DRAFT PWS Fiber Density 03-22-2024.pdf

PERFORMANCE WORK STATEMENT

Nerve Fiber Testing for the

Department of Pathology, Madigan Army Medical Center (MAMC), Fort Lewis, WA

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 QUALITY ASSURANCE SURVEILLANCE PLAN

5.0 POSITION DESCRIPTIONS

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

1.0 INTRODUCTION

1.1. The contractor shall provide the non-personal services of Epidermal Nerve Fiber Density Analysis and Sweat Gland Analysis for Madigan Army Medical Center (MAMC) which shall contribute to a stable workforce tasked with providing quality health care services to a diverse beneficiary population. All testing will be performed at the contractor’s laboratory. At no time will an employee of the contractor be required to enter Joint Base Lewis McChord.

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 always has available a healthy military force supported by a combat ready healthcare system. Health care services for eligible MHS beneficiaries are provided at MTF’s located on or near military installations or posts. The MTF 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. The Madigan Army Medical Center, located on Joint Base Lewis-McChord in Tacoma, Washington, and is a key component of the Madigan Healthcare System. MAMC one of the largest military hospitals on the West Coast of the United States. The hospital today is a 205-bed, Joint Commission-accredited facility, expandable to 318 beds in the event of a disaster. Major services include general medical and surgical care, adult and pediatric primary care clinics, 24-hour Emergency department, specialty clinics, clinical services, wellness and prevention services, veterinary care, and environmental health services. Madigan Army Medical Center received designation as a level 2 trauma center by the Washington State Department of Health in 1995, and has maintained level 2 status to the present day. The Madigan Army Medical Center is one of three designated trauma centers in the United States Army Medical Department (AMEDD).

3.0 SCOPE OF WORK.

3.1 The Contractor shall plan, program, administer, manage, and execute the work necessary to provide the required services. The Contractor shall provide all personnel, management, transportation, labor, supplies, and equipment necessary to provide Nerve Fiber Testing to support Madigan Army Medical Center (MAMC), Tacoma, WA. The laboratory testing services to be provided shall include Epidermal Nerve Fiber Density Analysis and Sweat Gland analysis. All testing will be performed at the contractor’s laboratory.

3.1.1 Specimens to be submitted for testing are solely at the discretion of MAMC. MAMC reserves the right to withhold, at any time, tests previously sent to the Contractor, or to add tests not previously sent.

3.1.2 The Contractor shall have established all of the analytic test procedures required for Epidermal Nerve Fiber Density and Sweat Gland Analysis and shall be able to perform them upon request. The Contractor shall be a dedicated and accredited diagnostics laboratory.

3.1.2.1 The Contractor shall provide specific specimen requirements for each analysis; Specific method and interpretation where specified; Qualitative and quantitative data where specified; Sensitivity and detection limits where specified.

3.1.3 Specimen Collection and Test Ordering: Tests will be requested on forms provided by the Contractor. Upon award, the Contractor shall provide five (5) 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. Test kits and reagents necessary for these reference tests will not incur additional fees to the agreed price schedule.

3.1.3 Pickup and Courier Services: Madigan Army Medical Center will utilize mail services to send testing materials to the Contractor. No emergency or special pickups are required. No “chain of custody” service is required.

3.1.4 Turnaround Time: A turnaround time of less than 30 calendar days from receipt of specimen by Contractor’s laboratory to receipt of result by MAMC is required for all requested testing unless otherwise identified.

3.1.5 Results shall be faxed and/or emailed to both the Department of Pathology and the Department of the requesting physician. Telephone numbers, email addresses and facsimile numbers for the Departments of Pathology and the requesting physician will be provided on the test requisition form. All results require appropriate normal ranges or interpretive explanations. Each report shall be reviewed and signed by a Board-Certified Laboratory Director.

3.1.6 Handling of Specimen or Request 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.

3.1.7 Specimen Retention: Contractor may be required to return specimens to MAMC upon completion of testing if requested by MAMC. Contractor will utilize a standard carrier service of the contractor’s choice to ensure timely delivery.

3.1.8 Utilization Reports: The contractor shall provide an utilization or summary report that includes patient name, patient DOB, provider’s name, date of biopsy, and biopsy results.

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 Director. 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. CONDUCT.

3.5.1. 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.

4. QUALITY STANDARDS:

4.1 Accreditation. The Contractor’s laboratory shall be currently accredited by the College of American Pathologists (CAP) and maintain accreditation for the duration of this contract. The laboratory shall also certify that it is in full compliance with the requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA 88) as they exist at date of solicitation. The Contractor shall provide copies of all current accreditation and certification documents. Contractor shall notify MAMC immediately in the event of loss of any accreditation or membership.

Loss of any accreditation, certification, or membership may, at the Contracting Officer’s discretion, be grounds for termination of the contract.

4.2 Personnel. The Laboratory Director shall be a fully licensed MD or PhD who is an active, full-time Director.

The Contractor shall have a full-time staff of in-house professional scientists and consultants at the MD and PhD levels, including a geneticist. Medical doctors should have specialty or subspecialty boards in areas of expertise.

4.3 The Contractor shall, at no additional cost, provide MAMC with consultative service concerning interpretation.

of tests. This consultative service shall meet the minimum requirements listed below:

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

Prompt (within 5-10 minute) access to a certified professional call provider who has access to the results of test(s) in question during the contractor’s normal business hours Monday through Friday.

Provide patient educational materials for testing.

5. MANAGEMENT REPORTS:

5.1 Billing: Invoices shall be submitted IAW FAR 252.232-7006 contained within the contract. Invoices submitted in Wide Area Workflow shall include as an attachment to the invoice within the system the patient’s name, date of service, procedure name, and the amount billed. Invoices shall be submitted no more frequently than monthly.

6. OTHER RESPONSIBILITIES:

6.1 The contractor shall keep the COR informed of the most recent developments in clinical laboratory methods and medical interpretation through periodic newsletters, reports and data sheets.

7.0 ACCOUNTING FOR CONTRACT SERVICES

UICs for reports are:

UIC FACILITY

HT0864 Madigan Army Medical Center and Associated Clinics

Report Schedules are based on the Government’s Fiscal Year cycle, regardless of the contract period of performance cycle. Report cycles are as follows for any reporting year in which performance occurs:

Report #1: 1 October 2024 through 30 September 2025 – Report due no later than 30 November 2025 Report #2: 1 October 2025 through 30 September 2026 – Report due no later than 30 November 2026 Report #3: 1 October 2026 through 30 September 2027 – Report due no later than 30 November 2027 Report #4: 1 October 2027 through 30 September 2028 – Report due no later than 30 November 2028 Report #3: 1 October 2028 through 30 September 2029 – Report due no later than 30 November 2029

8.0 Anti-Terrorism/Operations Security

8.1 AT Level I training. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

http://jko.jten.mil.

8.2. 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, DHHQ 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.

8.3. For contractors that do not require CAC, but require access to a DoD facility or installation. 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), 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.

8.4 For US based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)-specific AT awareness training as directed by SHA-AI 078, Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

8.5. iWATCH/Suspicious Activity Reporting Training. The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally 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 COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

9.0 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 001 Telework Program DHA-AI 003 Physical Security Program DHA-AI 034 Drug-Free Workplace Program DHA-AI 050 Accounting of Disclosures of Personally Identifiable Information (PII) and Protected Health

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

DHA-AI

DHAPI 6000.03 Life Support Training Certification Requirements and Guidance DHAPI 6010.02 MHS Prescription Drug Monitoring Program DHAPI 6015.02 Beneficiary Counseling and Assistance Coordinator (BCAC) and Debt Collection Assistance

Officer (DCAO) DHAPI 6025.04 Pain Management and Opioid Safety in the MHS DHAPI 6025.06 Standardized Templates for Primary Care Clinical Encounter Documentation DHAPI 6025.10 Standard Processes, Guidelines, and Responsibilities of the DoD Patient Bill of Rights and

Responsibilities in the Military Health System (MHS) Military Medical Treatment Facilities (MTFs)

DHAPI 6025.20 Medical Management (MM) Program within the Military Health System (MHS) DHAPI 6025.26 Standard Processes for the Military Health System (MHS) Nurse Advice Line (NAL) DHAPI 6025.27 Integration of Primary Care Behavioral Health (PCBH) Services into Patient-Centered Medical

Home (PCMH) and Other Primary Care Service Settings within the Military Health System

(MHS)

DHAPI 6025.28 Standard Processes and Procedures for Communication of Laboratory and Radiology Results DHAPI 6025.29 Provision of Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) for Persons at High Risk of Acquiring HIV Infection DHAPI 6025.33 Acupuncture Practice in Military Treatment Facilities DHAPI 6025.39 Medical Ethics in the Military Health System

DHAPI 6025.42 Routine Adult Transthoracic Echocardiogram (TTE) Standards for all Military Medical Treatment Facilities (MTFs)

DHAPI 6040.07 Medical Coding of the DOD Health Record DHAPI 6401.01 Dental Sedation Medical Management DHAPI 6490.02 Behavioral Health (BH) Treatment and Outcomes Monitoring DHAPM 6025.01 Primary Care Behavioral Health (PCBH) Standards DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System

Department of Defense (DoD):

DoD 5200.1-R Information Security Program DoD 5200.2 Personnel Security Program DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card DoD 5210.42-R Nuclear Weapons Personnel Reliability Program (PRP) Regulation DoD 5400.7-R DoD Freedom of Information Act DoD 5400.11-R Department of Defense Privacy Program DoD 6010.13-M Medical Expense and Performance reporting System for Fixed Military Medical And Dental

Treatment Facilities Manual DoD 6010.15-M Military Treatment Facility Uniform Business Office (UBO) Manual DoD 6015.1-M Glossary of Healthcare Terminology DoD 6025.18-R DoD Health Information Privacy Regulation DoD 6055.5-M Occupational Medical Examinations and Surveillance Manual DoD 8580.02-R HIPAA Security Rule DoDD 5144.02 Information Technology Standards in the DoD DoDD 5205.2 DoD Operations Security (OPSEC) Program DoDD 5400.11 DoD Privacy Program DoDD 5500.07 Standards of Conduct DoDD 6000.14 Patient Bill of Rights and Responsibilities in the Military Health System (MHS) DODM 6025.13 Medical Quality Assurance (MQA) in the Military Health System (MHS) DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities DoDD 6205.02E Policy and Program for Immunizations to Protect the Health of Service Members and Military

Beneficiaries DoDD 8190.3 Smart Card Technology DoDD 8500.01E Information Assurance DoDI 1100.22 Policy and Procedures for Determining Workforce Mix DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services DoDI 3020.37 Continuation of Essential DoD Contractor Services During a Crises DoDI 5200.02 DoD Personnel Security Program (PSP) DoDI 6000.11 Patient Movement DoDI 6015.23 Delivery of Healthcare at Military Treatment Facilities: Foreign Service Care; Third Party

Collection; Beneficiary Counseling and Assistance Coordinators (BCACs) DoDI 6025.8 Ambulatory Procedure Visit (APV) DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System DoDM 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System (MHS) DoDI 6025.18 Privacy of Individual Identifiable Health Information in DoD Health Care Programs DoDI 6040.40 Military Health System Data Quality Management Control Procedures DoDI 6040.42 Medical Encounter and Coding at Military Treatment Facilities DoDI 6040.43 Custody and Control of Outpatient Medical Records DoDI 6205.2 Immunization Requirements DoDD 6459.01 Sexual Assault and Response (SAPR) Program