Attachment 1 SOW SPS Water Testing 9_13 Final.docx

VA Erie Medical Center Erie, PA 16504

SERVICE CONTRACT SCOPE OF WORK

1.0 General

This is a non-personal services contract to provide water testing in the Sterile Processing Services (SPS) Decontamination Room in support of the Erie VA Medical Center. This service is required to be compliant with VA Regulations 2020-08-28 and the AAMI TIR 34 Standards. The tests will be performed monthly.

1.1 The Contractor shall provide all personnel, equipment, materials, facilities, transportation, tools, and supervision to perform these services for the "SPS Water Testing” Service Contract.

2.0 Objective: The purpose of this support is to be compliant with the following and they are all in the attachments in 7.0:

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 Testing shall be on the following:

3.1.1 Test two DI water points, Instrument Sink Nozzle 1 & Scope Sink Nozzle 2.

3.1.2 Test one utility cold water tap point, Water Faucet at the Scope Sink.

3.1.3 Test one utility hot water tap point, Water Faucet at the Instrument Sink.

3.1.4 Test utility water supplied to the two Medivators (AER’s) after the filters, Medivator 1 & Medivator 2 per the equipment IFU and AAMI TIR 34 Annex B.

3.1.5 Test the DI water Supply to the system located in the Mechanical room.

3.1.6 Test the DI water Return from the system located in the Mechanical room.

3.1.7 Test DI port for testing between the SPS washers.

3.2 Testing shall consist of:

3.2.1 Monthly Testing is required to be conducted at least 20 days from previous monthly testing.

3.2.1.1 Conductivity

3.2.1.2 pH

3.2.1.3 Chlorides

3.2.1.4 Bacteria

3.2.1.4.1 Not required for Utility water at sinks.

3.2.1.4.2 Required for all other test ports.

3.2.2 Quarterly Testing is required to be conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing.

3.2.2.1 Total Organic Carbon, TOC

3.2.3 Annual Testing is required to be conducted at least 320 days from previous annual testing and will coincide with the monthly testing.

3.2.3.1 Ionic Contaminants

3.2.3.2 Hardness

3.2.4 On Demand

3.2.4.1 Endotoxins

3.2.4.1.1 After system modifications.

3.2.4.1.2 After repeat positives for bacteria.

3.3 Testing requirements (reference 2.1 of this SOW, AAMI TIR)

3.3.1 Ensure all points are flushed/ running after for sixty (60) seconds prior to sample collecting into the container.

3.3.2 Container requirements will follow all standards 1.3 of this SOW.

3.3.2.1 Sterile, endotoxin-free container.

3.3.2.2 Shall not be made of polypropylene.

3.3.2.3 Shall follow transport and temperature requirements per 3.5.1.3 of this SOW.

3.4 Retesting

3.4.1 In the event that retesting is required, the contractor must be available to draw samples and begin retesting within 48 hours of notification or on the next testing day as described in 4.0 of this SOW.

3.4.2 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.

3.4.3 If the retesting is on one of the Medivators the samples will then be drawn from 2 bowls inside the machine. Sterile Processing Services staff shall cycle Medivators per IFU for collection and collect samples from within bowls.

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

3.5 Reporting

3.5.1 Chain of Custody Requirements

3.5.1.1 The form will have actual signatures for transfer.

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

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

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

3.5.1.4.1 Additional Erie VAMC Requirements: Heterotrophic Plate Count-8 hour maximum hold time before processing.

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

3.5.2 Reporting requirements

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

3.5.2.2 Name of person collecting the sample

3.5.2.3 Date & time

3.5.2.4 Identification of the sample:

3.5.2.4.1 DI Scope Nozzle

3.5.2.4.2 DI Instrument Nozzle

3.5.2.4.3 DI Washers

3.5.2.4.4 DI System Return

3.5.2.4.5 DI System Supply

3.5.2.4.6 Cold water scope sink

3.5.2.4.7 Hot water instrument sink

3.5.2.4.8 Medivator 1

3.5.2.4.9 Medivator 2

3.5.2.5 Date of analysis

3.5.2.6 Laboratory and person responsible for performing the analysis

3.5.2.7 Analytical technique/method used

3.5.2.8 Results of analysis

3.5.2.9 Temperature of sample

3.5.2.10 Building number, room number, room name

3.5.3 Any discrepancies found on reports missing required information from 3.1 to 3.3 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.

3.5.4 Results, in AAMI standard units, shall be provided to the Government POC within 5 days of the sample taking.

3.5.4.1 Results shall be provided via email on PDF format.

3.5.4.2 Vendor shall notify Erie VAMC COR immediately upon positive bacteria or endotoxin results.

4.0 Emergency Services:

4.1 Emergency Services outside the regular SOW for retesting and extra items not covered under Contractor warranty will be covered in CLIN 0004, 1004, 2004, 3004, and 4004.

4.2 If system is modified or sanitized because of repeated positives, Endotoxin test is required and will be covered in CLIN 0004, 1004, 2004, 3004, and 4004.

5.0 Contractor Qualifications

5.1 Contractor laboratory qualification requirements: 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 Evaluations program as proficient at performing the culture of AAMI compliance with water quality from environmental samples.

5.2 Contractor employee requirements: Trained per AAMI collection and processing standards.

6.0 Other general information

6.1 Hours of operation & scheduling

6.1.1 No sampling on Holidays, Fridays, Saturdays, and Sundays

6.1.2 Hours of test sample taking 6:00 AM to 8:00 AM Monday, Tuesday, and Thursday.

6.2 Testing coordination will be with the COR, Daniel Ambrose at Daniel.Ambrose@va.gov.

6.3 Place of performance will be the Erie VA Medical Center, 135 East 38th Street, Erie, PA 16505

6.4 Privacy Training:

6.4.1 VA Privacy and Information Security Awareness and Rules of Behavior Course (text version) must be completed by all contractors and subcontractor employees assigned to VA accounts prior to delivery of service and annually thereafter as long as the contract is in place.

6.4.2 The contractor shall provide to the VA COR a copy of the completed training certificate(s).

6.4.3 Certification and accreditation requirements do not apply, and a Security Accreditation Package is not required. At no time will the vendor be in contact or have access to VA sensitive information. VA sensitive information procedures will be followed per VA Handbook 6500.6.

6.4.4 The contractor shall provide to the VA COR a copy of the completed training certificate(s).

6.4.5 The generalized privacy training “VA Privacy Training for Personnel Without Access to VA Computer Systems or Direct Access or Use to VA Sensitive Information” must be completed by all contractors and subcontractor employees assigned to VA accounts prior to delivery of services and annually thereafter as long as the contract is in place.

7.0 Attachments

7.1 The contactor will provide to the VA COR a copy of the completed training certifications.

7.2 AAMI TIR 34 Standards

7.3 2020-08-28 Required Critical Water Systems Testing for SPS

7.4 ANSI_AAMI ST79_2017

7.5 Medivator DSD Edge Critical Water Sample Collection Process

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