Clinical_Reference_Laboratory_Services_DRAFT_PWS.docx

PERFORMANCE WORK STATEMENT

REFERENCE LABORATORY TESTING SERVICES

1. GENERAL. This is a non-personal services contract to provide clinical reference laboratory services. The Government will not exercise any supervision or control over the Contract Service Providers (CSP(s)) performing services herein. Such CSPs shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.2. SCOPE. The Contractor shall provide clinical reference laboratory services to the government at Contiguous/Continental United States (CONUS) and Outside the Contiguous/Continental United States (OCONUS).

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies. Clinical reference laboratory services will support the U.S. Army, U.S. Navy, U.S. Air Force, Coast Guard, and the Defense Health Agency (DHA). Use of this contract will be limited to those agencies identified. (See Exhibit B)

1.2.1. All tests shall be executed at the Contractor’s premises, or within the Contractor's network of laboratories [affiliate(s) or qualified subcontractor(s)].

1.2.2. The Army Medical Command Contracting Officer Representative (MEDCOM COR) at the U.S. Army MEDCOM, Fort Sam Houston, TX, is the focal point for this requirement. Each submitting activity will have their own Submitting Activity Contracting Officer Representative (TO/COR).

1.3. CONTRACTOR RESPONSIBILITY.

1.3.1. The Contractor shall provide all management services, planning, programming, administration, supervision, personnel, labor, materials, facilities, transportation, general and specialized equipment, supplies and execution necessary to provide the specified services.

1.3.2. The Contractor shall perform all work in accordance with this contract and all applicable Federal and state laws, regulations, and directives to include applicable publications and instructions listed in Exhibit G.

1.3.3. The Contractor shall only accept orders for tests incorporated into the contract at Technical Exhibit C (Contractor’s Pricelist). The Contractor shall not increase prices on the Contractor’s Pricelist without prior written approval of the Contracting Officer. Changes to the Pricelist to include increase or decrease of prices, and/or addition of new tests, shall only be made via a bi-lateral modification between the Contractor and the Contracting Officer.

1.3.4. The Contractor shall compile historical data, prepare required reports, and submit information as specified in this contract.

1.3.5. The Contractor shall ensure work meets quality and timeliness requirements specified in this contract, to include scheduling change(s) of technicians, courier services and responding to critical requirements such as emergency contingencies.

1.3.6. The Contractor shall ensure all laboratory facilities used to perform the requirements of this contract meet and maintain all state, federal and occupational standards, certification(s), accreditation(s), license(s), etc., required when executing performance under this contract.

1.3.7. The Contractor shall ensure all CSPs are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.3.8. 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, the College of American Pathology (CAP) accreditation standards, and/or other accrediting organizations’ and State standards.

1.3.9. The Contractor shall ensure every contract laboratory; prime or subcontractor, performing drug abuse blood or urine testing under this contract shall be currently certified by the National Institutes of Drug Abuse (NIDA) or American Board of Forensic Toxicologists (ABFT). If the prime Contractor does not have NIDA certification and proposes a subcontractor with NIDA or ABFT certification, the subcontractor shall meet all of the other required certifications and qualifications herein.

1.3.10. The Contractor shall use the Security of Unclassified DoD Information Instructions (DoDI 8582.01) to ensure their system will achieve and maintain adequate security for all unclassified DoD information on non DoD information systems. The Contractor shall refer to DoD Instruction 8582.01 for instructions on maintaining and achieving security for all unclassified DoD information on DoD information systems, and work with appropriate Government personnel to ensure this requirement is met. The Contractor shall coordinate with the Government to ensure that the appropriate Information Assurance (IA) controls have been identified prior to beginning the development of the system. The Contractor will address how applicable safeguards will be implemented prior to 31 March 2014.

1.3.11. The Contractor shall ensure that all Information Systems (IS)/networks used to perform under this requirement are operated in accordance with applicable laws, regulations, and Army and/or other Agency’s policy(ies) to include Identification of Privacy Act, which requires the development of a system of records in accordance with the Privacy Act of 1974.

1.3.12. The Contractor shall submit a copy of the professional certification and/or licensure of all CSPs to include, the corporate Laboratory Director and/or Medical Director and Technical Supervisors of the Primary Contractor’s laboratory to the MEDCOM/COR within 10 working days after contract award.

1.3.13. The Contractor shall keep the MEDCOM/COR, all Contracting Officers and the TO/COR as identified on each task order, 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 on a quarterly basis.

1.3.14. The Contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.3.15. The Contractor shall require all Contract Service Providers (CSP) will knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor shall immediately (within 24 hours) report the incident in writing to the government’s COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.3.16 The Contractor shall require all CPSs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government’s COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.4. CONTRACTOR PERSONNEL.

1.4.1. Contractor Representative. The Contractor shall provide a Contractor Representative, to resolve any administrative, technical issues, and/or problem areas the customers may be experiencing in the field. The Contractor Representative shall be available 24 hours 7 days a week via telephone, and be available in person by appointment, upon request by the Contracting Officer or the Contracting Officer’s Representative. The Contractor Representative shall be available to support each Submitting Activity(SA) within their assigned territory, for services that include but are not limited to, troubleshooting, servicing, and introducing new tests, within 72 hours.

1.4.2. Data Entry Technician(s). The Contractor shall provide Data Entry/Specimen Processing Technician(s) to assist with processing specimens and accurate entry of laboratory results into Composite Health Care System (CHCS), when interface between Contractor’s Laboratory Information System (LIS) and CHCS (or current LIS) is not available. The technician shall also be responsible for entering laboratory test requests, retrieving laboratory results, obtaining test information, printing patient reports, and printing utilization reports from the Contractor’s LIS.

Contractor provided technicians must complete DoD Information Assurance General User Training and achieve Access National Agency Check (security clearance) and complete on-site CHCS training within 30 calendar days, after task order award.

1.4.2.1. The Contractor shall provide Data Entry/Specimen Processing Technician(s) to spin and package specimens for pickup and delivery for laboratory testing, labeling specimens as required, and placing all necessary items in the proper shipping envelope and/or container. The technician shall also maintain and order all necessary supplies to support this effort.

1.4.3. Customer Services. The Contractor shall provide customer service personnel who shall be accessible by a 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, requesting emergency courier service, using the provided computer system, and other applicable related issues/problems that may arise in the performance of work under this contract.

1.4.4. Courier Services. The Contractor shall provide courier service personnel (transportation) for shipping, pick up, and delivery of specimens from the SA site to the Contractor laboratory. The courier shall ensure that all specimens picked up are checked and logged before leaving the SA laboratory shipping room as part of their certification of receipt procedures.

1.4.5. Computer Support. The Contractor shall provide computer support personnel to address CHCS Lab Test file/ table build. CSP personnel will assist sites with the modification and/ or build of CHCS Lab Test file/table build to support the vendor’s electronic interfacing capabilities. Upon completion of the file/table build across the enterprise and after any sustainment activities are complete; these services wil only be required for new activities. Contractor personnel will require and must succesfully complete a security investigation, e.g., National Agency Check with Law Enforcement and Credit (NACLC) or equivalent and ADP/IT-II for access to MHS systems including CHCS.

1.5. PERFORMANCE QUALITY.

1.5.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall implement and sustain, through-out the life of the contract, an industry acceptable quality control program for Reference Laboratory Services in accordance with (IAW) commercial industry standards, and as required by CLIA and CAP. Current CLIA requirements are located at the Health Care Financing Administration’s website:

http://www.phppo.cdc.gov/CLIA. The Contractor shall provide a copy of its existing Quality Control System to the MEDCOM COR within 15 days after award.

1.5.1.1. The Contractor shall submit any changes made to the QC plan, after award, to the MEDCOM/COR, and to the Contracting Officer, within 15 calendar days after the change.

1.5.1.2. The Contractor shall provide upon request of the MEDCOM/COR, the following documentation: 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; documentation of appropriate analyzer maintenance; verification results for assays of non-regulated analytes; and analytes for which proficiency testing does not currently exist.

1.5.1.3 The Contractor shall implement and sustain QC System records that are complete and accurate through-out the life of the contract.

1.5.1.4. The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the MEDCOM/COR a listing of external proficiency surveys that the laboratory participates IAW CLIA requirements. Survey results and statistical reviews for specific laboratory specialties shall be provided to MEDCOM/COR upon request.

1.5.1.5. All test methods shall be Food and Drug Administration (FDA) approved. Any non-FDA approved method being performed shall have a documented validation plan that as a minimum meets guidelines established by the Clinical Laboratory Standards Institute, and any applicable portions of the CFR for the implementation of non-FDA approved (commonly referred to as Laboratory Developed Tests) assays for use in human testing. Documentation will be provided to MEDCOM COR upon request.

1.5.1.6. The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure. The Contractor shall provide CAP interim checklist reports and CAP inspection reports to include deficiencies and corrective actions within 10 calendar days of receiving the report. The Contractor shall submit to the MEDCOM COR notification of completion of corrective action.

1.6. SAFETY REQUIREMENTS/OPERATIONAL SECURITY

1.6.1. The Contractor shall 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.

1.6.2. The Contractor shall submit a written property damage report to the MEDCOM COR, within 72 hours, for any accident caused by any CSP working at SAs which result in damage to Government property.

1.6.3.

1.6.3. Operational Security (OPSEC). IAW AR 530-1 Operations Security, Contractors for all types of Army contracts shall practice OPSEC to protect critical information for specific government contracts and subcontracts.

Neither the contractor, nor any of its contract service providers, nor the family members of its employees shall disclose or cause to disseminate any information concerning operations of military activities. Such action(s) could result in violation of the contract and possible legal actions.

1.6.3.1. OPSEC Training. Per AR 530-1, Operations Security, new contractor employees must complete Level I OPSEC training within 30 calendar days of reporting for duty. All contractor employees must complete annual OPSEC awareness training.

1.6.4. Antiterrorism and Operations Security Compliance. The contractor shall comply with each of the following if checked:

1.6.4.1. Contractor employees with an area of performance within an Army-controlled installation, facility, or area shall comply with the following requirement.

1.6.4.2. _ X__ AT Level I Training. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR (or to the contracting Officer, if a COR is not assigned) within 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil/at.

1.6.4.3._ X__ Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures (provided by the Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

The contractor shall comply with all personal identity verification requirements as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

1.6.4.4._ X__ iWATCH Training. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award, and within 5 calendar days of new employees’ commencing performance, with the results reported to the COR no later than 45 calendar days after contract award.

1.7. SECURITY REQUIREMENTS.

1. 7.1. Physical Security.

1.7.1.1. The Contractor shall ensure all CSPs performing work on a government facility observe and comply with all local rules and regulations prescribed by the installation and other federal authorities concerning fire, safety, sanitation, security and possession of firearms or other lethal weapons. No CSP shall be permitted on the installation when his/her presence would be detrimental to the security of the installation.

1.7.1.2. The Government reserves the right to require removal from the job site any CSP who endangers persons or property and whose continued employment is inconsistent with the interest of government security. In such cases, the Contracting Officer will advise the Contractor of the reason for requesting a CSP’s removal or withdrawing his permit to enter the installation.

1.7.1.3. The Contractor shall remove from duty any CSP found to be incapacitated or under the influence of alcohol or drugs, or other incapacitating agents and shall not return such CSP to duty until such CSP is fully able to perform the normally assigned duties. Removal of CSP(s) for such causes does not relieve the Contractor of the requirement to provide sufficient personnel to adequately perform services specified under this contract.

1.7.2. Information Security. The Contractor shall ensure that the computer system has the appropriate security features to process and transfer data that is classified as Sensitive But Unclassified (SBU). 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.

1.7.2.1. The Contractor shall ensure that CSPs performing under this contract do not disclose or cause to be disseminated any information concerning military activity operations.

1.7.2.2. The Contractor shall ensure that CSPs performing under this contract do not disclose private medical information concerning patients to third parties other than those personnel designated by the Contracting Officer Representative 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 in PWS.

1.7.2.3. The Contractor shall ensure that 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 MEDCOM COR for resolution.

1.7.3. TRUSTED ASSOCIATE SPONSORSHIP SYSTEM (TASS).

1.7.3.1. The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

1.7.3.2. The Contractor shall comply with agency personal identity verification procedures in all subcontracts when the subcontractor is required to have physical access to a federally-controlled facility or access to a Federal information system.

1.7.3.3. The Contractor shall ensure compliance with the provisions set forth below. For purposes of FAR Clause 52.204-9, the Government will designate a Trusted Agent (TA), and the Contractor shall designate a Facility Security Officer (FSO), for this contract. The government reserves the right to amend or supplement these provisions pursuant to the Changes clause in the contract.

1.7.3.4. In-processing Requirements. The Contractor shall ensure that CSPs adhere to all in-processing requirements; CSPs are prohibited from performing services under this contract absent compliance with the inprocessing requirements set forth below.

1.7.3.5. The government will sponsor the contract CSPs for an Army Knowledge Online (AKO) account. All CSP e-mail addresses will identify them as a contractor and use the format firstname.lastname.ctr@us.army.mil. The AKO will be discontinued by the government when the CSPs no longer require access.

1.7.3.6 The government TA will send a notice through the TASS to the AKO e-mail address provided IAW the above requirement. The CSP’s user ID and password will be provided in the e-mail and will be require a change at first log-in. In the event the e-mail message is not received, the contractor may request the username and password from the TA and proceed to the website https://www.dmdc.osd.mil/tass to complete the process.

1.7.3.7. The CSP shall log into the TASS and complete the verification process by submitting the application back to the TA for approval.

1.7.3.8 The application will be accepted, returned, or rejected by the TA. Notice as to whether the application has been accepted, returned, or rejected will be provided to the CSP’s e-mail address within 48 hours after submission.

If the application is returned or rejected, the CSP shall contact the TA and comply with the TA’s guidance to attempt to correct and resolve the issue(s).

1.7.3.9 Upon approval of the application, the CSP will receive an e-mail stating the CAC application was approved.

The applicant must then go to a RAPIDS Issuing Facility to have the government credential issued. Effective 1 December 2011, Fort Sam Houston, Randolph Air Force Base and Lackland Air Force Base ID sections require an appointment. To make an appointment, the CSP will follow the instructions provided by the TA and contact the COR for instructions. If the CSP chooses Randolph or Lackland AFB, the supervisor or government task manager must send a visitor message prior to the CSPs arrival on-site. The CSP must present two acceptable forms of ID which may include: Driver's License, Military ID, Contractor Company ID with picture and expiration date, charge card with picture imprinted, or passport.

1.7.3.10. Revalidation Requirements. The Trusted Agent (TA) is required to revalidate all CSPs, in the TASS System, every 6 months. In the event revalidation is denied, the CAC credentials shall be revoked and the CAC will not be useable to login.

1.7.3.11. Out-processing Requirements. When a CSP’s performance under this contract ceases, the CSP shall personally bring the CAC to the TA and complete the DA Form 2962. The TA will revoke the CAC from the

TASS.

1.7.3.12. The Contractor is responsible for absences of CSPs due to expired identification and access documents.

Such absences shall not relieve the Contractor of its obligation to perform the health care services required under this contract.

1.7.3.13. The Contractor shall ensure that CSPs immediately report any lost or stolen badges to the TO/COR.

1.7.4. Health and Immunization requirements. The Contractor shall ensure that all CSPs/technicians performing services in Medical Treatment Facilities (MTF(s)) under this contract shall comply with the Health and Immunization requirements identified below at the time of initial request for clinical privileges and annually thereafter.

1.7.4.1. The Contractor shall ensure that all CSPs performing services under this contract in MTFs shall receive a general physical examination prior to commencement of services. The Contractor shall provide the TO/COR, 10 calendar days before beginning services under this contract, a physical examination certificate for each individual CSPs who will provide services. The certification shall state the date on which the physical examination was completed and the name of the physician who performed the examination. This certification shall be signed by the physician performing the examination. For the purposes of this paragraph, a physical examination administered more than 45 days prior to performance of the contract will not be considered adequate. The physical examination shall include the following:

(1) A history to show that CPSs has completed a primary series of immunization with tetanus and diphtheria toxoids and that a booster dose is current (within the past 10 years).

(2) A test for the hepatitis (Type B) virus with documentation of the results. A profile shall be established to show immune status to hepatitis. Non-immune Health Care Workers (lacking anti-HB(c) or anti- HB(s)) shall be required to complete an immunization series with a Hepatitis B vaccine (e.g., Recombivax, Engerix).

(3) The physical examination shall also document serologic evidence of immunity to measles and rubella or to provide documentation of immunization with measles, mumps and rubella (MMR) vaccine using the following guidelines:

(4) CSP shall be screened for tuberculosis by a tuberculin skin test using the Mantoux technique. A skin test result of 10 mm of indurations or more shall be required to have a chest roentgenogram and an evaluation performed. A tuberculin skin test of 10 mm of indurations or more will require documentation providing an assessment of the patient (status of infection active, inactive; need for preventive treatment or not as determined by age, history of Bacillus Calmette Guerin (BCG) vaccination; duration of skin test positivity, etc).

1.7.4.2. If all of the immunizations and tests set forth in the preceding paragraphs have not been completed, the Contractor shall issue a certificate providing evidence of immunizations and tests that have been completed or started and shall provide a schedule for the completion of unfinished immunizations and lab tests. After the schedule is completed, the Contractor must provide an updated and complete certificate.

1.7.4.3. The Contractor shall ensure that all CSPs performing services under this contract in MTFs, who experience a parenteral (e.g., needle stick or cut) or mucous membrane exposure (e.g., splash to the eye or mouth) to blood or bloody body fluids, shall receive prompt treatment. The medical treatment facility (MTF) will evaluate the source of exposure for risk of Hepatitis B, Hepatitis C, and Human Immunodeficiency virus (HIV) and will provide a report of the findings to the Contractor and the CSP. It shall be the Contractor's responsibility to provide appropriate treatment as needed to possibly include Tetanus Diphtheria booster, Immune Globulin, Hepatitis B vaccine booster, or Hepatitis B Immune Globulin. The Contractor shall be responsible for providing the CSP with initial testing and if the source of exposure was unknown, positive, or considered at high risk for HIV infection, follow-up testing 3, 6, and 12 months after exposure. In the event of a confirmed or highly suspected parenteral exposure to HIV, the Contractor shall insure that the CSP receives appropriate counseling and is referred immediately to a private infectious disease specialist for consideration of any experimental therapy (e.g., AZT). The Government may require the Contractor to provide evidence of the status of treatment and testing of the CSP under the contract.

1.7.4.4. Failure to meet the requirements stated herein, or when test results determine a CSP has a contagious disease, the Contracting Officer may, upon the advice of the MTF commander or his clinical staff, determine that such provider is not an acceptable individual to perform services under this contract.

1.8. Computer Security. Computer system processing is sensitive, but unclassified information, and shall have the appropriate security features in accordance with requirements in DoDD 8500.01E, Information Assurance, U.S.

Army’s or other Government Agency basic policy of initial and periodic security training and the need for physical controls to protect hardware and data.

1.9. CONTRACT TRANSITION PERIOD. The Contract Transition period will be 6 months prior to commencement of full performance. During the Contract Transition period, the Contractor shall become familiar with test requirements and make all necessary preparations to assume full testing services on 31 March 2014. The Contracting Officer or the Contracting Officer Representative shall be authorized to visit the testing facility and assess the Contractor's ability to meet contractual requirements. The Contractor shall provide, within 10 calendar days of award of the contract, a detailed plan for the Transition period to include timeline to meet the electronic interface DODI 8582.01requirements of the contract. The Contractor must provide a monthly status report, due the 5th of each month, on efforts to achieve the required electronic interface IAW DODI 8582.01, to ensure secure electronic data transfer capability, until it is complete. The Contractor must have the ability to electronically transfer data correctly no later than 31 March 2014. (also see Task Order Start-Up at paragraph 5.15)

1.9.1. The Contractor shall work with Government personnel to meet DoD System Security Requirements IAW

DODI 8582.01.

1.10. A progress meeting shall be held within 60 days after the contract start date between the MEDCOM/COR and the Contractor to discuss any issues; throughout the life of the contract, the contractor shall be available to meet with the TO/COR or MEDCOM/COR upon request, thereafter.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS:

2.1.1. ACCREDITATION. The formal approval by the Army to operate the contractor's IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections; and with appropriate level of protection for the specified period.

2.1.2. AUTHORIZATION TO OPERATE. (ATO). Authorization granted by a Designated Approval Authority (DAA) for a DoD IS to process, store, or transmit information. An ATO indicates a DoD IS has adequately implemented all assigned IA controls to the point where residual risk is acceptable to the DAA. ATOs may be issued for up to 3 years.

2.1.3. CERTIFICATION. The determination of the appropriate level of protection required for IS/networks.

Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network.

2.1.4. CERTIFICATE OF NET WORTHINESS (CoN) AR 25-1 par 6-3c The Networthiness Certification Program manages the specific risks and impacts associated with the fielding of ISs and supporting efforts, requires formal certification throughout the life cycle of all ISs that use the IT infrastructure, and sustains the health of the AEI.

Networthiness Certification is concerned with the identification, measurement, control, and minimization of security risks and impacts in IT systems to a level commensurate with the value of the assets protected. Networthiness Certification applies to all organizations fielding, using, or managing ISs on the AEI/ LWN, to include COTS and GOTS. Activities must obtain a Certificate of Networthiness before they connect hardware/software to the LWN.

The contractor shall support the CoN process.

2.1.5. COMPOSITE HEALTH CARE SYSTEM (CHCS). The DoD's standard hospital and laboratory medical information system.

2.1.6. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors.

2.1.7. 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. The basic contract will be administered by the Center for Health Care Contracting/Contracting Officer.

2.1.8. 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.

2.1.9. CONTRACT SERVICE PERSONNEL/PROVIDER (CSP). An employee of the Contractor, subcontractor and/or subcontractor personnel or providers. (i.e., Contractor representative, customer service personnel, data entry/specimen processing technician, and courier)

2.1.10. CRITICAL RESULTS. 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. 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.

2.1.11. CURRENT PROCEDURE TERMINOLOGY (CPT). A listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians.

2.1.12. C-2 SECURITY REQUIREMENTS. These are found in DoDD 8500.01E, Information Assurance.

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. Army’s 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).

2.1.13. DEFECTIVE SERVICE. A unit of service which contains one or more defects, or noncompliance with specified requirements.

2.1.14. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72.

2.1.15. FAMILY MEMBER PREFIX (FMP). A two-digit numeric code used as a prefix to the social security number that categorizes health care beneficiaries. See Exhibit F.

2.1.16. LOGICAL OBSERVATION IDENTIFIER NAMES AND CODES (LOINC). The LOINC Laboratory terms set provides a standard set of universal names and codes for identifying individual laboratory and clinical results. LOINC Codes allow users to merge clinical results from many sources into one database for patient care, clinical research, or management.

2.1.17. MEDICAL EXPENSE AND REPORTING SYSTEM (MEPRS) CODE. An ordering code (three to four alpha-numeric characters) that identify the sub-specialty within the hospital to charge expenses. As an example, code AAAA, is charged to Inpatient Internal Medicine Services.

2.1.18. QUALITY ASSURANCE. The procedures used to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.19. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken to assure that the quality of an end product or service shall meet contract requirements.

2.1.20. SHIPPING FORM. Form(s) used to initiate shipping actions.

2.1.21. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.22. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary Contractor.

2.1.23. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract.

2.1.24. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the

PWS.

2.1.25. TASK ORDER CONTRACTING OFFICER. Contracting Officer who issues an individual task order against the basic contract, other than the CHCC/KO

2.1.26. TRUSTED ASSOCIATED SPONSORSHIP SYSTEM. Web-based system which replaces the Contractor Verification System (CVS)

2.2. ACRONYMS.

Atlanta, GA.

MEDCOM/COR - Army Medical Command Contracting Officer Representative

TA/KO - Task Order Contracting Officer

3. GOVERNMENT INFORMATION.

3.1. RESPONSIBILITIES. The Government will:

3.1.1. Perform specimen collection.

3.1.2. 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 standard quality procedures.

3.1.3. Order required tests in CHCS or other LIS, if available, and provide the Contractor with test requests, lists, or work documents with required patient demographics and ordering information. When the interface is established and installed and SA site has been automated, 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:

· Patient’s full name.

· Patient’s Family Member Prefix (FMP)

· Social Security Number (SSN) or Unique Patient Identifier.

· Submitting Activity’s Name and Accession Number.

· Date of Specimen Collection.

· Date Specimen Shipped.

· Test(s) Requested/Code and Name.

· Ordering Physician’s Name.

· Ordering Remarks/Comments (if clinically appropriate).

· Patient’s Age or Date of Birth.

· Patient’s Sex.

· MEPRS Code.

· Submitting Activity Site

· Submitting Activity Site Account Number

3.1.4. The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/ time availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

3.2. GOVERNMENT-FURNISHED ITEMS.

3.2.1. Specimens for testing.

3.2.2. The Government will provide, without cost to the Contractor, limited space for support services to be performed at the MTFs.

4. CONTRACTOR -FURNISHED ITEMS.

4.1. COMMERCIAL CATALOG OF LABORATORY SERVICES. The Contractor shall provide a copy of its commercial catalog of laboratory services. Information shall also be provided by the Contractor to the TO/COR.

The Contractor shall provide a hard copy or electronic copy during the start-up period to each SA. The website for electronic copy or hardcopy shall be provided at time of award of each task order. The catalog will be used by the government as a reference to determine the specimen requirements, methodology and clinical utility of the tests offered by the contractor. The catalog will not serve as a test price list or comprehensive list of tests available to the government. 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, adjusted for age, sex, or race, when required.

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

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

. Test Order Code . Current Procedure Terminology (CPT) Code . Result Code

4.1.2. 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 the MEDCOM/COR, Center for Health Care Contracting (CHCC) Contracting Officer and Contracting Officers for each task order and each TO/COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for updating CHCS files and informing Medical Staff. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the TO/COR. The COR will notify the Centralized Program Manager, U.S. Army MEDCOM, Fort Sam Houston, TX and all contracting officers in the event of noncompliance with this requirement.

4.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to Centralized Program Manager, U.S. Army MEDCOM, Fort Sam Houston, TX, all contracting officers, and each TO/COR once test procedure validation is complete.

4.3. SUPPLIES. The Contractor shall provide an initial 8-week stock of materials or supplies to be used by the SA identified in each task order in preparation for shipment of specimens for testing requirements. Supplies required for the initial 8-week period shall be a part of the contract start-up period responsibilities. The Contractor shall be responsible for providing items needed for shipment of specimens from SA to Contractor.

4.3.1. 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 is the responsibility of the Contractor. On a case-by-case basis, emergency supplies may be requested by each SA POC and shall be provided by the Contractor as required. The Contractor shall meet with SA COR within 5 working days after the award of a task order to determine the quantity required for each site. The Contractor shall:

4.3.2. Furnish materials, supplies, equipment, and reagents necessary to meet the requirements for the provision of services established under the terms of this contract.

4.3.3. Shipping and packaging containers. Packing material capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory under the terms of this contract.

4.3.4. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

4.3.5. Test request forms, preprinted with the appropriate Shipping Section and account information for the tests offered. Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.). Forms and special handling procedures for medico-legal specimens when required by the Government.

4. 3.6. Impervious bags for specimen pick-up. Bags shall have at least two sections, one for specimen(s) and one for paperwork.

4. 3.7. Printer supplies including paper and labels, laser printer consumable supplies such as toner and cartridges in sufficient quantities to perform work under this contract.

4. 3.8. Barcode labels for identification on each sample transfer tube, or specimen container if requested. (Labels may be furnished by printing with the Contractor-provided laboratory information system).

4.3.9. Furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers.

4.3.10. The Contractor shall provide maintenance and replacement of furnished to the Government for the entire contract period. The Contractor shall provide repair and/or replacement equipment within 24 working hours of notification by the Government of equipment failures.

4.4. Furnish toll-free customer service/Help Desk telecommunication lines (including installation and maintenance service charges) to support incoming Government personnel calls for assistance.

5. DESCRIPTION OF WORK: The Contractor shall provide services required to perform Reference Laboratory Testing services to include but not limited to, providing testing, supplies, labor, customer services, courier services, software, equipment, computers, information technology, reporting/interpreting, result reporting, and management reports. The Contractor shall provide three means of order entry and result retrieval. One, through the Contractors web-based system; two, through the CHCS portal; and three through courier services. These services will be provided to military treatment facilities via task order issued by each ordering activity. The Contractor shall comply with all provisions of the Privacy Act of 1974 (Public Law 93-579) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) when providing Reference Laboratory Services.

5.1. The quality for services rendered hereunder shall conform to best practices and the highest standards in Clinical Laboratory Medicine. The contractor's laboratory operations must conform to best practice requirements as outlined by the CAP (inspection checklists - most current edition) or other CLIA approved accreditation agency's checklist or inspection criteria, which are hereby incorporated by reference with the same force and effect as if set forth in full text.

5.2. TASK - TESTING. The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute required tests defined in the Contractor’s Price list (Technical Exhibit C). All clinical reference laboratory testing shall be executed in accordance with standard industry practices.

5.2.1. The Contractor shall not charge any set-up fees for cytogenetic tests showing no growth.

5.2.2. The Contractor shall ensure the accurate and timely performance of laboratory testing services in biologic specimens provided by SAs. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions. Such standards and operating manuals shall include the procedures as outlined in the CAP Inspection Checklists (current edition) which are hereby incorporated by reference with the same force and effect as if set forth in full text.

5.2. 3. 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.