PWS_Decipher Prostate Genomic Classifier testing.docx

PERFORMANCE WORK STATEMENT

DECIPHER PROSTATE GENOMIC CLASSIFIER

FOR MADIGAN ARMY MEDICAL CENTER, JBLM, WA

TABLE OF CONTENTS

1.0. INTRODUCTION.

1.1. The contractor shall provide the non-personal services of Decipher Prostate Genomic Classifier testing for Madigan Army Medical Center (MAMC), Department of Pathology, 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. Madigan Army Medical Center comprises a network of Army medical facilities located in Washington and California that serve more than 100,000 active duty service members, their families and retirees. As the U.S. Army’s second largest medical treatment facility and a state-of-the-art and technologically advanced medical center, Madigan is one of only two designated Level II trauma centers in Army Medicine and one of four in the state of Washington. Madigan maintains approximately 220 beds for inpatient care and can expand to accommodate more than 300 inpatients during periods of urgent need including emergencies. Outpatients are seen at the hospital's medical mall complex handling nearly one million visits annually. Madigan performs more than 45 surgeries, fills nearly 4,000 prescriptions, and delivers eight babies daily.

3.0 SCOPE OF WORK.

3.1 The Contractor shall provide personnel, management, transportation, labor, supplies, and equipment necessary to provide Decipher Prostate Genomic Classifier testing services to support Madigan Army Medical Center (MAMC), Tacoma, WA. The laboratory testing services to be provided shall include, but not be limited to the following: Decipher Prostate Genomic Classifier testing. 100% performance of work will be completed off post/base.

3.1.1. All tests shall be performed entirely on the premises of the Contractor or within its network of laboratories.

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 Contracting Officer’s Representative (COR) 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 COR, 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 Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the COR.

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

3.6.1. Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

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. MAMC Department of Pathology – Anatomic Pathology (Monday – Friday 0730-1600)

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 COR.

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 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: MAMC will use FedEx to deliver all specimens to the Contractor at the designated location/address. Contractor will provide all shipping and transportation kits/boxes which will include a prepaid FedEx Express Package U.S. Airbill shipping envelope and label with the contractor shipping account number. No emergency or special pickups are required. No “chain of custody” service is required. The contractor shall complete work within times specified in 5.1.3.3 Turn-Around Times.

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 of performance, de-obligate 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. RESERVED

3.12. QUALITY MANAGEMENT

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

3.12.2. The Contractor shall ensure services meet quality and timeliness requirements specified in this contract, to include specimen submission accuracy and discrepancy resolution, specimen retention, specimen result reporting, and customized reports.

4.0 QUALITY ASSURANCE SURVEILLANCE PLAN: See Attachment 01.

4.1. Inspection. The inspection and acceptance point for all services rendered under this contract will be the COR. 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 COR. Any services rendered by the contract personnel to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO will 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: Decipher Prostate Genomic Classifier

5.1.1. Government Department or Clinic: MAMC Department of Pathology

5.1.2. Qualifications:

5.1.2.1. Licensure/Certification/Registration: All Contractor laboratories shall be accredited by a deemed organization approved by the Centers for Medicare and Medicaid Services (CMS). All Contractor laboratories shall be Clinical Laboratory Improvement Amendments (CLIA) certified. Both certificates of accreditation and CLIA certification will be provided to MAMC upon request. The Contractor shall notify MAMC within 72 hours in the event of loss of accreditation or CLIA Certification. Loss of accreditation and/or certification, at the Contracting Officer’s discretion, may be grounds for termination of the contract.

5.1.2.2. All tests shall be performed entirely on the premises of the Contractor or within its network of laboratories.

5.1.2.3. Experience: All Contractor personnel who perform laboratory testing and/or consultation services shall meet requirements outlined in Part 493 of Title 42, Code of Federal Regulations.

5.1.3. Specific Duties/Tasks: The Contractor Shall:

5.1.3.1. Laboratory Services. Provide specific specimen requirements for each analysis, specific methods and interpretation where specified, qualitative and quantitative data where specified, and sensitivity and detection limits where specified.

5.1.3.2. Specimen Collection and Test Ordering. Tests will be requested on forms provided by the Contractor. The Contractor shall provide two (2) copies of test directories which shall include all tests available, specimen requirements, normal ranges, interpretive information, and any other instruction necessary to order tests from the Contractor’s laboratory.

5.1.3.3. Turn Around Time. Complete tests and fax and/or email results to both the Department of Pathology and the Department of the requesting physician within 7 – 10 calendar days from receipt of specimen by Contractor laboratory unless otherwise identified.

5.1.3.4. Specimen Submission Discrepancies. Specimen loss due to breakage, spillage, misplacement, mishandling, or any other Contractor-related problem will be considered unacceptable if more than two (2) specimens are lost or otherwise compromised per month. Repeated problems with specimen loss may be grounds for termination of the contract for cause. The Contractor shall resolve request discrepancies (i.e., illegible request, missing patient information, or other clerical errors) via telephone or e-mail with MAMC laboratory personnel before canceling test or discarding specimen within 72 hours of discovery.

5.1.3.5. Specimen Retention. Contractor is required to return specimens to MAMC, Department of Pathology upon completion of testing.

5.1.3.6. Specimen Result Reporting. All results shall be faxed and/or emailed to both the Department of Pathology and the Department of the requesting physician. All results require appropriate normal ranges or interpretive explanations. Each report shall be reviewed and signed by a Board-Certified Laboratory Director. The Contractor shall report all abnormal cytogenetic results to the MAMC Laboratory and the MAMC requesting healthcare provider telephonically. The Contractor shall also send abnormal cytogenetic results via fax and/or email to the MAMC Laboratory and the MAMC requesting healthcare provider. Telephone and fax numbers will be provided on the test requisition form. The Contractor shall also make reports available in a secure WEB portal.

5.1.3.7. Customized Reports. The Contractor shall provide a customized utilization report of services rendered upon request from the COR within 10 business days of request.

5.1.3.8. Consultative Services. The Contractor shall, at no additional cost, provide MAMC with consultative service regarding the interpretation of tests. This consultative service shall meet the minimum requirements listed below:

1. One (1) telephone number for MAMC healthcare providers to call regarding all results.

1. Provide patient educational materials for genetic testing.

1. Provide genetic coordinators to assist in coordination of “Special Studies” specimens.

5.1.3.9. Management Reports. The Contractor shall provide monthly reports of tests performed under this contract. The information to be reported shall include test name, contractor’s test code, number of tests performed during the month reported, number performed year to date, individual test cost, monthly total cost, and cost year to date. This information shall be provided in one report with tests listed alphabetically. This report shall be provided within thirty (30) days or sooner after the end of the month being reported. Reports shall be submitted electronically to the COR..

5.1.3.10. The Contractor shall keep the COR informed of any changes to test methodologies or scope of practice as those changes occur.

5.1.3.11. The Contractor shall have representative(s) available during normal business hours to assist with requested services, problem solving, and/or reporting at no additional cost to the Government.

5.1.3.12. The Contractor shall provide telephonic contact from an account representative/consultant for troubleshooting, servicing account, introducing new tests, etc.

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.

5.3. 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. Additional publications may be listed by call. The Contractor is obligated to follow these publications. Current issues of Army publications and links to other service publications can be accessed at http://www.apd.army.mil/. Army publications not on the internet or MTF policies and procedures can be obtained from the MTF. Department of Defense publications can be found at www.defenselink.mil/pubs or www.dtic.mil/whs/directives.

The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

Mandatory Publications:

Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual

Current issues of many forms can be accessed at http://www.usapa.army.mil/forms

7.0. ACRONYMS AND DEFINITIONS.

8.0 LIST OF ATTACHMENTS

1. Performance Requirements Summary

END OF PERFORMANCE WORK STATEMENT