ATTACHMENT 1 - PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

Performance Work Statement (PWS)

TB Isolation Inspection & Certification Services

A. GENERAL GUIDANCE

Title of Project: TB isolation, biological safety cabinet certification, and maintenance.

Location: 13000 Bruce B. Downs Blvd., Tampa, Florida 33612.

Scope of Work: The contractor shall provide inspection and certification services for biological safety cabinets TB isolation, general isolation room, separative enclosures and glove box.

Background: Currently, the Contractor performs semi-annual certification of all biological safety cabinets and negative pressure isolation rooms. Periodic decontamination and maintenance/repair of biological safety cabinets is also performed.

Hours of work: Work required in the performance of the contract shall be performed during the working hours (8:00 a.m. – 4:30 p.m.) Monday through Friday excluding holidays.

B. CONTRACT AWARD MEETING

The contractor shall commence work only when the Contracting Officer (CO) has conducted a “kick-off” meeting or has elected to waive the meeting. This meeting is very beneficial to the success of the project. Various aspects of work details can be discussed so there is a consistent understanding among all parties. Roles and responsibilities of the Contracting Officer’s Representative (COR) are issued by the CO at the meeting. The nature of some small projects may not require a “kick-off” meeting with the CO. This will be determined on a case-by-case basis by the CO.

C. GENERAL REQUIREMENTS

Inspection & testing of all HEPA exhaust units designated for tuberculosis (TB) control shall be conducted semi-annually (static pressure and HEPA filter leak test). Each HEPA exhaust unit, Laminar Flow hood, or Biological Safety Cabinet (BSC) shall be certified 6 months following previous certification.

Inspections & testing shall be scheduled with the Contracting Officer's Representative (COR) a minimum of three (3) working days in advance. There is a potential difficulty in accessing some HEPA units due to the nature of patient care activities, therefore close coordination with the COR is necessary. The contractor will be responsible for ensuring all certifications are completed within the required time frame (semi-annually) for all hoods and HEPA units.

Inspections shall consist of a complete check of equipment, making all necessary adjustments, alignments, cleaning, lubrication, performance testing and calibration to ensure equipment meets or exceeds manufacturers’ original specifications available in manuals on site.

4. Any work requiring decontamination of Equipment/Components shall be performed with Hydrogen Peroxide Vapor decontamination.

Calibration/Certification Procedures:

1) Certifiers Instrument Calibration: Certificates of Calibration substantiating NIST (National Institute of Standards & Technology) traceability annual compliance with requirements, and minimum sensitivities of instruments used in conducting testing in accordance with national Sanitation Standard No. 49 for Class I and Class II Biological Safety Cabinets (BSC); and ISO Standard 146447 for Laminar Flow Clean Workstations.

2) Photometers and Particle Counters to have a minimum sample flow rate of 1.0 CFM.

3) Scan rate for filter leak testing shall be no more than 3 inches per second against filter surface.

4) Field calibration of Photometer used for filter leak testing shall be made by inserting an aerosol challenge upstream of the filter and sampling between the blower and filter to verify an upstream challenge concentration of at least 10 micrograms of DOP or similar challenge medium of air volume handled by the filter.

5) Particle Counter shall be challenged with a particle count greater than 100,000 particles at 0.3 microns prior to use.

6) Inspections and testing for BSC’s in Microbiology acid fast bacteria (AFB) Room shall require the use of a HEPA Respirator. Inspections and testing of any items, TB isolation rooms, shall require the use of a HEPA Respirator while the rooms are occupied by known or rule-out TB patients, in accordance with CDC guidelines.

7) Service to include all necessary performance testing and minor repairs to ensure equipment meets or exceeds manufacturer’s original specifications.

8) The cost of this certification agreement will include all necessary equipment, labor, and travel. All work to be warranted for a period of one year for parts and labor furnished by the contractor. The contractor shall provide emergency repair on an as needed basis, with charges originating only when required.

Routine and Emergency Services beyond preventative maintenance Procedures:

The contractor shall furnish equipment, parts, material, labor and supplies necessary to repair equipment listed in the PWS. The contractor shall return equipment to full operational condition in accordance with manufacture specifications. The contractor shall provide a written estimate with a breakout cost of labor, travel, material and parts prior to performance of repairs. The written estimate shall be provided to the Contracting Officer Representative (COR) for Contracting Officer final approval and funding.

EQUIPMENT LISTING AND LOCATIONS:

a. Location: 13000 Bruce B Downs. Building # 1, Tampa Florida 33612

· 1D-185 CYTOLOGY EE 70883 Class II type A2 NuAire Biolog Safety Cabinet

· 1D-188 HISTOLOGY EE 72479 MOPEC GROSSING HOOD (FLOW)

· 1D-188 HISTOLOGY EE 72478 MOPEC GROSSING HOOD (FLOW)

· 1D-188 HISTOLOGY EE 72477 MOPEC GROSSING HOOD (FLOW)

· 1D-188 HISTOLOGY EE 72481 MOPEC GROSSING HOOD (FLOW)

· 1D-195h ROOM 2 EE 70826 Class II type A2 BSC NuAire

· 1D-196f Micro EE 113589 Class II type A2 BSC Thermo Scientific (model 1325)

· 1D-196f Micro EE 124292 Class II type A2 BSC Thermo Scientific (model 1325)

· 1D-195h ROOM 2 EE 70827 Class II type A2 NuAire BSC

· 1D-195h ROOM 2 EE 70825 Class II type A2 NuAire BSC

· 1D-195i LAB CONCO Laminar Flow Enclosure

· 1D-196 MICRO EE 70580 Class II type A2 NuAire BSC

· 1D-196 MICRO EE 62114 Labconco Purifier Class II BSC

· 1D-196h AFB EE 70882 Class II type A2 NuAire BSC

· 1D-196h AFB EE 70884 Class II type A2 NuAire BSC

· 1D-162 LCMS EE 133611 Endeavor Ductless Fume Hood (model ACPT 4000S)

· A108D IV PREP EE 47620 Germ Free Laminar Flow Hood

· A108D IV PREP EE 47619 Germ Free Laminar Flow Hood

· A108D IV PREP EE 53808 Germ Free Laminar Flow Hood

· A108D IV PREP EE 13370 Baker Laminar Flow Hood

· A108D CHEMO PREP FOR PHARM EE 34328, Germ Free Class II Chemo

· 1D-110 CHEMO PREP FOR PHARM EE 34328, Germ free Class II Chemo Prep

· B-315 NUCLEAR MEDICINE EE 7482, Germ Free Class II

· 1-128 RESEARCH ELECTRON MICROSC P&LMS EE 7483 Germ Free Class II

· HEPA EXHAUST UNIT, ROOM 738, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 739, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 740, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 741, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 743, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 744, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 745, 7 NORHT

· HEPA EXHAUST UNIT, ROOM 746, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 748, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 749, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 750, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 754, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 763, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 765, 7 NORTH

· HEPA EXHAUST UNIT, ROOM 704, 7 WEST

· HEPA EXHAUST UNIT, ROOM 705, 7 WEST

· HEPA EXHAUST UNIT, ROOM 707, 7 WEST

· HEPA EXHAUST UNIT, ROOM 708, 7 WEST

· HEPA EXHAUST UNIT, ROOM 711, 7 WEST

· HEPA EXHAUST UNIT, ROOM 712, 7 WEST

· HEPA EXHAUST UNIT, ROOM 713, 7 WEST

· HEPA EXHAUST UNIT, ROOM 714, 7 WEST

· HEPA EXHAUST UNIT, ROOM 716, 7 WEST

· HEPA EXHAUST UNIT, ROOM 718, 7 WEST

· HEPA EXHAUST UNIT, ROOM 721, 7 WEST

· HEPA EXHAUST UNIT, 6B-616d CCU, 6 WEST

· HEPA EXHAUST UNIT, 6B-616e CCU, 6 WEST

· HEPA EXHAUST UNIT, ROOM 6A-618, 6 SOUTH

· HEPA EXHAUST UNIT, ROOM 6A-625, 6 SOUTH

· HEPA EXHAUST UNIT, ROOM 5A-517, 5 SOUTH

· HEPA EXHAUST UNIT, ROOM 5A-518, 5 SOUTH

· HEPA EXHAUST UNIT, ROOM 3A-350, (BRONCH ROOM) 3 NORTH

· HEPA EXHAUST UNIT, ROOM 3A-353 (BRONCH ROOM) 3 NORTH

· HEPA EXHAUST UNIT, ROOM 3A-354 (BRONCH ROOM) 3 NORTH

· HEPA EXHAUST UNIT, ROOM 4B-417g (MICU)

· HEPA EXHAUST UNIT, ROOM 4B-417h (MICU)

· HEPA EXHAUST UNIT, ROOM 4B-417i (MICU)

· HEPA EXHAUST UNIT, ROOM 4B-417j (MICU)

· HEPA EXHAUST UNIT, ROOM C-184 (INTERVENTIONAL RADIOLOGY)

· HEPA EXHAUST UNIT, ROOM C-174a (INTERVENTIONAL RADIOLOGY)

· HEPA EXHAUST UNIT, ROOM 2D-252u (SICU)

· HEPA EXHAUST UNIT, ROOM 2D-252v (SICU)

· HEPA EXHAUST UNIT, ROOM 2D-252k (SICU)

· HEPA EXHAUST UNIT, ROOM 2D-252l (SICU)

· HEPA EXHAUST UNIT, 1A-104

· HEPA EXHAUST UNIT, 1A-132 (ER #3)

· HEPA EXHAUST UNIT, 1E-129, NEW ED

· HEPA EXHAUST UNIT, 1E-131, NEW ED

· HEPA EXHAUST UNIT, 1E-141, NEW ED

· HEPA EXHAUST UNIT, 1E-142, NEW ED

b. Location: 13000 Bruce B Downs. Building # 38, Tampa Florida 33612

· HEPA EXHAUST UNIT, B-022, SCI

· HEPA EXHAUST UNIT, D-015, SCI

· HEPA EXHAUST UNIT, D-053, SCI

· HEPA EXHAUST UNIT, E-015, SCI

· HEPA EXHAUST UNIT, E-053, SCI

· HEPA EXHAUST UNIT, F-011, SCI

· HEPA EXHAUST UNIT, F-012, SCI

· HEPA EXHAUST UNIT, F-013, SCI

· HEPA EXHAUST UNIT, F-014, SCI

· HEPA EXHAUST UNIT, F-015, SCI

· 11.HEPA EXHAUST UNIT, F-016, SCI

c. Location: 13000 Bruce B Downs. Building # 38, Tampa Florida 33612

· HEPA EXHAUST UNITS, Room B-205, Polytrauma

· HEPA EXHAUST UNITS, Room C215, Polytrauma

· HEPA EXHAUST UNITS, Room C218, Polytrauma

· HEPA EXHAUST UNITS, Room C316, Polytrauma

· HEPA EXHAUST UNITS, Room C319, Polytrauma

d. Location: 13000 Bruce B Downs. Building # 100, Tampa Florida 33612

· HEPA EXHAUST UNIT, ROOM 2A-241, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2A-241, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2A-243, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2A-243, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-229, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-229, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-231, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-231, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-247, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-247, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-249, 2A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 2B-249, 2B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-325, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-325, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-327, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-327, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-331, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-331, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-341, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-341, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-343, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-343, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-325, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-325, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-329, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-329, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-331, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-331, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-347, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-347, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-349, 3A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3B-349, 3B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-425, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-425, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-427, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 3A-427, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-431, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-431, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-441, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-441, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-443, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4A-443, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-425, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-425, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-429, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-429, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-431, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-431, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-447, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-447, 4B, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-449, 4A, NEW BED TOWER

· HEPA EXHAUST UNIT, ROOM 4B-449, 4B, NEW BED TOWER

e. Location: New Port Richey VA Clinic 7900 Little Road New Port Richey FL 34654.

· Room 1PA-015 Class II type A2 BSC Thermo Scientific (model 1375) NPR VA CLINIC

f. Location: South Hillsborough VA Clinic 12920 Summerfield Crossing Blvd. Riverview, FL 33579

· HEPA EXHAUST UNIT, Room 240, South Hillsborough VA Clinic

· HEPA EXHAUST UNIT, Room 239, South Hillsborough VA Clinic

D. REPORTING REQUIREMENTS

Service personnel shall sign in and out at Hospital Police Dispatch (Bldg. 1 Room1A-147). Failure to adhere to the reporting procedures may be cause for delay of payment for services performed.

When service is completed, the servicemen must indicate on his service report the specific action taken and all parts replaced. The equipment serviced must be identified clearly by name, serial number, location, and PMI number.

At the conclusion of each certification inspection a report shall be submitted to the Engineering Service indicating the elements of the inspection performed, findings, and recommendation (if applicable). This report may be submitted in the form of a checklist or regular service slip, provided all requested information is supplied.

Additionally, an inspection certification sticker shall be placed on each piece of equipment receiving certification inspection. The sticker will have the technician’s signature that performed the certification inspection and date of service, the date of the certification inspection, the next due date and the name of the company performing the certification.

Upon completion of service, the COR located in Safety Office Building 1 Room GD-017 813 972 2000 ext. 5789 will sign the service report. When work is performed off site, e-mail notification of completion shall be sufficient.

E. GOVERNMENT RESPONSIBILITIES

The government will make the equipment available in accordance with the established schedule for the work.

FEDERAL LEGAL HOLIDAYS:

The following Federal legal holidays are observed by this facility:

Juneteenth Day Independence Day 19th June 4 July

Note: Any of the above holidays falling on Saturday will be observed on the preceding Friday; holidays falling on Sunday will be observed on the following Monday. Contractor’s days to perform are reflected in the Performance Work Statement.

F. CHANGES TO THE PERFORMANCE WORK STATEMENT (PWS)

Any changes to this PWS shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

G. PERFORMANCE QUALITY SATANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards.

The Performance Requirements are listed below. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

PERFORMANCE MEASUREMENTS:

(Para C.2)

(Para C.1)

periodic inspection Failure affects performance evaluations and increases potential patient care conflict.

(Para D.4)

validated customer complaints, periodic inspection Failure affects performance evaluations and increases potential regulatory violations.

Payment only for properly performed services

(Para s)

Payment only for properly performed services

H.

CONTRACTOR EXPERIENCE REQUIREMENTS

Qualifications of Key Personnel Certification under the NSF Biohazard Cabinet Field Certifier Accreditation Program for the International Air Filtration Certifiers Association (IAFCA).

Staff shall be certified in USP 797 and USP 800

Respirator trained and fit-tested for protection against TB in accordance with

29 CFR 1910.134.

I. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this contract are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the contract.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO in response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

J. INFORMATION SECURITY

The C&A requirements do not apply, and a Security Accreditation Package is not required.

POTENTIAL REQUIREMENT GROWTH:

The Government may require additional effort to successfully accomplish the Government’s scope of this requirement. The Government reserves the right to include services at additional locations within the VISN as required and funding becomes available. Additional locations include VA Medical Facilities in Bay Pines, Gainesville, Miami, Tampa, West Palm Beach, and San Juan. In accordance with Federal Acquisition Regulation 52.212-4, any changes in the terms and conditions of this contract may be made only by written agreement of the Contractor and Government. The price for services at additional locations are to be determined upon agreement between the Contractor and the Government via bi-lateral modification at the Government’s request.

With No Sensitive Data but Requires Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

c. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

d. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal violations associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. The contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide the contracting officer and/or the COR with a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required for this PWS.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions, so they follow James A. Haley Veterans’ Hospital policies listed on the JAHMC Document Management Center share point site:

HPM NO. 90-25; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; SECURITY MANAGEMENT PROGRAM

HPM NO. 132‑05; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR is required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR is not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued daily and must include the following information: Company name, project number, date and name of individual. The contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to the police dispatch. The contractor will provide the Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.

Records Management Language for Contracts When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. The National Archives and Records Administration (NARA) has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. Most contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

includes [Agency] records.

does not include personal materials.

applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

may include deliverables and documentation associated with deliverables.

C. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

James A. Haley Veterans’ Hospital and Clinics and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of James A. Haley Veterans’ Hospital and Clinics or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to James A. Haley Veterans’ Hospital and Clinics. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment are properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment are no longer required, it shall be returned to James A. Haley Veterans’ Hospital and Clinics control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and James A. Haley Veterans’ Hospital and Clinics guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with James A. Haley Veterans’ Hospital and Clinics policy.

The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ Hospital and Clinics information that are not specifically tied to or authorized by the contract.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

James A. Haley Veterans’ Hospital and Clinics owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which James A. Haley Veterans’ Hospital and Clinics shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take James A. Haley Veterans’ Hospital and Clinics-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party services and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow VA directive requirements.

c. Prior to termination or completion of this contract, the contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer to all requests for demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for a response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer to such court orders or other requests to the VA contracting officer for response.

For service that involves storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of…