Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 11, 2017 FBO #5648
DOCUMENT

65 -- Muskogee VA Medical Center Blood & Blood Products - Attachment

Notice Date

5/9/2017
 

Notice Type

Attachment
 

NAICS

621991 — Blood and Organ Banks
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
 

ZIP Code

80246
 

Solicitation Number

VA25917N0490
 

Response Due

5/23/2017
 

Archive Date

6/7/2017
 

Point of Contact

Sura-Quay Arbon, Sura-Quay.Arbon@va.gov
 

E-Mail Address

Sura-Quay.Arbon@va.gov
(Sura-Quay.Arbon@va.gov)
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The VISN 19 Contracting Center, 4100 E. Mississippi Ave, Glendale CO is performing market research to locate qualified firms to provide the services detailed below in the draft Statement of Work. The Government will use responses to this notice to make appropriate acquisition decisions. All interested firms who can meet the requirements stated below should respond, in writing (via email), with information describing their interest, capabilities, geographic location and indicate which socio-economic business category for which they qualify to the Contract Specialist Sura-Quay M. Arbon, Sura-Quay.Arbon@va.gov, no later than5:00 p.m. (Mountain Time), May 23, 2017. Ensure the Sources Sought identifier VA259-17-N-0490 Muskogee Blood & Blood Products is in the subject line. Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. Please note delivery and STAT requirements. Additionally this is being proposed as a multi-year (base + four) firm-fixed price requirements contract. STATEMENT OF WORK A. GENERAL INFORMATION 1. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. You will be required to furnish Blood and Blood Products to the Jack C Montgomery VA Medical Center (JCMVAMC), 1011 Honor Heights Drive, Muskogee, Ok 74401, in accordance with the terms and conditions of the contract. 2. Background: The awarding contractor will be required to furnish Blood and Blood Products to the JCMVAMC, in accordance with the terms and conditions of the contract, for estimated quantities and procedures listed on a schedule sheet. Contractor shall provide estimated quantities and procedures to be provided on a scheduled sheet. 4. A Point of Contact (POC) will be designated to act for the Contracting Officer in determining compliance with the contract and accepting or rejecting invoices submitted based on work performance. GENERAL REQUIREMENTS 1. The contractor will furnish all personnel, supplies and facilities necessary to collect, process, store and deliver human blood components and derivatives. The blood bank must currently be registered and/or licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug, and Cosmetic Act, as amended. 21 USC Section 260. 2. The contractor must submit proof that they hold an unrevoked U.S. License which is issued by the Director of Biologics, Food and Drug Administration (FDA) under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. 3. Specimen and blood components must be transported/shipped is such a way to ensure the integrity of specimens and blood components, and comply with accreditation standards and requirements as defined by FDA and American Association of Blood Banks (AABB). If interstate shipment of blood or blood component is involved, the contractor must submit with the offer a statement that such approval has been authorized under Public Health Service Act 351, as amended, 42 USC Section 62. 4. Contractor will provide human blood components only from volunteer donors in accordance with the latest FDA regulations. A volunteer donor is a person who does not receive monetary payment for blood donations. The contractor must maintain readily available blood donor lists including names, addresses, and Social Security numbers. Such lists should indicate whether, and on what date, blood of a particular donor was furnished to JCMVAMC under this contract. Donor selection must be accordance with criteria established by the FDA and the AABB. The contractor certifies that he will comply with the donor requirements with respect to donors, containers, delivery, etc. 5. All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms. 6. The VA reserves the right to inspect the contracted facility at any time. The VA shall notify the contractor in advance of anticipated inspections. The POC shall inspect the blood and has the authority to inspect quality, quantity, and verify adherence to the technical and delivery requirements of the contract. The JCMVAMC will retain all such information viewed and obtained during the audits as confidential. 7. The POC for JCMVAMC is Jana Burk, Blood Bank Supervisor, 918-577-3678 or 918-577-3176. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period. Once a task order is awarded, the requirements for the contractor shall not be changed in any way whatsoever by anyone other than the CO. 1. All blood components will be tested according to the current edition of the American Association of Blood Banks (AABB) standards. This testing will include, but is not limited to the following: (a) ABO Group (b) Rh type, a test for weak D when the initial test with Anti-D is negative (c ) A test for clinically significant antibodies, when appropriate 2. All blood components will be tested and found to be negative for HBsAg, Anti-HBc, anti-HTLV, HIV-1 Ag, anti-HIV, anti-HIV-2, anti-HCV, HIV/HCV, and WNV by NAT and a serological test for syphilis. In the event that FDA or the AABB requires additional testing, these tests will also be performed. 3. All blood components will be collected from volunteer donors and will be processed according to FDA (Food and Drug Administration) and AABB regulations. 4. All blood is to be collected by the closed system under aseptic conditions and Plasma is prepared and frozen under conditions and procedures mandated by FDA and required by AABB. All blood supplied shall be grossly free of hemolysis, excessive chyle and clots. In addition, all Fresh Frozen Plasma shall have been tested negatively utilizing Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus (HIV) and Hepatitis C virus prior to shipment. Assigned expiration dates for all blood components are to comply with 21CFR 610.53 and the manufacturer s recommendations. 5. The contractor will supply the VA with assurance of the following: (a) Traceability of all products from collection to delivery (b) Quality Control (QC) procedures and the contractor shall make QC data available for review. (c) Quality Management systems are in place (d) Current good manufacturing practices are followed 6. The contractor shall have the following licenses and or registration and shall make them available for review by the VA: (a) The contractor shall maintain an unrevoked U.S. license which is issued by the Director, Bureau of Biologics, FDA under section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. (b) If the contractor is involved in interstate shipment of blood or blood components, the contractor must maintain approval authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. (c) The contractor s Blood Bank must maintain registration and/or licensing with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food and Drug Cosmetic Act, as amended, 21 USC Section 260 at all times during the contract period. (d) Certificate of Accreditation under the Clinical Laboratory Improvement Act of 1988 or current certification by the College of American Pathologists. 7. The contractor shall deliver the components under storage conditions as required by FDA and AABB regulations and standards. 8. Red blood cells delivered shall have a dating period of one (1) week or more from the date of delivery. 9. Platelet Apheresis delivered shall have a dating period of one (1) to four (4) days from date of delivery. Platelet Apheresis products with less than one (1) day may be provided, upon approval by JCMVAMC. 10. Cryoprecipitate and Fresh frozen plasma shall have a dating period of at least sixty (60) days from the date of delivery. Any breakage or leakage during thawing will be replaced or credit given to JCMVAMC. 11. All blood components will be labeled using ISBT labeling as to A, B, O, and Rh type, unit identification number, product code, expiration date, and CMV negative if applicable. 12. As per FDA requirements: Immediately after bleeding, the blood shall be refrigerated between 1-6 °C with fluctuation of no more than 2 °C within this range. Freezing must be avoided at all times. If public transportation of blood is necessary it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 °C if it has been cooled. If the blood has not been cooled the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 °C preferably 1-6 °C while in transit. 13. As per FDA requirements: Immediately after bleeding, the platelets shall rest for 3 hours and then placed on shaker until processed, then stored between 20-24 °C with continuous rocking with fluctuation of no more than 2 °C within this range. Refrigeration and freezing must be avoided at all times. If public transportation of platelets is necessary it shall be transported in clean shipping containers provided with temperatures sufficient to hold the platelets at 20-24 °C while in transit. 14. As per FDA requirements: Immediately after bleeding, the cryoprecipitate shall be prepared by a method known to separate the cold insoluble portion from fresh frozen plasma and be frozen at a temperature of <-18 °C within 24 hours of collection. If public transportation of cryoprecipitate is necessary it shall be transported in clean shipping containers provided with temperature sufficient to hold the cryoprecipitate at <-18 °C while in transit. 15. As per FDA requirements: Immediately after bleeding, the fresh frozen plasma shall be prepared by a method known to separate the plasma from whole blood and be frozen at a temperature of <-18 °C within 24 hours of collection. If public transportation of fresh frozen plasma is necessary it shall be transported in clean shipping containers provided with temperature sufficient to hold the fresh frozen plasma at <-18 °C while in transit. 16. JCMVAMC shall promptly report to the contractor any possible infectious disease or other serious complication associated with the transfusions which may have resulted from any blood provided by the contractor, included suspected post-transfusion Hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) and death. JCMVAMC shall cooperate with the contractors investigation of any and all such diseases or complications and supply to contractor in confidence information concerning the recipient of the blood, upon forms provided by contractor, to the extent permissible under the laws applicable to patient confidentiality. JCMVAMC shall maintain complete and accurate records of patients supplied with blood (including product names, lot identificaitons, and quantities), and therapeutic adverse effects, complaints, or other pertinent information relating to blood. 17. JCMVAMC acknowledges the results of tests performed by the contractor cannot be guaranteed by the contractor and occurrences of some errors (either false positives, or false negatives) cannot be eliminated due to the nature of the tests. Contractor cannot and does not guarantee the blood products or services in any way. In no event is the contractor responsible for any loss or damage arising out of the defective or incorrect blood products or services unless attributable to contractor s gross negligence or willful misconduct. Notwithstanding anything herein to the contrary in no event shall the contractor be liable or responsible to JCMVAMC or to the any of the JCMVAMCs patients for the unavailability of blood products or services either in the quantity requested or at the time specified, provided the contractor has made reasonable efforts to provide such blood products or services. This clause shall supersede and replace Section 52-212-4 (o) of the solicitation as permitted by FAR Clause 12-302. E. SCHEDULE FOR DELIVERABLES 1. If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to explain why in writing to the POC, including a firm commitment of when the work shall be completed. This notice to the POC shall cite the reasons for the delay, and the impact on the overall project. The POC will then review the facts and issue a response, in accordance with applicable regulations. 2. All deliverables shall be made to the Blood Bank within JCMVAMC premises. Contractor agrees to deliver supplies and/or services that are requested by JCMVAMC on a 24-hours, 7-day week availability regardless of Federal Holidays. Deliveries designated as routine shall not carry additional charges. Additional charges may be applied for after-hour services. 3. The contractor will supply the Blood Bank with a minimum estimated inventory of Leuko-depleted Red Blood Cells, Cryoprecipitate and Fresh Frozen Plasma (FFP) as follows: LEUKO-Depleted RED BLOOD CELLS O Positive 12-16 units A Positive 12-16 units AB Positive 4 units B Positive 4-6 units A Negative 4-6 units O Negative 4-6 units B Negative as needed AB Negative as needed FFP O 4-6 units A 4-6 units B 4 units AB 4 units CRYOPRECIPITATE O 2 units 4. The contractor will supply the Blood Bank with Platelet Apheresis with a minimum inventory as needed. Platelets will not be kept on hand at JCMVAMC but rather ordered as needed. 5. Routine deliveries of blood/blood products will be a minimum of 2 to 3 times a week. Each morning the blood bank technologist will review all blood/blood product inventory for routine stock needs and special order needs. The technologist will enter routine order/orders into Blood Hub for routine scheduled delivery. 6. Routine deliveries for blood/blood products not included above shall be delivered within 8 hours of request. ASAP and STAT requests for these items shall be processed within one (1) hour of the order and delivered within one and half (1-1/2) hours of processing. 7. Deliveries shall be made to the JCMVAMC, 1011 Honor Heights Drive, Muskogee, OK 74401, Pathology & Laboratory Medicine Service, Room 2C-52H. 8. The contractor must allow for credit of units with a minimum of 7 days prior to expiration date. Credit can be applied if the contractor allows this facility to hold units until they expire, then these units will be either destroyed according to FDA regulations or returned to the contractor. An invoice will be sent to contractor for reference of credit. 9. The contractor must allow credit of units transferred to another facility using the same contractor to cover emergency needs of the requesting facility. 10. Items requiring Emergency Reference Laboratory Services shall be picked up within one (1) hour of the request, services started within two (2) hours of pickup and returned within one (1) hour of completion of tests or the results provided to JCMVAMC within one (1) hour of completion of test. After hour charges may be charged when the VA requests services before 08:00am or after 4:30pm on any working day or any time on nonworking days. Working days are Monday-Friday excluding official Federal Holidays. 11. Payment will be made promptly upon receipt and certification of a proper invoice at the designated payment office. A detailed invoice shall list the total quantities of each product or service provided or credited during a particular month, including date, description, amounts, and quantity with appropriate referenced CLIN. Invoices shall also be sent via mail, email or both to: Jack C Montgomery VA Medical Center Attention: Jana Burk Blood Bank (113) 1011 Honor Heights Drive Muskogee, OK 74401 Email: Jana.Burk@va.gov 12. By the 10th of each month, the contractor shall provide the POC the totals of items and services used during the preceding calendar month using the item numbers and descriptions exactly as they are listed in the contract. 13. The schedule of supplies/services represents estimated requirements of JCMVAMC. JCMVAMC will be obligated to pay for only those items and/or services ordered and received. F. QUALITY MONITOR FOR DELIVERABLES 1. All blood/blood products will be inspected upon receipt from the supplier. If the blood/blood products are found to be unacceptable they will be rejected by JCMVAMC and returned to supplier. Inspection will include the following: a. Abnormal color and appearance b. Proper labeling and shipping conditions to include: 1. Unit number 2. Product Code 3. ABO/Rh 4. Expiration date 5. CMV negative or Antigen negative (if applicable) 6. Condition of coolant c. Bag integrity, hemolysis, and clots d. Segments and ports for adequate sealing or closure ANNUAL SCHEDULE OF SUPPLIES/SERVICE Item No Test Unit Minimum Quantity Estimated Quantity 16B LPC EA 1,000 1,500 16I LPC-irrad EA 1 5 61 Plat (full dose) EA 50 100 61I Plat (full dose) irrad EA 1 2 62 Plat-HLA typed EA 0 1 63 Plat (half dose) EA 0 1 98 Irradiation fee EA 0 5 42HR Fresh Frozen Plasma EA 25 50 44PD10 Cryo (pooled) 10 pk EA 2 2 01A ABO/Rh EA 10 50 02A DAT EA 50 100 04A AB Id (cold panel) EA 0 2 04B AB Id EA 1 10 04E Antibody Identification EA 1 5 04F Addt'l RBC Panel EA 10 50 12B Compatibility Test EA 50 75 14 CMV Testing EA 0 1 EXT Ext of DNA for RBC EA 1 5 FY1 FY(a) EA 1 20 FY2 FY(b) EA 0 5 JK1 Jk(a) EA 1 60 JK2 Jk(b) EA 0 1 K1 K EA 1 10 L03 Antibody Screen EA 10 40 L04 Antibody ID EA 10 40 L08 After Hours Tech Fee EA 5 10 L13 DTT EA 1 10 L14 DTT Treatment of RBC EA 1 15 L30 Blood Comp Prep EA 5 20 L31 Sample Resubmission Fee EA 0 1 LE1 LEA Antigen Type EA 0 1 LE2 LEB Antigen Type EA 0 1 MS1 M Antigen Type EA 0 1 MS2 N Antigen Type EA 0 1 MS3 S Antigen Type EA 0 1 MS4 S Antigen Type EA 0 1 P1 P1 Antigen Type EA 0 1 RH2 C Antigen Type EA 1 20 RH3 E Antigen Type EA 1 10 RH4 C Antigen Type EA 0 1 RH5 E Antigen Type EA 0 1 OTH Rare Anti-sera EA 0 1 RMT RBC Molecular Typing EA 0 5 THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25917N0490/listing.html)
 

Document(s)

Attachment
 

File Name: VA259-17-N-0490 VA259-17-N-0490.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3481394&FileName=VA259-17-N-0490-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3481394&FileName=VA259-17-N-0490-000.docx

 

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

Record

SN04502042-W 20170511/170509235728-6f7d9f263986045720300aeebd24e121 (fbodaily.com)
 

Source

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

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