PWS.pdf

AUG 22

Performance Work Statement

(Includes associated Performance Requirements Summary (PRS)

PERFORMANCE WORK STATEMENT (PWS)

Pharmacy Surface Sampling

May 15, 2023

Part 1

General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) 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.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide 10 months of surface sampling tests. The test includes 16 bacterial and 16 fungal for a total of 32 monthly samples/tests. These tests are for fungal and bacterial growth within Inpatient, Oncology and Nuclear

Pharmacies located at William Beaumont Army Medical Center. The testing will not be performed on months May and November as they will be conducted by the contract maintained under WBAMC’s

Medical Maintenance when their Bio-Safety Cabinets and Fume Hoods are inspected and certified. The media plates used for the sampling will be visually inspected prior to use with a pharmacy staff member present to ensure the plates appear clear, and free of any defects, growths, or condensation.

1.2 Background: United States Pharmacopeia 797 (USP 797) and Defense Health Agency Procedural

Instruction 6021.31 (DHAPI 6025.31) recently updated the requirement of monthly surface testing areas for pharmacy to include 16 bacterial and 16 fungal tests (32 total). Medical Maintenance provides 2 months of coverage in their contract (May and November). The Department of Pharmacy must have the other 10 months performed to be in compliance with USP 797 and DHAPI 6025.31

1.3 Scope: The Contractor shall provide non-personal service(s). The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services. The Contractor shall perform to the standards and acceptable quality levels identified in this PWS and associated contract documents. This is a non-personal service(s) contract to provide 10 months of surface sampling tests. The test includes 16 bacterial and 16 fungal for a total of 32 monthly samples/tests. These tests are for fungal and bacterial growth within Inpatient, Oncology and Nuclear Pharmacies located at William Beaumont Army Medical

Center. The testing will not be performed on months May and November as they will be conducted by the contract maintained under WBAMC’s Medical Maintenance when their Bio-Safety Cabinets and

Fume Hoods are inspected and certified. The media plates used for the sampling will be visually inspected prior to use with a pharmacy staff member present to ensure the plates appear clear, and free of any defects, growths, or condensation. Inpatient pharmacy: buffer room with 2 hoods, repeater pump, and cart. Oncology pharmacy: buffer room #1 with 2 hoods, cart, and medication storage cabinet refrigerator. buffer room #2 with 1 hood and cart. Nuclear pharmacy: buffer room with 2 hoods, shield waste receptacle, and cart. Results will be turned into the COR within 14 working days. Total monthly testing is 32 samples, 16 bacterial and 16 fungal. If there is any reason for the delay in the reports the contractor must notify the COR no later than 3 days.

1.4 Objectives: The objective of this contract is to provide 10 months’ worth of surface sampling to be conducted in Inpatient, Oncology, and Nuclear Pharmacy to be in compliance with USP 797 and DHAPI

6025.31.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The

Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract. Contractor will provide only technically qualified technicians who are formally trained on conducting surface samplings within a pharmaceutical compounding sterile preparation area. Contract provides a plan for service coverage if less than two (2) personnel are trained on collecting samples. The plan describes and ensures the Government is not without service support for more than one day (i.e., coverage during technician illnesses, vacations, terminations, and or strikes).

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the

Contracting Officer’s Representative (COR) for review within (ten (10) days) after date of contract award (Deliverable # 1).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within (ten (10) days). If the Government has provided comments, the Contractor shall then have (ten (10) days) to submit a Final QCP. After receipt of the

Final QCP, the Contractor may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer no later than (ten (10) days) prior to the anticipated change and before implementation by the

Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team.

(b) How the Contractor will monitor work to ensure performance complies with all deliverables

(etc. timelines, deadlines, and goals).

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses.

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance.

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7

Key Control).

(f) How the Contractor will inventory and track maintenance of all Government Provided

Equipment / Materials.

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.1.1 Reserved

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 24 working hours of identifying those issues. Verbal reports shall be followed up by written reports within (three (3) days) (Deliverable # 2).

1.5.2 Quality Assurance: 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 must 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 the acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g., deliverables, submittals, etc.) deadlines fall on a holiday, the closest workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan

Presidents’ Day 3rd Monday in February Memorial Day last Monday in May

Juneteenth June 19th Independence Day July 4th

Labor Day 1st Monday in September Columbus Day 2nd Monday in October

Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November

Christmas Day December 25th

1.5.3.2 Operating Hours: The Government facility office hours, facility operating hours, and the

Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4. Government Facility Office Hours: The Government facility office hours are 0500 to 1600, and days Monday thru Friday except U.S. Holidays identified in paragraph 1.5.3.1 above or when the

Government facility is closed due to local or national emergencies, administrative closings, or similar

Government directed facility closings. Each pharmacy has different working hours, Nuclear Pharmacy is 0500-1330 hours, Inpatient and Oncology is 0700-1600 hours. The contractor will visit the sites during these hours and report the date and times to conduct samplings with the COR so he or she can coordinate access.

1.5.4.1 Contractor Support Hours: The Contractor shall provide support between the hours of 0500-

1600, Monday thru Friday the Government facility is closed during local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this

PWS when the Government facility is not closed for the above reasons. When hiring personnel, the

Contractor shall keep in mind that the stability and continuity of the workforce is essential. For other than firm fixed price contracts, the Contractor will not be reimbursed when the Government facility is closed for the above reasons.

1.5.4.2 Contractor Work Plan: Reserved

1.5.5 Training Holidays: has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (for example, Christmas half days or days on day off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled after the training holiday. However, announced training holidays or exodus of military personnel may provide the

Contractor with an opportunity for unrestricted access to facilities and areas. The Contractor shall take full advantage of such opportunities by planning maintenance or actions that are better accomplished when such areas are vacant.

1.5.6 Place of Performance: The work to be performed under this contract will be performed in inpatient, oncology and nuclear pharmacy located in William Beaumont Army Medical center.

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: Reserved

1.6.2 Personnel Security Clearance Requirements: Reserved

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access

Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.3.1 Installation Pass Log: The contractor will sign in with medical maintenance to coincide with their log and contract along with the pharmacy COR. The vendor will be escorted by the pharmacy staff or medical maintenance to receive their badge from the security office.

1.6.3.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within (3 days).

1.6.3.3 Common Access Cards (CAC) and CAC Log: Reserved

1.6.4 Background Checks: Reserved

1.6.4.1 U.S. Citizen: Reserved

1.6.4.2 Local Nationals and Third Country Nationals: Reserved

1.6.5 PHYSICAL Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. For this contract no Government equipment will be furnished.

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Key Control: Reserved

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with

FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the

Contracting Officer 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.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.8.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the

Government to provide effective communication and impart necessary information. The Contract

Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a

COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and

Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: The following personnel are considered key personnel by the Government:

Program / Contract manager and Alternate, and the Contractor’s technician performing testing. The

Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work. The name of this person and an Alternate Program/Contract Manager, who shall act for the

Contractor when the Program/Contract Manager is absent. The Contract Manager and Alternate

Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The technician will be certified to perform required testing in this contract. The Contract Manager or Alternate Contract Manager shall be available between 0500-1600

Monday thru Friday excluding weekends and Federal Holidays

a. Contract Manager and Alternate Contract Manager: “Contract Manager and Alternate

Contract Manager: Must have knowledge of testing being performed as stated on this contract.

b. Technicians performing testing: The vendor must verify that the technician(s) performing the testing is certified and trained.

1.11 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 must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12.1 Reserved

1.12.2 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). The Contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge. The badge must include the employee’s name, the contractor’s company name, and a recent color photograph of the employee if available. Companies with U.S. Government contracts will require their employees to wear these badges visibly when performing work at Government workplaces unless this would be impractical because of mission or safety considerations. The contractor is responsible for maintain and issuing identification for their company.

1.13 Contractor Travel: Reserved

1.14 Other Direct Costs (ODCs): Reserved.

1.15 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting

Officer. 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.

1.16 Non-Disclosure Requirements: Reserved

1.17 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.18 Non-Disclosure Statements: Reserved.

1.19 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work 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 OCI as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer 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 Contracting Officer to avoid or mitigate any such

OCI (Deliverable # 3). The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect 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.

http://www.dimoc.mil/resources/limitations/

1.20 Phase In /Phase Out Period Reserved

1.21 Safety: Contractors will leave the work area the site shall be lift in a clean, neat, and orderly condition.

1.22 Environmental Compliance: Reserved

1.22.1 Environmental Compliance Plan and Program: Reserved

1.23 Required Training: The following provides information on training requirements.

1.23.1 Anti-Terrorism (AT) Level I Training: All Contractor employees, including subcontractor employees, who are employed under the contract, shall complete AT Level I Training within (30 days)

(Deliverable #4) after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or (30 days) after employment of new personnel. Contractor personnel travelling overseas shall complete area of responsibility (AOR) specific AT awareness training for U.S.

based Contractor employees and associated subcontractor employees. The Contractor shall submit certificates of completion (Deliverable #5) for each affected Contractor employee and subcontractor employee to the COR (or to the Contracting Officer, if a COR is not assigned) within (30 days) after completion of this training by all employees and subcontractor personnel. AT Level I awareness training is available at https://jkodirect.jten.mil. Contractor personnel shall complete refresher training

(Deliverable #6) every twelve (12) months except AOR specific AT Level I training which shall be completed as required by local AT policies

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer at their assigned location for classroom training. Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the AT Officer. Verification of the training shall be provided to the COR within (30 of days) after completion of the training (Deliverable #7).

1.23.2 OPSEC Training: Reserved.

1.23.3 iWATCH Training: The Contractor and all associated subcontractors shall brief all employees on the local iWATCH 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 days) after the contract is awarded and within (30 days) after new employees commence contract performance, with the results reported to the COR within (30 days) (Deliverable #8). Verification of the training shall be provided to the COR within (30 days) after completion of the training (Deliverable #9). Training slides can be found on the Army OneSource we site:

http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx

1.23.3.1 Information Assurance (IA) Training Reserved

1.23.3.2 Reserved

https://jkodirect.jten.mil/ http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx

1.23.3.3 Reserved

1.23.4. Reserved

1.23.5 Personally Identifiable Information (PII): Reserved

1.25 Notice to Proceed: Reserved

1.27 Government Property and Services: Reserved

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the 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.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means 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.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the

Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property

“means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government. Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved.

Each HLO may have several statements to flesh out the areas necessary to meet the objective.

Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

ACOR Alternate Contracting Officer's Representative

AE Army in Europe

AFARS Army Federal Acquisition Regulation Supplement

AHA Activity Hazard Analysis

AOR Area of Responsibility

AR Army Regulation

AT Anti-terrorism

ATCTS Army Training Certification Tracking System

CAC Common Access Card

CCE Contracting Center of Excellence

CFE Conventional Forces Europe

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska and Hawaii)

COR Contracting Officer’s Representative

COTS Commercial-Off-the-Shelf

DA Department of the Army

DD250 Department of Defense Form 250 (Receiving Report)

DD254 Department of Defense Contract Security Requirement List

DFARS Defense Federal Acquisition Regulation Supplement

DHAPI Defense Health Agency Procedural Instruction

DMDC Defense Manpower Data Center

DoD Department of Defense

FAR Federal Acquisition Regulation

FRG Federal Republic of Germany

GFP Government Furnished Property

HLO High Level Objective

HIPAA Health Insurance Portability and Accountability Act of 1996

IA Information Awareness

IAC Installation Access Control

IACO Installation Access Control Office

ID Identification

IGCE Independent Government Cost Estimate

IT Information Technology

JTR Joint Travel Regulation

JPAS Joint Personnel Adjudication System

KO Contracting Officer

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

OPSEC Operations Security

PA Property Administrator

PII Personally Identifiable Information

PIPO Phase In/Phase Out

POC Point of Contact

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Program

RA Requiring Activity

RCO Regional Contracting Office

SIGE Safety and Health Protection Plan

TE Technical Exhibit

USAG United States Army Garrison

USAREUR United States Army Europe

USP United States Pharmacopeia

UOM Unit of Measure

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: Reserved

3.2 Facilities: The Government will provide necessary workspace to conduct testing The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the

Government installation. If the Contractor’s failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the

Contracting Officer directs. If the Contractor fails or refuses to make such repair or replacement, the

Contractor shall be liable for the cost, which may be deducted from the contract price.

3.3 Utilities: The Government will provide all utilities in the facility will be available for the

Contractor’s use in performance of the tasks outlined in the PWS, The Contractor shall instruct employees in utilities conservation practices. The Contractor shall operate under conditions that preclude the waste of utilities, which include turning off the water faucets or valves, light switches, etc.

after using the required amount to accomplish tasks requiring the use of the utilities.

3.4 Equipment: Reserved

3.5 Special Tooling and Test Equipment: Reserved

3.6 Materials: Reserved

3.7 Training: The Government will provide the following training: AT Level 1 Awareness, and iWATCH.

3.8 Common Access Cards (CAC): Reserved

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and

Services.

4.2 Secret Facility Clearance: Reserved.

4.3 Materials: Reserved

4.4 Vehicles and Equipment: The Contractor shall provide all necessary vehicles (no GSA vehicles provided to Contractor for use on this contract) and equipment to perform the work described in this

PWS. All Contractor provided vehicles and equipment shall have the company name prominently displayed on both sides of the vehicle or equipment and present a neat, professional appearance.

Contractor's vehicles and equipment used in the performance of this contract shall meet all local traffic, safety, and environmental requirements. Vehicles and equipment found to be unsafe shall be removed from the installation and replaced. The Contractor shall not use any Government-owned tools, materials, or parts to maintain Contractor vehicles and equipment without prior written approval of the Contracting

Officer. The COR may inspect the Contractor’s vehicles and equipment at any time.

4.5 Background Checks: Reserved.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for the Department of Pharmacy by conducting 16 bacterial and 16 fungal test samplings within Inpatient, Oncology and Nuclear Pharmacy for 10 out of 12 months (2 months are covered in medical maintenance’s hood certifications May and

November). A certified technician will make arrangements with the pharmacy COR for the date and times he or she will come to the pharmacies mentioned to conduct testing. These testing results will be submitted to the COR within 14 working days. The tests will be done in accordance with USP 797 standards.

5.2 Tasks: Tasks consist of the following:

For the designated 10 months the contractor will perform sampling/testing for (16) bacterial and (16) fungal growths in the following locations and reporting the findings to the pharmacy COR: Inpatient pharmacy: buffer room with 2 hoods, repeater pump, and cart. Oncology pharmacy: buffer room #1 with 2 hoods, cart, and medication storage cabinet refrigerator. buffer room #2 with 1 hood and cart.

Nuclear pharmacy: buffer room with 2 hoods, shield waste receptacle, and cart. Results will be turned into the COR within 14 working days. Total monthly testing is 32 samples, 16 bacterial and 16 fungal.

If there is any reason for the delay in the reports the contractor must notify the COR, no later than 3 days

(deliverable #10). The media plates used for the sampling will be visually inspected prior to use with a pharmacy staff member present to ensure the plates appear clear, and free of any defects, growths, or condensation.

5.3 Service Contract Reporting

5.3.1 System for Award Management (SAM) Service Contract Report (SCR): The Contractor shall report ALL Contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Department of Pharmacy via a secure data collection site.

The Contractor is required to completely fill in all required data fields through the following web address: www.sam.gov. Reporting inputs will be for the labor executed during the period of performance during each Government FY, which runs from 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 by clicking “View Assistance for

SAM.gov” which is located at the top of the SAM.gov website. From there, you can the select “Contact

Our Service Desk” which will allow you to contact SAM.gov directly. If contract period of performance ends prior to September 30, the Contractor has 30 calendar days from end date of the contract to complete the SAM SCR requirement.

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

http://www.sam.gov/

3. SAM displays your entities which have service contracts and meet the reporting criteria. Select

View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service Contract

Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

• Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

• Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract

Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able to view the current SCR, edit available fields, and resubmit the record. You can also delete previously entered information altogether.

STD: All information provided by the Contractor shall be accurate, complete, and not exceed suspense dates noted in corresponding paragraph above.

AQL: 100% Compliant

(Deliverable #11)

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc.

are mentioned in this PWS and are listed below.

1.2 United States Pharmacopeia paragraph 797

6.1.1 Department of Defense Contract Security Classification Specification (DD Form 254)

6.1.2 Department of Defense Security Agreement (DD Form 441)

6.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.1.4 Installation Access Control (AE Reg 190-16)

6.1.5 The Army Physical Security Program (AR 190-13)

6.1.6 Contractor Identification (AE Reg 27-715)

6.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

6.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD

8570.01)

6.1.10 Information Assurance (AR 25-2)

6.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

6.1.12 Policies and Procedures for Property Accountability (AR 735-5)

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

7.2 Technical Exhibit B – Deliverables Schedule

7.3 Attachment 1 – Estimated Workload Data

7.4 Attachment 2 – Reserved

7.5 Attachment 3- Reserved

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY

LEVELS (AQLs)

METHOD OF

SURVEILLANCE

PRS#1 - PWS para 5.2

The contractor shall perform surface sampling for 10 months in Inpatient pharmacy:

buffer room with 2 hoods, repeater pump, and cart. Oncology pharmacy: buffer room

#1 with 2 hoods, cart, and medication storage cabinet refrigerator.

buffer room #2 with 1 hood and cart. Nuclear pharmacy: buffer room with 2 hoods, shield waste receptacle, and cart. The media plates used for the sampling

32 Monthly samplings

(16 bacterial and 16 fungal) to occur 10 out of 12 months M-F between 0500-1600.

100% Compliance

Zero Deviation from standard tests are performed on the required days without deviation from standard.

100% inspection as this is a TJC requirement will be visually inspected prior to use with a pharmacy staff member present to ensure the plates appear clear, and free of any defects, growths, or condensation.

PRS#2 - PWS para (5.2)

Results will be turned into the COR within 14 working days. Total monthly testing is 32 samples, 16 bacterial and 16 fungal. Delays must be reported within

3 days

Results of the 32 samples will be provided to the COR within 14 working days. Any delays will be reported within 3 days.

100% Compliance

Zero Deviation from standard

Results are provided without deviation from standard.

100% inspection as this is a TJC requirement

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To

1.5.1 QCP

#1

One time, 30 days

Microsoft Office

Word

COR

1.5.1.2 potential issues #2

Continuous communication throughout contract, 3 days to report the issue

1 Verbal and in writing within 3 days Microsoft

Office Word

1.19 Conflict of

interest

Continuous, within 3 days of conflict of interest

1 Microsoft Office

Word

1.23.1 Anti-

terrorism training #3-7

Within 30 days of contract and new hires, renewal every 12 months

1 for each employee

PDF or Microsoft

1.23.3 IWATCH

training

#8-9

Within 30 days, and new hires

1 for each employee

Deliverable Frequency # of Copies Medium/Format Submit To

5.2 tasks (results of testing)

#10

Results of samples 32 tests for 10 designated months (16 bacterial and 16 fungal)

5.3.1 Submit

Service contract report

#11 continuous, entering in reports to www.sam.gov for work performed

1 for each time work is performed

Online at www.sam.gov reported onlinewww.sa m.gov

ATTACHMENT 1

ESTIMATED WORKLOAD DATA

ITEM NAME ESTIMATED QUANTITY

1 Labor 2 hours each visit

20 hours for the entire 10 months of testing

ATTACHMENT 2

HISTORICAL WORKLOAD DATA

Reserved

ITEM NAME ESTIMATED QUANTITY

ATTACHMENT 3

GOVERNMENT FURNISHED PROPERTY (GFP)

Reserved http://www.sam.gov/