Attachment A PWS RFQ 36C24821Q0523_USP 825_25 Feb 2021.pdf

VETERANS AFFAIRS CARIBBEAN HEALTHCARE SYSTEM

SAN JUAN, PUERTO RICO

PERFORMANCE WORK STATEMENT

USP 825 Personnel, Room and Environmental Monitoring Certifications for VA Caribbean Healthcare System Nuclear Medicine

Service Radiopharmaceutical Laboratory

1.0. Introduction. This is a non-personal services contract to provide “USP 825 Personnel, Room and Environmental Monitoring Certifications for VA Caribbean Healthcare System (VACHS) Nuclear Medicine Service Radiopharmaceutical Laboratory. The government shall not exercise any supervision or control over the contract service providers performing the services herein.

Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the government. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the required service at VACHS as defined in this Performance Work Statement (PWS), section three (3.0) except for those items specified as Government-furnished property and services. The contractor shall perform to the standards of this PWS.

1.1 Background. The VA Caribbean Healthcare System provides services to a population of 150,000 Veterans in Puerto Rico and the U.S. Virgin Islands. In FY 2008, the VA Caribbean Healthcare System registered 66,955 unique patients with 11,428 inpatients treated and provided 927,072 outpatient visits at all clinic areas in Puerto Rico and the U.S. Virgin Islands. The VACHS is located at 10 Casia St. San Juan, Puerto Rico.

1.2 Scope. The Government requires personnel certification testing of gloved fingertip and thumb testing, media fill testing, facility compounding area surface monitoring, and air viable and non-viable testing in accordance (IAW) with USP <825>, CETA, and FDA guidelines in support of the VA Caribbean Healthcare System Nuclear Medicine that prepare, compound and dispense Radiopharmaceuticals.

2.0 General Requirements. This section describes the general requirements for this effort. The following sub-sections provide details of various considerations on this effort.

2.1 Non-Personal Services. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer immediately.

2.1.2 Type of Contract. The Government will award a Requirements Type Firm-Fixed price contract. Services rendered will be invoiced based on task orders. Contractor shall include a detailed pricing schedule for the services to be rendered for base year and four (4) option years IAW USP-825 to include mobilization expenses and resampling mobilization expenses.

2.1.3 Period of Performance. The period of performance for this effort will be a base year of 12 months and four (4) option periods of twelve (12) months each.

2.1.4 Locations and Hours of Work. The Contractor shall perform services at Main Building, Nuclear Medicine Service Hot Lab. Additional locations or personnel may be added or removed depending on fluctuations in compounding production. during the core hours of operation from

7:30 AM 4:00 PM Monday through Friday. The exception are Federal holidays, Good Friday, and/or when the government facility is closed due to local or national emergencies, administrative closings, or similar government directed facility closings. The contractor shall always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the government facility is not closed for the above reasons. Prior to performance of services outside the locally established hours of operation, the Contractor shall request and obtain, in writing, approval from the Contracting Officer.

2.1.5 Recognized Government Holidays. The Contractor is not required to work on the legal public holidays listed below. Holidays occurring on weekends will be observed as directed by the published United States Office of Personnel Management (OPM) calendar.

New Year’s: Day 1 January Martin Luther King Jr. Birthday: 3rd Monday in January Washington’s Birthday: 3rd Monday in February Good Friday: Friday preceding Easter Sunday Memorial Day: Last Monday in May Independence Day: 4th of July Labor Day: 1st Monday in September Columbus Day: 2nd Monday in October Veterans Day: 11th of November Thanksgiving Day: 4th Thursday in November Christmas Day: 25 December

2.1.6 Medical Emergency Services. The Contractor shall make available competent personnel trained and capable of dealing with minor personnel injuries. The contractor or their employees shall immediately notify their supervisor of any accident requiring emergency medical treatment.

In case of emergency the Contractor shall contact their immediate supervisor for further assistance. Emergency medical treatment and services for Contractor personnel is the responsibility of the Contractor.

2.2 Business Relations. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors.

The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel. Within the bounds of acquisition policy, the VACHS intends to work to find solutions that will be beneficial to both the Government and its Contractors.

2.3 Contract Administration and Management

2.3.1 Post Award Conference/Performance Evaluation Meetings. Post Award Conference / Performance Evaluation Meetings. The Contractor shall attend the post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. Written minutes of such meetings will be recorded by the Contractor and signed by the Program/Project Manager and the contracting officer (CO), or COR and distributed within five (5) workdays after the meeting. The contractor may request a meeting with the CO or COR when the Contractor believes such a meeting is necessary.

2.3.1.1 Performance/Progress Meetings will be held as necessary. There may be occasions when subsequent meetings will be called by either party to reconfirm mutual understandings and/or address deficiencies in the Quality Control (QC) system or procedures which may require corrective action by the Contractor. The Contractor Representative shall meet with the COR and/or CO as required. A mutual effort will be made to resolve all problems identified. The Contractor Representative and the COR shall sign the written minutes of these meetings.

2.3.2 Contract Administration. Notwithstanding the contractor’s responsibility for total management during the performance of this contract, the administration of the contract requires maximum coordination between the government and the contractor.

2.3.2.1 Contracting Officer (CO). The CO is the only person authorized to direct changes in any of the requirements under this contract, and, notwithstanding any provisions contained elsewhere in this contract, said authority remains solely in the CO. In the event the contractor effects any such change at the direction of any person other than the CO, the change will be considered to have been made without authority and solely at the risk of the contractor. All contract administration will be coordinated by the CO. Communications pertaining to contractual administrative matters shall be addressed to the CO. No changes in or deviation from the terms and conditions shall be affected, without a written modification to the contract, executed by the CO authorizing such changes.

2.3.2.2 Contracting Officer's Representative (COR). In accordance with Veteran Affairs Acquisition Regulation (VAAR) Clause 852.270-1, Representatives of the Contracting Officers, the CO reserve the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority.

A copy of the designation shall be furnished to the contractor.

2.3.3 Personnel Qualification:

2.3.3.1 Contractor Personnel: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

2.3.3.2 Key Personnel: All work shall be completed by CETA Certified technicians in accordance with all applicable Federal, State, Local, and industry: standards, laws, policies, procedures, codes and any other applicable governing body for the proper performance of all equipment per manufactures specifications/calibrations. Personnel performing all certifications must have current CETA National Board of Testing (CNBT) accreditation and hold classification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities (RCCP- SCF). Proof of certification must be provided prior to the start of the contract. The contractor must provide written notification to the Contracting Officer & Contracting Officer Representative (COR) if RCCP-SCF certification lapses or is terminated.

2.3.3.3 Contractor employees performing services under this order will be controlled, directed, and always supervised by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3.4 Contractor Identification. Contractor personnel shall wear a laminated contractor identification badge at all times when performing services under this Contract. The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. They must also ensure that all documents or reports produced by Contractor personnel are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

2.3.5 Standards of Conduct. Contractor personnel shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The hospital director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel. The Contractor shall ensure that personnel present a professional appearance. The Contractors employees shall observe and comply with all local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substances.

The Contractor is responsible for ensuring that any contractor employees providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner. The contractor shall remove, from the job site, any employee for reasons of misconduct or security. The contractor shall ensure employee conduct complies with 41 U.S.C.

423, Procurement Integrity. The contractor shall also ensure that no contractor employees conduct political related activities or events on the VACHS facilities.

2.3.5.1 The Contractor shall prohibit his employees form disturbing/removing papers, opening desk drawers or cabinets, or using telephones or office equipment provided for official Medical Center use.

2.3.5.2 Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

2.3.5.3 Working Attire and Appearance: Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities.

2.3.6 Contractor personnel and property shall be subject to search and seizure upon entering and leaving the confines of VACHS. The Contractor shall be responsible for assuring that all personnel authorized to perform work under this contract obtain facilities’ access as required.

The Contractor shall provide a current personnel roster listing all employees and the last four numbers of social security number for each to the COR. Contractor access to the VA facilities will be exclusively for work in connection with this contract.

2.3.7 Contractor is responsible for the supervision of all their employees while on government property. It is the Contractor's responsibility to assure compliance with this PWS and requirements referenced in this contract. Provisions provided in the PWS are not intended to relieve the Contractor of this responsibility.

2.4 Health and Safety. The contractor and its subcontractors shall comply with Public Law 91- 596, Occupational Safety and Health Act (OSHA). In addition, the contractor shall comply with all other applicable federal, state and local requirements for protecting the safety of the contractor's employees, building occupants and the environment. All applicable standards of the Occupational Safety and Health Act (OSHA) shall be followed when working in accordance with this project.

2.4.1 Occupants Safety. No process or materials shall be employed in such a manner that they will introduce additional hazards into occupied space.

2.4.2 The Contractor shall adhere to all applicable Environmental Protection Agency (EPA), National Fire Protection Association (NFPA) Life Safety Codes, and all other regulatory requirements.

2.4.3 In performance of this contract, the Contractor shall follow Veterans Affairs Central Office (VACO) Directive 7710, Occupational Safety and Health, for safe work practices and take such safety precautions as the Safety Officer or designee may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall comply with VACHS smoking policy, which designates all space as non-smoking areas.

2.4.5 The Contractor is responsible to identify, provide and maintain all personal protective equipment (PPE) required to perform the duties outlined in the contract. In addition, the contractor is responsible for identifying and providing all applicable safety programs required to perform the work. Training on required safety programs and the proper use of PPE's shall be provided, and documentation maintained by the contractor.

2.4.6 If the Government notifies the Contractor of any non-compliance, the contractor shall, after receipt of such notice, immediately correct the condition and notify the CO in writing that the condition has been corrected. If, in the opinion of the Safety Officer or designee the condition is life threatening he/she shall instruct the contractor to stop work until the condition has been corrected. If the Contractor fails or refuses to comply promptly, the CO may issue and order halting of all or any part of the work, and Contractor may be held in default. The Contractor bears all costs of stop work time and correcting safety hazards.

2.5 Injury or Accident Reporting. The Contractor shall maintain an accurate record of accidents resulting in injury or death and accidents resulting in damage to government property, supplies, and equipment.

2.5.1 As defined by OSHA, EPA, NFPA Life Safety Codes, and all other regulatory requirements any incident of a major malfunction, accident or injury, a written report shall be submitted by the Contractor to VACHS within five (5) working days following the incident. The report shall state the cause, what, where and when and why the incident happened and the repairs and tests that were or are to be made to correct the cause of the incident.

2.6 Environmental Requirements.

2.6.1 Executive Order (EO) 13834, Efficient Federal Operations applies to this service. A copy of this EO can be found at https://www.federalregister.gov/documents/2018/05/22/2018- 11101/efficient-federal-operations

2.6.2 Environmental Compliance. The Contractor shall comply with all federal, state, local and facilities environmental laws, rules and plans. The Contractor shall use and store all materials, chemicals, and equipment used in the performance of this contract with these applicable laws.

2.7 Physical Security. The Contractor shall protect existing buildings, facilities, utilities, and equipment during working period and will be responsible for any damages resulting from operation and/or execution of this contract. The Contractor shall conduct his operations to cause the least possible interference with normal operations of the government because the facilities will remain in operation during the entire maintenance period.

2.8 Liability and Responsibility for Damaged Property.

2.8.1 Damage to Government Property. The contractor shall be held responsible for cleaning up all spillage and/or leakage at no additional cost to the government. The contractor shall be held liable for damage or destruction of Government property (e.g. buildings, vehicles, sidewalks, fences, etc.) caused by the contractor, contractor personnel or representatives of the contractor in the performance of services on this contract. The contractor shall submit their damage report to the COR within 24 hours of damage and shall include the repairs and corrective action plan, as applicable. If the contractor fails to take the required corrective action, the government retains the right to exercise other rights or remedies available to the CO.

2.8.2 Damage to Privately-Owned Property. The Contractor shall be held liable for damage or destruction of privately owned property (e.g. privately owned vehicles), as defined in this PWS, caused by the contractor, contractor personnel or representatives of the contractor in the performance of services in this contract. The contractor shall take corrective action within 5 working days to repair damages or replace destroyed property. Contractor shall purchase and maintain at all times a general third-party liability insurance policy of not less than $500,000 per event coverage (See FAR Clause 52.228-5).

2.8.3 Damage Reports. The contractor shall submit a damage reports to the CO and designated representative within 24 hours of damage or destruction to government property or privately owned property caused by the contractor, contractor personnel or representatives of the contractor. The damage report shall detail the facts and the extent of damages or destruction and the corrective action taken by the contractor to repair damages or replace destroyed property.

2.9 Fraud, waste, and abuse. The Contractor shall be responsible for maintaining proper conduct and good discipline. Contractor personnel shall be encouraged to be alert to and report suspected situations of fraud, waste, and abuse, or other intentionally dishonest conduct against the government observed during or in the performance of this contract. The contractor lines of communication are with the COR and the CO.

2.10 COVID-19. All contractors’ employees and its representative, to include subcontractors, are required to wear surgical masks face covering during their time at the VHA facility.

2.10.1 Vendors that are located outside of Puerto Rico must comply with the entry requirements established by the Government of Puerto Rico and by VACHS to access the hospital premises.

Requirements may vary; therefore, the contractor shall comply with the stringent one.

3.0 Performance Requirements. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1: The vendor shall refer to the most current versions of standards including but not limited to USP, FDA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure should be determined by the most updated version of CETA, USP <825> and per specific facility requirements and/or requests. The vendor shall be responsible for complying with the most updated versions of this guidance and will conduct all sampling per the procedures outlined within the official chapters.

3.1.1. Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling and media-fill test. The vendor shall use the facility’s standard operating procedure as guidance for their evaluation.

3.1.2. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for the expected number of employees from the facility. This should be done in conjunction with media-fill testing. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results will be reported to the Chief, Nuclear Medicine Service and corresponding Nuclear Medicine Service point of contact (contracting officer representative {COR}, etc.) as soon as the initial result is known. Final results will be expeditiously reported after further antimicrobial testing is complete.

3.1.3. Media-Fill Testing: The Vendor shall perform media-fill testing for the expected number of employees from the facility. This should be done in conjunction with gloved fingertip and thumb sampling. The results should include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer. Failure of the test in indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, the preliminary results will be reported to the COR as soon as the initial result is known, and final results will be reported within five (5) calendar days after further antimicrobial testing is complete.

3.1.4 Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Certification must include the following:

3.1.4.1 Airflow testing: The air changes per hour (ACPH) & Static Pressure from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

3.1.4.2 HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again, after installation and as part of recertification.

3.1.4.3 Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC and compounding areas at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas including the buffer room(s) and anteroom(s), should be taken at representative locations that reflect the quality of air in the room(s).

3.1.4.4. Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in DVD format to comply with VHA guidance for media. No .zip files, USB storage, flash drives, or downloadable files from vendor web sites.

3.1.4.5. Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 μm and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements.

3.1.4.6. Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces. USP chapter <825> requires a minimum pressure differential of 0.020” w.c. relative to adjacent spaces.

3.1.5 Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air should be sampled at each designated location. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each plate as CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the COR as soon as the initial result is known, and final results will be reported within five (5) calendar days after further antimicrobial testing is complete.

3.1.6. Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least monthly. Sampling should be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each device as CFU per sample based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the COR as soon as the initial result is known, and final results will be reported within five (5) calendar days after further antimicrobial testing is complete.

3.1.7. The COR will schedule testing with the vendor. The vendor shall provide the corresponding Nuclear Medicine Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the COR for signature and verification of work performed.

3.1.8. All equipment shall be maintained in proper operating condition as specified by the Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer’s manual and quality control manual, and with all terms, conditions, provisions, schedules and specifications provided herein.

3.2. In the event that the facility or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request. If vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

3.3. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

4.0 Performance Requirements Summary (PRS) Matrix

The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. The government expects the contractor to perform at a minimum, the identified acceptable levels throughout the life of the contract, and the contractor’s performance shall be given significant consideration when evaluating recommendations for future government contracts and or awards.

Method of Surveillance: The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).

P R S

Performance Objective Performance Standard

Acceptable Quality Level

Surveillance Method

Remedies

1 Fingertip testing, media fill testing, viable air and surface sampling, hazardous drug environmental wipe sampling, non-viable testing, and hood/room certification testing completed

All testing is completed prior to due date

99% acceptable level

Random inspection conducted by the COR

Re-perform tasks within 3 working days at no additional costs to the Government

2 Reports Receive field action report

Receiving documents are

Random inspection

Re-perform tasks within 3 working accurate 98% of the time.

conducted by

COR

days at no additional costs to the Government

3 7.2 Certifying Personnel Submission of proof of current CNBT certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities

(RCCP-SCF).

100% compliance

Random inspection conducted by the COR

Re-perform tasks within 3 working days at no additional costs to the Government

4.1 Quality Assurance. The Government will evaluate the Contractor’s performance under the contract, IAW the PRS Matrix. The Government retains the right to inspect and test all services called for by the contract. The Government will perform inspections and tests in a manner that will not unduly delay the work. If any of the services performed do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount.

4.2 Whenever the COR notifies the contractor of any deficiencies detected in the work performed, the contractor shall correct cited deficiencies within three (3) working days, or as otherwise authorized by the COR, after the notification in writing by the COR without affecting the regularly scheduled work.

4.3 Upon satisfactory completion by the Contractor and acceptance by the COR of the work completed by the contractor in accordance with this Performance Work Statement, payment will be approved. Failure to complete the work stated in this PWS may result in unfavorable Contractor Performance Assessment Reporting System (CPARS) ratings and/or deduction to be determined by the Contracting Officer.

4.4 Quality Control. The contractor shall maintain an effective Quality Control Program to ensure services are performed IAW this PWS. The purpose of this program is to identify, prevent, and ensure non-recurrence of defective services.

5.0 Deliverables

Deliverable Frequency # of

Copies Medium/Format Distribution

Certificate of Liability

Within 10 days after contract award

1 PDF CO

Meeting Minutes As needed 1 Word CO/COR

Key Personnel Within 10 days after contract award

1 PDF CO/COR

CETA National Board of Testing Documentation

Within 10 days after contract award

1 PDF CO/COR

5.1. Reports shall include all components specified in 3.0 through 3.3. The structure of the report should follow specifications outlined in the CETA application guides.

5.2. Report of all testing results shall be sent via e-mail with a hard copy sent by mail to the

COR.

6.0 Related Documents

6.1 Definitions

CONTRACTING OFFICER (CO): A Contracting Officer is a government employee who has authority to enter into, administer, and or terminate contracts, as well as 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) - A representative from the requiring activity appointed by the Contracting Officer to perform surveillance and to act as liaison to the contractor

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.

DEFECTIVE SERVICE: A service output that does not meet the standard of performance associated with it in the Performance Work Statement

DELIVERABLE: A tangible or intangible object produced as a result of the project that is intended to be delivered to a customer (either internal or external). Examples of a deliverable are a report, a document, a server upgrade or any other building block of an overall project.

FISCAL YEAR: A period beginning in October 1 and ending September 30 of the consecutive calendar year. The fiscal year is designated by the calendar year in which it ends.

GOVERNMENT FURNISHED PROPERTY (GFP): All equipment, goods and land possessed by the government and subsequently delivered or otherwise made available to the Contractor.

INSPECTION. Examining and testing supplies or services (including, when appropriate, raw materials, components, and intermediates assemblies) to determine whether they conform to contract requirements

Injury or Accident Reporting

Within 5 days after event 1 PDF CO/COR

Safety Data Sheets In a timely manner 1 PDF COR Damage Reports Within 24 hours of event 1 PDF CO/COR Reports Listed in Section 3.0

Varies 1 PDF COR

MATERIAL. Property that may be consumed or expended during the performance of a contract, component parts of a higher assembly, or items that lose their individual identity through incorporation into an end-item. Material does not include equipment, special tooling, and special test equipment or real property.

MINOR DISCREPANCIES. Problems identified during maintenance checks that do not require significant time or significant materials to correct, such as loose wires or belts, hoses, clamps, coolant additives and other minor adjustments.

NATIONAL FIRE PROTECTION ASSOCIATION (NFPA): A non-profit organization that is concerned with the public safety and protection of the people and properties. The fire protection pamphlets published by the NFPA are accepted by the Federal Government and considered as directive in nature for this contract.

NON-PERSONAL SERVICES. The personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. Non personal service contracts are authorized by the government in accordance with FAR 37.012, under general contracting authority, and do not require specific statutory authorization.

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA): Government agency part of the US Department of Labor with the primary responsibility for administrating the Occupational Safety and Health act of 1970. This act has the purpose of preservation of human resource.

PETROLEUM PRODUCTS. Products and materials derived from fossil fuels.

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

PROPERTY. All tangible property, both real and personal.

QUALITY ASSURANCE (QA): A procedure or set of procedures taken by the Government to ensure that services acquired under government contracts conform to the contract’s quality and quality requirements.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): A plan specifying the surveillance methodology used by the COR for surveillance of the contractor’s performance.

QUALITY CONTROL (QC): Task performed by the contractor to ensure excellence of the organization’s output.

REPAIR. The correction of a malfunction or non-conformance that cannot be accomplished without significant time and/or material, as determined by the COR.

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

6.2 Acronyms

ACPH Air Changes per Hour CA Corrective Action CAP Corrective Action Plan CDR Contract Discrepancy Report CETA Controlled Environment Testing Association CNBT CETA National Board of Testing CFR Code of Federal Regulations CFU Colony-Forming Units COR Contracting Officer Representative CPARS Contractor Performance Assessment Reporting System FAR Federal Acquisition Regulation FDA United States Food and Drug Administration FFP Firm-Fixed Price FY Fiscal Year IAW In Accordance With ISO International Organization for Standardization CO Contracting Officer NCO Network Contracting Office NLT No Later Than ODR Observed Defect Rate OSH Occupational Safety and Health OSHA Occupational Safety and Health Act PEC Primary Engineering Control PM Project Manager POC Point of Contact PR Puerto Rico PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control RCCP-SCF Registered Cleanroom Certified Professional for Sterile Compounding Facilities TE Technical Exhibit TPOC Technical Point of Contact USP United States Pharmacopeia VA Veterans Affairs VACHS Veterans Affairs Caribbean Healthcare System VACO Veterans Affairs Central Office

6.3 Applicable Directives and Publications

The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

USP United States Pharmacopeia http://www.usp.org/

CETA Controlled Environment Testing Association https://www.cetainternational.org/

FDA U.S. Food and Drug Administration https://www.fda.gov/

29 CFR, Part 1910 Occupational Safety and Health Standards

40 CFR Part 302 Protection of Environment, Designation, Reportable

Quantities and Notification

EO 13834 Efficient Federal Operations

Federal Standard #313 Safety Data and Disposal Data for Hazardous Materials

Furnished to Government Activities

FIPS PUB 201-2 Personal Identity Verification (PIV) of Federal Employees and Contractors

HSPD 12 Homeland Security Presidential Directive 12 Policy for a

Common Identification Standard for Federal Employees and Contractor

OMB M-05-24 Office of Management and Budget (OMB) Guidance

Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors

USP <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging

VACO Directive 7710 Occupational Safety and Health