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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 08, 2015 FBO #5067
DOCUMENT

Q -- Histocompatibility Testing (HLA) Services - Attachment

Notice Date

10/6/2015
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Birmingham VA Medical Center;700 South 19th Street;Birmingham AL 35233
 

ZIP Code

35233
 

Solicitation Number

VA24715Q0870
 

Archive Date

11/30/2015
 

Point of Contact

Connie Ganier
 

E-Mail Address

3-8101
 

Small Business Set-Aside

N/A
 

Award Number

VA247-15-D-0302
 

Award Date

10/1/2015
 

Awardee

UNIVERSITY OF ALABAMA AT BIRMINGHAM;701 S 20TH ST;BIRMINGHAM;AL;35294
 

Award Amount

292,486.30
 

Description

STATEMENT OF WORK (SOW) A.GENERAL GUIDANCE 1.Title of Project: Histocompatibility Testing for Transplant Patients and Donors 2.Scope of Work: The contractor shall provide all labor, supervision and all other resources required to deliver the requirements stated herein, except as may otherwise be specified in this statement of work. 3.Background: This service is required as frequent testing is needed to support the Birmingham VA Medical Center's Kidney Transplant program. Histocompatibility testing is done to identify which human leukocyte antigen (HLA) genes and antigens a person has inherited, primarily to match up donors and recipients of organ transplants and to detect antibodies to HLA antigens that would cause transplants to be unsuccessful. The services required by contact include miscellaneous STAT tests, Histocompatibility Testing for Solid Organ Transplantation. Histocompatibility testing includes the following assays: "HLA typing of recipients "HLA typing of living donors "HLA typing of deceased donors "Screening for anti-HLA antibodies pre and post-transplant-single antigen specificity "Cross matching of donor and recipient pairs The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical specimens as requested by the BVAMC. The referencing lab shall be available twenty-four hours per day, seven days per week, including holidays. The BVAMC will be responsible for specimen collection, preparation, and preservation. The following services are also required: "Must be a certified OPTN/UNOS Histocompatibility Laboratory "Archiving of serum for cross matching for regular antibody screening and cross matching donor and recipient pairs with multiple samples, especially if the recipient is sensitized. "Virtual cross matching expertise 24/7 for deceased donor offers "24/7 final cross matches for deceased donor transplants "Post-transplant screening for Donor Specific Antibodies (DSA) on a regular basis for all patients who are high immunologic risk and all who develop rejection. "Listing and maintenance of all histocompatibility information in Donor-net (the UNOS site for organ allocation) "Must be located within 30 minutes ground transportation time from the BVAMC, to ensure a turnaround time for cross matched less than four hours "Must have the ability to directly enter HLAs, PRAs, and Unacceptables into UNet SM, UNOS' computer-based network for allocating donated organs and managing transplant data "Must comply with all Organ Procurement and Transplantation Network (OPTN) (see embedded document below) The Contractor must provide the BVAMC a Directory of Laboratory Services. The following information shall be included in the Directory of Lab Services. "Test-specific specimen collection and preservation requirements for each test or analytic "Test-specific method and interpretation for each test or analytic "Test-specific method reference ranges, adjusted for age, sex, or race, when required "Test-specific method sensitivity and specificity, when required "Test-specific schedule of performance and maximum turnaround time for each "Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units. In the event of any change, the information must first be provided to the BVAMC Point of Contact and/or the COR at least 14 days prior to the Contractor's change. No changes to procedures will be made with less than fourteen days' notice. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the BVAMC. For all tests identified in the Schedule of Supplies/ Services, the contractor will provide the following information: "Ordering Code (Contractor's Identification Code) "CPT Codes "Test Description "Test methodology "Specimen types "Specimen collection and handling requirements "Test result interpretation or interpretive remarks, if appropriate "Testing site "Maximum turnaround time (TAT) for each test listed 4.Qualifications: The Contractor shall have all licenses, permits, accreditation, and certificated required by law. The reference laboratory must be licensed/ accredited by The Joint Commission, College of American Pathologists (CAP), and/or any other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act (CLIA) of 1988. For Histocompatibility testing, the Contractor must maintain accreditation through the American Society of Histocompatibility and Immunogenetics (ASHI). The Contractor shall maintain current accreditation and notify the Contracting Officer Representative (COR) of any lapse in state license, CLIA certification, or clinical pathology, Histocompatibility, or Cytogenetics certification. The Contractor shall provide a copy of the renewed licenses/certificates to the COR before expiration. The Histocompatibility Lab must be a member of the Organ Procurement and Transplantation Network (OPTN), and such a laboratory must conform to the Standards for Histocompatibility Testing set by OPTN. OPTN policies are embedded above. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America along with proposal. Additionally, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors, if applicable, have appropriate licensure and accreditation. 5.Test Results: Stat- The Contractor shall provide telephonic, fax, or electronic response within twenty-four (24) hours from notification for specimen pick up, unless otherwise agreed, for STAT test results. The Contractor shall report all normal and abnormal test results to ordering laboratory upon completion of testing. Renal transplant histocompatibility- A deceased donor cross match must be completed within six to eight (6-8) hours from receipt of the specimen, unless otherwise agreed. The Contractor shall provide telephonic, fax, or electronic response with the results (preliminary or final) of other histocompatibility tests between twenty-four (24) and seventy-two (72) hours, depending on the test requested and the specimen source. The Contractor shall report all normal and abnormal test results to the ordering laboratory upon completion of testing. Reporting will be done via the UAB HLA Laboratory database Patient Viewer when it becomes available to VA Personnel. Telephone consultation- The Contractor shall consult with the COR, the requesting Clinician, or the designee at the ordering laboratory by telephone as needed. The Contractor shall immediately report critical values or test results that may indicate a life-threatening condition to a physician or a designated coordinator. When critical values are given, the recipient of the results is required to read the result back to the caller. The information will be documented in the printed report along with the date and time of the call and the identification of the caller and recipient. Reporting results- A report is defined as a printed final copy of laboratory testing results. This report shall be received by fax, tele-printer or computer (Patient Viewer) where applicable. If results are previously telephoned, the report must include the name of the individual who was notified of the results. Each test report shall, at minimum, indicate the following information: "Patient's name and/or identification code (Social Security number) "Physician's name (if supplied) "Patient's identification number, (social security number (SSN), medical record number) "Submitting facility name "Submitting facility account number "Patient's location (clinical/ward), (if supplied) "Date/time specimen received in Reference Lab "Test ordered "Date/time of specimen collection (when available) "Date/time test completed "Test result "Flag abnormal results "Reference intervals (adjusted for age, sex or race, when appropriate) "Toxic and/or therapeutic range, where applicable "Flagged abnormal results "Reference laboratory accession number "Name of testing laboratory and address (Contractor and/or subcontractor) "Type of specimen "Any additional comments related to test provided by submitting labs. "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. 6.Performance Period: The period of performance will be October 1, 2015 - September 30, 2016, with up to four option years.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BiVAMC521/BiVAMC521/Awards/VA247-15-D-0302.html)
 

Document(s)

Attachment
 

File Name: VA247-15-D-0302 VA247-15-D-0302_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2356648&FileName=VA247-15-D-0302-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2356648&FileName=VA247-15-D-0302-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03915475-W 20151008/151006234926-a1f71884078f1f5a337dea7906c1fc66 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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