15 May_Revised_PATS Vendor Questions_.pdf

Portable Audiometric Testing Services (PATS) Vendor Questions

May 7, 2024

Question 1:

In the SOW, Paragraph B, Objective/Scope, it states that "the contractor shall ensure provision of annual audiometric examination services for an estimated 7,400 FSIS HCP participants" while the Addendum to FAR 52.212-2 states that the contractor shall "supports testing for up to 7800 employees over 10 Districts".

The total number of FSIS in-plant employees fluctuates per pay period based on the accessions and separations. The average number of in-plant employees is around 7,400. The addendum to FAR 52.212-2 has been updated and reflects 7,400.

Question 2:

In the SOW, Paragraph C, Period of Performance (POP), it states that "Shipment and delivery of devices to centralized/headquarter building for each district shall occur within 2 weeks after contract award."

Please confirm that the USDA will require shipping of equipment to 10 separate locations, as well as the number of units that will be shipped to each of these locations.

The SOW has been updated to reflect shipment of all devices (100) to one centralized location to the George Washington Carver Center (GWCC). Please use the updated address in the SOW.

Question 3:

In the SOW, Section C, Period of Performance (POP), it states that "all below sub-paragraphs shall take no more than 4 weeks". While, below sub-paragraph (e), it states that "the total duration of the timelines from (a) - (e) shall take no more than 8 weeks total".

Please confirm the total timeline for completion of sub-paragraphs (a) through (e).

The total duration of the timelines from (a) – (e ) shall take no more than 8 weeks total and Section C has been updated to reflect that, and that all below sub-paragraphs shall take no more than 8 weeks.

Testing is anticipated to start 1 August and will be updated to reflect that.

Question 4:

In the SOW, Section I. Recordkeeping, Reports, and Records Disposition, it states that "All audiograms shall be downloadable from the Contractor’s Portal/Database as individual files in PDF format, with the specific naming convention (Last Name_First Name_Last 4)."

Please clarify the (Last Name_First Name_Last 4) naming convention. Currently, SHOEBOX uses the following naming convention: Last name_First name_audiogram_yyyymmdd. Please confirm whether this format is acceptable, and/or provide a definition of "Last 4".

The naming convention (Last Name_First Name_Last 4) is required to place the audiogram in the employees’ electronic medical file/record. The “Last 4” is the last 4 digits of the employees’ social security number and will be provided in the .csv file.

Question 5:

In the SOW, Section I. Recordkeeping, Reports and Record Disposition, item (6) states that "the contractor shall send or provide access to information for downloading audiogram test reports with audiologist review to the COR and other authorized personnel that includes a summary sheet of number of employees tested, audiogram classification codes, number of STSs and abnormal results, individual audiograms with notification and signatory, evaluation and recommendations for employees, and the tested employee’s audiometric history."

Please clarify what are "audiogram classification codes".

Question 6:

In the SOW, Section L. Government Furnished /Information, it states that "The Government will provide the Contractor with a secured cloud/portal to access employee baseline audiograms."

Please note SHOEBOX requires that all historical records/employee files are provided in machine-readable format (.csv) to enable import into our data management portal. Please confirm that the Government portal/secured cloud will be able to meet this requirement.

Yes, all employee baseline audiograms will be in machine readable format (.csv).

Question 7:

The contractor is proposing 100 total test devices (system of headphones, tablet, and carrying case).

USDA FSIS needs a minimum of 10 devices per district, for a total of 100 devices. Individual carrying cases shall be included to ensure protection of devices.

This would be 10 for each district to share, is this number suitable for FSIS? Or would you prefer more?

No less than 100 test devices with each district receiving at least 10 test devices is required in this contract.

Question 8:

s F(4) - States “Provides option between fully automated/self-test or assisted test modes for employees who require assistance.” hearX devices offer fully automated and assisted test modes. Our understanding of the OSHA regulation is that all workplace hearing screenings must be conducted by a facilitator and cannot be done via self-test.

Will a self-test option still be required by the USDA?

Audiogram classification codes

Hearing Range dB HL

N Normal -10 to 25

M Mild 26-40

Mod Moderate 41-55

Mod Sev Moderately Severe

56-70

P Profound 91+

S Severe 70-90

USDA testing ensures that a facilitator is present to guide the employees to conduct their tests in both automated and assisted test modes if needed.

Question 9:

s F(5) - States “Software must ensure employees verify the correctness of their personal information and to contact Human Resources if corrections are required.”

What specific personal information needs to be verified?

Employees fist and last name, date of birth and last 4 digits of their social security number.

Question 10:

s F(8) - States “Portable Audiometer support administering of hearing exams without connection to Wi-Fi to include troubleshooting of test administration.”

Does offline (no wifi) troubleshooting refer to troubleshooting by the Tester? If it includes Remote Troubleshooting by hearX, then we'd need internet connectivity to access the device.

Offline troubleshooting refers to the facilitator conducting the troubleshooting with telephone or videotelephone support by the contractor.

Question 11:

s F(12) Are there any restrictions regarding the use of subcontractors/ partner companies to fulfill select service requirements within the contract. Specifically audiology support in in select geographies?

The resulting contract will incorporate FAR 52.219-9 Small Business Subcontracting Plan and FAR 52.219-8 Utilization of Small Business Subcontracting. Subcontracting/Partnering for audiology support in select geographies shall meet the subcontracting requirements outlined within the clauses.

Question 12:

s F(12)(a) - States “Up to 1 hour per month of consultation/questions/email/extra data analysis to the Audiology Team”.

Could you provide further clarification on who is entitled to this time? Additionally, could you specify the individuals comprising the Audiology Team?

Personnel comprising the Audiology Team is entitled to this time. The 1 hour consultation shall be coordinated/scheduled only by the COR. Personnel comprising the Audiology Team will be the District Safety Specialists, HCP Program Manager, COR and if needed a district supervisor for the respective district where testing was conducted.

Question 13:

s E(1)(c) Contractor Tasks/Deliverables - States “The professional notation must be recorded on each worker’s audiogram.”

Please clarify who’s the professional notation, the tester or the medical professional who reviews and signs off on the report online? Also, What information specifically will be required? Name, Surname, professional record number?

It is the medical professional who reviews and signs off on the report online. Professional notation is the Name, Surname, and Licensure (professional record number) of the audiologist.

Question 14:

s C(1)(b) Logistics & Shipping Requirements - states “Shipment and delivery of devices to centralized/headquarter building for each district shall occur within 2 weeks after contract award.” And s D(4) states “The government is responsible for shipping (at no additional cost) the devices back to the contractor for calibration. The contractor is responsible for shipping the devices to the districts upon calibration.”

Would the contractor be responsible for shipping to and from all 100 endpoints or to and from the 10 districts headquarters to distribute? Both for initial distribution and annual calibration.

The Contractor will be responsible for shipping all devices to the GWCC location. From there, the Government will ship the devices to each district location.

Question 15:

s G IT Systems & Data Requirements - We appreciate the change in wording with regards to Compliance.

Please just clarify if the intention is to have these all as "compliance with" (ensures adherence) or if the intention is "certification"

The intention is for it to say in “compliance with.”

Question 16:

s G(5) IT Systems & Data Requirements - Requirement states “Comply USDA policy for security awareness training for all employees and contractors who have access to sensitive data.”

Can you supply us with information on this policy and how it would have an effect on the product provided?

The SOW G(5) has been updated with the appropriate links. Performance of this contract involves access to a system of records on government employees; therefore the contractor shall comply with applicable USDA Privacy and Security Awareness Policies.

(1) USDA Information Security Awareness and Rules of Behavior Training Website:

https://deliver.courseavenue.com/Login/usda

(2) Information Security Awareness (ISA) Program: https://www.usda.gov/directives/dr-3545-001 https://deliver.courseavenue.com/Login/usda https://www.usda.gov/directives/dr-3545-001

Question 17:

s H(1) - states Participation: Personnel may decline to participate in the annual free hearing/audiology test.

Does the software need to record the "decline" by the Personnel? Or does the employee simply not get tested?

The software isn’t required to record the “decline” but prefer to have it as an option for the employee. If the employee declines the annual audiogram, they signs an internal USDA declination statement indicating that they are refusing the annual audiogram. The declination statement is an internal USDA document that will be placed in the employee’s electronic medical record in leu of the annual audiogram.

Question 18:

s I (1) - states “The contractor shall have an electronic record keeping database that stores all FSIS audiogram tables or audiometric test charts as specified in 29 CFR 1910.95(m). For each employee tested, the database must provide a historical record.“

Shouldn't this also include the Last Four; as we require this for the PDF download naming convention?

Yes, it shall include the last four of the employee’s SSN.

Question 19:

s I (1)(c) - states “Employee’s Gender” In accordance with OHSA, in order to generate an aging calculation on STS, we need the patient's gender at birth.

Is this fine from the USDA's perspective, as we would not be displaying options other than male/female?

Are there any equality requirements that need to be taken into account with regard to this record field?

Male/female options for gender are adequate in asking employees their gender at birth.

The Questions should reflect – what is your biological gender assigned at birth (this information is needed for the accuracy of the test).

Question 20:

With regards to the districts that the product needs to be supplied in, specifically the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, are there any language requirements that you would like us to provide our Information for Use manuals in?

Yes, in Spanish

Question 21:

Regarding Puerto Rico, Guam, the Virgin Islands, American Samoa, are there any additional regulatory or shipping requirements that you require us to comply with to ensure the devices can be shipped into the territory.

The hearX devices are FDA registered and CE marked and are allowed to enter these territories for use;

however, are there any additional requirements that you are aware of?

No, no additional requirements are needed, the Government will be responsible for shipping the equipment to each district location from the GWCC. If a device is overseas, the Government will transport it themselves.

Question 22:

We would like to know if this is a brand-new contract OR if there is (was) an incumbent performing these services?

This is a brand-new contract.

Question 23:

If not brand new requirement, could you please provide the current / previous contract number?

N/A

Question 24:

The SOW indicates that the HCP is elective testing.

Is any of the population required to have mandatory Audiometric Screens? Related to that, what is the estimated volume of portable audiometric testing?

USDA is strongly urging all employees enrolled in the hearing conservation program to obtain annual audiograms so we are working with the premise that all employees will be tested.

Question 25:

Will the contractor be responsible to determine ambient noise level determinations or is the audiometric device required to function within ANSI S3.1 parameters?

The audiometric device through its software is required to function within ANSI S3.1 parameters.

Question 26:

Is the expectation to provide care coordination and referral services to audiologist/physician when there is potential STS? If so, how is it recommended that the contractor price these services?

No, there is no expectation other than a recommendation for the affected employee to seek their own primary care physician for additional care and consultation.

Question 27:

To confirm, pricing, shipping, IT support should be Firm Fixed Price and included in Unit Price?

Shipping to the GWCC shall be included as well as shipment back from the districts for annual calibration to the vendor is required.