A.02 SOW.PDF

EVANS ARMY COMMUNITY HOSPITAL

REFERENCE LABORATORY TESTING SERVICES

STATEMENT OF WORK

1. DESCRIPTION OF WORK

1.1. The Contractor shall provide clinical reference laboratory services to the government at Contiguous/Continental United States. The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies. Clinical reference laboratory services will support the U.S. Army.

1.2. The performance of the Afirma Gene Expression Classifier test will be executed at the Contractor’s premises, or within the Contractor’s network of laboratories.

2. PERIOD OF COVERAGE

2.1. Starting 1 October 20 to 30 Sep 21 plus two additional option years.

3. SPECIFIC TASKS

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.

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.

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

3.4. 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.

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

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

3.7. The Contractor shall ensure the performance and interpretation of the proprietary Afirma Gene Expression Classifier as well as 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 accrediting organizations' and State standards.

3.8. 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.

4. CONTRACTOR PERSONNEL

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 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.

4.2. 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 tests 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.

5. PERFORMANCE QUALITY

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. The Contractor shall provide a copy of its existing Quality Control System to the COR within 15 days after award.

5.2. The Contractor shall submit any changes made to the QC plan, after award, to the COR, within 15 calendar days after the change.

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

5.4. The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes.

5.5. All test methods shall be Food and Drug Administration (FDA) approved.

5.6. The Contractor shall notify the Contracting Officer immediately, in writing, upon loss of any required certification, accreditation, or licensure.

6. ADDITION INFORMATON

6.1. Tobacco Control: The Contractor and his employee’s shall observe the Tobacco Control Requirements contained in AR 600-63 chapter 4-2, whenever performing services at Fort Carson. Regulation will be provided by Evans Army Hospital.

6.2. Post Access: Entry to the Installation requires the following: Current vehicle registration, proof of insurance, valid driver's license for the vehicle driver, and picture identification for other personnel.

6.3. Contractors/Subcontractors and their employees requiring access to the Installation will be required to comply with the Installation access control policy/procedures. The Government will not be responsible for damages due to delay/stoppages caused by failure to comply.

6.4. All vehicles and personnel are subject to search and seizure of contraband and/or unauthorized Government property. Contractor vehicles (Contractor-owned and personal), Contractor employees, and their personal property shall be subject to searches upon entering or leaving the Installation.

7.0. CONTRACT MANPOWER REPORTING. (Accounting for Contract Services) (Jul 2007) The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL Contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address “https://cmra.army.mil”. The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data; (5) Estimated direct labor hours (including sub-Contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-Contractor); (7) Total payments (including sub-Contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (10) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement.

Reporting period will be the period of performance not to exceed 12 months ending September 30 of each Government fiscal year and must be reported by 31 October of each calendar year. The Contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the Contractor will notify the Contracting Officer."

The following information is provided for the Contractor’s use in completing the above report:

Predominant Federal Service Code: J065 (Maintenance and Repair of Medical Dental and Veterinary Equipment)

Unit Identification Code for the Army Requiring Activity: W21PAA (Evans Army Community Hospital)

Report Schedules are based on the Government’s Fiscal Year cycle, regardless of the contract period of performance cycle. This contract requires a final CMR report which does NOT align to the Fiscal Year. The final CMR report shall be due NLT 30 days after the performance period ends. If this contract is extended beyond the final CMR reporting period, the modification authorizing the extension will reflect the revised final CMR due date.

(End of Statement of Work)