Attachment A - Statement of Work - Version 2.docx

Statement of Work Sterile Processing Service AAMI ST108 Water Testing Requirement VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240

1.0 General

This scope of work is to request a non-personal services contract to provide water testing at the Veterans Affairs Pittsburgh Healthcare System (VAPHS). This request to provide water testing in the Sterile Processing Services (SPS) Decontamination Room required for our facility to be compliant with VA Regulations Association and the AAMI ST108 Standards. The tests will be performed monthly and in accordance with this Scope of Work.

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 service contract is to be compliant with the following:

· Association for the Advancement of Medical Instrumentation (AAMI ST108-2023)

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

· American National Standard Institute ANSI/AAMI ST 79-2017 & 2020

VA Pittsburgh Healthcare System - Sterile Processing Service is requesting to enter into a contract to fulfill the critical monthly water testing requirements needed to ensure water used on reusable medical devices do not fall within negative levels to avoid the occurrences of patient safety issues per the Association for the Advancement of Medical Instrumentation (AAMI ST108-2023).

3.0 Scope

3.1 Testing shall be conducted:

1. ST108 Compliance Testing – CRITICAL & UTILITY WATER TESTING

2. All testing shall include sample collection and transport.

3. Pricing is inclusive of all materials.

3.2 CRITICAL WATER TESTING Monthly shall consist of (3 monthly sample points) Water testing for 3 points at the VAPHS at the University Drive campus; Bldg. 1 - AA117 as well as any additional Points and areas for new SPS equipment during the contract period at VAPHS locations referenced in 4.1 for the following items:

1. Alkalinity

2. Chlorides

3. Conductivity

4. Hardness

5. HPC (bacteria)

6. pH

7. Total Organic Carbon

8. LAL/Endotoxins

3.3 Quarterly Utility Water Testing is required to be conducted for 14 points, all located at the VAPHS at the University Drive campus; Bldg. 1 as well as any additional Points and areas for new SPS equipment during the contract period at VAPHS locations referenced in 4.2 for the following items:

1. Alkalinity

2. Chlorides

3. Conductivity

4. Hardness

5. HPC (bacteria)

6. pH

7. Total Organic Carbon

8. LAL/Endotoxins

UTILITY WATER TESTING (Quarterly Testing) shall be conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing.

3.4 Quarterly Testing for Ionic Testing (ST108 Ionic Contaminants) is required to be conducted at VAPHS all 17 points in SPS locations referenced in 4.3 for the following items:

1. Aluminum

2. Copper

3. Iron

4. Manganese

5. Nitrate

6. Phosphate

7. Sulfate

8. Silicate

9. Zinc

Quarterly Ionic Testing shall be conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing.

3.5 Testing areas shall include the points mentioned in section 4.3 as well as any additional points and areas where new SPS equipment is installed during the contract period at VAPHS locations - UD Bldg. 1.

3.6 On Demand Retesting

1. Heterotrophic Plate Count (HPCs) & Endotoxins

a. After system modifications

b. After repeat positives for bacteria.

c. After Installation of New Equipment

d. As requested by designated program representative

e. Timeframe should follow the referenced guidelines listed in the 3.0 Scope and specifically in sections 3.2, 3.3 of this contract.

of this contract

2. 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 this SOW.

3. Retesting is at the discretion of the designated program official and will be based on accurate findings at the same rate as the initial test.

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

3.7 Testing requirements (reference this SOW, AAMI ST 108-2023)

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

2. Wear clean gloves for collection.

3. Collects sample in a sterile container.

4. Container requirements shall follow all required standards.

a. Sterile, endotoxin-free container.

b. Shall not be made of polypropylene.

c. Shall follow transport and temperature requirements per this SOW.

3.8 Reporting Chain of Custody (COC) Requirements

1. The form will be a paper or electronic document and shall have actual wet signatures or digital if electronic for transfer.

2. The form shall have the date and time of all transfers.

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

4. Note time sensitive samples from sample collection to plating must follow all standards in this SOW.

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

6. If the document is paper, it can be given to the POCs listed in section 5.0

7. If the document is electronic, the COC document can be sent via email to the government POCs referenced in section 5.0 of this contract.

3.9. Reporting requirements

1. At the time of sampling, the contractor shall provide the following:

a. Name of person collecting the sample

b. Date & time

c. Identification of the samples listed in SOW details in entire Scope section 3.0

d. Date of analysis

e. Laboratory and person responsible for performing the analysis.

f. Analytical technique/method used.

g. Results of analysis

h. Temperature of sample

i. Building number, room number, room name

4.0 Locations

Testing shall be collected and conducted at VA Pittsburgh Healthcare System – Sterile Processing Service in Sample Testing Points as listed in sections 4.1, 4.2 & 4.3 in the following locations:

4.1 Area #1 - CRITICAL WATER TESTING Monthly is required in the SPS Proper area of the hospital on the ground floor. AAMI ST108 SPS results are given monthly reports at the Water Safety Meeting. Areas to be tested are listed in the chart below.

Testing frequency shall consist of 3 points mentioned above as well as any additional points and areas for new SPS equipment acquired during the contract period at VAPHS locations UD Bldg. 1 Points and locations listed in sections 3.2.

Monthly Sample Collection/Travel (required once per month) of the current 3 sample points. Testing areas shall include: any additional Points and areas for new SPS equipment during the contract period at VAPHS locations UD Bldg. 1.

4.2 Area #2 - Quarterly Utility Water Testing which is a separate testing for areas as listed below. AAMI ST108 results are reported via a recurring action item at the VISN level for areas where High-level disinfection is performed on endoscopes in the following locations:

Quarterly Utility Testing areas shall include the 14 points mentioned in section 4.2 as well as any additional points and areas where new SPS equipment is installed during the contract period at VAPHS locations - UD Bldg. 1.

Conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing requirement included in the 3.0 entire Scope of this agreement.

4.3 Quarterly Ionic Testing is a separate testing for 17 points as listed below as well as any additional points and areas where new SPS equipment is installed during the contract period at VAPHS locations - Bldg. 1. Quarterly Ionic testing (in accordance AAMI ST108-2023 Ionic Testing) results are reported via a recurring action item at the VISN level for areas where the reprocessing of reusable medical devices occurs:

Quarterly Testing for Ionic Testing

Conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing requirement included in the 3.0 entire Scope of this agreement.

5.0 Collection and testing protocols

1. The contractor shall supply all equipment to complete testing. Equipment may include but is not limited to the following:

a. Hach DR1900 and DR3900 Spectrophotometers

b. YSI Multi Lab 4010-W3

c. reactor/heat block, autoclave

d. pH meter

e. TDS meter

f. Colorimeter

g. Shaker

h. incubator

i. pipettors

j. ICP/MS for low lever metals (yearly).

k. Clean gloves for sample collection

2. Vendor shall coordinate and provide a certified analyst to come to VA Pittsburgh Healthcare System onsite. Vendor qualifications shall include EPA, CDC and ISO (17025) certifications primarily for water testing. Vendor quality assurance plan for services must include the ability to perform quality control procedures on reagents and supplies (for sterility and product efficacy), document equipment performance and maintain equipment to manufacturer recommendations.

3. Vendor analysts and contractors must be trained in best practices of sample collection and preservation and must be able to perform on-site testing when necessary (such as for pH which must be analyzed at the time of collection.)

4. Pre-scheduled sample collections shall occur monthly prior to the last business day of every month. Samples must be collected during normal business hours between 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays.

5. Vendor laboratory proximity to VA Pittsburgh Healthcare hospital must allow for prompt collection of the samples and return to lab for immediate analysis. Although some of the required tests do allow for a hold time (time between collection and analysis) of 24 hours or longer, it is preferable to minimize this time in accordance with best practices.

6. Vendor must perform the sample collections at each of the sample sites in four departments (SPS, GI, GU, and ENT). Services must be coordinated in advance by vendor with the VA Pittsburgh Chief Sterile Processing Service and/or VA Pittsburgh Sterile Processing Service team prior to visit. Vendor will provide two Symplr accredited Analysts for collection at the VA Pittsburgh Healthcare System University Drive campus.

7. Vendor/Contractor arrives with required materials, sample vessels and supplies required to perform services for proper sample collection up to 300ml per sampling. Vendor will bring a calibrated pH meter as pH must be tested immediately (within 15 minutes) at the sample draw. Vendor will also be required to bring a cooler with ice packs to keep the bacterial samples chilled as required during transport. Samples shall be maintained by vendor in a cooler to maintain temperatures between 2 and 6 degrees Celsius, which PA state recommendations. VIII. Vendor shall include maintained temperatures in the sample collection result report to the VA Pittsburgh Healthcare System.

8. Samples collected are transported back to vendor laboratories and the bacterial analysis is started immediately as that is the most time sensitive and requires 72 hours of incubation. Afterwards, vendor will process the samples for the other parameters after calibrating the necessary equipment as required by the standard methods.

9. VA Pittsburgh requires results returned within 4 days following sample collection including weekends. Results are required to be reported via email to the VA Pittsburgh Chief Sterile Processing Service within 72-96 hours (4 days)

1. Frequency of the service provided by vendor will be monthly as early as the 15th of every month and no later than the last business day of every month; to be coordinated by the SPS Chief and the collecting vendor analyst and shall not impact workflow (or minimize the departmental interruption as much as possible).

2. The four reports will be issued within 4 days of sample collection. One for each department (SPS, GI, GU, and ENT)

12. Vendor does not receive travel pay, per se. Vendor does not charge a flat, mileage-based fee for each trip.

6.0 Period of Performance

VA Pittsburgh Healthcare System Sterile Processing Service needs to have this contract in place to commence water testing required monthly. Estimated POP August 2024.

7.0 Delivery Location

Results of the testing are via email to SPS Chief, VA Pittsburgh Healthcare System.

8.0 Security Requirements

1. Have VA approved form of identifications to include a driver’s license or photo and Symplr badge.

2. Will need to wear a mask while on the premises and be screened on the way in each day.

3. Contractor Personnel Security Requirements:

a. Contractor may not have access to the VA network or any VA sensitive information under this contract.

b. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

c. DESIGNATED PROGRAM REPRESENTATIVEA compliant ID badge must be worn by Contractors at all times while on VA premises mention in 8.0(1)

d. Contractor may not have access to the VA network or any VA sensitive information under this contract.

e. All Contractors must receive Privacy training annually using one of the following methods:

f. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/SecureAuth35/).

g. Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The DESIGNATED PROGRAM REPRESENTATIVE must ensure that all contractors are validated in the PIH domain.

h. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”.

i. Signed training documents must be submitted to the DESIGNATED PROGRAM REPRESENTATIVE.

j. Training must be completed prior to the performance of the contract and annually thereafter.

k. Proof of training completion must be verified and tracked by the DESIGNATED PROGRAM REPRESENTATIVE.

8.0 Records Management Language

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.

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.

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.

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.

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

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.

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.].

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.

10. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

9.0 SYMPLR Requirement for On-Site Appointments

Vendor access to the VA Pittsburgh Healthcare System and sister locations are by appointment only and requires credentialing through our vendor credentialing partner Symplr. Symplr is a cost to each vendor, vendor representative or vendor contractor requiring entry to:

1. VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

2. Each person entering campuses must obtain the required credentialing as advertised on the Symplr site. The link to the Symplr site is as follows: https://www.symplr.com

a. Vendor, vendor representatives or vendor contractors must login to the Symplr site:

b. Create an account on the Symplr Site

c. Select the plan pertaining to the contract requirements for the on-site visit at:

(1) VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

(2) Each person, vendor, vendor representative, vendor contractor must pay for plan to begin the required credentialing on Symplr.

(3) Vendor, contractors, or vendor representatives must be in a green light status on Symplr to be permitted to proceed with on-site appointments. In the event a vendor is red lighted, a replacement vendor must be substituted and in a green light status or the appointment will be cancelled.

(4) All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite.

(5) Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

3. Plan Costs to Vendor is as advertised on the Symplr Website:

1. Clinical Vendors (entering patient care areas/direct patient involvement)

1. Service (Non-Clinical) Vendors

4. All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite. Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

10.0 INFLUENZA VACCINATION:

VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

1. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

2. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

3. Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

4. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

5. The contractor is required to submit annual certification in the form of a memorandum to the Designated Program Representative that all contract staff performing services at VA facilities are in compliance with VHA Directive 1192.

11.0 TUBERCULOSIS PREVENTION:

1. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the DESIGNATED PROGRAM REPRESENTATIVE and Contracting Officer. Tests shall be current within the past year.

2. Tuberculosis Testing: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

3. Rubella Testing: Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella, or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the DESIGNATED PROGRAM REPRESENTATIVE.