PWS - BPA Genetic Testing TAMC.docx

PERFORMANCE WORK STATEMENT

GENETIC TESTING

FOR TRIPLER ARMY MEDICAL CENTER, HI

TABLE OF CONTENTS

1.0. INTRODUCTION.

1.1. The contractor shall provide the non-personal services of Genetic Testing for Tripler Army Medical Center which shall contribute to a stable workforce tasked with providing quality health care services to a diverse beneficiary population.

1.2. All services shall be provided in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission (JC) standards, applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facility (MTF) specific policies, procedures, and job descriptions.

1.3. RESERVED

1. 4. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

2.0 BACKGROUND.

2.1. The mission of the military healthcare system (MHS) is to ensure the nation has available at all times a healthy military force supported by a combat ready healthcare system. Health care services for eligible MHS beneficiaries are provided at military treatment facility (MTF) located on or near military installations or posts. The military treatment facility may be a clinic, Hospital, or Medical Center. Clinics are outpatient facilities offering primary care or simple specialty care (routine exams, tests, treatments). The Clinic may be a stand-alone site or a satellite of a larger Clinic, Hospital, or Medical Center. Army Community Hospitals (ACH) offer more complex, resource-intensive secondary care (e.g. inpatient care, surgery under anesthesia) and primary care at outpatient clinics inside and outside the hospital. Army Medical Centers (MEDCENs) offer tertiary (sophisticated diagnosis/treatment of any ailment), secondary, and primary care, hospital services, preventive services, blood bank, and other services. In addition, all MEDCENs offer graduate medical education programs for physicians.

2.2. Tripler Army Medical Center is the headquarters of the Pacific Regional Medical Command of the armed forces administered by the United States Army in the State of Hawaii. It is the largest military hospital in the Asian and Pacific Rim region and serves a military sphere of jurisdiction. During a single day of operations at Tripler Army Medical Center, personnel serve an average of 1,728 meals, tend to 2,248 clinic visits and 110 emergency room visits, fill 1,193 prescriptions, complete 25,000 pathology procedures and deliver eight (8) infants. On a typical day, 32 new patients are admitted as 159 beds are occupied. Of those patients, 19 go through ambulatory surgery.

3.0 SCOPE OF WORK.

3.1 The reference lab shall provide mission essential genetic testing services consisting of Next generation sequencing, consultation, and interpretation to aid in the diagnosis and treatment for specimens submitted by Tripler Army Medical Center, Department of Pathology. Work includes the testing of specimens, and communication of results back to TAMC to include electronic and hard copy results. Services shall be in accordance with the established principles, practices and ethics of the laboratory profession

3.2 Administrative.

3.2.1. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award. Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

3.2.2. The Individual Authorized to Place Calls (IAP) will be the KO’s authorized representative in administering the contract at the MTF level. The Contractor’s representative shall be available to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

3.2.3. The use of non-compete conditions in employment agreements or in subcontracts (to prevent loss of personnel by the contractor) effective only during the period of the contract performance is acceptable. However, the use of non-compete conditions in employment agreements and/or in subcontracts that prevent employees and/or subcontractors of the incumbent from being interviewed by, employed, or accepting offers of employment and/or subcontracts by the new contractor on the follow-on contracts is unacceptable. It hinders the government’s ability to accomplish the mission of providing medical care to beneficiaries. Inclusion of such conditions in an employer’s employment agreement and/or subcontracts will result in an offeror’s proposal being unacceptable. Awardee, and their subcontractors, may not include such conditions in employment agreements and/or subcontracts while performing under this contract.

3.2.4. The Contractor and contract personnel shall abide by all MTF standards, rules, and procedures including requirements for any licensure, credentialing and quality assurance requirements. Such regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives.

3.2.5. Media and Other Inquiries. The Contractor shall not respond to any media inquiries. Any inquiries from the media, third parties, or public agencies shall be immediately relayed to the IAP, who will relay them to the MTF Public Affairs Officer or, after duty hours, to the Administrative Officer of the Day (AOD). There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Director. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the IAP.

3.3. Conflict of Interest.

3.3.1. The Contractor or contract personnel shall not bill the patient for services rendered under this contract. The Contractor or contract personnel shall not request or accept compensation of any kind for patients treated, procedures performed, or any other actions performed, except under the terms and conditions of this contract, at the rate specified.

3.3.2. The Contractor or contract personnel shall not, while performing services under this contract, advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor or contract personnel or from any third party at any place other than as designated under this contract.

3.3.3. Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of healthcare services under this contract. The Contractor shall not release any of the above information without prior written consent of the KO. The Contractor/contract personnel shall not use patient care rendered pursuant to this contract as part of a study, research project, or publication. The contract personnel shall prepare medical records, forms and documents as required, in accordance with the regulations and established guidelines listed in the contract.

3.3.4. The Contractor shall not employ active duty military or Government civilian employees to perform services under this contract.

3.4. Safeguarding Material. The contract personnel shall be responsible for safeguarding all Government property. The Contractor shall safeguard information of a confidential or sensitive nature. All patient related information is considered confidential and sensitive. If working remotely, Contractors are prohibited from reproducing patient information in any way. This includes printing. Neither the Contractor nor any of its contract personnel shall disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the possibility of a breach in security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974. However, the Contractor may be required to provide testimony or disposition in cases of due process action.

3.5.RESERVED

3.6. AT/OPSEC REQUIREMENTS: NONE

3.7. MTF HOURS OF OPERATION

3.7.1. ACH’s and MEDCEN’s provide services 24 hours a day, 365 days a year (366 days during leap years) including holiday. Clinics have designated operating hours.

3.7.1.1. TAMC Core Laboratory – Department of pathology Shipping Hours are: Monday – Friday 0700 – 1600 Hawaii-Aleutian Standard Time

3.7.2. Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday, holidays falling on a Sunday will be observed on the following Monday. Contract personnel may be required to work on legal holidays as determined by the IAP.

New year’s Day, January 1st Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth National Independence Day, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

NOTE 1: Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

3.8. HOURS OF PERFORMANCE.

3.8.1. Scheduling process: The contractor shall complete work within times specified in 5.1.4.1 Turn-Around Times, and notification shall be given if there is a delay.

3.8.2. The Contractor is responsible for submitting an accurate invoice.

3.8.2.1. The Contractor may only invoice and be paid for the services actually rendered. If the Contractor performs fewer services than are provided in the contract schedule, the Government may, at the end of the applicable contract period, deobligate the excess quantities.

3.9. CONDUCT.

3.9.1. Contract personnel shall abide by federal, state, and local MTF regulations and requirements concerning the nature of limited privileged communication between patients and the contract personnel as may be necessary for security and personnel reliability programs. They shall also abide by federal, state, and local MTF regulations concerning the confidentiality of patient records, as embodied in federal statutes including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. All medical records and reports will remain the property of the Government.

3.10. RESERVED

3.11. QUALITY MANAGEMENT

3.11.1 The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

3.11.2. The Contractor shall ensure services meet quality and timeliness requirements specified in this contract, for mission essential genetic testing services consisting of Next generation sequencing, consultation, and interpretation to aid in the diagnosis and treatment for specimens submitted by Tripler Army Medical Center, Department of Pathology.

4.0 QUALTIY ASSURANCE

4.1. Inspection. The inspection and acceptance point for all services rendered under this contract will be the IAP. The performance by the contract personnel, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the KO or IAP. Any services rendered by the contract personnel to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO may be grounds for immediate termination for default or cause. Quality Assurance procedures established by the MTF shall be used for continuous monitoring. Other performance evaluation factors will be monitored that are not quantified by numerical measurements which include: Contractor providing personnel not meeting the minimum qualification standards; inappropriate prescriptions; patient customer service comments; Contractor relationship with hospital staff/Government contracting personnel; compliance with hospital healthcare policies and procedures.

5.0. DESCRIPTION OF SERVICES.

5.1 Required Services: Genetic Testing

5.1.1. Government Department or Clinic: Department of Pathology and Areal Laboratories

5.1.3. Qualifications

5.1.3.1. RESERVED

5.1.3.2. Licensure/Certification/Registration: Contractor shall be accredited by Clinical Laboratory Improvement Amendments (CLIA) and/or College of American Pathologists (CAP) and shall provide a copy of current CLIA and/or CAP certificate with their offer.

5.1.3.2.1. 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), accreditations(s), license(s), etc., required when executing performance under this contract.

5.1.3.2.2. The Contractor shall ensure all testing and supervisory personnel at all Contactor-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.

5.1.3.3. Experience: Contractor shall have at least two (2) years of CAP oversight and have passed its most recent CAP inspection.

5.1.4. Specific Duties/Tasks:

5.1.4.1. The laboratory shall provide a turnaround time of 21 calendar days from the receipt of specimen, with exception to the Breast Cancer STAT Panels, which shall be resulted within 12 calendar days from receipt of specimen. Exome sequencing shall have a turnaround time of eight (8) weeks. A comprehensive report shall be submitted within seven (7) working days of the stated turnaround time.

5.1.4.2 The Government will package specimens for shipment and ensure specimens are accompanied by a written order specifying the tests to be performed.

5.1.4.3 Contractor shall provide all packing materials (e.g. cardboard shipping containers and packing inserts) to ship specimens to the Contractor’s testing facility at no cost to the government.

5.4.4.4 Contractor shall provide a traceable means of shipping specimens required for testing from the department of Pathology, Tripler Army Medical Center to the Contractor’s testing facility.

5.4.4.5 Complete tests ordered and return results per published turnaround times in test menu see Attachment 1. FAX results to (808) 433-5008 and mail a hard copy to Triple Army Medical Center, Department of Pathology, Room 2G-008, ATTN: MCHK-DP, 1 Jarret White Road, Tripler AMC, HI 96859-5000. If available, the reference laboratory shall provide access to a secured website to retrieve laboratory reports. If the Contractor anticipates a delay in sample testing they must contact the Department of Pathology, Tripler Army medical Center Point of Contract: Shipping Technician at (808) 433-4119.

5.1.4.6 Contractor shall provide Department of Pathology, TAMC with a list of all laboratory tests performed with Reference Ranges and test interpretations. Contactor shall notify Department of Pathology, TAMC within 2 weeks of any test interpretations changes and amended results reflecting those changes. Notifications shall be made in writing.

5.1.4.7 Contractor shall notify Department of Pathology, TAMC Shipping Section of any testing discrepancies identified after initial reporting of patient results. Documentation shall include the affected specimen(s), description of the discrepancy, and the corrective action(s) taken to remedy the situation.

5.1.5 TEST DESCRIPTIONS

5.1.5.1 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. All clinical reference laboratory testing shall be executed in accordance with standard industry practices.

5.1.5.2. Test Menu – See Attachment 1.

5.2. Requirements for all positions.

5.2.1. The Contractor shall ensure that all contract personnel providing services under this contract shall be able to read, write, and speak English well enough to effectively communicate with all parties and other health care providers. In addition, if the position requires the use of computers, the contract personnel shall be computer literate.

5.2.2. The contract personnel shall possess sufficient initiative, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to a variety of patients from diverse backgrounds.

5.2.3 The contract personnel shall have the required education, training, experience and documented current competence in the required specialty position description.

5.2.4 Continuing Education. The Contractor shall ensure that contract personnel who are licensed, registered or certified by state bodies, professional organizations or national/medical associations continue to meet the minimum, standards for continuing education to remain current as prescribed by their professional agency and applicable regulatory guidelines and policies. The Contractor shall ensure contract personnel obtain continuing education at no additional cost to the Government. The Government may approve contract personnel to attend continuing education courses at the place of performance on a space available basis; however that time shall not be billable to the Government.

5.3. If services are provided remotely, the Contractor must adhere to all IT requirements for utilizing Government equipment and accessing Government systems. Supporting equipment will be at the vendor’s expense. i.e. interfaces, hardware, and software.

6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

Following is a list of basic publications applicable to this performance based statement of work. The Contractor is obligated to follow these publications.

Applicable Publications

Public Law:

Public Law 91-596 Occupational Safety and Health Act of 1970 Public Law 104-191 Health Insurance Portability and Accountability Act of 1996

Accreditation Manuals:

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System

Department of Defense (DoD):

DoDD 8500.01E Information Assurance

7.0. ACRONYMS AND DEFINITIONS.

8.0 LIST OF ATTCHMENTS

Attachment 1 – Price List

END OF PERFORMANCE WORK STATEMENT