Statement of Work - Laboratory Medical Testing.docx

Statement of work, Laboratory Medical Testing Safety Office U.S. Army Corps of Engineers Vicksburg District Headquarters (MVK)

1.0 The MVK Safety Office requires a contractual vehicle for medical testing (blood and urine) services for the 4155 Clay Street, Vicksburg, MS location.

1.1 Purpose and Scope.

This is a non-personal services contract to provide select lab testing services for MVK employees. The government shall not exercise any supervision or control over the contract services provided.

The contractor shall provide all personnel, supervision, services, and supplies necessary to perform select lab testing services (blood and urine) for MVK. The services would be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality, meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

The vendor is not required to draw blood samples but is required to transport samples, analyze samples, and report/deliver results of samples. NOTE: Pricing for special/additional test(s) will be negotiated with MVK Contracting Office prior to being performed under this contract.

The period of performance for this contract is a base of 12 months and four 12-month options for a total of 5 years if all options are exercised.

2.1 Performance requirements:

The contract lab must be within 15 miles for drop off by our office or within 50 miles for pick-up. Not acceptable is pick-up by a mail service provider such as USPS, UPS, or FEDEX etc. The contractor is required to pick up samples between 12:00 am and 3:00 pm on Tuesday and Thursday of each week. The specimen pickup must be made before 3 p.m. central time at MVK Headquarters, 4155 Clay Street Vicksburg, MS 39183-3435. No minimum will be guaranteed. The Government shall only be required to pay for actual tests picked up, analyzed, and reported in accordance with this contract.

2.2 The contractor shall provide the following equipment and supplies:

· Centrifuge machine

· Specimen Collection Box

· Blood drawing equipment (including all blood drawing tubes and needles, butterflies, specimen bags, urine cups, 24-hour urine jugs)

· Forms for packing/shipping

· Results printer & supplies (if not available on the web site)

2.3 The contractor shall provide the following services:

The contractor is required to perform analytical testing for MVK patients for the tests defined in Section B. The Contractor is required to provide a report (separate and independent of the invoice for payment) of analytical test results and consultative services as required. The test results will be supplied to MVK for entry into the patient’s chart.

The contractor shall provide a Laboratory Manual (or have available on the website) to include testing methodology and containing the following information for testing services:

· Department hours of operation

· Technical Staff

· Licensing and Accreditation: Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP)

· Service Departments (Method of contacting, phone numbers, hours of availability)

· Quality Assurance Information

· Billing Procedures (fees for tests must be included in Section B of the solicitation)

· Procedures and criteria for phoning reports and other important information

The contractor shall provide telephone number(s) and contact person(s) available to MVK to make specimen problem inquiries and problem solving. The contractor agrees to maintain the minimum acceptable service, reporting systems, and quality control as specified herein.

Immediate (within 24 hours) notification must be given to MVK upon adverse action by a regulatory agency. The contractor shall assign a specific local account representative. The contractor shall advise MVK of any changes in methodology, procedure, or reference ranges.

The Contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. The contracting laboratory shall not release patient’s records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the requesting agency. All member records shall be treated as confidential to comply with all local, state, and federal laws regarding the confidentiality of patient’s records. This provision shall survive expiration or termination of the resulting contract award. The contractor shall certify and ensure that all employees, officers, or agents do not use Protected Health Information (PHI) received from MVK that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

Contactor personnel shall NOT perform inherently governmental functions (i.e., representation of government, decision authority, etc.).

Contractor personnel are responsible for protecting the confidential nature of employee files and medical issues.

The contractor is prohibited from releasing any medical, personnel, financial or supporting data provided by MVK to any government, non-government agency, or individual unless specifically authorized, in writing, by the Contracting Officer. This includes any proprietary contractor information.

2.4 Test Results/Deliverables. Results of laboratory tests shall be completed and made available to the MVK Safety Office. Electronic delivery of results is the preferred method of delivery and shall be secure and meet Personal Identifiable Information (PII) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements. The contractor is required to have the capability of faxing results if requested.

2.5 Licensing and Accreditation. The contractor shall have all licenses, permits, accreditation certificates required by Federal law and State law in Mississippi. The contractor shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications will be provided and updated as needed to the Contracting Officer. The vendor shall notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.

3.0 Quality Control Plan (QCP): The contractor must operate a successful quality control program as required by CLIA or CAP. Services are to be performed in accordance with this SOW. The quality control program must include procedures to identify, prevent, and ensure non- recurrence of defective services. The contractor’s quality control program is the means by which the contracting laboratory assures that work complies with the requirement of the contract. A quality control program shall be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to this QC system.

4.0 Quality Assurance (QA): The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

5.0 Security Requirements.

5.1 General security requirements and guidance: The security requirements described below apply to all contract personnel (including employees of the prime Contractor (“Contractor”) and all subcontractor employees) supporting the performance requirements of this contract. The Contractor is responsible for compliance with these security requirements. Questions regarding security matters shall be addressed to the designated Government representative (e.g., Contracting Officer Representative (COR), Requiring Activity (RA) representative, or Contracting Officer (if a COR or other RA representative is not appointed)). Contract personnel are critical to the overall security and safety of US Army Corps of Engineers (USACE) installations, facilities and activities, and security awareness training contributes to those efforts. The Department of Defense (DoD) and Army security training requirements specified below, if applicable, are performance requirements; all applicable contract personnel shall complete initial training within 30 days of contract award or the date new contract personnel begin performance on the contract. Within five business days from the completion of training, the Contractor shall provide written documentation (e.g., email or memorandum) to the Government representative. The documentation shall include the names of contract personnel trained and which training they completed; the Contractor shall maintain training records as part of their contract files and be prepared to provide copies of training certificates to the Government representative. Contractor personnel and vehicles are subject to search when entering federal installations. Additionally, all contract personnel shall comply with Force Protection Condition (FPCON) measures, Random Antiterrorism Measures (commonly referred to as “RAMs”), and Health Protection Condition (HPCON) measures. The Contractor is responsible for meeting performance requirements during elevated FPCON and/or HPCON levels in accordance with applicable RA plans and procedures, to include identifying mission essential and non-mission essential personnel. In addition to the changes otherwise authorized by the changes clause of this contract, should the FPCON or HPCON levels at any individual facility or installation change, the Government may implement security changes that affect contract personnel. The Contractor shall ensure all contract personnel are aware of their security responsibilities, including any site-specific requirements identified in local policies or procedures.

5.2 Physical security and access control requirements: All contract personnel requiring physical access to a federal installation or facility shall comply with the access control procedures of that location. Contract personnel requiring unescorted access to meet contract performance requirements on a DoD installation in the US shall be vetted by the installation/facility Provost Marshal/Directorate of Emergency Services/Security Office using the National Crime Information Center-Interstate Identification Index (commonly referred to as “NCIC-III”) and Terrorist Screening Database (commonly referred to as “TSDB”). Contract personnel shall comply with all personal identity verification requirements specified in installation/facility policies and procedures. Contract personnel who do not meet requirements for unescorted access to USACE facilities shall coordinate escorted access with the Government representative, as needed. Contract personnel who receive keys, access cards, or lock combinations that provide access to government-owned property shall comply with key and lock control procedures of the RA.

5.3 Suspicious Activity Reporting training (e.g., iWATCH, CorpsWatch, or See Something, Say Something): All contract personnel shall receive initial and annual refresher training from the RA representative on the local suspicious activity reporting program. This locally developed training provides contract personnel with general information on suspicious behavior, and guidance on reporting suspicious activity to the project manager, security representative or law enforcement entity.

5.4 Escorting in classified and/or sensitive areas: In accordance with applicable regulations, all contract personnel who do not possess the appropriate security clearance or access privileges will be escorted in areas where they may be exposed to classified information or operations, sensitive information or activities, or restricted areas.

5.5 Pre-screen candidates using E-Verify Program: Contractors shall comply with the requirements set forth in FAR clause 52.222-54 Employment Eligibility Verification and FAR Subpart 22.18 in using the E-Verify Program at (https://www.e-verify.gov/) (website subject to change) to meet the contract employment eligibility requirements. Contractors are encouraged to cooperate with Federal and State agencies responsible for enforcing labor requirements to include eligibility for employment under United States immigration laws in accordance with FAR 22.102-1(i). An initial list of verified/ eligible candidates shall be provided to the COR no later than three business days after the initial contract award. When contracts are with individuals, the individuals will be required to complete a Form I-9, Employment Eligibility Verification, and submit it to the Contracting Officer to become part of the official contract file.

6. Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the Contracting Officer. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review contactor performance.

7. Billing Procedures:

7.1. The contractor is required to invoice electronically in accordance with clause FAR 252.232- 7006.

7.2. The contractor shall bill for actual number/type of tests performed. Patient names, birth dates, social security numbers, or other personally identifiable information (PII) shall not be on invoices submitted for payment.

7.3. A separate document identifying the name of the patient (Last, First, MI) for which lab tests were performed is required to be submitted to the Contracting Officer Representative (COR) prior to or concurrent with the invoice posting in Wide Area Workflow (WAWF). However, due to the sensitive nature of this information, the document should not be attached to the invoice in WAWF and is required to be submitted via encrypted email or other security means deemed to be acceptable by the COR.

8. Performance Metrics:

No unsecure transactions within contract period.