PWS - LAB SERVICES.pdf

PERFORMANCE WORK STATEMENT (PWS)

for

Laboratory Services for The Ohio Army National Guard

1.0 General:

1.1 Scope: Laboratory will provide supplies/ containers, prepaid packaging, and instructions to the Ohio Army National Guard (OHARNG) regarding their procedures for the collection and shipment of laboratory specimens. Shipping cost will be inclusive, as there will not be a separate funding Contract Line-Item Number (CLIN) to cover shipping. These requirements must be included in the response to this quote.

1.2 Background: The Ohio Army National Guard Medical Detachment requires vendor to process laboratory specimens to assist medical providers in determining Soldiers’ medical readiness status. The OHARNG has qualified personnel to collect the required specimens but does not have the required equipment to process the specimens.

1.3 Period of Performance (PoP): The period of performance shall be up to five years from the final blanket purchase agreement date.

1.4 General Information:

1.4.1 Place and Performance of Services: The contractor shall provide services and be available to the OHARNG between the hours of 0900 and 1600 on Monday through Friday, except on recognized US holidays. The contractor shall at all times maintain an adequate work force for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the work force are essential.

1.4.2 Recognized Holidays: The following are recognized US holidays. The contractor will not be expected to perform services on these days:

1.4.2.1 New Year’s Day: January 1st

1.4.2.2 Martin Luther King, Jr.’s Birthday: 3rd Monday in January

1.4.2.3 President’s Day: 3rd Monday in February

1.4.2.4 Memorial Day: Last Monday in May

1.4.2.5 Juneteenth: June 19th

1.4.2.6 Independence Day: July 4th

1.4.2.7 Labor Day: 1st Monday in September

1.4.2.8 Columbus Day/Indigenous People’s Day: 2nd Monday of October

1.4.2.9 Veteran’s Day: November 11th

1.4.2.10 Thanksgiving Day: Last Thursday of November

1.4.2.11 Christmas Day: December 25th

Extraordinary Federal Leave days authorized by Executive Order, ex. National Day of Observance, and the day before or after Christmas. Regardless of the Contractor’s recognition of these dates and authorizations, processing on these days is at the discretion of the Contractor and solely on the Contractor. No additional cost to the Government is authorized.

1.4.3 Quality Control (QC): The Contractor shall develop and maintain an effective QC Plan (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures, and follow regulatory guidance to identify, prevent, and ensure non-recurrence of defective services. The contractor’s QCP is the means by which they assure that their work complies with the requirements of the contract. As a minimum, the contractor shall develop QC procedures that address the areas identified in Technical Exhibit 1, Performance Requirements Summary. After acceptance of the QCP, the contractor shall obtain the Contracting Officer’s acceptance in writing of any proposed changes to its QCP.

1.4.4 Quality Assurance (QA): The Government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP) (see attached). This plan is primarily focused on what the Government will do to ensure that the contractor 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)).

1.4.5 Installation Access and Security Requirements: N/A

1.4.6 Physical Security. The contractor shall safeguard all Government property. At the close of each workday, contractors shall ensure all specimens and materials are secured.

1.4.7 Special Qualifications: The contractor shall ensure all employees possess all required licenses for operating equipment used in the performance of this contract. This does not include education or other qualifications for the position in which the contractor employee is performing, dress codes, or other information. (NOTE: The Government does not provide training to contractors. Contractors must ensure that any personnel performing under a contract are fully trained, licensed, certified, and otherwise qualified to provide services.)

1.4.7.1 Protection of Personally Identifiable Information (PII): The contractor shall protect all Personally Identifiable Information (PII) encountered in the performance of services in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 224.103 and Department of Defense Directive (DoDD) 5400.11, Department of Defense Privacy Program, and Department of Defense (DOD) 5400.11-R. If a PII breach results from the contractor’s violation of the aforementioned policies, the contractor shall bear all notification costs, call-center support costs, and credit monitoring service costs for all individuals who’s PII has been compromised.

1.4.7.2 Health Information Portability and Accountability Act (HIPAA): The HIPAA Privacy Rule creates national standards to protect individuals’ medical records and other personal health information.

1.4.8 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the KO in accordance with FAR 42.5. The KO, COR and other Government personnel, as appropriate, may meet periodically with the contractor to review the contactor’s performance. At these meetings, the KO will apprise the contractor of how the Government views the contractor’s performance and the contractor shall apprise the Government of problems, if any, being experienced. The contractor shall resolve outstanding issues raised by the Government. Contractor 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 contractor when the CM is absent, shall be designated in writing to the KO. The CM or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The CM shall work through the COR, to resolve issues, receive technical instructions, and ensure adequate performance of services. The CM shall ensure that contractor employees do not perform any services outside the scope of the contract without an official modification issued by the KO. The CM shall ensure contractor employees understand that services performed outside the scope of the contract are performed wholly at the expense of the contractor.

1.4.10 Identification of Contractor Employees: N/A

1.4.11. Combating Trafficking in Persons: N/A

1.4.12 Contractor Travel: N/A

1.4.13 Data Rights: N/A

1.4.14 Organizational Conflicts of Interest (OCI): The contractor and subcontractor personnel performing services under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCIs, as defined in FAR Subpart 9.5. The contractor shall notify the KO immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the KO to avoid or mitigate any such OCI. The contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the KO. In the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO may impose other remedies as he or she deems necessary, including prohibiting the contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.4.15 Phase In / Phase Out Periods: N/A

2.0 Definitions and Acronyms:

2.1 Definitions:

2.1.1 Contractor. A supplier or vendor awarded a contract to provide specific supplies or service 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 CO 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 the 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 which does not meet the standard of performance associated with the Performance Work Statement.

2.1.5 Physical Security. Actions that prevent the loss or damage of Government property.

2.1.6 Quality Assurance. The government procedures to verify services being performed by the Contractor are performed according to acceptable standards.

2.1.7 Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.8 Quality Control. All necessary measures taken by the Contractor to assure the quality of an end product or service meets contract requirements.

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

2.1.10 Work Hours. The number of hours per day the Contractor provides services in accordance with the contract. Overtime is not authorized.

2.1.11 Work Week. Monday through Friday, unless specified otherwise.

2.2 Acronyms:

ADCO/PC Alcohol Drug Coordination Officer and Prevention Coordinator AEI Army Enterprise Infostructure AFARS Army Federal Acquisition Regulation Supplement

AHLTA Armed Forces Health Longitudinal Technology AKO Army Knowledge Online AMEDD Army Medical Department APA Aviation Physician Assistant AR Army Regulation ARNG Army National Guard AUP Acceptable Use Policy AT/OPSEC Antiterrorism/Operational Security ATCTS Army Training Certificate Tracking System AVS Automated Voucher System BBP Best Business Practices BH Behavioral Healthcare BI Background Investigation CAC Common Access Card CFP/M/E Contractor Furnished Property, Materials, and Equipment CFR Code of Federal Regulations CI Counterintelligence COMSEC Communications Security CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTS Commercial-Off-the-Shelf CMRA Contractor Manpower Reporting Application DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DEERS Defense Enrollment Eligibility Reporting DENCLASS Dental Classification Module DFARS Defense Federal Acquisition Regulation Supplement DOD Department of Defense DODAAC Department of Defense Activity Address Code DODM Department of Defense Manual DSS Deputy State Surgeon eCASE Electronic Case Management ePROFILE Electronic Profile System eQUIP Electronic Questionnaires for Investigations Processing FAR Federal Acquisition Regulation FBI Federal Bureau of Investigation FOUO For Official Use Only FPCON Force Protection Condition FSO Corporate Facility Security Officer GFP/M/E/S Government Furnished Property/Material/Equipment/Services HIPAA Health Insurance Portability and Accountability Act of 1996 HQDA Headquarters Department of Army HRR Health Readiness Record HSS Health Services Specialist IA Information Assurance

IAW In Accordance With IMR Individual Medical Readiness IS Information System(s) iPERMS Interactive Personal Electronic Records IT Information Technology JTR Joint Travel Regulation KO Contracting Officer LAN Local Access Network LPN Licensed Practical Nurse LPVN Licensed Practical Vocational Nurse LOD Line of Duty MEB Military Evaluation Board MEDCHART Medical Electronic Data Care History and Readiness Tracking MEDCOM Medical Command MEDPROS Medical Protections System MHA Medical Health Assessment MODS Medical Operational Data Systems MMPS Medical Management Processing System MND Medically Non-deployable MRDP Medical Readiness Decision Point MRE Medical Readiness Event MTU Medical Transition Unit NACI National Agency Check with Inquiries NARSUM Narrative Summary NGB National Guard Bureau OCI Organizational Conflict of Interest ODC Other Direct Costs OPM Office of Personnel Management OPSEC Operations Security OTSG Office of the Surgeon General OY Option Year PEB Physical Evaluation Board PHA Periodic Health Assessment PII Personally Identifiable Information PIPO Phase In/Phase Out PIV Personal Identity Verification POC Point of Contact PROFIS Professional Filler System PRS Performance Requirements Summary PSIP Personnel Security Investigation Portal PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program

RAPIDS Real-Time Automated Personnel ID System RN Registered Nurse ROI Release of Information SIBX SIDPERS Interface Branch SIDPERS Standard Installation/Division Personnel System SM Service Member SOP Standard Operating Procedures SRP Soldier Readiness Processing SSN Social Security Number STR Soldier Treatment Records TA Trusted Agent TASS Trusted Associate Sponsorship System TEM Traumatic Event Management TE Technical Exhibit USDI Under Secretary of Defense Intelligence

3.0 Government Furnished Property, Materials, and Equipment (GFP/M/E):

3.1 Property: N/A.

3.2 Materials: N/A.

3.3 Equipment: N/A

3.4 Utilities: N/A

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 as required by the contract.

4.3 Secret Facility Clearance: N/A.

5.0 Requirements:

5.1 Contractor shall ensure they have a fully trained and qualified workforce. Therefore, except as otherwise indicated, the contractor shall train, qualify, and certify personnel for specific job tasks to be performed at its own expense. Records of training, qualification, and certification shall be maintained by the contractor and made available for Government review upon request. Employment and staffing difficulties shall not be justification for the contractor’s failure to meet established schedules.

5.2 Testing lab will provide the necessary collection containers and return paid packaging prior to scheduled event. Specimens will be collected and processed for testing using the requirements provided by the testing lab. Qualified members of the OHARNG will collect the specimens for testing. Supplies and equipment will be provided by the lab. The testing lab will provide detailed results of each individual test within 5 days of receipt of specimens.

5.3 Table 1 identifies the routine laboratory tests that are conducted by the OHARNG, most on a regular basis. All tests must be priced and the code for testing stated. The “Per Month Average” is an estimate of the number of tests conducted per month. Tests listed as “0” are tests that are conducted on an irregular basis (less than monthly) but must remain on the testing matrix in case the test is needed. There may be other additional requirements on an irregular basis; The contractor should provide a comprehensive list of tests, with codes for those tests, this laboratory provides with the price also listed with this PWS.

5.4 Contractor shall meet all Performance Work Statement, Local, State, and/or Federal training, licensing, and certification requirements, whether specified or not.

5.5 The vendor shall submit an invoice detailing the test conducted, date of test and name of examinee. The vendor must submit invoices and itemized statements through Wide Area Work Flow in accordance with DFARS 252.232-7006. Payment will be made monthly via a Blanket Purchase Agreement (BPA) CALL. Each CALL will have a roll-up of all tests conducted that month. A comprehensive list of labs with prices and codes will be listed in Table 2 and a list of the labs that the Medical Detachment will run on a regular basis, will be listed and prices with be based on the price sheet outlined in Table 1.

5.6 Service Contract Reporting (SCR): N/A

Table 1: Routine Labs

TEST CODE PER MONTH

AVERAGE

COST

Hemoglobin A1C, IEC 0

G-6-PD (B) 10

Sickle Cell Screen 10

CBC (H/H, RBC, WBC, PLT) 2

UA, Comp w/ RFL Culture 2

Prostate Specific AG 5

Urinalysis, Complete 5

CBC (DIFF/PLT) 2

Comprehensive Drug Screen (U) 100

ABO Group & RH Type 40

Basic Metab PNL 2

Lipid Panel 5

Quantiferon TB Gold 10

Lead Blood Test 2

Zinc Protoporphyrin 2

Complete Metabolic Panel 5

RPR (Rapid Plasma Reagin) 5 hCG Serum 0

Hepatitis Panel 2

ETOH 100

Fecal Occult Stool 5

Total Cost

Table 2: Comprehensive List of Labs Offered

TEST CODES COST

Cholesterol, Total

Glucose, Serum

Hemoglobin A1C, IEC

G-6-PD (B)

Hematocrit

Hemoglobin (B)

LDL, total

HDL, total

Sickle Cell Screen

Triglycerides

TP Rand UR w/ Creat

CBC (H/H, RBC, WBC, PLT)

UA, Comp w/ RFL Culture

Draw Fee, PSC Spec.

Prostate Specific AG

Urinalysis, Complete

CBC (DIFF/PLT)

Urinalysis, Macro

Microalb/Creat Ratio

Comprehensive Drug Screen (U)

ABO Group & RH Type

Urinalysis, Reflex

Volatiles (U) QL

Basic Metab PNL

Hepatic Func PNL

CCP AB IGG

Volatiles, Urine

Cyto, Thinprep Pap

HPV Reflex

SurePath Pap

SurePath w/RFL HPV High Risk

SurePath Pap with HPV/Chlamydia/

Gonorrhea DNA, SDA, OTV

Chlamydia/Gonorrhea Urine

Quantiferon TB Gold

MMR Titer

Varicella Titer

Lead Blood Test

Zinc Protoporphyrin

Comprehensive Metabolic Panel

TSH

Free T4

Free T3

Hymenoptra profile

Fecal Occult Stool

6.0 Applicable Publications: Publications applicable to this PWS are listed within.

Publication (Chapter/Page)

Date of Publication

Mandatory or Advisory

Website

Fed Acquisition Reg 9.5, 22.17, 42.5, 52.204-2, 52.204-9

Mandatory https://www.acquisition.gov/ ?q=browsefar

Defense Fed Acquisition Reg Supplement 224.103, 252.239.7001

Mandatory http://www.acq.osd.mil/dpap/ dars/dfarspgi/current/index.h tml

DoDD 5400.11 Dept of Defense Privacy Program

10/29/2014 Mandatory http://www.dtic.mil/whs/direc tives/corres/dir.html#

DoD 5400.11-R Dept of Defense Privacy Program

05/14/2007 Mandatory http://www.dtic.mil/whs/direc tives/corres/pub1.html

DoDM 1000.13-M-V1 DoD Identification (ID) Cards

(Encl 2, para 3.b)

01/23/2014 Mandatory http://www.dtic.mil/whs/direc tives/corres/pub1.html

FIPS (Fed Information Processing Standards) Publication 201-2

August

Mandatory http://nvlpubs.nist.gov/nistpu bs/FIPS/NIST.FIPS.201-

2.pdf http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/pub1.html

Personal Identity Verification (PIV) of Fed Employees and Contractors (para 9)

HSPC (Homeland Security Presidential Directive) -12 Policy for a Common

Identification Standard for Fed Employees and Contractors

08/27/2004 Mandatory https://www.dhs.gov/homela nd-security-presidential-directive-12

DoD Reg 5200.2-R Dept of Defense Personnel Security Program

01/01/1987 Mandatory http://www.dtic.mil/whs/direc tives/corres/pub1.html

DoDD 8140.01 Cyberspace Workforce Management

08/11/2015 Mandatory http://www.dtic.mil/whs/direc tives/corres/dir.html

DoD 8570.01-M Information Assurance Workforce

Improvement Program

12/19/2005 (Change 4:

11/10/2015)

Mandatory http://www.dtic.mil/whs/direc tives/corres/pub1.html

AR 25-2

Information Assurance

10/24/2007 Mandatory http://armypubs.army.mil/Se arch/ePubsSearch/ePubsSe archForm.aspx?x=AR

AR 530-1

Operations Security

09/26/2014 Mandatory http://armypubs.army.mil/Se arch/ePubsSearch/ePubsSe archForm.aspx?x=AR

AR 381-12

Threat Awareness and Reporting Program

(TARP) (Section II, Para 2-4.b)

06/01/2016 Mandatory http://armypubs.army.mil/Se arch/ePubsSearch/ePubsSe archForm.aspx?x=AR

Technical Exhibit 1:

Performance Requirements Summary

This Performance Requirements Summary includes performance standards. 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

5.1 Contractor has a

fully trained and qualified workforce

Maintain 100% qualified workforce

0% Customer Feedback/ Monthly

5.2 Specimens will be

processed within 5 days of receipt

Specimens are accurately processed 95%

5%. Customer Feedback/Spot Checks

Monthly

5.5 Invoices are

processed and submitted through Wide Area Work

Flow

Invoices are processed accurately at 95%.

5% Periodic Inspection/Customer

Feedback/Spot Checks Monthly http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/dir.html