowing for easier visualization of epithelial cells, diagnostically relevant cells and infectious organisms.



The SurePath process begins with qualified medical personnel using a broom-type sampling device (e.g., Cervex Brush® Rovers Medical Devices B.V., Oss - The Netherlands) or an endocervical brush/plastic spatula combination (e.g., Cytobrush PlusGT and Pap Perfect® spatula, Medscand (USA) Inc., Trumbull, CT) with detachable head(s) to collect a gynecologic specimen. Rather than smearing cells collected by the sampling devices on a glass slide, the heads of the sampling devices detach from the handle and are placed into a vial of SurePath Preservative Fluid. The vial is capped, labeled, and sent with appropriate paperwork to the laboratory for processing. The heads of the sampling devices are never removed from the preservative vial containing the collected sample.



Requirements:







Description of Equipment: 1 490100 each Prepstain Slide Processor



2 491243 each Vacuum Pumps



1 490410 each PrepMate Automated Accessory



1 490663 each Centrifuge



1 491073 each Computer



1 490528 each Install Kit Customer: VA Medical Center:

800 Poly Place



Brooklyn, NY 11209







Standard Warranty: 12 months







Extended Warranty: additional 2 years



Compliance (If applicable)



The vendor shall be responsible for determination of and compliance with federal and state or local code requirements, design data, and other factors necessary to design and install the items at the desired location.



The system will not require any new construction, space, special wirings etc.



Training of Operating personnel (If Applicable)



(a) The price quoted shall include contractor responsibility for providing on-site orientation and training of using personnel in operation and care of the equipment furnished. This training shall include actual demonstration and operation of the equipment, preventative maintenance, and any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action shall in no way jeopardize the Government's rights under contract guarantee clause. Upon completion of installation, this training shall be given by qualified contractor representatives on a date to be determined by the using service POC. Operator and maintenance training shall not be conducted concurrently.



(b) Vendor shall submit training materials and training videos (prepared in CD or DVD format) on each piece of equipment for operation and maintenance. Any available training videos shall be for operation and maintenance and shall not be combined. These training materials and videos shall demonstrate the operation and maintenance of the equipment and any adjustments or other actions that may be undertaken by VA operating personnel in the event of failure of equipment. These training materials and videos shall be submitted to the responsible operations official or his designee prior to beginning of training.



(c) The Vendor shall consult with the Contracting Officer Representative or person acting in that capacity regarding the time this training will begin. These officials will be responsible for arranging for the presence of personnel to be trained.



Place Of Delivery



The result(s) will be delivered to



Path and Lab Service Attn: Mr. Babb Pelham

VA New York Harbor Healthcare System 800 Poly Place, Brooklyn NY 11209



Time Of Delivery

The required delivery date shall be as soon as possible. Delivery dates specified on delivery orders may be adjusted by the contracting officer to coincide with the date the hospital needs the results.



Acceptance Procedures



Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the Government in accordance with this clause.