J046--Sterile Processing Water Quality Testing

SPS Water Testing to AAMI TIR 34: Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Oklahoma VA Health Care System (OKCVAHCS) BRIEF SCOPE OF WORK (This is for information only) PURPOSE: The Oklahoma City VA Health Care System (OKCVAHCS) 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, in a cost-effective, efficient manner, contributing to the VA Mission. This is a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose of fulfilling the PWS and shall be considered employees of the Contractor. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications and supervision necessary to provide services in accordance with this Performance Work Statement (PWS). SCOPE OF WORK: 3.1 Contractor will come to the Oklahoma City VA Healthcare System to collect water samples in secured areas of the Oklahoma City VA Healthcare Sterile Processing Service area. 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. 3.3 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: Sample Location OKC VA Monthly Tests Endotoxin Decontamination Area Sink #1 * 3 samples HPC ** Sink #2 * 3 samples HPC ** Sink #3 * 3 samples HPC ** Sink #4 * 3 samples HPC ** Boiler Plant (incoming water from city) 1 sample HPC ** *Each sink has cold water/hot water and Deionize water ** Endotoxins required initially and as needed for positive HPC samples Total Samples 13 samples *** HPC Testing Requirements 3.5.1 OKCVAHCS/SPS requires water testing to occur between 7:00am and 8:30 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 OKCVAHCS/SPS 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 OKCVAHCS SPS 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 or designated ports 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 OKC VA SPS. 3.5.3.4 The sample should not be collected until the disinfectant has evaporated. The sample should not be collected until dwell time is complete for chemicals used. 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 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 A.5.3 Quality Characteristics 3.5.5.1.1.1 Bacterial (HPC) 3.5.5.1.1.2 Endotoxin (LAL) 3.5.5.1.2 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: 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 OKC VA 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 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). This is on a case-by-case basis and follows limits: 4.2 Endotoxin test is covered 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. IMPORTANT NOTE: This Sources Sought is for information only (to determine the socioeconomic status of interested companies). No award will be made off of this posting. LIMITATIONS OF SUBCONTRACTING: The Limitations of Subcontracting may or may not apply to a resulting solicitation from this Market Research. Vendors are advised to familiarize themselves with Federal Acquisition Regulation parts 19.505(a)(2) and 19.505(b)(1) as it pertains to subcontracting limitations. Vendors are also advised to familiarize themselves with 13 CFR 125.6 and the penalties described in this regulation. Please communicate via e-mail to contact@example.gov by COB 01/04/2022 as to your company s interest and ability to perform service per this brief Scope of Work. If interested, please provide the following: Please state your company s business size as related to NAICS code XXXXXX As per the Limitations of Subcontracting: (see FAR 19.505) As Primary Contractor: what % of Total Contract Value will you retain? If using a Subcontractor: what % of Total Contract Value will go to them? 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