Amendment 0002 to RFP 36C26222R0074 - amended Section B.3 Statement of Work.docx

B.3 STATEMENT OF WORK

1. Background:

0. The VA San Diego is required to implement a multi-disciplinary team approach to ensure testing, routine preventative maintenance, and reporting requirements are performed for the Sterile Processing Services (SPS) critical and utility water systems per Veterans Health Administration (VHA) Directive 1116(2). Appropriate water testing must occur per schedule, with flushing as necessary regardless of whether SPS is operating at full capacity.

0. Water quality requirements within Sterile Processing Services (SPS) are defined in the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR)34: 2014/(r)2017, Water for the Reprocessing of Medical Devices which is referenced in AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. These documents define both the parameters to be monitored and outline the frequency of quality testing and limits for the noted contaminants in utility water and critical water. Water quality parameters include hardness, conductivity, pH, chlorides, bacteria and endotoxins, total organic carbon, color or turbidity, temperature, and filters.

0. In the SPS design guide, VHA states that “the quality of the water used in SPS equipment vastly affects the end result of reusable medical equipment (RME) reprocessing.” While tap water may be used in some phases of reprocessing, water that has been “extensively treated” (i.e., critical water) should be used in the final rinse of instruments to remove inorganic components as well as microorganisms.

0. Basis of Need for Professional Support Services: Water quality is important in all stages of RME reprocessing. The primary objective of RME reprocessing is to ensure that a device is safe for patient use and does not cause an adverse event as detailed in the AAMI technical reports and guides. Because of this risk and reprocessing requirements on water quality, the water used is required to be regularly monitored to ensure the control measures are working properly. Ensuring the adequacy of water quality requires a team approach between RME processing personnel and personnel that maintain the water treatment system. The two AAMI technical report/guidelines referenced above provide guidelines on the quality of water (e.g., utility vs. critical) needed at each category of medical device. Specifically, the guides include:

1. Importance of water quality and effective water treatment

1. Categories of water quality for medical device reprocessing

1. Selection of water quality

1. Water treatment systems

1. Monitoring of water quality

1. Strategies for microorganism control

1. Personnel considerations

1. Continuous quality improvement

1. Troubleshooting water quality issues

1. Scope of Work:

The contractor shall provide sampling and analysis of those water quality parameters requiring monthly, quarterly, and/or annual testing. Those parameters with daily frequencies will be collected by VA Engineering Staff. Additionally, the contractor shall conduct a review and evaluation of water parameter criteria records of daily sampling events and of the Critical Water standard operating procedures for the SPS. The Contractor shall provide updates/ recommendations upon request.

1. Specific Tasks:

The contractor shall provide professional water testing services for the sampling, analysis, and reporting of results of critical water within the SPS at the VA San Diego. At least three monthly bacterial test locations are required; one post critical water production at the Engineering plant, one post critical water in room B171-B (SPS Sterilizer closet) and one post facility filtration system of utility water. Test locations shall be: B149 (Men’s locker room), B251 (Mechanical Room), B171 (SPS Sterilizer closet). The Scope of Work encompasses sampling water using for the following parameters (Table 1) and frequency (Table 2):

2. Table 1. Categories and Recommended Levels of Water Quality for Medical Device Reprocessing.

<1 mg/mL <1 mg/mL

2. Table 2. Abbreviated AAMI TIR34 water quality testing frequency for Critical Water compliance.

1. Deliverables:

The Contractor shall provide an electronic format report and a paper copy of the Critical Water Systems Testing and Reporting for Sterile Processing Services. Results shall define the scope of the work performed and shall include details of actions and methods used to perform work and recommendations. During data collection, the Contractor shall report discrepancies in existing system to include Gap analysis results to determine need and policies to implement and maintain compliance with VHA Directive 1116(2). The Contractor shall notify the COR on a monthly basis regarding any deficiencies.

1. Performance Monitoring:

The VASDHS COR or designee shall monitor Contractor performance using the following criteria including:

4. Knowledge of Sterile Processing Services procedures, and VHA Directive 1116(2) requirements.

4. Ability to perform work and provide reports at the specified dates.

4. Proven exemplary work history in medical facility systems.

4. Contractor certification to perform work in Sterile Processing Services.

4. Familiarity with VA procedures and specifically, the VASDHS facility.

4. Employee qualifications and experience in performing required work.

4. Past similar work on-site or within other VA facilities or Federal entities of comparable size.

1. Safety Precautions:

5. The Contractor shall comply with all applicable Federal, State, and local requirements regarding workers’ health and safety. The requirements include those found in the VHA Directive 11161(2), Centers for Disease Control and Prevention (CDC), Federal and State Occupational Safety and Health Act (OSHA) statutes and regulations, such as applicable provisions of Title 29, Code of Federal Regulations (CFR), Parts 1910 and 1926, CFR 1910.132(d)(1)(iii), 29CFR1910.137.

5. In the performance of this contract, the Contractor shall take such safety precautions as necessary while operating in construction area. Contractor shall provide all necessary tools, equipment, labels, and Personal Protective Equipment (PPE) to perform the work safely, effectively, and timely.

1. Other Contract Requirements:

6. Contractor employees shall notify the COR or designee before entering a designated permit required confined space so that appropriate precautions may be taken. In addition, there are special precautions to be taken when working on 2S Mental Health unit or other locations of this facility. If required, the Contractor shall keep tools and materials under their control at all times. The facility will be functional during contractor operation. The Contractor shall therefore schedule the work accordingly and coordinate operation with the facility construction safety manager and project’s COR. Several inspections will be conducted in locations that may require additional personal protective equipment. The Contractors shall notify the VA representative at any time the contractor is on VA grounds.

6. VASDHS La Jolla facility is a Federal property. The Contractor shall coordinate with the facility Engineering Service if warranted for access in restricted spaces or any required support in the performance of this work. The designated COR or designee shall coordinate the request.

6. If work will be conducted in areas identified as containing asbestos materials, the Contractor shall comply with the public laws and statutes including all changes and amendments of Federal, State, and local environmental statutes and regulations governing Asbestos containing materials-ACM, to include:

1. 29 CFR 1926.1101 Asbestos Regulations for the Construction Industry.

1. 29 CFR 1910.134 Respiratory Protection Standard

1. EPA, Asbestos Hazard Emergency Response Act (AHERA) protocols.

1. Guidance for Controlling Asbestos-Containing Materials in Buildings, EPA 560/5-85-024.

1. Acceptance Criteria:

The COR or designee can perform inspection of the work performed without the presence of the Contractor and determine whether the work performed is within standards expressed in this scope of work. It is VA prerogative to hire an independent qualified third party to check the validity of the work conducted.

1. Contractor Qualifications & Other Responsibilities:

8. The Contractor shall obtain all necessary licenses required to perform this work. Contractor shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. The Contractor shall be responsible for any injury to himself/herself, his/her employees, or others, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by him/her or his/her employees’ fault or negligence. The Contractor shall maintain personal liability and property damage insurance prescribed by the laws of the Federal Government.

8. Contractor personnel collecting water samples on site VA San Diego shall have one year of water sampling experience.

8. All personnel will be supervised by an individual shall possess a bachelor’s degree in science, be certified as an Industrial Hygienist, and have at least 3 years of experience in water quality. The Industrial Hygienist shall interpret the water samples and provide the required reports to the VA. The Industrial Hygienist is not required to be on site.

8. The Government reserves the right to accept or reject Contractor’s employee for the rendering of services. Complaints concerning Contract Personnel’s performance or conduct will be dealt with by the Contractor and COR or designee with the final decision being made by the Contracting Officer.

1. Safety Requirements:

9. All personnel employed by the Contractor in the performance of this contract, or any representative of the Contractor entering on VASDHS property shall comply with applicable Federal, State, and VA safety and fire regulations and codes, which are in effect during the performance period of the contract.

9. The Contractor shall perform work in strict accordance with existing relevant, accredited standards and codes to minimize the possibility of injury to personnel, or damage to Government equipment. Every effort shall be made to safeguard human life and property.

9. The Contractor shall comply with all applicable Federal, State, and local requirements regarding workers’ health and safety, particularly those found in Federal and State Occupational Safety and Health Act (OSHA) statutes and regulations, such as applicable provisions of Title 29, Code of Federal Regulations (CFR), Parts 1910 and 1926.

9. The Contractor shall provide all necessary tools, and Personal Protective Equipment (PPE) to perform the work safely, effectively, and timely.

9. The VAMC San Diego building 1, main building, contains asbestos. Any worker entering these asbestos containing areas must have an asbestos certification of no less than 16 hours and a valid fit test certification. Certifications must be presented to the VA project manager before any work in an asbestos area may begin.

1. Changes:

10. The Contractor is advised that only the Contracting Officer, acting within the scope of the contract has the authority to make changes which affect the contract in terms of quality, quantity, price, or delivery.

10. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof.

1. VA Policy:

Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court.

1. Parking Policy:

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not validate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

1. Identification Badges:

All Contractor personnel are required to wear identification (I.D.) badges during the entire time they are on the VA Healthcare System grounds. I.D. badges must have an identification picture and shall state the name of the individual and the company represented.

1. Smoking Policy:

Smoking is not permitted within the VA Healthcare System facilities campus.

1. Normal Working Hours:

15. Normal hours of operation are Monday through Friday from 7:30 am to 4:00 pm Pacific time. All work is expected to be performed generally during normal hours of coverage unless requested or approved by the COR or designee or his/her designee.

15. Before commencement of work, the Contractor shall confer with the VA COR or designee and Contracting Office to agree on a sequence of procedures; means of access to premises and building. All work performed, to include delivery of materials and equipment, shall be made with minimal interference to Government operations and personnel.

15. Work performed outside the normal hours of coverage must be approved by the COR or his/her designee.

1. Overtime and National Holidays:

16. Any overtime or holiday pay that may be entitled to the Contractor’s employees shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

16. The Contractor is not required to provide service on the following U.S. Government holidays, nor shall the Contractor be paid for these days:

1. INVOICE AND PAYMENT:

17. Payment to be made monthly in arrears. The Vendor shall submit original invoices in proper electronic format to the Financial Services Center (FSC). Proper electronic format means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

0. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please see OB10 contact information below to begin submitting electronic invoices, free of charge.

0. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

17. Vendor e-Invoice Set-Up Information:

1. OB10 e-Invoice Setup Information: 1-877-752-0900

1. OB10 e-Invoice e-mail: USClientServices@ob10.com

1. Financial Services Center e-Invoice Contact Information: 1-877-353-9791

1. Financial Service Center e-Invoice e-mail: vafsccshd@va.gov