PRESOL | Q | Blood Donor Testing Services

FBO DAILY ISSUE OF NOVEMBER 15, 2009 FBO #2913
SOLICITATION NOTICE

Q -- Blood Donor Testing Services

Notice Date: 11/13/2009
Notice Type: Combined Synopsis/Solicitation
NAICS: 621511 — Medical Laboratories
Contracting Office: Center for Health Care Contracting, ATTN: MCAA C BLDG 4197, 2107 17TH Street, Fort Sam Houston, TX 78234-5015
ZIP Code: 78234-5015
Solicitation Number: W81K0410Q0002
Response Due: 11/20/2009
Archive Date: 1/19/2010
Point of Contact: Brandon York, 210-221-3347
E-Mail Address: Center for Health Care Contracting
(brandon.york2@amedd.army.mil)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, Streamlined Procedures For Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only synopsis/solicitation; quotations are being requested and a written solicitation will not be issued. This solicitation # W81K04-10-Q-0002 is issued as a request for quotations (RFQ). The U.S. Medical Command (MEDCOM), Center for Health Care Contracting (CHCC) intends to award a six (6) month Blanket Purchase Agreement (BPA) for blood donor testing services in support of three (3) Army (Forts Bragg, NC, and Gordon and Benning, GA) and two (2) Navy (Portsmouth, VA and Camp Lejeune, NC) Blood Donor Centers in accordance with the attached Performance Work Statement (PWS). Testing shall be performed preformed IAW Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards. (1) The standard test panel shall be in accordance with the Food and Drug Administration regulations for the manufacturing of transfusable blood products and shall include at least Hepatitis B Surface Antigen (HBsAg), Hepatitis B Virus Core Antibody (HBcAb), Human T-Lymphotropic Viruses Type 1 & 2 (HTLV 1/2), Human Immunodeficiency Virus (EIA), Hepatitis C Virus (HCV), Treponema Pallidum (Syphilis), ABO/Rh, and Antibody Screen. Estimated 5,000 per month. (2) Cytomegalovirus (CMV) (currently only ordered by the Navy sites, but may be used by Army in the future). Estimated 1,140 per month. (3) Nucleic Acid Test (NAT) Panel consisting of HIV NAT, HCV NAT, WNV NAT, HBV NAT. Estimated 5,000 per month. (4) Hepatitis B Surface Antigen (HBsAg Neutralization) Confirmatory Testing. Estimated 5 per month. (5) Hepatitis B Virus Core (EIA) Confirmatory Testing. Estimated 5 per month. (6) Human T-Lymphotropic Viruses, Type 1/2 (HTLV 1/2) Confirmatory Testing. Estimated 10 per month. (7) Human Immunodeficiency Virus (HIV 1 Western Blot & HIV 2 EIA) Confirmatory Testing. Estimated 15 per month. (8) Hepatitis C Virus (HCV RIBA 3.0) Confirmatory Testing. Estimated 15 per month. (9) Treponema Pallium (Syphilis) Confirmatory Testing. Estimated 23 per month. (10) Contractor Manpower Reporting (see PWS paragraph 5.12. below), 1 each. This BPA requirement is an interim requirement pending release and award of a long term contract for the same services. This is a combined synopsis and request for quote for the services as defined in the attached PWS. All prospective offerors interested in submitting a proposal on this requirement must have a Commercial And Government Entity Code (CAGE Code) and be registered in the Central Contractor Registration (CCR). The following provisions and clauses will be incorporated by reference: FAR 52.212-4 Contract Terms and Conditions Commercial Items. ADDENDUM TO 52.212-4 to include the following FAR and DFARS clauses: 52.203-12 Limitation on Payments to Influence Certain Federal Transactions 52.204-4 Printed or Copied Double-Sided on Recycled Paper 52.209-6 Protecting the Governments Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment 52.242-13 Bankruptcy 252.201-7000 Contracting Officer's Representative 252.203-7002 Requirement to Inform Employees of Whistleblower Rights 252.204-7000 Disclosure of Information 252.209-7004 Subcontracting w/ Firms Owned or Controlled by the Government of a Terrorist Country 252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns 252.232-7010 Levies on Contract Payments 252.243-7001 Pricing of Contract Modifications 52.217-9 Option to Extend the Term of the Contract 52.252-2 Clauses Incorporated by Reference web sites are: http://farsite.hill.af.mil/ 252.212-7001 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Applicable To Defense Acquisitions Of Commercial Items. The following additional DFARS clauses cited in this clause are applicable: 52.203-3 Gratuities 252.203-7000 Requirements Relating to Compensation of Former DoD Officials 252.205-7000 Provision of Information to Cooperative Agreement Holders 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports Invoicing will be completed through Wide Area Workflow Receipt and Acceptance (WAWF-RA). END TO ADDENDUM TO 52.212-4 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Aug 2009) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 Alt 1, Restrictions on Subcontractor Sales to the Government 52.219-8 Utilization of Small Business Concerns 52.222-3 Convict Labor 52.222-21 Prohibition of Segregated 52.222-26 Equal Opportunity 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-36 Affirmative Action for Workers with Disabilities 52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees 52.222-54 Employment Eligibility Verification 52.225-13 Restrictions on Certain Foreign Purchases 52.232-33 Payment by Electronic Funds TransferCentral Contractor Registration 52.222-41 Service Contract Act of 1965 52.222-42 Statement of Equivalent Rates for Federal Hires 52.222-44 Fair Labor Standards Act and Service Contract Act -- Price Adjustment FAR 52.212-1 Instruction to Offerors Commercial Items ADDENDUMS TO FAR 52.212-1: 52.209-5 Certification Regarding Responsibility Matters 52.252-1 Solicitation Provisions Incorporated by Reference web sites are: http://farsite.hill.af.mil/ 252.212-7000 Offerors Representations and Certifications END TO ADDENDUM TO FAR 52.212-1 FAR 52.212-2 Evaluation Commercial Items The contract will be awarded to the Lowest Price Technical Acceptable with consideration for: Price. The Government is not responsible for locating or securing any information which is not identified in the offer. The Government reserves the right to make an award without discussions. The Government reserves the right to award on all or none basis. 52.212-3 ALT 1, Offerors Representations and Certifications Commercial Items- Vendors shall include a completed copy of FAR provision 52.212-3 with their offer. An offeror shall complete only paragraph (l) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (b) through (k) of this provision. This acquisition is being solicited using full and open procedures. The NAICS code is 621511, Medical Laboratories. The small business size is $13.5M average annual receipts over the last 3 years. The anticipated period of performance is 23 November 2009 22 May 2010. Anyone interested in the referenced services shall submit their offer to the contracting officer, Gary D. Hankins, Contracting Officer at Gary.Hankins@amedd.army.mil, or contract specialist, Shirley Tolbert, Contract Specialist at Shirley.Tolbert@amedd.army.mil not later than November 16, 2009, 4:00 PM Central Time. You may also fax your offer to (210) 221-5402 with Attention to Gary Hankins and/or Shirley Tolbert. Contracting Office Address: Center for Health Care Contracting, ATTN: MCAA-C, BLDG 4197, Suite 68, 2107 17TH Street, Fort Sam Houston, TX 78234-5068 Performance Work Statement: 1. GENERAL. This is a nonpersonal services contract to provide blood donor testing services. The Government will not exercise any supervision or control over the Contractor employees performing services herein. Such employees shall be accountable solely to the Contractor who, in turn, is responsible to the Government. 1.1. SCOPE. The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide blood donor testing services in support of the U.S. Army, U. S. Navy, U. S. Air Force. Use of this contract will be limited to those agencies identified. No other federal agencies will be considered at this time. 1.1.1. All tests shall be executed at the Contractors premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Contractor will have a plan, in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service. 1.1.2. The standard test panel will be in accordance with the Food and Drug Administration regulations for the manufacturing of transfusable blood products. It will including at least: ABO/Rh, Antibody screen, STS, HBsAg, HBcAb, HCV, HIV 1 and 2, HTLV 1 and 2, WNV NAT, HIV NAT, HCV NAT and HBV NAT (see Section 2.2 for explanation of acroynms). The confirmatory testing will consist of individually run tests: Antibody Identification, HBsAg Neutralization, HCV RIBA 3.0, HIV 1 Western Blot, and HIV 2 EIA. The contractor will also provide any additional testing that is deemed by the Food and Drug Administration (FDA) as required for the safety of the national blood supply. All tests included in the standard blood donor testing and confirmation testing required by the Kendrick Memorial blood center FT Gordon, GA, FT Benning, GA, Ft. Bragg, NC, and two Navy sites (Camp Lejeune, NC and Portsmouth, VA) (herein referred to as the blood donor centers (BDC)) will be preformed IAW Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards. 1.2. CONTRACTOR RESPONSIBILITY. 1.2.1. The Contractor shall ensure all employees under this contract who will be interacting with government personnel (i.e., contractor representative, customer service personnel, data entry/specimen processing technician, and courier) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate. 1.2.2. The Contractor shall ensure each laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located. The Contractor shall ensure any subcontractors performing services hereunder shall meet the same requirements as the prime contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be provided to the BDCs IAW the FDA regulations. 1.2.3. The Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. The Contractor shall ensure all laboratory testing staff complies with minimum Federal, State, and local law qualifications/requirements. The Contractor shall ensure all employees comply with applicable State regulations regarding their certification or registry, or license for the State in which the Contractors testing facility is located. 1.2.4. The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations. 1.2.5. The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the COR within 10 working days after contract award. The Contractor shall also submit copies of all certifications/licenses for the Technical Supervisors of the Primary Contractors laboratory. 1.2.6. CONTRACTOR PERSONNEL. 1.2.6.1. Contractor Representative. The Contractor shall designate and submit, in writing, within 10 working days after award, the name of a full-time contractor representative and alternate. The written designation shall be submitted to the contracting officer; and the COR as identified on contract. The Contractor shall also provide the telephone, pager, cell phone and facsimile numbers and email address for the designated full-time contractor representative and alternate. 1.2.6.1.1. The contractor shall ensure the contractor representative is available telephonically, or in person by appointment, as needed, for troubleshooting, servicing, introducing new tests, etc. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager. 1.2.6.1.2. The contractor shall ensure the contractor representative is available telephonically, or in person by appointment, to meet, as necessary, with the COR, as identified on contract or task order, to discuss immediate administrative, technical issues, and problem areas the customers may be experiencing in the field. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager number. 1.2.6.2. Customer Services. The Contractor shall provide customer service which shall be accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other applicable related issues/problems that may arise in the performance of work under this contract. The Contractor shall provide toll-free number(s) as applicable to each task order. 1.2.6.3. The contractor shall provide testing service 7 days a week. 1.2.6.3.1. The Contractor shall provide all necessary instructions for shipping and supplies for biologic specimens to be transported from the blood donor centers submitting test requests under this contract to the Contractor. 1.2.6.3.2. The primary result reporting will be by secure e-mail to the represenitives of the blood donor centers. Results must be e-mailed upon completion of the testing and verification of results for accuracy within a 12 hour period following receipt of the specimens. Contractor shall inform the COR of any delay in test results within the 12-hour period via e- mail or secure fax. Repeat positive results for initially reactive and failed run sample shall be available within 24 hours of receipt of donor specimens. The contractor shall provide additional confirmatory testing for donor specimens that are initially reactive for donor specimens that are initially reactive for Hepatitis B Surface Antigen (EIA), Hepatitis B Virus Core (EIA), Human T- Lymphotropic VirusesType I & II (HTLV I/II) (EIA), Human Immunodeficiency Virus (EIA/NAT), Hepatitis C Virus(EIA/NAT), Treponema pallidum (Syphilis) as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 5 to 7 business days to the blood donor centers via e- mail or secure fax.Confirmation test results will be available based upon the requirements established by the specific testing procedure. Original hard copy results must be sent to the represenitives of the blood donor centers by courier or mail. Facsimile will be utilized as a back-up to e-mail. A list of email addresses will be provided by the represenitives of the blood donor centers within 10 working days after award to the Contractor to provide results electronically through email. Original test results will be mailed to the following addresses: Naval Medical Center Portsmouth 620 John Paul Jones Circle Portsmouth, VA 23708-2111 NAVAL HOSPITAL Fort Bragg Blood Donor Center 100 Brewster Blvd BLDG 8-2809, Scott Street Camp Lejeune, NC 28547-0100 Fort Bragg, NC 28310 Kendrick Memorial Blood Center Fort Benning Blood Donor Center Bldg 257128995 2nd Infantry Division Rd., Sandhill (Bldg #3271) Ft Gordon, GA 30905-5650Ft. Benning, GA 31905 1.2.6.3.3. The Contractor shall bring any errors or discrepancies to the attention of the represenitives of the blood donor centers immediately upon discovery. The names of authorized represenitives of blood donor center personnel will be provided, in writing, by the Government within 10 working days after award of the contract, to the Contractor and updated as necessary throughout the contract period. 1.3.PERFORMANCE QUALITY. 1.3.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall provide a copy of its existing Quality Control System within 10 working days after award of the contract. Any changes made after award of contract shall be submitted to the COR and to the Contracting Officer for Governments review and approval prior to implementation. 1.3.1.1. The Contractor shall maintain QC System records that are complete and reliable. 1.3.1.2. A progress meeting shall be held by telephone within 60 calendar days after contract start date between the COR and the Contractor to discuss any issues. 1.3.1.3. The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the COR a listing of external proficiency surveys that the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request. 1.3.1.4. The Contractor shall operate a quality control program as required by FDA; Current CLIA requirements are located at the Health Care Financing Administrations website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR, the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist. 1.3.1.5. All test methods shall be FDA approved for blood donor testing. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation and testing methods, standard operating procedures must be validated prior to implementation and use by the Contractor providing blood donor testing IAW FDA requirements. 1.3.1.6. The Contractor shall ensure that Subcontracted laboratories comply with and meet all accreditations/certifications as the prime contractor. 1.3.2. Government Performance Requirements Summary (PRS). The Government will monitor the Contractors performance under this contract, in part using specimen pick times, result turn-around times, percentage of discrepant results and by selected inspections or audits of the Contractors own written instructions and procedures. 1.3.3 The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure. 1.4. SAFETY REQUIREMENTS. The Contractor shall: 1.4.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. 1.5. SECURITY REQUIREMENTS. 1.5.1. Physical Security. 1.5.1.1. All Contractor employees performing work on a government facility shall observe and comply with all local rules and regulation prescribed by the installation and other federal authorities concerning fire, safety, sanitation, security and possession of firearms or other lethal weapons. No Contractor employee shall be permitted on the installation when his/her presence would be detrimental to the security of the installation. 1.5.1.2. The Contractor shall obtain all local, State and Federal government licenses, passes and permits necessary to enter the government installation to include motor vehicle registration and insurance as required. 1.5.2. Information Security. The computer system shall be processing and transferring data that is classified as Sensitive But Unclassified (SBU) and shall have the appropriate security features. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the DoD, U.S. Army, or other government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware. 1.5.2.1. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations. 1.5.2.2. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government at each Submitting Activity to receive patient results. Results shall be handled as private medical records in accordance with Privacy Act Requirements for Medical Records Systems (Technical Exhibit G). 1.5.2.3. All inquiries, comments or complaints pertaining to patient information or government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution. 1.5.3. Computer Security. Computer system processing is sensitive, but unclassified information, and shall have the appropriate security features in accordance with requirements in the National Security Agency Orange Book (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria), U.S. Armys or other Government Agency basic policy of initial and periodic security training and the need for physical controls to protect hardware. The website for the Orange Book is http://www.radium.ncsc.mil/tpep/library/rainbow/5200.28-STD.html. 2. DEFINITIONS/ACRONYMS. 2.1. DEFINITIONS. 2.1.1. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors. 2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government. 2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract. 2.1.4. C-2 SECURITY REQUIREMENTS. These are found in the National Security Agency Orange Book (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria). Basically, computer system processing is sensitive, but unclassified information, and shall have the appropriate security features. The following security requirements are in addition to the U.S. Armys basic policy of initial and periodic security training and the need for physical controls to protect hardware. For example:. Discretionary Access Control; (access control lists).. Object Reuse; (hard drives/diskettes shall be wiped clean of information before turned in to supply for transfer back to the Contractor).. Identification and Authentication (user ID and passwords to use the system).. Audit (the system shall have audit trail capability).. Operational Assurance (protection from external interference or tampering).. Accreditation (signed by a designated accreditation authority). 2.1.5. DEFECTIVE SERVICE. A unit of service which contains one or more defects, or noncompliance with specified requirements. 2.1.6. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72. 2.1.7. QUALITY ASSURANCE. The Government procedures used to verify that services being performed by the Contractor are performed according to acceptable standards. 2.1.8. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken by the Government to assure that the quality of an end product or service shall meet contract requirements. 2.1.9. SHIPPING FORM. Form(s) used to initiate shipping actions. 2.1.10. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes. 2.1.11. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary Contractor. 2.1.12. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract. 2.1.13. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the PWS. 2.2. ACRONYMS. AQL- Acceptable Quality Level ASCII - American Standard Code for Information Interchange ASCP - American Society of Clinical Pathologists CAP - College of American Pathologists CDC - Centers for Disease Control CFR - Code of Federal Regulations CLIA - Clinical Laboratory Improvement Amendments of 1988 CME - Continuing Medical Education CONUS- Continental United States COR - Contracting Officer Representative CV - Curriculum Vitae DES - Defense Encryption Standard DD250 - Department of Defense Form 250 (Receiving Report) DoD - Department of Defense EIA- Enzyme Immunoassay FDA - United States Food and Drug Administration HBcAb- Hepatitis B Virus Core Antibody HBsAg- Hepatitis B Surface Antigen HBV- Hepatitis B Virus HCV- Hepatitis C Virus HHS - U.S. Department of Health and Human Services HIV 1&2- Human Immunodeficiency Virus 1&2 HL7 - Health Level 7 HTLV 1&2- Human T-Lymphotropic Viruses Types I&II IATA - International Air Transport Association LAN - Local Area Network MIS - Management Information System ml - Milliliter MTF - Medical Treatment Facility NAT- Nucleic Acid Test OSHA - Occupational, Health, and Safety Administration OTSG - Office of the Surgeon General, U.S. Army POC - Point of Contact PRS- Performance Requirements Summary QAP - Quality Assurance Plan QA - Quality Assurance QAP - Quality Assurance Program QNS - Quantity Not Sufficient COR - Contracting officer Representative PBWS - Performance Based Work Statement RIBA- Recombinant Immunoblot Assay SSN - Social Security Number STS- Treponema Pallidum (Syphilis) TE - Technical Exhibit VPN - Virtual Private Network WNV- West Nile Virus 3. GOVERNMENT INFORMATION. 3.1. RESPONSIBILITIES. The Government will: 3.1.1. Perform specimen collection. 3.1.1.2. Provide biologic specimens that have been collected and processed per the Contractors published pre-analytical requirements, and in accordance with standard quality procedures. 3.1.1.3. Label each sample with a unique unit number and provide the Contractor with test requests, lists, or work documents with required ordering information per the contractors requirements. 3.1.1.4. Provide donor notification IAW FDA requirements and established DoD policies 3.2. GOVERNMENT-FURNISHED ITEMS. 3.2.1. Specimens for testing. 4. CONTRACTOR RESPONSIBILITIES. 4.1. CONTRACTOR-FURNISHED ITEMS 4.1.1. COMMERCIAL CLIENT SERVICES MANUAL. The Contractor shall provide a hard copy (electronic copy optional) of its Client Services Manual to the COR at each BDC during the start-up period. Examples of the information to be provided include the following:. Test specific specimen collection and preservation requirements for each test or analyte.. Test specific method and interpretation for each test or analyte.. Test specific method reference ranges, when required.. Test specific method sensitivity, specificity, and interferences, when required.. Test specific schedule of performance and average turn around time for each.. Result Code 4.1.1.1. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc). In the event of any methodology change, written information/instruction shall be provided to the contracting officer and COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for changes in testing algorithms if needed. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement. 4.1.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to contracting officer and COR once test procedure validation is complete. 4.1.3. SUPPLIES. If the Contractor requires unique supplies, the Contractor shall provide an initial 6-week stock of materials or supplies to be used by submitting facilities identified in each task order in preparation for shipment of specimens for testing requirements. Supplies required for the initial 6-week period shall be a part of the contract start-up period responsibilities. Government-held stock of Contractor-furnished items shall be routinely replenished by the Contractor to allow performance of all contract requirements without interruption. Maintenance of the stock will be by request from the COR POC to the Contractor. On a case-by-case basis, emergency supplies may be requested by each COR POC and shall be providedby the Contractor as required. The Contractor shall meet with COR within 5 working days after the award of a task order to determine the quantity required for each site. The Contractor shall: 4.1.3.1. Furnish materials and supplies necessary to meet the requirements for the provision of services established under the terms of this contract. 4.1.3.2. Furnish materials/supplies to submitting facilities to prepare specimens for shipping to the Contractor facility for processing and testing. Some examples of supplies required may include, but are not limited to: 4.1.3.3. Shipping and packaging containers for submitting specimens in a manner required for efficient processing at the Contractors facility. 4.1.3.4. As necessary, test request forms required for the Contractor. 4.1.3.5. Furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers. 4.1.4. Government facilities will utilize unique Barcode labels for identification on each sample transfer tube, or specimen container. The Contractor must be capable of accepting labels in ISBT 128 technology for samples received for testing. The Contractor shall furnish instructions on how to place the barcode labels on each transfer tube or specimen container. 4.2. FACILITIES. The Contractor shall maintain the necessary facilities to perform services under the terms of this contract. 4.3. LABOR: The Contractor shall maintain necessary labor to perform the services under the terms of this contract. 5. DESCRIPTION OF WORK. 5.1. TESTING. The Contractor shall be FDA licensed for blood donor testing and provide the full range of blood donor testing currently required by FDA. Approximately 56,000 units of whole blood and 1200 units of platelet apheresis or plasma apheresis units annually from the blood donor centers will require the routine blood donor testing panel and repeat testing, as well as confirmation testing. Contractor shall inform of any delay in test results within the 24 hour period via telephone, e- mail or secure fax. Repeat positive results for initially reactive and failed run sample shall be available within 48 hours of receipt of donor specimens. The contractor shall provide additional confirmatory testing for donor specimens that are initially reactive for Hepatitis B Surface Antigen (EIA), Hepatitis B Virus Core (EIA), Human T- Lymphotropic VirusesType I & II (HTLV I/II) (EIA), Human Immunodeficiency Virus (EIA/NAT), Hepatitis C Virus(EIA/NAT), Treponema pallidum (Syphilis) as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 5 to 7 business days to the blood donor centers via e- mail or secure fax. Approximately, 800 confirmatory tests will be required by the blood donor centers per year. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices. Contractor must have a sample surge capacity of at least 1000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement. 5.1.1. The Contractor shall ensure the accurate and timely performance of laboratory testing services in biologic specimens provided by CORs. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies. Contractor will have a plan, in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service. 5.2. CONTRACTOR LABORATORY INFORMATION SYSTEM. 5.2.1. The Contractor shall provide and maintain a computerized laboratory information and management system for rapid retrieval and printing of laboratory results including elements within the Contractors laboratory. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines. 5.2.2. The Contractor's automation shall provide: 5.2.2.1. Test results reporting. Routine test results shall be sent by facsimile and or electronically transmitted to each to the submitting facility, within 12 hours from receipt of samples. 5.2.2.2. Any delays in testing due to failed runs, or instrument malfunctions should be reported immediately if delay in testing beyond 12 hrs will occur. 5.2.2.3. Once corrective actions have been taken or resolved and testing resumed, test results will be made available immediately upon completion of review. 5.5. HANDLING OF SPECIMEN OR REQUEST DISCREPANCIES. 5.5.1. Specimen loss due to breakage, spillage/leakage, insufficient dry ice, misplacement, mishandling or any other Contractor-related problem(s) shall be reported immediately to the impacted blood donor center upon knowledge or detection of problem. Repeated problems with compromised specimens may be grounds for termination for cause of the contract. 5.5.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be immediately reported to the appropriate blood donor center upon unpacking at the contractors laboratory. 5.5.3. All specimens shall be processed within 12 hours of receipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention of the submitting facility within the 12-hour period. 5.6. SPECIMEN RETENTION. 5.6.1. Specimens shall be stored/retained by the Contractor for at least 7 days after the reporting of the results. In selected cases, and upon request by a site, the Contractor shall store/retain specimens for up to 30 days at no additional cost. 5.7. REFERRALS TO ANOTHER LABORATORY OR INSTITUTION. The contractor shall ship specimens to other laboratories as required when referral work is sent by the Government to another institution which may be conducting joint studies or when the specimen is time sensitive. Specimen transport expense for referrals to another laboratory or institution are at no additional cost to the Government. 5.8. RESULTS REPORTING. 5.8.1. The Contractor shall provide reports of donor testing to the submitting facility within a 12 hour turn-around time from receipt. 5.8.2.Blood donor testing reports meeting CLIA requirements shall be faxed and or electronically transmitted to each to submitting facility for local printing. As a minimum, printed reports shall include:. The name and address of the contract laboratory where each test was performed.. The specimen blood donor unit number assigned by the COR.. The name of the contract Laboratory Director or Medical Director.. A phone number to contact the contract laboratory concerning the test results.. The specimen collection date.. The Contractors report date and time.. The test name.. The test result(s).. The unit of measurement for quantitative tests.. The normal or expected range.. The report status (i.e., final or interim).. Other interpretive information appropriate for the test(s). 5.8.3. Abnormal results (results outside the reference range), or incomplete testing shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). Reports will be released by the Contractor, even if all of the results in each batch have not been completed within the run, with the understanding that when incomplete tests or confirmation tests are completed, reports will be available to the submitting facility. This will allow for unit release and appropriate unit quarantine. It is imperative that the results per batch be released even if some of the tests are incomplete due to mission requirements of the submitting facility to release blood products as quickly as possible after the lot review process which is dependent upon test results. Units with incomplete testing results will be quarantined by the submitting facility, until such completion and release of the results and review by the lot release process. 5.8.4. In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed reports to each COR until the automated information system is properly functioning. 5.9. MANAGEMENT REPORTS. 5.9.1. Monthly COR Reports. The Contractor shall provide separate monthly data summary reports of tests performed for each COR under this contract. The printed reports shall be delivered to the contracting officer and to the COR as identified on each task order, by the tenth calendar day of the month after the end of each monthly reporting period. 5.9.1.1. The reported information shall include subtotals for each test and the test name, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year to date (per test), and cost year to date (per test). The contractor shall also provide notice of when a selected test is subject to a unit price reduction based on the discount terms incorporated under contract. The test name, vendors test code, the revised unit cost per test, and effective date shall be annotated. 5.9.1.2. The reports with data required in PWS paragraph 5.9.1. shall reported using the primary method. Results may be sorted by three additional methods: 5.9.1.2.1 Results listed chronologically by unit number is the primary reporting method. 5.9.1.2.2. Test names listed alphabetically. 5.9.1.2.3. Test names listed in order of year-to-date test frequency (highest to lowest). 5.9.1.2.4. Test names listed in order of year-to-date total test cost (highest to lowest). 5.9.2. Quarterly Regional Reports. The Contractor shall provide quarterly data summary reports of tests performed for each COR as identified under this contract. The printed reports shall be delivered to the COR, and contracting officer no later than the tenth calendar day of the month after the end of each quarter. Letter issued to the contractor after award of the contract will identify the COR. 5.9.2.1. The reported information shall include subtotals by COR for each test and include test name, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year to date (per test), and cost year to date (per test). 5.9.2.2. The reports with data required in PWS paragraph 5.9.2 shall be sorted by the COR using the primary method (unit numbers chronologically) and may be reported by the additional three methods outlined at paragraphs PWS paragraph 5.9.1.2.1. through 5.9.1.2.3. 5.9.2.3. The Contractor shall provide the COR and contracting officer a Quarterly Summary Report. The recorded information shall as the minimum include: 5.9.2.3.1. Cumulative subtotals for each test ordered. Identify the test name, vendor's test code, and current test cost (Unit). 5.9.2.3.2. Cumulative dollar subtotal for each test ordered. Identify the test name, vendor's test code, and current test cost (per unit). 5.9.2.3.3. Notification of when a specific test is subject to a unit price reduction based on the contractors proposed discount schedule/terms incorporated under contract shall be provided by the Contractor to the COR and the contracting officer. Identify the test name, vendor's test code, and revised unit cost per test. 5.9.2.3.4. Notification of the revised pricing for a given test based on price reductions will be made to the contracting officer and notification provided to CORs and other contracting officers by modification to the basic contract. Change will be reflected in the contractors price list (technical exhibit) as well. 5.9.2.3.5. All reports shall be submitted in electronic spreadsheet form. Electronic supplemental narrative shall be forwarded as appropriate. 5.10. MISCELLANEOUS CONTRACTOR RESPONSIBILITIES. 5.10.1. The Contractor shall keep the contracting officer and the COR, informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide quarterly updates. 5.10.2. The Contractor shall provide through its toll free customer service network, with minimal transfers and holding, access to knowledgeable, responsive laboratory professionals. 5.11. CONTRACT START-UP PERIOD. Immediately upon award of a task order, there will be a start-up period consisting of a maximum of 60 calendar days. The intent of this start-up period is to enhance coordination between the Government and the Contractor in order to avoid misunderstanding or mistakes on the part of both parties. The Contractor shall provide the necessary personnel required to perform training/orientation with coordination from the COR. During this period, the following shall take place: 5.11.1. The Government CORs will brief the Contractor as to where to ship their shipping/packaging materials.If needed, the Contractor will make a site visit to the donor center to instruct personnel on labeling, packing and shipping requirements. 5.11.2. The Contractor shall provide materials and supplies needed for shipment of specimens from COR to Contractor to last for the initial 6-week period. 5.11.3 The Contractor shall provide each COR with processing and shipping information and their commercial client services manual during the start-up period. 5.12. CONTRACTOR MANPOWER REPORTING ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil. The required information includes the following: (1) Contracting Office, Contracting Officer, Contracting Officers Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Total payments (including sub-contractor); (6) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (7) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (8) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. This cost will be reflected on a separate line item and can be invoiced upon completion of the report. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officers Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer. The following information is provided for the Contractors use in completing the above report: Predominant Federal Service Code: Q301 6. APPLICABLE REGULATIONS, MANUALS, TECHNICAL BULLETINS, PAMPHLETS, AND SPECIFICATIONS. The following regulations are Mandatory. Electronic or scanned copies of all applicable regulations will be made available to the contractor after award, but prior to performance of the contract. REGULATION NAME AR 40-3Medical, Dental, and Veterinary Care, CH 5 Army Blood Program (11 MAY 2009) AR 340-17 Release of Information and Records (15 Dec 86). AR 340-21 The Army Privacy Program (5 Jul 85). AR 340-21-1 The Army Privacy Program: System Notices and Exceptions Rules (16 Dec 85). AR 380-19 Information System Security OPNAVINST 6530.4B Department of the Navy Blood Program (13 AUG 2007) DA PAM 25-51 Privacy Requirements for Medical Records Systems MEDDAC CLIA Clinical Laboratory Improvement Amendments of 1988 DoD 5200.28-STD DoD Trusted Computer Evaluation Criteria Orange Book. Title 42 CFR, Part 72 Interstate Shipment of Etiologic Agents. Title 29 CFR Occupational Safety and Health Standards (1990) Title 21 CFR, Food and Drug Administration: Drug (210-211), Biological Parts 210-211, 600-680Products (600-680)
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Place of Performance: Address: Center for Health Care Contracting ATTN: MCAA C BLDG 4197, 2107 17TH Street Fort Sam Houston TX; Zip Code: 78234-5015
Record: SN02003916-W 20091115/091114000527-f939132d0f153285ccb8471283f8c55c (fbodaily.com)
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Q -- Blood Donor Testing Services