PERFORMANCE WORK STATEMENT Rev 2.docx

PERFORMANCE WORK STATEMENT

ON ISLAND REFERENCE LABORATORY TESTING AND COURIER SERVICES

AT TRIPLER ARMY MEDICAL CENTER, HI

TABLE OF CONTENTS

1.1. The contractor shall provide the non-personal services of On Island Clinical Reference Laboratory Testing services for Tripler Army Medical Center, Department of Pathology which shall contribute to a stable workforce tasked with providing quality health care services to a diverse beneficiary population. This service will provide STAT courier pick up (within 1.5 hours of telephonic contact) during business hours for high priority (“STAT” tests requiring less than one hour reporting times) and extremely limited specimen stability samples. The On Island Testing will facilitate the immediate receipt and reporting of results for STAT turnaround time requirements that are critical for the diagnosis and treatment for the patients of Tripler Army Medical Center.

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 facilities (MTF) specific policies, procedures, and job descriptions.

1.3. This agreement is a non-personal services agreement under which the personnel rendering the services are not subject, either by the agreement’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 facilities (MTFs) 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 Contractor shall provide all reference laboratory testing services necessary to aid in the diagnosis and treatment for specimens submitted by the Tripler Army Medical Center, Department of Pathology. Services include daily courier services for routine specimens, STAT courier services for STAT and limited specimen stability specimens during normal business hours, and 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 coordination and implementation not later than five business days after receiving notice of agreement. 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 agreement 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 agreement. 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. 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 Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the IAP.

3.3. Security.

3.3.1. Safeguarding Material. The contractor 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 employees 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.

3.4. AT/OPSEC REQUIREMENTS

3.4.1 AT Level I training - All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 90 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the Government Representative or to the contracting officer, if a Government Representative is not assigned, within 10 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf. [On the log-in page, use JS-US007 Level 1 Antiterrorism Awareness Training for Non-CAC users. Click on the link.]

3.4.2 Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office.

Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) 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.

3.4.3 Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

3.4.4 iWATCH Training - The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local 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 Government Representative. This training shall be completed within 90 calendar days of contract award and within 90 calendar days of new employees commencing performance with the results reported to the Government Representative NLT 95 calendar days after contract award.

3.4.5 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.

3.5. MTF HOURS OF OPERATION

3.5.1. Department of Pathology Shipping Hours are: Monday – Friday 0700 - 1600 Hawaii-Aleutian Standard Time.

3.6. HOURS OF PERFORMANCE.

3.6.1. Scheduling process: The contractor shall complete work within times specified in 5.1.3.6 Turn-Around- Times, and notification shall be given if there is a delay.

3.6.2. The Contractor is responsible for submitting an accurate, itemized invoice electronically. The invoice will contain the agreement number, date and time of collection, specimen number, test name, and amount billed.

3.7. CONDUCT.

3.7.1. Contractor personnel shall abide by federal, state, and local MTF regulations and requirements concerning the nature of limited privileged communication between patients and the contractor 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.

3.8. QUALITY MANAGEMENT

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

4.0 QUALITY ASSURANCE:

4.1. Inspection. The inspection and acceptance point for all services rendered under this agreement will be the IAP. The performance by the contractor 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.

5.0. DESCRIPTION OF SERVICES.

5.1 Required Services: The Contractor shall provide On Island Reference STAT and Routine Laboratory Testing services to include but not limited to, clinical chemistry, hematology, and microbiological testing. Services provided shall include testing, supplies, labor, customer services, courier services, reporting/interpreting, result reporting, and management reports.

5.1.1 Reports to: IAP, phone (808) 433-6044 Secure Shipping Fax number is (808) 433-5008

5.1.2. Qualifications

5.1.2.1. 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.

5.1.2.3. 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.

5.1.2.4. 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.

5.1.2.5. The Contractor shall have at least 1 year of experience in handling and transporting clinical diagnostic specimens; and shall use vehicles with active temperature-control systems to transport laboratory specimen. The Contractor shall have the appropriate insurance to prevent the U.S. Government from being held liable in the event of an accident, once samples are within the courier’s custody.

5.1.3. Specific Duties/Tasks:

5.1.3.1. All tests shall be executed at the Contractor’s premises, or within the Contractor's network of laboratories.

5.1.3.2. The laboratory shall provide a turnaround time for the tests provided on their Price Sheet. Any delay in testing shall be communicated within 1 day of the turnaround time specification.

5.1.3.3 The Government shall package specimens for shipment as required by the Contractor for the specific test(s) ordered, and ensure specimens are accompanied by a written order specifying the tests to be performed.

5.1.3.4 Contractor shall provide all packing materials (e.g. cardboard shipping containers, and packing inserts and biohazard bags) to ship specimens in accordance with specimen stability requirements to the Contractor’s testing facility at no cost to the government.

5.1.3.5 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.

5.1.3.6 Turn-Around-Times. Complete tests ordered and return results for STAT testing, which shall be defined as non-reflexed tests, within 1 hour of receipt of specimen in the testing laboratory, and of routine testing within 1 day of published turnaround times in test menu (refer to the routine turnaround times in the laboratory test menu). FAX results to (808) 433-5008. Mailed copies can be sent to Tripler Army Medical Center, Department of Pathology, Room 2G-008, ATTN: MCHK-DP, 1 Jarrett White Road, Tripler AMC, HI 96859-5000. If the Contractor anticipates a delay in sample testing they must contact the Department of Pathology, Tripler Army Medical Center at (808) 433-6044 Point of Contact is the Shipping Technician. Abnormal results (results outside the reference range) shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). Amended results must also be flagged and copies of revised reports must be provided to the SAs.

5.1.3.7 Contractor shall provide Department of Pathology, TAMC with a list of all laboratory tests performed with Reference Ranges and test interpretations. Specimen handling instructions, minimum volumes, alias names, and any special instructions, such as required patient information or consent. Contractor shall notify Department of Pathology, TAMC within 2 weeks of any test interpretations changes and amended results reflecting those changes.

Notification shall be made in writing.

5.1.3.8 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.

5.1.3.9 The Contractor shall provide a toll-free number for customer services. The services shall be available during normal business hours. Through this service Government staff shall be assisted with the following: tracking test results, modifying test requests, obtaining information regarding specimen requirements, requesting STAT courier service, and other applicable related issues/problems that may arise in the performance of work under this contract.

The Contractor shall ensure that Government personnel receive quality customer service through the assistance of knowledgeable and responsive laboratory professionals. Proper phone numbers should be provided so transfers are kept at a minimum. Hold times should be minimized.

5.1.3.10 Routine Clinical Reference Laboratory Testing Services. The Contractor shall provide routine local courier pick-up services on a daily basis (Monday – Friday, excluding federal holidays) at a time mutually agreed upon by the IAP and the Contractor or Shipping services (FedEx) at no expense to the government.

5.1.3.11 STAT Clinical Reference Laboratory Testing Services. The Contractor shall provide STAT local courier pick up services within 1.5 hours of notification during business hours, at no additional expense to the government.

The Contractor is required to transport specimens to ensure viability and stability for testing, and to meet the STAT and Routine reporting timeframes. The MTF shall provide its own courier service during Non-Business hours.

STAT results will be phoned and/or faxed as directed on the requisition.

5.1.3.12 Specimen Pick-Up Location. The Contractor shall pick up all specimen at Tripler Army Medical Center, Department of Pathology, Shipping Section, Room 2G008. For ready access, the courier should enter through the Mountain Side Entrance and proceed past the Pharmacy to the Mountain Side Elevators; take the elevator to the second floor, and proceed straight out the door towards the Core Laboratory sign, the Shipping Section is the first door on the right.

5.1.4. TEST DESCRIPTIONS

5.1.4.1 The Contractor shall provide the full range of clinical pathology diagnostic testing capabilities to execute required tests defined in the Contractor’s Price list. The Contractor’s testing ability and Price Schedule should include as many of the tests listed in Appendix A. All clinical reference laboratory testing shall be executed in accordance with standard industry practices.

5.1.4.2 Test Menu. On-line access or customer service access to detailed reference data, is required. Such data shall include all items listed in paragraph 5.1.3.7 and must include updates as described in paragraph 5.1.3.7. See Appendix A for test menu.

5.2. Requirements for all positions.

5.2.1. The Contractor shall ensure that all contractor personnel providing services under this agreement 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 contractor personnel shall be computer literate.

5.2.2. The contractor 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 contractor 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 agreement. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the agreement. Advisory publications may be used for information and guidance but are not binding for compliance.

Mandatory Publications:

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration Public Law 104-191 21 Aug 96 Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual AR 25-2 Information Assurance AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-3 Medical Services: Medical, Dental, and Veterinary Care AR 40-4 Army Medical Department Facilities/Activities AR 40-5 Preventive Medicine AR 40-66 Medical Records Administration and Health Care Documentation AR 40-68 Clinical Quality Management AR 40-330 Rates Codes, Expense and Performance Reporting Systems, Centralized, Billing, and Medical Service Accounts AR 40-400 Patient Administration AR 40-407 Nursing Records and Reports AR 40-501 Standards of Medical Fitness AR 40-562 Immunizations and Chemoprophylaxis AR 340-21 The Army Privacy Program AR 380-5 Department of Army Information Security Program AR 380-53 Information Systems Security Monitoring AR 380-67 The Department of the Army Personnel Security Program AR 385-40 Accident Reporting and Records and HSC Supplements AR 608-18 Army Family Advocacy Program AR 600-85 Alcohol & Drug Abuse Prevention and Control Program MEDCOM Pam 25-31 Index of Command Administrative Publications DA PAM 40-11 Preventive Medicine DoD 6055.5-M Occupational Medical Surveillance Manual TG 149 Guidelines for Controlling Occupational Exposure to Hazardous Drugs TG 190 Guide to Managing Exposure to Bloodborne Pathogens TB MED 510 Guidelines for the Recognition Evaluation, and Control of Occupational Exposure to Waste Anesthetic Gases Advisory Publications.

AMA CPT Physician’s Current Procedural Terminology, updated annually See https://catalog.ama.assn.org TB Med 2 Sterilizing Medical, Surgical, Dental, and Veterinary Material AR 40-501 Medical Examinations AR 190-13 The Army Physical Security Program AR 608-1 Army Community Service Program DA Pam 25-51 The Army Privacy Program: System Notices and Exemptions Rule DoD 1341.2-M DEERS Program Manual DoD 5200.2 DoD Personal Security DoD 6010.8-R Civilian Health and Medical Program of the Uniformed Services CHAMPUS, Ch 9, 1 Jul 1991 FM 3-19.30 Physical Security PL 89-614 Chapter 55, 10 U.S.C. (1071-1088) Title 29, CFR Occupational Safety and Health Standards

OTSG/MEDCOM

Policy Memo 13-062 Sexual Assault Prevention and Response Program (SHARP) Current issues of many forms can be accessed at http://www.usapa.army.mil/forms

7.0. ACRONYMS AND DEFINITIONS.

ADM - Ambulatory Data Module ADS - Ambulatory Data System AHA - American Hospital Association AHLTA - Armed Forces Health Longitudinal Technology Application AKO - Army Knowledge Online AMA - American Medical Association AOD - Administrative Officer of the Day AR - Army Regulation CAC - Common Access Card CAMH - Comprehensive Accreditation Manual for Hospitals CFR - Code of Federal Regulations CHCS - Composite Health Care System CLIN - Contract Line Item Number COR - Contracting Officer's Representative COTR - Contracting Officer’s Technical Representative CPT - Current Physicians Terminology DA - Department of the Army DoD - Department of Defense DODI - Department of Defense Instruction EFT - Electronic Funds Transfer FAR - Federal Acquisition Regulation FSO - Facility Security Officer FTE - Full Time Equivalent HCP - Healthcare Provider HIPAA - Health Insurance Portability & Accountability Act of 1996 IAP - Individual Authorized to Place Calls JC - The Joint Commission KO - Contracting Officer LADS - Labor and Delivery Statistics System MEDCENs - Army Medical Centers MEDCOM - Medical Command MHS - Military Healthcare System MTF - Medical Treatment Facility OIC - Officer in Charge OSHA - Occupational Safety and Health Administration PAM - Pamphlet PAR - Performance Assessment Report POC - Point of Contact PWS - Performance Work Statement PL - Public Law QASP - Quality Assurance Surveillance Plan QC - Quality Control RVU - Relative Value Units SF - Standard Form SHARP - Sexual Harassment / Assault Response and Prevention TA - Trusted Agent TAMC - Tripler Army Medical Center TASS - Trusted Associated Sponsorship System UCAPERS - Uniform Charts of Accounts Personnel System

Appendix A

ON-ISLAND REFERENCE LABORATORY TESTING

TEST CATEGORIES

Chemistry Coagulation Endocrinology Flow Cytometry – if Available Hematology Histocompatibility Immunology Microbiology Molecular Pathology Mycology Reproductive Medicine Therapeutic Drug Monitoring Toxicology Transfusion Medicine Viral Markers Virology