ATTACHMENT A - PWS.pdf

Ver. May 2018 (July 2020)

PERFORMANCE WORK STATEMENT (PWS)

FOR

Laboratory Testing Services

1.0 General:

1.1 Scope: The purpose of this contract is to provide clinical laboratory testing not routinely available at Michigan Army National Guard. This requirement is designed to be flexible, responsive, and meets the ever-evolving needs of the government. DoDI 6025.19, Individual Medial Readiness (IMR) establishes aggressive quarterly and annual metric goals for the IMR elements and for the overall IMR category of Fully Medically Ready (FMR) Soldiers. The ultimate goals are to produce real-time reports based on complete, accurate data. The minimum goal for overall medical readiness is more than 85% of Service members FMR, with the ideal goal being 100%. The Michigan Army National Guard (MIARNG) Surgeon’s Office requires a highly responsive process whereby the government can quickly obtain needed support and services.

1.1.2 The Contractor shall furnish all labor and services required to provide a wide range of clinical laboratory testing services. The contractor shall provide all personnel, equipment, tools, materials, supervision, and quality control necessary, except as specified in Paragraph 3.0 as Government Furnished, to perform Laboratory Testing Services, as defined in this PWS.

1.2 Background: The Michigan Army National Guard (MIARNG) requires support for laboratory testing services in order to meet the screen requirements for service members in accordance with the Medical Standards of Fitness. Due to the geographical array of forces across Michigan it is necessary to have site locations in Battle Creek, Belmont, Detroit, Grand Ledge, Grayling, Ishpeming, Lansing, and Ypsilanti.

1.3 Period of Performance (PoP): The Period of Performance shall be for 60 months during the life of the BPA beginning September 1, 2020 and ending August 31, 2025.

1.4 General Information:

1.4.1 Quality Control (QC): The Contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS.

The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. After acceptance of the quality control plan the Contractor shall receive the contracting officer’s acceptance in writing of any proposed change to his QC system.

ATTACHMENT A

Total Pages: 12W912JB-20-Q-0139

1.4.2 Quality Assurance (QA): The Government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). 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) or defect rate(s).

1.4.3 Recognized Holidays: The following are recognized United States (US) holidays.

The contractor shall not perform services on these days:

1.4.3.1 New Year’s Day: January 1st

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: July 4th

1.4.3.6 Labor Day

1.4.3.7 Columbus Day

1.4.3.8 Veteran’s Day: November 11th

1.4.3.9 Thanksgiving Day

1.4.3.10 Christmas Day: December 25th

1.4.4 Place and Performance of Services The contractor shall provide services between the hours of 0730-1700 7 days a week 7 (Sunday through Saturday) except on recognized US holidays. Expected locations would be Detroit, Lansing, Battle Creek, Ypsilanti, Grand Ledge, Grayling and Ishpeming or the Contractor’s site by special arrangement. 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.

1.4.4.1 Telework: Reserved

1.4.4.2 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. Contractors are not compensated for unexpected closures or delays. Vehicles operated by contractor 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 contractor employee’s installation driving privileges.

1.4.4.3 The contractor’s employees shall become familiar with and obey the regulations of the installation; including fire, traffic, safety and security regulations while on the installation. Contractor employees should only enter restricted areas when required to do so and only upon prior approval. All contractor employees shall carry proper identification with them at all times, and shall be subject to such checks as may be deemed necessary. The contractor shall ensure compliance with all regulations and orders of the installation which may affect performance. The Government reserves the right to direct the removal of an employee for misconduct, security reasons, or any overt evidence of communicable disease. Removal of contractor employees for reasons stated above does not relieve the Contractor from responsibility for total performance of this contract.

1.4.5. Reserved

1.4.6 Reserved

1.4.7 Reserved.

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 Subpart 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: All contractor personnel attending meetings, answering Government telephones and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression that they are Government employees. The contractor shall ensure that all documents or reports produced by contractor personnel are suitably marked as contractor products or that contractor participation is appropriately disclosed. The contractor’s status as a “contractor” shall be predominantly displayed in all correspondence types (to include signature blocks on e-mail) and dealings with Government or non-Government entities. 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 its employees who depart employment for any reason.

1.4.11. Combating Trafficking in Persons: The United States Government has adopted a zero tolerance policy regarding trafficking in persons. Contractors and contractor employees shall not engage in severe 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. 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.

1.4.12 Contractor Travel-Contractor The contractor shall be required to travel to off-site locations (Battle Creek, Belmont, Detroit, Grand Ledge, Grayling, Ishpeming, Lansing, and Ypsilanti) in the performance of this contract. The cost shall be borne by the contractor.

1.4.13 Data Rights. The Government has unlimited rights to all documents/materials produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

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 Reserved

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 Representative (COR): An employee of the U.S. Government designated by the KO to monitor contractor performance. Such appointment will be in writing and will 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 PWS.

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 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 ensure 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.

2.2 Acronyms:

AEI Army Enterprise Infostructure AR Army Regulation AT/OPSEC Antiterrorism/Operational Security BI Background Investigation CHCS Composite Health Care System CM Contract Manager CMRA Contractor Manpower Reporting Application COR Contracting Officer Representative DA Department of the Army DD254 Department of Defense Contract Security Classification Specification DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense FAR Federal Acquisition Regulation FMR Fully Medically Ready GFP/M/E/S Government Furnished Property/Material/Equipment/Services HQDA Headquarters, Department of the Army HSPD Homeland Security Presidential Directive IA Information Assurance IS Information System(s) IMR Individual Medical Report KO Contracting Officer NGB National Guard Bureau OCI Organizational Conflict of Interest PII Personally Identifiable Information PIPO Phase In/Phase Out 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 SSN Social Security Number TE Technical Exhibit USD(I) Under Secretary of Defense for Intelligence

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

The Government will not provide the property, material, equipment, and/or services listed below solely for the purpose of performance under this contract:

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 indicated in Paragraph 1.1.

5.0 Requirements: The selected company shall provide the MIARNG with access to the database for electronic viewing and notice of lab results as well as input capabilities on site and search by both SSN and name, supplies, forms and supplies for our staff to label specimens.

5.1. A list of authorized users will be provided as the only individuals allowed to place orders, have access to database, request supplies and schedule drop in testing.

5.2. Frequently ordered tests as listed in Technical Exhibit 3 but not limited to those on the attachment, and shall be performed using blood, urine, serum, body fluids, or stool samples as appropriate. Miscellaneous chemistry, serology, hematology, microbiology and immunity tests, which are infrequently ordered, shall be performed either by the contracting laboratory or its subcontractor as appropriate.

5.2.4 Test results shall include the following information:

5.2.4.1 Performing laboratory identification/name

5.2.4.2 Patient's name

5.2.4.3 Test name and identification number

5.2.4.4 Expected normal value

5.2.4.5 Contract number

5.2.4.6 Delivery order number

5.2.4.7 Results shall be sequential in Composite Health Care System (CHCS) numeric order

5.3 The contractor shall provide MIARNG a copy of its catalog including any updates published during contract performance period.

5.3.1 Once laboratory requests are processed by the Contractor, the results shall be returned to the MIARNG via secure fax or secure computer work station for entering results in appropriate military medical system. The contract laboratory shall call all results to MIARNG facility for stat results and follow with written report faxed to the MIARNG. The Government will provide more detailed information to the selected vendor.

5.3.2 Unless specifically provided in this contract, the quality of all services rendered under this contract shall conform to the highest standards of the laboratory profession.

5.3.3 The contractor does not have exclusive rights to the laboratory samples for tests on contract. It is not a violation of this contract if our facility brings new test on board or desires to send specimens to another facility.

5.3.4 Laboratory testing services shall include any and all urgent clinical pathology.

They are to be processed and completed within standardized laboratory standards.

Vendor shall process all urgent test requirements on an as needed basis. The results will be called into the Medical Detachment with a hard copy faxed to 313-826-3485.

5.3.5 On occasion some tests could be order by an authorized individual that is not on the list, a price will be required prior to ordering test. See attachment for individual lab pricing. Surcharges for emergency (STAT) testing will be in addition to routine test costs. Tests will be billed at Medicare rates in effect at the time of testing. Billing is to be monthly in arrears.

5.3.6 The tests to be provided will include those identified on the approved testing list, but may include additional tests with prior approval from the Contracting Officer.

5.4 Contractor shall maintain medical liability insurance, no less than $1,000,000 which is the normal prevailing within the local community for the medical specialty concerned.

5.4.1 Contractor shall ensure that its subcontractors, if any, for provisions of laboratory testing services, contain the requirements of the clause at 52.237-7, Indemnification and Medical Liability Insurance, including the maintenance of liability insurance.

5.4.2 Contractor shall ensure all procedures are conducted in accordance with applicable American Board of Occupational and Environmental Medicine (ABOEM), U.S. Department of Labor, Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) Standards.

Personnel shall be certified under the American Society of Clinical Pathology

5.5 Contractor shall ensure each healthcare worker complies with the requirements of 29 CFR 1910.1030 Blood borne Pathogens Standard.

5.5.1 Contractor shall ensure puncture resistant sharps containers are readily accessible to healthcare workers and located in all treatment areas where sharps could potentially be used.

5.8 MEDICAL REPORTS AND RECORDKEEPING

5.8.1 Contractor shall bill on the first day of each a month for all locations during the POP. Contractor shall submit invoice in WIDE AREA WORKFLOW SYSTEM (WAWF) in accordance with FAR regulation based on net 30 day terms once the invoice is accepted.

5.8.2 Services performed will be monitored and validated against billings using Wide Area Work Flow. This system will be used to verify statistics reflecting Current

Procedural Terminology (CPT) codes that will be used to validate services provided under the terms of the contract.

5.8.3 The COR will track and record difficulties such as poor turnaround time. Any noted difficulties or deficiencies will be reported to the contracting officer for appropriate action and remedy.

5.9 Contractor Manpower Reporting Application (CMRA):

5.9.1 The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Michigan Army National Guard via a secure data collection site.

5.9.2 The contractor shall completely fill in all required data fields using the following web address: http://www.sam.gov Reporting inputs shall be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year.

Contractors may direct questions to the help desk at http://www.sam.gov.

6.0 Applicable Publications: Publications applicable to this PWS are listed below:

Publication

(Chapter/Page) Date of

Publication Mandatory or Advisory

Website

Occupational Safety and Health Standards.

Title 29, Code of Federal Regulations, Part 1910

15 Jul 1993 Mandatory https://www.osha.gov/pls/oshaweb/owadisp.

show_document?p_table=Standards&p_id=1

Safety and Health Provisions for Federal Employees

Title 29, Code of Federal Regulations, Part 1960

26 Nov 2004 Mandatory https://www.osha.gov/laws-regs/regulations/standardnumber/1960

Threshold Limit Values and Biological Exposure Indices

(TLVs), American Conference of Governmental

Industrial Hygienists (ACGIH), Cincinnati,Ohio.

31 Dec 2005 Advisory http://www.acgih.org/forms/st ore/ProductFormPublic/docu mentation-of-the-threshold- limit-values-and-biological- exposure-indices-7th-edition-

2006-supplement

Army Regulation 40-5, Preventive Medicine

25 May 2007 Mandatory https://armypubs.army.mil/ProductMaps/Pub Form/Details.aspx?PUB_ID=500

Department of Defense 6055.05M,Occupational

Medical Surveillance Manual

2 May 2007 Mandatory www.dtic.mil/whs/directives/ corres/pdf/605505mp.pdf

Army Regulation 11-34, The Army Respiratory Protection

Program

25 July 2013 Mandatory https://armypubs.army.mil/ProductMaps/Pub Form/Details.aspx?PUB_ID=67365

Headquarters, Department of the Army Pamphlet (DA

08 Jan 2015 Mandatory https://armypubs.army.mil/ProductMaps/ PubForm/Details.aspx?PUB_ID=68571 http://www.sam.gov/ https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=Standards&p_id=10106 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=Standards&p_id=10106 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=Standards&p_id=10106 https://www.osha.gov/laws-regs/regulations/standardnumber/1960 https://www.osha.gov/laws-regs/regulations/standardnumber/1960 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=500 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=500 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=67365 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=67365 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=68571 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=68571

PAM) 40-501 Hearing Conservation

Headquarters, Department of the Army Pamphlet (DA

PAM) 40-506 Vision Conservation

15 July 2009 Mandatory https://armypubs.army.mil/ProductMaps/Pub Form/Details.aspx?PUB_ID=78813

29 CFR 1910.1030 Blood borne Pathogens Standard

Mandatory https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.

6.1 Applicable Forms: Forms applicable to the PWS are listed below:

Form Date Website

DD 250

Material Inspection and Receiving Report

Aug 2000 http://dtic.mil/whs/directives/forms/dd/ddforms0001- 0499.htm https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=78813 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=78813 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 http://dtic.mil/whs/directives/forms/dd/ddforms0001-0499.htm http://dtic.mil/whs/directives/forms/dd/ddforms0001-0499.htm

TECHNICAL EXHIBIT 1

Performance Requirements Summary (PRS)

This PRS includes performance objectives the Government will use to determine contractor performance and will compare contractor performance to the Acceptable Quality Level (AQL).

Performance Objective

Performance Standard

Acceptable Quality Levels

(AQL)

Surveillance Method / By Whom

5.4.2 Provide qualified

personnel

0% allowed to be uninsured or not licensed

100% Inspection/COR

5.8 Medical Reports

and Recordkeeping

5% reports submitted late Periodic Inspection/COR

5.4.2 Equipment

Certification

0% allowed use of uncertified equipment; 5% certifications provided late

Periodic Inspection/COR

5.5.1 Infectious Waste

Disposal

0% non- compliance Periodic Inspection/COR

5.3.1 Laboratory

Results

5% laboratory results provided untimely

Periodic Inspection/COR

TECHNICAL EXHIBIT 2

Estimated Workload Data

This information is provided for historical background only. It is not a guarantee of workload quantities.

The estimated number of personnel to be examined is 1,500.

The Government has the right to increase and/or decrease the number of employees/military personnel and the locations for service.

TECHNICAL EXHIBT 3

Laboratory Testing List

Laboratory Testing

Urine Specific Gravity (Microscopic Urine)

Heavy Metals (Blood) - Cadmium, Arsenic, Mercury, Lead

Heavy Metals (Urine) - Cadmium, Arsenic, Mercury, Lead

Comprehensive Panel

Lipid Profile

CBC with Differential

Beta 2 Microglobulin

Liver Panel (Alk PO4, SGOT, SGPT and GGTP)

Benzene (Blood)

Lead/ZPP