MODIFICATION
Q -- Medical Laboratory Sources Sought
- Notice Date
- 11/2/2006
- Notice Type
- Modification
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of the Air Force, Air Force Reserve Command, 94 CONF/LGC, 1538 Atlantic Ave, Dobbins ARB, GA, 30069-4824, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-F5B0816236A100
- Response Due
- 11/17/2006
- Archive Date
- 12/2/2006
- Description
- PERFORMANCE WORK STATEMENT (Parts 4 - 5) Dobbins ARB, GA 20 September 2006 4. CONTRACTOR-FURNISHED ITEMS. The Contractor shall furnish all shipping, facilities, labor, materials, equipment, software, and services as required. In addition, the Contractor shall provide: 4.1. INFORMATION (CATALOG) OF LABORATORY SERVICES. Information to be provided by the Contractor includes: 4.1.1. Test specific specimen collection and preservation requirements for each test or analyte. 4.1.2. Test specific method and interpretation for each test or analyte. 4.1.3. Test specific method reference ranges, adjusted for age, sex, or race, when required. 4.1.4. Test specific method sensitivity, specificity, and interferences, when required. 4.1.5. Test specific schedule of performance and average turnaround time for each. 4.1.6. 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 94ASTS/Senior ART for dissemination to Lab Manager, and the Government Contracting Officer within 15 calendar days prior to the Contractor implementing said change. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the Contracting Officer. 4.1.7. Product Information on new test(s) offered by the Contractor after commencement of services. 4.2. PICK-UP, COURIER, AND SHIPPING SERVICES. 4.2.1. Shipping transportation for: 4.2.1.2. Biological specimens from all government activities submitting test requests under this contract. 4.2.2. Routine and expedited overnight courier shipping/mailing and/or transportation to pick-up specimens for testing, or return of printed reports of completed test results, when electronic reporting capabilities are inoperable under contract. 4.3. FACILITIES. The Contractor shall provide and maintain the necessary facilities to perform services under the terms of this contract. 4.4. SUFFICIENT STAFF LEVELS to: 4.4.1. Process and ship supplies, specimens, and reports to and from Contractor and Government. 4.4.2. Process, test, and monitor specimen testing through completion of each task, and to accurately certify and report test results in accordance with GLP. 4.4.3. Provide customer service functions and assist with computer help desk requests such as responding to field queries, and requests to track testing progress and test reporting. Respond to requests for assistance to correct/answer on-site computer system and Government remote site equipment problems, questions, and failures to operate software and/or online systems. 4.5. MATERIALS. The Contractor shall: 4.5.1. Furnish materials, supplies, equipment, and reagents necessary to meet all requirements during the term of the contract. 4.5.2. Furnish materials/supplies at Exhibit D to prepare specimens for shipping to the Contractor facility for processing, testing, reporting, and storage. Supplies required include, but are not limited to: 4.5.2.1. Shipping and packaging containers. Packing material shall be capable of maintaining temperature requirements and stability for specimens until they reach the contractor?s laboratory. 4.5.2.2. Leak-proof plastic tubes and containers for routine shipment of diagnostic specimens. 4.5.2.3. Specialized media and tubes for genetic studies, and special test requests. 4.5.2.4. A customized test request form, preprinted with the appropriate Shipping Section and account information for the tests offered. 4.5.2.5. Customized test request forms for specialized testing (i.e., cytogenetics, tissue, etc). 4.5.2.6. Impervious bags for specimen pick-up. Bags shall have at least two sections, one for specimen(s) and one for paperwork. 4.5.2.7. Special forms and special handling procedures for medico-legal specimens when required by the Government. 4.5.2.8. Barcode labels for identification on each sample transfer tube, or specimen container. (Labels may be furnished by printing with the Contractor-provided laboratory information system). The Contractor shall furnish instructions on how to place the barcode labels on each transfer tube or specimen container. 4.5.3. Furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and transshipping transport containers necessary to meet the requirements established under the terms of this contract. 4.5.4. Provide an initial eight (8) week supply of supplies to meet transshipment and testing requirements. Government-held stocks of contractor-furnished materials shall be routinely replenished by the Contractor to allow performance of all contract requirements without interruption. Maintenance of the stock is a responsibility of the Contractor. Emergency supplies can be requested and shall be delivered by the Contractor, as required. 4.6. EQUIPMENT. The Contractor shall: 4.6.1. Furnish and install equipment to include barcode label maker and provide at least two (2) hours of training; and provide instrumentation necessary to computerize data entry, provide test/assay information, complete testing, store and print transmitted results, transfer data, manage operations, label and identify specimens, print chartable patient reports. 4.6.1.1. Provide an automated administrative and laboratory information system with equipment to enter, produce, view, query, print, transfer and retrieve data and required reports. The Contractor shall provide an online test request and reporting system and software. 4.6.1.2. Provide secured system hardware and software meeting C-2 security requirements as outlined in the National Security Agency (NSA) "Orange Book" (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria), transmission security requirements in accordance with current DoD protocol at time of award. As a minimum, if using the Internet for data transmission, the Contractor shall provide a Virtual Private Network (VPN) or Defense Encryption Standard (DES) encryption device, or current approved DoD method. 4.6.1.2.1. This online 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 Health Insurance Portability and Accountability Act (HIPAA). 4.6.1.2.1.1. Identification and Authentication. User ID and Passwords shall be required for system access and use. 4.6.1.2.1.2. Audit. The system shall have audit trail capability. 4.6.1.2.1.3. Operational Assurance. The system shall afford protection from external interference and tampering. 4.6.1.2.1.4. Accreditation. Documents shall be signed by the designated authority. 4.6.2. Provide maintenance and replacement of all equipment and instrumentation furnished to the Government for the entire contract period. The Contractor shall provide repair and/or replacement equipment within 24 hours of notification by the Government of equipment failures. 4.7. SOFTWARE. The Contractor shall: 4.7.1. Develop, furnish, and install software to execute and support data transaction transfers, data retrieval (access patient test history over the life of the contract), view patient files and on-line laboratory reference manuals, report patient results, query patient test status, and to note error messages and troubleshooting. 5. DESCRIPTION OF WORK. 5.1. Scope of Testing. The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute required tests annotated in Exhibit A plus other new tests added during the term of the contract. All medical reference laboratory testing shall be executed in accordance with standard industry practices. 5.2. Pick-Up and Courier Services. 5.2.1. The Contractor shall provide routine local courier pick-up, between 9:00 a.m. and 3:00 p.m., local time, unless, a different time is mutually agreed upon by the POC and the Contractor, Monday-Friday, excluding Federal holidays. 5.2.2. The Contractor shall accommodate additional specimen pick-ups for unscheduled testing, Monday-Friday between 9:00 a.m. and 3:00 p.m., local time, for each facility. Courier response time shall be within three (3) hours after notification. Unscheduled specimen transport costs are a separate line item at (0001AB) and shall be the only additional charge for unscheduled testing. 5.2.3. The Contractor?s courier shall: 5.2.3.1. Bring any errors or discrepancies to the attention of Government shipping personnel for correction before leaving the site. 5.2.3.2. Transport specimens under required conditions to ensure viability and stability for testing. 5.3. Operational Procedures/Standards shall incorporate CAP Inspection Checklists (current edition). 5.3.1. All laboratory testing staff shall comply with minimum Federal, State, and local law qualifications/requirements. The laboratory shall hold 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. 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 furnished to the Government (See 1.2.3.1). 5.4. Time Required for Test Completion (TURNAROUND TIME). 5.4.1.The test results shall be received by the Government within 72 hours post courier pick-up. Electronically transmitted test results shall be received by the Government within 72 hours or less of test completion. Preliminary reports shall be delivered for those tests requiring such, within 24 hours. 5.4.2. At any time from 7:00 a.m. to 5:00 p.m., during the testing process, the POC may contact the Contractor (either telephonically or by computer) to determine the current status of the patient's specimen and test result. 5.5. CONTRACTOR-INSTALLED LABORATORY INFORMATION SYSTEM. 5.5.1. The Contractor shall maintain a computerized laboratory information and management system for rapid retrieval and printing of laboratory results including elements within the Contractor?s laboratory and on-site at each Government facility. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines. The Contractor?s system shall be usable by personnel with only minimal computer knowledge. The Contractor shall provide reference materials, instruction, and training on the operation of hardware and software as requested. Any required follow-on training shall be at no additional cost to the government. 5.5.2. The Contractor's automation shall provide: 5.5.2.1. Test results reporting. Routine test results shall be electronically transmitted, at a minimum weekly, but remain in compliance within 72-hour reporting guidelines. 5.5.2.2. Test Management Information Support. Direct, user-friendly, immediate on-line access to the Contractor's test management information support system, if required. 5.5.2.3. Minimum on-line capabilities shall include: Patient information. The capability to build a patient information record and access patient test history during the term of the contract. 5.5.2.4. Reference Manual. On-line access to detailed reference data, such as might be normally available through a hardcopy Contractor reference manual, is required. Such data might include: the test description and its requirements, methodology used to perform the test, schedule for test performance (if any), and date the test was last changed (i.e., incorporation of regulatory changes). 5.5.2.5. Test Results. Test result information shall also be available on-line through "patient information" record. Reprints of patient test results using the system shall be available for at least 2 years or to meet the CAP guidelines. 5.5.2.6. Patient Information Backup Capability. The ability to develop and maintain backup patient information shall be available on a daily basis, including tests results processed. 5.5.2.7. The software shall have the following or equivalent menu selections: 5.5.2.7.1. Browse by shipping facility accession number. 5.5.2.7.2. Browse by Contractor's identification. 5.5.2.7.3. Browse result by patient name. 5.5.2.7.4. List requests with no test results (Pending Results). 5.5.2.7.5. List results overdue. 5.5.2.7.6. Change entry password. 5.6. REPORTING AND INTERPRETATION OF CRITICAL RESULTS AND PROCEDURES ORDERED. Critical results shall be telephoned and electronically transmitted to the Government immediately upon completion of testing and verification procedures. The Contractor shall submit the protocol for reporting critical values. 5.7. HANDLING OF SPECIMEN OR REQUEST DISCREPANCIES. 5.7.1. Specimen loss due to breakage, spillage/leakage, insufficient dry ice, misplacement, mishandling or any other Contractor-related problem(s) shall be reported within 1 work hour (maximum) of detection. Repeated problems with compromised specimens may be grounds for termination of the contract by default. 5.7.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be immediately reported upon unpacking at the Contractor?s laboratory. The Contractor is required to pick-up the new specimen at no additional cost to the Government. The pick-up of the new specimen shall be made during the routine courier pick-up times, unless emergency pick-up is requested in which case the unscheduled fee applies. 5.7.3. All specimens shall be processed and shipped within one business day of receipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention of the POC within one business day. 5.8. SPECIMEN RETENTION. 5.8.1. Specimens shall be stored/retained by the Contractor for at least seven (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. The Government may request repeat determinations or add-on tests by telephone during this 7 or extended 30-day period. Repeat determinations shall be requested by sites when test results do not fit the clinical picture of the patient, and shall be performed at no cost to the Government. Specimen retention applies to blood, serum, CSF, urine, and other body fluids. 5.9. CONTRACTOR'S QUALITY CONTROL SYSTEMS. 5.9.1. The Contractor shall successfully perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the Contracting Officer 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 POC upon request. 5.9.2. The Contractor shall operate a successful quality control program as required by CLIA and CAP. Current CLIA requirements are located at the Health Care Financing Administraton?s website : www.phppo.cdc.gov/CLIA. Upon request of the Contracting Officer, the Contractor shall provide documentation of quality control policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, 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. 5.9.3. All test methods shall be FDA approved, when available. 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. 5.9.4. Subcontracted laboratories shall comply with and meet all accreditations/certifications as the prime contractor. 5.10. RESULTS REPORTING. 5.10.1. The Contractor shall provide reports of laboratory testing to the Government within the turn-around time specified herein. 5.10.2. Individual patient-chartable reports meeting CLIA requirements shall be electronically transmitted to each Government for local printing with hard copy to follow. As a minimum, printed reports shall include: 5.10.2.1. The name and address of the contract laboratory where each test was performed. 5.10.2.2. The specimen accession number of the contract laboratory. 5.10.2.3. A phone number to contact the contract laboratory concerning the test results. 5.10.2.4. The contract laboratory?s CLIA certification number. 5.10.2.5. The patient?s name. 5.10.2.6. The patient?s SSN. 5.10.2.7. The patient?s age or date of birth. 5.10.2.8. The patient?s sex. 5.10.2.9. The Government specimen identification number. 5.10.2.10. The specimen collection date. 5.10.2.11. The Contractor?s report date and time. 5.10.2.12. The test name. 5.10.2.13. The test result(s). 5.10.2.14. The unit of measurement for quantitative tests. 5.10.2.15. The normal or expected range (reference range adjusted for age, sex, or race when appropriate). 5.10.2.16. The report status (i.e., final or interim). 5.10.2.17. Other interpretive information appropriate for the test(s). 5.10.2.18. CPT Code. 5.10.2.19. LOINC Result Code. 5.10.3. Abnormal results (results outside the reference range) shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). 5.10.4. The Contractor shall immediately telephone all critical results to the POC after being confirmed and certified by the Contractor. The telephonic report shall be followed by an electronic transmission. The report shall be an individualized chartable patient report. 5.10.5. 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 until the automated information system is properly functioning. 5.11. MISCELLANEOUS CONTRACTOR RESPONSIBILITIES. 5.11.1. The Contractor shall keep the Government 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 updates at least quarterly. 5.11.2. Set-up fees shall not be charged by the Contractor for cytogenetic tests showing no growth. 5.11.3. The Contractor shall provide through its customer service network, with minimal transfers and holding, access to knowledgeable, responsive laboratory professionals. 5.11.4. At Government expense, a Government representative shall be given the opportunity to visit the Contractor?s testing laboratory to examine the Contractor?s facility regarding contract compliance. Compliance visits may occur at any time during normal business hours after award of the contract. Meeting times shall be arranged as mutually agreed to between the government and the contractor. 5.11.5. If a medico-legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain valid ?chain-of-custody possession? and develop the formal documentation necessary for that purpose. The Contractor?s testing personnel that performed the analysis may be required to provide Court testimony. Contractor?s testimony shall be provided as required at no additional expense to the Government. If a specimen is required for medical-legal issues, at the request of the Government, the specimen shall be retained indefinitely. 5.11.6. Chain-of-Custody. Offerors shall submit, after award, a copy of its protocol for Chain-of-Custody for toxicology specimens, approved by the Laboratory Director.
- Place of Performance
- Address: Dobbins ARB, GA
- Zip Code: 30069
- Country: UNITED STATES
- Zip Code: 30069
- Record
- SN01175190-W 20061104/061102220709 (fbodaily.com)
- Source
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