PWS_Flow Cytometry Analyzers_W81K0225QA059 (DRAFT).pdf

PERFORMANCE WORK STATEMENT

Flow Cytometry Analyzers

Reagents, Maintenance & Support Services

Madigan Army Medical Center

Joint Base Lewis-McChord, WA

1. GENERAL REQUIREMENTS

1.1. SCOPE OF WORK. The Contractor shall provide flow cytometry reagents used in support of the mission at

Madigan Army Medical Center, Joint Base Lewis McChord, WA.

1.2. The Contractor shall be responsible for maintaining Government-owned Beckman Coulter Navios 10 analyzer system (10 color / 3 laser field) and TQ Prep workstation (inclusive of instruments, ancillary equipment, computer, external drives, printer, UPS, sturdy wheeled table, etc.), maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition.

1.3. The Contractor shall be responsible for assisting with upgrade of current laser to 10 color / 3 laser field to latest technology (e.g. DxFLEX Flow Cytometer).

1.4. 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 Defense Health Agency (DHA) and Department of Defense (DoD) specific regulations, directives, and policies, and military treatment facilities (MTF) specific policies, procedures, and job descriptions.

1.5. 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. The Contractor shall perform to the standards of this Performance Work Statement (PWS).

2. SPECIFIC TASKS

2.1. DESCRIPTION.

2.1.1. The Contractor shall maintain Government-owned flow cytometry analyzers. The Contractor shall provide supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

2.1.2. Reagents, maintenance, and service shall be provided by a single Contractor.

2.1.3. Reagents, calibrators, quality control, and consumables needed to perform the method validation for the new laser and reagents shall be provided by the Contractor at no cost to the Government.

2.1.4. Vendor must assist with 10 color panels and recommendations of procedures.

2.1.5. All costs will be calculated on a cost per kit/ reagent requested.

2.1.6. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

2.2. REAGENTS.

2.2.1. The Contractor shall ship and ensure that the items are delivered within 7 days of order placement. The reagents must be shipped and stored at the appropriate temperatures.

2.2.2. Reagents must have a shelf life not less than 6 months upon receipt.

2.2.3. Reagent quality controls must have a shelf life not less than 3 months upon receipt.

2.2.4. Alternate quality control shall be provided by the Contractor if the newly delivered lots are within 2 weeks of their expiration date.

2.3. MAINTENANCE AND SERVICE.

2.3.1. ANCILLARY MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition, to include ancillary equipment (computer, printer, UPS, etc.).

2.3.2. The Contractor shall provide a full unscheduled and preventive maintenance service for the length of the contract. Service shall include repair and replacement of defective parts, complete maintenance program

(as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems.

2.3.3. REPAIR. Upon notification of equipment failure, the Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractor’s Customer

Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within 4 hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Should both instruments become inoperable, the

Contractor’s technical specialist must be on-site within four 4 hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The Contractor shall provide replacement parts as necessary for operator level maintenance.

2.3.3.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

2.3.3.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the

Government to trouble shoot the instrument failure prior to notification to the Contractor.

2.3.3.3. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the

Contracting Officer Representative (COR) one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the military Medical

Treatment Facility (MTF). The report shall be in English and shall contain, as a minimum, the following information:

(a) Nomenclature and serial number

(b) Date

(c) Description of services performed (i.e., preventive maintenance service or unscheduled repair service)

(d) Location of services performed

(e) Duration of performance (hours)

(f) List of parts replaced or other actions taken to restore operability of the instrument

(g) Name of technician

2.3.4. The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the Government.

3. INFORMATION MANAGEMENT

3.1. The analyzer system must be capable of interfacing with the military hospital computer system, i.e., MHS

Genesis. The Contractor must have an established driver compatible for interfacing the analyzer with the IM.

The interface between IM and the analyzer shall be bi-directional.

3.2. Data Management system must have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

4. RESERVED

5. ANTI-TERRORISM / OPERATIONS SECURITY

5.1. 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.

5.2. 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.

5.3. 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.

5.4. iWATCH/Suspicious Activity Reporting Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. 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.

5.5. Contracts that Require OPSEC Training. Per DHA-AI 5200.03, 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.

5.6. Cyber Awareness (Information Assurance (IA) / Information Technology (IT) Training. All contractor employees and associated subcontractor employees must complete the DoD Cyber Awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD requirements DoD 8570.01 and DoD 8570.01-M within six months of http://jko.jten.mil/ appointment to IA/IT functions. DoD Cyber Awareness Challenge Training is available at the following website: https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf.

6. 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.

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

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 www.health.mil/Reference-Center/DHA-publications

Department of Defense (DoD):

DoD 5200.1-R Information Security Program https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf

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

7. ACRONYMS AND DEFINITIONS

AHLTA Armed Forces Longitudinal Technology Application

AQL Acceptable Quality Level

BAA Business Associate Agreement

BLS Basic Life Support

CAC Common Access Card

CAF Central Adjudication Facility

CDC Centers for Disease Control

CE Continuing Education

CFR Code of Federal Regulations

CHBC Criminal History Background Check

CHCS Composite Health Care System

CLIN Contract Line Item Number

CNACI Child Care National Agency Check with Inquiries

COR Contracting Officer Representative

CPARS Contractor Performance Assessment Reporting System

DEA Drug Enforcement Administration

DFARS Defense Federal Acquisition Regulation Supplement

DHA Defense Health Agency

DMHRSi Defense Medical Human Resources System - internet

DoD Department of Defense

DoDD Department of Defense Directive

DoDI Department of Defense Instruction

DTF Dental Treatment Facility e-QIP Electronic Questionnaires for Investigations Processing

ERP Enterprise Resource Planning

FAR Federal Acquisition Regulation

FIPS PUB Federal Information Processing Standards Publication

FTE Full-Time Equivalent

FTR Federal Travel Regulation

HIPAA Health Insurance Portability and Accountability Act of 1996

HSPD Homeland Security Presidential Directive

IA Information Assurance

IAW In Accordance With

JTR Joint Travel Regulation

KO Contracting Officer

KPP Key Performance Parameter

MAC Multiple Award Contract

MHS Military Health System

MTF Military or Medical Treatment Facility

NACI National Agency Check with Written Inquiries

NAICS North American Industry Classification System

NoPP Notice of Privacy Practices

PHI Protected Health Information

PII Personally Identifiable Information

PKO Procuring Contracting Officer

PMO Program Management Office

PRS Performance Requirements Summary

PSC Product Service Code

PWS Performance Work Statement

QA Quality Assurance

QASP Quality Assurance Surveillance Plan

QCP Quality Control Plan

WAWF Wide Area Work Flow

(END OF PERFORMANCE WORK STATEMENT)