Attachment 1 - Performance Work Statement - Lab Testing.pdf

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Laboratory Testing Services
Solicitation number
FA670324Q0015
Issued by

About this file

This document is a Performance Work Statement (PWS) for Laboratory Testing Services at Dobbins Air Reserve Base in Georgia. The PWS outlines the requirements for a contractor to provide certified technicians to perform various laboratory testing services for military and DoD civilian personnel at Dobbins ARB. Key details include:

The contractor shall provide all personnel, services, transportation, materials, equipment, and supplies to perform the required laboratory testing services. Services include routine local courier pick-up and delivery of specimens, electronic transmission of test results within 72 hours, and access to a computerized laboratory information system. The contractor must maintain all required licenses, certifications, and accreditations, and comply with HIPAA and other regulatory requirements. The period of performance is one year from date of award with four option years.

The related federal contract opportunity is a solicitation (FA670324Q0015) issued by the Department of the Air Force Reserve Command for these laboratory testing services to support the Contingency Aeromedical Staging Facility (CASF) at Dobbins ARB.

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Last Revised August 26, 2024

Performance Work Statement (PWS) Laboratory Testing Services

Dobbins Air Reserve Base, Georgia

1. Introduction.

1.1. Mission. Provides manpower to support the Contingency Aeromedical Staging Facility (CASF).

Administratively prepares patients for flight, making sure patients are clinically supported while in the CASF awaiting transportation and assisting with transportation to and from mode of transport; accomplishes Reserve Component Periodic Health Assessment (RCPHA) ensuring the wing’s medical requirement for deployment is met.

1.2. Scope. This contract shall serve as a vehicle to provide certified technicians who can perform various Laboratory Testing services identified in Attachment 2 - Pricing Schedule, and any additional tests that may be included for military and DoD civilians at Dobbins ARB, GA

1.3 Non-Personal Services. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of a personal nature or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the CO immediately.

1.4. Definitions

Critical Results are laboratory values for tests that by their nature (either below or above the reference range) are significantly abnormal and for which immediate medical attention may be required to prevent significant patient morbidity or mortality.

C-2 Security Requirements 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.

Quality Assurance is Government procedures used to verify that services being performed by the Contractor are performed according to acceptable standards.

Quality Assurance Program is necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Shipping Form are form(s) used to initiate shipping actions.

Specimen is a quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

Subcontractor is a business/company that enters into a subcontract and assumes some of the obligations of the primary contractor.

Transfer Tubes are any tube used to collect, transport, transship, and store samples under terms of the PWS.

1.5. Acronyms

AQL Acceptable Quality Level ASCP American Society of Clinical Pathologists CAP College of American Pathologists CDC Centers for Disease Control and Prevention, U.S. Public Health Service, Atlanta, GA.

CFR Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments of 1988

CME Continuing Medical Education CSF Cerebrospinal Fluid CV Curriculum Vitae DES Defense Encryption Standard DD250 Department of Defense Form 250 (Receiving Report) DoD Department of Defense FDA United States Food and Drug Administration GLP Good Laboratory Practices HIPAA Health Insurance Portability and Accountability HL7 Health Level 7 IATA International Air Transport Association ICD Interchange Control Document LIS Laboratory Information System ml Milliliter MTF Medical Treatment Facility NIDA National Institutes of Drug Abuse OSHA Occupational, Health, and Safety Administration POC Point of Contact PWS Performance Work Statement QAP Quality Assurance Plan QC Quality Control QCP Quality Control Program QNS Quantity Not Sufficient PWS Performance Work Statement SBU Sensitive, but Unclassified SSN Social Security Number VPN Virtual Private Network

2. General Requirements.

2.1. 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.

2.2. Validation of qualifications, licensor, and certification (as applicable). The contractor shall provide written verification (and photocopies where necessary) showing required certification(s), accreditation(s), license(s), etc.

and shall be furnished to the 94 ASTS/SGP via contracting officer within 3-business days of any changes and prior to performing any services under this contract for the Prime or subcontractor.

2.3. The contractor shall provide point-of-contact (POC) who shall be responsible for the performance of work. The name of this POC and the alternate(s) who shall act for the contractor when the POC is absent shall be designated in writing to the CO within 2 days of contract award.

2.4. The contractor shall not employ any person who is a spouse or dependent child of a Department of Defense (DoD) employee (military or civilian) when such DoD employee would be in a conflict of interest by virtue of such employment.

2.5. Contractor personnel shall present a neat and clean appearance and be easily recognized as contractor employees. Employees must wear identification at all times.

2.6. Contractor personnel shall conduct themselves in a professional manner at all times while on Dobbins ARB.

Cell phones shall not be used by the driver of a vehicle while the vehicle is in motion.

2.7. Quality Control. The basic quality management system must provide for the appropriate controls of service characteristics and attributes during performance and include inspection and test criteria/methodology/data that is used to verify/validate conformance to acceptance criteria established for the contract. It should describe specific policies, procedures, and practices and identify quality responsibilities for all operational interfaces.

2.8. Quality Assurance. The Government will evaluate the contractor’s performance under this contract.

Government personnel will record all surveillance observations. When an observation indicates defective performance, the COR personnel will notify the contractor, the POC or the alternate. Government surveillance of tasks not listed in the SDS may occur during the performance period of this contract.

2.9. Location and Hours of Work. Contractor shall establish employee work schedules to accommodate timely completion of tasks to ensure delivery and pick up schedules are met. If pick up or delivery falls on a recognized holiday, the contractor shall coordinate 3 days in advance, with 94 ASTS/SGP via CO to determine a date and time that will meet their needs. The contractor is not required to provide service on the following recognized federal holidays:

New Year's Day Birthday of Martin Luther King, Jr.

Washington’s Birthday (President’s Day)Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

2.10. Transferring or Receiving Select Agents. Contractor shall adhere to the policies and procedures outlined from the Department of Health and Human Services 42 CFR Part 72 RIN 0905-AE70, Additional Requirements for Facilities Transferring or Receiving Select Agents.

2.11. HIPAA. All contracted management staff performing services for the Air Force have been trained and/or familiar with HIPAA Privacy & Security Rule and will be held accountable for complying with health information privacy and security policies and procedures. Reference HIPAA of 1996 for detailed language.

3. Description of Services.

3.1 The contractor shall provide all personnel, services, transportation, materials, equipment and supplies to perform laboratory testing services. All services will be for military and DoD civilian personnel located on Dobbins ARB, Georgia. The contractor shall perform all work in accordance with the Performance Work Statement (PWS) and contract.

3.2. Laboratory testing will not be performed on Government-Owned property. All services shall be executed at the contractor’s premises or within the Contractor’s network of facilities (affiliate or qualified subcontractor) which must be located within a 25-mile radius of Dobbins ARB, GA (zip code 30069).

3.3. Laboratory Testing Services will be performed on an annual basis consisting of military and/or DoD Civilians employed at Dobbins ARB, GA. The period of performance is one year from date of award plus 4-option years.

3.4. Laboratory Testing Services

3.4.1. Scope of Testing. The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute required tests annotated in Attachment 2 - Pricing Schedule, of contract 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.

3.5. Pick-Up and Courier Services.

3.5.1. 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.

3.5.2. 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 contract line item and shall be the only additional charge for unscheduled testing.

3.5.3. The Contractor’s courier shall:

3.5.3.1. Bring any errors or discrepancies to the attention of Government shipping personnel for correction before leaving the site.

3.5.3.2. Transport specimens under required conditions to ensure viability and stability for testing.

3.5.3.3. Time Required for Test Completion (TURNAROUND TIME).

3.5.3.4. 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.

3.5.3.5. 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.

3.6. Contractor-Installed Laboratory Information System.

3.6.1. 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.

3.6.2. The Contractor's automation shall provide:

3.6.2.1. Test results reporting. Routine test results shall be electronically transmitted, at a minimum weekly, but remain in compliance within 72-hour reporting guidelines. Test results reporting notification will be in accordance with test results reporting outlined in paragraph 3.7.2.1.

3.6.2.2. Test Management Information Support. Direct, user-friendly, immediate on-line access to the Contractor's test management information support system, if required.

3.6.2.3. 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.

3.6.2.4. 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).

3.6.2.5. 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.

3.6.2.6. Patient Information Backup Capability. The ability to develop and maintain backup patient information shall be available on a daily basis, including tests results processed.

3.6.2.7. The software shall have the following or equivalent menu selections:

3.6.2.7.1. Browse by shipping facility accession number.

3.6.2.7.2. Browse by Contractor's identification.

3.6.2.7.3. Browse result by patient name.

3.6.2.7.4. List requests with no test results (Pending Results).

3.6.2.7.5. List results overdue.

3.6.2.7.6. Change entry password.

3.7. Reporting and Interpretation of Critical Results and Procedures Ordered.

3.7.1. The Contractor’s laboratory shall publish a list of tests with results it deems to be in the critical range, and the special notification procedures it shall follow.

3.7.2. The contractor will establish a critical values reference list per testing facility

3.7.2.1. The contractor will follow the flowchart for notification procedures which are:

3.7.2.1.1. Telephoned to (678) 655-4315/4260/4829/4256/4995/4996.

3.7.2.1.2. If these individuals cannot be reached call the Senior Medical Officer / Commander at (404) 313-4621,

(678) 758-0794 or (678) 655-4260/4829/4996.

3.7.3. The Contractor shall submit the protocol for reporting critical values.

3.8. Handling of Specimen or Request Discrepancies.

3.8.1. 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.

3.8.2. 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.

3.8.3. 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.

3.9. Specimen Retention. 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.

3.10. Contractor’s Quality Control Systems.

3.10.1. 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.

3.10.2. 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 Administration’s website : http://wwwn.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.

3.10.3. 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 CO.

3.10.4. Subcontracted laboratories shall comply with and meet all accreditations/certifications as the prime contractor.

3.11. Results Reporting.

3.11.1. The Contractor shall provide reports of laboratory testing to the Government within the turn-around time specified herein.

3.11.2. 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:

3.11.2.1. The name and address of the contract laboratory where each test was performed.

3.11.2.2. The specimen accession number of the contract laboratory.

3.11.2.3. A phone number to contact the contract laboratory concerning the test results.

3.11.2.4. The contract laboratory’s CLIA certification number.

3.11.2.5. The patient’s name.

3.11.2.6. The patient’s SSN or DOD ID #.

3.11.2.7. The patient’s age or date of birth.

3.11.2.8. The patient’s sex.

3.11.2.9. The Government specimen identification number.

3.11.2.10. The specimen collection date.

3.11.2.11. The Contractor’s report date and time.

3.11.2.12. The test name.

3.11.2.13. The test result(s).

3.11.2.14. The unit of measurement for quantitative tests.

http://wwwn.cdc.gov/clia/

3.11.2.15. The normal or expected range (reference range adjusted for age, sex, or race when appropriate).

3.11.2.16. The report status (i.e., final or interim).

3.11.2.17. Other interpretive information appropriate for the test(s).

3.11.2.18. CPT Code.

3.11.2.19. LOINC Result Code.

3.11.3. 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).

3.11.4. 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.

3.11.5. 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.

3.12. Miscellaneous Contractor Responsibilities.

3.12.1. 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.

3.12.2. Set-up fees shall not be charged by the Contractor for cytogenetic tests showing no growth.

3.12.3. The Contractor shall provide through its customer service network, with minimal transfers and holding, access to knowledgeable, responsive laboratory professionals.

3.12.4. 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.

3.12.5. 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.

3.12.6. 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.

4. Deliverables.

4.1. Government-Furnished Items

4.1.1. Government shall perform specimen collection (e.g., phlebotomy services) to obtain acceptable specimens from patients.

4.1.2. Provide biologic specimens that have been collected and processed (centrifuged and separated, labeled, and preserved) per the Contractor’s published pre-analytical requirements, and in accordance with good laboratory practices (GLP).

4.1.3. Order required tests via approved software or online service, and provide the Contractor with test requests, lists, or work documents with required patient demographics and ordering information. For these automated sites, the Government will not complete additional Contractor’s forms, data entry or test requisitions in the Contractor’s automated laboratory system. For each test requisition, Government personnel will provide:

4.1.3.1. Patient’s full name.

4.1.3.2. Patient’s Social Security Number (SSN).

4.1.3.3. Dobbins ARB Accession Number.

4.1.3.4. Date of Specimen Collection.

4.1.3.5. Date Specimen Shipped.

4.1.3.6. Test(s) Requested/Code and Name.

4.1.3.7. Ordering Physician’s Name.

4.1.3.8. Ordering Remarks/Comments (if clinically appropriate).

4.1.3.9. Patient’s Age or Date of Birth.

4.1.3.10. Patient’s Sex.

4.2. Contractor-Furnished Items.

4.2.1. The Contractor shall furnish all shipping, facilities, labor, materials, equipment, software, and services as required. In addition, the Contractor shall provide:

4.2.1.1. Additionally, contractor shall provide Information (catalog) of Laboratory Services which includes:

4.2.1.2. Test specific specimen collection and preservation requirements for each test or analyte.

4.2.1.3. Test specific method and interpretation for each test or analyte.

4.2.1.4. Test specific method reference ranges, adjusted for age, sex, or race, when required.

4.2.1.5. Test specific method sensitivity, specificity, and interferences, when required.

4.2.1.6. Test specific schedule of performance and average turnaround time for each.

4.2.2. 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.

4.2.3. Product Information on new test(s) offered by the Contractor after commencement of services.

4.3. Pick-up, Courier, and Shipping Services.

4.3.1. Shipping transportation for biological specimens from all government activities submitting test requests under this contract.

4.3.2. 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.

4.3.3. The contractor shall provide pick-up service daily upon notification of the contractor by the Medical Squadron by 1200 of the day service is requested. Pick-up will be no later than 1600 on the date of pick-up. For pick-up services on Saturday/Sunday of drill weekends, the medical unit will notify the contractor of this requirement in advance.

4.4. Facilities. The Contractor shall provide and maintain the necessary facilities to perform services under the terms of this contract.

4.5. Sufficient Staff Levels.

4.5.1. Process and ship supplies, specimens, and reports to and from Contractor and Government.

4.5.2. Process, test, and monitor specimen testing through completion of each task, and to accurately certify and report test results in accordance with GLP.

4.5.3. 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.

4.6. Materials

4.6.1. Contractor shall furnish materials, supplies, equipment, and reagents necessary to meet all requirements during the term of the contract.

4.6.2. Furnished materials/supplies at Exhibit A to prepare specimens for shipping to the Contractor facility for processing, testing, reporting, and storage. Supplies required include, but are not limited to:

4.6.3. Shipping and packaging containers. Packing material shall be capable of maintaining temperature requirements and stability for specimens until they reach the contractor’s laboratory.

4.6.4. Leak-proof plastic tubes and containers for routine shipment of diagnostic specimens.

4.6.5. Specialized media and tubes for genetic studies, and special test requests.

4.6.6. A customized test request form, preprinted with the appropriate Shipping Section and account information for the tests offered.

4.6.7. Customized test request forms for specialized testing (i.e., cytogenetics, tissue, etc).

4.6.8. Impervious bags for specimen pick-up. Bags shall have at least two sections, one for specimen(s) and one for paperwork.

4.6.9. Special forms and special handling procedures for medico-legal specimens when required by the Government.

4.6.10. 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.

4.6.11. 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.

4.6.12. 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.

4.7. Equipment. The Contractor shall:

4.7.1. 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.

4.7.2. 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.

4.7.3. 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.

4.7.4. 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).

4.7.5. Identification and Authentication. User ID and Passwords shall be required for system access and use.

4.7.6. Audit. The system shall have audit trail capability.

4.7.7. Operational Assurance. The system shall afford protection from external interference and tampering.

4.7.8. Accreditation. Documents shall be signed by the designated authority.

4.7.9. 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.

4.8. Software. Contractor shall 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.

EXHIBIT A

LIST OF SUPPLIES NEEDED

LABELS FOR LABEL MAKER

PRE-PRINTED REQUISITION SHEETS (IN EVENT ON-LINE SYSTEM FAILS)

SHIPPING TUBES

COVID Collection Kits

VACU-TAINER TUBES: PURPLE TOP

o MARBLE TOP o GREY TOP o GREEN TOP

LIST OF SUPPLIES NEEDED

File details come from the government source that posted it. Updated .