Attachment 1 PWS Medical Lab Services 10 Feb 21.pdf

Performance Work Statement (PWS)

PERFORMANCE WORK STATEMENT (PWS)

FOR

North Carolina Army National Guard (NCARNG)

Medical Laboratory Services

Table of Contents

1.0 General

2.0 Definitions and Acronyms

3.0 Government Furnished Property, Material, Equipment and Services (GFP/M/E/S)

4.0 Vendor Furnished Property, Materials, and Equipment (CFP/M/E)

5.0 Requirements

6.0 Applicable Publications

TECHNICAL EXHIBIT 1 ‐ Performance Requirements Summary

TECHNICAL EXHIBIT 2 ‐ Deliverables Schedule

1.0 General.

1.1 Scope. The vendor shall provide laboratory services to the North Carolina Army National Guard

(NCARNG) for analyzing blood and urine samples as provided by the National Guard. Provide all personnel, equipment, tools, materials, supervision, and quality control necessary, except as specified in

Paragraph 3.0 as Government Furnished, to perform for Laboratory services for the NCARNG as defined within this PWS.

1.2 Background. The basic principles of force‐sustainment for the NCARNG include physical readiness which translates to mobility readiness. The Medical Readiness Requirements for the North Carolina

Army National Guard (NCARNG) has significantly increased. Increased deployments and missions locally and around the globe have required Soldiers to be deployed more frequently, for longer periods in high physical and mental stress operations.

1.3 Period of Performance (PoP). The Period of Performance shall be 4 years.

1.4 General Information.

1.4.1 Quality Control (QC). The vendor shall develop and maintain an effective QC Plan (QCP) to ensure services are performed in accordance with this PWS. The vendor shall develop and implement procedures to identify, prevent, and ensure non‐recurrence of defective services. The vendor’s QCP is the means by which it assures itself that its work complies with the requirements of the contract. As a minimum, the vendor shall develop QC procedures that address the areas identified in Technical Exhibit

1, Performance Requirements Summary (PRS). A final QCP shall be submitted to the Contracting Officer

Representative (COR) NLT 10 days after contract award. A final QCP shall be submitted to the

Contracting Officer Representative (COR) NLT 10 days after contract award. After acceptance of the

QCP, the contractor shall obtain the Contracting Officer’s (KO’s) acceptance in writing of any proposed changes to its QCP.

1.4.2 Quality Assurance (QA). The Government shall evaluate the vendor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the vendor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and acceptable quality level(s) (defect rate(s)).

1.4.3 Recognized Holidays: The following are recognized US holidays. The vendor shall not perform services on these days:

1.4.3.1 New Year’s Day

1.4.3.2 Martin Luther King, Jr.’s Birthday

1.4.3.3 President’s Day

1.4.3.4 Memorial Day

1.4.3.5 Independence Day

1.4.3.6 Labor Day

1.4.3.7 Columbus Day

1.4.3.8 Veteran’s Day

1.4.3.9 Thanksgiving Day

1.4.3.10 Christmas Day

1.4.4 Place and Performance of Services. At vendor site.

1.4.4.4.1 The vendor must be available to pick up samples on any day (weekday or weekend) excluding federal holidays between the hours of 0800 and 1630 at the following locations (NOTE: Vendor must pick‐up samples within 24 hours of notification as outlined below):

MED DET POC: Readiness or Supply NCO

475 Roberts Chapel Road 919‐664‐7326/7327/7329

Stem, NC 27581

JFHQ/G1 Medical POC: G1 Medical Branch NCO

1636 Goldstar Drive 919‐664‐6623/6729

Raleigh, NC 27607

1.4.4.4.2. Vendor must also provide a drop‐off location within 30 miles of MED DET, and within 10 miles of JFHQ for samples between the hours of 0700‐1630 on any day (weekday or weekend).

1.4.4.4.3 The vendor shall at all times maintain an adequate work force for the uninterrupted performance of all tasks defined within this PWS.

1.4.4.4.4 Unscheduled gate closures by the Security Police may occur at any time causing all personnel entering or exiting a closed installation to experience a delay. This cannot be predicted or prevented.

Vendors are not compensated for unexpected closures or delays. Vehicles operated by vendor personnel are subject to search pursuant to applicable regulations. Any moving violation of any applicable motor vehicle regulation may result in the termination of the vendor employee’s installation driving privileges.

1.4.4.4.5 The vendor’s employees shall become familiar with and obey the regulations of the installation; including fire, traffic, safety and security regulations while on the installation. Vendor employees should only enter restricted areas when required to do so and only upon prior approval. All vendor employees shall carry proper identification with them at all times. The vendor shall ensure compliance with all regulations and orders of the installation which may affect performance.

1.4.5 Security Requirements. The vendor shall comply with all applicable installation/facility access and local security policies and procedures, which may be obtained from the Contracting Officer’s Representative (COR). The vendor shall also 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. The vendor shall ensure compliance with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. Should the Force Protection Condition (FPCON) change, the Government may require changes in vendor security matters or processes.

1.4.5.1 Reserved

1.4.5.2 For vendors that do not require a CAC, but require access to a DoD facility or installation:

Vendor and all associated sub‐vendors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification (NCIC‐III) and Terrorist Screening Database (TSDB) (Army Directive 2014‐05/AR 190‐13), and applicable installation, facility and area commander installation/facility access, and local security policies and procedures (provided by a government representative).

1.4.5.3 Communications Security/Information Technology (COMSEC/IT) Security. All communications with DoD organizations are subject to COMSEC review. All telephone communications networks are continually subject to intercept by unfriendly intelligence organizations. DoD has authorized the military departments to conduct COMSEC monitoring and recording of telephone calls originating from, or terminating at, DoD organizations. Therefore, the vendor is advised that any time vendor personnel place or receive a call they are subject to COMSEC procedures. The vendor shall ensure wide and frequent dissemination of the above information to all employees dealing with DoD information. The vendor shall abide by all Government regulations concerning the authorized use of the Government's computer network, including the restriction against using the network to recruit Government personnel or advertise job openings.

1.4.5.4 Reserved

1.4.5.5 Protection of Personally Identifiable Information (PII)/Health Information Portability and Accountability Act (HIPAA). The vendor shall protect all PII encountered in the performance of services in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 224.103 Personally Identifiable Information and Department of Defense Directive (DoDD) 5400.11, Department of Defense Privacy Program, and DoD 5400.11‐R. If a PII breach results from the vendor’s violation of the aforementioned policies, the vendor shall bear all notification costs, call‐center support costs, and credit monitoring service costs for all individuals whose PII has been compromised. Additionally, the HIPAA Privacy Rule creates national standards to protect individuals’ medical records and other personal health information. All contract employees shall complete HIPAA certification course on a yearly basis. The vendor shall submit certificates of completion for each affected vendor and subvendor employee, to the COR, or to the KO if a COR is not assigned, within 15 calendar days after completion of training. HIPAA training is available at http://www.health.mil/Training‐Center/Joint‐Knowledge‐ Online‐JKO (https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf)

1.4.6 Physical Security. The vendor shall safeguard all Government property provided for vendor use. At the close of each work period, Government facilities, equipment and materials shall be secured.

1.4.6.1 Key Control. This PWS does not require handling of keys.

1.4.7 Special Qualifications. The vendor shall ensure all employees possess all required licenses and any other certifications to operate in a Laboratory environment, in the performance of this contract. The Government does not provide training to vendors. Vendors must ensure that any personnel performing under a contract are fully trained, licensed, certified and qualified to provide services. Vendor shall provide all management, labor, test material and certifications necessary to provide all listed services while maintaining compliance with current HIPAA, Privacy Act, OSAH, and any other applicable federal regulations.

1.4.8 Post Award Conference/Periodic Progress Meetings. The vendor agrees to attend any post award conference convened by the KO in accordance with Federal Acquisition Regulations Subpart 42.5. The

KO, Contracting Officer’s Representative (COR), and other Government personnel, as appropriate, may meet periodically with the vendor to review the contactor’s performance. At these meetings, the Contacting Officer will apprise the vendor of how the Government views the vendor’s performance and the vendor shall apprise the Government of problems, if any, being experienced The vendor shall resolve outstanding issues raised by the Government. Vendor attendance at these meetings shall be at no additional cost to the Government.

1.4.9 Contract Manager (CM). The contactor shall designate a CM who shall ensure performance under this contract. The name of this person, and an alternate who shall act for the vendor when the CM is absent, shall be designated in writing to the KO within 3 calendar days after contract award. The CM or alternate shall have full authority to act for the vendor on all contract matters relating to daily operation of this contract. The CM shall work through the COR, (or the KO if a COR is not assigned), to resolve issues, receive technical instructions, and ensure adequate performance of services. The CM shall ensure that vendor employees do not perform any services outside the scope of the contract without an official modification issued by the KO. The CM shall ensure vendor employees understand that services performed outside the scope of the contract are performed wholly at the expense of the vendor.

1.4.10 Identification of Contractor Employees. Contractor personnel shall wear identification badges distinguishing themselves as such. The badges shall have the company name, employee name and the word “contractor” displayed. The contractor shall retrieve all identification media (including vehicle passes) from their employees who depart employment for any reason. All identification media (i.e., badges and vehicle passes shall be returned to the COR within the 10 days of an employee’s departure).

1.4.11 Combating Trafficking in Persons. The United States Government has adopted a zero tolerance policy regarding trafficking in persons. Vendors and vendor employees shall not engage in any forms of trafficking in persons during the period of performance of the contract; procure commercial sex acts during the period of performance of the contract; or use forced labor in the performance of the contract. The Contractor shall notify its employees of the United States Government’s zero tolerance policy, the actions that will be taken against employees for violations of this policy. Such actions may include, but are not limited to, removal from the contract, reduction in benefits, or termination of employment. The Contractor shall take appropriate action, up to and including termination, against employees or subcontractors that violate the US Government policy as described at FAR 22.17.Contractor shall complete the following online training within 10 calendar days after contract award: Course number is N‐US189‐HB; available at: http://jko.jten.mil

1.4.12 Contractor Travel: Travel costs incurred by contractors are not reimbursable under the subject contract, and should be incorporated into FFP pricing along with any other direct/indirect costs.

1.4.13 Data Rights: The Government has unlimited rights to all documents/material produced under this contract.

1.4.14 Reserved.

2.0 Definitions and Acronyms.

2.1 Definitions.

2.1.1 CONTRACTOR. A supplier or contractor awarded a contract to provide specific supplies or services to the government. The term used in this contract refers to the prime.

2.1.2 CONTRACTING OFFICER (KO). A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government designated by the KO to monitor contractor performance. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4 DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5 DELIVERABLE. Anything that can be physically delivered and includes non‐ manufactured things such as meeting minutes or reports.

2.1.6 KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS.

When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7 PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8 QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10 QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11 SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12 WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.13 WORK WEEK. Monday through Friday, unless specified otherwise.

2.2 Acronyms

ARNG Army National Guard CM Contract Manager COMSEC Communications Security COTR Contracting Officer's Technical Representative DFARS Defense Federal Acquisition Regulation Supplement DOD Department of Defense FAR Federal Acquisition Regulation FPCON Force Protection Condition HIPAA Health Insurance Portability and Accountability Act of 1996 HQDA Headquarter Department of Army IT Information Technology JFHQ Joint Forces Headquarters KO Contracting Officer NLT Not Later Than PII Protection of Personally Identifiable Information POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program

3.0 Government Furnished Property, Material, Equipment and Services (GFP/M/E/S).

The Government will provide the property, material, equipment, and/or services listed below solely for the purpose of performance under this contract.

3.1 Property: None.

3.2 Materials: None.

3.3 Equipment: None.

3.4 Services: None.

3.5 Utilities: None.

4.0 Contractor Furnished Property, Materials, and Equipment (CFP/M/E).

4.1 General: Except for those items specifically stated to be Government‐Furnished in Paragraph 3.0, the contractor shall furnish everything required to perform these services.

5.0 Requirements.

5.1 Laboratory Service Regulatory Compliance: All clinical laboratory services shall be performed by a laboratory licensed through the U.S. Department of Health and Human Services (DHHS), Health Care Financing Administration pursuant to the terms of the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 263a) and the College of American Pathologies. Laboratory services shall be performed by personnel certified under the American Society of Clinical Pathology.

5.1.2 Bloodborne Pathogens Regulatory Compliance: All healthcare workers shall comply with the requirements of 29 CFR 1910.1030 Bloodborne Pathogens Standard.

5.1.3 Hazardous Waste Regulatory Compliance: All infectious waste shall be disposed of in accordance with local, state, and federal regulation and disposed of by the contractor

5.1.4 Equipment Regulatory Compliance: Instrumentation shall meet or exceed appropriate performance standards, and calibration accuracy in accordance with local, state, and federal regulation.

Supporting documentation indicating equipment compliance shall be provided as requested.

5.1.5 Laboratory services: The contractor shall conduct and perform services being requested in this PWS. Lab tests results shall be returned electronically to the Gov’t POCs NLT 12:30 PM EST same day of testing.

Basic Metabolic Panel (8) Blood Type CBC With Differential/Platelet CBC/Diff Ambiguous Default CBC‐Complete Blood Count (HGB/HCT, WBC, Platelet count) Chlamydia (Urinalysis) Complete Cholesterol (Total cholesterol, LDL,HDL, and Triglycerides) Creatine Kinase,Total DNA Testing Drug and Alcohol Test Fasting blood glucose and A1C Glucose Glucose‐6‐phosphate dehydrogenase (G6PD) Gonorrhea (Urinalysis) HCV Antibody RFX to Quant PCR Hematocrit Hemoglobin HEP B Surface Antibody HEP B Surface Antigen Hepatic Function Panel (7) Hepatitis C (HCV) Hgb Frac. Profile Hgb Solubility Hgb+Hct

LDL Cholesterol (Direct) Lipid (LP) Panel Lipid Panel w/ Chol/HDL Ratio Lipid Panel w/Glucose

LP+1AC+PSA

LP+Glu+PSA+UA/M+Hct LP+Glu+PSA+UA/M+Hct LP+Glu+PSA+UA/M+Hgb PA+Hct LP+Glu+PSA+UA/M+Sickle+Hct+...

LP+Glu+RPR+UA+Sickle+CBC/Plt LP+Glu+UA/M+Hct LP+Glu+UA/M+Hgb PA+Hct LP+Glu+UA/M+Sickle+Hct+G6PD...

LP+Glu+UA+Sickle+Hct LP+UA/M+Hct LP+UA/M+Sickle+Hct Measles/Mumps/Rubella Immunity Occult Blood, Fecal, IA Platelet Count Pregnancy Testing (Urinalysis) Price Per Pick Up Trip (unlimited samples) Prostate Specific Antigen Test (PSA) PSA, Serum Rfx ProstaSURE(TM) RPR (Rapid Plasma Reagin) Sickle Cell Testing Occult Blood, Fecal, IA Thyroid‐Stimulating Hormone (TSH)

Laboratory services (continued):

Thyroxine (T4) Free, Direct, S Tuberculin Purified Protein Derivative (PPD) Uric Acid

Urinalysis, Complete Urine Culture, Routine Urine specific gravity and urine microscopic

Technical Exhibit 1 Performance Requirements Summary

This Performance Requirements Summary includes performance standards applicable to this PWS. The Government will use these standards to determine contractor performance and will compare contractor performance to the Acceptable Quality Level (AQL).

PWS

Paragraph

Task

Performance Standard

Acceptable

Quality Levels

(AQL)

Surveillance Method By

Whom

1.4.4.4.1 1.4.4.4.2

Timely Performance:

Pickups & Drop‐off Times & Location

Compliance

Contractor shall be available for pickups/drop offs at designated hours, and pick up samples NLT 24 hours after placement of pickup call

No more than one instance monthly of late pickup or unavailability of dropoff

Periodic Inspection

5.1.5

Laboratory Test Compliance with Local, State and

Federal Regulations

Exams shall be performed in accordance with all regulations in PWS

Zero instances of incompliant tests

5.1.5

Results Delivery Lab tests results shall be returned electronically to the Gov’t POCs NLT 12:30 PM EST same day of testing.

No more than one instance monthly of late results delivery

PERFORMANCE WORK STATEMENT (PWS)

FOR

North Carolina Army National Guard (NCARNG)

Laboratory Services

Technical Exhibit 2 Deliverables Schedule

PWS Reference / Deliverable Title

Frequency Number of

Copies

Medium/Format Submit To

1.3.1 Quality

Control Plan

Provide within 10 calendar days after Contract Award

1 Electronic Submission

KO

1.7 Contract Manager Provide within 3

calendar days after Contract Award

1 Electronic Submission

COR