36C24720Q0989 – Sources Sought – Automated Semen Analyzer

Jul 31, 2020 | Sources Sought

This is a Sources Sought to conduct market research to determine the availability of small business vendors capable of providing the requirement for SQA-Vison Automated Semen Analyzer. Please see Statement of Work and Item List below for details.

This requirement is for the Atlanta VA Medical Center. The sources sought does not guarantee the issuance of an RFQ. If you have the availability to provide the requirement, please respond to the sources sought with a capabilities statement.

The sources sought is issued solely for information and planning purposes. It does not commit the Government to contract for any supply or service whatsoever. The VA is not, at this time, seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to the sources sought; all costs associated with responding to the sources sought will be solely at the interested vendor’s expense. Not responding to the sources sought does not preclude participation in any future RFQ, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned.
 

Please note that requirements defined to date may change before a final solicitation is released. Sources Sought requirements are as follows:

  1. Please acknowledge if your company is an authorized provider of the of these services.
     
  2. Submit responses and related information via email to LaTerrica.Sewell@va.gov by 16:30 PM EST, August 6, 2020. Proprietary/Confidential material shall be clearly marked on every page that contains such. Include the name, phone number, and email address of the lead from your organization. VA reserves the right not to respond to any or all emails or materials submitted.

      3.Provide Past Performance (if applicable)

                                                                                          STATEMENT OF WORK

                                                                    HEMATOLOGY AUTOMATED SEMEN ANALYZER

BACKGROUND

The Hematology laboratory has a requirement to provide semen analysis service to the medical staff and VAMC Atlanta patient.    The Government will award a single contractor for the outright purchase of an Automated Semen Analyzer.    

SCOPE

A Semen analysis that can process a minimum of 10 samples per hour.  The analyzer must produce acceptable results for analysis.  Additional requirements will include a programmable data management system as on or within an automation process.

Specimen management system- A component of the processing automation that directs and manages the operation and components of the pre-analytical processing automation system and can connect with the hospital/laboratory information system (LIS).

The automated Sperm Quality analyzer system must include a PC and a printer for producing patient written report.  Shall include a large (at least 21.5 in) high resolution visualization touch screen monitor. The PC shall include LIS interface software.

On -board QC data management system with minimum storage capacity of QC files and to include Levy-Jennings graphs.  Analyzer must have ability to monitor instrument performance.  The ability to capture, store and electronically transfer QC data.

A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system.  The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

Tasks

Continuous monitoring of vital instrument functions with immediate operator notification of failure(s).  A record of the vital instrument function failure must be maintained and stored electronically on board the equipment

Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor.

Instrument maintenance information, patient demographic information and samples results

Contractor shall collaborate with the lab to write /develop protocols to establish customer configurable rules to enhance workflow management and productivity.

Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

Basic operator training shall be provided by the contractor on site for all shifts, as applicable.

Advance training shall be provided on instruments troubleshooting, advance middleware rules writing, data analysis, report writing and customization.

Fully Automated Test results will include, sperm concentration, percent Motility (%), percent Progressive Motility (%), percent Non-Progressive Motility, percent Normal Morphology (%), functional sperm, pH, volume, liquefication and Velocity.  The analyzer shall be able to perform auto calibration on start-up.

Equipment must be able to support multiple barcode formats (code 39, code 128) that must be enable concurrently.

Minimal personnel intervention for instrument maintenance, to reduce the instrument downtown.

Semi-Automated Test Results will include Full Morphology Differential, Vitality, Pinheads and Debris/Round Cells.

Deliverables

A barcode reading accuracy rate of 99% or greater for any component that requires barcode reading (samples labels)

Testing Instrumentation – The testing instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

Contractor shall provide safety features to avoid unnecessary exposure to biohazardous and chemical materials.  The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and requires a minimum amount of handling.

Hardware Features – The instrumentation shall have the following:

All monitors/screens will clearly display information in all light conditions.

A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

Patient testing is disable if QC failures occurs.

The technology to print results in real time or on demand, as well as an option to print exception report held in the middleware for auto verification purposes.

Method performance/comparison shall be at the expense of the contractor, shall include linearity material and reagents, and be consistent with current the Clinical Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologist (CAP) Standards and Federal regulations.  Method must also be consistent with World Health Organization (WHO).  All studies performed will be appropriate for the test menu of the respective laboratory to include seminal fluids. These validation requirements are applicable to all new testing analyzers.  Correlate for each analyte.  A minimum of 10 – 20 samples spanning the reportable range shall be run comparing the present and the proposed method.  In system where multiple samples modes exist, mode to mode correlation studies must be performed.  Contractor shall analyze results and provide statistical data to support acceptance of the new method for the above studies. Statistics shall consist of at least the mean, bias, slope, y-intercept, correlation coefficient, ROC analysis and meet current standards defined by Clinical and Laboratory Standards Institute (CLSI).

Analytical Measurement Range (AMR) Validation shall be performed on proposed instruments for each analyte to validate the reportable range.  The material must have values, which are near the low, mid and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method.

Precision study using normal and abnormal control material.  This shall include at a minimum, within run precision study of ten normal control and ten abnormal control.

Sensitivity may be validated concurrently with correlation studies.  Mathematical calculation to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

Specificity studies – a review of product literature and assay inserts to determine any adverse effect for increase bilirubin, hemolysis, lipemia or other interfering substances.

Carryover studies – successful carryover shall be completed by the contractor on all analyzers during installation.  These studies shall be performed using either contractor developed programs or programs develop by a third party (CAP/CLSI).  The program shall be provided to each laboratory at no charge.

Reference Range – A reference range must be determined for each test following CLSI guidelines.  Sample used for the reference range study must be representative of patient population being tested.  Reference ranges assessment must be performed for each lab.  One of the following protocols shall be used:

A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects.  The manufacturer shall provide specific information defining how the suggested range was determined.  A minimum of 20 reference individual shall be used to verify the manufacturer’s range.  An apparent outlier should be discarded, and a new specimen obtained to provide a statistically valid verification.

If the suggested manufacturer’s range is not appropriate for the patient population a reference range shall be established.  Establishing a reference must follow CLSI guidelines.  This requires a minimum of 120 reference individual to be used to establish a reference range.  The interval should be determined using the nonparametric method.

If a laboratory is currently using the proposed instrument/reagents system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two system proves to be acceptable.  If comparison studies are not acceptable, one of the two above items must be performed.

Items are delivered and accepted by warehouse personnel who bring them to the laboratory to the Hematology Supervisor.  Material will include the following that will be required for the performance and operation of the analyzer:

Testing Capillaries for SQA-V

QwikCheck Quality Control Beads (3 Levels)

QwikCheck WBC/pH Test Strips

QwikCheck Dilution Kit

QwikCheck Liquefaction Kit

QwikCheck Fixed Cover Slip Slides Kits

Cleaning Kit for SQAIIC-P

And any additional material or Reagent required by the manufacture for optimal analyzer performance.

SALIENT CHARACTERSITICS

The Vendor/Contractor will supply one Semen analysis automated analyzers that can access sample via manual syringe injection.  The analyzer must be able to provide all required parameter for a semen analysis.

 

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