SOW SPS AAMI water testing rev9-20.docx

Statement of Work SPS Water Testing to AAMI TIR 34: 2014-2017 Standard

1.0 General:

The Butler VA Healthcare Center (BVA) has a requirement for the monthly collection and testing of critical and utility water in the Sterile Processing Service Area in accordance with AAMI TIR 34:2014-2017.

2.0 Objective: Objective: The purpose of this support is to be compliant with the following and they are all in the attachments:

2.1 AAMI TIR 34

2.2 Memorandum 2020-08-28 Required critical water systems for testing and report for Sterile Processing Services (SPS)

2.3 ANSI/AAMI ST 79_2017

3.0 Scope

3.1 Contractor will come to the BVA to collect water samples in secured areas of the BVA Sterile Processing Service areas. Reports will be supplied electronically and hard copy.

3.2 Critical and utility water will be collected and tested monthly for HPC & TOC:

3.2.1 Heterotrophic Plate Count (HPC) six tests to be performed monthly.

3.2.2 Total Organic Carbon (TOC) two (2) tests to be performed monthly.

3.3 Endotoxin (LAL) testing will be required annually and upon installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by HPC.

3.4 Locations:

3.5 Testing Requirements

3.5.1 BVA-SPS requires water testing to occur between 7:00am and 9:30 am local time to ensure water testing does not interfere with SPS workflow due to safety reasons or risk of workflow causing contaminated sample. The decontamination side has contaminated sharp instruments and the washer disinfector continually runs throughout the day. It is not safe to access while it is operating. The sterilization side has two sterilizers running and not safe to enter the access area while these are in operation.

3.5.1.1 Butler VA POC will coordinate and schedule sampling date and time with contractor.

3.5.1.2 Sampling needs to occur before the 20th of each month.

3.5.2 Required- collection of samples will be performed in full compliance with facility PPE practice and policy. The Butler VA will supply the required PPE which vendor staff is required to wear due to decontamination and sterile prep standards.

3.5.3 Water samples should be performed using the criteria below:

3.5.3.1 Contractor required to provide trained staff to perform sample collections.

3.5.3.2 Water samples should be collected directly from outlet taps situated in different parts of the water distribution system using aseptic technique.

3.5.3.3 Sample taps should be treated with disinfectants prior to sampling. Disinfectant will be provided by the Butler VA.

3.5.3.4 The sample should not be collected until the disinfectant has evaporated. The sample should not be collected until all the alcohol has evaporated so that no disinfectant residual will be left in the sample.

3.5.3.5 The sample taps must be opened, and the water allowed to run for at least 60 seconds before a sample is aseptically collected in a sterile, endotoxin-free container per AAMI Tier 34 standard.

3.5.3.6 At least 100 to 300 mL of water should be collected.

3.5.3.7 Bacterial replication shall be prevented by holding the sample on ice (or at 4°C [39.2°F]) until it is delivered to the laboratory for testing.

3.5.4 Required- unscheduled Event related collections may be required to be collected on weekends and federal holidays.

3.5.5 REQUIRED-Sampling for SPS water quality of Utility and Critical water:

3.5.5.1 Laboratory and Chemical Analysis:

3.5.5.1.1 Requirements for testing per TIR 34 2014 R2017 A.5.3 Quality Characteristics

3.5.5.1.1.1 Bacterial (HPC)

3.5.5.1.1.2 Endotoxin (LAL)

3.5.5.1.1.3 Total Organic Carbon (TOC)

3.5.5.1.2 Requirements and Procedures for Sampling of SPS water lines for HPC and Endotoxin (LAL):

3.5.5.1.2.1 The contractor shall be certified by the Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic).

3.5.5.1.2.2 The contractor shall utilize the Standard Spread Plate Method 9215C using R2A agar.

3.5.5.1.2.3 The contractor will provide an outline of their actual testing procedures with their technical quote.

3.5.5.1.2.4 Proof of certification and outline of actual testing procedures must be provided before acceptance of the contract.

3.5.5.1.2.5 Sampling results shall report the number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml).

3.5.5.1.2.6 Sampling results shall report the number of endotoxin units per milliliter of water (EU/ml).

3.5.5.1.2.7 Endotoxin testing must be in compliance with use of Limulus Amoebocyte Lysate testing as listed in AAMI TIR 34: 2017. Please reference paragraph 5.2

3.5.5.1.3 Bacteria in water readings of less than 1CFU may be recorded as <1CFU. Critical water quality HPC results > 10 CFU/ml and/or LAL results >10 Eu/ml and/or TOC results > 1.0 mg/ml are required to be immediately (<24 hours) notified by both telephone and email to identified BVA Point of Contacts.

3.5.5.1.4 REQUIRED- Testing should be conducted and resulted in less than 7 days. Parameters for HPC, LAL and TOC testing as listed in AAMI TIR 34:2017 and referenced above in 3.5.5.1.3.

3.5.5.1.5 Contractor shall provide all sample analysis reports via e-mail to the assigned Points of Contact within the BVA-SPS service within 7 calendar days including weekends and holidays of receiving the sample.

3.5.5.1.5.1 If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

3.5.5.1.6 Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology. Dates and times of sampling and testing are required to be included in the reports.

3.5.6 The contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing.

3.5.6.1 Sample collection bottles and containers must be sterile, appropriate for the analysis, properly preserved, and placed on ice (provided by Butler VA) ready to transport to laboratory for prompt (defined as within the 8-24 hour time frame as long as transferred appropriately on ice) transportation to the laboratory under strict chain of custody procedures. The collection container cannot be made of polypropylene, because polypropylene has been shown to inhibit endotoxin detection.

3.5.6.2 The temperature and time of the water specimens upon delivery and the times testing was started shall be included in the chain of custody.

3.5.6.3 Contractor shall provide submittals of water testing equipment and lab certification that they intend on using to carry out the requirements of this contract prior to awarded contract and during contract if testing equipment or lab certification changes. Submittals will then be evaluated to ensure that equipment is appropriate and certified.

3.6 Retesting

3.6.1 In the event that retesting is required, the contractor shall be available to draw samples and begin retesting within 48 hours of notification or on the next testing day as described in 6.0 of this SOW.

3.6.2 Retesting is at the discretion of the Contracting Officer’s Representative and will be based on accurate findings at the same rate as the initial test.

3.6.3 Retesting will not be conducted on Fridays, Saturdays, Sundays, or Holidays.

3.6.4 Retesting resulting from inappropriate handling by contractor of samples or inaccurate testing procedures shall be done at no additional cost to the Government.

3.6.5 Additional sampling due to positive test results is included on CLINS 0004, 1004, 2004, 3004 and 4004:

3.6.5.1 Should the quantity listed in the price schedule be exceeded, additional tests are considered outside the scope of this contract and shall be procured using other means.

3.7 Reporting

3.7.1 Chain of Custody Requirements

3.7.1.1 The form will have actual signatures for transfer.

3.7.1.2 The form will have date and time of all transfers.

3.7.1.3 The form will include temperature of the samples requiring temperature control at the point of sampling and each transfer.

3.7.1.4 Note time sensitive samples from sample taken to plating the sample must follow all standards in 2.0 of this SOW.

3.7.1.5 Report form will have column titles at the top of each column that identify standards for low to high limits.

3.7.2 Reporting requirements

3.7.2.1 At the time of sampling, the contractor shall provide the following:

3.7.2.2 Name of person collecting the sample

3.7.2.3 Date & time

3.7.2.5 Date of analysis

3.7.2.6 Laboratory and person responsible for performing the analysis

3.7.2.7 Analytical technique/method used

3.7.2.8 Results of analysis

3.7.2.9 Temperature of sample

3.7.2.10 Building number, room number, room name

3.7.3 Any discrepancies found on reports missing required information from 3.7 are required to be corrected within 2 days. A trend (defined as two or more instances of discrepancies) may result in notice of concern or other action as determined by the Contracting Officer.

3.7.4 Results, in AAMI standard units, shall be provided to the Government POC within 7 days of the sample taking. Contractor Analytical reports shall include a signed copy of the chain of custody and identification of sampling locations. Sample analysis reports must be provided within 7 calendar days of the lab receiving the samples. If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

3.7.4.1 Results shall be provided via electronic and hard copy/paper.

3.7.4.2 Contractor required to make notification of any critical water sampling results of HPC >10 CFU/ml, and/or LAL >10 EU/ml and/or TOC > 1.0mg/ml. Notification will be made within 24 hours or 1 working day of making this determination.

4.0 Emergency Services and other tests

4.1 Emergency Services for retesting (paragraph 3.6) and for Endotoxins (3.3) will be covered in CLINS 0002, 1002, 2002, 3002 and 4002. This is on a case-by-case basis and follows limits: parts/services above $2,500.00 and up to $25,000.

4.2 Endotoxin test is covered under CLINs 0002, 1002, 2002, 3002 and 4002 only upon installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by HPC.

4.3 Prior to engaging in service or repair under this paragraph the contractor shall obtain written approval from the CO (funds are not available on subject CLIN) or the Government POC/COR (funds are available on subject CLIN). Email is an acceptable form of written approval. Any work performed without CO or COR/Government POC approval shall not be approved for payment and considered and Unauthorized Commitment. Testing shall be conducted IAW with rates found in the subject CLIN unless further discounts are applied.

5.0 Contractor Qualifications

5.1 The Contractor services shall be performed by trained and qualified personnel using aseptic techniques and performed in accordance with manufacturer’s guidelines.

5.2 The testing laboratory processing the water samples for AAMI compliance with water quality must be certified by the Centers for Disease Control and Prevention (CDC) Environmental AAMI compliance with water quality Isolation Techniques Evaluation program as proficient at performing the culture of AAMI compliance with water quality from environmental samples.

5.3 The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body. Proof of certification must be provided before acceptance of contract.

6.0 Other General Information

6.1 Hours of operation and scheduling

6.1.1 Normal hours of coverage are Monday through Friday from 7:00 am to 4:30 pm, excluding holidays.

6.1.2 Testing shall occur as described in 3.5.1 above. All other services will be performed during normal hours of coverage unless requested or approved by Government POC or SPS POC.

6.1.3 Federal Holidays observed by Veterans Health Administration are: New Years' Day, Labor Day, Martin Luther King Day, Columbus Day, Presidents' Day, Veterans' Day, Memorial Day, Thanksgiving, Independence Day, Christmas Day, and Juneteenth.

6.2 Testing Coordination

6.2.1 BVA-SPS Chief: Will be provided at time of contract award

6.2.2 Government POC: Will be provided at time of contract award

6.3 Place of Performance: Sample collection will be obtained in the SPS Department at Butler VA Medical Center located at 353 North Duffy Road, Butler, PA 16001.

6.4 Privacy

6.4.1 The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

6.5 Security and Safety

6.5.1 Information Technology Security: The contractor will not have access to VA Desktop computers. They will not have access to online resources belonging to the VA or the U.S. government.

6.5.2 Security:

6.5.2.1 The certification and accreditation (C&A) does not apply.

6.5.2.2 The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

6.5.2.3 Identification, Parking, Smoking and VA Regulations:

6.5.2.4 It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Service. The BVA will not validate or make reimbursements for parking violations to the Contractor under any conditions. Smoking is prohibited on BVA campus.

6.5.2.5 Possession of weapons, illegal drugs & alcohol is prohibited.

6.5.2.6 Enclosed containers, including tool kits, shall be subject to search.

6.5.2.7 Collection team will be escorted into SPS restricted access areas.

6.5.2.8 Contractor takes all responsibility of their staff while on BVA property.

6.5.2.9 Contractor responsible for any damage to property whether personal, private or government owned. Contractor responsible for actions of their workers.

6.6 Records Management

6.6.1 Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

6.6.2 Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

6.6.3 Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

6.6.4 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 by the Freedom of Information Act.

6.6.5 Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6.6.6 The Government Agency owns the rights to all data/records produced as part of this contract.

6.6.7 The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

6.6.8 Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

6.6.9 No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

7.0 Task Orders

7.1 All worked performed under this contract shall only be performed by the contractor via Government issued task orders award against the base contract.

7.2 The Task Order will include the line items, quantities and associated pricing. All pricing shall be determined directly from the base contract Pricing Schedule.

7.3 The Task Order will include the location of the work, and an effective start and ending dates for the period of performance.

7.4 Invoices will be paid upon satisfactory completion of all project-specific tasks, requirements, and acceptance. Individual purchase order numbers will be issued on each task order for invoicing purposes.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.